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IntroductionPrimary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.Methods and analysisMixed methods will be used: (1) design: intervention content will be compared with ‘usual care’; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.Ethics and disseminationFavourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.Trial registration numberNCT03353519; Pre-results.

INTRODUCTION: Stroke survivors have complex health needs requiring long-term, integrated care. This study aimed to elicit generalists' and specialists' experience of stroke-related interprofessional communication, including perceived barriers and enablers. DESIGN AND SETTING: Qualitative study involving generalist (primary care) and specialist services (acute and community) in England. Six focus groups (n = 48) were conducted. METHOD: Healthcare professionals were purposively selected and invited to participate. Audio-recordings were transcribed verbatim and analysed using Framework Analysis. RESULTS: Four themes were identified: 1) Generalists and specialists have overlapping roles but are working in silos; 2) Referral decision-making process as influential to generalist-specialist communication; 3) Variable quality of communication; and 4) Improved dialogue between generalist and specialist services. CONCLUSIONS: Generalists and specialists recognise the need for better communication with each other. Current care is characterised by silo-based working that ignores the contribution of other sectors. Failure to bridge this communication gap will result in people with stroke continuing to experience unmet stroke needs and fragmented care.

Background There is guidance in the United Kingdom about what long-term care stroke survivors should receive, but a lack of guidance about who should deliver it and where this care should take place. This is a key issue given the evidence that current needs are not well addressed. The purpose of this study was to explore when a referral from generalist to specialist services is appropriate in the long-term management of stroke survivors. Methods A modified RAND-Appropriateness method was used to gain consensus from a range of stroke specialist and generalist clinicians. Ten panelists rated fictional patient scenarios based on long-term post-stroke needs. Round 1 was an online survey in which panelists rated the scenarios for a) need for referral to specialist care and b) if referral was deemed necessary, need for this to be specifically to a stroke specialist. Round 2 was a face-to-face meeting in which panelists were presented with aggregate scores from round 1, and invited to discuss and then re-rate the scenarios. Results Seventeen scenarios comprising 69 referral decisions were discussed. Consensus on whether the patient needed to be referred to a specialist was achieved for 59 (86%) decisions. Of the 44 deemed needing referral to specialists, 18 were judged to need referral to a stroke-specialist and 14 to a different specialist. However, for 12 decisions there was no consensus about which specialist the patient should be referred to. For some scenarios (spasticity; incontinence; physical disability; communication; cognition), referral was deemed to be indicated regardless of severity, whereas indications for referral for topics such as risk factor management and pain depended on complexity and/or severity. Conclusions There was broad agreement about when a stroke survivor requires referral to specialist care, but less agreement about destination of referral. Nevertheless, there was agreement that some of the longer-term issues facing stroke survivors are best addressed by stroke specialists, some by other specialists, and some by primary care. This has implications for models of longer-term stroke care, which need to reflect that optimal care requires access to, and better co-ordination between, both generalist and specialist healthcare.

IntroductionSurvival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care.Methods and analysisImproving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation.Ethics and disseminationFavourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan.Trial registration numberNCT03353519

© The Author(s) 2018. Objectives. Evidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA. Methods. A trial-based cost-utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective. Results. The UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £-62.10 to £562.60; TEA-UC: £141.80, 95% CI: £-135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: -0.015, 95% CI: -0.057 to 0.026; TEA-UC: -0.003, 95% CI: -0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability < 40% of ITE or TEA cost-effective at £20 000/QALY). Differences in total costs were attributable to intervention costs, number of visits to NHS consultants and knee surgery, which were higher in both ITE and TEA groups. Conclusion. This is the first economic evaluation comparing usual physical therapy care vs enhanced exercise interventions for knee OA that involves greater exercise individualization, supervision and progression or that focuses on exercise and physical activity adherence over the longer term. Our findings show that UC is likely to be the most cost-effective option., This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (grant number: RP-PG-0407-10386) and the Arthritis Research UK Centre in Primary Care grant (grant number: 18139). Time from E.L.H. was supported, in part, by the NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands and time from M.A.H. was supported, in part, by the NIHR School for Primary Care Research. N.E.F. was supported through an NIHR Research Professorship (NIHR-RP-011-015). N.E.F. and E.M.H. are NIHR Senior Investigators. The NIHR Clinical Research Network West Midlands (previously PCRN West Midlands North) and North Staffordshire Primary Care Research Consortium provided additional funding for GP and physical therapy Research Facilitators to support engagement of NHS providers in the BEEP trial; NIHR PCRN West Midlands North funded NHS service support costs for the delivery of the trial.

Objective\ud To explore whether participating in the Benefits of Effective Exercise for knee Pain (BEEP) trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain in older adults.\ud \ud Design\ud Before/after training program evaluation. Physiotherapists were asked to complete a questionnaire before the BEEP trial training program, immediately after, and 12 to 18 months later (postintervention delivery in the BEEP trial). The questionnaire included a case vignette and associated clinical management questions. Questionnaire responses were compared over time and between physiotherapists trained to deliver each intervention within the BEEP trial.\ud \ud Setting\ud Primary care.\ud \ud Participants\ud Physiotherapists (N=53) who completed the BEEP trial training program.\ud \ud Interventions\ud Not applicable.\ud \ud Main Outcome Measures\ud Self-confidence in the diagnosis and management of knee pain in older adults; and intended clinical behavior measured by a case vignette and associated clinical management questions.\ud \ud Results\ud Fifty-two physiotherapists (98%) returned the pretraining questionnaire, and 44 (85%) and 39 (74%) returned the posttraining and postintervention questionnaires, respectively. Posttraining, self-confidence in managing older adults with knee pain increased, and intended clinical behavior regarding exercise for knee pain in older adults appeared more in line with clinical guidelines. However, not all positive changes were maintained in the longer-term.\ud \ud Conclusions\ud Participating in the BEEP trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain, but by 12 to 18 months later, some of these positive changes were lost. This suggests that brief training programs are useful, but additional strategies are likely needed to successfully maintain changes in clinical behavior over time.

BACKGROUND: Compared to the general population, the Traveller community has substantial health inequalities. Vaccination coverage in Traveller children is estimated to be low and Travellers are at higher risk of vaccine-preventable diseases due to their social circumstances. METHODS: Audit of vaccination history of Traveller (n = 214) and non-Traveller (n = 776) children registered at a general practice in England. The Green Book childhood immunization schedule was used as a reference standard. RESULTS: There was significantly lower coverage for Traveller children compared to non-Traveller children for all vaccinations in the routine childhood immunization schedule. The percentage of children completing the schedule at all time points was significantly lower in the Traveller community. CONCLUSIONS: Traveller communities have significantly lower uptake of vaccinations, and therefore Travellers' children should be targeted by general practitioners for catch-up vaccination to improve outcomes for individuals and local herd immunity.

BACKGROUND: Medications are highly effective at reducing risk of recurrent stroke, but success is influenced by adherence to treatment. Among survivors of stroke and transient ischaemic attack (TIA), adherence to medication is known to be suboptimal. AIM: To identify and report barriers to medication adherence for the secondary prevention of stroke/TIA. DESIGN AND SETTING: A qualitative interview study was conducted within general practice surgeries in the East of England, UK. METHOD: Patients were approached by letter and invited to take part in a qualitative research study. Semi-structured interviews were undertaken with survivors of stroke, caregivers, and GPs to explore their perspectives and views around secondary prevention and perceived barriers to medication adherence. Key themes were identified using a grounded theory approach. Verbatim quotes describing the themes are presented here. RESULTS: In total, 28 survivors of stroke, including 14 accompanying caregivers and five GPs, were interviewed. Two key themes were identified. Patient level barriers included ability to self-care, the importance people attach to a stroke event, and knowledge of stroke and medication. Medication level barriers included beliefs about medication and beliefs about how pills work, medication routines, changing medications, and regimen complexity and burden of treatment. CONCLUSION: Patients who have had a stroke are faced with multiple barriers to taking secondary prevention medications in UK general practice. This research suggests that a collaborative approach between caregivers, survivors, and healthcare professionals is needed to address these barriers and facilitate medication-taking behaviour.

OBJECTIVES: To understand the perspectives of stroke survivors, caregivers and general practitioners (GPs) on a polypill approach, consisting of blood pressure and cholesterol-lowering therapies, with or without aspirin, for the secondary prevention of stroke. METHODS: A qualitative interview study was undertaken in 5 GP surgeries in the East of England. 28 survivors of stroke/transient ischaemic attack (TIA) were interviewed, 14 of them with a caregiver present, along with a convenience sample of 5 GPs, to assess attitudes towards a polypill and future use. Topic guides explored participants attitudes, potential uptake and long-term use, management of polypill medication and factors influencing the decision to prescribe. Data were analysed using a grounded theory approach. Key themes are presented and illustrated with verbatim quotes. RESULTS: The analysis identified 3 key themes: polypill benefits, polypill concerns and polypill lessons for implementation. Stroke/TIA survivors were positive about the polypill concept and considered it acceptable in the secondary prevention of stroke. Perceived benefits of a polypill included convenience resulting in improved adherence and reduced burden of treatment. Caregivers felt that a polypill would improve medication-taking practices, and GPs were open to prescribing it to those at increased cardiovascular risk. However, concerns raised included whether a polypill provided equivalent therapeutic benefit, side effects through combining medications, consequences of non-adherence, lack of flexibility in regulating dosage, disruption to current treatment and suitability to the wider stroke population. CONCLUSIONS: Participants acknowledged potential advantages in a polypill approach for secondary prevention of stroke; however, significant concerns remain. Further research on the efficacy of a polypill is needed to reassure practitioners whose concerns around inflexibility and treatment suitability are likely to influence the decision to prescribe a polypill for secondary prevention of stroke. Acceptability among survivors, caregivers and GPs is likely to determine the uptake and subsequent use of a polypill in the future.

OBJECTIVE: This review explored whether cardiorespiratory fitness or physical activity act as either confounders or effect modifiers of the relationship between adiposity markers and all-cause mortality in older adults. METHODS: Systematic searches were carried out to identify observational studies that examined the association of adiposity markers (BMI, waist circumference, and waist-hip ratio) with all-cause mortality in adults aged ≥ 60 which took into account cardiorespiratory fitness or physical activity. Data from each included study was analyzed to produce a graphical representation of this relationship. RESULTS: Fourteen of the fifteen identified studies found that increasing BMI had a non-positive association with all-cause mortality, with persistence of the obesity paradox despite adjustment for physical activity or cardiorespiratory fitness. Physical activity measurement methods were all subjective and often unvalidated. The two studies stratifying for cardiorespiratory fitness did not find that fitness had a significant impact on the relationship between excess adiposity and mortality but found that overweight and fit people had better survival than normal-weight unfit people, CONCLUSIONS: The predominant use of poor physical activity measurement suggests that studies are currently not adequately accounting for possible physical activity confounding. More studies are needed for addressing the modification of the relationship between adiposity markers and mortality by cardiorespiratory fitness.

STUDY DESIGN: Within-study cost-utility analysis. OBJECTIVE:To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within risk-defined patient subgroups (that is, patients at low, medium, and high risk of persistent disabling pain). SUMMARY OF BACKGROUND DATA: Individual-level data collected alongside a prospective, sequential comparison of separate patient cohorts with 6-month follow-up. METHODS: Adopting a cost-utility framework, the base case analysis estimated the incremental LBP-related health care cost per additional quality-adjusted life year (QALY) by risk subgroup. QALYs were constructed from responses to the 3-level EQ-5D, a preference-based health-related quality of life instrument. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses examined alternative methodological approaches, including a complete case analysis, the incorporation of non-back pain-related health care use and estimation of societal costs relating to work absence. RESULTS: Stratified care was a dominant treatment strategy compared with usual care for patients at high risk, with mean health care cost savings of £124 and an incremental QALY estimate of 0.023. The likelihood that stratified care provides a cost-effective use of resources for patients at low and medium risk is no greater than 60% irrespective of a decision makers' willingness-to-pay for additional QALYs. Patients at medium and high risk of persistent disability in paid employment at 6-month follow-up reported, on average, 6 fewer days of LBP-related work absence in the stratified care cohort compared with usual care (associated societal cost savings per employed patient of £736 and £652, respectively). CONCLUSION: At the observed level of adherence to screening tool recommendations for matched treatments, stratified care for LBP is cost-effective for patients at high risk of persistent disabling LBP only. LEVEL OF EVIDENCE: 2.

Background Exercise therapy for knee pain and osteoarthritis remains a key element of conservative treatment, recommended in clinical guidelines. Yet systematic reviews point to only modest benefits from exercise interventions. One reason for this might be that clinical trials tend to use a one-size-fits-all approach to exercise, effectively disregarding the details of their participants' clinical presentations. This uncontrolled before-after study (TargET-Knee-Pain) aims to test the principle that exercises targeted at the specific physical impairments of older adults with knee pain may be able to significantly improve those impairments. It is a first step towards testing the effectiveness of this more individually-tailored approach. Methods/Design We aim to recruit 60 participants from an existing observational cohort of community-dwelling older adults with knee pain. Participants will all have at least one of the three physical impairments of weak quadriceps, a reduced range of knee flexion and poor standing balance. Each participant will be asked to undertake a programme of exercises, targeted at their particular combination and degree of impairment(s), over the course of twelve weeks. The exercises will be taught and progressed by an experienced physiotherapist, with reference to a "menu" of agreed exercises for each of the impairments, over the course of six fortnightly home visits, alternating with six fortnightly telephone calls. Primary outcome measures will be isometric quadriceps strength, knee flexion range of motion, timed single-leg standing balance and the "Four Balance Test Scale" at 12 weeks. Key secondary outcome measures will be self-reported levels of pain, stiffness and difficulties with day-to-day functional tasks (WOMAC). Outcome measures will be taken at three time-points (baseline, six weeks and twelve weeks) by a study nurse blinded to the exercise status of the participants. Discussion This study (TargET-Knee-Pain) is the first step towards exploring whether an impairment-targeted approach to exercise prescription for older adults with knee pain may have sufficient efficacy to warrant further testing. If warranted, future randomised clinical trials may compare this approach with more traditional one-size-fits-all exercise approaches. Trial registration Current Controlled Trials ISRCTN61638364.

Background Prognostic assessment tools to identify subgroups of patients at risk of persistent low back pain who may benefit from targeted treatments have been developed and validated in primary care. The IMPaCT Back study is investigating the effects of introducing and supporting a subgrouping for targeted treatment system in primary care. Methods/Design A prospective, population-based, quality improvement study in one Primary Care Trust in England with a before and after design. Phases 1 and 3 collect data on current practice, attitudes and behaviour of health care practitioners, patients' outcomes and health care costs. Phase 2 introduces and supports the subgrouping for targeted treatment system, via a multi-component, quality improvement intervention that includes educational courses and outreach visits led by opinion leaders, audit/feedback, mentoring and organisational support to embed the subgrouping tools within IT and clinical management systems. We aim to recruit 1000 low back pain patients aged 18 years and over consulting 7 GP practices within one Primary Care Trust in England, UK. The study includes GPs in participating practices and physiotherapists in associated services. The primary objective is to determine the effect of the subgrouping for targeted treatment system on back pain related disability and catastrophising at 2 and 6 months, comparing data from phase 1 with phase 3. Key secondary objectives are to determine the impact on: a) GPs' and physiotherapists' attitudes and behaviour regarding low back pain; b) The process of care that patients receive; c) The cost-effectiveness and sustainability of the new clinical system. Discussion This paper details the rationale, design, methods, planned analysis and operational aspects of the IMPaCT Back study. We aim to determine whether the new subgrouping for targeted treatment system is implemented and sustained in primary care, and evaluate its impact on clinical decision-making, patient outcomes and costs. Study registration International Standard Randomised Controlled Trial Number Register ISRCTN55174281