Abstract
BackgroundSubcutaneous self-injection of medication has benefits for the patient and healthcare system, but there are barriers such as dexterity problems and injection anxiety that can prevent self-injection being used effectively. An accurate method of evaluating patients' experiences with self-injection would enable assessment of their success in giving self-injections and the likelihood of them adhering to a self-injection regimen. The aim of this study was to develop a questionnaire to measure overall patient experience with subcutaneous self-injection (the Self-Injection Assessment Questionnaire [SIAQ]), and to investigate its psychometric properties.MethodsThe construct validity and reliability of the SIAQ were tested in patients with rheumatoid arthritis who volunteered to inject certolizumab pegol using a standard syringe during an open-label multinational extension trial of the long-term safety and efficacy of this drug. The SIAQ PRE module was self-completed before the first self-injection, and the POST module was self-completed following each of three fortnightly self-injections.ResultsNinety-seven patients completed the SIAQ. All items correlated well with their respective domains in confirmatory factor analysis. As predicted, compared with other participants, patients with very low scores (less than 3 out of 10) in PRE causal domains (Feelings about injections and Self-confidence) were significantly less satisfied with their first self-injection, as were patients with a very low score in any POST causal domain (Self-confidence, Feelings about injections, Injection-site reactions and Ease of use), demonstrating known-groups validity. Causal domain scores generally correlated most strongly with the Satisfaction with self-injection domain, supporting convergent validity. The SIAQ demonstrated internal consistency and reproducibility; Cronbach's α and the test-retest coefficient were > 0.70 for all domains. Sensitivity and responsiveness were also shown, where measurable. Each language version showed structural validity.ConclusionThe SIAQ was demonstrated to be a valid, reliable tool in patients with rheumatoid arthritis.
Highlights
Subcutaneous self-injection of medication has benefits for the patient and healthcare system, but there are barriers such as dexterity problems and injection anxiety that can prevent self-injection being used effectively
The disease leads to pain, fatigue and impairment in physical function, which limit activities and result in a significant decline in health-related quality of life (HRQoL) [3]
The SIAQv1.0 was designed as two Questionnaire development The initial version of the SIAQ (SIAQv1.0) was developed in accordance with a rigorous process based on modules: one that was designed to be completed by patients before their first self-injection (PRE module); and one that was designed to be completed by patients after self-injection (POST module)
Summary
Subcutaneous self-injection of medication has benefits for the patient and healthcare system, but there are barriers such as dexterity problems and injection anxiety that can prevent self-injection being used effectively. While intravenous infusion requires commitment to regular clinic visits, subcutaneous injection offers the option of self-administration and is likely to provide a better treatment experience for patients. Self-injection may offer psychological benefits over administration by healthcare professionals, including improved self-esteem [9,10]. This improved treatment experience may lead to better adherence, improved therapeutic outcomes and improved HRQoL. Removing the need to attend a clinic or hospital for regular injections brings economic benefits to both the patient and the healthcare system
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