Comparison of randomized controlled trials discontinued or revised for poor recruitment and completed trials with the same research question: a matched qualitative study.

Details

Ressource 1Download: 2019_Briel_Comparisaon_Trials.pdf (1057.09 [Ko])
State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_3A5B3EF12BBB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Comparison of randomized controlled trials discontinued or revised for poor recruitment and completed trials with the same research question: a matched qualitative study.
Journal
Trials
Author(s)
Briel M., Speich B., von Elm E., Gloy V.
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Publication state
Published
Issued date
30/12/2019
Peer-reviewed
Oui
Volume
20
Number
1
Pages
800
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
More than a quarter of randomized controlled trials (RCTs) are prematurely discontinued, mostly due to poor recruitment of patients. In this study, we systematically compared RCTs discontinued or revised for poor recruitment and completed RCTs with the same underlying research question to better understand the causes of poor recruitment, particularly related to methodological aspects and context-specific study settings.
We compared RCTs that were discontinued or revised for poor recruitment to RCTs that were completed as planned, matching in terms of population and intervention. Based on an existing sample of RCTs discontinued or revised due to poor recruitment, we identified matching RCTs through a literature search for systematic reviews that cited the discontinued or revised RCT and matching completed RCTs without poor recruitment. Based on extracted data, we explored differences in the design, conduct, and study settings between RCTs with and without poor recruitment, separately for each research question using semi-structured discussions.
We identified 15 separate research questions with a total of 29 RCTs discontinued or revised for poor recruitment and 48 RCTs completed as planned. Prominent research areas in the sample were cancer and acute care. The mean number of RCTs with poor recruitment per research question was 1.9 ranging from 1 to 4 suggesting clusters of research questions or settings prone to recruitment problems. The reporting quality of the recruitment process in RCT publications was generally low. We found that RCTs with poor recruitment often had narrower eligibility criteria, were investigator- rather than industry-sponsored, were associated with a higher burden for patients and recruiters, sometimes used outdated control interventions, and were often launched later in time than RCTs without poor recruitment compromising uncertainty about tested interventions through emerging evidence. Whether a multi- or single-center setting was advantageous for patient recruitment seemed to depend on the research context.
Our study confirmed previously identified causes for poor recruitment, i.e., narrow eligibility criteria, investigator sponsorship, and a reduced motivation of patients and recruiters. Newly identified aspects were that researchers need to be aware of all other RCTs on a research question so that compromising effects on the recruitment can be minimized and that a larger number of centers is not always advantageous.
Keywords
early termination of clinical trials, poor recruitment, qualitative analysis, randomized controlled trials, systematic reviews
Pubmed
Web of science
Open Access
Yes
Create date
03/01/2020 21:26
Last modification date
29/09/2020 5:25
Usage data