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

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

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...

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Bibliographic Details
Published in:Quality of life research Vol. 26; no. 8; pp. 2041 - 2055
Main Authors: Nguyen, Allison M., Arbuckle, Rob, Korver, Tjeerd, Chen, Fang, Taylor, Beverley, Trunbull, Alice, Norquist, Josephine M.
Format: Journal Article
Language:English
Published: Cham Springer 01-08-2017
Springer International Publishing
Springer Nature B.V
Subjects:
Adolescent
Adult
Clinical outcomes
Dysmenorrhea - therapy
Female
Humans
INSTRUMENT DEVELOPMENT
Medicine
Medicine & Public Health
Menstruation
Middle Aged
Patient assessment
Patient Reported Outcome Measures
Psychometrics - methods
Public Health
Quality of life
Quality of Life - psychology
Quality of Life Research
Quantitative psychology
Reproducibility of Results
Sociology
Surveys and Questionnaires
Young Adult
Psychometric evaluation
Patient-reported outcome
Electronic diary
Symptom assessment
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Summary: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 ShortForm 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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ISSN:0962-9343
1573-2649
DOI:10.1007/s11136-017-1562-0