The Standard of Care: Evidence-Based

Recognizing the inherent variability in the customary care standard, many in healthcare have suggested moving towards an evidence based care standard.[1] Evidence-based medicine (EBM) is the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients.[2] Instead of the practitioner consensus found in customary care, evidence-based standards use empirical data generated by clinical outcomes and effectiveness research to suggest optimum treatment in clinical conditions.[3] EBM creates a reproducible care standard by providing a decision matrix for diagnostic and treatment complexities.[4]

Currently, EBM’s Achilles heel lies in the strength of the supporting research. The growth of performance measurement has been accompanied by increasing concerns about heterogeneity in the scientific rigor, transparency, and limitations of available measure sets, and how measures should be used to provide proper incentives to improve performance.

The underlying quality of clinical-research information is qualified by entities like the U.S. Preventive Services Task Force (USPSTF), which ranks the strength of available evidence for certain treatments.[5] The strongest evidence is the scarcest and comes from systematic review of randomized, controlled trials that are rigorously designed to factor out biases and extraneous influences on results.[6] Weaker evidence comes from less rigorously designed studies that may let bias creep into the results.[7] The weakest evidence comes from anecdotal case reports or expert opinion that is not grounded in careful testing.[8]

If EBM were available for every medical decision, it would take away the need for trials in medical malpractice litigation. However, the strongest evidence-based research currently exists for less than 12% of known healthcare issues.[9] And clinical knowledge generated by randomized, controlled trials takes up to 17 years to reach the frontlines of medical practice.[10] Doctors who want to use evidence-based standards to improve their care are required to juggle a number of factors and liability concerns, including determining the strength of the underlying research and the consequences of bucking customary care traditions.

[1] Shannon Brownlee et al., Improving Patient Decision-Making in Health Care: A 2011 Dartmouth Atlas Report Highlighting Minnesota, http://www.dartmouthatlas.org/downloads/reports/Decision_making_report_022411.pdf, (last visited February 23, 2015). [2] Sackett DL, Rosenberg WM, Gray JA, et al. Evidence-based medicine: What it is and what it isn't. BMJ 312:71–72. [3] Anna B. Laakmann, When Should Physicians Be Liable for Innovation?, 36 Cardozo L. Rev. 913, 918 (2015). [4] Sackett DL, et al. Evidence-based medicine: What it is and what it isn't. BMJ 312:71–72. [5] About the UPSTF, http://www.uspreventiveservicestaskforce.org/Page/Name/about-the-uspstf (last visited March 5, 2015). [6] Id. [7] Id. [8] Id. [9] Human Disease, http://www.who.int/genomics/public/geneticdiseases/en/index2.html, (last visited February 23, 2015), CPT Process, http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-process-faq/code-becomes-cpt.page, (last visited February 23, 2015). Research has identified over 13,000 diseases, syndromes, and types of injury. Over 6,000 drugs and 4,000 medical procedures have been designed to treat them. [10] Id.