Patterning of antibodies using flexographic printing.

Antibodies were patterned onto flexible plastic films using the flexographic printing process. An ink formulation was developed using high molecular weight polyvinyl alcohol in carbonate-bicarbonate buffer. In order to aid both antibody adhesion and the quality of definition in the printed features, a nitrocellulose coating was developed that was capable of being discretely patterned, thus increasing the signal-to-noise ratio of an antibody array. Printing antibody features such as dots, squares, text, and fine lines were reproduced effectively. Furthermore, this process could be easily adapted for printing of other biological materials, including, but not limited to, enzymes, DNA, proteins, aptamers, and cells.

Telemonitoring in patients with heart failure.

BACKGROUND: Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established. METHODS: We randomly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring (826 patients) or usual care (827 patients). Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients' clinicians. The primary end point was readmission for any reason or death from any cause within 180 days after enrollment. Secondary end points included hospitalization for heart failure, number of days in the hospital, and number of hospitalizations. RESULTS: The median age of the patients was 61 years; 42.0% were female, and 39.0% were black. The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point, which occurred in 52.3% and 51.5% of patients, respectively (difference, 0.8 percentage points; 95% confidence interval [CI], -4.0 to 5.6; P=0.75 by the chi-square test). Readmission for any reason occurred in 49.3% of patients in the telemonitoring group and 47.4% of patients in the usual-care group (difference, 1.9 percentage points; 95% CI, -3.0 to 6.7; P=0.45 by the chi-square test). Death occurred in 11.1% of the telemonitoring group and 11.4% of the usual care group (difference, -0.2 percentage points; 95% CI, -3.3 to 2.8; P=0.88 by the chi-square test). There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components. No adverse events were reported. CONCLUSIONS: Among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00303212.).

Discharge planning from hospital to home.

BACKGROUND: Discharge planning is a routine feature of health systems in many countries. The aim of discharge planning is to reduce hospital length of stay and unplanned readmission to hospital, and improve the co-ordination of services following discharge from hospital. OBJECTIVES: To determine the effectiveness of planning the discharge of patients moving from hospital. SEARCH STRATEGY: We updated the review using the Cochrane EPOC Group Trials Register, MEDLINE, EMBASE and the Social Science Citation Index (last searched in March 2009). SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared an individualised discharge plan with routine discharge care that was not tailored to the individual patient. Participants were hospital inpatients. DATA COLLECTION AND ANALYSIS: Two authors independently undertook data analysis and quality assessment using a predesigned data extraction sheet. Studies are grouped according to patient group (elderly medical patients, surgical patients and those with a mix of conditions) and by outcome. MAIN RESULTS: Twenty-one RCTs (7234 patients) are included; ten of these were identified in this update. Fourteen trials recruited patients with a medical condition (4509 patients), four recruited patients with a mix of medical and surgical conditions (2225 patients), one recruited patients from a psychiatric hospital (343 patients), one from both a psychiatric hospital and from a general hospital (97 patients), and the final trial recruited patients admitted to hospital following a fall (60 patients). Hospital length of stay and readmissions to hospital were significantly reduced for patients allocated to discharge planning (mean difference length of stay -0.91, 95% CI -1.55 to -0.27, 10 trials; readmission rates RR 0.85, 95% CI 0.74 to 0.97, 11 trials). For elderly patients with a medical condition (usually heart failure) there was insufficient evidence for a difference in mortality (RR 1.04, 95% CI 0.74 to 1.46, four trials) or being discharged from hospital to home (RR 1.03, 95% CI 0.93 to 1.14, two trials). This was also the case for trials recruiting patients recovering from surgery and a mix of medical and surgical conditions. In three trials patients allocated to discharge planning reported increased satisfaction. There was little evidence on overall healthcare costs. AUTHORS' CONCLUSIONS: The evidence suggests that a structured discharge plan tailored to the individual patient probably brings about small reductions in hospital length of stay and readmission rates for older people admitted to hospital with a medical condition. The impact of discharge planning on mortality, health outcomes and cost remains uncertain.

Outcomes of patients with stable heart failure undergoing elective noncardiac surgery.

OBJECTIVE: To evaluate modern surgical outcomes in patients with stable heart failure undergoing elective major noncardiac surgery and to compare the experience of patients with heart failure who have reduced vs preserved left ventricular ejection fraction (EF). PATIENTS AND METHODS: We retrospectively studied 557 consecutive patients with heart failure (192 EF less than or equal to 40% and 365 EF greater than 40%) and 10,583 controls who underwent systematic evaluation by hospitalists in a preoperative clinic before having major elective noncardiac surgery between January 1, 2003, and March 31, 2006. We examined outcomes in the entire cohort and in propensity-matched case-control groups. RESULTS: Unadjusted 1-month postoperative mortality in patients with both types of heart failure vs controls was 1.3% vs 0.4% (P equals .009), but this difference was not significant in propensity-matched groups (P equals .09). Unadjusted differences in mean hospital length of stay among heart failure patients vs controls (5.7 vs 4.3 days; P less than .001) and 1-month readmission (17.8% vs 8.5%; P less than .001) were also markedly attenuated in propensity-matched groups. Crude 1-year hazard ratios for mortality were 1.71 (95% confidence interval [CI], 1.5-2.0) for both types of heart failure, 2.1 (95% CI, 1.7-2.6) in patients with heart failure who had EF less than or equal to 40%, and 1.4 (95% CI, 1.2-1.8) in those who had EF greater than 40% (P less than .01 for all 3 comparisons); however, the differences were not significant in propensity-matched groups (P equals .43). CONCLUSION: Patients with clinically stable heart failure did not have high perioperative mortality rates in association with elective major noncardiac surgery, but they were more likely than patients without heart failure to have longer hospital stays, were more likely to require hospital readmission, and had a substantial long-term mortality rate.

Usefulness of B-type natriuretic peptide and cardiac troponin levels to predict in-hospital mortality from ADHERE.

B-type natriuretic peptide (BNP) and cardiac troponin (Tn) I or T have been demonstrated to provide prognostic information in patients with acute coronary syndromes. Whether admission BNP and Tn levels provide additive prognostic value in acutely decompensated heart failure (HF) has not been well studied. Hospitalizations for HF from April 2003 to December 2004 entered into ADHERE were analyzed. BNP assessment on admission was performed in 48,629 (63%) of 77,467 hospitalization episodes. Tn assessment was performed in 42,636 (88%) of these episodes. In-hospital mortality was assessed using logistic regression models adjusted for age, gender, blood urea nitrogen, systolic blood pressure, creatinine, sodium, pulse, and dyspnea at rest. Median BNP was 840 pg/ml (interquartile range 430 to 1,730). Tn was increased in 2,370 (5.6%) of 42,636 HF episodes. BNP above the median and increased Tn were associated with significantly increased risk of in-hospital mortality (odds ratios [OR] 2.09 and 2.41 respectively, each p value <0.0001). Mortality was 10.2% in patients with BNP >or=840/Tn increased compared with 2.2% with BNP <840/Tn not increased (OR 5.10, p <0.0001). After covariate adjustment, mortality risk remained significantly increased with BNP >or=840/Tn not increased (adjusted OR 1.56, 95% confidence interval 1.40 to 1.79, p <0.0001), BNP <840/Tn increased (adjusted OR 1.69, 95% confidence interval 1.17 to 2.45, p = 0.006), and BNP >or=840/Tn increased (adjusted OR 3.00, 95% confidence interval 2.47 to 3.66, p <0.0001). Admission BNP and cardiac Tn levels are significant, independent predictors of in-hospital mortality in acutely decompensated HF. Patients with BNP levels >or=840 pg/ml and increased Tn levels are at particularly high risk for mortality. In conclusion, a multimarker strategy for the assessment of patients hospitalized with HF adds incremental prognostic information.

Recommendations for teaching about racial and ethnic disparities in health and health care.

Racial and ethnic minorities often receive lower-quality health care than white patients, even when socioeconomic status, education, access, and other factors are used as controls. To address these pervasive disparities, health care professionals should learn more about them and the roles they can play in eliminating them, but few curricula are focused on understanding and addressing racial and ethnic health disparities, and well-accepted guidelines on what and how to teach in this complex area are lacking. The Society of General Internal Medicine Health Disparities Task Force used a review and consensus process to develop specific recommendations and guidelines for curricula focusing on health disparities. Learning objectives, content, methods for teaching, and useful resources are provided. Although the guidelines were developed primarily for teaching medical students, residents, and practitioners in primary care, the Task Force's general recommendations can apply to learners in any specialty. The Task Force recommends that a curricula address 3 areas of racial and ethnic health disparities and focus on the following specific learning objectives:1) examining and understanding attitudes, such as mistrust, subconscious bias, and stereotyping, which practitioners and patients may bring to clinical encounters; 2) gaining knowledge of the existence and magnitude of health disparities, including the multifactorial causes of health disparities and the many solutions required to diminish or eliminate them; and 3) acquiring the skills to effectively communicate and negotiate across cultures, languages, and literacy levels, including the use of key tools to improve communication. The broad goal of a curriculum on disparities should be for learners to develop a commitment to eliminating inequities in health care quality by understanding and assuming their professional role in addressing this pressing health care crisis.

Adverse effects of combination angiotensin II receptor blockers plus angiotensin-converting enzyme inhibitors for left ventricular dysfunction: a quantitative review of data from randomized clinical trials.

BACKGROUND: We performed a meta-analysis of randomized controlled trials to assess ongoing concerns about the safety profile of combination angiotensin II receptor blockers (ARBs) plus angiotensin-converting enzyme (ACE) inhibitors in symptomatic left ventricular dysfunction. METHODS: MEDLINE (January 1966-December 2006) and Web sites for the National Institute of Health Clinical Trials and the Food and Drug Administration were searched for eligible RCTs that included 500 or more subjects, had a follow-up of 3 months or longer, and reported adverse effects. We used a random effects model to calculate the relative risk (RR) and 95% confidence interval (CI) for the following outcome measures: medication discontinuations because of adverse effects, worsening renal function (an increase in serum creatinine level of > 0.5 mg/dL [to convert to micromoles per liter, multiply by 88.4]), hyperkalemia (serum potassium level > 5.5 mEq/L [to convert to millimoles per liter, multiply by 1]), and symptomatic hypotension. RESULTS: Four studies (N = 17 337; mean follow-up, 25 months [range, 11-41 months]) were selected. Combination ARB plus ACE inhibitor vs control treatment that included ACE inhibitors was associated with significant increases in medication discontinuations because of adverse effects in patients with chronic heart failure (RR, 1.38 [95% CI, 1.22-1.55]) or in patients with acute myocardial infarction with symptomatic left ventricular dysfunction (RR, 1.17 [95% CI, 1.03-1.34]), and for both conditions there were significant increases in worsening renal function (RR, 2.17 [95% CI, 1.59-2.97] and RR, 1.61 [95% CI, 1.31-1.98], respectively), hyperkalemia (RR, 4.87 [95% CI, 2.39-9.94] and RR, 1.33 [95% CI, 0.90-1.98], respectively; the latter was not significant), and symptomatic hypotension (RR, 1.50 [95% CI, 1.09-2.07], and RR, 1.48 [95% CI, 1.33-3.18], respectively). CONCLUSION: Combination ARB plus ACE inhibitor therapy in subjects with symptomatic left ventricular dysfunction was accompanied by marked increases in adverse effects.

Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure.

OBJECTIVES: This study was designed to determine whether admission B-type natriuretic peptide (BNP) levels are predictive of in-hospital mortality in acute decompensated heart failure (HF). BACKGROUND: Levels of BNP have been demonstrated to facilitate the diagnosis of HF and predict mortality in chronic systolic HF. METHODS: B-type natriuretic peptide levels within 24 h of presentation were obtained in 48,629 (63%) of 77,467 hospitalization episodes entered in ADHERE (Acute Decompensated Heart Failure National Registry). In-hospital mortality was assessed by BNP quartiles in the entire cohort and in patients with reduced (n = 19,544) as well as preserved (n = 18,164) left ventricular systolic function using chi-square and logistic regression models. RESULTS: Quartiles (Q) of BNP were Q1 (<430), Q2 (430 to 839), Q3 (840 to 1,729), and Q4 (> or =1,730 pg/ml). The BNP levels were <100 pg/ml in 3.3% of the total cohort. Patients in Q1 versus Q4 were younger, more likely to be women, and had lower creatinine and higher left ventricular ejection fraction. There was a near-linear relationship between BNP quartiles and in-hospital mortality: Q1 (1.9%), Q2 (2.8%), Q3 (3.8%), and Q4 (6.0%), p < 0.0001. B-type natriuretic peptide quartile remained highly predictive of mortality even after adjustment for age, gender, systolic blood pressure, blood urea nitrogen, creatinine, sodium, pulse, and dyspnea at rest, Q4 versus Q1 (adjusted odds ratio 2.23 [95% confidence interval 1.91 to 2.62, p < 0.0001]). The BNP quartiles independently predicted mortality in patients with reduced and preserved systolic function. CONCLUSIONS: An elevated admission BNP level is a significant predictor of in-hospital mortality in acute decompensated HF with either reduced or preserved systolic function, independent of other clinical and laboratory variables. (Registry for Acute Decompensated Heart Failure Patients; http://www.clinicaltrials.gov/show/NCT00366639; NCT00366639).

Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care.

CONTEXT: Delayed or inaccurate communication between hospital-based and primary care physicians at hospital discharge may negatively affect continuity of care and contribute to adverse events. OBJECTIVES: To characterize the prevalence of deficits in communication and information transfer at hospital discharge and to identify interventions to improve this process. DATA SOURCES: MEDLINE (through November 2006), Cochrane Database of Systematic Reviews, and hand search of article bibliographies. STUDY SELECTION: Observational studies investigating communication and information transfer at hospital discharge (n = 55) and controlled studies evaluating the efficacy of interventions to improve information transfer (n = 18). DATA EXTRACTION: Data from observational studies were extracted on the availability, timeliness, content, and format of discharge communications, as well as primary care physician satisfaction. Results of interventions were summarized by their effect on timeliness, accuracy, completeness, and overall quality of the information transfer. DATA SYNTHESIS: Direct communication between hospital physicians and primary care physicians occurred infrequently (3%-20%). The availability of a discharge summary at the first postdischarge visit was low (12%-34%) and remained poor at 4 weeks (51%-77%), affecting the quality of care in approximately 25% of follow-up visits and contributing to primary care physician dissatisfaction. Discharge summaries often lacked important information such as diagnostic test results (missing from 33%-63%), treatment or hospital course (7%-22%), discharge medications (2%-40%), test results pending at discharge (65%), patient or family counseling (90%-92%), and follow-up plans (2%-43%). Several interventions, including computer-generated discharge summaries and using patients as couriers, shortened the delivery time of discharge communications. Use of standardized formats to highlight the most pertinent information improved the perceived quality of documents. CONCLUSIONS: Deficits in communication and information transfer at hospital discharge are common and may adversely affect patient care. Interventions such as computer-generated summaries and standardized formats may facilitate more timely transfer of pertinent patient information to primary care physicians and make discharge summaries more consistently available during follow-up care.

Telemonitoring for patients with chronic heart failure: a systematic review.

BACKGROUND: Telemonitoring, the use of communication technology to remotely monitor health status, is an appealing strategy for improving disease management. METHODS AND RESULTS: We searched Medline databases, bibliographies, and spoke with experts to review the evidence on telemonitoring in heart failure patients. Interventions included: telephone-based symptom monitoring (n = 5), automated monitoring of signs and symptoms (n = 1), and automated physiologic monitoring (n = 1). Two studies directly compared effectiveness of 2 or more forms of telemonitoring. Study quality and intervention type varied considerably. Six studies suggested reduction in all-cause and heart failure hospitalizations (14% to 55% and 29% to 43%, respectively) or mortality (40% to 56%) with telemonitoring. Of the 3 negative studies, 2 enrolled low-risk patients and patients with access to high quality care, whereas 1 enrolled a very high-risk Hispanic population. Studies comparing forms of telemonitoring demonstrated similar effectiveness. However, intervention costs were higher with more complex programs (8383 dollars per patient per year) versus less complex programs (1695 dollars per patient per year). CONCLUSION: The evidence base for telemonitoring in heart failure is currently quite limited. Based on the available data, telemonitoring may be an effective strategy for disease management in high-risk heart failure patients.

Rescue angioplasty or repeat fibrinolysis after failed fibrinolytic therapy for ST-segment myocardial infarction: a meta-analysis of randomized trials.

OBJECTIVES: We sought to best estimate the benefits and risks associated with rescue percutaneous coronary intervention (PCI) and repeat fibrinolytic therapy as compared with conservative management in patients with failed fibrinolytic therapy for ST-segment myocardial infarction (STEMI). BACKGROUND: Fibrinolytic therapy is the most common treatment for STEMI; however, the best therapy in patients who fail to achieve reperfusion after fibrinolytic therapy remains uncertain. METHODS: We performed a meta-analysis of randomized trials using a fixed-effects model. We included 8 trials enrolling 1,177 patients with follow-up duration ranging from hospital discharge to 6 months. RESULTS: Rescue PCI was associated with no significant reduction in all-cause mortality (relative risk [RR] 0.69; 95% confidence interval [CI] 0.46 to 1.05), but was associated with significant risk reductions in heart failure (RR 0.73; 95% CI 0.54 to 1.00) and reinfarction (RR 0.58; 95% CI 0.35 to 0.97) when compared with conservative treatment. Rescue PCI was associated with an increased risk of stroke (RR 4.98; 95% CI 1.10 to 22.5) and minor bleeding (RR 4.58; 95% CI 2.46 to 8.55). Repeat fibrinolytic therapy was not associated with significant improvements in all-cause mortality (RR 0.68; 95% CI 0.41 to 1.14) or reinfarction (RR 1.79; 95% CI 0.92 to 3.48), but was associated with an increased risk for minor bleeding (RR 1.84; 95% CI 1.06 to 3.18). CONCLUSIONS: Rescue PCI is associated with improved clinical outcomes for STEMI patients after failed fibrinolytic therapy, but these benefits must be interpreted in the context of potential risks. On the other hand, repeat fibrinolytic therapy is not associated with significant clinical improvement and may be associated with increased harm.

Risks associated with statin therapy: a systematic overview of randomized clinical trials.

BACKGROUND: Although statins reduce the risk of cardiovascular events, concerns about adverse effects may deter physicians from prescribing these agents. We performed a systematic overview of randomized statin trials to quantify the risks of musculoskeletal, renal, and hepatic complications associated with therapy. METHODS AND RESULTS: Major statin trials were identified by electronic search of the MEDLINE database from 1966 to December 2005. We included English language reports of adults with documented hyperlipidemia; double-blind, random allocation of > or = 100 patients to statin monotherapy versus placebo; and reports of myalgia, creatine kinase elevations, rhabdomyolysis, transaminase elevations, and discontinuation due to adverse events. Among 74,102 subjects enrolled in 35 trials (follow-up range, 1 to 65 months), statin therapy (excluding cerivastatin) did not result in significant absolute increases in risks of myalgias (risk difference/1000 patients [RD], 2.7; 95% CI, -3.2 to 8.7), creatine kinase elevations (RD, 0.2; 95% CI, -0.6 to 0.9), rhabdomyolysis (RD, 0.4; 95% CI, -0.1 to 0.9), or discontinuation due to any adverse event (RD, -0.5; 95% CI, -4.3 to 3.3). The absolute risk of transaminase elevations was significantly higher with statin therapy (RD, 4.2; 95% CI, 1.5 to 6.9). CONCLUSIONS: On the basis of data available from published clinical trials, statin therapy is associated with a small excess risk of transaminase elevations, but not of myalgias, creatine kinase elevations, rhabdomyolysis, or withdrawal of therapy compared with placebo. Further study is necessary to determine whether the results from these published clinical trials are similar to what occurs in routine practice, particularly among patients who are older, have more severe comorbid conditions, or receive higher statin doses than most patients in these clinical trials.

Proton pump inhibitor therapy for suspected GERD-related chronic laryngitis: a meta-analysis of randomized controlled trials.

OBJECTIVE: The role of proton pump inhibitors (PPIs) in suspected GERD-related chronic laryngitis (CL) is controversial. Hence, we performed a meta-analysis of the existing randomized controlled trials (RCTs) to evaluate the efficacy of PPIs in this disorder. METHODS: Data extracted from MEDLINE (1966 to August 2005), Cochrane Controlled Trials Register (1997 to August 2005), EMBASE (1980 to August 2005), ClinicalTrials.gov website, and meetings presentations (1999-2005). Published and unpublished randomized placebo-controlled trials of PPIs in suspected GERD-related CL were selected by consensus. Random effects model was utilized with standard approaches to quality assessment, sensitivity analysis, and an exploration of heterogeneity and publication bias. The primary outcome measure was defined as the proportion of patients with >or=50% reduction in self-reported laryngeal symptoms. RESULTS: Pooled data from 8 studies (N = 344, PPI 195, placebo 149; mean age 51 yr; males 55%; study duration 8-16 wk) were analyzed. No significant quantitative heterogeneity was found among the studies (chi2= 11.22, P= 0.13). Overall, PPI therapy resulted in a nonsignificant symptom reduction compared to placebo (relative risk 1.28, 95% confidence interval 0.94-1.74). No clinical predictors of PPI response were identified on meta-regression analysis done at study level. CONCLUSIONS: PPI therapy may offer a modest, but nonsignificant, clinical benefit over placebo in suspected GERD-related CL. Validated diagnostic guidelines may facilitate the recognition of those patients most likely to respond favorably to PPI treatment.

A taxonomy for disease management: a scientific statement from the American Heart Association Disease Management Taxonomy Writing Group.

BACKGROUND: Disease management has shown great promise as a means of reorganizing chronic care and optimizing patient outcomes. Nevertheless, disease management programs are widely heterogeneous and lack a shared definition of disease management, which limits our ability to compare and evaluate different programs. To address this problem, the American Heart Association's Disease Management Taxonomy Writing Group developed a system of classification that can be used both to categorize and compare disease management programs and to inform efforts to identify specific factors associated with effectiveness. METHODS: The AHA Writing Group began with a conceptual model of disease management and its components and subsequently validated this model over a wide range of disease management programs. A systematic MEDLINE search was performed on the terms heart failure, diabetes, and depression, together with disease management, case management, and care management. The search encompassed articles published in English between 1987 and 2005. We then selected studies that incorporated (1) interventions designed to improve outcomes and/or reduce medical resource utilization in patients with heart failure, diabetes, or depression and (2) clearly defined protocols with at least 2 prespecified components traditionally associated with disease management. We analyzed the study protocols and used qualitative research methods to develop a disease management taxonomy with our conceptual model as the organizing framework. RESULTS: The final taxonomy includes the following 8 domains: (1) Patient population is characterized by risk status, demographic profile, and level of comorbidity. (2) Intervention recipient describes the primary targets of disease management intervention and includes patients and caregivers, physicians and allied healthcare providers, and healthcare delivery systems. (3) Intervention content delineates individual components, such as patient education, medication management, peer support, or some form of postacute care, that are included in disease management. (4) Delivery personnel describes the network of healthcare providers involved in the delivery of disease management interventions, including nurses, case managers, physicians, pharmacists, case workers, dietitians, physical therapists, psychologists, and information systems specialists. (5) Method of communication identifies a broad range of disease management delivery systems that may include in-person visitation, audiovisual information packets, and some form of electronic or telecommunication technology. (6) Intensity and complexity distinguish between the frequency and duration of exposure, as well as the mix of program components, with respect to the target for disease management. (7) Environment defines the context in which disease management interventions are typically delivered and includes inpatient or hospital-affiliated outpatient programs, community or home-based programs, or some combination of these factors. (8) Clinical outcomes include traditional, frequently assessed primary and secondary outcomes, as well as patient-centered measures, such as adherence to medication, self-management, and caregiver burden. CONCLUSIONS: This statement presents a taxonomy for disease management that describes critical program attributes and allows for comparisons across interventions. Routine application of the taxonomy may facilitate better comparisons of structure, process, and outcome measures across a range of disease management programs and should promote uniformity in the design and conduct of studies that seek to validate disease management strategies.

Renal impairment and outcomes in heart failure: systematic review and meta-analysis.

OBJECTIVES: We estimated the prevalence of renal impairment in heart failure (HF) patients and the magnitude of associated mortality risk using a systematic review of published studies. BACKGROUND: Renal impairment in HF patients is associated with excess mortality, although precise risk estimates are unclear. METHODS: A systematic search of MEDLINE (through May 2005) identified 16 studies characterizing the association between renal impairment and mortality in 80,098 hospitalized and non-hospitalized HF patients. All-cause mortality risks associated with any renal impairment (creatinine >1.0 mg/dl, creatinine clearance [CrCl] or estimated glomerular filtration rate [eGFR] <90 ml/min, or cystatin-C >1.03 mg/dl) and moderate to severe impairment (creatinine > or =1.5, CrCl or eGFR <53, or cystatin-C > or =1.56) were estimated using fixed-effects meta-analysis. RESULTS: A total of 63% of patients had any renal impairment, and 29% had moderate to severe impairment. After follow-up > or =1 year, 38% of patients with any renal impairment and 51% with moderate to severe impairment died versus 24% without impairment. Adjusted all-cause mortality was increased for patients with any impairment (hazard ratio [HR] = 1.56; 95% confidence interval [CI] 1.53 to 1.60, p < 0.001) and moderate to severe impairment (HR = 2.31; 95% CI 2.18 to 2.44, p < 0.001). Mortality worsened incrementally across the range of renal function, with 15% (95% CI 14% to 17%) increased risk for every 0.5 mg/dl increase in creatinine and 7% (95% CI 4% to 10%) increased risk for every 10 ml/min decrease in eGFR. CONCLUSIONS: Renal impairment is common among HF patients and confers excess mortality. Renal function should be considered in risk stratification and evaluation of therapeutic strategies for HF patients.

Isolation of health services research from practice and policy: the example of chronic heart failure management.

This study examined how health services research connects with practice and policy, first by investigating whether successful research projects continued in their test settings and engendered replication and then by examining whether a coherent body of research helped shape public policy. Chronic heart failure (CHF) was studied because randomized, controlled trials of posthospital CHF disease management have repeatedly demonstrated patient benefits and reduced costs, yet this practice has not become standard in the United States. Literature review produced 30 randomized, controlled trials of multidisciplinary outpatient CHF management, generally yielding improved patient outcomes. An e-mail survey of first authors (97% response rate) showed that practices proven to be effective in U.S. studies generally did not continue or expand (13 of 15 studies), mostly attributed to financial constraints (11 of 13), whereas similar projects in other countries often became permanent (7 of 13). U.S. respondents generally rated current quality of clinical care as good, whereas those elsewhere mostly rated it as excellent. Recent Medicare reforms implemented a model of CHF management substantially different from those studied in health services research. The Congressional hearings leading to these Medicare reforms, and the statute itself, mostly evidence the model used by commercial disease-management firms. Policy-makers, health service researchers, and funding agencies could develop more-effective methods for translating proven models of healthcare delivery into routine practice. Reforms that might improve the effectiveness of the linkages between research, policy, and practice are suggested.

Complexity of program and clinical outcomes of heart failure disease management incorporating specialist nurse-led heart failure clinics. A meta-regression analysis.

OBJECTIVES: To determine whether a hierarchy of effectiveness exists with respect to complexity of published protocols of heart failure (HF) disease management (DM) incorporating specialist nurse-led HF clinics. DATA SOURCES AND STUDY SELECTION: We searched MEDLINE (1966-November 2004), the Cochrane Library, article bibliographies, and contacted experts. Inclusion criteria were random allocation of at least 100 patients, specialist HF nurses, HF clinics, and readmission as an outcome measure. DATA EXTRACTION: Paired reviewers conducted quality assessment, deconstructed and categorized protocols by complexity, and extracted results for readmission, mortality, the combined endpoint of mortality and hospitalization, HF readmission, and hospital days utilized. DATA SYNTHESIS: Six trials were selected (N=949, mean age 73 years [range 62-79], men 58%, LVEF 34% [27-41], and average follow-up of 8.5 months [3-12]). Compared with usual care, the overall relative risk [95% confidence interval] for readmission with this strategy was 0.91 [0.72, 1.16], mortality was 0.80 [0.57, 1.06], and the combined endpoint of mortality and hospitalization was 0.88 [0.74, 1.04]. We observed better outcomes for programs with versus programs without hospital discharge planning and immediate post-discharge follow-up; readmission 0.30 [0.04, 2.60] vs. 1.00 [0.86, 1.17], mortality 0.96 [0.63, 1.47] vs. 0.75 [0.55, 1.03], the combined endpoint of mortality and hospitalization 0.61 [0.18, 2.02] vs. 0.91 [0.80, 1.03], HF readmission 0.09 [0.10, 0.65] vs. 0.65 [0.43, 1.00], and hospitalized days utilized per patient -0.26 [-0.49,-0.02] vs. 0.09 [-1.17, 1.34]. CONCLUSIONS: HF DM with specialist nurse-led HF clinics is a promising strategy or effective alternative whose benefit may be optimized by programs with a homogeneous structure and components that are delivered with consistency.

Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure: a meta-analysis.

CONTEXT: Comprehensive discharge planning plus postdischarge support may reduce readmission rates for older patients with congestive heart failure (CHF). OBJECTIVE: To evaluate the effect of comprehensive discharge planning plus postdischarge support on the rate of readmission in patients with CHF, all-cause mortality, length of stay (LOS), quality of life (QOL), and medical costs. DATA SOURCES: We searched MEDLINE (1966 to October 2003), the Cochrane Clinical Trials Register (all years), Social Science Citation Index (1992 to October 2003), and other databases for studies that described such an intervention and evaluated its effect in patients with CHF. Where possible we also contacted lead investigators and experts in the field. STUDY SELECTION: We selected English-language publications of randomized clinical trials that described interventions to modify hospital discharge for older patients with CHF (mean age > or =55 years), delineated clearly defined inpatient and outpatient components, compared efficacy with usual care, and reported readmission as the primary outcome. DATA EXTRACTION: Two authors independently reviewed each report, assigned quality scores, and extracted data for primary and secondary outcomes in an unblinded standardized manner. DATA SYNTHESIS: Eighteen studies representing data from 8 countries randomized 3304 older inpatients with CHF to comprehensive discharge planning plus postdischarge support or usual care. During a pooled mean observation period of 8 months (range, 3-12 months), fewer intervention patients were readmitted compared with controls (555/1590 vs 741/1714, number needed to treat = 12; relative risk [RR], 0.75; 95% confidence interval [CI], 0.64-0.88). Analysis of studies reporting secondary outcomes found a trend toward lower all-cause mortality for patients assigned to an intervention compared with usual care (RR, 0.87; 95% CI, 0.73-1.03; n = 14 studies), similar initial LOS (mean [SE]: 8.4 [2.5] vs 8.5 [2.2] days, P =.60; n = 10), greater percentage improvement in QOL scores compared with baseline scores (25.7% [95% CI, 11.0%-40.4%] vs 13.5% [95% CI, 5.1%-22.0%]; n = 6, P =.01), and similar or lower charges for medical care per patient per month for the initial hospital stay, administering the intervention, outpatient care, and readmission (-359 dollars [95% CI, -763 dollars to 45 dollars]; n = 4, P =.10 for non-US trials and -536 dollars [95% CI, -956 dollars to -115 dollars]; n = 4, P =.03, for US trials). CONCLUSION: Comprehensive discharge planning plus postdischarge support for older patients with CHF significantly reduced readmission rates and may improve health outcomes such as survival and QOL without increasing costs.