Sexual activity questionnaires in clinical trials: acceptability to patients with gynaecological disorders

Objective To assess the feasibility and acceptability of including sexual a ctivity questionnaires in gynaecological clinical trials. Design A longitudinal quality of life study during the Maintenance Interfer on Trial and the EVALUATE Hysterectomy Trial. Setting Gynaecology clinics and women's homes. Sample Ninety-six women with advanced ovarian cancer participating in the M aintenance Interferon Trial and 542 women undergoing a hysterectomy in the EVALUATE Hysterectomy Trial. Methods Quality of life questionnaires, including the sexual activity quest ionnaire, were completed by women prior to randomisation and periodically a fter randomisation. Main outcome measures Compliance rates of the sexual activity questionnaire , both overall and with respect to the level of sexual functioning and age of the women. Attitudes of the women towards completing the questionnaire, and suitability of using the sexual activity questionnaire in clinical tria ls. Results Compliance rates of over 80% were achieved in both trials, both ove rall and for each questionnaire completed. The age of the woman did not app ear to influence the completion of the questionnaire, nor did her level of sexual functioning. Women were supportive of the research and did not find the questionnaire intrusive. Conclusions It is feasible to include sexual activity questionnaires in gyn aecological clinical trials requiring repeated assessment of quality of lif e over a long period of time. The sexual activity questionnaire is an appro priate tool to carry out investigations of sexual functioning and is worth considering for use in future clinical trials.