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clinmed/2001090001v1 (September 4, 2001)
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Reporting on sexual function in randomised controlled trials
Ian Harvey, and Jenny L Donovan
Objectives - To evaluate the means by which sexual function has been reported on and measured in randomised controlled trials (RCTs).
Methods - Design: Search of the Cochrane Controlled Trials Register (1977 to 1998) to identify all trials reporting on sexual function or dysfunction outcomes. Assessment of abstracts of all articles. Full assessment of a random sample of articles for methods of measuring and reporting on sexual function, and overall trial quality. Main outcome measures: methods of measuring and reporting on sexual function, overall trial quality.
Results - Of 38 trials obtained for full assessment, 13 (34%) measured sexual function using questionnaires, 5 (13%) used objective measures, 4 (11%) used both and 16 (42%) did not use any measures (12 used adverse event recording). Seven trials (18%) did not provide response rates for sexual function measures and nearly half (18, 47.4%) only measured sexual function at follow-up (not reported in 2 trials). In six (16%) articles it was not clear who was reporting function or how the information was collected. The mean Jadad score (overall reporting quality) in these articles was 60.00% of the maximum possible score.
Conclusions - There are specific deficits in the reporting and measurement of the different components of sexual function in randomised controlled trials. These deficits could lead to misinterpretation of findings and need to be addressed in future studies.
Key Words: Sexual function, randomised controlled trials, measurement scales, reporting quality, patient outcomes