Background: Clinical Practice Guidelines (CPG) played a key role during the COVID-19 pandemic. CPGs oriented decision-making in a period of high information requirements and massive research generation. One of the fundamental steps in the development of CPGs is the prioritization of the outcomes that will inform the recommendations. In this process, various stakeholders, including patients, rate and select the most relevant outcomes for decision-making. Ideally, these are the outcomes that researchers should address in the studies that inform such CPGs. However, the reporting and selection of outcomes in primary studies are not necessarily in accordance with the CPG.
Objectives: To assess if randomized trials evaluating pharmacological treatments for nonsevere COVID-19 prioritize patient-important outcomes in their results.
Methods: We will include randomized trials evaluating pharmacological treatments for nonsevere COVID-19 identified in the COVID-19 living systematic review. We will consider the outcomes used in the COVID-19 living guidelines of the World Health Organization as the list of outcomes critical and important for decision-making (admission to hospital, death, quality of life, adverse events leading to drug discontinuation and time to symptom resolution).
Results: This project is in progress. We will describe the frequency that each outcome is reported in the included trials. We will also describe how many of the outcomes are reported at the trial level. In addition, we will describe whether authors present their results in a manner that can be included in a meta-analysis. We will perform a description by subgroups: funding sources and the availability of a published protocol before/after the publication of the first version of the World Health Organization guideline (September 2020).
Conclusions: This study can evaluate whether the initiatives that promote the measurement and reporting of patient-important outcomes have had an impact on the development of COVID-19 randomized trials. In addition, we can know if there is any factor that affects prioritization. This study is relevant to patients because the selection and reporting of outcomes should be patient centered.