Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study

Abstract Background The coronavirus disease 19 (covid-19) pandemic has underscored the need to expedite clinical research, which may lead investigators to shift away from measuring patient-important outcomes (PIO), limiting research applicability. We aim to investigate if randomized controlled trial...

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Autores principales:	Mario A. Jimenez-Mora, Andrea Ramírez Varela, Jose F. Meneses-Echavez, Julia Bidonde, Adriana Angarita-Fonseca, Reed A. C. Siemieniuk, Dena Zeraatkar, Jessica J. Bartoszko, Romina Brignardello-Petersen, Kimia Honarmand, Bram Rochwerg, Gordon Guyatt, Juan José Yepes-Nuñez
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 Medicine R
Acceso en línea:	https://doaj.org/article/4ad1c46a4def4d14a7cd3c8366c1070a
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spelling	oai:doaj.org-article:4ad1c46a4def4d14a7cd3c8366c1070a2021-11-07T12:08:00ZPatient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study10.1186/s13643-021-01838-82046-4053https://doaj.org/article/4ad1c46a4def4d14a7cd3c8366c1070a2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13643-021-01838-8https://doaj.org/toc/2046-4053Abstract Background The coronavirus disease 19 (covid-19) pandemic has underscored the need to expedite clinical research, which may lead investigators to shift away from measuring patient-important outcomes (PIO), limiting research applicability. We aim to investigate if randomized controlled trials (RCTs) of covid-19 pharmacological therapies include PIOs. Methods We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confirmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identified in a living network metanalysis (NMA). The main data sources are the living WHO covid-19 database up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Two reviewers independently will review each citation, full-text article, and abstract data. To categorize the outcomes according to their importance to patients, we will adapt a previously defined hierarchy: a) mortality, b) quality of life/ functional status/symptoms, c) morbidity, and d) surrogate outcomes. Outcomes within the category a) and b) will be considered critically important to patients, and outcomes within the category c) will be regarded as important. We will use descriptive statistics to assess the proportion of studies that report each category of outcomes. We will perform univariable and multivariable analysis to explore associations between trial characteristics and the likelihood of reporting PIOs. Discussion The findings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are effectively assessing and reporting the outcomes that are important to patients. If a deficiency in capturing PIOs is identified, this information may help inform the development of future RCTs in covid-19. Systematic review registrations Open Science Framework registration: osf.io/6xgjz .Mario A. Jimenez-MoraAndrea Ramírez VarelaJose F. Meneses-EchavezJulia BidondeAdriana Angarita-FonsecaReed A. C. SiemieniukDena ZeraatkarJessica J. BartoszkoRomina Brignardello-PetersenKimia HonarmandBram RochwergGordon GuyattJuan José Yepes-NuñezBMCarticlePatient-important outcomeReportingTreatmentPreventionCoronavirusCovid-19MedicineRENSystematic Reviews, Vol 10, Iss 1, Pp 1-6 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 Medicine R
spellingShingle	Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 Medicine R Mario A. Jimenez-Mora Andrea Ramírez Varela Jose F. Meneses-Echavez Julia Bidonde Adriana Angarita-Fonseca Reed A. C. Siemieniuk Dena Zeraatkar Jessica J. Bartoszko Romina Brignardello-Petersen Kimia Honarmand Bram Rochwerg Gordon Guyatt Juan José Yepes-Nuñez Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study
description	Abstract Background The coronavirus disease 19 (covid-19) pandemic has underscored the need to expedite clinical research, which may lead investigators to shift away from measuring patient-important outcomes (PIO), limiting research applicability. We aim to investigate if randomized controlled trials (RCTs) of covid-19 pharmacological therapies include PIOs. Methods We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confirmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identified in a living network metanalysis (NMA). The main data sources are the living WHO covid-19 database up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Two reviewers independently will review each citation, full-text article, and abstract data. To categorize the outcomes according to their importance to patients, we will adapt a previously defined hierarchy: a) mortality, b) quality of life/ functional status/symptoms, c) morbidity, and d) surrogate outcomes. Outcomes within the category a) and b) will be considered critically important to patients, and outcomes within the category c) will be regarded as important. We will use descriptive statistics to assess the proportion of studies that report each category of outcomes. We will perform univariable and multivariable analysis to explore associations between trial characteristics and the likelihood of reporting PIOs. Discussion The findings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are effectively assessing and reporting the outcomes that are important to patients. If a deficiency in capturing PIOs is identified, this information may help inform the development of future RCTs in covid-19. Systematic review registrations Open Science Framework registration: osf.io/6xgjz .
format	article
author	Mario A. Jimenez-Mora Andrea Ramírez Varela Jose F. Meneses-Echavez Julia Bidonde Adriana Angarita-Fonseca Reed A. C. Siemieniuk Dena Zeraatkar Jessica J. Bartoszko Romina Brignardello-Petersen Kimia Honarmand Bram Rochwerg Gordon Guyatt Juan José Yepes-Nuñez
author_facet	Mario A. Jimenez-Mora Andrea Ramírez Varela Jose F. Meneses-Echavez Julia Bidonde Adriana Angarita-Fonseca Reed A. C. Siemieniuk Dena Zeraatkar Jessica J. Bartoszko Romina Brignardello-Petersen Kimia Honarmand Bram Rochwerg Gordon Guyatt Juan José Yepes-Nuñez
author_sort	Mario A. Jimenez-Mora
title	Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study
title_short	Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study
title_full	Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study
title_fullStr	Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study
title_full_unstemmed	Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study
title_sort	patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for covid-19: a protocol of a meta-epidemiological study
publisher	BMC
publishDate	2021
url	https://doaj.org/article/4ad1c46a4def4d14a7cd3c8366c1070a
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Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study

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