Standardised reporting frameworks
Standardised frameworks to improve the design and reporting of anaesthesia interventions in clinical trials
The evaluation of perioperative interventions through randomised controlled trials (RCTs) is fundamentally important for evidence-based care. Information about intervention delivery is required to confidently interpret trial results. Anaesthetic interventions are complex, often comprising multiple interacting components, and there is significant variation in how these are defined and reported in RCTs.
Frameworks for general, regional and sedation anaesthetic interventions have been developed by a research team at the University of Bristol with the aim of helping triallists and clinicians approach the process of designing, standardising, and reporting anaesthetic interventions in trials.
Trial reports and associated protocols identified in a recent systematic review of anaesthesia RCTs provided the data for development of the provisional frameworks [. A framework approach to thematic analysis of qualitative data was used to code and categorise text into components of anaesthetic interventions. An iterative process of selecting papers and amending the coding framework was repeated until data saturation was reached. Focus groups were then conducted with triallists, key stakeholders and journal editors to elicit additional categories to be added and consider clarity and feasibility issues. The frameworks were updated based on this feedback. Finally, the frameworks were refined through cognitive interviews with triallists to test the real-world feasibility of using the frameworks in contemporary perioperative RCTs.
The aim is for these frameworks to be used by research teams at the initial stages of trial design when developing protocols for the delivery of anaesthetic interventions and comparators. They would be used to help triallists 1) describe anaesthetic interventions fully and 2) decide when and how individual components should be standardised and monitored within the trial.
We are now disseminating the final frameworks to be used by professionals currently designing or undertaking anaesthesia trials.
Access to each framework is through the link below:
Funding: This study is supported by a grant from the Association of Anaesthetists via the National Institute of Academic Anaesthesia and has stakeholder support from the Perioperative Medicine Clinical Trials Network and the Anaesthesia Research Society.
Researchers:
Dr Lucy Elliott, Dr Karen Coulman, Prof Natalie Blencowe, Prof Joyce Yeung, Prof Robert J Hinchliffe and Professor Ronelle Mouton
Centre for Surgical Research, Population Health Sciences, University of Bristol
Contact: le17602@bristol.ac.uk
Reference:
[1] Elliot L, Coulman K, Blencowe NS, et al. A systematic review of reporting quality for anaesthetic interventions in randomised controlled trials. Anaesthesia. 2021;76(6):832-836. doi:10.1111/anae.15294
