The ORTHO BC-SAT – a satisfaction questionnaire for women using hormonal contraceptives H.H. Colwell 1 , S.D. Mathias 1 , T.A. Cimms 1 , M. Rothman 2 , A.J. Friedman 2 & D.L. Patrick 3 1 Ovation Research Group, 188 Embarcadero, Suite 200, San Francisco, CA 94105, USA (E-mail: hcolwell@ovation.org); 2 Johnson & Johnson Pharmaceutical Research and Development, Raritan, NJ, USA; 3 University of Washington, Seattle, WA, USA Accepted in revised form 27 May 2006 Abstract Objective: To assess the reliability and validity of the ORTHO Birth Control Satisfaction Assessment Tool (ORTHO BC-SAT). Design: 339 women using 1 of 4 hormonal birth control methods (oral con- traceptives, transdermal patch, vaginal ring, injections), completed the questionnaire 1–2 times. Materials and methods: The questionnaire was developed based on findings from the literature, focus groups, and interviews. Internal consistency reliability, test–retest reliability, construct validity, and known groups validity were evaluated. Results: Based on variable clustering, 8 domains were identified (Ease of Use/ Convenience, Compliance, Lifestyle Impact, Symptom/Side Effect Bother, Menstrual Impact, Future Fertility Concerns, Assurance/Confidence, Overall Satisfaction). Internal consistency reliability was demonstrated with Cronbach’s a values ranging from 0.70 to 0.89. All multi-item scales reported acceptable test–retest reliability (0.79–0.87). Construct validity was demonstrated by support of a hy- pothesized pattern of correlations. Known groups validity was confirmed by examining scale scores of women categorized by levels of symptom bother. As expected, women with the least amount of bother reported higher scores on all satisfaction scales than those with higher bother (p < 0.0001), except on Future Fertility Concerns (p = 0.27). Conclusion: Our results support the reliability and validity of the ORTHO BC-SAT. It may be used in future studies to evaluate satisfaction among hormonal contra- ceptive users. Key words: Contraceptives, Questionnaire, Reliability, Satisfaction, Validity Abbreviations: HRQoL – Health-Related Quality of Life; ICC – Intra-class Correlation Coefficient; MHI-5 – Mental Health Index-5; OCs – Oral Contraceptives; ORTHO BC-SAT – ORTHO Birth Control Satis- faction Assessment Tool; SF-12v2 – Short Form-12 version 2.0 Introduction In the past several years, several new hormonal contraceptive methods have become available in the United States. Currently, there are a variety of delivery mechanisms including oral formulations, injections, a vaginal ring, and a transdermal patch. Each method differs in a variety of ways including route of administration, dosing frequency, side effect profile, and perceived ease of use and con- venience. Ultimately, perceptions of, and satisfac- tion with the selected method will determine both continuation and adherence rates. Recently, several studies have been published evaluating satisfaction among women using various methods of birth control [1–4]. However, based on a literature search from 1995 through the present, it appears that very few investigations have been Quality of Life Research (2006) 15:1621–1631 Ó Springer 2006 DOI 10.1007/s11136-006-0026-8