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PART V CONCLUSIONS AND RECOMMENDATIONS
13 Conclusions and Recommendations rT\he Social Security Administration (SSA) and the ~ Congress have acknowledged difficulties in eval- uating claimants for disability benefits whose complaints and dysfunc- tion are not fully accounted for by clinical evidence of disease or injury. Persons with chronic pain, especially musculoskeletal back pain, are thought to constitute the largest category of such claimants. The Institute of Medicine (IOM) was asked by the SSA to follow up on the work of the Department of Health and Human Services (HHS) Commission on the Evaluation of Pain to further elucidate the factors that influence the course of development from acute to chronic pain, to explicate the concept of illness behavior as applied to chronic pain, to review the state of the art of assessing and measuring pain, to consider making recommendations about how the SSA disability programs might better evaluate claimants with chronic pain and provide incen- tives for rehabilitation, and to make suggestions about research that holds promise for improving our understanding of chronic pain and the disability process. The SSA disability program is the largest in the world. Thousands of people at the local, state, and federal levels are involved in the eligibility determination process and program administration. As discussed in Chapter 4, differences in the perspectives and goals within various program elements and among the many levels of review and adjudication create a variety of tensions and conflicts. For example, differences in the perspectives of physicians and administrators and of SSA-employed physicians and consulting physicians are likely to have 263
264 CONCLUSIONS ED RECOMMENDATIONS a differential impact on judgments about eligibility for benefits. Furthermore, despite detailed rules and regulations for determining eligibility for benefits, subjectivity is inherent in the process. This is most striking at the administrative law judge level of appeal (the only time a claimant is seen face to face), where approximately half the decisions of the administrative paper reviews are overturned. The entire program operates within the constraints of laws and congressional and public pressures that reflect economic conditions and societal views about the extent and nature of governmental responsibility to care for those who are unable to work (see Chapter 21. Like other cash transfer programs, there is a constant tension between forces trying to expand the program and forces trying to keep it tightly constrained. This derives in part from conflicting views about whether the provision of benefits is inherently a disincentive to work. In conducting this study the lOM committee assumed that it was inappropriate to consider recommending changes in the legal defini- tion of disability under which the SSA operates, which implies a total and permanent inability to work in any gainful occupation. Not only would such considerations go far beyond the study's mandate, but the definition is too central to the basic philosophy of the SSA disability program to expect Congress to seriously entertain revisions. Nonethe- less, within the constraints of the existing definition of disability, the committee did explore numerous procedural issues. In reviewing data from the SSA, hearing testimony from SSA officials and experts in pain assessment, analyzing the published literature, and in its own discussions, the study committee was struck by the complexity of the disability system and by the extraordinary complexity and multifaceted nature of chronic pain. Several crucial gaps in knowledge about chronic pain and its relation to disability bear importantly on the study mandate. These include, for example: · inconsistencies in definitions and measurement that make it difficult to generate reliable estimates about the numbers of people in the population with chronic pain and associated dysfunction; these are the people at risk for becoming unable to work and applying for SSA disability benefits; · lack of data about the numbers and characteristics of SSA cIaim- ants and beneficiaries in the disability program whose primary com- plaint is pain and how they fare over time; · lack of reliable methods for predicting which patients with acute and subacute pain will develop chronic disabling pain; although many factors are known to correlate with chronic disabling pain, predictive models have not been developed;
CONCLUSIONS ED RECOMMENDATIONS 265 · untested assumptions about the ability of early treatment and rehabilitation to interrupt the course of chronic pain; although there is general agreement that the longer a person has had a chronic condi- tion, the more difficult it is to achieve rehabilitation, there are few data that attest to the effectiveness of early intervention; and · imperfect correspondence between severity of pain and dysfunc- tion; people can have severe pain with minimal functional limitations or minimal pain with severe limitations. In light of these and other considerations that will be discussed, the committee cannot responsibly make recommendations for major changes in the way the SSA disability programs operate. In the absence of more specific and refined data, the implications of such changes cannot be accurately estimated in terms of their monetary costs, administrative burden, or their effects on the fair and equitable functioning of the programs. However, the committee does recom- mend one important change that holds promise for improving the way the SSA handles chronic pain complaints (see Recommenda- tion 31. Furthermore, in order to clarify a number of aspects of the problem and provide the basis for making well-informed decisions about other significant changes that might be entertained in the future, the committee recommends several demonstration projects and research studies. The committee also makes recommendations about clinical practice and the education of health professionals to improve the prevention, diagnosis, treatment, and rehabilitation of chronic pain. On the basis of its deliberations and an analysis of the available literature, the TOM study committee makes six major recommenda- tions. 1. The SSA should develop a better system for routine data collec- tion and information retrieval for the disability programs in order to know more about the numbers, characteristics, and outcomes of claimants and beneficiaries generally and to know more about pain claimants and other troublesome categories of claimants specifically. 2. Neither "chronic pain syndrome" nor "illness behavior" should be added to the listings of impairments. 3. Significant pain, even in the absence of clinical findings to account for it, should trigger a functional assessment of the capacity for work. 4. The SSA should support the design and execution of two major demonstration/evaluation projects: one to develop and compare several methods for assessing pain claimants early in the evaluation process,
266 CONCLUSIONS ED RECOMMENDATIONS and one to assess the efficacy of early multidisciplinary rehabilitation interventions with chronic pain patients. 6. The Secretary should take the lead in ensuring that a broad research initiative on pain and disability is undertaken within HHS. This should include at least one major longitudinal epidemiological study to identify the determinants of chronic disabling pain; clinical studies on the efficacy of commonly used treatment modalities and the optimal timing of interventions to prevent chronic disabling pain; methodological studies to develop and validate measures of clinical phenomena, psychosocial variables, and pertinent outcomes relevant to chronic pain and disability; and health services research to elucidate the contributions of important sociocultural variables to illness pro- gression and illness behavior and to study the interactions of the health care delivery system and disability programs with patient/ claimant behavior. 6. The training of health care professionals should entail a compre- hensive and multidisciplinary approach to patients with pain that includes attention to important psychological, social, and cultural contributions to the development of chronicity and associated illness behavior. Such an orientation is likely to improve the diagnosis, treatment, and rehabilitation of chronic pain patients and to prevent or mitigate long-term negative outcomes. A discussion of each of these recommendations and the conclusions on which they are based follows. Recommendation ~ DATA COLLECTION AT THE SSA In the course of its activities, the committee found that specific figures and reliable estimates about the numbers and characteristics of pain claimants in the SSA disability programs and about what happened to claimants and beneficiaries over time were not available. Thus, the committee finds that routine data collection activities for the entire disability system should be improved. Recognizing that the creation of a data collection system for such a large program is a major undertaking, the committee suggests that collaboration with other government agencies, especially the National Center for Health Sta- tistics and the Bureau of the Census, on routine and special data collection activities, might be especially useful and efficient. Better data collection and retrieval capabilities would provide valuable infor- mation to the program administrators and would also facilitate re- search by the agency or others.
CONCLUSIONS ED RECOMMENDATIONS 267 An improved data collection system would permit the SSA to define more concretely its problem with chronic pain claims. The committee recommends that the SSA commission a study to address the following questions. · What proportion of claims are based primarily on pain? · What proportion of pain claimants are found eligible under the existing rules and at what level of review or adjudication? · What share of the appeals at each level are pain cases and what are the results? · How much time elapses between the onset of chronic disabling pain and application for the disability benefits? · Is the SSA a last resort or a first resort for chronic pain patients? To what extent do Social Security Disability Insurance pain claimants also seek and receive benefits from Workers' Compensation or other public and private disability programs? e What happens to people with claims based primarily on pain who are denied eligibility? How many ever return to work or enter the disability system at a later time? Expert consultation should be sought for the design of both the information system and the study to ensure their scientific validity and maximum utility to the SSA. Recommendation 2 NO NEW LISTINGS FOR PAIN OR ILLNESS BEHAVIOR "Chronic pain" alone should not be added to the SSA regulatory listing of impairments that allow a presumption of disability, nor should "chronic pain syndrome" be added to the listings. Likewise, "illness behavior" should be neither a diagnosis nor a listing. Although acknowledging the value of the terms chronic pain syn- drome and illness behavior in certain contexts, the committee has reservations about their use. First, the lack of consistent definitions of each term is likely to cause confusion and misunderstanding. Second, each term risks reifying conditions that are highly variable, thereby implying a homogeneity in patients and conditions that does not exist. As discussed in Parts lIT and IV of this report, chronic pain does not present a coherent, clearly defined constellation of symptoms and signs that can appropriately be called a clinical syndrome or a medical diagnosis. There has been no demonstration of a common etiology, a predictable natural history, or specific treatment for the various pain conditions that would suggest a basis for positing a single chronic pain
268 CONCLUSIONS ED RECOMMENDATIONS syndrome. Therefore, the committee recommends using terms that are more specific to the particular complaints, problems, and deficits being discussed. Similarly, the committee's judgment is that illness behavior is neither a disease nor a diagnosis. As described in Chapter 8, the term refers to a concept intended to describe the behavior of individuals responding to illness or to the belief that they are ill. All individuals exhibit such behaviors in varying ways. The concept and the perspec- tives associated with it facilitate appropriate inquiry and provide a framework for understanding behavior but are not intended to de- scribe clinical status. The key variables underlying the concept are the particular types and intensity of the behavioral manifestations of illness. The recommendation that there be no listing for chronic pain syndrome and illness behavior certainly does not mean that chronic pain, and chronically painful conditions, should be ignored in the a~ninistrative process. On the contrary, as discussed throughout this volume, the committee believes that pain should be attended to in a more thorough and systematic fashion in clinical practice and in the determination of eligibility for disability benefits. - Recommendation 3 SIGNIFICANT PAIN SHOULD TRIGGER AN ASSESSMENT The committee recommends that significant pain as a primary complaint should trigger a functional assessment, even in the absence of objective clinical findings that could reasonably produce the pain. In the current sequential evaluation process (see Chapter 3), once it has been established that the claimant is not working, the second step is to determine whether the claimant has a "severe impairment" (e.g., one that interferes with the performance of basic work activities). When symptoms such as pain are alleged, there must be objective physical findings to substantiate the presence of an "impairment" (the SSA uses the term impairment to refer to both a disease and to an inability to do something that results from a disease) that could reasonably produce the symptoms. If such findings do not exist and it has been determined that there is no mental impairment (as defined in the SSA's Listing of Impairments) to account for the pain, the claim is denied on medical grounds alone without considering vocational factors. If the impairment is determined to be severe, the third step is to determine whether the impairment "meets or equals the listings." The listings include diagnoses and associated signs, symptoms, and
CONCLUSIONS ID RECOMMENDATIONS 269 findings, usually at a specified level of severity, all of which must be present in order to meet the listing. Many listings, such as arth- ritis, include pain as one criterion that must be present along with several others. If a claimant meets or equals the listings, benefits are granted; if a claimant does not satisfy the listings, the evaluation proceeds to an assessment of the cIaimant's residual functional capac- ity to perform past relevant work. It is at this fourth stage that vocational factors are considered. An assessment is made of exertional and nonexertional limitations in order to determine whether the claimant has the capacity to perform work-related physical and mental functions despite the limitations caused by a medically determinable impainnent. The residual functional capacity assessment is based on a paper review of medical findings that must therefore be detailed enough to permit a medical judgment about the cIaimant's functional capacities. In this sequential evaluation, a pain claimant without clinical findings to account for the symptom would be denied benefits at the second level. The committee's recommendation is for a primary com- plaint of pain to allow assessment of the claimant's functional capac- ities for work in other words, essentially to proceed to the fourth level. The SSA's recently revised mental illness listings provide a precedent for this approach. They are based on integrated functional criteria, not simply a diagnosis, by which claimants are evaluated primarily on their ability to function in activities of daily life, includ- ing work. Disability benefits have not been awarded on the basis of self-reported pain uncorroborated by objective findings, nor does the committee believe they should be. However, the kinds of acceptable evaluation and corrob- oration should not be limited to medical evidence of an underlying disease process. With or without such findings, consideration should also be given to serious functional limitations and serious problems on measures of integrated behavior. This means not only assessing physical abilities such as sitting, standing, lifting, and walking, but also examining how the limitations imposed by pain affect aspects of the individual's daily life: sleeping, eating, self care, interpersonal relationships, the ability to concentrate, and work activities. In the comm~ttee's view, an increased emphasis on functional assessment of claimants early in the evaluation process holds promise for preventing some errors of commission and omission in eligibility determinations and for averting at least some of the later appeals for higher review and adjudication. Moreover, while recognizing that government agencies and programs con never be shielded finally from politics, it is important to protect individual disability
270 CONCLUSIONS ID RECOMMENDATIONS determinations from political pressures by making judgments as scien- tifically and clinically sound as possible given the inherent difficulties and subjectivity involved. Recommendation 4 DEMONSTRATION PROJECTS The committee recommends two distinct but interdependent types of studies. One type is research to further scientific understanding of chronic pain and disability and to develop improved methods for conducting such studies (see Recommendation 5~. The other type is demonstration projects with immediate policy relevance whose purpose is to assess the feasibility and consequences of changes in SSA proce- dures. Demonstration: The Feasibility and Consequences of Early Assessment Because of the general lack of information about pain claimants and how best to assess them, the committee recommends that a well- designed and well-evaluated demonstration project be undertaken by the SSA: (1) to evaluate the effects of assessing pain complaints at the initial state level of review, (2) to compare several methods of evalu- ating pain and associated dysfunction, and (3) to determine and compare the impact of each type of assessment on the following kinds of procedural and outcome variables: ~ allowance and denial rates for pain claimants in general and to determine whether certain types of pain claimants are more likely than others to be found eligible with each method; · appeal rates for each method among pain claimants who are found ineligible for benefits at the initial determination; · reversal rates for cases appealed to the administrative law judge level; · average length of time to final decision for each method; · overall costs to the program for each method; and · claimants' and evaluators' views of the fairness of the process, and evaluators' views of the ease with which the assessment can be done. The recommendation for a demonstration project to evaluate various methods for assessing pain early in the eligibility determination process is based on a number of observations and conclusions. First, the TOM committee concurs with the HIS Pain Commission that pain
CONCLUSIONS ACED RECOMMENDATIONS 271 is subjective and that there is no completely reliable or valid way to measure it. Furthermore, because pain and functional impairment are imperfectly correlated, even if there were an instrument to measure pain, it would not necessarily provide an accurate assessment of functional impairmentwhich should be the key to eligibility for disability benefits. As discussed in Chapter 7, by measuring nervous system activity one can measure activity that reliably produces pain; but pain itself cannot be measured in an equivalently objective way. Because the perception of pain is subjective, it will always be an inference from neural activity or observations of behavior. Because pain cannot be measured directly, various indirect methods have been developed to assess the effect of pain as perceived by the patient or by observers. No one method is complete by itself. Each method has some positive and negative features in terms of practical considerations (e.g., how Tong each takes to administer, ease of interpretation, and costs) and in terms of reliability. Second, although a number of sophisticated means of assessing chronic pain claimants have been developed, as discussed in Chapter 11, it has not been demonstrated that these methods provide more accurate measures of pain or of the relation between pain and func- tional impairment than some simpler methods, such as systematic observation of the claimant directly or using videotape recordings. Third, the committee believes that assessment for clinical purposes and assessment for the purpose of certification/eligibility are and should be distinct processes. Clinical assessment is performed to diagnose and treat pain. Assessment for SSA disability screening or other certification purposes, however, is done to determine whether the claimant qualifies for benefits. While risky evaluation procedures may be acceptable in the context of treatment that includes discussion with the patient and fully informed consent, from an ethical perspective it would be inappropriate to require claimants to undergo such proce- dures to determine their eligibility for benefits. Furthermore, using the same personnel for treatment and for eligibility determination risks compromising the doctor-patient relationship and producing conflicting obligations for the physician. From a programmatic per- spective, practical considerations, including costs, may further con- strain the nature and extent of assessment. Finally, the committee cautions that an unnecessarily sophisticated assessment process for disability determinations is likely to delay decisions and increase costs. In the interest of developing a decision- making process that is optimally efficient in terms of time and money,
272 CONCLUSIONS ED RECOMMENDATIONS while at the same time rendering fair and consistent results to claimants, the committee believes that the SSA should look for methods of assessment that are as simple, valid, and equitable as possible. In light of all these considerations, the committee recom- mends that several methods be tested and compared at the initial determination level. Simple Assessment Tool Several states have been experimenting with various questionnaires for assessing pain at the initial determination level. In addition to recommending that such natural experiments be evaluated, the com- mittee also recommends that one or more easily a~ninistered ques- tionnaires or visual analogue scales be incorporated into the initial determination in a more rigorous experiment in order to test their reliability, their effects on the ratio of allowances to denials, and the practical constraints of including such instruments in this stage of the review. Early Face-to-Face Hearing Recognizing the value of observation for evaluating pain, numerous observers, including the Pain Commission and SSA program adminis- trators, have recommended that claimants have an early face-to-face hearing at the state disability determination level rather than rely solely on a review of the medical record. The committee is aware that the SSA is currently designing a feasibility study of face-to-face assessments at the initial consideration level to assess practical and procedural issues. The TOM committee recommends a demonstration project that goes beyond procedural feasibility issues to evaluate the consequences of an early personal hearing as detailed previously, and to determine the extent to which such an approach could be standard- ized and would yield consistent decisions. Integrated Functional Assessment The third method to be tested is an integrated functional assessment at the initial determination level for pain claimants. In the current system, such assessments are conducted late in the evaluation process, if at all. Included are reports of the claimant, family, and former employer; the history and physical examination (which should include a neurological and musculoskeletal examination); and a psychosocial
CONCLUSIONS ED RECOMMENDATIONS 273 assessment, including an evaluation for possible psychiatric disorder. In addition to these elements of the evaluation, the committee recom- mends (1) the use of a standardized pain questionnaire or visual analogue scale to help systematize information from observation, interviews, and the physical examination and (2) an integrated func- tional assessment going beyond simple range of motion tests (see Chapter 111. The committee believes that there is potential for using careful description and measures of functional disturbances in per- formance and activities of living as surrogate variables for the severity of chronic pain conditions. This should be tested rigorously in this demonstration. Demonstration Project: Does Early Rehabilitation Work? The TOM committee was charged to examine possible disincentives to rehabilitation and to consider making recommendations about how rehabilitation could be better incorporated into the SSA disability programs. Incentives and Disincentives for Rehabilitation As discussed in Chapter 4, the question of whether the SSA disabil- ity system contains elements that encourage or discourage rehabilita- tion is part of a much larger issue about economic incentives and work. The narrower question about whether receipt of benefits is an imped- iment to successful treatment and rehabilitation has not been well researched. The studies reviewed in Chapter 12 on the effects of compensation on rehabilitation outcomes are too imprecise in terms of their operational definitions and measurement to Craw any definite conclusions. Nonetheless, the committee notes that there are several features of the disability program itself (including its definitions, eligibility requirements, and determination procedures) that appar- ently work at cross-purposes to rehabilitation. First, the committee concurs with the Pain Commission that under the current disability system the need to "prove and re-prove" one's disability is so great that it is likely to undermine claimants' subse- quent ~noti~ration for rehabilitation. Second, the requirements for proving work disability and the re- quirements for acceptance into rehabilitation need to be disentan- gled if rehabilitation is to become a realistic goal within the SSA. The SSA definition of disability requires a long-term, virtually total inability to work. To be eligible for rehabilitation, however, a claimant
274 CONCLUSIONS ID RECOMMENDATIONS must be able to demonstrate a potential to work and benefit from a rehabilitation program. These two requirements work at cross-pur- poses. Third, as noted by the Pain Commission, although the Social Security disability programs include features intended to provide incentives for rehabilitation (e.g., a trial work period with continuation of disability and medical benefits), such opportunities are seldom used. This appears to be due largely to two factors: fear of losing benefits and lack of knowledge about the existence and details of such provisions. The committee strongly endorses the Pain Commission's recommendation that a con- certecI educational/informational campaign should be undertaken to acquaint beneficiaries, physicians, lawyers, and employers with the existing SSA provisions for rehabilitation and return to work. Finally, although the details go well beyond the scope of this inquiry, the committee notes that the lack of coordination between agencies providing disability benefits and those providing rehabilita- tion services in terms of their eligibility requirements, administration, and funding does not encourage rehabilitation. Furthennore, the committee notes that several basic features of the SSA disability program, including the definition of disability and the 5-month wait- ing period, may preclude rehabilitation as a realistic goal on a large scale because most of those who qualify for disability may simply be too impaired to return to work. The HHS Pain Commission's Proposal A key recommendation of the Pain Commission was that the SSA undertake a demonstration project "to determine what proportion of individuals determined to meet the [commission's] selection criteria for impairment due primarily to pain can be reactivated and vocation- ally rehabilitated through intensive treatment in appropriate treat- ment centers anchor vocational rehabilitation centers and the treat- ment modalities which achieve maximum success with these individuals." The cost-effectiveness of rehabilitating this population and of"incorporating a reactivation/vocational rehabilitation program as an integral part of case evaluation in disability claims where impairment is due primarily to pain" are to be evaluated. The commission's proposal is to test the efficacy of rehabilitation quite late in the chronic pain/disability process. The IOM committee endorses this recommendation, but also suggests that a related demonstration project should be designed to assess the effects of intervention earlier in the course of chronic pain.
CONCLUSIONS ED RECOMMENDATIONS 275 Demonstration Project for Early Rehabilitation By the time claimants apply for SSA disability benefits, chronicity is well established and functional impairments are severe. Early identi- fication and rehabilitation hold promise for preventing Tong-term disability, which would ultimately reduce the number of claimants and beneficiaries. Thus, in the committee's view, it is appropriate for the SSA to sponsor this demonstration. The possible value of early and active rehabilitation for pain patients should be thoroughly explored. The committee recommends a demonstration/evaluation project to identify pain patients before they apply for disability benefits and to over them a package of multidis- ciplinary rehabilitation, time-limited cash benefits, and medical ben- efits. Several critical questions must be addressed in planning such an effort. For example: · When is the optimum time to identify those at risk? · How can they be identified? VVhat screening tools should be used? A relatively simple screening method should be developed to attempt to identify those at highest risk for Tong-term disability. The informed judgment of the committee is that a mobility scale may prove to be a reliable indicator of those at high risk for maintaining a chronic pain problem in the long term; such scales assess the functioning of an individual in his or her usual activities, such as working, household responsibilities, leisure activities, and use of transportation. This and other methods should be tested and compared. · Who should identify the study population? · What kinds of people are being sought? Are there particular categories of people, such as those with back pain of uncertain origin or those with pain and depression, for example, who are at high risk for the development and maintenance of chronic pain problems? · What should constitute appropriate rehabilitation services and what standards should be set to allow for comparative studies? · Who should provide rehabilitation services? Presumably a sample of multidisciplinary pain clinics would be selected, but the population of such specialized centers is difficult to define because of the variation among such centers in their approaches to pain rehabilitation. The committee recognizes that these are difficult issues to resolve, but not prohibitively so. A well-designed, well-evaluated demonstra- tion to develop and test methods for reliably identifying patients likely to develop chronic disabling pain and for testing the efficacy of
276 CONCLUSIONS kD RECOMMENDATIONS particular rehabilitation techniques will yield invaluable information for the disability program that may suggest ways to better integrate the rehabilitation aspect of the program with the disability benefits part. For clinicians also, this demonstration is of paramount impor- tance to the prevention, treatment, and rehabilitation of chronic pain. Evaluation of the Demonstrations Rigorous evaluation must accompany the demonstrations if they are to provide reliable information on which to base policy decisions. Accordingly, we make the following four recommendations. 1. Plans and/or requests for proposals to execute demonstration projects should be separate from requests for proposals to evaluate those projects. 2. "Evaluators" should be investigators neither accountable nor beholden to the "demonstrators" in order to assure objectivity of the evaluation. Evaluation of demonstration projects should not be con- ducted by the SSA staff. 3. Requests for evaluation of proposals should require details about research design, specification and measurement of key variables, as well as criteria for success of the demonstration and of the evaluation component. 4. The evaluation should be designed and baseline data gathered before the demonstrations begin. The committee recognizes that such evaluation is costly and could be even more expensive than the demonstration. Justification of the costs of evaluation and the time needed to do it should be linked to the resource and cost implications of widespread implementation of a successful model, or the accrued savings when an ineffective but politically appealing demonstration is shown to be worthless. A Note About Research with Human Subjects The committee is aware that the Social Security Act gives the Secretary authority to suspend the normal rules for purposes of demonstration projects without institutional review board review and all that that entails. Although the federal requirements for research with human subjects are not strictly applicable to testing modifications of entitlement programs, the committee voiced concern that in imple- menting the demonstration projects the Secretary should be sensitive to the needs of the claimants regarding appropriate notice, ir~forma-
CONCLUSIONS AND RECOMMENDATIONS 277 tion, and consent. Specifically, claimants should be informed that they are involved in a demonstration project and that the old rules and regulations do not apply; they should be informed about the new procedures and regulations. The right to appeal must be maintained. Participants should be informed of this right and how to exercise it. In addition, the committee shares the concern of the Pain Commis- sion about the interpretation and application of results from demon- stration and research projects. Caution should be exercised in applying summary statistics and general research findings to the decisions made about individual claimants. The Social Security Act requires personalized adjudication of disability claims. Therefore, research results documenting aggregate behavior should not be the basis for denying benefits to an individual. Results of research and demonstra- tion projects can be useful in designing an equitable system, but they must not substitute for the personal assessment and adjudication to which claimants are legally entitled. Recommendation 5 RESEARCH AGENDA Throughout its work, the committee found critical information lacking about every aspect of the chronic painJ6isability problem. Epidemiological, clinical, health services, and methodological studies are needed. Recognizing that such a broad research initiative goes far beyond the immediate concerns of the SSA, the committee recom- mends that the Secretary coordinate this effort within HHS in consul- tation with SSA officials and other federal agencies that have pro- grams and conduct research relevant to these issues. Epidemiological Initiatives Epidemiological initiatives should be directed primarily to a pro- spective study of at least two cohorts. Such a study will help elucidate the determinants of chronicity, disability, and other poor outcomes. As discussed at length in Chapter 6, virtually all of our information about chronic pain comes from cross-sectional studies. Although rec- ognizing that prospective studies are expensive and difficult to execute, the committee feels strongly that such a study is the only way to get the critical information needed to understand who is at risk for developing chronic pain, and hence, who is a potential claimant for disability benefits. Until the size of the universe of potential pain claimants has been estimated and their characteristics described,
278 CONCLUSIONS ED RECOMMENDATIONS entertaining proposals for major changes in the disability programs would be unwise. Furthermore, such a study would point the way to the development of successful prevention strategies, including the critical issue of the optimal timing of interventions and directing efforts at those most likely to require and benefit from them. Clinical Research Clinically, the compelling need is to demonstrate the effectiveness of commonly used therapeutic and rehabilitative interventions used singly and in various combinations. The most powerful method for investigation is the randomized controlled trial. There have been very few such studies to assess the benefits and harms of the many medications, physical therapy techniques, and surgical interventions that are frequently used for back pain. Little is known about the characteristics of those for whom particular interventions are likely to be more or less successful or about the optimal timing of specific treatment methods. Important factors such as concurrent diagnoses and compensation status have rarely been described in detail or controlled for in clinical trials. In the rehabilitation studies there are significant biases in the selection criteria for admission to programs. What happens to people who are not admitted and the effects of such a selection on outcomes have not been analyzed clearly. As discussed in Chapter 12, none of the studies that purport to address the question of whether receipt of benefits affects rehabil~ta- tion potential has systematically examined the particular elements within the categories of "compensation" versus "no compensation" that may account for the findings in either direction. Although it is certainly possible that receiving benefits could be a deterrent to rehabilitation, as discussed in Chapters 4 and 12, many other equally plausible explanations have little to do with compensation itself. Related to the need for clinical trials of commonly used interventions is the need to apply promising findings from laboratory research to the treatment of pain patients. A National Academy of Sciences Research Briefing Panel on Pain and Pain Management (1985) found that clinical research had lagged behind laboratory research and that there was an unfortunate delay in disseminating laboratory findings to clinical settings. The pane} urged the establishment of multidiscipli- nary research centers to promote the development and the application of new knowledge in pain and pain control. This committee concurs and recommends that the results of basic biological, neurological, and behavioral pain research be better tested in clinical settings and used
CONCLUSIONS ID RECOMMENDATIONS 279 in the planning and evaluation of research on clinical management and therapeutic procedures. Furthermore, a number of basic clinical questions about pain have yet to be adequately studied. For example, not much is known about the relation between chronic pain and the actual diagnosis given to patients, about the cause and effect relation between chronic pain and disorders such as depression and alcoholism, and about the natural histories of the various chronically painful conditions. Prospective studies particularly cohort analytic studies of at least several years duration are needed on the clinical disorders and psychosocial factors related to chronic pain. These could be done as part of the longitudinal cohort study discussed previously or as separate clinical studies. Well-designed cross-sectional studies with appropriate control groups would also be useful. Health Services Research Very little is known about patterns of utilization of traditional and nontraditional health care among chronic pain patients other than the fact that care from multiple sources is often sought (see Chapters 6 and 81. Studies of the sequence of help-seeking and the effects of different kinds of care on subsequent health status for patients with various pain conditions and personal characteristics would provide valuable information about patients' decision making and about the appropriate timing of interventions. Such studies would also elucidate the process of illness behavior and hold promise for identifying critical elements or stages in the process for successful intervention. It is generally asserted that features of the health care and disability systems, and the nature of the interactions with health care profes- sionals and disability examiners, affect the behavior of pain pa- tients/ciaimants. This assertion has not been systematically studied. Such research holds promise for discovering important clues for altering behavior, optimizing the organization and content of health services, and identifying elements of the eligibility determination process that may encourage illness behavior. Improved Methodology and Multidisciplinary Research As discussed throughout this volume, definitions of key terms, outcome measures, follow-up periods, assessment methods, intervention strate- gies, and selection criteria vary widely. Most existing studies rely on small, poorly described heterogeneous samples and rarely use control
280 CONCLUSIONS ID RECOMMENDATIONS groups. Progress in this field depends on developing and refining uniform definitions and approaches to measuring numerous independent once dependent variables, including patient classification, psychosocial vari- ables, the delineation of interventions, and outcomes. Methodological research of this type is extremely sophisticated and requires input from experts in a number of disciplines in order to be effective. Ideally, all of the studies in this research agenda would be designed and executed by multidisciplinary teams of clinicians and epidemiol- ogists in collaboration with psychologists, sociologists, economists, policy analysts, and statisticians as appropriate to the issue being addressed. The design of the sampling frames will be particularly important in several of these studies. Recognizing that the recom- mended research is likely to go well beyond what the agency is able to do in-house, the committee recommends that the SSA consult with appropriate experts in research design, measurement, and statistics in planning these various studies, and that the actual studies be con- ducted by a multidisciplinary group of outside experts. The research agenda recommended by this committee will facilitate judicious inquiry into important clinical and policy-relevant questions. Much of the agenda pertains to issues of prevention. Epidemiological studies to identify people at risk for chronic pain before negative outcomes are apparent, methodological research to develop and test ways of identifying people early in the pain trajectory who are likely to go on to chronicity, controlled trials of particular treatment techniques alone and in combination, and studies of the optimal times to intervene all hold promise for preventing chronic disabling pain. It is not possible to estimate the cost of this research without designing the individual studies. However, the committee notes that the cost of these studies is likely to be slight compared with the potential savings in medical care expenditures and disability benefits for chronic pain. Recommendation 6 EDUCATION TO IMPROVE THE CLINICAL CARE AND TREATMENT OF CHRONIC PAIN PATIENTS Among the committee's members were clinicians and researchers knowledgeable about and experienced in the care of medical and surgical patients with pain and the course of their illnesses. There was much discussion of the appropriate and inappropriate treatment of those with chronic pain, especially musculoskeletal back pain. In addition, the committee reviewed the available epidemiological and clinical data about pain and the development of chronic pain in order to determine the range
CONCLUSIONS ED RECOMMENDATIONS 281 of techniques used in practice and their effectiveness in eliminating, reducing, and preventing chronic pain and associated dysfunction and disability. These activities have led to a number of conclusions about the nature of chronic pain and appropriate clinical management, and to recommendations about the postgraduate medical training of primary care practitioners and specialists. Everyone supers severe pain from time to time; for most of us, each episode ends with the resolution ofthe symptom or the disorder producing it. A small but significant proportion of individuals treated may get less than optimal relief, have recurrences, and develop chronic pain. What differentiates people who develop chronic pain, who can function with it, or who become disabled is not well understood. At the time of the first episode of pain it is difficult to predict the course of the condition for a given patient, the likelihood of recovery, the response to specific thera- pies, or the potential for rehabilitation and return to a more active role. What is known is that physical, psychological, socioeconomic, cul- tural, and situational factors all interact to influence the development, course, and outcome of persisting pain. As discussed in Chapter 10, in order to understand and electively manage patients with chronic conditions, a mode] is needed that includes attention to multiple variables including psychological, sociocultural, and behavioral factors. Pain patients, regardless of the duration of illness, should have a comprehensive assessment. A thorough history and physical examina- tion is needed to detect the presence of physical, neurological, or musculoskeletal abnormalities and to determine what diagnosis, if any, can be confirmed. Comprehensive clinical assessment requires a variety of measures and data. Sources of information include subjec- tive report data, information from others close to the patient, behav- ioral data, organic findings, and direct observation by physicians and other professionals experienced in functional assessment. An evalua- tion of contributing psychosocial and behavioral factors should be conducted by collecting information on the patient's family, work, school, and community in which the pain is experienced and by which it is influenced. Using a variety of methods from many disciplines, it is possible to build a more accurate picture of the effects of pain on a patient than by relying on a single method. Such evaluations require expertise in a number of disciplines and in skills such as functional and psychosocial assessment and neurological and muscuToskeletal examinations. Currently, few individual clini- cians are competent to conduct such multidisciplinary evaluations of pain patients or to recommend and coordinate appropriate therapy. The patient is typically referred to a series of experts, each of whom
282 CONCLUSIONS ~p RECOMMENDATIONS does part of the assessment and/or part of the treatment. Alterna- tively, the committee recommends that individual clinicians receive training in those aspects of the various specialty disciplines that deal with significant numbers of pain patients (e.g., orthopedics, neurology, psychiatry, anesthesiology, and physical medicine and rehabilitation). Such individual clinicians would then be qualified to conduct multi- faceted evaluations, institute appropriate therapeutic measures, and coordinate treatments that are beyond their own expertise. Practitioners must be aware that chronic pain is best understood as a process that evolves over time. The problem results from the entire progression of the patient's illness, the sociocultural context in which it occurs, and the interactions between health care professionals and patients. Health care professionals may inadvertently reinforce illness behavior. Medical interventions, whether physical, pharmacological, behavioral, psychological, or surgical, may also affect the illness' course. In the case of back pain, for example, some potentially negative effects of treatment include multiple surgery, prescription of drugs that risk further compromise of function, and excessive bed rest for patients who would do better by remaining active. Extended periods of inactivity often exacerbate the problem of back pain physically (by weakening muscles), psychologically (by making patients feel that they are sicker than they are), socially (by restricting interpersonal activities and altering family interactions), and economically (by removing them from gainful work). In the treatment and management of chronic pain, and most partic- ularly in rehabilitation, it is important to distinguish "hurt" from "harm." Pain patients, especially those with musculoskeletal pain, may hurt when they exercise or continue their daily routines and activities (including working), but they may not be harmed by such activity. Patients must, of course, be carefully evaluated to be sure that they do not have undiagnosed underlying disease or injury such that harm could occur as a result of exercise or other activity. Once this has been established, however, the committee's judgment is that patients should be encouraged to remain reasonably active despite their pain. Surgery, especially multiple operations, is rarely indicated for chronic back pain. In the long run, repeated surgery for chronic back pain is likely to cause more harm than benefit (see Chapter 101. Attention must be paid to any psychological or psychiatric disorders discovered in chronic pain patients, particularly depression, anxiety, and alcoholism or other substance abuse. As discussed in Chapter 9, clinical experience suggests that treating these conditionswhether they are coexisting, contributory, or conseq;uential~an sometimes
CONCLUSIONS ID RECOMMENDATIONS 283 alleviate the pain. Even in the absence of pain relief, if the accompa- nying mental disorder or substance abuse problem can be eased, the likelihood that the patient can be rehabilitated increases. On the basis of the available evidence, the committee believes that practitioners are not adequately trained to manage patients with pain, despite increased attention to this area in recent years. In light of this conclusion the committee makes two recommendations. First is that a cadre of physicians should be trained in those aspects of each of the medical specialties most relevant to pain. This group of experts would then be available not only to perform the multidisciplinary assessment and treatment necessary for patients with particularly difficult pain problems, but also to help train primary care providers who handle the majority of pain complaints. Because pain patients typically first seek help from primary care providers, it is important that these health care professionals understand the nature of pain and become skilled in assessment, treatment, and referrals. Thus, the second recommenda- tion is that organizations and boards that review postgraduate train- ing programs for primary care providers (family physicians, internists, pediatricians, gynecologists, nurse practitioners, etc.) examine their accreditation processes to assure that these programs attend to a number of educational goals so that primary care providers: · appreciate the complexity of the chronic pain progression and associated illness behavior and understand the contributions of psy- chosocial and cultural factors to the process; ~ are aware of commonly overlooked psychological concomitants of pain, and physical and psychiatric disorders that may account for the pain or contribute to it significantly, and of the variety of treatment modalities that may provide pain relief; · know about the work of practitioners in other disciplines, are able to make appropriate referrals, and can participate effectively in multidisciplinary teams; · understand the potential for an inadvertent adverse impact of health care providers on the course of chronic pain problems and disability; and ~ understand the processes by which the medical records of the treating physicians are used in the disability evaluation process to determine eligibility for disability. * ~ ~ Chronic pain, especially muscuToskeletal pain, is a common health problem that afflicts a substantial proportion of the adult population
284 CONCLUSIONS ED RECOMMENDATIONS and interferes with every aspect of their lives. The chronic pain- disability course is inextricably intertwined with social, psychological, economic, and cultural factors. As a clinical problem, chronic pain is often elusive and intractable. As a public policy problem, determining whether claimants whose pain and dysfunction are not accounted for by objective physical findings are disabled for work is difficult to do in an efficient, fair, and reliable manner. Pain is inherently subjective, there are no thoroughly reliable ways to measure it, and the correla- tion between the severity of pain and dysfunction is imperfect. Eval- uation of pain claimants will always contain a subjective element regardless of the specificity of the rules and regulations developed to guide disability examiners. In this report, the Institute of Medicine study committee has attempted to elucidate the issues and to provide some guidance to the Social Security Administration and other disability insurers about how pain complaints might be better handled. In addition, the com- mittee hopes that its analysis of the many facets of chronic pain and the disability process provides useful information to researchers, clinicians, and others about this complex problem.