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ORIGINAL ARTICLES |
From the Department of Psychiatry (K.E.F., J.A.S., R.M.C.), Washington University School of Medicine, St. Louis, Missouri; Behavioral Medicine Unit and Department of Health Behavior (J.M.R.), University of Alabama at Birmingham, Birmingham, Alabama; Department of Psychiatry (C.B.T.), Stanford University School of Medicine, Palo Alto, California; Department of Preventive Medicine (C.F.MDL.), Rush-Presbyterian-St. Lukes Medical Center, Chicago, Illinois; Department of Psychology (G.I.), University of Miami, Coral Gables, Florida; Department of Biostatistics (M.E.Y.), University of North Carolina, Chapel Hill, North Carolina; Department of Psychiatry (K.R.R.K.), Duke University Medical Center, Durham, North Carolina; and Department of Psychiatry and Behavioral Sciences (R.C.V.), University of Washington, Seattle, Washington.
Address reprint requests to: James D. Hosking, PhD, Collaborative Studies Coordinating Center, Department of Biostatistics CB 8030, University of North Carolina, 137 E. Franklin Street, Suite 203, Chapel Hill, NC 27514-4145.
| ABSTRACT |
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METHODS: In the validity study, the DISH and the Structured Clinical Interview for DSM-IV (SCID) were administered in randomized order to 57 patients. Trained interviewers administered the DISH, and clinicians administered the SCID. In ENRICHD, trained research nurses administered the DISH and recorded a diagnosis. Clinicians reviewed 42% of the interviews and recorded their own diagnosis. The Beck Depression Inventory (BDI) was administered in both studies.
RESULTS: In the validity study, the SCID diagnosis agreed with the DISH on 88% of the interviews (weighted
= 0.86). In ENRICHD, the clinicians agreed with 93% of the research nurses diagnoses. The BDI and the Hamilton depression scores derived from the DISH in the two studies correlated 0.76 (p < .0001) in the validity study and 0.64 (p < .0001) in ENRICHD.
CONCLUSIONS: These findings support the validity of the DISH as a semistructured interview to assess depression in medically ill patients. The DISH is efficient in yielding both a DSM-IV depression diagnosis and a 17-item Hamilton depression score.
Key Words: depressive disorder, psychiatric status rating scales, psychological tests, coronary disease, myocardial infarction.
Abbreviations: BDI = Beck Depression Inventory;; DISH = Diagnostic Interview and Structured Hamilton;; DSM-IV = Diagnostic and Statistic Manual of Mental Disorders, 4th edition;; ENRICHD = Enhancing Recovery in Coronary Heart Disease;; HRSD = Hamilton Rating Scale for Depression;; MI = myocardial infarction;; SIGH-D = Structured Interview Guide for the Hamilton Depression Scale.
| INTRODUCTION |
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| Rationale |
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To identify a suitable interview, we conducted literature reviews, sought the advice of experts in psychiatric interviewing, diagnosis, and epidemiology, and examined a variety of widely used instruments, including the Diagnostic Interview Schedule (DIS) (711), modified versions of the DIS used in previous studies of depression in cardiac patients (12, 13), the Composite International Diagnostic Interview (CIDI) (1417), the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) (18, 19), and the Structured Clinical Interview for DSM (SCID) (2022).
Unfortunately, none of these instruments completely met the requirements discussed above. The DIS was developed for the Epidemiologic Catchment Area Study (23), and the CIDI was used in the National Comorbidity Survey (24, 25) and the World Health Organization study of Psychological Problems in General Health Care (26, 27). Both are suitable for lay interviewers, but they are inflexible and insensitive to change, and they emphasize lifetime rather than current psychopathology. The modified DIS (12) assesses the presence and duration of depression and anxiety symptoms in cardiac patients. It emphasizes current psychopathology, and the symptoms are probed in a different order than on the standard DIS: somatic symptoms are assessed first. Although the modified DIS is for lay interviewers, it is inflexible and insensitive to change, and the diagnosis is determined by clinicians. The World Health Organization SCAN (18, 19) is a complex, minimally structured interview for experienced mental health clinicians. Finally, the SCID (2022) is a widely used, semistructured diagnostic interview. The nonpatient version is used with nonpsychiatric populations, including medical patients, but it is administered by experienced mental health clinicians. Also, if the SCID is administered shortly after an MI, its "past month" duration probes are insensitive to depression symptoms with a post-MI onset.
Even if these instruments had been suitable, they could be used only to diagnose depression, not to measure its current severity. Despite its shortcomings, the Hamilton Rating Scale for Depression (HRSD) (4) is used in most treatment trials to measure depression severity. Its reliability is low even in the hands of experienced clinicians. Williams developed the Structured Interview Guide for the Hamilton Depression scale (SIGH-D) (5) to improve the reliability of the HRSD and to facilitate its use by lay interviewers. Because some of its probes overlap with ones needed to diagnose depressive disorders, sequential administration of the SIGH-D and a diagnostic interview would increase respondent burden. We realized, however, that this could be prevented by integrating the SIGH-D and an interview for diagnosing DSM-IV depressive disorders in medical patients.
| Development of the Interview |
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| Characteristics of the DISH |
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The next section isentitled "Current Depression Symptoms." As shown in Table 1 and Figure 1, it includes the probes needed to diagnose major and minor depression and dysthymia and to rate the severity of depression for the past week on the 17-item Hamilton scale. The items eliminate redundancies between the SIGH-D and DSM-IV probes. DSM-IV symptoms are coded absent, subthreshold, present, or present but due entirely to direct physiological effects of medical illness or its treatment. Symptom duration in weeks is specified in an adjacent column. There is a separate "days" field for symptoms present less than 2 weeks (eg, symptoms with post-MI onset).
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The threshold is very high in DSM-IV for attributing symptoms to medical illness, medication, or substance abuse rather than to depression. In DSM-IV and on the DISH, symptoms count toward depression except if clearly and completely accounted for by the direct physiological effects of a medical condition or medication (eg, weight gain due solely to edema). Symptoms such as fatigue or dysphoric mood rarely meet this stringent test, even in acute MI patients.
The Current Depression items can be administered in the order they appear on the interview form. The first items assess the cardinal symptoms of depression (dysphoric mood and loss of interest or pleasure in usual activities). This facilitates rapid screening of nondepressed patients, but many medical patients are more comfortable if somatic symptoms are assessed first. The order may be varied as needed to facilitate disclosure and rapport.
At the end of the Current Depression section, there is a brief assessment of signs or symptoms of major psychiatric disorders (eg, paranoia, delusions, hallucinations, hypomania, confusion). This is not a comprehensive evaluation but rather a brief screen for severe psychiatric comorbid conditions, such as schizophrenia or bipolar disorders, that are rarely encountered in studies of post-MI patients but that would require exclusion from the trial if present.
The Psychiatric History section concludes the interview. As shown in Table 2, most of the items address past history and treatment of major depression. The number of past episodes, the age at first onset, and the age at onset of the last prior episode are elicited, along with family history of depression. Other items screen for history of bipolar disorder, alcoholism, and other disorders that might necessitate exclusion from the study. This section is not repeated when the DISH is readministered at follow-up. Instead, the Longitudinal Course Chart is used to document the interim course of the depressive disorder (if any) since the baseline interview. The approximate dates of any exacerbations, remissions, relapses, recurrences, or new depressive episodes are recorded.
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| Diagnostic Forms |
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| STUDY 1: CLINICAL VALIDITY ANCILLARY STUDY |
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The ancillary study and ENRICHD samples were mutually exclusive. The participants were cardiology patients at Washington University Medical Center who responded to recruitment flyers or who were approached by study recruiters and who signed an informed consent document approved by the Washington University Medical Center Human Studies Committee. Medical records were reviewed to document heart disease, including 13 (23%) patients with stable coronary disease, 15 (26%) with a history of MI, 9 (16%) with unstable angina, 15 (26%) with cardiomyopathy, 17 (30%) with congestive heart failure, 9 (16%) with an arrhythmia, 6 (11%) with a history of coronary artery bypass graft surgery, and 9 (16%) with a history of coronary angioplasty. The aim was to evaluate the validity of the DISH for patients with various forms of heart disease, not only patients recovering from an acute MI.
Unlike the ENRICHD trial, ancillary study participants were medically stable, had been out of the hospital for at least 2 weeks, and were interviewed in a quiet, secluded interview room. These were more favorable conditions than typical of ENRICHD baseline interviews.
The BDI was administered approximately 10 minutes before the first interview. The order of interview administration was randomized (DISH first in 28 cases; SCID first in 29), and the patients had a 10-minute break between the interviews. The second interviewer was blind to the results of the first interview, and participants were asked to reveal nothing to the second interviewer about the first interview. The DISH interviews were administered by five research nurses and lay interviewers who had studied the DISH manual, completed a 6-hour DISH training course, and had experience with a minimum of three DISH administrations with supervisory feedback before interviewing any study participants. Two interviewers conducted 84% of the interviews. The SCID was administered by a clinical social worker and two clinical psychologists, all with formal training and experience in diagnosing and treating depression in cardiac patients. They also completed the SCID videotape training course (31) and completed at least three practice SCID administrations under supervision of the first author before conducting the study interviews. One interviewer conducted 74% of the interviews. There was no relationship between the DISH and SCID interviewer pairings (p = .61).
Results
The participants (N = 57) were 57 ± 10 years old; 26 (46%) were female and 17 (30%) were African American. The diagnoses were combined into three categories: nondepressed vs. minor depression or dysthymia vs. major depression. The DISH and SCID diagnoses agreed in 88% of the cases (weighted
= 0.81, 95% CI = 0.680.94;
2 = 73.6, p < .0001). Out of seven discordant cases, three were between minor depression and no depression, and four were between minor and major depression (ie, all disagreements were between adjacent categories). The former occurred at lower BDI scores (mean = 9.7) than the latter (mean = 20.0). The diagnoses were then collapsed into two categories, depressed vs. nondepressed, corresponding to how the DISH was used to determine eligibility for ENRICHD. In this analysis,
= 0.89 (95% CI = 0.781.00;
2 = 45.6, p < .0001). With the SCID diagnosis as the criterion and the DISH as the test, sensitivity = 0.94, specificity = 0.96, positive predictive value = 0.97, and negative predictive value = 0.93.
The Pearson correlation coefficient between the BDI and the 17-item HRSD embedded in the DISH was 0.76 (p < .0001). Analysis of variance (ANOVA) was used to compare the BDI and HRSD scores of the DISH diagnosis groups. The BDI scores in the major depression (N = 17), minor depression or dysthymia (N = 13), and nondepressed groups (N = 27) were 24.3 ± 6.9, 19.7 ± 6.6, and 6.1 ± 4.4, respectively (F = 58.7, p < .0001). Post hoc tests showed significant differences among all three groups. The HRSD scores were 21.6 ± 6.6, 13.7 ± 4.1, and 5.6 ± 5.2, respectively (F = 11.7, p < .0001). Subsequent tests again identified significant differences among all three groups.
ANOVA was also used to compare the groups as to the time required to administer the DISH. Including instructions to the patient and the Optional Opening Questions, the DISH required 38 ± 18 minutes for nondepressed patients, 58 ± 18 minutes for patients with minor depression or dysthymia, and 64 ± 20 minutes for patients with major depression (F = 11.7, p < .0001). Subsequent tests showed significant differences between the nondepressed and both depressed groups, but not between the major depression and minor depression or dysthymia groups.
STUDY 2: ENRICHD TRIAL
Methods
The methods and baseline findings of ENRICHD have been reported elsewhere (1, 2). All participants signed informed consent documents approved by the clinical sites institutional review board. We report here on baseline data from ENRICHD concerning the validity of the DISH. Research nurses from eight ENRICHD clinical sites studied the DISH manual, completed two intensive DISH training workshops, and administered at least three DISH interviews under supervision before interviewing study patients. The DISH and the BDI (32) were administered within 28 days of the patients index MI. The nurses were instructed to consult with a clinical supervisor or the first author only if unable to reach an independent diagnosis in especially difficult cases. Consults were requested on fewer than 1% of the baseline interviews. Seventy-eight percent of the interviews were conducted at bedside during the hospitalization; the others were conducted after discharge at the patients residence (9%), an outpatient facility (5%), or elsewhere (8%). Participants were enrolled for depression alone, low perceived social support alone (as assessed by the ENRICHD Social Support Instrument; 1), or both. Because all nondepressed participants had low social support, they are unrepresentative of the nondepressed post-MI population as a whole.
During the first year of recruitment, almost 100% of the interviews were independently reviewed by designated study clinical psychologists or psychiatrists at each clinical site. The purpose of this procedure was to determine the extent to which mental health clinicians with advanced training and experience in psychiatric diagnosis would agree with the nurse-interviewers diagnostic conclusions. The reviewers were given DISH forms that had been completed by nurse-interviewers and asked to read the qualitative notes, inspect the symptom and psychiatric history codes, form diagnostic impressions based solely on the interview material, and code their diagnoses on standardized forms. The reviewers were asked to determine their diagnoses before being unblinded to the nurse-interviewers diagnostic conclusions. Individual clinicians were excused from reviewing any interview on which they been consulted by the nurse-interviewer; in these cases, the review was reassigned to a different clinician. The review requirement was relaxed in the second year because by then most of the nurses had extensive experience with the interview and diagnostic disagreements had become rare. Nurses who joined the staff in year 2 were still required to submit their interviews for review until there was diagnostic agreement in 10 successive cases.
Results
All 2481 ENRICHD participants completed the baseline DISH. BDI scores were obtained from 2456 (99%) and 17-item HRSD scores were extracted from the DISH from 2404 (97%) of these patients.1 The mean age was 61 ±13 years; 44% were female, 34% were racial minorities, and 26% had less than 12 years of education. The most common comorbid medical conditions were hypercholesterolemia (63%), hypertension (61%), cardiovascular disease (45%), and diabetes (33%); 65% had a history of cigarette smoking, and 27% had at least one previous MI.
One thousand thirty-seven (42%) of the interviews were independently reviewed by clinicians. The specific diagnoses agreed in 969 (93%) of the cases, and there was 98% agreement as to whether the patient was depressed (
= 0.95). Table 3 shows that 647 (26%) of the patients were nondepressed and enrolled solely on the basis of low social support. Of the remaining patients, 957 (39%) had major depression, 811 (33%) had minor depression, and 66 (3%) had dysthymia.2
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, F = 405.2, p < .0001), as were the univariate effects of diagnosis on the BDI (F = 539.8, p < .0001) and HRSD (F = 817.5, p < .0001). The covariate (low social support) had a significant effect on the BDI (F = 77.3, p < .0001) but not on the HRSD (F = 3.3, p = .07). On post hoc tests, all groups differed significantly from all other groups on both measures (p < .0001). The HRSD and BDI scores were correlated to test the concurrent validity of the SIGH-D version of the HRSD embedded in the DISH. In previous studies, correlations between BDI and HRSD scores have ranged from 0.61 to 0.87 across a variety of clinical populations (33). Among the 2379 ENRICHD patients with both scores, the correlation was 0.64 (p < .0001.)
| DISCUSSION |
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None of the challenges that necessitated the development of the DISH are unique to the ENRICHD trial. Furthermore, similar challenges will confront investigators of comorbid depressive disorders in other medical patients, such as those with diabetes, cancer, or AIDS. With relatively minor modifications (in particular, with a different set of optional opening questions), the DISH can be adapted for use with these patients.
Limitations of the Studies
Although the ancillary validity study (study 1) was specifically designed to evaluate the concurrent validity of the DISH, the same cannot be said of the ENRICHD trial itself (study 2). The primary purpose of the trials clinical review procedure was to determine whether given the same set of interview data, psychologists and psychiatrists with expertise in psychiatric diagnosis would agree with the research nurse-interviewers depression diagnoses. The procedure was included in the study protocol because of the importance of depression as an eligibility criterion and as an outcome variable. Evaluation of the clinical validity of the DISH was only a secondary aim. Consequently, the review procedure lacked the methodological rigor of studies designed specifically to evaluate the concurrent validity of diagnostic interviews.
The discriminant validity of the DISH (ie, its ability to differentiate between depressive disorders and other psychiatric disorders) and its sensitivity to change have also not yet been studied. The sensitivity of the HRSD to change is well established, but the sensitivity of the DISH to remission of DSM-IV depressive disorders deserves further investigation.
Neither the interrater reliability nor the test-retest reliability of the DISH were evaluated in either study. The reliability of instruments such as the DIS that are used in epidemiological studies is maximized by eliminating as much variance as possible in the administration of the interview. Nearly all questions are mandatory, and they are presented in an invariant order. These techniques could have been used to maximize the reliability of the DISH, but only at the expense of its clinical validity and of the willingness of some patients to be interviewed at all. Because the DISH is a flexible, semistructured interview, reliability analysis is a high priority for further research.
Limitations of the DISH
It is often quite difficult for interviewers to distinguish between threshold and subthreshold symptoms, especially for features that are mild or that fluctuate from day to day. This is a source of error variance at the item level on the DISH that can be minimized by rigorous training and quality assurance efforts, but it probably cannot be eliminated.
Symptoms that seem to be due to the medical illness also pose a dilemma. A symptom counts toward a depression diagnosis unless there is clear evidence that it is due entirely to the direct physiological effects of the medical condition. Many symptoms, however, cannot be so easily disqualified. Interviewers are often reluctant to count ambiguous symptoms such as fatigue unless there is some affirmative evidence that they actually are due, at least in part, to depression. The interviewers decision about whether to count such symptoms may be context-dependent: If cognitive or affective symptoms such as dysphoria are present, it may be easier for the interviewer to believe that somatic symptoms such as fatigue might also be due to depression. This may reflect good clinical judgment, but it is technically at odds with the rules of DSM-IV. It is another source of error variance at the item level. Uncertainty about whether to count ambiguous symptoms may also contribute to inaccurate diagnoses.
Some patients can recall the durations of their depressive symptoms with great precision, especially if they were precipitated by a salient, discrete event. Many patients, however, provide only vague descriptions of symptom durations or onsets, and some give very confusing, inconsistent estimates. Furthermore, the temporal relationship between acute stressors and depressive episodes varies considerably across individuals. An acute MI can precipitate the onset of depression in patients who were not depressed before their MI. If such patients are interviewed during the index hospitalization, as in ENRICHD, the duration of depressive symptoms may be less than the 2-week minimum required by DSM-IV, and the stability of the diagnosis becomes a matter of concern. In other cases, the onset of some or all of the depressive symptoms precede the MI by weeks, months, or even years. For these patients, the MI might have exacerbated existing depressive symptoms, masked them, or had no discernible effect on them. In short, it may be even more difficult to determine symptom and episode durations in studies of comorbid depression in hospitalized medical patients than it is in studies of stable medical outpatients, psychiatric patients, or community populations. The reliability of symptom and episode duration data on the DISH should be studied.
| CONCLUSION |
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| ACKNOWLEDGMENTS |
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| NOTES |
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2 These figures are not interpretable as prevalence estimates because patients who screened negative both for depression and inadequate social support were excluded from participation. ![]()
Received for publication May 22, 2001.
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