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Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ).

ABSTRACT: 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.

SUBMITTER: Keininger D

PROVIDER: S-EPMC3027089 | biostudies-other | 2011

REPOSITORIES: biostudies-other

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Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ).

Keininger Dorothy D Coteur Geoffroy G

Health and quality of life outcomes 20110113

<h4>Background</h4>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 ...[more]

PMID: 21232106

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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:BackgroundRisk perception is a multidimensional phenomenon that describes the individual's judgment of the likelihood of experiencing something unpleasant. Risk perception helps to understand how rheumatoid arthritis patients perceive disease-related-risks. We developed and validated a risk perception questionnaire for Spanish speaking rheumatoid arthritis patients.MethodsThe questionnaire development and validation was performed in 3 steps, using respective convenience samples. Step-1 included the conceptual model construction, 20 patient's interviews to identify components from the conceptual model-dimensions and 11 healthcare provider´s consultations who identified RA related manifestations/complications (network and frequencies analysis). Step-2 consisted of item generation and reduction and questionnaire feasibility (n = 100). Step-3 consisted of the questionnaire psychometric validation (n = 270), which included content, face, construct (exploratory factor analysis) and criterion validity (logistic regression analysis) and consistency and stability (Cronbach's ? and test-retest).ResultsSamples were representative of typical RA outpatients. Initial conceptual model included 7 dimensions, 3 for probability and 1 each, for responsibility, prevention, control and for severity (Step-1). The final version was considered feasible by the patients and included 27 items (Step-2). A five-factor model was most appropriated and resulted in 68.8% of the variance explained: Cronbach's ? = 0.90, intraclass-correlation-coefficient = 0.93 (95% CI = 0.90-0.95). A positive relation between number of external criteria from the charts and risk perception was found; all items had ?80% agreement from experts; patients agreed about item´s semantic clarity (89%) and format adequacy (97%), (Step-3).ConclusionsThe risk perception questionnaire was valid and reliable to evaluate risk perception construct in RA outpatients; it can be incorporated to routine care and clinical research, and guide interventions to improve patient's health behaviors.

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:BackgroundRheumatoid arthritis (RA) knowledge has been constructed with studies performed in Caucasians patients; Latin American patients present unique characteristics. Empowerment is a social multidimensional construct that has been associated to better health-related quality of life in RA. There is no validated instrument for use with Spanish-speaking patients. The objective of the study was to adapt the Spanish version of the Health Empowerment Scale (S-HES), which was selected for its psychometric properties and suitability for low-literacy populations, for RA Hispanic patients (RAEH), and to perform its psychometric validation.MethodsRAEH adaptation, pilot testing, and psychometric validation were performed. Three convenience samples of RA outpatients from a national tertiary care level center were used. For RAEH adaptation, the word "health" was substituted with "RA" in the original S-HES, integrated by 8 items. Pilot testing (in 50 patients) assessed feasibility. Psychometric validation included content validity (nine experts rated item convenience, clarity, and cultural semantic accuracy), internal consistency (in 200 patients, Cronbach's alpha) and test-retest (in a subsample of 50 patients, ICC and 95% CI), construct validity (factor analysis), and face validity (in 20 patients, % of agreement). Patients gave written informed consent.ResultsPatients were primarily middle-aged females and had typical long-standing disease, although early disease was represented. In the psychometric validation sample, the majority of the outpatients had autoantibodies; meanwhile, half of them had no evidence of disease activity, with acute reactants phase determinations within normal range. Patients with comorbidities and joint replacement were also included. Experts agreed upon the attributes of content validity: 83-100% considered the item was essential, 100% agreed on the item's clarity and 80-100% on the cultural semantic accuracy. In the pilot sample, ? 80% of the patients agreed with the item's clarity and format. In the psychometric validation sample, mean RAEH was 34 (maximum possible score: 40?=?highest score). RAEH had a good internal consistency, Cronbach's ??=?0.86, and moderately good reliability (ICC [95% CI] test-retest: 0.79 [0.62-0.88]). Factor analysis for construct validity showed a single factor explaining 52% of the variance. Patients agreed with each item content validity (85-100%) and clarity (75-100%).ConclusionsRAEH was valid and reliable to evaluate empowerment in Spanish-speaking RA patients.

Project description:ObjectiveDespite the development of new biologic therapies, methotrexate (MTX) remains the preferred initial disease-modifying anti-rheumatic drug to treat rheumatoid arthritis (RA). Adherence to disease-modifying anti-rheumatic drugs is suspected to be highly variable potentially leading to reduced treatment effectiveness. This work aimed to develop and validate the Methotrexate Experience Questionnaire (MEQ), a tool to identify and characterize non-adherence to oral MTX.MethodsMEQ development included a literature review and qualitative interviews with RA patients and physicians in the United States. A retrospective, cross-sectional study using data from Optimum Patient Care Research Database, a large primary care database of electronic medical records in the United Kingdom, was conducted to finalize the MEQ and evaluate its psychometric properties.ResultsThree hundred seven e-consented subjects (66% women, mean age of 65 years) completed the MEQ remotely, and were included in this analysis. Item-convergent and divergent validity were generally supportive of the construct validity of the MEQ and Cronbach's alpha of 0.87 supported its reliability. The MEQ Total score presented statistically significant correlations of small to medium size with all selected concurrent scales, as expected; the highest correlation was obtained between the general acceptance score of ACCEPT and the MEQ Total score (0.55, p < 0.001). Known-groups validity was demonstrated as a logical pattern of higher MEQ scores was obtained for patients considered adherent with both the 6- and 12-month Proportion of Days Covered (mean MEQ total score 82.7 for 12-month PDC ≥ 80% against 76.3 for 12-month PDC < 80%, p< 0.0001). Additionally, a pattern of lower MEQ scores was obtained for patients with more severe disease assessed with Routine Assessment of Patient Index Data 3.ConclusionThe 24-item MEQ is a reliable and valid instrument to assess the adherence of RA patients taking MTX, potentially improving over historical refill rate metrics by providing insights into the individual reasons for lack of adherence. This information should facilitate clinician-patient discussions and help inform treatment decisions.

Dataset Information

Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ).

Publications

Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ).

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