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Primary prevention of sudden cardiac death using implantable cardioverter defibrillators.

Europace. 2008 Sep;10(9):1034-41

Authors: Ding L, Hua W, Niu H, Chen K, Zhang S

Despite substantial advances in prevention and treatment of cardiovascular diseases, sudden cardiac death (SCD) remains a leading cause of death in industrialized countries. Implantable cardioverter defibrillator (ICD) has been demonstrated to be an attractive option for primary prevention of SCD in high-risk patients. This review discusses the progress in the risk stratification for selecting high-risk patients, highlights the clinical trials of primary prevention for SCD, outlines the efficacy of combined use of cardiac resynchronization therapy with ICD, and analyses the cost-effectiveness issue of this device.

PMID: 18559335 [PubMed - indexed for MEDLINE]

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Critical Events in the Lives of Interns.

J Gen Intern Med. 2008 Oct 30;

Authors: Ackerman A, Graham M, Schmidt H, Stern DT, Miller SZ

BACKGROUND: Early residency is a crucial time in the professional development of physicians. As interns assume primary care for their patients, they take on new responsibilities. The events they find memorable during this time could provide us with insight into their developing professional identities. OBJECTIVE: To evaluate the most critical events in the lives of interns. PARTICIPANTS: Forty-one internal medicine residents at one program participated in a two-day retreat in the fall of their first year. Each resident provided a written description of a recent high point, low point, and patient conflict. MEASUREMENTS: We used a variant of grounded theory to analyze these critical incidents and determine the underlying themes of early internship. Independent inter-rater agreement of >90% was achieved for the coding of excerpts. MAIN RESULTS: The 123 critical incidents were clustered into 23 categories. The categories were further organized into six themes: confidence, life balance, connections, emotional responses, managing expectations, and facilitating teamwork. High points were primarily in the themes of confidence and connections. Low points were dispersed more generally throughout the conceptual framework. Conflicts with patients were about negotiating the expectations inherent in the physician-patient relationship. CONCLUSION: The high points, low points, and conflicts reported by early residents provide us with a glimpse into the lives of interns. The themes we have identified reflect critical challenges interns face the development of their professional identity. Program directors could use this process and conceptual framework to guide the development and promotion of residents' emerging professional identities.

PMID: 18972091 [PubMed - as supplied by publisher]

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Patients’ Perception of Hospital Care in the United States.

N Engl J Med. 2008 Oct 30;359(18):1921-1931

Authors: Jha AK, Orav EJ, Zheng J, Epstein AM

BACKGROUND: Patients' perceptions of their care, especially in the hospital setting, are not well known. Data from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey provide a portrait of patients' experiences in U.S. hospitals. METHODS: We assessed the performance of hospitals across multiple domains of patients' experiences. We examined whether key characteristics of hospitals that are thought to enhance patients' experiences (i.e., a high ratio of nurses to patient-days, for-profit status, and nonacademic status) were associated with a better experience for patients. We also examined whether a hospital's performance on the HCAHPS survey was related to its performance on indicators of the quality of clinical care. RESULTS: We found moderately high levels of satisfaction with care (e.g., on average, 67.4% of a hospital's patients said that they would definitely recommend the hospital), with a high degree of correlation among the measures of patients' experiences (Cronbach's alpha, 0.94). As compared with hospitals in the bottom quartile of the ratio of nurses to patient-days, those in the top quartile had a somewhat better performance on the HCAHPS survey (e.g., 63.5% vs. 70.2% of patients responded that they "would definitely recommend" the hospital; P<0.001). Hospitals with a high level of patient satisfaction provided clinical care that was somewhat higher in quality for all conditions examined. For example, those in the top quartile of HCAHPS ratings performed better than those in the bottom quartile with respect to the care that patients received for acute myocardial infarction (actions taken to provide appropriate care as a proportion of all opportunities for providing such actions, 95.8% vs. 93.1% in unadjusted analyses; P<0.001) and for pneumonia (90.5% vs. 88.6% in unadjusted analyses, P<0.001). CONCLUSIONS: This portrait of patients' experiences in U.S. hospitals offers insights into areas that need improvement, suggests that the same characteristics of hospitals that lead to high nurse-staffing levels may be associated with better experiences for patients, and offers evidence that hospitals can provide both a high quality of clinical care and a good experience for the patient. Copyright 2008 Massachusetts Medical Society.

PMID: 18971493 [PubMed - as supplied by publisher]

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Two decades of Title VII support of a primary care residency: process and outcomes.

Acad Med. 2008 Nov;83(11):1064-70

Authors: Lipkin M, Zabar SR, Kalet AL, Laponis R, Kachur E, Anderson M, Gillespie CC

PURPOSE: To assess 23 years of Health Resources and Services Administration (HRSA) Title VII Training in Primary Care Medicine and Dentistry funding to the New York University School of Medicine/Bellevue Primary Care Internal Medicine Residency Program. The program, begun in 1983 within a traditional, inner-city, subspecialty-oriented internal medicine program, evolved into a crucible of systematic innovation, catalyzed and made feasible by initiatives funded by the HRSA. The curriculum stressed three pillars of generalism: psychosocial medicine, clinical epidemiology, and health policy. It developed tight, objectives-driven, effective, nonmedical specialty blocks and five weekly primary care activities that created a paradigm-driven, community-based, role-modeling matrix. Innovation was built in. Every block and activity was evaluated immediately and in an annual, program-wide retreat. Evaluation evolved from behavioral checklists of taped interviews to performance-based, systematic, annual objective structured clinical examinations. METHOD: The authors reviewed eight grant proposals, project reports, and curriculum and program evaluations. They also quantitatively and qualitatively surveyed the 122 reachable graduates from the first 20 graduating classes of the program. RESULTS: Analysis of program documents revealed recurring emphases on the use of proven educational models, strategic innovation, and assessment and evaluation to design and refine the program. There were 104 respondents (85%) to the survey. A total of 87% of the graduates practice as primary care physicians, 83% teach, and 90% work with the underserved; 54% do research, 36% actively advocate on health issues for their patients, programs, and other constituencies, and 30% publish. Graduates cited work in the community and faculty excitement and energy as essential elements of the program’s impact; overall, graduates reported high personal and career satisfaction and low burnout. CONCLUSIONS: With HRSA support, a focused, innovative program evolved which has already met each of the six recommendations for future innovation of the Alliance for Academic Internal Medicine Education Redesign Task Force. This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

PMID: 18971659 [PubMed - in process]

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Providing culturally competent care: residents in HRSA Title VII funded residency programs feel better prepared.

Acad Med. 2008 Nov;83(11):1071-9

Authors: Green AR, Betancourt JR, Park ER, Greer JA, Donahue EJ, Weissman JS

BACKGROUND: The Health Resources and Services Administration (HRSA) funds primary care residency programs through its Title VII training grants, with a goal of ensuring a well-prepared, culturally competent physician workforce. The authors sought to determine whether primary care residents in Title VII-funded training programs feel better prepared than those in nonfunded programs to provide care to culturally diverse patients. METHOD: The authors analyzed data from a national mailed survey of senior resident physicians conducted in 2003-2004. Of 1,467 randomly selected family medicine, internal medicine, and pediatrics residents, 866 responded–403 in Title VII-funded programs and 463 in nonfunded programs (response rate = 59%). The survey included 28 Likert-response questions about residents' preparedness and perceived skills to provide cross-cultural care, sociodemographics, and residency characteristics. RESULTS: Residents in Title VII-funded programs were more likely than others to report being prepared to provide cross-cultural care across all 8 measures (odds ratio [OR] = 1.54-2.61, P < .01) and feeling more skilled in cross-cultural care for 6 of 10 measures (OR = 1.30-1.95, P < .05). Regression analyses showed that characteristics of the Title VII-funded residency training experience related to cross-cultural care (e.g., role models, cross-cultural training, and attitudes of attending physicians) accounted for many of the differences in self-reported preparedness and skills. CONCLUSIONS: Senior residents in HRSA Title VII-funded primary care residency training programs feel better prepared than others to provide culturally competent care. This may be partially explained by better cross-cultural training experiences in HRSA Title VII-funded programs.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

PMID: 18971660 [PubMed - in process]

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Changing conversations: teaching safety and quality in residency training.

Acad Med. 2008 Nov;83(11):1080-7

Authors: Voss JD, May NB, Schorling JB, Lyman JA, Schectman JM, Wolf AM, Nadkarni MM, Plews-Ogan M

Improving patient safety and quality in health care is one of medicine’s most pressing challenges. Residency training programs have a unique opportunity to meet this challenge by training physicians in the science and methods of patient safety and quality improvement (QI).With support from the Health Resources and Services Administration, the authors developed an innovative, longitudinal, experiential curriculum in patient safety and QI for internal medicine residents at the University of Virginia. This two-year curriculum teaches the critical concepts and skills of patient safety and QI: systems thinking and human factors analysis, root cause analysis (RCA), and process mapping. Residents apply these skills in a series of QI and patient safety projects. The constructivist educational model creates a learning environment that actively engages residents in improving the quality and safety of their medical practice.Between 2003 and 2005, 38 residents completed RCAs of adverse events. The RCAs identified causes and proposed useful interventions that have produced important care improvements. Qualitative analysis demonstrates that the curriculum shifted residents’ thinking about patient safety to a systems-based approach. Residents completed 237 outcome assessments during three years. Results indicate that seminars met predefined learning objectives and were interactive and enjoyable. Residents strongly believe they gained important skills in all domains.The challenge to improve quality and safety in health care requires physicians to learn new knowledge and skills. Graduate medical education can equip new physicians with the skills necessary to lead the movement to safer and better quality of care for all patients.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

PMID: 18971662 [PubMed - in process]

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Multiple sclerosis.

Lancet. 2008 Oct 25;372(9648):1502-17

Authors: Compston A, Coles A

Multiple sclerosis is primarily an inflammatory disorder of the brain and spinal cord in which focal lymphocytic infiltration leads to damage of myelin and axons. Initially, inflammation is transient and remyelination occurs but is not durable. Hence, the early course of disease is characterised by episodes of neurological dysfunction that usually recover. However, over time the pathological changes become dominated by widespread microglial activation associated with extensive and chronic neurodegeneration, the clinical correlate of which is progressive accumulation of disability. Paraclinical investigations show abnormalities that indicate the distribution of inflammatory lesions and axonal loss (MRI); interference of conduction in previously myelinated pathways (evoked electrophysiological potentials); and intrathecal synthesis of oligoclonal antibody (examination by lumbar puncture of the cerebrospinal fluid). Multiple sclerosis is triggered by environmental factors in individuals with complex genetic-risk profiles. Licensed disease modifying agents reduce the frequency of new episodes but do not reverse fixed deficits and have questionable effects on the long-term accumulation of disability and disease progression. We anticipate that future studies in multiple sclerosis will provide a new taxonomy on the basis of mechanisms rather than clinical empiricism, and so inform strategies for improved treatment at all stages of the disease.

PMID: 18970977 [PubMed - in process]

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Treprostinil for pulmonary hypertension.

Vasc Health Risk Manag. 2008;4(3):507-13

Authors: Skoro-Sajer N, Lang I, Naeije R

Treprostinil is a stable, long-acting prostacyclin analogue which can be administered as a continuous subcutaneous infusion using a portable miniature delivery system. Subcutaneous treprostinil has been shown in a large multicenter randomized controlled trial to improve exercise capacity, clinical state, functional class, pulmonary hemodynamics, and quality of life in patients with pulmonary arterial hypertension, an uncommon disease of poor prognosis. Side effects include facial flush, headache, jaw pain, abdominal cramping, and diarrhea, all typical of prostacyclin, and manageable by symptom-directed dose adjustments, and infusion site pain which may make further treatment impossible in 7%-10% of the patients. Long-term survival in pulmonary arterial hypertension patients treated with subcutaneous treprostinil is similar to that reported with intravenous epoprostenol. There are uncontrolled data suggesting efficacy of subcutaneous treprostinil in chronic thromboembolic pulmonary hypertension. Treprostinil can also be administered intravenously, although increased doses, up to 2-3 times those given subcutaneously, appear to be needed to obtain the same efficacy. Preliminary results of a randomized controlled trial of inhaled treprostinil on top of bosentan and sildenafil therapies have shown significance on the primary endpoint, which was exercise capacity as assessed by the distance walked in 6 minutes. Trials of oral formulations of treprostinil have been initiated.

PMID: 18827901 [PubMed - indexed for MEDLINE]

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Perioperative hypertension management.

Vasc Health Risk Manag. 2008;4(3):615-27

Authors: Varon J, Marik PE

Perioperative hypertension is commonly encountered in patients that undergo surgery. While attempts have been made to standardize the method to characterize the intraoperative hemodynamics, these methods still vary widely. In addition, there is a lack of consensus concerning treatment thresholds and appropriate therapeutic targets, making absolute recommendations about treatment difficult. Nevertheless, perioperative hypertension requires careful management. When treatment is necessary, therapy should be individualized for the patient. This paper reviews the pharmacologic agents and strategies commonly used in the management of perioperative hypertension.

PMID: 18827911 [PubMed - indexed for MEDLINE]

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Comparison between angiotensin-converting enzyme inhibitors and angiotensin receptor blockers on the risk of myocardial infarction, stroke and death: a meta-analysis.

J Hypertens. 2008 Jul;26(7):1282-9

Authors: Reboldi G, Angeli F, Cavallini C, Gentile G, Mancia G, Verdecchia P

OBJECTIVES: To compare the effects of angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors on the risk of myocardial infarction, stroke, cardiovascular mortality and total mortality. METHODS: We conducted a meta-analysis of randomized comparative trials between angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors. Inclusion criteria were publication in peer-reviewed journals indexed in Medline, randomized comparison of angiotensin II receptor blockers vs. angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers + angiotensin-converting enzyme inhibitors vs. angiotensin-converting enzyme inhibitors, report of major complications including myocardial infarction, stroke, cardiovascular mortality or all-cause mortality; average follow-up of at least 1 year in at least 200 patients. RESULTS: Six trials fulfilled the inclusion criteria, for a total of 49 924 patients. In the pooled estimate, there were no significant differences between angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors on the risk of myocardial infarction (odds ratio 1.01; 95% confidence interval 0.95-1.07; P = 0.75), cardiovascular mortality (odds ratio 1.03; 95% confidence interval 0.98-1.08; P = 0.23) and total mortality (odds ratio 1.03; 95% confidence interval 0.97-1.10; P = 0.20). This was the case also when the analysis involved only the comparison between angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers. Overall, the risk of stroke was slightly lower with angiotensin II receptor blockers than angiotensin-converting enzyme inhibitors (odds ratio 0.92; 95% confidence interval 0.85-0.99; P = 0.037), the direct angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers comparison showing a nonsignificant trend in a similar direction. Statistical heterogeneity among trials was not significant, with a low to null inconsistency statistic, for stroke (P = 0.67), myocardial infarction (P = 0.86), cardiovascular mortality (P = 0.14) and total mortality (P = 0.12). CONCLUSION: This overview suggests that angiotensin II receptor blockers are as effective as angiotensin-converting enzyme inhibitors on the risk of myocardial infarction, cardiovascular mortality and total mortality. Angiotensin II receptor blockers may be slightly more protective than angiotensin-converting enzyme inhibitors on the risk of stroke.

PMID: 18550998 [PubMed - indexed for MEDLINE]

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Relationship between vancomycin MIC and failure among patients with methicillin-resistant Staphylococcus aureus bacteremia treated with vancomycin.

Antimicrob Agents Chemother. 2008 Sep;52(9):3315-20

Authors: Lodise TP, Graves J, Evans A, Graffunder E, Helmecke M, Lomaestro BM, Stellrecht K

There is growing concern that vancomycin has diminished activity for methicillin-resistant Staphylococcus aureus (MRSA) infections, with vancomycin MICs at the high end of the CLSI susceptibility range. Despite this growing concern, there are limited clinical data to support this notion. To better elucidate this, a retrospective cohort study was conducted among patients with MRSA bloodstream infections who were treated with vancomycin between January 2005 and May 2007. The inclusion criteria were as follows: at least 18 years old, nonneutropenic, with an MRSA culture that met the CDC criteria for bloodstream infection, had received vancomycin therapy within 48 h of the index blood culture, and survived >24 h after vancomycin administration. Failure was defined as 30-day mortality, bacteremia >or=10 days on vancomycin therapy, or a recurrence of MRSA bacteremia within 60 days of vancomycin discontinuation. Classification and regression tree (CART) analysis identified the vancomycin MIC breakpoint associated with an increased probability of failure. During the study period, 92 patients met the inclusion criteria. The vancomycin MIC breakpoint derived by CART analysis was >or=1.5 mg/liter. The 66 patients with vancomycin MICs of >or=1.5 mg/liter had a 2.4-fold increase in failure compared to patients with MICs of <or=1.0 mg/liter (36.4% and 15.4%, respectively; P = 0.049). In the Poisson regression, a vancomycin MIC of >or=1.5 mg/liter was independently associated with failure (adjusted risk ratio, 2.6; 95% confidence interval, 1.3 to 5.4; P = 0.01). These data strongly suggest that patients with MRSA bloodstream infections with vancomycin MICs of >or=1.5 mg/liter respond poorly to vancomycin. Alternative anti-MRSA therapies should be considered for these patients.

PMID: 18591266 [PubMed - indexed for MEDLINE]

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Ramelteon: a novel approach in the treatment of insomnia.

Ann Pharmacother. 2008 Sep;42(9):1262-71

Authors: Reynoldson JN, Elliott E, Nelson LA

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of ramelteon in the treatment of primary insomnia in adults, including elderly adults. DATA SOURCES: MEDLINE (1966-July 2008) and PsycINFO (1985-July 2008) literature searches were conducted to identify clinical data involving ramelteon. The manufacturer provided a summary of clinical data and abstracts of unpublished studies. STUDY SELECTION AND DATA EXTRACTION: All primary literature, including abstracts, focusing on the pharmacology and pharmacokinetics of ramelteon and clinical trials evaluating its use was reviewed. Information deemed most relevant was incorporated. Our search revealed 5 controlled trials evaluating the short-term efficacy and safety of ramelteon in the treatment of primary insomnia: 3 in adults and 2 in geriatric patients. Additionally, 2 studies in abstract form that evaluated the long-term effects of ramelteon were included. DATA SYNTHESIS: Ramelteon is the first selective melatonin receptor agonist approved by the Food and Drug Administration. It has no affinity for the gamma-aminobutyric acid receptor complex or for receptors that bind acetylcholine, cytokines, dopamine, norepinephrine, neuropeptides, opiates, and serotonin. In the only published Phase 3 trial in adults, investigators found that latency to persistent sleep decreased with ramelteon to 31.5 +/- 2.91 minutes with 8 mg and 29.5 +/- 2.96 minutes with 16 mg compared with 42.5 +/- 2.97 minutes with placebo (p = 0.007 and p = 0.002, respectively). Total sleep time was not significantly different from that with placebo. Safety data from short-term studies showed advantages of ramelteon over other sleep agents including no potential for abuse, no rebound insomnia, and lack of effect on motor and cognitive function. The adverse effects seen most frequently in ramelteon clinical trials were headache, somnolence, fatigue, nausea, dizziness, and insomnia. The overall incidence was similar to that of placebo. CONCLUSIONS: Ramelteon offers a novel mechanism of action for the treatment of insomnia. Studies support its short- and long-term use in adults and elderly adults for the treatment of primary insomnia characterized by difficulty with sleep initiation. Efficacy studies comparing ramelteon with other sleep agents are needed to further solidify the role of ramelteon in the treatment of insomnia.

PMID: 18648020 [PubMed - indexed for MEDLINE]

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The safety of rosiglitazone in the treatment of type 2 diabetes.

Expert Opin Drug Saf. 2008 Sep;7(5):579-85

Authors: Singh S, Loke YK

BACKGROUND: Cardiovascular disease is the leading cause of mortality among adults with Type 2 diabetes. The thiazolidinediones including rosiglitazone are approved for the treatment of Type 2 diabetes on the basis of their ability to lower blood sugar and surrogate markers of cardiovascular disease. OBJECTIVES: To ascertain the cardiovascular, skeletal and hematologic safety profile of rosiglitazone. METHODS: Synthesis of evidence from recent trials, systematic reviews, meta-analysis, regulatory documents and clinical trials registries of manufacturers. CONCLUSION: Rosiglitazone increases the risk of heart failure, myocardial infarction and fractures (in women) with Type 2 diabetes.

PMID: 18759710 [PubMed - indexed for MEDLINE]

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Rapid carvedilol up-titration in hospitalized patients with systolic heart failure.

J Heart Lung Transplant. 2008 Aug;27(8):914-6

Authors: Martínez-Sellés M, Datino T, Alhama M, Barrueco N, Castillo I, Fernández-Avilés F

To determine whether carvedilol can be safely up-titrated before hospital discharge, we studied 372 consecutive patients with systolic heart failure who were being treated with carvedilol. Carvedilol was initiated a median of 3 days after admission, with a mean starting dose of 12 mg. Up-titration was performed in 67% of patients, with a mean increase of 16 mg and a mean discharge daily dose of 23 +/- 17 mg. Mean daily dose at the end of follow-up was 35.3 +/- 25.3 mg and it increased with higher discharge dose.

PMID: 18656807 [PubMed - indexed for MEDLINE]

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Gadolinium-based contrast agents and nephrogenic systemic fibrosis: a systematic review and meta-analysis.

Nephrol Dial Transplant. 2008 Oct 24;

Authors: Agarwal R, Brunelli SM, Williams K, Mitchell MD, Feldman HI, Umscheid CA

BACKGROUND: In the past decade, more than 200 cases of nephrogenic systemic fibrosis (NSF) have been identified, primarily among patients with advanced kidney disease. Multiple studies have suggested an association between gadolinium-based contrast agents (GBCAs) and NSF. We performed a systematic review and meta-analysis to examine this potential association. METHODS: A systematic review of studies examining the association between any GBCA and NSF was performed. A search for controlled studies was conducted in MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. If controlled data for a GBCA was not available, we searched for case reports and series. Relevant data were extracted and meta-analyses were performed. RESULTS: Seven of 144 identified studies met inclusion criteria; gadodiamide was the sole or predominant GBCA in four of these; one study exclusively examined gadopentetate. Other GBCAs were not specifically examined in controlled or uncontrolled studies. Meta-analysis of controlled trials demonstrated a significant association between GBCA exposure and NSF [odds ratio (OR) 26.7; 95% confidence interval (CI) 10.3-69.4] and gadodiamide and NSF (OR 20.0; 95% CI 3.7-107.8). Examination of the evidence using established criteria suggested that this association was causal. CONCLUSIONS: The current state of evidence suggests an association and potentially causal link between the use of GBCAs and the development of NSF among patients with advanced kidney disease. Additional study is warranted to clarify the potential association of GBCAs other than gadodiamide with NSF.

PMID: 18952698 [PubMed - as supplied by publisher]

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