Preparing the SAMS-CI for Clinical Use

For clarity, the original proposed method published by the NLA Statin Muscle Safety Task Force will be referred to as the SMCI (Fig. ​(Fig.1).1). The intermediate version following author interviews and review will be called the interim SAMS-CI (not shown), and the version prepared for clinical use is denoted as the SAMS-CI (Fig. ​(Fig.33).

Statin-Associated Muscle Symptoms Clinical Index (SAMS-CI)

Adaptation of the original SMCI for routine clinical use proceeded with three activities, as shown in Fig. ​Fig.2.2. First, between October 16 and 22, 2014, hour-long telephone interviews were conducted with a convenience sample of three of the five authors of the SMCI (RSR, BT, and TAJ, also authors of this paper). These semi-structured interviews covered several topics, including the thought process behind each question; the response options, scoring algorithm, and importance weights; the precise definition of certain terms; the type of patient best suited to take the SMCI; and reasons for excluding certain concepts from the SMCI. The interviews were audiotaped and transcribed for analysis.

Second, we conducted a review of the SMCI with regard to everyday use, assessing any missing features and applying survey design principles to the content and layout. Changes to the SMCI following the author interviews and this review resulted in the interim SAMS-CI.

Third, between January 23 and 30, 2015, we conducted content validation interviews of the interim SAMS-CI among 10 clinicians who had no involvement in drafting the SMCI or SAMS-CI. The sample included two primary care physicians and eight cardiologists across the USA (further description available in Online Resource 1). To be included, clinicians needed to write an average of 40 or more statin prescriptions per month, have treated at least 10 patients with statin-associated muscle symptoms in the previous year, and have been in practice post-residency for at least 5 years. These interviews followed a rigorous, standardized qualitative methodology using a semi-structured interview guide to gather detailed information from respondents on the conceptual domains, language clarity, suggested changes, and other reactions to each element of the interim SAMS-CI (instructions, questions, response options, and scoring). The interviews were audiotaped and transcribed for analysis. Respondents were blinded to the identity of the sponsor. We applied the information gathered in these interviews to generate the final SAMS-CI (Fig. ​(Fig.33).