title: Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©.
abstract: The National Lipid Association Statin Intolerance (SI) Panel recognized the need for better understanding of the patient SI experience.
  
  
  
  The objective of this research was to develop a patient-reported outcome (PRO) questionnaire to assess a patient's experience with SI.
  
  
  
  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.
  
  
  
  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.
  
  
  
  The SEAQ
authors.affiliation: Emory University School of Medicine, Lipid Clinic and Cardiovascular Risk Reduction Program, Department of Medicine, 49 Jesse Hill Jr Drive SE, Atlanta, GA, 30303, USA. tjaco02@emory.edu.
authors.forename: Terry A
authors.initials: TA
authors.lastname: Jacobson
authors.affiliation: University of California San Diego School of Medicine, Veterans Affairs Medical Center, 3350 La Jolla Village Drive (111G), San Diego, CA, 92161, USA.
authors.forename: Steven V
authors.initials: SV
authors.lastname: Edelman
authors.affiliation: Adelphi Values, 290 Congress Street, 7th Floor, Boston, MA, 02210, USA.
authors.forename: Nina
authors.initials: N
authors.lastname: Galipeau
authors.affiliation: Adelphi Values, 290 Congress Street, 7th Floor, Boston, MA, 02210, USA.
authors.forename: Alan L
authors.initials: AL
authors.lastname: Shields
authors.affiliation: Sanofi US, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.
authors.forename: Usha G
authors.initials: UG
authors.lastname: Mallya
authors.affiliation: Sanofi US, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Koren
authors.affiliation: University of Chicago Pritzker School of Medicine, 150 E. Huron, Suite 900, Chicago, IL, 60611, USA.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Davidson
mesh_terms: D000368:Aged; D018771:Arthralgia / Q000139:chemically induced* / Q000523:psychology; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced* / Q000523:psychology; D000071066:Patient Reported Outcome Measures; D011594:Psychometrics; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires / Q000592:standards*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors