Synthesis of guidance available for assessing methodological quality and grading of evidence from qualitative research to inform clinical recommendations: a systematic literature review.

OBJECTIVE: To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR). METHODS: A systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies. RESULTS: Of 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid. CONCLUSION: There is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level.

Examining the Effectiveness of Social Media for the Dissemination of Research Evidence for Health and Social Care Practitioners: Systematic Review and Meta-Analysis.

BACKGROUND: Social media use has potential to facilitate the rapid dissemination of research evidence to busy health and social care practitioners. OBJECTIVE: This study aims to quantitatively synthesize evidence of the between- and within-group effectiveness of social media for dissemination of research evidence to health and social care practitioners. It also compared effectiveness between different social media platforms, formats, and strategies. METHODS: We searched electronic databases for articles in English that were published between January 1, 2010, and January 10, 2023, and that evaluated social media interventions for disseminating research evidence to qualified, postregistration health and social care practitioners in measures of reach, engagement, direct dissemination, or impact. Screening, data extraction, and risk of bias assessments were carried out by at least 2 independent reviewers. Meta-analyses of standardized pooled effects were carried out for between- and within-group effectiveness of social media and comparisons between platforms, formats, and strategies. Certainty of evidence for outcomes was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework. RESULTS: In total, 50 mixed-quality articles that were heterogeneous in design and outcome were included (n=9, 18% were randomized controlled trials [RCTs]). Reach (measured in number of practitioners, impressions, or post views) was reported in 26 studies. Engagement (measured in likes or post interactions) was evaluated in 21 studies. Direct dissemination (measured in link clicks, article views, downloads, or altmetric attention score) was analyzed in 23 studies (8 RCTs). Impact (measured in citations or measures of thinking and practice) was reported in 13 studies. Included studies almost universally indicated effects in favor of social media interventions, although effect sizes varied. Cumulative evidence indicated moderate certainty of large and moderate between-group effects of social media interventions on direct dissemination (standardized mean difference [SMD] 0.88; P=.02) and impact (SMD 0.76; P<.001). After social media interventions, cumulative evidence showed moderate certainty of large within-group effects on reach (SMD 1.99; P<.001), engagement (SMD 3.74; P<.001), and direct dissemination (SMD 0.82; P=.004) and low certainty of a small within-group effect on impacting thinking or practice (SMD 0.45; P=.02). There was also evidence for the effectiveness of using multiple social media platforms (including Twitter, subsequently rebranded X; and Facebook), images (particularly infographics), and intensive social media strategies with frequent, daily posts and involving influential others. No included studies tested the dissemination of research evidence to social care practitioners. CONCLUSIONS: Social media was effective for disseminating research evidence to health care practitioners. More intense social media campaigns using specific platforms, formats, and strategies may be more effective than less intense interventions. Implications include recommendations for effective dissemination of research evidence to health care practitioners and further RCTs in this field, particularly investigating the dissemination of social care research. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42022378793; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=378793. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/45684.

The effectiveness of social prescribing in the management of long-term conditions in community-based adults: A systematic review and meta-analysis.

OBJECTIVE: The objective of this systematic review and meta-analysis was to evaluate the effectiveness of social prescribing interventions in the management of long-term conditions in adults. DATA SOURCES: Eleven electronic databases were searched for randomised and quasi-randomised controlled trials. REVIEW METHODS: Outcomes of interest were quality of life, physical activity, psychological well-being and disease-specific measures. Bias was assessed with the Cochrane Risk of Bias 2 tool. A narrative synthesis and meta-analysis were performed. RESULTS: Twelve studies (n = 3566) were included in this review. Social prescribing interventions were heterogeneous and the most common risks of bias were poor blinding and high attrition. Social prescribing interventions designed to target specific long-term conditions i.e., cancer and diabetes demonstrated significant improvements in quality of life (n = 2 studies) and disease-specific psychological outcomes respectively (n = 3 studies). There was some evidence for improvement in physical activity (n = 2 studies) but most changes were within group only (n = 4 studies). Social prescribing interventions did not demonstrate any significant changes in general psychological well-being. CONCLUSION: Social prescribing interventions demonstrated some improvements across a range of outcomes although the quality of evidence remains poor.

The feasibility, acceptability, safety, and effects of early weight bearing in humeral fractures - a scoping review.

PURPOSE: Non-weight bearing is often recommended after humeral fractures. This review aims to summarise the extent and nature of the evidence for the feasibility, acceptability, safety, and effects of early weight bearing (EWB) in people with humeral fractures, treated operatively or non-operatively. . METHODS: Data sources identified published (PUBMED, EMBASE, CINAHL) and unpublished (ClinicalTrials.gov, CENTRAL, NIHR Open Research, OpenGrey) literature. Independent data extraction was conducted by two reviewers. RESULTS: 13 901 records were retrieved. Ten studies, involving 515 post-operative patients and 351 healthcare professionals, were included. EWB was found to be feasible in nine studies. There was limited evidence regarding adherence to EWB. Trauma and orthopaedic surgeons reported that EWB was acceptable. This depended on surgery type and whether it was a post-operative polytrauma case. No acceptability data was reported from patients' perspectives. Only one study reported two patients who developed unsatisfactory outcomes from excessive post-operative EWB. Positive effects of EWB were reported on disability level, pain, shoulder and elbow motion, and union. CONCLUSION: There is some evidence for the feasibility, safety, and effectiveness of post-operative EWB after humeral fractures. There was limited data on the acceptability of EWB. Heterogeneous study designs, and variations in EWB protocols limit conclusions.

There is some evidence to support the feasibility, safety, and effectiveness of early weight bearing following operative management of humeral fractures.Early weight bearing after some humeral fractures is acceptable to some subspecialities of orthopaedic surgeons but is not universally accepted.Rehabilitation professionals should discuss the option of early weight bearing after operative management of humeral fracture with patients and their multidisciplinary team.

The effectiveness of knowledge-sharing techniques and approaches in research funded by the National Institute for Health and Care Research (NIHR): a systematic review.

BACKGROUND: The National Institute of Health and Care Research (NIHR), funds, enables and delivers world-leading health and social care research to improve people's health and wellbeing. To achieve this aim, effective knowledge sharing (two-way knowledge sharing between researchers and stakeholders to create new knowledge and enable change in policy and practice) is needed. To date, it is not known which knowledge sharing techniques and approaches are used or how effective these are in creating new knowledge that can lead to changes in policy and practice in NIHR funded studies. METHODS: In this restricted systematic review, electronic databases [MEDLINE, The Health Management Information Consortium (including the Department of Health's Library and Information Services and King's Fund Information and Library Services)] were searched for published NIHR funded studies that described knowledge sharing between researchers and other stakeholders. One researcher performed title and abstract, full paper screening and quality assessment (Critical Appraisal Skills Programme qualitative checklist) with a 20% sample independently screened by a second reviewer. A narrative synthesis was adopted. RESULTS: In total 9897 records were identified. After screening, 17 studies were included. Five explicit forms of knowledge sharing studies were identified: embedded models, knowledge brokering, stakeholder engagement and involvement of non-researchers in the research or service design process and organisational collaborative partnerships between universities and healthcare organisations. Collectively, the techniques and approaches included five types of stakeholders and worked with them at all stages of the research cycle, except the stage of formation of the research design and preparation of funding application. Seven studies (using four of the approaches) gave examples of new knowledge creation, but only one study (using an embedded model approach) gave an example of a resulting change in practice. The use of a theory, model or framework to explain the knowledge sharing process was identified in six studies. CONCLUSIONS: Five knowledge sharing techniques and approaches were reported in the included NIHR funded studies, and seven studies identified the creation of new knowledge. However, there was little investigation of the effectiveness of these approaches in influencing change in practice or policy.

Gujarati translation, validity and reliability of Walking Impairment Questionnaire in people with intermittent claudication due to peripheral artery disease.

INTRODUCTION: The Walking Impairment Questionnaire (WIQ) is a common and easy-to-use assessment of walking incapacity in people with claudication due to peripheral artery disease (PAD). It has four subscales: pain severity, walking distance, walking speed, and ability to climb stairs. It has not been translated into Gujarati, which limits its use in Indian subjects. AIM: This study aims to translate and assess the validity and reliability of a Gujarati version of WIQ. MATERIALS AND METHODS: This study had three phases: 1. Forward and backward translation and Cultural adaptation of WIQ into the Gujarati language by two independent translators, 2. Face and content validation by six clinical reviewers and 10 participants with PAD and Type II diabetes, 3. Concurrent and construct validity, test-retest reliability, and internal consistency of Gujarati, the WIQ was assessed on 160 participants with PAD and Type II diabetes who had a mean Ankle Brachial Index (standard deviation) <0.40 (0.1). The concurrent and construct validity of the WIQ was analyzed by correlating the WIQ distance and speed score with 6-minute walk distance (6MWD) and speed and WIQ total score with the Medical Outcome Study Questionnaire Short Form 36 (SF-36) score using Pearson's correlation coefficient. Test-retest reliability was analyzed using an intraclass correlation coefficient (ICC) with a seven-day interval between two questionnaire applications. Internal consistency of the total WIQ score was determined using Cronbach's alpha. RESULTS: Following translation, the Gujarati WIQ was considered acceptable and understandable by people with PAD. There was excellent correlation between the WIQ distance score and 6-minute walk test distance (r = 0.95, P < .05)) , the WIQ speed score and 6-minute walk test speed score (r = 0.89, P < .05)) and the Gujarati WIQ total score and total score of physical functioning domain of SF- 36 (r = 0.99, P < .05). There was excellent test-retest reliability over 7 days for total WIQ score (ICC = 0.94). The Cronbach's alpha for internal consistency of 0.97 for total WIQ score were excellent. This demonstrates the sufficient homogeneity of the total questionnaire. CONCLUSION: The Gujarati version of the WIQ is reliable and valid and can be used to assess self-reported walking impairment in Gujarati-speaking people with PAD and Type II Diabetes.

Participants' experiences and acceptability of a home-based walking exercise behaviour-change intervention (MOtivating Structure walking Activity in people with Intermittent Claudication (MOSAIC)).

OBJECTIVES: This study explored the experiences and acceptability of a novel, home-based, walking exercise behaviour-change intervention (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in adults with Peripheral Arterial Disease (PAD). DESIGN AND SETTING: Individual semi-structured audio-recorded interviews were conducted with adults with Peripheral Arterial Disease who had completed the MOSAIC intervention as part of a randomised clinical trial. Data were analysed using inductive reflexive thematic analysis and interpreted using the seven-construct theoretical framework of acceptability of healthcare interventions (TFA). PARTICIPANTS: Twenty participants (mean age (range) 67(54-80) years, 70% male, 55% White British) were interviewed. RESULTS: One central theme was identified: Acceptability of walking exercise as a treatment. This theme was explained by four linked themes: Exploring walking exercise with a knowledgeable professional, Building confidence with each step, Towards self-management-learning strategies to continue walking and The impact of walking exercise. These themes were interpreted using six of the seven TFA constructs: affective attitude, burden, perceived effectiveness, intervention coherence, opportunity costs, and self-efficacy. CONCLUSIONS: Participants perceived MOSAIC as an effective, acceptable, and low burden intervention. Physiotherapists were regarded as knowledgeable and supportive professionals who helped participants understand PAD and walking exercise as a treatment. Participants developed confidence to self-manage their condition and their symptoms. As participants confidence and walking capacity improved, they expanded their activities and gained a more positive outlook on their future. MOSAIC is an acceptable intervention that may facilitate adoption of and access to exercise for people with PAD.

Exploring needs, barriers to, and facilitators of rehabilitation exercise following revision hip replacement - A grounded theory study.

PURPOSE: Evidence on rehabilitation after revision total hip replacement (THR) is inadequate and development of rehabilitation interventions is warranted. Even so, little is known about patients' experiences with revision THR rehabilitation. This study aimed to explore patients' rehabilitation exercise experiences after revision THR. MATERIALS AND METHODS: Using constructivist grounded theory, we conducted semi-structured qualitative interviews with twelve patients with completed or almost completed rehabilitation exercise after revision THR. Data collection and analysis were a constant comparative process conducted in three phases; initial, focused, and theoretical. FINDINGS: From the data, we generated a substantial theory of the participant's circumstances and ability to integrate rehabilitation exercise into their everyday life after revision THR. Four categories were constructed based on patients' experiences in different contexts: hesitance, fear avoidance, self-commitment, and fidelity. CONCLUSIONS: This study highlighted that patients' expectations, past experiences, attitudes, trusts, and circumstances interact to influence engagement and adherence to rehabilitation exercise and described four categories relating to the integration of revision THR rehabilitation exercise into their everyday life. Clinicians should be aware of and account for these categories during rehabilitation exercise. Tailored individual rehabilitation exercise interventions and clinician approaches to optimize engagement and adherence are needed among patients with revision THR.

Patients' rehabilitation exercise experiences after revision total hip replacement may serve as guidance for clinicians.A need exists to tailor individual rehabilitation interventions and clinicians' approaches to optimize patients' engagement and rehabilitation exercise adherence following revision total hip replacement.Clinicians can tailor rehabilitation exercise for patients with revision total hip replacement by focusing on therapeutic relationships, support needs, and physical function while incorporating insights from previous rehabilitation exercise experiences.An important goal of rehabilitation exercise is to enhance patient engagement, thereby facilitating the integration of rehabilitation exercises into the patients' everyday life.

Exploring how members of the public access and use health research and information: a scoping review.

BACKGROUND: Making high-quality health and care information available to members of the general public is crucial to support populations with self-care and improve health outcomes. While attention has been paid to how the public accesses and uses health information generally (including personal records, commercial product information or reviews on healthcare practitioners and organisations) and how practitioners and policy-makers access health research evidence, no overview exists of the way that the public accesses and uses high quality health and care information. PURPOSE: This scoping review aimed to map research evidence on how the public accesses and uses a specific type of health information, namely health research and information that does not include personal, product and organisational information. METHODS: Electronic database searches [CINAHL Plus, MEDLINE, PsycInfo, Social Sciences Full Text, Web of Science and SCOPUS] for English language studies of any research design published between 2010-2022 on the public's access and use of health research or information (as defined above). Data extraction and analysis was informed by the Joanna Briggs Institute protocol for scoping reviews, and reported in accordance with the PRISMA extension for scoping reviews. RESULTS: The search identified 4410 records. Following screening of 234 full text studies, 130 studies were included. One-hundred-and-twenty-nine studies reported on the public's sources of health-research or information; 56 reported the reasons for accessing health research or information and 14 reported on the use of this research and information. The scoping exercise identified a substantial literature on the broader concept of 'health information' but a lack of reporting of the general public's access to and use of health research. It found that 'traditional' sources of information are still relevant alongside newer sources; knowledge of barriers to accessing information focused on personal barriers and on independent searching, while less attention had been paid to barriers to access through other people and settings, people's lived experiences, and the cultural knowledge required. CONCLUSIONS: The review identified areas where future primary and secondary research would enhance current understanding of how the public accesses and utilises health research or information, and contribute to emerging areas of research.

Can social prescribing put the 'social' into the biopsychosocial management of people with long-term musculoskeletal disorders?

BACKGROUND: Chronic musculoskeletal disorders (MSD) are a significant burden on individuals' quality of life and society and are made more complex by the presence of multimorbidity. It is recommended that interventions targeting MSD be sustainable, equitable and incorporate the biopsychosocial model of care (BPS). AIMS: A criticism of the BPS approach is that the social component of this model is not addressed adequately during the management of people with long-term MSD and that a gap exists between theory and implementation. The use of social prescribing (SP) as an intervention to bridge this gap is discussed. RESULTS AND DISCUSSION: Social prescribing is a holistic non-medical person-centered approach to well-being that utilizes link workers (LW) to support individuals with long-term conditions (LTC) in the community. Social prescribing referrals are received from primary healthcare practitioners to LW and range from light touch signposting for employment or financial advice to more intensive support for LTC such as obesity, decreased physical activity and mental health needs. CONCLUSION: There is evidence to suggest that SP interventions are effective in the management of LTC; however, due to the paucity of high-quality evidence, it is difficult to be conclusive. Large-scale randomised controlled trials are recommended to support the use of SP interventions in the management of LTC.

The Use of Social Media for Dissemination of Research Evidence to Health and Social Care Practitioners: Protocol for a Systematic Review.

BACKGROUND: Effective dissemination of research to health and social care practitioners enhances clinical practice and evidence-based care. Social media use has potential to facilitate dissemination to busy practitioners. OBJECTIVE: This is a protocol for a systematic review that will quantitatively synthesize evidence of the effectiveness of social media, compared with no social media, for dissemination of research evidence to health and social care practitioners. Social media platforms, formats, and sharing mechanisms used for effective dissemination of research evidence will also be identified and compared. METHODS: Electronic database searches (MEDLINE, PsycINFO, CINAHL, ERIC, LISTA, and OpenGrey) will be conducted from January 1, 2010, to January 10, 2023, for studies published in English. Randomized, nonrandomized, pre-post study designs or case studies evaluating the effect of social media on dissemination of research evidence to postregistration health and social care practitioners will be included. Studies that do not involve social media or dissemination or those that evaluate dissemination of nonresearch information (eg, multisource educational materials) to students or members of the public only, or without quantitative data on outcomes of interest, will be excluded. Screening will be carried out by 2 independent reviewers. Data extraction and quality assessment, using either the Cochrane tool for assessing risk of bias or the Newcastle-Ottawa Scale, will be completed by 2 independent reviewers. Outcomes of interest will be reported in 4 domains (reach, engagement, dissemination, and impact). Data synthesis will include quantitative comparisons using narrative text, tables, and figures. A meta-analysis of standardized pooled effects will be undertaken, and subgroup analyses will be applied, if appropriate. RESULTS: Searches and screening will be completed by the end of May 2023. Data extraction and analyses will be completed by the end of July 2023, after which findings will be synthesized and reported by the end of October 2023. CONCLUSIONS: This systematic review will summarize the evidence for the effectiveness of social media for the dissemination of research evidence to health and social care practitioners. The limitations of the evidence may include multiple outcomes or methodological heterogeneity that limit meta-analyses, potential risk of bias in included studies, and potential publication bias. The limitations of the study design may include potential insensitivity of the electronic database search strategy. The findings from this review will inform the dissemination practice of health and care research. TRIAL REGISTRATION: PROSPERO CRD42022378793; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=378793. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45684.

Inequity in exercise-based interventions for adults with rheumatoid arthritis: a systematic review.

Objectives: This systematic review describes the extent to which PROGRESS-Plus equity factors were considered in the eligibility criteria of trials of exercise interventions for adults with RA. Methods: Electronic databases were searched for published (Cinahl, Embase, Medline, Physiotherapy Evidence Database), unpublished (Opengrey) and registered ongoing (International Standard Randomized Controlled Trial Number registry) randomized controlled trials (RCTs) of exercise interventions for adults with RA. Two authors independently performed study selection and quality assessment (Cochrane risk of bias tool). Results: A total of 9696 records were identified. After screening, 50 trials were included. All trials had either some concerns or high risk of bias and reported at least one PROGRESS-Plus equity factor within the eligibility criteria; this included place of residence, personal characteristics (age and disability), language, sex, social capital, time-dependent factors or features of relationship factors. Where reported, this equated to exclusion of 457 of 1337 potential participants (34%) based on equity factors. Conclusion: This review identified the exclusion of potential participants within exercise-based interventions for people with RA based on equity factors that might affect health-care opportunities and outcomes. This limits the generalizability of results, and yet this evidence is used to inform management and service design. Trials need to optimize participation, particularly for people with cardiovascular conditions, older adults and those with cognitive impairments. Reasons for exclusions need to be justified. Further research needs to address health inequalities to improve treatment accessibility and the generalizability of research findings. PROSPERO registration: CRD42021260941.

Inequity in exercise-based interventions for adults with intermittent claudication due to peripheral arterial disease: a systematic review.

PURPOSE: To determine the equity in access to trials of exercise interventions for adults with intermittent claudication due to peripheral arterial disease. METHODS: Systematic electronic database searches of MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Clinical Trials, PEDRO, Opengrey, ISRCTN and ClinincalTrials.gov for randomised controlled trials of exercise interventions for adults with intermittent claudication were conducted. Data extraction was informed by Cochrane's PROGRESS-Plus framework. RESULTS: Searches identified 6412 records. Following the screening of 262 full texts, 49 trials including 3695 participants were included. All trials excluded potential participants on at least one equity factor. This comprised place of residence, language, sex, personal characteristics (e.g., age and disability), features of relationships (e.g., familial risk factors) and time-dependent factors, (e.g., time since revascularisation). Overall, 1839 of 7567 potential participants (24.3%) were excluded based on equity factors. Disability was the most frequently reported factor for exclusions. CONCLUSION: Trialists endeavour to enrol a representative sample in exercise trials whilst preserving the safety profile of the intervention. This review highlights that these efforts can inadvertently lead to inequities in access as all trials excluded potential participants on at least one equity factor. Future exercise trials should optimise participation to maximise generalisability of findings. PROSPERO registration no. CRD42020189965.Implications for rehabilitationEquity factors influence health opportunities and outcomes.All trials of exercise for people with intermittent claudication excluded adults on at least one equity factor.Disability was the predominant factor for exclusions from trials.Trials should optimise participation to maximise generalisability of results as these findings are used to inform treatment and service design.

Experience and perceptions of Social Prescribing interventions; a qualitative study with people with long-term conditions, link workers and health care providers.

Background: Long-term conditions (LTC) are a leading cause of reduced quality of life and early mortality. People with LTC are living longer with increasing economic and social needs. Novel patient centred care pathways are required to support traditional medical management of these patients. Social Prescribing (SP) has gained popularity as a non-medical approach to support patients with LTC and their unmet health needs. The current focus group study aims to explore the experiences and perceptions to SP interventions from the perspective of people with long-term conditions, link workers, healthcare providers and community-based services. Methods: Six toeight participants will be recruited into three specific 60 to 90 minute focus groups relative to their role as a patient, link worker and community-based service. 8 to12 participants with a Health care provider and GP background will be interviewed individually online. The participants within these focus groups and semi-structured interviews will be invited to provide opinions on what factors they think are important to the successful implementation of a SP service from their respective stakeholder positions. The data will be recorded and exported to NVivo software for further analysis using Thematic Reflexive analysis methods. Coded categorical data will inform emerging themes from which a narrative summary will be consolidated and presented for dissemination. Conclusion: The conclusions made from this study will help inform the next study, which will aim to develop a pilot SP service for patients with long-term musculoskeletal conditions as part of an overall larger project.

The experiences and acceptability of a novel multimodal programme for the management of fibromyalgia: A qualitative service evaluation.

INTRODUCTION: Fibromyalgia guidelines recommend multi-modal, non-pharmacological interventions but there is limited evidence on the optimal programme. The Fibromyalgia Active Management and Exercise programme (FAME) aimed to improve function and quality of life. It consisted of 12 sessions delivered by a multidisciplinary team and incorporated education, exercise, Cognitive Behavioural Therapy and mindfulness approaches. This qualitative service evaluation explored the experience and acceptability of FAME from the perspective of the patients' and healthcare practitioners' (HCP). METHODS: All patients and HCP involved in the first FAME programme were invited to attend either one audio-recorded focus group or an individual semi-structured interview. Topic guides were developed a priori. Data were transcribed verbatim and analysed thematically. RESULTS: Thirteen participants (six HCP (three physiotherapists, two nurses, one psychologist)) and seven patients (mean age 46 (7.5) years, all female,) were enroled. FAME was acceptable to HCP participants but not to all patient participants. Where patient participants understood and anticipated the aims of FAME, the programme was found to be acceptable. Whereas, patient participants who did not fully understand the aims of the programme reported lower acceptability. Three themes were generated: expectations and preparation for FAME, the value of social support, and FAME as a learning opportunity. The themes could be explained by five constructs of the Theoretical Framework of Acceptability. CONCLUSION: FAME was acceptable to HCPs but not to all patient participants. Patient and HCP participants valued social support and regarded this as central to their learning. Further adaptation of FAME is required to optimise acceptability.

Gait rehabilitation for foot and ankle impairments in early rheumatoid arthritis: a feasibility study of a new gait rehabilitation programme (GREAT Strides).

BACKGROUND: Foot impairments in early rheumatoid arthritis are common and lead to progressive deterioration of lower limb function. A gait rehabilitation programme underpinned by psychological techniques to improve adherence, may preserve gait and lower limb function. This study evaluated the feasibility of a novel gait rehabilitation intervention (GREAT Strides) and a future trial. METHODS: This was a mixed methods feasibility study with embedded qualitative components. People with early (< 2 years) rheumatoid arthritis (RA) and foot pain were eligible. Intervention acceptability was evaluated using a questionnaire. Adherence was evaluated using the Exercise Adherence Rating Scale (EARS). Safety was monitored using case report forms. Participants and therapists were interviewed to explore intervention acceptability. Deductive thematic analysis was applied using the Theoretical Framework of Acceptability. For fidelity, audio recordings of interventions sessions were assessed using the Motivational Interviewing Treatment Integrity (MITI) scale. Measurement properties of four candidate primary outcomes, rates of recruitment, attrition, and data completeness were evaluated. RESULTS: Thirty-five participants (68.6% female) with median age (inter-quartile range [IQR]) 60.1 [49.4-68.4] years and disease duration 9.1 [4.0-16.2] months), were recruited and 23 (65.7%) completed 12-week follow-up. Intervention acceptability was excellent; 21/23 were confident that it could help and would recommend it; 22/23 indicated it made sense to them. Adherence was good, with a median [IQR] EARS score of 17/24 [12.5-22.5]. One serious adverse event that was unrelated to the study was reported. Twelve participants' and 9 therapists' interviews confirmed intervention acceptability, identified perceptions of benefit, but also highlighted some barriers to completion. Mean MITI scores for relational (4.38) and technical (4.19) aspects of motivational interviewing demonstrated good fidelity. The Foot Function Index disability subscale performed best in terms of theoretical consistency and was deemed most practical. CONCLUSION: GREAT Strides was viewed as acceptable by patients and therapists, and we observed high intervention fidelity, good patient adherence, and no safety concerns. A future trial to test the additional benefit of GREAT Strides to usual care will benefit from amended eligibility criteria, refinement of the intervention and strategies to ensure higher follow-up rates. The Foot Function Index disability subscale was identified as the primary outcome for the future trial. TRIAL REGISTRATION: ISRCTN14277030.

Effect of a Home-Based, Walking Exercise Behavior Change Intervention vs Usual Care on Walking in Adults With Peripheral Artery Disease: The MOSAIC Randomized Clinical Trial.

Importance: Home-based walking exercise interventions are recommended for people with peripheral artery disease (PAD), but evidence of their efficacy has been mixed. Objective: To investigate the effect of a home-based, walking exercise behavior change intervention delivered by physical therapists in adults with PAD and intermittent claudication compared with usual care. Design, Setting, and Participants: Multicenter randomized clinical trial including 190 adults with PAD and intermittent claudication in 6 hospitals in the United Kingdom between January 2018 and March 2020; final follow-up was September 8, 2020. Interventions: Participants were randomized to receive a walking exercise behavior change intervention delivered by physical therapists trained to use a motivational approach (n = 95) or usual care (n = 95). Main Outcomes and Measures: The primary outcome was 6-minute walking distance at 3-month follow-up (minimal clinically important difference, 8-20 m). There were 8 secondary outcomes, 3 of which were the Walking Estimated Limitation Calculated by History (WELCH) questionnaire (score range, 0 [best performance] to 100), the Brief Illness Perceptions Questionnaire (score range, 0 to 80 [80 indicates negative perception of illness]), and the Theory of Planned Behavior Questionnaire (score range, 3 to 21 [21 indicates best attitude, subjective norms, perceived behavioral control, or intentions]); a minimal clinically important difference was not defined for these instruments. Results: Among 190 randomized participants (mean age 68 years, 30% women, 79% White race, mean baseline 6-minute walking distance, 361.0 m), 148 (78%) completed 3-month follow-up. The 6-minute walking distance changed from 352.9 m at baseline to 380.6 m at 3 months in the intervention group and from 369.8 m to 372.1 m in the usual care group (adjusted mean between-group difference, 16.7 m [95% CI, 4.2 m to 29.2 m]; P = .009). Of the 8 secondary outcomes, 5 were not statistically significant. At 6-month follow-up, baseline WELCH scores changed from 18.0 to 27.8 in the intervention group and from 20.7 to 20.7 in the usual care group (adjusted mean between-group difference, 7.4 [95% CI, 2.5 to 12.3]; P = .003), scores on the Brief Illness Perceptions Questionnaire changed from 45.7 to 38.9 in the intervention group and from 44.0 to 45.8 in the usual care group (adjusted mean between-group difference, -6.6 [95% CI, -9.9 to -3.4]; P < .001), and scores on the attitude component of the Theory of Planned Behavior Questionnaire changed from 14.7 to 15.4 in the intervention group and from 14.6 to 13.9 in the usual care group (adjusted mean between-group difference, 1.4 [95% CI, 0.3 to 2.5]; P = .02). Thirteen serious adverse events occurred in the intervention group, compared with 3 in the usual care group. All were determined to be unrelated or unlikely to be related to the study. Conclusions and Relevance: Among adults with PAD and intermittent claudication, a home-based, walking exercise behavior change intervention, compared with usual care, resulted in improved walking distance at 3 months. Further research is needed to determine the durability of these findings. Trial Registrations: ISRCTN Identifier: 14501418; ClinicalTrials.gov Identifier: NCT03238222.