Health Complaints and Outcome Assessment in Coronary Heart Disease JOHAN DENOLLET, PH.D. Research on coronary heart disease (CHD) lacks sensitive outcome measures. Health complaints, although subjective in nature, may provide information on the degree of recovery from CHD. The purpose of Study 1 was to identify common health complaints in a group of 535 men (mean age, 57.5 years) with CHD. In the weeks after a coronary event, they frequently reported somatic (e.g., chest pain, dyspnea, fatigue, sleep problems) and cognitive (e.g., concern about health and functional status) health complaints. Statistical analyses produced the Health CompJaints Scale (HCS), which comprises 12 somatic and 12 cognitive complaints. Confirmatory factor analysis provided evidence for the model undergirding the HCS, and the somatic and cognitive scales of the HCS were found to have high internal consistency (a > .89), adequate test-retest reliability (r > .69), and good construct validity. Study 2 provided evidence for the idea that the HCS can be distinguished from standard scales of psychopathology. Statistical analyses in 266 men with CHD indicated that, compared to symptoms of psychopathology, the HCS scales displayed discrete factor loadings as well as higher scores at baseline and a normal clustering of scores. Important to note, HCS scores decreased in 60 subjects participating in cardiac rehabilitation (p < .0001) but not in 60 control subjects. Although research should not disregard psychological biases on symptom reporting, it is argued that health complaints need to be accurately assessed in CHD patients. Key words: coronary heart disease, health complaints, outcome assessment, quality of life, cardiac rehabilitation. INTRODUCTION Outcome assessment in medical settings is a matter that will receive considerable attention in the coming years (1). It is important that health care professionals have finely tuned, sensitive measures in order to keep track of the impact of chronic disease on functional status and well being and to monitor the effects of their care on these outcomes (2). Research on recovery from coronary heart disease (CHD), however, lacks standardized instruments for measuring psychological constructs that match the theoretically prescribed effect of treatment in this population (3). That is, standard distress scales predominantly measure the stable disposition to experience negative emotions (i.e., negative affectivity) in patients with CHD (4) and thus are less sensitive to change. Scales that were specifically designed for patients with CHD may be more appropriate to assess psychological effects of treatment (5). Of note, findings from the Medical Outcomes Study indicate that CHD is a medical condition that has a significant impact on the patient's perceived health status (2). Decrements in perceived health, in From the University Hospital of Antwerp, Antwerp, Belgium. Address reprint requests to: Johan Denollet, Ph.D., UZA — Cardiale Revalidatie, Wilrijkstraat, 10, B-2650 Edegem, Belgium. Received for publication March 26, 1993; revision received October 25, 1993. Psychosomatic Medicine 56:463-474 (1994) 0033-3174/94/5605-0463S03.00/0 Copyright © 1994 by (he American Psychosomatic Society turn, are intimately linked to psychosocial morbidity associated with CHD, including the likelihood of seeking medical care (6) and failure to return to work (7). In fact, one of the primary goals of health care for these patients is to enhance daily functioning (8). It follows that health complaints, although not always paralleling the seriousness of CHD, may provide information on the degree of psychosociaJ recovery from CHD. Therefore, this paper addresses the assessment of health complaints in the context of CHD. Study 1 focused on the prevalence of health complaints and the construction of a new scale. Study 2 focused on the rationale for using health complaints as an outcome measure in CHD. STUDY 1: ASSESSMENT OF HEALTH COMPLAINTS First, the assessment of health complaints should be relevant from a theoretical point of view. Accordingly, a limited number of somatic and cognitive symptom clusters, rather than a heterogeneous conglomerate of symptoms, were studied. Somatic health complaints focused on "cardiopulmonary problems," "fatigue," and "sleep problems" symptom clusters. These health complaints have been associated with myocardial infarction and cardiac death (9-13) and with coronary risk factors, such as hypercholesterolemia (14). Cognitive health complaints focused on the "health worry" (i.e., anxious concern about health) and "illness disruption" (i.e., 463 J. DENOLLET concern about the extent to which illness interferes with one's life) symptom clusters that were identified in the psychometric analysis of the illness behavior concept (15). Self-ratings of poor health (16) and functional status (17) have been associated with mortality. Second, the assessment of health complaints should also be relevant from the patient's point of view. Accordingly, research needs to identify health complaints that occur frequently in patients with CHD. Traditional psychometric measures may be burdensome for nonclinical (with respect to mental health) populations to complete on a frequent basis (18). The more burdensome the scale, the greater likelihood of poor response rate or quality of data (19). Health complaints with a high frequency of endorsement, however, are likely to comprise a measure that may be perceived as being immediately relevant to patients with CHD. The purposes of Study 1 were to: a) identify somatic and cognitive health complaints that occur frequently in patients recovering from a coronary event; and b) devise, on this basis, a psychometrically sound scale of selfreported health complaints in CHD. Specifically, the focus was on the primary factors (i.e., the a priori defined symptom clusters) and their relationship to the second-order construct of self-rated health in the context of CHD. METHOD Subjects Subjects were 535 men with CHD drawn from four hospitals in the Dutch-speaking part of Belgium: the University (N = 341), Middelheim (N = 105) and Saint Jozef (N = 16) hospitals in Antwerp, and the Maria's Voorzienigheid Hospital (N = 73) in Kortrijk. Subjects of the University Hospital were referred by their attending physician to an outpatient rehabilitation program; subjects from the other hospitals either participated in homebased cardiac rehabilitation or received standard medical care. The mean age was 57.5 years (SD = 8.6). All subjects agreed to participate in the study and filled out questionnaires at 3 to 6 weeks after the incidence of myocardial infarction {MI, N = 126), coronary artery bypass surgery (CABG, N = 324), or percutaneous transluminal coronary angioplasty (PTCA, N = 85). Assessment of Health Complaints An initial item pool of 20 somatic and 20 cognitive health complaints was based on: a) items that were derived from the Illness Behavior Questionnaire (20), the Heart Patients Psychological Questionnaire (21), and the SCL-90 (22); and b) items that were specifically written for the purpose of this study. The Illness Behavior Questionnaire predominantly taps cognitive modes of responding to one's state of health (15). The Heart Patients Psy- 464 chological Questionnaire comprises items that address the discrepancy between the time before and after onset of an acute coronary event. The SCL-90 contains a number of cardiopulmonary complaints and one item that reflects concern with global health. Subjects were asked to rate how much they had been bothered lately by each health complaint on a 5-point scale of distress ranging from 0 (not at all) to 4 (extremely). In order to provide a representative picture of relatively enduring changes in subjective health, "lately" was used as a temporal reference. The time frame depends on the researcher's interest. If one wishes to assess rapid changes in a patient's condition that are associated with particular events (e.g., CABG) a more specific time frame (e.g., past week) may be used. Statistical analyses in a subset of 205 subjects were used to reduce the initial item pool; health complaints with a high endorsement frequency, factor loading, and corrected item-scale correlation were retained. Health complaints with too much redundancy were deleted. An intermediate 30item scale was administered to a second subsample, and further analyses produced 12 somatic and 12 cognitive items, each describing a common health complaint. Construct Validity The following scales were used to examine the construct validity of the self-reported health complaints. The disability scale of the Heart Patients Psychological Questionnaire (21) was predicted to correlate positively, and the well being scale to correlate negatively with health complaints. Health complaints were also validated against three broad and stable personality traits: negative affectivity, self-deception, and social inhibition. Negative affectivity is the tendency to experience somatic and emotional distress (23) and is assessed well by the trait scale of State-Trait Anxiety Inventory. The Dutch adaptation of this scale (24) was predicted to correlate positively with self-reported health complaints. Self-deception and social inhibition are two traits that are distinctly different from negative affectivity. Self-deception is the tendency to remain unaware of unpleasant emotional realities and is assessed well by the Marlowe-Crowne scale (25). Social inhibition is the tendency to inhibit one's feelings and behaviors and is assessed well by the social inhibition scale of the Heart Patients Psychological Questionnaire (21). Importantly, these self-deception and social inhibition measures were predicted to be largely unrelated to self-reported health complaints. Procedure and Statistical Analysis All subjects filled out a questionnaire comprising the somatic and cognitive symptom clusters that were devised on theoretical grounds. In order to isolate items with a high frequency of endorsement, the frequency distribution of each health complaint was calculated. The self-reported health complaints were analyzed on two levels in the hierarchy of constructs: the first-order level where each item is more or less an alternate form of each other item and the second-order level that is defined by the intercorrelations among symptom clusters (26). Confirmatory factor analysis was used to examine the accuracy of both the firstorder (i.e., specific symptom clusters) and second-order (i.e., general construct of self-rated health as defined by intercorrelations among symptom clusters) a priori model. Important to note, one can develop a test of the model's fit with this statistical method. LISREL VI was used for this purpose (27). Exploratory factor Psychosomatic Medicine 56:463-474 (1994) HEALTH COMPLAINTS IN CHD analysis was used to examine the intercorrelations among somatic and cognitive health complaints. Scree plot and eigenvalue criteria were used to decide on the optimum number of factors to retain. Cronbach's a was used to obtain internal-consistency estimates of reliability of the scales that emerged from these analyses. Pearson's correlations and exploratory factor analysis were used to examine the construct validity of the self-reported health complaints. RESULTS AND DISCUSSION Assessment of Health Complaints The majority of somatic health complaints were marked positively (i.e., score > 0) in at least 50% of the cases (Table 1). A confirmatory 3-factor solution indicated that of the 12 somatic health complaints, five were related to the "cardiopulmonary," four to the "fatigue," and three to the "sleep problems" a priori symptom clusters. The goodness of fit index for this first-order model of somatic complaints was .92. Cronbach's a indicated an adequate level of internal consistency for each of these symptom clusters (a = .80, .91, and .89, respectively). Exploratory factor analysis of the 24 somatic and cognitive health complaints yielded two factors that accounted for 56% of the total variance. Scree plot indicated that eigenvalues tended to level after the second factor. All of the somatic health complaints had their highest loading on Factor II. Accordingly, corrected itemtotal correlations indicated that cardiopulmonary complaints, fatigue, and sleep problems tended to go together in this population of coronary patients (a = .89). Eleven cognitive health complaints were marked positively (i.e., score > 0) in at least 50% of the cases (Table 2). A confirmatory two-factor solution indicated that six cognitive complaints were related to the "health worry" and six to the "illness disruption" a priori cluster. The goodness of fit index for this first-order model of cognitive complaints was .90. Cronbach's a indicated an adequate level of internal consistency for both the "health worry" and "illness disruption" symptom clusters (a = .92 and .91, respectively). Further, exploratory factor analysis of the 24 health complaints showed that all of the cognitive health complaints had their highest loading on Factor I. Cronbach's a indicated a high level of internal consistency (a — .95), and 11 cognitive complaints had corrected item-total correlations greater than .70. In general, these findings suggest the psychometric soundness of the a priori symptom clusters that were conceptualized for the assessment of health complaints at the first-order level. Consistent with the higher order model of perceived health, the somatic and cognitive symptom clusters were found to be highly intercorrelated, and confirmatory factor analysis indicated the existence of one, single second-order construct (Table 3). The goodness of fit index for this second-order model was .92. Corrected item-total correlations and Cronbach's a (.84) provided further evidence for the existence of a general, broad, second-order factor. TABLE 1. Frequency of Endorsement, Factor Loading, and Internal Consistency of Somatic Health Complaints [N = 535) Item N A Priori Symptom Clusters Frequency of Endorsement1 Confirmatory Factor Analysis* L1 A10. A9. A2. A6. A7. Pain in heart or chest Shortness of breath Tightness of the chest Inability to take a deep breath Stabbing pain in heart or chest 52% 51% 50% 43% 36% A4. A11. A3. A8. Fatigue Feeling weak Feeling that you are not rested Feeling exhausted without any reason 69% 66% 57% 49% A1. A5. A12. Sleep that is restless or disturbed Trouble falling asleep Feeling you can't sleep 64% 60% 49% L2 L3 .67 .72 .70 .67 ..56 .87 .81 .82 .88 .76 .88 .93 Exploratory Factor Analysis* Internal Consistency* I II .21 .22 .22 .16 .21 .60 .61 .58 .59 .50 .55 .56 .55 .51 .47 .45 .46 .38 .38 .64 .61 .68 .69 .69 .67 .71 .73 .12 .07 .08 .63 .67 .66 .55 .57 .57 ' Mean = 54%. •Analysis of the 12 somatic health complaints; L1-L3, Lisrel estimates (maximum likelihood). ' Analysis of the 24 somatic and cognitive health complaints; l-ll, extracted factors; items assigned to a factor are in boldface; eigenvalue 1 = 2.33. * Corrected item-total correlations for the Somatic Complaints scale; Cronbach's a = .89. Psychosomatic Medicine 56:463-474 (1994) 465 J. DENOLLET TABLE 2. Frequency of Endorsement, Factor Loading, and Internal Consistency of Cognitive Health Complaints [N = 535) Confirmatory Item .. N * D• •c . r-, A Priori Symptom Clusters Frequency of , ' , c Endorsement" Exploratory Factor Factor B11. B3. B8. B6. B12. B1. Worrying about health Being afraid of illness Something serious is wrong with body The idea that you have a serious illness All worries over if physically healthy Bad health is the biggest problem in life 71% 59% 56% 52% 52% 51% Analysis* /Midiys.1;. L2 L1 .83 .77 .88 .84 .76 .83 B4. B9. B5. B7. B2. B10. Able to take on much more work formerly No longer worth as much as used to be Feeling blocked in getting things done Feeling you are not able to do much Not being able to work fluently Feeling despondent 78% 76% 75% 70% 66% 49% .82 .82 .84 .78 .76 .74 Analysis' ""d'"bl:> I II .79 .22 .76 .16 .84 .17 .82 .16 .75 .22 .80 .17 .73 .79 .70 .63 .61 .63 .29 .25 .39 .47 .45 .48 Internal rJ Consistency' .78 .71 .81 .77 .74 .76 .74 .79 .77 .72 .69 .72 8 Mean = 63%. 'Analysis of the 12 cognitive health complaints; L1-L2, Lisrel estimates (maximum likelihood). ' Analysis of the 24 somatic and cognitive health complaints; l-ll, extracted factors; items assigned to a factor are in boldface; eigenvalue = 11.03. * Corrected item-total correlations for the Cognitive Complaints scale; Cronbach's a = .95. TABLE 3. Intercorrelation Matrix and Secondary Factor Analysis of the Five A Priori Symptom Clusters (N = 535) IntercomNation Matrix* 2. 3. 4. 5. Confirmatory Factor Analysis1 Internal Consistency* .60 .34 .43 .43 .54 .35 .55 .73 .37 60 .77 .41 .59 .73 .44 .78 .80 .96 .70 .83 A Priori Symptom Clusters Somatic 1. Cardiopulmonary problems 2. Fatigue 3. Sleep problems Cognitive 4. Health worry 5. Illness disruption * All correlations, p < .001. ' Lisrel estimates (maximum likelihood). ' Corrected item-total correlations for the second-order factor of perceived illness; Cronbach's a = .84. Because the five a priori symptom clusters were found to measure a common dimension of perceived health, this list of items was termed the Health Complaints Scale (HCS) (Fig. 1). In further analyses, HCS items were summed to obtain somatic and cognitive health complaint scores that are situated on the intermediate level of assessment that spans the hierarchical levels of first-order and secondorder constructs (26). Construct Validity of the Health Complaints Scale Correlations in the range of .54 to .66 indicated that the somatic and cognitive health complaints scores (range, 0-48) of the HCS shared 30 to 50% variance with the disability and well being scales of 466 the Heart Patients Psychological Questionnaire (Table 4). The HCS scales were also associated with the tendency to experience distress as measured by the negative affectivity scale (r = .53 and .60, respectively). Furthermore, the HCS was largely unre lated to measures of self-deception and social inh i b i t i o n (i.e., correlations in the range of .15 to .20). I n k e e p i n g w i t h t h e s e findingS( exploratory factor analysis yielded somatopsychic distress, self-deception, and social inhibition dimensions. In general, these findings revealed a remarkably consistent pattern of convergent and discriminant validity of the somatic and cognitive health complaints scales. Clearly, male patients frequently experience health complaints in the weeks after MI, CABG, or PTCA. Patients with a spontaneous coronary event (e.g., MI) reported less somatic complaints (M = 9.4, Psychosomatic Medicine 56:463-474 (1994) HEALTH COMPLAINTS IN CHD HCS Name: Sex: Date: Age: Below are a number of problems and complaints that ill people often have. Please read e a c h item carefully and then circle the a p p r o p r i a t e n u m b e r next to that problem. Indicate how much each problem has b o t h e r e d you lately. Please use the following scale to record your answers. 0 SOI \ l M l 1 \ I II I I I - l;ll 2 M O D I |{ \ l l Lately, how much were you bothered by the following specific problems : 3 .H III \ lill Lately, how much were you bothered by the following general problems : Sleep that is restless or disturbed 0 1 2 3 Dl The idea that your bad health is the biggest problem in your life 1 2 3 Tightness of the chest 0 1 2 3 4 02 Not being able to work fluently, also with hobbies 1 2 2 Feeling that you are not rested 0 1 2 3 4 Fatigue 0 1 2 3 4 m The idea that you were able to take on much more work formerly Trouble falling asleep 0 1 2 3 4 D5 Feeling blocked in getting things done -» 0 1 2 3 4 Inability to take a deep breath 0 1 2 3 06 The idea that you have a serious illness 0 1 2 3 Stabbing pain in heart or chest 0 1 2 3 4 Feeling you are not able to do much 1 2 3 A8 Feeling exhausted without any reason 0 1 2 3 4 The 'idea that something serious is wrong with your body 1 2 3 4 A9 Shortness of breath 0 1 2 3 4 Feeling you are no longer worth as much as you used to be 12 3 '° Pain in heart or chest 0 1 2 3 4 Feeling despondent 0 1 2 3 4 Feeling weak 0 1 2 3 4 Worrying about your health 0 1 2 3 4 Feeling you can't sleep 0 1 2 3 4 Thinking that all your worries would be over if you were physically healthy 0 3 A Being afraid of illness 1)12 - ^ • 0 1 2 3 4 - ^ 0 1 2 3 4 0 1 2 4 4 Fig. 1. The Health Complaints Scale. Psychosomatic Medicine 56:463-474 (1994) 467 J. DENOLLET TABLE 4. Intercorrelation Matrix and Factor Loading of the HCS, HPPQ, STAI, and MC Scales [N = 535) Intercorrelation Matrix * HCS 1. Somatic complaints 2. Cognitive complaints HPPQ 3. Disability 4. Well being STAI 5. Negative affectivity MC 6. Self-deception HPPQ 7. Social inhibition 5. Exploratory Factor Analysis' Factor 1 Factor II .15 .20 .82 .87 -.03 -.05 .02 .08 -.11 .23 .27 -.13 .75 -.83 .07 .21 .24 .00 -.29 .21 .72 -.37 .12 .00 -.10 .96 .01 .12 -.01 .98 3.46 1.05 0.89 2. 3. 4. .67 .54 .59 -.55 -.66 .53 .60 -.15 -.15 -.54 .41 -.67 Eigenvalue 6. 7. Factor III HCS, Health Complaints Scale; HPPQ, Heart Patients Psychological Questionnaire; STAI, State-Trait Anxiety Inventory (Dutch adaptation of the trait form); MC, Marlowe-Crowne scale. * All correlations: p < .01, except r = .00: not significant. f Loadings of scales that are assigned to a factor are in boldface. SD = 8.6) than patients who underwent CABG or PTCA (M = 11.8, SD = 8.8, F(l,533) = 7.12, p < .01). On a cognitive level, however, neither group of patients experienced significant differences in subjective health status (F(l,533) = 0.27, p = .60). Consistent with the findings of Study 1, by far the most common problem reported by the subjects in the Ischemic Heart Disease Life Stress Monitoring Program was concern about the impact of CHD on their life (28). Not surprisingly, 80% of the interventions in this trial focused on the implications of chest pain, dyspnea, and fatigue. Factor analytic techniques in the present study clearly identified the somatic and cognitive symptom clusters of cardiopulmonary problems, fatigue, sleep problems, health worry, and illness disruption. With reference to this issue, the variables measured by the HCS can be situated on different levels in the hierarchy of constructs (26). At the lowest level of this hierarchy (i.e., the level of the a priori defined symptom clusters) each item is more or less an alternate form of each other item. At the intermediate level of the hierarchy (i.e., the level of somatic vs. cognitive health complaints) some of the defining items for the factor are alternate-forms types of items, but there are other items with substantial loadings that are not. At the highest level (i.e., the level of intercorrelations among the various symptom clusters) the five variables that define the second-order construct of perceived health are correlated, but they are not alternate forms of one another in their apparent logical content. Depending on the researcher's interest, the symptom clusters of 468 the HCS can either be scored separately (assessment of specific first-order constructs) or can be aggregated to obtain somatic and cognitive scores (assessment of more global constructs) or one single score that reflects perceived health status (assessment of one global second-order construct). In this study, perceived health was measured at the intermediate level of somatic and cognitive health complaints. On the whole, the HCS appeared to be a reliable and valid measure of health complaints in men with CHD. However, given the fact that there already exist a large number of widely used distress scales, it is important to answer the question why a new scale is needed. The purpose of Study 2 was to address this central issue somewhat more in detail. STUDY 2: HEALTH COMPLAINTS VS. PSYCHOPATHOLOGY There appears to be a tendency to use familiar instruments, even if these instruments are less appropriate for the target population or the therapeutic intervention under investigation. However, the quality of outcome assessment depends heavily on the theoretical relevance, the appropriateness, and the responsiveness of the instruments used. Problems with standard distress scales in the context of CHD may include measurement of wrong constructs (3), lack of cover of relevant aspects (29), and a limited range resulting in floor/ceiling effects (30). For example, previous research suggests that Psychosomatic Medicine 56:463-474 (1994) HEALTH COMPLAINTS IN CHD standard measures of psychopathology may be less appropriate to assess change in coronary patients (target population) as a function of rehabilitation (therapeutic intervention) (3). Measures that match the theoretically prescribed effect of cardiac rehabilitation (i.e., enhancement of subjective health and well being) are more appropriate to assess change in this context. In other words, identifying appropriate measures of key constructs is an important factor in outcome assessment. Considerable difficulties may also arise because many instruments are based on what health care professionals regard as important and take little account of the patient's view about what is important (29). Items that are perceived as being relevant to the patient's situation may comprise a measure that is appealing to complete. The more burdensome the instrument, the greater likelihood of it not being completed. Finally, responsiveness (i.e., sensitivity to changes in what is being measured) is a crucial requirement in quality of life research (31). The major flaw with the method of defining quality of life by the absence of psychopathology is that this approach does not provide for supranormal levels of functioning and therefore can lead to underestimates of actual changes in quality of life. Therefore, evidence should be provided for the notion that the HCS can be distinguished from standard scales of psychopathology. Because the HCS and SCL-90 have the same item-format (a list of symptoms) and response-format (a 5-point scale of distress), differences in construct validity, distribution of scores, and responsiveness among these measures are likely to reflect differences in content: health complaints vs psychopathology. It is important to note that research has shown that the SCL-90 is not sufficiently sensitive in the context of cardiac rehabilitation (3). The purpose of Study 2 was to examine: a) the construct validity of health complaints vs. symptoms of psychopathology; b) differences in baseline scores of health complaints and psychopathology; and c) changes in health complaints as a function of cardiac rehabilitation. METHOD Subjects and Measures The study population consisted of two groups of men with CHD. The first group was a subset of 266 subjects of Study 1 who completed the Dutch adaptation of the SCL-90 (32). This adaptation of the SCL-90 comprises seven symptom dimensions that closely resemble those of the original version (22): somatization, obsessive-compulsive behavior, interpersonal sensitivity, depres- Psychosomatic Medicine 56:463-474 (1994) sion, anxiety, hostility, and phobic anxiety. The second group consisted of 120 men [mean age, 56.3 years) with CHD (MI N = 55, CABG N = 48, PTCA N = 17) who participated in an ongoing trial of cardiac rehabilitation (3, 5). In brief, 60 of these 120 subjects received standard medical care at the Maria's Voorzienigheid Hospital of Kortrijk, and 60 subjects completed the rehabilitation program of the University Hospital of Antwerp between July 1989 and December 1990. This 3-month program included exercise training, health education, and individual psychosocial counseling. The second group of subjects was used to examine the responsiveness of the HCS because previous research indicated that rehabilitation subjects, but not control subjects, experienced significant improvements in perceived health status (3) and subjective well being (3, 5). Because the cardiac rehabilitation program is doing what it is claiming, the HCS scales should be sensitive to changes in perceived health status that are associated with this program. Procedure and Statistical Analysis Pearson's correlations and exploratory factor analysis were used to examine the relationship between the HCS and SCL-90 scales (N = 266). Next, descriptive characteristics (mean, median, quartiles, kurtosis, skewness) of both measures were examined. In this analysis, a median split on the Trait Anxiety Scale (24) classified subjects as being high (N = 131) or low (N = 135) in their tendency to experience distress. The 120 subjects that participated in the rehabilitation trial filled out the HCS scales again at 3 months after the initial assessment (i.e., at the end of rehabilitation in the experimental group). Repeated measures MANOVA, with rehabilitation as between-subjects factor and time as within-subjects factor, was used to analyze changes in HCS scores. Finally, test-retest reliability was examined in the 60 control subjects receiving standard medical care alone. RESULTS AND DISCUSSION Correlations that were mostly in the range of .50 to .70 indicated that the HCS and SCL-90 scales shared 25 to 55% of variance (Table 5). Exploratory factor analysis yielded two dimensions (eigenvalues > 1.0) of subjective distress. Factor I was largely defined by the SCL-90 scales, whereas Factor II was defined by scales that were specifically designed for cardiac patients. Of note, the SCL-90 scales predominantly reflected a general and broad dimension of psychological distress in this population of coronary patients. Despite the fact that both distress measures have the same format, the HCS and SCL-90 appeared to have a related, but not an identical, scope. This finding corroborates the idea that the health complaints of the HCS can be distinguished jrom symptoms of psychopathoJogy in patients with CHD. The strong factor loadings of the HCS and the Heart Patients Psychological Questionnaire indicated that these instruments were measuring a similar construct. 469 J. DENOLLET TABLE 5. Intercorrelation Matrix and Factor Loading of the HCS, HPPQ, and SCL-90 scales (N = 266) Exploratory Factor Analysis1 Intercorrelation Matrix* HCS 1. Somatic Complaints 2. Cognitive Complaints HPPQ 3. Disability 4. Well-Being SCL-90 5. Somatization 6. Obsessive-Compulsive 7. Interpersonal Sensitivity 8. Depression 9. Anxiety 10. Hostility 11. Phobic Anxiety 5. 6. 7. 8. 9. -.63 -.69 .74 .68 .63 .66 .51 .58 .61 .71 .66 .74 .39 .39 .44 .60 .40 .50 .74 .71 -.67 .56 -.57 .50 -.52 .32 -.43 .47 -.63 .45 -.64 .30 -.35 .35 -.48 .11 -.29 .86 -.82 .74 .62 .74 .74 .70 .77 .74 .69 .69 .86 .48 .54 .60 .54 .55 .60 .62 .55 .71 .71 .36 .62 .71 .87 .79 .77 .74 .68 .60 .46 .20 .46 .49 .10 .35 6.95 1.09 2. 3. 4. .73 .57 .58 10. 11. Eigenvalue Factor 1 Factor II HCS, Health Complaints Scale; HPPQ, Heart Patients Psychological Questionnaire; SCL-90, Symptom Check List (Dutch adaptation). * All correlations: p < .001. ' Loadings of scales that are assigned to a factor are in boldface. TABLE 6. Descriptive Characteristics of the HCS and SCL-90 Instruments [N = 266)* Total Croup High Distress (N = 131) Low Distress (N = 135) Descriptive Characteristics Mean Standard deviation Median Frequency distribution of scores (quartiles) 0-24 25-49 50-74 75-100 HCS SCL-90 HCS SCL-90 HCS 25.1 20.8 19 12.8 11.9 10 35.8 21.7 33 19.5 12.9 16 14.7 13.4 10 6.4 57 5 57% 28% 12% 3% 85% 14% 1% 0% 35% 39% 21% 5% 70% 28% 2% 0% 80% 16% 4% 0% 100% 0% 0% 0% SCL-90 * HCL denotes extrapolated total score (range 0-100) of the Health Complaints Scale; SCL-90 denotes extrapolated General Severity Index (range 0-100) of the Symptom Check List. Apart from construct validity (or theoretical relevance), a major point in the development of the HCS is its appropriateness (or relevance from the patient's point of view). Undoubtedly, the Global Severity Index of the SCL-90 is a good marker of psychopathology. This implies that the distribution of SCL-90 scores reflects the actual self-report of psychiatric symptoms in CHD populations. However, the present research did not focus on psychopathology but on self-rated health. If the notion that coronary patients may perceive HCS items as being more relevant to their situation than SCL-90 items is correct, then HCS scores should be significantly higher than SCL-90 scores. To test this hypothesis, differencesin the frequency distribution of the mean HCS and SCL-90 scores at baseline were examined. 470 It is important to note that evidence suggests that an instrument with a less skewed distribution may sensitively reflect subclinical improvements in selfrated health as a function of cardiac rehabilitation (3). Because the HCS was specifically designed to have less extreme response categories than the SCL90, the HCS should be less skewed toward severe pathology than the SCL-90. Because both instruments have a different range of scores, baseline scores with a range of 0 to 100 were first extrapolated in the following manner: HCS = total score/24 x 25; SCL-90 = total score/90 X 25. Next, the distribution of these scores was examined (Table 6). The mean HCS score was twice as high than the mean SCL-90 score (p < .0001). This difference in HCS and SCL-90 baseline scores was found in both Psychosomatic Medicine 56:463-474 (1994) HEALTH COMPLAINTS IN CHD TABLE 7. Mean HCS Entry and End Scores, and Analyses of Variance Results for Rehabilitation and Control Subjects (A' = 120)* HCS Scale Somatic complaints Rehabilitation (N = 60) Entry Score End Score Change 10.1 (7 3) 6.1 (7.5) -4.0] 10.4 (8.8) 11.1 (8.9) +0.7J 13.6(10.5) 8.9 (8.3) -4.7] 14.4 (10.5) 16.0(11.2) + 1.6J Rehabilitation x Time Interaction Effect F(1,118) = 19.32, Control (N = 60) Cognitive complaints Rehabilitation (N = 60) \ Control (N = 60) p<.0001 F(1,118) = 24.16, p < . 0 0 0 1 * HCS denotes Health Complaints Scale; entry score, mean score within 6 weeks after the coronary event; end score, mean score 3 months after the initial assessment; standard deviations appear in parentheses. high-distress and low-distress subjects (p < .0001). Furthermore, the SCL-90 scores were largely restricted to the lower quartiles, whereas the HCL scores could be found in the higher quartiles as well. The HCS scores also displayed a normal clustering around a central point (kurtosis = 0.09), whereas the SCL-90 clearly displayed a peaked distribution of low scores (kurtosis = 1.63). Both scales were skewed to the right, but the HCS (skewness = 0.96) to a lesser extent than the SCL-90 (skewness = 1.43). The fact that standard distress scales are usually skewed toward more severe disability makes it difficult to measure improvement after treatment (29). In general, these findings are consistent with the notion that patients with CHD may perceive the items of the HCS as being more reJevant to their situation than the items of the SCL-90. A final point in the development of the HCS concerns its sensitivity to change as a function of treatment. In a previous study, the differential sensitivity to change of the SCL-90 and the Heart Patients Psychological Questionnaire was examined in a sample of 162 men with CHD who completed the Antwerp cardiac rehabilitation program (3). The results of this study indicated that the SCL-90 was significantly less sensitive to change than the Heart Patients Psychological Questionnaire. Furthermore, the anxiety, depression, and hostility subscales of the SCL-90 were not sensitive enough to detect actual changes in quality of life in patients who report a low level of emotional distress at baseline. By contrast, the HCS items may mirror one of the primary goals of cardiac rehabilitation, i.e. enhancing functional status and perceived health. This hypothesis was tested in a sample of 120 patients with CHD, 60 of which participated in the Antwerp rehabilitation program. Previous research in this sample of patients indicated that the 60 rehabilitation subjects, but not the 60 control subjects, rePsychosomatic Medicine 56:463-474 (1994) ported a significant increase in well being and positive affect and a significant decrease in disability and negative affect as measured by the Heart Patients Psychological Questionnaire and the Global Mood Scale (3, 5). There also was significantly less tranquilizer use in the rehabilitation group than in the control group. In the present study, there was no significant difference between the rehabilitation and control subjects with reference to age, medical category, or HCS scores at baseline. Repeated measures MANOVA indicated a significant rehabilitation x time interaction effect for somatic as well as cognitive health complaints (Table 7). In other words, changes in HCS scores differed as a function of treatment. Three months after the initial assessment, rehabilitation subjects, but not control subjects, reported a significant decrease in somatic and cognitive health complaints (p < .0001). This finding suggests that the HCS reflected the changes in perceived health that occur during cardiac rehabilitation. Test-retest reliability (3-month period) of the HCS scales in the control group was r = .73 and r = .69, respectively (N = 60). In general, the findings of Study 2 were consistent with the notion that the HCS measures a construct that is not tapped by standard scales of psychopathology. First, factor analysis yielded a distinct distress factor that had its highest loadings on the HCS and the Heart Patients Psychological Questionnaire but not on any of the SCL-90 symptom dimensions. Second, the HCS had a higher mean score than the SCL-90, despite the fact that both scales have the same format. It should be remembered that theoretical relevance and frequency of endorsement were used as criteria for the selection of items comprising the HCS. Accordingly, the HCS displayed a normal clustering of scores. By contrast, the narrow range of SCL-90 scores indicates that most patients with 471 J. DENOLLET CHD affirm only a small number of items. Third, the HCS reflected the clinical changes that occur during cardiac rehabilitation, whereas previous research found the SCL-90 to be less sensitive to assess change in this context (3). Hence, the HCS did meet the criteria of content validity, appropriateness, and responsiveness. The nonrandom assignment of subjects to rehabilitation and control groups, however, requires a conservative interpretation of some findings, and more research is needed to examine the notion that health complaints are more than mere markers of psychopathology in this setting. With reference to this issue, I do not suggest that research should ignore the coronary patient's level of psychopathology. On the contrary, evidence indicates that symptoms of psychopathology are associated with an adverse prognosis in patients with CHD (e.g., reference 33). Measures such as the SCL-90 may serve as a screen to detect patients that are more vulnerable to serious health problems in the years after a coronary event. However, in addition to assessing where the patient is in terms of psychopathology, it is also important to assess other psychological constructs that are relevant in the context of CHD. That is, the strategy of defining quality of life by the absence of psychopathology leads to underestimates of actual changes in quality of life (3). The findings of Study 2 suggest that an instrument that is sensitive to common problems of patients with CHD (such as the HCS) better mirrors the changes in perceived health status in the weeks and months after a coronary event. GENERAL DISCUSSION Validation is an ongoing process of obtaining multiple sources of empirical evidence to assess whether the instrument actually measures what it purports to (31). It is important to note that this paper does not provide evidence for the predictive validity of the HCS. More research is needed to examine the utility of this new instrument for the prediction of disease outcome or treatment effects. With reference to this issue, it is not clear whether the HCS is superior to other, more general instruments. The present research only examined the superiority of the HCS over the SCL-90 for assessing the effect of cardiac rehabilitation on quality of life. However, the contribution of this research is mostly methodological in that it describes the rational development of a potentially useful instrument. Three major principles undergird the devel472 opment of the HCS: a) the HCS is based on a clear a priori model. The accuracy of this model was tested with the use of appropriate multivariate statistical procedures (27); b) the items of the HCS are relevant from the patient's point of view. The patient was considered to be the best informant on the way in which illness affects well being (29); and c) the HCS is responsive to a clinical intervention. Responsiveness to change was considered to be a dimension of validity that incorporates longitudinal information (i.e., change) (31). These methodological issues apply equally well to other health-related outcome measures. On the assumption that validity should be built into a scale from the outset, this paper describes a new measure of health complaints that are relevant to patients with CHD. Ideally, the HCS had to be psychometrically sound, sensitive to change, and easy to administer. The HCS demonstrated a sound factor structure that accounted for a large proportion of variance at both the first- and second-order level of assessment and was found to have high internal consistency (a > .80) and adequate test-retest reliability over a 3-month period (r > .69). Significant correlations with widely used distress measures (STAI and SCL-90) and with a measure that was designed for cardiac patients (Heart Patients Psychological Questionnaire) provided evidence for its construct validity. Furthermore, the HCS was largely unrelated to self-deception or social inhibition, and sensitively reflected changes in perceived health that occur frequently in patients with CHD. In addition to psychometric soundness and sensitivity, the HCS is appealing in its practicality; the scale is brief and easy to use in a medical setting. With reference to this issue, the HCS appears to have broad applicability. Apart from the cardiopulmonary complaints, the items of the HCS may monitor outcomes for other chronic medical conditions as well. As a matter of fact, the majority of health complaints of the HCS are symptoms that would be associated with any serious health or psychiatric problem. However, cross-validation in other patient groups is needed. Although both instruments are closely related, the HCS is distinctive from the Heart Patients Psychological Questionnaire. The Heart Patients Psychological Questionnaire comprises a mixture of 24 health-related items (i.e., disability and well-being scales), 16 personality items (i.e., neuroticism and social inhibition scales), and 12 filler items. As a consequence, the HCS is shorter (24 vs. 52 items) and more straightforward than the Heart Patients Psychological Questionnaire. Moreover, the Psychosomatic Medicine 56:463-474 (1994) HEALTH COMPLAINTS IN CHD Heart Patients Psychological Questionnaire does not comprise somatic health complaints. An unsolved problem, however, concerns the degree to which the present results would generalize to female patients with CHD. Furthermore, the convergent validity of the HCS was examined by direct comparison to only one measure of perceived health in cardiac patients. Another important issue is the meaning of health complaints per se in patients with CHD. That is, the reporting of health complaints is not only dependent on physiological factors, but also on psychological factors (34). It is by now well established that symptom reporting is influenced by common beliefs about disease (35), the amplification of bodily sensations (36), and the tendency to interpret bodily sensations as signs of disease (23). Accordingly, complaints of chest pain (37), dyspnea (38), fatigue (5), and sleep problems (39) are often a function of psychological distress. Although some individuals tend to overperceive symptoms, others may fail to report significant bodily sensations (40). Clearly, self-reported health complaints are error prone and do not always parallel the objectively assessed health status. Nonetheless, I believe health complaints should not be ignored in the context of CHD. First, the assessment of health complaints may serve as a rough screen to identify a subset of patients that are more liable to long-term health complications. Self-report health scales are likely to have two distinct components: one that is psychological and another that is health related (23). In other words, the fact that symptom reporting is biased does not mean that health complaints cannot also play a true role in CHD (9-13). In fact, symptom reporting (41) and poor self-rated health (42) have been associated with a poor prognosis in patients with documented CHD. Research also suggests that coronary spasm may be an organic source of chest pain in the absence of angiographically documented CHD (43). Of course, it is unfortunate that most health complaints, such as discomfort in the chest or undue fatigue, are not specific of CHD. Nonspecific symptoms do not help a clinician make decisions concerning prognosis and therapy, but they do warrant further examination of the patient in question. Dismissing measures of perceived health as merely indicating the illegitimacy of symptom reports may result in the delay of much needed treatment in some coronary patients. Second, a finely tuned assessment of health complaints may help to evaluate the treatment of patients with CHD. Mortality is not the only outcome worth studying (1). In fact, a primary goal of health Psychosomatic Medicine 56:463-474 (1994) care for coronary patients is to enhance daily functioning and well being (44). Among other things, this implies the identification of coronary patients at risk of "medically unnecessary" disability as early as possible so that they may be given extra help (29). Another important issue concerns the effect of drug therapy on quality of life (45). Unquestionably, the pervasive influence of psychological biases, such as the tendency to experience distress, is a factor with which to be reckoned in the context of CHD (4). I merely want to stress that health complaints, albeit subjective in nature, should be accurately assessed in patients with CHD. As pointed out by Goodwin (46): " All too often, excellent papers describing results of sophisticated research techniques in groups of patients pay little attention to the clinical aspects studied or to the patients and their symptoms.. . 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