Study: Incidental MRI findings lead to ethical, economic questions
Tailored strategies based on the characteristics of research participants, including gender, age and family history, as well as willingness to pay for a quality-adjusted life-year are required to address the problem of incidental findings in functional MRI studies, according to research published online in Value of Health on June 18.
The issue of managing incidentally detected findings in brain studies using MRI has not been investigated from a health economics viewpoint, explained Mohsen Sadatsafavi, MD, of the collaboration for outcome research and evaluation of the faculty of pharmaceutical sciences at the University of British Columbia in Vancouver, British Columbia, and colleagues.
Utilizing intracranial aneurysms as a model, the researchers applied a decision analytics approach to assess the benefit of various strategies for functional MRI (fMRI) studies.
Sadatsafavi and colleagues employed a decision tree and Markov model to simulate the impact on the lifetime costs and QALYs of four different strategies for review of scans for the presence of intracranial aneurysms. By way of current literature, the authors populated the decision model.
The four strategies were:
The researchers determined that cost effective strategies include the full clinical exam of women with a positive family history prior to enrollment, however, men with no such family history have a lower risk of developing aneurysm and thus the cost of performing full neurologic scans prior to enrolling in a study is not justified.
The cost effectiveness of reviewing scans depends on the willingness to pay for a QALY of $50,000 per QALY. For willingness to pay for a QALY of $100,000 per QALY, a full clinical workup is the best option, found the authors.
In addition, review of anatomical scans by a nonspecialist was not found to be cost effective in any of the participant subgroup, and when compared with not reviewing any scans, a customized strategy for each subgroup of participants resulted in an incremental cost effectiveness ratio of $12,503 for willingness to pay for a QALY of $50,000 per QALY and $32,767 for a willingness to pay for a QALY of $100,000 per QALY.
The authors explained that more than 1,800 functional MRI studies were published between 2002 and 2008. Incidental findings that require clinical follow up were detected in two to three percent of healthy participants in these studies.
While currently, protocols for handling incidental findings vary widely across institutions, “the appropriate and efficient use of resources in research, as in healthcare, is an ethical obligation,” concluded the authors. “Therefore, decisions about how to manage findings detected incidentally in brain imaging studies should be informed by costs that affect both research and healthcare budgets.”
The issue of managing incidentally detected findings in brain studies using MRI has not been investigated from a health economics viewpoint, explained Mohsen Sadatsafavi, MD, of the collaboration for outcome research and evaluation of the faculty of pharmaceutical sciences at the University of British Columbia in Vancouver, British Columbia, and colleagues.
Utilizing intracranial aneurysms as a model, the researchers applied a decision analytics approach to assess the benefit of various strategies for functional MRI (fMRI) studies.
Sadatsafavi and colleagues employed a decision tree and Markov model to simulate the impact on the lifetime costs and QALYs of four different strategies for review of scans for the presence of intracranial aneurysms. By way of current literature, the authors populated the decision model.
The four strategies were:
- Research scans are not routinely reviewed and no diagnostic or therapeutic workup is performed on any participant;
- Research scans are reviewed by a researcher, often a graduate student or postdoctoral fellow with no formal clinical training in radiology (nonspecialist), and are referred to an MR-trained radiologist (specialist) for evaluation if a brain anomaly is detected; if the finding is confirmed to be suspicious by the specialist, the participant is referred for a full diagnostic workup;
- Research scans are referred directly to an MR radiologist for formal review, and subjects with suspicious findings are sent for full diagnostic workup; and
- Prior to study enrollment, all research participants undergo a full workup including clinical-grade MR angiography.
The researchers determined that cost effective strategies include the full clinical exam of women with a positive family history prior to enrollment, however, men with no such family history have a lower risk of developing aneurysm and thus the cost of performing full neurologic scans prior to enrolling in a study is not justified.
The cost effectiveness of reviewing scans depends on the willingness to pay for a QALY of $50,000 per QALY. For willingness to pay for a QALY of $100,000 per QALY, a full clinical workup is the best option, found the authors.
In addition, review of anatomical scans by a nonspecialist was not found to be cost effective in any of the participant subgroup, and when compared with not reviewing any scans, a customized strategy for each subgroup of participants resulted in an incremental cost effectiveness ratio of $12,503 for willingness to pay for a QALY of $50,000 per QALY and $32,767 for a willingness to pay for a QALY of $100,000 per QALY.
The authors explained that more than 1,800 functional MRI studies were published between 2002 and 2008. Incidental findings that require clinical follow up were detected in two to three percent of healthy participants in these studies.
While currently, protocols for handling incidental findings vary widely across institutions, “the appropriate and efficient use of resources in research, as in healthcare, is an ethical obligation,” concluded the authors. “Therefore, decisions about how to manage findings detected incidentally in brain imaging studies should be informed by costs that affect both research and healthcare budgets.”