Psychosocial Status of Patients Randomly Assigned to Medical or Surgical Therapy for Chronic Stable Angina

JULIA S. BROWN, PhD MAY E. RAWLINSON, PhD

POH/and, Oregon

Aspects of social and psychologic functioning are compared for 51 patients randomly assigned to surgical or medical management of chronic stable angina. No differences were found between the two groups in work status, social activity, adequacy of family functioning, perceived health, life satisfaction, memory span, extent of anxiety, hypochondriasis and hysteria. However, surgically treated patients were significantly less depressed and more likely to report improvement in health and family functioning after the initiation of treatment. It is concluded that the psychologic and social outcomes appear slightly more favorable in patients treated surgically than in those treated medically.

Coronary bypass surgery has become increasingly accepted as the treatment of choice for coronary heart disease. However, the superiority of surgery over medical management has not yet been clearly demonstrated. Recently, several investigations have been undertaken to test the relative merits of the two modes of therapy. One such study’ has been in progress since 1971 at the University of Oregon Health Sciences Center and Veterans Administration Hospital at Portland, Oregon. Its purpose is to compare the cardiac functioning of patients with chronic stable angina treated by the two methods. We sought to expand the scope of this investigation by examining selected social and psychologic concomitants of the alternative treatments. To our knowledge, no other study has attempted such a comparison of the quality of life of the patients involved. If recovery signifies the adequate functioning of patients as well as the repair of damaged organs, then these psychologic and social conditions cannot be ignored, but must be evaluated along with the physical status of patients. In this report we present our findings regarding these dimensions of recovery. Method Subjects

From the Graduate Department, School of Nursing, University of Oregon Health Sciences Center, Portland, Oregon. This study was supported in part by a 19751976 Grant from the Oregon Heart Association, Portland, Oregon. Manuscript received January 29, 1979; revised manuscript received March 21, 1979, accepted April 2, 1979. Address for reprints: Julia S. Brown, PhD, School of Nursing, University of Oregon Health SciencesCenter, Portland, Oregon 9720 1.

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The subjects of this study are persons participating in the aforementioned long-range comparison of the effects of bypass surgery and medical management in chronic stable angina. Kloster et a1.l reported that criteria for inclusion in their sample were chronic disabling angina pectoris for at least 1 year, 62 years of age or less, no episodes of unstable angina pectoris or myocardial infarction within 6 months, no clinical evidence of heart failure or cardiomegaly on X-ray study and absence of other major disabling illnesses. Additionally, the suitability of patients for aortocoronary bypass surgery was determined by staff cardiologists and cardiovascular surgeons on the basis of extensive testing, including coronary and left ventricular angiography, myocardial metabolic studies, graded exercise st?ess electrocardiography and evaluation of risk factors for coronary heart disease. Patients were judged appropriate candidates for surgery who showed

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“more than 50 percent narrowing of one or more major coronary arteries, satisfactory vessels for grafting and reasonably preserved left ventricular function (ejection fraction 30 percent or greater). Patients with disease of the left main coronary artery were exc1uded.l” Follow-up of surgical and medical groups: Subjects who met these criteria and who agreed to participate were then randomly assigned to either the medical or surgical treatment group. Patients treated surgically received prompt operation, whereas patients treated medically had their programs reviewed to ensure optimal treatment. All patients were followed up in a special clinic designed to provide uniform clinical care and follow-up evaluation, initially at 2 month intervals. Six months after entry, each patient was readmitted to the hospital to repeat the initial tests. In both groups, patients “received appropriate medical therapy for symptoms of coronary heart disease and other related problems” and “were encouraged to remain physically active, to stop cigarette smoking and to modify other risk factors related to coronary disease, but no special measures such as smoking clinics or physical training programs were undertaken . . .“.l By December 1976, the desired sample size of 100 was reached, with 49 patients assigned to medical treatment and 51 to surgical treatment; attrition commenced almost immediately. Of the 49 cases lost to the study to date, 10 were withdrawn because of death (6 from the medical, 4 from the surgical group), 21 because of myocardial infarction (10 medical, 11 surgical) and 12 because of development of unstable angina unresponsive to conventional medical therapy (8 medical, 4 surgical). The number of patients lost to study slightly exceeds that reported by Kloster et al.l, because our count is of more recent date (December rather than summer 1978). Additionally, six patients moved out of the state, where they were under the care of physicians other than the project staff. This high attrition rate is not surprising in view of the high risk nature of the group under study and in view of human rights guidelines mandating the withdrawal of patients from experimental programs when their welfare requires it. Fortunately, the scientific issue regarding attrition revolves mainly around differential loss or “selective mortality” from comparison groups. The preceding statistics clearly indicate that attrition was very similar in amount and nature for the two therapy groups. Hence, comparisons remain meaningful. Demographic characteristics of the two groups: In this study, we assessed the psychologic and social condition of patients 9 or more months after their entry into the randomized experimental study. That interval was selected as the “lag time” needed to permit convalescence from the trauma of surgery, and to enable treatments to take effect. Selected demographic characteristics of our 51 subjects (25 medically treated, 26 surgically treated patients) are presented in Table I. Note that the medical and surgical groups do not differ greatly in age, sex composition, marital status, source (Veterans Administration Hospital or University of Oregon Health Sciences Center Hospital), years of education, socioeconomic status2 or length of illness. Hence, any differences in outcome between the two groups cannot be attributed to differences in these characteristics. Data

Physiologic and physical data regarding patients were extracted from records maintained by the Divisions of Cardiology, Cardiovascular Radiology and Cardiopulmonary Surgery of the University of Oregon Health Sciences Center and Veterans Administration Hospital of Portland. Psychologic

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TABLE I Selected Demographic Characteristics of Medlcal and Surgical Groups Medical Group

Surgical Group

51

25

26

54.12 7.12

53.44 5.59

54.77 a.45

48 3

23 2

25 1

46 5

21 4

25

22 29

1:

Total Patients (no.)

Age WI

Mean SD Sex Male Female Marital status Married Single, divorced, widowed Source VA UOHSC Educr&n (yr) SD Socioec_onomic status* SD Duration of illness (mo) Median Range

13 13

10.16 3.01

9.48 1.05

10.15 2.82

50.20 6.90

50.72 6.88

49.69 7.01

55.0 15-420

56.0 22-348

52.5 15-420

Assessed with Green’s Socioeconomic Status Index. SD = standard deviation: UOHSC = University of Oregon Health Sciences Center Hospital, Portland, Oregon; VA = Veterans Administration Hospital, Portland, Oregon. l

data were obtained from tests administered to patients during regular follow-up visits at the Cardiology Clinic, 9 months or more after admission to the study. These tests included the Minnesota Multiphasic Personality Inventory (MMPI), Rumbaugh’s Cardiac Adjustment Scale3 and two subtests of the Wechsler Memory Scale,4 namely, Memory Span for Digits and Associate Learning. Demographic, social and social-psychologic data were elicited through a structured interview. These data concerned the patient’s work life, social activity, family adjustment, general adjustment and life satisfaction and health perceptions. Specific measures are described later. Psychologic measures: The psychologic scales of hypochondriasis, depression and hysteria (the “neurotic triad”), and Welsh’s Anxiety Scale were selected from the MMPI repertoire for examination because these have been identified in previous report&s as of special relevance for cardiac patients. Raw scores on these tests were transformed to T scores, to permit comparison with population norms. (The mean score for the population is 50, and the standard deviation is 10.) Low scores indicate absence of the trait in question, high scores its presence. The tests are fairly reliable. Performing a test-retest check, Cattle” obtained coefficients of 0.66 for the depression scale, 0.81 for hvnochondriasis and 0.72 for hysteria. Rumbaugh’s &-d&c Adjustment Scale measures, at least in part, emotional stability, cooperativeness and objectivity, but it was designed mainly to predict return to work of patients with cardiac problemss Scores may in principle range from 0 (poorest adjustment) to 156 (best adjustment). The reliability of the scale is attested to by a Spearman-Brown coefficient of 0.94 obtained between parallel forms of the test administered to 79 patients. The validity of the test was established by a check on the employment status of 85 patients some 3 years after these measures were administered.”

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Additionally, subscales of the Wechsler Memory Scale were administered, inasmuch as concern has been expressed9

that open heart surgery may have adverse effects on mental functioning. The Memory Span for Digits is especially sensitive to the effects of any kind of brain injury. It has a potential range in scores from 0 to 15. The average adult’s raw score is 11, and scores under 8 are taken to indicate some degree of mental impairment. Reliability was determined by the splithalf correlation method, using the Spearman-Brown formula to correct for length. lo On the basis of the scores of subjects aged 45 to 54 years, the reliability coefficient was 0.66. The Associate Learning subtest has a possible range of scores from 0 to 21. A score of 8 was taken as the cutoff point to indicate impaired functioning. Hulicka” reported a mean score of 11.5 (standard deviation = 4.5) in the subjects aged 60 to 69 years. Family adjustment: Pless and Satterwhite12 have developed a comprehensive instrument to reflect the multidimensional nature of this construct. The principal components of their Family Functioning Index are intrafamily communications, decision making, frequency and resolution of disagreements, level of happiness, closeness of the family unit, marital satisfaction and child orientation. Inasmuch as the majority of our subjects did not have minor children living at home, the items on relations with children were deleted. As thus modified, the Family Functioning Index scale can produce scores from 0 (poorest level of family functioning) to 24 (optimal functioning.) High scores signify that spouses agree on most important aspects of family life, resolve their differences satisfactorily through open discussion, view themselves as happier and closer than most families and are well satisfied with those aspects of marriage they value most. The reliability13 of this index is indicated by a correlation of 0.72 between the scores of spouses, obtained independently, and also by a test-retest correlation of 0.83 between scores obtained from 29 subjects 5 years apart. Some estimate of the validity of this index is provided by the magnitude of the correlations obtained between index scores derived from responses of husbands and wives, and independent ratings of the same families by experienced case workers. These correlation coefficients were 0.35 and 0.48. Life satisfaction: This variable was estimated by means of a Cantrill ladder. Respondents were shown a picture of a nine rung ladder, inscribed at the top, “extremely satisfied” (rung 9) and at the bottom, “extremely dissatisfied” (0). They were requested to indicate on this ladder where their satisfaction with life was “right now.” Additionally they marked on the ladder the extent of their satisfaction with life before treatment and also the presumed satisfaction of the “average” person their age, and the “sick person” their age. From these data, social comparisons are possible. Advantages of the Cantril ladder technique are that it results theoretically in a continuous and equal-interval scale, and is “self-anchoring” because scores are relative to each person’s own perception of maximal and minimal satisfaction. The technique has enjoyed wide popularity and is viewed as providing a useful and stable assessment.l” Robinson and Shave+ have given a full description and discussion of the technique and related research. An alternative measure of satisfaction was provided by Koltuv’s Index of Satisfaction,17 which contains 11 items,

each pertaining to a different area of life. The respondent is asked to check on a six point scale how satisfied he is with marriage, his physical condition, leisure time, personal friendships, kin relations, sexual life, financial situation, intelligence, personality, coping style and work. Scores may vary

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from 11 (extremely satisfied) to 66 (extremely dissatisfied.) Because depression is often conceptualized as the negative pole of a continuum of satisfaction, the correlation of 0.44 between this scale score and the score on the MMPI depression scale (in a sample of 150 patients who had had valvereplacement surgery) is one indication of the concurrent validity of this scale.18 Social activity: An “objective” and a “subjective” measure of social activity were calculated. The more “objective” measure, Phillips’ Social Participation Index,lg taps three components-namely, number of friends visited in the past week, number of neighbors known well enough to call on and number of formal organizations in which the person is active. Scores may range from 3 (least activity) to 8 (most activity). No data are available regarding the reliability or validity of this widely used index. To obtain a more “subjective”estimate

of social activity,

each subject was requested to indicate the extent of his social life on a nine rung Cantril ladder14 labeled “most active social life” at the top (score = 9) and “least active social life” on the bottom (score = 0). Subjects were additionally asked to estimate the extent of their own social life before entry into the randomized study, the extent of the social life of the “average” person their age and of the “sick person” their age. Comments made earlier regarding the technique of the Cantril ladder apply here as well. Health status: The “objective” physical and physiologic status of the patients is not the focus of this paper, and has been reported elsewhere.’ Here, only figures concerning the ejection fraction and the left ventricular end-diastolic pressure at the 6 month follow-up for our 51 subjects are reported. Two measures that assess the extent of physical activity possible for the patient are included; first, the patient’s New York Heart Association20 functional classification at the time of interview; and second, the patient’s score on the Health Status Scale of Rosow and Breslau.21 The latter is a Guttman scale, and generates scores from 1 (worst health) to 6 (best health). Finally, each patient’s perception of his current health was assessed by means of a Cantril ladder, ranging from 0 (worst possible health) to 9 (best possible health). The patient also indicated on the ladder his perception of his health before treatment, and his perceptions of the health of the “average person” and of the “sick person” his age. These data permit social comparisons and enhance interpretation. Analysis Because we do not have available data on the psychologic and social condition of our 51 patients at time of entry into the randomized study, the present investigation has a posttestonly control group design. This design controls for sources of internal invalidity and also avoids the threat to external validity posed by a pretest session. In this latter respect, it has an advantage over the more usual pretest-posttest control group design of experiment. Campbell and Stanley22 state that for this design (no. 6 in their typology), the t test is the optimal statistic. In the analysis to follow, then, the t test will be used to determine the significance of the differences between means for the surgical and medical groups. Where it appears more feasible to utilize frequency distributions to demonstrate differences, the chi square statistic will be used. Results Health status (Table II): Kloster et al.’ found “no overall differences in survival or the incidence of major cardiac morbidity between the medical and surgical groups at this

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point in the study.” There was also no difference between the groups in left ventricular function 6 months after initiation of therapy. However, for a subgroup of 46 patients with three vessel disease, “there was a significant difference in unstable angina requiring operation between the medical and surgical patients,” but “there was no difference in the other two terminating events, death or myocardial infarction.” Objective evidence of improved capability of patients in the surgical group was indicated by their significantly increased mean values for maximal work load and maximal heart rate during exercise at the 6 month follow-up. In parallel with this objective evidence was the greater improvement in functional status for the surgical group and a lesser incidence of unstable angina pectoris.

gical groups did not differ in the two physiologic measures of cardiac capacity, the ejection fraction and left ventricular end-diastolic pressure, as determined by angiography at 6 months follow-up. Surgically treated patients performed everyday activities more adequately than medically treated patients, as indicated by the distribution of their functional classification scores. The superiority of the surgically treated patients is again attested to by their higher scores on the Health Index of Rosow and Breslau,21 which also estimates the capacity of persons to perform everyday activities and withstand physical exertion. Both these measures reflect behavioral rather than physiologic factors and may be highly amenable to subjective influences. Our findings in these respects confirm those reported by Kloster et al.’

Health data for the 51 patients of our subsample of that larger study are presented in Table II. The medical and sur-

With regard topatients’perceptions of their own current health, considered in absolute terms, medically and surgically

TABLE II Comparison of Health Status and Perceptions Medical Group

Total Patients (no.) Physical measures Ejection fraction (6 mot) Normal (254%) Depressed (

Psychosocial status of patients randomly assigned to medical or surgical therapy for chronic stable angina.

Psychosocial Status of Patients Randomly Assigned to Medical or Surgical Therapy for Chronic Stable Angina JULIA S. BROWN, PhD MAY E. RAWLINSON, PhD...
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