The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability

Robert S Rosenson, Kate Miller, Martha Bayliss, Robert J Sanchez, Marie T Baccara-Dinet, Daniela Chibedi-De-Roche, Beth Taylor, Irfan Khan, Garen Manvelian, Michelle White, Terry A Jacobson, Robert S Rosenson, Kate Miller, Martha Bayliss, Robert J Sanchez, Marie T Baccara-Dinet, Daniela Chibedi-De-Roche, Beth Taylor, Irfan Khan, Garen Manvelian, Michelle White, Terry A Jacobson

Abstract

Purpose: The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application.

Methods: For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice.

Results: Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple scoring process) and some possible concerns (workflow issues and applicability in primary care). The inter-rater reliability of the SAMS-CI was estimated to be 0.77 (confidence interval 0.66-0.85), indicating high concordance between raters. With additional provider feedback, a revised SAMS-CI instrument was created suitable for further testing, both in the clinical setting and in prospective validation studies.

Conclusions: With standardized questions, vetted language, easily interpreted scores, and demonstrated reliability, the SAMS aims to estimate the likelihood that a patient's muscle symptoms were attributable to statins. The SAMS-CI may support better detection of statin-associated muscle symptoms in clinical practice, optimize treatment for patients experiencing muscle symptoms, and provide a useful tool for further clinical research.

Keywords: Clinical measurement; Inter-rater reliability; Muscle symptoms; Myalgia; Myopathy; Statin adverse events; Statin intolerance; Statin-associated muscle symptoms.

Conflict of interest statement

Ethical Approval

This article does not contain any studies with human participants performed by any of the authors.

Conflicts of Interest

Robert Rosenson has received grant support from Amgen, AstraZeneca, Catabasis, Medicines Company, Sanofi-Aventis; is a consultant/advisor for Akcea, Amgen, AstraZeneca, Eli Lilly, Regeneron Pharmaceuticals, Inc., and Sanofi-Aventis; has received honoraria from Kowa; and receives royalties from UpToDate, Inc. Kate Miller, Martha Bayliss, and Michelle White are employees of Optum Patient Insights, which was retained by Regeneron Pharmaceuticals, Inc. for this work. Beth Taylor served on Amgen’s Pharmacovigilance Monitoring Board and receives research support from Regeneron Pharmaceuticals, Inc. Robert Sanchez and Garen Manvelian are employees of Regeneron Pharmaceuticals, Inc. and have stock/ownership in Regeneron Pharmaceuticals, Inc. Marie Baccara-Dinet, Daniela Chibedi-De-Roche, and Irfan Khan are employees of Sanofi and have stock/ownership in Sanofi. Terry Jacobson is a consultant/advisory board member for Amarin, Amgen, AstraZeneca, Merck, Regeneron Pharmaceuticals, Inc., and Sanofi.

Role of the Funding Source

This work was funded by Sanofi and Regeneron Pharmaceuticals, Inc.

Figures

Fig. 1
Fig. 1
Original Statin Myalgia Clinical Index as proposed by the NLA. Reprinted with permission from Rosenson et al. [2]. NLA National Lipid Association, SMCI Statin Myalgia Clinical Index, SAMS-CI Statin-Associated Muscle Symptom Clinical Index
Fig. 2
Fig. 2
Study phases and SAMS-CI versions
Fig. 3
Fig. 3
Statin-Associated Muscle Symptoms Clinical Index (SAMS-CI)

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