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Structured Abstract
Background
Systematic reviews of comparative effectiveness topics are increasing in number, and groups including the Institute of Medicine emphasize the importance of attention to financial conflicts of interest. Little guidance exists, however, on how to manage the risk of bias for systematic reviews (SRs) from nonfinancial conflicts of interest (NFCOI) such as strongly held beliefs, personal relationships, and desire for career advancement. Our objective was to provide practical guidance on ensuring adequate clinical or content expertise while maintaining independence of judgment on SR teams by (1) defining NFCOI as it applies to SR teams, (2) developing guidance and an instrument, supported by examples, on to identify, characterize, and manage NFCOI, and (3) improve transparency of judgment regarding NFCOI for users of reviews.
Methods
Fourteen workgroup members reviewed existing guidance from international and domestic institutions on managing conflicts. We built on these approaches to define NFCOI. We then developed practical guidance in the form of an instrument and examples for each potential source of conflict. Authors revised the draft document following peer review and public comment.
Results
We modified the Institute of Medicine's definition of conflict of interest to arrive at a definition specific to NFCOI in the context of systematic review. We define NFCOI as "a set of circumstances that creates a risk that the primary interest--the quality and integrity of the systematic review--will be unduly influenced by a secondary or competing interest that is not mainly financial." We believe that context influences the risk of NFCOI. We propose questions for funders and SR principal investigators to evaluate whether the SR topic is subject to intense advocacy, active policy debate, large interspecialty variations, and limited availability of clinical or content expertise. Responses to these contextual questions can serve as a guide to creating an SR team that appropriately balances critical clinical and content expertise with independence of judgment. Once the team is assembled, we suggest additional questions on personal beliefs, previously published opinions, institutional relationships, and career advancement. Once the risk of NFCOI has been identified, the range of options for managing conflicts include: disclosure followed by no change in the SR team or activities, inclusion on the team along with other members with differing viewpoints to ensure diverse perspectives, exclusion from certain SR activities, and exclusion from the project entirely. The selection of one or more approach will depend upon the risk of NFCOI based on the context of the topic.
Conclusions
NFCOI, when ignored, can call into question the impartiality of a review. Equally, the results of a review can be invalid when management of NFCOI results in the exclusion of necessary topical expertise. This document is a consensus effort attempting to achieve the appropriate balance between supplying needed expertise and minimizing NFCOI by proposing approaches to identify and evaluate NFCOI. However, the utility of these approaches and barriers to implementation must be investigated.
