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"First, Do No Harm:" The Primary Criterion for A Quality Measure

By Susan Eymann, MS05 Jan 2016

Healthy_Patient_I.jpg"First, Do No Harm," (Primum non nocere, Latin) or non-malfeasance is a fundamental precept of bioethics. It can be traced to the Hippocratic Corpus in Epidemics: "The physician must ... have two special objects in view with regard to disease, namely, to do good or to do no harm,” or, in other words, "given an existing problem, it may be better not to do something, or even to do nothing, than to risk causing more harm than good." It is a constant reminder to the health care provider to be cognizant of the possible harm of any patient intervention.

In her recent Seminars in Dialysis publication, Dr. Julia B. Lewis, from the Division of Nephrology and Hypertension, Vanderbilt Medical Center, Nashville, calls out this axiom as she reports on the findings of an expert panel that advised the Centers for Medicare and Medicaid Services (CMS)  on the creation of quality measures for mineral and bone metabolism in hemodialysis patients.

Dr. Lewis notes that creation and collection of quality metrics (measures) by CMS are integral to its goal of improving quality in patient care. They define the quality of care to be provided by physicians, hospitals and other health care providers. Such measures differ from clinical guidelines that represent current expert opinion based on available evidence to help inform and guide physicians in the care of individual patients rather than from aggregated data from and for a large population of patients,

Dr. Lewis reports that, given the complexities in defining any quality to be measured, her group evaluated each potential measure with regards to its importance, usability, feasibility and scientific acceptability.

  • Importance: The measure must be important enough to track and will likely make a difference in public health.
  • Feasibility: Data for the measure are routinely available, interpretable, and can be collected without undue burden on the patient and staff
  • Usability: Results are relevant, not duplicative, harmonize with other measures, and can be used for quality initiatives and decision-making.
  • Scientific Acceptability: Implemented measure will yield consistent and credible results about the quality of care. Generally, a compelling clinical trial rather than an observational trial, is needed to support the measure.

Moreover, the panel considered of paramount importance, any evidence of the quality measure that could cause harm to patients or to the delivery of their health care. “First, do not harm,” must be the foremost criterion for any quality measure to improve the quality of health care.


Lewis JB, “Government Quality Measures: First Do No Harm,” Semin Dial. 2015 Nov;28(6):657-60.

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