Collateral Findings
Section 3
Stakeholder Perspectives
Three recent empirical studies elicited views of stakeholders about collateral findings in pragmatic clinical trials and their preferences for management and disclosure.
| Table 1. Empirical Research on PCT Collateral Findingsa |
|
|---|---|
| a Table adapted from Morain et al (2021). | |
| Study | Methods and Study Sample |
| Key stakeholder interviews | In-depth, semistructured interviews (N = 41) with pragmatic trial investigators, healthcare system leaders, institutional review board (IRB) chairs, and other stakeholders with expertise in the conduct or oversight of pragmatic trials (Morain et al 2020) |
| Patient focus groups | Nine focus groups conducted with patients (N = 66) in 3 geographically diverse cities exploring patients’ views about disclosure and management of a hypothetical collateral finding in a pragmatic trial (Bollinger et al 2020) |
| Public survey | Web-based survey experiment (N = 4080) assessing public reactions to letters communicating hypothetical collateral findings in a pragmatic trial (Weinfurt et al 2022) |
Key findings of these studies include:
- In general, investigators, healthcare system leaders, and other stakeholders had not previously considered the potential of collateral findings in pragmatic trials, but they shared a belief in the importance of anticipating and planning for such findings (Morain et al 2020a).
- Management of collateral findings pragmatic trials is context-dependent. There is no one-size-fits-all management approach. Instead, appropriate management will depend on several ethically relevant dimensions. Examples of such dimensions are presented in Table 2 (Morain et al 2020a; Morain et al 2021).
- Institutions will play a central role in the management of collateral findings in pragmatic trials. Relevant institutional roles will include (a) evaluating potential collateral findings to assess the likelihood that they indicate findings of true clinical relevance (rather than misleading signals resulting from incomplete or fragmented data); (b) deciding whether a given collateral finding should be disclosed to patients and/or clinicians; and (c) implementing processes for disclosure and subsequent management (Morain et al 2021).
- Patients generally want to receive information about collateral findings in pragmatic trials that may have clinical implications. However, such disclosure may be met with negative reactions (Bollinger et al 2020; Weinfurt et al 2022).
- Patients recommend that, when disclosing collateral findings in pragmatic trials to patients, institutions design communication processes to demonstrate respect for patient-subjects while aiming to minimize undue anxiety (Bollinger et al 2020; Weinfurt et al 2022).
| Table 2. Considerations for Managing Collateral Findings of Pragmatic Trialsa | |
|---|---|
| Consideration | Relevance for Decision Making |
| Clinical relevance | There may be a stronger argument for disclosing collateral findings that have more serious healthcare implications or that are more medically actionable. |
| Timeliness of identification | If data from the trial are not analyzed in real time, the delay between data collection and the collateral findings may mean the information is less medically actionable and, thus, may weigh against disclosure. The healthcare system may want to assess whether the collateral findings suggest a need for practice improvements. |
| Uniqueness of knowledge | If the information would not otherwise be known to the treating clinicians or the healthcare system, there may be a stronger argument for disclosure. |
| System-level impact | The costs and burdens associated with evaluating and managing collateral findings may need to be considered in disclosure decisions. |
| Whether prospective consent was obtained | The presence or absence of prior informed consent—or waivers or alterations of consent—may influence the disclosure or and response to collateral findings. |
| a Table adapted from Morain et al (2021). | |
SECTIONS
Resources
Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration; NIH Pragmatric Trials Collaboratory Grand Rounds; May 13, 2022
REFERENCES
Bollinger JM, Geller G, Weinfurt K, et al. 2020. Patients’ views about the disclosure of collateral findings in pragmatic clinical trials: a focus group study. J Gen Intern Med. 35(12):3436-3442. doi: 10.1007/s11606-020-06113-5. Epub 2020 Aug 19. PMID: 32815061.
Morain SR, Weinfurt K, Bollinger J, Geller G, Mathews DJ, Sugarman J. 2020a. Ethics and collateral findings in pragmatic clinical trials. Am J Bioeth. 20:6-18. doi:10.1080/15265161.2020.1689031. PMID: 31896322.
Morain SR, Mathews DJH, Geller G, et al. 2021. Identification and management of pragmatic clinical trial collateral findings: a current understanding and directions for future research. Healthcare. 9(4):100586. doi: 10.1016/j.hjdsi.2021.100586. Epub 2021 Sep 29. PMID: 34600345.
Morain SR, Mathews DJH, Weinfurt K, et al. 2020. Stakeholder perspectives regarding pragmatic clinical trial collateral findings. Learn Health Syst. 5(4):e10245. doi: 10.1002/lrh2.10245. PMID: 34667872.
Weinfurt KP, Bollinger J, May E, et al. 2022. Patients’ reactions to letters communicating collateral findings of pragmatic clinical trials: a national web-based survey. J Gen Intern Med. 2022 May;37(7):1658-1664. doi: 10.1007/s11606-021-07087-8. Epub 2021 Aug 12. PMID: 34383228.