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13 Articles in Volume 11, Issue #4
Diagnosing and Managing Hand Osteoarthritis
Difficult Migraine Patient
Electromagnetic Applications In Biology and Medicine
Excerpt from the Book Avoiding Opioid Abuse While Managing Pain
Hormone Therapies: Newest Advance in Pain Care
Make the Family Your Best Friend
Medications for Chronic Pain—Opioid Analgesics
Nonpharmacologic Remedies for Back Pain During Pregnancy
Reconsidering and Revising Evidence-Based Practice in Pain Medicine: Steps Toward Sustaining the Profession?
The Value of Blood Analysis for Compliance Monitoring
Treatment of Neuropathic Pain: The Role of Unique Opioid Agents
Understanding Potential Complications Of Epidural Steroid Injections
Unmasking Post-traumatic Headache

Reconsidering and Revising Evidence-Based Practice in Pain Medicine: Steps Toward Sustaining the Profession?

The funding scheduled to be allocated to the National Institutes of Health (NIH) and the National Science Foundation (NSF) for the upcoming fiscal year appears to reflect—and support—the call for enhanced scientific research and education advocated by President Obama in his recent State of the Union address.1,2 Surely, some portion of these funds would be allotted to basic, translational, and clinical sciences in general. We hope, somewhat optimistically, that funding will be provided to support and sustain studies relevant to pain medicine that were fostered during the Decade of Pain Control and Research.

We ground this hope in the reality that to remain viable—if not “survive”—as both a profession and a practice, pain medicine must incorporate new information and capabilities and be empowered in these pursuits. Research—at both the bench and bedside—is the vehicle through which knowledge is obtained,3 and given the call for evidence to be the basis of healthcare reforms,4 the underlying mission of any such research endeavors is the realistic assessment of what works (and what doesn’t), in whom, and for what reason(s).

As we have noted, this may be especially problematic, given “…an ever-present gap between objectifiable aspects of pain and the pain patient that can be quantified and qualified via current techniques of assessment and diagnosis, and the subjectivity of pain…that remains inaccessible to these means.”5 This poses challenges to obtaining reliably objective measures and representations of pain with which to establish clinically relevant determinations of if, when, who, and how much to treat and gives rise to questions of what system or process of metric(s) can or should be used to evaluate the genuine clinical utility of current and emerging techniques and technologies.

The Genuine Clinical Utility of Evidence

At this point, it is crucial to inquire what “genuine clinical utility” actually means in pain care. We have repeatedly argued against “cookie-cutter” approaches to pain diagnosis and treatment in light of the individual patterns of neurological network development, structure, and function (which reflect the interaction of biological and environmental variables) and the effect of such variation on the experience and expression of pain. This reinforces the maxim that any clinical intervention represents “an experiment with an n of 1.”6-8 But even an agnostic approach to experimentation begins from a point of prior evidence from which to guide hypotheses and methods.9 Therefore, given that contemporary neuroscience reveals the uniqueness of the brain-mind and that multidisciplinary pain research has shown the individuality of the phenomenal experience of pain,10 we suggest that any consideration of evidence must be grounded to the n of 1 peculiarities of each pain patient.

However, we posit that the current paradigm of evidence assessment and evaluation—evidence-based practice (EBP)—may not be ideally configured so as to enable such personalized applications. As presented in Table 1, the limitations of EBP include 1) lack of a consistent base of scientific evidence, 2) difficulties in applying techniques studied in controlled settings to the actual care of individual patients, and 3) limited time and resources for physicians to effectively review available evidence so as to determine its relevance to the case(s) at hand.11

This is not to say that EBP lacks validity; to be sure, it can serve as a valuable method for discerning the relative benefits of various treatments. But to do so, EBP must remain current and contextual; thus, we opine that its strengths must be fortified and its limitations and weaknesses elucidated and corrected. This will require reassessment and some revision of both the evidence at hand and the concept of EBP at large. Such efforts will be important, if not necessary, in order to 1) align EBP with the current body of epistemic capital (about neuroscience and pain),12 2) validly engage EBP as a system of evaluating clinical information, and 3) regard and use differing types and levels of evidence in appropriate ways to guide clinical care.13

Issues and Problems of Evidence-Based Practice

The present state of EBP overemphasizes and overvalues certain types of studies or data and undervalues others. As a result, biases for or against systems and categories of treatment can occur that affect any realistic consideration of clinical appropriateness, resolution of equipoise, and the rendering of right and good care.11

Table 1. Issues/Problems of Evidence-Based Practice

As Manchikanti recently reported, the values of various types of treatment are qualified by the “level of evidence” used to assess their utility.14 Very often, the multicenter randomized controlled trial (RCT) is judged as the sine qua non of any such evaluation, as it can demonstrate the salience of certain treatment effects. But the RCT assumes a ceteris paribus orientation to pain and patients with pain, which we feel is naïve at best and wholly unrealistic at worst (given the current state of knowledge regarding genetics, phenotype-environmental interactions, etc). The two key elements of the RCT—randomization and control—tend to limit utility in any attempt at evaluating effectiveness relevant to a personalized approach to care and restrict the ecological validity of such studies, respectively.

Of course, methods such as preselection of subjects with specific characteristics so as to establish particular attributes that may render susceptibility to various treatment interactions can be implemented to counter these effects, at least to some degree. The modified randomized trial could then be employed to assess the influence of environmental/situational (ie, ecological) factors in the therapeutic milieu.15,16 In such cases, patient-focal “meaning effects” that can elicit placebo responses cannot and should not be disregarded, as these variables are important to those aspects of the clinical environment and encounter, are influential to therapeutic outcomes, and provide evidence to guide what treatment scenarios should entail.17-19 Thus, although the RCT has been generally viewed as the “gold standard” of evidence, a corpus of literature warns that “…all that glitters is not gold” and that modifications to the RCT as well as other clinical research protocols may be of equal, if not superior value.20

Utilization of various levels of information is vital to answer the prudential clinical question “What can be done to treat this type of disorder?” and to address such choices as “What should be done to treat this patient?”21 Therefore, the fundamental process of EBP should support evaluation of the “best” evidence for both the general circumstance(s) of the malady and the appropriateness of care for each patient. The process of EBP conjoins the most current information, medical needs of the patient, and clinical expertise of the physician. It is important to note that particular values often affect physicians’ predispositions about the use of various clinical approaches and types of care and may ultimately influence their decision making. We opine that authentic clinical expertise is reliant, at least in part, on the physician’s ability to put aside (or at the very least recognize and attempt to balance the possible effects of) such values in order to more accurately intuit the benefits, burdens, and risks of treatment(s) that are relative to both a patient’s diagnosis and (the treatment’s impact on) the patient’s life world.11

As seen in Table 2, we view EBM as a 3-step process that involves:

1) critical appraisal of any/all available evidence, 2) integration of appraised evidence with the bio-psychosocial dimensions of a given patient’s disorder, and 3) evaluation of the process itself. Key to this is whether the type and level(s) of evidence sufficiently align with the parameters and variables of a particular case to justify use. This establishes a basis for using information in critical decision making and the resolution of equipoise.11,20 However, like any tool or technique, it must be used in ways that are specific and germane to the circumstances of employ. This is where we feel that EBP requires more thorough consideration and certain revision in its overall methodology.

Table 2. Principal Steps in Evidence-Based Practice

Toward Revision and Improvement

It is crucial to frame evidence-based assessment within the shifting architectonics of biomedical science and technology and the bio-psychosocial parameters of each patient’s expression of pain. This would allow EBP to comport with goal-directed and/or values-based approaches to pain care.22,23 We have posited a construct for using differing types and levels of evidence that is presented in Table 3. In this schema, more common clinical problems require a generalized review and appraisal of evidence; less frequent clinical problems require information from larger databases; and rare clinical problems necessitate either replication of some other (low n or n=1) clinical report or may mandate employing a new therapeutic approach that is based on rationally intuitive interpretation and extrapolation of related information (what we have referred to as extrapolative casuistry).11

But such a system of information acquisition, provision, and use requires administrative and executive infrastructures to support 1) ongoing research that is translated and/or interpretable to clinical practice, 2) means and programs to acquire, focus, integrate, and update this information, 3) methods and resources for storing and distributing such information, and last, but certainly not least 4) actual (and regular) use of these services by practicing physicians. This would necessitate a more thorough use of existing resources and, perhaps, revamping and renovating of these systems to incorporate novel and more capable methods. Thus, although there is certainly a need for increased studies in pain medicine, there is also an accompanying requirement for health services research (ie, studies of pain medicine) and for the development and use of data acquisition, storage, and provision mechanisms that can bridge research findings to clinical practice.

In this latter regard, we have posed that large-scale data banks and cloud-computing methods will allow individual-to-group comparisons that can substantiate neuroimaging and genetic assessments and provide evidentiary bases for the use (or non-use) of certain techniques and technologies to treat specific patients. However, the use of computational technology can also create problems that will need to be acknowledged, prevented, or rectified if such systems are to be of any real value.24-26 Yet recognition of potential problems is not sufficient reason to retard progress, and we have argued strongly against the use of a simple precautionary principle when considering the possible use(s) of any new technology.24,26,27 As Jane Ballantyne so eloquently stated, “We are on the brink of being able to tailor treatments much more precisely…computer- and Internet-based programs are opening up new possibilities in…outcomes research, overcoming the limitations of randomized trials, and truly understanding in large populations what …treatments are doing.”28 We must ask: Are we truly prepared to use these new tools and the information they render?

Systemic Revision to Sustain Pain Medicine

There is mounting concern that the inadequacies of EBP will promote inapt use of various techniques and technologies, lead to widespread clinical failure, disrupt the already fragile fiduciary of pain medicine to the public, and contribute to the demise of pain medicine as a discipline. Indeed, we argue that such failure to recognize—and correct—the extant limitations and shortcomings of EBP is not merely impractical, but also unethical on a number of grounds and in accordance with a number of ethical approaches. Most fundamentally, it can be seen as an abrogation of the intellectual duties inherent to the profession of pain medicine. Also, it is dissonant to a meaningful regard for act utilitarian aims of pain medicine as a practice (ie, to render the best treatments so as to uphold the primacy of patients’ best interests), and it disserves the therapeutic and moral virtues that are critical to the agency of the physician as a steward of knowledge who is responsible for the patients in his or her charge.29 There is an equally strong sentiment that lassitude and impropriety in EBP is legally problematic, although a complete discussion of such issues is beyond the scope of this essay.

Table 3. Proposed Method of Engaging Tiers Of Evidence in Practice

This speaks to the need for a more critical evaluation of all of the facets of pain medicine, from education and research through clinical care and its supporting infrastructures to the extrastructures (eg, insurance systems; local, state and national politics and policies) that engage the public sphere.30 In these latter domains, we have stated that an awareness of systemic issues is critical “…when formulating policies that … direct and support basic and clinical research…and … empower and subsidize healthcare programs that utilize appropriate evidence in clinical practice.”11

Ballantyne asks, “…[W]hat should our leaders be doing…?” and calls for change at the clinical to the governmental levels.28 We share her perspective and have claimed that, in any and all such pursuits, practical wisdom (ie, prudence) is a fulcral virtue that enables pragmatic evaluation of the current conditions of pain care and navigation of possible paths toward real progress.31 To be sure, pain medicine has a variety of techniques and technologies at its disposal, each possessing some merit, limitation(s), and risk. We believe that these should be employed as bricolage—a combination of old and new methods and instruments to best suit the exigencies and contingencies of circumstance.32 We concur with Dr. Ballantyne’s invocation to “…perform the outcomes research coupled with the basic science that will allow us to identify who is helped and by what means….”28 New knowledge, techniques, and technologies are of little benefit to pain care if we choose to employ old data and use outdated methods to discern the validity and value of the information and tools that may shape—if not sustain—the future of the profession.

This work was funded, in part, by the N3P3 (Neuroscience, Neurophilosophy and Neuroethics of Pain, Pain Care and Policy) Project (JG, MVB) and is adapted from the chapter “Upholding tekne in pain care: Toward a reassessment and revision of evidence-based practice” in Giordano J, Boswell MV, Cole BE, eds, The War on Pain and the War on Drugs: Collaboration or Collateral Damage? Practical, Ethical and Legal Issues in the Care of Chronic Pain. Arlington: Potomac Institute Press (forthcoming, 2011).
Last updated on: September 13, 2011
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