Understanding risk: a randomized controlled trial of communicating contraceptive effectiveness.

OBJECTIVE: To determine which of three different approaches increased women's understanding of risk of pregnancy associated with different contraceptive methods. METHODS: We randomly assigned 461 reproductive-age women to one of three tables presenting pregnancy risk (Food and Drug Administration table with numbers, World Health Organization table with numbers and categories, or table with categories). We evaluated participant knowledge before and after being shown the assigned table. RESULTS: The most important reason for choosing a contraceptive was how well it works (53%), followed by ease of use (13%), and protection against sexually transmitted disease or human immunodeficiency virus (11%). Before looking at the tables, about half the participants knew that hormone shots are more effective than pills (48%) and that pills are more effective than condoms (57%). For these two key comparisons, the category table compared to the Food and Drug Administration table with numbers improved knowledge significantly more (37% versus 20% and 27% versus 14%; both P <.05). Compared with those assigned to the Food and Drug Administration table with numbers, significantly fewer participants assigned to the category table said the table was difficult to read (6% versus 19%; P <.01). Most participants in all three groups said their assigned table provided enough information to choose a contraceptive method. CONCLUSION: The table with categories communicated relative contraceptive effectiveness better than the tables with numbers. However, without being presented with numbers, participants grossly overestimated the absolute risk of pregnancy using contraceptives. A combination of categories and a general range of risk for each category may provide the most accurate understanding of both relative and absolute pregnancy risk.

"Actual use" study of emergency contraceptive pills provided in a simulated over-the-counter manner.

OBJECTIVE: To evaluate use of an emergency contraceptive pill product dispensed under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS: The study was conducted at family planning clinics and pharmacies in the United States. During enrollment, these facilities did not provide unsolicited counseling about or evaluations for emergency contraceptive pills. Women who requested emergency contraception were asked to examine a package that was modified for over-the-counter use. A package (levonorgestrel, two 0.75-mg tablets) was provided to each woman who met study criteria and indicated that she wished to receive one. Each subject paid the amount normally charged by the facility for emergency contraceptive pills. Subjects were contacted 1 and 4 weeks later and asked about use of the product, side effects, and pregnancy. RESULTS: Of 665 women screened for the study, 585 received at least one package, and 540 reported having used the product. Of classifiable first uses, 1.3% (97.5% confidence interval [CI] 0.5%, 3%) were contraindicated and 28% (97.5% CI 23%, 32%) were incorrect by strict primary definitions of these inappropriate use patterns, based on the label instructions. Only 6.6% (97.5% CI 4.3%, 9.5%) of classifiable first uses were incorrect by a reasonable alternate definition. Ten subjects received the product more than once, and ten were found to be pregnant during the study. The pattern of adverse events was consistent with findings of previous studies. CONCLUSION: Most women used emergency contraceptive pills appropriately without provider evaluation and counseling.

Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product.

OBJECTIVE: This study was designed to evaluate comprehension of a prototype over-the-counter package label for an emergency contraceptive pill product. METHODS: Interviews were conducted with 663 women in malls and family planning clinics in eight United States cities. The sample included many young and minority women and women of low literacy. After looking at the package, subjects were asked 30 questions that addressed 11 communication objectives about indications, contraindications, instructions, side effects, and management of serious complications. Most questions asked whether or not use of the product would be appropriate in a described situation. RESULTS: Seven of the 11 communication objectives were each understood by more than 85% of subjects. Most women in the study understood the most important objectives: that the product is indicated for prevention of pregnancy after unprotected sex (93%), that the first pill should be taken within 72 hours or as soon as possible after intercourse (97%), that the product should not be used by women who are already pregnant (98%), and that the product does not prevent sexually transmitted diseases or human immunodeficiency virus/acquired immune deficiency syndrome (94%). More-literate women were more likely to understand the objectives than less-literate women. CONCLUSION: These results indicate that by reading the prototype label, most women could understand key information necessary for safe and effective use of this product.