Brief report of a pilot test of an audit tool for assurance of Declarations of Interest policy in NICE COVID-19 guidance production.

Introduction: The National Institute for Health and Care Excellence (NICE) UK helps practitioners and commissioners to achieve high-quality, cost-effective patient care by publishing relevant evidence-based recommendations, including guidelines. These are developed by NICE advisory committees comprising health and care professionals, service users, and their carers. To ensure NICE's independence it has a comprehensive policy on declaring and managing interests for advisory committees. The application of the policy is not straightforward and the aim of this work was to pilot test an audit tool for external assurance of self-declared interests; and to produce methodology with wider applicability for other research and guideline-producing organisations. Methods: A pilot study of adherence to the NICE DOI policy was undertaken. The number and type of DOIs made by the 48 panel members developing the NG191 Managing COVID-19 guideline was assessed, using multiple external sources to check for undeclared interests. DOIs were reviewed from a 6-month period at the height of activity (1 March-31 August 2021). DOIs were checked by assessors (experienced NICE staff involved in application of the DOI policy) against a comprehensive search strategy including multiple public sources (PubMed, Google Scholar, Disclosure, etc.) of information for undisclosed DOIs over the 12 months preceding the member's contribution and the 12 months during which they contributed. Results: There was a total of 126 unique self-declared interests during the 6-month time period and we found a further 280 undeclared interests. Of these 280, 75 were deemed likely to be relevant (27%) but only 10 (4%), would have led to a request for more information from the panel member had it been declared (according to DOI policy version 1.4 in place at that time). The team considered that 7 of the undeclared interests would have led to exclusion from decision-making had they been known (3% of the undeclared interests). All related to academic output. Discussion: This pilot provided useful insight into NICE DOI policy compliance. The methodology needs further testing and development for wider, routine contexts. A digital version of the audit tool would enable routine, more efficient audit of declarations of interest. This study was an important quality assurance exercise from which we have been able to propose methodology that can be automated and widely adopted.