Development and Content Validity Testing of a Patient-Reported Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection

Abstract

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.

Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk

“…DM-DYSLIPIDEMIA also explores treatment acceptance through the I-TAQ, a patient-reported outcome measure [34]. Alirocumab requires patients to self-administer the medication via subcutaneous injections, a treatment strategy that has previously been rarely used in the management of hyperlipidaemia; therefore, understanding patients’ perspectives about using injection treatments versus oral medications is important but difficult to measure with existing methods.…”

“…Alirocumab requires patients to self-administer the medication via subcutaneous injections, a treatment strategy that has previously been rarely used in the management of hyperlipidaemia; therefore, understanding patients’ perspectives about using injection treatments versus oral medications is important but difficult to measure with existing methods. Based on previous data, the majority of study participants and physicians have considered the alirocumab pre-filled pen to be easy to use, and participants have shown a willingness to self-inject [50]; high rates of treatment adherence (~98%) have been reported with alirocumab [34]. Further information on treatment acceptance will be provided by DM-INSULIN, which investigates alirocumab in individuals being treated with insulin (and hence already familiar with self-injection) [49].…”

“…Treatment acceptance will be assessed for study participants randomised to alirocumab at weeks 8 and 24 using the I-TAQ [34], a 22-item validated patient-reported outcome measure. Specifically, the I-TAQ assesses four domains of treatment acceptance: perceived efficacy (i.e.…”

Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY DM–INSULIN trial

“…This may be a consequence of patients with DM being more accustomed to receiving injectable medications and/or performing blood glucose monitoring. The present ongoing study should provide more information on injection-site reactions in this population, while also exploring treatment acceptability by administration of the I-TAQ, a patient-reported outcome questionnaire specifically developed to investigate perspectives on treatment with LLTs requiring subcutaneous injections [25]. Based on previous data, most participants and physicians consider the alirocumab prefilled pen easy to use, and patients have shown a willingness to self-inject [27].…”

“…Endpoints related to DM focus on changes from baseline in indices of glucose homoeostasis (HbA 1c and fasting plasma glucose), total daily insulin dose and the number of glucose-lowering agents. Treatment acceptability is assessed at weeks 8 and 24 in those who self-inject, using a 22-item validated patient-reported InjectionTreatment Acceptance Questionnaire (I-TAQ) [25]. Specifically, the I-TAQ assesses four domains of treatment acceptability: perceived efficacy (i.e.…”