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Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol.

ABSTRACT:

Introduction

Clinical guidelines for the treatment of hip and knee osteoarthritis recommend non-pharmacological and non-surgical treatments. Exercise treatments are recommended as primary strategies, but specific exercise programme components have not been specified. Early evidence indicates that manual physiotherapy is effective for hip and knee osteoarthritis. The Management of Osteoarthritis (MOA) Trial was designed to evaluate the effectiveness and cost-effectiveness of physiotherapist-led, individualised exercise, manual physiotherapy and a combination of these two interventions in the treatment of adults with hip or knee osteoarthrits. This paper describes the methods that will be used to conduct the economic evaluation of these interventions within the MOA Trial.

Methods and analysis

This comprehensive economic evaluation will assess the incremental cost-effectiveness of physiotherapy plus usual care versus usual care alone from a societal perspective. The authors will conduct a cost-consequences analysis using end-points such as Outcomes Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International responder criteria and quality-adjusted life years. The evaluation will have a time horizon of 1 year (and so discounting will not be necessary). All costs will be reported in 2009 New Zealand dollars. The authors will address uncertainty via bootstrapping to calculate CIs for the mean incremental cost-effectiveness ratios and by performing sensitivity analyses.

Ethics and dissemination

Ethical approval was granted by the Lower South Regional Ethics Committee of the New Zealand Ministry of Health (ethics reference: LRS/07/11/044). All participants of the MOA Trial provided written informed consent for the capture of their healthcare costs. We will submit the results of the study for publication irrespective of outcome. Clinical trials registration number ACTRN12608000130369.

SUBMITTER: Pinto D

PROVIDER: S-EPMC3191427 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol.

Pinto Daniel D Robertson M Clare MC Hansen Paul P Abbott J Haxby JH

BMJ open 20110617 1

<h4>Introduction</h4>Clinical guidelines for the treatment of hip and knee osteoarthritis recommend non-pharmacological and non-surgical treatments. Exercise treatments are recommended as primary strategies, but specific exercise programme components have not been specified. Early evidence indicates that manual physiotherapy is effective for hip and knee osteoarthritis. The Management of Osteoarthritis (MOA) Trial was designed to evaluate the effectiveness and cost-effectiveness of physiotherapi ...[more]

PMID: 22021774

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Project description:Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) what is the feasibility of a randomised controlled trial (RCT) investigating a targeted physiotherapy intervention for early-onset hip osteoarthritis (OA) post-hip arthroscopy? and (ii) what are the within-group treatment effects of the physiotherapy intervention and a health-education control group?This study was a pilot single-blind RCT conducted in a private physiotherapy clinic in Hobart, Australia. Patients included 17 volunteers (nine women; age 32 ± 8 years; body mass index = 25.6 ± 5.1 kg/m2) who were recruited 4-14 months post-hip arthroscopy, with chondropathy and/or labral pathology at the time of surgery. Interventions included a physiotherapy treatment program that was semi-standardised and consisted of (i) manual therapy; (ii) hip strengthening and functional retraining; and (iii) health education. Control treatment encompassed individualised health education sessions. The primary outcome measure was feasibility, which was reported as percentage of eligible participants enrolled, adherence with the intervention, and losses to follow-up. The research process was evaluated using interviews, and an estimated sample size for a definitive study is offered. Secondary outcomes included the Hip disability and Osteoarthritis Outcome Score (HOOS) and the International Hip Outcome Tool (IHOT-33) patient-reported outcomes.Seventeen out of 48 eligible patients (35%) were randomised. Adherence to the intervention was 100%, with no losses to follow-up. The estimated sample size for a full-scale RCT was 142 patients. The within-group (95% confidence intervals) change scores for the physiotherapy group were HOOS-Symptoms 6 points (-4 to 16); HOOS-Pain 10 points (-2 to 22); HOOS-Activity of Daily Living 8 points (0 to 16); HOOS-Sport 3 points (-12 to 19); HOOS-Quality of Life 3 points (-7 to 13); and IHOT-33 7 points (-10 to 25). The within-group (95% confidence intervals) change scores for the control group were HOOS-Symptoms -4 points (-17 to 9); HOOS-Pain -2 points (-18 to 13); HOOS-Activity of Daily Living -7 points (-17 to 4); HOOS-Sport 4 points (-16 to 23); HOOS-Quality of Life -5 points (-18 to 9); and IHOT-33 -4 points (-27 to 19). Suggestions to improve study design included greater supervision of exercises and increased access to physiotherapy appointments.Results support the feasibility of a full-scale RCT, and recommendations for an adequately powered and improved study to determine the efficacy of this physiotherapy intervention post-hip arthroscopy to reduce pain and improve function are provided.Australian Clinical Trials Registry, ACTRN12614000426684.

Project description:ObjectiveTo evaluate the cost-utility and cost-effectiveness of the dr. Bart app compared to usual care in people with osteoarthritis (OA) of the knees and hips, applying a health care payer perspective.MethodsThis economic evaluation was conducted alongside a 6-month randomized controlled trial that included 427 participants. The dr. Bart app is a stand-alone eHealth application that invites users to select pre-formulated goals (i.e., "tiny habits") and triggers for a healthier lifestyle. Self-reported outcome measures were health care costs, quality-adjusted life years (QALYs) according to the EuroQol 5-dimension 3-level (EQ-5D-3L) descriptive system, the EuroQol visual analog scale (QALY VAS), patient activation measure 13 (PAM-13), and 5 subscales of the Knee Injury and Osteoarthritis Outcome Score/Hip Disability and Osteoarthritis Outcome Score. Missing data were multiply imputed, and bootstrapping was used to estimate statistical uncertainty.ResultsThe mean ± SD age of the study participants was 62.1 ± 7.3 years, and the majority of participants were female (72%). Health care costs were lower in the intervention group compared to the group who received usual care (€-22 [95% confidence interval €-36, -3]). For QALY and QALY VAS, the probability of the dr. Bart app being cost-effective compared to usual care was 0.71 and 0.67, respectively, at a willingness-to-pay (WTP) of €10,000 and 0.64 and 0.56, respectively, at a WTP of €80.000. For self-management behavior, symptoms, pain, and activities of daily living, the probability that the dr. Bart app was cost-effective was >0.82, and the probability that the dr. Bart app was cost-effective in the areas of activities and quality of life was <0.40, regardless of WTP thresholds.ConclusionThis economic evaluation showed that costs were lower for the dr. Bart app group compared to the group who received usual care. Given the noninvasive nature of the intervention and the moderate probability of it being cost-effective for the majority of outcomes, the dr. Bart app has the potential to serve as a tool to provide education and goal setting in OA and its treatment options.

Project description:ObjectiveTo investigate the effectiveness of exercise and/or educational intervention on physical activity and pain in patients with hip/knee osteoarthritis (OA) using systematic review and meta-analysis.MethodsWe searched randomized controlled trials that investigated physical activity and pain and compared exercise and/or educational intervention with usual care in patients with hip/knee OA in MEDLINE (PubMed), ProQuest, Scopus, and the Physiotherapy Evidence Database (PEDro), including all those published by April 30, 2022 and written in English. Studies that newly applied analgesics after onset of the intervention were excluded. The revised Cochrane risk-of-bias tool for randomized trials was used to assess the methodological qualities. The random-effects model was used for meta-analysis with standard mean differences using RevMan version 5.4. The body of evidence for each study was synthesized using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.ResultsTwenty studies including 2,350 patients were included (7 exercise studies, 8 educational intervention studies and 5 combination studies). The meta-analysis demonstrated that there is very low evidence that combination therapy of exercise and educational intervention improve the physical activity level at the endpoint (4 articles; SMD 0.33, 95% CI 0.04 to 0.51, P = 0.03). Low evidence was observed for combination therapy reducing pain (4 articles; SMD -0.15, 95% CI -0.29 to -0.02, P = 0.03).DiscussionThe current evidence indicated that combination therapy of exercise and educational intervention leads to improved physical activity and pain reduction in hip/knee OA patients, but the risk of bias in each study, especially in allocation concealment, downgraded the evidence level. These findings support the use of a combination therapy of exercise and educational intervention to promote physical activity levels in patients with hip/knee OA.Trail registrationThere was no financial support for this research. The protocol was registered at the International Prospective Register of Systematic Reviews (registration code: CRD42020205804).

Project description:BackgroundClinical practice guidelines recommend exercise as the first line of management for hip osteoarthritis, yet high-quality evidence from Cochrane reviews suggest only slight benefits for pain and physical function; and no benefit on quality of life (low-quality evidence). However, the scope of physical impairments identified in people with hip osteoarthritis may not have been adequately addressed with targeted rehabilitation options in previous randomised controlled trials (RCTs). Potential targeted options include gait retraining to address spatio-temporal impairments in walking; motor control training to address deep gluteal (gluteus minimus) dysfunction; and progressive, high-intensity resistance exercises to address atrophy of the gluteal muscles. The aim of this study is to investigate the effect of a targeted gluteal rehabilitation programme that incorporates gait retraining, motor control and progressive, high-intensity resistance-strength training, to address physical activity levels and self-reported physical function in people with mild to moderate disability from hip osteoarthritis.MethodsNinety people diagnosed with mild to moderately disabling hip osteoarthritis will be recruited and randomised to receive one of two exercise programmes (sham or GHOst programme). Interventions will be 12 weeks in duration, with weekly, supervised physiotherapy sessions, and daily home exercises. Both groups will receive standardised education. Outcomes will be assessed at baseline, 7 weeks, 13 weeks (primary time-point) and 25 weeks. The primary outcome will be self-reported physical function measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include physical activity measured with a tri-axial accelerometer, physical function tests, self-reported physical activity, isometric hip-muscle strength tests, hip-related patient-reported outcome measures, pain thoughts and depressive symptoms, quality of life, global rating of change, gluteal-muscle activity (electromyography (EMG)) and gluteal-muscle size and adiposity (magnetic resonance imaging (MRI)).DiscussionThis will be the first study to compare a targeted gluteal rehabilitation programme to a sham exercise programme. The targeted GHOst programme includes exercises designed to address gait impairments as well as gluteal-muscle atrophy and dysfunction.Trial registrationAustralian New Zealand Clinical Trials Registry, ID: ACTRN12617000970347 . Registered retrospectively on 5 July 2017. Protocol version 3.0.

Project description:ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.

Project description:BackgroundTherapeutic exercise is a currently recommended nonpharmacological treatment for knee osteoarthritis (KOA). The optimal treatment dose (frequency or duration) has not been determined.ObjectiveTo examine dose-response relationships, minimal effective dose, and baseline factors associated with the timing of response from 2 exercise interventions in KOA.DesignSecondary analysis of a single-blind, randomized trial comparing 12-week Tai Chi and physical therapy exercise programs (Trial Registry #NCT01258985).SettingUrban tertiary care academic hospital PARTICIPANTS: A total of 182 participants with symptomatic KOA (mean age 61 years; BMI 32 kg/m2, 70% female; 55% white).MethodsWe defined dose as cumulative attendance-weeks of intervention, and treatment response as ≥20% and ≥50% improvement in pain and function. Using log-rank tests, we compared time-to-response between interventions, and used Cox regression to examine baseline factors associated with timing of response, including physical and psychosocial health, physical performance, outcome expectations, self-efficacy, and biomechanical factors.Main outcome measuresWeekly Western Ontario and McMasters Osteoarthritis Index (WOMAC) pain (0-500) and function (0-1700) scores.ResultsBoth interventions had an approximately linear dose-response effect resulting in a 9- to 11-point reduction in WOMAC pain and a 32- to 41-point improvement in function per attendance-week. There was no significant difference in overall time-to-response for pain and function between treatment groups. Median time-to-response for ≥20% improvement in pain and function was 2 attendance-weeks and for ≥50% improvement was 4-5 attendance-weeks. On multivariable models, outcome expectations were independently associated with incident function response (hazard ratio = 1.47, 95% confidence interval 1.004-2.14).ConclusionsBoth interventions have approximately linear dose-dependent effects on pain and function; their minimum effective doses range from 2-5 weeks; and patient perceived benefits of exercise influence the timing of response in KOA. These results may help clinicians to optimize patient-centered exercise treatments and better manage patient expectations.Level of evidenceII.

Dataset Information

Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol.

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