A recent article in Learning Health Systems from members of the NIH Collaboratory’s Ethics and Regulatory Core and colleagues describes key themes from stakeholder interviews about collateral findings in pragmatic clinical trials (PCTs). A collateral finding is information that emerges in a PCT that is unrelated to the primary research question but which may have implications for patients, clinicians, and health systems.

The authors conducted semi-structured interviews with 41 key stakeholders experienced in the conduct or oversight of PCTs and those in health system leadership. The interviews explored respondents’ experience with collateral findings in PCTs and their reactions to how such findings should be managed. The authors identified four themes that emerged from the responses:

• Collateral findings are complicated by layers of ambiguity about the nature of PCTs and how to characterize unanticipated results.
• No one-size-fits-all approach exists to managing collateral findings in PCTs, as such findings are context-specific.
• There is a range of attitudes regarding the scope of research responsibilities and obligations in PCTs.
• While prospective planning for collateral findings in PCTs is critical, such planning has not yet been widely undertaken.

The article provides additional details on each theme, including excerpts from stakeholder responses that show a range of insights for managing unanticipated findings in PCTs. A clear takeaway is that prospective planning is an essential step in addressing the ethical management of collateral findings to inform the future conduct of PCTs.

The expansion of PCTs makes it likely healthcare systems will increasingly encounter [collateral findings], yet little guidance exists regarding their appropriate management. – Morain et al. 2020

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health. The aim of the supplement, Management of Trial Incidental Findings Study (MOTIFS), is to develop an empirically informed, ethically sound approach to managing incidental findings in PCTs.

Members of the NIH Collaboratory’s Ethics and Regulatory Core, and colleagues, recently published an article in the Journal of General Internal Medicine highlighting potential challenges in managing collateral findings in pragmatic clinical trials (PCTs). A collateral finding is information that emerges in a PCT that is unrelated to the primary research question but which may have implications for patients, clinicians, and health systems.

In their study, the authors presented focus group participants with a hypothetical scenario, asking them to imagine they were a patient in a PCT wherein it was discovered incidentally that they were taking two contraindicated medications. The authors then explored participants’ reactions to the discovery and their preferences for whether or not they would want to be informed about the collateral finding, how it should be communicated and by whom, and the type and amount of information that should be communicated.

The article provides excerpts from participants’ reactions—which varied across the spectrum from fear and anger to gratitude. Their preferences for how to disclose collateral findings in PCTs also suggest several important considerations for clinicians, including the expectation that patients will question them about such findings, and how to develop approaches for disclosure that align with patients’ values.

Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. – Bollinger et al 2020

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health. The aim of the supplement, Management of Trial Incidental Findings Study (MOTIFS), is to develop an empirically informed, ethically sound approach to managing incidental findings in PCTs.