Evidence map›Paper›PMID 31449856›Full record

ArticleJournal of clinical epidemiology2019

The moral and legal status of Health Care Workers in Cluster Randomized Trials: a response to Weijer and Taljaard.

Rieke van der Graaf, Ghislaine J M W van Thiel, Esther Oomen-de Hoop, Karel G M Moons, Diederick E Grobbee, Johannes J M van Delden

Abstract readComment
PubMed Publisher
In one paragraph

Article in Journal of clinical epidemiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Rieke van der GraafDepartment of Medical Humanities, University Medical Center Utrecht, Utrecht University, Julius Center of Health Sciences and Primary Care, Utrecht, The Netherlands. Electronic address: r.vandergraaf@umcutrecht.nl.
Ghislaine J M W van ThielDepartment of Medical Humanities, University Medical Center Utrecht, Utrecht University, Julius Center of Health Sciences and Primary Care, Utrecht, The Netherlands.
Esther Oomen-de HoopDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Karel G M MoonsDepartment of Epidemiology, University Medical Center Utrecht, Utrecht University, Julius Center of Health Sciences and Primary Care, Utrecht, The Netherlands.
Diederick E GrobbeeDepartment of Epidemiology, University Medical Center Utrecht, Utrecht University, Julius Center of Health Sciences and Primary Care, Utrecht, The Netherlands.
Johannes J M van DeldenDepartment of Medical Humanities, University Medical Center Utrecht, Utrecht University, Julius Center of Health Sciences and Primary Care, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In 2012, Weijer et al published "The Ottawa Statement on the ethical design and conduct of cluster randomized trials". In 2015, we reflected on this statement and argued that three recommendations in this statement need to be further refined. Weijer and Taljaard have responded to our comments in this issue of the journal. They agree with one of the proposed revisions but not with two others. In this commentary, we argue that the main reason why there is disagreement about two of our refinements is that we have different views on the moral and legal status of the health care workers as "research participants" in cluster randomized trials (CRTs). In this commentary, we clarify misunderstandings about our view expressed in 2015 and elaborate on the positions of health care workers in CRTs. We argue that there is sufficient reason to doubt whether the rights and interests of health care workers (HCWs) should be protected by means of ethics guidance documents and laws on human subjects research. Their interests are protected in the first place by professional codes of conduct which ensure that they cannot provide substandard care. Furthermore, protection of HCWs by ethics guidance on human subjects research will create an enormous burden for principle investigators and research ethics committees. Further debate is essential to determine how the interests of HCWs in CRTs can be protected best.

Indexed as

Informed ConsentResearch DesignEthics Committees, ResearchHealth PersonnelHumansRandomized Controlled Trials as TopicCluster randomized trialHealth care workerOttawa statementResearch ethicsResearch participantRole of physician

Identifiers

PMID31449856

What OpenQuestion holds

Textmetadata
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.