title: Development and Content Validity Testing of a Patient-Reported Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection.
abstract: BACKGROUND
  New therapies in development for lowering low-density lipoprotein cholesterol, such as alirocumab, require administration by subcutaneous injections. There is a need to assess the acceptance of such treatments and their mode of administration.
  
  
  OBJECTIVE
  To develop a novel patient-reported outcome measure, the Injection-Treatment Acceptance Questionnaire (I-TAQ), and assess its content validity using qualitative methods.
  
  
  METHODS
  Concepts generated from a literature and instrument review informed the initial drafting of 17 items in the I-TAQ, with item wording adapted from three existing instruments. Three rounds of qualitative interviews were conducted with 29 US-English speaking patients at high cardiovascular risk. Concept elicitation questioning was used to explore patients' treatment experiences followed by cognitive debriefing of the I-TAQ using "think-aloud" methods. Verbatim transcripts were analyzed using thematic analysis.
  
  
  RESULTS
  Qualitative analysis of concept elicitation data identified the following relevant concepts: perceived efficacy, side effects, self-efficacy, convenience, and overall acceptance. Seven (24%) patients discussed an initial fear of needles, but described this as subsiding with no impact on adherence. Five items were added after round one interviews, three of which were retained after round two testing in which two further items were added, forming the conceptually comprehensive 22-item I-TAQ. Patients demonstrated good understanding of item wording, instructions, response scales, and recall period.
  
  
  CONCLUSIONS
  Successive rounds of in-depth interviews resulted in a treatment acceptance measure with strong content validity. Pending demonstration of its psychometric properties, the I-TAQ may prove to be a valuable measure of patients' perspectives toward being treated with low-density lipoprotein cholesterol-lowering therapies requiring subcutaneous injections.
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire, UK. Electronic address: sophi.tatlock@adelphivalues.com.
authors.forename: Sophi
authors.initials: S
authors.lastname: Tatlock
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Grant
authors.affiliation: Mid America Heart Institute of Saint Luke's Hospital and the University of Missouri - Kansas City, Kansas City, MO, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Spertus
authors.affiliation: Sanofi, Bridgewater, NJ, USA.
authors.forename: Irfan
authors.initials: I
authors.lastname: Khan
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire, UK.
authors.forename: Rob
authors.initials: R
authors.lastname: Arbuckle
authors.affiliation: Regeneron Pharmaceuticals, Tarrytown, NY, USA.
authors.forename: Garen
authors.initials: G
authors.lastname: Manvelian
authors.affiliation: Regeneron Pharmaceuticals, Tarrytown, NY, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Sanchez
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007279:Injections, Subcutaneous / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D011594:Psychometrics; D036301:Qualitative Research; D011788:Quality of Life; D015203:Reproducibility of Results; D012307:Risk Factors; D011795:Surveys and Questionnaires / Q000592:standards*
chemical_list: D000960:Hypolipidemic Agents
keywords: acceptance; instrument development; patient-reported outcome; qualitative research