Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol
Introduction The introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to dev...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/7/e084252.full |
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| author | Deborah D Stocken Natalie S Blencowe Jane Blazeby Kerry Avery Rhiannon Macefield Daisy Elliott Shelley Potter Neil Corrigan Christin Hoffmann Jozel Ramirez Matthew Kobetic |
| author_facet | Deborah D Stocken Natalie S Blencowe Jane Blazeby Kerry Avery Rhiannon Macefield Daisy Elliott Shelley Potter Neil Corrigan Christin Hoffmann Jozel Ramirez Matthew Kobetic |
| author_sort | Deborah D Stocken |
| collection | DOAJ |
| description | Introduction The introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to develop a core data set that can be applied in all studies describing or measuring the learning curve in novel invasive procedures.Methods A core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials initiative. The study will involve three phases: (1) Identification of a comprehensive list of data items through (a) an umbrella review of existing systematic reviews on the learning curve in surgery and (b) qualitative interviews with key stakeholders. (2) Key stakeholders (eg, clinical innovators, clinicians, patients, methodologists, statisticians, journal editors and governance representatives) will complete a Delphi survey to score the importance of each data item, generating a shortened list. (3) Consensus meeting(s) with stakeholders to discuss and agree on the final core data set.Ethics and dissemination The study is approved by an Institutional Ethics Committee at the University of Bristol (ref: 111362). Participants will complete written informed consent to participate. Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, patient engagement events, use of social media platforms, workshops and other events. |
| format | Article |
| id | doaj-art-dd8de22345dc4a4abb3dfa8ef8823e2c |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-dd8de22345dc4a4abb3dfa8ef8823e2c2025-08-20T02:48:20ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2024-084252Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocolDeborah D Stocken0Natalie S Blencowe1Jane Blazeby2Kerry Avery3Rhiannon Macefield4Daisy Elliott5Shelley Potter6Neil Corrigan7Christin Hoffmann8Jozel Ramirez9Matthew Kobetic10Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKCentre for Surgical Research, University of Bristol, Bristol, UKCentre for Surgical Research, University of Bristol, Bristol, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKIntroduction The introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to develop a core data set that can be applied in all studies describing or measuring the learning curve in novel invasive procedures.Methods A core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials initiative. The study will involve three phases: (1) Identification of a comprehensive list of data items through (a) an umbrella review of existing systematic reviews on the learning curve in surgery and (b) qualitative interviews with key stakeholders. (2) Key stakeholders (eg, clinical innovators, clinicians, patients, methodologists, statisticians, journal editors and governance representatives) will complete a Delphi survey to score the importance of each data item, generating a shortened list. (3) Consensus meeting(s) with stakeholders to discuss and agree on the final core data set.Ethics and dissemination The study is approved by an Institutional Ethics Committee at the University of Bristol (ref: 111362). Participants will complete written informed consent to participate. Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, patient engagement events, use of social media platforms, workshops and other events.https://bmjopen.bmj.com/content/14/7/e084252.full |
| spellingShingle | Deborah D Stocken Natalie S Blencowe Jane Blazeby Kerry Avery Rhiannon Macefield Daisy Elliott Shelley Potter Neil Corrigan Christin Hoffmann Jozel Ramirez Matthew Kobetic Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol BMJ Open |
| title | Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol |
| title_full | Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol |
| title_fullStr | Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol |
| title_full_unstemmed | Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol |
| title_short | Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol |
| title_sort | development of a core data set for describing measuring and reporting the learning curve in studies of novel invasive procedures study protocol |
| url | https://bmjopen.bmj.com/content/14/7/e084252.full |
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