CHAPTER 113 Tertiary Rehabilitation Program Outcomes
Pain is usually broadly defined as either acute, chronic, or recurrent, depending on its time course.1
Of course, the above types of pain require different treatment approaches.2 In discussing back pain rehabilitation, for example, primary care is applied usually to acute cases of pain of limited severity. Basic symptom control methods are utilized in relieving pain during the normal early healing period. Frequently, some basic psychological reassurance that the acute pain episode is temporary, and will soon be resolved, is quite effective. There is now evidence for safety, treatment- and cost-effectiveness of evidence-based guidelines for the management of acute low back pain in primary care.3 Secondary care represents ‘reactivation’ treatment administered to those patients who do not improve simply through the normal healing process. It is administered during the transition from acute (primary) care to the eventual return to work. Such treatment has been designed in order to promote return to productivity before advanced physical deconditioning and significant psychosocial barriers to returning to work occur. At this phase, more active psychosocial intervention may need to be administered to those patients who do not appear to be progressing. Finally, tertiary care requires an interdisciplinary and intensive treatment approach. It is intended for those patients suffering the effects of physical deconditioning and chronic disability. In general, it differs from secondary treatment in regard to the intensity of rehabilitation services required, including psychosocial and disability management.
THE BIOPSYCHOSOCIAL MODEL OF PAIN
Before discussing tertiary care, which is a topic of the present chapter, it is important to first review the underlying theoretical model of pain upon which tertiary rehabilitation is based – the biopsychosocial model of pain. Today, this biopsychosocial model is accepted as the most heuristic perspective to the understanding and treatment of chronic pain disorders.4,5 This model views physical disorders such as pain as the result of a complex and dynamic interaction among physiologic, psychologic, and social factors that perpetuate and may even worsen the clinical presentation. Each individual experiences pain uniquely, as the result of the range of psychologic, social, and economic factors that can interact with physical pathology to modulate that individual’s report of symptoms and subsequent disability. The development of this biopsychosocial approach has grown rapidly during the past decade, and a great deal of scientific knowledge has been produced in this short period of time concerning the best care of individuals with complex pain problems, as well as pain prevention and coping techniques.
As Turk and Monarch5 and Gatchel and Maddrey6 have discussed in their comprehensive reviews of the biopsychosocial perspective on chronic pain, people differ significantly in how frequently they report physical symptoms, in their tendency to visit physicians when experiencing identical symptoms, and in their responses to the same treatments. Often, the nature of a patient’s response to treatment has little to do with his or her objective physical condition. For example, White and colleagues7 have noted that less than one-third of all individuals with clinically significant symptoms consult a physician. On the other hand, 30–50% of patients who seek treatment in primary care do not have specific diagnosable disorders!8 Turk and Monarch5 also make the distinction between disease and illness in better understanding chronic pain. The term disease is basically used to define ‘an objective biological event’ that involves the disruption of specific body structures or organ systems caused by either anatomical, pathological, or physiological changes. Illness, in contrast, is generally defined as a ‘subjective experience or self-attribution’ that a disease is present. An illness will produce physical discomfort, behavioral limitations, and psychosocial distress. Thus, illness refers to how a sick individual and members of his or her family live with, and respond to, symptoms and disability. This distinction between disease and illness is analogous to the distinction made between pain and nociception. Nociception involves the stimulation of nerves that convey information about tissue damage to the brain. Pain, on the other hand, is a more subjective perception that is the result of the transduction, transmission, and modulation of sensory input. This input may be filtered through a person’s genetic composition, prior learning history, current physiological status, and sociocultural influences. Pain, therefore, cannot be comprehensively assessed without a full understanding of the individual who is exposed to the nociception. The biopsychosocial model focuses on illness, which is the result of the complex interaction of biological, psychological, and social factors. With this perspective, a diversity in pain or illness expression (including its severity, duration, and psychosocial consequences) can be expected. The interrelationships among biological changes, psychological status, and the sociocultural context all need to be taken into account in fully understanding the pain patient’s perception and response to illness. A model or treatment approach that focuses on only one of these core sets of factors will be incomplete. Indeed, the treatment efficacy of a biopsychosocial approach to pain has consistently demonstrated the heuristic value of this model.5
THE BIOPSYCHOSOCIAL APPROACH TO TERTIARY PAIN MANAGEMENT
Thus, the biopsychosocial approach to tertiary pain management appropriately conceptualizes pain as a complex and dynamic interaction among physiologic, psychologic, and social factors that often results in, or at least maintains, pain. It cannot be broken down into distinct, independent psychosocial or physical components. Each person also experiences pain uniquely. The complexity of pain is especially evident when it persists over time, as a range of psychological, social, and economic factors can interact with pathophysiology to modulate a patient’s report of pain and subsequent disability. The model utilizes physiologic, biologic, cognitive, affective, behavioral, and social factors, as well as their interplay, when explaining a patient’s report of pain. As will be discussed, there have been a number of reviews that have documented the clinical effectiveness of such interdisciplinary treatment of patients with chronic pain.9–12 Interdisciplinary programs are needed for patients with chronic pain who have complex needs and requirements. One variant of interdisciplinary tertiary pain management programs – functional restoration (FR) – has been comprehensively presented in Chapter 112. It has also been described in detail in a number of publications.13–19 The primary goal of this rehabilitation process is to improve function and deal with any potential psychosocial and economic barriers to attaining this goal. As will be noted, these components are amenable to systematic outcome quantification. Indeed, this FR approach to the treatment of low back pain disability has received increasing attention in recent years because of its documented clinical effectiveness. Research has shown that the FR program, when fully implemented, is associated with substantive improvement in various important societal outcome measures (e.g. return to work and resolution of outstanding legal and medical issues) in chronically disabled patients with spinal disorders in a 6-month follow-up study,20 1-year follow-up studies,21–26 as well as a 2-year follow-up study.27 For example, in the 2-year follow-up study by Mayer et al.,27 87% of the FR treatment group was actively working at 2 years as compared to only 41% of a nontreatment comparison group. Moreover, about twice as many of the comparison group of patients had both additional spine surgery and unsettled workers’ compensation litigation relative to the treatment group. The comparison group continued with approximately a fivefold higher rate of patient visits to health professionals and had higher rates of recurrence or reinjury. Thus, the results demonstrate the striking impact that an FR program can have on these important outcome measures in a chronic group consisting primarily of workers’ compensation cases (traditionally the most difficult cases to treat successfully).
Finally, it should be noted that the original FR program was independently replicated by Hazard et al.23 in this country, as well as Bendix and Bendix24 and Bendix et al.25 in Denmark, Jousset et al. in France,20 Hildebrandt et al.26 in Germany, and Corey et al.28 in Canada. The fact that different clinical treatment teams, functioning in different states (Texas and Vermont) and different countries, with markedly different economic/social conditions and workers’ compensation systems, produced comparable outcome results speaks highly for the robustness of the research findings and utility, as well as the fidelity, of the FR approach. In addition, Burke et al.29 have demonstrated its efficacy in 11 different rehabilitation centers across 7 states. Hazard30 has also reviewed the overall effectiveness of FR.
Thus, the clinical effectiveness of FR has been well documented. Indeed, Gatchel and Turk31 and Turk32 have reviewed both the therapeutic- and cost-effectiveness of interdisciplinary programs, such as functional restoration, for the wide range of chronic pain conditions. One of the hallmarks of FR since its development by Mayer and Gatchel16 has been the objective documentation of outcomes, even before it became a requirement in today’s evidence-based medicine environment.
THE IMPORTANCE OF TREATMENT OUTCOMES EVALUATION
As Mayer et al.33 have noted, healthcare costs are continuing to increase at an alarming rate in the United States. Therefore, changes in healthcare policy and demands for improved allocations of health resources have recently placed great pressure on healthcare professionals to provide the most cost-effective treatment for pain syndromes and to validate treatment efficacy. As a result, treatment-outcome monitoring has gained new importance in healthcare. Indeed, as highlighted in an Outcomes Symposium sponsored by the American Orthopedic Association, the current outcomes movement has begun to revolutionize clinical research, with the concomitant increased emphasis on the use of well-validated outcome measures.34 Healthcare professionals are now themselves being monitored to determine the effectiveness of the treatments they provide, as well as patient satisfaction with their treatment. Often, a ‘scorecard’ is maintained by third-party payers to monitor practitioners’ efficacy.1 Healthcare professionals also need to monitor such outcomes for quality assurance purposes. In addition, data are also needed that can provide third-party payers with demonstrations of treatment efficacy. This can be an important marketing strategy to highlight the effectiveness of one’s pain management program.
Unfortunately, many healthcare professionals do not have a background in conducting program or treatment evaluations because of the requisite experimental methodology and statistical tools needed for such evaluations. One needs to set up a database with appropriate psychometrically sound measures to use at baseline and follow-up evaluations. Such data then need to be statistically analyzed. Fortunately, there are now templates and reviews available for conducting such evaluations. Flores et al.,35 Gatchel,36 and Mayer et al.37 have provided such overviews. These will be discussed below. Morley and Williams38 have also presented a comprehensive review of how to conduct and evaluate treatment outcome studies.
It should also be noted that, at an early point in time, Blanchard39 highlighted six important dimensions that one should consider in evaluating clinical applications and effectiveness of therapeutic modalities, using biofeedback as an example. These same six dimensions would similarly be appropriate for the evaluation of various pain management procedures. These dimensions consist of the following:
Each of these dimensions is important, and should be considered when evaluating the therapeutic effectiveness of any pain management intervention. Finally, in any discussion of treatment outcomes monitoring, clinicians now need to be aware of the HIPAA Privacy Rules. These rules establish patients’ rights concerning the use and disclosure of their healthcare information (including when it is being used for research outcomes purposes). Besides the usual informed consent obtained according to each institution’s review board monitoring the safety of subjects involved in any clinical research trial, an additional HIPAA consent form must also be obtained. Healthcare professionals may order HIPAA Privacy Rules from their specialty organizations. For example, HIPAA for Psychologists can be ordered by going to www.apapractice.org.
REVIEW OF OUTCOME MEASURES
The article by Flores and colleagues35 reviewed the three broad categories of measures that have been used to objectively evaluate functional improvement in patients with spinal pain disability: physical, psychological and socioeconomic. Moreover, within each of these three categories, some of the major measures utilized were discussed. This review started with the following folk tale:
