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Assessment of the psychometric properties and refinement of the Health and Self-Management in Diabetes Questionnaire (HASMID).

ABSTRACT: BACKGROUND:The Health And Self-Management In Diabetes (HASMIDv1) questionnaire consists of 8 attributes, 4 about quality of life, and 4 about self-management. The overall aim of this study was to rigorously examine the psychometric properties of the HASMIDv1 questionnaire. METHODS:The study comprised two phases. Phase 1 identified items of the HASMIDv1 questionnaire that potentially required rewording through consultation with a patient involvement panel and two focus groups of people with diabetes. Phase 2 involved a cross-sectional longitudinal survey where HASMID, EQ-5D-5L, health, treatment and sociodemographic questions were administered using both paper and online versions to people with diabetes. Participants were asked to complete the survey again approximately 3?months later. Psychometric analyses were undertaken to examine floor and ceiling effects, item distributions, known group differences and internal consistency. Rasch analysis was undertaken to assess differential item functioning and disordered thresholds. RESULTS:Phase 1 derived five alternative wordings to items: Irritable, Affects Mealtimes, Daily Routine, Social Activities and Problem. Phase 2 achieved 2835 responses at time point 1 (n?=?1944 online, n?=?891 paper version) and 1243 at time point 2 (n?=?533 online, n?=?710 paper version). Overall the HASMID items performed well, though two alternative worded items (Irritable and Social Activities) provided additional information not fully captured by the original HASMID items. CONCLUSION:Psychometric evaluation and Rasch analysis were used in conjunction with expert opinion to determine the final questionnaire. The application of psychometric analyses or Rasch analysis alone to inform item selection would have resulted in different items being selected for the final instrument. The benefit of a combined approach has produced an instrument which has a broader evaluation of self-management. The final validated HASMID-10 is a short self-report PRO that can be used to evaluate the impact of self-management for people living with diabetes. HASMID-10 can be scored using total summative scores, with utility and monetary values also available for use in cost-utility and cost-benefit analyses.

SUBMITTER: Carlton J

PROVIDER: S-EPMC7059394 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Assessment of the psychometric properties and refinement of the Health and Self-Management in Diabetes Questionnaire (HASMID).

Carlton Jill J Rowen Donna D Elliott Jackie J

Health and quality of life outcomes 20200305 1

<h4>Background</h4>The Health And Self-Management In Diabetes (HASMID<sup>v1</sup>) questionnaire consists of 8 attributes, 4 about quality of life, and 4 about self-management. The overall aim of this study was to rigorously examine the psychometric properties of the HASMID<sup>v1</sup> questionnaire.<h4>Methods</h4>The study comprised two phases. Phase 1 identified items of the HASMID<sup>v1</sup> questionnaire that potentially required rewording through consultation with a patient involvement ...[more]

PMID: 32138742

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Project description:Numerous study tools on diabetes self-care have been introduced; however, most existing tools do not show expectable and meaningful correlations with patients' glycaemic control. The Diabetes Self-Management Questionnaire (DSMQ) was designed to appraise self-care activities which can predict glycaemic control outcomes. However, this tool has not been validated in Pakistan. Therefore, the aim of this study was to translate and examine the psychometric properties of the Urdu version of DSMQ among type 2 diabetes patients.Standard forward-backward translation was used to translate the DSMQ into Urdu language. A convenience sample of 130 patients with type 2 diabetes was collected to assess the Urdu version's psychometric properties. Reliability was assessed by Cronbach's coefficient ? and validity was assessed using confirmatory factor analysis and criterion-related correlations.High internal consistency was found for all DSMQ scales (Sum scale: ? = 0.96, Glucose Management: 0.91; Dietary Control: 0.88; Physical Activity: 0.89; Health-Care Use: 0.73). The DSMQ subscales showed significant correlations with HbA1c (Glucose Management: -0.75; Dietary Control: -0.76; Physical Activity: -0.71; Health-Care Use: -0.64; Sum Scale: -0.78; all p < 0.001). However, when associations with HbA1c were assessed in one multiple linear regression model, only Glucose Management and Dietary Control were significantly associated with lower HbA1c values (Beta = -0.42, p = 0.004 and Beta = -0.30, p = 0.028, respectively), while Physical Activity and Health-Care Use were not (p > 0.05). Adequate fit to the data was achieved for single factor model after successively modelling all significant correlations between the items' error terms, with Chi2 = 106.6, df = 84, p = 0.049; TLI = 0.98, CFI = 0.99 and RMSEA = 0.05 (90% CI 0.01-0.07). Whereas a comparatively lower fit indices to data were observed in case of four factor model.The findings support the Urdu version of the DSMQ as a reliable and valid instrument for assessing self-care activities associated with glycaemic control in type 2 diabetes patients.

Project description:BACKGROUND:Patient-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. METHODS:A 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 ?. RESULTS:The 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 (??>?0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity. CONCLUSIONS:The 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 REGISTRATION:NCT03357471.

Project description:BACKGROUND: 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. 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. METHODS: The 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. RESULTS: Ninety-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 ? 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. CONCLUSION: The SIAQ was demonstrated to be a valid, reliable tool in patients with rheumatoid arthritis.

Dataset Information

Assessment of the psychometric properties and refinement of the Health and Self-Management in Diabetes Questionnaire (HASMID).

Publications

Assessment of the psychometric properties and refinement of the Health and Self-Management in Diabetes Questionnaire (HASMID).

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