Mental Disorders in Primary Care: Epidemiologic, Diagnostic, and Treatment Research Directions* Herbert C. Schulberg, Ph.D. Department
of Psychiatry,
University of Pittsburgh
School of Medicine,
Pittsburgh,
Pennsylvania
Barbara J. Burns, Ph.D. Departmenf
of Psychiaf y,
University of Ma yland
Medical School, Baltimore,
Abstract: An extensive series of investigations over the past 2 decades clearly demonstrate that mental disorders are present in approximatelty 25% of primary care patients and that physicians underdiagnose these illnesses. The factors producing this bias are poorly understood and should be focused upon in future research. Also requiring much more study is the efficacy of pharmacologic and psychosocial treatments initially validated with psychiatric populations. Clinical trials should determine whether standardized interventions can be utilized with medical patients whose symptom profiles and organic comorbidity may differ from those of psychiatric populations.
Introduction Research into the nature of mental disorders in primary care settings is now in its third decade. Despite persisting problems in the design of needed studies, one must be impressed by the field’s vibrancy and diversity. Earlier reviews of primary care research indicate the progress to date [l-3], as well as the optimistic prospects for growing sophistication in the issues to be studied and the methodologies with which they are to be investigated. An anticipated primary care research initiative by the National Institute of Mental Health in 1988 will likely stimulate still further refinements. Given past accomplishments and future funding prospects, what guidelines may be offered with regard to future research directions and prior*A brief version of this paper was presented at “Medical Disorders in General Health Care Settings: A Research Conference,“ cosponsored by NIMH, Univeysity of Washington, and Group Health Cooperative of Puget Sound, Seattle, Washington, June 25-26, 1987. General Hospital Psychiatry 10, 79-87, 1988 Q 1988 Elsevier Science Publishing Co., Inc. 52 Vanderbilt Ave., New York, NY 10017
Ma yland
ities? After presenting a brief overview of the field’s development, we will focus upon three key aspects 01 mental disorders in primary care settings: 1. The epidemiology of such psychiatric morbidity. 2. Physician assessment and diagnostic practices. 3. Treatment strategies and patient outcomes. Findings in each of these areas, factors affecting the interpretation of available data, and procedures for advancing present knowledge will be emphasized.
Historical Overview The seminal work by Shepherd and his English colleagues in stimulating awareness of psychiatric illness among primary care patients can be traced back to the 1960s [4]. More than 2 decades later, activities of their General Practice Research Unit at the Institute of Psychiatry in London remain at the cutting edge of the field. Parallel to the English contributions have been the NIMH-stimulated activities in the United States. These efforts also originated in the late 196Os, a time when this country’s mental-health providers were being pressured to demonstrate the cost-effectiveness of psychiatric care. The initial studies [5,6] responding to these pressures soon evolved into broader analyses about service delivery and quality of care, as well as about the epidemiology of mental illness among medical patients. American primary care studies during the 1970s
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H. C. Schulberg and B. J. Bums
typically were designed by NIMH staff and contracted to economists, statisticians, and health services researchers. They worked with large data sets abstracted from existing medical records and national surveys. As the focus shifted in the late 1970s from concern about service delivery systems to epidemiology and clinical services, investigator-inicontracts. tiated grants started to replace Prospective studies within a single or several health care organizations using quasi-experimental designs, perhaps even a clinical trial, became the dominant methodology. Much of this transition in focus and strategy resulted from the establishment by NIMH of a Primary Care Research Program within the framework suggested by Regier’s 1977 position paper [7]. Indeed, many of the reports published during the past decade [8] represent first and second generation products from the NIMH investment of over $7 million in primary care research. With respect to systems research, perhaps its most critical finding is that almost 60% of the care for mental illness episodes is provided exclusively by general medical providers [9,10]. This data generated much concern about the effects of organizational structure and financing mechanisms on care delivery. Surprisingly, it was found that only slightly more persons turn to mental health specialists even when financial barriers are minimized [ll-131. Concern about the structure of care also led to studies of whether psychiatric treatment can reduce medical utilization. This work has produced mixed results (141. To the extent that cost-offset research is revived, it probably will focus upon the hospitalization experience, where there is a greater potential for significant savings [15]. In terms of studies regarding the prevalence of psychiatric morbidity among primary care patients and the manner in which such disorders are managed, Hankin and Oktay’s literature review comprehensively documented the need for objective diagnostic assessments and quality of care research [16]. We will note shortly that the first study using a standardized psychiatric interview with ambulatory medical patients found that almost one-third had a diagnosable disorder [17]. The recent Epidemiologic Catchment Area studies provide further evidence about the significant prevalence of mental illness in this patient population and their service utilization patterns [ 18,191. A key research area, not reviewed here, consists of the efforts to increase physician recognition of mental illness. These include the training 80
of family practice residents in interviewing techniques [20] and the providing of physicians with feedback on a patient’s psychosocial screening score. Some investigators found that such interventions produce little or no improvement in physician awareness [21,22] but others found that providing information about a specific disorder like depression does enhance the assessment process [23,24]. The somewhat discouraging results from earlier efforts to improve diagnostic practice have emphasized the clinical complexities facing primary care physicians and the need for fresh research directions [25]. During the 198Os, NIMH has therefore, focused, upon specific disorders such as depression [26-281 and somatization [29,30], and upon distinct populations such as children [31,32] and the elderly [33]. In addition to these targeted efforts, NIMH staff have sought to inject a primary care perspective into all diagnostic and treatment activities [34]. This broader strategy is spawning research on the characteristics of psychiatric disorders as they present in primary care versus specialty mental health settings, clinical decisionmaking processes among generalists and specialists, and various related efforts aiming to clarify quality of care issues.
Epidemiology of Psychiatric Morbidity Mental illness rates are derived from varying data sources such as patient self-reports on screening questionnaires, physician assessments, psychiatric interviews, and standardized interview schedules. Initial prevalence estimates relied heavily on physician judgments and patient scores on screening instruments like the General Health Questionnaire. It was thought that the varying prevalence estimates generated by these studies might stem from the differing case definitions utilized by each assessment procedure [35-361. Presently, however, standardized interviews conducted with the Schedule for Affective Disorders and Schizophrenia (SADS), Diagnostic Interview Schedule (DIS), Clinical Interview Schedule (CIS), or the Present State Exam (PSE) constitute the state of the art for establishing a psychiatric diagnosis. Indeed, nine studies have incorporated this more rigorous assessment procedure in formulating a diagnosis of mental illness among primary care patients. A key purpose of standardized interviews is to enhance reliability in the diagnostic decision. Have they, then, produced more uniform prevalence
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rates? A review of the pertinent studies [18,26,3743] indicates that psychiatric morbidity rates still differ markedly, ranging from a low of 11% to a high of 36% (Table 1). Do these three-fold differences reflect true variation among primary care populations, or do they result from persisting problems in classification? Furthermore, since the 6 month prevalence of mental illness among community samples [44] is estimated at 15-20%, are primary care patients at equal or greater risk for persisting psychiatric morbidity [45]? One strategy for exploring whether prevalence rates truly differ is to distinguish studies of American patients from those conducted with patients in other countries. The rationale for doing so is that service delivery structures, particularly gatekeeping practices, vary markedly between countries. When this distinction is made, a slightly narrowed prevalence ranging from 15-31% is obtained in the five U.S. studies [18,26,40,41,43]. Since socio-demographic factors influence the prevalence of mental illness, it is reasonable that a relatively low rate of 22% was derived among medical care users in the representative sample studied in the ECA sites [RX], while the highest rate of 31% was obtained in the study of low SES subjects sampled in Pittsburgh primary care clinics [26]. The four remaining studies utilizing standardized psychiatric assessments were conducted with primary care patients in several different countries [37-39,421. The prevalence findings range from ll-36%, a wide-ranging difference, the basis for which is not readily apparent. It is difficult to determine from these various reports whether, for example, unadjusted sampling factors such as seasonality and the impact of high service utilizers affected prevalence rates. Since standardized interview schedules have not produced consistent prevalence rates, it is possible Table 1. Prevalence
of current psychiatric
Investigator (ref. no.) Bellantuono et al. [37] Cooper [ 381 Harding et al. [39] Hoeper et al. [40] Hough et al. [41] Kessler et al. [18] Schulberg et al. [26] Skuse and Williams. [42] Von Korff et al. [43] Abbreviations: CIS, Clinical Interview DIS, Diagnostic Interview Schedule.
illness estimated
Study site Italy Germany Developing USA USA USA USA England USA Schedule;
that the classificatory system within which each such instrument formulates a diagnosis is responsible for the variation. Thus, differing rates of psychiatric illness may be generated by DSM-III, ICD9, and the multiaxial systems that assess symptoms, personality, and social state. However, no such comparative study has yet been conducted with primary care patients in a single practice setting. In contemplating the design of such a future study, researchers also should ponder whether distinct diagnostic criteria are required when assessing medical patients whose organic illness may relate to, or confound, a psychiatric diagnosis. For example, is it clinically valid to use somatic symptoms in diagnosing depression among medical patients, or should alternative symptoms such as cognitive impairment be substituted for the neurovegetative ones [46]? Another persisting ambiguity about the epidemiology of mental illness is whether symptom clusters in primary care patients resemble or differ from those of patients seeking care in psychiatric facilities. Concern about “disease congruence” has been highlighted by inconsistent findings in studies of depressed patients conducted in England and the United States. English investigators have found that depressives treated in general practice are less severely ill, have briefer illnesses, and display a lower incidence of mood disturbance than psychiatric patients assigned this diagnosis [47-491. In contrast, congruent depressive illness profiles among primary care and psychiatric patients were reported by Coulehan et al. who found that somatic and mood symptoms were described with equal frequency by members of each cohort assigned the diagnosis of major affective disorder [50]. Preliminary analyses by Burns of data from three Epidemiologic Catchment Area Program sites about
countries
from standardized Interview schedule
interview
schedules Prevalence
CIS CIS PSE SADS DIS DIS DIS CIS DIS
PSE, Present State Exam; SADS, Schedule for Affective Disorders
rate %
36’% 33’% ll-17% 27% 15% 22% 31% 24% 25% nd Schizophrenia;
81
H. C. Schulberg and B. J. Bums
major depression found significantly more symptoms in specialty sector patients but no differences between them and general medical patients on such indices as number of prior depressive episodes or age of first episode. The question arises, then, as to whether the differences in symptom profiles for depression reported in the English studies are clinically valid, or whether they result from gatekeeping and more restrictive referral practices in the National Health Service? Alternatively, are the congruent symptom profiles displayed by depressives studied in the Pittsburgh primary care and psychiatric facilities [26] clinically genuine, a sampling artifact, or perhaps a product of the Diagnostic Interview Schedule scoring algorithm that does not identify minor depressions? Further studies are needed, therefore, to determine the extent of variation in mental illness among primary care populations. The last epidemiologic issue to be considered here is the natural course of psychiatric morbidity among ambulatory medical patients. What proportion remits spontaneously and what proportion persists at the level of caseness in the absence of treatment? Furthermore, is the natural course of mental disorders related to a patient’s clinical, sociodemographic, and constitutional characteristics? Such information would clarify the process of mental illness among medical patients and provide baseline measures for determining the efficacy of drug and psychosocial treatments administered to this population. Despite the significance of such issues, few studies have addressed them directly. This is not surprising since explicit assignment to a “no treatment” condition is not usually conceived as clinically appropriate when psychiatric illness is identified in medical patients. Given the absence of direct evidence, one may turn to several studies that indirectly address the natural course of mental illness in primary care patients. In these investigations, psychiatric disorders were unrecognized in the vast majority of diagnosable morbidity and, thus, presumably remained untreated [51-551. The persisting caseness rate, upon follow-up time periods ranging from 6 to 36 months, was found to vary from 21-68%. This three-fold difference possibly stems from the use of patient cohorts with heterogenous psychiatric diagnoses and clinical severity levels. With regard to additional factors that could affect psychiatric outcome, few investigators have analyzed such potential relationships. Mann et al. found that the presence of physical illness 82
surprisingly is not associated with outcome in neurotic disorders [54]. This suggests the need to elucidate further the clinical implications of comorbidity . While the preceding studies include ambulatory medical patients with various psychiatric disorders, other reports focus upon the natural course of depressive disorders in primary care populations. Does diagnostic homogeneity influence rates of caseness of remission upon follow-up? The answer appears to be no. Improvement, in the absence of treatment, was again found to range from 18-70% in several studies restricted to depressed primary care patients 1561. Again, however, many critical factors other than diagnostic homogeneity remained uncontrolled in these investigations, e.g., a patient’s number of prior depressive episodes. Interestingly enough, Schulberg et al. found that a higher number of medical diagnoses is strongly associated with persisting depression [57], even though Mann et al. found no such relationship for comorbidity among neurotic disorders 1541. We conclude that little is known about factors affecting the course of psychiatric morbidity among primary care patients when such illness remains untreated. Equally ambiguous is the natural course of untreated symptomatology among such patients who score above the threshold on psychiatric screening instruments but who fail to meet diagnostic criteria for caseness. What proportion of these patients become asymptomatic, remain highly symptomatic (but at a subclinical level), or develop into diagnosable cases? Also, little is known about patient factors affecting these possible clinical courses.
Physician Diagnostic Practices Given that approximately 25-30% of ambulatory medical patients have a diagnosable mental illness, how accurately is it assessed by primary care physicians? The many investigators studying this issue consistently have found that medical clinicians underdiagnose mental illness. Before suggesting future research that should focus upon patient, physician, and setting factors producing this diagnostic bias, we will briefly update findings regarding “hidden psychiatric morbidity” in primary care practice. Two key methodologic issues affecting studies of physician accuracy are: 1) The range of psychiatric diagnoses about which a clinical judgement is
Mental Disorders in Primary Care
being sought-are physicians more able to indicate the presence of any such morbidity than to ascertain the presence of a particular mental disorder? 2) The criterion measure against which the physician’s formulation is to be compared-does a standardized diagnostic instrument produce different physician agreement rates than do psychiatric interviews or screening measures? With regard to the issue of diagnostic homogeneity, previous studies have focused upon physician assessment of any psychiatric illness, or they have been specifically concerned with depression. In terms of recognizing broader morbidity, Wilkinson reviewed the earlier English studies by Goldwhich found undetected berg and others, psychiatric morbidity in general practice to range from 33%-60% [25]. A recent study of Italian general practice by Bellantuono et al. [37] has again generated a rate at the uppermost end of this continuum under the clinical circumstance of the GP being unobservered by a psychiatrist. In a study of American family physicians, Jones et al. determined that 79% of the psychiatric diagnoses assigned to patients were undetected [58]. Marked underestimates by physicians of patient problem areas and psychosocial distress levels have also been noted. Interestingly enough, Kessler et al. found that failure to recognize SADS-L diagnoses only decreased from 80% to 70% even when the physician’s observation period was extended from 1 to 6 months [55]. How do nonrecognition rates for any psychiatric illness compare with those for depression per se? The latter rates vary across a simiIarly broad range, extending from a low of 20% to a high of 85% [26,42,59-661. An intriguing possibility as to why physicians underassess affective disorders is the finding by Mann et al. that GPs misdiagnosed as anxious many patients whom psychiatrists considered depressed [54]. This suggests the need to distinguish depressive and anxiety disorders when studying physician recognition patterns. Failure to do so may explain why Von Korff et al. obtained the unusually low nonrecognition rate of only 27% among internists assessing these two disorders 1431. We had asked previously whether the criterion measure’s content and psychometric characteristics influence physician recognition rates. The several studies utilizing diagnostic instruments, like the SADS or DlS, have generated hidden morbidity rates in the range of 70-90% [26,40,55,58]. When a psychiatrist’s formulation has constituted the
yardstick, physician nonrecognition ranges from 46-59%. Highly variable rates of nonrecognition were found in those studies using screening instruments as the assessment yardstick since each instrument has differing sensitivity and specificity rates, and positive and negative predictive values. The confounded conclusions that may result from use of screening instruments alone as the criterion for determining physician awareness of psychiatric illness are evident in the study by Hankin and Locke 1631. They concluded that physicians failed to classify as depressed 85% of those patients scoring 16 + on the CES-D, the accepted positivity criterion at the time of their work. Schulberg et al. found that 86% of medical patients scoring 16+ indeed are false positives [26], i.e., they fail to meet DIS criteria for a depressive disorder! Given these persistent findings across study designs, the time is overdue for research on why rather than whether hidden psychiatric morbidity occurs. We suggest that investigators consider the nature of clinical decision making in primary care practice, and also consider characteristics of the interaction that facilitate or patient-physician hinder diagnostic accuracy [67]. Virtually no prior work has analyzed how physicians assess a patient’s presenting complaint to determine whether its etiology is organic, psychological, or both. No studies have yet scrutinized whether and how primary care physicians elicit information, interpret cues, and formulate hypotheses about mental illness in medical populations [68]. Future investigators should also consider that the physician’s problem-solving strategy consists of both cognitive and behavioral elements. The cognitive component includes preconceptions regarding the probability, severity, and treatability of psychiatric and organic illnesses [69]; probabilistic models regarding the utility of screening, laboratory, and treatment procedures [70]; and “conceptdriven perceptions” that increase the likelihood of diagnosing those conditions one is comfortable treating [71]. The influence of cognitive elements could be analyzed through such techniques as protocol analysis, which is used in studies of general problem solving 1721, and/or with the simulation strategies devised to analyze how medical diagnoses are formulated 1731. The behavioral component of a clinical assessment includes interviewing style and other aspect of the physician’s verbal interaction with the patient [74]. Its influence on diagnostic accuracy could be studied with such measures as the Interaction Analysis System for 83
H. C. Schulberg and B. J. Bums
Interview Evaluation (ISIE) developed by the National Board of Medical Examiners to evaluate a physician’s skills [75].
Treatment Strategies and Patient Outcomes Determining the effectiveness of psychiatric interventions with emotionally disturbed primary care patients is most cogent when: 1) physician recognition of psychiatric disorders can be significantly improved; 2) a diagnostic formulation generates specific treatment implications; and 3) the course of illness established for untreated cases constitutes a valid yardstick against which to measure treatment outcomes. Some would argue that one, two, or even all three of these conditions cannot presently be fulfilled [25]. Nevertheless, this framework has heuristic value and it is utilized in the following review of the effectiveness of psychopharmacologic, psychotherapeutic, and combined treatments. In analyzing this literature, it is necessary to consider whether the quality of research designs and the reports within which findings are presented conform to contemporary scientific standards. Is information provided about the setting within which the study was conducted; the criteria for diagnosing psychiatric disorder; characteristics of the study cohort; etc.? Since most follow-up studies with primary care patients fail to meet such standards, the credibility of data reported about the outcome of treated and untreated primary care cohorts is open to question. Turning first to the clinical course of patients treated with medications, numerous placebo-controlled double blind studies with patients in psychiatric settings have demonstrated the efficacy of psychotropic and antidepressant drugs. Given that the severity and course of illness may differ among patients presenting in the specialist and generalist sectors, is it valid to extrapolate outcome expectations from the former to the latter group? The complexity of this issue and uncertainty about its resolution are underscored by the admonition of a 1985 NIMH Consensus Development Panel to not generalize findings about the course and outcome of mood disorders from psychiatric patients to other populations [76], but nevertheless recommending unitary treatment standards for all depressed persons. Given this inherent contradition, what empirical evidence exists about the efficacy
of psychotropic medications with ambulatory medical patients experiencing a psychiatric disorder? To focus this analysis, our critique is restricted to knowledge about the management of depressive illnesses. Studies of treatment efficacy in resolving anxiety and other mental disorders in medical patients are reviewed by Wilkinson [25]. Only a small number of investigators have compared the outcome of treated and untreated cohorts of primary care patients with mood disorders. To the extent that their findings are valid despite the absence of clinical trial design features, what may be concluded about depression’s course among medical patients treated with antidepressant drugs? Approximately 65-86% improve when provided this treatment; approximately l&70% show improvement when not so treated [56]. This pattern parallels that reported in studies with psychiatric patients. What may explain the wide range of spontaneous remission rates among untreated depressed patients? One possibility is that high rates are obtained with patients experiencing an initial depressive episode; in this circumstance, drug treatment would add little to the outcome. Conversely, low spontaneous remission rates possibly were exhibited by patients who already had experienced two or more prior episodes; drug treatment might well benefit this cohort. Further clinical trials, ‘thus, are needed to clarify which medical patients do and do not benefit from antidepressant drugs. Controlling for number of prior episodes of mood disorder would be a crucial design feature in such protocols. Turning to nonpharmacologic approaches for resolving an affective disorder, distinctive rationales and procedures have been developed for this purpose. It is noteworthy that while medical training is predominantly biological in its orientation, internists do express a willingness to utilize psychosocial interventions with depressed patients [77781. Is data available, then, regarding the efficacy of these treatments? We had noted that drug studies with primary care patients suffered from methodologic flaws. However, there are virtually no studies -flawed or unflawed- of psychotherapy’s efficacy in treating depressed medical patients. The prospective controlled trials by Brodaty and Andrews [79] and Klerman et al. [80] of brief psychotherapy’s efficacy in primary care settings included patients with various psychiatric disorders. Their findings cannot be disaggregated for a single disorder alone. In the only study specific to
Mental Disorders in Primary Care
depressed primary care patients, Corney provided nonstandardized “social work help” that included elements of both counselling and practical assistance [Bl]. Therefore, the meaning of her findings as to the efficacy of a distinct psychotherapy in primary care is difficult to discern. The issue once again, then, is the appropriateness of generalizing such findings as that about interpersonal psychotherapy’s effectiveness with psychiatric outpatients [82] to depressed primary care patients. The most complex treatment strategy is that which combines drugs with psychotherapy. Conte’s review of clinical evidence about this approach with depressed patients found that the combined treatments produced an additive effect and were superior to either alone [83]. Virtually all of these trials were conducted with psychiatric patients. Two studies, however, included medical patients as well. Blackbum et al. (84) found little difference between the efficacy of cognitive therapy alone as compared to the efficacy of this treatment plus antidepressants [84]. Teasdale et al. obtained similar results about the value of cognitive therapy alone [85]. They concluded that a purely psychological intervention substantially improves recovery rates among depressed general practice patients. Having reviewed the few available studies about the treatment of depressive disorders in medical patients, what may be concluded about the effectiveness of pharmacologic and/or psychotherapeutic interventions? The supporting evidence is sparse, selective, and methodologically below scientific standards. From the available data, we hypothesize that medical patients with recurrent depressions benefit most when antidepressants are combined with either cognitive or interpersonal psychotherapy; medical patients in an initial episode possibly remit spontaneously or do best with psychotherapy alone. However, the small number of patients studied, the lack of information about the patient’s psychiatric history and medical comorbidity, etc., render the present findings suggestive at best. The need for more extensive, carefully designed clinical trials cannot be overemphasized.
Summary Past research on mental disorders in primary care settings has focused on epidemiologic and diagnostic concerns. Recent studies of the prevalence of psychiatric illness utilize standardized assessment
interviews
to formulate
a diagnosis.
Despite
this methodologic advance, prevalence rates still range from ll-36%. The reasons for this variation in practices within the United States and elsewhere are unclear. Equally ambiguous are the factors leading primary care physicians to underdiagnose mental disorders. Studies are needed of the clinical assessment process and the manner whereby physicians discriminate and interpret patient cues. Little research has been conducted as to whether treatment strategies developed with psychiatric populations are effective with primary care groups as well. Since the latter may have confounding somatic illnesses and the nature/severity of their symptoms profiles may differ from those of psychiatric populations, clinical trials are required to determine what pharmacologic and psychotherapeutic treatments are effective with ambulatory medical patients.
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Direct reprint requests to: Herbert C. Schulberg, Ph.D. Western Psychiatric Institute and Clinic 3811 O’Hara Street Pittsburgh, PA 15213-2593
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