Evidence map›Paper›PMID 37257937›Full record

ArticleBMJ global health2023

Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review.

Nick Wilmes, Charlotte W E Hendriks, Caspar T A Viets, Simon J W M Cornelissen, Walther N K A van Mook, Josanne Cox-Brinkman, Leo A Celi, Nicole Martinez-Martin, Judy W Gichoya, Craig Watkins and 4 more

Abstract readScoping Review
In one paragraph

Article in BMJ global health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. 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

14 authors.

Nick Wilmes *Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0002-7231-8654
Charlotte W E Hendriks *Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands cwe.hendriks@student.maastrichtuniversity.nl.ORCID 0000-0001-6778-4397
Caspar T A VietsDeparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0003-1270-0699
Simon J W M CornelissenDeparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0002-3472-095X
Walther N K A van MookDeparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0003-2398-8878
Josanne Cox-BrinkmanDepartment of Health Law, Maastricht University Medical Centre, Maastricht, The Netherlands.
Leo A CeliDivision of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Centre, Boston, Massachusetts, USA.ORCID 0000-0001-6712-6626
Nicole Martinez-MartinDepartment of Pediatrics, Stanford Center for Biomedical Ethics, Stanford University, San Jose, California, USA.
Judy W GichoyaDepartment of Radiology and Imaging Sciences, Emory University School of Medicine, Emory University, Atlanta, Florida, USA.
Craig WatkinsSchool of Journalism and Media, University of Texas, Austin, Texas, USA.
Ferishta Bakhshi-RaiezDepartment of Medical Informatics, Amsterdam University Medical Centre, Amsterdam and Amsterdam Public Health, Quality of care The Netherlands, Amsterdam, The Netherlands.ORCID 0000-0002-5992-3032
Laure WynantsDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.ORCID 0000-0002-3037-122X
Iwan C C van der HorstDeparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0003-3891-8522
Bas C T van BusselDeparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0003-1621-7848

Funding

Critical Care Informatics: Ethical considerations around the use and sharing of health-related dataR01EB017205 · NIBIB · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI CELI, LEO ANTHONY G, MARK, ROGER GREENWOOD · 2014 to 2021
$3.8M
NIBIB NIH HHS R01 EB017205
6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic required science to provide answers rapidly to combat the outbreak. Hence, the reproducibility and quality of conducting research may have been threatened, particularly regarding privacy and data protection, in varying ways around the globe. The objective was to investigate aspects of reporting informed consent and data handling as proxies for study quality conduct.

methodsA systematic scoping review was performed by searching PubMed and Embase. The search was performed on November 8th, 2020. Studies with hospitalised patients diagnosed with COVID-19 over 18 years old were eligible for inclusion. With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data anonymisation, data sharing and data transfer as proxies for study quality. For reasons of comparison, data regarding country income level, study location and journal impact factor were also collected.

results972 studies were included. 21.3% of studies reported informed consent, 42.6% reported waivers of consent, 31.4% did not report consent information and 4.7% mentioned other types of consent. Informed consent reporting was highest in clinical trials (94.6%) and lowest in retrospective cohort studies (15.0%). The reporting of consent versus no consent did not differ significantly by journal impact factor (p=0.159). 16.8% of studies reported a prestudy protocol registration or design. Ethical approval was described in 90.9% of studies. Information on anonymisation was provided in 17.0% of studies. In 257 multicentre studies, 1.2% reported on data sharing agreements, and none reported on Findable, Accessible, Interoperable and Reusable data principles. 1.2% reported on open data. Consent was most often reported in the Middle East (42.4%) and least often in North America (4.7%). Only one report originated from a low-income country. DISCUSSION: Informed consent and aspects of data handling and sharing were under-reported in publications concerning COVID-19 and differed between countries, which strains study quality conduct when in dire need of answers.

Indexed as

COVID-19PandemicsAdolescentHumansInformed ConsentReproducibility of ResultsRetrospective StudiesCOVID-19ReviewStudy design

Identifiers

PMID37257937
PMCPMC10254958

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.