Evidence map›Paper›PMID 30458809›Full record

ArticleBMC medical ethics2018

Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.

Stuart G Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E Goldstein, Merrick Zwarenstein, Ian D Graham, Joanne E McKenzie, Lauralyn McIntyre and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical ethics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi.Malawi medical journal : the journal of Medical Association of Malawi · 2022
    Article
  3. Article
  4. Article
  5. Article
  6. 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

15 authors.

Stuart G NichollsClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada. snicholls@ohri.ca.ORCID 0000-0003-0485-9069
Kelly CarrollClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.
Jamie BrehautClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.
Charles WeijerRotman Institute of Philosophy, Western University, London, ON, Canada.
Spencer Phillips HeyCenter for Bioethics, Harvard Medical School, Boston, MA, USA.
Cory E GoldsteinRotman Institute of Philosophy, Western University, London, ON, Canada.
Merrick ZwarensteinCentre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
Ian D GrahamClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.
Joanne E McKenzieSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Lauralyn McIntyreClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.
Vipul JairathDepartment of Medicine, Division of Gastroenterology, Western University, London, ON, Canada.
Marion K CampbellHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jeremy M GrimshawClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.
Dean A FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, 1053 Carling Avenue, Civic Box 693, Admin Services Building, ASB 2-013, Ottawa, ON, K1Y 4E9, Canada.

Funding

Chief Scientist OfficeCIHR FDN# 143237CIHR FDN# 143269CIHR PJT-153045
6 · The paper itself

Abstract

backgroundRandomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices.

methodsSemi-structured interviews with key stakeholders (e.g. trialists, methodologists, lay members of study teams, bioethicists, and research ethics committee members), across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. DISCUSSION: We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications.

Indexed as

Attitude of Health PersonnelClinical ProtocolsHumansInterviews as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignResearch Personnel

Identifiers

PMID30458809
PMCPMC6247737

What OpenQuestion holds

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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.