Development and psychometric evaluation of the Endometriosis Treatment Satisfaction Questionnaire

Deal LS, Linda S Deal, Valerie Williams, Valerie S L Williams, Dana Britt DiBenedetti, Dana DiBenedetti, Sheri Fehnel, Sheri E Fehnel
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2010 · vol. 19(6) , pp. 899–905 · doi:10.1007/s11136-010-9640-6 · PMID:20364332 · W2055749934
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The Endometriosis Treatment Satisfaction Questionnaire was developed and psychometrically evaluated to assess patient satisfaction with endometriosis treatments.

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The paper studied the development and psychometric evaluation of the Endometriosis Treatment Satisfaction Questionnaire (ETSQ), a patient-reported instrument to assess satisfaction with endometriosis treatment. The ETSQ was built using results from five focus groups, three iterative rounds of cognitive interviews, expert input, and a literature review, and its psychometric properties were tested using data from a multicenter randomized proof-of-concept trial following FDA guidance for patient-reported outcome measures. The authors report that the ETSQ showed no evidence of distributional anomalies or response scale biases, was unidimensional with excellent internal consistency reliability, discriminated between known groups, and correlated well with other endometriosis patient-reported outcome measures without redundancy. The paper’s main limitation is that validation was based on a proof-of-concept trial dataset rather than broader, fully confirmatory validation across diverse settings. This paper is centrally about endometriosis—specifically the development and validation of a questionnaire to measure endometriosis treatment satisfaction.

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Abstract

PurposeTo develop and psychometrically evaluate the Endometriosis Treatment Satisfaction Questionnaire, a patient-reported assessment of satisfaction with endometriosis treatment.MethodsThe Endometriosis Treatment Satisfaction Questionnaire was developed based on the results of five focus groups and three iterative sets of cognitive interviews along with expert opinion and a review of the literature. The psychometric properties were assessed using data collected during a multicenter, randomized, proof-of-concept trial. The development and validation processes followed the guidance recommended by the United States FDA for patient-reported outcome instruments.ResultsThe Endometriosis Treatment Satisfaction Questionnaire's reliability, validity, and utility as a measure of patient satisfaction with their endometriosis treatment were supported. The results of the item-level analyses showed no evidence of distributional anomalies or response scale biases. The Endometriosis Treatment Satisfaction Questionnaire is unidimensional, has excellent internal consistency reliability, and discriminates well between known groups. Scores correlated well with other patient-reported outcome measures of endometriosis without being redundant.ConclusionsThe Endometriosis Treatment Satisfaction Questionnaire has utility for assessing patient satisfaction with endometriosis treatment and may be useful in clinical trials that are assessing new treatments for endometriosis, especially when deciding between competing treatments or regimens that are found to have similar tolerability and efficacy.
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Abstract

Purpose To develop and psychometrically evaluate the Endometriosis Treatment Satisfaction Questionnaire, a patient-reported assessment of satisfaction with endometriosis treatment.

Methods

The Endometriosis Treatment Satisfaction Questionnaire was developed based on the results of five focus groups and three iterative sets of cognitive interviews along with expert opinion and a review of the literature. The psychometric properties were assessed using data collected during a multicenter, randomized, proof-of-concept trial. The development and validation processes followed the guidance recommended by the United States FDA for patient-reported outcome instruments.

Results

The Endometriosis Treatment Satisfaction Questionnaire’s reliability, validity, and utility as a measure of patient satisfaction with their endometriosis treatment were supported. The results of the item-level analyses showed no evidence of distributional anomalies or response scale biases. The Endometriosis Treatment Satisfaction Questionnaire is unidimensional, has excellent internal consistency reliability, and discriminates well between known groups. Scores correlated well with other patient-reported outcome measures of endometriosis without being redundant.

Conclusions

The Endometriosis Treatment Satisfaction Questionnaire has utility for assessing patient satisfaction with endometriosis treatment and may be useful in clinical trials that are assessing new treatments for endometriosis, especially when deciding between competing treatments or regimens that are found to have similar tolerability and efficacy. Similar content being viewed by others Abbreviations - B & B: - Biberoglu and Behrman - EFA: - Exploratory factor analyses - EHP-30: - Endometriosis Health Profile–30 - ETSQ: - Endometriosis Treatment Satisfaction Questionnaire - FDA: - Food and Drug Administration - GnHR: - Gonadotropin-releasing hormone - NSAIDs: - Non-steroidal anti-inflammatory drugs - PCA: - Principal components analysis - PRO: - Patient-reported outcome

References

Gao, X., Outley, J., Botteman, M., et al. (2006). Economic burden of endometriosis. Fertility and Sterility, 86, 1561–1572. D’Hooghe, T., & Hummelshoj, L. (2006). Multi-disciplinary centres/networks of excellence for endometriosis management and research: A proposal. Human Reproduction, 21, 2743–2748. Atkinson, M. J., Sinha, A., Hass, S. L., et al. (2004). Validation of a general measure of treatment satisfaction, the treatment satisfaction questionnaire for medication (TSQM), using a national panel study of chronic disease. Health and Quality of Life Outcomes, 2, 12. Weaver, M., Patrick, D. L., Markson, L. E., et al. (1997). Issues in the measurement of satisfaction with treatment. American Journal of Managed Care, 3, 579–594. US Department of Health and Human Services (2009). Guidance for industry: Patient reported outcome measures: Use in medical product development to support labeling claims. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed 29 January 2010. Biberoglu, K. O., & Behrman, S. J. (1981). Dosage aspects of danazol therapy in endometriosis: short-term and long-term effectiveness. American Journal of Obstetrics and Gynecology, 139, 645–654. Jones, G., Kennedy, S., Barnard, A., et al. (2001). Development of an endometriosis quality-of-life instrument: The endometriosis health profile-30. Obstetrics and Gynecology, 98, 258–264. Jones, G. L., Jenkinson, C., & Kennedy, S. (2004). Evaluating the responsiveness of the endometriosis health profile questionnaire: The EHP-30. Quality of Life Research, 13, 705–713. Cronbach, L. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16, 294–334. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates. MacCallum, R. C., Widaman, K. F., Zhang, S., et al. (1999). Sample size in factor analysis. Psychological Methods, 4, 84–99. SAS Institute Inc. (2005). SAS proprietary software, version 9.1. Cary, NC: SAS Institute, Inc. Streiner, D. L., Norman, G. R. (1995). Health measurement scales: A practical guide to their development and use. 2nd ed. New York: Oxford University Press. Acknowledgments The authors wish to acknowledge Dr. Charles Cleeland, University of Texas and Dr. David Olive, University of Wisconsin for their review of the questionnaire for content validity; Dr. Gayle Orczyk, Wyeth who was the study monitor; Dr. Lauren Nelson and Mr. Mark Price, RTI Health Solutions for their statistical expertise; and Maria B. Vinall, Medical Communications Depot, Inc. for her writing assistance (Study sponsor: Wyeth Research). Author information Authors and Affiliations Corresponding author Rights and permissions About this article Cite this article Deal, L.S., Williams, V.S.L., DiBenedetti, D.B. et al. Development and psychometric evaluation of the Endometriosis Treatment Satisfaction Questionnaire. Qual Life Res 19, 899–905 (2010). https://doi.org/10.1007/s11136-010-9640-6 Accepted: Published: Issue date: DOI: https://doi.org/10.1007/s11136-010-9640-6

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endometriosis

MeSH descriptors

Endometriosis Patient Satisfaction Psychometrics Surveys and Questionnaires Adult Endometriosis Endometriosis Female Focus Groups Humans Middle Aged Multicenter Studies as Topic Patient Satisfaction Psychometrics Psychometrics Randomized Controlled Trials as Topic Reproducibility of Results Surveys and Questionnaires Treatment Outcome United States

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