Anil Jain

Coronary-Artery Bypass Surgery in Patients with Left Ventricular Dysfunction

BACKGROUND The role of coronary-artery bypass grafting (CABG) in the treatment of patients with coronary artery disease and heart failure has not been clearly established. METHODS Between July 2002 and May 2007, a total of 1212 patients with an ejection fraction of 35% or less and coronary artery disease amenable to CABG were randomly assigned to medical therapy alone (602 patients) or medical therapy plus CABG (610 patients). The primary outcome was the rate of death from any cause. Major secondary outcomes included the rates of death from cardiovascular causes and of death from any cause or hospitalization for cardiovascular causes. RESULTS The primary outcome occurred in 244 patients (41%) in the medical-therapy group and 218 (36%) in the CABG group (hazard ratio with CABG, 0.86; 95% confidence interval [CI], 0.72 to 1.04; P=0.12). A total of 201 patients (33%) in the medical-therapy group and 168 (28%) in the CABG group died from an adjudicated cardiovascular cause (hazard ratio with CABG, 0.81; 95% CI, 0.66 to 1.00; P=0.05). Death from any cause or hospitalization for cardiovascular causes occurred in 411 patients (68%) in the medical-therapy group and 351 (58%) in the CABG group (hazard ratio with CABG, 0.74; 95% CI, 0.64 to 0.85; P<0.001). By the end of the follow-up period (median, 56 months), 100 patients in the medical-therapy group (17%) underwent CABG, and 555 patients in the CABG group (91%) underwent CABG. CONCLUSIONS In this randomized trial, there was no significant difference between medical therapy alone and medical therapy plus CABG with respect to the primary end point of death from any cause. Patients assigned to CABG, as compared with those assigned to medical therapy alone, had lower rates of death from cardiovascular causes and of death from any cause or hospitalization for cardiovascular causes. (Funded by the National Heart, Lung, and Blood Institute and Abbott Laboratories; STICH ClinicalTrials.gov number, NCT00023595.).

Electronic Health Records and Quality of Diabetes Care

BACKGROUND Available studies have shown few quality-related advantages of electronic health records (EHRs) over traditional paper records. We compared achievement of and improvement in quality standards for diabetes at practices using EHRs with those at practices using paper records. All practices, including many safety-net primary care practices, belonged to a regional quality collaborative and publicly reported performance. METHODS We used generalized estimating equations to calculate the percentage-point difference between EHR-based and paper-based practices with respect to achievement of composite standards for diabetes care (including four component standards) and outcomes (five standards), after adjusting for covariates and accounting for clustering. In addition to insurance type (Medicare, commercial, Medicaid, or uninsured), patient-level covariates included race or ethnic group (white, black, Hispanic, or other), age, sex, estimated household income, and level of education. Analyses were conducted separately for the overall sample and for safety-net practices. RESULTS From July 2009 through June 2010, data were reported for 27,207 adults with diabetes seen at 46 practices; safety-net practices accounted for 38% of patients. After adjustment for covariates, achievement of composite standards for diabetes care was 35.1 percentage points higher at EHR sites than at paper-based sites (P<0.001), and achievement of composite standards for outcomes was 15.2 percentage points higher (P=0.005). EHR sites were associated with higher achievement on eight of nine component standards. Such sites were also associated with greater improvement in care (a difference of 10.2 percentage points in annual improvement, P<0.001) and outcomes (a difference of 4.1 percentage points in annual improvement, P=0.02). Across all insurance types, EHR sites were associated with significantly higher achievement of care and outcome standards and greater improvement in diabetes care. Results confined to safety-net practices were similar. CONCLUSIONS These findings support the premise that federal policies encouraging the meaningful use of EHRs may improve the quality of care across insurance types.

Converted laparoscopic colorectal surgery.

BackgroundConversion rates following laparoscopic colorectal surgery vary widely between studies, and the outcome of converted patients remains controversial.MethodsA comprehensive search of the English-language literature was updated until May 1999.ResultsTwenty-eight studies on 3232 patients were considered for analysis. The overall conversion rate was 15.38%. Seventy nine percent of the studies did not include a definition for conversion; in these studies, the conversion rate was significantly lower than in the series where a specific definition was considered (13.7% vs 18.9%, chi-square test, p<0.001). Converted patients had a prolonged hospital stay (11.38 vs 7.41 days) and operative time (209 vs 189 min) in comparison with laparoscopically completed patients (95% confidence interval (CI), 1.70–4.00 and 35.90–37.10, respectively). The factors associated with an increased rate for conversion were left colectomy (Odds Ratio [OR]=1.061), anterior resection of the rectum (OR=1.088), diverticulitis (OR=1.302), and cancer (OR=2.944) (for each parameter, Wald chi-square value, p<0.001).ConclusionsIn nonrandomized studies, the rate of laparoscopically completed colorectal resections is close to 85%. Because converted patients have a distinct outcome, a clear definition of conversion is required to compare the results of randomized trials. Such trials should also consider a 20% rate of conversion when estimating the sample size for the desired power level. It is likely that converted patients will have a significant impact on the results of future clinical research in laparoscopic colorectal surgery.

Evaluation and Long-Term Prognosis of New-Onset, Transient, and Persistent Anemia in Ambulatory Patients With Chronic Heart Failure

OBJECTIVES This study sought to determine the characteristics and long-term prognosis of anemia in ambulatory patients with chronic heart failure. BACKGROUND Anemia is prevalent in heart failure, and may portend poor outcomes. METHODS We reviewed 6,159 consecutive outpatients with chronic stable heart failure at baseline, short-term (3-month) follow-up, and long-term (6-month) follow-up between 2001 and 2006. Clinical, demographic, laboratory, and echocardiographic data were reviewed from electronic medical records. Mortality rates were determined from 6-month follow-up to end of study period. RESULTS Prevalence of anemia (hemoglobin [Hb] <12 g/dl for men, <11 g/dl for women) was 17.2% in our cohort. Diabetes, B-natriuretic peptide, left ventricular ejection fraction, and estimated glomerular filtration rate were independent predictors of baseline anemia. Documented evaluation of anemia was found in only 3% of all anemic patients, and better in internal medicine than in cardiology clinics. At 6-month follow-up, new-onset anemia developed in 16% of patients without prior anemia, whereas 43% patients with anemia at baseline had resolution of their hemoglobin levels. Higher total mortality rates were evident in patients with persistent anemia (58% vs. 31%, p < 0.0001) or with incident anemia (45% vs. 31%, p < 0.0001) compared with those with without anemia at 6 months. CONCLUSIONS These observations in a broad unselected outpatient cohort suggest that anemia in patients with heart failure is under-recognized and underevaluated. However, resolution of anemia was evident in up to 43% of patients who presented initially with anemia, and did not pose greater long-term risk for all-cause mortality. However, the presence of persistent anemia conferred poorest survival in patients with heart failure when compared with that of incident, resolved, or no anemia.

Association Between Proton Pump Inhibitor Therapy and Clostridium difficile Infection in a Meta-Analysis

BACKGROUND & AIMS In the past decade, there has been a growing epidemic of Clostridium difficile infection (CDI). During this time, use of proton pump inhibitors (PPIs) has increased exponentially. We evaluated the association between PPI therapy and the risk of CDI by performing a meta-analysis. METHODS We searched MEDLINE and 4 other databases for subject headings and text words related to CDI and PPI in articles published from 1990 to 2010. All observational studies that investigated the risk of CDI associated with PPI therapy and used CDI as an end point were considered eligible. Two investigators screened articles independently for inclusion criteria, data extraction, and quality assessment; disagreements were resolved based on consensus with a third investigator. Data were combined by means of a random-effects model and odds ratios were calculated. Subgroup and sensitivity analyses were performed based on study design and antibiotic use. RESULTS Thirty studies (25 case-control and 5 cohort) reported in 29 articles met the inclusion criteria (n = 202,965). PPI therapy increased the risk for CDI (odds ratio, 2.15, 95% confidence interval, 1.81-2.55), but there was significant heterogeneity in results among studies (P < .00001). This association remained after subgroup and sensitivity analyses, although significant heterogeneity persisted among studies. CONCLUSIONS PPI therapy is associated with a 2-fold increase in risk for CDI. Because of the observational nature of the analyzed studies, we were not able to study the causes of this association. Further studies are needed to determine the mechanisms by which PPI therapy might increase risk for CDI.

Diagnostic Accuracy of Real-time Polymerase Chain Reaction in Detection of Clostridium difficile in the Stool Samples of Patients With Suspected Clostridium difficile Infection: A Meta-Analysis

BACKGROUND Current detection methods for Clostridium difficile infection (CDI) can be time-consuming and have variable sensitivities. Real-time polymerase chain reaction (PCR) may allow earlier and more accurate diagnosis of CDI than other currently available diagnostic tests. A meta-analysis was performed to determine the diagnostic accuracy of real-time PCR. METHODS We searched MEDLINE (Pubmed/Ovid) and 4 other online electronic databases (1995-2010) to identify diagnostic accuracy studies that compared PCR with cell culture cytotoxicity neutralization assay (CCCNA) or anaerobic toxigenic culture (TC) of C. difficile. Screening for inclusion, data extraction, and quality assessment were carried out independently by 2 investigators and disagreements resolved. Data were combined by means of a random-effects model, and summary receiver operating characteristic curves and diagnostic odds ratios were calculated. RESULTS Nineteen studies (7392 samples) met our inclusion criteria. The overall mean sensitivity of PCR was 90% (95% confidence interval [CI]: 88%-91%), specificity 96% (CI: 96%-97%), positive likelihood ratio 26.89 (CI: 20.81-34.74), negative likelihood ratio 0.11 (CI: .08-.15), diagnostic odds ratio 278.23 (CI: 213.56-362.50), and area under the curve 0.98 (CI: .98-.99). Test accuracy depended on the prevalence of C. difficile but not on the reference test used. At C. difficile prevalence of <10%, 10%-20% and >20% the positive predictive value and the negative predictive value were 71%, 79%, 93% and 99%, 98% and 96%, respectively. CONCLUSIONS Real-time PCR has a high sensitivity and specificity to confirm CDI. Overall diagnostic accuracy is variable and depends on CDI prevalence.

The risk of developing coronary artery disease or congestive heart failure, and overall mortality, in type 2 diabetic patients receiving rosiglitazone, pioglitazone, metformin, or sulfonylureas: a retrospective analysis

Oral anti-diabetic agents have been associated with adverse cardiovascular events in type 2 diabetes (DM2). We investigated the risk of coronary artery disease (CAD), congestive heart failure (CHF), and mortality using multivariable Cox models in a retrospective cohort of 20,450 DM2 patients from our electronic health record (EHR). We observed no differences in CAD risk among the agents. Metformin was associated with a reduced risk of CHF (HR 0.76, 95% CI 0.64–0.91) and mortality (HR 0.54, 95% CI 0.46–0.64) when compared to sulfonylurea. Pioglitazone was also associated with a lower risk of mortality when compared to sulfonylurea (HR 0.59, 95% CI 0.43–0.81). No other significant differences were found between the oral agents. In conclusions, our results did not identify an increased CAD risk with rosiglitazone in clinical practice. However, the results do reinforce a possible increased risk of adverse events in DM2 patients prescribed sulfonylureas.

Prevalence and severity of urinary incontinence and pelvic genital prolapse in females with anal incontinence or rectal prolapse

PURPOSE: The aim of this study was to determine the prevalence, severity, and associations between urinary incontinence and genital prolapse in females after surgery for fecal incontinence or rectal prolapse. METHODS: All patients who underwent surgery for fecal incontinence (Group I) or rectal prolapse (Group II) were compared with a control group of females (Group III) by 43 questions regarding demographic data, past medical and surgical history, and diagnosis and treatment of anal and urinary incontinence and genital and rectal prolapse. The type (stress, urge, and total) of urinary incontinence was determined and graded using an incontinence severity questionnaire (Individual Incontinence Impact Questionnaire). RESULTS: Overall response rate in the three groups of patients was 40.1 percent. The questionnaire was sent to 240 patients operated on for fecal incontinence or rectal prolapse, and 83 of them responded (34.5 percent). The patients were distributed into three groups: Group I consisted of 51 patients (mean age 56.7±14); Group II consisted of 32 patients (69.7±11); and Group III consisted of 40 patients (60.5±16). The prevalence of urinary incontinence in Group I was 27 (54 percent), in Group II was 21 (65.6 percent), and Group III was 12 patients (30 percent;P=0.003). Genital prolapse was present in 9 (17.6 percent), 11 (34.3 percent), and 5 patients (12.5 percent), respectively (P=0.03). The prevalence of coexistent urinary incontinence and genital prolapse in both study groups was 22.8 percent (19 patients). There were no statistically significant differences between Groups I and II relative to prevalence, type, and severity of urinary incontinence and genital prolapse, but there were significant differences between the two study groups and the control group. Of the patients in the study group, 67 percent had urinary incontinence before or at the time of surgery. CONCLUSION: There is a higher prevalence and severity of urinary incontinence and pelvic genital prolapse in females operated on for either fecal incontinence or rectal prolapse than in a control group. Therefore, female patients with fecal incontinence or rectal prolapse should be evaluated and treated by a multidisciplinary group of pelvic floor clinicians, including a gynecologist or urologist with special training in female pelvic floor dysfunction and a colorectal surgeon.

Increase in overall mortality risk in patients with type 2 diabetes receiving glipizide, glyburide or glimepiride monotherapy versus metformin: A retrospective analysis

Aims: It remains uncertain if differences in mortality risk exist among the sulfonylureas, especially in patients with documented coronary artery disease (CAD). The purpose of this study was to assess the overall mortality risk of the individual sulfonylureas versus metformin in a large cohort of patients with type 2 diabetes.

The association between personal health record use and diabetes quality measures.

BackgroundElectronic personal health records (PHRs) have the potential to empower patients in self-management of chronic diseases, which should lead to improved outcomes.ObjectiveTo measure the association between use of an advanced electronic medical record-linked PHR and diabetes quality measures in adults with diabetes mellitus (DM).DesignRetrospective audit of PHR use and multivariable regression analyses.Patients10,746 adults 18–75-years of age with DM seen at least twice at the office of their primary care physician at the Cleveland Clinic from July 2008 through June 2009.Main MeasuresPHR use was measured as number of use days. Diabetes quality measures were: hemoglobin A1c (HbA1c), LDL cholesterol, blood pressure, body mass index (BMI), HbA1c testing, ACEi/ARB use and/or microalbumin testing, pneumococcal vaccination, foot and dilated eye examination, and smoking status.Key ResultsCompared to non-users, PHR users were younger, had higher incomes and educational attainment, were more likely to identify as Caucasian, and had better unadjusted and adjusted diabetes quality measure profiles. Adjusted odds ratio of HbA1c testing was 2.06 (p < 0.01) and most recent HbA1c was 0.29% lower (p < 0.01). Among PHR users, increasing number of login days was generally not associated with more favorable diabetes quality measure profiles.ConclusionsPHR use, but not intensity of use, was associated with improved diabetes quality measure profiles. It is likely that better diabetes profiles among PHR users is due to higher level of engagement with their health among those registered for the PHR rather than PHR use itself. PHR use was infrequent. To maximize value, next-generation PHRs must be designed to engage patients in everyday diabetes self-management.