Paul A. Pirraglia

Improvement of outcomes after coronary artery bypass: A randomized trial comparing intraoperative high versus low mean arterial pressure

BACKGROUND The objective of this randomized clinical trial of elective coronary artery bypass grafting was to investigate whether intraoperative mean arterial pressure below autoregulatory limits of the coronary and cerebral circulations was a principal determinant of postoperative complications. The trial compared the impact of two strategies of hemodynamic management during cardiopulmonary bypass on outcome. Patients were randomized to a low mean arterial pressure of 50 to 60 mm Hg or a high mean arterial pressure of 80 to 100 mm Hg during cardiopulmonary bypass. METHODS A total of 248 patients undergoing primary, nonemergency coronary bypass were randomized to either low (n = 124) or high (n = 124) mean arterial pressure during cardiopulmonary bypass. The impact of the mean arterial pressure strategies on the following outcomes was assessed: mortality, cardiac morbidity, neurologic morbidity, cognitive deterioration, and changes in quality of life. All patients were observed prospectively to 6 months after the operation. RESULTS The overall incidence of combined cardiac and neurologic complications was significantly lower in the high pressure group at 4.8% than in the low pressure group at 12.9% (p = 0.026). For each of the individual outcomes, the trend favored the high pressure group. At 6 months after coronary bypass for the high and low pressure groups, respectively, total mortality rate was 1.6% versus 4.0%, stroke rate 2.4% versus 7.2%, and cardiac complication rate 2.4% versus 4.8%. Cognitive and functional status outcomes did not differ between the groups. CONCLUSION Higher mean arterial pressures during cardiopulmonary bypass can be achieved in a technically safe manner and effectively improve outcomes after coronary bypass.

Depressive symptomatology in coronary artery bypass graft surgery patients

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 ≥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. Copyright

Alcohol Use and Sexual Risk Behavior Among Human Immunodeficiency Virus–Positive Persons

BACKGROUND This study was undertaken to determine if alcohol use is associated with sexual risk taking among human immunodeficiency virus (HIV)-infected persons. METHODS Cross-sectional interviews of 262 HIV-infected patients in the Brown University AIDS Program were performed. Factors associated with any sexual activity, unsafe sexual activity, and a 4-fold typology of sexual risk were examined. Alcohol measures included drinking days, drinks per drinking day, binge drinking, and hazardous alcohol use. RESULTS The sample was 58% male and 40% white; 67% of patients were self-identified as heterosexual, and 48% drank alcohol. Nearly two thirds of patients reported sexual activity in the past 6 months, with 38% reporting unprotected sex during that period. All measures of alcohol use were significantly associated with any sexual activity and with unsafe sexual behavior. As an example, controlling for age, HIV transmission risk, marital status, and HIV clinical indicators, hazardous drinkers were 5.64 times more likely to report unprotected sex and have multiple partners (p < 0.01) than were those not drinking at hazardous levels. CONCLUSIONS A high proportion of HIV-infected persons were sexually active and having unsafe sex. Alcohol, at all levels of use, was associated with increased sexual risk taking.

Pharmacist-Led Shared Medical Appointments for Multiple Cardiovascular Risk Reduction in Patients With Type 2 Diabetes:

Purpose To assess whether VA MEDIC-E (Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction[EM DASH] Extended for 6 months), a pharmacist-led shared medical appointments program, could improve attainment of target goals for hypertension, hyperglycemia, hyperlipidemia, and tobacco use in patients with type 2 diabetes compared to standard primary care after 6 months of intervention. Methods A randomized, controlled trial of VA MEDIC-E (n = 50) versus standard primary care (n = 49) in veterans with type 2 diabetes, hemoglobin A1c (A1C) > 7%, blood pressure (BP) > 130/80 mmHg, and low density lipoprotein cholesterol (LDL-C) > 100mg/dl (2.59 mmol/l) in the previous 6 months was conducted. The VA MEDIC-E intervention consisted of 4 weekly group sessions followed by 5 monthly booster group sessions. Each 2-hour session included 1 hour of multidisciplinary diabetes specific healthy lifestyle education and 1 hour of pharmacotherapeutic interventions performed by a clinical pharmacist. Evaluation measures included lab values of A1C, LDL cholesterol, BP, and goal attainment of these values, and diabetes self-care behavior questionnaires at 6 months. Results The randomization groups were similar at baseline in all cardiovascular risk factors except for LDL, which was significantly lower in the MEDIC-E arm. At 6 months, significant improvements from baseline were found in the intervention arm for exercise, foot care, and goal attainment of A1C, LDL-C, and BP but not in the control arm. Conclusions The results of this study demonstrate that the pharmacist-led group intervention program for 6 months was an efficacious and sustainable collaborative care approach to managing diabetes and reducing associated cardiovascular risk.

Caregiver Burden and Depression Among Informal Caregivers of HIV-infected Individuals

BACKGROUND: Few studies have examined the factors associated with depression in informal caregivers of HIV-infected persons.OBJECTIVE: To investigate the relationship between depression and caregiver burden among informal caregivers of HIV-infected individuals.DESIGN: Cross-sectional study using baseline data from an ongoing randomized trial of a supportive telephone intervention.PARTICIPANTS: One hundred seventy-six dyads of HIV patients and their informal caregiver.MEASUREMENTS: Depression was defined as a Beck Depression Inventory >10. A Caregiver Strain Index >6 identified informal caregivers with a high caregiver burden. We used logistic regression to identify characteristics that were associated with depression in the informal caregiver.RESULTS: Informal caregivers were 42 years old (SD, 13), 53% female, 59% nonwhite, and 30% had education beyond high school. Forty-seven percent of informal caregivers were the patient’s partner, 18% a friend, and 35% a family member. Twenty-seven percent of informal caregivers had a high caregiver burden, and 50% were depressed. We found significantly greater odds of informal caregiver depression with high caregiver burden (OR, 6.08; 95% CI, 2.40 to 15.4), informal caregiver medical comorbidity besides HIV (OR, 2.32; 95% CI, 1.09 to 4.92), spending all day together (OR, 3.92; 95% CI, 1.59 to 9.69), having to help others besides the HIV patient (OR, 2.55; 95% CI, 1.14 to 5.74), and duration of the HIV patient’s diagnosis (OR, 1.01 per month; 95% CI, 1.00 to 1.01).CONCLUSIONS: High caregiver burden was strongly associated with depression among HIV-infected individuals’ informal caregivers, who themselves had difficult life circumstances. Informal caregivers of HIV patients may be in need of both mental health services and assistance in caregiving.

Pharmacist-Led Group Medical Appointment Model in Type 2 Diabetes

Purpose The purpose of this study was to assess whether the VA-MEDIC (Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction), a pharmacist-led group medical visit program, could improve achievement of target goals in hypertension, hyperglycemia, hyperlipidemia, and tobacco use in patients with type 2 diabetes compared to usual care. Methods This was a randomized controlled trial of VA-MEDIC intervention in addition to usual care versus usual care alone in diabetic patients to reduce cardiac risk factors. VA-MEDIC consisted of a 40- to 60-minute educational component by nurse, nutritionist, physical therapist, or pharmacist followed by pharmacist-led behavioral and pharmacological interventions over 4 weekly sessions. Measures The attainment of target goals in hemoglobin A1C (A1C), blood pressure, fasting lipids, and tobacco use recommended by the American Diabetes Association. Results Of 118 participants, 109 completed the study. VA-MEDIC (n = 58) participants were younger and had greater tobacco use at baseline than usual care but were similar in other cardiovascular risk factors. After 4 months, a greater proportion of VA-MEDIC participants versus controls achieved an A1C of less than 7% and a systolic blood pressure less than 130 mm Hg. No significant change was found in lipid control or tobacco use between the 2 study arms. Conclusion Pharmacist-led group medical visits are feasible and efficacious for improving cardiac risk factors.

Computerized data collection in the operating room during coronary artery bypass surgery: A comparison to the hand-written anesthesia record

OBJECTIVE To investigate variability between hand-written and computerized anesthesia records and evaluate any associated bias. DESIGN AND MEASUREMENTS A computer system that was used to collect intraoperative data for a study of hemodynamic management during coronary artery bypass graft surgery is described. The system collected and recorded hemodynamic data automatically downloaded from the anesthesia monitor as well as surgical events and drug administration data entered through menu options. The system then combined, summarized, and graphed the data as well as formatted it for export to a commercially available database program. In a sample of 14 patients, blood pressure data collected by the computer system was compared with the blood pressure data charted in the hand-written anesthesia record. MAIN RESULTS Although general linear models controlling for within-patient variation and randomization assignment for mean arterial pressure range on cardiopulmonary bypass showed a significant relationship; low R2 values indicated that much of the variability could not be explained and that there was, therefore, poor agreement between the two records. Furthermore, a systematic bias in the hand-written anesthesia record was found when the computer system record was compared with the hand-written record and to the difference of the two records, so that extremes seen in the computer system record tended to be minimized in the hand-written anesthesia record. CONCLUSIONS Because of the lack of explained variability between the computer system and hand-written anesthesia records and the bias in the hand-written anesthesia record, the hand-written anesthesia record should not be relied on as a source of accurate data for research purposes.

Attrition in longitudinal randomized controlled trials: home visits make a difference

BackgroundParticipant attrition in longitudinal studies can introduce systematic bias, favoring participants who return for follow-up, and increase the likelihood that those with complications will be underestimated. Our aim was to examine the effectiveness of home follow-up (Home F/U) to complete the final study evaluation on potentially “lost” participants by: 1) evaluating the impact of including and excluding potentially “lost” participants (e.g., those who required Home F/U to complete the final evaluation) on the rates of study complications; 2) examining the relationship between timing and number of complications on the requirement for subsequent Home F/U; and 3) determining predictors of those who required Home F/U.MethodsWe used data from a randomized controlled trial (RCT) conducted from 1991–1994 among coronary artery bypass graft surgery patients that investigated the effect of High mean arterial pressure (MAP) (intervention) vs. Low MAP (control) during cardiopulmonary bypass on 5 complications: cardiac morbidity/mortality, neurologic morbidity/mortality, all-cause mortality, neurocognitive dysfunction and functional decline. We enhanced completion of the final 6-month evaluation using Home F/U.ResultsAmong 248 participants, 61 (25%) required Home F/U and the remaining 187 (75%) received Routine F/U. By employing Home F/U, we detected 11 additional complications at 6 months: 1 major neurologic complication, 6 cases of neurocognitive dysfunction and 4 cases of functional decline. Follow-up of 61 additional Home F/U participants enabled us to reach statistical significance on our main trial outcome. Specifically, the High MAP group had a significantly lower rate of the Combined Trial Outcome compared to the Low MAP group, 16.1% vs. 27.4% (p=0.032). In multivariate analysis, participants who were ≥ 75 years (OR=3.23, 95% CI 1.52-6.88, p=0.002) or on baseline diuretic therapy (OR=2.44, 95% CI 1.14-5.21, p=0.02) were more likely to require Home F/U. In addition, those in the Home F/U group were more likely to have sustained 2 or more complications (p=0.05).ConclusionsHome visits are an effective approach to reduce attrition and improve accuracy of study outcome reporting. Trial results may be influenced by this method of reducing attrition. Older participants, those with greater medical burden and those who sustain multiple complications are at higher risk for attrition.

Association of change in depression and anxiety symptoms with functional outcomes in pulmonary rehabilitation patients

OBJECTIVE Pulmonary rehabilitation (PR) has emerged over the last decade as an essential component of an integrated approach to managing patients with chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD). We sought to examine how depression and anxiety symptom changes relate to disease-specific quality of life outcomes following PR. METHODS We performed a cohort study of 81 patients with COPD who completed PR at a Veterans Administration Medical Center. Pulmonary rehabilitation consisted of supervised exercise training and education twice weekly for 8 weeks. Beck Depression and Anxiety Inventories (BDI and BAI) assessed symptom burden at baseline and completion of PR. We measured change in disease-specific quality of life using the dyspnea, mastery, emotion and fatigue domains of the Chronic Respiratory Questionnaire Self-Reported (CRQ-SR) from baseline to completion of PR. RESULTS Participants were 69.8±9.1 years old and all male. Forced expiratory volume in 1 s (FEV1) was 1.23±0.39 L. The CRQ-SR scores improved significantly: dyspnea (P<.0001), mastery (P=.015) and fatigue (P=.017). The BDI scores improved significantly (13.1±10.5 to 10.8±9.9, P=.003; BAI: 13.1±10.1 to 12.1±11.7). Multivariate regression models controlling for age, FEV1, depression treatment and anxiety treatment showed that improvement in depressive symptoms were associated with improvement in fatigue (P=.003), emotion (P=.003) and mastery (P=.01). Anxiety symptom change was not significantly associated with change in disease-specific quality of life domains. CONCLUSION Addressing anxiety symptoms in PR patients may be indicated because disease-specific quality of life improvement appears to be associated with mood.

Is the collaborative chronic care model effective for patients with bipolar disorder and co-occurring conditions?

BACKGROUND The effectiveness of bipolar collaborative chronic care models (B-CCMs) among those with co-occurring substance use, psychiatric, and/or medical conditions has not specifically been assessed. We assessed whether B-CCM effects are equivalent comparing those with and without co-occurring conditions. METHODS We reanalyzed data from the VA Cooperative Study #430 (n=290), an 11-site randomized controlled trial of the B-CCM compared to usual care. Moderators included common co-occurring conditions observed in patients with bipolar disorder, including substance use disorders (SUD), anxiety, psychosis; medical comorbidities (total number), and cardiovascular disease-related conditions (CVD). Mixed-effects regression models were used to determine interactive effects between moderators and 3-year primary outcomes. RESULTS Treatment effects were comparable for those with and without co-occurring substance use and psychiatric conditions, although possibly less effective in improving physical quality of life in those with CVD-related conditions (Beta=-6.11;p=0.04). LIMITATIONS Limitations included multiple comparisons and underpowered analyses of moderator effects. CONCLUSIONS B-CCM effects were comparable in patients with co-occurring conditions, indicating that the intervention may be generally applied. Specific attention to physical quality of life in those with CVD maybe warranted.