DEVELOPING A NOVEL PRO MEASURE IN MULTIPLE GLOBAL REGIONS AND LANGUAGES FOR KEY CONTRACEPTIVE SIDE EFFECTS
Author(s)
Amelia Mackenzie, PhD, ScM1, Jenni Smit, PhD, MS, BPharm2, Marija Miric, PhD, MA3, Alison Edelman, MD, MPH4, Mags Beksinska, PhD , MSc2, Vivian Brache, MD5, Angely Catano, MD3, Stephanie Chung, MSPH6, Leila Cochón, MD5, Eunice Cuevas, MD3, Maddison Delacerda, BS4, Marci Forbes, RN, MSN, ND, FNP4, Emily Hoppes, MPH, MA6, Leah Ingeno, BA4, Laura Jacobson, PhD, MPH4, Mbali Khomo, NSC2, Elena Lebetkin, MPH6, Sarah McCaffrey, MPH6, Thandiwe Majola, NSC2, Melissa Matos, MD3, Mbali Mavundla, NSC2, Alicia Mendez, MD3, Massiel Mendez, MD3, Nothando Mhlaba, BA2, Nzwakie Mosery, BSS, DHC2, Lungelo Ndlovu, MSS2, Bongeka Qiya, BA2, Kayla Stankevitz, MPH6, Alexis Sullivan, MPH6, Bongiwe Zulu, PGDip2;
1FHI 360, Washington, DC, USA, 2Wits MRU (Maternal, Adolescent, and Child Health Research Unit, University of the Witwatersrand), Durban, South Africa, 3Two Oceans in Health, Santo Domingo, Dominican Republic, 4Oregon Health & Science University, Portland, OR, USA, 5Profamilia, Santo Domingo, Dominican Republic, 6FHI 360, Durham, NC, USA
1FHI 360, Washington, DC, USA, 2Wits MRU (Maternal, Adolescent, and Child Health Research Unit, University of the Witwatersrand), Durban, South Africa, 3Two Oceans in Health, Santo Domingo, Dominican Republic, 4Oregon Health & Science University, Portland, OR, USA, 5Profamilia, Santo Domingo, Dominican Republic, 6FHI 360, Durham, NC, USA
OBJECTIVES: Our research collective aims to develop a PRO measure capturing the ways contraception can change the menstrual cycle. Menstrual changes are one of the most notable contraceptive side effects, impacting healthcare decision-making and quality of life. Yet, no PRO exists with evidence of validation aligned with good research practice and regulatory methodological guidance for use across contraceptive method development.
METHODS: Building upon previous formative work (i.e., global convenings, key informant interviews, a systematic review, and expert consensus-building), we conducted 18 interactive focus groups with 106 people experiencing menstrual changes in the Dominican Republic in Spanish, South Africa in isiZulu, and the United States in English. From these data, we developed a conceptual model of contraceptive user experiences with menstrual changes. Based on key model domains, we drafted a PRO measure. A global interdisciplinary group of 75 experts is currently completing a Delphi-like survey and providing feedback on the draft PRO measure, which we will revise, and then further refine via cognitive interviews and pilot testing in our three languages and countries.
RESULTS: Our conceptual model details what menstrual changes happen (i.e., changes in bleeding volume, patterns, predictability, blood characteristics, and pain), other conceptually-linked effects, perceptions of the changes, and impacts of the changes on people’s lives (e.g., daily activities, managing menstrual health and pain, mental burden, relationships). Our current draft PRO measure includes 15 daily items assessing what menstrual changes happened and 27 monthly items assessing perceptions and impacts of those changes. By ISPOR, we will have the PRO measure revised and initial findings from cognitive interviews.
CONCLUSIONS: This work advances PRO methodology by simultaneously developing a novel PRO in three languages with data from three different global regions and meets the unmet need of rigorously measuring contraceptive menstrual changes to inform evidence-driven healthcare decision-making for people, providers, payers, funders, sponsors, and regulators.
METHODS: Building upon previous formative work (i.e., global convenings, key informant interviews, a systematic review, and expert consensus-building), we conducted 18 interactive focus groups with 106 people experiencing menstrual changes in the Dominican Republic in Spanish, South Africa in isiZulu, and the United States in English. From these data, we developed a conceptual model of contraceptive user experiences with menstrual changes. Based on key model domains, we drafted a PRO measure. A global interdisciplinary group of 75 experts is currently completing a Delphi-like survey and providing feedback on the draft PRO measure, which we will revise, and then further refine via cognitive interviews and pilot testing in our three languages and countries.
RESULTS: Our conceptual model details what menstrual changes happen (i.e., changes in bleeding volume, patterns, predictability, blood characteristics, and pain), other conceptually-linked effects, perceptions of the changes, and impacts of the changes on people’s lives (e.g., daily activities, managing menstrual health and pain, mental burden, relationships). Our current draft PRO measure includes 15 daily items assessing what menstrual changes happened and 27 monthly items assessing perceptions and impacts of those changes. By ISPOR, we will have the PRO measure revised and initial findings from cognitive interviews.
CONCLUSIONS: This work advances PRO methodology by simultaneously developing a novel PRO in three languages with data from three different global regions and meets the unmet need of rigorously measuring contraceptive menstrual changes to inform evidence-driven healthcare decision-making for people, providers, payers, funders, sponsors, and regulators.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR106
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Reproductive & Sexual Health