Original research articleA comparison of three daily coital diary designs and a phone-in regimen
Introduction
Because of their potential for both pregnancy prevention and protection against sexually transmitted infections (STIs), barrier contraceptives now receive considerable scientific scrutiny. Compliance data can aid in the interpretation of barrier contraceptive effectiveness results, whether for pregnancy or STI prevention. Trials may include collection of product use data on coital diaries, with information on dates and frequency of intercourse, product use, correctness of use, additional or alternative contraceptive use, and menstrual bleeding. The advantages and disadvantages of these diaries have recently been summarized [1], [2]. In some cases, diaries appear to have collected more valid data on sexual exposures than recall measures. Negative aspects of diaries include the time, effort, and expense to administer and analyze them, and participant fatigue and reactivity during their use.
While it is infeasible to validate coital data, it is possible to develop study materials and methods that improve participant motivation and satisfaction, thereby reducing the likelihood of erroneous inference. Electronic data collection is a recent innovation, and telephone reporting is used in developed countries. Both approaches allow more precise ascertainment of when events occurred and data were recorded, and allow study staff to track data collection and intervene with additional support in case compliance drops or errors are observed. But these newer methods require substantial financial and/or technological resources. They may not be practical in developing countries, and simpler yet valid approaches should be tested.
Assuming that coital diary data are imperfect but broadly valid [3], there are various aspects of diary design that can enhance accuracy, such as minimizing missing data, minimizing the interval between coitus and data recording, and balancing the amount of information desired against the participant burden. We conducted a randomized trial to address these issues. The primary objectives of the study were to compare participant ratings of 3 different diary designs, the promptness with which participants recorded information, and the effect of a weekly telephone call-in regimen. The secondary objective was to assess the concordance between retrospective information collected on an end-of-study questionnaire with prospective diary information.
Section snippets
Study design
This 3 × 2 factorial, randomized design studied the type of diary (Diary 1, 2, and 3) and type of phone-in regimen (none or weekly). After agreeing to enroll, we assigned each participant to one of the six experimental groups formed by all possible combinations of the two factors, using a computer-generated blocked randomization list.
Women between the ages of 18 and 35 who were sexually active and expected to remain so during the 6-week study period were recruited. To be eligible, women had to
Results
A total of 90 participants were enrolled in the study. Participants were mainly young, Caucasian, well-educated, and single (Table 1). Women in the Diary 3 group were most likely to be single and not cohabitating (data not shown). Women using Diary 2 were the longest-term condom users (median 22 months) but almost all women were consistent condom users (data not shown). Background characteristics varied less by phone-in regimen. One participant failed to make her final 6-week visit, could not
Discussion
The broad accuracy of coital diary data are asserted by many researchers [1], [2], [3], but confirmation is scant. At the very least, important caveats for the use of diaries must be adduced. Agreement between prospective (diary) and retrospective (questionnaire) reports is variable: some studies find higher retrospective frequencies [9], [10], and some roughly equal frequencies [2]. Accuracy of coital data may vary dramatically according to features of the participants such as age [2] or
Acknowledgments
Support for this study was provided with funds from the U.S. Agency of International Development (USAID, Cooperative Agreement # DPE-3041-A-00-0043-00), although the views expressed in this article do not necessarily reflect those of USAID. Family Health International is an international nonprofit organization that conducts research and provides technical assistance in reproductive health, family planning, sexually transmitted diseases and AIDS.
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Currently at GlaxoWellcome, Research Triangle Park, NC 27709, USA.