Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials
Background: Interventions from RCTs can only be replicated and implemented if reported in sufficient detail. This study developed frameworks to assist researchers with describing, monitoring, and reporting the key components of anaesthetic interventions in trials. Methods: This study comprised three...
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Elsevier
2025-03-01
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| Series: | BJA Open |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772609624001242 |
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| author | Karen D. Coulman Lucy Elliott Natalie S. Blencowe Joyce Yeung Leila Rooshenas Robert J. Hinchliffe Ronelle Mouton Eric Albrecht David Bosanquet Kariem El-Boghdadly Gudrun Kunst Mandeep Phull Helen Galley Ben Gibbison Suzanne Harrogate Anna Simpson Jasmeet Soar Michael Gillies Mr James Glasbey Sina Grape David Hewson Simon Howell Louise Savic Alan MacFarlane Brendan McGrath Ciara O'Donnell Jon Silversides Katrina Pirie Andrew Toner |
| author_facet | Karen D. Coulman Lucy Elliott Natalie S. Blencowe Joyce Yeung Leila Rooshenas Robert J. Hinchliffe Ronelle Mouton Eric Albrecht David Bosanquet Kariem El-Boghdadly Gudrun Kunst Mandeep Phull Helen Galley Ben Gibbison Suzanne Harrogate Anna Simpson Jasmeet Soar Michael Gillies Mr James Glasbey Sina Grape David Hewson Simon Howell Louise Savic Alan MacFarlane Brendan McGrath Ciara O'Donnell Jon Silversides Katrina Pirie Andrew Toner |
| author_sort | Karen D. Coulman |
| collection | DOAJ |
| description | Background: Interventions from RCTs can only be replicated and implemented if reported in sufficient detail. This study developed frameworks to assist researchers with describing, monitoring, and reporting the key components of anaesthetic interventions in trials. Methods: This study comprised three phases: (1) initial framework development—text describing the delivery of anaesthetic interventions was coded and categorised into components using thematic analysis; (2) refinement of frameworks—facilitated structured group discussions were conducted with perioperative clinicians, researchers, and journal editors to elicit additional framework categories and consider clarity and feasibility; (3) framework testing and further refinement—cognitive interviews with professionals undertaking trials evaluating anaesthesia interventions to test the feasibility of using the frameworks in contemporary perioperative trials. Results: Three frameworks were developed for general, regional, and sedation anaesthesia interventions. Data saturation of categories within the frameworks was reached after inclusion of 15 RCTs for general and regional anaesthesia, and 13 for sedation. Each framework is structured into three main sections: (1) professional(s) delivering the intervention; (2) setting; and (3) intervention components, with descriptions of the preoperative, intraoperative, and postoperative stages unique to each anaesthetic intervention. Each framework deconstructs an anaesthetic intervention into component parts to support researchers with the design and reporting of RCTs. Final frameworks are available at: https://anaesthesiaframeworks.blogs.bristol.ac.uk/. Conclusions: We provide novel frameworks to be used during the design of perioperative trials to facilitate the design, delivery, and reporting of anaesthesia interventions. |
| format | Article |
| id | doaj-art-b76d33a4418445c5a9c38d24d9d3df4b |
| institution | Kabale University |
| issn | 2772-6096 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | BJA Open |
| spelling | doaj-art-b76d33a4418445c5a9c38d24d9d3df4b2025-02-06T05:13:05ZengElsevierBJA Open2772-60962025-03-0113100374Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trialsKaren D. Coulman0Lucy Elliott1Natalie S. Blencowe2Joyce Yeung3Leila Rooshenas4Robert J. Hinchliffe5Ronelle Mouton6Eric Albrecht7David Bosanquet8Kariem El-Boghdadly9 Gudrun Kunst10Mandeep Phull11Helen Galley12Ben Gibbison13Suzanne Harrogate14Anna Simpson15Jasmeet Soar16Michael Gillies17Mr James Glasbey18Sina Grape19David Hewson20Simon Howell21Louise Savic22Alan MacFarlane23Brendan McGrath24Ciara O'Donnell25Jon Silversides26Katrina Pirie27Andrew Toner28Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Corresponding author.Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKCentre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Leeds Teaching Hospitals NHS Trust, Leeds, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Warwick, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKBristol Surgery & Perioperative Care Complex Intervention Collaboration, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; North Bristol NHS Trust, Bristol, UKBristol Surgery & Perioperative Care Complex Intervention Collaboration, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; North Bristol NHS Trust, Bristol, UKLausanne, SwitzerlandCardiff, UKLondon, UKLondon, UKLondon, UKAberdeen, UKBristol, UKBristol, UKBristol, UKBristol, UKEdinburgh, UKBirmingham, UKValais, SwitzerlandNottingham, UKLeeds, UKLeeds, UKGlasgow, UKManchester, UKBelfast, UKBelfast, UKMelbourne, AustraliaPerth, AustraliaBackground: Interventions from RCTs can only be replicated and implemented if reported in sufficient detail. This study developed frameworks to assist researchers with describing, monitoring, and reporting the key components of anaesthetic interventions in trials. Methods: This study comprised three phases: (1) initial framework development—text describing the delivery of anaesthetic interventions was coded and categorised into components using thematic analysis; (2) refinement of frameworks—facilitated structured group discussions were conducted with perioperative clinicians, researchers, and journal editors to elicit additional framework categories and consider clarity and feasibility; (3) framework testing and further refinement—cognitive interviews with professionals undertaking trials evaluating anaesthesia interventions to test the feasibility of using the frameworks in contemporary perioperative trials. Results: Three frameworks were developed for general, regional, and sedation anaesthesia interventions. Data saturation of categories within the frameworks was reached after inclusion of 15 RCTs for general and regional anaesthesia, and 13 for sedation. Each framework is structured into three main sections: (1) professional(s) delivering the intervention; (2) setting; and (3) intervention components, with descriptions of the preoperative, intraoperative, and postoperative stages unique to each anaesthetic intervention. Each framework deconstructs an anaesthetic intervention into component parts to support researchers with the design and reporting of RCTs. Final frameworks are available at: https://anaesthesiaframeworks.blogs.bristol.ac.uk/. Conclusions: We provide novel frameworks to be used during the design of perioperative trials to facilitate the design, delivery, and reporting of anaesthesia interventions.http://www.sciencedirect.com/science/article/pii/S2772609624001242anaesthesia interventionsprotocol standardsrandomised controlled trialsreporting standards |
| spellingShingle | Karen D. Coulman Lucy Elliott Natalie S. Blencowe Joyce Yeung Leila Rooshenas Robert J. Hinchliffe Ronelle Mouton Eric Albrecht David Bosanquet Kariem El-Boghdadly Gudrun Kunst Mandeep Phull Helen Galley Ben Gibbison Suzanne Harrogate Anna Simpson Jasmeet Soar Michael Gillies Mr James Glasbey Sina Grape David Hewson Simon Howell Louise Savic Alan MacFarlane Brendan McGrath Ciara O'Donnell Jon Silversides Katrina Pirie Andrew Toner Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials BJA Open anaesthesia interventions protocol standards randomised controlled trials reporting standards |
| title | Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials |
| title_full | Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials |
| title_fullStr | Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials |
| title_full_unstemmed | Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials |
| title_short | Frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials |
| title_sort | frameworks for the design and reporting of anaesthesia interventions in perioperative clinical trials |
| topic | anaesthesia interventions protocol standards randomised controlled trials reporting standards |
| url | http://www.sciencedirect.com/science/article/pii/S2772609624001242 |
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