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Development and psychometric evaluation of the Endometriosis Treatment Satisfaction Questionnaire

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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.

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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

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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).

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Authors and Affiliations

  1. Pfizer, Patient-reported Outcomes, Primary Care, 500 Arcola Rd, Collegeville, PA, 19426, USA

    Linda S. Deal

  2. Patient Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA

    Valerie S. L. Williams, Dana Britt DiBenedetti & Sheri E. Fehnel

Authors
  1. Linda S. Deal
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  2. Valerie S. L. Williams
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  3. Dana Britt DiBenedetti
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  4. Sheri E. Fehnel
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Correspondence to Linda S. Deal.

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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

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  • DOI: https://doi.org/10.1007/s11136-010-9640-6

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