Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial.
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SUBMITTER: Bennell KL
PROVIDER: S-EPMC7068989 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
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Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial.
Bennell Kim L KL Keating Catherine C Lawford Belinda J BJ Kimp Alexander J AJ Egerton Thorlene T Brown Courtney C Kasza Jessica J Spiers Libby L Proietto Joseph J Sumithran Priya P Quicke Jonathan G JG Hinman Rana S RS Harris Anthony A Briggs Andrew M AM Page Carolyn C Choong Peter F PF Dowsey Michelle M MM Keefe Francis F Rini Christine C
BMC musculoskeletal disorders 20200312 1
<h4>Background</h4>Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise interve ...[more]
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Project description:BackgroundThere is limited information on the costs and benefits of alternative adjunct non-pharmacological treatments for knee osteoarthritis and little guidance on which should be prioritised for commissioning within the NHS. This study estimates the costs and benefits of acupuncture, braces, heat treatment, insoles, interferential therapy, laser/light therapy, manual therapy, neuromuscular electrical stimulation, pulsed electrical stimulation, pulsed electromagnetic fields, static magnets and transcutaneous electrical nerve Stimulation (TENS), based on all relevant data, to facilitate a more complete assessment of value.MethodsData from 88 randomised controlled trials including 7,507 patients were obtained from a systematic review. The studies reported a wide range of outcomes. These were converted into EQ-5D index values using prediction models, and synthesised using network meta-analysis. Analyses were conducted including firstly all trials and secondly only trials with low risk of selection bias. Resource use was estimated from trials, expert opinion and the literature. A decision analytic model synthesised all evidence to assess interventions over a typical treatment period (constant benefit over eight weeks or linear increase in effect over weeks zero to eight and dissipation over weeks eight to 16).ResultsWhen all trials are considered, TENS is cost-effective at thresholds of £20-30,000 per QALY with an incremental cost-effectiveness ratio of £2,690 per QALY vs. usual care. When trials with a low risk of selection bias are considered, acupuncture is cost-effective with an incremental cost-effectiveness ratio of £13,502 per QALY vs. TENS. The results of the analysis were sensitive to varying the intensity, with which interventions were delivered, and the magnitude and duration of intervention effects on EQ-5D.ConclusionsUsing the £20,000 per QALY NICE threshold results in TENS being cost-effective if all trials are considered. If only higher quality trials are considered, acupuncture is cost-effective at this threshold, and thresholds down to £14,000 per QALY.
| S-EPMC5340388 | biostudies-literature
Project description:Osteoarthritis of the knee is a common disease that causes significant disability. Most patients can be managed conservatively in the outpatient setting. A small minority require surgery. The cornerstones of treatment are weight loss, exercise and analgesia. Walking aids, medial patellar taping, acupuncture and transcutaneous electrical nerve stimulation are useful management adjuncts. Current evidence does not support routine prescription of glucosamine and chondroitin supplements. Early consultation with an orthopaedic surgeon should be made when conservative measures fail.
| S-EPMC5651502 | biostudies-literature
Project description:BACKGROUND: Self-management has become increasingly popular in the management of chronic diseases. There are many different self-management models. Meta analyses of arthritis self-management have concluded that it is difficult to recommend any one program in preference to another due to inconsistencies in the study designs used to evaluate different programs.The Stanford Arthritis Self-Management Program (ASMP), most commonly delivered by trained lay leaders, is a generic program widely used for people with rheumatological disorders. We have developed a more specific program expressly for people with osteoarthritis of the knee (OAKP). It includes information designed to be delivered by health professionals and results in improvements in pain, function and quality of life. AIM: To determine whether, for people with osteoarthritis (OA) of the knee, the OAKP implemented in a primary health care setting can achieve and maintain clinically meaningful improvements in more participants than ASMP delivered in the same environment. METHODS/DESIGN: The effectiveness of the programs will be compared in a single-blind randomized study. PARTICIPANTS: 146 participants with established OA knee will be recruited. Volunteers with coexistent inflammatory joint disease or serious co-morbidities will be excluded. INTERVENTIONS: Participants will be randomised into either OAKP or ASMP groups and followed for 6 months. MEASUREMENTS: Assessments will be immediately before and after the intervention and at 6 months. Primary outcome measures will be WOMAC and SF-36 questionnaires and a VAS for pain. Secondary outcomes will include balance, tested using a timed single leg balance test and a timed step test and self-efficacy. Data will be analysed using repeated measures ANOVA. DISCUSSION: With an aging population the health care costs for people with arthritis are ever increasing. Although cost analysis is beyond the scope of this study, it is reasonable to expect that costs will be greater when health professionals deliver self-management programs as opposed to lay leaders. Consequently it is critical to examine the relative effectiveness of the primary care management strategies available for OA. TRIAL REGISTRATION: This study is registered with the Australian New Zealand Clinical Trials Registry: 12607000031460.
| S-EPMC2850876 | biostudies-other
Project description:ObjectiveDescribe the co-design process and learnings related to developing the web-based Translating Research Evidence and Knowledge (TREK) 'My Knee' education and self-management toolkit for people with knee osteoarthritis.Co-design processStage (i): Understand and define; systematically reviewed education interventions in published trials; appraised web-based information about knee osteoarthritis; and used concept mapping to identify education priorities of people with knee osteoarthritis and physiotherapists. Stage (ii): Prototype; created a theory-, guideline- and evidence-informed toolkit. Stage (iii): Test and iterate; completed three co-design workshops with end-users (i.e., people with knee osteoarthritis and health professionals); plus an expert review.ResultsThe toolkit is available at myknee.trekeducation.org. Stage (i) identified the need for more accurate and co-designed resources to address broad education needs generated during concept mapping, including guidance on surgery, dispelling common misconceptions and facilitating engagement with exercise therapy and weight management. A theory- and research-informed prototype was created in Stage (ii) to address broad learning and education needs. Stage (iii) co-design workshops (n = 15 people with osteoarthritis and n = 9 health professionals) informed further content creation and refinement, alongside improvements to optimise usability. Expert opinion review (n = 8) further refined accuracy and usability.ConclusionsThe novel co-design methodology employed to create the TREK 'My Knee' toolkit facilitated the alignment of the content and usability to meet the broad education needs of people with knee osteoarthritis and health professionals. This toolkit aims to improve and facilitate engagement with guideline-recommended first-line care for people with knee osteoarthritis. Future work will determine its effectiveness in improving clinical outcomes in this population.
| S-EPMC10052584 | biostudies-literature
Project description:Objective To estimate the potential lifetime health gains, healthcare costs, and cost-effectiveness of recommended adjunctive treatments for knee osteoarthritis delivered in addition to established core treatments, relative to core treatment only, from the perspective of the New Zealand (NZ) healthcare sector. Design Recommended adjunctive knee osteoarthritis treatments were identified in clinical practice guidelines. Evidence of effectiveness was sourced from existing systematic reviews and meta-analyses. Treatment costs were calculated by applying local reference prices to estimated resource use. We used a validated computer simulation model of the impacts of knee osteoarthritis to estimate the cost-effectiveness of each adjunctive treatment at willingness-to-pay thresholds of one (primary), two, and three times per-capita GDP ($NZ52 300). Results Data were collected on nine recommended adjunctive treatments: aquatic-based exercise, heat therapy, massage therapy, walking cane, cognitive behavioural therapy (CBT), topical non-steroidal anti-inflammatory drugs (NSAIDs), oral NSAIDs, intra-articular corticosteroids, and duloxetine. Relative to core treatments only, walking cane and heat therapy were cost-saving and provided greater QALYs; aquatic exercise and intra-articular corticosteroids were also cost-effective at all WTP thresholds. Topical NSAIDs and CBT were cost-effective only at higher WTP thresholds, while duloxetine, massage therapy, and oral NSAIDs were not cost-effective at any relevant threshold. Results were generally robust to varying modelling assumptions, although topical and oral NSAIDs and CBT became cost-effective in some scenarios. Conclusions Delivering high-value, low-cost adjunctive interventions for knee osteoarthritis, alongside recommended core treatment, could deliver substantial health gains at low cost to the health system.
| S-EPMC9718247 | biostudies-literature
Project description:IntroductionKnee osteoarthritis is a chronic degenerative disease associated with significant chronic pain, disability and impaired quality of life and is the most common form of osteoarthritis. There is no cure for knee osteoarthritis, and the main therapeutic goals are pain management and improving quality of life. The objective of this study is to evaluate the relative efficacy and acceptability of available interventions using network meta-analysis (NMA) to provide a comprehensive evidence base to inform future treatment guidelines.Methods and analysisA comprehensive literature search of major electronic databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials) and clinical trial registries will identify randomised control trials (RCTs) of interventions listed in NICE guidelines for the treatment of knee osteoarthritis in adults. We will perform an NMA to estimate relative intervention effects across the whole treatment network. If any studies use multicomponent intervention packages, we will employ a component NMA model to estimate the contribution of individual components. The quality of evidence will be assessed using the Confidence in Network Meta-Analysis approach, which is based on the traditional GRADE framework adapted for NMA. Risk of bias (RoB) will be assessed using the revised Cochrane RoB 2.0 tool for RCTs.Ethics and disseminationThis study does not require ethical approval. Findings will be submitted to a peer-reviewed journal.Prospero registration numberCRD42020184192.
| S-EPMC8479979 | biostudies-literature
Project description:BACKGROUND:Osteoarthritis (OA) is not curable, but the symptoms can be managed through self-management programs (SMPs). Owing to the growing burden of OA on the health system and the need to ensure high-quality integrated services, delivering SMPs through digital technologies could be an economic and effective community-based approach. OBJECTIVE:This study aims to analyze the effectiveness of digital-based structured SMPs on patient outcomes in people with OA. METHODS:A total of 7 web-based and 3 gray literature databases were searched for randomized controlled trials assessing digital-based structured SMPs on self-reported outcomes including pain, physical function, disability, and health-related quality of life (QoL) in people with OA. Two reviewers independently screened the search results and reference lists of the identified papers and related reviews. Data on the intervention components and delivery and behavioral change techniques used were extracted. A meta-analysis, risk of bias sensitivity analysis, and subgroup analysis were performed where appropriate. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to assess the quality of evidence. RESULTS:A total of 8 studies were included in this review involving 2687 patients with knee (n=2); knee, hip, or both (n=5); and unspecified joint (n=1) OA. SMPs were delivered via telephone plus audio and video, internet, or mobile apps. Studies reported that digital-based structured SMPs compared with the treatment as usual control group (n=7) resulted in a significant, homogeneous, medium reduction in pain and improvement in physical function (standardized mean difference [SMD] -0.28, 95% CI -0.38 to -0.18 and SMD -0.26, 95% CI -0.35 to -0.16, respectively) at posttreatment. The digital-based structured SMP effect on pain and function reduced slightly at the 12-month follow-up but remained to be medium and significant. The posttreatment effect of digital-based structured SMPs was small and significant for disability, but nonsignificant for QoL (SMD -0.10, 95% CI -0.17 to 0.03 and SMD -0.17, 95% CI -0.47 to 0.14, respectively; each reported in 1 study only). The 12-month follow-up effect of the intervention was very small for disability and QoL. The quality of evidence was rated as moderate for pain and physical function and low and very low for disability and QoL, respectively, using the GRADE approach. CONCLUSIONS:Digital-based structured SMPs may result in improvement in pain and physical function that is largely sustained at the 12-month follow-up in people with knee and hip OA. The effects on disability and QoL are smaller and less clear. The quality of evidence is moderate to low, and further research is required to confirm the findings of the review and assess the effects of digital-based structured SMPs on other health-related outcomes.
| S-EPMC7428148 | biostudies-literature
Project description:Surgical interventions for knee osteoarthritis (OA) have markedly different procedure attributes and may have dramatic differences in patient desirability. A total of 323 patients with knee OA were included in a dual response, choice-based conjoint analysis to identify the relative preference of 9 different procedure attributes. A model was also developed to simulate how patients might respond if presented with the real-world knee OA procedures, based on conservative assumptions regarding their attributes. The "amount of cutting and removal of the existing bone" required for a procedure had the highest preference score, indicating that these patients considered it the most important attribute. More specifically, a procedure that requires the least amount of bone cutting or removal would be expected to be the most preferred surgical alternative. The model also suggested that patients who are younger and report the highest pain levels and greatest functional limitations would be more likely to opt for surgical intervention.
| S-EPMC5613842 | biostudies-literature
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.
| S-EPMC8296761 | biostudies-literature
Project description:ObjectiveTo investigate the trajectories of work and activity impairments among people participating in a digital self-management program for osteoarthritis (OA).MethodsWe conducted an observational longitudinal study using data for baseline, 3, 6, 9 and 12 months follow ups from people participating in a digital OA treatment between June 2018 and September 2021. The Work Productivity and Activity Impairment-Osteoarthritis (WPAI-OA) questionnaire was used to measure work and activity impairments. We applied linear mixed models and group-based trajectory modelling (GBTM) to assess the trajectories of work and activity impairments and their variability. Dominance analysis was performed to explore the relative importance of baseline characteristics in predicting the trajectory subgroup membership.ResultsA total of 14,676 participants with mean (± standard deviation) age 64.0 (± 9.1) years and 75.5% females were included. The adjusted mean improvements in work impairment from baseline were 5.8% (95% CI 5.3, 6.4) to 6.1% (95% CI 5.5, 6.8). The corresponding figures for activity impairment were 9.4% (95% CI 9.0, 9.7) to 11.3% (95% CI 10.8, 11.8). GBTM identified five (low baseline-declining, moderate baseline-declining, high baseline-declining, very high baseline-substantially declining, and very high baseline-persistent) and three (low baseline-declining, mild baseline-declining, high baseline-declining) subgroups with distinct trajectories of activity and work impairments. Dominance analysis showed that baseline pain was the most important predictor of membership in trajectory subgroups.ConclusionWhile participation in a digital self-management program for OA was, on average, associated with improvements in work and activity impairments, there were substantial variations among the participants. Baseline pain may provide useful insights to predict trajectories of work and activity impairments.
| S-EPMC10024026 | biostudies-literature