Steven Woloshin, MD, MS; Lisa M. Schwartz, MD, MS; H. Gilbert Welch, MD, MPH
Disclaimer: The views expressed herein do not necessarily represent the views of the Department of Veterans Affairs or the U.S. government.
Note: The first two authors contributed equally to the creation of this manuscript. The order of authorship is arbitrary.
Acknowledgments: The authors thank Donald St. Germaine, MD, and Wendy Murphy for their assistance in recruiting Dartmouth Community Medical School alumni; Jennifer A. Snide for technical assistance; and Baruch Fischhoff, PhD, and Wylie Burke, MD, PhD, for helpful comments on earlier drafts of the primer.
Grant Support: Drs. Woloshin and Schwartz are supported by Robert Wood Johnson Generalist Faculty Scholars Awards and receive infrastructure support from a Research Enhancement Award from the Department of Veterans Affairs. The study was supported by a grant from the National Cancer Institute (R01CA104721).
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Lisa M. Schwartz, MD, MS, VA Outcomes Group (11B), Department of Veterans Affairs Medical Center, White River Junction, VT 05009; e-mail, Lisa.email@example.com.
Current Author Addresses: Drs. Woloshin, Schwartz, and Welch: VA Outcomes Group (11B), Department of Veterans Affairs Medical Center, White River Junction, VT 05009.
Author Contributions: Conception and design: S. Woloshin, L.M. Schwartz, H.G. Welch.
Analysis and interpretation of the data: S. Woloshin, L.M. Schwartz, H.G. Welch.
Drafting of the article: S. Woloshin, L.M. Schwartz, H.G. Welch.
Critical revision of the article for important intellectual content: S. Woloshin, L.M. Schwartz.
Final approval of the article: S. Woloshin, L.M. Schwartz, H.G. Welch.
Provision of study materials or patients: S. Woloshin, L.M. Schwartz.
Statistical expertise: S. Woloshin, L.M. Schwartz.
Obtaining of funding: S. Woloshin, L.M. Schwartz.
Woloshin S, Schwartz LM, Welch HG. The Effectiveness of a Primer to Help People Understand Risk: Two Randomized Trials in Distinct Populations. Ann Intern Med. 2007;146:256-265. doi: 10.7326/0003-4819-146-4-200702200-00004
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Published: Ann Intern Med. 2007;146(4):256-265.
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Jose R Goldim
Hospital de Clinicas de Porto Alegre
April 19, 2007
Dear Sirs: In 2004 we conduct a study on Informed Consent Process in gynecologic area. The informational step was conducted collectively and consent was individually obtained. The principal investigator give an oral presentation using tables, maps, and other elucidative figures to allow better understanding. All potential participants are allowed to ask questions orally or in a written instrument. After that, the Consent form was shown. A new round of questions was taken. Forty-five patients were interviewed, immediately after the consent obtainment. Remembrance capacity of information about procedures, risks and benefits explained were verified. All participants (100%) remembered the procedures, 54% the risks and 96% the probable benefits. Comparing these data with others from a similar study using conventional informed consent process (individual information transmission) the subjects remember more information in the present study. In early studies only 47,5% remembered procedures, 47,5% benefits and 22,0% risks. These results show that informing collectively the research subjects when getting the Informed Consent increment understanding. Reference: Goldim JR, Pithan CF , Oliveira JG , Raymundo MM. Consentimento informado em pesquisa: uma nova abordagem [Informed consent in research: a new approach]. Rev Assoc Med Bras 2003:49(4):374-6.
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