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Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in men after taking sildenafil or other phosphodiesterase 5 inhibitors for erectile dysfunction (ED). The incidence of NAION in men receiving sildenafil treatment for ED was estimated using pooled safety data from global clinical trials and European observational studies. Based on clinical trial data in more than 13,000 men and on more than 35,000 patient-years of observation in epidemiologic studies, we estimated an incidence of 2.8 cases of NAION per 100,000 patient-years of sildenafil exposure. This is similar to estimates reported in general US population samples (2.52 and 11.8 cases per 100,000 men aged >or=50 years). The data cited herein do not suggest an increased incidence of NAION in men who took sildenafil for ED.

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Depression is commonly reported in coronary artery bypass graft (CABG) surgery patients. This study assesses the relationship of preoperative characteristics, life stressors, social support, major cardiac and neurologic outcomes and other complications to depressive symptomatology. Demographic and clinical data, CES-D score and information on life stressors and social support were collected from 237 patients; 92% completed 6-month follow-up. CES-D score > or = 16 was defined as significant depressive symptomatology. Significant depressive symptomatology was found in 43% of patients preoperatively and 23% postoperatively. In multivariate models, low social support (p = 0.008), presence of at least one life stressor within a year of surgery (p = 0.006), moderate to severe dyspnea (p = 0.003), little to no available help (p = 0.05) and less education (p = 0.05) were associated with higher preoperative CES-D score, while longer intensive care unit (ICU) stay (p = 0.0001) and little or no available help (p = 0.0008) predicted higher postoperative CES-D scores when controlling for preoperative CES-D scores. Neither pre- nor postoperative depressive symptomatology was related to major outcomes or other complications. A high rate of significant depressive symptomatology exists in CABG patients preoperatively, and it decreases significantly postoperatively. Patients with the above preoperative characteristics as well as those who stay in the ICU postoperatively for more than 2 days might benefit from psychosocial interventions.

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OBJECTIVE: Few studies have evaluated the determinants of perceived health in patients with chronic illness. The present study was designed to evaluate the role of biomedical, demographic, and psychosocial influences on global subjective health by means of a structural equation modeling approach. METHOD: A conceptual model of perceived health was tested in a subsample of patients (N = 146) from the multicenter Studies of Left Ventricular Dysfunction (SOLVD) trial. Domain-specific quality of life constructs (emotional status, social support, and physical functioning), were assessed by means of multiple indicators. These latent (mediating) variables, along with six single-indicator biomedical and background variables, were modeled as predictors of a composite index of perceived health. RESULTS: A satisfactory fit was obtained for the proposed model, with practical fit indices ranging from .89 to .95. High levels of perceived health were associated with low levels of emotional distress and high levels of physical functioning. Social support was positively correlated with physical functioning and negatively associated with emotional distress. Among the background variables, no direct associations were observed between any of the single-indicator variables and perceived health. Several background variables (eg, age, income, walk-test scores) had indirect effects via associations with the latent variables of physical functioning and emotional distress. CONCLUSIONS: These findings support the use of a structural modeling approach in assessing determinants of perceived health in patients with congestive heart failure. Further research is needed to evaluate the utility of the model in other patient populations.

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This study examined the independent relation of health-related quality of life (HRQL) to mortality and congestive heart failure (CHF)-related hospitalizations in patients with an ejection fraction of < 0.35 followed for a mean of 36.5 months. A brief HRQL questionnaire was administered at baseline to patients randomized to placebo or enalapril in the Studies of Left Ventricular Dysfunction (SOLVD) trial. Participants had an ejection fraction of < 0.35 and either symptomatic CHF (treatment trial, n = 2,465) or asymptomatic CHF (prevention trial, n = 2,560). Baseline assessment of HRQL predicted mortality and CHF-related hospitalizations in symptomatic and asymptomatic patients randomized to enalapril and placebo treatment. Domains that were the stronger univariate predictors of mortality and CHF-related hospitalizations were activities of daily living (relative risk [RR] for mortality: 1.163, p < 0.000; for hospitalization: 1.215, p < 0.000), general health (RR for mortality: 1.205, p < 0.000; for hospitalization: 1.188, p < 0.000), and social functioning (RR for mortality 1.098, p < 0.000; for hospitalization: RR 1.156, p < 0.000). In the multivariate model, activities of daily living (RR for mortality 1.41, p < 0.000; for hospitalization: RR 1.43, p < 0.002), general health (RR for mortality 1.21, p < 0.000; for hospitalization RR 1.16, p < 0.013) and heart failure symptoms (RR for mortality 1.02, p < 0.025; for hospitalization RR 1.03, p < 0.004) were found to be independent risk factors. HRQL independently predicted mortality and CHF-related hospitalizations after adjustment for ejection fraction, age, treatment, and New York Heart Association classification in patients with an ejection fraction of < 0.35, randomized to enalapril and placebo treatment. HRQL provides additional clinical information regarding disease course and outcome that is not captured by traditional indexes of clinical status.

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Clearly, age and education are important factors for predicting adherence in CAST, given that they appear in all three regressions. Moreover, the 4-month and 1-year results indicate that mental health and presence of a spouse are important predictors. Physical function, stress, angina, and history of MI may also provide additional information regarding adherence levels. It is interesting to note that although adherence was higher for patients who have "good" social characteristics, such as having a spouse, support, integration, perceived good health, good mental health, low stress, and education, it was also better for those patients who had "poor" physical characteristics such as a history of angina, a history of MI, and low physical function. In the multivariate analysis, older age was also associated with good adherence. These observations are not necessarily intuitive and support the need for further research in this area. If patients at risk for poor adherence can be identified prospectively, strategies may be developed to improve their subsequent medical care in such a way to favorably affect and improve their outcomes.

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The Recruitment and Enrollment Assessment in Clinical Trials (REACT) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.

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OBJECTIVE: To evaluate the incidence of discontinuation of and changes in treatment after newly prescribed courses of antihypertensive drugs of the four primary therapeutic classes: beta blocker, calcium channel blocker, and angiotensin converting enzyme inhibitor. DESIGN: A retrospective analysis of patients on an automated database of 1.2 million patients was conducted on visits between 1 October 1992 and 30 September 1993. SETTING: General practices in the United Kingdom. SUBJECTS: 37,643 patients with hypertension receiving a relevant drug in the time period were identified. A new course of treatment in at least one of the four therapeutic classes, defined as a drug not prescribed in the previous four months, was observed in 10,222 patients aged > or = 40 years. MAIN OUTCOME MEASURES: Patients changing to other treatment or discontinuing after initiating a new course of treatment, defined as the absence of a refill prescription for the new drug or another in its category within a six month observation period. RESULTS: Changes in or discontinuation of treatment were frequently observed, and by month six continuation rates ranged between 40% to 50% for all four classes of drugs. CONCLUSION: Low rates of continuation with a newly prescribed antihypertensive drug exist regardless of which drug is prescribed.

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The Cardiac Arrhythmia Suppression Trial II (CAST II) was a double-masked placebo-controlled randomized trial that compared the survival effects of moricizine to placebo in postmyocardial infarction arrhythmia patients. The quality-of-life outcome measures were designed prospectively for CAST and were previously shown to have high reliability and clinical discriminative validity. The CAST quality-of-life instrument detected significant differences between moricizine and placebo. In particular, moricizine was most strongly associated with inferior social activity and satisfaction scores (p = .014) and lower scores for overall contentment with life (p = .007). Moreover, the quality-of-life measures improved significantly for both the moricizine and placebo treatment groups after entry into the clinical trial. These results indicate that the CAST quality-of-life instrument is sensitive for assessing pharmacological therapies in the treatment of heart disease.

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A quality of life ancillary study was incorporated into the Survival and Ventricular Enlargement (SAVE) trial of captopril versus placebo among patients who survived an acute myocardial infarction with compromised ventricular functioning, but no overt heart failure. Assessments included patient symptoms, health perceptions, emotional, cognitive, social and sexual levels of functioning, as well as potential covariates, such as life events and social support. The purpose of this study was to evaluate the psychometric properties of the quality of life measures in the SAVE at baseline, and provide a pre-randomization profile of the SAVE patients. One hundred and eighty-four patients participated in this aspect of the trial. Reliability alpha coefficients were adequate or better for all questionnaires, except for life events and sexual activities. Consistent with prior studies, the quality of life parameters were uncorrelated with ventricular ejection fraction. Despite experiencing a recent myocardial infarction with compromised ventricular functioning, patients at baseline generally neither appeared depressed nor focused on symptoms. The baseline findings support the inclusion of the quality of life ancillary study in the overall SAVE trial because of the independent contribution likely to be achieved in terms of evaluating both disease progression and treatment efficacy.

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The improvement of aspects of a patient's quality of life may be as important as prolonging survival in evaluating clinical trials of heart failure. The purpose of this study was to analyze the psychometric properties of the baseline measures from the quality-of-life substudy from the Studies of Left Ventricular Dysfunction (SOLVD) trial. The measures included the 6-Minute Walk Test, Dyspnea Scale, Living with Heart Failure, Physical Limitations, Psychologic Distress and Health Perceptions, as reported by both patients and staff. Cognitive functioning, such as Vocabulary, Digit Span and Trails Making, was also assessed. Patients were classified as New York Heart Association class I (n = 158) versus II or III (n = 150). The internal consistencies (i.e., reliabilities) of the self-report measures were high, except for the Health Perceptions of Class II or III patients. Reliability of the SOLVD quality-of-life battery was confirmed by significantly better life quality among New York Heart Association class I patients versus class II or III patients combined on the Walk Test, Physical Limitations, Dyspnea, Living with Heart Failure, Psychologic Distress and staff perceptions of patient health. In accordance with prior studies, the measures were uncorrelated with left ventricular ejection fraction. By demonstrating strong internal consistencies, reliability based on physician reports, and independence of ejection fraction levels, use of this quality-of-life assessment battery in this and other clinical trials of compromised ventricular functioning is supported.

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Psychosocial variables predict the recurrence of clinical events in symptomatic patients, controlling for measures of disease severity. The Cardiac Arrhythmia Suppression Trial-1, a pharmacologic test of the arrhythmia suppression and mortality hypothesis among postmyocardial infarction patients, allowed a prospective test of the relationship of distress, perceived support, social interaction, life stress, and other variables, to mortality, adjusting statistically for ejection fraction, arrhythmia rates, and other known risk factors for coronary heart disease. Results indicated that the treatment medications, encainide and flecainide, were powerful predictors of mortality. Although the psychosocial variables were significant as univariate predictors, these variables were not significant as predictors in a multivariate model that included drug treatment. When the data analysis was restricted to patients randomized to placebo, thereby eliminating the antiarrhythmic drug effect, the level of perceived social support was a significant multivariate predictor of mortality, adjusting for measures of disease severity. The adjusted hazards ratio for a 1-point decrease in the perceived support score is equal to 1.46, based on the multivariate model.

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Recruitment and Enrollment Assessment in Clinical Trials (REACT), an NHLBI-sponsored substudy of the Cardiac Arrhythmia Suppression Trial (CAST), was conducted to assess factors associated with enrollment in clinical trials. We report on the relationships of institutional factors at CAST sites to patient enrollment. The proportion of CAST-eligible patients enrolling at each CAST site during the REACT study period was defined as the number of subjects enrolled divided by the sum of (1) the number enrolled plus (2) the number of eligibles who refused plus (3) the number of eligibles whose physicians refused to permit CAST personnel to attempt to enroll them. A questionnaire that included 78 questions regarding factors hypothesized to be associated with enrollment was completed between August 1988 and February 1990 by the nurse coordinators at all 112 CAST sites in the United States and Canada. Sixteen items were unanalyzable, and 37 of the remaining 62 were grouped into seven scales. The remaining items were analyzed individually. Enrollment proportions varied widely across the 112 CAST sites (mean 32.7% SD 22.6). Five variables or scales were included in the final multiple regression model (multiple R2 = .39). The most important of these was the proportion of eligible patients at a site cared for by medical staff other than private attending physicians (multiple R2 for this variable alone, .26). This proportion tended to be high in teaching hospitals. Other variables in this model that were associated with higher enrollment proportions included the number of days per week a nurse coordinator was present at the site, the number of nurse coordinator full-time equivalents at the site, fewer other clinical trials for which the nurse coordinator was responsible, and fewer perceived obstacles to enrollment. These findings indicate that enrollment was more successful at hospitals with higher proportions of eligible subjects cared for by fellows, housestaff, and service attending physicians and at institutions with the committed presence of a nurse-coordinator.

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The CAST was a randomized, double-blind placebo-controlled multicentre trial of antiarrhythmic medications designed to suppress ventricular arrhythmias in patients after an acute myocardial infarction (MI). A collection of 21 items derived from established scales was used to assess aspects of quality of life in CAST. The questions focused on symptoms, mental health, physical functioning, social functioning, life satisfaction, and life expectancy. Additional aspects included exposure to major stressful life events, and perceived social support and social integration. Work status was also recorded. Using the baseline values of 1465 (98%) out of 1498 patients enrolled in the CAST main study between 15 June 1987 and 19 April 1989, the reliability and validity of the scales used in CAST were computed. High internal consistency reliability (> or = 0.70) was found for Symptoms, Mental Health, and Physical Functioning. The discriminative validity, in particular for Symptoms, Mental Health, Physical and Social Functioning, showed that patients with heart failure and previous MI, as well as those suffering from angina and dyspnea, had a worse quality of life than those patients who were not experiencing these symptoms. It was concluded that the scales selected to form the CAST quality of life questionnaire were both reliable and clinically valid for this patient population and therefore could be used to detect disease progression and treatment effects.

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This is a retrospective case control study of the relationship between work pace of selectors at a food distribution center and the subsequent incidence of compensable back injuries. Subject employment records for 1 month were evaluated for degree of variation of actual-from-scheduled performance of weekly work pace as selectors, defined in terms of absolute values (either above or below criterion). Subjects were divided among those with no compensable claims for back injury (n=14) and those with multiple compensable claims (n=12) over a 2-year period of employment. Other dependent measures included percentage of tasks that each group completed by or before the scheduled criterion and the percentage of time working that employees engaged in selector activities. The groups differed in age, averaging 38 vs. 31 years for the no claims and multiple claims groups, respectively. The groups did not differ in terms of educational background or length of service at the food distribution center. The major finding was that there was a group difference in the actual-from-scheduled, absolute mean performance values. As expected, the multiple claims group had significantly more variability in their work pace than the no claims group. The no claims group also worked significantly more often at or faster than criterion and spent, on average, a higher percentage of their day performing selector duties. These preliminary results suggest an association between work patterns and occupational injury that warrant further research, such as a clinical trial manipulating the scheduled work criterion.

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We examined the effects of psychological stress on plasma lipid, lipoprotein, and apolipoprotein levels in three related studies. In the first study, tax accountants (N = 20) and a comparable control group (N = 20) were assessed during and after the tax season. In the second and third studies, first-year medical students (N = 24 and N = 16) were assessed at midsemester and immediately before the examinations. Across studies, the stressors induced significant psychological distress. There were no corresponding changes in lipid and lipoprotein levels. Mean stress-induced change in total cholesterol level was -0.04 mmol/L (-1.6 mg/dL) (95% confidence interval, -0.23 to 0.16 mmol/L [-9 to 6 mg/dL]) for the accountants and 0 mmol/L (0 mg/dL) (95% confidence interval, -0.16 to 0.21 mmol/L [-6 to 8 mg/dL]) and 0.10 mmol/L (4 mg/dL) (95% confidence interval, -0.18 to 0.39 mmol/L [-7 to 15 mg/dL]) for medical students in the second and third studies, respectively. In all studies, change in total cholesterol level correlated with change in total serum protein levels (r = .42 to .60). These results suggest that commonly occurring stressful situations do not produce significant changes in plasma lipid and lipoprotein levels.

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The frequency of ventricular premature complexes and the degree of impairment of left ventricular ejection fraction are major predictors of cardiac mortality and sudden death in the year after acute myocardial infarction. Recent studies have implicated psychosocial factors, including depression, the interaction of social isolation and life stress, and type A-B behavior pattern, as predictors of cardiac events, controlling for known parameters of disease severity. However, results tend not to be consistent and are sometimes contradictory. The present investigation was designed to test the predictive association between biobehavioral factors and clinical cardiac events. This evaluation occurred in the context of a prospective clinical trial, the Cardiac Arrhythmia Pilot Study (CAPS). Five-hundred two patients were recruited with greater than or equal to 10 ventricular premature complexes/hour or greater than or equal to 5 episodes of nonsustained ventricular tachycardia, recorded 6 to 60 days after a myocardial infarction. Baseline behavioral studies, conducted in approximately 66% of patients, included psychosocial questionnaires of anxiety, depression, social desirability and support, and type A-B behavior pattern. In addition, blood pressure and pulse rate reactivity to a portable videogame was assessed. The primary outcome was scored on the basis of mortality or cardiac arrest. Results indicated that the type B behavior pattern, higher levels of depression and lower pulse rate reactivity to challenge were significant risk factors for death or cardiac arrest, after adjusting statistically for a set of known clinical predictors of disease severity. The implication of these results for future research relating behavioral factors to cardiac endpoints is discussed.

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Both animal and human data implicate psychosocial distress and cardiovascular reactivity in response to challenge in the etiology of sudden cardiac death. In this study, the relation of these biobehaviorial factors to frequency of ventricular premature complexes, a predictor of sudden death was investigated. The study population was made up of patients enrolled in the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Pilot Study (CAPS). Ventricular premature complexes (VPCs) were assessed by multiple, 24-hour ambulatory electrocardiographic recordings. Patients completed trait psychosocial measures assessed at baseline and state psychosocial measures assessed periodically during a 1-year follow-up period. Psychosocial measures included self-reports of depression, anxiety, anger and type A behavior pattern. A competitive challenge using a video game was used as a stressor to elicit cardiovascular reactivity and was administered at baseline and during follow-up sessions. Cardiovascular reactivity was defined as peak level during stressor exposure minus the mean of resting levels for systolic and diastolic blood pressure and pulse rate. Results indicated that biobehavioral factors were not associated with diurnal VPC rates. Furthermore, biobehavioral factors did not predict response to antiarrhythmic therapy. Based upon the results of this study, it is speculated that the established relation between behavioral factors and sudden death may not be mediated by VPC rates.

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We evaluated the effect on morbidity and mortality of a post-myocardial infarction management and intervention system. One thousand four patients were prospectively randomized to an intervention group that included routine and emergency transtelephonic follow-up and ECG monitoring or to control; all subjects were followed for 1 year. For symptoms suggestive of myocardial ischemia, intervention patients telephoned the project emergency office, were instructed by a project nurse to self-administer intramuscular lidocaine with an auto-injector, and were then transported to the nearest emergency facility. Cardiac death or arrest was decreased 29% in intervention patients (p = 0.066), while all-cause mortality was decreased by 24% (p less than 0.11). Routine transtelephonic ECG monitoring detected ventricular ectopy in 48% of intervention patients, with almost 50% of these findings classified as complex forms. Ventricular ectopy detected during routine calls within 60 days of the acute myocardial infarction conferred a threefold increase in mortality (p = 0.001). In addition, control patients were 2.4 times more likely to be clinically depressed (p less than 0.03) and returned to work less quickly (p less than 0.03) when compared to intervention patients. Lidocaine injections were associated with an absence of ventricular ectopy on arrival at the Emergency Room in 64% and with a low incidence of lidocaine-associated side effects. There was only one case of unauthorized use of the self-injector. These findings demonstrate that an outpatient post-myocardial infarction transtelephonic surveillance program can be safely and effectively conducted, can detect complex ventricular arrhythmias of prognostic significance, can improve the quality of life, and may reduce 1-year cardiac mortality.

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A prospective study examining the relationship between psychological distress and ventricular ectopy was conducted with 125 post-myocardial infarction patients equipped with a transtelephonic ECG monitor. Subjects were subsequently grouped according to the occurrence (n = 59) or nonoccurrence (n = 65) of ventricular arrhythmias over a 1-year period. Results indicated a direct relationship between self-reported distress levels and occurrence of ectopic beats. This relationship was unaltered by adjusting simultaneously for known predictors of arrhythmias, including cardiac risk, age, and the prescription of beta-blocker agents. Thus this study represents an initial demonstration in a post-myocardial infarction population that psychosocial factors have prognostic significance for arrhythmias and, presumably, sudden death.

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The impact of an outpatient, risk-management system, including a transtelephonic electrocardiographic monitor and lidocaine injector, on the quality of life in post-myocardial infarction patients was examined. Patients (n = 238) were assigned randomly to either the system or to standard medical care (control). Quality of life was defined in terms of psychological status, return to work, and social functioning. Relative to control patients, system patients showed a significant decrease in concerns about physical functioning and symptoms, and, over time, reported less depressive affect. At 9-month follow-up, control patients were more than twice as likely to be in the range of clinical depression. Patients' perceptions of their ability to manage a recurrence of cardiac symptoms appeared to be related inversely to depressive affect. Moreover, a larger percentage of system patients (92%) had returned to work by the 9-month follow-up, compared with control patients (76%). There were, however, no significant differences between groups in the degree of impairment in social interaction. Overall, these results indicate that the use of a "system" encouraging patient participation in treatment can significantly improve qualify of life after a myocardial infarction.

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