DEVELOPMENT AND VALIDATION OF THE PREMENSTRUAL SYMPTOMS IMPACT SURVEY

Author(s)

Gene V. Wallenstein, PhD, Senior Consulting Researcher1, Bonnie Blaisdell, MA, Senior Outcomes Consulting Analyst1, Kavita L. Gajria, BSPharm, MS, Outcomes Consulting Analyst1, Kimberly A. Yonkers, MD, Associate Professor2, Susan G. Kornstein, MD, Executive Director31QualityMetric Inc, Lincoln, RI, USA; 2 Yale University, School of Medicine, New Haven, CT, USA; 3 VCU Institute for Women's Health, Richmond, VA, USA

OBJECTIVES: To develop and validate the Premenstrual Symptoms Impact Survey (PMSIS), a brief instrument for evaluating impact of premenstrual symptoms on quality of life (QOL). METHODS: An item bank of 73 questions was administered to a general US sample of women aged 18-45. Item reduction was performed using forward stepwise linear regression of symptom severity scores onto item scores. Three standards were used to validate the instrument: 1) the American College of Obstetricians and Gynecologists diagnostic criteria for premenstrual syndrome (PMS); 2) the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for premenstrual dysphoric disorder (PMDD); and 3) feedback from a panel of practicing physicians. A “known groups” analysis was used to determine discriminant validity. RESULTS: Six items met entry criteria in the model using a discrimination cutoff of p <.01. The overall fit was statistically significant (F = 279.4; p <0.001; R2 = 0.64). Approximately 20.4% of the sample screened positive for PMS and 16.1% screened positive for PMDD. Univariate ANOVA showed that the PMS positive group (m = 49.2) had a significantly larger PMSIS mean score (0-100 range with greater values indicating more impact of symptoms on QOL) than the PMS negative group (m = 20.1) (F = 414.2, p <0.001). Likewise, the PMDD positive group (m = 52.3) had a significantly larger PMSIS mean score than the PMDD negative group (m = 21.0) (F = 393.8, p <0.001). The mean minimum score at which practicing physicians recommended an office visit was 46.7 (SD = 7.1). CONCLUSIONS: These results demonstrate that the PMSIS has excellent discriminative ability to detect differences in groups known to differ in terms of clinical criteria. As premenstrual symptoms can significantly impact QOL, the PMSIS can be used to educate consumers about the impact of their symptoms on QOL.

Conference/Value in Health Info

2006-05, ISPOR 2006, Philadelphia, PA

Value in Health, Vol. 9, No.3 (May/June 2006)

Code

PIH11

Topic

Methodological & Statistical Research, Patient-Centered Research

Topic Subcategory

Modeling and simulation, Patient-reported Outcomes & Quality of Life Outcomes

Disease

Reproductive and Sexual Health

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