Dataset Information

Validity and analysis of the Diabetes Injection Device Preference Questionnaire (DID-PQ).

ABSTRACT: Introduction: The Diabetes Injection Device Preference Questionnaire (DID-PQ) was designed to assess patient preference between two non-insulin injection devices. In a recent crossover study, people with type 2 diabetes (T2D) completed the DID-PQ after performing mock injections with two non-insulin injection devices. The purpose of the current analysis was to use these data to assess construct validity of the DID-PQ and demonstrate one way to test whether there is a significant preference for one injection device over another.

Methods: Data were from an open-label, multicenter, randomized, crossover study assessing preference between the dulaglutide and semaglutide injection pens. In addition to the 10-item DID-PQ, people with T2D completed a global item assessing overall preference. DID-PQ responses were compared to the global preference item (percent agreement, Gwet's AC1, prevalence-adjusted and bias-adjusted Kappa [PABAK]). For each item of the DID-PQ, a two-sided binomial test assessed whether the difference in preference was statistically significant.

Results: The sample included 310 participants (48.4% female; mean age?=?60.0). The DID-PQ had minimal missing data. There was strong concordance (percent agreement >?78%) between the global preference item and all DID-PQ items except item 6, which assesses preference related to needle size (59.7%). The Gwet AC1 and PABAK statistics also indicated strong agreement between the global preference item and all DID-PQ items except item 6. There was a statistically significant difference (p?
Discussion: Patient preference has been recommended as a "major factor driving the choice of medication" in a consensus report by the American Diabetes Association and the European Association for the Study of Diabetes. Current findings suggest that the DID-PQ may be a useful tool for providing insight into preferences of people with T2D using non-insulin injectable medication.

SUBMITTER: Boye KS

PROVIDER: S-EPMC7726085 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Validity and analysis of the Diabetes Injection Device Preference Questionnaire (DID-PQ).

Boye Kristina S KS Matza Louis S LS Currie Brooke M BM Coyne Karin S KS

Journal of patient-reported outcomes 20201209 1

<h4>Introduction</h4>The Diabetes Injection Device Preference Questionnaire (DID-PQ) was designed to assess patient preference between two non-insulin injection devices. In a recent crossover study, people with type 2 diabetes (T2D) completed the DID-PQ after performing mock injections with two non-insulin injection devices. The purpose of the current analysis was to use these data to assess construct validity of the DID-PQ and demonstrate one way to test whether there is a significant preferenc ...[more]

PMID: 33296064

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Project description:Background:Previous research has examined patient perceptions of insulin injection devices. However, a range of injectable medications other than insulin are now used to treat type 2 diabetes. No patient-reported outcome (PRO) instruments have been developed taking into account the perceptions of patients using newer injection devices, which are often different from those used in the past. Therefore, the primary purpose of this study was to evaluate a new PRO instrument focusing on patients' experiences with injection devices, including those used for newer treatments such as GLP-1 receptor agonists. Methods:Patients with T2D treated with non-insulin injectable medications were recruited via advertisements and six clinical sites in the US. All participants completed the draft Diabetes Injection Device - Experience Questionnaire (DID-EQ) and additional measures administered for validity assessment. Participants who had experience with two non-insulin injection devices also completed the draft Diabetes Injection Device - Preference Questionnaire (DID-PQ). Analyses focused on item reduction (item performance, exploratory factor analysis), reliability, and validity. Results:One hundred fourty two patients (mean age?=?63.0y; 56.3% female) participated. Item reduction yielded a 10-item version of the DID-EQ, including a 7-item Device Characteristics subscale and three global items assessing satisfaction, ease of use, and convenience of the injection device. The DID-EQ demonstrated good internal consistency reliability (Cronbach's alpha of Device Characteristics subscale?=?0.80) and 7-day test-retest reliability (ICCs: 0.92 for Device Characteristics subscale; 0.65 to 0.91 for the three global items). Construct validity was demonstrated via correlations with previously validated instruments (e.g., correlations with the DTSQ treatment satisfaction subscale ranged from 0.56 to 0.60, all p?<?0.0001; correlations with the TRIM-D Device ranged from 0.63 to 0.77, all p?<?0.0001). Descriptive analyses of the DID-PQ were conducted with a subset of 27 participants who were able to use it to compare two devices. Conclusions:This psychometric evaluation supports the reliability and validity of the DID-EQ, while providing initial information on the performance of the DID-PQ. These brief questionnaires complement measures of treatment efficacy and provide a more thorough picture of patients' experiences with non-insulin injectable treatments for type 2 diabetes.

Project description:BackgroundPatient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties.MethodsA mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ɑ.ResultsThe literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (ɑ > 0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity.ConclusionsThe ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making.Trial registrationNCT03357471.

Dataset Information

Validity and analysis of the Diabetes Injection Device Preference Questionnaire (DID-PQ).

Publications

Validity and analysis of the Diabetes Injection Device Preference Questionnaire (DID-PQ).

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