When is referral from primary care to specialist services appropriate for survivors of stroke? A modified RAND-appropriateness consensus study.

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.

Using a checklist to facilitate management of long-term care needs after stroke: insights from focus groups and a feasibility study.

BACKGROUND: Long-term needs of stroke survivors are often not adequately addressed and many patients are dissatisfied with care post-discharge from hospital. Primary care could play an important role in identifying need in people with stroke. AIM: We aimed to explore, refine and test the feasibility and acceptability of a post-stroke checklist for stroke reviews in primary care. DESIGN AND SETTING: Focus groups (using a generic qualitative approach) and a single-centre feasibility study. METHOD: Five focus groups were conducted; three with healthcare providers and two with stroke survivors/carers. The focus groups discussed acceptability of a checklist approach and the content of an existing checklist. The checklist was then modified and piloted in one general practice surgery in the East of England. RESULTS: The qualitative data found the concept of a checklist was considered valuable to standardise stroke reviews and prevent post-stroke problems being missed. Items were identified that were missing from the original checklist: return to work, fatigue, intimate relationships and social activities. Time constraints was the main concern from healthcare professionals and pre-completion of the checklist was suggested to address this. Thirteen stroke survivors were recruited to the feasibility study. The modified checklist was found to be feasible and acceptable to patients and primary care clinicians and resulted in agreed action plans. CONCLUSION: The modified post-stroke checklist is a pragmatic and feasible approach to identify problems post-stroke and facilitate referral to appropriate support services. The checklist is a potentially valuable tool to structure stroke reviews using a patient-centred approach.

Content and Evaluation of the Benefits of Effective Exercise for Older Adults With Knee Pain Trial Physiotherapist Training Program.

OBJECTIVE: 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. DESIGN: 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. SETTING: Primary care. PARTICIPANTS: Physiotherapists (N=53) who completed the BEEP trial training program. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Impairment-targeted exercises for older adults with knee pain: a proof-of-principle study (TargET-Knee-Pain).

BACKGROUND: Therapeutic exercise is an effective intervention for knee pain and osteoarthritis (OA) and should be individualised. In a preliminary, proof-of-principle study we sought to develop a home exercise programme targeted at specific physical impairments of weak quadriceps, reduced knee flexion range of motion (ROM) and poor balance, and evaluate whether receipt of this was associated with improvements in those impairments and in patient-reported outcomes among older adults with knee pain. METHODS: This community-based study used a single group, before-after study design with 12-week follow-up. Participants were 58 adults aged over 56 years with knee pain and evidence of quadriceps weakness, loss of flexion ROM, or poor balance, recruited from an existing population-based, observational cohort. Participants received a 12-week home exercise programme, tailored to their physical impairments. The programme was led, monitored and progressed by a physiotherapist over six home visits, alternating with six telephone calls. Primary outcome measures were maximal isometric quadriceps strength, knee flexion ROM and timed single-leg standing balance, measured at baseline, 6 and 12 weeks by a research nurse blinded to the nature and content of participants' exercise programmes. Secondary outcome measures included the WOMAC. RESULTS: At 12 weeks, participants receiving strengthening exercises demonstrated a statistically significant change in quadriceps isometric strength compared to participants not receiving strengthening exercises: 3.9 KgF (95 % CI 0.1, 7.8). Changes in knee flexion ROM (2.1° (-2.3, 6.5)) and single-leg balance time (-2.4 s (-4.5, 6.7)) after stretching and balance retraining exercises respectively, were not found to be statistically significant. There were significant improvements in mean WOMAC Pain and Physical Function scores: -2.2 (-3.1, -1.2) and -5.1 (-7.8, -2.5). CONCLUSIONS: A 12-week impairment-targeted, home-based exercise programme for symptomatic knee OA appeared to be associated with modest improvements in self-reported pain and function but no strong evidence of greater improvement in the specific impairments targeted by each exercise package, with the possible exception of quadriceps strengthening. TRIAL REGISTRATION: Clinical Trial Registration Number: ISRCTN 61638364 Date of registration: 24 June 2010.

Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison.

PURPOSE: We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs. METHODS: The IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. RESULTS: The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed. CONCLUSIONS: Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended.

The development of a self-management intervention for stroke survivors - My Life After Stroke (MLAS).

PURPOSE: Long-term needs of stroke survivors (especially psychosocial needs and stroke prevention) are not adequately addressed. Self-management programmes exist but the optimal content and delivery approach is unclear. We aim to describe the process undertook to develop a structured self-management programme to address these unmet needs. MATERIALS AND METHODS: Based on the Medical Research Council framework for complex interventions, the development involved three phases: "Exploring the idea": Evidence synthesis and patient and public involvement (PPI) with stroke survivors, carers and healthcare professionals. "The iterative phase": Development and iterative refinement of the format, content, underpinning theories and philosophy of the self-management programme My Life After Stroke (MLAS), with PPI. MLAS consists of two individual appointments and four group sessions over nine weeks, delivered interactively by two trained facilitators. It aims to build independence, confidence and hope and focusses on stroke prevention, maximising physical potential, social support and managing emotional responses. MLAS is grounded in the narrative approach and social learning theory. "Ready for research": The refinement of a facilitator curriculum and participant resources to support programme delivery. RESULTS: Through a systematic process, we developed an evidence- and theory-based self-management programme for stroke survivors. CONCLUSIONS: MLAS warrants evaluation in a feasibility study.Implications for rehabilitationMy Life After Stroke(MLAS) has been developed using a systematic process, to address the unmet needs of stroke survivors.This systematic process, involved utilising evidence, theories, patient and public involvement, expertise and guidelines from other long-term conditions. This may further help the development of similar self-management programme within the field of stroke.MLAS warrants further evaluation within a feasibility study.

Accounts of preventative coping: an interview study of stroke survivors on general practice registers.

OBJECTIVES: Preventative coping is an underexplored aspect of coping behaviour. Specifically, coping is a key concern in stroke survivor accounts, but this has yet to be investigated with reference to secondary prevention. DESIGN: Secondary analysis of a qualitative data set comprising semistructured interviews of 22 stroke survivors recruited from five general practices in the East of England. The topic guide included exploration of advice and support given by their doctor on medication and lifestyle. The interviews were coded using thematic analysis. RESULTS: The accounts emphasised individual responsibility. Two key themes were identified, which foregrounded the role of self-concept for coping: (a) striving to be 'good', (b) appeal to ideas of 'personality'. In the former, preventative behaviour was depicted in moralistic terms, with the doctor as an adjudicator. In the latter, participants attributed their coping behaviour to their personality, which might help or hinder these efforts. CONCLUSIONS: We highlight that coping was characterised by survivors as something enacted by the individual self, and consider how constructions of self may impact preventative coping efforts.

Patients' experience of and participation in a stroke self-management programme, My Life After Stroke (MLAS): a multimethod study.

OBJECTIVE: A self-management programme, My Life After Stroke (MLAS), was developed to support stroke survivors. This evaluation reports patients' experience. DESIGN: Multimethod, involving interviews and questionnaires. SETTING: 23 general practices in the intervention arm of a cluster randomised controlled trial in East of England and East Midlands, UK. PARTICIPANTS: People on the stroke registers of participating general practices were invited to attend an MLAS programme. INTERVENTIONS: MLAS comprises one-to-one and group-based sessions to promote independence, confidence and hope. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was uptake of the programme. Participants who declined MLAS were sent a questionnaire to ascertain why. Attendees of four programmes completed evaluation forms. Attendees and non-attendees of MLAS were interviewed. Ad-hoc email conversations with the lead author were reviewed. Thematic analysis was used for qualitative data. RESULTS: 141/420 (34%) participants (mean age 71) attended an MLAS programme and 103 (73%) completed 1. 64/228 (28%) participants who declined MLAS gave reasons as: good recovery, ongoing health issues, logistical issues and inappropriate. Nearly all attendees who completed questionnaires felt that process criteria such as talking about their stroke and outcomes such as developing a strong understanding of stroke had been achieved. CONCLUSIONS: MLAS was a positive experience for participants but many stroke survivors did not feel it was appropriate for them. Participation in self-management programmes after stroke might be improved by offering them sooner after the stroke and providing a range of delivery options beyond group-based, face-to-face learning. TRIAL REGISTRATION NUMBER: NCT03353519, NIH.

Impairment-targeted exercises for older adults with knee pain: protocol for a proof-of-principle study.

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.

IMPaCT Back study protocol. Implementation of subgrouping for targeted treatment systems for low back pain patients in primary care: a prospective population-based sequential comparison.

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.

"It's Difficult, There's No Formula": Qualitative Study of Stroke Related Communication Between Primary and Secondary Healthcare Professionals.

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.

Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation.

INTRODUCTION: Primary 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 ANALYSIS: Mixed 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 DISSEMINATION: Favourable 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 NUMBER: NCT03353519; Pre-results.

Testing a model of association between patient identified problems and responses to global measures of health in low back pain patients: a prospective study.

BACKGROUND: Self-rated health status has been shown to be related to physical function. Therefore, changes in functional ability should be associated with changes in general health. However, functional needs may vary greatly between individuals. The purpose of this study was to propose and test a model of association between patient identified functional problems and responses to global measures of health in low back pain patients. METHODS: Participants in a low back pain clinical trial were followed up for 12 months. A series of analyses were undertaken using the Jonckheere-Terpstra test and chi-square for trends to determine the associations between two individualised items related to function, and measures of "overall improvement in condition", "general health status" and performance of "usual activities". RESULTS: Significant associations between responses to the five items were found. Performance of usual activities is significantly associated with ratings of general health status (p < 0.001) and overall condition of the back (p < 0.001). The extent to which the patient identified problems influence an individual's perception on multi-task performance is dependent upon the degree of difficulty and level of importance attached to these problems. CONCLUSION: The relationship between patient identified problems and responses to global measures of health is complex. The explanatory model proposed here may improve our understanding of these interactions. TRIAL REGISTRATION: ISRCTN 32765488.

Conceptualising post-stroke fatigue: a cross-sectional survey of UK-based physiotherapists and occupational therapists.

With survival after stroke improving, more people are discharged into the community with multiple and persistent deficits. Fatigue is a common unmet need for stroke survivors, but there are no evidence-based guidelines for its assessment and management. This study explored how UK-based therapists conceptualise post-stroke fatigue (PSF) in current practice. OBJECTIVE: To describe current understanding of PSF among physiotherapists (PT) and occupational therapists (OT). DESIGN: A cross-sectional online survey using Qualtrics software (a survey creation and analysis programme) was sent to therapists working with stroke survivors in 2019. Responses to the open ended question, 'How would you describe PSF if approached by another healthcare professional?' were analysed thematically by two independent researchers. PARTICIPANTS: 137 survey respondents (71 PT and 66 OT) from a range of clinical settings (25 acute care, 24 sub-acute rehabilitation care, 3 primary care and 85 community care) with 7 months-36 years of experience working with stroke survivors completed the survey. RESULTS: Respondents stated that PSF should be regarded as an important medical condition because it is common and can be associated with severe symptoms. Symptoms were perceived to be highly variable and the syndrome was difficult to define objectively. It was felt to have both physical and cognitive components. A variety of different opinions were expressed with regard to causation, conceptualisation and best management. CONCLUSION: Therapists working with stroke survivors conceptualise and manage PSF in different ways. Clinical practice is hampered by a lack of a widely adopted definition, and a small evidence base. Research into causes and management of PSF is a priority.

How is poststroke fatigue understood by stroke survivors and carers? A thematic analysis of an online discussion forum.

OBJECTIVE: To understand poststroke fatigue from the perspective of stroke survivors and caregivers expressed in an online discussion forum. DESIGN: The search terms 'tiredness', 'fatigue', 'tired', 'weary' and 'weariness' were used to identify relevant posts. Thematic analysis performed by two independent researchers who coded all forum posts and identified pertinent themes. Posts were coded in relation to two research questions: (1) how is poststroke fatigue described? and (2) what coping strategies are suggested to target poststroke fatigue? Each theme was then summarised by a lead quotation in forum users' own words. SETTING: UK-based web forum hosted by Stroke Association, TalkStroke. Archives from 2004 to 2011 were accessed. PARTICIPANTS: 65 stroke survivors and caregivers (mean age 54 years, 61% female) contributed to 89 relevant posts that included a relevant search term. This included 38 stroke survivors, 23 individuals with family or carer role and 4 others unidentified. RESULTS: Six themes were generated: (1) medicalisation of poststroke fatigue: 'a classic poststroke symptom', (2) a tiredness unique to stroke: 'a legacy of stroke', (3) normalisation and acceptance of poststroke fatigue: 'part and parcel of stroke', (4) fighting the fatigue: 'an unwelcome guest', (5) survivors' and caregivers' biological explanations: 'the brain healing' and (6) coping mechanisms: 'pace yourself'. Forum users also repeatedly commented that poststroke fatigue was 'not understood by the profession'. CONCLUSION: This is the first study to employ data from an online forum to characterise poststroke fatigue. Our data are considered naturalistic owing to the absence of a researcher guiding the discussion and thus generates useful insights for healthcare professionals. Findings suggest a requirement for consistent understanding and explanation to be provided by healthcare professionals. The beliefs outlined here highlight the gap between clinical and community knowledge. Further research to translate understanding of patient and carer perspective into improved management of poststroke fatigue is required.

Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community.

INTRODUCTION: Survival 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 ANALYSIS: Improving 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 DISSEMINATION: Favourable 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 NUMBER: NCT03353519.

Correction: Stroke survivors' and informal caregivers' experiences of primary care and community healthcare services - A systematic review and meta-ethnography.

[This corrects the article DOI: 10.1371/journal.pone.0192533.].

Stroke survivors' and informal caregivers' experiences of primary care and community healthcare services - A systematic review and meta-ethnography.

OBJECTIVE: To describe and explain stroke survivors and informal caregivers' experiences of primary care and community healthcare services. To offer potential solutions for how negative experiences could be addressed by healthcare services. DESIGN: Systematic review and meta-ethnography. DATA SOURCES: Medline, CINAHL, Embase and PsycINFO databases (literature searched until May 2015, published studies ranged from 1996 to 2015). ELIGIBILITY CRITERIA: Primary qualitative studies focused on adult community-dwelling stroke survivors' and/or informal caregivers' experiences of primary care and/or community healthcare services. DATA SYNTHESIS: A set of common second order constructs (original authors' interpretations of participants' experiences) were identified across the studies and used to develop a novel integrative account of the data (third order constructs). Study quality was assessed using the Critical Appraisal Skills Programme checklist. Relevance was assessed using Dixon-Woods' criteria. RESULTS: 51 studies (including 168 stroke survivors and 328 caregivers) were synthesised. We developed three inter-dependent third order constructs: (1) marginalisation of stroke survivors and caregivers by healthcare services, (2) passivity versus proactivity in the relationship between health services and the patient/caregiver dyad, and (3) fluidity of stroke related needs for both patient and caregiver. Issues of continuity of care, limitations in access to services and inadequate information provision drove perceptions of marginalisation and passivity of services for both patients and caregivers. Fluidity was apparent through changing information needs and psychological adaptation to living with long-term consequences of stroke. LIMITATIONS: Potential limitations of qualitative research such as limited generalisability and inability to provide firm answers are offset by the consistency of the findings across a range of countries and healthcare systems. CONCLUSIONS: Stroke survivors and caregivers feel abandoned because they have become marginalised by services and they do not have the knowledge or skills to re-engage. This can be addressed by: (1) increasing stroke specific health literacy by targeted and timely information provision, and (2) improving continuity of care between specialist and generalist services. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO 2015:CRD42015026602.

ICF core sets for low back pain: do they include what matters to patients?

OBJECTIVE: To investigate whether the International Classification of Functioning Disability and Health (ICF) Core Sets for low back pain encompass the key functional problems of patients. DESIGN: Cross-sectional evaluation of patient-centred problems with low back pain. SUBJECTS: A total of 402 patients living in the UK recruited into a randomized clinical trial. METHODS: Patients with acute or subacute low back pain were asked to identify: (i) the one thing they find most difficult to do, and (ii) something they usually enjoyed but were unable to do because of their back pain. Two raters classified responses according to the ICF. Inter-rater agreement was measured using the kappa statistic. The response categories were examined for inclusion within the Core Sets. RESULTS: For question (i) above, agreement between raters was 323/397 (81%), kappa (95% confidence interval (95% CI)) = 0.78 (0.73-0.82). A total of 329 (83%) fell within the ICF Brief Core Set; all except 3 were contained within the Comprehensive Core Set. For question (ii) agreement was 290/312 (93%), kappa (95% CI) = 0.91 (0.87-0.95). Only 54 (17%) of these fell within the Brief Core Set; the 2 most chosen categories (recreation and leisure: d920; caring for household objects: d650) accounted for 70% of responses, and were not included. All except 2 responses were encompassed by the Comprehensive Core Set. CONCLUSION: Addition of codes d920 and d650 to the low back pain Brief Core Set would significantly increase the inclusion rate in this cohort.

Validation of complex interventions in a low back pain trial: selective video analysis cross-referenced to clinical case notes.

INTRODUCTION: Auditing the interventions used in clinical trials to demonstrate that treatment protocols were adhered to and that discrete modalities were delivered, is essential in establishing internal validity. Pragmatic studies involving complex interventions provide a particular challenge. The value of case report forms which document individual treatment content relies upon accurate recall and recording by the clinician. This report describes a method to validate this type of data in a randomised clinical trial, by using video analysis on a sample of patient therapist interactions. METHODS: Six physiotherapists used standardised case report forms to record the treatment given to 402 patients recruited into the two treatment arms of a low back pain clinical trial. An audit checklist comprising the principal components of both management approaches was designed. Twelve treatment sessions were video recorded. Three independent clinicians viewed the recordings, using the checklist to identify the treatment content. These data were compared for agreement with the matching case report forms. The content of the interventions delivered to all of the trial patients was then audited. RESULTS: Agreement between the video observers, and between the observers and the case report forms ranged from moderate to very good (kappa=0.45-0.82). When compared with the video observations, some under-reporting of treatment occurred on the case report forms. Overall, 80% of the patients received the treatment to which they were allocated. CONCLUSIONS: This study has demonstrated that selective use of video recording, cross-referenced to clinical case notes may provide a feasible and relatively inexpensive means of establishing the internal validity of the interventions used in a pragmatic clinical trial.