Research on medical practices (ROMP) includes medical record reviews, comparative effectiveness research, quality improvement interventions, and point-of-care randomization, and may improve the efficiency, quality, and cost-effectiveness of medical care.
In a study by Maureen Kelly and colleagues recently published in The American Journal of Bioethics, researchers found that patients may not fully understand the rationale for ROMP or the extent to which this type of research already exists. Patients care most about how risks and consent are managed and communicated within the physician-patient relationship, view research as separate from usual care, and place their trust in their physician, whom they rely on to identify and filter risks.
Because current approaches to oversight, risk assessment, and informed consent are poorly suited to ROMP, the authors suggest a model of Shared Decision Making (SDM) as an approach to disclosure, consent, randomization and data sharing. With SDM, the physician engages the patient in the decision-making process and encourages conversations regarding the uncertainty of treatment options.
In a related commentary, Dr. Jeremy Sugarman urges consideration of the appropriateness of this analytic frame for ROMP due to the important differences between the primary aims of research and clinical care: in research the primary goal to generate information, while for clinical care, the primary goal is to benefit patients.
Reference: Kelley M, James C, Alessi Kraft S, et al. Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making. 2015;15:4–17. PMID: 26305741. doi: 10.1080/15265161.2015.1062163.
For more information on RoMP, see the Grand Rounds Presentation from December 2014: A RoMP through the Empirical Ethics of Pragmatic Clinical Trials