Core Outcome Sets for Clinical Trials and Observational Studies in Vulvovaginal Disease
Clinical trials and observational studies in medical research have been criticized for lack of clearly defined, well-validated, reliable, and responsive outcome measures resulting in poor reproducibility and difficulty with cross-comparison of studies. In addition, outcome assessment can vary greatly based on the specific “stake holder” involved (i.e., patient, medical researcher, practitioner, or healthcare payer). The collective recognition of the need for consensus in research outcomes methodology has spurred a number of major initiatives including, but not limited to: Patient-Reported Outcomes Measurement Information System,1 Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials,2 Outcome Measures in Rheumatology,3 and Harmonizing Outcome Measures for Eczema.4 In addition to providing standard, condition-specific research guidelines, these initiatives provide excellent roadmaps for research methodology improvement in other health care fields. A recent “call to action” in the field of women's health known as the Core Research Outcomes in Women's and Newborn health (CROWN) initiative has been endorsed by a substantial group of professional journals focused on women's health issues, including the Journal of Lower Genital Tract Disease.