Development and validation of a tool to aid writing and reviewing of healthcare safety investigation reports: a modified-Delphi study

IntroductionHealthcare organisations worldwide are expected to investigate or review incidents that unintentionally harm or could cause harm. Investigation findings are presented in a written report, which is arguably a proxy measure for the quality of investigations. The report is an important document to be read and acted upon. The aims of this study were: 1) to design a tool to support the writing and review of healthcare safety investigation reports, and 2) to validate the content of the tool. MethodsThe study was conducted in two phases. Phase 1: The initial content of the tool was developed using relevant published literature and building consensus with 23 specialist participants from the United Kingdom and Australia. Phase 2: Content validity of the tool was assessed for relevance and clarity in two e-Delphi survey rounds with users of the tool. Using a 4-point scale, a median of 3 or 4 and an interquartile range of less than or equal to 1.5 were used to determine consensus. ResultsPhase 1: A tool containing 8 areas of review with accompanying descriptors was developed. For each area of review, a 3-point ordinal rating scale along with a comments box for formative self-assessment were included. Phase 2: At the end of the round 1 survey, there was consensus on all but one area of review in the tool. By the end of round 2 survey, consensus was reached on all areas of review. No additional areas of review were added and none were removed. Some descriptors were amended to improve clarity. ConclusionWe co-designed and validated the content of a tool that can be used to inform the quality of safety investigation reports and learning in terms of a systems-based approach. The tool has multiple uses ranging from self-assessment for report writers to facilitating oversight of the quality of healthcare safety investigation reports. Future work could focus on building further evidence of the tools overall utility. What is already known on this topic- summarise the state of scientific knowledge on this subject before you did your study and why this study needed to be done O_LIThe standard of healthcare safety investigation and reports internationally is known to be variable and often lacks the use of a Human Factors informed "systems approach". C_LIO_LIA formal mechanism appears to be lacking to facilitate a review of, and provide feedback on, the standard of healthcare investigation reports, which arguably serves as a proxy for the overall quality of the investigation process. C_LI What this study adds- summarise what we now know as a result of this study that we did not know before O_LITo our knowledge, this is a first validated tool that has been developed to support self-assessment and oversight of written safety investigations reports and learning reviews. C_LIO_LIKey principles of a systems-based approach to healthcare safety investigations and learning reviews are incorporated into a single tool to guide self-assessment and improvement, where needed. C_LI How this study might affect research, practice or policy- summarise the implications of this study O_LIThe tool supports organisational quality assurance or oversight mechanisms for monitoring, evaluating and improving the standard of investigation reports. C_LIO_LIAs written report can act as a proxy measure for the quality of investigations, improving the standard of reports may inform the learning and associated action from healthcare safety investigations. C_LIO_LIFurther research and evaluation are necessary to provide greater evidence of the utility of the tool. C_LI