Peter Faris

One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients.

OBJECTIVES This study investigated the ongoing effects of participation in a mindfulness-based stress reduction (MBSR) program on quality of life (QL), symptoms of stress, mood and endocrine, immune and autonomic parameters in early stage breast and prostate cancer patients. METHODS Forty-nine patients with breast cancer and 10 with prostate cancer enrolled in an eight-week MBSR program that incorporated relaxation, meditation, gentle yoga and daily home practice. Demographic and health behaviors, QL, mood, stress symptoms, salivary cortisol levels, immune cell counts, intracellular cytokine production, blood pressure (BP) and heart rate (HR) were assessed pre- and post-intervention, and at 6- and 12-month follow-up. RESULTS Fifty-nine, 51, 47 and 41 patients were assessed pre- and post-intervention and at 6- and 12-month follow-up, respectively, although not all participants provided data on all outcomes at each time point. Linear mixed modeling showed significant improvements in overall symptoms of stress which were maintained over the follow-up period. Cortisol levels decreased systematically over the course of the follow-up. Immune patterns over the year supported a continued reduction in Th1 (pro-inflammatory) cytokines. Systolic blood pressure (SBP) decreased from pre- to post-intervention and HR was positively associated with self-reported symptoms of stress. CONCLUSIONS MBSR program participation was associated with enhanced quality of life and decreased stress symptoms, altered cortisol and immune patterns consistent with less stress and mood disturbance, and decreased blood pressure. These pilot data represent a preliminary investigation of the longer-term relationships between MBSR program participation and a range of potentially important biomarkers.

Associations Between Acute Kidney Injury and Cardiovascular and Renal Outcomes After Coronary Angiography

Background— Acute kidney injury (AKI) is associated with early mortality after percutaneous coronary revascularization procedures, but its prognostic relevance to long-term clinical outcomes remains controversial. Methods and Results— We conducted a retrospective study of 14 782 adults who received coronary angiography in the province of Alberta, Canada, between 2004 and 2006. AKI was identified on the basis of changes in serum creatinine concentration within 7 days of the procedure according to AKI Network criteria. The associations between AKI and long-term outcomes, including mortality, end-stage renal disease, and cardiovascular and renal hospitalizations, were studied with the use of Cox regression of multiple failure times. The adjusted risk of death increased with increasing severity of AKI; compared with no AKI, the adjusted hazard ratio for death was 2.00 (95% confidence interval, 1.69 to 2.36) with stage 1 AKI and 3.72 (95% confidence interval, 2.92 to 4.76) with stage 2 or 3 AKI. The adjusted risk of end-stage renal disease requiring renal replacement therapy also increased according to the severity of AKI (hazard ratio, 4.15 [95% confidence interval, 2.32 to 7.42] and 11.74 [95% confidence interval, 6.38 to 21.59], respectively), as did the risks of subsequent hospitalizations for heart failure and acute renal failure. Conclusions— These findings inform the controversy surrounding AKI after angiography, demonstrating that it is a significant risk factor for long-term mortality, end-stage renal disease, and hospitalization for cardiovascular and renal events after coronary angiography.

Risk adjustment performance of Charlson and Elixhauser comorbidities in ICD-9 and ICD-10 administrative databases

BackgroundThe performance of the Charlson and Elixhauser comorbidity measures in predicting patient outcomes have been well validated with ICD-9 data but not with ICD-10 data, especially in disease specific patient cohorts. The objective of this study was to assess the performance of these two comorbidity measures in the prediction of in-hospital and 1 year mortality among patients with congestive heart failure (CHF), diabetes, chronic renal failure (CRF), stroke and patients undergoing coronary artery bypass grafting (CABG).MethodsA Canadian provincial hospital discharge administrative database was used to define 17 Charlson comorbidities and 30 Elixhauser comorbidities. C-statistic values were calculated to evaluate the performance of two measures. One year mortality information was obtained from the provincial Vital Statistics Department.ResultsThe absolute difference between ICD-9 and ICD-10 data in C-statistics ranged from 0 to 0.04 across five cohorts for the Charlson and Elixhauser comorbidity measures predicting in-hospital or 1 year mortality. In the models predicting in-hospital mortality using ICD-10 data, the C-statistics ranged from 0.62 (for stroke) – 0.82 (for diabetes) for Charlson measure and 0.62 (for stroke) to 0.83 (for CABG) for Elixhauser measure.ConclusionThe change in coding algorithms did not influence the performance of either the Charlson or Elixhauser comorbidity measures in the prediction of outcome. Both comorbidity measures were still valid prognostic indicators in the ICD-10 data and had a similar performance in predicting short and long term mortality in the ICD-9 and ICD-10 data.

Outcomes of cardiac resynchronization therapy in patients with versus those without atrial fibrillation: A systematic review and meta-analysis

BACKGROUND Whether the benefits observed with cardiac resynchronization therapy (CRT) are similar in patients with versus those without atrial fibrillation (AF) is unclear. Furthermore, whether patients with AF receiving CRT should undergo atrioventricular nodal (AVN) ablation remains uncertain. OBJECTIVE The purpose of this study was to compare outcomes in patients with and those without AF receiving CRT and to evaluate the influence of AVN ablation on outcomes in patients with AF. METHODS A systematic review and meta-analysis was performed. Outcomes included death, CRT nonresponse, and changes in left ventricular (LV) remodeling, quality of life (QoL), and 6-minute hall walk distance (6MWD). RESULTS Twenty-three observational studies were included and followed a total of 7,495 CRT recipients, 25.5% with AF, for a mean of 33 months. AF was associated with an increased risk of nonresponse to CRT (34.5% vs 26.7%; pooled relative risk [RR] 1.32; 95% confidence interval [CI] 1.12, 1.55; P = .001)) and all-cause mortality (10.8% vs 7.1% per year, pooled RR 1.50, 95% CI 1.08, 2.09; P = .015). The presence of AF was also associated with less improvement in QoL, 6-minute hall walk distance, and LV end-systolic volume but not LV ejection fraction. Among patients with AF, AVN ablation appeared favorable with a lower risk of clinical nonresponse (RR 0.40; 95% CI 0.28, 0.58; P <.001) and a reduced risk of death. CONCLUSION The benefits of CRT appear to be attenuated in patients with AF. The presence of AF is associated with an increased risk of clinical nonresponse and death than in patients without AF. AVN ablation may improve CRT outcomes in patients with AF.

Physical activity for men receiving androgen deprivation therapy for prostate cancer: benefits from a 16-week intervention

Goals of workProstate cancer patients receiving androgen deprivation therapy (ADT) are vulnerable to a number of potentially debilitating side effects, which can significantly impact quality of life. The role of alternate therapies, such as physical activity (PA), in attenuating these side effects is largely understudied for such a large population. Thus, the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior, quality of life, and fitness measures.Patients and methodsOne hundred participants were randomized into an intervention (n = 53) or a wait-list control group (n = 47), with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing. The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions. PA, quality of life, fitness, and physiological outcomes were assessed pre and post the 16-week intervention.ResultsSignificant increases in PA, supported by changes in girth measures and blood pressure, support the beneficial impact of the intervention. Positive trends were also evident for depression and fatigue. However, due to the high dropout rate, these results must be interpreted with caution.ConclusionsPA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy. Determining the maintenance of this behavior change will be important for understanding how the long-term benefits of increased activity levels may alleviate the late effects of ADT.

Prevention of Dialysis Catheter Malfunction with Recombinant Tissue Plasminogen Activator

BACKGROUND The effectiveness of various solutions instilled into the central venous catheter lumens after each hemodialysis session (catheter locking solutions) to decrease the risk of catheter malfunction and bacteremia in patients undergoing hemodialysis is unknown. METHODS We randomly assigned 225 patients undergoing long-term hemodialysis in whom a central venous catheter had been newly inserted to a catheter-locking regimen of heparin (5000 U per milliliter) three times per week or recombinant tissue plasminogen activator (rt-PA) (1 mg in each lumen) substituted for heparin at the midweek session (with heparin used in the other two sessions). The primary outcome was catheter malfunction, and the secondary outcome was catheter-related bacteremia. The treatment period was 6 months; treatment assignments were concealed from the patients, investigators, and trial personnel. RESULTS A catheter malfunction occurred in 40 of the 115 patients assigned to heparin only (34.8%) and 22 of the 110 patients assigned to rt-PA (20.0%)--an increase in the risk of catheter malfunction by a factor of almost 2 among patients treated with heparin only as compared with those treated with rt-PA once weekly (hazard ratio, 1.91; 95% confidence interval [CI], 1.13 to 3.22; P = 0.02). Catheter-related bacteremia occurred in 15 patients (13.0%) assigned to heparin only, as compared with 5 (4.5%) assigned to rt-PA (corresponding to 1.37 and 0.40 episodes per 1000 patient-days in the heparin and rt-PA groups, respectively; P = 0.02). The risk of bacteremia from any cause was higher in the heparin group than in the rt-PA group by a factor of 3 (hazard ratio, 3.30; 95% CI, 1.18 to 9.22; P = 0.02). The risk of adverse events, including bleeding, was similar in the two groups. CONCLUSIONS The use of rt-PA instead of heparin once weekly, as compared with the use of heparin three times a week, as a locking solution for central venous catheters significantly reduced the incidence of catheter malfunction and bacteremia. (Current Controlled Trials number, ISRCTN35253449.).

Sex Differences in Access to Coronary Revascularization after Cardiac Catheterization: Importance of Detailed Clinical Data

Context Women are less likely to be offered therapeutic cardiac procedures than men; however, the reasongender bias or clinical factorsis unknown. Contribution This study of coronary revascularization procedures during the year after catheterization compared men and women with the same extent of coronary artery disease and ejection fraction. The rate of coronary revascularization was the same in men and women. Implications The sex differences in cardiac procedure rates after catheterization appear to reflect appropriate decisions rather than gender bias. However, sex-based differences in catheterization rates remain unexplained. The Editors Reports of sex differences in the likelihood of undergoing cardiac procedures have led to suggestions of gender bias in cardiac care decision making (1-14). Other proposed explanations for the variation in use of cardiac procedures between sexes include differing patient preferences or differing clinical characteristics (for example, smaller coronary vessels in women). Earlier studies did not unanimously find sex differences in cardiac procedure rates; some studies reported equivalent procedure rates for men and women (15-21). The inconsistency across studies may be related to differences in geographic regions and health systems. However, another possible explanation is that many earlier studies evaluated highly selected patient samples that may not reflect processes of care at a population level. Yet another possible explanation is that the published studies on this issue have used various data sources, ranging from highly detailed data from clinical trials to sparsely detailed administrative data. The Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) is a population-based registry that captures detailed clinical information on all adult patients undergoing cardiac catheterization in the province of Alberta, Canada (22). The clinically detailed data generated by APPROACH provide a unique opportunity to study sex differences in access to revascularization after cardiac catheterization without the limitations of a nonrepresentative study sample or insufficiently detailed clinical data. Furthermore, the detailed APPROACH data allow us to assess whether comorbid conditions, extent of coronary disease, and ejection fraction account for or explain any observed sex differences in access to revascularization procedurespercutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery. Using a two-step process, we statistically adjusted crude (unadjusted) rates of cardiac revascularization for men and women in the year following cardiac catheterization. The first (partial) adjustment was based on baseline clinical variables that are routinely available in most databases, including administrative databases. The second (full) adjustment also controlled for extent of coro nary disease and ejection fraction, variables that are uniquely available for a large unselected patient population in APPROACH data. Methods Data Source and Variables The APPROACH database is an inception cohort database that captures clinical information on all patients undergoing cardiac catheterization in Alberta, Canada (22). This province has a population of approximately 2.8 million persons, of whom 10% identify themselves as ethnic minorities (3.5% are of Chinese ethnicity, 2% are of South Asian ethnicity, 1% are black, and 4.5% are aboriginal inhabitants). In 1996, median individual income levels for postal codedefined regions ranged from

Randomized Controlled Trial of Mindfulness-Based Cancer Recovery Versus Supportive Expressive Group Therapy for Distressed Survivors of Breast Cancer (MINDSET)

12 000 to

Acute kidney injury following coronary angiography is associated with a long-term decline in kidney function

37 000 Canadian per year. Sixty-seven percent of Albertans older than 20 years of age have a high school diploma, and 25% have some university-level education. Patients in APPROACH are followed longitudinally for assessment of long-term outcomes after cardiac catheterization. Clinical risk variables recorded at the time of cardiac catheterization are age, sex, diabetes mellitus, cerebrovascular disease, congestive heart failure, chronic pulmonary disease, elevated creatinine level ( 200 mmol/L [ 22.62 g/L]), dialysis status, hyperlipidemia, hypertension, liver or gastrointestinal disease, malignancy or metastatic disease, previous myocardial infarction, previous thrombolytic therapy for myocardial infarction, and peripheral vascular disease. The indication for catheterization is recorded in one of four categories: myocardial infarction within 8 weeks of catheterization, unstable angina, stable angina, or other (for example, arrhythmias without associated angina, or study protocols). The results of cardiac catheterization, including extent of coronary disease and left ventricular ejection fraction, are also recorded. We graded extent of coronary disease according to six categories: normal or near normal, one- to two-vessel disease, two-vessel disease with proximal left anterior descending artery involvement, three-vessel disease, three-vessel disease with proximal left anterior descending artery involvement, or left main disease. A diseased vessel was one that contained a lesion involving more than 50% of the vessel diameter. Left ventricular ejection fraction was graded according to five categories: greater than 50%, 30% to 50%, less than 30%, ventriculography not done (usually because of renal insufficiency or severely depressed cardiac function), and data missing. The APPROACH database accurately captures the occurrence of revascularization procedures in Alberta hospitals and the time to revascularization after cardiac catheterization. We analyzed data from patients undergoing cardiac catheterization from 1995 through 1998, with follow-up data through 1999. The Ethics Review Boards of the University of Calgary and the University of Alberta, Canada, approved the APPROACH study protocol. Statistical Analysis We performed a chi-square test and two-sample t-tests to compare the clinical characteristics of men and women undergoing catheterization. Chi-square tests and log-rank tests were used to compare the unadjusted proportions of men and women having revascularization procedures within 1 year after cardiac catheterization. We then used multivariable Cox proportional-hazards analyses to control revascularization rates for differences in clinical characteristics between men and women undergoing catheterization. For these analyses, we modeled time to 1) any revascularization procedure, 2) PCI, and 3) CABG surgery, with follow-up to 1 year. We initially calculated crude relative risks for procedures for women relative to men and then sequentially modeled two sets of variables. First, for the partially adjusted model, we used a set of clinical variables (age, indication for cardiac catheterization, cardiac history, and the comorbidity variables listed earlier) that would generally be available in most administrative databases (throughout the paper, we call this initial step partial adjustment). Second, for the fully adjusted model, we added two clinical variables, left ventricular ejection fraction and extent of coronary disease, that are uniquely available at a population level in the clinically detailed APPROACH database. The relative risk for women compared with men was the variable of interest for each of the models generated. We calculated and plotted risk-adjusted time-to-revascularization curves for men and women by applying the corrected group prognosis method to the proportional hazards models that generated fully adjusted relative risks (23). By plotting log[log S(t)] versus t and log(t) for all of the above models, we found that the proportional hazards assumption was appropriate for all variables included in the models, except the variable of indication for cardiac catheterization. Therefore, we handled cardiac catheterization as a stratification variable in our models. To assess model performance, we also plotted both martingale and deviance residuals for individual observations and found that none of the observations were widely deviant (that is, almost all deviance residuals were between 1.96 and 1.96). We examined influential observations by measuring the changes in the coefficients after dropping each observation from the data. For sex, the most influential observations changed the coefficient by less than 5% of the standard error. The software product used to perform data analyses was S-PLUS 5 for Linux, version 5.1 (Insightful Corp., Seattle, Washington). Role of the Funding Sources The funding sources had no role in the design, conduct, or reporting of this study. Results A total of 21 816 patients underwent cardiac catheterization in Alberta between 1 January 1995 and 31 December 1998. Of these patients, 15 409 (70.6%) were men and 6407 (29.4%) were women. Within 1 year after catheterization, 8488 of the 15 409 men (55.1%) had undergone a revascularization procedure (PCI or CABG surgery) compared with only 2574 of the 6407 women (40.2%) (P < 0.001). The proportion having undergone PCI at 1 year was 32.2% for men versus 26.1% for women (P < 0.001). The proportion having CABG surgery by 1 year after catheterization was 22.9% for men and only 14.0% for women (P < 0.001). In a proportional hazards analysis, the corresponding crude relative risk (that is, the likelihood) for having any revascularization procedure for women compared with men was 0.67 (95% CI, 0.65 to 0.71). For PCI and CABG surgery, the corresponding relative risks were 0.77 (CI, 0.73 to 0.82) and 0.54 (0.51 to 0.58), respectively. Thus, in relative terms, women were 33% less likely to undergo any revascularization procedure, 23% less likely to undergo PCI, and 46% less likely to undergo CABG surgery than were men. Clinical Characteristics Clinical characteristics of men and women differed (Table 1). Men tended to be younger and had fewer comorbid conditions, including a lower prevalence of chronic lung disease, cerebrovascular disease, hypertension, diabetes mellitus, liver disease, and congestive heart failure. However, men

Contrast-Induced Acute Kidney Injury and Risk of Adverse Clinical Outcomes After Coronary Angiography A Systematic Review and Meta-Analysis

PURPOSE To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET). PATIENTS AND METHODS This multisite, randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR, SET, or a 1-day stress management control condition. MBCR focused on training in mindfulness meditation and gentle yoga, whereas SET focused on emotional expression and group support. Both intervention groups included 18 hours of professional contact. Measures were collected at baseline and after intervention by assessors blind to study condition. Primary outcome measures were mood and diurnal salivary cortisol slopes. Secondary outcomes were stress symptoms, quality of life, and social support. RESULTS Using linear mixed-effects models, in intent-to-treat analyses, cortisol slopes were maintained over time in both SET (P = .002) and MBCR (P = .011) groups relative to the control group, whose cortisol slopes became flatter. Women in MBCR improved more over time on stress symptoms compared with women in both the SET (P = .009) and control (P = .024) groups. Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group (P = .005) and in social support compared with the SET group (P = .012). CONCLUSION In the largest trial to date, MBCR was superior for improving stress levels, quality of life and social support [CORRECTED] for distressed survivors of breast cancer. Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition. The clinical implications of this finding require further investigation.