Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation

Aim. While essential hypertension (HT) is highly prevalent and health-care is on its way to be value-based, there still no Russian-language tools to assess health-related quality of life (HRQoL) exclusively in hypertensive patients. The aim of this first part of the study was to develop and primaril...

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Main Authors: M. V. Ionov, N. E. Zvartau, E. A. Dubinina, A. O. Konradi
Format: Article
Language:Russian
Published: «FIRMA «SILICEA» LLC 2019-07-01
Series:Российский кардиологический журнал
Subjects:
Online Access:https://russjcardiol.elpub.ru/jour/article/view/3177
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author M. V. Ionov
N. E. Zvartau
E. A. Dubinina
A. O. Konradi
author_facet M. V. Ionov
N. E. Zvartau
E. A. Dubinina
A. O. Konradi
author_sort M. V. Ionov
collection DOAJ
description Aim. While essential hypertension (HT) is highly prevalent and health-care is on its way to be value-based, there still no Russian-language tools to assess health-related quality of life (HRQoL) exclusively in hypertensive patients. The aim of this first part of the study was to develop and primarily evaluate a new core HT-specific patient-reported outcome measure (PROM).Material and methods. HT-specific PROM was established in several steps. As a first step conceptual framework was developed and quantity of domains and subdomains was determined. Psychometrics were also instituted for the whole scale. Next, the primary item pool was built via selection from open-access Russian-language generic and English-language specific PROMs (the latter proceeded with double-translation). Moreover some newly developed HT-specific items were introduced into scale. Finally the item pool was revised according to small pilot survey with subsequent experts’ scrutiny. Results. Four experts, three in HT, one in clinical psychology constituted the expert panel. After an iterative process of literature searches 14 relevant questionnaires were selected to build 264-item pool with five-point Likert response scales (poor to better HRQoL) with a global score. Based on conceptual framework 4 key domains (physiology, psychology, social, treatment) and 24 subdomains were drafted. On the basis of onsite and extra-mural interviews with 30 hypertensive patients (18 females, mean age 62,1±10,5 years old, 1-3 severity grades) extra questions on symptoms, psychological and social burden were developed and incorporated into corresponding domains. PROM draft underwent small pilot survey (n=50, 32 females, mean age 58,3±9,6 years old, 1-3 severity grades) and then was further revised, simplified by expert panelists. The initial PROM consisted of 163 items of which 36 were HT-specific.Conclusion. The forming HT-specific PROM is intended to measure basic HRQoL, elicit the differences between hypertensives with any stage and assess HRQoL dynamics in response to treatment. Further work will be focused on conducting a large-scale survey with PROM’ primary version.
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spelling doaj.art-6de54f45be614f96ad5a079fb4aec3f72023-03-29T21:23:32Zrus«FIRMA «SILICEA» LLCРоссийский кардиологический журнал1560-40712618-76202019-07-0106546010.15829/1560-4071-2019-6-54-602619Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluationM. V. Ionov0N. E. Zvartau1E. A. Dubinina2A. O. Konradi3V. A. Almazov National Medical Research Center; St. Petersburg National Research University of Information Technologies, Mechanics and Optics (ITMO University)V. A. Almazov National Medical Research Center; St. Petersburg National Research University of Information Technologies, Mechanics and Optics (ITMO University)A. I . Herzen State Pedagogical University of Russia; V. M. Bekhterev National Research Medical Center for psychiatry and neurologyV. A. Almazov National Medical Research Center; St. Petersburg National Research University of Information Technologies, Mechanics and Optics (ITMO University)Aim. While essential hypertension (HT) is highly prevalent and health-care is on its way to be value-based, there still no Russian-language tools to assess health-related quality of life (HRQoL) exclusively in hypertensive patients. The aim of this first part of the study was to develop and primarily evaluate a new core HT-specific patient-reported outcome measure (PROM).Material and methods. HT-specific PROM was established in several steps. As a first step conceptual framework was developed and quantity of domains and subdomains was determined. Psychometrics were also instituted for the whole scale. Next, the primary item pool was built via selection from open-access Russian-language generic and English-language specific PROMs (the latter proceeded with double-translation). Moreover some newly developed HT-specific items were introduced into scale. Finally the item pool was revised according to small pilot survey with subsequent experts’ scrutiny. Results. Four experts, three in HT, one in clinical psychology constituted the expert panel. After an iterative process of literature searches 14 relevant questionnaires were selected to build 264-item pool with five-point Likert response scales (poor to better HRQoL) with a global score. Based on conceptual framework 4 key domains (physiology, psychology, social, treatment) and 24 subdomains were drafted. On the basis of onsite and extra-mural interviews with 30 hypertensive patients (18 females, mean age 62,1±10,5 years old, 1-3 severity grades) extra questions on symptoms, psychological and social burden were developed and incorporated into corresponding domains. PROM draft underwent small pilot survey (n=50, 32 females, mean age 58,3±9,6 years old, 1-3 severity grades) and then was further revised, simplified by expert panelists. The initial PROM consisted of 163 items of which 36 were HT-specific.Conclusion. The forming HT-specific PROM is intended to measure basic HRQoL, elicit the differences between hypertensives with any stage and assess HRQoL dynamics in response to treatment. Further work will be focused on conducting a large-scale survey with PROM’ primary version.https://russjcardiol.elpub.ru/jour/article/view/3177hypertensionpatient-reported outcome measureshealth-related quality of lifequestionnaire
spellingShingle M. V. Ionov
N. E. Zvartau
E. A. Dubinina
A. O. Konradi
Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation
Российский кардиологический журнал
hypertension
patient-reported outcome measures
health-related quality of life
questionnaire
title Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation
title_full Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation
title_fullStr Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation
title_full_unstemmed Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation
title_short Arterial hypertension specific patient-reported outcome measure. Part I: development and primary evaluation
title_sort arterial hypertension specific patient reported outcome measure part i development and primary evaluation
topic hypertension
patient-reported outcome measures
health-related quality of life
questionnaire
url https://russjcardiol.elpub.ru/jour/article/view/3177
work_keys_str_mv AT mvionov arterialhypertensionspecificpatientreportedoutcomemeasurepartidevelopmentandprimaryevaluation
AT nezvartau arterialhypertensionspecificpatientreportedoutcomemeasurepartidevelopmentandprimaryevaluation
AT eadubinina arterialhypertensionspecificpatientreportedoutcomemeasurepartidevelopmentandprimaryevaluation
AT aokonradi arterialhypertensionspecificpatientreportedoutcomemeasurepartidevelopmentandprimaryevaluation