Abstract
BackgroundThe interest of patients in participating in randomized clinical trials involving treatments has been widely studied, but there has been much less research on interest in preventive trials. The objective of this study was to find out how many women would be interested in a trial involving postmenopausal hormone therapy (PHT) and how the women's background characteristics and opinions correlated to their interest.MethodsThe data come from recruitment questionnaires (n = 2000) sent to women in Estonia in 1998. A random sample of women aged 45 to 64 was drawn from the Population Registry. The trial is a two-group randomized trial comparing estrogen-progestogen therapy with placebo or no drugs. A brief description of the study was attached to the questionnaires. Women were not told at this stage of the recruitment which group they would be assigned to, however, they were told of the chance to receive either hormone, placebo or no treatment.ResultsAfter two reminders, 1312 women (66%) responded. Eleven percent of the women approached (17% of the respondents) were interested in joining the trial, and 8% wanted more information before deciding. When the 225 women who stated clearly that they were interested in joining and the 553 women who said they were not interested were compared, it was found that interested women were younger and, adjusting for age, that more had given birth; in other respects, the sociodemographic characteristics and health habits of the interested women were similar to those of the non-interested women. The interested women had made more use of more health services, calcium preparations and PHT, they were more often overweight, and more had chronic diseases and reported symptoms. Interested women's opinions on the menopause were more negative, and they favoured PHT more than the non-interested women.ConclusionUnlike the situation described in previous reports on preventive trials, in this case Estonian women interested in participating in a PHT trial were not healthier than other women. This suggests that trials involving PHT are more similar to treatment trials than to preventive trials. In a randomized controlled trial, more information should be obtained from those women who decline to participate.
Highlights
The interest of patients in participating in randomized clinical trials involving treatments has been widely studied, but there has been much less research on interest in preventive trials
Unlike the situation described in previous reports on preventive trials, in this case Estonian women interested in participating in a postmenopausal hormone therapy (PHT) trial were not healthier than other women
This suggests that trials involving PHT are more similar to treatment trials than to preventive trials
Summary
The interest of patients in participating in randomized clinical trials involving treatments has been widely studied, but there has been much less research on interest in preventive trials. There are many studies and reviews on factors that promote or hinder interest in participating in treatment trials – both in regard to patients and physicians [see e.g. Patients who are older, less educated and from lower socioeconomic backgrounds, non-whites, smokers, and persons lacking adequate social support are more willing to participate in clinical trials. They tend to be more severely ill than those who do not participate. Disinterest on the part of patients and physicians in participating in clinical trials constitutes a threat to the generalizability of RCTs [9]
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