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

Systematic Reviews

Jessica J. Bartoszko¹  Reed A. C. Siemieniuk¹  Dena Zeraatkar¹  Romina Brignardello-Petersen¹  Gordon Guyatt¹  Bram Rochwerg²  Jose F. Meneses-Echavez³  Julia Bidonde⁴  Kimia Honarmand⁵  Mario A. Jimenez-Mora⁶  Andrea Ramírez Varela⁶  Juan José Yepes-Nuñez⁷  Adriana Angarita-Fonseca⁸ 

[1] Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada;Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada;Department of Medicine, McMaster University, Hamilton, ON, Canada;Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway;Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway;School of Rehabilitation Science, Univ of Saskatchewan, Saskatoon, SK, Canada;Division of Critical Care, Department of Medicine, Western University, London, ON, Canada;School of Medicine, Universidad de los Andes, 111711, Bogotá, Colombia;School of Medicine, Universidad de los Andes, 111711, Bogotá, Colombia;Pulmonology Service, Internal Medicine Section, Fundación Santa Fe de Bogotá University Hospital, Bogotá, Colombia;Université de Montréal, Montréal, Quebec, Canada;Universidad de Santander, Bucaramanga, Santander, Colombia;

关键词: Patient-important outcome;    Reporting;    Treatment;    Prevention;    Coronavirus;    Covid-19;   

DOI  :  10.1186/s13643-021-01838-8

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsWe 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.DiscussionThe 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 registrationsOpen Science Framework registration: osf.io/6xgjz.

【 授权许可】

CC BY