Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment

Aim. Health-related quality of life in patients with arterial hypertension (HTN) is still determined by only generic patient-reported outcome measures (PROMs), although disease-specific ones are more reliable and highly valid. Previously, we reported the results of development and item-selection pro...

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Main Authors: M. V. Ionov, N. E. Zvartau, E. A. Dubinina, N. N. Khromov-Borisov, I. A. Tregubenko, A. O. Konradi
Format: Article
Language:Russian
Published: «FIRMA «SILICEA» LLC 2020-04-01
Series:Российский кардиологический журнал
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Online Access:https://russjcardiol.elpub.ru/jour/article/view/3438
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author M. V. Ionov
N. E. Zvartau
E. A. Dubinina
N. N. Khromov-Borisov
I. A. Tregubenko
A. O. Konradi
author_facet M. V. Ionov
N. E. Zvartau
E. A. Dubinina
N. N. Khromov-Borisov
I. A. Tregubenko
A. O. Konradi
author_sort M. V. Ionov
collection DOAJ
description Aim. Health-related quality of life in patients with arterial hypertension (HTN) is still determined by only generic patient-reported outcome measures (PROMs), although disease-specific ones are more reliable and highly valid. Previously, we reported the results of development and item-selection process of the new Russian HTN-specific PROM. The purpose of this last stage was to confirm validity, reliability, responsiveness and sensitivity of the scale and to present its final version.Material and methods. Analysis was done using data from a mass survey of patients with Grades 1-3 HTN (n=359, aged 25 to 91 y. o.) and healthy volunteers (n=48, aged 23 to 65 y.o), 407 returned questionnaires. We conducted two exploratory factor analyses (EFA) with the intermediate version of the PROM (80 questions, 20 of them HTN-specific). The Cattel’s scree test was used to select the optimal number of factors. After removing the items with a low factor loadings, a confirmatory factor analysis (CFA) was performed to assess the model’s fitindexes adequacy. The core indexes to be measured were SRMR, RMSEA, CFI. Finally, the PROM’s reliability (Cronbach’s α and McDonald’s ω) and criterion validity (responsiveness) were evaluated.Results. Both EFA with oblique and varimax rotation showed 35 questions have factor loadings ≥0,5 and assigned to one of 5 factors. The basic structure of the PROM was retained for further CFA. Most of indices of fit measured met the requirements: SRMR was 0,08, RMSEA was 0,07 (90% CI (0,07-0,08)) and CFI was 0,08, which confirms the construct validity. Both Cronbach’s α and MacDonald’s ω of each of the domains were ≥0,80 and the whole scale was 0,89 confirming satisfactory reliability. Scores of the questionnaire were positively correlated with the severity of HTN (p<0,001 for Grades 1-3 HTN) and between HTN and non-HTN patients (p=0,01 and 0,04 in psychologic and social domains respectively).Conclusion. Sequentially addressing of exploratory and confirmatory factor analyses and assessment of reliability and responsiveness allowed to form the final version of the patient-reported outcome measure for arterial hypertension. The new Russian-language questionnaire is a useful and feasible tool for routine practice and clinical trials.
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spelling doaj-art-e49789282bc74b8097ed2ed8d027a1b92025-08-20T03:43:36Zrus«FIRMA «SILICEA» LLCРоссийский кардиологический журнал1560-40712618-76202020-04-0125310.15829/1560-4071-2019-34382760Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessmentM. V. Ionov0N. E. Zvartau1E. A. Dubinina2N. N. Khromov-Borisov3I. A. Tregubenko4A. O. Konradi5Almazov National Medical Research Centre; St. Petersburg national research University of information technologies, mechanics and optics (ITMO University)Almazov National Medical Research Centre; St. Petersburg national research University of information technologies, mechanics and optics (ITMO University)A. I. Herzen Russian state pedagogical University; V. M. Bekhterev National medical research center of psychiatry and neurologyAlmazov National Medical Research CentreA. I. Herzen Russian state pedagogical University; I. P. Pavlov First St. Petersburg state medical University of the Ministry of Healthcare of RussiaAlmazov National Medical Research Centre; St. Petersburg national research University of information technologies, mechanics and optics (ITMO University)Aim. Health-related quality of life in patients with arterial hypertension (HTN) is still determined by only generic patient-reported outcome measures (PROMs), although disease-specific ones are more reliable and highly valid. Previously, we reported the results of development and item-selection process of the new Russian HTN-specific PROM. The purpose of this last stage was to confirm validity, reliability, responsiveness and sensitivity of the scale and to present its final version.Material and methods. Analysis was done using data from a mass survey of patients with Grades 1-3 HTN (n=359, aged 25 to 91 y. o.) and healthy volunteers (n=48, aged 23 to 65 y.o), 407 returned questionnaires. We conducted two exploratory factor analyses (EFA) with the intermediate version of the PROM (80 questions, 20 of them HTN-specific). The Cattel’s scree test was used to select the optimal number of factors. After removing the items with a low factor loadings, a confirmatory factor analysis (CFA) was performed to assess the model’s fitindexes adequacy. The core indexes to be measured were SRMR, RMSEA, CFI. Finally, the PROM’s reliability (Cronbach’s α and McDonald’s ω) and criterion validity (responsiveness) were evaluated.Results. Both EFA with oblique and varimax rotation showed 35 questions have factor loadings ≥0,5 and assigned to one of 5 factors. The basic structure of the PROM was retained for further CFA. Most of indices of fit measured met the requirements: SRMR was 0,08, RMSEA was 0,07 (90% CI (0,07-0,08)) and CFI was 0,08, which confirms the construct validity. Both Cronbach’s α and MacDonald’s ω of each of the domains were ≥0,80 and the whole scale was 0,89 confirming satisfactory reliability. Scores of the questionnaire were positively correlated with the severity of HTN (p<0,001 for Grades 1-3 HTN) and between HTN and non-HTN patients (p=0,01 and 0,04 in psychologic and social domains respectively).Conclusion. Sequentially addressing of exploratory and confirmatory factor analyses and assessment of reliability and responsiveness allowed to form the final version of the patient-reported outcome measure for arterial hypertension. The new Russian-language questionnaire is a useful and feasible tool for routine practice and clinical trials.https://russjcardiol.elpub.ru/jour/article/view/3438hypertensionpatient-reported outcome measureshealth-related quality of lifequestionnaire designexploratory factor analysisconfirmatory factor analysisreliabilityresponsiveness
spellingShingle M. V. Ionov
N. E. Zvartau
E. A. Dubinina
N. N. Khromov-Borisov
I. A. Tregubenko
A. O. Konradi
Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment
Российский кардиологический журнал
hypertension
patient-reported outcome measures
health-related quality of life
questionnaire design
exploratory factor analysis
confirmatory factor analysis
reliability
responsiveness
title Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment
title_full Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment
title_fullStr Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment
title_full_unstemmed Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment
title_short Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment
title_sort hypertension specific patient reported outcome measure part iii validation responsiveness and reliability assessment
topic hypertension
patient-reported outcome measures
health-related quality of life
questionnaire design
exploratory factor analysis
confirmatory factor analysis
reliability
responsiveness
url https://russjcardiol.elpub.ru/jour/article/view/3438
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AT nnkhromovborisov hypertensionspecificpatientreportedoutcomemeasurepartiiivalidationresponsivenessandreliabilityassessment
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