Osteoarthritis and Cartilage最新文献

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Why most responder analyses are misleading 为什么大多数回应分析都具有误导性
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2025-12-21 DOI: 10.1016/j.joca.2025.12.020
Aleksandra Turkiewicz , Marius Henriksen , Jos Runhaar , Martin Englund
{"title":"Why most responder analyses are misleading","authors":"Aleksandra Turkiewicz ,&nbsp;Marius Henriksen ,&nbsp;Jos Runhaar ,&nbsp;Martin Englund","doi":"10.1016/j.joca.2025.12.020","DOIUrl":"10.1016/j.joca.2025.12.020","url":null,"abstract":"<div><h3>Objective</h3><div>So-called responder analyses are commonly used in randomized controlled trials (RCT) for osteoarthritis and are typically based on observed change from baseline in self-reported pain. However, it is well known in the methodological literature that such responder analyses are misleading. We aimed to illustrate the size of the problem using simulation.</div></div><div><h3>Design</h3><div>We generated individual pain trajectories based on real-life assumptions: normal distribution, mean pain 45 on visual analogue scale (VAS, range 0–100), within person standard deviation 12, between person standard deviation 25. Further, we generated plausible data from RCTs with true treatment effect on pain varying from 0 to 15 points on VAS and true proportion of responders 0% or 100%. We applied typical responder analysis to these generated trials.</div></div><div><h3>Results</h3><div>With natural fluctuations of pain, the observed change in pain from baseline does not equal response to treatment. Even if a treatment is highly effective in reducing pain in all patients (100%) by 15 mm VAS, and no patient (0%) is responder to placebo, a typical responder analysis would suggest that 80% in the active treatment arm compared to 50% of persons in a placebo arm are responders, underestimating both the absolute and relative efficacy/effectiveness of the treatment and falsely implying heterogeneity in treatment effects.</div></div><div><h3>Conclusions</h3><div>Responder analysis based on change from baseline in VAS pain should be abandoned in analysis of parallel-group RCTs. Responder criteria based on change from baseline in other fluctuating outcomes, e.g. patients’ self-reported symptoms, function and global assessment, should be scrutinized, as they likely share similar limitations.”</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 716-720"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145796091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
More than a prescription: The need for behavioral theory to guide exercise interventions for osteoarthritis - A narrative review 不仅仅是处方:需要行为理论来指导骨关节炎的运动干预-叙述回顾。
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-02-27 DOI: 10.1016/j.joca.2026.02.012
Christine A. Pellegrini , Lisa C. Carlesso , Daniel K. White
{"title":"More than a prescription: The need for behavioral theory to guide exercise interventions for osteoarthritis - A narrative review","authors":"Christine A. Pellegrini ,&nbsp;Lisa C. Carlesso ,&nbsp;Daniel K. White","doi":"10.1016/j.joca.2026.02.012","DOIUrl":"10.1016/j.joca.2026.02.012","url":null,"abstract":"<div><h3>Objective</h3><div>Many clinical exercise trials show that participation in exercise, such as strength training and aerobic walking, reduce osteoarthritis (OA)-related pain and functional limitation. This has led to exercise being one of the most commonly prescribed treatments for OA. However, little attention is given to the complex <em>behavior</em> elements of exercise, that is exercise is an activity that adults need to choose to engage in regularly, which is necessary to ensure exercise can have long-term efficacy to address pain. The purpose of this review is to highlight the behavioral aspects of exercise.</div></div><div><h3>Design</h3><div>Narrative review</div></div><div><h3>Results</h3><div>Limitations of previous clinical exercise trials in OA and why and how behavioral theories should be used to guide exercise interventions are highlighted. Three behavioral theories commonly used for exercise and physical activity interventions in other populations are reviewed. An overview of choosing a behavioral theory, building a conceptual model, and linking behavior change techniques to theoretical constructs is provided. Finally, in order to make the results more generalizable and comparable across studies, a standardized approach to quantify exercise behaviors is recommended.</div></div><div><h3>Conclusion</h3><div>In conclusion, a shift to view exercise more as a behavior than a treatment is recommended. The use of behavioral theories is encouraged to guide interventions for clinical and research use to more effectively change exercise behaviors and reduce OA-related pain and functional limitations for the long-term.</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 761-766"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147326708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sex differences in preoperative pain intensity among patients undergoing total knee arthroplasty: A propensity score–matched cross-sectional study 全膝关节置换术患者术前疼痛强度的性别差异:倾向评分匹配的横断面研究
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2025-12-19 DOI: 10.1016/j.joca.2025.12.009
So Tanaka , Yuta Tomooka , Akira Mibu , Ryota Imai , Hirofumi Yamashita , Masahiro Manfuku , Keiko Yamada , Masami Tokunaga , Takaaki Yoshimoto , Takahiro Ushida , Tomohiko Nishigami
{"title":"Sex differences in preoperative pain intensity among patients undergoing total knee arthroplasty: A propensity score–matched cross-sectional study","authors":"So Tanaka ,&nbsp;Yuta Tomooka ,&nbsp;Akira Mibu ,&nbsp;Ryota Imai ,&nbsp;Hirofumi Yamashita ,&nbsp;Masahiro Manfuku ,&nbsp;Keiko Yamada ,&nbsp;Masami Tokunaga ,&nbsp;Takaaki Yoshimoto ,&nbsp;Takahiro Ushida ,&nbsp;Tomohiko Nishigami","doi":"10.1016/j.joca.2025.12.009","DOIUrl":"10.1016/j.joca.2025.12.009","url":null,"abstract":"<div><h3>Background</h3><div>Although sex differences in knee osteoarthritis (OA) pain are well documented, previous studies have not adequately adjusted for structural and inflammatory confounders. Clarifying whether preoperative sex differences in pain persist after such adjustment is clinically important in advanced OA because it may influence surgical decision-making, preoperative counselling, and strategies to prevent persistent postoperative pain.</div></div><div><h3>Objective</h3><div>To compare preoperative pain intensity, pain sensitivity, psychosocial characteristics, and physical function between women and men with advanced knee OA using propensity score–matched analysis.</div></div><div><h3>Methods</h3><div>In this cross-sectional study, 120 patients (60 women and 60 men) with advanced knee OA were propensity score–matched 1:1 on age, body mass index, Kellgren–Lawrence grade, C-reactive protein, synovitis, and bone marrow lesions. Primary outcomes were pain intensity at rest and during movement. Secondary outcomes were central sensitization-related symptoms (CSI-9), pressure pain thresholds (PPTs), psychosocial measures, and physical function.</div></div><div><h3>Results</h3><div>After matching, women reported significantly greater resting pain (23.3 ± 22.3 vs. 11.0 ± 15.2; mean difference = 12.3 mm, 95% CI: 5.1–19.5) but similar movement pain (47.2 ± 25.0 vs. 45.3 ± 24.6; mean difference = 1.9 mm, 95% CI: −7.4 to 11.2). They also showed higher CSI-9 scores, lower PPTs at the knee and forearm, and poorer physical function, with no significant differences in psychosocial measures.</div></div><div><h3>Conclusion</h3><div>Women with advanced knee OA awaiting surgery showed greater pain sensitivity and human-assumed central sensitization than men, independent of structural and inflammatory factors. This supports sex-specific mechanisms and underscores individualized pain assessment and rehabilitation.</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 707-715"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145784546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Feasibility and predictive value of proposed early endpoints for randomized controlled trials in knee osteoarthritis 膝关节骨关节炎随机对照试验早期终点的可行性和预测价值
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-02-20 DOI: 10.1016/j.joca.2026.02.001
Jamie E. Collins , Peter Mesenbrink , Robin Dunn , Leticia A. Deveza , Zhaohua Zhu , Amber Zimmerman , C. Kent Kwoh , Virginia B. Kraus , David J. Hunter
{"title":"Feasibility and predictive value of proposed early endpoints for randomized controlled trials in knee osteoarthritis","authors":"Jamie E. Collins ,&nbsp;Peter Mesenbrink ,&nbsp;Robin Dunn ,&nbsp;Leticia A. Deveza ,&nbsp;Zhaohua Zhu ,&nbsp;Amber Zimmerman ,&nbsp;C. Kent Kwoh ,&nbsp;Virginia B. Kraus ,&nbsp;David J. Hunter","doi":"10.1016/j.joca.2026.02.001","DOIUrl":"10.1016/j.joca.2026.02.001","url":null,"abstract":"<div><h3>Objective</h3><div>The designation of osteoarthritis (OA) as a serious disease allows for accelerated approval of a treatment based on an intermediate clinical endpoint. We evaluated proposed endpoints and assessed their feasibility for use in a randomized controlled trial (RCT). We examined associations between endpoints and subsequent total knee replacement (TKR), a proxy for long-term clinical benefit.</div></div><div><h3>Design</h3><div>We selected knees from the Osteoarthritis Initiative meeting typical RCT inclusion criteria, including pain and radiographic OA. Endpoints included TKR, end-stage knee OA (esKOA), Composite Knee Osteoarthritis Symptom Outcome (CKOASO), the FNIH OA Biomarkers Consortium endpoint, and several combinations of pain and/or functional limitations. We determined the cumulative incidence (CI) over four years and the associated sample size required for an RCT to detect a hazard ratio (HR) of 0.67 with 80% power (to assess feasibility). We assessed the association between reaching each endpoint and TKR over the subsequent 5 years.</div></div><div><h3>Results</h3><div>1350 knees (one per participant) were included. 4-year CI of TKR was 4.3%. CIs were highest for FNIH (13.8%), esKOA (34.4%), and CKOASO (63.6%). The required sample size per arm ranged from 229 (CKOASO) to 3028 (TKR). The relative risk (RR) of subsequent TKR was highest for the esKOA endpoint (RR 5.7), followed by CKOASO (4.3) and FNIH (2.6).</div></div><div><h3>Conclusions</h3><div>Based on feasibility (sample size) and clinical relevance (association with subsequent TKR), we propose that the esKOA, CKOASO, and FNIH endpoints be prioritized for further consideration. Given feasibility limitations, we would not recommend TKR alone as a DMOAD trial endpoint.</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 732-739"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146777357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Does hsCRP provide insights into an inflammatory phenotype of knee osteoarthritis? hsCRP是否为膝关节骨关节炎的炎症表型提供了见解?
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2025-09-05 DOI: 10.1016/j.joca.2025.08.019
Navya George , Jean W. Liew , Na Wang , Sarah Tilley , Ali Guermazi , John Lynch , Cora Lewis , James Torner , Tuhina Neogi
{"title":"Does hsCRP provide insights into an inflammatory phenotype of knee osteoarthritis?","authors":"Navya George ,&nbsp;Jean W. Liew ,&nbsp;Na Wang ,&nbsp;Sarah Tilley ,&nbsp;Ali Guermazi ,&nbsp;John Lynch ,&nbsp;Cora Lewis ,&nbsp;James Torner ,&nbsp;Tuhina Neogi","doi":"10.1016/j.joca.2025.08.019","DOIUrl":"10.1016/j.joca.2025.08.019","url":null,"abstract":"<div><h3>Objective</h3><div>Posthoc analysis of a canakinumab trial showed a risk reduction of joint replacement in participants with cardiac disease and elevated hsCRP (≥2mg/dL). We determined if hsCRP could serve as a marker to identify an inflammatory OA phenotype characterized by intra-articular synovitis.</div></div><div><h3>Method</h3><div>We used data from the NIH-funded MOST Study, where participants had baseline knee MRIs and hsCRP assays. Inflammation was scored using the Whole Organ MRI Score (WORMS), with presence defined as Hoffa’s synovitis or effusion-synovitis score ≥2 in ≥1 of 3 locations. We examined the relationship between hsCRP and inflammation presence using logistic regression, and the average inflammation score with linear regression. Analyses were repeated with hsCRP categorized as ≥2mg/dL vs. &lt;2mg/dL. Cubic spline regression and ROC curve were completed. Analyses were adjusted for age, sex, and body mass index.</div></div><div><h3>Results</h3><div>Out of 792 participants (mean age 62, 52% female), mean hsCRP was 2.98 mg/dL, with 41% having hsCRP ≥2mg/dL. Inflammation was present in 28% of knees. No association was found between hsCRP levels and inflammation presence (odds ratio 0.99, 95% confidence interval 0.96–1.01) or average score, including with dichotomized hsCRP. Cubic spline regression did not reveal non-linear associations. The ROC curve suggested poor predictive ability of hsCRP to identify knees with inflammation on MRI.</div></div><div><h3>Conclusion</h3><div>Despite interest in identifying an inflammatory phenotype in OA, hsCRP levels do not reliably identify knees with inflammation. Further investigation is needed to determine if hsCRP can predict knee response to therapies targeting inflammation not directly related to synovitis.</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 667-671"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Defining and interpreting between-group differences in clinical trials of patients with osteoarthritis: Challenges and potential solutions 定义和解释骨关节炎患者临床试验的组间差异:挑战和潜在的解决方案
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-01-27 DOI: 10.1016/j.joca.2026.01.013
Tim Schleimer , Tiziano Innocenti , Nadine E. Foster , Manuela L. Ferreira , Alessandro Chiarotto
{"title":"Defining and interpreting between-group differences in clinical trials of patients with osteoarthritis: Challenges and potential solutions","authors":"Tim Schleimer ,&nbsp;Tiziano Innocenti ,&nbsp;Nadine E. Foster ,&nbsp;Manuela L. Ferreira ,&nbsp;Alessandro Chiarotto","doi":"10.1016/j.joca.2026.01.013","DOIUrl":"10.1016/j.joca.2026.01.013","url":null,"abstract":"<div><h3>Objective</h3><div>Clinical relevance is an umbrella term that encompasses methods used to determine thresholds of relevant effects from the perspectives of patients, clinicians, and/or researchers. However, what represents a clinically relevant effect remains contentious. We provide an overview of current challenges and potential solutions for defining and interpreting the clinical relevance of between-group differences in osteoarthritis (OA) trials.</div></div><div><h3>Design</h3><div>Narrative review.</div></div><div><h3>Results</h3><div>We review common methods used to determine thresholds of clinical relevance and outline their limitations in interpreting between-group differences in OA trials. As a conceptually more appropriate method, we suggest considering the “smallest worthwhile effect” (SWE): the smallest beneficial effect of a treatment in comparison to another that justifies its costs, risks, and inconveniences. It incorporates all proposed necessary features of clinical relevance: the patients’ perspectives, consideration of intervention-specific characteristics, and a focus on outcome-specific between-group differences. We summarize the results of existing studies estimating the SWE, illustrate its potential for re-interpreting trials and meta-analyses in the field, and outline directions for future research and application of the SWE concept.</div></div><div><h3>Conclusion</h3><div>Commonly used methods to determine clinical relevance are conceptually and methodologically limited to interpret between-group differences in trials of patients with OA. To advance the field, we propose greater development and consideration of the SWE, given its conceptual advantages. While promising, the SWE is a multi-domain construct that can be challenging to apply and interpret. Therefore, further methodological work, empirical research in OA populations, and careful application are needed to ensure its proper implementation in OA trials.</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 721-731"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146048285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Digital mobility measures in osteoarthritis: Endpoint innovation without losing what matters 骨关节炎的数字移动测量:端点创新而不失去重要的东西。
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-03-02 DOI: 10.1016/j.joca.2026.02.013
Robin Christensen, Philip Rask Lage-Hansen, Philip G. Conaghan
{"title":"Digital mobility measures in osteoarthritis: Endpoint innovation without losing what matters","authors":"Robin Christensen,&nbsp;Philip Rask Lage-Hansen,&nbsp;Philip G. Conaghan","doi":"10.1016/j.joca.2026.02.013","DOIUrl":"10.1016/j.joca.2026.02.013","url":null,"abstract":"","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 654-656"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147351020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From measures to meaning: Advancing OA trials to meet patients’ expectations 从措施到意义:推进OA试验以满足患者期望。
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-03-30 DOI: 10.1016/j.joca.2026.03.124
Jos Runhaar , Carrie LaDuke , Franziska Saxer
{"title":"From measures to meaning: Advancing OA trials to meet patients’ expectations","authors":"Jos Runhaar ,&nbsp;Carrie LaDuke ,&nbsp;Franziska Saxer","doi":"10.1016/j.joca.2026.03.124","DOIUrl":"10.1016/j.joca.2026.03.124","url":null,"abstract":"","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 643-646"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147585702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The responsiveness of digital biomarkers as measurement tools in people with hip and knee osteoarthritis: A systematic review and meta-analysis 数字生物标志物作为髋关节和膝关节骨关节炎患者测量工具的响应性:一项系统回顾和荟萃分析。
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-02-17 DOI: 10.1016/j.joca.2026.02.002
Shiyi Julia Zhu , Md Abu Bakar Siddiq , Jocelyn L. Bowden , Venkatesha Venkatesha , Michelle Hall , David J. Hunter
{"title":"The responsiveness of digital biomarkers as measurement tools in people with hip and knee osteoarthritis: A systematic review and meta-analysis","authors":"Shiyi Julia Zhu ,&nbsp;Md Abu Bakar Siddiq ,&nbsp;Jocelyn L. Bowden ,&nbsp;Venkatesha Venkatesha ,&nbsp;Michelle Hall ,&nbsp;David J. Hunter","doi":"10.1016/j.joca.2026.02.002","DOIUrl":"10.1016/j.joca.2026.02.002","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the responsiveness of objective, quantifiable physiological or behavioural data measures (digital biomarkers) as outcome measures for people living with hip and/or knee osteoarthritis (OA) in community or home settings.</div></div><div><h3>Methods</h3><div>This systematic review and meta-analysis identified eligible studies from four electronic databases. Studies were required to use a digital biomarker as an outcome measure or had data collected by a portable or wearable device, usable at home, and without expert oversight (e.g., accelerometers, smartphone devices), and collected at a minimum of two time points. Two independent reviewers conducted screening and data extraction. A meta-analysis was performed using a random-effects model. Results were reported as standardized response means (SRMs) and 95% confidence intervals (CIs). Subgroup analyses were conducted based on intervention versus non-intervention groups and across different time periods (short, medium, long-term). Risk of bias was assessed using modified criteria for evidence quality.</div></div><div><h3>Results</h3><div>We identified 40 studies evaluating 18 digital biomarkers. Participants had a mean age of 64 (SD=4) years, with most having knee OA. The overall quality of the studies was high. Accelerometers (95%) were the most commonly used technology type. Mobility related outcomes were the most responsive digital biomarker domain. Cadence, walking speed, and step count showed moderate (SRM = 0.65, 95% CI: ), 0.42–0.87), small (SRM = 0.43, 95% CI: 0.15–0.70), and trivial (SRM = 0.19, 95% CI: 0.02–0.36) degrees of responsiveness, respectively. Energy expenditure demonstrated a trivial negative responsiveness (SRM = −0.16, 95% CI: −0.31 to −0.01). All digital biomarkers identified were based on land-based activities, which limits their application for monitoring non-land-based activities such as water exercises, cycling or sleep.</div></div><div><h3>Conclusions</h3><div>Digital biomarkers related to mobility measures, have the potential for greater uptake in OA clinical trials to assess mobility health in community and home-settings.</div></div><div><h3>Systematic review registration</h3><div>PROSPERO ID: CRD42024600515</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 740-752"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146227530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating the utility of prognostic enrichment in clinical trials: Applications to clinical trial design in osteoarthritis 评估临床试验中预后富集的效用:在骨关节炎临床试验设计中的应用
IF 9 2区 医学
Osteoarthritis and Cartilage Pub Date : 2026-05-01 Epub Date: 2026-02-23 DOI: 10.1016/j.joca.2026.02.005
Jamie E. Collins , Karen Smith , Faith Selzer , Jeffrey N. Katz , Elena Losina
{"title":"Evaluating the utility of prognostic enrichment in clinical trials: Applications to clinical trial design in osteoarthritis","authors":"Jamie E. Collins ,&nbsp;Karen Smith ,&nbsp;Faith Selzer ,&nbsp;Jeffrey N. Katz ,&nbsp;Elena Losina","doi":"10.1016/j.joca.2026.02.005","DOIUrl":"10.1016/j.joca.2026.02.005","url":null,"abstract":"<div><h3>Objective</h3><div>Prognostic enrichment in clinical trials aims to target potential participants at high risk for events of interest, such as disease progression or incident osteoarthritis (OA). The objective of this work is to describe and investigate key parameters that should inform the decision to implement an enrichment strategy.</div></div><div><h3>Design</h3><div>We apply the framework of the Biomarker Prognostic Enrichment Tool (BioPET) to develop the Research-Based Enrichment for Arthritis Clinical Trials (REACT) tool. REACT takes into consideration the cost of screening and enrichment accuracy to determine whether an enrichment strategy is cost- and time-saving as compared with no enrichment.</div></div><div><h3>Results</h3><div>Modestly accurate prognostic enrichment can yield cost-savings if the costs of enrichment are low; we show cost-savings for a scenario with a prognostic enrichment algorithm with an area under the curve (AUC) of 0.6 and a cost of enrichment of $25 per potential participant screened. The increased number of potential participants needed to screen in order to enroll an enriched sample may present logistical and/or feasibility challenges. While the example with a prognostic enrichment algorithm AUC of 0.6 is indeed cost-saving from a monetary perspective, enrichment in this scenario requires screening 1.7 times more potential participants than a strategy with no enrichment.</div></div><div><h3>Conclusions</h3><div>REACT is a user-friendly tool to assess the value of incorporating an enrichment algorithm into clinical trial design. It could assist investigators in evaluating enrollment strategies to critically evaluate enrichment trade-offs, consider operational feasibility, in addition to qualitative factors such as generalizability and acceptability by participants.</div></div>","PeriodicalId":19654,"journal":{"name":"Osteoarthritis and Cartilage","volume":"34 5","pages":"Pages 753-760"},"PeriodicalIF":9.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147278810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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