Evidence map›Paper›PMID 30261933›Full record

ArticleTrials2018

Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol.

Monica Taljaard, Charles Weijer, Jeremy M Grimshaw, Adnan Ali, Jamie C Brehaut, Marion K Campbell, Kelly Carroll, Sarah Edwards, Sandra Eldridge, Christopher B Forrest and 17 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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

18 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Randomized Trials Using Provincial Health Numbers for Group Assignment.Canadian journal of kidney health and disease · 2024
    Article
  7. Article
  8. Review
  9. 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
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. 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

27 authors.

Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada. mtaljaard@ohri.ca.
Charles WeijerRotman Institute of Philosophy, Western University, 1151 Richmond Street, London, ON, N6A 5B7, Canada.
Jeremy M GrimshawSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
Adnan AliPatient and Family Advisory Council, The Ottawa Hospital, Ottawa, ON, Canada.
Jamie C BrehautSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
Marion K CampbellHealth Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Kelly CarrollClinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.
Sarah EdwardsDepartment of Science and Technology Studies, University College London, 22 Gordon Square, King's Cross, London, WC1H 0AW, UK.
Sandra EldridgeCentre for Primary Care and Public Health, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.
Christopher B ForrestApplied Clinical Research Center, Children's Hospital of Philadelphia, 2716 South Street, Philadelphia, PA, 19146, USA.
Bruno GiraudeauUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France.
Cory E GoldsteinRotman Institute of Philosophy, Western University, 1151 Richmond Street, London, ON, N6A 5B7, Canada.
Ian D GrahamSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
Karla HemmingInstitute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Spencer Phillips HeyDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, 1620 Tremont Street, Boston, MA, 02120, USA.
Austin R HornRotman Institute of Philosophy, Western University, 1151 Richmond Street, London, ON, N6A 5B7, Canada.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.
Terry P KlassenChildren's Hospital Research Institute of Manitoba, 513-715 McDermot Avenue, Winnipeg, MB, R3E 3P, Canada.
Alex John LondonDepartment of Philosophy and Center for Ethics and Policy, Carnegie Mellon University, 150A Baker Hall, Pittsburgh, PA, 15213-3890, USA.
Susan MarlinClinical Trials Ontario, 661 University Avenue, MaRS Centre, West Tower, Toronto, ON, M5G 1M1, Canada.
John C MarshallSt. Michael's Hospital, Department of Surgery, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Lauralyn McIntyreSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
Joanne E McKenzieSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC, 3004, Australia.
Stuart G NichollsClinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada.
P Alison PapricaInstitute of Health Policy, Management and Evaluation, University of Toronto, Health Sciences Building, 155 College Street, Toronto, ON, M5T 3M6, Canada.
Merrick ZwarensteinCentre for Studies in Family Medicine, Department of Family Medicine Schulich School of Medicine & Dentistry Western University, 1151 Richmond Street, London, ON, N6A 3K7, Canada.
Dean A FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada.

Funding

Chief Scientist Office HSRU1CIHR PJT-153045Department of Health SRF-2017-10-002
6 · The paper itself

Abstract

backgroundThere is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered research, have created an unprecedented opportunity to advance the conduct of pragmatic trials, which can ultimately improve patient health and health system outcomes. Such trials raise ethical issues that have not yet been fully addressed, with existing literature concentrating on regulations in specific jurisdictions rather than arguments grounded in ethical principles. Proposed solutions (e.g. using different regulations in "learning healthcare systems") are speculative with no guarantee of improvement over existing oversight procedures. Most importantly, the literature does not reflect a broad vision of protecting the core liberty and welfare interests of research participants. Novel ethical guidance is required. We have assembled a team of ethicists, trialists, methodologists, social scientists, knowledge users, and community members with the goal of developing guidance for the ethical design and conduct of pragmatic trials.

methodsOur project will combine empirical and conceptual work and a consensus development process. Empirical work will: (1) identify a comprehensive list of ethical issues through interviews with a small group of key informants (e.g. trialists, ethicists, chairs of research ethics committees); (2) document current practices by reviewing a random sample of pragmatic trials and surveying authors; (3) elicit views of chairs of research ethics committees through surveys in Canada, UK, USA, France, and Australia; and (4) elicit views and experiences of community members and health system leaders through focus groups and surveys. Conceptual work will consist of an ethical analysis of identified issues and the development of new ethical solutions, outlining principles, policy options, and rationales. The consensus development process will involve an independent expert panel to develop a final guidance document. DISCUSSION: Planned output includes manuscripts, educational materials, and tailored guidance documents to inform and support researchers, research ethics committees, journal editors, regulators, and funders in the ethical design and conduct of pragmatic trials.

Indexed as

Ethics, ResearchResearch DesignConsensusConsensus Statements as TopicEthics Committees, ResearchHumansInterdisciplinary CommunicationMulticenter Studies as TopicPractice Guidelines as TopicPragmatic Clinical Trials as TopicReview Literature as TopicStakeholder ParticipationClinical trialsComparative effectiveness researchEthics guidelinesInformed consentLarge simple trialsMixed methodsPatient-centered researchPragmatic randomized controlled trialsResearch ethicsUsual care interventions

Identifiers

PMID30261933
PMCPMC6161426

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.