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Introduction Fatigue is a major cause of morbidity, limiting quality of life, in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The aetiology of fatigue is multifactorial; biological and psychosocial mediators, such as sleep deprivation, pain and anxiety and depression, are important and may be improved by increasing physical activity. Current self-management advice is based on expert opinion and is poorly adhered to. This study aims to investigate the feasibility of increasing physical activity using a programme of direct contact and telephone support, to provide patient education, encourage behaviour selfmonitoring and the development of an individual change plan with defined goals and feedback to treat fatigue compared with standard of care to inform the design of a large randomised controlled trial to test the efficacy and cost effectiveness of this programme. Methods and analysis Patients with AAV and significant levels of fatigue (patient self-report using multidimensional fatigue index score questionnaire =14) will be randomised in a 1:1 ratio to the physical activity programme supported by behavioural change techniques or standard of care. The intervention programme will consist of 8 visits of supervised activity sessions and 12 telephone support calls over 12 weeks with the aim of increasing physical activity to the level advised by government guidelines. Assessment visits will be performed at baseline, 12, 24 and 52 weeks. The study will assess the feasibility of recruitment, retention, the acceptability, adherence and safety of the intervention, and collect data on various assessment tools to inform the design of a large definitive trial. A nested qualitative study will explore patient experience of the trial through focus groups or interviews. Ethics and dissemination All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, patient networks and academic publications. [ABSTRACT FROM AUTHOR]

Summary Background Many individuals with chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. Health-care organisations are implementing case-finding programmes without good evidence of which are the most effective and cost-effective approaches. We assessed the effectiveness and cost-effectiveness of two alternative approaches to targeted case finding for COPD compared with routine practice. Methods In this cluster-randomised controlled trial, participating general practices in the West Midlands, UK, were randomly assigned (1:1), via a computer-generated block randomisation sequence, to either a targeted case-finding group or a routine care group. Eligible patients were ever-smokers aged 40–79 years without a previously recorded diagnosis of COPD. Patients in the targeted case-finding group were further randomly assigned (1:1) via their household to receive either a screening questionnaire at the general practitioner (GP) consultation (opportunistic) or a screening questionnaire at the GP consultation plus a mailed questionnaire (active). Respondents reporting relevant respiratory symptoms were invited for post-bronchodilator spirometry. Patients, clinicians, and investigators were not masked to allocation, but group allocation was concealed from the researchers who performed the spirometry assessments. Primary outcomes were the percentage of the eligible population diagnosed with COPD within 1 year (defined as post-bronchodilator forced expiratory volume in 1 s [FEV 1 ] to forced vital capacity [FVC] ratio <0·7 in patients with symptoms or a new diagnosis on their GP record) and cost per new COPD diagnosis. Multiple logistic and Poisson regression were used to estimate effect sizes. Costs were obtained from the trial. This trial is registered with ISRCTN, number ISRCTN14930255. Findings From Aug 10, 2012, to June 22, 2014, 74 818 eligible patients from 54 diverse general practices were randomly assigned and completed the trial. At 1 year, 1278 (4%) cases of COPD were newly detected in 32 789 eligible patients in the targeted case-finding group compared with 337 (1%) cases in 42 029 patients in the routine care group (adjusted odds ratio [OR] 7·45 [95% CI 4·80–11·55], p<0·0001). The percentage of newly detected COPD cases was higher in the active case-finding group (822 [5%] of 15 378) than in the opportunistic case-finding group (370 [2%] of 15 387; adjusted OR 2·34 [2·06–2·66], p<0·0001; adjusted risk difference 2·9 per 100 patients [95% CI 2·3–3·6], p<0·0001). Active case finding was more cost-effective than opportunistic case finding (£333 vs £376 per case detected, respectively). Interpretation In this well established primary care system, routine practice identified few new cases of COPD. An active targeted approach to case finding including mailed screening questionnaires before spirometry is a cost-effective way to identify undiagnosed patients and has the potential to improve their health. Funding National Institute for Health Research. [ABSTRACT FROM AUTHOR]

Introduction: The choice of the most appropriate approach to valuing productivity loss has received much debate in the literature. The friction cost approach has been proposed as a more appropriate alternative to the human capital approach when valuing productivity loss, although its application remains limited. This study reviews application of the friction cost approach in health economic studies and examines how its use varies in practice across different country settings.Methods: A systematic review was performed to identify economic evaluation studies that have estimated productivity costs using the friction cost approach and published in English from 1996 to 2013. A standard template was developed and used to extract information from studies meeting the inclusion criteria.Results: The search yielded 46 studies from 12 countries. Of these, 28 were from the Netherlands. Thirty-five studies reported the length of friction period used, with only 16 stating explicitly the source of the friction period. Nine studies reported the elasticity correction factor used. The reported friction cost approach methods used to derive productivity costs varied in quality across studies from different countries.Conclusions: Few health economic studies have estimated productivity costs using the friction cost approach. The estimation and reporting of productivity costs using this method appears to differ in quality by country. The review reveals gaps and lack of clarity in reporting of methods for friction cost evaluation. Generating reporting guidelines and country-specific parameters for the friction cost approach is recommended if increased application and accuracy of the method is to be realized. [ABSTRACT FROM AUTHOR]

Objectives. Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. Methods. A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. Results. Mean costs (QALYs) were £58.46 (S.D. 0.662) for leaflet and advice, £92.12 (S.D. 0.659) for joint protection, £64.51 (S.D. 0.681) for hand exercises and £112.38 (S.D. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. Conclusion. This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option. [ABSTRACT FROM AUTHOR]

Importance: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups.Objective: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease.Design, Setting, and Patients: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013.Interventions: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary.Main Outcomes and Measures: The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit.Results: Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events.Conclusions and Relevance: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months.Trial Registration: isrctn.org Identifier: ISRCTN87171227. [ABSTRACT FROM AUTHOR]

Background: Many people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach. Methods/Design: In this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations. All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants. The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure. A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach. Discussion: This will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first. [ABSTRACT FROM AUTHOR]

Background: Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness. Methods/Design: The study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed. Discussion: This protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial. [ABSTRACT FROM AUTHOR]

Background: Visual information comprises one of the most salient sources of information used to control walking and the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize, therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery and adaptability of gait following stroke. This feasibility trial aims to estimate probable recruitment rate, effect size, treatment adherence and response to gait training with visual cues in contrast to conventional overground walking practice following stroke. Methods/design: A 3-arm, parallel group, multi-centre, single blind, randomised control feasibility trial will compare overground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants (n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment, delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the OVCT or UC and in a University setting for T-VCT participants. Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included. The primary outcomes concerning participant enrolment, recruitment, retention, and health and social care resource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months (follow-up). Outcome measures will include gait speed and step length symmetry; time and steps taken to complete a 180° turn; assessment of gait adaptability (success rate in target stepping); timed up and go; Fugl-Meyer lower limb motor assessment; Berg balance scale; falls efficacy scale; SF-12; and functional ambulation category. Discussion: Participation and compliance measured by treatment logs, accrual rate, attrition, and response variation will determine sample sizes for an early phase randomised controlled trial and indicate whether a definitive late phase efficacy trial is justified. [ABSTRACT FROM AUTHOR]

Background: Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. Methods/Design: The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of selfmanagement of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. Discussion: The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. [ABSTRACT FROM AUTHOR]

Introduction: Patients benefit from early and intensive treatment in both acute ischaemic stroke and transient ischaemic attack. Recent audits of acute stroke/ transient ischaemic attack care suggest that although standards have improved, current services still fall short of optimal care. The aim of this study is to establish a database of patients accessing stroke services. Data will be collected and analysed to provide individualised feedback to healthcare professionals who can then use these findings to develop strategies for service improvement. Methods and analysis: This longitudinal observational study will evolve with the ongoing findings from the research output. The project will consist of three phases: assessment of current practice, feedback of findings and evaluation of service change. Consecutive patients will be recruited from participating hospitals, and identifiable data will be collected to link records from the Primary Care, Secondary Care and Emergency Services. As this study focuses on observation of current practice, a sample size calculation is not deemed appropriate. Patients will be sent follow-up questionnaires examining quality of life at 3 and 12 months post-event. Qualitative interviews will examine the care pathway through the experiences of patients, their carers, healthcare personnel and commissioners. Collected data will be used in economic analyses, which will evaluate the impact of current care and service redesign on the NHS costs and patient outcomes (death and quality of life). Ethics and dissemination: Ethical approval for this study has been obtained from the National Research Ethics Committee (reference; 09/H0716/71), and site-specific R&D approval has been acquired from the relevant NHS trusts. All findings will be presented at relevant healthcare/academic conferences and written up for publication in peer-reviewed journals. Results will be fed back to patients and participating trusts through a series of reports and presentations. These [ABSTRACT FROM AUTHOR]

Background: Blood pressure (BP) lowering in people who have had a stroke or transient ischaemic attack (TIA) leads to reduced risk of further stroke. However, it is not clear what the target BP should be, since intensification of therapy may lead to additional adverse effects. PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on quality of life. Methods/Design: This is a randomised controlled trial (RCT) in patients with a past history of stroke or TIA. Patients will be randomised to two groups and will either have their blood pressure (BP) lowered intensively to a target of 130 mmHg systolic, (or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg) compared to a standard group where the BP will be reduced to a target of 140 mmHg systolic. Patients will be managed by their practice at 1-3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months. 610 patients will be recruited from approximately 50 general practices. The following exclusion criteria will be applied: systolic BP <125 mmHg at baseline, 3 or more anti-hypertensive agents, orthostatic hypotension, diabetes mellitus with microalbuminuria or other condition requiring a lower treatment target or terminal illness. The primary outcome will be change in systolic BP over twelve months. Secondary outcomes include quality of life, adverse events and cardiovascular events. In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals understanding and views of BP management. Discussion: The results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care, and help determine whether or not further research is required before recommending such targets for this population. Trial Registration: ISRCTN29062286 [ABSTRACT FROM AUTHOR]

Objectives: To explore physiotherapists' experiences and perceived acceptability of delivering a bracing intervention for knee osteoarthritis (OA) in the 'PROvision of braces for Patients with knee OA' (PROP OA) randomised controlled trial. Method: Semi‐structured telephone interviews with consenting physiotherapists who received the PROP OA training programme and delivered the knee bracing intervention (advice, information and exercise instruction plus knee brace matched to patients' clinical and radiographic presentation and with adherence support). Interviews were recorded and transcribed verbatim. Two‐stage analytic framework: inductive thematic analysis preceded mapping to constructs of the Theoretical Framework of Acceptability. Results: Eight physiotherapists were interviewed and six key themes were developed. Perceptions of the training programme were generally positive, but additional formal training and experiential learning consolidated confidence and skills in novel intervention components. Advice, information, and exercise instruction reflected usual physiotherapy care for knee OA. Physiotherapists were confident in delivering the knee brace, but determining the pattern of knee OA to inform brace type selection was challenging. Physiotherapists valued brace adherence enhancing strategies and the follow‐up appointment to facilitate adherence. Perceived impact of the bracing intervention for people with OA was positive. The bracing intervention was perceived as acceptable, although improving self‐efficacy to deliver novel intervention components (e.g., reading x‐rays) would enhance acceptability. Conclusion: The complex knee bracing intervention was broadly perceived as acceptable by physiotherapists. If implemented within clinical practice beyond the trial, physiotherapists might benefit from not only initial training in brace selection but also ongoing support and mentoring to increase self‐efficacy in delivery. [ABSTRACT FROM AUTHOR]