Evidence map›Paper›PMID 33558355›Full record

ArticleBMJ open2021

Examination of patient characteristics and hydroxychloroquine use based on the US Food and Drug Administration's recommendation: a cross-sectional analysis in New York.

Eun Ji Kim, Kevin Coppa, Jamie S Hirsch, Sara Abrahams, Jennifer Johnson, Martin Lesser, Karina W Davidson, Joseph Conigliaro, Northwell Health COVID-19 Research Consortium, Northwell Health COVID-19 Research Consortium

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 26% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
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

10 authors at 1 institution in 1 country.

Eun Ji KimDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA.ORCID 0000-0002-4087-5261
Kevin CoppaDepartment of Information Services, Northwell Health, New Hyde Park, New York, USA.
Jamie S HirschDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA.
Sara AbrahamsDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA.
Jennifer JohnsonInstitute of Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, USA.
Martin LesserDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA.
Karina W DavidsonDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA.
Joseph ConigliaroDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA jconigliaro@northwell.edu.
Northwell Health COVID-19 Research Consortium
Northwell Health COVID-19 Research Consortium
Northwell Health · US

Funding

Re-engineering Precision Therapeutics Through N-of-1 TrialsR01LM012836 · NLM · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI DAVIDSON, KARINA W. · 2017 to 2023
$7.6M
Supporting Roybal P30 Centers Through a Single DSMBFR24AG064191 · NIA · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI Karina W. Davidson · 2019 to 2026
$6.0M
NIA NIH HHS R24 AG064191NLM NIH HHS R01 LM012836
6 · The paper itself

Abstract

objectiveTo describe the pattern of hydroxychloroquine use and examine the association between hydroxychloroquine use and clinical outcomes arising from changes in the US Food and Drug Administration (FDA)'s recommendation during the coronavirus disease 2019 (COVID-19) pandemic.

designA retrospective cross-sectional analysis. SETTING AND

participantsWe included hospitalised adult patients at Northwell Health hospitals with confirmed COVID-19 infections between 1 March 2020 and 11 May 2020. We categorised changes in the FDA's recommendation as pre-FDA approval (1 March 2020-27 March 2020), FDA approval (28 March 2020-23 April 2020), and FDA warning (24 April 2020-11 May 2020). The hydroxychloroquine-treated group received at least one dose within 48 hours of hospital admission. PRIMARY OUTCOME: A composite of intubation and inpatient death.

resultsThe percentages of patients who were treated with hydroxychloroquine were 192/2202 (8.7%) pre-FDA approval, 2902/6741 (43.0%) FDA approval, and 176/1066 (16.5%) FDA warning period (p<0.001). Using propensity score matching, there was a higher rate of the composite outcome among patients treated with hydroxychloroquine (49/192, 25.5%) compared with no hydroxychloroquine (66/384, 17.2%) in the pre-FDA approval period (p=0.03) but not in the FDA approval period (25.5% vs 22.6%, p=0.08) or the FDA warning (21.0% vs 15.1%, p=0.11) periods. Coincidently, there was an increase in number of patients with COVID-19 and disease severity during the FDA approval period (24.1% during FDA approval vs 21.4% during pre-FDA approval period had the composite outcome). Hydroxychloroquine use was associated with increased odds of the composite outcome during the pre-FDA approval period (OR=1.65 (95% CI 1.09 to 2.51)) but not during the FDA approval (OR=1.17 (95% CI 0.99 to 1.39)) and FDA warning (OR=1.50 (95% CI 0.94 to 2.39)) periods.

conclusionsHydroxychloroquine use was associated with adverse clinical outcomes only during the pre-FDA approval period but not during the FDA approval and warning periods, even after adjusting for concurrent changes in the percentage of patients with COVID-19 treated with hydroxychloroquine and the number (and disease severity) of hospitalised patients with COVID-19 infections.

Indexed as

COVID-19 Drug TreatmentUnited States Food and Drug AdministrationAdolescentAdultAgedAged, 80 and overCross-Sectional StudiesFemaleHumansHydroxychloroquineMaleMedicareMiddle AgedNew YorkPropensity ScoreRetrospective StudiesHydroxychloroquineCOVID-19epidemiologypublic health

Identifiers

PMID33558355
PMCPMC7871686
OpenAlexW3126169631

What OpenQuestion holds

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LicenceCC BY-NC
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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.