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John E. Wennberg, Annette M. O’Connor, E. Dale Collins, and James N. Weinstein Extending The P4P Agenda, Part 1: How Medicare Can Improve Patient Decision Making And Reduce Unnecessary Care Health Affairs, November/December 2007; 26(6): 1564-1574. [Abstract] [Full Text] [PDF] [Reprints & Permissions]

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Concerns Regarding the Extension of the P4P Agenda

Bradley K. Weiner   ( 28 January 2008 )

Concerns Regarding the Extension of the P4P Agenda 28 January 2008
Bradley K. Weiner, Associate Professor and Chief of Spinal Surgery The Methodist Hospital, Houston Texas Send comment to journal: Re: Concerns Regarding the Extension of the P4P Agenda bkweiner{at}tmhs.org Bradley K. Weiner	I read this article with great interest. Despite sharing the many of the authors’ beliefs on the subject, I have several concerns about the recommendations in the current paper. The authors argue that "the Centers for Medicare and Medicaid Services (CMS) should extend its pay-for performance (P4P) agenda to ensure that all Americans have access to a certified decision-making process." Such a process, they suggest, would allow maximization of informed patient choice, most commonly achieved/augmented, currently, by the use of patient decision aids (PtDAs). Greater patient autonomy would be achieved, Medicare would save money, and unnecessary interventions avoided. The following assumptions are made by the authors---all of which are assumed by consensus; but not beyond rational debate/dissent. 1. Autonomy is the trump card. Informed patient choice is grounded upon patient autonomy as the guiding ideal; derived from Engelhardt’s classic Foundations of Bioethics and his libertarian stance therein. There are, however, alternative guiding ideals that may temper autonomy -- ones that aim to maximize patient outcomes (conscientious and ethical caregivers aiming to do what’s best for the patient -- a reasonable (traditional) model of informed consent); ones that aim to limit exposures to risks (patient safety); and ones that aim to limit costs to society and fairly distribute resources (rationing, if you will). There are solid arguments that in some circumstances autonomy should not be king. 2. Regional variation is bad, and the less interventions undertaken, the better. These form the basis of the authors' argument for the need to improve the informed decision-making process -- yet in The Dartmouth Atlas the same authors have made it a point to suggest that the data on variation should be thought of as neither good nor bad and that the ideal amount/degree of intervention is undetermined. What is the foundation for their change of heart? How can we make value judgments with insufficient scientific outcomes data? We can’t -- or, better, we shouldn’t. Yet it is just those problems (lumbar disc herniations, degenerative disc disease, etc.) which have insufficient outcomes/scientific data that the authors aim to control (decrease variation) by the implementation of shared decision making. I suspect that the only legitimate way to conquer variation is by improving our outcomes data (and, in fairness, Dartmouth has been a leader here as well) -- not by mandating decision-making processes specifying multiple options with unclear scientific foundations. 3. Patients want to be involved in decision making. Multiple studies, from multiple medical disciplines ranging from oncology to our own study in spinal surgery, have demonstrated that the great majority of patients wish to be well-informed but prefer to delegate basic decisions, and certainly technical decisions, to their physicians. They believe that their physicians (to whom they’ve been referred commonly by friends, family, or their primary doctor) have a better grasp on the significant relevant information about the disease, treatment, and patient-specific details. "What would you do if I were your brother?" is a common question we here and one that conscientious, ethical, and evidence-based physicians probably should answer. It is almost a denial of autonomy and breach of trust to refer them back to mull it over. Engelhardt stated that "free societies are characterized by the commitment to live with the tragedies that result from the decisions of free individuals." Does it correlate that they must make decisions for themselves? Does autonomy demand decision making, or can an autonomous person defer -- even when the science is incomplete? 4. Payers should lead the way. The authors suggest that "private insurers, employers, and business coalitions should unite to encourage Congress to ensure that the CMS takes the lead." I am confident in suggesting that these entities’ primary concern is costs alone and any secondary interest they may have in shared decision making, outcomes, autonomy, etc. derives wholly from it. Political-economic mandates hardly seem an appropriate base from which to launch a national effort to reconstruct medical decision making without significantly more solid foundations than an honest-to-goodness belief in the priority of autonomy and a desire to reduce expenses. More science is needed here. 5. Shared decision making improves outcomes. I hope it is clear, from what has been outlined above, that the call for autonomy and cost reductions provides insufficient ground to require expansion of shared decision-making processes. What folks like Jim Weinstein have taught me regarding surgical care of patients must apply equally to the decision-making process. And that is that randomized trials provide the best available evidence regarding the efficacy of interventions. How about the impact of shared decision methods on outcomes? The authors acknowledge that more science here is needed; and much of what is relied upon is expert opinion and an honest faith in the benefits of the process. No doubt their hearts are in the right place, but we should require solid Level I evidence -- or certainly more than what is currently available prior to expansion. 6. Shared decision centers/patient decision aids are the best way to truly inform patients. In their current incarnation, most shared decision centers and patient decision aids rely heavily upon the presentation of the results of RCTs. The weakness of RCTs, acknowledged by both supporters/founders and critics of evidence-based medicine, is that patient-specific and physician/surgeon-specific factors can have a significant impact on the anticipated outcome for any particular patient -- and these factors are intentionally randomized out of RCTs, allowing the cleanest view of the efficacy of therapeutic interventions. Truly informed consent demands clear data on (a) physician/surgeon-specific outcomes and (b) the anticipated impact of patient-specific comorbidities. A clear description of RCT results provided within decision centers/decision aids is necessary, but insufficient for truly informed consent. In summary, I’d like to make it clear that the call for the greater expansion of the use of shared decision making, I believe, is the right one. But it is important to acknowledge that this is a "belief." A belief in the importance of autonomy; a belief that regional variation is likely due to scientifically unfounded physician/surgeon "signatures" as opposed to well-documented outcomes and free patient choice; a belief that, when it comes to interventions, less is more. But taking the next step and suggesting that government should assure that all Americans have access to "certified shared decision-making processes" should most certainly be based upon much better evidence than that which is presented or currently available, not on "beliefs." The study of medical decision making is still in a relative infancy -- I suspect that patience (and persistence) is appropriate.