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A qualitative study to develop a patient-reported outcome for dysmenorrhea

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Abstract

Purpose

Dysmenorrhea refers to the experience of pelvic pain/cramps experienced by women around or during menstruation. A literature review indicated that no existing patient-reported outcome measure was adequate to support labeling claims in dysmenorrhea. Therefore, this study aimed to develop a new measure that could be used as a primary end point in dysmenorrhea clinical trials.

Methods

Open-ended interviews were conducted with 52 dysmenorrhea patients, including a subset of 12 women with a comorbid pelvic pain condition (PPC). Verbatim transcripts were analyzed thematically. The findings were used to generate draft items for an electronic diary (eDiary). A further 24 dysmenorrhea patients pilot-tested the eDiary for 1–5 weeks and completed cognitive interviews to assess content validity. Revisions to the eDiary were implemented based on the findings.

Results

In the first set of interviews, 51 women (98 %) spontaneously reported pain/cramps in or around the pelvic region (abdomen, lower back, legs/upper thighs, and vaginal area). Pain experiences reported were similar across dysmenorrhea and dysmenorrhea plus PPC subgroups, except that the pelvic pain among PPC patients occurred throughout the month, not only during menstruation. All participants described the detrimental impact of dysmenorrhea on health-related quality of life.

Conclusions

The eDiary was conceptually comprehensive and easy to complete/understand during cognitive debriefing. The resulting nine-item diary included assessment of: menstrual bleeding severity; pain severity; use of analgesics; impact on work/school, physical activities, social and leisure activities, and sleep. Psychometric validation is ongoing and will assess the reliability, validity, and responsiveness of the eDiary as a comprehensive dysmenorrhea assessment.

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Acknowledgments

The authors gratefully acknowledge the contribution of Jane Scott for her strategic insight in the development of this study. We also appreciate and acknowledge the contribution of Marcy Fitz-Randolph, Vasudha Mukherjee, Laura Tesler, Andrea Zeytoonjian and Jessica Santicciolli for conducting interviews. Cara Thomas for analysis of data. We also acknowledge the clinical insight and review of the dysmenorrhea diary provided by Dr Serdar Bulun (Feinberg School of Medicine at North-Western University).

Conflict of interest

Louise Humphrey and Helen Kitchen were employed by Adelphi Values at the time of this work. Adelphi Values is a health outcomes agency that provides consulting services for various pharmaceutical companies, including Merck & Co. Allison Martin Nguyen and Josephine Norquist are employees of Merck Sharp & Dohme Corp.; Tayyaba Rehman was an employee of Merck, Sharp and Dohme Corp. at the time of this work.

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Authors and Affiliations

  1. Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, North Wales, PA, 19454, USA

    Allison Martin Nguyen, Tayyaba Rehman & Josephine M. Norquist

  2. Adelphi Values Ltd, Adelphi Mill, Bollington, SK10 5JB, Cheshire, UK

    Louise Humphrey & Helen Kitchen

Authors
  1. Allison Martin Nguyen
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  2. Louise Humphrey
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Correspondence to Allison Martin Nguyen.

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Nguyen, A.M., Humphrey, L., Kitchen, H. et al. A qualitative study to develop a patient-reported outcome for dysmenorrhea. Qual Life Res 24, 181–191 (2015). https://doi.org/10.1007/s11136-014-0755-z

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  • DOI: https://doi.org/10.1007/s11136-014-0755-z

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