Mediators of the effects of exercise and manual therapy for people with knee and hip osteoarthritis: A secondary, exploratory analysis of the MOA trial.

Objective: To explore whether pain beliefs and functional strength mediate the treatment effect of manual therapy (MT) and exercise therapy (ET) on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) composite scores and its subscales in individuals with hip and/or knee osteoarthritis in the MOA trial. Design: Secondary analysis of a randomised controlled trial that compared the incremental effects of supervised MT and ET in addition to usual care in patients with osteoarthritis of the hip or knee. 206 participants enrolled in the MOA trial were analysed. The primary outcome measure was the WOMAC composite score after 1 year. Results: Pain belief mediated the effect of MT (b: -10.7, 95 â€‹% CI: -22.3, -0.9), ET (b: -14.5 95%CI: -26.0, -4.4). Functional strength did not mediate the effect of MT, ET, or MT â€‹+ â€‹ET. Mediation sensitivity analyses suggest findings are likely to change if small confounding between those mediators and WOMAC composite score is present. Conclusions: We identified possible mediators of MT and ET. Future confirmatory studies could be designed to assess the mechanisms through which manual therapy and exercise cause improvements in pain and function scores in patients with hip or knee osteoarthritis.

Barriers and facilitators to implementation of outcome measures among physiotherapists in Nepal: A mixed-methods study.

BACKGROUND: Standardised outcome measures are essential to evidence-based practice but their implementation remains a significant challenge in low- and middle-income countries. The barriers and enablers for implementation of outcome measures are likely different in these settings. OBJECTIVES: We sought to understand barriers and facilitators to use of standardised outcome measures (e.g. patient-reported, performance-based, clinician-reported) in clinical practice among physiotherapists in Nepal. DESIGN: Exploratory sequential mixed-method study. METHODS: We conducted focus groups with physiotherapists in Nepal to understand factors contributing to standardised outcome measure use/non-use in depth and thematically analysed the data using Consolidated Framework for Implementation Research (CFIR). To triangulate the findings, we used an online survey which was distributed to practicing physiotherapists in Nepal using social media. RESULTS: We interviewed 26 physiotherapists for the qualitative phase and 125 physiotherapists responded to our online survey. The most endorsed facilitator was mandating outcome measure use through regulations at organisational or national level, for example, submission of patient-level outcome measures to an insurance system. Major barriers were lack of time, lack of outcome measures in local languages, inability to follow-up with patients and perceived inability of patients to understand outcome measures. Challenges that had not yet been identified in previous studies were inability to follow-up with patients and organisational culture (e.g., cultural hierarchy within an institution). CONCLUSION: The findings of our study provide an understanding of the contextual needs, and potential way forward for implementation of outcome measures in developing countries like Nepal. Future studies should focus on establishing consensus on which measures to use, the cross-cultural adaptation of these measures, and developing pathways for regulation.

Reducing the burden of knee osteoarthritis through community pharmacy: Protocol for a randomised controlled trial of the Knee Care for Arthritis through Pharmacy Service.

INTRODUCTION: Knee osteoarthritis (OA) negatively impacts the health outcomes and equity, social and employment participation, and socio-economic wellbeing of those affected. Little community-based support is offered to people with knee OA in Aotearoa New Zealand. Identifying Maori and non-Maori with knee OA in community pharmacy and providing co-ordinated, evidence- and community-based care may be a scalable, sustainable, equitable, effective and cost-effective approach to improve health and wellbeing. AIM: Assess whether the Knee Care for Arthritis through Pharmacy Service (KneeCAPS) intervention improves knee-related physical function and pain (co-primary outcomes). Secondary aims assess impacts on health-related quality of life, employment participation, medication use, secondary health care utilisation, and relative effectiveness for Maori. METHODS AND ANALYSIS: A pragmatic randomised controlled trial will compare the KneeCAPS intervention to the Pharmaceutical Society of New Zealand Arthritis Fact Sheet and usual care (active control) at 12 months for Maori and non-Maori who have knee OA. Participants will be recruited in community pharmacies. Knee-related physical function will be measured using the function subscale of the Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index. Knee-related pain will be measured using an 11-point numeric pain rating scale. Primary outcome analyses will be conducted on an intention-to-treat basis using linear mixed models. Parallel within-trial health economic analysis and process evaluation will also be conducted. ETHICS AND TRIAL DISSEMINATION: Ethical approval was obtained from the Central Health and Ethics Committee (2022-EXP-11725). The trial is registered with ANZCTR (ACTRN12622000469718). Findings will be submitted for publication and shared with participants.

Exploring the current and future osteoarthritis health service delivery needs in Aotearoa New Zealand.

AIM: Osteoarthritis (OA) affects the wellbeing of one in 10 people in Aotearoa New Zealand, yet current healthcare delivery for these people is fragmented, un-coordinated and inconsistent. How current and future needs should be addressed has not been systematically explored. This study aimed to describe the views of interested people from the health sector regarding current and future OA health service delivery in the public health system in Aotearoa New Zealand. METHOD: Data were collected via a co-design approach within an interprofessional workshop at the Taupuni Hao Huatau Kaikoiwi: Osteoarthritis Aotearoa New Zealand Basecamp symposium and analysed using direct qualitative content analysis. RESULTS: The results highlighted several promising current healthcare delivery initiatives. Health literacy and obesity prevention policies featured in the thematic analysis suggesting a lifespan or systemwide approach is needed. Data highlighted a need for reformed systems that enhances hauora/wellbeing, promotes physical activity, facilitates interprofessional service delivery and collaborates across care settings. CONCLUSION: Participants identified several promising healthcare delivery initiatives for people with OA in Aotearoa New Zealand. Public health policy initiatives are needed to reduce osteoarthritis risk factors. Developing future care pathways should support the diverse needs within Aotearoa New Zealand, coordinate and stratify care, value interprofessional collaboration and practice, and improve health literacy and self-management.

Clinicians' perspectives on planned interventions tested in the Otago MASTER feasibility trial: an implementation-based process evaluation study.

OBJECTIVES: This study reports a process evaluation of the Otago MASTER (MAnagement of Subacromial disorders of The shouldER) feasibility trial. This mixed-methods, process evaluation study was conducted parallel to the Otago MASTER feasibility trial. Our aims were to investigate: (1) supervised treatment fidelity of the interventions and (2) clinicians' perceptions of the trial interventions through a focus group. DESIGN: Nested process evaluation study using a mixed-methods approach. SETTING: Outpatient clinic. PARTICIPANTS: Five clinicians (two men, three women) aged 47-67 years, with clinical experience of 18-43 years and a minimum of postgraduate certificate training, were involved with the delivery of interventions within the feasibility trial. We assessed treatment fidelity for supervised exercises through audit of clinicians' records and compared those with the planned protocol. Clinicians took part in a focus group that lasted for approximately 1 hour. The focus group was transcribed verbatim and focus group discussion was analysed thematically using an iterative approach. RESULTS: The fidelity score for the tailored exercise and manual therapy intervention was 80.3% (SD: 7.7%) and for the standardised exercise intervention, 82.9% (SD: 5.9%). Clinicians' perspectives about the trial and planned intervention were summarised by one main theme 'conflict experienced between individual clinical practice and the intervention protocol', which was supported by three subthemes: (1) programme strengths and weaknesses; (2) design-related and administrative barriers; and (3) training-related barriers. CONCLUSION: This mixed-methods study assessed supervised treatment fidelity of interventions and clinicians' perceptions on planned interventions tested in the Otago MASTER feasibility trial. Overall, treatment fidelity was acceptable for both intervention arms; however, we observed low fidelity for certain domains within the tailored exercise and manual therapy intervention. Our focus group identified several barriers clinicians faced while delivering the planned interventions. Those findings are of relevance for planning the definite trial and for researchers conducting feasibility trials. TRIAL REGISTRATION NUMBER: ANZCTR: 12617001405303.

Are the outcomes of relative motion extension orthoses non-inferior and cost-effective compared with dynamic extension orthoses for management of zones V-VI finger extensor tendon repairs: A randomized controlled trial.

INTRODUCTION: There is no comparative evidence for relative motion extension (RME) orthosis with dynamic wrist-hand-finger-orthosis (WHFO) management of zones V-VI extensor tendon repairs. PURPOSE OF THE STUDY: To determine if RME with wrist-hand-orthosis (RME plus) is noninferior to dynamic WHFO for these zones in clinical outcomes. STUDY DESIGN: Randomized controlled non-inferiority trial. METHODS: Skilled hand therapists managed 37 participants (95% male; mean age 39 years, SD 18) with repaired zones V-VI extensor tendons randomized to RME plus (n = 19) or dynamic WHFO (n = 18). The primary outcome of percentage of total active motion (%TAM) and secondary outcomes of satisfaction, function, and quality of life were measured at week-6 and -12 postoperatively; percentage grip strength (%Grip), complication rates, and cost data at week-12. Following the intention-to-treat principle non-inferiority was assessed using linear regression analysis (5% significance) and adjusted for injury complexity factors with an analysis of costs performed. RESULTS: RME plus was noninferior for %TAM at week-6 (adjusted estimates 2.5; 95% CI -9.0 to 14.0), %TAM at week-12 (0.3; -6.8 to 7.5), therapy satisfaction at week-6 and -12, and orthosis satisfaction, QuickDASH, and %Grip at week-12. Per protocol analysis yielded 2 tendon ruptures in the RME plus orthoses and 1 in the dynamic WHFO. There were no differences in health system and societal cost, or quality-adjusted life years. DISCUSSION: RME plus orthosis wearers had greater injury complexity than those in dynamic WHFOs, with overall rupture rate for both groups comparatively more than reported by others; however, percentage %TAM was comparable. The number of participants needed was underestimated, so risk of chance findings should be considered. CONCLUSIONS: RME plus management of finger zones V-VI extensor tendon repairs is non-inferior to dynamic WHFO in %TAM, therapy and orthotic satisfaction, QuickDASH, and %Grip. Major costs associated with this injury are related to lost work time.

Singapore KneE osTeoarthritis CoHort (SKETCH): protocol for a multi-centre prospective cohort study.

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of global disability. The understanding of the role of psychosocial factors in knee OA outcomes is still evolving particularly in an Asian context. The primary aim of this study is to explore psychosocial factors that prognosticate short and long-term clinical outcomes, productivity, and healthcare utilization in patients with knee OA. Secondary aims are to explore the mediation and directional relationships and the role it plays in predicting the discordance between self-reported measures (SRM), physical-performance measures (PPMs) and objective clinical parameters. METHODS: A multi-centre prospective cohort study of community ambulant knee OA patients seeking treatment in the tertiary healthcare institutions in Singapore will be conducted. Patients with secondary arthritis, significant cognitive impairment, severe medical comorbidities or previous knee arthroplasty will be excluded. Primary clinical outcome measure is the Knee injury and OA Outcome Score-12 (KOOS-12). Baseline characteristics include sociodemographic status, arthritis status including symptom duration and radiographic severity, comorbidities and functional status through Charlson Comorbidities Index (CCI), Barthel Index (BI) and Parker Mobility Score (PMS). Psychosocial variables include social support, kinesiophobia, negative affect, self-efficacy, injustice, chronic illness shame and the built environment. Clinical outcomes include quality of life, physical performance, global assessment, satisfaction and physical activity levels. Productivity and healthcare utilization will be assessed by a modified OA Cost and Consequences Questionnaire (OCC-Q) and the Work Productivity and Activity Impairment Questionnaire (WPAI). Variables will be collected at baseline, 4, 12 months and yearly thereafter. Regression, mediation and structural equation modelling will be used for analysis. DISCUSSION: Results will allow contextualization, identification, and phenotyping of the critical (and potentially modifiable) psychosocial parameters that predict positive clinical outcomes in the OA population to guide optimization and refinement of healthcare and community. This will facilitate: 1. identification of high-risk knee OA subpopulations that will likely experience poor outcomes and 2. formulation of targeted multidisciplinary comprehensive approaches to address these psychosocial factors to optimize non-surgical treatment care, maximize functional outcomes and create more value-based care model for knee OA. ETHICS AND DISSEMINATION: The study has been registered under clinicaltrials.gov registry (Identifier: NCT04942236).

Leveraging the Short-Term Benefits of Manual Therapy which Includes Exercise Over Exercise Therapy Alone Appears Justified for Knee Osteoarthritis.

Letter to the Editor-in-Chief in response to JOSPT article "The Benefits of Adding Manual Therapy to Exercise Therapy for Improving Pain and Function in Patients with Knee or Hip Osteoarthritis: A Systematic Review with Meta-analysis" by Runge et al. J Orthop Sports Phys Ther 2023;53(1):49-50. doi:10.2519/jospt.2023.0201.

Education plus exercise for persistent gluteal tendinopathy improves quality of life and is cost-effective compared with corticosteroid injection and wait and see: economic evaluation of a randomised trial.

QUESTION: For patients with gluteal tendinopathy, what is the cost utility from health system and societal perspectives of three management approaches: education plus exercise, ultrasound-guided corticosteroid injection or wait and see? DESIGN: Economic evaluation alongside a three-group, parallel, randomised clinical efficacy trial. PARTICIPANTS: People aged between 35 and 70 years with image-confirmed gluteal tendinopathy were recruited via advertisements. INTERVENTIONS: Education plus exercise, consisting of 14 visits to a physiotherapist, with detailed instruction on tendinopathy management, twice weekly supervised exercise sessions, daily home exercises, a handout and a CD; corticosteroid injection, consisting of one ultrasound-guided injection and a handout on general tendon care; and 'wait and see', consisting of one visit to a physiotherapist with assurance and advice on staying active whilst respecting pain. OUTCOME MEASURES: Economic outcome measures were quality-adjusted life years (QALYs) calculated from EuroQol EQ-5D-3L using Australian population preference weights, and total economic costs obtained from participant-reported data collected over the 1-year follow-up period. Missing data (<12% per group) were imputed. Linear regression was used to estimate incremental QALYs and costs between interventions; uncertainty was assessed by calculating 90% confidence intervals, cost-effectiveness acceptability curves and confidence ellipses. RESULTS: A total of 204 individuals (82% women) were enrolled. Incremental cost-effectiveness ratio favoured education plus exercise over corticosteroid injection (AU$12,719 and $5,592 on societal and health system perspectives, respectively) and over wait and see ($29,258 and $3,444 on societal and health system perspectives, respectively). Complete case analysis and varying the direct intervention costs did not change the (imputed analysis) results, with the exception that corticosteroid injection was less cost-effective. CONCLUSION: Education plus exercise for gluteal tendinopathy improves health-related quality of life and is cost-effective compared with corticosteroid injection and wait and see for treating gluteal tendinopathy. REGISTRATION: ACTRN12612001126808.

The osteoarthritis knowledge scale.

OBJECTIVE: Accurate knowledge is central to effective self-care of osteoarthritis (OA). This study aimed to assess the measurement properties of the Osteoarthritis Knowledge Scale (OAKS) with versions for the hip and knee. METHODS: Participants with hip OA (n = 144), knee OA (n = 327), and no OA (n = 735) were recruited. Rasch analysis was conducted to assess psychometric properties using data from all participants with hip OA and 144 randomly selected participants with either knee OA or no OA. Test-retest reliability and measurement error were estimated among those with hip (n = 51) and knee (n = 142) OA. RESULTS: Four items from the draft scales were deleted following Rasch analysis. The final 11-item OAKS was unidimensional. Item functioning was not affected by gender, age, educational level, or scale version (hip or knee). Person separation index was 0.75. Test-retest intraclass correlation coefficient was 0.81 (95% CI 0.74, 0.86; hip version 0.66 [0.47, 0.79]; knee version 0.85 (0.79, 0.90)). Smallest detectable change was 9 points (scale range 11-55; hip OA version 11 points; knee OA version 8 points). CONCLUSION: The OAKS is a psychometrically adequate, unidimensional measure of important OA knowledge that can be used in populations with and without hip and knee OA. Caution is needed when using with populations with only hip OA as test-retest reliability of the hip version did not surpass the acceptable range.

A Guideline-Implementation Intervention to Improve the Management of Low Back Pain in Primary Care: A Difference-in-Difference-in-Differences Analysis.

BACKGROUND: Real-world adherence to clinical practice guidelines is often poor, resulting in sub-standard patient care and unnecessary healthcare costs. This study evaluates the effect of a guideline-implementation intervention for the management of low back pain (LBP) in general practice-the Fear Reduction Exercised Early (FREE) approach-on LBP-related injury insurance claims, healthcare utilisation, and costs of treatment. DESIGN: Data were extracted from comprehensive nationwide New Zealand injury insurance claims records. Data were analysed using a 'triple-difference' (difference-in-difference-in-differences) method to isolate the causal effect of FREE training on LBP claims activity, comparing the difference in general practitioner (GP) LBP claims and associated activity before and after training with their non-musculoskeletal injury claims for the same periods (assumed to be unaffected by training), relative to the same comparisons for GPs not trained in the FREE approach. RESULTS: Training GPs in the FREE approach resulted in significant reductions in the number of LBP injury claims lodged (- 19%, 95% CI -34 to -5), the use of physiotherapy (-30%, 95% CI - 42 to - 18) and imaging (- 27%, 95% CI - 46 to - 8%), and the healthcare costs (- 21%, 95% CI - 41 to - 1) of LBP injury. Changes in claims for earnings' compensation (- 10%, 95% CI - 34 to 13) were not significant. CONCLUSIONS: A brief guideline-implementation intervention following best-practice LBP management and guideline-implementation strategies achieved significant reductions, persisting over at least 6 to18 months, in healthcare utilisation consistent with improved delivery of guideline-concordant care.

Epidemiology of cruciate ligament injuries in New Zealand: exploring differences by ethnicity and socioeconomic status.

OBJECTIVES: To investigate the temporal trends and ethnic and socioeconomic disparities in cruciate ligament (CL) injury incidence and associated costs in New Zealand over a 14-year period. METHODS: All CL injury claims lodged between 2007 and 2020 were extracted from the Accident Compensation Corporation (a nationwide no-fault injury compensation scheme) claims dataset. Age-adjusted and sex-adjusted incidence rates, total injury costs and costs per claim were calculated for each year for total population and subgroups. RESULTS: The total number of CL injury claims increased from 6972 in 2007 to 8304 in 2019, then decreased to 7068 in 2020 (likely due to widespread COVID-19 restrictions; analysis is therefore restricted to 2007-2019 hereafter). The (age-adjusted and sex-adjusted) incidence rate remained largely unchanged and was 173 cases per 100 000 people in 2019. There was a 127% increase in total injury claims costs and a 90% increase in costs per claim. Pacific people had the highest incidence rate and costs per 100 000 people, while Asians had the lowest; European, Maori and 'other' ethnicities had similar incidence rates and total costs. Incidence rates and total costs increased with income and decreased with neighbourhood deprivation. Costs per claim differed little by ethnicity, but increased with income level. CONCLUSION: The number and costs of CL injury claims in New Zealand are increasing. There are ethnic and socioeconomic disparities in CL incidence rates and costs, which are important to address when designing CL injury prevention programmes and programmes aimed at improving equity of access to medical care.

Reliability, Validity, Responsiveness, and Minimum Important Change of the Stair Climb Test in Adults With Hip and Knee Osteoarthritis.

OBJECTIVE: The Osteoarthritis Research Society International (OARSI) recommends assessment of physical function using a performance-based test of stair negotiation but was unable to recommend any specific test. We assessed the reliability, validity, responsiveness, measurement error, and minimum important change (MIC) of the 6-step timed Stair Climb Test (SCT). METHODS: We used pooled data from 397 participants with hip or knee osteoarthritis (54% women) from 4 clinical trials (86% retained at 12-week follow-up). Construct validity was assessed by testing 6 a priori hypotheses against other OARSI-recommended physical function measures. A self-reported Global Rating of Change scale was used to classify participants as worsened, improved, and stable. Participants who worsened in physical function were excluded from all analyses. Responsiveness and MIC were assessed using multiple anchor-based and distribution-based approaches. Test-retest reliability, standard error of measurement (SEM), and smallest detectable change (SDC) were assessed on stable participants. RESULTS: Five of 6 hypotheses (83%) for construct validity were met. Test-retest reliability was excellent (intraclass correlation coefficient2,1 0.83; 95% confidence interval 0.71-0.90). The SEM and SDC values were 0.44 and 1.21 seconds, respectively. We did not find adequate support for responsiveness. The MIC values ranged from 0.78 to 1.95 seconds using different approaches (median 1.37 seconds). CONCLUSION: The 6-step timed SCT adequately assesses the construct of physical function in individuals with hip or knee osteoarthritis with excellent 12-week test-retest reliability. However, support for its responsiveness was inadequate to recommend its use as an outcome measure in people with osteoarthritis for research and clinical practice.

Knee osteoarthritis and the knowledgeable, trustworthy pharmacist: Patient and pharmacist perceptions of community pharmacy-based education and support.

BACKGROUND: Osteoarthritis (OA) clinical guidelines recommend self-management education, but education is often not included in primary care consultations. OBJECTIVE: To explore pharmacists' and patients' perceptions of a pharmacist-led model of service delivery for knee OA that was integrated within pharmacies' day-to-day workflow. METHODS: Cross-sectional qualitative design using Thematic Analysis. Community pharmacies were recruited in New Zealand and Australia. Pharmacy patients were screened for knee OA and offered tailored explanations, self-management information and referral for further support. Pharmacist focus groups and patient 1:1 interviews explored perceptions of the service delivery model. RESULTS: Nineteen pharmacists and 12 patients with knee OA participated. Pharmacist and patient data were analysed separately, with themes compared and contrasted to derive three meta-themes. Meta-theme 1: 'Welcome Engagement' included two pharmacist themes ('putting my broad skill set to use' and 'we're here and happy to help') and two patient themes ('information delivered well' and 'a welcome offer of help'). Meta-theme 2: 'The Knowledgeable and Trustworthy Pharmacist' included two pharmacist themes ('professional knowledge to help all sorts of patients' and 'managing time to help my patients') and one patient theme ('the accessible professional who I know and trust'). Meta-theme 3: 'The Opportunity for More Support' included one pharmacist theme ('this is not the end of the story') and one patient theme ('more help is available'). CONCLUSION: Community pharmacists are well-positioned to provide information and support to people with knee OA. Pharmacists appreciate the opportunity to better use their skills and accessibility for OA care, and patients welcome this engagement.

Feasibility of a randomised controlled trial of two types of written information for people with knee osteoarthritis.

Objective: Test the feasibility of conducting an individually randomised controlled trial recruiting people with knee osteoarthritis (OA) in community pharmacies and evaluate the impacts of a novel information booklet. Design: People with knee OA were identified by pharmacy staff using clinical criteria and randomised to receive a novel information booklet (intervention) or the currently available written OA resource (active control). Mixed-methods process evaluation assessed participant recruitment, retention, and experience. Participant-reported outcome measures, assessing OA illness perceptions, OA knowledge, fear of movement, and pain when walking at baseline and 4-weeks, were analysed using linear regression models (adjusted for baseline). Results: Of 72 eligible people, 64 were randomised to intervention (n â€‹= â€‹33) or control (n â€‹= â€‹31). The randomisation sequence was followed correctly and no protocol deviations identified. Mean recruitment rate was 2.7 participants per pharmacy per week. One-in-five participants had no educational qualifications and one-in-four had not received a knee OA diagnosis prior to the trial. Three meta-themes emerged from pharmacist and participant qualitative analysis: 'pleased to be asked'; 'easy process'; and 'successful process'. Three participants were lost to follow-up. At 4 weeks, intervention arm Knee Osteoarthritis Knowledge Scale scores improved (mean difference â€‹= â€‹3.6, 95%CI 0.7 to 6.5). Brief Illness Perceptions Questionnaire scores were similar between groups (mean difference 0.4, 95%CI -3.7 to 4.5). Conclusion: It is feasible to conduct an individually randomised trial in community pharmacy, a potentially effective setting to initiate accessible OA care. A novel information booklet improved OA knowledge, but is unlikely to affect illness perceptions on its own.

Economic evaluation: a reader's guide to studies of cost-effectiveness.

BACKGROUND: Understanding what an economic evaluation is, how to interpret it, and what it means for making choices in a health delivery context is necessary to contribute to decisions about healthcare resource allocation. The aim of this paper to demystify the working parts of a health economic evaluation, and explain to clinicians and clinical researchers how to read and interpret cost-effectiveness research. MAIN BODY: This primer distils key content and constructs of economic evaluation studies, and explains health economic evaluation in plain language. We use the PICOT (participant, intervention, comparison, outcome, timeframe) clinical trial framework familiar to clinicians, clinical decision-makers, and clinical researchers, who may be unfamiliar with economics, as an aide to reading and interpreting cost-effectiveness research. We provide examples, primarily of physiotherapy interventions for osteoarthritis. CONCLUSIONS: Economic evaluation studies are essential to improve decisions about allocating resources, whether those resources be your time, the capacity of your service, or the available funding across the entire healthcare system. The PICOT framework can be used to understand and interpret cost-effectiveness research.

Adjunctive therapies in addition to land-based exercise therapy for osteoarthritis of the hip or knee.

BACKGROUND: Land-based exercise therapy is recommended in clinical guidelines for hip or knee osteoarthritis. Adjunctive non-pharmacological therapies are commonly used alongside exercise in hip or knee osteoarthritis management, but cumulative evidence for adjuncts to land-based exercise therapy is lacking. OBJECTIVES: To evaluate the benefits and harms of adjunctive therapies used in addition to land-based exercise therapy compared with placebo adjunctive therapy added to land-based exercise therapy, or land-based exercise therapy only for people with hip or knee osteoarthritis. SEARCH METHODS: We searched CENTRAL, MEDLINE, PsycINFO, EMBASE, CINAHL, Physiotherapy Evidence Database (PEDro) and clinical trials registries up to 10 June 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-RCTs of people with hip or knee osteoarthritis comparing adjunctive therapies alongside land-based exercise therapy (experimental group) versus placebo adjunctive therapies alongside land-based exercise therapy, or land-based exercise therapy (control groups). Exercise had to be identical in both groups. Major outcomes were pain, physical function, participant-reported global assessment, quality of life (QOL), radiographic joint structural changes, adverse events and withdrawals due to adverse events. We evaluated short-term (6 months), medium-term (6 to 12 months) and long-term (12 months onwards) effects. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data, and assessed risk of bias and certainty of evidence for major outcomes using GRADE. MAIN RESULTS: We included 62 trials (60 RCTs and 2 quasi-RCTs) totalling 6508 participants. One trial included people with hip osteoarthritis, one hip or knee osteoarthritis and 59 included people with knee osteoarthritis only. Thirty-six trials evaluated electrophysical agents, seven manual therapies, four acupuncture or dry needling, or taping, three psychological therapies, dietary interventions or whole body vibration, two spa or peloid therapy and one foot insoles. Twenty-one trials included a placebo adjunctive therapy. We presented the effects stratified by different adjunctive therapies along with the overall results. We judged most trials to be at risk of bias, including 55% at risk of selection bias, 74% at risk of performance bias and 79% at risk of detection bias. Adverse events were reported in eight (13%) trials. Comparing adjunctive therapies plus land-based exercise therapy against placebo therapies plus exercise up to six months (short-term), we found low-certainty evidence for reduced pain and function, which did not meet our prespecified threshold for a clinically important difference. Mean pain intensity was 5.4 in the placebo group on a 0 to 10 numerical pain rating scale (NPRS) (lower scores represent less pain), and 0.77 points lower (0.48 points better to 1.16 points better) in the adjunctive therapy and exercise therapy group; relative improvement 10% (6% to 15% better) (22 studies; 1428 participants). Mean physical function on the Western Ontario and McMaster (WOMAC) 0 to 68 physical function (lower scores represent better function) subscale was 32.5 points in the placebo group and reduced by 5.03 points (2.57 points better to 7.61 points better) in the adjunctive therapy and exercise therapy group; relative improvement 12% (6% better to 18% better) (20 studies; 1361 participants). Moderate-certainty evidence indicates that adjunctive therapies did not improve QOL (SF-36 0 to 100 scale, higher scores represent better QOL). Placebo group mean QOL was 81.8 points, and 0.75 points worse (4.80 points worse to 3.39 points better) in the placebo adjunctive therapy group; relative improvement 1% (7% worse to 5% better) (two trials; 82 participants). Low-certainty evidence (two trials; 340 participants) indicates adjunctive therapies plus exercise may not increase adverse events compared to placebo therapies plus exercise (31% versus 13%; risk ratio (RR) 2.41, 95% confidence interval (CI) 0.27 to 21.90). Participant-reported global assessment was not measured in any studies. Compared with land-based exercise therapy, low-certainty evidence indicates that adjunctive electrophysical agents alongside exercise produced short-term (0 to 6 months) pain reduction of 0.41 points (0.17 points better to 0.63 points better); mean pain in the exercise-only group was 3.8 points and 0.41 points better in the adjunctive therapy plus exercise group (0 to 10 NPRS); relative improvement 7% (3% better to 11% better) (45 studies; 3322 participants). Mean physical function (0 to 68 WOMAC subscale) was 18.2 points in the exercise group and 2.83 points better (1.62 points better to 4.04 points better) in the adjunctive therapy plus exercise group; relative improvement 9% (5% better to 13% better) (45 studies; 3323 participants). These results are not clinically important. Mean QOL in the exercise group was 56.1 points and 1.04 points worse in the adjunctive therapies plus exercise therapy group (1.04 points worse to 3.12 points better); relative improvement 2% (2% worse to 5% better) (11 studies; 1483 participants), indicating no benefit (low-certainty evidence). Moderate-certainty evidence indicates that adjunctive therapies plus exercise probably result in a slight increase in participant-reported global assessment (short-term), with success reported by 45% in the exercise therapy group and 17% more individuals receiving adjunctive therapies and exercise (RR 1.37, 95% CI 1.15 to 1.62) (5 studies; 840 participants). One study (156 participants) showed little difference in radiographic joint structural changes (0.25 mm less, 95% CI -0.32 to -0.18 mm); 12% relative improvement (6% better to 18% better). Low-certainty evidence (8 trials; 1542 participants) indicates that adjunctive therapies plus exercise may not increase adverse events compared with exercise only (8.6% versus 6.5%; RR 1.33, 95% CI 0.78 to 2.27). AUTHORS' CONCLUSIONS: Moderate- to low-certainty evidence showed no difference in pain, physical function or QOL between adjunctive therapies and placebo adjunctive therapies, or in pain, physical function, QOL or joint structural changes, compared to exercise only. Participant-reported global assessment was not reported for placebo comparisons, but there is probably a slight clinical benefit for adjunctive therapies plus exercise compared with exercise, based on a small number of studies. This may be explained by additional constructs captured in global measures compared with specific measures. Although results indicate no increased adverse events for adjunctive therapies used with exercise, these were poorly reported. Most studies evaluated short-term effects, with limited medium- or long-term evaluation. Due to a preponderance of knee osteoarthritis trials, we urge caution in extrapolating the findings to populations with hip osteoarthritis.

Tailored exercise and manual therapy versus standardised exercise for patients with shoulder subacromial pain: a feasibility randomised controlled trial (the Otago MASTER trial).

OBJECTIVES: The aim of this study was to assess whether it was feasible to conduct a full trial comparing a tailored versus a standardised exercise programme for patients with shoulder subacromial pain. DESIGN: Two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial. METHODS: Twenty-eight participants with shoulder subacromial pain were randomly allocated into one of two intervention groups-tailored or standardised exercise. Participants in the tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments. Participants in the standardised exercise programme received progressive strengthening exercise. The primary outcome measures were (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme. Other outcome measures were: (5) pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy. We compared changes in pain and disability scores between groups using a repeated mixed-model analysis of variance. Since this is a feasibility study, we did not adjust alpha for multiple comparisons, and considered 75% CI as the probability threshold at 3-month follow-up. Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated. RESULTS: The recruitment rate was 3 participants per month, the proportion of participants enrolled was 23%, the drop-out rate was 14% and the overall adherence to the rehabilitation programme was 85%. No between-group differences were found for most outcome measures. Adverse events (n=2, only in the tailored group) were minor in nature and included skin injury or pain following taping. CONCLUSIONS: Our feasibility trial showed that additional strategies are required for improving recruitment, enrolment and minimising drop-out of participants into the trial and making it feasible to conduct a full trial. TRIAL REGISTRATION NUMBER: ANZCTR: 12617001405303.