TY - JOUR
T1 - Association Between Participant Retention and the Proportion of Included Elderly People in Rheumatology Trials
T2 - Results from a series of exploratory meta-regression analyses
AU - Palmowski, Andriko
AU - Nielsen, Sabrina M
AU - Buttgereit, Thomas
AU - Palmowski, Yannick
AU - Boers, Maarten
AU - Christensen, Robin
AU - Buttgereit, Frank
N1 - Funding Information: The authors thank Professor Wolfgang Viechtbauer, PhD, for his helpful assistance concerning meta-analytical issues. Publisher Copyright: © 2019 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Objective: The elderly, a population defined by an age of ≥65 years, are underrepresented in rheumatology trials, possibly due to investigators’ concerns of increased premature discontinuations in higher age groups. The present study was undertaken to evaluate whether the proportion of included elderly individuals (PE) is independently associated with participant retention in rheumatology trials. Methods: Medline was searched for randomized controlled trials (RCTs) in rheumatoid arthritis (RA) and osteoarthritis (OA) of any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. We used mixed-effects meta-regression models including several covariates to assess whether there is an independent association between PE and participant retention. Using sensitivity analyses, we evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE). Results: In total, 243 RCTs comprising >48,000 participants were included. Pooled participant retention was 88%. PE was not associated with retention in the unadjusted (P = 0.97) or adjusted (all: P ≥ 0.14) models. Of all covariates, only study duration and type of intervention were associated with retention (both: P < 0.001). Post hoc analyses allowing for interaction revealed a small but statistically significant positive association between PE and retention in pharmacologic interventions and a negative association in physical/physiotherapeutic interventions (overall P for interaction = 0.05). No associations were found for PE and attrition due to LoE or AE. Conclusion: Participant retention in RA and OA trials is high and not associated with PE. These findings should motivate investigators to include more elderly participants in rheumatology trials.
AB - Objective: The elderly, a population defined by an age of ≥65 years, are underrepresented in rheumatology trials, possibly due to investigators’ concerns of increased premature discontinuations in higher age groups. The present study was undertaken to evaluate whether the proportion of included elderly individuals (PE) is independently associated with participant retention in rheumatology trials. Methods: Medline was searched for randomized controlled trials (RCTs) in rheumatoid arthritis (RA) and osteoarthritis (OA) of any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. We used mixed-effects meta-regression models including several covariates to assess whether there is an independent association between PE and participant retention. Using sensitivity analyses, we evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE). Results: In total, 243 RCTs comprising >48,000 participants were included. Pooled participant retention was 88%. PE was not associated with retention in the unadjusted (P = 0.97) or adjusted (all: P ≥ 0.14) models. Of all covariates, only study duration and type of intervention were associated with retention (both: P < 0.001). Post hoc analyses allowing for interaction revealed a small but statistically significant positive association between PE and retention in pharmacologic interventions and a negative association in physical/physiotherapeutic interventions (overall P for interaction = 0.05). No associations were found for PE and attrition due to LoE or AE. Conclusion: Participant retention in RA and OA trials is high and not associated with PE. These findings should motivate investigators to include more elderly participants in rheumatology trials.
UR - http://www.scopus.com/inward/record.url?scp=85082482256&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/acr.24051
DO - https://doi.org/10.1002/acr.24051
M3 - Article
C2 - 31421022
SN - 2151-464X
VL - 72
SP - 1490
EP - 1496
JO - Arthritis care & research
JF - Arthritis care & research
IS - 10
ER -