Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases
Introduction A multidisciplinary heart team approach has been recommended by revascularisation guidelines, but how to organise and implement the heart team in a standardised way has not been validated. Inter-team and intra-team decision instability existed in the guideline-based heart team protocol,...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e064761.full |
| _version_ | 1797987262102765568 |
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| author | Yang Wang Xi Li Bo Xu Zhe Zheng Shen Lin Hanping Ma |
| author_facet | Yang Wang Xi Li Bo Xu Zhe Zheng Shen Lin Hanping Ma |
| author_sort | Yang Wang |
| collection | DOAJ |
| description | Introduction A multidisciplinary heart team approach has been recommended by revascularisation guidelines, but how to organise and implement the heart team in a standardised way has not been validated. Inter-team and intra-team decision instability existed in the guideline-based heart team protocol, and our standardised heart team protocol based on a mixed method study may improve decision stability. The objective of this study is to evaluate the effect of the standardised heart team protocol versus the guideline-based protocol on decision-making stability in stable complex coronary artery disease (CAD).Methods and analysis Eighty-four eligible interventional cardiologists, cardiac surgeons or non-interventional cardiologists from 26 hospitals in China have been enrolled. They will be randomised to a standardised heart team protocol group or a guideline-based protocol group to make revascularisation decisions for 480 historic cases (from a prospective registry) with stable complex CAD. In the standardised group, we will establish 12 heart teams based on an evidence-based protocol, including specialist selection, specialist training, team composition, team training and a standardised meeting process. In the guideline-based group, we will organise 12 heart teams according to the guideline principles, including team composition and standardised meeting process. The primary outcome is the overall percent agreement in revascularisation decisions between heart teams within a group. To demonstrate the clinical implication of decision-making stability, we will further explore the association between decision stability and 1-year clinical outcomes.Ethics and dissemination The study was approved by the Institutional Review Board (IRB) of Fuwai Hospital (No. 2019-1303). All participants have provided informed consent and all patients included as historic cases provided written informed consent at the time of entry to the prospective registry. The results of this trial will be disseminated through manuscript publication and national/international conferences, and reported in the trial registry entry.Trial registration number NCT05039567. |
| first_indexed | 2024-04-11T07:46:06Z |
| format | Article |
| id | doaj.art-5ce83a683cdf4c19b5f8e685a1a86350 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T07:46:06Z |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5ce83a683cdf4c19b5f8e685a1a863502022-12-22T04:36:18ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-064761Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic casesYang Wang0Xi Li1Bo Xu2Zhe Zheng3Shen Lin4Hanping Ma5Department of Endocrinology and Metabolism, Chinese Evidence-based Medicine Centre, Cochrane China Centre, and MAGIC China Centre, West China Hospital, Sichuan University, Chengdu, ChinaNational Clinical Research Center for Cardiovascular Diseases, NHC Key Laboratory of Clinical Research for Cardiovascular Medications, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, Beijing, ChinaDepartment of Immuno-Oncology, Beckman Research Institute, City of Hope, Duarte, California, USACardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, ChinaNational Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaIntroduction A multidisciplinary heart team approach has been recommended by revascularisation guidelines, but how to organise and implement the heart team in a standardised way has not been validated. Inter-team and intra-team decision instability existed in the guideline-based heart team protocol, and our standardised heart team protocol based on a mixed method study may improve decision stability. The objective of this study is to evaluate the effect of the standardised heart team protocol versus the guideline-based protocol on decision-making stability in stable complex coronary artery disease (CAD).Methods and analysis Eighty-four eligible interventional cardiologists, cardiac surgeons or non-interventional cardiologists from 26 hospitals in China have been enrolled. They will be randomised to a standardised heart team protocol group or a guideline-based protocol group to make revascularisation decisions for 480 historic cases (from a prospective registry) with stable complex CAD. In the standardised group, we will establish 12 heart teams based on an evidence-based protocol, including specialist selection, specialist training, team composition, team training and a standardised meeting process. In the guideline-based group, we will organise 12 heart teams according to the guideline principles, including team composition and standardised meeting process. The primary outcome is the overall percent agreement in revascularisation decisions between heart teams within a group. To demonstrate the clinical implication of decision-making stability, we will further explore the association between decision stability and 1-year clinical outcomes.Ethics and dissemination The study was approved by the Institutional Review Board (IRB) of Fuwai Hospital (No. 2019-1303). All participants have provided informed consent and all patients included as historic cases provided written informed consent at the time of entry to the prospective registry. The results of this trial will be disseminated through manuscript publication and national/international conferences, and reported in the trial registry entry.Trial registration number NCT05039567.https://bmjopen.bmj.com/content/12/12/e064761.full |
| spellingShingle | Yang Wang Xi Li Bo Xu Zhe Zheng Shen Lin Hanping Ma Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases BMJ Open |
| title | Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases |
| title_full | Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases |
| title_fullStr | Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases |
| title_full_unstemmed | Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases |
| title_short | Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases |
| title_sort | effect of a standardised heart team protocol versus a guideline based protocol on revascularisation decision stability in stable complex coronary artery disease rationale and design of a randomised trial of cardiology specialists using historic cases |
| url | https://bmjopen.bmj.com/content/12/12/e064761.full |
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