School-based healthy eating interventions for adolescents aged 10-19 years: an umbrella review.

BACKGROUND: The benefits of healthy eating are well known, yet adolescent diet is often poor. School based interventions offer a promising option to promote healthy eating, however, evidence is unclear. AIM: This umbrella review synthesised the current evidence on school-based interventions for healthy eating in adolescents (10-19 years old). METHODS: Using Joanna Briggs Institute (JBI) umbrella review guidelines, a systematic search was conducted on 11 electronic databases (PubMed, CINHAL, EMBASE, Science Direct, PsycINFO, MEDLINE, Scopus, ERIC, Web of Science, Cochrane Register of Systemic Review and JBI Evidence Synthesis) to identify reviews published between January 2000 and December 2023. Methodological quality was assessed using JBI critical appraisal tool. A narrative synthesis was conducted informed by the World Health Organisation's Health Promoting School (HPS) framework that categorises school-based interventions into three components i.e., health education, school environment changes, and family and community involvement. RESULTS: Seventeen reviews were identified (including 347 unique primary studies) that were published between 2008 and 2023. 87% of the reviews were based on interventions in high- income countries, limiting applicability to low- and middle-income countries. Fourteen reviews were rated as high, two as moderate, and one was rated as low methodological quality. Evidence from 71% of the reviews (n = 14 reviews, 13 = high methodological quality) found that multi-component interventions (i.e., interventions incorporating more than two components of the HPS framework) improved adolescents' knowledge and behaviour concerning healthy eating. At the individual level, tech-driven healthy eating curricula effectively improved eating behaviours of adolescents. These individual-level interventions proved to be more effective and sustainable when supported by system-level changes, such as modifying school environments including increased availability of healthy foods and involving parents to promote healthy eating for adolescents. However, limited evidence from only three reviews suggests mixed feasibility for technology-based interventions and lower feasibility for multi-component interventions. The lack of information on stakeholder involvement in intervention design is another critical evidence gap. CONCLUSION: School-based multi-component healthy eating interventions that combine individual-level interventions with system-level changes are effective in promoting healthy eating behaviours among adolescents. Future reviews should assess the effectiveness of participatory approaches in intervention design, feasibility and scale-up studies, and analysing evidence from low- and middle-income countries.

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.

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 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.

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.

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.

Pre-operative prognostic factors for walking capacity after surgery for lumbar spinal stenosis: a systematic review.

BACKGROUND: Lumbar spinal stenosis (LSS) reduces walking and quality of life. It is the main indication for spinal surgery in older people yet 40% report walking disability post-operatively. Identifying the prognostic factors of post-operative walking capacity could aid clinical decision-making, guide rehabilitation and optimise health outcomes. OBJECTIVE: To synthesise the evidence for pre-operative mutable and immutable prognostic factors for post-operative walking in adults with LSS. DESIGN: Systematic review with narrative synthesis. METHODS: Electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, OpenGrey) were searched for observational studies, evaluating factors associated with walking after surgery in adults receiving surgery for LSS from database inception to January 2020. Two reviewers independently evaluated studies for eligibility, extracted data and assessed risk of bias (Quality in Prognosis Studies). The Grading of Recommendations Assessment, Development and Evaluation method was used to determine level of evidence for each factor. RESULTS: 5526 studies were screened for eligibility. Thirty-four studies (20 cohorts, 9,973 participants, 26 high, 2 moderate, 6 low risk of bias) were included. Forty variables (12 mutable) were identified. There was moderate quality of evidence that pre-operative walking capacity was positively associated with post-operative walking capacity. The presence of spondylolisthesis and the severity of stenosis were not associated with post-operative walking capacity. All other factors investigated had low/very low level of evidence. CONCLUSION: Greater pre-operative walking is associated with greater post-operative walking capacity but not spondylolisthesis or severity of stenosis. Few studies have investigated mutable prognostic factors that could be potentially targeted to optimise surgical outcomes.

Fatigue in adults with primary antiphospholipid syndrome: findings from a mixed-methods study.

OBJECTIVE: This study aimed to explore the experience and impact of fatigue in adults with primary antiphospholipid syndrome (pAPS). METHODS: This sequential, explanatory mixed-methods study enrolled adults with a six-month or more history of pAPS. Consenting participants completed the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FS), Multi-Dimensional Perceived Social Support Scale, Patient Health Questionnaire (PHQ9), Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQMETS). Relationships between FS and other variables were explored with multiple linear regression. Interviews were conducted with a subgroup of participants, and the data were analysed thematically. RESULTS: A total of 103 participants were recruited (Mage = 50.3 years; standard deviation = 10.1 years; 18 males). Of these, 62% reported severe fatigue. Greater fatigue was associated with lower mood, physical inactivity, poorer sleep quality and lower perceived social support. The best-fit model explained 56% of the variance in FS (adjusted R2 = 0.560, F(3, 74) = 33.65, p > 0.001) and included PHQ9 and IPAQMETS as significant predictors, and PSQI as a non-significant predictor. Twenty participants completed interviews. Three key themes were identified: characteristics of fatigue, impact on life and coping strategies. CONCLUSION: Fatigue was a common symptom of pAPS and challenging to manage. Other factors, particularly mood and physical activity, influenced fatigue. Evidence-based self-management interventions are needed.

Are Walking Treatment Beliefs and Illness Perceptions Associated With Walking Intention and 6-Min Walk Distance in People With Intermittent Claudication? A Cross-Sectional Study.

Intermittent claudication is debilitating leg pain affecting older people with peripheral arterial disease, which is improved by regular walking. This study evaluated associations between psychosocial variables and 6-min walk distance (6MWD) to identify factors that motivate walking. A total of 142 individuals with intermittent claudication (116 males; Mage = 66.9 years [SD = 10.2]) completed cross-sectional assessments of sociodemographics, walking treatment beliefs and intention (Theory of Planned Behaviour), illness perceptions (Revised Illness Perceptions Questionnaire), and 6MWD. Multiple linear regression was used to evaluate relationships among psychosocial variables (treatment beliefs and illness perceptions) and outcomes (walking intention and 6MWD). Theory of planned behavior constructs were associated with intention (R = .72, p < .001) and 6MWD (R = .08, p < .001). Illness perceptions were associated with 6MWD only (R = .27, p < .001). Intention (ß = 0.26), treatment control (ß = -0.27), personal control (ß = 0.32), coherence (ß = 0.18), and risk factor attributions (ß = 0.22; all ps < .05) were independently associated with 6MWD. Treatment beliefs and illness perceptions associated with intention and 6MWD in people with intermittent claudication are potential intervention targets.

Exploring Professional Circus Artists' Experience of Performance-Related Injury and Management: A Qualitative Study.

AIMS: Circus is a physically demanding profession, but injury and help-seeking rates tend to be low. This qualitative interview study explored the perceptions and beliefs about injury and help-seeking of circus artists. METHODS: Ten professional circus artists (5 males, 5 females; mean age 33 yrs, range 27-42) were enrolled. Individual, semi-structured interviews were conducted until data saturation of themes was reached. Data were analysed thematically. FINDINGS: Four themes were identified: 1) the injured artist; 2) professionalism; 3) circus life; and 4) artists' experience of healthcare. Most participants described the circus as central to their lives, and injuries had wide-ranging psychosocial consequences. Injury adversely affected participants' mood and threatened their identity. Situational and personal factors (e.g., the belief that pain was normal) pushed participants to use adaptive strategies to perform when injured. Continuous touring and financial constraints affected help-seeking. Easy access to healthcare was rare and participants often self-managed injuries. Experiences of healthcare varied, and participants desired flexible and accessible approaches to prevention and injury management. A modified version of the integrated model of psychological response to injury and rehabilitation process and the concept of identity provided a framework to understand participants. CONCLUSION: Injuries had extensive negative consequences. Work schedules, financial factors, employer support, the artist's perception of the importance of the show, and the relationship between circus and identity influenced injury management and help-seeking. Injury prevention and management strategies could be optimised by developing centres of expertise, online resources, and better regulations of the profession.

The effect of interactive digital interventions on physical activity in people with inflammatory arthritis: a systematic review.

The aim of this systematic review was to evaluate the evidence from randomised controlled trials (RCTs) evaluating the effectiveness of interactive digital interventions (IDIs) for physical activity (PA) and health related quality of life (HRQoL) in people with Inflammatory Arthritis [rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) axial Spondyloarthritis (AS) and psoriatic arthritis (PsA)]. Seven electronic databases identified published and unpublished studies. Two reviewers conducted independent data extraction and quality assessment using the Cochrane risk of bias tool (RoB). The primary outcome was change in objective PA after the intervention; secondary outcomes included self-reported PA and HRQoL after the intervention and objective or self-reported PA at least 1 year later. Five manuscripts, reporting four RCTs (three high and one low RoB) representing 492 (459 RA, 33 JIA) participants were included. No trials studying PsA or AS met the inclusion criteria. Interventions ranged from 6 to 52 weeks and included 3-18 Behaviour Change Techniques. Due to heterogeneity of outcomes, a narrative synthesis was conducted. No trials reported any significant between group differences in objective PA at end of intervention. Only one low RoB trial found a significant between group difference in self-reported vigorous [MD Δ 0.9 days (95% CI 0.3, 1.5); p = 0.004], but not moderate, PA in people with RA but not JIA. There were no between group differences in any other secondary outcomes. There is very limited evidence for the effectiveness of IDIs on PA and HRQoL in RA and JIA and no evidence for their effectiveness in PsA or AS.

Patient involvement in the development of a handbook for moderate rheumatoid arthritis.

BACKGROUND: Self-management is a key recommendation for people with rheumatoid arthritis (RA). Educational materials may support self-management, and increasingly patients are becoming involved with the development of these materials. The TITRATE trial compares the effectiveness of intensive management to standard care in patients with moderate RA across England. As part of the intensive management intervention, participants are given a handbook. AIM AND OBJECTIVES: The aim of this study was to develop a handbook to support the intensive management. The objectives were to: (i) involve patients in the identification of relevant information for inclusion in the TITRATE handbook; (ii) ensure the content of the handbook is acceptable and accessible. DESIGN: We held an audio-taped workshop with RA patients. The transcript of the workshop was analysed using thematic content analysis. RESULTS: Five main themes were identified as follows: 'rheumatoid arthritis treatment, perceptions of rheumatoid arthritis, the importance of individualized goals, benefits of self-management and the patient handbook'. Feedback from the workshop was incorporated into the handbook, and patients' anonymous testimonies were added. CONCLUSION: This study demonstrates that patient contribution to the development of educational material to support intensive management of RA is both feasible and valuable. A qualitative evaluation of the use and impact of the handbook with patients and practitioners is planned on completion of the TITRATE trial.

National variation in the composition of rheumatology multidisciplinary teams: a cross-sectional study.

The objective of this study is to describe the composition of multidisciplinary teams (MDT) working within rheumatology departments across the UK. All rheumatology departments in the United Kingdom (UK) were invited to participate in a national electronic survey between February 2014 and April 2015 as a part of a national audit for the management of rheumatoid and early inflammatory arthritis commissioned by Healthcare Quality Improvement Partnership. Rheumatology departments were asked to report their MDT composition; defined as a rheumatologist (consultant or specialist trainee), specialist nurse, occupational therapist physiotherapist, and podiatrist. The data were collected as Whole Time Equivalent (WTE) of each professional group at each department adjusted to 100,000 population. The data were grouped according to British Society for Rheumatology regions to study regional variations. The survey was completed by 164/167 departments (98% response rate). All departments reported an MDT comprising a rheumatologist (consultant or specialist trainee) and almost all included a specialist nurse but only 28 (17%) of the departments had MDTs comprising all the professional groups. There was a high degree of regional variation in the provision of Allied Health Professionals (physiotherapists, occupational therapists, and podiatrists) in the UK. MDT care is recommended for the management of inflammatory arthritis, but few UK rheumatology departments have a full complement of healthcare professionals within their MDT. There is a high degree of regional variation in the composition and staffing levels of the rheumatology MDT across the UK; the impact of which warrants further investigation.

Multidisciplinary team care for people with rheumatoid arthritis: a systematic review and meta-analysis.

The objective of this study was to systematically review the evidence from randomised controlled trials (RCTs) evaluating the effectiveness of multidisciplinary team (MDT) care for the management of disability, disease activity and quality of life (QoL) in adults with rheumatoid arthritis (RA). Data sources identified published (MEDLINE, PsychINFO, EMBASE, CINAHL, Web of Science, CENTRAL) and unpublished (OpenGrey) literature. Independent data extraction and quality assessment, using the Cochrane risk of bias tool, were conducted by two reviewers. The primary outcome was change in disability at 12 months; secondary outcomes included disability at other time points and disease activity and QoL at 12 months. Where possible, the pooled effect sizes were calculated for inpatient or outpatient MDT interventions. Four hundred and fifteen studies were retrieved. Twelve manuscripts, which reported 10 RCTs, representing 1147 participants were included. Only data from five high- or moderate-quality trials were pooled according to clinical setting. There was no difference in disability between inpatient MDT care and any comparison group [mean difference (95% confidence intervals) 0.04, -0.13 to 0.20] or between outpatient MDT care and comparison groups (0.09, -0.07 to 0.25) at 12 months. There was no difference in disability at 2 years or <12 months or disease activity and QoL at 12 months between MDT care and any comparison group. There is limited evidence evaluating the effect of MDT care on disability, disease activity or QoL in people with RA. There is likely to be no effect of MDT care on disability at 12 months or other time points.

Economic evaluation of a brief education, self-management and upper limb exercise training in people with rheumatoid arthritis (EXTRA) programme: a trial-based analysis.

OBJECTIVE: The aim of this study was to conduct a cost-utility analysis of the Education, Self-management and Upper Limb Exercise Training in People with RA (EXTRA) programme compared with usual care. METHODS: A within-trial incremental cost-utility analysis was conducted with 108 participants randomized to either the EXTRA programme (n = 52) or usual care (n = 56). A health care perspective was assumed for the primary analysis with a 36 week follow-up. Resource use information was collected on interventions, medication, primary and secondary care contacts, private health care and social care costs. Quality-adjusted life years (QALYs) were calculated from the EuroQol five-dimension three-level (EQ-5D-3L) questionnaire responses at baseline, 12 and 36 weeks. RESULTS: Compared with usual care, total QALYs gained were higher in the EXTRA programme, leading to an increase of 0.0296 QALYs. The mean National Health Service (NHS) costs per participant were slightly higher in the EXTRA programme (by £82), resulting in an incremental cost-effectiveness ratio of £2770 per additional QALY gained. Thus the EXTRA programme was cost effective from an NHS perspective when assessed against the threshold of £20 000-£30 000/QALY gained. Overall, costs were lower in the EXTRA programme compared with usual care, suggesting it was the dominant treatment option from a societal perspective. At a willingness-to-pay of £20 000/QALY gained, there was a 65% probability that the EXTRA programme was the most cost-effective option. These results were robust to sensitivity analyses accounting for missing data, changing the cost perspective and removing cost outliers. CONCLUSION: The physiotherapist-led EXTRA programme represents a cost-effective use of resources compared with usual care and leads to lower health care costs and work absence. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register; http://www.controlled-trials.com/isrctn/ (ISRCTN14268051).

Translation, cross-cultural adaptation, and validation of a Gujarati version of a theory of planned behavior questionnaire that assesses walking treatment beliefs in people with intermittent claudication.

BACKGROUND: Walking as a treatment is recommended for people with intermittent claudication (IC), but participation tends to be poor. Walking treatment beliefs, as defined by the Theory of Planned Behaviour (TPB) are associated with walking behavior, so assessing and designing interventions targeting walking treatment beliefs are crucial. To assess walking treatment beliefs in people with IC in Gujarat, a translated, culturally adapted questionnaire that assesses the four TPB constructs (attitude, subjective normative beliefs, perceived behavioral control beliefs, and intention to walk) is required. AIM: To translate and cross-culturally assess the content validity and face validity of a Gujarati version of a TPB questionnaire that assesses walking treatment beliefs. MATERIALS AND METHODS: A forward-backward translation of the 12-item TPB questionnaire was applied using a standardized approach. The translated versions were compared with the original questionnaire, and ten experts, rated each item according to: clarity, semantic, appropriateness, and cultural relevance. Content Validity Index (CVI), item level content validity (I-CVI), Scale -content validity index (S-CVI/Ave), and universal agreement (UA) were computed to summarize the overall content validity of the questionnaire as well as a proportion of agreement with content experts. Face validity was assessed using a think-aloud approach with ten patients with IC. This cognitive interviewing approach (think-aloud approach) asked participants to describe their thoughts whilst completing the questionnaire. Responses were analyzed thematically. RESULTS: There was complete agreement between experts for 9/12 items (I-CVI=1.00), leading to an overall agreement (S-CVI/Ave) of 0.98. For face validation, at least 50% of the participants had no significant problems with any question in the questionnaire. Most problems participants encountered were straightforward, such as re-reading some questions or considering the questions carefully before answering. CONCLUSION: The Gujarati TPB questionnaire had excellent content validity and was comprehensible and answerable by the majority of our participants with IC and, therefore, had good face validity; this will enable walking treatment beliefs to be assessed in people with IC.

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.