Michael J. Follick

Biobehavioral variables and mortality or cardiac arrest in the Cardiac Arrhythmia Pilot Study (CAPS)

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.

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 sickness impact profile: a global measure of disability in chronic low back pain

&NA; This investigation examines the utility of the Sickness Impact Profile (SIP) for assessing disability associated with chronic pain and presents normative data on a sample of 107 patients experiencing chronic low back pain (CLBP). The results support the validity of the SIP as a measure of functional status with CLBP patients. Specifically, the psychosocial dimension was significantly correlated with the emotional distress categories of the MMPI and the physical dimension score was inversely associated with standing/walking and positively correlated with time spent lying down. In addition, the SIP appears to be a measure with sufficient sensitivity to detect pre‐/post‐treatment changes. Patients suffering from CLBP show significant impairment in physical, psychosocial, and work and recreational activities. The greatest impairment reported was in the area of work, but disability ratings for recreation, home management, social interaction, emotional behavior, and sleep and rest were also comparatively high. Based upon its reliability, validity, breadth of assessment, and ease of administration, the SIP appears to be well suited for the assessment of patients suffering from chronic pain and evaluating the efficacy of multidisciplinary pain units.

Comparison of lumbar paravertebral EMG patterns in chronic low back pain patients and non-patient controls

&NA; According to myogenic models that relate abnormal EMG patterns to the experience of pain, lumbar paravertebral muscle activity has been considered to play an important role in chronic low back pain. In the present study, 40 chronic low back pain patients and 40 matched non‐patient controls were compared on lumbar paravertebral EMG during mechanically stabilized static and dynamic postures. Differences between groups in lumbar curvature and spinal range of motion were determined using a dual goniometer technique. Although the two groups did not differ on absolute levels of EMG during quiet standing, significant differences were found for EMG patterns during dynamic postures. In addition, most patients did not show the flexion‐relaxation response or the expected pattern of EMG responses during trunk rotation, most likely because of restricted range of motion and/or compensatory posturing. These findings provide support for the biomechanical model of chronic pain and indicate the need for further research pertaining to pain behavior and movement‐related lumbar muscle activity.

Assessment of quality of life as observed from the baseline data of the Studies of Left Ventricular Dysfunction (SOLVD) trial quality-of-life substudy

The improvement of aspects of a patients 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.

Evaluation of a daily activity diary for chronic pain patients.

&NA; The present study examined the reliability and validity of a daily activity diary for chronic pain patients. The diary assesses various postures and activities including time spent lying, sitting, or standing/walking, the use of pain relief devices, time spent in pain relief activities, and the use of analgesic medications. The methodology compared patient self‐report on the daily activity diary to spouse observations of the same activities. In addition, patient self‐report of uptime/downtime was compared to the objective assessment of uptime/downtime by an automated electromechanical device. Reliability coefficients for the daily activity diary categories were all positive and statistically reliable as were correlations between patient and spouse ratings on lying down time, time spent standing/walking, and pain intensity. Also, patient self‐report of medication use correlated significantly with spouse pill count. Finally, the correlation between patient report of lying down time and downtime as measured by the electromechanical monitor was also positive and highly significant. These results indicate that the daily activity diary is a reliable and valid instrument for the assessment of daily activity patterns of chronic pain patients in their natural environment. These results are discussed in relation to other research and the use of daily diaries for assessment and treatment outcome research with this population.

Cognitive distortion and disability in chronic low back pain

Numerous authors have suggested that cognitions play an important role in the development, maintenance, and treatment of chronic low back pain (CLBP). However, little evidence exists to support the association between cognitive variables and the CLBP problem. The present study examined the relationship of cognitive distortion, as measured by the Cognitive Error Questionnaire, to disability, as measured by the Sickness Impact Profile, in a sample of 138 CLBP patients. As predicted, cognitive distortion was consistently related to several aspects of disability. The cognitive variables accounted for variance in disability beyond that accounted for by severity of pain, number of pain treatments, and depression. Also as predicted, cognitive distortion concerning low back pain situations was more closely correlated with disability than was distortion concerning general, nonpain situations. Overgeneralization was the specific cognitive error most closely and consistently correlated with disability. The results are interpreted as consistent with a cognitive-behavioral model of CLBP.

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.

Cognitive distortion and psychological distress in chronic low back pain.

Les patients depressifs souffrant de lombalgies chroniques presentent un taux eleve de distortions cognitives: le fait est bien documente. On a administre a 138 patients lombalgiques chroniques les echelles Depression, Psychothenie et Schizophrenie du MMPI

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 patients reading of the informed consent form and the patients lack of medical insurance. These results suggest that (1) the clinical trial staffs 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.