Clinical trial enrollers vs. nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project.

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.

Quality of life among patients post-myocardial infarction at baseline in the Survival and Ventricular Enlargement (SAVE) trial.

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.

Attendance and outcome in a work site weight control program: processes and stages of change as process and predictor variables.

This naturalistic study assessed client changes during treatment and identified salient predictors of therapy attendance and outcome. Subjects were assessed on processes and stages of change, self-efficacy, social support, weight history (including expectations, goals, and reasons for losing weight), and demographics at the beginning, middle, and end of a 10-week, behaviorally oriented work site program for weight control. Significant shifts from contemplation to action occurred for clients remaining in treatment. There were also significant modifications in the use of change processes as a result of treatment: counterconditioning, contingency management, stimulus control, interpersonal control, and social liberation increased while medication use, wishful thinking, and minimizing threats decreased. Change processes employed during the early portion of the group treatment were the best predictors of treatment attendance and outcome, superior to self-efficacy, social support, weight history, and demographic variables. The results supported a transtheoretical model that emphasizes dynamic processes and stages as core dimensions for understanding how people change.

The relationship of work pace to back injury in a supermarket distribution center.

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.

Lipid and lipoprotein responses to episodic occupational and academic stress.

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.

Relation of psychosocial and stress reactivity variables to ventricular arrhythmias in the Cardiac Arrhythmia Pilot Study (CAPS).

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.

Correlation of chronic low-back pain behavior and muscle function examination of the flexion-relaxation response.

The relationship between videotape ratings of pain behavior and the flexion-relaxation phenomenon was evaluated in a sample of 39 chronic low-back pain patients. The results showed that guarded movement explained approximately 27% of the variability in the flexion-relaxation phenomenon, adjusting for pain intensity rating. There were no significant differences in sex observed. It is recommended that clinicians pay close attention to qualitative aspects of patient behavior to improve the sensitivity of the physical examination in detecting bona fide impairment.

Interdisciplinary perspectives on mechanisms and management of low back pain.

Chronic low back pain (CLBP) is one of the most pervasive and costly problems facing medicine today. In addition to personal suffering, CLBP accounts for a greatly disproportionate amount of consumer health care over-utilization, employee absenteeism, lowered work productivity, disability and compensation payments. Recent research in the area has called attention to the complex nature of the problem and the need for an interdisciplinary approach to identification and management. Toward this end, a panel of health care professionals with skill in the assessment and treatment of chronic pain was convened on November 17, 1988. Sponsored by the Institute for Behavioral Medicine in Providence and with funding from the National Institute for Neurological Disorders and Stroke, Stroke and Trauma Program, the purpose of the panel discussion was to bring together clinicians and researchers from distinctly different specialties but who all work with CLBP patients. Topics of discussion included etiology, current status of medical diagnostics and treatments for chronic pain, conceptual and systems issues, and directions for future research.

A comparative evaluation of a restrictive smoking policy in a general hospital.

The impact of a restrictive smoking policy on the behavior and attitudes of smokers and non-smokers was assessed by surveying random cross-sectional samples of hospital employees before, six months after and 12 months after the policy was implemented, and comparing responses with those of employees of a hospital with no restrictive policy. Effectiveness of policy implementation was also evaluated. Results indicated that the policy was well-publicized and was approved by virtually all the non-smokers and the majority of the smokers. Following implementation, employees in the smoking policy hospital were less likely to report being bothered by smoke at their work stations than were employees of the comparison hospital. Six months and one year after the policy change, smokers reported lower smoking rates while at work, although quit smoking rates and home smoking rates were similar in both hospitals.

Effects of behavioral skills training and schedule of nicotine gum administration on smoking cessation.

Eighty-nine smokers were randomly assigned to four nicotine gum treatments for smoking cessation: behavioral treatment plus a fixed schedule of nicotine gum, behavioral treatment plus an ad lib schedule, education plus a fixed schedule, and education plus an ad lib schedule. The four treatment conditions produced similar rates of abstinence (40.9% to 58.3%) at the end of 11 weeks of treatment. However, at 6-month follow-up, the subjects who had received behavioral treatment had a significantly better abstinence rate (36.7%) than those receiving education (17.5%). Nicotine gum schedule had no effect on treatment outcome.

Evaluating worksite smoking policies. Methodologic issues.

This paper discusses the methodologic issues one confronts when studying the impact of worksite smoking policies, using one such study as an example. Topics covered include defining the research questions, deciding on timing of measurements in relation to policy implementation, advantages and disadvantages of cohort versus cross-sectional research designs, and alternative measurement techniques. The sample study examined changes over one year in the smoking-related behaviors and attitudes of employees of a hospital that initiated a restrictive smoking policy, in relation to employees of a comparable hospital without a restrictive policy. The short term impact on ambient carbon monoxide was also examined. A case is made for studying the impact of smoking policy in the context of other strategies for reducing smoking prevalence at the worksite, such as individual treatment and organizational initiatives to motivate smoking cessation.

The effects of a transtelephonic surveillance and prehospital emergency intervention system on the 1-year course following acute myocardial infarction.

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.

Chronic pain and functional impairment: assessing beliefs about their relationship.

Many chronic pain patients believe that they cannot function normally because of their pain. The Pain and Impairment Relationship Scale (PAIRS) was developed to assess the extent to which chronic pain patients endorse this belief, and the relationship of this belief to functional impairment, measured both subjectively and objectively. The PAIRS was administered to 56 patients in a chronic pain treatment program. The PAIRS demonstrated adequate internal consistency and it correlated significantly with another measure of the cognitive component of chronic pain syndrome, the Cognitive Errors Questionnaire--Low Back Scale. The PAIRS accounted for a significant proportion of variance in several measures of impairment (including the Sickness Impact Profile, restrictions in range of motion, and statements of limitation during a standardized exercise routine) beyond that accounted for solely by subjective pain estimate in multiple regression analyses. It appears that the belief that pain necessarily implies disability is associated with actual impairment, independent of the actual contribution of reported pain.

Psychological distress as a predictor of ventricular arrhythmias in a post-myocardial infarction population.

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.

Quality of life post-myocardial infarction: effects of a transtelephonic coronary intervention system.

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.

Saliva cotinine as a measure of smoking status in field settings.

The accuracy and reliability of saliva cotinine as an objective measure of smoking status was examined in two field studies. In Study I, saliva was collected from smokers and nonsmokers with repeated samples taken from a randomly selected subset of the smokers. Results indicated perfect classification of smokers versus nonsmokers and acceptable reliability of repeated samples. Study II investigated the accuracy of saliva cotinine in detecting recent quitters in a worksite smoking cessation program. Saliva cotinine showed greater accuracy than expired carbon monoxide at detecting quitters, provided they were abstinent for at least seven days. From pre- to post-treatment, subject's saliva cotinine levels dropped 19 per cent while self-reported rate of smoking dropped 54 per cent. Saliva collection in the field is feasible and cotinine appears to be one of the more sensitive assays currently available for epidemiologic and clinical applications.

The Framingham Type A Scale and severity of coronary artery disease.

The relationship between scores on the Framingham Type A Scale (FTAS) and angiographic severity of coronary artery disease (CAD) was examined in a sample of 50 patients undergoing diagnostic cardiac catheterization. Age and family history of coronary heart disease (CHD) were positively related to CAD severity. Contrary to prediction, the FTAS demonstrated a non-significant, inverse relationship with CAD. However, FTAS-defined Type As with at least some CAD were younger than Type Bs with CAD. This inverse relationship between FTAS scores and age was not found in patients without CAD. Thus, though the FTAS was related to a younger clinical presentation requiring catheterization, it was not associated with the severity of CAD.