Susan M. Czajkowski

Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium.

Treatment fidelity refers to the methodological strategies used to monitor and enhance the reliability and validity of behavioral interventions. This article describes a multisite effort by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium (BCC) to identify treatment fidelity concepts and strategies in health behavior intervention research. The work group reviewed treatment fidelity practices in the research literature, identified techniques used within the BCC, and developed recommendations for incorporating these practices more consistently. The recommendations cover study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Funding agencies, reviewers, and journal editors are encouraged to make treatment fidelity a standard part of the conduct and evaluation of health behavior intervention research.

A New Tool to Assess Treatment Fidelity and Evaluation of Treatment Fidelity across 10 Years of Health Behavior Research.

A. Bellg, B. Borrelli, et al. (2004) previously developed a framework that consisted of strategies to enhance treatment fidelity of health behavior interventions. The present study used this framework to (a) develop a measure of treatment fidelity and (b) use the measure to evaluate treatment fidelity in articles published in 5 journals over 10 years. Three hundred forty-two articles met inclusion criteria; 22% reported strategies to maintain provider skills, 27% reported checking adherence to protocol, 35% reported using a treatment manual, 54% reported using none of these strategies, and 12% reported using all 3 strategies. The mean proportion adherence to treatment fidelity strategies was .55; 15.5% of articles achieved greater than or equal to .80. This tool may be useful for researchers, grant reviewers, and editors planning and evaluating trials.

Depression and late mortality after myocardial infarction in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study

Objective: The Enhancing Recovery in Coronary Heart Disease study was a multicenter clinical trial in which patients with depression and/or low perceived social support after an acute myocardial infarction were randomly assigned to an intervention consisting of cognitive behavior therapy and, in some cases, sertraline, or to usual care. There was no difference in survival between the groups. A possible reason why the intervention failed to affect survival is that too many patients with mild, transient depression were enrolled. Another is that some patients died too soon to complete the intervention. This analysis evaluates whether there was a difference in late (ie, ≥6 months after the myocardial infarction) mortality among initially depressed patients who had a Beck Depression Inventory score ≥10 and a past history of major depression, and who completed the 6-month post-treatment assessment. It also examines the relationship between change in depression and late mortality. Methods: Out of the 1,165 (47%) of the Enhancing Recovery in Coronary Heart Disease study participants who met our criteria, 57 died in the first 6 months, and 858 (409 usual care, 449 intervention) completed the 6-month assessment. Cox regression was used to analyze survival. Results: The intervention did not affect late mortality. However, intervention patients whose depression did not improve were at higher risk for late mortality than were patients who responded to treatment. Conclusions: Patients whose depression is refractory to cognitive behavior therapy and sertraline, two standard treatments for depression, are at high risk for late mortality after myocardial infarction.

Medication adherence: a call for action.

Poor adherence to efficacious cardiovascular-related medications has led to considerable morbidity, mortality, and avoidable health care costs. This article provides results of a recent think-tank meeting in which various stakeholder groups representing key experts from consumers, community health providers, the academic community, decision-making government officials (Food and Drug Administration, National Institutes of Health, etc), and industry scientists met to evaluate the current status of medication adherence and provide recommendations for improving outcomes. Below, we review the magnitude of the problem of medication adherence, prevalence, impact, and cost. We then summarize proven effective approaches and conclude with a discussion of recommendations to address this growing and significant public health issue of medication nonadherence.

Assessment and treatment of depression in patients with cardiovascular disease: National Heart, Lung, and Blood Institute Working Group Report.

Objective: The National Heart, Lung, and Blood Institute convened an interdisciplinary working group of experts to develop recommendations for the assessment and treatment of depression in patients with coronary heart disease (CHD). Method: Consensus of experts. Results: Our current recommendations are that the Beck Depression Inventory-I be employed for epidemiological studies of depression and CHD, that the Patient Health Questionnaire 2-item version be employed for screening for trial eligibility, that the Depression Interview and Structured Hamilton (DISH) be employed for diagnostic ascertainment for trial inclusion, and that the Hamilton rating scale, which is part of the DISH, be employed for both depression symptom reduction and the remission criterion in any trial. We further recommend that a randomized controlled trial be undertaken to determine whether selective serotonin reuptake inhibitors, psychotherapy, or combined treatment can reduce the risk of CHD events and mortality associated with depression in CHD patients. Conclusions: This report summarizes the recommendations made by the working group and discusses the rationale for each recommendation, the strengths and weaknesses of alternative approaches to assessment and treatment, and the implications for future research in this area. ACS = acute coronary syndrome; BDI = Beck Depression Inventory; CBASP = Cognitive Behavioral Analysis System of Psychotherapy; CBT = cognitive behavior therapy; CIDI = Composite International Diagnostic Interview; CHD = coronary heart disease; CVD = cardiovascular disease; DISH = Depression Interview and Structured Hamilton; ENRICHD = Enhancing Recovery in Coronary Heart Disease; HAM-D = Hamilton Rating Scale for Depression; IDS-SR = Inventory of Depressive Symptomatology, self-report; IMPACT = Improving Mood–Promoting Access to Collaborative Treatment; IPT = interpersonal therapy; MI = myocardial infarction; NHLBI = National Heart, Lung, and Blood Institute; PHQ = Patient Health Questionnaire; RCT = randomized controlled trial; SADHART = Sertraline Antidepressant Heart Attack Randomized Trial; SCID = Structured Clinical Interview for DSM-IV; SSRI = selective serotonin reuptake inhibitor; STAR*D = Sequenced Treatment Alternatives to Relieve Depression.

Social support and cardiovascular disease

Key Concepts: An Introduction to Cardiovascular Disease D.M. Davidson. Measures of Health Outcome in Social Support Research R.M. Kaplan. Establishing a Relationship between Social Support and Cardiovascular Disease: International Epidemiological Evidence for a Relationship between Social Support and Cardiovascular Disease K. Orth-Gomer. A Critical Evaluation of United States Epidemiological Evidence, Including a Special Consideration of Ethnic Variation H.P. Hazuda. Individual, Environmental, and Cultural Factors in Social Support and Cardiovascular Disease: Gender Differences in Type A Behavior, Social Support, and Ischemic Heart Disease M.A. Morell, et al. Social Support in the Work Environment and Cardiovascular Disease J.V. Johnson, E.M. Hall. The Development of Cardiovascular Disease: Social Support and Coronary Heart Disease S. Cohen, et al. The Crisis and Rehabilitation Phases of Cardiovascular Disease: Cardiac Rehabilitation K. Dracup. 7 additional articles. Index.

Self-report measures of medication adherence behavior: recommendations on optimal use

Medication adherence plays an important role in optimizing the outcomes of many treatment and preventive regimens in chronic illness. Self-report is the most common method for assessing adherence behavior in research and clinical care, but there are questions about its validity and precision. The NIH Adherence Network assembled a panel of adherence research experts working across various chronic illnesses to review self-report medication adherence measures and research on their validity. Self-report medication adherence measures vary substantially in their question phrasing, recall periods, and response items. Self-reports tend to overestimate adherence behavior compared with other assessment methods and generally have high specificity but low sensitivity. Most evidence indicates that self-report adherence measures show moderate correspondence to other adherence measures and can significantly predict clinical outcomes. The quality of self-report adherence measures may be enhanced through efforts to use validated scales, assess the proper construct, improve estimation, facilitate recall, reduce social desirability bias, and employ technologic delivery. Self-report medication adherence measures can provide actionable information despite their limitations. They are preferred when speed, efficiency, and low-cost measures are required, as is often the case in clinical care.

Comparison of Preoperative Characteristics of Men and Women Undergoing Coronary Artery Bypass Grafting (The Post Coronary Artery Bypass Graft [CABG] Biobehavioral Study)

A cohort of 759 coronary artery bypass grafting (CABG) patients (269 women and 490 men) was enrolled in the prospective POST CABG Biobehavioral Study at 5 clinical centers in the United States and Canada. Sociodemographic and medical data were obtained by interview and from medical charts. Health-related quality of life and psychosocial data were ascertained preoperatively by interview and questionnaire for those patients whose condition allowed preoperative assessment and was compared among patients from hospitals enrolling both male and female patients (143 women and 267 men). Women enrolled in the Biobehavioral Study were older than men (65.4 +/- 9.0 vs 61.8 +/- 9.7 years, p < 0.001) and more likely to have a preoperative medical condition which precluded biobehavioral evaluation (47% vs 34%, p < 0.001). Women were less likely to be high school graduates (59% vs 74%, p < 0.001), were less likely to be earning > or =

Low perceived social support and post-myocardial infarction prognosis in the enhancing recovery in coronary heart disease clinical trial: the effects of treatment.

25,000 per year (39% vs 69%, p < 0.001), and were married less often at the time of surgery (59% vs 85%, p < 0.001). Fewer women than men were able to perform basic self-care activities (p < 0.001) and social activities (p < 0.001). Women were also less able to perform the more demanding activities required for independent living, recreation, and maintaining a household (p < 0.001). Women were also more anxious (p = 0.01) and reported more depressive symptoms (p < 0.001) than men. These data suggest that plans for perioperative and convalescent care for women undergoing CABG should take into account their less favorable medical and psychosocial status relative to men.

Comparison of health-related quality-of-life outcomes of men and women after coronary artery bypass surgery through 1 year: findings from the POST CABG Biobehavioral Study.

Objective: In post hoc analyses, to examine in low perceived social support (LPSS) patients enrolled in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial (n = 1503), the pattern of social support following myocardial infarction (MI), the impact of psychosocial intervention on perceived support, the relationship of perceived support at the time of MI to subsequent death and recurrent MI, and the relationship of change in perceived support 6 months after MI to subsequent mortality. Methods: Partner status (partner, no partner) and score (<12 = low support; >12 = moderate support) on the ENRICHD Social Support Instrument (ESSI) were used post hoc to define four levels of risk. The resulting 4 LPSS risk groups were compared on baseline characteristics, changes in social support, and medical outcomes to a group of concurrently enrolled acute myocardial infarction patients without depression or LPSS (MI comparison group, n = 408). Effects of treatment assignment on LPSS and death/recurrent MI were also examined. Results: All 4 LPSS risk groups demonstrated improvement in perceived support, regardless of treatment assignment, with a significant treatment effect only seen in the LPSS risk group with no partner and moderate support at baseline. During an average 29-month follow-up, the combined end point of death/nonfatal MI was 10% in the MI comparison group and 23% in the ENRICHD LPSS patients; LPSS conferred a greater risk in unadjusted and adjusted models (HR = 1.74–2.39). Change in ESSI score and/or improvement in perceived social support were not found to predict subsequent mortality. Conclusions: Baseline LPSS predicted death/recurrent MI in the ENRICHD cohort, independent of treatment assignment. Intervention effects indicated a partner surrogacy role for the interventionist and the need for a moderate level of support at baseline for the intervention to be effective. CAD = coronary artery disease; CHD = coronary heart disease; AMI = acute myocardial infarction; MI = myocardial infarction; ENRICHD = Enhancing Recovery in Coronary Heart Disease; LPSS = low perceived social support; ESSI = ENRICHD Social Support Instrument; UC = usual care; INT = intervention; DISH = Diagnostic Interview and Structured Hamilton; ECG = electrocardiogram; BDI = Beck Depression Inventory; HR = hazard ratio; CI = confidence interval.