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Evidence-Based Practice As Mental Health Policy: Three Controversies And A Caveat
Evidence-based practice (EBP) is the subject of vigorous controversy in the field of mental health. In this paper I discuss three distinct but interrelated controversies: how inclusive the mental health evidence base should be; whether mental health practice is a variety of applied science; and when and how the effectiveness goal in mental health is defined. I provide examples of evidence-based policy in mental health. These controversies pertain as well to general medicine. To the extent that they remain unresolved, evidence-based policy making may lead to ineffective and limited care.
Evidence-based practice (EBP) refers in a general way to the application of scientific research findings to the treatment of individual patients. Evidence-based medicine (EBM) is one field of EBP; evidence-based mental health care is another. EBP is ubiquitous. It has a powerful presence in the clinical literature and in plans for improvement of professional education, health care management, and health policy making. One commentator finds that physicians "cant kick over a bedpan without hearing the phrase evidence-based medicine rattle out."1 EBP is more than a version of health care practice, however. It is a movement, like the outcomes movement before it, of scientists, public officials, private payers, and advocacy groups that seek to establish a new knowledge regime in health services.2 This involves not only the funding and dissemination of clinical scientific research but also "epistemological politics," by which some knowledgeand some knowersare privileged in the consulting room and policy arena.3 One proponent of EBP portrays the movement as "a revolution... which asserts the supremacy of data over authority and tradition."4 EBP can also be viewed as asserting which data are supreme and pursuing the movements own authority in health care. This paper focuses mostly on psychologistswho share the field of mental health with psychiatrists, counselors, social workers, psychiatric nurses, and so forthbut not only as a concession to space. Rather, psychology is a primary locus of the EBP debate, and psychologists share many concerns with other professionals in the field. In psychology, EBP influences the research priorities of funding sources, the editorial policies of scholarly journals, the program agendas of scholarly conferences, the content of approved treatment lists from professional organizations and public agencies, and the tenor of intraprofessional discourse. EBP has been described as the cause of "psychological warfare between therapists and scientists."5 Whereas one prominent psychologist issued a "Manifesto for a Science of Clinical Psychology," the president-elect of the American Psychological Association (APA) considers it "fundamentally insane" to require the use of scientific treatment manuals in psychotherapy.6 The EBP debate is far ranging, and the various issues tend to run together. It is possible, however, to identify three distinct but interrelated and policy-relevant controversies. This paper depicts these three areas and offers a caveat about policy making in the face of these controversies not only in mental health but also in medicine. EBP sets methodological standards that may delegitimize effective treatments, and when those are incorporated into health policy making, patients and the polity may be adversely affected.
The first controversy is, How restrictive should the definition of "evidence" be; that is, does the dominant definition inappropriately privilege some kinds of treatment over others? Although a number of evidence hierarchiesfor example, that of David Sackett and colleaguesconsider randomized controlled trials (RCTs) to be the gold standard for clinical decision making, a recent reformulation of the need for evidence calls for "practical clinical trials" (PCTs), which "select clinically relevant interventions to compare, include a diverse population of study participants, recruit participants from a variety of practice settings, and collect data on a broad range of health outcomes."7 This proposal notes the limitations of various alternatives: Traditional RCTs measure efficacy but not effectiveness, and nonexperimental research methods suffer from selection bias and confounding. List of validated treatments. In psychology, perhaps the most influential evidence hierarchy has been the one adopted by the APAs Division 12 (Clinical Psychology). In the early 1990s Division 12 charged the Task Force on the Promotion and Dissemination of Psychological Procedures with creating a list of Empirically Validated Treatments (EVTs) for dissemination to practitioners and educators. These were treatments (more recently called "empirically supported" and then "evidence based") for which there existed sufficiently rigorous evidence of efficacyat least two RCTs or ten single-case experimental studieswith patients fitting the specific diagnostic criteria of the American Psychiatric Associations Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). A precondition for this efficacy research was that treatments were administered according to treatment manuals. Division 12 issued successive lists in the late 1990s. The Division 12 Web site maintains a list of "well established" treatments that meet the original evidentiary criteria. Although the Web site concedes that some "beneficial psychotherapies" may not yet have been studied, potential patients are urged to undergo those on the list because they have met "basic scientific standards of effectiveness."8 The Division 12 list has survived nearly a decade of controversy and has influenced mental health policy in a number of states. For example, in response to a 1999 consent decree, Hawaii established a Division 12like panel to review the effectiveness of treatments for a range of childhood and adolescent mental health conditions. The Empirical Basis to Services (EBS) Task Force searched and evaluated controlled studies in childhood mental health; it included administrators and parents as well as mental health professionals, but much like Division 12, the task force made between-group experimental design the gold standard.9 An EBS committee continues to review the literature to decide the content of practice guidelines; these are then appended to requests for proposal (RFPs) issued by the Child and Adolescent Mental Health Division of the Hawaii Department of Health to service providers seeking contracts. The guidelines specify what services will and will not be provided to the divisions clients.10 Controversies about the list. Critics of Division 12 raise several points. They object that the list glosses over the difference between treatments that do not appear because they have been found ineffective and those that do not appear because they have not had requisite study. Another common criticism is that RCTs measure efficacy but not effectivenessthat they put reliability above validity. EBP proponents have answered this critique in a number of ways, including the revision of earlier evidence hierarchies to favor PCTs, as above. APA Division 29 (Psychotherapy) responded to Division 12 by creating its own task force to evaluate the effectiveness of mental health treatment. Division 29 took the position that much, if not most, of the benefit from psychological services results from the relationship between psychotherapist and patient rather than from specific psychotherapeutic techniques. They proceeded to review psychotherapy research, including RCTs but also naturalistic and process-outcome studies, and to compile a list of psychotherapy relationships that work.11 To be sure, most psychologists recognize that techniques are executed within relationships, which in turn rely on relationship-building techniques. Still, they continue to debate the respective contributions of technique and relationship to the success of psychological treatment and the best way of framing the object of clinical inquiry.12 This controversy is complex, because underlying the debate is the question of whether the research methodology to which an activity is suited will determine whether or not it is deemed effective. In other words, assuming that psychotherapeutic relationships are less compatible with, say, PCTs than treatment techniques are, what should be the consequences for the psychological evidence base? Should the public compilation of approved treatments be organized around techniques, or around the kinds of relationships found to be as or more effective in less methodologically controlled studies? Many mental health interventions, as "socially complex services," necessarily violate the assumptionsprecise protocols, equivalent trial conditions, and moreof experimental research.13 Experimental methodology is especially ill suited to psychodynamic and humanistic psychotherapies: Such methods do not focus solely on a disorder to be alleviated (rather, on a relationship with an individual patient); they do not enlist a predetermined treatment (rather, principles of therapeutic process); and they do not seek uniformity among therapists (rather, each therapists adherence to a theoretical orientation and a set of techniques that are compatible with his or her persona and the patients needs).14 Perhaps not surprisingly, RCT findings favor the behavioral and cognitive psychotherapies, where technique is paramount and more easily codified in treatment manuals.15 On the other hand, high-quality naturalistic and process-outcome studies attest to the effectiveness of psychodynamic and other therapies. The weaknesses of nonexperimental research have been documented (and disputed), but what to do if the object of knowledgein this case, the value of psychotherapeutic relationshipsis not accessible to experimental study?16 One clinical leader implores, "Cant we have both relationship and technique?"17 A more policy-relevant question might be: Can EBP in mental health commit itself to an inclusive enough evidence hierarchy not to privilege technique unfairly over relationship? Can it do so without further stigmatizing psychology vis-à-vis medicine (including psychopharmacology), thus undermining mental health cares claim to effectiveness worthy of funding?
The second controversy is, Can, and if so, should, practice consist of the faithful application of research evidence? Applying research to practice is the raison detre of the EBP movement. Its goal is to change practitioners behavior by bridging the distance from research to practice and securing a central place for research in the consulting room. Proponents of EBP are intent on discovering how best to build this bridge. Generally speaking, they apply a diffusion-of-technology model, whereby experimental research is disseminated to clinicians, sometimes in the form of guidelines or protocols. EBP includes a role (for example, in the IOM definition) for clinical judgment. The weight of the EBP literature, however, holds that large numbers of uninformed (or unethical) practitioners are responsible for inadequate clinical care.18 More research, not more judgment, is prescribed. Dissemination and practice. The dissemination of research findings to practitioners has not, for the most part, brought practice into line with research. There is, therefore, a large body of work devoted to increasing practitioners uptake of study findings. Decision-support tools such as manuals, protocols, and guidelines are designed to specify practice with greater or lesser authority. The Cochrane Collaboration has built an electronic bridge with an accessible database of RCTs, meta-analyses, and systematic reviews. In mental health, the National Institute of Mental Health (NIMH) sponsors the assembly and distribution of "implementation toolkits," which contain information and training resources for creating evidence-based practitioners in NIMH-funded programs.19 Simultaneously, a team of psychologists is calling for more basic theory on transportability of research to practice.20 Science versus practice. The difficulty of changing practitioners behavior contributes to a larger controversy in mental health about whether practice is in fact applied science. Some parties to the dispute argue that no matter how rigorous, probabilistic research cannot say with certainty how to treat the next patient; knowledge of the aggregate is simply not knowledge of an individual. In this view, clinical care necessarily entails judgment, and the exemplary "reflective practitioner" decides what to do based not only on research but also on disciplined consideration of his clinical experience and in-depth knowledge of the patient.21 Thus, research pertains, but the attempt to substitute research for discretion is futile. Adherents to this position cite naturalistic studies of real-time expert decision making; these find nothing of the formal decision analysis that is used to turn research findings into clinical directives.22 One prominent psychologist protests that "science and practice are not the same, and no monistic ideology can make them the same."23 Psychologists who dispute the applied science model offer alternative models of practice-relevant inquiry. According to Donald Peterson, mature psychological practice requires "disciplined inquiry" wherein the practitioner brings a "guiding conception" as well as evidence and experience to bear on patient assessment, plan formulation, and psychological intervention. The clinicians ongoing evaluation may lead to reformulating the treatment plan, and the final evaluation will feed back into the clinicians experience base and guiding conception.24 Daniel Fishman, in turn, offers a Pragmatic Case Study Method that uses a highly specified report structure (corresponding to the disciplined inquiry model) to create large, searchable databases of case studies that allow for a practitioners inductive generalization.25 Proponents of EBP argue that this kind of practice knowledge is too weak methodologically to identify effective treatment the way experimental studies do. The actual evaluation of EBP (as opposed to clinical trials of some treatments) in mental health is as yet limited: How practitioners know remains a matter of dispute. Fidelity versus discretion. A recent report from the Milbank Memorial Fund describes several mental health interventions that have proved successful in clinical trials.26 The authors emphasize fidelity in the application of this researchfor example, the prescription not just of an effective antipsychotic medication but also of the dosage specified in the research. Among the reports eight "essential points," then, are that providers should be held accountable for delivering evidence-based practices and that measures of program fidelity are available to further that accountability. The authors go on to make two other points, however, that speak to the other side of the practice controversy. They conclude that "a wide variety of effective treatments" should be available because overall effectiveness may not translate into effectiveness in "significant subgroups." Furthermore, "treatment choice and wide selection" are necessary to "maximize treatment response and adherence to treatment." Admittedly, the authors urge variety and choice among effective treatments, but they also describe individual variation within an overall effect. They note that even an effective treatment does not work for every patient and that individual patients treatment preferences help determine what is effective for them. How does this square with maximal practitioner fidelity to research findings, especially when effective treatment but not all effective treatments are mandated? How should EBP operationalize fidelity to allow enough but not too much discretion? Managed mental health care. The effort to hold practitioners to evidence-based directives is widespread. Roughly two-thirds of Americans with private health insurance are enrolled in managed behavioral health care organizations (MBHOs), and these have used efficacy research to limit types and duration of care.27 In the public sector, the District of Columbia Department of Mental Health (DMH) has proposed a policy regarding evidence-based psychotherapy in that system.28 According to the draft policy, all psychotherapy services delivered to community-based adult consumers will conform to a short list of EBPs. The list includes twelve disorders, five of which have only one treatment option. Psychodynamic psychotherapy does not appear on the list, but techniques such as eye movement desensitization and reprocessing do. The chief clinical officer of the DMH, in consultation with experts, will review the list annually. Providers may submit requests to expand it, but they must also be specifically credentialed for any treatment they render. Otherwise, "they should not attempt to provide that evidence-based psychotherapy." Credentialing criteria are vague but represent a major departure from professional practice. Psychologist psychotherapists, for example, are licensed professionals whose scope of practice is delineated by legislatures. With few exceptions, they are not credentialed for one technique at a time. The controversy over psychological practice as applied science has implications for the health system as well as individual practitioners. In one well-developed scenario, mental health practice adheres increasingly to research-based manuals or guidelines, and most treatments are performed by clinicians with less training. Highly trained practitioners will design systems, conduct research, manage quality assurance programs, and, when necessary, care for patients whose "manualized" treatment did not succeed.29 There are obvious cost advantages to a system of this kind; some MBHOs now enjoy these advantages. It is unclear, however, whether cost containment is a felicitous side effect of EBP or whether EBP has been used to legitimate less costly treatment. Most mental health RCTs by design investigate manualizable treatment techniques. These, then, become the psychological services deemed effective in the treatment of mental illness. Proponents of this approach argue that if manualized services, delivered by less highly trained practitioners, are effective, it is inexcusably wasteful not to deliver them. Critics counter that more individualized therapy with a more highly trained clinician is more effective, even if less demonstrably so. From this perspective, the efficacy of manualized treatments is short-term symptom relief based on formal diagnosis under study conditions, which will prove limited for many mentally ill people. As the first controversy questioned the evidence half of EBP, this second one questions the practice half. As above, the issue is one of inclusiveness. The desirability of more high-quality evidence for mental health practice is a given, but does evidence include the quasi-experimentation suited to much of practice? The pertinence of high-quality research to mental health practice is also a given, but does practice include pluralistic and inductive knowledge that benefits from, but is not, experimental research? At stake in both cases is the rigor and perceived rigor of the mental health enterprise, along with the necessary complexity of effective mental health care.
The third controversy is, To the extent that EBP is the means to effective health care, what is meant by "effective," and who decides? For the movement, EBP is a moral imperative: Experimental research produces therapeutic efficacy and therefore better health, a largely uncontested moral good.30 In other words, EBP occupies the moral high ground because its practitioners do "what works." At the societal level, doing what works not only improves health care quality but presumably allows for an efficient allocation of scarce health care resources.31 It is not altogether clear, however, what it means for an intervention to work, and this is the occasion for a third controversy. What does effectiveness mean? EBPs definition of effectiveness (like its definitions of evidence and practice) privileges objectivity; it documents the quantifiable outcome of a standardized intervention. Even RCTs, however, are designed by researchers who make judgments about what effectiveness is, and these decisions are further interpreted by the clinicians who implement the trials.32 Definitions of effectiveness may respond to the mission of a funding agency or the data that are available for analysis, among other things. One review of physiotherapy research found thirty-one trials using twelve different outcome measures; only two were common enough to allow for meta-analysis.33 Were these the best measures of effectiveness? In the field of mental health, the meaning of effectiveness is especially contentious. As noted earlier, Division 12 defines effectiveness first as symptom relief. Varieties of functional dis/ability also figure as treatment outcomes. Some schools of psychotherapy, however, view symptoms as manifestations of underlying mental health conditions. For them, it is possible to eliminate symptoms but not suffering, and this does not amount to effective treatment. One possible effectiveness measure is the patients understanding of what has happened to him or her. Given that many "effective" treatments produce only partial relief, understanding may help patients relate better to their remaining symptoms.34 A simpler example of competing definitions is whether marital therapy is more effective when the partners remain married or when they are most satisfied, and does it depend on whether or not they have young children? In Oregon, "evidence based" has itself come to mean "cost-effective," although the meaning of cost-effectiveness is not very clear. In August 2003 the legislature passed Senate Bill 267, which requires that for the biennium beginning 1 July 2005, a number of state agencies, including those that deal with addiction and mental health, will spend 25 percent of their program budgets on evidence-based programs. The figure rises to 50 percent in 2007 and 75 percent in 2009. Agencies that do not meet this requirement will face budget consequences in the following biennium. According to the legislation, an evidence-based program is one that "(a) incorporates significant and relevant practices based on scientifically based research; and (b) is cost effective." The Oregon Office of Mental Health and Addiction Services offers an operational definition of evidence-based practice: RCTs are at the top of the evidence hierarchy, and except at the lowest level of acceptable evidence, implementation must be measured by a fidelity tool.35 For Oregonians, then, EBP research must include relative cost in its definition of effective treatment. Although effectiveness is a compelling goal, it is not the only one. Patients, for example, may forgo "what works" to avoid inhumane side effects or to preserve the personal meanings they give to health or illness. In mental health, especially, effectiveness can be used to justify coercive treatment of problematic patients. Even the psychiatric recovery movement parts ways with EBP. Recovering mental patients can benefit from information about effectiveness, but at least some see the effectiveness criterion as a possible infringement on their freedom.36 Most mentally ill people want what other people have: houses, jobs, and friends. Effective treatment may or may not be the best means of getting these, and even the most effective means of getting them may not include the value of finding ones own way. Finally, who gets to say what effectiveness is? EBP may create it, but what effectiveness looks like is only specified in the research process. Some proponents of EBP in mental health consider its adaptability to market and political goal setting as a strength.37 So if, in this view, managed care sets as an effectiveness goal fewer mental health episodes in the course of a year, EBP can identify the treatment to achieve this. Mental health care suppliers, including drug companies, and public agencies with large mental health caseloads also set effectiveness criteria. Their agendas are more or less transparent, invite more or less criticism, and are set through a more or less participatory process. In any event, EBP as effectiveness research responds to someones definition of effectiveness, and although it is often treated as self-evident, that definition has profound consequences. Patients values and preferences are putatively part of EBP, but they come into play mostly after the fact; once the effectiveness data have been collected and analyzed, patients may determine whether the "effective" treatment suits them individually. Perhaps this third controversy deserves a mini-hearing whenever EBP researchers state their outcome measures. They should say why they have chosen these measures, and whose interests they represent.
EBP in mental health may be more controversial than EBM. Psychologists may be more diverse or contentious than physicians. Managed mental health care may be more intrusive and rile practitioners more vigorously. The poignant failures of mental health policy may call more loudly for change. On the other hand, EBM is also broadly and deeply debated, and each of the controversies described here pertains to EBM as well.38 First, despite the dominance of the "medical model," medical practice is pluralistic, especially across specialties, and in general medicine there is new interest in the relational aspects of diagnosis and treatment. The same epistemological question arises: Can clinical research be both rigorous and inclusive? Second, EBM researchers do not easily effect behavioral change in medical practitioners, and this is sometimes blamed on the insufficiency of the applied science model. Disagreements about the nature and value of clinical judgment are joined. Third, the definition of medical effectiveness is in dispute. As in mental health, some physicians focus not on symptom relief or functional measures but on the nature of suffering.39 As in mental health, it is not always clear which effectiveness definition applies in a given study or review of studies, or why. Furthermore, both EBM and EBP in mental health participate in vital debate while the policy train is leaving the station. Proponents of EBP lament the difficulty of making policy responsive to evidence, and this is generally true. To the extent that EBP has not resolved its controversies, however, how much and what kind of policy making is called for? One recent policy analysis warned of the potential undesirability of introducing hospital quality standards into malpractice litigation. The authors examine the consequences of promulgating standards based on questionable evidence and say: "We should require especially convincing evidence when the law steps in to demand universal compliance with the standard."40 Implementation of the policies described in this paper deserves close and serious study. Suffice it to say that although they do not demand universal compliance, these policies are authoritative about access to critical services by vulnerable people. The evidence of effectiveness on which they rely is more or less convincing, from an EBP perspective or from others. The District of Columbias evidence-based psychotherapy policy permits only dialectical behavioral therapy (DBT) for people with borderline personality disorder (BPD). These patients represent 1020 percent of all mentally ill people and have high rates of service use, including hospitalization. There is, however, at least one high-quality RCT showing psychoanalytically oriented psychotherapy to be no less effective than DBT at termination and more so afterward; a compilation of clinical guidelines for BPD concludes that different interventions are most effective for different patients.41 Under circumstances like thesewhich are surely not uncommon in clinical sciencewhat authority should accrue to evidence-based policy? In EBM as well as in EBP in mental health, policy may risk unnecessary ineffectiveness and deprivation along with the political encumbrances of confusion and mistrust.
Sandra Tanenbaum (tanenbaum.1{at}osu.edu) is an associate professor in the School of Public Health at the Ohio State University in Columbus. The author acknowledges the help and encouragement of the editors and anonymous referees.
This article has been cited by other articles:
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