EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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80 EW Ophthalmology Business February 2013 Ethical issues in everyday ophthalmologic practice Applying Daubert to emerging interventions in ophthalmology by John Banja, Ph.D. I f Ecclesiastes had the opportunity to read some recent issues of EyeWorld, I doubt very much that he���d continue to believe that ���There is nothing new under the Sun.��� Consider, for example, the November 2012 issue that carried articles on corneal collagen crosslinking, glued IOL scaffolding, neuromodulators, navigated retinal photocoagulation, sublingual immunotherapy, cataract surgery for ocular hypertension, combined cataract and aqueous shunt surgery, and micro-bypass stents. These are just a few examples that can amaze or bewilder the ophthalmologist who wants to stay abreast of novel interventions or applications. Now, my goal in this column is certainly not to repudiate or criticize any of these newer technologies or interventions. It is rather to explore the question of what kind of critical intelligence or mindset ophthalmologists should bring to evaluating interventions that are quite new and therefore not yet endorsed to the point of qualifying as the ���standard of care.��� The question is hardly an idle one as competitive pressures alone might strongly incline ophthalmologists to adopt innovative devices, interventions, or techniques ���especially if their competitors down the street already are. On the one hand, ���innovation��� is how applied science, clinical medicine, and, indeed, the standard of care advances. But on the other hand, clinicians must protect their patients from unnecessary harm such that they are ethically obligated to exercise keen professional judgment in deciding which new or novel interventions they might incorporate into their own practices and for which patients. A project I���ve recently been working on required me to revisit the famous 1993 U.S. Supreme Court Daubert decision, which set forth a number of criteria that courts should use to determine the admissibility of scientific testimony offered by expert witnesses. Not only do these criteria seem eminently reasonable in qualifying scientific testimony as reliable, but it struck me that they are readily transportable to the clinical arena���in other words, that clinicians might use them to help judge whether or not to implement new, not-yet-widely used interventions in their clinical practice. So, without understanding the following as legal advice, let us nevertheless consider how the Daubert criteria might be applied to ophthalmologic practice. The first Daubert criterion is whether or not a claim about a theory or a diagnostic or interventional technique is, in fact, testable. Of course, this is what science is all about: If a claim about a drug, device, or intervention cannot in principle be determined to be true or false, the claim isn���t science. Applied to ophthalmology or any medical discipline, one would think that any claim made about a device or intervention would be testable by simply replicating the test conditions of the claim. In some instances, though, that could prove exceedingly difficult. For example, suppose an ophthalmologist would need some technology or material to perform the relevant test or intervention that is proprietary (and thus not widely available) or that is prohibitively expensive to acquire. Or suppose the questionable claim failed to come with a precise description of the methodology underlying and justifying it so that no one could replicate it. In instances where only a few select clinician-researchers���who might, incidentally, have proprietary interests of their own in the drug or device being tested���can confirm or disconfirm findings, clinicians might be wise to wait for wider clinical testing and results reporting before adopting the practice in their offices. The second Daubert criterion concerns the item being subjected to peer review and publication. Here, the hope is that the drug or device under consideration has been subjected to the kind of scientific scrutiny that occurs in peer-reviewed publications rather than in less rigorous publications. Thus, ophthalmologists should develop good ���research consumer��� skills and be able to differentiate poorly conducted studies from sound ones. A third criterion is the known or potential error rate of the methodology supporting the claim. Here Daubert���s concern was largely about the rate to which a given methodology is liable to generate false positive and false negative findings. Consequently, that kind of concern in the clinical arena would obviously apply to diagnostic procedures. In therapeutic applications, ���error rates��� might translate into fewer or less serious complications, or to better outcomes relative to competing interventions. So, here the question is what do the related assessment and outcome data show and how valid and reliable are the studies? Daubert���s fourth criterion involves the application or implementation of the item or intervention. Have standards and controls been carefully identified that inform the intervention���s operation such that it can be used on individual patients at an acceptable level of safety? The question at stake is whether the item has been tested enough so that clinicians are aware of any special modifications or considerations that need to be applied to particular patients, in contrast to findings that are reported as group data and thus leave open the issue of individualized patient care. Daubert���s last criterion is the degree to which the intervention is accepted by the relevant professional community. Daubert doesn���t provide any metrics that define when a particular intervention actually qualifies as ���generally accepted.��� But even if a particular drug or device enjoys great popularity, that fact, in and by itself, offers no assurance of its superiority relative to alternative treatments. The best approach is to consider the intervention���s degree of acceptability along with Daubert���s other criteria. In sum, Daubert would advise today���s ophthalmologist to seriously investigate the extent to which some new drug, device, or interventional technique has been rigorously tested; whether such testing has been reported in peer-reviewed publications; what are the rates and severity of associated diagnostic errors, complications, and reported outcomes; whether operational controls and other quality assurance considerations have been developed and disseminated so that they can inform decisions as to which interventions work for which patients; and how widely accepted the item is among the relevant clinical community. We must remember that the fundamental ethical obligation of the physician is not to cure or relieve suffering, but rather to refrain from harming. There are plenty of disturbing examples throughout medical history of physicians adopting a new or relatively untried practice in their zeal to help their patients. Applying Daubert���s criteria might therefore prove valuable in assisting physicians to self-regulate their interventional use according to rational and objective considerations, which is, after all, the ideal of evidence-based practice. EW Reference: The legal citation is Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). See also General Electric v. Joiner, 522 U.S. 136 (1997) and Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999). Editors��� note: Dr. Banja is a professor and medical ethicist, Emory University, Atlanta, and the public member of the ASCRS Governing Board. Contact information Banja: jbanja@emory.edu