Stead M L, Crocombe W D, Fallowfield L J, Selby P, Perren T J, Garry R, Brown J M
Northern and Yorkshire Clinical Trials and Research Unit, Leeds, UK.
Br J Obstet Gynaecol. 1999 Jan;106(1):50-4. doi: 10.1111/j.1471-0528.1999.tb08084.x.
To assess the feasibility and acceptability of including sexual activity questionnaires in gynaecological clinical trials.
A longitudinal quality of life study during the Maintenance Interferon Trial and the EVALUATE Hysterectomy Trial.
Gynaecology clinics and women's homes.
Ninety-six women with advanced ovarian cancer participating in the Maintenance Interferon Trial and 542 women undergoing a hysterectomy in the EVALUATE Hysterectomy Trial.
Quality of life questionnaires, including the sexual activity questionnaire, were completed by women prior to randomisation and periodically after randomisation.
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 trials.
Compliance rates of over 80% were achieved in both trials, both overall and for each questionnaire completed. The age of the woman did not appear 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.
It is feasible to include sexual activity questionnaires in gynaecological clinical trials requiring repeated assessment of quality of life over a long period of time. The sexual activity questionnaire is an appropriate tool to carry out investigations of sexual functioning and is worth considering for use in future clinical trials.
评估在妇科临床试验中纳入性活动问卷的可行性和可接受性。
在维持干扰素试验和评估子宫切除术试验期间进行的一项纵向生活质量研究。
妇科诊所和女性家中。
96名参与维持干扰素试验的晚期卵巢癌女性以及542名在评估子宫切除术试验中接受子宫切除术的女性。
女性在随机分组前及随机分组后定期完成包括性活动问卷在内的生活质量问卷。
性活动问卷的总体依从率以及与女性性功能水平和年龄相关的依从率。女性对完成问卷的态度，以及在临床试验中使用性活动问卷的适用性。
两项试验中，总体及每份完成的问卷的依从率均达到80%以上。女性的年龄似乎不影响问卷的完成情况，其性功能水平也无影响。女性支持该研究，且未觉得问卷具有侵扰性。
在需要长时间反复评估生活质量的妇科临床试验中纳入性活动问卷是可行的。性活动问卷是开展性功能调查的合适工具，值得在未来的临床试验中考虑使用。
