How to assess acceptability and satisfaction of contraceptive methods including vaginal rings in clinical studies?
ESC Congress Library. Delvaux T. May 4, 2016; 126886; A-060
Dr. Thérèse Delvaux
Dr. Thérèse Delvaux
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Abstract
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Objectives
Quantitative methods i.e structured questionnaires are commonly used in clinical studies or trials for assessing acceptability and satisfaction of a contraceptive method, even for methods that are introduced into the vagina, such as a contraceptive vaginal ring, and are likely to affect a sexual relationship. The objective of this study was to review the research methods used for assessing acceptability and satisfaction of contraceptive methods, and the vaginal ring (VR) in particular.

Methods
A systematic literature review on research methods used for assessing the acceptability and satisfaction of contraceptives and vaginal rings was conducted using the AMSTAR checklist.
Three electronic databases (PubMed, ISI Web of Knowledge, POPLINE) were explored systematically in order to retrieve relevant articles.

Results
Standard clinical trials in the field of contraception do not include a qualitative research component. Earlier studies on VR, mostly clinical trials often conducted by or with the support of pharmaceutical companies, tested acceptability using quantitative methods i.e structured questionnaires filled in during clinical visits, or self-answered questionnaires filled in by the patient after the visit or at home. User acceptability and satisfaction were assessed through a number of dimensions: ease of use; clarity of instructions; ease of package instructions; sexual comfort (whether the ring was felt by the woman or the male partner or whether the partner minded about the ring); cycle related characteristics (menstrual changes or pain); compliance (including removals); and finally overall satisfaction. The studies apart from investigating whether the ring was felt or not during sexual intercourse, did not enquire about the effect on sexual life e.g. pleasure or frequency. The role and importance of behavioral science and inclduing a qualitative component to document acceptability in clinical studies emerged in early 2000s with microbicides trials which showed that adherence was a key issue in order to achieve significant HIV prevention results. It is only at the time VRs were tested in the field of HIV prevention and multipurpose prevention trials, i.e. for both pregnancy and HIV/STI, and particularly in sub-Saharan Africa, that mixed methods including a qualitative component started to be applied. Sexual encounter attributes e.g. sexual pleasure and frequency were defined in frameworks of acceptability and tested in placebo vaginal ring studies for the first time.

Conclusion
These results indicate the potential role and importance of qualitative and mixed methods in contraceptive methods studies.

 

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