Evidence map›Paper›PMID 35190448›Full record

ArticleBMJ open2022

Patient engagement partnerships in clinical trials (PEP-CT): protocol for the systematic development and testing of patient partner and investigator decision aids.

Monica Parry, Tina Ceroni, David Wells, Dawn P Richards, Karine Toupin-April, Hafsa Ansari, Ann Kristin Bjørnnes, Heather Burnside, Sabrina Cavallo, Andrew Day and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

16 authors.

Monica ParryLawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada monica.parry@utoronto.ca.ORCID 0000-0002-6941-1380
Tina CeroniClinical Trials Ontario, Toronto, Ontario, Canada.
David WellsDiabetes Action Canada, Toronto, Ontario, Canada.
Dawn P RichardsClinical Trials Ontario, Toronto, Ontario, Canada.
Karine Toupin-AprilSchool of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada.
Hafsa AnsariLawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
Ann Kristin BjørnnesDepartment of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.ORCID 0000-0002-5356-3873
Heather BurnsideLawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
Sabrina CavalloSchool of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.
Andrew DayDepartment of Community Health and Epidemiology and CERU, Queen's Unversity, Kingston, Ontario, Canada.
Anne EllisDepartment of Medicine, Queen's University, Kingston, Ontario, Canada.
Debbie FeldmanSchool of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.
Ian GilronDepartments of Anesthesiology and Perioperative Medicine, Biomedical and Molecular Sciences and School of Policy Studies, Queen's University, Kingston, Ontario, Canada.ORCID 0000-0002-5293-8792
Adhiyat NajamDiabetes Action Canada, Toronto, Ontario, Canada.
Zoya ZulfiqarLawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
Susan MarlinClinical Trials Ontario, Toronto, Ontario, Canada.

Funding

CIHR 436272
6 · The paper itself

Abstract

introductionBuilding capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials requires training and support. The overall goal of this 2-year project is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials. METHODS AND ANALYSIS: Two decision aids were designed in Phase 1 of this programme of research and this protocol describes a subsequent sequential phased approach to refine/translate (Phase 2A) and conduct alpha/usability (Phase 2B) and beta/field (Phase 3) testing. Decision aid development is guided by the International Patient Decision Aid Standards, User-Centred Design, Ottawa Decision-Support Framework and the Ottawa Model of Research Use. We have integrated patient-oriented research methods by engaging patient partners across all phases of our programme of research. Decision aids will first be refined and then translated to French (Phase 2A). Eight iterative cycles of semistructured interviews with 40 participants (20 patient partners and 20 investigators) will be conducted to determine usability (Phase 2B). A pragmatic pre/post pilot study design will then be implemented for field/beta testing using another purposive sample of 80 English-speaking and French-speaking participants (40 patients and 40 investigators). The samples are purposive to ensure an equal representation of English-speaking and French-speaking participants and an equal representation of men and women. Since sex and/or gender differences in utilisation and effectiveness of decision aids have not been previously reported, Phase 3 outcomes will be reported for the total sample and separately for men and women. ETHICS AND DISSEMINATION: Ethics approval has been granted from the University of Toronto (41109, 28 September 2021). Informed consent will be obtained from participants. Dissemination will include co-authored publications, conference presentations, educational national public forums, fact sheets/newsletters, social media sharing and videos/webinars.

Indexed as

Patient ParticipationResearch PersonnelDecision Support TechniquesFemaleHumansMalePilot ProjectsPragmatic Clinical Trials as TopicTomography, X-Ray Computedhealth informaticsinformation technologyquality in health care

Identifiers

PMID35190448
PMCPMC8862478

What Socratic 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 Socratic graph.