Psychosomatic Medicine 67:S19-S25 (2005)
© 2005 American Psychosomatic Society
Reflections on Depression as a Cardiac Risk Factor
Nancy Frasure-Smith, PhD and
François Lespérance, MD
From the Department of Psychiatry (N.F.-S., F.L.) and School of Nursing (N.F.-S.), McGill University; the Research Center, Montreal Heart Institute (N.F.-S., F.L.); the Department of Psychiatry, University of Montreal (N.F.-S., F.L.); and the Research Center, Centre Hospitalier de l’Université de Montréal (N.F.-S., F.L.), Montreal, Canada.
Address correspondence and reprint requests to Nancy Frasure-Smith, Montreal Heart Institute Research Center, 5000 Bélanger St. E., Montreal, QC, Canada, H1T 1C8. E-mail: nancy.frasure-smith{at}mcgill.ca
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ABSTRACT
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Objective: Major North American cardiology organizations do not currently list depression among the officially recognized cardiac risk factors, yet many behavioral medicine specialists believe depression to be an important risk. We wondered what was missing from the available data.
Methods: The Medline, Current Contents, and PsychInfo databases were used to perform a systematic review of the literature linking depression and depressive symptoms with cardiac disease outcomes. Because of previous reviews, we paid particular attention to publications from 2001 to 2003.
Results: We identified 21 etiologic and 43 prognostic publications that had prospective designs, used recognized measures of depression, and included objective outcome measures. We also identified 79 review articles. In addition to issues of sample size, sample characteristics, and timing of measures, we noted heterogeneity in the definitions of depression, frequent repeat publications from the same data sets, heterogeneity of outcome measures, a variety of approaches for covariate selection, and a preponderance of review articles, all factors that cannot help to convince skeptics.
Conclusions: Despite these issues, the bulk of the data from prospective studies with recognized indices of depression and objective outcome measures is supportive of depression as a cardiac risk factor.
Key Words: depression • coronary disease • risk factors • prognosis
Abbreviations: CHD = coronary heart disease; MI = myocardial infarction.
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INTRODUCTION
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In 2002, the American College of Cardiology convened the 33rd Bethesda Conference to consider cardiac prevention. Ten cardiac risk factors were listed in the report (1), but depression was not among them. Are cardiologists particularly hard to convince, or is there something wrong with the data that has led many behavioral medicine specialists to believe that depression is a cardiac risk factor? To get a broader vision of the issues involved, we searched the Medline, Current Contents, and PsychInfo databases for combinations of the following terms: a) coronary heart disease (CHD), coronary artery disease, ischemic heart disease, myocardial infarction (MI), unstable angina, acute coronary syndrome, coronary bypass surgery, atherosclerosis, sudden death, ventricular fibrillation, or ventricular tachycardia; and b) mortality, survival, or prognosis; and c) depression, depressive symptoms, dysthymia, or mood. Because of very tight space limitations for this review, we focused on the literature since mid-2001, the cut-off for inclusion in an exhaustive review by Kuper et al. (2). We identified 23 articles published between mid-2001 and December 15, 2003, that met the criteria by Kuper et al. (2) of a) using prospective designs, b) 
500 subjects for etiological studies (those involving follow-up of community-based healthy subjects) and 100 for prognostic studies in cardiac patients, c) including "details of precisely which measurement scale was used," and d) reporting "fatal CHD, sudden cardiac death, incident nonfatal MI, incident angina, incident heart failure, and, for prognostic studies only, all cause mortality." However, we limited our review more strictly to include only those studies that reported at least one outcome other than angina or self-reported chest pain, and that used established indices of major depression, or depressive symptoms or measures with recognized depression subscales. We did not include studies that used antidepressant treatment, self-reported treatment of depression, single-item measures, or study-specific measures, or that mislabeled measures of nonspecific distress and screening indices as indices of depression. This restriction reduced the number of etiologic studies before mid-2001 from 22 to 15, and the number of prognostic studies in patients with established CHD from 34 to 26. Our updated search identified 4 etiologic and 16 prognostic publications with recognized measures of depression that have appeared since 2001 (one of these included both etiologic and prognostic data [3], and we have classified it as both), as well as 2 etiologic studies and 1 prognostic study published before 2001, but not included by Kuper et al. (2). The 63 articles (64 etiologic or prognostic reports) are summarized in Table 1.
Issues of sample size, sample characteristics, and timing of measures are important in understanding why some people are not convinced that depression is a cardiac risk factor, and these have been well discussed by others. We also noticed heterogeneity in the definitions for depression, frequent repeat publications from the same data sets, heterogeneity of outcome measures, a variety of approaches for covariate selection, and a preponderance of review articles. We briefly address each of these factors.
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DEFINITIONS OF DEPRESSION
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The ability to accumulate scientific evidence is dependent on the use of standard approaches to definition and measurement. Even restricting our review to the studies with recognized measures of depression revealed a total of 23 different approaches to measurement (Table 1). These counts do not include studies using different cut-off points for the same measure, those using cut-off points versus continuous scores, those operationalizing depression using different combinations of the same measures, or those measuring increases in depression over time versus baseline depression. It is remarkable that with such a variety of measures, multiple etiologic and prognostic studies have demonstrated significant links between depression and outcomes. Although this attests to the robustness of the underlying concept of depression, it is clear that greater standardization of depression measurement would be beneficial. In fact, the National Heart Lung and Blood Institute recently organized a working group to make recommendations about depression measurement in studies of CHD.
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REPEAT PUBLICATIONS
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Of the 63 articles identified, 18 came from databases with at least 2 publications. None of these articles represent actual duplicate publications. They represent analyses over different periods or with different measures or increased or restricted samples, or analyses that evaluate different outcomes. Nonetheless, the interrelatedness of the data sources needs to be considered. Defining independent publications as those representing a single publication from a database, or the first publication with a given sample and measure of depression, results in a total of 45 independent reports, including 15 etiologic and 30 prognostic studies. However, unraveling the interrelationships is not easy, particularly for complicated studies like Established Populations for Epidemiological Studies of the Elderly, which involved four sites with multiple waves of depression assessment and up to 14 years of follow-up for a variety of cardiac-related outcomes. What is clear is that a study that finds no link between depression and mortality over three periods is not the same as three separate negative results, nor is a study that finds a significant relationship over two periods the same as two independent positive studies.
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OUTCOMES
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On average, each of the studies reported 2.8 outcomes (range = 1–13). Although some defined a primary outcome, most did not, and the inclusion of multiple outcomes increases the chance of false-positive results. However, including multiple outcomes facilitates comparison across studies and, provided the outcomes are clearly secondary, is not as big a problem as the number of different ways that outcomes were defined. Our reading is that the studies included a total of 66 different operationalizations of outcome variables. Some studies failed to provide operational definitions for cardiovascular and cerebrovascular deaths and events. Others provided definitions based on International Classification of Diseases codes. However, even when International Classification of Diseases codes were provided, the specific codes used in the definition of outcomes, including CHD itself, varied from study to study. Despite the fact that all-cause mortality is the most easily validated result, it was reported in only 9 (43%) of the etiologic studies and 25 (58%) of the prognostic studies. Other outcomes reported more than once include fatal and nonfatal MI, nonfatal MI, angina, cardiovascular death, fatal CHD and nonfatal MI, all CHD, and heart failure. Several studies also included idiosyncratic composite measures, some of which included revascularization, an outcome that is dependent on symptom reporting and patient and physician preferences and, therefore, like reports of angina, is not among the most objective outcome indicators. A second issue related to outcome measurement involves the sources of the information. The reliance on death certificates to adjudicate the cause of death is problematic (4). In an editorial summarizing research on death certificates, Lenfant et al. (5) concluded that "... In the absence of adequate information, the more narrowly characterized the cause of death on the certificate, the more likely it is to be in error. Thus, more miscodings are likely when the cause of death is listed as acute myocardial infarction or chronic ischemic heart disease than when both of these causes of death are coded as coronary heart disease." We recommend that, when possible, attempts should be made to obtain additional data such as hospital charts, medicare, or insurance claims records, and that studies should establish clear a priori definitions of events including the selection of a primary outcome variable. Although of great theoretical interest, the distinction between arrhythmic or sudden cardiac deaths and other cardiac causes of death is fraught with difficulties because most individuals are not being monitored for arrhythmias when they die. Finally, we believe that the lack of standardization of outcome definitions for etiologic and prognostic studies of cardiac events is as problematic as the lack of standardization of depression measures, and would be an excellent choice for another the National Heart Lung and Blood Institute working group.
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COVARIATES
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Because it is never possible to control for all possible covariates, observational research can always be challenged on the basis of inadequate covariate adjustment. The majority of the studies did not explain the reasons behind their choice of covariates, and the variables selected are highly idiosyncratic, making comparisons of adjusted outcomes difficult. Among those reports that did specify their approach, various stepwise procedures, such as including all of the significant univariate predictors of outcome that remain significant when forced into the same multivariate model, were the most common. Recent simulation studies have shown that stepwise approaches yield unstable models that are highly sample-dependent (6). The perils of these approaches were recently eloquently discussed by Babyak (7), who suggested several alternatives including a priori specification of covariates during study design, limitation of the number of covariates in relation to the number of observed events (minimally 10–15 events are needed per covariate), and, provided the ratio of events to covariates is acceptable, inclusion of all relevant covariates that remain significant at p < .50 in a multivariate model without the predictor of interest. Further, adjustment for covariates that may be on the causal pathway between depression and cardiac outcomes and that may mediate the relationship—for example, smoking and heart rate variability—are not true confounders and require more careful consideration. Finally, many studies have adjusted for other cardiac risk factors like diabetes, obesity, and hypertension to estimate how much of depression’s impact is independent of other risks. However, risk factors tend to cluster, are likely to be highly intercorrelated, and may be involved in multiple interacting causal pathways. This requires the development and cross-validation of elaborate causal models based on studies using repeated measures over time. Further, this statistical exercise is probably of little value for clinical practice. It has recently been argued that the clinical reason for evaluating risk factors is to identify patients in need of intensive modification of all relevant risks, not to determine mathematical estimates of how much each risk contributes in the absence of other risks (8).
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REVIEWS
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We identified 32 review articles published over the 18-month period from mid-2001 through 2003. We repeated the search process and located 47 reviews published before 2001. Figure 1 shows the number of reviews and etiologic and prospective studies in relation to time period. Since 1997, the number of reviews has equaled or exceeded the number of primary publications. One possible explanation is that the heterogeneity of samples, depression measures, outcome measures, follow-up periods, and covariate adjustment approaches makes the literature hard, if not impossible, to summarize in an unbiased way. Many investigators may have been motivated to try to make sense of the data in their own fashion. There is also increasing emphasis on translation of research results to health care providers. The multiplicity of review articles, at least in part, may represent an attempt to educate a variety of health professionals. Finally, the most cynical interpretation is that obtaining funding, performing a study, and publishing results is more time-consuming than writing reviews. However, our experience in writing this review suggests that this is not always the case. Although it would be interesting to know how the ratio of reviews to original articles compares with those elsewhere in cardiology, time and space constraints prevent us from commenting further.
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SUMMARY
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The results of our review are difficult to summarize concisely. Some studies report mean depression scores for those with and without events, some give hazard ratios or relative risks with confidence intervals, others give p values, others only report the standard significance conventions of p < .05 or .01, and still others simply say the results were or were not significant. Adding to this, the complexities of covariate control and measurement described, multiple outcomes, and multiple publications with multiple follow-up periods make an accurate, unbiased summary statement nearly impossible. Kuper et al. (2) dealt with this problem by classifying studies on the basis of the size of the risk estimates after covariate adjustment without consideration for confidence intervals. As they point out, this approach, without consideration for sample size and statistical significance, favors large effect sizes from small samples. It also favors negative results from small studies that are not adequately powered. Instead, we examined the studies using p values 
.05 after covariate adjustment as the indicator of positive results. Although this is also simplistic and ignores the issue of choice of covariates, it nonetheless gives an indication of the robustness of findings.
Of the 15 independent reports of etiologic studies, 11 reported significant p values for the association between depression and some measure of the development of CHD for at least one sex. If we restrict the summary to those etiologic studies that reported all-cause mortality, the results are even more consistent, with seven out of eight studies reporting significant results. For the independent reports from prognostic studies, 19 out of 30 showed significant associations between depression and some measure of prognosis. Restricting this to all-cause mortality, 9 of 19 studies showed significant results. However, all but one of the studies showing no significant association had low power to detect moderate associations between depression and prognosis. Assuming a 30% prevalence for elevated depression symptoms and an overall 1-year mortality of 10%, a sample of more than 600 would be needed to have at least 80% power (two-tailed 
= 0.05) to detect a doubling in risk associated with depressive symptoms (9). Only one prognostic study showing no significant association had a sample size >600 (10), and that study used a measure of depression based on the Minnesota Multiphasic Personality Inventory. When the investigators later repeated their analyses over a longer follow-up period using a better recognized measure, results were highly significant (11).
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CONCLUSIONS
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Despite multiple methodological differences from study to study, the data from prospective adequately powered etiologic and prognostic studies with objective outcome measures and recognized indices of depression are remarkably consistent in their support of depression as a risk factor for both the development of and the worsening of CHD. It is likely that as investigators strive to increase the standardization of their approaches, this evidence will only grow stronger. As other reviews in this supplement attest, there is also no lack of data on plausible biological mechanisms. However, to date, only one trial, Enhancing Recovery in Coronary Heart Disease (12), has attempted to treat depression to improve prognosis. Although it did not succeed in altering prognosis, there are multiple potential explanations, including the relatively low efficacy of current treatments for the relief of depression symptoms. In short, the available data are more than sufficient to justify developing and evaluating better treatments for depression in CHD patients as well as in those at risk for its development.
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NOTES
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In accordance with CME accreditation guidelines, the authors of this article disclosed no real or potential conflicts of interest.
DOI:10.1097/01.psy.0000162253.07959.db
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TOP
ABSTRACT
INTRODUCTION
