SYMPTOMS AND IMPACT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD)- CONCEPTS AND MEASUREMENT

Author(s)

Rofail D1, Abetz L1, Lindemann M2, Filonenko A2, Colligs A2, Endicott J31Mapi Values Ltd, Bollington, Cheshire, United Kingdom, 2Bayer Schering Pharma AG, Berlin, Germany, 3Columbia Univeristy College of Physicians and Surgeons, New York, NY, USA

OBJECTIVES: To investigate the symptoms and impact associated with premenstrual dysphoric disorder (PMDD), and the appropriateness of the patient-reported Daily Record of Severity of Problems (DRSP) as an instrument to assess PMDD.   METHODS: A review of 47 published peer-review articles and conference presentations was conducted to aid the development of a PMDD conceptual model. The content of the DRSP was then compared to the conceptual model to assess face and content validity. The DRSP’s reliability and responsiveness was also assessed. RESULTS: Studies showed women with PMDD experience severe physical and emotional symptoms at the luteal stage of the menstrual cycle (five days before menses), primarily as a result of hormonal fluctuations associated with ovulation. Physical symptoms include: aches/pains; breast tenderness/swelling; bloating; weight gain; increased appetite/cravings; sleep problems; fatigue and difficulties concentrating. Emotional symptoms include: mood swings; depressed mood; anxiety/tension; anger; irritability; decreased interest; and feelings of being overwhelmed. The experience of these symptoms contributes to functional impairment in women with PMDD, particularly in terms of: social functioning; work/school functioning; productivity; role functioning; relationships; and activities of daily living. A review of DRSP item content revealed all symptoms and impacts of PMDD are captured by the DRSP, supporting the face and content validity of the instrument. Studies also showed the DRSP to have acceptable internal consistency (Chronbach’s alpha ≥ 0.7), test-retest reliability (ICC correlations 0.67-0.99) and responsiveness to improvements following treatment (effect sizes 0.64 -1.71).    CONCLUSIONS: PMDD is associated with physical and emotional symptoms which can have a significant impact on patients’ lives. The DRSP is a valid, reliable and responsive patient-reported  tool for assessing PMDD-related symptoms and their impact. The DRSP could be useful for clinicians during general practice, or for clinical trials in identifying PMDD populations or the impact during treatment.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PIH30

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Pediatrics, Reproductive and Sexual Health

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