About this item:

463 Views | 999 Downloads

Author Notes:

Corresponding Author: Terry A. Jacobson, Phone: +1 404-778-1625, Email: tjaco02@emory.edu

Writing and editorial support for this manuscript was provided by MicroMass Communications, Inc., Cary, NC, USA, with funding from Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, and Sanofi US, Bridgewater, NJ, USA.

Each author contributed to the conception and design of the study, acquisition, analysis, or interpretation of the data.

In addition, authors were involved in drafting and revising the manuscript critically for important intellectual content and provided final approval for the version submitted.

U.G. Mallya and A. Koren are employed by and have ownership interest in Sanofi US. M.H. Davidson is a consultant for Sanofi US and Amgen.

Subjects:

Research Funding:

Support for this study was provided by Regeneron Pharmaceuticals, Inc., and Sanofi US. The authors were responsible for all content and editorial decisions and received no honoraria related to the development of this publication.

Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©

Journal Title:

Patient

Volume:

Volume 10, Number 3

Publisher:

, Pages 321-334

Type of Work:

Article | Final Publisher PDF

Abstract:

Introduction: The National Lipid Association Statin Intolerance (SI) Panel recognized the need for better understanding of the patient SI experience. Objective: The objective of this research was to develop a patient-reported outcome (PRO) questionnaire to assess a patient’s experience with SI. Methods: Questionnaire development was informed via a series of research activities: literature review, concept elicitation, item generation, and content evaluation. Following the literature review and concept elicitation, a draft questionnaire was constructed and subsequently modified based on feedback from therapeutic area experts and patients via cognitive debriefing interviews. Results: Muscle-related symptoms were the most commonly reported symptoms associated with SI in the literature review (35 of 41 articles reviewed [85%]) and in semi-structured interviews with experts (n = 5 [100%]) and patients (n = 17 of 20 [85.0%]). Physical and other impacts of SI symptoms on daily activities were also frequently reported. A 17-item draft questionnaire was created, and cognitive debriefing with experts (n = 5) and patients (n = 15) was conducted. Overall, the items, response options, and instructions were comprehensible and positively reviewed; minor changes resulted in the 15-item Statin Experience Assessment Questionnaire (SEAQ)©. Using a 30-day recall period, the SEAQ© assesses the severity and impact of six SI symptoms (muscle ache, muscle pain, muscle cramps, muscle weakness, tiredness, and joint pain) on an 11-point numeric scale. Statin discontinuation and likelihood of discontinuation due to symptoms are assessed and scored on a yes/no and five-point verbal response scale, respectively. Conclusion: The SEAQ© is a novel content-valid PRO questionnaire that assesses patient SI experience and fosters dialogue about SI between patients and providers.

Copyright information:

© 2016, The Author(s).

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/).

Creative Commons License

Export to EndNote