No association between participant retention and the proportion of included elderly people in rheumatology trials: Results from a series of exploratory meta-regression analyses.

Sabrina Mai Nielsen, Andriko Palmowski, Kim Hørslev-Petersen, Thomas Buttgereit, Yannick Palmowski, Maarten Boersma, Robin Christensen, Frant Buttgereit

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

OBJECTIVE: The elderly (defined by an age of ≥65 years) are underrepresented in rheumatology trials, possibly due to investigator's concerns of increased premature discontinuations in higher age groups. We evaluated 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) on any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. Mixed effects meta-regression models including several covariates assessed whether there is an independent association between PE and participant retention. Sensitivity analyses evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE).

RESULTS: 243 RCTs comprising over 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 pharmacological and a negative association in physical/physiotherapeutic (overall p for interaction = 0.05) interventions. 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 stimulate investigators to include more elderly people in rheumatology trials. This article is protected by copyright. All rights reserved.

Original languageEnglish
JournalArthritis Care & Research
ISSN2151-464X
DOIs
Publication statusE-pub ahead of print - 17. Aug 2019

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Rheumatology
Meta-Analysis
Regression Analysis
Randomized Controlled Trials
Research Personnel
Manuscripts
Normal Distribution
MEDLINE
Age Groups
Research

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Mai Nielsen, Sabrina ; Palmowski, Andriko ; Hørslev-Petersen, Kim ; Buttgereit, Thomas ; Palmowski, Yannick ; Boersma, Maarten ; Christensen, Robin ; Buttgereit, Frant. / No association between participant retention and the proportion of included elderly people in rheumatology trials: Results from a series of exploratory meta-regression analyses. In: Arthritis Care & Research. 2019.
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title = "No association between participant retention and the proportion of included elderly people in rheumatology trials: Results from a series of exploratory meta-regression analyses.",
abstract = "OBJECTIVE: The elderly (defined by an age of ≥65 years) are underrepresented in rheumatology trials, possibly due to investigator's concerns of increased premature discontinuations in higher age groups. We evaluated 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) on any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. Mixed effects meta-regression models including several covariates assessed whether there is an independent association between PE and participant retention. Sensitivity analyses evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE).RESULTS: 243 RCTs comprising over 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 pharmacological and a negative association in physical/physiotherapeutic (overall p for interaction = 0.05) interventions. 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 stimulate investigators to include more elderly people in rheumatology trials. This article is protected by copyright. All rights reserved.",
author = "{Mai Nielsen}, Sabrina and Andriko Palmowski and Kim H{\o}rslev-Petersen and Thomas Buttgereit and Yannick Palmowski and Maarten Boersma and Robin Christensen and Frant Buttgereit",
year = "2019",
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doi = "10.1002/acr.24051",
language = "English",
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No association between participant retention and the proportion of included elderly people in rheumatology trials: Results from a series of exploratory meta-regression analyses. / Mai Nielsen, Sabrina; Palmowski, Andriko; Hørslev-Petersen, Kim; Buttgereit, Thomas; Palmowski, Yannick; Boersma, Maarten; Christensen, Robin; Buttgereit, Frant.

In: Arthritis Care & Research, 17.08.2019.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - No association between participant retention and the proportion of included elderly people in rheumatology trials: Results from a series of exploratory meta-regression analyses.

AU - Mai Nielsen, Sabrina

AU - Palmowski, Andriko

AU - Hørslev-Petersen, Kim

AU - Buttgereit, Thomas

AU - Palmowski, Yannick

AU - Boersma, Maarten

AU - Christensen, Robin

AU - Buttgereit, Frant

PY - 2019/8/17

Y1 - 2019/8/17

N2 - OBJECTIVE: The elderly (defined by an age of ≥65 years) are underrepresented in rheumatology trials, possibly due to investigator's concerns of increased premature discontinuations in higher age groups. We evaluated 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) on any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. Mixed effects meta-regression models including several covariates assessed whether there is an independent association between PE and participant retention. Sensitivity analyses evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE).RESULTS: 243 RCTs comprising over 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 pharmacological and a negative association in physical/physiotherapeutic (overall p for interaction = 0.05) interventions. 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 stimulate investigators to include more elderly people in rheumatology trials. This article is protected by copyright. All rights reserved.

AB - OBJECTIVE: The elderly (defined by an age of ≥65 years) are underrepresented in rheumatology trials, possibly due to investigator's concerns of increased premature discontinuations in higher age groups. We evaluated 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) on any intervention (years 2016 and 2017). PE was either extracted from the research manuscript or estimated from an assumed (truncated) normal distribution. Mixed effects meta-regression models including several covariates assessed whether there is an independent association between PE and participant retention. Sensitivity analyses evaluated whether associations were connected to attrition due to lack of efficacy (LoE) or adverse events (AE).RESULTS: 243 RCTs comprising over 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 pharmacological and a negative association in physical/physiotherapeutic (overall p for interaction = 0.05) interventions. 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 stimulate investigators to include more elderly people in rheumatology trials. This article is protected by copyright. All rights reserved.

U2 - 10.1002/acr.24051

DO - 10.1002/acr.24051

M3 - Journal article

C2 - 31421022

JO - Arthritis Care & Research

JF - Arthritis Care & Research

SN - 2151-464X

ER -