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Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study
INTRODUCTION: Management of an endoscopically resected malignant colorectal polyps can be challenging due to the risk of residual tumour and lymphatic spread. International studies have shown, that of those choosing surgical management instead of surveillance strategy, there are between 54% and 82%...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10649383/ https://www.ncbi.nlm.nih.gov/pubmed/37963688 http://dx.doi.org/10.1136/bmjopen-2023-073900 |
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author | Würtz, Helene Juul Rahr, Hans Bjarke Lindebjerg, Jan Edwards, Adrian Steffensen, Karina Dahl |
author_facet | Würtz, Helene Juul Rahr, Hans Bjarke Lindebjerg, Jan Edwards, Adrian Steffensen, Karina Dahl |
author_sort | Würtz, Helene Juul |
collection | PubMed |
description | INTRODUCTION: Management of an endoscopically resected malignant colorectal polyps can be challenging due to the risk of residual tumour and lymphatic spread. International studies have shown, that of those choosing surgical management instead of surveillance strategy, there are between 54% and 82% of bowel resections without evidence of residual tumour or lymphatic spread. As surgical management entails risks of complications and surveillance strategy entails risks of residual tumour or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision-making is a concept that can be used in preference-sensitive decision-making to facilitate patient involvement and empowerment to facilitate active patient participation in the decision-making process. METHODS AND ANALYSIS: This study protocol describes our clinical multi-institutional, non-randomised, interventional phase II study at Danish surgical departments planned to commence in the second quarter of 2024. The aim of this study is to examine whether shared decision-making and using a patient decision aid in consultations affect patients’ choice of management, comparing with retrospective data. The secondary aim is to investigate patients’ experiences, perceived involvement, satisfaction, decision conflict and other outcomes using questionnaire feedback directly from the patients. ETHICS AND DISSEMINATION: There are no conflicts of interest for principal or local investigators in any of the study sites. All results will be published at Danish and international meetings, and in English language scientific peer-reviewed journals. Our study underwent evaluation by the Regional Committees on Health Research Ethics for Southern Denmark (file number 20232000-47), concluding that formal approval was not required for this kind of research. TRIAL REGISTRATION NUMBER: NCT05776381. |
format | Online Article Text |
id | pubmed-10649383 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-106493832023-11-14 Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study Würtz, Helene Juul Rahr, Hans Bjarke Lindebjerg, Jan Edwards, Adrian Steffensen, Karina Dahl BMJ Open Surgery INTRODUCTION: Management of an endoscopically resected malignant colorectal polyps can be challenging due to the risk of residual tumour and lymphatic spread. International studies have shown, that of those choosing surgical management instead of surveillance strategy, there are between 54% and 82% of bowel resections without evidence of residual tumour or lymphatic spread. As surgical management entails risks of complications and surveillance strategy entails risks of residual tumour or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision-making is a concept that can be used in preference-sensitive decision-making to facilitate patient involvement and empowerment to facilitate active patient participation in the decision-making process. METHODS AND ANALYSIS: This study protocol describes our clinical multi-institutional, non-randomised, interventional phase II study at Danish surgical departments planned to commence in the second quarter of 2024. The aim of this study is to examine whether shared decision-making and using a patient decision aid in consultations affect patients’ choice of management, comparing with retrospective data. The secondary aim is to investigate patients’ experiences, perceived involvement, satisfaction, decision conflict and other outcomes using questionnaire feedback directly from the patients. ETHICS AND DISSEMINATION: There are no conflicts of interest for principal or local investigators in any of the study sites. All results will be published at Danish and international meetings, and in English language scientific peer-reviewed journals. Our study underwent evaluation by the Regional Committees on Health Research Ethics for Southern Denmark (file number 20232000-47), concluding that formal approval was not required for this kind of research. TRIAL REGISTRATION NUMBER: NCT05776381. BMJ Publishing Group 2023-11-14 /pmc/articles/PMC10649383/ /pubmed/37963688 http://dx.doi.org/10.1136/bmjopen-2023-073900 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Surgery Würtz, Helene Juul Rahr, Hans Bjarke Lindebjerg, Jan Edwards, Adrian Steffensen, Karina Dahl Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study |
title | Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study |
title_full | Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study |
title_fullStr | Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study |
title_full_unstemmed | Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study |
title_short | Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study |
title_sort | impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase ii study |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10649383/ https://www.ncbi.nlm.nih.gov/pubmed/37963688 http://dx.doi.org/10.1136/bmjopen-2023-073900 |
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