PMID- 35190448 OWN - NLM STAT- MEDLINE DCOM- 20220420 LR - 20220531 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 12 IP - 2 DP - 2022 Feb 21 TI - Patient engagement partnerships in clinical trials (PEP-CT): protocol for the systematic development and testing of patient partner and investigator decision aids. PG - e060267 LID - 10.1136/bmjopen-2021-060267 [doi] LID - e060267 AB - INTRODUCTION: Building 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. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Parry, Monica AU - Parry M AUID- ORCID: 0000-0002-6941-1380 AD - Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada monica.parry@utoronto.ca. FAU - Ceroni, Tina AU - Ceroni T AD - Clinical Trials Ontario, Toronto, Ontario, Canada. FAU - Wells, David AU - Wells D AD - Diabetes Action Canada, Toronto, Ontario, Canada. FAU - Richards, Dawn P AU - Richards DP AD - Clinical Trials Ontario, Toronto, Ontario, Canada. FAU - Toupin-April, Karine AU - Toupin-April K AD - School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada. AD - Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada. AD - Institut du Savoir Montfort, Ottawa, Ontario, Canada. FAU - Ansari, Hafsa AU - Ansari H AD - Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada. FAU - Bjornnes, Ann Kristin AU - Bjornnes AK AUID- ORCID: 0000-0002-5356-3873 AD - Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway. FAU - Burnside, Heather AU - Burnside H AD - Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada. FAU - Cavallo, Sabrina AU - Cavallo S AD - School of Rehabilitation, Faculty of Medicine, Universite de Montreal, Montreal, Quebec, Canada. FAU - Day, Andrew AU - Day A AD - Department of Community Health and Epidemiology and CERU, Queen's Unversity, Kingston, Ontario, Canada. FAU - Ellis, Anne AU - Ellis A AD - Department of Medicine, Queen's University, Kingston, Ontario, Canada. FAU - Feldman, Debbie AU - Feldman D AD - School of Rehabilitation, Faculty of Medicine, Universite de Montreal, Montreal, Quebec, Canada. FAU - Gilron, Ian AU - Gilron I AUID- ORCID: 0000-0002-5293-8792 AD - Departments of Anesthesiology and Perioperative Medicine, Biomedical and Molecular Sciences and School of Policy Studies, Queen's University, Kingston, Ontario, Canada. FAU - Najam, Adhiyat AU - Najam A AD - Diabetes Action Canada, Toronto, Ontario, Canada. FAU - Zulfiqar, Zoya AU - Zulfiqar Z AD - Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada. FAU - Marlin, Susan AU - Marlin S AD - Clinical Trials Ontario, Toronto, Ontario, Canada. LA - eng GR - 436272/CIHR/Canada PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220221 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Decision Support Techniques MH - Female MH - Humans MH - Male MH - *Patient Participation/methods MH - Pilot Projects MH - *Research Personnel MH - Tomography, X-Ray Computed PMC - PMC8862478 OTO - NOTNLM OT - *health informatics OT - *information technology OT - *quality in health care COIS- Competing interests: None declared. EDAT- 2022/02/23 06:00 MHDA- 2022/04/21 06:00 PMCR- 2022/02/21 CRDT- 2022/02/22 06:06 PHST- 2022/02/22 06:06 [entrez] PHST- 2022/02/23 06:00 [pubmed] PHST- 2022/04/21 06:00 [medline] PHST- 2022/02/21 00:00 [pmc-release] AID - bmjopen-2021-060267 [pii] AID - 10.1136/bmjopen-2021-060267 [doi] PST - epublish SO - BMJ Open. 2022 Feb 21;12(2):e060267. doi: 10.1136/bmjopen-2021-060267.