MOTIFS

May 11, 2022: MOTIFS Investigation of Collateral Findings in Pragmatic Trials Will Be Featured in PCT Grand Rounds

Posted on by Damon Seils

Head shots of Dr. Jeremy Sugarman, Dr. Stephanie Morain, Juli Bollinger, and Dr. Kevin WeinfurtIn this Friday’s PCT Grand Rounds, Dr. Jeremy Sugarman, Dr. Stephanie Morain, and Juli Bollinger of Johns Hopkins University and Dr. Kevin Weinfurt of Duke University will present “Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration.” The Grand Rounds session will be held on Friday, May 13, at 1:00 pm eastern.

The team will present lessons from MOTIFS, a recently completed multi-method investigation of the ethical and regulatory implications of “collateral findings” in pragmatic clinical trials.

Join the online meeting.

October 6, 2021: MOTIFS Team Shares Lessons From Multi-Method Study of Collateral Findings in Pragmatic Trials

Posted on by Damon Seils

A team of researchers from the NIH Collaboratory and the Johns Hopkins Berman Institute of Bioethics recently completed a multi-method investigation of the ethical and regulatory implications of “collateral findings” in pragmatic clinical trials. Lessons from the project—the Management of Trial Incidental Findings Study (MOTIFS)—were published online ahead of print in the journal Healthcare.

Collateral findings in pragmatic clinical trials are findings, whether discovered intentionally or unintentionally, that do not address the trial’s research question(s) but may have implications for the health of patients included in the trial. For example, when collecting data from electronic health records for a pragmatic trial, researchers might detect the use of contraindicated medications in some patients. It is uncertain how to manage these findings, including how best to notify patients of them.

The results of MOTIFS make clear that existing ethics guidance from other clinical research settings cannot easily be adapted to the challenges of collateral findings in pragmatic clinical trials. Moreover, the challenges are complex and do not lend themselves to a one-size-fits-all solution.

The authors offer advice for researchers, institutions, ethics oversight bodies, and funders involved in the design, conduct, and analysis of pragmatic clinical trials, and they recommend important areas for future research.

Read the full report.

This work was supported within the NIH 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.

August 18, 2021: MOTIFS Explores Patients’ Reactions to Notifications of Collateral Findings

Posted on by Damon Seils

Cover the the Journal of General Internal MedicinePatients’ reactions to a letter notifying them about collateral findings from a pragmatic clinical trial were unrelated to who signed the letter, the type of collateral finding, or the letter’s level of detail about the trial, according to a new study from the NIH Collaboratory.

The article was published online ahead of print in the Journal of General Internal Medicine.

Collateral findings of pragmatic clinical trials are findings, whether discovered intentionally or unintentionally, that do not address the trial’s research question but may have implications for the health of patients in the trial. For example, when collecting data from electronic health records for a pragmatic trial, the researchers might detect the use of contraindicated medications in some patients. It is uncertain how best to notify patients of these findings.

Researchers from the NIH Collaboratory’s Ethics and Regulatory Core Working Group and colleagues from the Johns Hopkins Berman Institute of Bioethics conducted a survey experiment in which participants were randomly assigned to respond to 1 of 16 hypothetical scenarios. In each scenario, the participant read a letter notifying them of a collateral finding from a pragmatic clinical trial and asking them to contact their doctor immediately. The scenarios differed by who signed the letter, the type of collateral finding, and whether the letter included a detailed description of the pragmatic trial.

Participants’ reactions to the letter and their intention to contact their doctor immediately were not affected significantly by who signed the letter or whether the pragmatic trial was described in the letter. Participants’ reported level of understanding was generally lower for versions of the letter that included a description of the trial.

Read the full report.

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 pragmatic clinical trials.

September 1, 2020: New Publication Explores Stakeholder Perspectives on Collateral Findings in Pragmatic Clinical Trials

Posted on by Gina Uhlenbrauck

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.

August 26, 2020: New Publication on Patients’ Views About Disclosure of Collateral Findings in Pragmatic Clinical Trials

Posted on by Gina Uhlenbrauck

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.