Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study.
Clinical equipoise
Clinical research
Controlled trials
Patient participation
Randomization
Study design
Journal
BMC medical research methodology
ISSN: 1471-2288
Titre abrégé: BMC Med Res Methodol
Pays: England
ID NLM: 100968545
Informations de publication
Date de publication:
26 04 2020
26 04 2020
Historique:
received:
01
05
2019
accepted:
13
04
2020
entrez:
28
4
2020
pubmed:
28
4
2020
medline:
22
6
2021
Statut:
epublish
Résumé
High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients' willingness to participate in research. We submitted by mail two vignettes that described clinical research studies - a drug trial and a diagnostic study - to patients recently discharged from hospital and assessed their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on request. Of 2600 patients contacted, 1140 (44%) participated. Globally, willingness to participate in a drug trial was lower than in a diagnostic study (44.8% vs. 76.2%; P < 0.001). In the drug trial, participation was significantly higher when the new drug was presented as presumably better than the old (vs. equipoise) and when the study was funded by public sources (vs. industry), but was not affected by the allocation method. None of the factors tested in the diagnostic study was associated with participation. Patients were more likely to participate in a hypothetical observational diagnostic study than in a hypothetical drug trial. Participation in the trial was lower when clinical equipoise was expressed and when the trial was funded by industry. These results suggest that some features of study design can influence participation.
Sections du résumé
BACKGROUND
High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients' willingness to participate in research.
METHODS
We submitted by mail two vignettes that described clinical research studies - a drug trial and a diagnostic study - to patients recently discharged from hospital and assessed their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on request.
RESULTS
Of 2600 patients contacted, 1140 (44%) participated. Globally, willingness to participate in a drug trial was lower than in a diagnostic study (44.8% vs. 76.2%; P < 0.001). In the drug trial, participation was significantly higher when the new drug was presented as presumably better than the old (vs. equipoise) and when the study was funded by public sources (vs. industry), but was not affected by the allocation method. None of the factors tested in the diagnostic study was associated with participation.
CONCLUSIONS
Patients were more likely to participate in a hypothetical observational diagnostic study than in a hypothetical drug trial. Participation in the trial was lower when clinical equipoise was expressed and when the trial was funded by industry. These results suggest that some features of study design can influence participation.
Identifiants
pubmed: 32336266
doi: 10.1186/s12874-020-00979-z
pii: 10.1186/s12874-020-00979-z
pmc: PMC7183682
doi:
Banques de données
Dryad
['10.5061/dryad.18931zct5']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
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