Cargando…
Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research
OBJECTIVES: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patien...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10583267/ https://www.ncbi.nlm.nih.gov/pubmed/37860179 http://dx.doi.org/10.1097/OI9.0000000000000287 |
_version_ | 1785122514204098560 |
---|---|
author | Pogorzelski, David Wells, Jeffrey L. Marvel, Debra Palmer, Jana E. Mullins, C. Daniel Medeiros, Michelle Gallant, Jodi L. Spicer, Ella Bergin, Patrick F. Gitajn, I. Leah Mullin, Devin S. Gaski, Greg E. Hymes, Robert Bzovsky, Sofia Slobogean, Gerard P. Sprague, Sheila |
author_facet | Pogorzelski, David Wells, Jeffrey L. Marvel, Debra Palmer, Jana E. Mullins, C. Daniel Medeiros, Michelle Gallant, Jodi L. Spicer, Ella Bergin, Patrick F. Gitajn, I. Leah Mullin, Devin S. Gaski, Greg E. Hymes, Robert Bzovsky, Sofia Slobogean, Gerard P. Sprague, Sheila |
author_sort | Pogorzelski, David |
collection | PubMed |
description | OBJECTIVES: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. METHODS: At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. RESULTS: Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. CONCLUSIONS: Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction. |
format | Online Article Text |
id | pubmed-10583267 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Wolters Kluwer |
record_format | MEDLINE/PubMed |
spelling | pubmed-105832672023-10-19 Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research Pogorzelski, David Wells, Jeffrey L. Marvel, Debra Palmer, Jana E. Mullins, C. Daniel Medeiros, Michelle Gallant, Jodi L. Spicer, Ella Bergin, Patrick F. Gitajn, I. Leah Mullin, Devin S. Gaski, Greg E. Hymes, Robert Bzovsky, Sofia Slobogean, Gerard P. Sprague, Sheila OTA Int Clinical/Basic Science Research Article OBJECTIVES: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. METHODS: At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. RESULTS: Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. CONCLUSIONS: Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction. Wolters Kluwer 2023-10-17 /pmc/articles/PMC10583267/ /pubmed/37860179 http://dx.doi.org/10.1097/OI9.0000000000000287 Text en Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Clinical/Basic Science Research Article Pogorzelski, David Wells, Jeffrey L. Marvel, Debra Palmer, Jana E. Mullins, C. Daniel Medeiros, Michelle Gallant, Jodi L. Spicer, Ella Bergin, Patrick F. Gitajn, I. Leah Mullin, Devin S. Gaski, Greg E. Hymes, Robert Bzovsky, Sofia Slobogean, Gerard P. Sprague, Sheila Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
title | Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
title_full | Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
title_fullStr | Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
title_full_unstemmed | Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
title_short | Pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
title_sort | pragmatic design and inclusion of patient–partner representatives improves participant experience in clinical research |
topic | Clinical/Basic Science Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10583267/ https://www.ncbi.nlm.nih.gov/pubmed/37860179 http://dx.doi.org/10.1097/OI9.0000000000000287 |
work_keys_str_mv | AT pogorzelskidavid pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT wellsjeffreyl pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT marveldebra pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT palmerjanae pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT mullinscdaniel pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT medeirosmichelle pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT gallantjodil pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT spicerella pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT berginpatrickf pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT gitajnileah pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT mullindevins pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT gaskigrege pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT hymesrobert pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT bzovskysofia pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT slobogeangerardp pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch AT spraguesheila pragmaticdesignandinclusionofpatientpartnerrepresentativesimprovesparticipantexperienceinclinicalresearch |