Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process

Aim. Improvement of the health-related quality of life (HRQoL) is one of the basic principles of value-based medicine. HRQoL could be assessed by the patient-reported outcome measures (PROMs) also in case of arterial hypertension (HTN). However for HTN patients only generic PROMs are still used. Pre...

Full description

Bibliographic Details
Main Authors: M. V. Ionov, N. E. Zvartau, E. A. Dubinina, N. N. Khromov-Borisov, A. O. Konradi
Format: Article
Language:Russian
Published: «FIRMA «SILICEA» LLC 2019-08-01
Series:Российский кардиологический журнал
Subjects:
Online Access:https://russjcardiol.elpub.ru/jour/article/view/3263
_version_ 1797856801912258560
author M. V. Ionov
N. E. Zvartau
E. A. Dubinina
N. N. Khromov-Borisov
A. O. Konradi
author_facet M. V. Ionov
N. E. Zvartau
E. A. Dubinina
N. N. Khromov-Borisov
A. O. Konradi
author_sort M. V. Ionov
collection DOAJ
description Aim. Improvement of the health-related quality of life (HRQoL) is one of the basic principles of value-based medicine. HRQoL could be assessed by the patient-reported outcome measures (PROMs) also in case of arterial hypertension (HTN). However for HTN patients only generic PROMs are still used. Previously the group of experts had created the primary version of HTN-specific PROM. The purpose of the second part was to conduct a validation survey and to select the items in a statistically-based manner.Material and methods. Validation survey was conducted in a large multidisciplinary center among patients with HTN stages 1-3 and healthy volunteers. Inclusion criteria were age >18 years old, ability to understand or complete the scale themselves, absence of significant illness requiring hospitalization. The items were selected according to the principles of classical test theory (CTT) and item response theory (IRT). The criteria for CTT were sensitivity (standard deviation and coefficient of variation with corresponding confidence intervals), representativeness (item-total Pearson’s correlation coefficient), internal consistency (Cronbach’s a coefficient). In IRT analysis two methods were adopted — value of four degrees of difficulty and the discrimination estimate. Each question was evaluated according to 8 criteria. An item was considered for selection when it was retained by ≥4 criteria. The expert panel considered practical significance of each item.Results. A total of 430 questionnaires were distributed and 407 (94,7%) of them were returned completed (from 359 hypertensive patients, mean age 62,3±11,7 y.o.; 48 healthy volunteers, mean age 38,8±10,5 y.o.). The average time for PROM filling was 24±4,2 minutes. Of 163 questions, 27 met all 8 criteria and 3 questions did not match any. Of the 36 HTN-specific questions, 11 matched ≥5 criteria and in the generic part there were 87 questions (33 in the PHY domain, 35 for PSY, 8 for SOC, 11 for THER). The symmetric distribution of criteria was seen in 25 questions, of which 11 were evaluated by experts and then retained. For 40 questions, <4 eligibility criteria were recorded, of which 9 were retained after expert review. The PROM draft contained 80 questions (19 questions in the physiology domain, 22 in psychology, 6 in social, 13 in therapy, 20 items are HTN-specific).Conclusion. The methods of CTT and IRT allowed to reduce the PROM volume without losing the semantic richness and the need to reorganize the conceptual structure. The next step is the validation of the scale.
first_indexed 2024-04-09T20:46:22Z
format Article
id doaj.art-33b1bce4c08b471d9f6e3dd3ce52adfd
institution Directory Open Access Journal
issn 1560-4071
2618-7620
language Russian
last_indexed 2024-04-09T20:46:22Z
publishDate 2019-08-01
publisher «FIRMA «SILICEA» LLC
record_format Article
series Российский кардиологический журнал
spelling doaj.art-33b1bce4c08b471d9f6e3dd3ce52adfd2023-03-29T21:23:33Zrus«FIRMA «SILICEA» LLCРоссийский кардиологический журнал1560-40712618-76202019-08-0107404610.15829/1560-4071-2019-7-40-462628Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection processM. V. Ionov0N. E. Zvartau1E. A. Dubinina2N. N. Khromov-Borisov3A. O. Konradi4Almazov National Medical Research Center; St. Petersburg National Research University of Information Technologies, Mechanics and Optics (ITMO University)Almazov National Medical Research Center; 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 CenterAlmazov National Medical Research Center; St. Petersburg National Research University of Information Technologies, Mechanics and Optics (ITMO University)Aim. Improvement of the health-related quality of life (HRQoL) is one of the basic principles of value-based medicine. HRQoL could be assessed by the patient-reported outcome measures (PROMs) also in case of arterial hypertension (HTN). However for HTN patients only generic PROMs are still used. Previously the group of experts had created the primary version of HTN-specific PROM. The purpose of the second part was to conduct a validation survey and to select the items in a statistically-based manner.Material and methods. Validation survey was conducted in a large multidisciplinary center among patients with HTN stages 1-3 and healthy volunteers. Inclusion criteria were age >18 years old, ability to understand or complete the scale themselves, absence of significant illness requiring hospitalization. The items were selected according to the principles of classical test theory (CTT) and item response theory (IRT). The criteria for CTT were sensitivity (standard deviation and coefficient of variation with corresponding confidence intervals), representativeness (item-total Pearson’s correlation coefficient), internal consistency (Cronbach’s a coefficient). In IRT analysis two methods were adopted — value of four degrees of difficulty and the discrimination estimate. Each question was evaluated according to 8 criteria. An item was considered for selection when it was retained by ≥4 criteria. The expert panel considered practical significance of each item.Results. A total of 430 questionnaires were distributed and 407 (94,7%) of them were returned completed (from 359 hypertensive patients, mean age 62,3±11,7 y.o.; 48 healthy volunteers, mean age 38,8±10,5 y.o.). The average time for PROM filling was 24±4,2 minutes. Of 163 questions, 27 met all 8 criteria and 3 questions did not match any. Of the 36 HTN-specific questions, 11 matched ≥5 criteria and in the generic part there were 87 questions (33 in the PHY domain, 35 for PSY, 8 for SOC, 11 for THER). The symmetric distribution of criteria was seen in 25 questions, of which 11 were evaluated by experts and then retained. For 40 questions, <4 eligibility criteria were recorded, of which 9 were retained after expert review. The PROM draft contained 80 questions (19 questions in the physiology domain, 22 in psychology, 6 in social, 13 in therapy, 20 items are HTN-specific).Conclusion. The methods of CTT and IRT allowed to reduce the PROM volume without losing the semantic richness and the need to reorganize the conceptual structure. The next step is the validation of the scale.https://russjcardiol.elpub.ru/jour/article/view/3263arterial hypertensionpatient-reported outcome measureshealth-related quality of lifequestionnaireclassical test theoryitem response theory
spellingShingle M. V. Ionov
N. E. Zvartau
E. A. Dubinina
N. N. Khromov-Borisov
A. O. Konradi
Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process
Российский кардиологический журнал
arterial hypertension
patient-reported outcome measures
health-related quality of life
questionnaire
classical test theory
item response theory
title Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process
title_full Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process
title_fullStr Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process
title_full_unstemmed Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process
title_short Hypertension specific patient-reported outcome measure. Part II: validation survey and item selection process
title_sort hypertension specific patient reported outcome measure part ii validation survey and item selection process
topic arterial hypertension
patient-reported outcome measures
health-related quality of life
questionnaire
classical test theory
item response theory
url https://russjcardiol.elpub.ru/jour/article/view/3263
work_keys_str_mv AT mvionov hypertensionspecificpatientreportedoutcomemeasurepartiivalidationsurveyanditemselectionprocess
AT nezvartau hypertensionspecificpatientreportedoutcomemeasurepartiivalidationsurveyanditemselectionprocess
AT eadubinina hypertensionspecificpatientreportedoutcomemeasurepartiivalidationsurveyanditemselectionprocess
AT nnkhromovborisov hypertensionspecificpatientreportedoutcomemeasurepartiivalidationsurveyanditemselectionprocess
AT aokonradi hypertensionspecificpatientreportedoutcomemeasurepartiivalidationsurveyanditemselectionprocess