Balancing Evidence, Efficacy and Stakeholder Values in Practical Pain Care
A New Year: Facing Durable Challenges and Tasks
In this issue of Practical Pain Management, Prof. Peter Moskovitz addresses the complexities, issues, and problems that arise in, and from, the diagnosis and treatment of complex regional pain syndrome (CRPS).1 As Prof. Moskovitz astutely notes, the “problem of CRPS” is in many ways representative of the more generalized problems in pain research and treatment. To be sure, these are multifold and multifocal, and questions of diagnostic accuracy, if not nosological validity, often reflect differing types and lines of evidence. Evidence, and/or evidence-hierarchies simply cannot—nor should not—be viewed as a “one-size-fits-all” construct.2 Heterogeneous bio-psychosocial variables inherent to each patient must be taken into account when examining what type and extent of evidence is right, and how any such evidence can, and should, be regarded and utilized to maximize the “good” of both the patient and the profession and practice of pain medicine.
The Obama healthcare plan proposes evidence-based analyses to guide diagnosis, treatments and outcomes.3 However, evidence-based medicine (EBM) like any other technique, has certain strengths, limits, and weaknesses. Such limitations do not refute EBM as concept but, instead, reveal EBM to exist within a milieu of new information, knowledge and practices. This mandates commitment to revise methods of research, as well as clinical evaluation, care and results. Any attempt at EBM (and its use in medical decision-making) must strive to remain progressive in this way, given the pace of scientific, technological and even socio-economic change. Thus, the goal of EBM is to utilize various levels of information to answer the prudential questions of “what can be done,” and most importantly, “what should be done to treat a given patient.”4
Evidence, Efficacy and the Environment of Pain Medicine
The relationship between “evidence” and therapeutic efficacy is neither trivial nor static. It obtains a multi-step process of: 1) critical appraisal of any evidence for its validity, 2) integration of this appraisal with a given patient’s specific biological condition and life circumstances, and 3) evaluating whether the evidence matches the variables of a particular case with sufficient alignment so as to justify use. In light of this, we have opined that EBM and therapeutic agency are both casuistic processes that are reliant—to a large degree—upon the practical wisdom of the physician.5 As Moskovitz rightly claims, the limitations of research to generate valid evidence, and of EBM to guide diagnosis and care, reflect the core constraints of much of pain care, if not medicine in general. These most certainly include a paucity of economic support for research, practice, and sustained patient care.
Rather than a “cooperative” that integrates the interests of involved parties (e.g., biomedical research, clinicians, patients, healthcare administrators, in-surers, et al.), the field tends to denigrate into tensions, if not frank conflicts, based upon seemingly dis-parate values of camps that Moskovitz appropriately refers to as ”stakeholders.” Undeniably, this has had a negative impact upon the scope, purpose(s), and moral and practical obligations of pain management.6 Such constraints both reflect and contribute to an economic turn away from collaboration and complementarity in pain care.7 These economic barriers are also an intimidating portent of the future that we believe should compel and guide reformation of guidelines and new policies—both in the United States and on a global scale—to sustain healthcare that more effectively conjoins multiple stakeholder views and values to focus upon: 1) advancing the research enterprise to generate new knowledge; 2) enabling comprehensive clinical care that employs this knowledge; and 3) empowering the patient to access and afford treatment and in this way lessen the personal and social impact of pain.8 Recent calls for government agencies, as well as insurance companies, to establish programs of long-term pain care reflect these concerns and prompts.
But, as we have claimed: “…the good of medicine does not exist in a socio-economic vacuum and, if these therapeutic and ethical goods are to be appropriately rendered to those in pain, systems utilized toward these ends must be practically enacted.”9 It therefore becomes vital to recognize how the relative interests of practitioners, healthcare and insurance communities, public, economic infrastructure, and body politic affect any realistic expression of costs and benefits in the provision of care. The needs and values of each of the involved stakeholder groups must be acknowledged and considered, not in isolation, but in concert within the paradigm of a healthcare system as it 1) actually exists and 2) would be proposed and/or planned to maximize specific outcome benefits. This may entail a two-step process of “forward and reverse gaming” tentative systems to determine those configurations of stakeholder interactions that are most effective toward the desired end-goals. It is also important to employ a strategy of rapprochement to reconcile the tensions that exist among these groups so as to facilitate collaborative discourse necessary to develop policies that incorporate “…structure and function that engages ethical systems and approaches in ways that support and sustain the good to be provided on individual and public levels.”10
Stakeholders, Values, Ethics, and Policy
But the question remains as to how such amelioration of stakeholder values might be accomplished in the real-world circumstances of medical practice. To complicate this question further, it is important to recall that these values are embedded within a larger value-edifice of the healthcare, socio-economic, and political systems in which patient care occurs. I have argued that the physician is both a therapeutic and moral agent, given that any, if not all, clinical decisions affect the existential “being” of the patient and impact the covenant of trust that undergirds the medical relationship.11,12 Yet, clinical and moral expertise are not monolithic entities. Each reflects particular values that may dictate physicians’ predispositions toward certain clinical approaches, types of care (perhaps even patients!), and all affect decisional process.13 Moreover, values and predispositions are reliant, to some extent, upon the overall “milieu” in which the practice occurs. So while we have called for the physician to be a prescient arbiter of clinical and moral good, the interaction of values cannot be ignored but, rather, should be openly acknowledged, identified, and figured into the calculus of relative attractors and constraints that could affect the trajectory of various decision moves within the medico-social system.