Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study.
PRO
PROMs
patient-reported outcome
patient-reported outcome measure
subject burden
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
pubmed:
31
7
2018
medline:
28
1
2020
entrez:
31
7
2018
Statut:
ppublish
Résumé
Understanding the perceived burden of clinical trial participation is an important element of patient-centric trial design and conduct. We report the results of a study to gain preliminary insights into the perceived burden associated with patient-reported outcome (PRO) data collection among a sample (n = 61) of volunteers from the general population including people with various health conditions resulting in chronic pain. Participants identified morning completion as more burdensome than completion of PRO measures in the evening. Weekly completion was perceived as less burdensome than daily, and twice-a-day more burdensome than once-a-day. Our results, while not generalizable in isolation, provide a valuable starting point to understand the complex construct of subject burden. This preliminary work is intended to be a catalyst for more in-depth research to better understand and predict burden and acceptable burden thresholds in clinical trials. Understanding subject burden is a vital component of human subject research that will be valuable in helping to inform future clinical trial designs.
Sections du résumé
BACKGROUND
Understanding the perceived burden of clinical trial participation is an important element of patient-centric trial design and conduct.
METHODS
We report the results of a study to gain preliminary insights into the perceived burden associated with patient-reported outcome (PRO) data collection among a sample (n = 61) of volunteers from the general population including people with various health conditions resulting in chronic pain.
RESULTS
Participants identified morning completion as more burdensome than completion of PRO measures in the evening. Weekly completion was perceived as less burdensome than daily, and twice-a-day more burdensome than once-a-day.
CONCLUSION
Our results, while not generalizable in isolation, provide a valuable starting point to understand the complex construct of subject burden. This preliminary work is intended to be a catalyst for more in-depth research to better understand and predict burden and acceptable burden thresholds in clinical trials. Understanding subject burden is a vital component of human subject research that will be valuable in helping to inform future clinical trial designs.
Identifiants
pubmed: 30058368
doi: 10.1177/2168479018788053
doi:
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
318-323Subventions
Organisme : FDA HHS
ID : U18 FD005320
Pays : United States