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Patient understanding of the content of informed consent: Reinforcing the degree of participant comprehension

Carrie Tudor, MPH1, Suellen Miller, PhD, CNM1, Nyima La, MD2, Sonam La, MD3, Droyoung La, MD4, Tsewang Sonam5, Linda L. Wright6, and Michael W. Varner, MD7. (1) OB/GYN and Reproductive Sciences, University of California, San Francisco, 50 Beale St, Suite 1200, UCSF Box 1224, San Francisco, CA 94105, 415-597-8136, ctudor@globalhealth.ucsf.edu, (2) Women's Department, Lhasa Municipal Hospital, No. 18 Beijing Middle Road, Lhasa, TAR, 850000, China, (3) Women's Department, Mentzikhang Traditional Tibetan Medicine and Astrology Hospital, No. 18 Beijing Middle Road, Lhasa, TAR, China, (4) Women's Department, Lhasa Maternal Child Health Hospital, No. 18 Beijing Middle Road, Lhasa, TAR, 850000, China, (5) Site 10 - Tibet, Global Network for Women's and Children's Health Research, No. 18 Beijing Middle Road, Room 307, Lhasa, TAR, 850000, China, (6) Center for Research for Mothers and Children NICHD, NIH, 6100 Executive Blvd, Rm4B05J, Rockville, MD 20852, (7) University of Utah Health Sciences Center-, University of Utah, 30 North 1900 East, Room 2B306, Salt Lake City, UT 84132

Background: The Tibet Autonomous Region of China has little history of the informed consent process in biomedical research, while illiteracy among women in Tibet is high. Prior to beginning a randomized control trial (RCT), we conducted formative research to develop and pilot a simple informed consent (IC) document.

Objectives: To determine comprehension of a simple, culturally acceptable IC document and process for an RCT to prevent postpartum hemorrhage involving a Tibetan traditional medicine versus misoprostol.

Methods: A simple IC document was used to consent pregnant women presenting at three study hospitals in Lhasa, Tibet. All women meeting eligibility requirements were read the IC document by study trained providers, who also asked a set of 16 open-ended questions following each section of the document to assess comprehension. If a woman was unable to answer 75% of the questions correctly after three attempts, she was considered ineligible to participate in the study.

Results: The majority of women responded correctly to all 16 questions. Thirteen percent answered all questions correctly on the first attempt, 66% on the second attempt and 20% on the third attempt. Less than 1% proved ineligible to participate. Sixty-six percent of women consented agreed to participate in the study.

Conclusions: Making an informed decision requires comprehension. Asking comprehension questions following each section of the IC document helps to reinforce information and allows researchers to determine what a woman truly understands. A follow-up study will be conducted to test participant's retention of the information within three days following delivery.

Learning Objectives:

Keywords: Research, International Health

Presenting author's disclosure statement:

Not Answered

Handout (.pdf format, 275.5 kb)

Taking Care of Mothers

The 134th Annual Meeting & Exposition (November 4-8, 2006) of APHA