Background:Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP. Objectives:To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP. Methods:A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1-12, monthly during months 4-12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0-10 numeric rating scale) between baseline and the average over 6-12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1-12, ii) pain at 6 and 12 months, and monthly from 3-12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout. Discussion:The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP. Trial registration:ISRCTN 12418153. Registration date 06 December 2022 https://doi.org/10.1186/ISRCTN12418153.

Introduction Transitions from the adult intensive care unit (ICU) to other care settings can be challenging for patients, families, and healthcare providers, with risks to communication, care continuity, and psychosocial well-being. Objective We aimed to codevelop patient- and family-centred resources to educate, empower, and engage adult ICU patients and their families during their ICU-to-ward and ICU-to-home transitions, supporting them as informed partners in their care journey. Methods Building on previously published scoping reviews and end-user input that identified 76 candidate ICU transition resources, we used a two-phase, user-centred approach to develop a transitions in care (TiC) Bundle. Phase 1: Using an adapted Appraisal of Guidelines for Research and Evaluation II process, which supports structured evaluation of health-related resources, and a multidisciplinary prioritisation exercise involving patients, families, and healthcare providers, we refined and organised content into four sections: A Guide to the ICU, How is My Loved One Doing?, Going Home from the ICU, and Going to Another Unit. Phase 2: We conducted three iterative cycles of usability testing with ICU patients/families (n = 15) and clinicians (n = 18). Content analysis guided revisions addressing readability, terminology, workflow fit, and content gaps. Results Patients and families valued practical checklists and guidance on “what to ask” during transitions. Clinicians appreciated the bundle’s simplicity, consistent layout, mental health focus, support group info, and QR-code references. Suggested improvements included clarifying resource use, detailing ward-based disciplines, and better explaining delirium. Integration into workflows (printing, documentation, and off-hour transfers) was a key consideration. Conclusions The TiC Bundle is a user-informed resource designed to address communication and psychosocial needs during ICU transitions. Future work will focus on feasibility and acceptability testing, with attention to how the resource influences patient and family experience, care continuity, and communication.

AbstractObjectivesTo describe the development and initial evaluation of a new context-specific patient decision aid for care-seeking patients with subacromial pain syndrome (SAPS) in primary care.MethodsTo develop a new contextually relevant decision aid, mixed methods research study with four components was conducted. We adapted a previously tested decision aid using the ADAPT guidance (Activity I) and simultaneously developed new items using the International Patient Decision Aid Standards and the Ottawa Decision Support Framework (Activity II) to inform a prototype of the decision aid. In activity III, we alpha tested the prototype through think-aloud interviews with 10 patients with SAPS and 10 healthcare practitioners of different disciplines. In the interviews, participants were also asked to rate their readiness for the decision-making process using the Preparation for Decision-Making (PrepDM) questionnaire and the face-validity of the prototype was evaluated using the QQ-10 questionnaire. Revisions were made based on the feedback from the participants, the project group and a reference group consisting of 26 individuals including patients and healthcare practitioners. Following this, the new prototype was beta-tested in primary care with 23 care-seeking patients with SAPS. All participants were asked to complete the Shoulder Pain and Disability Index (SPADI), EQ-5D-3L and Decisional Conflict Scale (DCS) before, after and two weeks after introduction to the decision aid. Participants also scored the Decision Regret Scale (DRS) after two weeks. Following beta-testing, 13 interviews were conducted to explore the acceptability and usability of the decision aid, guided by the Standards for UNiversal reporting of Decision Aid Evaluations (SUNDAE) guidelines and Preparation for Decision Making Scale (PrepDM).ResultsBased on the two first activities, the prototype decision aid included 10 treatments. Findings from alpha-testing highlighted that the prototype was acceptable and useful in preparing both patients and healthcare practitioners for the treatment decision-making process. Beta-testing showed that after introduction to the decision aid, the DCS decreased from 40+18 at baseline to 25+18 two weeks after the decision, indicating low levels of decisional conflict. Furthermore, after two weeks the DRS indicated low levels of decisional regret (25+9). SPADI and EQ-5D-3L scores were largely similarly across all time-points. Interviews highlighted that both patients and healthcare practitioners felt the decision aid was a valuable tool for clinical practice.ConclusionsOur decision aid is a promising tool for influencing the decision-making process in patients with SAPS in primary care. Further research that compares the offer of the decision aid to patients and healthcare practitioners in primary care with usual care is needed.Practice ImplicationsFurther research is needed to fully evaluate the effects of the decision aid.Support and SponsorThis study was funded by Novo Nordisk Foundation, TrygFonden, Danish Association of Physiotherapy and Aalborg University. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). JRZ is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: APP1194105). None of the funders were involved in the research. The sponsor is non-commercial and declares no conflicts of interest.

Introduction Musculoskeletal pain is the second leading cause of disease burden in Australia, and there is a need to investigate new models of care to cope with the increasing demand for health services. This paper describes the protocol for a randomised controlled trial investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6 months and superior for reducing treatment waiting times, compared with usual care for patients with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics.Methods and analysis A total of 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. We will recruit adult patients newly referred to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition that is typically managed by a physiotherapist (eg, back or neck pain, osteoarthritis, rehabilitation postorthopaedic surgery and sporting injuries). Participants will be randomised 1:1 to the physiotherapist-led triage and treatment service or usual care. A physiotherapist will telephone participants in the intervention group and match them to different modes and types of care based on baseline characteristics. Participants at low risk of poor outcomes (assessed by the Keele STarT MSK tool) will be given simple advice and education during this call and instructed to call back if their symptoms do not improve in 6 weeks. Participants at medium risk of poor outcomes or requiring postoperative rehabilitation will be offered a course of telehealth (videoconference) physiotherapy targeting exercise-based self-management. Participants at high risk of poor outcomes and/or with potential nonprogressive radiculopathy will be offered a course of usual clinic-based physiotherapy as per all participants in the usual care group. Physical function (Patient Specific Functional Scale) at 6 months postrandomisation and waiting time (time from randomisation to first treatment) are coprimary outcomes. Secondary outcomes include other patient outcomes (eg, pain), health resource use, adverse events, process measures (eg, adherence) and costs.Ethics and dissemination This trial has approval from the Sydney Local Health District Human Research Ethics Committee (RPAH Zone; X24-0090 and 2024/ETH00585). Recruitment will commence in September 2024 and is expected to be completed by December 2025 with follow-ups completed by December 2026. The results of the trial will be submitted for publication in reputable international journals and presented at relevant national and international conferences.Trial registration number ANZCTR (ACTRN12624000947505).

BACKGROUND:Around 2.5 million people in the UK are absent from work due to ill health, yet, for many, accessing work-orientated vocational support (VS) to facilitate return to work (RTW) is challenging. The majority of fit notes are issued in primary care, making this an ideal setting to provide VS. AIM:As part of the Work And Vocational advicE (WAVE) randomised controlled trial (RCT), we explored the delivery of VS by trained vocational support workers (VSWs), from the perspectives of patients, VSWs, employers, and GPs. DESIGN & SETTING:In the WAVE RCT, patients from 10 UK general practices were randomised to the offer of usual care or usual care plus VS. This qualitative study explored stakeholder perspectives of the VS intervention. METHOD:Semi-structured interviews were conducted with participants in the intervention arm (n = 10), employers, VSWs, and GPs (n = 5). Interviews were audio-recorded, transcribed, and analysed using thematic analysis. Public and patient involvement and engagement was embedded throughout. RESULTS:Taking a person-centred, individualised approach to VS enabled VSWs to identify and mitigate RTW obstacles and support participants' self-efficacy to proactively negotiate RTW. The perceived independence of the VSWs from employers and health care was considered important and facilitated more open discussions about capabilities and RTW planning. CONCLUSION:Findings indicated that individualised and independent VS offered to patients referred from primary care was perceived by all stakeholders to be valuable to patients absent from work due to illness and supported their RTW planning. These insights can inform future models of VS.

BACKGROUND:Subacromial pain syndrome (SAPS) is the most common shoulder pain condition in primary care. Despite the importance of shared decision-making (SDM) being increasingly recognised, its application in SAPS care remains poorly understood. The primary aim of this study was to explore the influence of a decision aid on patient and observer perceptions of SDM, and secondarily to explore correlations between these ratings in the primary care management of patients with SAPS. METHODS:We conducted a multi-methods study including observations of consenting patients with SAPS in their clinical consultations with clinicians from four Danish primary care practices using OPTION-12. We gathered patients' perceptions of SDM 2 weeks after the consultation using the CollaboRATE questionnaire and Shared Decision-Making Questionnaire (SDM-Q-9). We observed consultations with and without the introduction of a decision aid tailored to support the management of patients. RESULTS:Thirty-four consultations were observed (16 with and 18 without the decision aid). Without the aid, the mean (SD) OPTION-12 score was 10.5 (3.3), while the median (IQR) CollaboRATE and mean (SD) SDM-Q-9 scores were 5 (1.3) and 22.2 (7.5), respectively. With the aid, scores significantly increased: OPTION-12 to 22.7 (6.87, range 5-32), CollaboRATE to 6.5 (1.4), and SDM-Q-9 to 30.6 (8.4). Patients' and observers' OPTION-12 and SDM-Q-9 scores correlated significantly across both phases, but no significant correlation was found between CollaboRATE, OPTION-12, and SDM-Q-9 scores in either phase. CONCLUSION:A decision aid significantly improved observer- and patient-rated SDM in primary care consultations for patients with SAPS. Observer-rated SDM scores more than doubled with the decision aid, and patients reported higher levels of SDM.

Background People with rheumatoid arthritis experience foot and lower limb pain due to active synovitis, resulting in impaired lower limb function. Earlier intervention may help with prevention of functional decline. The aims of this research were to develop and evaluate a new gait rehabilitation intervention for people with early rheumatoid arthritis, evaluate its feasibility, and to test whether or not gait rehabilitation plus usual care is more clinically and cost-effective than usual care alone. Design and methods We undertook a single-arm, repeated-measures, pre- and post-intervention, mixed-methods feasibility study with embedded qualitative components. We planned to undertake a pragmatic, two-arm, multicentre, superiority randomised controlled trial, with health economic evaluation, process evaluation and internal pilot. Setting and participants Participants with early rheumatoid arthritis (< 2 years post diagnosis) were identified from early arthritis and rheumatology outpatient clinics and referred for intervention in either podiatry or physiotherapy clinics. Intervention(s) Participants were randomised to a gait rehabilitation programme (Gait Rehabilitation Early Arthritis Trial Strides) involving a six-task gait circuit. Sessions were underpinned by motivational interviewing to facilitate behaviour change, supported by trained physiotherapists or podiatrists for a minimum of two sessions. Both groups received their normal usual care from the rheumatology multidisciplinary team. Main outcome measures Outcome measures for the feasibility study were intervention acceptability, adherence using the Exercise Adherence Rating Scale and fidelity using the Motivational Interviewing Treatment Integrity Scale. The main outcome measure for the internal pilot/randomised controlled trial was the Foot Function Index disability subscale. Outcomes were measured at baseline, 3 months, 6 months and 12 months. Other outcomes: intervention acceptability questionnaire, Exercise Adherence Rating Scale, exercise treatment beliefs via the Theory of Planned Behaviour Questionnaire, intervention fidelity (Motivational Interviewing Treatment Integrity Scale), health-related quality of life (EuroQol-5 Dimensions, five-level score). Results Thirty-five participants were recruited for feasibility 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 and 22/23 indicated it made sense to them. Adherence was good, with a median (interquartile range) Exercise Adherence Rating Scale score of 17/24 (12.5–22.5). Twelve participants’ and nine therapists’ interviews confirmed intervention acceptability, identified perceptions of benefit, but highlighted some barriers to completion. Motivational Interviewing Treatment Integrity Scale scores demonstrated good fidelity. The trial did not progress from internal pilot to full main trial as a result of low recruitment and high attrition, after 53 participants were recruited from 9 sites over 12 months. Process evaluation confirmed good intervention acceptability and adherence, and fair fidelity. Evaluation of clinical and cost-effectiveness was not possible. Limitations Significant delays were experienced with the impact of coronavirus disease 2019, regulatory approvals, contracts and site readiness, resulting in few sites opening in time and low recruitment capacity. Foot and/or ankle pain prevalence was lower than anticipated, resulting in a low potential participant pool and a low conversion rate from screening to enrolment. Conclusions The Gait Rehabilitation Early Arthritis Trial Strides intervention was acceptable to people with early rheumatoid arthritis and intervention clinicians, safe, with good levels of adherence by participants, and fair intervention fidelity. The randomised controlled trial stopped early following failure to meet recruitment targets. Gait Rehabilitation Early Arthritis Trial Strides is a promising intervention that could be adapted for future evaluations. A definitive trial of the Gait Rehabilitation Early Arthritis Trial Strides gait rehabilitation intervention still needs to be done. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/165/04.

Predictive biomarkers (or moderators of treatment) are features, or more likely feature clusters, that discriminate individuals who are more likely to experience a favourable or unfavourable effect from a specific treatment. Utilization of validated predictive biomarkers for chronic low back pain (CLBP) treatments is a plausible strategy to guide patients more rapidly to effective treatments thereby reducing wastage of finite healthcare funds on treatments that are ineffective (or potentially harmful). Yet, few predictive biomarkers have been successfully validated in clinical studies. This paper summarizes work by the Phenotype/Precision Spine Focus Group of the International Society for the Study of the Lumbar Spine that addressed: (1) relevant definitions for terminology; (2) advantages and disadvantages of different research approaches for the specification of predictive biomarkers; (3) methods for assessment of clinical validity; (4) approaches for their implementation; (5) barriers to predictive biomarker identification; and (6) a prioritised list of recommendations for the development and refinement of predictive biomarkers for CLBP. Key recommendations include the harmonisation of data collection, data sharing, integration of theoretical models, development of new treatments, and health economic analyses to inform cost-benefit of assessments and the application of matched treatments. The complexity of CLBP demands large datasets to derive meaningful progress. This will require coordinated and substantive collaboration involving multiple disciplines and across the research spectrum from the basic sciences to clinical applications.

Background: There are a variety of different treatments for patients living with subacromial pain syndrome (SAPS). All treatments have small to moderate effect sizes, and it is challenging when healthcare practitioners and patients need to decide on which treatment options to choose. The aim of this study was to explore and understand the decisional needs of patients with SAPS, to inform and support the decision-making process. Methods: A qualitative research study, using semi-structured individual interviews with patients with SAPS. The interview guide was informed by the Ottawa Decision Support Framework (ODSF), previous research related to treatment decision-making, other decisional needs assessment studies, and inputs from patients with SAPS and healthcare practitioners. Data were analysed by using reflexive thematic text analysis and ODSF. The analysis was conducted in NVivo 12. Results: We invited 22 participants of which 17 (age 22-71 years) took part in the study. We found three main themes related to individual decisional needs in the context of decision-making: 1) The necessity of certainty and adequate information as fundamental prerequisites for effective decision-making, 2) The importance of personcentered care to achieve a desirable decision, and 3) The need for a supportive environment to facilitate adaptation and acceptance of the decision. Conclusion: The decision-making process faced by patients with SAPS is complex and involves several decisional needs. Our findings highlight the importance of healthcare professionals identifying and addressing patients' decisional needs in consultations with patients with SAPS.

Objective The SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention.Design This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).Setting Primary care in the UK (England).Participants 46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews.Intervention An internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support.Analysis Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.Results Four explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value.Conclusions Digital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.

OBJECTIVES: This study aimed to assess 12-month outcomes on return to work (RTW) and cost-effectiveness in adults on sick leave due to musculoskeletal disorders who were randomized to either usual case management (UC), UC+motivational interviewing (MI) or UC+stratified vocational advice intervention (SVAI). METHODS: The study was conducted in the Norwegian Labor and Welfare Administration (NAV). Workers on sick leave due to musculoskeletal disorders for ≥50% of their contracted work hours for ≥7 consecutive weeks were included. Trained caseworkers delivered MI in two face-to-face sessions, and physiotherapists provided SVAI and identified RTW obstacles. The main outcomes were sick leave days over 12 months and cost-effectiveness, cost-utility and cost-benefit. RESULTS: The trial included 509 workers with a mean age of 48 years. There were statistically significant differences between UC+MI versus UC [-15.6 days, 95% confidence interval (CI) -31.0– -0.2], and UC+SVAI versus UC (-17.6 days, 95% CI -33.0– -2.2). Compared to UC, odds ratios (OR) for receiving wage replacement benefits each month were lower for UC+MI (OR=0.73, 95% CI 0.64–0.84), and UC+SVAI (OR 0.74, 95% CI 0.64–0.84). The probabilities of cost-effectiveness were high for adding either MI or SVAI to UC (ceiling ratio 0.90), and the net benefit for MI was €5225 (95% CI -592–10 985) and for SVAI €7214 ((95% CI 1548–12 851) per person. CONCLUSIONS: Adding MI or SVAI to UC significantly improved RTW outcomes and was cost-effective among people on sickness absence due to musculoskeletal disorders.

BACKGROUND:Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears. METHODS:The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40-75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including-as indicated-bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery. DISCUSSION:The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears. TRIAL REGISTRATION:The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).

OBJECTIVES:Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT), comprising advice and education, with BCT plus a single ultrasound-guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 ml 1% lidocaine hydrochloride (BCT+US-T). METHODS:A trial-based cost-utility analysis of BCT+US-T compared with BCT was undertaken over 6 months. Patient-level cost data were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a UK National Health Service (NHS) perspective. RESULTS:BCT+US-T was associated with lower mean NHS costs (BCT+US-T minus BCT: -£161.6; 95% CI: -£583.95, £54.18) and small but significantly higher mean QALYs than BCT alone over 6 months (BCT+US-T minus BCT: 0.0487; 95% CI: 0.0091, 0.0886). In the base case, BCT+US-T was the most cost-effective and dominated BCT alone. Differences in total costs were driven by number of visits to NHS consultants, private physiotherapists and chiropractors, and hip surgery, which were more common with BCT alone than BCT+US-T. CONCLUSION:Intra-articular corticosteroid injection plus BCT (BCT+US-T) for patients with hip OA results in lower costs and better outcomes, and is highly cost-effective, compared with BCT alone. TRIAL REGISTRATION:EudraCT: 2014-003412-37 (8 August 2015) and registered with Current Controlled Trials: ISRCTN 50550256 (28 July 2015). TRIAL PROTOCOL:Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2153-0, doi: doi.org/10.1186/s12891-018-2153-0.

OBJECTIVES:Intervention fidelity is poorly reported in trials of nondrug, nonsurgical interventions. We aimed to review existing intervention fidelity guidance documents, assess their development methods, and synthesize their terminology, definitions, domains, and recommendations. STUDY DESIGN AND SETTING:We searched 6 databases from inception to September 2023 to identify documents describing explicit, actionable, and overarching recommendations on intervention fidelity. We supplemented this with backward citation searching in April 2024. Two reviewers independently screened titles, abstracts, and full texts. We conducted a qualitative content analysis, following JBI guidance, to extract and synthesize data on document characteristics, scope, methods, terminology, definitions, domains, and recommendations. RESULTS:After screening 7142 records from database searches and 1768 from citation searching, we included 73 documents. Most documents were unclear about the core methods used to develop recommendations (67/73, 92%), and only one document explicitly reported using consensus (1/73, 1%). We identified definitions of intervention fidelity across 6 categories and 7 intervention fidelity domain categories. Of these, only 2 ("provider delivery-related aspects" and "participant involvement-related aspects") were reported in most documents (>50%). We identified 81 recommendations across 10 categories, with only 14 being reported across more than half of the documents. CONCLUSION:Existing documents providing recommendations on intervention fidelity reflect the evolving nature of the field, with consensus still needed on several aspects. The gaps and inconsistencies identified in this review emphasize the need for clearer, more systematic, and globally applicable guidelines. These findings will inform the development of ReFiND, an international, consensus-based reporting guideline for intervention fidelity in nondrug, nonsurgical trials. PLAIN LANGUAGE SUMMARY:When studies are conducted to test how well an intervention works, it is key to evaluate the extent to which the intervention is delivered as planned. This is called intervention fidelity. We looked at 73 guides on how to check and report this. Most of these guides did not explain the methods used to decide what to include. The advice in these guides was often different from each other. As the field of intervention fidelity is still developing, many of these guides represent early attempts, where less structured methods were used before more organized approaches were established. This shows we need a global effort to create clear guidelines for reporting how well interventions are followed.

BACKGROUND: Low back pain (LBP) remains a leading source of disability and societal cost. In the UK, physiotherapists, osteopaths, and chiropractors are front-line providers of LBP care. Despite widespread dissemination of clinical guidelines, little is known about how their clinical practice has changed over time. METHODS: We conducted national surveys of UK physiotherapists, osteopaths and chiropractors in 2003 and 2023, using an identical acute non-specific LBP vignette to assess reported use of investigations and interventions at both time points. RESULTS: A total of 1,758 eligible clinicians participated in 2003 (834 physiotherapists; 592 osteopaths; and 332 chiropractors), and 1,388 in 2023 (511 physiotherapists; 621 osteopaths; and 255 chiropractors). At both time-points, there were significant inter-professional differences and numerous departures from guideline recommendations. Substantial temporal changes were observed. Physiotherapists shifted towards more restrictive recommendations for work and bed-rest, towards the use of massage, away from spinal mobilization, away from specific exercises, and away from general advice on back care. Chiropractors shifted towards more restrictive recommendations for bed-rest, towards spinal mobilization and acupuncture, and away from spinal manipulation and ultrasound. Osteopaths shifted towards less restrictive recommendations for activity, work, and bed-rest, towards acupuncture, and away from spinal manipulation. CONCLUSIONS: Between 2003 and 2023, UK physiotherapists, osteopaths, and chiropractors reported evolving management approaches to acute LBP. Substantial inter-professional differences and divergences from guideline recommendations were observed. Some inter-professional differences narrowed over time, suggesting partial convergence of practice.

Background:Low back pain is highly prevalent and a leading cause of disability. Internet-delivered interventions may provide rapid and scalable support for behavioural self-management. There is a need to determine the effectiveness of highly accessible, internet-delivered support for self-management of low back pain. Objective:To determine the clinical and cost-effectiveness of an accessible internet intervention, with and without physiotherapist telephone support, on low back pain-related disability. Design:A multicentre, pragmatic, three parallel-arm randomised controlled trial with parallel economic evaluation. Setting:Participants were recruited from 179 United Kingdom primary care practices. Participants:Participants had current low back pain without indicators of serious spinal pathology. Interventions:Participants were block randomised by a computer algorithm (stratified by severity and centre) to one of three trial arms: (1) usual care, (2) usual care + internet intervention and (3) usual care + internet intervention + telephone support. 'SupportBack' was an accessible internet intervention. A physiotherapist telephone support protocol was integrated with the internet programme, creating a combined intervention with three brief calls from a physiotherapist. Outcomes:The primary outcome was low back pain-related disability over 12 months using the Roland-Morris Disability Questionnaire with measures at 6 weeks, 3, 6 and 12 months. Analyses used repeated measures over 12 months, were by intention to treat and used 97.5% confidence intervals. The economic evaluation estimated costs and effects from the National Health Service perspective. A cost-utility study was conducted using quality-adjusted life-years estimated from the EuroQol-5 Dimensions, five-level version. A cost-effectiveness study estimated cost per point improvement in the Roland-Morris Disability Questionnaire. Costs were estimated using data from general practice patient records. Researchers involved in data collection and statistical analysis were blind to group allocation. Results:Eight hundred and twenty-five participants were randomised (274 to usual primary care, 275 to usual care + internet intervention and 276 to the physiotherapist-supported arm). Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months and 79% at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 internet intervention, 242 telephone support). There was a small reduction in the Roland-Morris Disability Questionnaire over 12 months compared to usual care following the internet intervention without physiotherapist support (adjusted mean difference of -0.5, 97.5% confidence interval -1.2 to 0.2; p = 0.085) and the internet intervention with physiotherapist support (-0.6, 97.5% confidence interval -1.2 to 0.1; p = 0.048). These differences were not statistically significant at the level of 0.025. There were no related serious adverse events. Base-case results indicated that both interventions could be considered cost-effective compared to usual care at a value of a quality-adjusted life-year of £20,000; however, the SupportBack group dominated usual care, being both more effective and less costly. Conclusions:The internet intervention, with or without physiotherapist telephone support, did not significantly reduce low back pain-related disability across 12 months, compared to usual primary care. The interventions were safe and likely to be cost-effective. Balancing clinical effectiveness, cost-effectiveness, accessibility and safety findings will be necessary when considering the use of these interventions in practice. Trial registration:This trial is registered as ISRCTN14736486. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/78) and is published in full in Health Technology Assessment; Vol. 29, No. 7. See the NIHR Funding and Awards website for further award information.

BackgroundPatients and families who have experienced delirium may seek information about delirium online, but the quality and reliability of online delirium-related websites are unknown. ObjectiveThis study aimed to identify and evaluate online delirium-related websites that could be used for patient and family education. MethodsWe searched Microsoft Bing, Google, and Yahoo using the keywords “delirium” and the misspelled “delerium” to identify delirium-related websites created to inform patients, families, and members of the public about delirium. The quality of identified delirium-related website content was evaluated by 2 authors using the validated DISCERN tool and the JAMA (Journal of the American Medical Association) benchmark criteria. Readability was assessed with the Simple Measure of Gobbledygook, the Flesch Reading Ease score, and the Flesch Kincaid grade level. Each piece of website content was assessed for its delirium-related information using a checklist of items co-designed by a working group, which included patients, families, researchers, and clinicians. ResultsWe identified 106 websites targeted toward patients and families, with most hospital-affiliated (21/106, 20%) from commercial websites (20/106, 19%), government-affiliated organizations (19/106, 18%), or from a foundation or advocacy group (16/106, 15%). The median time since the last content update was 3 (IQR 2-5) years. Most websites’ content (101/106, 95%) was written at a reading level higher than the recommended grade 6 level. The median DISCERN total score was 42 (IQR 33-50), with scores ranging from 20 (very poor quality) to 78 (excellent quality). The median delirium-related content score was 8 (IQR 6-9), with scores ranging from 1 to 12. Many websites lacked information on the short- and long-term outcomes of delirium as well as how common it is. The median JAMA benchmark score was 1 (IQR 1-3), indicating the quality of the websites’ content had poor transparency. ConclusionsWe identified high-quality websites that could be used to educate patients, families, or the public about delirium. While most delirium-related website content generally meets quality standards based on DISCERN and JAMA benchmark criteria, high scores do not always ensure patient and family-friendliness. Many of the top-rated delirium content were text-heavy and complex in layout, which could be overwhelming for users seeking clear, concise information. Future efforts should prioritize the development of websites with patients and families, considering usability, accessibility, and cultural relevance to ensure they are truly effective for delirium education.