Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: A protocol of a META-epidemiological study
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)...
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2021-11-01
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Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Fisioterapia Integral 2022-03-10T19:11:12Z 2022-03-10T19:11:12Z 2021-11-01 Digital 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 thera‑ pies include PIOs. Methods: We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confrmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identifed 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 out‑ comes according to their importance to patients, we will adapt a previously defned 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 fndings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are efectively assessing and reporting the outcomes that are important to patients. If a defciency in capturing PIOs is identifed, this information may help inform the development of future RCTs in covid-19. Systematic review registrations: Open Science Framework registration: osf.io/6xgjz. Ciencias Médicas y de la Salud 6 p application/pdf https://doi.org/10.1186/s13643-021-01838-8 https://repositorio.udes.edu.co/handle/001/6307 eng Reino Unido 6 289 1 10 Jimenez-Mora, M.A., Varela, A.R., Meneses-Echavez, J.F. et al. Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: a protocol of a META-epidemiological study. Syst Rev 10, 289 (2021). https://doi.org/10.1186/s13643-021-01838-8 Scopus Systematic Reviews © The Author(s) 2021. info:eu-repo/semantics/openAccess Atribución 4.0 Internacional (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/ https://systematicreviewsjournal.biomedcentral.com/track/pdf/10.1186/s13643-021-01838-8.pdf Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: A protocol of a META-epidemiological study Artículo de revista http://purl.org/coar/resource_type/c_6501 Text info:eu-repo/semantics/article http://purl.org/redcol/resource_type/ART info:eu-repo/semantics/publishedVersion Todas las Audiencias Publication http://purl.org/coar/access_right/c_abf2 http://purl.org/coar/version/c_970fb48d4fbd8a85 |
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Universidad EIA |
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d_repositorio.udes.edu.co-DSPACE |
| title |
Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: A protocol of a META-epidemiological study |
| spellingShingle |
Patient-important outcomes reported in randomized controlled trials of pharmacologic treatments for COVID-19: A protocol of a META-epidemiological study Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Fisioterapia Integral Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 |
| 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 |
| author |
Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Fisioterapia Integral |
| author_facet |
Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Jimenez‑Mora, Mario A. Ramírez-Varela, Andrea Meneses‑Echavez, Jose F. Bidonde, Julia Angarita‑Fonseca, Adriana Siemieniuk, Reed A. C. Zeraatkar, Dena Bartoszko, Jessica J. Brignardello‑Petersen, Romina Honarmand, Kimia Rochwerg, Bram Guyatt, Gordon Yepes‑Nuñez, Juan José Fisioterapia Integral |
| building |
Repositorio digital |
| topic |
Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 |
| topic_facet |
Patient-important outcome Reporting Treatment Prevention Coronavirus Covid-19 |
| publishDate |
2021-11-01 |
| language |
English |
| publisher |
Reino Unido |
| physical |
6 p |
| format |
Artículo de revista |
| description |
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 thera‑
pies include PIOs.
Methods: We will perform a meta-epidemiological study of RCTs that included people at risk for, or with suspected, probable, or confrmed covid-19, examining any pharmacological treatment or blood product aimed at prophylaxis or treatment. We will obtain data from all RCTs identifed 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 out‑
comes according to their importance to patients, we will adapt a previously defned 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 fndings from this meta-epidemiological study will help health care professionals and researchers understand if the current covid-19 trials are efectively assessing and reporting the outcomes that are important to patients. If a defciency in capturing PIOs is identifed, this information may help inform the development of future
RCTs in covid-19.
Systematic review registrations: Open Science Framework registration: osf.io/6xgjz.
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| url |
https://repositorio.udes.edu.co/handle/001/6307 |
| url_str_mv |
https://repositorio.udes.edu.co/handle/001/6307 |
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1763049532194553856 |
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11.260164 |
