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

Abstract

PurposeThe 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.MethodsFor 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.ResultsQualitative 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.ConclusionsWith 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.Electronic supplementary materialThe online version of this article (doi:10.1007/s10557-017-6723-4) contains supplementary material, which is available to authorized users.

Simulation of the Impact of Statin Intolerance on the Need for Ezetimibe and/or Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor for Meeting Low-Density Lipoprotein Cholesterol Goals in a Population With Atherosclerotic Cardiovascular Disease

“…19 Recently, Rosenson et al reported on the development of Statin Associated Muscle Symptom − Clinical Index (SAMS-CI) instrument to better understand whether adverse muscle symptoms experienced by a patient can be attributed to statins. 20 The negative predictive value of the SAMS-CI was found to be 91%, suggesting that Coronary Artery Disease/Simulated Impact of Varying Statin Intolerance Rates clinicians may use the tool to encourage statin continuation in patients who believe they have statin intolerance because of muscle-related symptoms. 21 The present study has several limitations.…”

Statin Intolerance

“…Statinlerle ilişkili miyopatiyi obejktif olarak ortaya koyabilmek için bazı öneriler ve semptom ölçekleri oluşturulmuş ve bunların kullanılması önerilmiştir. [23] Statin miyopatisi daha çok kalça, uyluk, baldır ve sırt kaslarını tutmaktadır. Özellikle proksimal ekstremite kaslarını simetrik olarak tutan ve statin başlanmasından <4 hafta içinde başlayan, ilaç kesilmesini takiben <2 hafta içinde sonlanan, ilaca tekrar başlama ile (rechallenge) <4 hafta içinde tekrar eden kas ağrıları SAMS olarak değerlendirilmektedir.…”

Statin-Associated Muscle Disease: Advances in Diagnosis and Management

“…The SMCI was updated and revised as the Statin-Associated Muscle Symptoms-Clinical Index (SAMS-CI; Fig. 1) based on author interviews and physician feedback [51]. The SAMS-CI scores SAMS as probable (score 9-11), possible (score 7-8), and unlikely (score 2-6) based on 4 scales of muscle symptom characteristics: location, pattern, timing of onset, and timing of improvement after statin withdrawal.…”

“…2) [56]. True SAMS is more likely when the typical clinical features are present [26,51], so a careful documentation of symptoms is the initial diagnostic step. In addition, there is almost uniform agreement that any definition of SAMS requires a dechallenge and rechallenge phase to assess potential causal associations, as well as attempting to use several (≥ 2) different statins to support the diagnosis [27].…”