Psychometric validation of the dysmenorrhea daily diary (DysDD): a patient-reported outcome for dysmenorrhea

Abstract

Purpose

The objective of this study was to evaluate the psychometric properties of the Dysmenorrhea Daily Diary (DysDD), an electronic patient-reported outcome, in a sample of 355 women with primary dysmenorrhea enrolled in a phase IIb, multicenter, randomized, partially blinded, placebo-controlled trial for treatment of dysmenorrhea.

Methods

Subjects completed the DysDD over three menstrual cycles, one pre-treatment baseline cycle and two treatment cycles. The DysDD was administered alongside the Menstrual Distress Questionnaire (MDQ), the Short-Form 36 Version 2.0 (SF-36v2), and a Global Assessment of Change (GAC). Item response distributions, test–retest reliability, concurrent and known groups validity, responsiveness, and minimally important difference (MID) were evaluated for the DysDD.

Results

As expected, item response distributions varied throughout the menstrual period for all items, with the response scales fully utilized. Within-cycle test–retest reliability was adequate (weighted kappa: 0.5–0.7), although between-cycle test–retest was poor (weighted kappa: 0.1–0.5), most likely due to the highly variable nature of dysmenorrhea between cycles rather than limitations of the measure. Correlations with the MDQ and SF-36v2 were low-moderate, but in the predicted direction, supporting concurrent validity. There were significant differences in DysDD scores across severity groups based on pain medication use. The DysDD was responsive to changes in patients’ dysmenorrhea with significantly different changes in scores between change groups (p < 0.0001). MID analyses suggest changes on the DysDD 0–10 pelvic pain score of three points can be considered clinically meaningful.

Conclusions

Overall, findings indicate that the DysDD has acceptable reliability and is a valid and responsive instrument for assessing dysmenorrhea.

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Acknowledgements

The authors gratefully acknowledge the contribution of Louise Humphrey and Helen Kitchen for their input into the design of the study and the psychometric analysis plan.

Authors’ contributions

AMN and JN contributed to the clinical trial design and wrote the psychometric analysis plan. RA provided scientific input throughout the project, helped with interpretation of the results, and was highly involved in the drafting of the manuscript. TK designed the clinical trial and provided clinical input and review. FC conducted the statistical programming and data analyses. BT and AT managed the project, interpreted the results, and drafted the manuscript. All authors contributed significantly to the interpretation of the findings, drafting the final manuscript, and approval of the final version.

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Correspondence to Allison M. Nguyen.

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Funding

This study was sponsored by Merck Sharp & Dohme Corporation.

Conflict of interest

Rob Arbuckle is an employee of Adelphi Values, a health outcomes agency that provides consulting services for various pharmaceutical companies, including Merck Sharp & Dohme Corp, and was contracted by Merck for involvement in this psychometric validation study. Alice Turnbull and Beverley Taylor were employees of Adelphi Values at the time of this study and analysis. Allison Martin Nguyen, Josephine Norquist, Tjeerd Korver, and Fang Chen were all employees of Merck Sharp & Dohme Corp. at the time of this study and analysis. Tjeerd Korver provides consulting services to Merck Sharp & Dohme Corp and was compensated financially for her involvement.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Nguyen, A.M., Arbuckle, R., Korver, T. et al. Psychometric validation of the dysmenorrhea daily diary (DysDD): a patient-reported outcome for dysmenorrhea. Qual Life Res 26, 2041–2055 (2017). https://doi.org/10.1007/s11136-017-1562-0

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Keywords

  • Patient-reported outcome
  • Electronic diary
  • Symptom assessment
  • Psychometric evaluation