PIH36 Content Validity and Scoring of Intrauterine System Daily Bleeding Diary (IUS-DBD) for Women Using Ius for Contraception

Abstract

The IUS Daily Bleeding Diary (IUS-DBD) is a single-item patient-reported outcome (PRO) measure with a 5-point Likert response scale and a 24-hour recall period, designed to evaluate the intensity and frequency of uterine bleeding. In accordance with United States (US) Food and Drug Administration (FDA) PRO Guidance for Industry 2009 requirements, this study evaluated the content validity (relevance, appropriateness, and understandability) and scoring of the IUS-DBD in a sample of women using IUS for contraception. This was a non-interventional, qualitative interview study. Participants were identified by clinicians in the US; women were eligible if they had used IUS contraception for 2–6 months and had experienced bleeding during this time or had the IUS removed due to bleeding. Interviews utilized a semi-structured interview guide with concept elicitation and cognitive debriefing methodology to evaluate the content validity of the IUS-DBD. Hypothetical bleeding profiles were assessed to explore clinically meaningful differences. Transcripts were analysed using framework analysis techniques in ATLAS.ti v7. Twenty women were interviewed. Participants (n=16/20, 80%) reported experiencing initial bothersome bleeding/spotting following IUS insertion and stated that fewer days of bleeding/spotting during the initial 3 months would be an important and meaningful improvement (n=18/18, 100%). Participants (n=20/20, 100%) interpreted the meaning of the IUS-DBD correctly (n=20/20, 100%) and found it easy to understand (n=18/19, 95%). Most correctly interpreted the recall period (n=17/20, 85%) and found the response options to be appropriate, distinct and usable (n=17/20, 85%). Based on hypothetical bleeding profiles, participants perceived a 10% reduction in days of bleeding/spotting per 30 days to be minimally improved (20%-42% participants), a 30% reduction to be minimally/much improved (>85% participants), and a 50% reduction to be much/very much improved (>75% participants). The IUS-DBD is a content valid PRO to evaluate uterine bleeding in clinical studies with women using IUS for contraception.