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

Mario A Jimenez-Mora,Romina Brignardello-Petersen,Jessica J Bartoszko,Andrea Ramírez Varela,Julia Bidonde,Kimia Honarmand,Adriana Angarita-Fonseca,Reed A C Siemieniuk,Juan José Yepes-Nuñez,Dena Zeraatkar,Jose F Meneses-Echavez,Bram Rochwerg,Gordon Guyatt

doi:10.1186/s13643-021-01838-8

Abstract

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.

Highlights

The coronavirus disease 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
This project is associated to a recently published living systematic review and network metanalysis (NMA) that compared the effects of treatments for covid-19 [16]
College Station, TX: StataCorp LLC). To our knowledge, this protocol describes the first meta-epidemiological study that examines the frequency of PIOs reporting in Randomized clinical trials (RCT) in covid-19

Summary

Introduction

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. Patient-important outcomes (PIO) are gaining wide acceptance in most fields of clinical research with clinicians and researchers advocating for “the patient at the center” of medical decision making [1]. This trend has provoked a shift when recommending interventions. The notion of “patient-important” sheds light on the individual clinical encounter and the importance of patients’ values and preferences. A PIO has been previously defined as: “a characteristic or variable that reflect how a patient feels, functions or survives” [2, 3]

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