PMID: 9179102Apr 1, 1997Paper

Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?

Journal of Clinical Epidemiology
Ron WinkensP Pop

Abstract

Due to possible methodological and practical problems, many researchers refrain from using a randomized controlled trial design to evaluate procedures already embedded in routine health care. We performed a randomized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians. The trial started after 4 years of feedback and lasted for 2.5 years. With some adaptations a randomized trial proved to be possible. In evaluating health-care procedures that cannot be blinded in a traditional way, asking full and study-specific informed consent may conflict with the validity of the design. In such studies, an alternative procedure is to be considered. Our trial, with doctors as study subjects, was held on an already accepted routine procedure (feedback). This made it possible to refrain from obtaining study-specific informed consent. Consequently, a Hawthorne effect and contamination of the trial arms through information leakage could be avoided. Justification and general criteria for not obtaining full and study-specific informed consent are worked out. In health-care research on the performance of doctors or on interventions into the quality of care, obtaining a general informed conse...Continue Reading

References

Apr 25, 1992·BMJ : British Medical Journal·R A WinkensJ A Knottnerus

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Citations

Mar 15, 2000·Controlled Clinical Trials·D De AmiciP Politi
Sep 2, 2000·Journal of Evaluation in Clinical Practice·A E WalkerUNKNOWN TEMPEST group (ThromboEMbolism Prevention Evaluation STudy)
Jan 28, 2003·Health Services Research·Rita Mangione-SmithElizabeth A McGlynn
Apr 2, 2002·BMJ : British Medical Journal·Ron Winkens, Geert-Jan Dinant
Mar 5, 2004·American Journal of Public Health·Allan Donner, Neil Klar
Sep 25, 2008·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Samuel G CampbellMegan Crawford
Jul 8, 2016·Journal of General Internal Medicine·James H FloryZachary I Goodman
Nov 30, 2004·Journal of Clinical Epidemiology·Wim H J M VerstappenRichard P T M Grol
Jun 10, 2017·Journal of Clinical Pharmacy and Therapeutics·B LakiK Gholami
Jun 15, 2012·The Cochrane Database of Systematic Reviews·Noah IversAndrew D Oxman
Apr 3, 2009·Scandinavian Journal of Clinical and Laboratory Investigation·Mirja Mindemark, Anders Larsson
May 22, 2004·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Carol L FreundBenjamin S Wilfond
Jun 30, 2019·Journal of the American Medical Directors Association·Allison M GustavsonUNKNOWN PACRATS Investigators

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