Strengthening validity in studies of pelvic floor disorders through qualitative research: an example from Ethiopia.

Introduction And Hypothesis: This formative qualitative follow-up study addresses validity concerns in the Dabat Incontinence and Prolapse (DABINCOP) study, which aimed to determine the prevalence of pelvic floor disorders in north-west Ethiopia. A pilot study using a questionnaire validated by pelvic exam showed severe underreporting of clinically relevant pelvic organ prolapse (POP). The objective of the follow-up study was to explore the reasons behind the underreporting and to gather information to strengthen the sensitivity and local relevance of the questionnaire to be employed in the main study.

Methods: A qualitative formative study nested within the DABINCOP study was carried out in rural and semiurban communities using an interpretive approach and in-depth qualitative interviews. Women (5) who had not self-reported POP in the pilot but were diagnosed with severe prolapse after pelvic examination, and health-care workers in the research team (7) were interviewed individually within 1 year of the pilot. Systematic text condensation was used in the analysis.

Results: The women explained that shame and fear of social exclusion, lack of trust in the study and data collectors, and lack of hope for cure prevented them from disclosing. The health-care workers reported weaknesses in the questionnaire and the research approach. Time pressure and competition among data collectors may have compromised women's motivation to disclose.

Conclusions: The study indicates that qualitative research may fruitfully be employed in the formative phase of an epidemiological study on sensitive reproductive health problems to enhance local relevance of the tool and overall validity of the study.