'ThinkCancer!' - Randomised feasibility trial of a novel practice-based early cancer diagnosis intervention.

BACKGROUND: UK cancer deaths remain high; primary care is key for earlier cancer diagnosis as half of avoidable delays occur here. Improvement is possible through lower referral thresholds, better guideline adherence, and better safety netting systems. Few interventions target whole practice teams. We developed a novel whole practice team intervention to address this. AIM: To test the feasibility and acceptability of a novel, complex behavioural intervention 'ThinkCancer!' for assessment in a subsequent Phase III trial. DESIGN & SETTING: Pragmatic, superiority pilot RCT with an embedded process evaluation and feasibility economic analysis in Welsh general practices. METHOD: Clinical outcome data were collected from practices (the unit of randomisation). Practice characteristics and cancer safety netting systems were assessed. Individual practice staff completed evaluation and feedback forms, and qualitative interviews. The intervention was adapted and refined. RESULTS: Trial recruitment and workshop deliveries took place between March 2020 to May 2021. Trial progression criteria for recruitment, intervention fidelity and routine data collection were met. Staff-level fidelity, retention and individual level data collection processes were reviewed and amended. Interviews highlighted positive participant views on all aspects of the intervention. All practices set out to liberalise referral thresholds appropriately, implement guidelines, and address safety netting plans in detail. CONCLUSION: 'ThinkCancer!' appears feasible and acceptable; the new iteration of the workshops was completed, and the Phase III trial has been funded to assess the effectiveness and cost effectiveness of this novel professional behaviour change intervention. Delivery at scale to multiple practices will likely improve fidelity and reach.

Effectiveness and cost-effectiveness of a web-based cardiac rehabilitation programme for people with chronic stable angina: protocol for the ACTIVATE (Angina Controlled Trial Investigating the Value of the 'Activate your heart' Therapeutic E-intervention) randomised controlled trial.

INTRODUCTION: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group. The objectives of this study are to compare the effectiveness and cost-effectiveness of the 'Activate Your Heart' cardiac rehabilitation programme for people with chronic stable angina compared with usual care. METHODS AND ANALYSIS: ACTIVATE is a multicentre, parallel-group, two-arm, superiority, pragmatic randomised controlled trial, with recruitment from primary and secondary care centres in England and Wales and a target sample size of 518 (1:1 allocation; allocation sequence by minimisation programme with built-in random element). The study uses secure web-based allocation concealment. The two treatments will be optimal usual care (control) and optimal usual care plus the 'Activate Your Heart' web-based cardiac rehabilitation programme (intervention). Outcome assessment and statistical analysis will be performed blinded; participants will be unblinded. Outcomes will be measured at baseline and at 6 and 12 months' follow-up. Primary outcome will be the UK version of Seattle Angina Questionnaire (SAQ-UK), physical limitations domain at 12 months' follow-up. Secondary outcomes will be the remaining two domains of SAQ-UK, dyspnoea, anxiety and depression, health utility, self-efficacy, physical activity and the incremental shuttle walk test. All safety events will be recorded, and serious adverse events assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be cost-utility analysis from health service perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme. ETHICS AND DISSEMINATION: North of Scotland National Health Service Research Ethics Committee approval, reference 21/NS/0115. Participants will provide written informed consent. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN10054455.

Antihypertensive treatment in people of very old age with frailty: time for a paradigm shift?

The optimal management of hypertension in individuals aged 80 years or older with frailty remains uncertain due to multiple gaps in evidence. Complex health issues, polypharmacy, and limited physiological reserve make responding to antihypertensive treatments unpredictable. Patients in this age group may have limited life expectancy, so their quality of life should be prioritized when making treatment decisions. Further research is needed to identify which patients would benefit from more relaxed blood pressure targets and which antihypertensive medications are preferable or should be avoided. A paradigm shift is required in attitudes towards treatment, placing equal emphasis on deprescribing and prescribing when optimizing care. This review discusses the current evidence on managing hypertension in individuals aged 80 years or older with frailty, but further research is essential to address the gaps in knowledge and improve the care of this population.

Barriers to and facilitators of physical activity in adults living with and beyond cancer, with special emphasis on head and neck cancer: a systematic review of qualitative and mixed methods studies.

PURPOSE: Physical activity can improve health outcomes for cancer patients; however, only 30% of patients are physically active. This review explored barriers to and facilitators of physical activity promotion and participation in patients living with and beyond cancer. Secondary aims were to (1) explore similarities and differences in barriers and facilitators experienced in head and neck cancer versus other cancers, and (2) identify how many studies considered the influence of socioeconomic characteristics on physical activity behaviour. METHODS: CINAHL Plus, MEDLINE, PsycINFO, Scopus and Cochrane (CDSR) were searched for qualitative and mixed methods evidence. Quality assessment was conducted using the Mixed Methods Appraisal Tool and a Critical Appraisal Skills Programme Tool. Thematic synthesis and frequency of reporting were conducted, and results were structured using the Capability-Opportunity-Motivation-Behaviour model and Theoretical Domains Framework. RESULTS: Thirty qualitative and six mixed methods studies were included. Socioeconomic characteristics were not frequently assessed across the included studies. Barriers included side effects and comorbidities (physical capability; skills) and lack of knowledge (psychological capability; knowledge). Having a dry mouth or throat and choking concerns were reported in head and neck cancer, but not across other cancers. Facilitators included improving education (psychological capability; knowledge) on the benefits and safety of physical activity. CONCLUSION: Educating patients and healthcare professionals on the benefits and safety of physical activity may facilitate promotion, uptakeand adherence. Head and neck cancer patients experienced barriers not cited across other cancers, and research exploring physical activity promotion in this patient group is required to improve physical activity engagement.

Effects of different exercise types on quality of life for patients with atrial fibrillation: a systematic review and meta-analysis.

AIM: To investigate the effectiveness of exercise and the most effective types of exercise for patients with atrial fibrillation (AF) to improve health-related quality of life (HRQoL) and exercise capacity, and reduce AF burden, AF recurrence and adverse events. METHODS AND RESULTS: Systematic search in PubMed, Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL Plus, and SPORTDiscus for randomized controlled trials (RCTs) and nonrandomized pre-post intervention studies investigating the effect of different types of exercise on AF patients. After exclusion, 12 studies (11 RCTs, 1 prepost) with a total of 670 participants were included. Exercise interventions consisted of aerobic exercise, aerobic interval training (AIT), Qigong, yoga, and exercise-based cardiac rehabilitation (CR). There were significant positive effects of exercise on general health {mean difference [MD] = 6.42 [95% confidence interval (CI): 2.90, 9.93]; P = 0.0003; I2 = 17%} and vitality [MD = 6.18 (95% CI: 1.94, 10.41); P = 0.004; I2 = 19%)] sub-scales of the Short Form 36-item questionnaire (SF-36). Qigong resulted in a significant improvement in the 6-min walk test [MD = 105.00m (95% CI: 19.53, 190.47)]. Exercise-based CR and AIT were associated with a significant increment in V̇O2peak, and AIT significantly reduced AF burden. Adverse events were few and one intervention-related serious adverse event was reported for exercise-based CR. CONCLUSION: Exercise led to improvements in HRQoL, exercise capacity, and reduced AF burden. The available exercise interventions for AF patients are few and heterogeneous. Future studies are needed for all types of exercise intervention in this patient group to (co-)develop an optimized exercise training intervention for AF patients.

STIMULATE-ICP-CAREINEQUAL (Symptoms, Trajectory, Inequalities and Management: Understanding Long-COVID to Address and Transform Existing Integrated Care Pathways) study protocol: Defining usual care and examining inequalities in Long Covid support.

INTRODUCTION: Individuals with Long Covid represent a new and growing patient population. In England, fewer than 90 Long Covid clinics deliver assessment and treatment informed by NICE guidelines. However, a paucity of clinical trials or longitudinal cohort studies means that the epidemiology, clinical trajectory, healthcare utilisation and effectiveness of current Long Covid care are poorly documented, and that neither evidence-based treatments nor rehabilitation strategies exist. In addition, and in part due to pre-pandemic health inequalities, access to referral and care varies, and patient experience of the Long Covid care pathways can be poor. In a mixed methods study, we therefore aim to: (1) describe the usual healthcare, outcomes and resource utilisation of individuals with Long Covid; (2) assess the extent of inequalities in access to Long Covid care, and specifically to understand Long Covid patients' experiences of stigma and discrimination. METHODS AND ANALYSIS: A mixed methods study will address our aims. Qualitative data collection from patients and health professionals will be achieved through surveys, interviews and focus group discussions, to understand their experience and document the function of clinics. A patient cohort study will provide an understanding of outcomes and costs of care. Accessible data will be further analysed to understand the nature of Long Covid, and the care received. ETHICS AND DISSEMINATION: Ethical approval was obtained from South Central-Berkshire Research Ethics Committee (reference 303958). The dissemination plan will be decided by the patient and public involvement and engagement (PPIE) group members and study Co-Is, but will target 1) policy makers, and those responsible for commissioning and delivering Long Covid services, 2) patients and the public, and 3) academics.

General medical services by non-medical health professionals: a systematic quantitative review of economic evaluations in primary care.

BACKGROUND: Previous systematic reviews have found that nurses and pharmacists can provide equivalent, or higher, quality of care for some tasks performed by GPs in primary care. There is a lack of economic evidence for this substitution. AIM: To explore the costs and outcomes of role substitution between GPs and nurses, pharmacists, and allied health professionals in primary care. DESIGN AND SETTING: A systematic review of economic evaluations exploring role substitution of allied health professionals in primary care was conducted. Role substitution was defined as 'the substitution of work that was previously completed by a GP in the past and is now completed by a nurse or allied health professional'. METHOD: The following databases were searched: Ovid MEDLINE, CINAHL, Cochrane Library, National Institute for Health and Care Excellence (NICE), and the Centre for Reviews and Dissemination. The review followed guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). RESULTS: Six economic evaluations were identified. There was some limited evidence that nurse-led care for common minor health problems was cost-effective compared with GP care, and that nurse-led interventions for chronic fatigue syndrome and pharmacy-led services for the medicines management of coronary heart disease and chronic pain were not. In South Korea, community health practitioners delivered primary care services for half the cost of physicians. The review did not identify studies for other allied health professionals such as physiotherapists and occupational therapists. CONCLUSION: There is limited economic evidence for role substitution in primary care; more economic evaluations are needed.

Development of an intervention to expedite cancer diagnosis through primary care: a protocol.

BACKGROUND: GPs can play an important role in achieving earlier cancer diagnosis to improve patient outcomes, for example through prompt use of the urgent suspected cancer referral pathway. Barriers to early diagnosis include individual practitioner variation in knowledge, attitudes, beliefs, professional expectations, and norms. AIM: This programme of work (Wales Interventions and Cancer Knowledge about Early Diagnosis [WICKED]) will develop a behaviour change intervention to expedite diagnosis through primary care and contribute to improved cancer outcomes. DESIGN & SETTING: Non-experimental mixed-method study with GPs and primary care practice teams from Wales. METHOD: Four work packages will inform the development of the behaviour change intervention. Work package 1 will identify relevant evidence-based interventions (systematic review of reviews) and will determine why interventions do or do not work, for whom, and in what circumstances (realist review). Work package 2 will assess cancer knowledge, attitudes, and behaviour of GPs, as well as primary care teams' perspectives on cancer referral and investigation (GP survey, discrete choice experiment [DCE], interviews, and focus groups). Work package 3 will synthesise findings from earlier work packages using the behaviour change wheel as an overarching theoretical framework to guide intervention development. Work package 4 will test the feasibility and acceptability of the intervention, and determine methods for measuring costs and effects of subsequent behaviour change in a randomised feasibility trial. RESULTS: The findings will inform the design of a future effectiveness trial, with concurrent economic evaluation, aimed at earlier diagnosis. CONCLUSION: This comprehensive, evidence-based programme will develop a complex GP behaviour change intervention to expedite the diagnosis of symptomatic cancer, and may be applicable to countries with similar healthcare systems.

Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture.

OBJECTIVES: To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation. DESIGN: Mixed methods process evaluation in a randomised feasibility study. SETTING: Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge. PARTICIPANTS: Sixty-one older adults (aged ≥65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers. INTERVENTIONS: Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions. PROCESS EVALUATION COMPONENTS: Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context. RESULTS: Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goal-setting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions. CONCLUSIONS: Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care. TRIAL REGISTRATION NUMBER: ISRCTN22464643; Post- results.

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).

BACKGROUND: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. METHODS: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. RESULTS: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. CONCLUSIONS: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

BACKGROUND: Health economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants' recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases.The aim was to test methods for obtaining these data and compare with those data collected using the CSRI, within a feasibility study of an enhanced rehabilitation intervention following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation: FEMuR). METHODS: Primary care activity including prescribing data was obtained from the Secure Anonymised Information Linkage (SAIL) Databank and secondary care activity (Emergency Department attendances, out-patient visits and in-patient days) directly from Betsi Cadwaladr University Health Board (BCUHB), North Wales, UK. These data were compared with patient responses from the CSRI using descriptive statistics and the intraclass correlation coefficient (ICC). RESULTS: It was possible to compare health service resource use data for 49 out of 61 participants in the FEMuR study. For emergency department (ED) attendances, records matched in 23 (47%) cases, 21 (43%) over-reported on electronic records compared with CSRI and five participants (10%) under-reported, with an overall ICC of 0.42. For out-patient episodes, records matched in only six cases, 28 participants over-reported on electronic records compared with CSRI and 15 (12%) under-reported, with an overall ICC of only 0.27. For in-patient days, records matched exactly in only five cases (10%), but if an error margin of 7 days was allowed, then agreement rose to 39 (66%) cases, and the overall ICC for all data was 0.88.It was only possible to compare prescribing data for 12 participants. For prescribing data, the SAIL data reported 117 out of 118 items (99%) and the CSRI only 89 (79%) items. CONCLUSIONS: The use of routinely collected data has the potential to improve the efficiency of trials and other studies. Although the methodology to make the data available has been demonstrated, the data obtained was incomplete and the validity of using this method remains to be demonstrated. TRIAL REGISTRATION: Trial registration: ISRCTN22464643 Registered 21 July 2014.

Preferences of older patients regarding hip fracture rehabilitation service configuration: A feasibility discrete choice experiment.

OBJECTIVE: As part of a wider feasibility study, the feasibility of gaining older patients' views for hip fracture rehabilitation services was tested using a discrete choice experiment in a UK context. DESIGN: Discrete choice experiment is a method used for eliciting individuals' preferences about goods and services. SUBJECTS/PATIENTS: The discrete choice experiment was administered to 41 participants who had experienced hip fracture (mean age 79.3 years; standard deviation (SD) 7.5 years), recruited from a larger feasibility study exploring a new multidisciplinary rehabilitation for hip fracture. METHODS: Attributes and levels for this discrete choice experiment were identified from a systematic review and focus groups. The questionnaire was administered at the 3-month follow-up. RESULTS: Participants indicated a significant preference for a fully-qualified physiotherapist or occupational therapist to deliver the rehabilitation sessions (ß = 0·605, 95% confidence interval (95% CI) 0.462-0.879), and for their rehabilitation session to last less than 90 min (ß = -0.192, 95% CI -0.381 to -0.051). CONCLUSION: The design of the discrete choice experiment using attributes associated with service configuration could have the potential to inform service implementation, and assist rehabilitation service design that incorporates the preferences of patients.

Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

BACKGROUND: Biological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. DESIGN: Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. SETTING: Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. PARTICIPANTS: Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. INTERVENTIONS: After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. MAIN OUTCOME MEASURES: Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. SAMPLE SIZE: To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t-test and 80% retention rate, 332 participants would have needed to be recruited. ANALYSIS PLAN: The primary effectiveness analysis would have been linear mixed models for repeated measures to measure the effects of time and group allocation. An internal pilot study would have involved the first 50 participants recruited across all centres. The primary economic analysis would have been a cost-utility analysis. RESULTS: The internal pilot study was discontinued as a result of low recruitment after eight participants were recruited from two out of six sites. One site withdrew from the study before recruitment started, one site did not complete contract negotiations and two sites signed contracts shortly before trial closure. In the two sites that did recruit participants, recruitment was slow. This was partly because of operational issues, but also because of a low rate of uptake from potential participants. LIMITATIONS: Although large numbers of invitations were sent to potential participants, identified by retrospective searches of general practitioner (GP) records, there was a low rate of uptake. Two sites planned to recruit participants during GP consultations but opened too late to recruit any participants. CONCLUSION: The main failure was attributable to problems with contracts. Because of this we were not able to complete the internal pilot or to test all of the different methods for primary care recruitment we had planned. A trial of biological therapy in patients with sciatica still needs to be done, but would require a clearer contracting process, qualitative research to ensure that patients would be willing to participate, and simpler recruitment methods. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14569274. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 60. See the NIHR Journals Library website for further project information.

Development of an evidence-based complex intervention for community rehabilitation of patients with hip fracture using realist review, survey and focus groups.

OBJECTIVES: To develop an evidence and theory-based complex intervention for improving outcomes in elderly patients following hip fracture. DESIGN: Complex-intervention development (Medical Research Council (MRC) framework phase I) using realist literature review, surveys and focus groups of patients and rehabilitation teams. SETTING: North Wales. PARTICIPANTS: Surveys of therapy managers (n=13), community and hospital-based physiotherapists (n=129) and occupational therapists (n=68) throughout the UK. Focus groups with patients (n=13), their carers (n=4) and members of the multidisciplinary rehabilitation teams in North Wales (n=13). RESULTS: The realist review provided understanding of how rehabilitation interventions work in the real-world context and three programme theories were developed: improving patient engagement by tailoring the intervention to individual needs; reducing fear of falling and improving self-efficacy to exercise and perform activities of daily living; and coordination of rehabilitation delivery. The survey provided context about usual rehabilitation practice; focus groups provided data on the experience, acceptability and feasibility of rehabilitation interventions. An intervention to enhance usual rehabilitation was developed to target these theory areas comprising: a physical component consisting of six additional therapy sessions; and a psychological component consisting of a workbook to enhance self-efficacy and a patient-held goal-setting diary for self-monitoring. CONCLUSIONS: A realist approach may have advantages in the development of evidence-based interventions and can be used in conjunction with other established methods to contribute to the development of potentially more effective interventions. A rehabilitation intervention was developed which can be tested in a future randomised controlled trial (MRC framework phases II and III). TRIAL REGISTRATION NUMBER: ISRCTN22464643, Pre-results.

Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR).

BACKGROUND: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking. OBJECTIVES: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation. DESIGN: Phase I - realist review, survey and focus groups to develop the rehabilitation package. Phase II - parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study. SETTING: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge. PARTICIPANTS: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area. INTERVENTIONS: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients' self-efficacy and increasing the amount and quality of patients' practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions. MAIN OUTCOME MEASURES: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale - International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers. RESULTS: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n = 32; intervention, n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen's d = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen's d = 0.31) and 1.3 (Cohen's d = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information.

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture.

OBJECTIVE: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. SETTING: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. PARTICIPANTS: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. INTERVENTION: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. RESULTS: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT. TRIAL REGISTRATION NUMBER: ISRCTN22464643; Results.

Health professionals' perspectives on exercise referral and physical activity promotion in primary care: Findings from a process evaluation of the National Exercise Referral Scheme in Wales.

BACKGROUND AND OBJECTIVES: Referring clinicians' experiences of exercise referral schemes (ERS) can provide valuable insights into their uptake. However, most qualitative studies focus on patient views only. This paper explores health professionals' perceptions of their role in promoting physical activity and experiences of a National Exercise Referral Scheme (NERS) in Wales. DESIGN: Qualitative semi-structured group interviews. SETTING: General practice premises. METHODS: Nine semi-structured group interviews involving 46 health professionals were conducted on general practice premises in six local health board areas. Purposive sampling taking into account area deprivation, practice size and referral rates was employed. Interviews were transcribed verbatim and analysed using the Framework method of thematic analysis. RESULTS: Health professionals described physical activity promotion as important, although many thought it was outside of their expertise and remit, and less important than other health promotion activities such as smoking cessation. Professionals linked decisions on whether to advise physical activity to patients to their own physical activity levels and to subjective judgements of patient motivation. While some described ERS as a holistic alternative to medication, with potential social benefits, others expressed concerns regarding their limited reach and potential to exacerbate inequalities. Barriers to referral included geographic isolation and uncertainties about patient selection criteria, medico-legal responsibilities and a lack of feedback about patient progress. CONCLUSION: Clinicians' concerns about expertise, priority setting and time constraints should be addressed to enhance physical activity promotion in primary care. Further research is needed to fully understand decision making relating to provision of physical activity advice and use of ERS.

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643].

BACKGROUND: Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An 'enhanced rehabilitation' intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living. METHODS/DESIGN: This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants' preference for rehabilitation services will be assessed in a discrete choice experiment. DISCUSSION: Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643, UKCRN16677.

Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses.

BACKGROUND: There are numerous treatment approaches for sciatica. Previous systematic reviews have not compared all these strategies together. PURPOSE: To compare the clinical effectiveness of different treatment strategies for sciatica simultaneously. STUDY DESIGN: Systematic review and network meta-analysis. METHODS: We searched 28 electronic databases and online trial registries, along with bibliographies of previous reviews for comparative studies evaluating any intervention to treat sciatica in adults, with outcome data on global effect or pain intensity. Network meta-analysis methods were used to simultaneously compare all treatment strategies and allow indirect comparisons of treatments between studies. The study was funded by the UK National Institute for Health Research Health Technology Assessment program; there are no potential conflict of interests. RESULTS: We identified 122 relevant studies; 90 were randomized controlled trials (RCTs) or quasi-RCTs. Interventions were grouped into 21 treatment strategies. Internal and external validity of included studies was very low. For overall recovery as the outcome, compared with inactive control or conventional care, there was a statistically significant improvement following disc surgery, epidural injections, nonopioid analgesia, manipulation, and acupuncture. Traction, percutaneous discectomy, and exercise therapy were significantly inferior to epidural injections or surgery. For pain as the outcome, epidural injections and biological agents were significantly better than inactive control, but similar findings for disc surgery were not statistically significant. Biological agents were significantly better for pain reduction than bed rest, nonopioids, and opioids. Opioids, education/advice alone, bed rest, and percutaneous discectomy were inferior to most other treatment strategies; although these findings represented large effects, they were statistically equivocal. CONCLUSIONS: For the first time, many different treatment strategies for sciatica have been compared in the same systematic review and meta-analysis. This approach has provided new data to assist shared decision-making. The findings support the effectiveness of nonopioid medication, epidural injections, and disc surgery. They also suggest that spinal manipulation, acupuncture, and experimental treatments, such as anti-inflammatory biological agents, may be considered. The findings do not provide support for the effectiveness of opioid analgesia, bed rest, exercise therapy, education/advice (when used alone), percutaneous discectomy, or traction. The issue of how best to estimate the effectiveness of treatment approaches according to their order within a sequential treatment pathway remains an important challenge.