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.firstname.lastname@example.org.
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.
People need basic data interpretation skills to understand health risks and to weigh the harms and benefits of actions meant to reduce those risks. Although many studies document problems with understanding risk information, few assess ways to teach interpretation skills.
To see whether a general education primer improves patients' medical data interpretation skills.
Two randomized, controlled trials done in populations with high and low socioeconomic status (SES).
The high SES trial included persons who attended a public lecture series at Dartmouth Medical School, Hanover, New Hampshire; and the low SES trial included veterans and their families from the waiting areas at the White River Junction Veterans Affairs Medical Center, White River Junction, Vermont.
334 adults in the high SES trial and 221 veterans and their families in the low SES trial were enrolled from October 2004 to August 2005. Completion rates for the primer and control groups in each trial were 95% versus 98% (high SES) and 85% versus 96% (low SES).
The intervention in the primer groups was an educational booklet specifically developed to teach people the skills needed to understand risk. The control groups received a general health booklet developed by the U.S. Department of Health and Human Services Agency for Health Care Research and Quality.
Score on a medical data interpretation test, a previously validated 100-point scale, in which 75 points or more is considered “passing.” Secondary outcomes included 2 other 100-point validated scores (interest and confidence in interpreting medical statistics) and participants' ratings of the booklet's usefulness.
In the high SES trial, 74% of participants in the primer group received a “passing grade” on the medical data interpretation test versus 56% in the control group (P = 0.001). Mean scores were 81 and 75, respectively (P = 0.0006). In the low SES trial, 44% versus 26% “passed” (P = 0.010): Mean scores were 69 and 62 in the primer and control groups, respectively (P = 0.008). The primer also significantly increased interest in medical statistics by 6 points in the high SES trial (a 4-point increase vs. a 2-point decrease from baseline) (P = 0.004) and by 8 points in the low SES trial (a 6-point increase vs. a 2-point decrease from baseline) (P = 0.004) compared with the control booklet. The primer, however, did not improve participants' confidence in interpreting medical statistics beyond the control booklet (a 2-point vs. a 4-point increase in the high SES trial [P = 0.36] and a 2-point versus a 6-point increase in the low SES trial [P = 0.166]). The primer was rated highly: 91% of participants in the high SES trial found it “helpful” or “very helpful,” as did 95% of participants in the low SES trial.
The primarily male low SES sample and the primarily female high SES sample limits generalizability. The authors did not assess whether better data interpretation skills improved decision-making.
The primer improved medical data interpretation skills in people with high and low SES.
ClinicalTrials.gov registration number: NCT00380432.
Educational materials aimed at improving people's ability to understand information about risk are scarce.
In 2 trials, adults with high or low socioeconomic status (SES) were randomly assigned to receive a primer about understanding risk or a general health booklet. In both SES groups, adults receiving the primer more often passed a medical data interpretation test than did those receiving the general health booklet. They also expressed greater interest in medical statistics but not greater confidence in interpreting statistics, and most rated the primer helpful or very helpful.
The authors did not examine whether improved data interpretation skills affected decision-making.
Overview of 2 randomized trials in distinct populations.
SES = socioeconomic status; VA = Veterans Affairs.
Key concepts taught in the primer, excerpted from the final pages.
Excerpts of primer.
Table 1. Baseline Characteristics of Participants in the High Socioeconomic Status and Low Socioeconomic Status Trials*
Medical data interpretation scores (mean and proportion exceeding threshold) for the primer and control groups.
Table 2. Participants' Ratings of the Primer and Control Booklets*
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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.
Steven Woloshin, Lisa M. Schwartz, H. Gilbert Welch. 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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