Evidence map›Paper›PMID 38951929›Full record

ArticleTrials2024

Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England.

Guilherme Pessoa-Amorim, Raphael Goldacre, Charles Crichton, Will Stevens, Michelle Nunn, Andy King, Dave Murray, Richard Welsh, Heather Pinches, Andrew Rees and 9 more

Registry-linked trialAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04381936 (Randomised Evaluation of COVID-19 Therapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT04381936 phase3recruitingnot on this map

Randomised Evaluation of COVID-19 Therapy

TypeinterventionalSponsorUniversity of OxfordRan2020 to 2038Enrolled70,000ConditionsPneumoniaArmsLopinavir-Ritonavir, Corticosteroid, Hydroxychloroquine, Azithromycin, Convalescent plasma
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

19 authors.

Guilherme Pessoa-Amorim *Clinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK. guilherme.pessoa-amorim@ndph.ox.ac.uk.ORCID http://orcid.org/0000-0002-4050-6191
Raphael Goldacre *Big Data Institute, Oxford Population Health, University of Oxford, Oxford, UK.
Charles Crichton *Big Data Institute, Oxford Population Health, University of Oxford, Oxford, UK.
Will StevensClinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Michelle NunnClinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Andy KingNational Perinatal Epidemiology Unit, Oxford Population Health, University of Oxford, Oxford, UK.
Dave MurrayNational Perinatal Epidemiology Unit, Oxford Population Health, University of Oxford, Oxford, UK.
Richard WelshNational Perinatal Epidemiology Unit, Oxford Population Health, University of Oxford, Oxford, UK.
Heather PinchesNHS DigiTrials, Leeds, UK.
Andrew ReesNHS DigiTrials, Leeds, UK.
Eva J A MorrisBig Data Institute, Oxford Population Health, University of Oxford, Oxford, UK.
Martin J LandrayClinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Richard HaynesClinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Peter HorbyCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Karl WallendszusClinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Leon PetoClinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Mark Campbell *Clinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Charlie Harper *Clinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.
Marion Mafham *Clinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX37LF, UK.

Funding

Medical Research Council MC_PC_19056MRC Network of Hubs for Trials Methodology Research MR/L004933/2National Institute for Health and Care Research MC_PC_19056Oxford BHF Centre of Research Excellence RE/18/3/34214UK Research and Innovation MC_PC_19056Wellcome Trust
6 · The paper itself

Abstract

backgroundRandomised trials are essential to reliably assess medical interventions. Nevertheless, interpretation of such studies, particularly when considering absolute effects, is enhanced by understanding how the trial population may differ from the populations it aims to represent.

methodsWe compared baseline characteristics and mortality of RECOVERY participants recruited in England (n = 38,510) with a reference population hospitalised with COVID-19 in England (n = 346,271) from March 2020 to November 2021. We used linked hospitalisation and mortality data for both cohorts to extract demographics, comorbidity/frailty scores, and crude and age- and sex-adjusted 28-day all-cause mortality.

resultsDemographics of RECOVERY participants were broadly similar to the reference population, but RECOVERY participants were younger (mean age [standard deviation]: RECOVERY 62.6 [15.3] vs reference 65.7 [18.5] years) and less frequently female (37% vs 45%). Comorbidity and frailty scores were lower in RECOVERY, but differences were attenuated after age stratification. Age- and sex-adjusted 28-day mortality declined over time but was similar between cohorts across the study period (RECOVERY 23.7% [95% confidence interval: 23.3-24.1%]; vs reference 24.8% [24.6-25.0%]), except during the first pandemic wave in the UK (March-May 2020) when adjusted mortality was lower in RECOVERY.

conclusionsAdjusted 28-day mortality in RECOVERY was similar to a nationwide reference population of patients admitted with COVID-19 in England during the same period but varied substantially over time in both cohorts. Therefore, the absolute effect estimates from RECOVERY were broadly applicable to the target population at the time but should be interpreted in the light of current mortality estimates.

trial registrationISRCTN50189673- Feb. 04, 2020, NCT04381936- May 11, 2020.

Indexed as

COVID-19HospitalizationAdultAgedAged, 80 and overComorbidityEnglandFemaleFrailtyHumansMaleMiddle AgedRandomized Controlled Trials as TopicSARS-CoV-2COVID-19Evidence translationRandomised trialsRECOVERY

Identifiers

PMID38951929
PMCPMC11218071

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Registered trials

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.