Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review
Introduction Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenou...
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e071646.full |
| _version_ | 1797745812425408512 |
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| author | Mike Stephens Karen Stevenson Andrew Jackson Rajesh Sivaprakasam Peter Thomson Ram Kasthuri Richard D White Colin Geddes Francis Calder Nikolaos Karydis Emma Aitken Ben Edgar David B Kingsmore Marco Franchin Nick Inston Rob G Jones Gaspar Mestres Georgios Papadakis Callum Stove Lazslo Szabo Matteo Tozzi |
| author_facet | Mike Stephens Karen Stevenson Andrew Jackson Rajesh Sivaprakasam Peter Thomson Ram Kasthuri Richard D White Colin Geddes Francis Calder Nikolaos Karydis Emma Aitken Ben Edgar David B Kingsmore Marco Franchin Nick Inston Rob G Jones Gaspar Mestres Georgios Papadakis Callum Stove Lazslo Szabo Matteo Tozzi |
| author_sort | Mike Stephens |
| collection | DOAJ |
| description | Introduction Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials.Methods and analysis The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data.Ethics and dissemination Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design. |
| first_indexed | 2024-03-12T15:28:19Z |
| format | Article |
| id | doaj.art-26a8000d83f9456f9a43dbf6d9cb9c73 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:28:19Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-26a8000d83f9456f9a43dbf6d9cb9c732023-08-10T10:15:07ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2023-071646Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic reviewMike Stephens0Karen Stevenson1Andrew Jackson2Rajesh Sivaprakasam3Peter Thomson4Ram Kasthuri5Richard D White6Colin Geddes7Francis Calder8Nikolaos Karydis9Emma Aitken10Ben Edgar11David B Kingsmore12Marco Franchin13Nick Inston14Rob G Jones15Gaspar Mestres16Georgios Papadakis17Callum Stove18Lazslo Szabo19Matteo Tozzi20Dialysis Access Team, University Hospital of Wales, Cardiff, UKDepartment of Renal Surgery and Transplantation, Queen Elizabeth University Hospital, Glasgow, UKDepartment of Renal Surgery and Transplantation, Queen Elizabeth University Hospital, Glasgow, UKRenal Transplantation, The Royal London Hospital, London, UKDepartment of Nephrology, Queen Elizabeth University Hospital, Glasgow, UKDepartment of Interventional Radiology, Queen Elizabeth University Hospital, Glasgow, UKDepartment of Interventional Radiology, University Hospital of Wales, Cardiff, UKDepartment of Nephrology, Queen Elizabeth University Hospital, Glasgow, UKRenal & Transplant Surgery, Guy`s and St Thomas` NHS Foundation Trust, London, UKDepartment of General and Transplant Surgery, University of Patras, Patra, GreeceDepartment of Renal Surgery and Transplantation, Queen Elizabeth University Hospital, Glasgow, UKSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UKDepartment of Renal Surgery and Transplantation, Queen Elizabeth University Hospital, Glasgow, UKDepartment of Vascular Surgery, University of Insubria, Varese, ItalyRenal and Transplant Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKInterventional Radiology, Queen Elizabeth Hospital, Birmingham, UKDepartment of Vascular Surgery, University of Barcelona, Barcelona, SpainRenal & Transplant Surgery, Guy`s and St Thomas` NHS Foundation Trust, London, UKDepartment of Interventional Radiology, Queen Elizabeth University Hospital, Glasgow, UKDialysis Access Team, University Hospital of Wales, Cardiff, UKDepartment of Vascular Surgery, University of Insubria, Varese, ItalyIntroduction Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials.Methods and analysis The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data.Ethics and dissemination Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design.https://bmjopen.bmj.com/content/13/7/e071646.full |
| spellingShingle | Mike Stephens Karen Stevenson Andrew Jackson Rajesh Sivaprakasam Peter Thomson Ram Kasthuri Richard D White Colin Geddes Francis Calder Nikolaos Karydis Emma Aitken Ben Edgar David B Kingsmore Marco Franchin Nick Inston Rob G Jones Gaspar Mestres Georgios Papadakis Callum Stove Lazslo Szabo Matteo Tozzi Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review BMJ Open |
| title | Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review |
| title_full | Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review |
| title_fullStr | Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review |
| title_full_unstemmed | Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review |
| title_short | Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review |
| title_sort | quality assurance in surgical trials of arteriovenous grafts for haemodialysis protocol for a systematic review |
| url | https://bmjopen.bmj.com/content/13/7/e071646.full |
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