TABLE 1

Key Ethical Considerations Regarding Programs for CMC

Ethical ConsiderationQuestions
Transparency• What is the underlying purpose and justification for the program? Is this purpose ethically appropriate? Our argument is that the chief justification should be that the program benefits patients and families, largely by lowering the risk of undesired events or outcomes.
• From whose perspective is the program evaluated: patients, families, health care systems, payers?
Clarifying potential benefit• What is the specific undesired outcome that is being targeted when seeking to reduce the risk? The target might be a decline in a child’s health, functioning, development, or quality of life; unmet health care needs; the parents’ and family’s function and quality of life; or excess health care use and cost.
• Whose values and priorities does the selection of the target risk or outcome reflect?
Benefit via effectiveness• Is the program effective in reducing the risk and improving outcomes? Ineffective programs are ethically problematic.
• How is the program’s effectiveness being evaluated? The program’s effectiveness should be evaluated regarding how well the program lowers or otherwise improves the target risk.
Potential burdens and costs• What are the costs of creating and maintaining an accurate risk stratification model?
• Who will bear the burdens and costs of the risk mitigation program? Will the burdens and costs be fairly distributed?
Fairness, effectiveness, and accuracy• How accurate is the predictive model at estimating the probability that a given individual will, in the future, experience the specific event or outcome? Inaccuracies can threaten fairness and erode effectiveness.
• How is risk estimated? Is it by a clinician, an algorithm, or some other means?
Fairness of distribution• Will the probability of risk be stratified fairly and not in an arbitrary fashion?
• Will the greatest risks or burdens align with the greatest potential for benefit from the intervention?
• Does the program unnecessarily burden families with less financial or social resources?
Fairness of processes and respect for autonomy• Does the program have a formal, auditable complaint process and appeals process?
• How does the program inform parents about the program and obtain consent to enroll a patient?
Potential unintended harm• Will a classification of medical complexity be used inappropriately, resulting in less or worse care?
• What are the potential consequences of program termination?