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Patients with heart failure have elevated levels of circulating inflammatory cytokines and commonly have iron deficiency anemia or anemia of chronic inflammation. Clinical trials in patients with congestive heart failure and iron deficiency have demonstrated that intravenous iron treatment appears to improve subjective and objective outcomes. Most patients in these trials were not anemic or only had mild anemia, and hemoglobin concentration rose only slightly after treatment with iron. Experimental evidence demonstrates that iron is a cofactor for muscle function, which could explain the improvement in clinical outcomes. Many questions remain to be answered to understand the role of iron therapy in patients with congestive heart failure.

SUMMARY Red blood cell transfusions are commonly used in orthopedic surgery and cost billions of dollars annually. The goals of transfusion are to reduce mortality, morbidity and functional impairment that result from anemia and inadequate oxygen delivery. Risks of infections from transfusion are low and continue to decline, but evidence is growing that red cell transfusions are immunosuppressive and predispose patients to postoperative infections. However, there actually are very little data on when transfusion is indicated. Observational data suggest that transfusion does not reduce mortality in patients with pre- or postoperative hemoglobin levels >8 g/dL, although no conclusions could be drawn about the effect of transfusion in patients with hemoglobin >8 g/dL. Large well-performed randomized clinical trials are needed to establish the efficacy of transfusion. Until better data are available, orthopedic surgeons will have to rely on clinical judgement in transfusion decisions. The author recommends using a higher transfusion threshold in patients with cardiovascular disease.

BACKGROUND: Previous analyses have found autologous transfusion to be very expensive but have not considered avoidance of postoperative bacterial infections as one of its benefits. STUDY DESIGN AND METHODS: A cost-utility analysis using a Markov cohort simulation model compared autologous blood transfusion to allogeneic transfusion in a hypothetical cohort of patients undergoing elective total hip replacement with respect to discounted quality-adjusted life years (QALYs) and health-care system costs. RESULTS: Assuming a base case rate of serious infection of 3.7 percent, a relative risk of infection of 1.85, and additional costs of $12,980 per infection, autologous transfusion has a cost-effectiveness of $2,470 per QALY. If the relative risk of bacterial infection following allogeneic transfusion exceeds 1.1, the cost-effectiveness of autologous transfusion is less than $50,000 per QALY and if the relative risk exceeds 2.4, autologous transfusion is dominant, resulting in both lower costs and greater QALYs. If there were no increased risk of transfusion, the cost-effectiveness of autologous transfusion would be $3,400,000 per QALY. CONCLUSIONS: If there is only a modest increase in the risk of bacterial infection following allogeneic transfusion, autologous transfusion would result in improved outcomes at a cost of less than $50,000 per QALY. Autologous transfusion would be dominant above a relative risk of infection that is within the range of values observed in randomized controlled trials. However, if there is no increased risk of bacterial infection, autologous transfusion would be a very expensive strategy. Until more definitive data are available on the magnitude and costs of this risk, we advise against prematurely closing the debate about the cost-effectiveness of autologous transfusion.

BACKGROUND: The relationship between allogeneic blood transfusion and bacterial infection remains uncertain. An increased risk of bacterial infection would represent the most important risk of allogeneic transfusion, because viral disease transmission has become so rare. STUDY DESIGN AND METHODS: A retrospective cohort study of 9598 consecutive hip fracture patients at least 60 years old who underwent surgical repair was performed. The primary outcome was serious bacterial infection, defined as bacteremia, pneumonia, deep wound infection, or septic arthritis or osteomyelitis. Secondary outcomes included two individual infections, pneumonia and urinary tract infection (UTI), and the cost of infection. Hospital cost of infection was assessed by linking the study population to Medicare data. RESULTS: Fifty-eight percent of patients received at least one transfusion. Serious bacterial infection occurred in 437 patients (4.6%); 28.8 percent of this group died during the hospital stay. Pneumonia occurred in 361 patients (3.8%) and UTI occurred in 1157 patients (12.1%). The adjusted risk of serious bacterial infection associated with transfusion was 1.35 (95% CI, 1.10-1.66). The adjusted risk for pneumonia was 1.52 (95% CI, 1.21-1.91), and that for UTI was 1.03 (95% CI, 0.91-1.17). A dose-response relationship was present for serious bacterial infection (p = 0.001) and pneumonia (p = 0.001). The cost of hospitalization was $14,000 greater for patients with serious infection than for patients without infection. CONCLUSION: Blood transfusion is associated with a 35-percent greater risk of serious bacterial infection and a 52-percent greater risk of pneumonia. Postoperative infections are costly. The risk of bacterial infection may be the most common life-threatening adverse effect of allogeneic blood transfusion.

Blood transfusion has for years been considered to have obvious clinical benefits and to be a relatively low-risk procedure. Not until the early 1980s did transfusion practices begin to come under systematic scrutiny. Initially, this trend was driven by concern about transfusion-related infection, particularly by human immunodeficiency virus, but advances in transfusion medicine have greatly decreased the risk of transmission of viruses by transfused blood. Now, other concerns — the effects of transfusion on the immune system, transfusion-related acute lung injury, and the age of transfused blood — drive the debate over transfusion practice and have led to methodical examinations . . .

BACKGROUND: The indications for transfusion have never been evaluated in an adequately sized clinical trial. A pilot study was conducted to plan larger clinical trials. STUDY DESIGN AND METHODS: Hip fracture patients undergoing surgical repair who had postoperative hemoglobin levels less than 10 g per dL were randomly assigned to receive 1) symptomatic transfusion: that is, transfusion for symptoms of anemia or for a hemoglobin level that dropped below 8 g per dL or 2) threshold transfusion: that is, patients receive 1 unit of packed RBCs at the time of random assignment and as much blood as necessary to keep the hemoglobin level above 10 g per dL. Outcomes were 60-day mortality, morbidity, functional status, and place of residence. RESULTS: Among 84 eligible patients enrolled, mean (± SD) prerandomization hemoglobin was 9.1 (± 0.6) g/ dL. The median number of units transfused in the threshold transfusion group was 2 (interquartile range, = 1–2), and that in the symptomatic transfusion group was 0 (6; interquartile range, = 0–2) (p < 0.001). Mean hemoglobin levels were approximately 1 g per dL higher in the threshold group than in the symptomatic group: for example, on Day 2, 10.3 (± 0.9) g per dL versus 9.3 (± 1.2) g per dL, respectively (p < 0.001). At 60 days, death or inability to walk across the room without assistance occurred in 16 (39.0%) of the symptomatic transfusion group and 19 (45.2%) of the threshold transfusion group. Death occurred by 60 days in 5 (11.9%) of the symptomatic transfusion group and 2 (4.8%) in the threshold transfusion group (relative risk = 2.5; 95% CI, 0.5–12.2). Other outcomes were similar for the two groups. CONCLUSIONS: Symptomatic transfusion may be an effective blood-sparing protocol associated with the transfusion of appreciably fewer units of RBCs and lower mean hemoglobin levels than are associated with the threshold transfusion policy. However, it is unknown whether these two clinical strategies have comparable mortality, morbidity, or functional status. A definitive trial is needed.

OBJECTIVES This study examines the influence of risk factors such as cigarette smoking, blood pressure, serum cholesterol, or chronic illness on frequency of hospital admission in a population-based sample. METHODS Data from the National Health and Nutrition Examination Survey I Epidemiologic Followup Study for 6,461 adults aged 45 years and older were used to assess the influence of risk factors measured by interview, physical examination, and laboratory tests on frequency of hospital admission over a 12- to 16-year follow-up period. Cox proportional hazard regressions were estimated separately for men and women and for ages 45 to 64 years and 65 years and older. SUDAAN software was used to correct for clustering, stratification, unequal weighting, and multiple observations per respondent. RESULTS Risk of hospitalization was higher for current but not former smokers (relative risk [RR] = 1.17-1.34 for different age-sex groups; P < 0.01), higher blood pressure (RR = 1.25-1.28 for ages 45-64; RR = 1.07-1.15 for ages 65 and older; P < 0.01), and lower serum albumin (RR = 1.08-1.14; P < 0.01). Diabetes, lung conditions, heart attack, and ulcer each were associated with higher risk in at least three of the four age-sex groups, as was arthritis among the middle-aged (45-64 years). Serum cholesterol was not associated with hospitalization. CONCLUSIONS Chronic conditions with high morbidity as well as many factors associated with mortality are associated with a higher frequency of hospitalization.

The purpose of this report is to discuss methodologic issues in using Medicaid claims data to conduct epidemiologic analyses in reproductive health.We conducted case-control studies that used Medicaid claims data to evaluate two specific reproductive health questions. Case and control pregnancies were selected from among 106,000 women identified in a Medicaid claims file. Medical record review was conducted for randomly selected cases and controls.Several methodological issues were identified. Women could contribute multiple pregnancies that qualified as either case pregnancies, control pregnancies, or both. The results of the medical record review indicated that 25% of one case group (low-birthweight infants) could not be confirmed, and 70% of the second case group (CNS birth defects) were misclassified. Thirty-five percent of women classified as not having undergone diagnostic ultrasonography based on Medicaid claims data had evidence of having received diagnostic ultrasound during pregnancy on the basi...

Every medical decision involves weighting the risk versus benefit. The risks related to red blood cell transfusion include the adverse effects of allogeneic blood and the risks of anemia. The potential benefits of blood transfusion are reduction of mortality and morbidity and improvement in functional recovery. In this lecture, I will focus on risks related to anemia and what is know about the benefits of allogeneic transfusion. I will complete the presentation with a description of a new clinical trial called FOCUS.

Despite its high prevalence, anemia often does not receive proper clinical attention, and detection, evaluation, and management of iron deficiency anemia and iron-restricted erythropoiesis can possibly be an unmet medical need. A multidisciplinary panel of clinicians with expertise in anemia management convened and reviewed recent published data on prevalence, etiology, and health implications of anemia as well as current therapeutic options and available guidelines on management of anemia across various patient populations and made recommendations on the detection, diagnostic approach, and management of anemia. The available evidence confirms that the prevalence of anemia is high across all populations, especially in hospitalized patients. Anemia is associated with worse clinical outcomes including longer length of hospital stay, diminished quality of life, and increased risk of morbidity and mortality, and it is a modifiable risk factor of allogeneic blood transfusion with its own inherent risks. Iron deficiency is usually present in anemic patients. An algorithm for detection and management of anemia was discussed, which incorporated iron study (with primary emphasis on transferrin saturation), serum creatinine and glomerular filtration rate, and vitamin B12 and folic acid measurements. Management strategies included iron therapy (oral or intravenous), erythropoiesis-stimulating agents, and referral as needed.

We performed a pilot trial evaluating transfusion thresholds in symptomatic cardiac disease. Pilot studies are performed to determine feasibility of a research project and often provide essential experience needed to plan a definitive study. In the MINT pilot trial, we evaluated recruitment rates, ability to implement transfusion protocol, procedures for follow-up, classification of outcomes, data collection forms, and the resources needed to carry out the study. Overall, the MINT pilot was successful, and the experience gained will result in changes in the protocol that will assure successful completion of a definitive trial. Pilot studies are not designed to answer clinical questions because the sample size required to determine the feasibility of a study is much smaller than that needed to answer a clinical question. Small trials commonly have unequal distribution of baseline characteristics even with the use of optimal randomization procedures like those used in MINT. The clinical results of small studies may not provide accurate estimate of treatment effect because of random variation. Each of these points was described in our manuscript. In response to the assertions made by Dr Sandar et al, enrollment in the trial was terminated because recruitment was slower than anticipated, the allotted recruitment period was over, and the goal of determining the feasibility of the trial had beenestablishedwith 110patients. A central telephone randomization system was used in the MINT pilot, which assures concealment of the random assignment. The differences found in baseline characteristics are common in small trials and are the result of chance. We clearly state in the methods and discussion that we defined the significant P value as b.01 for secondary outcomes and that theP valuewas .032 for death at 30 days.We reference the CRIT trial, which was performed in only 45 patients. The meta-analysis referenced by Dr Sandar is likely to be biased because all but one of the studies included in the analysis used an observational design, rather than a randomized trial design, and because of other methodological limitations of the analysis. We believe the MINT pilot raises the hypothesis that patients with acute coronary syndrome with hemoglobin level b10 g/dL might benefit from liberal transfusion to maintain the hemoglobin N10 g/dL. Approximately 25% of patients with acute coronary syndrome have hemoglobin b10 g/dL. An adequately powered clinical trial is essential to provide the evidence needed to establish the optimal transfusion threshold in patients with acute coronary syndrome.

This review provides a summary of the clinical trials evaluating transfusion thresholds and recommendations for red blood cell transfusion. We highlight the trial results in patients in the critical care setting, undergoing surgery, and patients with gastrointestinal bleed, acute coronary syndrome, and acute brain injury.Clinical trials in hip fracture patients with underlying cardiovascular disease or risk factors, and in cardiac surgery, support the findings from prior studies in intensive care unit patients that restrictive transfusion (7-8 g/dl) is well tolerated even in elderly high-risk patients. Restrictive transfusion strategy (7 g/dl) was further supported by the statistically lower mortality in patients with gastrointestinal bleeding compared with liberal transfusion (10 g/dl) strategy. Pilot trials in acute coronary syndrome raise the possibility that liberal transfusion improves outcome, but large trials are needed.A restrictive transfusion strategy of administering red blood cell transfusion in patients with hemoglobin concentration of 7-8 g/dl in most patients is supported by randomized clinical trials. Further randomized clinical trials are needed to establish the optimal transfusion threshold in patients with acute coronary syndrome and brain injury, and to elucidate physiological triggers.

Background Previous studies suggest that most patients with pulmonary embolism die of their underlying diseases and pulmonary embolism is itself responsible for a minority of deaths. It has not been determined whether pulmonary embolism is associated with increased mortality among patients with different specific diseases. Methods We assessed the mortality in 1, 487 patients who had lung scans to pursue the diagnosis of pulmonary embolism. An outcome classification committee prospectively reviewed deaths occurring up to 1 year after each patient's entry into the study. Results Ninety-five (23.8%) patients with pulmonary embolism and 189 (18.9%) without pulmonary embolism died within 1 year of study entry (estimated relative risk, 1.34; 95% confidence interval, 1.01 to 1.79). Mortality according to pulmonary embolism status was different among patients with COPD from mortality among patients who did not have COPD (interaction p=0.03). Of 45 patients with COPD and pulmonary embolism, 24 (53.3%; 95% confidence interval, 38.8 to 67.9%) died within 1 year. After adjustment for patient characteristics, the estimated risk of dying within 1 year was 1.94 times (95% confidence interval, 1.17 to 3.24) for patients with COPD and pulmonary embolism compared with those without pulmonary embolism, and 1.14 (95% confidence interval, 0.85 to 1.54) for patients without COPD (interaction p=0.08). Conclusions Patients with COPD and pulmonary embolism have an increased 1-year mortality. Further study is needed to clarify the reason(s) for the increase in mortality.

Guidelines have been offered on haemoglobin thresholds for blood transfusion in surgical patients. However, good evidence is lacking on the haemoglobin concentrations at which the risk of death or serious morbidity begins to rise and at which transfusion is indicated.A retrospective cohort study was performed in 1958 patients, 18 years and older, who underwent surgery and declined blood transfusion for religious reasons. The primary outcome was 30-day mortality and the secondary outcome was 30-day mortality or in-hospital 30-day morbidity. Cardiovascular disease was defined as a history of angina, myocardial infarction, congestive heart failure, or peripheral vascular disease.The 30-day mortality was 3.2% (95% CI 2.4-4.0). The mortality was 1.3% (0.8-2.0) in patients with preoperative haemoglobin 12 g/dL or greater and 33.3% (18.6-51.0) in patients with preoperative haemoglobin less than 6 g/dL. The increase in risk of death associated with low preoperative haemoglobin was more pronounced in patients with cardiovascular disease than in patients without (interaction p0.03). The effect of blood loss on mortality was larger in patients with low preoperative haemoglobin than in those with a higher preoperative haemoglobin (interaction p0.001). The results were similar in analyses of postoperative haemoglobin and 30-day mortality or in-hospital morbidity.A low preoperative haemoglobin or a substantial operative blood loss increases the risk of death or serious morbidity more in patients with cardiovascular disease than in those without. Decisions about transfusion should take account of cardiovascular status and operative blood loss as well as the haemoglobin concentration.

The nonsteroidal anti-inflammatory drugs (NSAIDs) are the most frequently used medications worldwide for the treatment of a variety of common chronic and acute inflammatory conditions. The association between NSAIDs and liver disease is poorly documented, the exceptions being sulindac and, to a lesser degree, diclofenac. The incidence of liver disease is very low and is relatively unimportant compared with the risk of peptic ulcer disease and gastrointestinal bleeding. Reports of hepatic injury range from insignificant and transient liver enzyme elevation to severe and fulminant hepatitis.

Blood transfusion is an essential treatment for patients suffering blood loss associated with trauma and surgery. This chapter discusses the goal and rationale for allogeneic red cell transfusion in surgical and traumatic hemorrhage in a hospital setting. A large number of patients have now been enrolled in clinical trials. This experience provides high quality evidence to inform the transfusion decision. A restrictive transfusion has been established to be safe in adult and pediatric patients in many clinical settings. The criteria used for making the decision to transfuse and current clinical practice guidelines and evidence-based recommendations are provided.

OBJECTIVE To assess whether there is a population of physicians who have consistently poor malpractice claims experiences over time. DESIGN Retrospective cohort study. POPULATION 12,730 physicians insured in New Jersey from 1977 to 1991. MAIN OUTCOME MEASURES After adjusting for specialty, the physicians were grouped according to who had the highest, very high, and high rates of malpractice claims, approximating 1%, 5%, and 10% respectively, of the insured population. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated comparing the physicians in these high-risk categories with the other physicians. RESULTS Of the 55 physicians who had the highest malpractice claims rates during the first four years, two (3.6%) were in the highest group during the subsequent three years (OR 2.8; 95% CI 0.7 to 10.8), five (9.1%) were in the very high group (OR 2.0; 95% CI 0.7 to 5.3), and 11 (20%) were in the high group (OR 2.3; 95% CI 1.1 to 4.6). Of the 260 physicians in the very high group during the first four years, 11 (4.2%) were in the highest group during the subsequent three years (OR 3.6; 95% CI 1.8 to 6.4), 26 (10.0%) were in the very high group (OR 2.3; 95% CI 1.5 to 3.6), and 46 (17.7%) were in the high group (OR 2.0; 95% CI 1.4 to 2.8). Of the 947 physicians in the high group during the first four years, 24 (2.5%) were in the highest group during the subsequent three years (OR 2.3; 95% CI 1.4 to 3.7), 62 (6.6%) were in the very high group (OR 1.5; 95% CI 1.1 to 1.9), and 118 (12.5%) were in the high group (OR 1.3; 95% CI 1.1 to 1.6). Similar results were found when using awards as the outcome. CONCLUSIONS Most physicians who have high malpractice rates during their first four years improve over time. Physicians who have high rates of malpractice during one period should not be subjected to disciplinary action. However, carefully evaluating physicians who consistently have high rates of malpractice during two periods may represent an effective strategy for identifying problem physicians.

Importance More than 100 million units of blood are collected worldwide each year, yet the indication for red blood cell (RBC) transfusion and the optimal length of RBC storage prior to transfusion are uncertain. Objective To provide recommendations for the target hemoglobin level for RBC transfusion among hospitalized adult patients who are hemodynamically stable and the length of time RBCs should be stored prior to transfusion. Evidence Review Reference librarians conducted a literature search for randomized clinical trials (RCTs) evaluating hemoglobin thresholds for RBC transfusion (1950-May 2016) and RBC storage duration (1948-May 2016) without language restrictions. The results were summarized using the Grading of Recommendations Assessment, Development and Evaluation method. For RBC transfusion thresholds, 31 RCTs included 12 587 participants and compared restrictive thresholds (transfusion not indicated until the hemoglobin level is 7-8 g/dL) with liberal thresholds (transfusion not indicated until the hemoglobin level is 9-10 g/dL). The summary estimates across trials demonstrated that restrictive RBC transfusion thresholds were not associated with higher rates of adverse clinical outcomes, including 30-day mortality, myocardial infarction, cerebrovascular accident, rebleeding, pneumonia, or thromboembolism. For RBC storage duration, 13 RCTs included 5515 participants randomly allocated to receive fresher blood or standard-issue blood. These RCTs demonstrated that fresher blood did not improve clinical outcomes. Findings It is good practice to consider the hemoglobin level, the overall clinical context, patient preferences, and alternative therapies when making transfusion decisions regarding an individual patient. Recommendation 1: a restrictive RBC transfusion threshold in which the transfusion is not indicated until the hemoglobin level is 7 g/dL is recommended for hospitalized adult patients who are hemodynamically stable, including critically ill patients, rather than when the hemoglobin level is 10 g/dL (strong recommendation, moderate quality evidence). A restrictive RBC transfusion threshold of 8 g/dL is recommended for patients undergoing orthopedic surgery, cardiac surgery, and those with preexisting cardiovascular disease (strong recommendation, moderate quality evidence). The restrictive transfusion threshold of 7 g/dL is likely comparable with 8 g/dL, but RCT evidence is not available for all patient categories. These recommendations do not apply to patients with acute coronary syndrome, severe thrombocytopenia (patients treated for hematological or oncological reasons who are at risk of bleeding), and chronic transfusion–dependent anemia (not recommended due to insufficient evidence). Recommendation 2: patients, including neonates, should receive RBC units selected at any point within their licensed dating period (standard issue) rather than limiting patients to transfusion of only fresh (storage length: Conclusions and Relevance Research in RBC transfusion medicine has significantly advanced the science in recent years and provides high-quality evidence to inform guidelines. A restrictive transfusion threshold is safe in most clinical settings and the current blood banking practices of using standard-issue blood should be continued.

BACKGROUND : Cimetidine is perceived as sufficiently safe that it is being considered for over-the-counter use. However, because of residual concerns about cimetidine-induced neutropenia, a study was conducted to evaluate this association. METHODS : A population-based, case-control study was undertaken using a large database with Medicaid data from six states. Cases were defined as patients hospitalized with a discharge diagnosis of neutropenia. Medical records were sought to validate the diagnoses of neutropenia and to characterize the severity of disease. Four controls were randomly selected for each case, matched for age, sex, state, and year of diagnosis. The frequency of exposures to cimetidine in the 30 days prior to hospital admission in the cases was compared to that in the identical time periods in the controls. RESULTS : When investigators simultaneously controlled for multiple, potentially confounding variables by using conditional logistic regression, the odds ratio associated with the use of cimetidine was 1.2 (P = 0.33), with a one-sided upper 95% confidence limit of 2.6 for all patients over 20 years of age, and 0.6 (P = 0.30) with a one-sided upper 95% confidence limit of 3.1 for validated cases over 12 years of age. Neither a dose-response relationship nor a duration-response relationship was evident (P = 0.899 and P = 0.716, respectively, when excluding the nonusers, or P = 0.245 and P = 0.215, respectively, when including the nonusers). From these data, one can exclude the occurrence of hospitalization with neutropenia or agranulocytosis due to cimetidine occurring more often than once in every 116,000 patients and once in every 573,000 patients receiving a 6-week course of the drug, respectively. CONCLUSION : If there is an association between cimetidine and neutropenia, it appears to be very small.

Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients. Patients with acute coronary syndrome may benefit from higher hemoglobin levels.We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin10 g/dL. Patients in the liberal transfusion strategy received one or more units of blood to raise the hemoglobin level ≥10 g/dL. Patients in the restrictive transfusion strategy were permitted to receive blood for symptoms from anemia or for a hemoglobin8 g/dL. The predefined primary outcome was the composite of death, myocardial infarction, or unscheduled revascularization 30 days post randomization.Baseline characteristics were similar between groups except age (liberal, 67.3; restrictive, 74.3). The mean number of units transfused was 1.6 in the liberal group and 0.6 in the restrictive group. The primary outcome occurred in 6 patients (10.9%) in the liberal group and 14 (25.5%) in the restrictive group (risk difference = 15.0%; 95% confidence interval of difference 0.7% to 29.3%; P = .054 and adjusted for age P = .076). Death at 30 days was less frequent in liberal group (n = 1, 1.8%) compared to restrictive group (n = 7, 13.0%; P = .032).The liberal transfusion strategy was associated with a trend for fewer major cardiac events and deaths than a more restrictive strategy. These results support the feasibility of and the need for a definitive trial.

Background Payments for red blood cell (RBC) transfusions are separate from US Medicare bundled payments for dialysis-related services and medications. Our objective was to examine the economic burden for payers when chronic dialysis patients receive outpatient RBC transfusions. Methods Using Truven Health MarketScan® data (1/1/02-10/31/10) in this retrospective micro-costing economic analysis, we analyzed data from chronic dialysis patients who underwent at least 1 outpatient RBC transfusion who had at least 6 months of continuous enrollment prior to initial dialysis claim and at least 30 days post-transfusion follow-up. A conceptual model of transfusion-associated resource use based on current literature was employed to estimate outpatient RBC transfusion payments. Total payments per RBC transfusion episode included screening/monitoring (within 3 days), blood acquisition/administration (within 2 days), and associated complications (within 3 days for acute events; up to 45 days for chronic events). Results A total of 3283 patient transfusion episodes were included; 56.4% were men and 40.9% had Medicare supplemental insurance. Mean (standard deviation [SD]) age was 60.9 (15.0) years, and mean Charlson comorbidity index was 4.3 (2.5). During a mean (SD) follow-up of 495 (474) days, patients had a mean of 2.2 (3.8) outpatient RBC transfusion episodes. Mean/median (SD) total payment per RBC transfusion episode was $854/$427 ($2,060) with 72.1% attributable to blood acquisition and administration payments. Complication payments ranged from mean (SD) $213 ($168) for delayed hemolytic transfusion reaction to $19,466 ($15,424) for congestive heart failure. Conclusions Payments for outpatient RBC transfusion episodes were driven by blood acquisition and administration payments. While infrequent, transfusion complications increased payments substantially when they occurred.

Description: Although approximately 85 million units of red blood cells (RBCs) are transfused annually worldwide, transfusion practices vary widely. The AABB (formerly, the American Association of Blood Banks) developed this guideline to provide clinical recommendations about hemoglobin concentration thresholds and other clinical variables that trigger RBC transfusions in hemodynamically stable adults and children. Methods: These guidelines are based on a systematic review of randomized clinical trials evaluating transfusion thresholds. We performed a literature search from 1950 to February 2011 with no language restrictions. We examined the proportion of patients who received any RBC transfusion and the number of RBC units transfused to describe the effect of restrictive transfusion strategies on RBC use. To determine the clinical consequences of restrictive transfusion strategies, we examined overall mortality, nonfatal myocardial infarction, cardiac events, pulmonary edema, stroke, thromboembolism, renal failure, infection, hemorrhage, mental confusion, functional recovery, and length of hospital stay. Recommendation 1: The AABB recommends adhering to a restrictive transfusion strategy (7 to 8 g/dL) in hospitalized, stable patients (Grade: strong recommendation; high-quality evidence). Recommendation 2: The AABB suggests adhering to a restrictive strategy in hospitalized patients with preexisting cardiovascular disease and considering transfusion for patients with symptoms or a hemoglobin level of 8 g/dL or less (Grade: weak recommendation; moderate-quality evidence). Recommendation 3: The AABB cannot recommend for or against a liberal or restrictive transfusion threshold for hospitalized, hemodynamically stable patients with the acute coronary syndrome (Grade: uncertain recommendation; very low-quality evidence). Recommendation 4: The AABB suggests that transfusion decisions be influenced by symptoms as well as hemoglobin concentration (Grade: weak recommendation; low-quality evidence).

Comparative effectiveness research (CER) is the study of existing treatments or ways to deliver health care to determine what intervention works best under specific circumstances. CER evaluates evidence from existing studies or generates new evidence, in different populations and under specific conditions in which the treatments are actually used. CER does not embrace one research design over another but compares treatments and variations in practice using methods that are most likely to yield widely generalizable results that are directly relevant to clinical practice. Treatments used in transfusion medicine (TM) are among the most widely used in clinical practice, but are among the least well studied. High-quality evidence is lacking for most transfusion practices, with research efforts hampered by regulatory restrictions and ethical barriers. To begin addressing these issues, the National Heart, Lung, and Blood Institute convened a workshop in June 2011 to address the potential role of CER in the generation of high-quality evidence for TM decision making. Workshop goals were to: 1) evaluate the current landscape of clinical research, 2) review the potential application of CER methods to clinical research, 3) assess potential barriers to the use of CER methodology, 4) determine whether pilot or vanguard studies can be used to facilitate planning of future CER research, and 5) consider the need for and delivery of training in CER methods for researchers.

Physician specialty has been consistently associated with different malpractice claim rates, with neurosurgery, orthopedics, and obstetrics and gynecology having the highest rates. Whether these differences reflect physician performance or other aspects of patient care that are unique for each specialty is unclear. A retrospective cohort study was performed including 12,829 physicians involved in 8,221 closed cases from 1977 to 1991. For each case an assessment was made whether the plaintiff received an award and whether the physician care of the patient was indefensible. An award was made to the plaintiff in 42% of cases. Physician care was considered indefensible in 23% of the cases. The specialties with the highest award rates were anesthesiology (58.3%), obstetrics and gynecology (47.5%), and radiology (43.0%). Neurosurgery had the lowest rate of award (30.2%). The specialties with the highest indefensibility rates were radiology (36%), obstetrics and gynecology (27%), and anesthesiology (27%). Neurosurgery had the lowest indefensibility rate (10%). These results were unchanged after controlling for physician age, degree, site of training, certification status, and severity of patient injury. In conclusion, differences in award rate and indefensibility are present, but not large enough to explain the large variation in specialty claim rates. This suggests that the variation in malpractice rates results from factors other than a meaningful difference in physician performance.

We performed a case-control study with the aims of documenting the ability of Medicaid data to be used to study acute liver disease, to determine the incidence rate of idiopathic liver disease resulting in hospitalization, and to evaluate the relationship between nonsteroidal anti-inflammatory drugs and acute liver disease. We reviewed the medical records of 408 Medicaid patients age 20 or older with an ICD-9-CM inpatient billing code consistent with acute hepatitis. We calculated the incidence rate of acute hepatitis resulting in hospitalization. After excluding patients with other forms of liver disease or in whom a diagnosis could not be confirmed, 107 cases were eligible for the case-control analysis. The annual incidence rate (95 per cent confidence interval) of acute idiopathic symptomatic hepatitis resulting in hospitalization was 2.2 (2.0–2.4) per 100,000 per year. Nine cases (8.4 per cent) and 26 controls (6.1 per cent) were exposed to nonsteroidal anti-inflammatory drugs, yielding an odds ratio of 1.4 (0.6–3.1). After adjustment for potential confounding variables, the odds ratio was 1.2 (0.5–2.8). We conclude that Medicaid billing data has high reliability and validity for the diagnosis of acute liver disease. However, primary medical records are essential for the study of drug-induced hepatitis. Acute symptomatic idiopathic liver disease severe enough to result in hospitalization is uncommon, and no association was evident between nonsteroidal anti-inflammatory drugs and acute hepatitis.

Objectives: To evaluate the incidence of postoperative sepsis after elective procedures, to define surgical procedures with the greatest risk for developing sepsis, and to evaluate patient and hospital confounders. Background Data: The development of sepsis after elective surgical procedures imposes a significant clinical and resource utilization burden in the United States. We evaluated the development of sepsis after elective procedures in a nationally representative patient cohort and assessed the effect of sociodemographic and hospital characteristics on the development of postoperative sepsis. Methods: The Nationwide inpatient sample was queried between 2002 and 2006 and patients developing sepsis after elective procedures were identified using the patient safety indicator “Postoperative Sepsis” (PSI-13). Case-mixadjusted rates were calculated by using a multivariate logistic regression model for sepsis risk and an indirect standardization method. Results: A total of 6,512,921 weighted elective surgical cases met the inclusion criteria and 78,669 cases (1.21%) developed postoperative sepsis. Case-mix adjustment for age, race, gender, hospital bed size, hospital location, hospital teaching status, AHRQ comorbidities, and patient income demonstrated esophageal, pancreatic, and gastric procedures represented the greatest risk for the development of postoperative sepsis. Thoracic, adrenal, and hepatic operations accounted for the greatest mortality rates if sepsis developed. Increasing age, Blacks, Hispanics, and men were more likely to develop sepsis. Decreased median household income, larger hospital bed size, urban hospital location, and nonteaching status were associated with greater rates of postoperative sepsis. Conclusions: The development of postoperative sepsis is multifactorial and procedures most likely to develop sepsis did not demonstrate the greatest mortality after sepsis developed. Factors associated with the development of sepsis included race, age, hospital size, hospital location, and patient income. Further evaluation of high-risk procedures, populations, and environments may assist in reducing this costly complication.

Objectives Catheter-based revascularization has emerged as an alternative to surgical bypass for the tibioperoneal vessels. The purpose of this analysis was to describe the outcomes of tibial angioplasty interventions for critical limb ischemia (CLI) in the hospitalized Medicare population, to examine in-hospital complications, to define the 30-day readmission and mortality rates, and to assess secondary procedures performed in this population. Methods In-patients with CLI undergoing tibioperoneal angioplasty were identified using The Centers for Medicare & Medicaid Services in-patient claims for 2005 to 2007. In-hospital complications, mortality, 30-day secondary procedures, and 30-day rehospitalization after discharge were described. Results A total of 13,258 in-patients underwent tibioperoneal angioplasty (54.2% men; 75.7% white, 17.1% African American; 42.8% gangrene, 46.7% rest pain, 10.5% claudication) and 29.3% had a stent, 47.3% had femoral-popliteal angioplasty, and 20.1% had atherectomy during their initial procedure. Initial hospital complications included renal complications (8.1%), respiratory complications and pneumonia (5.1%), and cardiac complications with acute myocardial infarction (3.2%). Mortality in-hospital was 2.8% and at 30 days was 6.7%. Thirty-day rehospitalization rate was 29.6%. Thirty-day reinterventions included repeat angiogram (8.5%), repeat tibioperoneal angioplasty (3.2%), open bypass (2.1%), and lower extremity amputations (23.8%). Gangrene was the most frequent diagnosis at rehospitalization (13.5%). Patients with gangrene as an indication for tibioperoneal angioplasty were 1.8 times (95% confidence interval [CI], 1.56-2.10) as likely as patients with rest pain to be rehospitalized during 30 days after discharge. Among comorbidities, predictors of 30-day rehospitalization included chronic renal failure (odds ratio [OR], 1.4; 95% CI, 1.27-1.52), chronic pulmonary disease (OR, 1.1; 95% CI, 1.01-1.25), and congestive heart failure (CHF; OR, 1.1; 95% CI, 1.01-1.22). About one-quarter of patients (23.8%) within 30 days after their initial procedure underwent amputation at any level of the lower limb. Conclusion Tibioperoneal angioplasty is associated with frequent in-hospital complications, an overall 30-day amputation rate of 23.8% for all procedures and indications, and a 30-day rehospitalization rate of almost 30%. Further detailed analysis of tibioperoneal intervention is essential to define best treatment strategies and to minimize complications and readmission rates.

To determine the feasibility of the use of Medicaid data to study drug-induced acute liver disease, we reviewed the medical records of 414 patients receiving Medicaid, age 20 or older, with an ICD-9-CM inpatient billing code consistent with acute hepatitis. Of the patients whose records were reviewed, 15.9% were alcoholics, 31.9% had acute hepatitis A or B, 13.5% were intravenous drug users, 8.2% had acute cholecystitis or choledocholithiasis, and 4.1% had received a blood transfusion within the previous 6 months. No diagnosis of liver disease was found in 10.6% of the patients, and 5.7% had chronic liver disease. Of the 169 patients with idiopathic acute liver disease identified, many had very mild liver disease and were hospitalized for reasons other than liver disease. We conclude that Medicaid billing data has high reliability and validity for the diagnosis of acute liver disease. However, primary medical records are essential for the study of drug-induced hepatitis, to be able to exclude other causes of liver disease, and to obtain information not included in the computer data.

Pulmonary embolism is a potentially fatal disorder. Information about the outcome of clinically recognized pulmonary embolism is sparse, particularly given that new treatments for more seriously ill patients are now available.We prospectively followed 399 patients with pulmonary embolism diagnosed by lung scanning and pulmonary angiography, who were enrolled in a multicenter diagnostic trial. We reviewed all hospitalizations, all new investigations of pulmonary embolism, and all deaths among the patients within one year of diagnosis.Of the 399 patients, 375 (94 percent) received treatment for pulmonary embolism, usually conventional anticoagulation. Only 10 patients (2.5 percent) died of pulmonary embolism; 9 of them had clinically suspected recurrent pulmonary embolism. Clinically apparent pulmonary embolism recurred in 33 patients (8.3 percent), of whom 45 percent died during follow-up. Ninety-five patients with pulmonary embolism (23.8 percent) died within one year. The conditions associated with these deaths were cancer (relative risk, 3.8; 95 percent confidence interval, 2.3 to 6.4), left-sided congestive heart failure (relative risk, 2.7; 95 percent confidence interval, 1.5 to 4.6), and chronic lung disease (relative risk, 2.2; 95 percent confidence interval, 1.2 to 4.0). The most frequent causes of death in patients with pulmonary embolism were cancer (in 34.7 percent), infection (22.1 percent), and cardiac disease (16.8 percent).When properly diagnosed and treated, clinically apparent pulmonary embolism was an uncommon cause of death, and it recurred in only a small minority of patients. Most deaths were due to underlying diseases. Patients with pulmonary embolism who had cancer, congestive heart failure, or chronic lung disease had a higher risk of dying within one year than did other patients with pulmonary embolism.

purpose: The acquired immunodeficiency syndrome epidemic has greatly increased concern about the risk of blood transfusion. Many transfusions are now autologous, and when these are not available, both physicians and patients are more likely to question the advisability of transfusion. We evaluate the risk of preoperative blood transfusion and the contribution of human immunodeficiency virus (HIV) infection to that risk. methods: We used decision analysis to characterize the risk associated with HIV infection in days of life lost. The contributions to risk of acute transfusion reaction, hepatitis B, and nonA, non-B hepatitis are also estimated. Sensitivity analyses show the implications for transfusion risk of recent information about HIV infection in the blood supply and a new test for hepatitis C. results: The analysis shows that the contribution of HIV infection to the risk of death from transfusion, expressed in days of life expectancy lost, has become extremely small over the last several years. Currently, HIV infection accounts for less than 1% of the risk of death, while nonA, non-B hepatitis accounts for 97% to 98%. Further reductions in the risk of HIV infection, even to zero, will make relatively little difference in the safety of transfusion. The analysis also shows that the remaining risk from transfusion should decrease sharply, by more than two thirds, with the adoption of the test for hepatitis C. conclusions: Efforts to improve the safety of blood should focus on reducing the risk of non-A, non-B hepatitis. The remaining risk of HIV infection is very small.

Anemia is commonly encountered in the preoperative patient. With variable etiology, determination of the cause of the anemia can impact perioperative surgical and medical management and outcome. Red blood cell transfusions are often administered during the perioperative time period in patients with preoperative anemia, although evidence to support the optimal transfusion threshold is limited. We review the evaluation of anemia, as well as evidence regarding perioperative blood transfusions. Recommendations on the treatment of anemia, including perioperative blood transfusions, are outlined.

ObjectiveThis study was conducted to evaluate and compare the rates of postoperative infectious complications and death after elective vascular surgery, define vascular procedures with the greatest risk of developing nosocomial infections, and assess the effect of infection on health care resource utilization.MethodsThe Nationwide Inpatient Sample (2002-2006) was used to identify major vascular procedures by International Classification of Diseases, 9th Clinical Modification (ICD-9-CM) codes. Infectious complications identified included pneumonia, urinary tract infections (UTI), postoperative sepsis, and surgical site infections (SSI). Case-mix-adjusted rates were calculated using a multivariate logistic regression model for infectious complication or death as an outcome and indirect standardization.ResultsA total of 870,778 elective vascular surgical procedures were estimated and evaluated with an overall postoperative infection rate of 3.70%. Open abdominal aortic surgery had the greatest rate of postoperative infections, followed by open thoracic procedures and aorta-iliac-femoral bypass. Thoracic endovascular aneurysm repair (TEVAR) infectious complication rates were two times greater than after EVAR (P < .0001). Pneumonia was the most common infectious complication after open aortic surgery (6.63%). UTI was the most common after TEVAR (2.86%) and EVAR (1.31%). Infectious complications were greater in octogenarians (P < .0002), women (P < .0001), and blacks (P < .0001 vs whites and Hispanics). Nosocomial infections after elective vascular surgery significantly increased hospital length of stay (13.8 ± 15.4 vs 3.5 ± 4.2 days; P < .001) and reported total hospital cost ($37,834 ± $42,905 vs $11,851 ± $11,816; P < .001).ConclusionsElective vascular surgical procedures vary widely in the estimated risk of postoperative infection. Open aortic surgery and endarterectomy of the head and neck vessels have, respectively, the greatest and the lowest reported incidence for postoperative infectious complications. Women, octogenarians, and blacks have the highest risk of infectious complications after elective vascular surgery. Disparities in the development of infectious complications on a systems level were also found in larger hospitals and teaching hospitals. Hospital infectious complications were found to significantly increase health care resource utilization. Strategies that reduce nosocomial complications and target high-risk procedures may offer significant future cost savings.

BACKGROUND: Mortality increases as hemoglobin (Hb) levels fall. Among severely anemic patients, the clinical course, cause of death, and whether there are any warning signs before death are unknown. STUDY DESIGN AND METHODS: A retrospective cohort study was performed of surgical patients who refused red blood cell transfusions for religious reasons and died with a Hb concentration 6 g/dL or less. Mortality was defined as death that occurred during hospitalization. RESULTS: Among the 1958 Jehovah's Witness patients that had surgery, 117 (5.6%) had a postoperative Hb level of 6 g/dL or less and 39 (33.3%) of these individuals died in the hospital. The median number of days from surgery to the lowest Hb level was 3 days (range, 0-22 days; interquartile range, 1-8 days) and from the lowest postoperative Hb level to death was 2 days (range, 0-40 days; interquartile range, 1-12 days). Individuals with a Hb level of 2.0 g/dL or less had on median 1.0 (interquartile range, 0.5-1.5) day from their lowest Hb to death while individuals with their lowest Hb ranging between 4.1 and 5.0 g/dL had on median 11 (interquartile range, 1-23) days from their lowest Hb to death. Except for anemia, no single etiology of death was predominant. CONCLUSIONS: While there does not appear to be any single etiology that can be predictive or preventative of mortality for anemic patients, individuals with very low Hb concentrations often do not die quickly. Thus, there appears to be a potential time window where transfusion medicine physicians may intervene.

Objective:To study the design, method of implementation, perceived benefits, and problems associated with a night float system. Design:Self-administered questionnaire completed by program directors, which included both structured and open-ended questions. The answers reflect resident and student opinions as well as those of the program directors, since program directors regularly obtain feedback from these groups. Setting/participants:The 442 accredited internal medicine residency programs listed in the 1988–89 Directory of Graduate Medical Education Programs. Results:Of the 442 programs, 79% responded, and 30% had experience with a night float system. The most frequent methods for initiating a night float system included: decreasing elective time (42.3%), hiring more residents (26.9%), creating a non-teaching service (12.5%), and reallocating housestaff time (9.6%). Positive effects cited include decreased fatigue, improved housestaff morale, improved recruiting, and better attitude toward internal medicine training. The quality of medical care was considered the same or better by most programs using it. The most commonly cited problems were decreased continuity of care, inadequate teaching of the night float team, and miscommunication. Conclusion:Residency programs using a night float system usually observe a positive effect on housestaff morale, recruitment, and working hours and no detrimental effect on the quality of patient care. Miscommunication and inadequate learning experience for the night float team are important potential problems. This survey suggests that the night float represents one solution to reducing resident working hours.

In order to explore a priori hypotheses about drug-induced Stevens-Johnson Syndrome (SJS), a case-control study was initiated using data from COMPASS, a computerized data base consisting of Medicaid claims data. The records of 3.8 million patients in five U.S. states were searched to identify patients with an inpatient diagnosis of ICD-9-CM code 695.1 (erythema multiforme-EM). Out of the total of 367 cases that were identified, primary medical records for 249 were sought and 128 (51.4 per cent) of these were obtained. The remainder could not be obtained because: in 36 (29.8 per cent) the hospital refused to provide medical records; in 33 (27.3 per cent) there were transcription errors; in 20 (16.5 per cent) the state could not translate the identification number, primarily because the patients lost Medicaid eligibility too long before our request; in 27 (22.3 per cent) the hospital could not locate the patient's record; and in 5 (4.1 per cent) there were other reasons. Of those with a medical record, 121 (94.5 per cent) had a skin diagnosis and 109 (85.2 per cent) had a diagnosis compatible with ICD-9-CM code 695.1 specified on their discharge summary. However, in 35 (27.3 per cent) an expert reviewer felt that the discharge diagnosis was incorrect. In 50 (39 per cent) the computer diagnosis was incorrect. Only 19 (14.8 per cent) were judged by the expert reviewer to truly have Stevens-Johnson Syndrome, and an additional 37 (28.9 per cent) were judged to have erythema multiforme minor. Thus, the computerized diagnosis agreed very well with the diagnoses specified on the discharge summary. However, EM is frequently misdiagnosed, ICD-9-CM code 695.1 contains multiple other diagnoses which are not EM, and much of hospitalized EM is EM minor. Thus, studies of SJS cannot be performed except in patients whose medical records are available.

Anemia is characterized by less than the normal number of red blood cells (RBCs) (as a result of underproduction, increased loss, or destruction) or decreased quantity of hemoglobin (Hgb) in the blood, thereby reducing the blood's oxygen-carrying capacity.