A guest post by William Paolo (@paolomd1), the Program Director of Emergency Medicine at SUNY Upstate.
“Standard of care” is a legal term whose colloquial medical usage, outside of tort law, has been unfortunately adopted by the medical infrastructure into its cultural lexicon. The implications of its usage, when related amongst physicians, is the suggestion that there is an accepted, established, and parsimonious rendering of medical care that all reasonable providers would, under similar circumstances, judiciously employ. It serves as an idealistic touchstone resting upon the foundations of summated evidence via which clinicians measure their individual and collective performances. Actions that deviate from the collective wisdom are deemed inappropriate, negligent, and worthy of derision for failing to practice within the established evidentiary parameters of the authoritative collective guild. Undermining this concept are the radical disparities of an agreed upon standard among clinical specialists and varying geographical norms that disrupt the foundations of a standardized standard of care. The very term itself is normative, proposing what ought to be rather than what currently is, based upon a leap of logic that has never been fully supported by medical empiricism as expressed within the evidentiary literature. The standard therefore may be determined by the collective, but more often it is determined by a scant few individuals utilizing the argument from authority to prescribe practice patterns. The difficulty lies in prospectively determining what current “standard of care” actually results in patient harm, as the medical story is replete with examples of injury obvious only in retrospect.
The PROWESS study was released in 2001 in which activated protein C as manufactured and distributed by Eli-Lilly under the name Xigris was evaluated for the treatment of severe sepsis. 1690 people with septic shock requiring vasopressors were randomized to receive either activated protein-C or placebo. The primary end point was death from any cause 28 days after infusion. Because of the results the phase 3 trial was stopped early having demonstrated an absolute mortality reduction of 6% yielding a number needed to treat of 17. As is now widely known there were multiple issues with the original study and the subsequent 2012 PROWESS-Shock study demonstrated no benefit and potential harms of Xigris. In 2014 it is easy to appreciate the issues of harm and need for reproduction and verification of PROWESS to overcome equipoise however physicians in 2001 had a very well done study (as most industry supported research is—though it is also done well to bias in their favor) that was stopped early due to patient benefit. One could not fault a 2001 physician for referring to activated protein C as the new standard of care for sepsis---or can we?
Standard of care forces physicians to adopt an intellectually closed approach to evidence presuming that science has settled particular questions regarding clinical conundrums. Retrospectively the foolishness of this position is obvious as the inexorable progress of empiricism wrought through experimentation recurrently dismantles accepted evidentiary norms. The “standard” of current epochal standard care has no more underlying claim to absolute truth-value than previous erroneous medical misadventures exemplified by the various theories of humorism. The problem, as it were, is one of perspective as it is difficult discern objective truths when temporally related to the perpetuation of often faulty ideas and attitudes. Only the march forward of time and accumulated wisdom is able to dismantle that which seemed once intuitively and evidentially obvious in a given medical period. The reasonable intellectual position to therefore adopt, as a profession, is one of radical agnosticism towards absolute truth claims and delineations of care as defined by standards. This is not to say that we should fall into nihilism and presume that all of our current care will one day be proven mistaken and therefore be paralyzed by the knowledge of transformation. The story of medical science, as all of science, is replete with advancements and misadventures with a clear arrow of progression. “Standard of care” adopts a position of unsupported truth-value without the reason necessary for its nuanced interpretation. Though we may continue to utilize it as a profession it would be preferable to hand it, in its entirety, back to the lawyers who endowed us with it at the beginning.
"Efficacy and safety of recombinant human activated protein C for severe sepsis."