Patients' beliefs regarding informed consent for low-risk pragmatic trials.

ABSTRACT:

Background

The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients.

Methods

This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing

SUBMITTER: Dal-Re R 

PROVIDER: S-EPMC5604493 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature