Evidence map›Paper›PMID 34724980›Full record

ArticleSystematic reviews2021

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, 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 and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Systematic reviews, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 4 countries.

Mario A Jimenez-MoraSchool of Medicine, Universidad de los Andes, Bogotá, 111711, Colombia.
Andrea Ramírez VarelaSchool of Medicine, Universidad de los Andes, Bogotá, 111711, Colombia.
Jose F Meneses-EchavezDivision for Health Services, Norwegian Institute of Public Health, Oslo, Norway. jose.meneses@fhi.no.ORCID 0000-0003-4312-6909
Julia BidondeDivision for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
Adriana Angarita-FonsecaUniversité de Montréal, Montréal, Quebec, Canada.
Reed A C SiemieniukDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Dena ZeraatkarDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Jessica J BartoszkoDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Romina Brignardello-PetersenDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Kimia HonarmandDivision of Critical Care, Department of Medicine, Western University, London, ON, Canada.
Bram RochwergDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Gordon GuyattDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Juan José Yepes-NuñezSchool of Medicine, Universidad de los Andes, Bogotá, 111711, Colombia. jj.yepesn@uniandes.edu.co.
Impact · CAUniversidad de Los Andes · CONorwegian Institute of Public Health · NOUniversidad De Santander · COWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 .

Indexed as

COVID-19Epidemiologic StudiesHumansPatient Reported Outcome MeasuresRandomized Controlled Trials as TopicSARS-CoV-2Systematic Reviews as TopicCoronavirusCovid-19Patient-important outcomePreventionReportingTreatment

Identifiers

PMID34724980
PMCPMC8559914
OpenAlexW3209505693

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.