Recommendations for standardization of bleeding data analyses in contraceptive studies Comment

To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulatory agencies. We propose three criteria for assessing bleeding out-comes: pattern, flow, and duration. The descriptors within each criterion depend on whether the contra-ceptive is designed to result in a predictable or unpredictable bleeding pattern. Predictable pattern out-comes quantify days of scheduled, unscheduled and no bleeding, while unpredictable pattern outcomes assess frequency. Flow is quantified based on patient comparisons to their typical flow when not using contraception, with spotting representing no menstrual products use. Duration of a prolonged bleeding and/or spotting episode is more than 7 days. Studies should assess bleeding characteristics for a mini-mum of 12 months for 21/7, 24/4, extended cycle or continuous regimens, two years for injectables, and the full duration of use for long-acting contraceptives. Describing pattern, flow and duration as indepen-dent categories allows a fuller understanding of the bleeding outcomes and better future assessments of acceptability and continuation. Standardization of outcomes permits better comparison between studies and data synthesis; standardization will also improve the ability of clinicians and patients to understand differences between products. (C) 2022 Elsevier Inc. All rights reserved.

Automated summary

This study aims to address limitations in existing definitions of menstrual bleeding changes associated with contraceptive methods and proposes new recommendations for standardized bleeding data analyses. The study suggests three criteria for assessing bleeding outcomes: pattern, flow, and duration, and provides descriptors for each criterion based on the predictability of bleeding patterns. Standardizing outcomes allows for better comparison between studies and improved understanding of differences between contraceptive products for both clinicians and patients.