Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials.
Health Qual Life Outcomes
; 19(1): 164, 2021 Jun 13.
Article
en En
| MEDLINE
| ID: mdl-34120618
ABSTRACT
OBJECTIVES:
There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge.METHODS:
Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States.RESULTS:
Think Tank members identified one key challenge a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims.CONCLUSIONS:
A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Participación del Paciente
/
Enfermedades Cardiovasculares
/
Ensayos Clínicos como Asunto
/
Medición de Resultados Informados por el Paciente
Tipo de estudio:
Guideline
/
Prognostic_studies
/
Qualitative_research
Aspecto:
Patient_preference
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Health Qual Life Outcomes
Asunto de la revista:
SAUDE PUBLICA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos