Evidence map›Paper›PMID 32790704›Full record

Observational studyPloS one2020

Intensive care unit patients' opinion on enrollment in clinical research: A multicenter survey.

Flavia Julie do Amaral Pfeilsticker, Carolina Aguiar Sant Anna Siqueri, Niklas Soderberg Campos, Fernanda Guimarães Aguiar, Maria Laura Romagnoli, Renato Carneiro de Freitas Chaves, Carolina Scoqui Guimarães, Adriano José Pereira, Ricardo Luiz Cordioli, Ary Serpa Neto and 2 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  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

12 authors.

Flavia Julie do Amaral PfeilstickerDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Carolina Aguiar Sant Anna SiqueriDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Niklas Soderberg CamposDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Fernanda Guimarães AguiarDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Maria Laura RomagnoliDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Renato Carneiro de Freitas ChavesDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Carolina Scoqui GuimarãesIntensive Care Unit, Hospital Municipal Vila Santa Catarina, São Paulo, Brazil.
Adriano José PereiraDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.ORCID 0000-0002-3528-3800
Ricardo Luiz CordioliDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Ary Serpa NetoDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Murillo Santucci Cesar AssuncãoDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Thiago Domingos CorrêaDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.ORCID 0000-0001-9546-3910

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn most emergency situations or severe illness, patients are unable to consent for clinical trial enrollment. In such circumstances, the decision about whether to participate in a scientific study or not is made by a legally designated representative.

objectiveTo address the willingness of patients admitted to the intensive care unit (ICU) to be enrolled in a scientific study as volunteers, and to assess the agreement between patients' and their legal representatives' opinion concerning enrollment in a scientific study.

methodsThis survey was conducted in two hospitals in São Paulo, Brazil. Patients (≥18 years) with preserved cognitive functions accompanied by a surrogate admitted to the ICU were eligible for this study. A survey containing 28 questions for patients and 8 questions for surrogates was applied within the first 48h from ICU admission. The survey for patients comprised three sections: demographic characteristics, opinion about participation in clinical research and knowledge about the importance of research. The survey for legal representatives contained two sections: demographic characteristics and assessment of legal representatives' opinion in authorizing patients to be enrolled in research.

resultsBetween January 2017 and May 2018, 208 pairs of ICU patients and their respective legal representatives answered the survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were willing to be enrolled in the study as volunteers. Of those patients, 65.1% (97/149) would continue participating in a research even if their legal representative did not support their enrollment. Agreement between patients' and surrogates' opinion concerning participation was poor [Kappa = 0.11 (IC95% -0.02 to 0.25)]. If a consent for study participation had been obtained, 69.1% (103/149) of patients would continue participating in the study until its conclusion, and 23.5% (35/149) would allow researchers to use data collected to date, but would withdraw from the study on that occasion.

conclusionThe majority of patients admitted to the ICU were willing to be enrolled in a scientific study as volunteers, also after a deferred informed consent procedure has been used. Nevertheless, contradictory opinions between patients and their and their legal representatives' concerning enrollment in a scientific study were often observed.

Indexed as

Informed ConsentResearch SubjectsAdultAgedAged, 80 and overAttitudeBiomedical ResearchBrazilCritical CareFemaleHumansIntensive Care UnitsMaleMiddle AgedProspective StudiesSurveys and Questionnaires

Identifiers

PMID32790704
PMCPMC7425869

What OpenQuestion holds

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LicenceCC BY
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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.