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Informed Consent in Randomized Quality Improvement Trials

Informed Consent in Randomized Quality Improvement Trials Opinion EDITORIAL Informed Consent in Randomized Quality Improvement Trials A Critical Barrier for Learning Health Systems Mark J. Pletcher, MD, MPH; Bernard Lo, MD; Deborah Grady, MD The widespread implementation of electronic medical rec- not complete the end-of-trial survey (a departure from “in- ords (EMRs), stimulated by the Patient Protection and Afford- tention-to-treat” principles and an invitation to selection bias); able Care Act, provides a major opportunity to conduct (2) the contact and informed consent statement may have al- inexpensive pragmatic ran- tered participants’ behavior or how they report that behavior 1,2 domized trials that are em- (perhaps differentially so between treatment arms); and (3) the bedded into the clinical prac- surveys dramatically increased the burden on both partici- Related article page 671 tice of health care delivery. pants (time) and investigators (expense). This last problem se- Electronic medical records allow health systems to identify par- verely limits the scalability of the trial design: If the adminis- ticular types of patients, deliver targeted interventions de- trative costs and burdens of a study, excluding the cost of the signed to improve health, and measure how those interven- QI intervention itself, must increase directly with the sample tions impact health care http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Informed Consent in Randomized Quality Improvement Trials

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Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2013.13297
pmid
24615554
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL Informed Consent in Randomized Quality Improvement Trials A Critical Barrier for Learning Health Systems Mark J. Pletcher, MD, MPH; Bernard Lo, MD; Deborah Grady, MD The widespread implementation of electronic medical rec- not complete the end-of-trial survey (a departure from “in- ords (EMRs), stimulated by the Patient Protection and Afford- tention-to-treat” principles and an invitation to selection bias); able Care Act, provides a major opportunity to conduct (2) the contact and informed consent statement may have al- inexpensive pragmatic ran- tered participants’ behavior or how they report that behavior 1,2 domized trials that are em- (perhaps differentially so between treatment arms); and (3) the bedded into the clinical prac- surveys dramatically increased the burden on both partici- Related article page 671 tice of health care delivery. pants (time) and investigators (expense). This last problem se- Electronic medical records allow health systems to identify par- verely limits the scalability of the trial design: If the adminis- ticular types of patients, deliver targeted interventions de- trative costs and burdens of a study, excluding the cost of the signed to improve health, and measure how those interven- QI intervention itself, must increase directly with the sample tions impact health care

Journal

JAMA Internal MedicineAmerican Medical Association

Published: May 1, 2014

References