What question did this study set out to answer?

This study investigates how psychological factors affect patients' decisions to participate in randomized controlled trials for knee osteoarthritis treatment.

May 10, 2026Open Access

Psychological factors associated with trial participation among patients eligible for total knee arthroplasty with a non-surgical treatment arm: a comparative cross-sectional study

NKNina Jullum KiseMartina Hansens Hospital SESiri EliassenMartina Hansens Hospital CGCaryl GayUniversity of California, San Francisco

Key Points

This study investigates how psychological factors affect patients' decisions to participate in randomized controlled trials for knee osteoarthritis treatment.
Compared psychological factors such as anxiety, depression, fear of movement, and knee symptoms between participants and non-participants in the MultiKnee trial.
Utilized multiple logistic regression models to analyze associations between psychological factors and willingness to participate.
Sample included 280 participants in the RCT and 373 declined patients.
Declining participants had higher fear avoidance (FABQ 1.6 points higher) and lower knee awareness (FJS 4.0 points lower).
Each 1-point increase in FABQ-Physical activity score reduced odds of participating by 3.9% (OR 0.96, CI 0.94-0.99).
Higher HADS Anxiety scores increased odds of participating by 5.4% (OR 1.05, CI 1.00-1.11).

Abstract

BACKGROUND AND PURPOSE: Knowledge of psychological factors' influence on patients' decisions to participate in randomized controlled trials (RCTs) is scarce. We aimed to compare levels of psychological factors in patients with knee osteoarthritis (OA) eligible for total knee arthroplasty in those who agree to participate in an RCT with those who declined. METHODS: We compared anxiety and depression (Hospital Anxiety and Depression Scale HADS), pain-related fear of movement (Fear-Avoidance Belief Questionnaire FABQ), catastrophizing (Pain Catastrophizing Scale PCS), knee symptoms (Knee Osteoarthritis and Outcome Scale KOOS), and knee awareness (Forgotten Joint Score FJS), in patients in the Multidisciplinary Intervention in Total Knee Arthroplasty (MultiKnee) trial (n = 280) and in patients who declined (n = 373). Simple and multiple logistic regression models explored associations between psychological factors and patients' willingness to participate. RESULTS: Patients declining participation had more fear avoidance (FABQ 1.6 points higher, 95% confidence interval CI 0.6-2.6), more knee awareness (FJS 4.0 points lower, CI 1.9-6.1), and worse KOOS scores (ranging from 3.4, CI 0.6-6.1 to 5.6 points, CI 3.1-8.2). In simple regression analysis, each 1-point increase in FABQ-Physical activity score was associated with a 3.9% decrease in odds of participating (OR 0.96, CI 0.94-0.99), and in adjusted analyses, a 3.0% decrease in odds (OR 0.97, CI 0.94-1.0). When considering a clinically meaningful difference of 4 points, this corresponds to a 14.7% reduction in crude odds and a 11.5% reduction in adjusted odds of study participation. Each 1-point increase in HADS Anxiety score was associated with a 5.4% increase in odds of participating (OR 1.05, CI 1.00-1.11). HADS Depression and PCS were not associated with RCT participation. CONCLUSION: Patients with higher fear avoidance of physical activity were less willing to participate in the RCT, while patients with higher anxiety were more willing. These findings may weaken the generalizability of the findings from the RCT.

Perguntar à IA

Bookmark

View Full Paper

Cite This Study

Kise et al. (Fri,) studied this question.

synapsesocial.com/papers/6a001ff2c8f74e3340f9b312 https://doi.org/https://doi.org/10.2340/17453674.2026.45869

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

Perguntar à IA

Bookmark

View Full Paper