Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy

Abstract 

Purpose

To compare the effect of blind design (active drug and placebo) and nonblind design (active drug and no treatment) on recruitment.

Setting

A primary prevention trial with postmenopausal hormone therapy in Estonia.

Methods

Women who were eligible and willing to participate on the basis of the questionnaire survey were randomized into blind and nonblind groups. Recruitment rates are based on record keeping, and reasons for participating were requested in the first-year follow-up.

Results

The recruitment was 30% higher in the nonblind group: of the 4,295 women invited, 37% (95% confidence interval CI=35–39%) in the blind group and 48% (95% CI=46–49%) in the nonblind group were recruited. In both groups, once randomized, most of the losses were women who did not attend the first clinical examination: 49% (blind; 95% CI=47–51%) and 40% (nonblind; 95% CI=38–42%). The rest were found ineligible or lost their interest during clinical examinations. The reasons for joining the trial were relatively similar in the two groups.

Conclusions

Blinding decreased women's interest in joining a long-term preventive trial. Women's reasons for joining the trial were not influenced by blinding.

Keywords: Prevention trial, Recruitment, @@@Blinding, Hormone therapy