Application of the Statutory Duty of Candour in the Management of Patient Safety Events: Systematic Review and Narrative Synthesis

Objective: With limited evidence to date about the application of Statutory Duty of Candour, we sought to synthesize evidence of the application of this legislation in health service organisations and determine its impacts on patients, families and staff. Methods: A search strategy was developed and applied to 6 electronic databases, along with relevant websites, to identify evidence in published and gray literature. Eligible articles were published from 2010 onwards, reported primary or secondary analysis of data of the application of the Statutory Duty of Candour in relation to patient safety events in countries that have enacted the Duty. Two reviewers independently extracted data and assessed the risk of bias. Narrative synthesis was conducted using the Synthesis Without Meta-Analysis (SWiM) guideline. The certainty of evidence was rated by the Grading of Recommendations Assessment and Evaluation (GRADE) approach. Results: Included articles (n=15) originated from the United Kingdom (n=14) and Ireland (n=1); 9 were retrieved from the electronic and 6 from the gray literature search. Findings predominantly focused on the implementation of duty of candour, including understanding requirements and thresholds for use (12 articles), with limited evidence of staff (2 articles), health service (2 articles), and particularly patient and carer outcomes (1 article). Conclusions: Limited evidence is available about the use and impacts of the duty of candour despite 10 years passing since its initial implementation in the United Kingdom. Few peer-reviewed studies have captured primary evaluative data, none of the scale and breadth in terms of health care providers required to draw conclusions about the use or effectiveness of the duty of candour for achieving open and honest communication about health care incidents.