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Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

ABSTRACT: 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.

SUBMITTER: Pompilus F

PROVIDER: S-EPMC7640481 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

Pompilus Farrah F Ciesluk Anna A Strzok Sara S Ciaravino Valerie V Harris Kristina K Szegvari Boglarka B Mountian Irina I Cleanthous Sophie S Meunier Juliette J

Health and quality of life outcomes 20201104 1

<h4>Background</h4>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.<h4>Methods</h4>A mixed-methods approach was ...[more]

PMID: 33148261

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Project description: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.

Project description:BackgroundBack pain is an important public health problem and the leading cause of adult disability worldwide and is rising among schoolchildren populations. Despite numerous studies reporting on back care interventions in pediatric population; there is currently no existing theory-based instrument to assess impact and outcome of these programs. This paper reports on development and psychometric testing of a theory based back-care behavior instrument for use among elementary schoolchildren.MethodsThis was a three-phases study that included the following steps: a) a literature research to review existing instruments that assess healthy spine-related behavior in elementary schoolchildren; b) development of a new instrument namely the Back-care Behavior Assessment Questionnaire (BABAQ) based on the Social Cognitive Theory and existing instruments, and c) conducting a cross sectional study to test psychometric properties of the BABAQ by estimating the content validity ratio (CVR), the content validity index (CVI), performing confirmatory factor analysis (CFA), reliability analysis, and convergent validity as estimated by the Average Variance Extracted (AVE).ResultsFirst, a questionnaire (the BABAQ) was developed. It contained of 49 items tapping into 5 pre-defined constructs (skills, knowledge, self-efficacy, expectation beliefs, and behavior). Then, 610 fifth-grade female schoolchildren were entered into a cross sectional study and they completed the BABAQ. The CVR and the CVI of the questionnaire was found to be ≥0.54 and > 0.7, respectively. The CFA confirmed the five constructs and showed good fit for the data. The intraclass correlation (ICC) and the Cronbach's alpha coefficients for the BABAQ were 0.84 (P < 0.001) and 0.93, respectively. The convergent validity as measured by the AVE also showed satisfactory results.ConclusionThe findings suggest that the Back-care Behavior Assessment Questionnaire (BABAQ) is a valid instrument for measuring healthy spine-related behaviors among schoolchildren.

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:BackgroundPsychometrically sound measures of chronic disease self-management tasks are needed to improve identification of patient needs and to tailor self-management programs. This study aimed to develop and conduct a preliminary psychometric analysis of the CanSMART questionnaire among a diverse, multimorbid Canadian population.MethodsThe data were drawn from a cross-sectional online survey to examine self-management needs and support preferences. Participants were 306 Canadian adults with one or more physical and/or emotional chronic conditions. The questionnaire on frequency of self-management tasks was developed with substantial patient partner input. We conducted Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) of the 11 self-management tasks comprising the scale in two randomly selected subsamples, followed by Rasch analysis. Associations between patient characteristics and the self-management task subscales and individual items were explored.ResultsThe factor analyses identified two self-management task subscales that were labelled Coping tasks (6 items) and Physical tasks (3 items), with Cronbach's alpha of 0.70 and 0.67, respectively. Rasch analysis suggested that participants had difficulty discriminating between response options "mostly" and "always". In analyses of independent associations with patient characteristics, both Coping and Physical tasks were associated with reporting more than one chronic disease and employment disability. The Coping tasks subscale was associated with female sex. Two items, on medication use and monitoring biological parameters, did not load on either scale. Both were associated with specific diagnoses.ConclusionsIn this preliminary analysis, two self-management tasks subscales exhibit good psychometric properties. Two items that did not load on either scale may represent additional dimensions of self-management. This work provides the basis for further scale development and use in research and clinical practice.

Project description:BACKGROUND:Despite the general agreement regarding the central role of the clinical learning environment in graduate medical education, its assessment remains challenging owing to the lack of available standardized measures. We report on the cross-cultural adaptation and psychometric assessment of the Brazilian-Portuguese version of Seelig's Resident Questionnaire. METHODS:The present study was performed in two steps. First, a cross-cultural translation and adaptation of the Resident Questionnaire was conducted through multiple translations, synthesis of versions, back-translation, content validation, and face validation. Subsequently, a sample of 288 (72%) resident physicians enrolled in 40 residency programs at a Brazilian university hospital completed the following measures: 1) the Brazilian-Portuguese version of the Resident Questionnaire (for factor analysis and to determine internal consistency, reliability, and validity); 2) three existing, validated psychometric measures (to determine convergent and divergent validity); and 3) a self-report questionnaire. RESULTS:Confirmatory factor analysis results provided support for the three-dimensional model of the Resident Questionnaire in use on a sample of Brazilian resident physicians, having been previously verified for use in American samples. All three factors (emotional distress, learning environment satisfaction, and workload satisfaction) verified in the confirmatory factor analysis showed good internal consistency (? > .80), reliability (Raykov's rho > .80), and correlations in the expected directions and magnitude with measures of depressive symptoms, duty hours, organizational conditions, and emotional exhaustion. CONCLUSIONS:This study is the first to adapt a measure of the clinical learning environment of residency programs into Brazilian Portuguese. Our findings suggest that the adapted version of the Resident Questionnaire is valid and reliable for assessing Brazilian residency programs. This free, easy-access, and fast-application instrument may be a useful standardized measure for research and educational purposes concerning the clinical learning environments of resident physicians.

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Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

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Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

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