Professor Heather Gage

Care needs amongst 425,000 dependent older residents in English care homes are becoming more complex. The quality of care in these homes is influenced by staffing levels, especially the presence of registered nurses (RNs). Existing research on this topic, often US-focused and relying on linear assumptions, has limitations. This study aims to investigate the non-linear relationship between RN staffing and care quality in English care homes using machine learning and administrative data from two major care home providers. A retrospective observational study was conducted using data from two English care home providers. Each was analysed separately due to variations in data reporting and care processes. Various care quality indicators and staffing metrics were collected for a 3.5-year period. Regression analysis and machine learning (random forest) were employed to identify non-linear relationships. Ethical approval was obtained for the study. Using linear methods, higher skill mix – more care provided by RNs – was associated with lower incidence of adverse outcomes, such as urinary tract infections and hospitalisations. However, non-linear skill mix–outcome relationship modelling revealed both low and high skill mix levels were linked to higher risks. The effects of agency RN usage varied between providers, increasing risks in one but not the other. The study highlights the cost implications of increasing RN staffing establishments to improve care quality, suggesting a non-linear relationship and an optimal staffing threshold of around one-quarter of care provided by nurses. Alternative roles, such as care practitioners, merit exploration for meeting care demands whilst maintaining quality. This research underscores the need for a workforce plan for social care in England. It advocates for the incorporation of machine learning models alongside traditional regression-based methods. Our results may have limited generalisability to smaller providers and experimental research to redesign care processes effectively may be needed. RNs are crucial for quality in care homes. Contrary to the assumption that higher nurse staffing necessarily leads to better care quality, this study reveals a nuanced, non-linear relationship between RN staffing and care quality in English care homes. It suggests that identifying an optimal staffing threshold, beyond which increasing nursing inputs may not significantly enhance care quality may necessitate reconsidering care system design and (human) resource allocation. Further experimental research is required to elucidate resource-specific thresholds and further strengthen evidence for care home staffing. How much nursing care is needed to assure quality in care homes? Evidence from 2 English care home providers shows that nurse sensitive outcomes (an indicator of quality) are better when ~25 % of care is provided by nurses. Nurse shortages increase risks for residents.

Quality of life and care varies between and within the care homes in which almost half a million older people live and over half a million direct care staff (registered nurses and care assistants) work. The reasons are complex, understudied and sometimes oversimplified, but staff and their work are a significant influence. To explore variations in the care home nursing and support workforce; how resident and relatives' needs in care homes are linked to care home staffing; how different staffing models impact on care quality, outcomes and costs; how workforce numbers, skill mix and stability meet residents' needs; the contributions of the care home workforce to enhancing quality of care; staff relationships as a platform for implementation by providers. Mixed-method (QUAL-QUANT) parallel design with five work packages. WP1 - two evidence syntheses (one realist); WP2 - cross-sectional survey of routine staffing and rated quality from care home regulator; WP3 - analysis of longitudinal data from a corporate provider of staffing characteristics and quality indicators, including safety; WP4 - secondary analysis of care home regulator reports; WP5 - social network analysis of networks likely to influence quality innovation. We expressed our synthesised findings as a logic model. English care homes, with and without nursing, with various ownership structures, size and location, with varying quality ratings. Managers, residents, families and care home staff. Staffing's contribution to quality and personalised care requires: managerial and staff stability and consistency; sufficient staff to develop 'familial' relationships between staff and residents, and staff-staff reciprocity, 'knowing' residents, and skills and competence training beyond induction; supported, well-led staff seeing modelled behaviours from supervisors; autonomy to act. Outcome measures that capture the relationship between staffing and quality include: the extent to which resident needs and preferences are met and culturally appropriate; resident and family satisfaction; extent of residents living with purpose; safe care (including clinical outcomes); staff well-being and job satisfaction were important, but underacknowledged. Many of our findings stem from self-reported and routine data with known biases - such as under reporting of adverse incidents; our analysis may reflect these biases. COVID-19 required adapting our original protocol to make it feasible. Consequently, the effects of the pandemic are reflected in our research methods and findings. Our findings are based on data from a single care home operator and so may not be generalised to the wider population of care homes. Innovative and multiple methods and theory can successfully highlight the nuanced relationship between staffing and quality in care homes. Modifiable characteristics such as visible philosophies of care and high-quality training, reinforced by behavioural and relational role modelling by leaders can make the difference when sufficient amounts of consistent staff are employed. Greater staffing capacity alone is unlikely to enhance quality in a cost-effective manner. Social network analysis can help identify the right people to aid adoption and spread of quality and innovation. Future research should focus on richer, iterative, evaluative testing and development of our logic model using theoretically and empirically defensible - rather than available - inputs and outcomes. This study is registered as PROSPERO CRD42021241066 and Research Registry registration: 1062. This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/144/29) and is published in full in ; Vol. 12, No. 8. See the NIHR Funding and Awards website for further award information.

Early nutrition programming as an origin of obesity is well acknowledged, but to what extent is this concept communicated to parents? In five European countries, UK, Finland (FI), Germany (DE), Hungary (HU) and Spain (ES), a total of 130 stand alone leaflets and 161 articles from parenting magazines providing information on feeding of healthy infants aged 0-12 months were identified and screened for nutrition programming statements. Obesity was mentioned in 8.5% (54/638) of the statements, and was the fourth most frequent outcome after allergy (20.7%), risk of infections (15.5%) and growth and development (11.4%). A temporal prognosis was given in 39% of obesity related statements, 6% referring to short- ( 15 years) duration of effects. So advice on obesity focuses oil the intrinsic long-term perspective of programming in contrary to other surveyed health-outcomes where only 8% considered a lifelong approach. The major programming related behaviour concerned breast-feeding compared to formula and complementary feeding with meaningful differences concerning the recommended duration: for ES and HU the predominant advice was for exclusive breast-feeding for 6 months, for DE exclusive breast-feeding for 4-6 months and for UK and FI breast-feeding without further specification. In summary, statements relating to the programming of later obesity have been partially integrated into feeding information in five European countries. These Countries have slightly different breastfeeding recommendations, but consistently refer to the preventive potential of breastfeeding in general. This is important as obesity and its resulting morbidity are of increasing public health concern in developed countries.

First Contact Physiotherapy Practitioners (FCPPs) are embedded within general practice, providing expert assessment, diagnosis and management plans for patients with musculoskeletal disorders (MSKDs), without the prior need for GP consultation. To determine the clinical effectiveness and costs of FCPP-led compared to GP-led models of care. Multiple site case study design. UK GP practices. General Practice sites were recruited representing three models: 1. GP-led care; 2. FCPPs who could not prescribe/inject (Standard (St)); 3. FCPPs who could prescribe/inject (Additional Qualifications (AQ)). Patient participants from each site completed clinical outcome data at baseline, 3 and 6 months. The primary outcome was the SF-36v.2 Physical Component Score (PCS). Healthcare usage was collected for 6 months. N=426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF36-PCS) across all three arms at 6 months (p=0.999). At 3 months a significant difference in numbers improving was seen between arms: 54.7% GP consultees; 72.4% FCPP-St, 66.4% FCPP-AQ; (p=0.037). No safety issues were identified. Following initial consultation, a greater proportion of patients received medication (including opioids) in the GP-led arm (44.7%) compared with FCPP-St (17.5%) and FCPP-AQ (22.8%); (p

Background Cognitive-behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.

Background: Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely. Objective: We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities. Methods: PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson’s Disease Rating Scale estimations by clinicians were explored. Results: Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers’ burden. Motor Aspects of Experiences of Daily Living and patients’ self-rated health status also influence the system’s use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. Conclusions: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care.

Background: First Contact Physiotherapy Practitioners (FCPPs) are embedded within general practice, providing expert assessment, diagnosis and management plans for patients with musculoskeletal disorders (MSKDs), without the prior need for GP consultation. Aim: To determine the clinical effectiveness and costs of FCPP-led compared to GP-led models of care. Design and Setting: Multiple site case study design. UK GP practices. Method: General Practice sites were recruited representing three models: 1. GP-led care; 2. FCPPs who could not prescribe/inject (Standard (St)); 3. FCPPs who could prescribe/inject (Additional Qualifications (AQ)). Patient participants from each site completed clinical outcome data at baseline, 3 and 6 months. The primary outcome was the SF-36v.2 Physical Component Score (PCS). Healthcare usage was collected for 6 months. Results: N=426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF36-PCS) across all three arms at 6 months (p=0.999). At 3 months a significant difference in numbers improving was seen between arms: 54.7% GP consultees; 72.4% FCPP-St, 66.4% FCPP-AQ; (p=0.037). No safety issues were identified. Following initial consultation, a greater proportion of patients received medication (including opioids) in the GP-led arm (44.7%) compared with FCPP-St (17.5%) and FCPP-AQ (22.8%); (p

The aim of the study was to describe the expectations and experiences of end-of-life care of older people resident in care homes, and how care home staff and the healthcare practitioners who visited the care home interpreted their role. A mixed-method design was used. The everyday experience of 121 residents from six care homes in the East of England were tracked; 63 residents, 30 care home staff with assorted roles and 19 National Health Service staff from different disciplines were interviewed. The review of care home notes demonstrated that residents had a wide range of healthcare problems. Length of time in the care homes, functional ability or episodes of ill-health were not necessarily meaningful indicators to staff that a resident was about to die. General Practitioner and district nursing services provided a frequent but episodic service to individual residents. There were two recurring themes that affected how staff engaged with the process of advance care planning with residents; ‘talking about dying’ and ‘integrating living and dying’. All participants stated that they were committed to providing end-of-life care and supporting residents to die in the care home, if wanted. However, the process was complicated by an ongoing lack of clarity about roles and responsibilities in providing end-of-life care, doubts from care home and primary healthcare staff about their capacity to work together when residents’ trajectories to death were unclear. The findings suggest that to support this population, there is a need for a pattern of working between health and care staff that can encourage review and discussion between multiple participants over sustained periods of time.

Background/Aims: Use of placebo is the ideal for comparison in clinical trials to reduce biases. With digital technology being used more frequently in healthcare interventions, how do we determine the placebo effect where interventions exploit technology? If placebo in medicine is traditionally defined by a lack of pharmacological agents, how might we begin to move towards controlling for effects of digital technology? Method: This paper explores the traditional placebo effect and discusses its impact in healthcare contexts with digital technology with reference to a particular trial. Different meanings of placebo in the context of evaluating technology suggest new challenges and positive consequences. Results: Methodological considerations are discussed, which enabled the development of a placebo-controlled evaluation of a digital technology in healthcare and rehabilitation. Conclusion: Digital placebo was controlled in our trial by employing technology across all groups in the absence of evidence-based practice and shows how to control for unknown and hidden effects of technology.

Objectives: Younger people with dementia face significant challenges in gaining access to age- and needs-appropriate support. In this paper, we tell the story so far, of the ANGELA Research Project, which seeks to develop guidance to improve the ‘dementia journey’ for younger people with dementia and their families/supporters. Design: Our story is one of a research group aiming to conduct clinically relevant research to achieve positive changes for younger people with dementia. Our research journey will last 3 years and is now almost one year in. In this article, we aim to convey some of the decisions we have made to date, and what lies ahead for a successful implementation. Methods: So far, we have been forming as a research group and turning our initial ideas into plans that will work in the real world. Our methods for ensuring all elements of the project work well have involved internal and external aspects and processes. These have included involvement with and feedback from experts-by-experience and an advisory panel. Results: To date we have generated a protocol for all the key elements and have launched the Improving Support and Service Use Survey; a national survey gathering evidence from younger people with dementia and their supporters. In this article, we present how we aim to move forward to bring positive real-life changes to the lives of those affected by young onset dementia. Conclusions: There is a cautiously happy ending to this first phase, as we are now collecting data. However, the judgement of whether the Angela Project is a success overall will depend on whether it makes a difference at its conclusion to younger people with dementia and their supporters.

Families with children with disabilities can feel isolated during school holidays and concerns exist that they face greater difficulties than families of children without disabilities in finding enriching activities for their child. In the context of national policies that encourage integrated play, local service commissioners in England require evidence on what sort of short breaks parents and children prefer. The parents of 99 children with disabilities and 43 children without disabilities attending various holiday play schemes in summer 2010 completed mailed questionnaires. Parents of children with disabilities reported more difficulty getting information, less choice of schemes and further distances to travel than parents of children without disabilities. Although 72% of parents of children without disabilities and 55.5% of parents of children with disabilities stated integrated schemes would be suitable for their child, open text comments provided weaker support. Variety of provision is required to meet all needs and preferences.

Background The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. Methods This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. Discussion If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK’s National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. Trial registration Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Objective To appraise and synthesise research on the impact of physician assistants/associates (PA) in secondary care, specifically acute internal medicine, care of the elderly, emergency medicine, trauma and orthopaedics, and mental health. Design Systematic review. Setting Electronic databases (Medline, Embase, ASSIA, CINAHL, SCOPUS, PsycINFO, Social Policy and Practice, EconLit and Cochrane), reference lists and related articles. Included articles Peer-reviewed articles of any study design, published in English, 1995–2017. Interventions Blinded parallel processes were used to screen abstracts and full text, data extractions and quality assessments against published guidelines. A narrative synthesis was undertaken. Outcome measures Impact on: patients’ experiences and outcomes, service organisation, working practices, other professional groups and costs. Results 5472 references were identified and 161 read in full; 16 were included—emergency medicine (7), trauma and orthopaedics (6), acute internal medicine (2), mental health (1) and care of the elderly (0). All studies were observational, with variable methodological quality. In emergency medicine and in trauma and orthopaedics, when PAs are added to teams, reduced waiting and process times, lower charges, equivalent readmission rate and good acceptability to staff and patients are reported. Analgesia prescribing, operative complications and mortality outcomes were variable. In internal medicine outcomes of care provided by PAs and doctors were equivalent. Conclusions PAs have been deployed to increase the capacity of a team, enabling gains in waiting time, throughput, continuity and medical cover. When PAs were compared with medical staff, reassuringly there was little or no negative effect on health outcomes or cost. The difficulty of attributing cause and effect in complex systems where work is organised in teams is highlighted. Further rigorous evaluation is required to address the complexity of the PA role, reporting on more than one setting, and including comparison between PAs and roles for which they are substituting.

Background Multidisciplinary rehabilitation is recommended for Parkinson's disease, but evidence suggests that benefit is not sustained. Objectives (1) Implement a specialist domiciliary rehabilitation service for people with Parkinson's and carers. (2) Provide continuing support from trained care assistants to half receiving the rehabilitation. (3) Evaluate the clinical effectiveness of the service, and the value added by the care assistants, compared with usual care. (4) Assess the costs of the interventions. (5) Investigate the acceptability of the service. (6) Deliver guidance for commissioners. Design Pragmatic three-parallel group randomised controlled trial. Setting Community, county of Surrey, England, 2010–11. Participants People with Parkinson's, at all stages of the disease, and live-in carers. Interventions Groups A and B received specialist rehabilitation from a multidisciplinary team (MDT) – comprising Parkinson's nurse specialists, physiotherapists, occupational therapists, and speech and language therapists – delivered at home, tailored to individual needs, over 6 weeks (about 9 hours’ individual therapy per patient). In addition to the MDT, participants in group B received ongoing support for a further 4 months from a care assistant trained in Parkinson's (PCA), embedded in the MDT (1 hour per week per patient). Participants in control group (C) received care as usual (no co-ordinated MDT or ongoing support). Main outcome measures Follow-up assessments were conducted in participants’ homes at 6, 24 and 36 weeks after baseline. Primary outcomes: Self-Assessment Parkinson's Disease Disability Scale (patients); the Modified Caregiver Strain Index (carers). Secondary outcomes included: for patients, disease-specific and generic health-related quality of life, psychological well-being, self-efficacy, mobility, falls and speech; for carers, strain, stress, health-related quality of life, psychological well-being and functioning. Results A total of 306 people with Parkinson's (and 182 live-in carers) were randomised [group A, n = 102 (n = 61); group B, n = 101 (n = 60); group C, n = 103 (n = 61)], of whom 269 (155) were analysed at baseline, pilot cohort excluded. Attrition occurred at all stages. A per-protocol analysis [people with Parkinson's, n = 227 (live-in carers, n = 125)] [group A, n = 75 (n = 45); group B, n = 69 (n = 37); group C, n = 83 (n = 43)] showed that, at the end of the MDT intervention, people with Parkinson's in groups A and B, compared with group C, had reduced anxiety (p = 0.02); their carers had improved psychological well-being (p = 0.02). People with Parkinson's in groups A and B also had marginally reduced disability (primary outcome, p = 0.09), and improved non-motor symptoms (p = 0.06) and health-related quality of life (p = 0.07), compared with C. There were significant differences in change scores between week 6 (end of MDT) and week 24 (end of PCA for group B) in favour of group B, owing to worsening in group A (no PCA support) in posture (p = 0.001); non-motor symptoms (p = 0.05); health-related quality of life (p = 0.07); and self-efficacy (p = 0.09). Carers in group B (vs. group A) reported a tendency for reduced strain (p = 0.06). At 36 weeks post recruitment, 3 months after the end of PCA support for group B, there were few differences between the groups. Participants reported learning about Parkinson's, and valued individual attention. The MDT cost £833; PCA support was £600 extra, per patient (2011 Great British pounds). Conclusions Further research is needed into ways of sustaining benefits from rehabilitation including the use of care assistants.

Objectives: To use databases of the US Veterans Health Administration (VHA) to describe the impact of Parkinson's disease on health related quality of life (HRQoL) of veterans; to compare the HRQoL of veterans with Parkinson's disease with that of veterans reporting eight other neurological or chronic conditions; and to estimate the unique effect of Parkinson's disease on HRQoL. Methods: Respondents to the VHA 1999 large national health survey of veteran enrollees with a diagnosis of Parkinson's disease in VHA treatment files for the fiscal years 1997–1999 were identified by merging databases. The survey incorporated the Veterans SF-36, a well validated generic measure of HRQoL and functional status. This was used to compare patient groups. Mean physical (PCS) and mental (MCS) component summary scores were calculated for Parkinson's disease and eight other diseases by multivariable regressions that adjusted for age, sex, race, education, and 15 mental and physical co-morbid conditions that were self reported in the survey. Results: Of 887 775 survey respondents, 14 530 (1.64%) had a Parkinson's disease diagnosis. Controlling for sociodemographic factors and co-morbidities, veterans with Parkinson's disease had PCS and MCS below veterans with angina/coronary heart disease, arthritis, chronic low back pain, congestive heart failure, diabetes, and stroke. Veterans with spinal cord injury reported slightly lower PCS than veterans with Parkinson's disease (32.38 v 32.72; 0.03 of 1 SD). Veterans with depression reported markedly lower MCS than veterans with Parkinson's disease (35.94 v 41.48; 0.55 of 1 SD). The unique effect of having Parkinson's disease on HRQoL was to lower PCS and MCS by 4.10 and 3.42 points (0.41 and 0.34 of 1 SD), respectively. Conclusions: The analysis quantifies the negative impact of Parkinson's disease on HRQoL, after controlling for sociodemographic factors and co-morbidities. Compared with eight other chronic conditions, Parkinson's disease imposes a relatively heavy burden on US veterans in the VHA health care system.

People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. South Asian, men or women, age 40-70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0-6.4% inclusive). known type 1 or 2 diabetes, normal or underweight (body mass index

Background and context Most people with urinary incontinence are given limited choice when provided with absorbent products through the British National Health Service (NHS), even though the available range is large. Objective To investigate users' preferences for four disposable designs (inserts, all-in-ones, belted/T-shaped and pull-ups) and towelling washable/reusable products, day and night. Design Shopping experiment. Setting and participants Community-dwelling women and men in England with moderate-to-heavy urinary incontinence recruited to a larger trial. Intervention Participants tested each design and selected products they would prefer with a range of different budgets. Main outcome measures Design preferences (rankings); 'purchasing' decisions from designated budgets. Results Eighty-five participants (49 men) tested products, 75 completed the shopping experiment. Inserts, most frequently supplied by the NHS, were ranked second to pull-ups by women and lowest by men. When faced with budget constraints, up to 40% of participants opted to 'mix-and-match' designs. Over 15 different combinations of products were selected by participants in the shopping experiment. Most (91%) stated a willingness to 'top-up' assigned budgets from income to secure preferred designs. © 2012 John Wiley & Sons Ltd.

Background: Therapeutic radiotherapy is an important treatment of pelvic cancers. Historically, low-fiber diets have been recommended despite a lack of evidence and potentially beneficial mechanisms of fiber. Objective: This randomized controlled trial compared low-, habitual-, and high-fiber diets for the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy. Design: Patients were randomly assigned to low-fiber [≤10 g nonstarch polysaccharide (NSP)/d], habitual-fiber (control), or high-fiber (≥18 g NSP/d) diets and received individualized counseling at the start of radiotherapy to achieve these targets. The primary endpoint was the difference between groups in the change in the Inflammatory Bowel Disease Questionnaire–Bowel Subset (IBDQ-B) score between the starting and nadir (worst) score during treatment. Other measures included macronutrient intake, stool diaries, and fecal short-chain fatty acid concentrations. Results: Patients were randomly assigned to low-fiber (n = 55), habitual-fiber (n = 55), or high-fiber (n = 56) dietary advice. Fiber intakes were significantly different between groups (P < 0.001). The difference between groups in the change in IBDQ-B scores between the start and nadir was not significant (P = 0.093). However, the change in score between the start and end of radiotherapy was smaller in the high-fiber group (mean ± SD: −3.7 ± 12.8) than in the habitual-fiber group (−10.8 ± 13.5; P = 0.011). At 1-y postradiotherapy (n = 126) the difference in IBDQ-B scores between the high-fiber (+0.1 ± 14.5) and the habitual-fiber (−8.4 ± 13.3) groups was significant (P = 0.004). No significant differences were observed in stool frequency or form or in short-chain fatty acid concentrations. Significant reductions in energy, protein, and fat intake occurred in the low- and habitual-fiber groups only. Conclusions: Dietary advice to follow a high-fiber diet during pelvic radiotherapy resulted in reduced gastrointestinal toxicity both acutely and at 1 y compared with habitual-fiber intake. Restrictive, non–evidence-based advice to reduce fiber intake in this setting should be abandoned. This trial was registered at clinicaltrials.gov as NCT 01170299.

Building an evidence base for the effects of different types of staff in general practice is challenging and takes time. McCartney is right to say that no evidence shows that physician associates make a difference to clinician stress and burnout. But more evidence is available than she suggests, which may be important at a time of considerable vacancies for general practitioners and practice nurses.

Background There is a high prevalence of health problems among single people who are homeless. Specialist primary health care services for this population have been developed in several locations across England; however, there have been very few evaluations of these services. Objectives This study evaluated the work of different models of primary health care provision in England to determine their effectiveness in engaging people who are homeless in health care and in providing continuity of care for long-term conditions. It concerned single people (not families or couples with dependent children) staying in hostels, other temporary accommodation or on the streets. The influence on outcomes of contextual factors and mechanisms (service delivery factors), including integration with other services, were examined. Data from medical records were collated on participants’ use of health care and social care services over 12 months, and costs were calculated. Design and setting The evaluation involved four existing Health Service Models: (1) health centres primarily for people who are homeless (Dedicated Centres), (2) Mobile Teams providing health care in hostels and day centres, (3) Specialist GPs providing some services exclusively for patients who are homeless and (4) Usual Care GPs providing no special services for people who are homeless (as a comparison). Two Case Study Sites were recruited for each of the specialist models, and four for the Usual Care GP model. Participants People who had been homeless during the previous 12 months were recruited as ‘case study participants’; they were interviewed at baseline and at 4 and 8 months, and information was collected about their circumstances and their health and service use in the preceding 4 months. Overall, 363 participants were recruited; medical records were obtained for 349 participants. Interviews were conducted with 65 Case Study Site staff and sessional workers, and 81 service providers and stakeholders. Results The primary outcome was the extent of health screening for body mass index, mental health, alcohol use, tuberculosis, smoking and hepatitis A among participants, and evidence of an intervention if a problem was identified. There were no overall differences in screening between the models apart from Mobile Teams, which scored considerably lower. Dedicated Centres and Specialist GPs were more successful in providing continuity of care for participants with depression and alcohol and drug problems. Service use and costs were significantly higher for Dedicated Centre participants and lower for Usual Care GP participants. Participants and staff welcomed flexible and tailored approaches to care, and related services being available in the same building. Across all models, dental needs were unaddressed and staff reported poor availability of mental health services. Limitations There were difficulties recruiting mainstream general practices for the Usual Care GP model. Medical records could not be accessed for 14 participants of this model. Conclusions Participant characteristics, contextual factors and mechanisms were influential in determining outcomes. Overall, outcomes for Dedicated Centres and for one of the Specialist GP sites were relatively favourable. They had dedicated staff for patients who were homeless, ‘drop-in’ services, on-site mental health and substance misuse services, and worked closely with hospitals and homelessness sector services. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (HSDR 13/156/03) and will be published in full in Health and Social Care Delivery Research ; Vol. 11, No. 16. See the NIHR Journals Library website for further project information.

Background Fear of falling is common in older people and associated with serious physical and psychosocial consequences. Exercise (planned,structured, repetitive and purposive physical activity aimed at improving physical fitness) may reduce f ear of falling by improving strength, gait, balance and mood, and reducing the occurrence of falls. Objectives To assess the effects (benefits, harms and costs) of exercise interventions for reducing fear of falling in older people living in the community. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2013), the Central Register of ControlledTrials (CENTRAL 2013, Issue 7), MEDLINE (1946 to July Wee k 3 2013), EMBASE (1980 to 2013 Week 30), CINAHL (1982 toJuly 2013), PsycINFO (1967 to August 2013), AMED (1985 to August 2013), the World Health Or ganization International Clinical Trials Registry Platform (accessed 7 August 2013) and Current Controlled Trials (accessed 7 August 2013). We applied no language restrictions. We handsearched reference lists and consulted experts

Background UK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition now the third most common cause of premature death. Most patients with advanced cirrhosis (end-stage liver disease [ESLD]) develop ascites. This is often managed with diuretics, but if refractory, then the fluid is drained from the peritoneal cavity every 10–14 days by large volume paracentesis (LVP), a procedure requiring hospital admissions. As the life expectancy of patients with ESLD and refractory ascites (if ineligible for liver transplantation) is on average ≤ 6 months, frequent hospital visits are inappropriate from a palliative perspective. One alternative is long-term abdominal drains (LTADs), used successfully in patients whose ascites is due to malignancy. Although inserted in hospital, these drains allow ascites management outside of a hospital setting. LTADs have not been formally evaluated in patients with refractory ascites due to ESLD. Methods/design Due to uncertai/nty about appropriate outcome measures and whether patients with ESLD would wish or be able to participate in a study, a feasibility randomised controlled trial (RCT) was designed. Patients were consulted on trial design. We plan to recruit 48 patients with refractory ascites and randomise them (1:1) to either (1) LTAD or (2) current standard of care (LVP) for 12 weeks. Outcomes of interest include acceptability of the LTAD to patients, carers and healthcare professionals as well as recruitment and retention rates. The Integrated Palliative care Outcome Scale, the Short Form Liver Disease Quality of Life questionnaire, the EuroQol 5 dimensions instrument and carer-reported (Zarit Burden Interview) outcomes will also be assessed. Preliminary data on cost-effectiveness will be collected, and patients and healthcare professionals will be interviewed about their experience of the trial with a view to identifying barriers to recruitment. Discussion LTADs could potentially improve end-of-life care in patients with refractory ascites due to ESLD by improving symptom control, reducing hospital visits and enabling some self-management. Our trial is designed to see if such patients can be recruited, as well as to inform the design of a subsequent definitive trial. Trial registration ISRCTN, ISRCTN30697116. Registered on 7 October 2015.

Introduction: Nutrition plays an important role in the development of children affecting them physically and mentally. Teachers are in a unique position to observe what factors influence a child’s cognitive development and performance hence it’s important to understand if they perceive diet to have an effect on mental performance. Objectives: Examine teachers’ understanding of the effect of diet on children’s mental performance, using semi-structured interviews. Method/Design: The study was conducted in England, Germany, Hungary and Spain. Participants were teachers of children aged 4-10 years old recruited in state elementary schools. Semi-structured interviews were used to ask what they thought about the effects of diet on mental performance. Responses were recorded, coded and group analysed using the Nudist-Vivo 8.0 program. Reports on the national data from each country were analysed to make cross- country comparisons. Results: Preliminary analysis reveals that teachers highlight having a healthy diet affects mental aspects of children’s lives. The principal aspects of mental performance mentioned by them were attention and concentration. Most of the teachers expressed the opinion that hunger acts as a barrier to concentrating in class. Many teachers recognized an association between low levels of attention and students not having breakfast: it was highlighted as an important habit to avoid lethargy or becoming tired quickly throughout the school day. Teachers also noted unhealthy foods (sweets and junk foods) provide a quick burst of energy in a short period of time but also Irritability, nervousness or hyperactivity resulting in an inability to concentrate. Conclusions: Teachers perceive diet has a direct influence on the ability of children to concentrate, as well as on their mood and behavior. Their opinion of what a child eats affecting their health and development is closely linked to some specific foods which teachers label as “unhealthy”. Study Supported by 7th Framework Programme (NUTRIMENTHE Grant-agreement: 212652)

Abstract Objective There is a paucity of randomised diagnostic studies in women with suspected coronary artery disease(CAD). This study sought to assess the relative value of exercise stress echocardiography (ESE) compared with exercise ECG (Ex-ECG) in women with CAD. Methods Accordingly, 416 women with no prior CAD and intermediate probability of CAD (mean pre-test probability 41%), were randomized to undergo either Ex-ECG or ESE. The primary endpoints were the positive predictive value (PPV) for the detection of significant CAD and downstream resource utilisation. Results The PPV of ESE and Ex-ECG were 33% and 30% (p = 0.87) respectively for the detection of CAD. There were similar clinic visits (36 vs 29, p = 0.44) and emergency visits with chest pain (28 vs 25, p = 0.55) in the Ex-ECG and ESE arms respectively. At 2.9 years,cardiac events were 6 Ex-ECG vs 3 ESE, p = 0.31. Although initial diagnosis costs were higher for ESE, more women underwent further CAD testing in the Ex-ECG arm compared to the ESE arm (37 vs 17, p = 0.003). Overall, there was higher downstream resource utilisation (hospital attendances and investigations) in the Ex-ECG arm (p=0.002). Using National Health Service tariffs 2020/21 (British pounds) the cumulative diagnostic costs were 7.4% lower for Ex-ECG compared with ESE, but this finding is sensitive to the cost differential between ESE and Ex-ECG. Conclusion In intermediate-risk women who are able to exercise, Ex-ECG had similar efficacy to an ESE strategy, with higher resource utilisation whilst providing cost savings.

Holistic needs assessment (HNA) and care planning is proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer. Methods Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs. usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, three and six months. The outcomes were six month change in EORTC-QLQ-C30 global score (primary), and in EORTC sub-scales, generic quality of life, self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and Quality Adjusted Life Years (from SF-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview. Results 150 women consented (75 per group), ten undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary end-point. The majority of those interviewed reported important personal gains they attributed to the intervention which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30,000/QALY threshold. Conclusion: Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage 1-111 gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.

Purpose To describe trends and explore factors associated with quality of life (QoL) and psychological morbidity and assess breast cancer (BC) health service use over a 12-month period for patients joining the supported self-management (SSM)/ patient-initiated follow-up ( PIFU) pathway. Methods Participants completed questionnaires at baseline, 3, 6, 9 and 12 months that measured QoL (FACT-B, EQ 5D-5L), self-efficacy (GSE), psychological morbidity (GHQ-12), roles and responsibilities ( PRRS) and service use (cost diary). Results 99/110 patients completed all timepoints; 32% (35/110) had received chemotherapy. The chemotherapy group had poorer QoL; FACT-B total score mean differences were 8.53 ( 95% CI: 3.42 to 13.64), 5.38 (95% CI: 0.17 to 10.58) and 8.00 (95% CI: 2.76 to 13.24) at 6, 9 and 12 months, respectively. The odds of psychological morbidity (GHQ12 >= 4) were 5.5-fold greater for those treated with chemotherapy. Financial and caring burdens (PRRS) were worse for this group (mean difference in change at 9 months 3.25 (95% CI: 0.42 to 6.07)). GSE and GHQ-12 scores impacted FACT-B total scores, indicating QoL decline for those with high baseline psychological morbidity. Chemotherapy patients or those with high psychological morbidity or were unable to carry out normal activities had the highest service costs. Over the 12 months, 68.2% participants phoned/emailed breast care nurses, and 53.3% visited a hospital breast clinician. Conclusion The data suggest that chemotherapy patients and/or those with heightened psychological morbidity might benefit from closer monitoring and/or supportive interventions whilst on the SSM/PIFU pathway. Reduced access due to COVID-19 could have affected service use.

Aims:  To (i) compare the views of general practitioners (GPs) and parents about the causes, consequences and management of childhood overweight/obesity; and (ii) explore the extent to which they can identify overweight/obesity in children. Methods:  A questionnaire was mailed to all GPs in one Primary Care Trust and all parents in one primary school in southern England, 2008. Information was gathered on socio-demographic background, views about causes, consequences and management of childhood overweight/obesity; judgements about the weight status of 14 images of children (seven boys, seven girls) in the Children's Body Image Scale (CBIS). Comparisons were made between GP and parents' responses using unpaired bivariate tests. Results:  The response rate was 33%. Differences exist between the views of GPs and parents about childhood weight management: 86.4% of parents felt GPs should be involved, compared to 73.3% of GPs (P < 0.001). Parents thought GPs should be more proactive than the GPs stated they would be. GPs were significantly more likely than parents to see a role for school nurses and dieticians. One third of respondents thought GPs lacked expertise in child weight management. Most GPs and parents correctly identified obese children from the images, but inaccuracies occurred at category margins. Conclusions:  Childhood overweight/obesity is a serious public health concern, and primary care has a role to play in tackling it. GPs in England need more training in childhood overweight/obesity management. Their role needs to be clarified in the context of multiagency approaches.

Background: Increasing numbers of nurses, pharmacists and allied health professionals across the world have prescribing rights for medicines: over 90,000 of the eligible United Kingdom workforce are qualified as non-doctor prescribers. In order to inform future developments, it is important to understand the benefits and impact of prescribing by allied health professionals including physiotherapists and podiatrists.

This article aims to investigate associations between perceived control and health-related quality of life (HRQOL) with dietary changes after prostate cancer diagnosis and to explore General Practitioners’ (GPs) perceptions on the role of diet in prostate cancer post-diagnosis. Ninety-five prostate cancer patients completed measures of dietary change, one for after diagnosis and another for after therapy. They also scored their HRQOL and perceived control. There were discrepancies in dietary changes reported between a general question (28.4% no dietary changes) and a specific (42.1%– 51.5% range of no change for various food items). Most patients initiated healthy changes. Patients who changed their diet after diagnosis had lower cognitive functioning and external locus of control (doctors). Patients who changed their diet after therapy had lower cognitive and emotional functioning, quality of life and external locus of control (doctors). Then, fourty-four GPs responded to an online survey. Their open-ended responses were analysed using Content Analysis. They reported interest in the role of diet in cancer but also lack of relevant knowledge. They were skeptical on providing information. Clinical interventions should consider patients’ cognitive ability, their relationship with their health professional and their wellbeing. Also, GPs’ confidence to provide dietary advice needs to be addressed.

Introduction Care home residents are often unable to complete health-related quality of life questionnaires for themselves because of prevalent cognitive impairment. This study compared care home resident and staff proxy responses for two measures, the EQ-5D-5L and HowRU. Methods A prospective cohort study recruited residents ≥60 years across 24 care homes who were not receiving short stay, respite or terminal care. Resident and staff proxy EQ-5D-5L and HowRu responses were collected monthly for 3 months. Weighted kappa statistics and intra-class correlation coefficients (ICCs) adjusted for clustering at the care home level were used to measure agreement between resident and proxies for each time point. The effect of staff and resident baseline variables on agreement was considered using a multilevel mixed effect regression model. Results 117, 109 and 104 matched pairs completed the questionnaires at 1, 2 and 3 months, respectively. When clustering was controlled for, agreement between resident and staff proxy EQ-5D-5L responses was fair for mobility (ICC: 0.29) and slight for all other domains (ICC ≤ 0.20). EQ-5D Index and Quality-Adjusted Life Year scores (proxy scores higher than residents) showed better agreement than EQ-5D-VAS (residents scores higher than proxy). HowRU showed only slight agreement (ICC ≤ 0.20) between residents and proxies. Staff and resident characteristics did not influence level of agreement for either index. Discussion The levels of agreement for EQ-5D-5L and HowRU raise questions about their validity in this population.

Background The number of beds in care homes (with and without nurses) in the United Kingdom is three times greater than the number of beds in National Health Service (NHS) hospitals. Care homes are predominantly owned by a range of commercial, not-for-profit or charitable providers and their residents have high levels of disability, frailty and co-morbidity. NHS support for care home residents is very variable, and it is unclear what models of clinical support work and are cost-effective. Objectives To critically evaluate how the NHS works with care homes. Methods A review of surveys of NHS services provided to care homes that had been completed since 2008. It included published national surveys, local surveys commissioned by Primary Care organisations, studies from charities and academic centres, grey literature identified across the nine government regions, and information from care home, primary care and other research networks. Data extraction captured forms of NHS service provision for care homes in England in terms of frequency, location, focus and purpose. Results Five surveys focused primarily on general practitioner services, and 10 on specialist services to care home. Working relationships between the NHS and care homes lack structure and purpose and have generally evolved locally. There are wide variations in provision of both generalist and specialist healthcare services to care homes. Larger care home chains may take a systematic approach to both organising access to NHS generalist and specialist services, and to supplementing gaps with in-house provision. Access to dental care for care home residents appears to be particularly deficient. Conclusions Historical differences in innovation and provision of NHS services, the complexities of collaborating across different sectors (private and public, health and social care, general and mental health), and variable levels of organisation of care homes, all lead to persistent and embedded inequity in the distribution of NHS resources to this population. Clinical commissioners seeking to improve the quality of care of care home residents need to consider how best to provide fair access to health care for older people living in a care home, and to establish a specification for service delivery to this vulnerable population.

A dementia care coordinator (DCC) service has recently been implemented across Kent and Medway Integrated Care Board (ICB). DCCs are provided at the Primary Care Network (PCN) level and work closely with GP practice teams. The service is intended to help service users navigate the care system and provide proactive support to mitigate crisis points. However, the value of this service, from key stakeholder perspectives is not yet known. The University of Surrey is conducting a realist evaluation into the service to explore what works, for whom, how, why and under what circumstances. This working paper reports on interim findings from an analysis of: (1) staffing and key performance indicators at the 12 month point in the project (October 2023); and (2) responses to an initial questionnaire sent to coordinators. Findings indicate DCCs enjoy being people-focused in their approach, and value being empathetic, well organised and effective. This may facilitate their ability to make a difference, provide individualised support, advocate for service users, and achieve job satisfaction. Working to high standards, in a joined-up way, with embedded knowledge and networks are important components to this. There is now a crucial need to enhance the support of this workforce (e.g. through formal, recognised training, caseload management, time, and knowledgeable management) in order to ensure sustainability of this service. This evaluation is on-going.

Background: exercise can reduce osteoporotic fracture risk by strengthening bone or reducing fall risk. Falls prevention exercise programmes can reduce fall incidence, and also include strengthening exercises suggested to load bone, but there is little information as to whether these programmes influence bone mineral density (BMD) and strength. Objective: to evaluate the skeletal effects of home (Otago Exercise Programme, OEP) and group (Falls Exercise Management, FaME) falls prevention exercise programmes relative to usual care in older people. Methods: men and women aged over 65 years were recruited through primary care. They were randomised by practice to OEP, FaME or usual care. BMD, bone mineral content (BMC) and structural properties were measured in Nottingham site participants before and after the 24-week intervention. Results: participants were 319 men and women, aged mean(SD) 72(5) years. Ninety-two percentage of participants completed the trial. The OEP group completed 58(43) min/week of home exercise, while the FaME group completed 39(16) and 30(24) min/week of group and home exercise, respectively. Femoral neck BMD changes did not differ between treatment arms: mean (95% CI) effect sizes in OEP and FaME relative to usual care arm were −0.003(−0.011,0.005) and −0.002(−0.010,0.005) g cm−2, respectively; P = 0.44 and 0.53. There were no significant changes in BMD or BMC at other skeletal sites, or in structural parameters. Conclusions: falls prevention exercise programmes did not influence BMD in older people. To increase bone strength, programmes may require exercise that exerts higher strains on bone or longer duration.

Objective Hospice at Home (HAH) services aim to enable patients to be cared for and die at home, if that is their choice and achieve a ‘good death’. A national survey, in 2017, aimed to describe and compare the features of HAH services and understand key enablers to service provision. Methods: Service managers of adult HAH services in the ‘Hospice UK’ and National Association for Hospice at Home directories within England were invited to participate. Information on service configuration, referral, staffing, finance, care provision and enablers to service provision were collected by telephone interview. Results: Of 128 services invited, 70 (54.7%) provided data. Great diversity was found. Most services operated in mixed urban/rural (74.3%) and mixed deprivation (77.1%) areas and provided hands-on care (97.1%), symptom assessment and management (91.4%), psychosocial support (94.3%) and respite care (74.3%). Rapid response (within 4 hours) was available in 65.7%; hands-on care 24 hours a day in 52.2%. Charity donations were the main source of funding for 71.2%. Key enablers for service provision included working with local services (eg, district nursing, general practitioner services), integrated health records, funding and anticipatory care planning. Access to timely medication and equipment was critical. Conclusion: There is considerable variation in HAH services in England. Due to this variation it was not possible to categorise services into delivery types. Services work to supplement local care using a flexible approach benefitting from integration and funding. Further work defining service features related to patient and/or carer outcomes would support future service development.

OBJECTIVES: Young onset dementia is associated with distinctive support needs but existing research on service provision has been largely small scale and qualitative. Our objective was to explore service use, cost and satisfaction across the UK. METHODS: Information about socio-demographic characteristics, service use and satisfaction were gathered from people with young onset dementia (YOD) and/or a family member/supporter via a national survey. RESULTS: Two hundred and thirty-three responses were analysed. Diagnosis was most commonly received through a Memory Clinic or Neurology. The type of service delivering diagnosis impacted on post-diagnostic care. Those diagnosed in specialist YOD services were more likely to receive support within the first 6 weeks and receive ongoing care in the service where they were diagnosed. Ongoing care management arrangements varied but generally care was lacking. Around 42% reported no follow-up during 6-weeks after diagnosis; over a third reported seeing no health professional within the previous 3 months; just over a third had a key worker and just under a third had a care plan. Satisfaction and quality of care were highest in specialist services. Almost 60% of family members spent over 5 h per day caring; median costs of health and social care, 3 months, 2018, were £394 (interquartile range £389 to 640). CONCLUSIONS: Variation across diagnostic and post-diagnostic care pathways for YOD leads to disparate experiences, with specialist young onset services being associated with better continuity, quality and satisfaction. More specialist services are needed so all with YOD can access age-appropriate care.

Objectives: To compare the contribution of physician associates to the processes and outcomes of emergency medicine consultations with that of foundation year two doctors-in-training. Design: Mixed-methods study: retrospective chart review using 4 months’ anonymised clinical record data of all patients seen by physician associates or foundation year two doctors-in-training in 2016; review of a subsample of 40 records for clinical adequacy; semi-structured interviews with staff and patients; observations of physician associates. Setting: Three emergency departments in England. Participants: The records of 8816 patients attended by 6 physician associates and 40 foundation year two doctors-in-training; of these n=3197 had the primary outcome recorded (n=1129 physician associates, n=2068 doctor); 14 clinicians and managers and 6 patients or relatives for interview; 5 physician associates for observation. Primary and secondary outcome measures: The primary outcome was unplanned re-attendance at the same emergency department within 7 days. Secondary outcomes: consultation processes, clinical adequacy of care, and staff and patient experience. Results: Re-attendances within 7 days (n=194 (6.1%)) showed no difference between physician associates and foundation year two doctors-in-training (OR 0.87, 95% CI 0.61 to 1.24, p=0.437). If seen by a physician associate, patients were more likely receive an X-ray investigation (OR 2.10, 95% CI 1.72 to 4.24), p

In autosomal recessive dystrophic Epidermolysis bullosa, repeat blistering results in finger webbing and severe contractures of the hands. The aim of this study was to codesign patient-reported outcome indicators for hand therapy with patients, carers and clinicians, and use these to proof-of-concept test a novel dressing glove for recessive dystrophic Epidermolysis bullosa, with cost analysis. Qualitative interviews and focus groups with patients and carers generated content for the indicators. Validity and reliability were established through expert review, piloting and consensus between patients, carers and clinicians. The indicators were self-reported by patients before and while wearing the dressing glove in an N-of-1 study. Time for dressing changes and use of conventional products were also self-reported. A total of 11 indicators were initially generated from the thematic analysis. Expert review, piloting and consensus involved six patients, five carers and eight clinicians (total n=19). Participants agreed 14 indicators, covering hand skin condition (n=4), webbing between the digits (n=4), experiences of wearing and changing dressings (n=2), hand function (n=2), wrist function (n=1) and hand pain (n=1). In Phase 3, 12 patients scored indicators before wearing the gloves and four patients completed scoring while wearing the gloves. Statistically significant improvements between pre-glove and with-glove periods were found for most participants' experience scores. Skin appearance also improved for most participants. The indicators generated useful data, differentiation between scores and participants demonstrating proof-of-concept for patients with recessive dystrophic Epidermolysis bullosa who could wear the dressing gloves. The indicators are being used in routine practice, supporting clinical follow up, commercialisation and regulatory governance of the dressing glove.

Background/aims: Direct-acting antivirals (DAAs) provide an unprecedented opportunity for a “find-and-treat strategy.” We aimed to report real-world clinical, patient reported and health economic outcomes of community-based hepatitis C virus (HCV) screening/treatment in people who use drugs (PWUDs). Methods: Project ITTREAT (2013-2021), established at a drug and alcohol treatment centre, offered a comprehensive service. Generic (SF-12v2 and EQ-5D-5L) and liverspecific (SFLDQoL) health-related quality of life (HRQoL) were assessed before and after HCV treatment. Costs/case detected and cured were calculated. Primary outcome measure was sustained virological response (SVR) (intention to treat). Results: Till March 2018, 573 individuals recruited, 462 (81%) males, mean age 40.5 ± 10.0 years. Of the 125 treated, 115 (92%) had past/current history of injecting drug use, 88 (70%) were receiving opioid agonist treatment and 50 (40%) were homeless. Twenty-six per cent received interferon-based and 74% DAA-only regimens. SVR (ITT) was 87% (90% with DAAs). Service uptake/HCV treatment completion rates were >95%, HCV reinfection being 2.63/100 person years (95% CI 0.67-10.33). HRQoL improved significantly at end of treatment (EOT) in those with SVR: SFLDQoL (symptoms, memory, distress, loneliness, hopelessness, sleep and stigma) (P

Introduction: Nutrition is one of many factors influencing a child’s learning abilitiy. Objectives: This study aims to assess parents’ views on the effect of food on children’s ability to learn in four European countries (England, Germany, Hungary, Spain). Method. Design: Parents of children aged 4 to 10 years were recruited through state elementary schools. Participants were asked to sort 18 cards representing possible determinants of learning (in 6 categories: 4 food related, 3 educational, 2 physical, 4 social, 2 psychological, 3 biological) according to their views about strength of effect. Determinants were identified from the literature. Effects were scored: 0=none; 1=moderate; 2=strong. Results: 201 parents took part. There were no significant differences among countries in age, gender, number of children of participants. Higher proportions of parents in England and Germany had received university education than in the other countries (p=0.015); significantly fewer parents in Spain were in employment (p

Background: Primary health care is changing as it responds to demographic shifts, technological changes and fiscal constraints. This, and predicted pressures on medical and nursing workforces, raises questions about staffing configurations. Physician assistants (PAs) are mid-level practitioners, trained in a medical model over 2 years at postgraduate level to work under a supervising doctor. A small number of general practices in England have employed PAs. Objective: To investigate the contribution of PAs to the delivery of patient care in primary care services in England. Design: A mixed-methods study conducted at macro, meso and micro organisational levels in two phases: (1) a rapid review, a scoping survey of key national and regional informants, a policy review, and a survey of PAs and (2) comparative case studies in 12 general practices (six employing PAs). The latter incorporated clinical record reviews, a patient satisfaction survey, video observations of consultations and interviews with patients and professionals. Results: The rapid review found 49 published studies, mainly from the USA, which showed increased numbers of PAs in general practice settings but weak evidence for impact on processes and patient outcomes. The scoping survey found mainly positive or neutral views about PAs, but there was no mention of their role in workforce policy and planning documents. The survey of PAs in primary care (n = 16) found that they were mainly deployed to provide same-day appointments. The comparative case studies found that physician assistants were consulted by a wide range of patients, but these patients tended to be younger, with less medically acute or complex problems than those consulting general practitioners (GPs). Patients reported high levels of satisfaction with both PAs and GPs. The majority were willing or very willing to consult a PA again but wanted choice in which type of professional they consulted. There was no significant difference between PAs and GPs in the primary outcome of patient reconsultation for the same problem within 2 weeks, investigations/tests ordered, referrals to secondary care or prescriptions issued. GPs, blinded to the type of clinician, judged the documented activities in the initial consultation of patients who reconsulted for the same problem to be appropriate in 80% (n = 223) PA and 50% (n = 252) GP records. PAs were judged to be competent and safe from observed consultations. The average consultation with a physician assistant is significantly longer than that with a GP: 5.8 minutes for patients of average age for this sample (38 years). Costs per consultation were £34.36 for GPs and £28.14 for PAs. Costs could not be apportioned to GPs for interruptions, supervision or training of PAs.Conclusions: PAs were found to be acceptable, effective and efficient in complementing the work of GPs. PAs can provide a flexible addition to the primary care workforce. They offer another labour pool to consider in health professional workforce and education planning at local, regional and national levels. However, in order to maximise the contribution of PAs in primary care settings, consideration needs to be given to the appropriate level of regulation and the potential for authority to prescribe medicines. Future research is required to investigate the contribution of PAs to other first contact services as well as secondary services; the contribution and impact of all types of mid-level practitioners (including nurse practitioners) in first contact services; the factors and influences on general practitioner and practice manager decision-making as to staffing and skill mix; and the reliability and validity of classification systems for both primary care patients and their presenting condition and their consequences for health resource utilisation.

Parents’ decisions about whether to breastfeed their infant, and when to introduce complementary foods, are important public health issues. Breastfeeding has beneficial health effects and is widely promoted. Leaflets and magazine articles on infant feeding were collected in 2005, in five European countries (England, Finland, Germany, Hungary, Spain), and screened for statements that link feeding behaviours to infant health outcomes. A total of 127 leaflets contained 512 statements (0.38 / published page). Magazines contained approximately 1 article / month. Health outcomes were more intensively covered in England and Germany. Most statements referred to short term health implications. Lack of scientific agreement may underlie lack of cover of longer term health effects. Scope may exist to promote improved infant feeding practices by increasing the quantity and specificity of messages about health effects. Further research is required to evaluate the impact of alternative means of providing information on infant feeding practices.

Background Many people prefer to die at home when the time comes. Hospice at home services aim to support patients to achieve this. A range of hospice at home services exist; some services have been evaluated, but there has been limited evidence synthesis. Objectives The main objective was to find out what models of hospice at home services work best, for whom and in what circumstances. Other objectives supported this aim, including an analysis of the health economic costs of hospice at home models. Design The study was an overarching, non-interventional, realist evaluation comprising three phases. Phase 1 was a survey of hospice at home services. Phase 2 involved 12 case studies, grouped into four models on the basis of size and 24 hours per day, 7 days per week (24/7), operations, from which quantitative and health economics data were gathered. Qualitative interview data from bereaved carers, commissioners and providers were analysed to generate context–mechanism–outcome configurations. Phase 3 comprised stakeholder consensus meetings. Setting Hospice at home services across England. Participants A total of 70 hospice at home managers responded to the survey. A total of 339 patient and family/informal carer dyads were recruited; 85 hospice at home providers and commissioners were interviewed. A total of 88 stakeholders participated in consensus meetings. Main outcome measures The quality of dying and death of patients was assessed by bereaved carers (using the Quality of Dying and Death questionnaire). A patient’s use of services was collected using the Ambulatory and Home Care Record. Results Hospice at home services varied; two-thirds were mainly charitably funded, and not all operated 24/7. Most patients (77%) had cancer. Hospice at home services overall provided care that was likely to deliver ‘a good death’, and 73% of patients died in their preferred place. Six context–mechanism–outcome configurations captured factors relevant to providing optimum hospice at home services: (1) sustainability (of the hospice at home service); (2) volunteers (use of, in the hospice at home service); (3) integration and co-ordination (with the wider health and social care system); (4) marketing and referral (of the hospice at home service); (5) knowledge, skills and ethos (of hospice at home staff); and (6) support directed at the carer at home. Key markers of a good service included staff who had time to care, providing hands-on care; staff whose knowledge and behaviour promoted supportive relationships and confidence through the process of dying; and services attending to the needs of the informal carer. Areas of potential improvement for most hospice at home services were the use of volunteers in hospice at home, and bereavement care. Limitations The study had the following limitations – heterogeneity of hospice at home services, variations in numbers and patient clinical statuses at recruitment, a low Quality of Dying and Death questionnaire response rate, and missing data. Only patients with an informal carer involved on a daily basis were eligible for the study. Conclusions Hospice at home services delivered high-quality care and a ‘good death’, with the majority of patients dying in their stated preferred place. Hospice at home providers can improve their impact by focusing on the features identified that deliver the best patient outcomes. Commissioners can facilitate patient preference and reduce the number of hospital deaths by working with hospice at home services to secure their financial sustainability and increase the numbers and range of patients admitted to hospice at home services. Future research Future research should explore the use of volunteers in the hospice at home setting and evaluate approaches to bereavement support. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research ; Vol. 10, No. 24. See the NIHR Journals Library website for further project information.

The COVID-19 pandemic resulted in catastrophic levels of morbidity and mortality for care home residents. Despite this, research platforms for COVID-19 in care homes arrived late in the pandemic compared with other care settings. The Prophylactic Therapy in Care Homes Trial (PROTECT-CH) was established to provide a platform to deliver multi-centre cluster-randomized clinical trials of investigational medicinal products for COVID-19 prophylaxis in UK care homes. Commencing set-up in January 2021, this involved the design and development of novel infrastructure for contracting and recruitment, remote consent, staff training, research insurance, eligibility screening, prescribing, dispensing and adverse event reporting; such infrastructure being previously absent. By the time this infrastructure was in place, the widespread uptake of vaccination in care homes had changed the epidemiology of COVID-19 rendering the trial unfeasible. While some of the resources developed through PROTECT-CH will enable the future establishment of care home platform research, the near absence of care home trial infrastructure and nationally linked databases involving the care home sector will continue to significantly hamper progress. These issues are replicated in most other countries. Beyond COVID-19, there are many other research questions that require addressing to provide better care to people living in care homes. PROTECT-CH has exposed a clear need for research funders to invest in, and legislate for, an effective care home research infrastructure as part of national pandemic preparedness planning. Doing so would also invigorate care home research in the interim, leading to improved healthcare delivery specific to those living in this sector.

Background: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care. Methods: The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference >= 95 cm in Sri Lanka or >= 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c >= 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance. Discussion: The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP. Ethics and dissemination: The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.

Background Dementia care is a key priority for both NHS England and the UK Government. National guidelines highlight the importance of care coordination to address the challenges people living with dementia and their carers can encounter when trying to access the health and care system. To counter these challenges, Kent and Medway Integrated Care Board (ICB) have recently implemented a proactive Dementia Care Coordinator (DCC) service to support people with dementia and their carers from pre diagnosis to end of life care. Aim To understand how the DCC service works, (or not) for whom and in what circumstances. The findings will inform service development and future investment decisions. Design and setting This study uses a realist approach to evaluate the DCC service in Kent and Medway ICB, south-east England, population 1.9 million, comprising 42 Primary Care Networks (groups of general practices) each having a DCC. Methods An initial programme theory will be developed from existing literature, and in collaboration with stakeholders. Mixed methods including questionnaires to DCCs; service provider metrics; and qualitative interviews will be used to collect data on service provider and service user experiences. Interpretive comparative analysis and narrative synthesis including evaluation of service costs against outcomes will produce a refined final programme theory. Results Results from this project will produce evidence-based recommendations to help improve service delivery and possible service expansion. Conclusion This protocol describes a realist evaluation designed to investigate the recently implemented DCC service in Kent and Medway ICB. How this fits in Dementia services in primary care are undergoing a period of transformation. In Kent and Medway, a recent implemented service has been that of the dementia care coordinator, a proactive role to help people living with dementia and carers navigate the care system. Yet challenges exist when implementing a new role and new service into existing primary care organisation. This realist evaluation will explore what works, for whom, how, why and under what circumstances. Findings will provide evidence capable of informing future decisions about the DCC service including how the service can be successfully improved and expanded where appropriate.

Nutrition is one of many factors that affect development of the brain and hence the mental performance of children; the latter term being used to describe a great variety of different brain-mediated functions and processes. The brain develops throughout childhood and an adequate diet is required for its optimal functioning and development(1). Consequently undernutrition has been associated with problems of cognition and behaviour, both on a short-term and long-term basis(2). To remain metabolically active the brain requires a constant supply of glucose as well as a range of other nutrients and both the nature of children’s diets and pattern of meal consumption may influence mental performance. Parents are responsible for the provision of food within the home and as such play a key role in the development of children’s food choices and eating behaviours(3,4). There is little published research on parent’s perceptions of the relationship between a child’s diet and their mental performance. The aim of the present qualitative study was to explore the attitudes, knowledge and perceptions of parents of the effect of diet on children’s development. Parents were recruited through a number of primary schools in the Guildford area. A semistructured interview schedule was used; topics included the effect of food on children’s wellbeing and development, the physical and mental effects of food and the short- and long-term effects of children’s diets. Further questions were asked about possible effects of specific foods, meals and supplements as well as the impact of what children eat in school on their performance. Analysis of the interviews identified a number of themes including the overarching relationship between diet and health. Parents spoke of the effects of diet in terms of physical, mental and behavioural outcomes, clearly distinguishing between what they perceived as positive and negative foods: ‘I’ve seen children’s behaviour different when they’ve eaten certain foods, like they get hyper when they have sweet stuff and drink sugary stuff and eat sweets and cakes’. Concentration was the aspect of mental performance most discussed by parents, being affected both by particular foods and by feelings of hunger: ‘I would imagine that if they’re hungry they will be tired, they’re not going to concentrate, they’re not going to do as well as they could do’. Parents attested to the importance of establishing good eating habits in childhood, as these habits would continue into adult life with implications for future health. The present study provides evidence of parents’ views on the effects of food on children’s performance. Further research is needed to examine the views of others with insights in relation to children’s development (e.g. teachers). This research is funded by the European Community’s 7th Framework Programme (FP7/2008–2013) under grant agreement no. 212652 (NUTRIMENTHE Project ‘The effect of diet on the mental performance of children’).

Objective: To determine whether a programme of multidisciplinary rehabilitation and group support achieves sustained benefit for people with Parkinson’s disease or their carers. Methods: The study was a randomised controlled crossover trial comparing patients and carers who had received rehabilitation four months before assessment with those who had not. Patients were recruited from a neurology clinic, attended a day hospital from home weekly for six weeks using private car or hospital transport, and received group educational activities and individual rehabilitation from a multidisciplinary team. Patients were assessed at entry and at six months using a 25 item self assessment Parkinson’s disease disability questionnaire, Euroqol-5d, SF-36, PDQ-39, hospital anxiety and depression scale, and timed stand-walk-sit test. Carers were assessed using the carer strain index and Euroqol-5d. Results: 144 people with Parkinson’s disease without severe cognitive losses and able to travel to hospital were registered (seven were duplicate registrations); 94 had assessments at baseline and six months. Repeated measures analysis of variance comparing patients at the 24 week crossover point showed that those receiving rehabilitation had a trend towards better stand-walk-sit score (p = 0.093) and worse general and mental health (p = 0.002, p = 0.019). Carers of treated patients had a trend towards more strain (p = 0.086). Analysis comparing patients before and six months after treatment showed worsening in disability, quality of life, and carer strain. Conclusions: Patients with Parkinson’s disease decline significantly over six months, but a short spell of multidisciplinary rehabilitation may improve mobility. Follow up treatments may be needed to maintain any benefit.

OBJECTIVE: Current plans in the English National Health Service are to replace block contracts for mental health providers with a single tariff for each 'cluster' of conditions. A single tariff will not take into account the potential additional complexity and costs inherent in caring for older people. To examine the basis for a uniform tariff, differences in service utilisation and costs between working age adults and older adults in two populous clusters (non-psychotic, psychotic) were investigated across five mental health healthcare providers in and around London. METHODS: Retrospective review of records over 3 months assessing service utilisation and costs using the Client Services Receipt Inventory. RESULTS: Records of 362 patients were reviewed, 179 older adults (90 non-psychotic, 89 psychotic) and 183 adults of working age (83 non-psychotic, 100 psychotic). Older adults in both clusters had more tests, assessments and home visits. Overall costs of care of older adults were significantly higher in the non-psychotic cluster (£5634, vs £4405 psychotic, p = 0.044). CONCLUSIONS: An appropriate age-related tariff is required for each cluster. Copyright © 2016 John Wiley & Sons, Ltd.

Although the impact of diet on physical health is an important public health issue, less attention has been devoted to the relationship between nutrition and children's mental development. The views of parents and teachers about the extent to which diet affects physical and mental development of children were compared in four European countries. An online questionnaire (developed in English and translated) was circulated through a market research agency. Participants were parents or teachers of children aged 4-10 years without learning or behavioural issues. Questionnaires were returned by 1606 parents (401 in England, Germany and Hungary; 403 in Spain) and 403 teachers (100 in each country, except for 103 in Hungary). Teachers were older than parents (35·3 % v. 18·3 % over 45 years; P

Objectives To test the feasibility of conducting a controlled trial into the effectiveness of a self-management programme integrated into stroke rehabilitation. Design A feasibility cluster-randomised design was utilised with stroke rehabilitation teams as units of randomisation. Setting Community-based stroke rehabilitation teams in London. Participants 78 patients with a diagnosis of stroke requiring community based rehabilitation. Intervention The intervention consisted of an individualised approach to self-management based on self-efficacy. Clinicians were trained to integrate defined self-management principles into scheduled rehabilitation sessions, supported by a patient-held workbook. Main outcomes measures Patient measures of quality of life, mood, self-efficacy and functional capacity, and health and social care utilisation, were carried out by blinded assessors at baseline, 6 weeks and 12 weeks. Fidelity and acceptability of the delivery were evaluated by observation and interviews. Results 4 community stroke rehabilitation teams were recruited, and received a total of 317 stroke referrals over 14 months. Of these, 138 met trial eligibility criteria and 78 participants were finally recruited (56.5%). Demographic and baseline outcome measures were similar between intervention and control arms, with the exception of age. All outcome measures were feasible to use and clinical data at 12 weeks were completed for 66/78 participants (85%; 95% CI 75% to 92%). There was no significant difference in any of the outcomes between the arms of the trial, but measures of functional capacity and self-efficacy showed responsiveness to the intervention. Observation and interview data confirmed acceptability and fidelity of delivery according to predetermined criteria. Costs varied by site. Conclusions It was feasible to integrate a stroke self-management programme into community rehabilitation, using key principles. Some data were lost to follow-up, but overall results support the need for conducting further research in this area and provide data to support the design of a definitive trial.

Copyright © 2014 John Wiley & Sons, Ltd.Objectives: This study aimed to compare costs of caring for people with dementia in domiciliary and residential settings, central England. Methods: A cohort of people with dementia was recruited during a hospital stay 2008-2010. Data were collected by interview at baseline, and 6- and 12-month follow-up, covering living situation (own home with or without co-resident carer, care home); cognition, health status and functioning of person with dementia; carer stress; utilisation of health and social services; and informal (unpaid) caring input. Costs of formal services and informal caring (replacement cost method) were calculated. Costs of residential and domiciliary care packages were compared. Results: Data for 109 people with dementia were collected at baseline; 95 (87.2%) entered hospital from their own homes. By 12 months, 40 (36.7%) had died and 85% of the survivors were living in care homes. Over one-half of people with dementia reported social care packages at baseline; those living alone had larger packages than those living with others. Median caring time for co-resident carers was 400 min/day and 10 h/week for non co-resident carers. Residential care was more costly than domiciliary social care for most people. When the value of informal caring was included, the total cost of domiciliary care was higher than residential care, but not significantly so. Carer stress reduced significantly after the person with dementia entered a care home. Conclusions: Caring for people with dementia at home may be more expensive, and more stressful for carers, than care in residential settings.

Background Measuring service use and costs is an important aspect of service delivery evaluation. In end-of-life care, there is heavy reliance on care by family/friends (informal carers) and this should be reflected in the total cost of care alongside formal services. The Ambulatory and Home Care Record, developed in Canada, is both comprehensive in coverage and validated for collecting data on formal and informal caring. This study aimed to adapt and pilot the Ambulatory and Home Care Record questionnaire for use in the UK within a study evaluating a new palliative care service. The objectives were to test if family carers could be recruited and assess acceptability and usability of data gathered. Methods Single cohort pilot study using a structured telephone questionnaire carried out every other week. Family carers of patients newly added to the palliative care register or referred to hospice services in the South East of England were invited to participate by mail. Volunteers remained in the study for a maximum of six interviews or until the patient died. Results In total, 194 carers were invited by mail to participate in the study, of which 23 (11.8%) completed at least one interview and 16 (8.2%) completed all possible interviews. Recruitment to the study was lower than anticipated, but most participants seemed to find the interviews acceptable. The modified questionnaire produced usable and relevant data for an economic evaluation of formal and informal caring costs. Conclusions Modifications are needed to the process of recruitment as a postal recruitment strategy did not have a high response rate. The Ambulatory and Home Care Record has proved a viable tool for use in the UK setting, with a few minor modifications, and will be used in a larger study comparing hospice models.

Aim To compare sole nurse and doctor-led multidisciplinary team delivery of community clozapine services for people with treatment-resistant schizophrenia. Background Around 20% of people with schizophrenia are treatment resistant and fail to respond to front line medications. Clozapine, a second-line treatment, has potentially serious side effects requiring regular monitoring. Different models of community clozapine services are emerging in the British National Health Service, but there is little evidence about which is best. Design Questionnaire survey of service users. Methods All patients on the lists of seven clozapine clinics (four sole nurse, three multidisciplinary team) in one trust were invited to participate, 2009–2010. Forward stepwise regression was used to investigate associations between patient well-being, functioning, self-efficacy and satisfaction, and clinic model attended, controlling for socio-demographic and health characteristics and processes of care. Use (and costs) of other health and social services accessed was compared between models. Results Sixty-six service users (35% participation rate) responded. Well-being and functioning were associated with patient characteristics and processes of care, not clinic model. Patients managed by sole nurses reported, over 3 months: more community psychiatric nurse visits and hospital psychiatrist appointments. Clinic list size affects costs per patient. Conclusions Multidisciplinary team delivery may reduce use of other services. Although multidisciplinary team delivery is regarded as best practice, sole nurses can effectively provide clozapine services and may be warranted in areas of low population density.

Introduction Research into interventions to improve health and well-being for older people living in care homes is increasingly common. Health-related quality of life (HRQoL) is frequently used as an outcome measure, but collecting both self-reported and proxy HRQoL measures is challenging in this setting. This study will investigate the reliability of UK care home staff as proxy respondents for the EQ-5D-5L and HowRu measures. Methods and analysis This is a prospective cohort study of a subpopulation of care home residents recruited to the larger Proactive Healthcare for Older People in Care Homes (PEACH) study. It will recruit residents ≥60 years across 24 care homes and not receiving short stay or respite care. The sample size is 160 participants. Resident and care home staff proxy EQ-5D-5L and HowRu responses will be collected monthly for 3 months. Weighted kappa statistics and intraclass correlation adjusted for clustering at the care home level will be used to measure agreement between resident and proxy responses. The extent to which staff variables (gender, age group, length of time caring, role, how well they know the resident, length of time working in care homes and in specialist gerontological practice) influence the level of agreement between self-reported and proxy responses will be considered using a multilevel mixed-effect regression model. Ethics and dissemination The PEACH study protocol was reviewed by the UK Health Research Authority and University of Nottingham Research Ethics Committee and was determined to be a service development project. We will publish this study in a peer-reviewed journal with international readership and disseminate it through relevant national stakeholder networks and specialist societies.

Objectives To investigate the deployment of physician associates (PAs); the factors supporting and inhibiting their employment and their contribution and impact on patients’ experience and outcomes and the organisation of services. Design Mixed methods within a case study design, using interviews, observations, work diaries and documentary analysis. Setting Six acute care hospitals in three regions of England in 2016–2017. Participants 43 PAs, 77 other health professionals, 28 managers, 28 patients and relatives. Results A key influencing factor supporting the employment of PAs in all settings was a shortage of doctors. PAs were found to be acceptable, appropriate and safe members of the medical/surgical teams by the majority of doctors, managers and nurses. They were mainly deployed to undertake inpatient ward work in the medical/surgical team during core weekday hours. They were reported to positively contribute to: continuity within their medical/surgical team, patient experience and flow, inducting new junior doctors, supporting the medical/surgical teams’ workload, which released doctors for more complex patients and their training. The lack of regulation and attendant lack of authority to prescribe was seen as a problem in many but not all specialties. The contribution of PAs to productivity and patient outcomes was not quantifiable separately from other members of the team and wider service organisation. Patients and relatives described PAs positively but most did not understand who and what a PA was, often mistaking them for doctors. Conclusions This study offers new insights concerning the deployment and contribution of PAs in medical and surgical specialties in English hospitals. PAs provided a flexible addition to the secondary care workforce without drawing from existing professions. Their utility in the hospital setting is unlikely to be completely realised without the appropriate level of regulation and authority to prescribe medicines and order ionising radiation within their scope of practice.

Purpose: To compare patient-triggered follow-up (PTFU) for curatively treated colorectal cancer against traditional outpatient follow-up (OPFU). Methods: Questionnaires were mailed at four time points over one-year post-treatment to two prospectively-recruited cohorts: A, patients entering follow-up and receiving OPFU pre-implementation of PTFU; B, patients entering follow-up (FU) and receiving either OPFU (B1) or PTFU (B2) post-implementation of PTFU. Bi-variate tests were used to compare patient characteristics and outcomes eight months after entering follow-up (generic and cancer-specific quality of life (QoL), satisfaction). Regression analysis explored associations between follow-up model and outcomes. Resource implications and costs of models were compared. Results: Patients in Cohort B1 were significantly more likely to have received chemotherapy (p

Objectives: To compare the performance and cost-effectiveness of the key absorbent product designs to provide a more solid basis for guiding selection and purchase. Also to carry out the first stage in the development of a quality of life (QoL) instrument for measuring the impact of absorbent product use on users' lives. Design: Three clinical trials focused on the three biggest market sectors. Each trial had a similar crossover design in which each participant tested all products within their group in random order. Setting, participants and interventions: In Trial 1, 85 women with light urinary incontinence living in the community tested three products from each of the four design categories available (total of 12 test products): disposable inserts (pads); menstrual pads; washable pants with integral pad; and washable inserts. In Trial 2a, 85 moderate/ heavily incontinent adults (urinary or urinary/faecal) living in the community (49 men and 36 women) tested three (or two) products from each of the five design categories available (total of 14 test products): disposable inserts (with mesh pants); disposable diapers ( nappies); disposable pull-ups (similar to toddlers' trainer pants); disposable T-shaped diapers (nappies with waist-band); and washable diapers. All products were provided in a daytime and a (mostly more absorbent) night-time variant. In these first two trials, the test products were selected on the basis of data from pilot studies. In Trial 2b, 100 moderate/ heavily incontinent adults (urinary or urinary/faecal) living in 10 nursing homes (27 men and 73 women) evaluated one product from each of the four disposable design categories from Trial 2a. Products were selected on the basis of product performance in Trial 2a and, again, day time and night-time variants were provided. The first phase of developing a QoL tool for measuring the impact of using different pad designs was carried out by interviewing participants from Trials 1 and 2a. Main outcome measures: Product performance ( e. g. comfort, discreetness) was characterised using a weekly validated questionnaire. A daily pad change and leakage diary was used to record severity of leakage, numbers of laundry items and pads. Skin health changes were recorded weekly. At a final interview preferences were ranked, acceptability of each design recorded, and overall opinion marked on a visual analogue scale (VAS) of 0 - 100 points. This VAS score was used to estimate cost-effectiveness. In addition, a timed pad changing exercise was conducted with 10 women from Trial 2b to determine any differences between product designs. Results: Disposable inserts are currently the mainstay of management for lightly incontinent women ( Trial 1) and they were better for leakage and other variables ( but not discreetness) and better overall than the other three designs. However, some women preferred menstrual pads (6/85) or washable pants (13/85), both of which are cheaper to use. Washable inserts were worse both overall and for leakage than the other three designs (72/85 found them unacceptable). For disposable inserts and disposable diapers, findings from the community ( Trial 2a) and nursing home trials (Trial 2b) were broadly similar. Leakage performance of disposable inserts was worse than that of the other designs for day and night. Pull-ups were preferred over inserts for the daytime. The new T-shaped diaper was not better overall than the traditional disposable one. However, there were important differences in performance and preference findings for men and women from both trials. Pull-ups ( the most expensive) were better overall than the other designs for women during the day and for community-dwelling women during the night. Although disposable diapers were better for leakage than disposable inserts ( the cheapest), women did not prefer them ( except in nursing homes at night), but for men the diapers were better both overall and for leakage and were the most cost-effective design. No firm conclusions could be drawn about the performance of designs for faecal incontinence. Nursing home carers found pull-ups and inserts easier to apply (in the standing position) and quicker (in the pad change experiment) than the diaper designs; the ability to stand was associated with preference for pull-ups or inserts. The T-shaped diaper was not easier or quicker to change than the diaper. The washable products (Trial 2a) gave diverse results: they were better for leakage at night, but were worse overall for daytime than the other designs. Threequarters of the women (27/36) found them unacceptable, but nearly two-thirds of men (31/49) found them highly acceptable at night. Findings from the two community trials (Trials 1 and 2a) showed that there were many practical problems in dealing with washable products but, together with the less effective and less expensive products, such as menstrual pads, they were more acceptable at home (and, in the case of washables, at night). This suggests that cost-effective management may involve combining products by using more effective (for a given user) but more expensive designs (e. g. pull-ups) when out and less effective but less expensive designs when at home. The interviews examining the impact of pad use on QoL provided themes and domains that can be further developed into a tool for further evaluation of absorbent products. Conclusions: This study showed that there were significant and substantial differences between the designs of absorbent products and for moderate/heavy incontinence some designs are better for men/women than others. There was considerable individual variability in preferences and cost-effective management may best be achieved by allowing users to choose combinations of designs for different circumstances within a budget. Further research is needed into the feasibility of providing choice and combinations of designs to users, as well as into the development of more effective washables and of specifically male disposable products. QoL measurement tools are needed for users of absorbent products, as are clinical trials of designs for community-dwelling carer-dependent men and women with moderate/heavy incontinence.

Background: Demand for diagnostic assessment in children with possible autism has recently increased significantly. Services are under pressure to deliver timely and high-quality diagnosis, following National Institute and Care Excellence multidisciplinary assessment guidelines. This UK National Health Service study aimed to answer: how many hours of health professional time are required to deliver autism diagnostic assessment, and how much does this cost?. Method: Case notes of 20 children (1–16 yrs.) from 27 NHS trusts, assessed through an autism diagnostic pathway in the previous year, were examined retrospectively. Data included: hours of professional time, diagnostic outcome. Assessment costs calculated using standardised NHS tariffs. Results: 488 children (aged 21–195 months, mean 82.9 months, SD 39.36) from 22 Child Development Services (CDS), four Child and Adolescent Mental Health Services (CAMHS) and one tertiary centre; 87% were either under 5 (36%) or 5 to 11 years (51%). Children seen by CDS were younger than CAMHS (mean (SD) 6.10 (2.72) vs. 10.39 (2.97) years, p 

Background: Rapid response services operating 24 h a day have been advocated in UK health policy to support dying patients at home, though there is limited evidence of their effectiveness. Aim: To assess the impact of a rapid response hospice at home service (intervention) on people dying in their preferred place, and carer quality of life, compared to usual care (control). Design: Quasi-experimental multi-centred controlled evaluation. Patient data were collected from hospice records; carers completed postal questionnaires to report quality of life, anxiety and depression. Setting and participants: Community served by one hospice (three contiguous sites) in South East England; 953 patients who died with a preferred place of death recorded and 64 carers who completed questionnaires. Results: There was no significant difference between control and intervention groups in proportions achieving preferred place of death (61.9% vs 63.0% (odds ratio: 0.949; 95% confidence interval: 0.788–1.142)). People living at home alone were less likely to die where they wanted (0.541; 95% confidence interval: 0.438–0.667). Carers in the intervention group reported worse mental health component summary scores (short form-12, p = 0.03) than those in the control group; there were no differences in other carer outcomes. Conclusion: The addition of a rapid response hospice at home service did not have a significant impact on helping patients to die where they wanted in an area already well served by community palliative care. Recording preferences, and changes over time, is difficult and presented challenges for this study.

H. Dowson, H. Gage, D. Jackson Y. Qiao, P. Williams, T. Rockall

BACKGROUND/OBJECTIVES: Infant feeding decisions made by new parents have significant health implications. The study aimed to investigate: influences on infant feeding decisions; characteristics of mothers reporting reliance on alternative information sources; associations between reliance on different sources and intentions to exclusively breastfeed and introduce complementary foods later; and subsequent breastfeeding and weaning behaviours. SUBJECTS/METHODS: First-time mothers in five European countries (England, Finland, Germany, Hungary, Spain) completed questionnaires about the importance of 17 influences on infant feeding choices at birth and 8 months later, during 2007–2008. Use of individual sources and reliance on four categories (family and friends, health professionals, written materials, audio-visual media) were compared between countries. Associations between information sources used and mother characteristics, feeding intentions and behaviours were investigated using appropriate statistical tests. RESULTS: In all, 2071 first-time mothers provided baseline data; 78% at 8 months. Variation exists between countries in the influence of different sources on feeding decisions of first-time mothers. Across all countries, the most important influences at both time points were books, partner and antenatal midwife. Mothers in higher income quintiles and remaining at school beyond age 16 years reported greater reliance on written sources (P

The aim of this study is to explore the information needs of men with prostate cancer and their partners retrospectively at various points in the treatment process. An online questionnaire was used to collect information from men with prostate cancer and their partners about information needs, and when these developed. Readers of a Prostate Care Cookbook and members of a Prostate Cancer Charity were invited to participate: 73 men with prostate cancer and 25 partners completed the questionnaire. Responses showed that participants develop their information needs close to diagnosis. Less educated men with prostate cancer and partners developed their needs closer to the time after diagnosis than those with higher education. Partners develop an interest on information related to treatment and interaction earlier than patients. Patients prioritised treatment and disease-specific information. Patients and partners differ in how their information needs develop. Medical information is prioritized by patients as opposed to practical information by partners. Health care provision can be tailored to meet the different needs of prostate cancer patients and their partners at different times in the treatment process.

The paper questions whether the recent reform package of the NHS will solve its ongoing problems, or whether a more fundamental reappraisal of the system is required.

Background: The programming concept suggests that poor early nutrition causes an array of medical problems later in life. Public health messages about the implications of programming may not be reaching parents and influencing infant feeding behaviors. Objective: The views of new mothers were sought about the extent to which lifelong health is influenced by diet as an infant, rather than by genetic predispositions or lifestyles and behaviors. Design: A questionnaire survey of first-time mothers was undertaken in 5 European countries. Results: A convenience sample of 2071 mothers from England (438), Finland (426), Germany (414), Hungary (389), and Spain (404) self-completed the questionnaire. High proportions of mothers agreed that how an infant is fed affects his or her health over the first year (95.8%) and in subsequent years (88.5%), but the effect of infant feeding decisions on the development of long-term conditions was the least-cited underlying reason. Diet as an infant was rated an extremely/very important influence on adult health by 64% of mothers, equivalent to environmental pollution (63%), but by fewer mothers than were diet and physical activity in childhood/adolescence (79%, 84%) and adulthood (81%, 83%), genetics/inheritance (70%), and exposure to cigarette smoke (81%). Inter- and intracountry differences were observed. Conclusions: Mothers in this study consider diet as an infant to be a less important influence on lifelong health than many lifestyle, behavioral, and environmental factors and genetics. Further dissemination of the implications of programming to consumers may be warranted.

Objective: Typically, attention focuses on how nutrition affects physical health. The present study investigated the importance that parents attach to the impact of diet on mental performance when choosing food for their child. Design: Questionnaire. Setting: Four European countries. Subjects: Parents of children aged 4–10 years (n 1574): England (n 397), Germany (n 389), Hungary (n 398) and Spain (n 390). Results: Most parents (80–85 %) considered the effect of food on four elements of mental performance (child’s ability to learn, attention, behaviour, mood) to be moderately, very, extremely (v. slightly, not at all) important in food choices; over 90% considered healthiness of food and making food appealing to their child important; 79·8% cost; 76·8% convenience. Belief that food affects mental performance was 57·4% (ability to learn), 60·5% (attention); less than 40% of parents agreed they were aware which foods had an effect. Parents with lower general interest in healthy eating were less likely to consider the effect of food on mental performance elements as important. Respondents from Germany were more likely to rate mental performance as important (except behaviour); those in Hungary less likely. The most important influence on parents’ decisions about feeding their child was their own experience, except Spain, where family/friends/ health professionals were more important. Conclusions: Nutrition affects brain development and cognitive functioning. Low prioritisation of the effect of food on mental performance indicates potential for educating parents.

Nutrition is one of the many factors that influence a child’s cognitive development and performance. Understanding the relationship between nutrition and mental performance in children is important in terms of their attainment and productivity both in school and later life. Since parents are seen as nutritional gatekeepers for their children’s diets, their views and beliefs are of crucial importance. The present study aims to qualitatively examine parents’ perceptions of the relationship between diet and mental performance of children. The study was conducted with a total of 124 parents in four European countries using a semi-structured interview schedule. Parents speak of the effects of diet at two levels; the nature of the effects of diet and the characteristics of the foods responsible for these effects. Mental outcomes are related to diet, with the effects perceived to be associated with attention and concentration, often mediated by effects on children’s mood and behaviour. Parents categorise foods as ‘good’ or ‘bad’ with positive effects related generally to a healthy balanced diet while negative effects are perceived to be associated with sugary and fatty foods. Understanding parental perceptions is important for many purposes including the targeting of dietary advice and prioritising of public health issues.

Objectives and Study: Parents have a direct influence on the food choices presented to children in the home. Thinking of what parents consider when choosing foood for their children it is important to know what factors they perceive to influence a child’s cognitive development and mental performance. Parents play a very important role in the development of children food choices and eating habits which may in turn influence children’s future health positively or negatively. The present study aims to quantitatively examine parents’ understanding of the factors influencing children’s mental performance. Methods: The study was conducted in Spain and participants were parents of children aged 4–10 years recruited through state elementary schools. A card sorting task was developed and used to conduct interviews with a total of 50 parents. Parents were asked about five different group of influencing factors: Biological, Educational, Social, Environmental and Psychological (18 factors in total), factors were based on evidence from scientific literature. Mental performance was defined in terms of Attention, Learning, Mood and Behavior Parents were asked to rate the effect of each factor as strong, moderate or no effects on child’s mental development in relation to each of the chosen aspects of mental performance. Responses were recorded manually, coded and group analysed using Friedman test and Cronbach Alpha test with the SPSS version 15.0. Results: The Friedman test for the general analysis show that factors that have a strong effect on mental performance for the participant were ‘‘School discipline’’, ‘‘Parents education level’’, ‘‘Class size’’, ‘‘Regularity of meals’’ and ‘‘Nutrition as a baby’’ for the four groups of cards colors sorting. Although Mood is considered lower than Attention, Learning and Behavior, all were taking from the strong effects answers groups. The card sorting colors game was tested in the study. Using the Cronbach Alpha test the questions’ homogenity, averaging all correlations between all items, were measured giving a mean value of 95,26/100. Conclusion: Spanish data reveal that parents perceive the Environmental, Social and Educational group of factors as having most influence on children’s mental performance. Mood is valued by the Spanish parents with less responses regarding the strengths compared with Attention, Learning and Behavior, which appear more homogeneous in relation to wich factors have an influence in mental performance. Disclosure of Interest: This study is part of the FP7 Project NUTRIMENTHE Grant agreement n8: 212652.

Despite Ireland's temperate maritime climate, it has the third highest rate of malignant melanoma in the European Union, indicating the need to recognise tanning practices as a risky behaviour, especially amongst those most at risk (the younger population).To explore the factors associated with deliberate sun tanning amongst university students in Cork, Ireland.Self-reported sun exposure, attitudes to tanning and sun protection practices were investigated using an online questionnaire in April 2010.There were 833 responses (8.33 %), mean age 22 years, 75 % female. Reporting deliberate tanning in the previous summer (n = 389, 46.7 %) was positively correlated (r = 0.622, p 

Objectives: Evidence of how health-related quality of life (HRQOL) changes following laparoscopic and open colorectal surgery in the first 6 weeks of postoperative recovery is needed to inform cost-effectiveness evaluations. Methods: Pragmatic prospective cohort study design. Consecutive patients requiring elective colorectal surgery were allocated to either laparoscopic or open surgery by administrative staff in a district general hospital in England, 2006-2007. Patients completed two validated, generic measures of HRQOL at baseline (preoperatively) and on multiple occasions in the first 6 weeks postsurgery using diaries (EuroQol five-dimensional [EQ-5D] questionnaire: 16 times; short-form 36 health survey [SF-36]: 4 times; HRQOL was compared between groups at each time point, and overall using repeated-measures analysis. Results: Of 201 consecutive patients recruited, 32 (15.1%) were unable to complete diaries. Of the remaining 169 patients, 120 (71%) returned completed diaries at 28 days and 105 (62.1%) at 42 days. There was no difference in preoperative HRQOL scores between surgical groups, but the postoperative EQ-5D questionnaire and SF-36 scores were significantly higher in the laparoscopic group (EQ-5D questionnaire P = 0.005, SF-36 P = 0.007). Subgroup analysis showed that patients with a stoma have worse HRQOL than those without. HRQOL did not differ between the laparoscopic and open stoma patients. Conclusions: This study presents unique prospective data demonstrating that laparoscopic surgery confers HRQOL benefits for patients in the early recovery period following colorectal surgery, compared with open surgery. Consideration of these data in the context of a cost-effectiveness analysis will be reported separately. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Background: Regular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements. Objective: To evaluate the impact of two exercise promotion programmes on PA in people aged ≥65 years. Design: The ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥65 years) in primary care. Setting: Forty-three UK-based general practices in London and Nottingham/Derby. Participants: A total of 1256 people ≥65 years were recruited through their general practices to take part in the trial. Interventions: The FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking. Main outcome measures: The primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial. Results: In total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants.The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87; p=0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92; p=0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99; p=0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93).Conclusion: The FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms.

Purpose: To review the literature focusing on the effects of dietary behavioural changes on cancer patients’ health-related quality of life (HRQOL). Methods: Relevant databases were searched for studies that report the relationship between dietary changes and HRQOL of people with cancer and synthesized and systematically reviewed the available evidence. Papers were assessed for methodological quality and the themes identified were summarized. Results: The selected studies included only randomized-controlled trials, which target changes in diet. Twelve studies were identified which focus on the association between lifestyle changes which included changes in diet and HRQOL among cancer patients. Results have been mixed and dietary changes have been shown to partly affect HRQOL, but other factors seem to be important as well in defining that relationship. Moreover cancer groups with higher survival rates (prostate, breast, colorectal) seem to benefit more from dietary changes while different HRQOL constructs are affected with no clear indication of directional benefits on physical or mental health. Conclusions: Even though there are some indications of a direct relationship between dietary changes and HRQOL further research should establish which areas of HRQOL are directly affected. Perhaps nutritional changes in future interventions can be isolated in order to identify a potential direct relationship with HRQOL.

Introduction care home residents have high healthcare needs not fully met by prevailing healthcare models. This study explored how healthcare configuration influences resource use. Methods a realist evaluation using qualitative and quantitative data from case studies of three UK health and social care economies selected for differing patterns of healthcare delivery to care homes. Four homes per area (12 in total) were recruited. A total of 239 residents were followed for 12 months to record resource-use. Overall, 181 participants completed 116 interviews and 13 focus groups including residents, relatives, care home staff, community nurses, allied health professionals and General Practitioners. Results context-mechanism-outcome configurations were identified explaining what supported effective working between healthcare services and care home staff: (i) investment in care home-specific work that legitimises and values work with care homes; (ii) relational working which over time builds trust between practitioners; (iii) care which ‘wraps around’ care homes; and (iv) access to specialist care for older people with dementia. Resource use was similar between sites despite differing approaches to healthcare. There was greater utilisation of GP resource where this was specifically commissioned but no difference in costs between sites. Conclusion< activities generating opportunities and an interest in healthcare and care home staff working together are integral to optimal healthcare provision in care homes. Outcomes are likely to be better where: focus and activities legitimise ongoing contact between healthcare staff and care homes at an institutional level; link with a wider system of healthcare; and provide access to dementia-specific expertise.

BACKGROUND: Available evidence that compares outcomes from laparoscopic and open surgery for colorectal cancer shows no difference in disease free or survival time, or in health-related quality of life outcomes, but does not capture the short term benefits of laparoscopic methods in the early postoperative period. AIM: To explore the cost-effectiveness of laparoscopic colorectal surgery, compared to open methods, using quality of life data gathered in the first 6 weeks after surgery. METHODS: Participants were recruited in 2006-2007 in a district general hospital in the south of England; those with a diagnosis of cancer or polyps were included in the analysis. Quality of life data were collected using EQ-5D, on alternate days after surgery for 4 weeks. Costs per patient, from a National Health Service perspective (in British pounds, 2006) comprised the sum of operative, hospital, and community costs. Missing data were filled using multiple imputation methods. The difference in mean quality adjusted life years and costs between surgery groups were estimated simultaneously using a multivariate regression model applied to 20 imputed datasets. The probability that laparoscopic surgery is cost-effective compared to open surgery for a given societal willingness-to-pay threshold is illustrated using a cost-effectiveness acceptability curve. RESULTS: The sample comprised 68 laparoscopic and 27 open surgery patients. At 28 days, the incremental cost per quality adjusted life year gained from laparoscopic surgery was £12,375. At a societal willingness-to-pay of £30,000, the probability that laparoscopic surgery is cost-effective, exceeds 65% (at £20,000 ≈60%). In sensitivity analyses, laparoscopic surgery remained cost-effective compared to open surgery, provided it results in a saving ≥£699 in hospital bed days and takes no more than 8 minutes longer to perform. CONCLUSION: The study provides formal evidence of the cost-effectiveness of laparoscopic approaches and supports current guidelines that promote use of laparoscopy where suitably trained surgeons are available.

Introduction Hospice at home (HAH) services aim to enable patients to be cared for and die in their place of choice, if that is at home, and to achieve a ‘good death’. There is a considerable range of HAH services operating in England. The published evidence focuses on evaluations of individual services which vary considerably, and there is a lack of consistency in terms of the outcome measures reported. The evidence, therefore, does not provide generalisable information, so the question ‘What are the features of hospice at home service models that work, for whom, and under what circumstances?’ remains unanswered. The study aims to answer this question. Methods and analysis This is a mixed-methods study in three phases informed by realist evaluation methodology. All HAH services in England will be invited to participate in a telephone survey to enable the development of a typology of services. In the second phase, case study sites representing the different service types will collect patient data and recruit carers, service managers and commissioners to gather quantitative and qualitative data about service provision and outcomes. A third phase will synthesise and refine the results through consensus workshops. Ethics and dissemination The first survey phase has university ethics approval and the second phase, Integrated Research Application System (IRAS) and Health Research Authority (HRA) approval (IRAS ID:205986, REC:17/LO/0880); the third phase does not require ethics approval. Dissemination will be facilitated by project coapplicants with established connections to national policy-making forums, in addition to publications, conference presentations and reports targeted to service providers and commissioners.

Background: Quality improvement collaboratives (QICs) bring together multidisciplinary teams in a structured process to improve care quality. How QICs can be used to support healthcare improvement in care homes is not fully understood. Methods: A realist evaluation to develop and test a programme theory of how QICs work to improve healthcare in care homes. A multiple case study design considered implementation across 4 sites and 29 care homes. Observations, interviews and focus groups captured contexts and mechanisms operating within QICs. Data analysis classified emerging themes using context-mechanism-outcome configurations to explain how NHS and care home staff work together to design and implement improvement. Results: QICs will be able to implement and iterate improvements in care homes where they have a broad and easily understandable remit; recruit staff with established partnership working between the NHS and care homes; use strategies to build relationships and minimise hierarchy; protect and pay for staff time; enable staff to implement improvements aligned with existing work; help members develop plans in manageable chunks through QI coaching; encourage QIC members to recruit multidisciplinary support through existing networks; facilitate meetings in care homes and use shared learning events to build multidisciplinary interventions stepwise. Teams did not use measurement for change, citing difficulties integrating this into pre-existing and QI-related workload. Conclusions: These findings outline what needs to be in place for health and social care staff to work together to effect change. Further research needs to consider ways to work alongside staff to incorporate measurement for change into QI.

Background Organizational climate relates to how employees perceive and describe the characteristics of their employing organization. It has been found to have an impact on healthcare professionals' and patients' experiences of healthcare (e.g. job satisfaction, patient satisfaction), as well as organizational outcomes (e.g. employee productivity). This research used organizational theory to explore dynamics between health care professionals (pharmacists, doctors and nurses) in mental health outpatients' services for patients taking clozapine, and the perceived influence on patient care. Setting Seven clozapine clinics (from one NHS mental health Trust in the UK) which provided care for people with treatment resistant schizophrenia. Methods This study used qualitative methods to identify organizational climate factors such as deep structures, micro-climates and climates of conflict that might inhibit change and affect patient care. Using Interpretative Phenomenological Analysis, semistructured interviews were conducted with 10 healthcare professionals working in the clinics to explore their experiences of working in these clinics and the NHS mental health Trust the clinics were part of. Main outcome measure Health Care Professionals' perceptions of the care of patients with treatment resistant schizophrenia. Results Three superordinate themes emerged from the data: philosophy of care, need for change and role ambiguity. Participants found it difficult to articulate what a philosophy of care was and in spite of expressing the need for change in the way the clinics were run, could not see how 'changing things would work'. There was considerable role ambiguity with some 'blurring of the boundaries between roles'. Factors associated with organizational climate (role conflict; job satisfaction) were inhibiting team working and preventing staff from identifying the patients' health requirements and care delivery through innovation in skill mix. There were mixed attitudes towards the pharmacist's inclusion as a team member. Conclusions Our findings suggest deficiencies within the clinics that may be manifestations of the wider culture of the NHS. The implications for mental health outpatient clinics are that local initiatives are crucial to the implementation of recovery models; clear guidance should be provided on the skill mix required in clozapine clinics and interprofessional learning should be encouraged to reduce role conflict.

Primary care provision is important in the delivery of health care but many countries face primary care workforce challenges. Increasing demand, enlarged workloads, and current and anticipated physician shortages in many countries have led to the introduction of mid-level professionals, such as Physician Assistants (PAs). Objective: This systematic review aimed to appraise the evidence of the contribution of PAs within primary care, defined for this study as general practice, relevant to the UK or similar systems.

The concept of early nutrition programming is appearing in policy documents, leaflets and magazine articles with different types of statements. However, the level of representation and influence of this concept is unknown in the area of infant nutrition. We established the degree of reflection and the impact of the concept of nutrition programming among the different government stakeholders of infant nutrition in four European countries. In each country, a list of stakeholders in the area of infant feeding was established and key persons responsible for the remit of infant nutrition were identified. We conducted standardised face-to-face or phone interviews from January 2006 to January 2007. The interview guide included questions about the concept of nutrition programming. All interviews were digitally recorded and qualitative data analysis was done using QRS NVivo V2. In total, we analyzed 17 interviews from government organizations in England (5 interviews), Germany (4 interviews), Hungary (3 interviews) and Spain (5 interviews). The concept of nutrition programming was recognized from 4/5 English and 3/4 German interviewees, whereby one organisation reflected the concept in their documents in both countries. In Hungary, 1/3 interviewees recognised the concept and reflected it in their documents. All interviewed Spanish governmental bodies (5/5) recognised the concept of nutrition programming and three of them reflected the concept in their documents. The concept of early nutrition programming was widely recognized among the key persons of government bodies in all four European countries. However, the concept was not necessarily represented in the produced documents.

Aims: To identify and describe infant feeding policy documents in Hungary and compare them to the documents of other four European countries (England, Finland, Germany and Spain). The question was also addressed how the phenomenon of nutritional programming was represented in the documents. Subjects: Policy documents on infant feeding were identified and analyzed in the five European countries by using uniform methods for searching and coding. Results: Twenty-six documents were identified: 4 in England, 2 in Finland, 9 in Germany, 6 in Hungary and 5 in Spain. Altogether 203 statements linked to references were identified: benefits of breast-feeding in general (24%), protection against infections (32%), long-term advantages like the prevention of diabetes (31%) or allergy (12%). Considerable variations were found within and between countries in the evaluation of the duration and character of the positive effects. The majority of the statements in the Hungarian documents referred either to the role of breast-feeding in infection protection (n = 8), or to long-term protective effects (n = 13). Conclusion: Policy documents in the study countries varied both in their extent and in the description of the long-term effects of infant nutrition. Majority of the documents failed to contain evidence based discussion of the phenomenon of early nutritional programming.

Introduction Accurate and timely dispatch of emergency medical services (EMS) is vital due to limited resources and patients’ risk of mortality and morbidity increasing with time. Currently, most UK emergency operations centres (EOCs) rely on audio calls and accurate descriptions of the incident and patients’ injuries from lay 999 callers. If dispatchers in the EOCs could see the scene via live video streaming from the caller’s smartphone, this may enhance their decision making and enable quicker and more accurate dispatch of EMS. The main aim of this feasibility randomised controlled trial (RCT) is to assess the feasibility of conducting a definitive RCT to assess the clinical and cost effectiveness of using live streaming to improve targeting of EMS.Methods and analysisThe SEE-IT Trial is a feasibility RCT with a nested process evaluation. The study also has two observational substudies: (1) in an EOC that routinely uses live streaming to assess the acceptability and feasibility of live streaming in a diverse inner-city population and (2) in an EOC that does not currently use live streaming to act as a comparator site regarding the psychological well-being of EOC staff using versus not using live streaming.Ethics and disseminationThe study was approved by the Health Research Authority on 23 March 2022 (ref: 21/LO/0912), which included NHS Confidentiality Advisory Group approval received on 22 March 2022 (ref: 22/CAG/0003). This manuscript refers to V.0.8 of the protocol (7 November 2022). The trial is registered with the ISRCTN (ISRCTN11449333). The first participant was recruited on 18 June 2022.The main output of this feasibility trial will be the knowledge gained to help inform the development of a large multicentre RCT to evaluate the clinical and cost effectiveness of the use of live streaming to aid EMS dispatch for trauma incidents.Trial registration numberISRCTN11449333.

Background Recent policy initiatives seeking to address the workforce crisis in general practice have promoted greater multi-disciplinarity. Evidence is lacking on how changes in staffing and the relational climate in practice teams affect the experiences of staff and patients. Aim To synthesise evidence on how the composition of the practice workforce and team climate affect staff job satisfaction and burnout, and the processes and quality of care for patients. Design & setting This is a systematic literature review of international evidence. Method Four different searches were carried out using MEDLINE, Embase, Cochrane, CINAHL PsycINFO and Web of Science. Evidence from English language papers from 2012–2022 was identified, with no restriction on study design. PRISMA guidelines were followed and data were synthesised thematically. Results Eleven studies in primary healthcare settings were included, ten from US integrated healthcare systems, one from Canada. Findings indicate that when teams are understaffed and work environments are stressful, patient care and staff wellbeing suffer. However, a good relational climate can buffer against burnout and protect patient care quality in situations of high workload. Good team dynamics and stable team membership are important for patient care coordination and job satisfaction. Women physicians are at greater risk of burnout. Conclusion Evidence regarding team composition and team climate in relation to staff and patient outcomes in general practice remains limited. Challenges exist when drawing conclusions across different team compositions and definitions of team climate. Further research is needed to explore the conditions that generate a ‘good’ climate.

Objectives: To estimate the proportion of cancer outpatients who visit a Complementary and Alternative Medicine (CAM) unit that is located within a conventional cancer treatment centre; to compare the characteristics of CAM unit visitors with those of all outpatients; to monitor the demand for 20 CAM therapies delivered by professionals, and the use of the CAM unit for waiting, gathering information and informal support from volunteer staff. Design: Prospective, observational, over a six month period. Setting: CAM unit within a NHS cancer treatment centre. Main outcome measures: Utilisation of the CAM unit for 20 complementary therapies, and for waiting, gathering information, informal support; characteristics of CAM users compared with those of all cancer outpatients attending the cancer centre; predictors of CAM therapy use and frequent use. Results: 761 (95% of those approached) people were recruited, 498 (65.4%) cancer patients, 202 (26.5%) relatives, 37 (4.8%) friends/carers, 24 (3.2%) staff. Women predominated (n = 560, 73.6%). Of all outpatients attending the cancer centre, 498 (15.8%) visited the CAM unit, 290 (9.2%) accessed therapies. Compared to all outpatients, those visiting the CAM unit were: younger (mean 63.7 vs. 58.4 years), more likely to be female (57.9% vs. 78.7%), have breast (14.8% vs. 51.9%), gynaecotogical (5.0% vs. 9.1%) cancer, live in local postal district (57.3% vs. 61.6%). Significant predictors of therapy use and frequent visits were being a patient, female, higher education, living closer to the cancer centre. Conclusions: Despite easy access to CAM therapies, a relatively small number of people regularly used them, whilst a larger number selectively tried a few. The integrated CAM unit meets a demand for information and informal support. The findings inform emerging policy on integrating CAM and conventional cancer treatment to address psychosocial needs of people with cancer. More research is needed on why people do not use integrated CAM services and how charges affect demand. (C) 2008 Published by Elsevier Ltd.

Background Medication-related harm (MRH) is an escalating global challenge especially among older adults. The period following hospital discharge carries high-risk for MRH due to medication discrepancies, limited patient/carer education and support, and poor communication between hospital and community professionals. Discharge Medical Service (DMS), a newly introduced NHS scheme, aims to reduce post-discharge MRH through an electronic communication between hospital and community pharmacists. Our study team has previously developed a risk-prediction tool (RPT) for MRH in the 8-weeks period post discharge from a UK hospital cohort of 1280 patients. In this study, we aim to find out if a Medicines Management Plan (MMP) linked to the DMS is more effective than the DMS alone in reducing rates of MRH. Method Using a randomized control trial design, 682 older adults >= 65 years due to be discharged from hospital will be recruited from 4 sites. Participants will be randomized to an intervention arm (individualised medicine management plan (MMP) plus DMS) or a control arm (DMS only) using a 1:1 ratio stratification. Baseline data will include patients' clinical and social demographics, and admission and discharge medications. At 8-weeks post-discharge, a telephone interview and review of GP records by the study pharmacist will verify MRH in both arms. An economic and process evaluation will assess the cost and acceptability of the study methods. Data analysis Univariate analysis will be done for baseline variables comparing the intervention and control arms. A multivariate logistic regression will be done incorporating these variables. Economic evaluation will compare the cost-of-service use among the study arms and modelled to provide national estimates. Qualitative data from focus-group interviews will explore practitioners' understanding, and acceptance of the MMP, DMS and the RPT. Conclusion This study will inform the use of an objective, validated RPT for MRH among older adults after hospital discharge, and provide a clinical, economic, and service evaluation of a specific medicines management plan alongside the DMS in the National Health Service (UK).

Objectives Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer. Methods Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview. Results 150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a 30 pound 000/QALY threshold. Conclusion Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.

Introduction: We conducted a survey amongst families of children with cerebral palsy to ascertain the ownership and therapeutic use and potential of commercial games consoles to improve motor function. Method: Three hundred families in South East England were identified through clinical records, and were requested to complete an anonymised questionnaire. Results: A total of 61 families (20% response) returned a completed questionnaire with 41 (68%) identified males and 19 (32%) identified females with cerebral palsy, with a mean age of 11 years 5 months (SD 3Y 7M). The large majority of families, 59 (97%), owned a commercial console and the child used this for 50–300 minutes a week. Returns by severity of motor impairment were: Gross Motor Function Classification System I (22%), II (32%), III (13%), IV (15%), V (18%). Consoles were used regularly for play across all Gross Motor Function Classification System categories. Conclusion: The potential of games consoles, as home-based virtual reality therapy, in improving the motor function of children with cerebral palsy should be appropriately tested in a randomised controlled trial. Wide ownership, and the relative ease with which children engage in the use of commercially-based virtual reality therapy systems, suggests potential as a means of augmenting therapy protocols, taking advantage of interest and participation patterns of families.

This study appraises the effectiveness and cost-effectiveness of consumption of plant sterol-enriched margarine-type spreads for the prevention of cardiovascular disease (CVD) in people with hypercholesterolemia in England, compared to a normal diet. A nested Markov model was employed using the perspective of the British National Health Service (NHS). Effectiveness outcomes were the 10-year CVD risk of individuals with mild (4–6 mmol/l) and high (above 6 mmol/l) cholesterol by gender and age groups (45–54, 55–64, 65–74, 75–85 years); CVD events avoided and QALY gains over 20 years. This study found that daily consumption of enriched spread reduces CVD risks more for men and older age groups. Assuming 50% compliance, 69 CVD events per 10,000 men and 40 CVD events per 10,000 women would be saved over 20 years. If the NHS pays the excess cost of enriched spreads, for the high-cholesterol group, the probability of enriched spreads being cost-effective is 100% for men aged over 64 years and women over 74, at £20,000/QALY threshold. Probabilities of cost-effectiveness are lower at younger ages, with mildly elevated cholesterol and over a 10-year time horizon. If consumers bear the full cost of enriched spreads, NHS savings arise from reduced CVD events.

BACKGROUND: Insulin-dependent diabetes mellitus, also known as type 1 diabetes, is a life-threatening condition and is the third most common chronic illness among young people. As a result of minimal or non-existent insulin production, people with diabetes must take over the normally automatic task of regulation of blood glucose levels. This is achieved by a complex regimen involving multiple, daily administrations of insulin coordinated with dietary intake and energy expenditure and monitored by blood glucose testing. OBJECTIVES: To examine the effectiveness of educational and psychosocial interventions for adolescents with type 1 diabetes designed to improve their diabetes management. Specifically, it addressed the following research questions: (1) Do educational and psychosocial interventions for adolescents with type 1 diabetes have beneficial effects on biological and psychosocial outcomes? (2) Are there types or features of interventions that have been shown to be more effective than others? (3) What evidence is there of the cost-effectiveness of interventions? METHODS: A search strategy was formulated, piloted and refined. Three journals were handsearched, 11 electronic databases were searched and personal contacts, flyers, conferences and websites were used to notify the research community of the review to access further literature. This process generated 10,535 abstracts, which, after screening, resulted in 367 articles identified for retrieval. This number was augmented by hand-searching, personal contact and exploding references, and a final total of 457 articles were scrutinised. Of these, 64 reports describing 62 studies were identified as empirical papers evaluating educational or psychosocial interventions. The relevant data were extracted from the papers and summary tables for each study were prepared. Where possible, effect sizes were computed for outcomes from studies that included a randomised control group (CG) and other relevant information. RESULTS: A descriptive analysis of the 62 studies was undertaken. Most studies (67.7%) were conducted in the USA and 41% were randomised controlled trials (RCTs), none of which were UK-based. Only 48% of the reports provided an explicit theoretical rationale for the intervention. The mean number of participants was 53.8. The studies took place in various settings, evaluated a variety of interventions, involved various interventionists, addressed various components and assessed the effects by a range of outcomes, including measures of metabolic control and psychological and behavioural outcomes. Follow-up assessments were relatively rare. RESULTS - THE EFFECTIVENESS OF INTERVENTIONS: The 25 RCTs were examined in more detail and three of the most effective were described in depth. Effect sizes could be calculated for 14 studies. The mean (pooled) effect size for psychosocial outcomes was 0.37 and 0.33 for glycated haemoglobin with outliers (0.08 without outliers), indicating that these interventions have small to medium beneficial effects on diabetes management outcomes. A narrative review of the 21 pre-post studies with no CG was performed, including evaluations of interventions conducted at summer camps, interventions for poorly controlled patients and educational interventions. All studies reported beneficial effects. RESULTS - COST-EFFECTIVENESS: Few studies addressed economic considerations associated with interventions, and the lack of information on costs and the diversity of outcomes included by investigators impeded cost- effectiveness comparisons. Shorter hospitalisation at diagnosis is at least as effective in achieving control and avoiding complications in adolescence as longer stays. Home care may result in improved outcomes but may not be cheaper than hospital care at diagnosis. Targeting poorly controlled subjects may reduce adverse events and hospitalisations and may be more cost-effective than generic interventions. There is a need for rigorous cost-effectiveness studies of educational and psychosocial interventions for adolescents with type 1 diabetes that include longer-term considerations. CONCLUSIONS: The following conclusions were drawn from this review: (1) Educational and psychosocial interventions have small to medium beneficial effects on various diabetes management outcomes. (2) Well-designed trials of such interventions are needed in the UK (no completed RCTs of educational or psychosocial interventions for adolescents with type 1 diabetes conducted in the UK were found). (3) The evidence, arising primarily from studies in the USA, provides a starting point for the design of interventions in the UK. (4) Quantitative and narrative analysis of the evidence suggested that interventions are more likely to be effective if they demonstrate the inter-relatedness of the various aspects of diabetes management. (ABSTRACT TRUNCATED)

Abstract Background Increasing numbers of nurses, pharmacists and allied health professionals across the world have prescribing rights: over 90,000 of the eligible United Kingdom workforce are qualified as non-doctor prescribers. In order to inform future developments, it is important to understand the benefits and impact of prescribing by allied health professionals including physiotherapists and podiatrists. Aim: to compare outcomes of Physiotherapist and Podiatrist Independent Prescriber (PP-IP) patients with those of Physiotherapist and Podiatrist non-prescribers (PP-NPs). Outcome measures included patient satisfaction, ease of access to services, quality of life and cost implications. Design: a quasi-experimental, post-test control group design Methods: Using mixed methods outcomes were compared between 7 sites where care was provided from a PP-IP (3 podiatrist and 4 physiotherapist IPs) and 7 sites from a PP-NP (3 podiatrist and 4 physiotherapist NPs). Patients were followed up for 2 months (2015-2016). Results: 489 patients were recruited: n=243 IP sites, and n=246 NP sites. Independent prescribing was found to be highly acceptable, and equivalent in terms of quality of life (p>0.05) and patient satisfaction (p≤0.05) compared to care provided by NPs. PP-IP care delivery was found to be more resource intensive than NP-PP, with longer consultation duration for IPs (around 6.5 mins), and a higher proportion of physiotherapy patients discussed with medical colleagues (around 9.5 minutes). Conclusion This study provides new knowledge that PP-IPs provide high levels of care. PP-IP care delivery was found to be more resource intensive. Further research is required to explore cost effectiveness. A more focussed exploration within each profession using targeted outcome measures would enable a more robust comparison, inform future developments around the world and help ensure non-doctor prescribing is recognised as an effective way to alleviate shortfalls in the global workforce.

Background: The National Institute for Health and Care Excellence (NICE) recommends that Cognitive Behaviour Therapy for psychosis (CBTp) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBTp. This is attributable, in part, to the resource-intensive nature of CBTp. One response to this problem has been the development of CBTp in brief formats that are targeted at a single symptom and the mechanisms that maintain distress. We have developed a brief form of CBTp for distressing voices and reported preliminary evidence for its effectiveness when delivered by highly trained therapists (clinical psychologists). This study will investigate the delivery of this intervention by a cost-effective workforce of assistant psychologists following a brief training and evaluate the acceptability and feasibility of conducting a future, definitive, randomised controlled trial (RCT). Methods: This is a feasibility study for a pragmatic, three-arm, parallel-group, superiority 1:1:1 RCT comparing a Guided self-help CBT intervention for voices and treatment as usual (GiVE) to Supportive Counselling and treatment as usual (SC) to treatment as usual alone (TAU), recruiting across two sites, with blinded post-treatment and followup assessments. A process evaluation will quantitatively and qualitatively explore stakeholder experience. Discussion: Expected outcomes will include an assessment of the feasibility of conducting a definitive RCT, and data to inform the calculation of its sample size. If evidence from a subsequent, fully powered RCT suggests that GiVE is clinically and cost-effective when delivered by briefly trained assistant psychologists, CBTp offered in these less resource-intensive forms has the potential to generate benefits for individual patients (reduced distress, enhanced recovery and enhanced quality of life), service-level patient benefit (increased access to evidence-based psychological therapies) and economic benefits to the NHS (in terms of the reduced use of mental health inpatient services).

Objective To compare the health-related quality of life (HRQoL) of patients following laparoscopic and open colorectal surgery. Method A systematic review was performed according to Quorum guidelines. Prospective studies comparing the HRQoL of patients after laparoscopic and open colorectal surgery were identified. The primary outcome measure was postoperative quality of life; performance status and cosmesis were secondary outcome measures. Results Twenty-three studies were identified that satisfied the inclusion criteria; 18 assessed HRQoL, four performance status, and three cosmesis. It was not possible to perform a meta-analysis due to study heterogeneity. The studies reported outcomes for 2946 patients. The most frequent HRQoL instruments employed were Short Form 36, European Organization for Research and Treatment of Cancer, and gastrointestinal quality of life index. Six studies, using a total of 12 separate measures, evaluated QoL during the first three postoperative months: 10 of these measures showed no significant difference, and two showed an improved HRQoL with laparoscopy. Twelve further studies evaluated HRQoL up to 5 years postoperatively: nine showed no difference between the two groups, and three demonstrated a benefit for laparoscopy. Three of four studies assessing performance status on discharge, and all three studies assessing cosmesis, reported benefits with the laparoscopic approach. Conclusions The current evidence suggests there is no significant difference in HRQoL following laparoscopic and open colorectal surgery, although there is a lack of good quality data. There is a trend towards improved quality of life outcomes and performance status with laparoscopy in the early postoperative period. There is a need for further research, particularly assessing quality of life in the early postoperative period.

Purpose The Covid-19 pandemic saw a dramatic rise in the number of people volunteering to support older people shielding at home. This study aimed to determine the processes by which volunteers were rapidly engaged in their communities and their impact on the older people who were supported and health and social care services. Design/methodology/approach The study took place in South East England between May–August 2020. Semi-structured interviews were conducted with 88 participants including health and social care practitioners (n = 12), leaders of voluntary, community and social enterprise (VCSE) organisations (n = 25), volunteers (n = 26) and older people receiving volunteer support (n = 25). Policy and procedure documents were sourced from the VCSE organisation leaders. Data were analysed thematically according to a framework method. Findings The authors identified key themes of People, Process and Planning. People: volunteers had a significant, positive impact on older people in their communities, with volunteers themselves, also benefiting. Process: VCSE organisations needed to work together and with health and care providers to avoid gaps and duplication of services. VCSE organisations were able to act quickly, by-passing many complex operational procedures. However, there was a need to ensure the safety of both volunteers and older people. Planning: Looking forward, there were concerns about the long-term funding of VCSE organisations and the availability of volunteers. Originality/value This study took place during the first wave of the pandemic, hence, it provides a snapshot of how voluntary organisations operated at this time and highlights the importance of integration with health and care statutory services.

Objectives: Studies on service needs of people with young onset dementia have taken a problem-oriented approach with resulting recommendations focusing on reducing service shortcomings. This study aimed to build on 'what works' in real-life practice by exploring the nature of post-diagnostic support services that were perceived positively by younger people with dementia and carers.Method: Positive examples of support were gathered between August 2017 and September 2018, via a national survey. Inductive thematic analysis was employed to explore the nature of positively experienced services provided for younger people with dementia, including analysis of what was provided by positively experienced services.Results: Two hundred and thirty-three respondents reported 856 positive experiences of support. Data analysis yielded eight themes regarding the objectives of positive services: Specialist Advice and Information on Young Onset Dementia, Access to Age-appropriate Services, Interventions for Physical and Mental Health, Opportunities for Social Participation, Opportunities to Have a Voice, Enablement of Independence while Managing Risk, Enablement of Financial Stability, and Support Interventions for Family Relationships.Conclusion: The study findings (a) suggest that positive services may collectively create an enabling-protective circle that supports YPD to re-establish and maintain a positive identity in the face of young onset dementia, and (b) provide a basis from which future good practice can be developed.

Objective To compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence (>1 year) after treatment for prostate cancer. Patients and Methods Randomised, controlled trial of 56 men with 1-year follow-up. Three devices were tested for 3 weeks each: sheath drainage system, body-worn urinal (BWU) and penile clamp. Device and pad performance were assessed. Quality of life (QoL) was measured at baseline and follow-up with the King's Health Questionnaire. Stated (intended use) and revealed (actual use) preference for products were assessed. Value-for-money was gathered. Results Substantial and significant differences in performance were found. The sheath was rated as ‘good’ for extended use (e.g. golf and travel) when pad changing is difficult; for keeping skin dry, not leaking, not smelling and convenient for storage and travel. The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath (e.g. retracted penis) and was not good for seated activities. The clamp was good for short vigorous activities like swimming/exercise; it was the most secure, least likely to leak, most discreet but almost all men described it as uncomfortable or painful. The pads were good for everyday activities and best for night-time use; most easy to use, comfortable when dry but most likely to leak and most uncomfortable when wet. There was a preference for having a mixture of products to meet daytime needs; around two-thirds of men were using a combination of pads and devices after testing compared with baseline. Conclusions This is the first trial to systematically compare different continence management devices for men. Pads and devices have different strengths, which make them particularly suited to certain circumstances and activities. Most men prefer to use pads at night but would choose a mixture of pads and devices during the day. Device limitations were important but may be overcome by better design.

This study assessed access to Complementary and Alternative Medicine (CAM) therapies for people with cancer within the British National Health Service. CAM units were identified through an internet search in 2009. A total of 142 units, providing 62 different therapies, were identified: 105 (74.0%) England; 23 (16.2%) Scotland; 7 (4.9%) each in Wales and Northern Ireland. Most units provide a small number of therapies (median 4, range 1–20), and focus on complementary, rather than alternative approaches. Counselling is the most widely provided therapy (available at 82.4% of identified units), followed by reflexology (62.0%), aromatherapy (59.1%), reiki (43.0%), massage (42.2%). CAM units per million of the population varied between countries (England: 2.2; Wales: 2.3; Scotland: 4.8; Northern Ireland: 5.0), and within countries. Better publicity for CAM units, greater integration of units in conventional cancer treatment centres may help improve access to CAMs.

Background: Over 20 distressing gastrointestinal symptoms affect many patients after pelvic radiotherapy, but in the United Kingdom few are referred for assessment. Algorithmic-based treatment delivered by either a consultant gastroenterologist or clinical nurse specialist has been shown in a randomised trial to be statistically and clinically more effective than provision of a self-help booklet. In this study we assessed cost-effectiveness. Methods: Outcomes were measured at baseline (pre randomisation) and six months. Change in quality adjusted life years (QALY) was the primary outcome for the economic evaluation; a secondary analysis used change in the bowel subset score of the modified Inflammatory Bowel Disease Questionnaire (IBDQ-B). Intervention costs, British pounds 2013, covered visits with the gastroenterologist or nurse, investigations, medications and treatments. Incremental outcomes and incremental costs were estimated simultaneously using multivariate linear regression. Uncertainty was handled non-parametrically using bootstrap with replacement. Results: The mean (SD) cost of treatment was £895 (499) for the nurse, £1101 (567) for the consultant. The nurse was dominated by usual care which was cheaper and achieved better outcomes. The mean cost per QALY gained from the consultant, compared to usual care, was £250,455; comparing the consultant to the nurse, it was £25,875. Algorithmic care produced better outcomes compared to the booklet only, as reflected in the IBDQ-B results, at a cost of approximately £1,000. Conclusion: Algorithmic treatment of radiation bowel injury by consultant or nurse results in significant symptom relief for patients, but was not found to be cost-effective according to the NICE criteria.

Early nutrition programming as an origin of obesity is well acknowledged, but to what extent is this concept communicated to parents? In five European countries, UK, Finland (FI), Germany (DE), Hungary (HU) and Spain (ES), a total of 130 stand alone leaflets and 161 articles from parenting magazines providing information on feeding of healthy infants aged 0-12 months were identified and screened for nutrition programming statements. Obesity was mentioned in 8.5% (54/638) of the statements, and was the fourth most frequent outcome after allergy (20.7%), risk of infections (15.5%) and growth and development (11.4%). A temporal prognosis was given in 39% of obesity related statements, 6% referring to short- ( 15 years) duration of effects. So advice on obesity focuses oil the intrinsic long-term perspective of programming in contrary to other surveyed health-outcomes where only 8% considered a lifelong approach. The major programming related behaviour concerned breast-feeding compared to formula and complementary feeding with meaningful differences concerning the recommended duration: for ES and HU the predominant advice was for exclusive breast-feeding for 6 months, for DE exclusive breast-feeding for 4-6 months and for UK and FI breast-feeding without further specification. In summary, statements relating to the programming of later obesity have been partially integrated into feeding information in five European countries. These Countries have slightly different breastfeeding recommendations, but consistently refer to the preventive potential of breastfeeding in general. This is important as obesity and its resulting morbidity are of increasing public health concern in developed countries.

Background Use of bystander video livestreaming from scene to Emergency Medical Services (EMS) is becoming increasingly common to aid decision making about the resources required. Possible benefits include earlier, more appropriate dispatch and clinical and financial gains, but evidence is sparse. Methods A feasibility randomised controlled trial with an embedded process evaluation and exploratory economic evaluation where working shifts during six trial weeks were randomised 1:1 to use video livestreaming during eligible trauma incidents (using GoodSAM Instant-On-Scene) or standard care only. Pre-defined progression criteria were: (1) ≥70% callers (bystanders) with smartphones agreeing and able to activate live stream; (2) ≥50% requests to activate resulting in footage being viewed; (3) Helicopter Emergency Medical Services (HEMS) stand-down rate reducing by ≥10% as a result of live footage; (4) no evidence of psychological harm in callers or staff/dispatchers. Observational sub-studies included (i) an inner-city EMS who routinely use video livestreaming to explore acceptability in a diverse population; and (ii) staff wellbeing in an EMS not using video livestreaming for comparison to the trial site. Results Sixty-two shifts were randomised, including 240 incidents (132 control; 108 intervention). Livestreaming was successful in 53 incidents in the intervention arm. Patient recruitment (to determine appropriateness of dispatch), and caller recruitment (to measure potential harm) were low (58/269, 22% of patients; 4/244, 2% of callers). Two progression criteria were met: (1) 86% of callers with smartphones agreed and were able to activate livestreaming; (2) 85% of requests to activate livestreaming resulted in footage being obtained; and two were indeterminate due to insufficient data: (3) 2/6 (33%) HEMS stand down due to livestreaming; (4) no evidence of psychological harm from survey, observations or interviews, but insufficient survey data from callers or comparison EMS site to be confident. Language barriers and older age were reported in interviews as potential challenges to video livestreaming by dispatchers in the inner-city EMS. Conclusions Progression to a definitive RCT is supported by these findings. Bystander video livestreaming from scene is feasible to implement, acceptable to both 999 callers and dispatchers, and may aid dispatch decision-making. Further assessment of unintended consequences, benefits and harm is required. Trial registration Trial registration: ISRCTN 11449333 (22 March 2022). https://www.isrctn.com/ISRCTN11449333

Introduction Provision of clinically assisted hydration (CAH) at the end of life is one of the most contentious issues in medicine. The aim of the ‘CHELsea II’ trial is to evaluate CAH in patients in the last days of life. The objectives are to assess the effect of CAH on delirium, audible upper airway secretions, pain and other symptoms, and overall survival, as well as the tolerability of CAH, and the health economic impact. Methods and analysis The study is a cluster randomised trial, involving 80 sites/clusters (mainly hospices) and 1600 patients. Sites will be randomised to an intervention, and this will become the standard of care during the trial. Intervention ‘A’ involves continuance of drinking (if appropriate), mouth care and usual end-of-life care. Intervention ‘B’ involves continuance of drinking, mouth care, usual end-of-life care and CAH, that is, parenteral fluids. The fluid may be given intravenously or subcutaneously, the type will be dextrose saline (4% dextrose, 0.18% sodium chloride) and the volume will be dependent on weight.Participants will be assessed every 4 hours by the clinical team. The primary endpoint is the proportion of participants who develop delirium determined using the Nursing Delirium Screening Scale (using a cut-off score of ≥2). A mixed-effects logistic regression will be used to assess the difference in the odds of developing delirium between the interventions. Ethics and dissemination Ethical committee approval has been granted by the Brighton and Sussex Research Ethics Committee (REC) (main REC for the UK: reference—IRAS 313640), and by the Scotland A REC (REC for adults with incapacity in Scotland: reference—22/SS/0053-IRAS-317637). The consent process follows the Mental Capacity Act: if the patient has capacity, then consent will be sought in the normal way; if the patient does not have capacity, then a personal/nominated consultee will be approached for advice about the patient entering the study. The consent process is slightly different in Scotland.The results of the trial will be published in general medical/palliative care journals, and presented at general medical/palliative care conferences.

Physician associates (PAs) are a new type of healthcare professional to the United Kingdom; however, they are well established in the United States (where they are known as physician assistants). PAs are viewed as one potential solution to the current medical workforce doctor shortage. This study investigated the deployment of PAs within secondary care teams in England, through the use of a cross-sectional electronic, self-report survey. The findings from 14 questions are presented. Sixty-three PAs working in a range of specialties responded. A variety of work settings were reported, most frequently inpatient wards, with work generally taking place during weekdays. Both direct and non-direct patient care activities were reported, with the type of work undertaken varying at times, depending on the presence or absence of other healthcare professionals. PAs reported working within a variety of secondary care team staffing permutations, with the majority of these being interprofessional. Line management was largely provided by consultants; however day-to-day supervision varied, often relating to different work settings. A wide variation in ongoing supervision was also reported. Further research is required to understand the nature of PAs’ contribution to collaborative care within secondary care teams in England.

Background Many people with a terminal illness would prefer to die at home. A new palliative rapid response service (RRS) provided by a large hospice provider in South East England was evaluated (2010) to provide evidence of impact on achieving preferred place of death and costs. The RRS was delivered by a team of trained health care assistants and available 24/7. The purpose of this study was to (i) compare the characteristics of RRS users and non-users, (ii) explore differences in the proportions of users and non-users dying in the place of their choice, (iii) monitor the whole system service utilisation of users and non-users, and compare costs. Methods All hospice patients who died with a preferred place of death recorded during an 18 month period were included. Data (demographic, preferences for place of death) were obtained from hospice records. Dying in preferred place was modelled using stepwise logistic regression analysis. Service use data (period between referral to hospice and death) were obtained from general practitioners, community providers, hospitals, social services, hospice, and costs calculated using validated national tariffs. Results Of 688 patients referred to the hospice when the RRS was operational, 247 (35.9 %) used it. Higher proportions of RRS users than non-users lived in their own homes with a co-resident carer (40.3 % vs. 23.7 %); more non-users lived alone or in residential care (58.8 % vs. 76.3 %). Chances of dying in the preferred place were enhanced 2.1 times by being a RRS user, compared to a non-user, and 1.5 times by having a co-resident carer, compared to living at home alone or in a care home. Total service costs did not differ between users and non-users, except when referred to hospice very close to death (users had higher costs). Conclusions Use of the RRS was associated with increased likelihood of dying in the preferred place. The RRS is cost neutral.

Diabetes incurs heavy personal and health system costs. Self-management is required if complications are to be avoided. Adolescents face particular challenges as they learn to take responsibility for their diabetes. A systematic review of educational and psychosocial programmes for adolescents with diabetes was undertaken. This aimed to: identify and categorise the types of programmes that have been evaluated; assess the cost-effectiveness of interventions; identify areas where further research is required. Sixty-two papers were identified and Subjected to a narrative review. Generic programmes focus on knowledge/skills, psychosocial issues, and behaviour/self-management. They result in modest improvements across a range of outcomes but improvements are often not sustained, suggesting a need for continuous support, possibly integrated into normal care. In-hospital education at diagnosis confers few advantages over home treatment. The greatest returns may be obtained by targeting poorly controlled individuals. Few studies addressed resourcing issues and robust cost-effectiveness appraisals are required to identify interventions that generate the greatest returns on expenditure. (C) 2004 Elsevier Ireland Ltd. All rights reserved.

Background: United Kingdom legislation allows nurses to autonomously provide medications as indepen- dent nurse prescribers or using patient group directions. Evidence of medication safety and appropriate- ness is limited. We compared nurse prescribers and patient group direction users in terms of prevalence, types and severity of medication provision errors. Methods: Objectives: Compare safety and appropriateness of medication provision between nurse pre- scribers and patient group direction users. Design: Mixed methods: clinical notes review and nurse-patient consultation observations. Setting: Five United Kingdom sexual health services. Selection criteria: ‘Clinical notes review’ included a random selection of nurse-patient consultations July- December 2015, 743 consultations managed by nurse prescribers and 939 consultations by patient group direction users. ‘Observation study’ involved 15 nurse prescriber and 15 patient group direction user nurse-patient medication consultations. Patients aged under 16 or non-English speaking were excluded. Measurements: Medication safety/appropriateness was compared between nurse prescribers and patient group direction users. Medication provision errors were categorised and assigned severity ratings. The Medication Appropriateness Index and the Prescribing Framework were used to assess medication provi- sion. Results: Of 1682 clinical notes (nurse prescribers = 743, 44%; patient group directions = 939, 56%), 879 in- volved the provision of 1357 medications (nurse prescribers = 399, 54%; patient group directions = 480, 51%). The overall error rate was 8.5% (1844 errors from a potential 21,738 errors), predominantly re- lated to documentation omissions. Nurse prescribers were more likely to make an error compared to pa- tient group directions users (error rates 9% versus 8%, respectively; p = 0.001); most were ‘minor’ (nurse prescribers = 489, 56%; patient group directions = 602, 62%). Both nurse prescribers and patient group di- rection users made safe medication decisions ( n = 1640 of 1682 patient care episodes, 98%); however, patient group directions users worked outside patient group directions restrictions in 39 (8%) of consul- tations. In 101 consultations, medication was indicated but not documented as offered/provided. From 30 observed consultations assessed against the Prescribing Framework, nurse prescribers’ and patient group directions users’ clinical practice were comparable (maximum score 46: nurse prescribers = 44.7; patient group direction = 45.4, p = 0.41).

BACKGROUND: Fear of falling is common in older people and associated with serious physical and psychosocial consequences. Exercise (planned, structured, repetitive and purposive physical activity aimed at improving physical fitness) may reduce fear of falling by improving strength, gait, balance and mood, and reducing the occurrence of falls. OBJECTIVES: To assess the effects (benefits, harms and costs) of exercise interventions for reducing fear of falling in older people living in the community. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2013), the Central Register of Controlled Trials (CENTRAL 2013, Issue 7), MEDLINE (1946 to July Week 3 2013), EMBASE (1980 to 2013 Week 30), CINAHL (1982 to July 2013), PsycINFO (1967 to August 2013), AMED (1985 to August 2013), the World Health Organization International Clinical Trials Registry Platform (accessed 7 August 2013) and Current Controlled Trials (accessed 7 August 2013). We applied no language restrictions. We handsearched reference lists and consulted experts. SELECTION CRITERIA: We included randomised and quasi-randomised trials that recruited community-dwelling people (where the majority were aged 65 and over) and were not restricted to specific medical conditions (e.g. stroke, hip fracture). We included trials that evaluated exercise interventions compared with no intervention or a non-exercise intervention (e.g. social visits), and that measured fear of falling. Exercise interventions were varied; for example, they could be 'prescriptions' or recommendations, group-based or individual, supervised or unsupervised. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently assessed studies for inclusion, assessed the risk of bias in the studies and extracted data. We combined effect sizes across studies using the fixed-effect model, with the random-effect model used where significant statistical heterogeneity was present. We estimated risk ratios (RR) for dichotomous outcomes and incidence rate ratios (IRR) for rate outcomes. We estimated mean differences (MD) where studies used the same continuous measures and standardised mean differences (SMD) where different measures or different formats of the same measure were used. Where possible, we performed various, usually prespecified, sensitivity and subgroup analyses. MAIN RESULTS: We included 30 studies, which evaluated 3D exercise (Tai Chi and yoga), balance training or strength and resistance training. Two of these were cluster-randomised trials, two were cross-over trials and one was quasi-randomised. The studies included a total of 2878 participants with a mean age ranging from 68 to 85 years. Most studies included more women than men, with four studies recruiting women only. Twelve studies recruited participants at increased risk of falls; three of these recruited participants who also had fear of falling.Poor reporting of the allocation methods in the trials made it difficult to assess the risk of selection bias in most studies. All of the studies were at high risk of performance and detection biases as there was no blinding of participants and outcome assessors and the outcomes were self reported. Twelve studies were at high risk of attrition bias. Using GRADE criteria, we judged the quality of evidence to be 'low' for fear of falling immediately post intervention and 'very low' for fear of falling at short or long-term follow-up and all other outcomes.Exercise interventions were associated with a small to moderate reduction in fear of falling immediately post intervention (SMD 0.37 favouring exercise, 95% confidence interval (CI) 0.18 to 0.56; 24 studies; 1692 participants, low quality evidence). Pooled effect sizes did not differ significantly between the different scales used to measure fear of falling. Although none of the sensitivity analyses changed the direction of effect, the greatest reduction in the size of the effect was on removal of an extreme outlier study with 73 participants (SMD 0.24 favouring exercise, 95% CI 0.12 to 0.36). None of our subgroup analyses provided robust evidence of differences in effect in terms of either the study primary aim (reduction of fear of falling or other aim), the study population (recruitment on the basis of increased falls risk or not), the characteristics of the study exercise intervention or the study control intervention (no treatment or alternative intervention). However, there was some weak evidence of a smaller effect, which included no reduction, of exercise when compared with an alternative control.There was very low quality evidence that exercise interventions may be associated with a small reduction in fear of falling up to six months post intervention (SMD 0.17, 95% CI -0.05 to 0.38; four studies, 356 participants) and more than six months post intervention (SMD 0.20, 95% CI -0.01 to 0.41; three studies, 386 participants).Very low quality evidence suggests exercise interventions in these studies that also reported on fear of falling reduced the risk of falling measured either as participants incurring at least one fall during follow-up or the number of falls during follow-up. Very low quality evidence from four studies indicated that exercise interventions did not appear to reduce symptoms of depression or increase physical activity. The only study reporting the effects of exercise interventions on anxiety found no difference between groups. No studies reported the effects of exercise interventions on activity avoidance or costs. It is important to remember that our included studies do not represent the totality of the evidence of the effect of exercise interventions on falls, depression, anxiety or physical activity as our review only includes studies that reported fear of falling. AUTHORS' CONCLUSIONS: Exercise interventions in community-dwelling older people probably reduce fear of falling to a limited extent immediately after the intervention, without increasing the risk or frequency of falls. There is insufficient evidence to determine whether exercise interventions reduce fear of falling beyond the end of the intervention or their effect on other outcomes. Although further evidence from well-designed randomised trials is required, priority should be given to establishing a core set of outcomes that includes fear of falling for all trials examining the effects of exercise interventions in older people living in the community.

Abstract Background Care home residents in England have variable access to health care services. There is currently no coherent policy or consensus about the best arrangements to meet these needs. The purpose of this review was to explore the evidence for how different service delivery models for care home residents support and/or improve wellbeing and health-related outcomes in older people living and dying in care homes. Methods We conceptualised models of health care provision to care homes as complex interventions. We used a realist review approach to develop a preliminary understanding of what supported good health care provision to care homes. We completed a scoping of the literature and interviewed National Health Service and Local Authority commissioners, providers of services to care homes, representatives from the Regulator, care home managers, residents and their families. We used these data to develop theoretical propositions to be tested in the literature to explain why an intervention may be effective in some situations and not others. We searched electronic databases and related grey literature. Finally the findings were reviewed with an external advisory group. Results Strategies that support and sustain relational working between care home staff and visiting health care professionals explained the observed differences in how health care interventions were accepted and embedded into care home practice. Actions that encouraged visiting health care professionals and care home staff jointly to identify, plan and implement care home appropriate protocols for care, when supported by ongoing facilitation from visiting clinicians, were important. Contextual factors such as financial incentives or sanctions, agreed protocols, clinical expertise and structured approaches to assessment and care planning could support relational working to occur, but of themselves appeared insufficient to achieve change. Conclusion How relational working is structured between health and care home staff is key to whether health service interventions achieve health related outcomes for residents and their respective organisations. The belief that either paying clinicians to do more in care homes and/or investing in training of care home staff is sufficient for better outcomes was not supported.

Background: Parkinson’s disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD_Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD_ Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD_Manager for clinical decision making and the acceptability of the system in clinical practice. Methods/design: This trial is an unblinded, parallel, two-group, randomised controlled pilot study. A total of 200 persons with Parkinson’s disease (Hoehn and Yahr stage 3, experiencing motor fluctuations at least 2 h per day), with primary family carers, in three countries (110 Rome, 50 Venice, Italy; 20 each in Ioannina, Greece and Surrey, England) will be recruited. Following informed consent, baseline information will be gathered, including the following: age, gender, education, attitudes to technology (patient and carer); time since Parkinson’s diagnosis, symptom status and comorbidities (patient only). Randomisation will assign participants (1:1 in each country), to PD_Manager vs control, stratifying by age (1 ≤ 70 : 1 > 70) and gender (60% M: 40% F). The PD_Manager system captures continuous data on motor symptoms, sleep, activity, speech quality and emotional state using wearable devices (wristband, insoles) and a smartphone (with apps) for storing and transmitting the information. Control group participants will be asked to keep a symptom diary covering the same elements as PD_Manager records. After a minimum of two weeks, each participant will attend a consultation with a specialist doctor for review of the data gathered (by either means), and changes to management will be initiated as indicated. Patients, carers and clinicians will be asked for feedback on the acceptability and utility of the data collection methods. The PD_ Manager intervention, compared to a symptom diary, will be evaluated in a cost-consequences framework Discussion: Information gathered will inform further development of the PD_Manager system and a larger effectiveness trial. Trial registration: ISRCTN Registry, ISRCTN17396879. Registered on 15 March 2017.

Background Regular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups. Aim To evaluate two exercise programmes promoting physical activity among older people. Design and setting Pragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby. Method Practices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs. Results In total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar. Conclusion The FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.

Background: Published evaluations of successful interventions to prevent falls in people with sight impairment (SI) are limited. The aim of this feasibility study is to optimise the design and investigation of home safety (HS) and home exercise (HE) programmes to prevent falls in older people with SI. Methods: A community-based feasibility study in north-west England comprising a three-arm randomised controlled trial (RCT) allocated participants to (1) a control group receiving usual care and social visits, (2) an experimental group receiving the HS programme and (3) an experimental group receiving the HS + HE programme. Participants were community-dwelling, aged 65 years and older and sight impaired. Primary outcome data on falls were collected continuously over 6 months. Secondary outcomes on physical activity (self-report and instrumented) and adherence were collected at baseline and 3 and 6 months for HE and at 6 months for the HS programme. Costs for the HS and HS + HE groups were calculated from logs of time spent on home visits, telephone calls and travel. The research assistant and statistician were blinded to group allocation. Results: Altogether, 49 people were recruited over a 9-month period (randomised: 16 to control, 16 to HS, 17 to HS + HE). The interventions were implemented over 6 months by an occupational therapist at a cost per person (pounds sterling, 2011) of £249 (HS) and £674 (HS + HE). Eighty-eight percent (43/49) completed the trial and 6-month follow-up. At 6-month follow-up, 100 % reported partially or completely adhering to HS recommendations but evidence for adherence to HE was equivocal. Although self-reported physical activity increased, instrumented monitoring showed a decrease in walking activity. There were no statistically significant differences in falls between the groups; however, the study was not powered to detect a difference. Conclusion: It is feasible and acceptable for an occupational therapist to deliver HS and HE falls prevention programmes to people with SI living independently in the community. Future studies could access Local Authority Registers of people with SI to improve recruitment rates. Further research is required to identify how to improve adherence to HE and to measure changes in physical activity before conducting a definitive RCT. Trial registration: ISRCTN53433311, registered on 8 May 2014.

Background: Young Onset Dementia (YOD), defined by first symptoms of cognitive or behavioral decline occurring before the age of 65 years, is relatively rare compared to dementia of later onset, but it is associated with diagnostic difficulty and heavy burden on affected individuals and their informal carers. Existing health and social care structures rarely meet the needs of YOD patients. Internet-based interventions are a novel format of delivering health-related education, counseling and support to this vulnerable yet underserved group. Methods: The RHAPSODY (Research to Assess Policies and Strategies for Dementia in the Young) project is a European initiative to improve care for people with YOD by providing an internet-based information and skill-building program for family carers. The e-learning program focuses on managing problem behaviors, dealing with role change, obtaining support and looking after oneself. It will be evaluated in a pilot study in three countries using a randomized unblinded design with a wait-list control group. Participants will be informal carers of people with dementia in Alzheimer’s disease or behavioral-variant Frontotemporal degeneration with an onset before the age of 65 years. The primary outcome will be caregiving self-efficacy after 6 weeks of program use. As secondary outcomes caregivers’ stress and burden, carer health-related quality of life, caring-related knowledge, patient problem behaviors and user satisfaction will be assessed. Program utilization will be monitored and a health-economic evaluation will also be performed. Conclusions: The RHAPSODY project will add to the evidence on the potential and limitations of a conveniently accessible, user-friendly and comprehensive internet-based intervention as an alternative for traditional forms of counseling and support in healthcare, aiming to optimize care and support for people with YOD and their informal caregivers.

Objective: To explore the impact of price manipulation and healthy eating information on intended food choices Design: Health information was provided to a random half of subjects (vs. information on Saudi agriculture). Each subject chose from the same lunch menu, containing two healthy and two unhealthy entrees, deserts and beverages, on five occasions. Reference case prices were 5, 3 and 2 Saudi Arabian Reals (SARs). Prices of healthy and unhealthy items were manipulated up (taxed) and down (subsidised) by 1 SAR in four menu variations (random order); subjects were given a budget enabling full choice within any menu. The number of healthy food choices were compared with different price combinations, and between information groups. Linear regression modelling explored the effect of relative prices of healthy / unhealthy options and information on number of healthy choices controlling for dietary behaviours and hunger levels. Setting: University campus, Saudi Arabia, 2013 Subjects: 99 women students Results: In the reference case, 49.5% of choices were for healthy items. When the price of healthy items was reduced, 58.5% of selections were healthy; 57.2% when the price of unhealthy items rose. In regression modelling, reducing the price of healthy items and increasing the price of unhealthy items increased the number of healthy choices by 5% and 6% respectively. Students reporting a less healthy usual diet selected significantly fewer healthy items. Providing healthy eating information was not a significant influence. Conclusion: Price manipulation offers potential for altering behaviours to combat rising youth obesity in Saudi Arabia.

The aim of this study were to compare nurse prescribers and non-prescribers managing people with diabetes in general practice regarding: (a) patient characteristics; (b) activities and processes of care; (c) patient outcomes (self-management, clinical indicators, satisfaction) and (d) resource implications and costs. Over 28,000 nurses in the UK can prescribe the same medicines as doctors provided that it is in their level of experience and competence. Over 30%, mostly in general practice, prescribe medicines for patients with diabetes. A comparative case study. Nurses managing care of people with Type 2 diabetes were recruited in twelve general practices in England; six could prescribe, six could not. Patients, recruited by nurses, were followed up for 6 months (2011–2012). The patient sample comprised 131 in prescriber sites, 83 in non-prescriber sites. Patients of prescribers had been diagnosed and cared for by the nurse longer than those of non-prescribers. There were no differences in reported self-care activities or HbA1c test results between the patients of prescribers and non-prescribers. Mean HbA1c decreased significantly in both groups over 6 months. Patients of prescribers were more satisfied. Consultation duration was longer for prescribers (by average of 7·7 minutes). Non-prescribing nurses sought support from other healthcare professionals more frequently. Most prescribing nurses were on a higher salary band than non-prescribers. Clinical outcomes of patients managed by prescribing and non-prescribing diabetes nurses are similar. Prescribing nurses had longer relationships with their patients and longer consultations, possibly contributing to higher satisfaction with care. Employment costs of prescribing nurses are potentially higher.

Background People living with dementia often develop distressing behavioural and psychological symptoms (BPSD) that can affect their quality of life and the capacity of family carers and staff providing support at home. This systematic review of qualitative studies considers the views and experiences of people living with dementia and care providers about these symptoms and what helps to reduce their impact. Methods The two-stage review involved (a) An initial mapping of the literature to understand the range of BPSD, and how it is operationalised by different groups, to develop a search strategy; (b) A search of electronic databases from January 2000 to March 2015, updated in October 2016. Included studies focused on people living in their own homes. Data extraction and thematic analysis were structured to provide a narrative synthesis of the evidence. Results We retrieved 17, 871 records and included relevant qualitative papers (n = 58) targeting community-dwelling people with dementia and family carers around the management of BPSD. Five key themes were identified: (1) Helpful interventions/support for BPSD management, (2) Barriers to support services for BPSD management, (3) Challenges around recognition/diagnosis of BPSD, (4) Difficulties in responding to aggression and other BPSD, and (5) Impact of BPSD on family carers and people living with dementia. Conclusions Family carers sometimes feel that their experiences of BPSD may not be evident to professionals until a crisis point is reached. Some helpful services exist but access to support, lack of knowledge and skills, and limited information are consistently identified as barriers to their uptake. The lack of common terminology to identify and monitor the range of BPSD that people with dementia living at home may experience means that closer attention should be paid to family carer accounts. Future research should include qualitative studies to evaluate the relevance of interventions.

Background Care homes provide personal care and support for older people who can no longer be supported in the community. As part of a larger study of integrated working between the NHS and care homes we asked older people how they accessed health care services. Our aim was to understand how older people resident in care homes access health services using the Andersen model of health care access. Methods Case studies were conducted in six care homes with different socio-economic characteristics, size and ownership in three study sites. Residents in all care homes with capacity to participate were eligible for the study. Interviews explored how residents accessed NHS professionals. The Andersen model of health seeking behaviour was our analytic framework. Findings Thirty-five participants were interviewed with an average of 4 different conditions. Expectations of their health and the effectiveness of services to mitigate their problems were low. Enabling factors were the use of intermediaries (usually staff, but also relatives) to seek access. Residents expected that care home staff would monitor changes in their health and seek appropriate help unprompted. Conclusions Care home residents may normalise their health care needs and frame services as unable to remediate these which may combine to disincline older care home residents to seek care. Care access was enabled using intermediaries -either staff or relatives-and the expectation that staff would proactively seek care when they observed new/changed needs. Residents may over-estimate the health-related knowledge of care home staff and their ability to initiate referrals to NHS professionals.

Background: Physician Associates are new to English general practice and set to expand in numbers. Objective: To investigate the patients’ perspective on consulting with PAs in general practice. Design: A qualitative study, using semi structured interviews, with thematic analysis. Setting and participants: Thirty volunteer patients of 430 who had consulted PAs for a same day appointment and had returned a satisfaction survey, in six general practices employing physician associates in England. Findings: Some participants only consulted once with a physician associate and others more frequently. The conditions consulted for ranged from minor illnesses to those requiring immediate hospital admission. Understanding the role of the physician associate varied from: certain and correct, to uncertain, to certain and incorrect, where the patient believed the physician associate to be a doctor. Most, but not all, reported positive experiences and outcomes of their consultation, with some choosing to consult the physician. Those with negative experiences described problems when the limits of the role was reached, requiring additional GP consultations or prescription delay. Trust and confidence in the physician associate was derived from trust in the NHS, the general practice and the individual physician associate. Willingness to consult a physician associate was contingent on the patient’s assessment of the severity or complexity of the problem and the desire for provider continuity. Conclusion: Patients saw PAs as an appropriate general practitioner substitute. Patients’ experience could inform delivery redesign.

Background/Aims Approaching hepatitis C virus (HCV) elimination we are left with an increasing complex and marginalised cohort such as people who are homeless (PWAH). We aimed to assess not only clinical but patient reported outcomes (PRO) and health economic outcomes of a novel community-based care model for PWAH. Methods The END C study (2019–2023) based at multiple community homeless sites in southeast England provided point of care HCV testing, transient elastography (TE), onsite direct acting antiviral (DAA) treatment, peer mentor support, and contingency management (food vouchers). Generic (SF-12v2 and EQ-5D-5L) and liver-specific (SFLDQoL) health related quality of life (HRQoL) was assessed before and at end of HCV treatment. Costs/HCV case detected and cured were calculated. Primary outcome measure was sustained virological response (SVR12) (intention to treat ITT). Results A total of 418 individuals were recruited, mean age 44 ± 10.6, 78% male, 74% being homeless at initial assessment. Prevalence of current injecting drug use (IDU), alcohol use and positive HCV RNA were 25% (95% CI 21%-29%), 65% (95% CI 60%-69%) and 28% (95% CI 24%-33%) respectively. Forty-seven percent of the cohort had previously been incarcerated. Of the 344 individuals with a valid TE result, prevalence of cirrhosis (LSM≥12kpa) was 12%. Of the n=116 with a positive RNA, n=105 (91%) received DAAs of whom 91% were currently homeless, current IDU and current alcohol use being 88% and 93% respectively. ITT SVR12 rates were 81% (95% CI 72%-88%). The only predictor of non-SVR 12 was ≥80% adherence (OR 0.04, 95% CI 0.012–0.148, p

This study assessed access to Complementary and Alternative Medicine (CAM) therapies for people with cancer within the British National Health Service. CAM units were identified through an internet search in 2009. A total of 142 units, providing 62 different therapies, were identified: 105 (74.0%) England; 23 (16.2%) Scotland; 7 (4.9%) each in Wales and Northern Ireland. Most units provide a small number of therapies (median 4, range 1–20), and focus on complementary, rather than alternative approaches. Counselling is the most widely provided therapy (available at 82.4% of identified units), followed by reflexology (62.0%), aromatherapy (59.1%), reiki (43.0%), massage (42.2%). CAM units per million of the population varied between countries (England: 2.2; Wales: 2.3; Scotland: 4.8; Northern Ireland: 5.0), and within countries. Better publicity for CAM units, greater integration of units in conventional cancer treatment centres may help improve access to CAMs.

The Nutrition and Health Claims Regulation (EC No. 1924/2006) has established a common framework for the regulation of nutrition and health claims used on foods across the European Union. This regulation aims to provide the European food industry opportunities for product innovation whilst protecting consumer interests with respect to controlling misleading advertising and promoting public health. However, in order to satisfy the approval of new health claims procedure particularly for new ‘reduction of disease risk’ claims [Article 14(1)(a) claims] , significant research activity is required by industry to scientifically substantiate the claims they wish to make. There is a need to establish whether the implementation of this legislation is in fact driving product innovation and the development of healthy foods or whether it forms a barrier to such developments. The EU-funded REDICLAIM project is currently considering these issues. This article describes the project’s preliminary results and outlines the further programme of work.

PURPOSE: Recent studies have confirmed the clinical efficacy of laparoscopic colorectal surgery; however, its use has not become widespread. One reason for this is perceived economic implications. A systematic review was undertaken examining the costs of laparoscopic colorectal surgery. METHODS: Electronic databases were searched for articles comparing laparoscopic colorectal surgery and open surgery. Primary outcome measures were operating room, direct hospital, and indirect costs. Secondary outcomes were conversion rates and length of hospital stay. The percentage difference in costs was used for comparisons between studies. RESULTS: Twenty-nine articles were identified in which cost data were presented (total number of patients 3,681); the economic data in most studies was limited. Operating room costs were greater for laparoscopic colorectal surgery than open surgery in all studies (median difference, 50 percent; interquartile range, 27-78 percent; P < 0.001). There was no overall difference in total hospital costs (median difference, 0 percent; interquartile range, -17.5 to 21 percent). Only two articles collected data on indirect costs, with both in favor of laparoscopic colorectal surgery. Hospital stay was shorter for laparoscopic colorectal surgery in all studies (median difference, 2.8 days; interquartile range, 1.3-3.7; P < 0.001). Median conversion rate was 7.8 percent (mean, 14 percent; interquartile range, 6-21 percent). CONCLUSIONS: Operating room costs are greater for laparoscopic colorectal surgery than open surgery. Total hospital costs are similar. There may be societal benefits associated with lower indirect costs for laparoscopic colorectal surgery. Cost should not be a deterrent to performing laparoscopic colorectal surgery.

Background:Hospice-at-home aims to enable patients approaching end-of-life to die at home and support their carers. A wide range of different service models exists but synthesised evidence on how best to support family carers to provide sustainable end-of-life care at home is limited. Aim:To explore what works best to promote family carers’ experiences of hospice-at-home. Design:Realist evaluation with mixed methods. This paper focuses on qualitative interviews with carers (to gain their perspective and as proxy for patients) and service providers from 12 case study sites in England. Interviews were coded and programme theories were refined by the research team including two public members. Setting/participants:Interviews with carers (involved daily) of patients admitted to hospice-at-home services (n = 58) and hospice-at-home staff (n = 78). Results:Post bereavement, 76.4% of carers thought that they had received as much help and support as they needed and most carers (75.8%) rated the help and support as excellent or outstanding. Of six final programme theories capturing key factors relevant to providing optimum services, those directly relevant to carer experiences were: integration and co-ordination of services; knowledge, skills and ethos of hospice staff; volunteer roles; support directed at the patient–carer dyad. Conclusions:Carers in hospice-at-home services identified care to be of a higher quality than generic community services. Hospice staff were perceived as having ‘time to care’, communicated well and were comfortable with dying and death. Hands-on care was particularly valued in the period close to death.

Objectives To identify information available in six European countries (England, France, Germany, Netherlands, Portugal, Sweden) that addresses the specific needs of people with young onset dementia (YOD) and their carers, and identify gaps. Methods Search of websites of organisations with potential interest in dementia. Narrative synthesis and comparative analysis. Results 21 sources of information were identified (Netherlands 6, England 6, France 3, Germany 2, Portugal 2, Sweden 2); 11 were from voluntary sector organisations. Sources dedicated to YOD were limited (4 websites, 4 books); all other YOD information was sub-entries in generic dementia sources, difficult to locate and with limited coverage of relevant topics. Gaps related to implications of living with YOD in Germany, Portugal and Sweden. Conclusion Availability of information varies among countries, some having no dedicated source and incomplete coverage of issues of importance to YOD. Practical implications Information is an important means of supporting carers; their needs change as the condition progresses. A comprehensive resource collating key information is needed so that the issues that differentiate the specific needs of people living with YOD from those of people with dementia in older age are available and easily located.

Physician associates [PAs] (also known as physician assistants) are new to the NHS and there is little evidence concerning their contribution in general practice. This study aimed to compare outcomes and costs of same-day requested consultations by PAs with those of GPs.

Background: As more men survive a diagnosis of prostate cancer, alternative models of follow-up care that address men’s enduring unmet needs and are economical to deliver are needed. This paper describes the protocol for an ongoing evaluation of a nurse-led supported self-management and remote surveillance programme implemented within the secondary care setting. Methods/design: The evaluation is taking place within a real clinical setting, comparing the outcomes of men enrolled in the Programme with the outcomes of a pre-service change cohort of men, using a repeated measures design. Men are followed up at four and eight months post recruitment on a number of outcomes, including quality of life, unmet need, psychological wellbeing and activation for self-management. An embedded health economic analysis and qualitative evaluation of implementation processes are being undertaken. Discussion: The evaluation will provide important information regarding the effectiveness, cost effectiveness and implementation of an integrated supported self-management follow-up care pathway within secondary care.

Background: Despite the established evidence and theoretical advances explaining human judgments under uncertainty, developments of mobile health (mHealth) Clinical Decision Support Systems (CDSS) have not explicitly applied the psychology of decision making to the study of user needs. We report on a user needs approach to develop a prototype of a mHealth CDSS for Parkinson’s Disease (PD), which is theoretically grounded in the psychological literature about expert decision making and judgement under uncertainty. Methods: A suite of user needs studies was conducted in 4 European countries (Greece, Italy, Slovenia, the UK) prior to the development of PD_Manager, a mHealth-based CDSS designed for Parkinson’s Disease, using wireless technology. Study 1 undertook Hierarchical Task Analysis (HTA) including elicitation of user needs, cognitive demands and perceived risks/benefits (ethical considerations) associated with the proposed CDSS, through structured interviews of prescribing clinicians (N=47). Study 2 carried out computational modelling of prescribing clinicians’ (N=12) decision strategies based on social judgment theory. Study 3 was a vignette study of prescribing clinicians’ (N=18) willingness to change treatment based on either self-reported symptoms data, devices-generated symptoms data or combinations of both. Results: Study 1 indicated that system development should move away from the traditional silos of ‘motor’ and ‘non-motor’ symptom evaluations and suggest that presenting data on symptoms according to goal-based domains would be the most beneficial approach, the most important being patients’ overall Quality of Life (QoL). The computational modelling in Study 2 extrapolated different factor combinations when making judgements about different questions. Study 3 indicated that the clinicians were equally likely to change the care plan based on information about the change in the patient’s condition from the patient’s self-report and the wearable devices. 3 Conclusions: Based on our approach, we could formulate the following principles of mHealth design: 1) enabling shared decision making between the clinician, patient and the carer; 2) flexibility that accounts for diagnostic and treatment variation among clinicians; 3) monitoring of information integration from multiple sources. Our approach highlighted the central importance of the patient-clinician relationship in clinical decision making and the relevance of theoretical as opposed to algorithm (technology)-based modelling of human judgment.

Background/Objectives: Several factors affect the mental performance of children. The importance that parents attribute to food-related determinants, compared with genetic, socio-economic and school environment, was investigated. Subjects/Methods: Parents of school children (aged 4–11) were recruited through state primary schools in four European countries. Interviews were conducted in which participants were asked to sort 18 cards representing possible determinants of four elements of mental performance (attention, learning, mood and behaviour) according to perceived strength of effect. Determinants were identified from the literature and grouped in six categories: food-related, school environment, physical, social, psychological and biological. Effects were scored: 0=none; 1=moderate; and 2=strong. Views were compared between and within countries. Results: Two hundred parents took part (England: 53; Germany: 45; Hungary: 52; Spain: 50). Differences existed between countries in the proportions reporting university education and being in employment. Taking all countries together, parents consider the food category (mean 1.33) to have a lower impact on a child’s mental performance than physical (activity and sleep, 1.77), psychological (mood and behaviour, 1.69) and school environment (1.57). Social (1.12) and biological (0.91) determinants were ranked lower than food. Of determinants in the food category, parents thought regularity of meals had more influence on mental performance (1.58) than what a child eats now (1.36), food at school (1.35), nutrition as a baby/infant (1.02). Conclusion: Scope exists to improve parental awareness of the repercussions of their dietary choices for the mental performance of their children.

Objectives and Study: Nutrition is one of the many factors that influence a child’s cognitive development and mental performance. Understanding the relationship between nutrition and mental performance in children is important in terms of their attainment and productivity both in school and later life. Parents play a key role in the development of children’s food choices and dietary habits. To date, there is little published research on parent’s perceptions of the relationship between diet and mental performance of children. The present study aims to qualitatively examine parents’ perceptions and beliefs about this relationship. Methods: The study was conducted in four European countries, England, Germany, Hungary and Spain. Participants were parents of children aged 4–10 years recruited through state elementary schools. A semi-structured interview schedule was used to conduct interviews with a total of 127 parents; it included questions on the effect of food on a child’s physical.and mental wellbeing and development. Further questions were asked about short or long term effects of diet, the effects of specific foods, meals and supplements. All interviews were transcribed and thematically analysed using NVIVO8. Results: Four main themes emerged from the interviews with a number of subthemes: ‘‘physical effects of diet’’, ‘‘mental effects of diet’’, ‘‘healthiness of diet’’ and ‘‘parenting (responsibility, food preferences, dietary habits)’’. The mental effects of diet are perceived by parents to be on attention and concentration as well as on children’s mood and behaviour. Negative effects are associated with sugary and fatty foods while positive effects are associated more generally with a healthy balanced diet. Conclusion: In all countries parents perceive attention and concentration to be negatively affected by sugary and fatty foods while a healthy balanced diet is believed to have a positive effect on mental outcomes. Based on the exploratory findings of this study, subsequent quantitative studies will need to further examine the prevalence of these perceptions in relation to socioeconomic factors. A detailed understanding of parents’ perceptions of the relationship between diet and mental performance can provide valuable input for better targeted and formulated communication with parents, including intervention programmes as well as claims related to specific food products. Disclosure of Interest: None declared.

Objectives The European RHAPSODY project sought to develop and test an online information and support programme for caregivers of individuals diagnosed with young onset dementia. The objectives were to assess user acceptability and satisfaction with the programme and to test outcome measures for a larger effectiveness study. Design A pilot randomised controlled trial in England, France, and Germany was conducted with 61 caregivers for adults with young onset Alzheimer's disease or frontotemporal degeneration. Evaluations at baseline, week 6, and week 12 assessed user acceptability and satisfaction. Use of the programme was measured from online back‐end data. Qualitative feedback on user experiences was collected via semi‐structured interviews. Measures of caregiver well‐being (self‐efficacy, stress, burden, frequency of patient symptoms, and caregiver reactions) were explored for use in a subsequent trial. Results Participants logged in online on average once a week over a 6‐week period, consulting approximately 31% of programme content. Seventy percent of participants described the programme as useful and easy to use. Eighty‐five percent expressed intent to use the resource in the future. Reductions in reported levels of stress and caregivers' negative reactions to memory symptoms were observed following use of the programme. Conclusions Results indicated that the RHAPSODY programme was acceptable and useful to caregivers. The programme may be complementary to existing services in responding to the specific needs of families affected by young onset dementia. Distribution of the programme is underway in England, France, Germany, and Portugal.

Purpose To investigate clinical, demographic and dietary factors associated with constipation in a sample of community dwelling people with Parkinson’s disease, recruited through a specialist outpatient clinic. Partners/carers provided a convenience control group. Scope Participants completed a baseline questionnaire (background information, diet and exercise, activities of daily living: mobility and manual dexterity, health-related quality of life (SF-12), stool frequency and characteristics, extent of concern due to constipation, laxative taking), and a four-week stool diary. The Rome criterion was used to determine constipation status. Multiple regression methods were used to explore the correlates of constipation. Baseline data were provided by 121 people with Parkinson’s, (54 controls), of whom 73% (25%) met the Rome criterion. Prospective diary data from 106 people with Parkinson’s (43 controls) showed lower proportions: 35% (7%) meeting the Rome criterion. Among all study subjects, i.e. Parkinson’s patients and controls taken together, the presence of constipation is predicted by having Parkinson’s disease (p = .003; odds ratio 4.80, 95% CI 1.64–14.04) and mobility score (p = .04; odds ratio 1.15, 95% CI 1.01–1.31), but not by dietary factors. Amongst people with Parkinson’s constipation is predicted by number of medications (p = .027). Laxative taking masks constipation, and is significantly associated with wearing protection against bowel incontinence (p = .009; odds ratio 4.80, 95% CI: 1.48–15.52). Conclusions Constipation is disease-related, not a lifestyle factor. More research is needed on optimal management and laxative use.

Background: Recent policy initiatives seeking to address the workforce crisis in general practice have promoted greater multidisciplinarity. Evidence is lacking on how changes in staffing and the relational climate in practice teams affect the experiences of staff and patients. Aim: To synthesise evidence on how the composition of the practice workforce and team climate affect staff job satisfaction and burnout, and the processes and quality of care for patients. Method: Four different searches were carried out between December 2021 and March 2022 using MEDLINE, Embase, Cochrane, CINAHL PsycINFO and Web of Science. PRISMA guidelines were followed and data were synthesised thematically. Results: Eleven studies set in primary care were included, 10 from US integrated healthcare systems, one from Canada. Findings indicate that when teams are understaffed and work environments are stressful, patient care and staff wellbeing suffer. However, a good relational climate can buffer against burnout and protect patient care. Good team dynamics and team cohesion have a greater impact on job satisfaction and patient care coordination than team composition; stable team membership is also important. Better patient experiences are associated with female physicians. However, these same physicians are at higher risk of burnout. Conclusion: Evidence regarding team composition and team climate in relation to staff and patient outcomes remains limited. Challenges exist when drawing conclusions across different team compositions and differing definitions of team climate. Future research may benefit from exploring the conditions that generate a productive team climate.

The concept of early nutrition programming is appearing in policy documents, leaflets and magazine articles with different types of statements. However, the level of representation and influence of this concept is unknown in the area of infant nutrition. We established the degree of reflection and the impact of the concept of nutrition programming among the different government stakeholders of infant nutrition in four European countries. In each country, a list of stakeholders in the area of infant feeding was established and key persons responsible for the remit of infant nutrition were identified. We conducted standardised face-to-face or phone interviews from January 2006 to January 2007. The interview guide included questions about the concept of nutrition programming. All interviews were digitally recorded and qualitative data analysis was done using QRS NVivo V2. In total, we analyzed 17 interviews from government organizations in England (5 interviews), Germany (4 interviews), Hungary (3 interviews) and Spain (5 interviews). The concept of nutrition programming was recognized from 4/5 English and 3/4 German interviewees, whereby one organisation reflected the concept in their documents in both countries. In Hungary, 1/3 interviewees recognised the concept and reflected it in their documents. All interviewed Spanish governmental bodies (5/5) recognised the concept of nutrition programming and three of them reflected the concept in their documents. The concept of early nutrition programming was widely recognized among the key persons of government bodies in all four European countries. However, the concept was not necessarily represented in the produced documents.

OBJECTIVES: To evaluate the effectiveness, acceptability and costs of Active Residents in Care Homes, ARCH - a programme aiming to increase opportunities for activity in older care home residents. DESIGN: Feasibility study. SETTING: Residential care homes for older people. PARTICIPANTS: 10-15 residents, staff and family members will be recruited in each of the three participating care homes. INTERVENTION: ARCH is a 12-month 'whole-systems' programme implemented by occupational therapists and physiotherapists. They will conduct a comprehensive assessment of each care home, considering the physical environment, working practices and organisation structure as well as residents' individual needs, and recommend ways to address barriers and increase residents' activity levels. The therapists will then work with staff to improve understanding of the issues, instigate training, environmental, organisational and working practice changes as necessary. MAIN OUTCOME MEASURES: Residents' activity levels, health and quality of life will be tested using several measures to see which are practicable and appropriate for this population in this context. This includes: Assessment of Physical Activity in Frail Older People; Pool Activity Level Checklist; Dementia Care Mapping observations; and EQ-5D-5L. Residents will be assessed prior to programme implementation then 4- and 12-months post-implementation. Semi-structured interviews will explore the experiences of residents, staff, family members and therapists. CONCLUSIONS: Providing evidence of effectiveness and acceptability of ARCH, and documenting factors that impede/facilitate implementation will help us identify ways to enhance the care and quality of life of older people in residential care, and our understanding of how to implement them. TRIAL REGISTRATION: ISRCTN24000891.

Background Early or timely recognition of dementia is a key policy goal of the National Dementia Strategy. However, older people who are homeless are not considered in this policy and practice imperative, despite their high risk of developing dementia. Objectives and study design This 24-month study was designed to (1) determine the prevalence of memory problems among hostel-dwelling homeless older people and the extent to which staff are aware of these problems; (2) identify help and support received, current care and support pathways; (3) explore quality of life among older homeless people with memory problems; (4) investigate service costs for older homeless people with memory problems, compared with services costs for those without; and (5) identify unmet needs or gaps in services. Participants Following two literature reviews to help study development, we recruited eight hostels – four in London and four in North England. From these, we first interviewed 62 older homeless people, exploring current health, lifestyle and memory. Memory assessment was also conducted with these participants. Of these participants, 47 were included in the case study groups – 23 had ‘memory problems’, 17 had ‘no memory problems’ and 7 were ‘borderline’. We interviewed 43 hostel staff who were participants’ key workers. We went back 3 and 6 months later to ask further about residents’ support, service costs and any unmet needs. Findings Overall, the general system of memory assessment for this group was found to be difficult to access and not patient-centred. Older people living in hostels are likely to have several long-term conditions including mental health needs, which remain largely unacknowledged. Participants frequently reported experiences of declining abilities and hostel staff were often undertaking substantial care for residents. Limitations The hostels that were accessed were mainly in urban areas, and the needs of homeless people in rural areas were not specifically captured. For many residents, we were unable to access NHS data. Many hostel staff referred to this study as ‘dementia’ focused when introducing it to residents, which may have deterred recruitment. Conclusions To the best of our knowledge, no other study and no policy acknowledges hostels as ‘dementia communities’ or questions the appropriateness of hostel accommodation for people with dementia. Given the declining number of hostels in England, the limits of NHS engagement with this sector and growing homelessness, this group of people with dementia are under-recognised and excluded from other initiatives. Future work A longitudinal study could follow hostel dwellers and outcomes. Ways of improving clinical assessment, record-keeping and treatment could be investigated. A dementia diagnosis could trigger sustained care co-ordination for this vulnerable group.

Background Older people living in care homes often have limited life expectancy. Practitioners and policymakers are increasingly questioning the appropriateness of many acute hospital admissions and the quality of end-of-life care provided in care homes.Aim To describe care home residents’ trajectories to death and care provision in their final weeks of life.Design and setting Prospective study of residents in six residential care homes in three sociodemographically varied English localities: Hertfordshire, Essex, and Cambridgeshire. Method Case note reviews and interviews with residents, care home staff, and healthcare professionals.Results Twenty-three out of 121 recruited residents died during the study period. Four trajectories to death were identified: ‘anticipated dying’ with an identifiable end-of-life care period and death in the care home (n = 9); ‘unexpected dying’ with death in the care home that was not anticipated and often sudden (n = 3); ‘uncertain dying’ with a period of diagnostic uncertainty or difficult symptom management leading to hospital admission and inpatient death (n = 7); and ‘unpredictable dying’ with an unexpected event leading to hospital admission and inpatient death (n = 4). End-of-life care tools were rarely used. Most residents who had had one or more acute hospital admission were still alive at the end of the study.Conclusion For some care home residents there was an identifiable period when they were approaching the end-of-life and planned care was put in place. For others, death came unexpectedly or during a period of considerable uncertainty, with care largely unplanned and reactive to events.

Background: While most people faced with a terminal illness would prefer to die at home, less than a third in England are enabled to do so with many dying in National Health Service hospitals. Patients are more likely to die at home if their carers receive professional support. Hospice rapid response teams, which provide specialist palliative care at home on a 24/7 on-call basis, are proposed as an effective way to help terminally ill patients die in their preferred place, usually at home. However, the effectiveness of rapid response teams has not been rigorously evaluated in terms of patient, carer and cost outcomes. Methods/Design: The study is a pragmatic quasi-experimental controlled trial. The primary outcome for the quantitative evaluation for patients is dying in their preferred place of death. Carers quality of life will be evaluated using postal questionnaires sent at patient intake to the hospice service and eight months later. Carers perceptions of care received and the patients death will be assessed in one to one interviews at 6 to 8 months post bereavement. Service utilisation costs including the rapid response intervention will be compared to those of usual care. Discussion: The study will contribute to the development of the evidence base on outcomes for patients and carers and costs of hospice rapid response teams operating in the community. Trial registration: Current controlled trials ISRCTN32119670. © 2012 Butler et al.; licensee BioMed Central Ltd.

Introduction: Diet is one of many factors influencing a child’s mental performance. but little is known about the beliefs. attitudes and knowledge of parents. and how these affect food choices. A survey of parents of children aged 4-10 years was conducted in four European countries (England. Germany. Hungary. Spain) to explore their views about the effect of diet on children’s attention and ability to learn. Objectives: Diet is one of many factors influencing a child’s mental performance. but little is known about the beliefs. attitudes and knowledge of parents. and how these affect food choices. A survey of parents of children aged 4-10 years was conducted in four European countries (England. Germany. Hungary. Spain) to explore their views about the effect of diet on children’s attention and ability to learn. Method/Design: A questionnaire was designed. translated and piloted in the four countries. Parents of children in mainstream education and without diagnosed pathologies such as Attention Deficit Hyperactivity Disorder were recruited through online panels accessed by a market research company. Background information was collected on respondents’ personal characteristics (household composition and demography. socioeconomic status. education. ethnicity). The questionnaire explored views on the relationship between diet and physical and mental development. attention and ability to learn. and how such considerations affected food choices. Results: 1604 parents completed the questionnaire (401 in England. Germany and Hungary. 403 in Spain); 61% female (range 54% Spain – 68% England). Most respondents had completed higher education (range 66% England – 39% Hungary). Almost one half were current smokers (range 42% England – 52% Germany). Many parents thought that a child’s ability to learn was very much . extremely dependent on diet (71% overall. range 64% Spain – 78% Hungary). but smaller proportions reported that they considered this (very much. extremely) when providing food for their child (51% overall. range 47% England and Hungary – 55 % Germany). Differences between views and reported behaviours of parents were smaller for other aspects of mental performance. Conclusions: Parents may belief that diet affects mental performance but other factors. such as providing variety and overall healthiness of diet. may be more important in the food choices they make for their children.

Background Local services in the United Kingdom National Health Service enable autonomous provision of medication by nurses, supporting individual nurses to gain prescribing qualifications or by introducing local patient group directions. Aim To compare nurse prescribing and patient group directions about clinic processes, patients' experiences, and costs from the perspectives of providers, nurses, and patients. Design Mixed methods, comparative case study in five urban sexual health services in the United Kingdom. Methods Data were collected from nurse prescribers, patient group direction users and their patients July 2015 to December 2016. Nurse questionnaires explored training (funding and methods). Nurses recorded consultation durations and support from other professionals in clinical diaries. Patient notes were reviewed to explore medication provision, appropriateness and safety; errors were judged by an expert panel. Patients completed satisfaction questionnaires about consultations and information about medications. Results Twenty-eight nurse prescribers and 67 patient group directions users took part; records of 1682 consultations were reviewed, with 1357 medications prescribed and 98.5% therapeutically appropriate. Most medication decisions were deemed safe (96.0% nurse prescribers, 98.7% patient group directions, Fisher's Exact Test p = .55). Errors were predominantly minor (55.6% nurse prescribers, 62.4% patient group directions) and related to documentation omissions (78.0%); no patients were harmed. Consultation durations and unplanned re-consultations were similar for both groups. Nurse prescribers sought assistance from colleagues less frequently (chi-squared = 46.748, df = 1, p < .001) but spent longer discussing cases. Nurse prescribing training required more resources from providers and nurses, compared with patient group directions. Nurse prescribers were on higher salary bands. Patient satisfaction was high in both groups (>96%). Conclusions Nurse medication provision by both nurse prescribers and patient group direction users is safe and associated with high patient satisfaction; effects on clinic processes and costs are similar. Undertaking the prescribing qualification involves independent study but may bring longer-term career progression to nurses.

Objectives To explore the supportive care needs of cancer survivors, the characteristics of patients with high levels of unmet need, changes in unmet need after treatment ends and differences in unmet needs of breast, colorectal and testicular survivors. Methods The method used was a prospective longitudinal mailed survey. Unmet needs, measured by 25-item modified Cancer Survivors Unmet Needs survey at baseline (immediately post-treatment) and 8 months later, were analysed descriptively. Results Of 434 breast, 186 colorectal and 75 testicular patients responding at baseline, 56.2%, 65.6% and 50.7%, respectively, had no unmet needs, the top decile having >= 10 (breast) or seven (colorectal and testicular) different needs and seven different unmet needs. The most frequently reported unmet need (all groups) was fear of cancer recurrence. Unmet needs fell significantly at 8 months for breast patients. Some patients reported new needs. Needs were lowest amongst colorectal survivors and differed between the three groups. Higher levels of unmet needs (breast and colorectal) were associated with having had chemotherapy. Conclusion Most survivors reported few unmet needs, but a small proportion have persisting or emerging needs. Routine or regular monitoring of unmet needs is required so that healthcare professionals can deliver personalised care based on individual needs, preferences and circumstances.

In the UK secondary care setting, the case for physician associates is based on the cover and stability they might offer to medical teams. We assessed the extent of their adoption and deployment - that is, their current usage and the factors supporting or inhibiting their inclusion in medical teams - using an electronic, self-report survey of medical directors of acute and mental health NHS trusts in England. Physician associates - employed in small numbers, in a range of specialties, in 20 of the responding trusts - were reported to have been employed to fill gaps in medical staffing and support medical specialty trainees. Inhibiting factors were commonly a shortage of physician associates to recruit and lack of authority to prescribe, as well as a lack of evidence and colleague resistance. Our data suggest there is an appetite for employment of physician associates while practical and attitudinal barriers are yet to be fully overcome.

Background Two-thirds of people living with dementia live at home in the UK and many experience distressing behavioural and psychological symptoms. This systematic review evaluates the effectiveness of non-pharmacological interventions for behavioural and psychological symptoms among community-dwelling people living with dementia. Methods This two-stage review undertook an initial mapping of the literature followed by a systematic review of relevant randomised controlled trials. We searched electronic databases for pertinent studies reporting outcomes from interventions from January 2000 to March 2015 and updated searches in October 2016. We included studies that considered behavioural and psychological symptom management for older people living with dementia who live at home and excluded studies conducted in long-term care settings. This paper presents findings from a narrative synthesis of 48 randomised controlled trials evaluating interventions for people living with dementia alone, family carers alone and patient-carer dyads. Results We retrieved 17,871 de-duplicated records and screened them for potential inclusion. Evidence from 48 randomised controlled trials suggests that family carer training and educational programmes that target problem behaviours and potential triggers can improve outcomes. Nurses and occupational therapists appear to help people with dementia with behavioural and psychological symptoms, but professional comparisons are lacking and there is no shared language about or understanding of behavioural and psychological symptoms amongst professionals, or between professionals and family carers. Conclusions Future research should focus on the effectiveness of components of multi-faceted programmes and their cost effectiveness and include qualitative data to better target interventions for behavioural and psychological symptoms. It is important to consider family carer readiness to use non-pharmacological strategies and to develop a shared language about the inherent needs and communications of behavioural and psychological symptoms.

Background:Alcohol-related harm is currently estimated to cost the National Health Service (NHS) in England £3.5 bn a year. Of the estimated 1.6 million people with some degree of alcohol dependence, some 600,000 are believed to be moderately or severely dependent and may benefit from intensive treatment. Outcomes from medically assisted withdrawal, also referred to as detoxification, are often poor, with poor engagement in relapse prevention interventions and subsequent high relapse rates. Detoxification is costly both financially and to the individual. It has been found that people who experience multiple detoxifications show more emotional and cognitive impairments. These changes may confer upon them the inability to resolve conflict and increased sensitivity to stress thus contributing to increased vulnerability risk of relapse. The study aims to test the feasibility of using a group intervention aiming to prepare participants for long-term abstinence before, rather than after, they have medically assisted detoxification. The current study will establish key parameters that influence trial design such as recruitment, compliance with the intervention, retention, and sensitivity of alternative outcome measures, in preparation for a future randomised controlled trial (RCT). This paper presents the protocol of the feasibility study. Methods:The study corresponds to phase 2 of the Medical Research Council (MRC) complex interventions guidelines which cover the development and feasibility testing of an intervention. The work is in three stages. The development, adaptation and implementation of the Structured Preparation before Alcohol Detoxification (SPADe) intervention (stage 1), a randomised feasibility study with economic evaluation (stage 2) and a qualitative study (stage 3). Fifty participants will be recruited from two community alcohol treatment services in England. Participants will be randomised in two arms: the treatment as usual arm (TAU), which includes planned medically assisted detoxification and aftercare and the intervention arm in which participants will receive structured group preparation before detoxification in addition to TAU. The main outcomes are duration of continuous abstinence with no incidents of lapse or relapse, percentage of days abstinent and time to relapse. Discussion:The socioeconomic harms associated with alcohol have been well-documented, yet existing treatment options have not been able to reduce high relapse rates. This study will build on existing naturalistic studies underpinned by psychological interventions offered early and before detoxification from alcohol, which aim to reverse automatised habitual behaviours and thus may help us to understand how better to support people to remain abstinent and improve post detoxification outcomes.

Objectives: Maintaining physical activity for older residents in care homes maximises their physical and mental health and wellbeing, independence, dignity and quality of life. Unfortunately, most residents do not participate in regular physical activity. Active Residents in Care Homes, ARCH, was designed to increase physical activity by facilitating whole-system change in a care home. We evaluated whether ARCH can be delivered, its effects on resident’s physical activity, wellbeing and costs. Design: Feasibility study. Setting: Three residential care homes. Participants: Care home residents and staff. Intervention: Occupational and physiotherapists implemented ARCH over 4 months with an 8-month follow-up. Main outcome measures: Assessment of Physical Activity, Pool Activity Level, EQ5D-5 L, Dementia Care Mapping, cost of implementing ARCH, health and social care utilisation. Results: After implementing ARCH, residents displayed more positive behaviours, better mood and engagement and higher physical activity levels, but these improvements were not sustained at 8-month follow-up. The cost (2016 prices) of implementing ARCH was £61,037, which equates to £1,650/resident. Healthcare utilisation was £295/resident (SD320) in the 4 months prior to ARCH, £308/resident (SD406) during the 4-month implementation and £676/resident (SD438) in the 8-month follow-up. Conclusions: The ARCH programme can be delivered, it may have some short-term benefits and is affordable. Rather than have unrealistic increases in the health and longevity of older care home residents, ARCH may slow the decline in physical, mental and emotional well-being usually seen in older people in care homes, return some dignity and improve their quality of life in their last months or years.

Abstract Background Individuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members) and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support but outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) puts an emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence? Methods This is a pragmatic, parallel, two-arm, feasibility RCT comparing SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community addiction services in London. Feasibility outcomes, exploration of primary and secondary clinical outcomes and health economic outcomes are analysed. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. Results We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial for the whole period of the 12 months was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months, respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n = 54.5) versus control (n = 41.5). Conclusions The results of this feasibility trial indicate that with the appropriate modifications, a full multicentred trial would be possible to test the effectiveness and cost-effectiveness of a pre-habilitation approach such as the SPADe group intervention in addition to usual care against usual care only. Trial registration Name of registry: ISRCTN; Trial Registration Number: 14621127; Date of Registration: 22/02/2017.

South Asians are at high risk of type 2 diabetes (T2D). We assessed whether intensive family-based lifestyle intervention leads to significant weight loss, improved glycaemia and blood pressure in adults at elevated risk for T2D. This cluster randomised controlled trial (iHealth-T2D) was conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. We included 3684 South Asian men and women, aged 40-70 years, without T2D but with raised haemoglobin A1c (HbA1c) and/or waist circumference. Participants were randomly allocated either to the family-based lifestyle intervention or control group by location clusters. Participants in the intervention received 9 visits and 13 telephone contacts by community health workers over 1-year period, and the control group received usual care. Reductions in weight (aim >7% reduction), waist circumference (aim ≥5 cm reduction), blood pressure and HbA1C at 12 months of follow-up were assessed. Our linear mixed-effects regression analysis was based on intention-to-treat principle and adjusted for age, sex and baseline values. There were 1846 participants in the control and 1838 in the intervention group. Between baseline and 12 months, mean weight of participants in the intervention group reduced by 1.8 kg compared with 0.4 kg in the control group (adjusted mean difference -1.10 kg (95% CI -1.70 to -1.06), p

To compare the satisfaction of patients managed by independent nurse prescribers with that of patients managed by nurses using PGDs with respect to experience of the consultation and information received about the medication. Survey. Patients receiving medications from nurses in five urban sexual health services in the United Kingdom completed validated questionnaires immediately after the consultation, September 2015-August 2016. Scores of independent nurse prescribers and nurses using patient group directions were compared about consultation experience (5 items) Satisfaction with Information about Medicines (SIMS 16 items scale). Of 808 patients receiving medications, 393 (48.6%) received questionnaires and 380 were returned (independent nurse prescribers 180 of 198, 90.9%; patient group directions 173 of 195, 88.7%). Patients in both groups reported high levels of satisfaction. About the consultation experience, patients found nurses friendly/ approachable (>99%), instilling confidence and trust (>99%) and explaining reasons for medications clearly (97%). Satisfaction with medication information: Of 348 (92%) respondents completing SIMS, the overall mean score was 13.4 of maximum 16 (no difference between groups, t-test, p = .63). Patients were highly satisfied with nurse consultations and information around medications regardless of whether they were managed by independent nurse prescribers or nurses using patient group directions. Findings provide evidence in support of autonomous provision of medications by nurses in sexual health clinics.

The aim of this Study was to know how the early nutrition programming concept and its relation with long-term diseases such as obesity is reflected in policy recommendations on infant nutrition in five European countries (Finland, Germany. Hungary, Spain and England). After collating and evaluating infant nutrition policy documents, statements about early nutrition programming, as the origin of diseases such as obesity, were analysed. The number of policy documents analysed were 38 (England: 10, Finland: 2, Germany: 11, Hungary: 8, Spain: 7) with a total of 455 statements identified and categorized into 53 different health outcomes. Obesity was mentioned in 5.5% (n = 25) of the statements, the third most frequent outcome after allergy (14.1%, n = 64) and health in general (5.7%, n = 26). Twenty six percent (it = 6) of the obesity related statements referred to short-term duration of the effects, 48% (n = 12) to medium-term, 24% (n = 6) to long-term effects and the rest were not identified. Only 22% of the obesity statements were evidence based. The link between infant feeding and obesity is integrated into policy documents, but most of the statements did not fully specify the short, medium and long term health implications. Action may be required to keep documents up to date as new evidence emerges and to ensure the evidence base is properly recorded.

Background and aims: Ascites develops in about 90% with advanced cirrhosis; when refractory to medical therapy, standard of care is repeated large volume paracentesis (LVP) with albumin support. Refractory ascites (RA) confers a median life expectancy of six months without liver transplantation (LT). LVP is not an optimal palliative strategy. One alternative is long-term abdominal drains (LTAD), used in advanced malignant ascites, also enabling community management. Our ultimate aim is to improve end of life care (EoLC) in advanced cirrhosis and RA. This feasibility randomised controlled trial (RCT) aimed to resolve uncertainties in designing a definitive RCT. Method: Multicentre feasibility RCT with 1:1 randomisation between standard of care (LVP) vs. LTAD (Rocket Medical) in adults with RA, ineligible for LT. Both arms received prophylactic antibiotics. LTAD were inserted under ultrasound guidance. Community nurses undertook home visits to drain ascites dependent on symptoms; (maximum 6L/week), without albumin support. Follow-up was 12 weeks with home visits every two weeks for the following assessments: clinical, questionnaire based to include quality of life, palliative care needs, carer burden and health economics (HE). Here we report clinical and HE outcomes. Results: Thirty six patients were randomised; 19 LVP (two withdrew, wanting LTAD) and 17 LTAD (one withdrew-insufficient ascites). Mean age (years) LTAD vs. LVP 66 + 10.4 vs. 68 ± 12; predominately male (76% vs. 74%). Participants were well matched at baseline in liver tests and prognostic scores: LTAD vs. LVP (serum bilirubin (μmol/L) 26 ± 15.8 vs. 16 ±10, serum albumin (g/L) 33 ± 4.2 vs. 31 ± 3.3, serum creatinine (mmol/L) 113 ± 46.7 vs.118 ± 53.1; MELD 14 ± 4.6 vs. 16 ± 7.2). One LTAD participant required hospitalisation for repeated LVP. Serum albumin (g/L) in the LTAD arm declined to 29 ± 3.3 at week two, subsequently remaining stable LTAD vs. LVP (29 ± 5.6 vs. 31 ± 5.5). Serum creatinine remained stable in both arms. There were no LTAD related serious adverse reactions. LTAD related adverse reactions included mild cellulitis (n = 4) and small volume leakage around LTAD insertion site (n = 3), all resolving rapidly. Peritonitis was rare, LTAD (possible) n = 1 and LVP n = 2. Overall mortality was 36% (12/33). Mortality and median survival (days in those who died) were 7/16 (44%) vs. 5/17 (29%), 53 days (IQR 43) vs. 61 days (IQR 35) in LTAD vs. LVP respectively. All but one death was liver related. Those in LTAD arm spent ≈20% less time in hospital. All nine alive in the LTAD arm at end of study elected to keep LTAD in. Detailed clinical and HE analysis is underway. Conclusion: Preliminary data from the REDUCe study supports the safety and efficacy of palliative LTAD in RA due to advanced cirrhosis. LTAD allows successful management in the community with reduction in health resource utilisation. Proceeding to a definitive RCT is justified.

OBJECTIVES: To calculate the prevalence of long term catheter use in the community in two areas in the south and west of England. SUBJECTS/PATIENTS (OR MATERIALS) AND METHODS: People in England register with general practices to access health care through a National Health Service. Catheters are provided by prescription free of charge. In 2008, patients using urinary catheters for over 3 months were identified, and demographic information collected, from databases of general practices, using catheter prescribing records. The age and sex distributions of people in each practice were obtained from capitation claims. Overall, and age and sex-specific prevalence were calculated separately for each area, and compared. RESULTS: A total of 583 long term catheter users (329 south, 254 west) were identified from 404,328 people registered with practices. The overall population prevalence is similar in both locations (0.146% southern, 0.141% western). Extrapolating for the United Kingdom, this is over 90,000 long term catheter users. Prevalence increases with age (0.732% in over 70 years, 1.224% over 80), especially amongst men. Overall, higher proportions have neurological (vs. non-neurological) reasons (62.9% vs. 37.1%) and use urethral (vs. suprapubic) catheters (59.7% vs. 40.3%). Compared to men, more women tend to use suprapubic (56.4% vs. 29.3%) and have a catheter for neurological reasons (71.8% vs. 56.2%, P = 0.053). CONCLUSIONS: Previous evidence on prevalence of long term catheter use is sparse, and of variable quality. The strength of this study is utilisation of a reliable source of data (catheter prescriptions) from a large population of patients. Neurourol. Urodynam. © 2016 Wiley Periodicals, Inc.

Objective: Complex cardiac devices including implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices can safely be implanted as a day case procedure as opposed to overnight stay. We assess how common day case complex device therapy is and the cost implications of more widespread adoption across the UK. Methods: A freedom of information request was sent to all centres performing complex cardiac devices across the UK to assess the adoption of this technique. Cost implications were assessed using Department of Health National Schedule of Reference Costs 2016–2017. Results: 100 UK centres were surveyed, 80% replied. Eighty per cent of UK centres already implant complex cardiac devices as a day case to some extent. 64.06% of centres have a protocol for this. 12.82% of centres do ˂25% of complex devices as a day case. 15.38% do 25%–50% as day case. 17.95% do 50%–75% as day case and 33.33% do ˃75% as day case. There was no relationship between centre volume and the proportion of devices done as a day case as opposed to overnight stay. The cost saving of performing a complex device as a day case as opposed to overnight stay was £412 per ICD, £525 per CRT-pacemaker and £2169 per CRT-defibrillator. Conclusions: Day case complex devices are already widespread across the UK, however, there is scope for increase. An increase in proportion of day case devices could translate to £5 583 265 in savings annually for the National Health Service if all centres performed 75% of devices as a day case.

Background:Increasing demand for hospital services and staff shortages has led NHS organisations to review workforce configurations. One solution has been to employ physician associates (PAs). PAs are trained over 2 years at postgraduate level to work to a supervising doctor. Little is currently known about the roles and impact of PAs working in hospitals in England. Objectives:(1) To investigate the factors influencing the adoption and deployment of PAs within medical and surgical teams in secondary care and (2) to explore the contribution of PAs, including their impact on patient experiences, organisation of services, working practices, professional relationships and service costs, in acute hospital care. Methods:This was a mixed-methods, multiphase study. It comprised a systematic review, a policy review, national surveys of medical directors and PAs, case studies within six hospitals utilising PAs in England and a pragmatic retrospective record review of patients in emergency departments (EDs) attended by PAs and Foundation Year 2 (FY2) doctors. Results:The surveys found that a small but growing number of hospitals employed PAs. From the case study element, it was found that medical and surgical teams mainly used PAs to provide continuity to the inpatient wards. Their continuous presence contributed to smoothing patient flow, accessibility for patients and nurses in communicating with doctors and releasing doctors’ (of all grades) time for more complex patients and for attending to patients in clinic and theatre settings. PAs undertook significant amounts of ward-based clinical administration related to patients’ care. The lack of authority to prescribe or order ionising radiation restricted the extent to which PAs assisted with the doctors’ workloads, although the extent of limitation varied between teams. A few consultants in high-dependency specialties considered that junior doctors fitted their team better. PAs were reported to be safe, as was also identified from the review of ED patient records. A comparison of a random sample of patient records in the ED found no difference in the rate of unplanned return for the same problem between those seen by PAs and those seen by FY2 doctors (odds ratio 1.33, 95% confidence interval 0.69 to 2.57; p = 0.40). In the ED, PAs were also valued for the continuity they brought and, as elsewhere, their input in inducting doctors in training into local clinical and hospital processes. Patients were positive about the care PAs provided, although they were not able to identify what or who a PA was; they simply saw them as part of the medical or surgical team looking after them. Although the inclusion of PAs was thought to reduce the need for more expensive locum junior doctors, the use of PAs was primarily discussed in terms of their contribution to patient safety and patient experience in contrast to utilising temporary staff. Limitations:PAs work within medical and surgical teams, such that their specific impact cannot be distinguished from that of the whole team. Conclusions:PAs can provide a flexible advanced clinical practitioner addition to the secondary care workforce without drawing from existing professions. However, their utility in the hospital setting is unlikely to be fully realised without the appropriate level of regulation and attendant authority to prescribe medicines and order ionising radiation within their scope of practice. Future research:Comparative investigation is required of patient experience, outcomes and service costs in single, secondary care specialties with and without PAs and in comparison with other types of advanced clinical practitioners. Study registration:The systematic review component of this study is registered as PROSPERO CRD42016032895. Funding:The National Institute for Health Research Health Services and Delivery Research programme.

BackgroundAlternative models of cancer follow-up care are needed to ameliorate pressure on services and better meet survivors’ long-term needs. This paper reports an evaluation of a service improvement initiative for the followup care of prostate cancer patients based on remote monitoring and supported self-management. Methods:This multi-centred, historically controlled study compared patient reported outcomes of men experiencing the new Programme with men experiencing a traditional clinic appointment model of follow-up care, who were recruited in the period immediately prior to the introduction of the Programme. Data were collected by self-completed questionnaires, with follow up measurement at four and eight months post-baseline. The primary outcome was men’s unmet survivorship needs, measured by the Cancer Survivors’ Unmet Needs Survey. Secondary outcomes included cancer specific quality of life, psychological wellbeing and satisfaction with care. The analysis was intention to treat. Regression analyses were conducted for outcomes at each time point separately, controlling for pre-defined clinical and demographic variables. All outcome analyses are presented in the paper. Costs were compared between the two groups. Results: Six hundred and twenty-seven men (61%) were consented to take part in the study (293 in the Programme and 334 in the comparator group.) Regarding the primary measure of unmet survivorship needs, 25 of 26 comparisons favoured the Programme, of which 4 were statistically significant. For the secondary measures of activation for self-management, quality of life, psychological well-being and lifestyle, 20 of 32 comparisons favoured the Programme and 3 were statistically significant. There were 22 items on the satisfaction with care questionnaire and 13 were statistically significant. Per participant costs (British pounds, 2015) in the 8 month follow up period were slightly lower in the programme than in the comparator group (£289 versus £327). The Programme was acceptable to patients. Conclusion:The Programme is shown to be broadly comparable to traditional follow-up care in all respects, adding to evidence of the viability of such models.

Overweight and obesity is a global problem incurring substantial health and economic implications. This has also been highlighted by the ongoing COVID-19 pandemic which has disproportionately affected overweight and obese individuals. Most of the interventions have concentrated on promotion of physical activities and healthy eating which may involve current sacrifices for future health gains. The purpose of this study was to explore the relationship between bodyweight and how individuals state they would trade-off immediate income for higher amounts in the future (time preference). An online survey was conducted targeting adults aged >16 years in the UK (England, Northern Ireland, Scotland, and Wales) from January 1, 2016 to July 31, 2016. Using paid online adverts, as well as personal and professional networks for distribution of links to the online survey, the questionnaire asked respondents to report socio-economic and demographic information, height, and weight and to complete a time preference exercise. Data were analysed using descriptive statistics; associations were explored between BMI and respondents' characteristics and time preference using Spearman rank-order correlation and χ2 tests as appropriate. We adopted STROBE guidelines for the reporting of the study. A total of 561 responses were analysed (female = 293, males = 268). The relationship between time preference and overweight/obesity, using BMI as the measure is highly significant (χ2 = 95.92: p < 0.001). Individuals of normal weight have low time preferences and are more likely to invest in activities in a bid to reap future health benefits. There are also significant relationships between BMI and employment status (χ2 = 37.03; p < 0.001), physical activities (p < 0.0001), income levels (χ2 = 6.68; p < 0.035), family orientation, i.e., with or without children (χ2 = 12.88; p < 0.012), and ethnicity (χ2 = 18.31; p < 0.001). These imply that individuals in employment and with children in their families are less likely to be overweight or obese compared to those who do not. People from black backgrounds are also more likely to be overweight or obese and have higher time preferences compared to people from white backgrounds. People's preventive behaviours today can be predicted by their time preference and this understanding could be vital in improving population's uptake and maintenance of overweight and obesity prevention actions. People who have low time preference are more likely to invest time and resources in physical activities and healthy lifestyles to reap future health benefits hence value utilities-in-anticipation. Public health programmes should therefore use the knowledge of the association between time preference and overweight/obesity to inform designs of intervention programmes.

Palliative care remains suboptimal in end-stage liver disease.

Background There are limited case-mix classification systems for primary care settings which are applicable when considering the optimal clinical skill mix to provide services. Aim To develop a case-mix classification system (CMCS) and test its impact on analyses of patient outcomes by clinician type, using example data from physician associates’ (PAs) and GPs' consultations with same-day appointment patients. Design & setting Secondary analysis of controlled observational data from six general practices employing PAs and six matched practices not employing PAs in England. Method Routinely-collected patient consultation records (PA n = 932, GP n = 1154) were used to design the CMCS (combining problem codes, disease register data, and free text); to describe the case-mix; and to assess impact of statistical adjustment for the CMCS on comparison of outcomes of consultations with PAs and with GPs. Results A CMCS was developed by extending a system that only classified 18.6% (213/1147) of the presenting problems in this study's data. The CMCS differentiated the presenting patient’s level of need or complexity as: acute, chronic, minor problem or symptom, prevention, or process of care, applied hierarchically. Combination of patient and consultation-level measures resulted in a higher classification of acuity and complexity for 639 (30.6%) of patient cases in this sample than if using consultation level alone. The CMCS was a key adjustment in modelling the study’s main outcome measure, that is rate of repeat consultation. Conclusion This CMCS assisted in classifying the differences in case-mix between professions, thereby allowing fairer assessment of the potential for role substitution and task shifting in primary care, but it requires further validation.

Purpose:Evidence is increasing for effective virtual reality therapy for motor rehabilitation for children with Cerebral Palsy. We assessed the feasibility of a virtual reality therapy mode of intervention, appropriateness of measures, and potential cost-effectiveness. Methods:A 12-week, 2-group, parallel-feasibility trial (ISRCT 17624388) using Nintendo Wii FitTM at home. Children aged 5–16, with ambulatory Cerebral Palsy, who were able to follow simple instructions were randomised to two groups; one supported by physiotherapists (individualised activity programme), the other unsupported with children having free choice (control). Children were assessed in clinic at baseline, week 6, and week 12 by blinded assessors. Feasibility of the intervention was assessed via recruitment, adherence, and usefulness of measurement tools. Results:Forty-four children were eligible (out of 48 approached): 31 consented, 30 were randomised, 21 completed the study; 10 in the supported group and 11 in the unsupported group. Nine children discontinued from tiredness, after-school activities, homework, surgery, technical difficulties or negative system feedback. The supported group completed 19 of 36 (IQR 5-35) possible sessions; the unsupported group 24 of 36 sessions (IQR 8-36). Gross Motor Function Measure scores varied by Cerebral Palsy severity after the intervention. There were no adverse events. Conclusion: Virtual reality therapy offers potential as a therapeutic adjunct for children with Cerebral Palsy, warranting substantive confirmatory study. Gross Motor Function Measure, with modifications to improve sensitivity, appeared appropriate as a primary measure, with Timed up and Go test secondary. The intervention was inexpensive costing £20 per child. An explanatory trial to evaluate the clinical/cost effectiveness of commercial system virtual reality therapy is feasible with minor methodological adaptation.

Background: Care homes are the institutional providers of long-term care for older people. The OPTIMAL study argued that it is probable that there are key activities within different models of health-care provision that are important for residents’ health care. Objectives: To understand ‘what works, for whom, why and in what circumstances?’. Study questions focused on how different mechanisms within the various models of service delivery act as the ‘active ingredients’ associated with positive health-related outcomes for care home residents. Methods: Using realist methods we focused on five outcomes: (1) medication use and review; (2) use of out-of-hours services; (3) hospital admissions, including emergency department attendances and length of hospital stay; (4) resource use; and (5) user satisfaction. Phase 1: interviewed stakeholders and reviewed the evidence to develop an explanatory theory of what supported good health-care provision for further testing in phase 2. Phase 2 developed a minimum data set of resident characteristics and tracked their care for 12 months. We also interviewed residents, family and staff receiving and providing health care to residents. The 12 study care homes were located on the south coast, the Midlands and the east of England. Health-care provision to care homes was distinctive in each site. Findings: Phase 1 found that health-care provision to care homes is reactive and inequitable. The realist review argued that incentives or sanctions, agreed protocols, clinical expertise and structured approaches to assessment and care planning could support improved health-related outcomes; however, to achieve change NHS professionals and care home staff needed to work together from the outset to identify, co-design and implement agreed approaches to health care. Phase 2 tested this further and found that, although there were few differences between the sites in residents’ use of resources, the differences in service integration between the NHS and care homes did reflect how these institutions approached activities that supported relational working. Key to this was how much time NHS staff and care home staff had had to learn how to work together and if the work was seen as legitimate, requiring ongoing investment by commissioners and engagement from practitioners. Residents appreciated the general practitioner (GP) input and, when supported by other care home-specific NHS services, GPs reported that it was sustainable and valued work. Access to dementia expertise, ongoing training and support was essential to ensure that both NHS and care home staff were equipped to provide appropriate care. Limitations: Findings were constrained by the numbers of residents recruited and retained in phase 2 for the 12 months of data collection. Conclusions: NHS services work well with care homes when payments and role specification endorse the importance of this work at an institutional level as well as with individual residents. GP involvement is important but needs additional support from other services to be sustainable. A focus on strategies that promote co-design-based approaches between the NHS and care homes has the potential to improve residents’ access to and experience of health care. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Ensuring that healthcare teams have a mix of skilled professionals to meet patient needs and deliver safe and cost-effective services is a major imperative in all health services. The health services in the UK, like a number of other countries, have been exploring the contribution that physician assistants (PAs) can make to healthcare teams including primary care. PAs are well established in the USA, where they have a recognized qualification and undertake physical examinations, investigations, diagnosis, treatment and prescribing within their scope of practice as agreed with their supervising doctor. The first UK-trained PAs graduated in 2009 from post-graduate courses, which are modeled closely on those in the USA to a UK agreed set of competencies and curriculum. There is evidence of the substantive employment of PAs in primary care teams in England. The UK has a well-developed primary care system, with most care delivered via general practice teams which generally include a mix of medical, nursing and support staff. The extent of the employment of PAs in primary care in the England and their contribution within the team to patient care is unknown. This paper reports on a survey that investigated these questions.

Background: Physician associates are new to English general practice and set to expand in numbers. Objective: To investigate the patients’ perspective on consulting with physician associates in general practice. Design: A qualitative study, using semi-structured interviews, with thematic analysis. Setting and participants: Thirty volunteer patients of 430 who had consulted ­physician associates for a same-day appointment and had returned a satisfaction survey, in six general practices employing physician associates in England. Findings: Some participants only consulted once with a physician associate and others more frequently. The conditions consulted for ranged from minor illnesses to those requiring immediate hospital admission. Understanding the role of the physician associate varied from ‘certain and correct’ to ‘uncertain’, to ‘certain and incorrect’, where the patient believed the physician associate to be a doctor. Most, but not all, reported positive experiences and outcomes of their consultation, with some choosing to consult the physician. Those with negative experiences described problems when the limits of the role were reached, requiring additional GP consultations or prescription delay. Trust and confidence in the physician associate was derived from trust in the NHS, the general practice and the individual physician associate. Willingness to consult a physician associate was contingent on the patient’s assessment of the severity or complexity of the problem and the desire for provider continuity. Conclusion: Patients saw physician associates as an appropriate general practitioner substitute. Patients’ experience could inform delivery redesign.

A quasi-experimental study tested a clinical benchmarking tool (Essence of Care) to improve bowel-related care for older people living in six care homes. In the intervention care homes, district nurses and care home staff used the clinical benchmarking tool to discuss and plan how to improve bowel care for residents. In the control care homes, staff were provided with detailed information about the residents and continence services contact details. The intervention was acceptable to care home and district nursing staff, and possible to incorporate into existing working patterns. The study did not demonstrate a significant reduction in bowel-related problems, although there was evidence in one care home of reduction in episodes of avoidable faecal incontinence. At an individual level of care, there were observable benefits, and examples of person-centred care were prompted through participating in the intervention and improved staff awareness. Clinical benchmarking tools can be used to structure discussion between district nurses and care home staff to review and plan care for residents. However, it takes time to achieve change and embedding this kind of approach requires either robust pre-existing working relationships or the involvement of a facilitator.