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BACKGROUND: Hip fractures are associated with a high rate of morbidity and mortality, and successful ambulation after surgery is an important outcome in this patient population. OBJECTIVE: This study aims to determine whether 25-hydroxyvitamin D [25(OH)D] concentration or the Geriatric Nutritional Risk Index (GNRI) is associated with mortality or rates of walking in a patient cohort after hip fracture surgery. METHODS: Patients undergoing hip fracture repair from a multisite study in North America were included. Mortality and mobility were assessed at 30 and 60 d after surgery. Serum albumin, 25(OH)D, and intact parathyroid hormone were measured. Patients were characterized according to 25(OH)D

The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied.We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days.A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P = 0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30).Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia. (Funded by the Patient-Centered Outcomes Research Institute; REGAIN ClinicalTrials.gov number, NCT02507505.).

BACKGROUND Plasma is frequently administered to patients with prolonged INR prior to invasive procedures. However, there is limited evidence evaluating efficacy and safety. STUDY DESIGN AND METHODS We performed a pilot trial in hospitalized patients with INR between 1.5 and 2.5 undergoing procedures conducted outside the operating room. We excluded patients undergoing procedures proximal to the central nervous system, platelet counts

Rationale: Continuous positive airway pressure (CPAP) adherence is often poor in obstructive sleep apnea (OSA) and may be influenced by nasal resistance. CPAP with a reduction of expiratory pressure (CPAPflex) may reduce discomfort in those with high nasal resistance and improve adherence in this subgroup. Objectives: To evaluate the association of positive airway pressure (PAP) treatment adherence to nasal resistance and examine if CPAPflex improves adherence over CPAP in subjects with high nasal resistance. Methods: A randomized double-blind crossover trial of 4 weeks each of CPAPflex versus CPAP in subjects exposed to World Trade Center dust with OSA stratified by nasal resistance, measured by 4-Phase Rhinomanometry. Results: Three hundred seventeen subjects with OSA (mean, apnea–hypopnea index with 4% O(2) desaturation for hypopnea = 17 ± 14/h) were randomized. Overall, PAP adherence was poor, but adherence to CPAP (n = 239; mean hours per night [95% confidence interval (CI)]), 1.97 h (1.68 to 2.26) was greater than adherence to CPAPflex (n = 249; 1.65 h [1.39 to 1.91]; difference of 0.31 h [0.03; 0.6]; P

OBJECTIVES: To present the consensus recommendations and supporting literature for RBC transfusions in general critically ill children from the Pediatric Critical Care Transfusion and Anemia Expertise Initiative.DESIGN: Consensus conference series of international, multidisciplinary experts in RBC transfusion management of critically ill children.METHODS: The panel of 38 experts developed evidence-based and, when evidence was lacking, expert-based recommendations and research priorities regarding RBC transfusions in critically ill children. The subgroup on RBC transfusion in general critically ill children included six experts. Electronic searches were conducted using PubMed, EMBASE, and Cochrane Library databases from 1980 to May 30, 2017, using a combination of keywords to define concepts of RBC transfusion and critically ill children. Recommendation consensus was obtained using the Research and Development/UCLA Appropriateness Method. The results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method.RESULTS: Three adjudicators reviewed 4,399 abstracts; 71 papers were read, and 17 were retained. Three papers were added manually. The general Transfusion and Anemia Expertise Initiative subgroup developed, and all Transfusion and Anemia Expertise Initiative members voted on two good practice statements, six recommendations, and 11 research questions; in all instances, agreement was reached (> 80%). The good practice statements suggest a framework for RBC transfusion in PICU patients. The good practice statements and recommendations focus on hemoglobin as a threshold and/or target. The research questions focus on hemoglobin and physiologic thresholds for RBC transfusion, alternatives, and risk/benefit ratio of transfusion.CONCLUSIONS: Transfusion and Anemia Expertise Initiative developed pediatric-specific good practice statements and recommendations regarding RBC transfusion management in the general PICU population, as well as recommendations to guide future research priorities. Clinical recommendations emphasized relevant hemoglobin thresholds, and research recommendations emphasized a need for further understanding of physiologic thresholds, alternatives to RBC transfusion, and hemoglobin thresholds in populations with limited pediatric literature.

OBJECTIVE: To determine if adjusted mortality, walking ability or return home differed after hip fracture surgery between Canada and the USA. DESIGN: Secondary analysis of the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) trial data. SETTING: Data were collected from 47 American and Canadian hospitals. PARTICIPANTS: Overall, 2016 subjects with a hip fracture (USA = 1222 (60.6%); Canada = 794 (39.4%)) were randomized to a liberal or restrictive transfusion strategy. Subjects were 50 years and older, with cardiovascular disease and/or risk factors and hemoglobin

OBJECTIVES: Hip fractures are associated with a high rate of morbidity and mortality, and successful ambulation after surgery is an important outcome in this patient population. This study aims to determine whether 25-hydroxyvitamin D (25(OH)D) or the Geriatric Nutritional Risk Index (GNRI) is associated with short term mortality or ability to walk after hip fracture surgery. METHODS: Patients undergoing hip fracture repair were included in this study. Mortality and walking ability were assessed at 30 and 60 days after hip fracture surgery. Pre-operative serum albumin and 25(OH)D were measured. Patients were characterized with 25(OH)D

Background Patients with cancer or other diagnoses associated with chronic anemia often receive red blood cell (RBC) transfusion as outpatients, but the effect of transfusion on functional status is not well demonstrated. Study design and methods To estimate the effect of transfusion on functional status and quality of life, we measured 6-minute walk test distance and fatigue- and dyspnea-related quality-of-life scores before and 1 week after RBC transfusion in 208 outpatients age ≥50 with at least one benign or malignant hematology/oncology diagnosis. To account for potential confounding effects of cancer treatment, patients were classified into two groups based on cancer treatment within 4 weeks of the study transfusion. Minimum clinically important improvements over baseline were 20 meters in walk test distance, 3 points in fatigue score, and 2 points in dyspnea score. Results The median improvement in unadjusted walk test distance was 20 meters overall and 30 meters in patients not receiving recent cancer treatment. Fatigue scores improved overall by a median of 3 points and by 4 points in patients without cancer treatment. There was no clinically important change in dyspnea scores. In multiple linear regression analysis, patients who maintained hemoglobin (Hb) levels of 8 g/dL or greater at 1 week posttransfusion, who had not received recent cancer treatment, and who did not require hospitalization during the study showed clinically important increases in mean walk test distance. Conclusions Red blood cell transfusion is associated with a modest, but clinically important improvement in walk test distance and fatigue score outcomes in adult hematology/oncology outpatients.

Background:Randomized clinical trial findings support decreased red blood cell (RBC) transfusion and short-term tolerance of in-hospital anemia. However, long-term outcomes related to changes in transfusion practice have not been described. Objective:To describe the prevalence of anemia at and after hospital discharge and associated morbidity and mortality events. Design:Retrospective cohort study. Setting:Integrated health care delivery system with 21 hospitals serving 4 million members. Participants:445371 surviving adults who had 801261 hospitalizations between January 2010 and December 2014. Measurements:Hemoglobin levels and RBC transfusion, rehospitalization, and mortality events within 6 months of hospital discharge. Generalized estimating equations were used to examine trends over time, accounting for correlated observations and patient-level covariates. Results:From 2010 to 2014, the prevalence of moderate anemia (hemoglobin levels between 7 and 10 g/dL) at hospital discharge increased from 20% to 25% (P < 0.001) and RBC transfusion declined by 28% (39.8 to 28.5 RBC units per 1000 patients; P < 0.001). The proportion of patients whose moderate anemia had resolved within 6 months of hospital discharge decreased from 42% to 34% (P < 0.001), and RBC transfusion and rehospitalization within 6 months of hospital discharge decreased from 19% to 17% and 37% to 33%, respectively (P < 0.001 for both). During this period, the adjusted 6-month mortality rate decreased from 16.1% to 15.6% (P= 0.004) in patients with moderate anemia, in parallel with that of all others. Limitation:Possible unmeasured confounding. Conclusion:Anemia after hospitalization increased in parallel with decreased RBC transfusion. This increase was not accompanied by a rise in subsequent RBC use, rehospitalization, or mortality within 6 months of hospital discharge. Longitudinal analyses support the safety of practice recommendations to limit RBC transfusion and tolerate anemia during and after hospitalization. Primary Funding Source:National Heart, Lung, and Blood Institute.

Background Several new trials evaluating transfusion strategies in patients with cardiovascular disease have recently been published, increasing the number of enrolled patients by over 30%. The objective was to evaluate transfusion thresholds in patients with cardiovascular disease. Methods We conducted an updated systematic review of randomized trials that compared patients assigned to maintain a lower (restrictive transfusion strategy) or higher (liberal transfusion strategy) hemoglobin concentration. We focused on new trial data in patients with cardiovascular disease. The primary outcome was 30-day mortality. Specific subgroups were patients undergoing cardiac surgery and with acute myocardial infarction. Results A total of 37 trials that enrolled 19,049 patients were appraised. In cardiac surgery, mortality at 30 days was comparable between groups (risk ratio 0.99; 95% confidence interval 0.74-1.33). In 2 small trials (n = 154) in patients with myocardial infarction, the point estimate for the mortality risk ratio was 3.88 (95% CI, 0.83-18.13) favoring the liberal strategy. Overall, from 26 trials enrolling 15,681 patients, 30-day mortality was not different between restrictive and liberal transfusion strategies (risk ratio 1.0, 95% CI, 0.86-1.16). Overall and in the cardiovascular disease subgroup, there were no significant differences observed across a range of secondary outcomes. Conclusions New trials in patients undergoing cardiac surgery establish that a restrictive transfusion strategy of 7 to 8 g/dL is safe and decreased red cell use by 24%. Further research is needed to define the optimal transfusion threshold in patients with acute myocardial infarction.

Objectives To determine the stability of psychomotor subtypes of delirium over time and identify characteristics associated with delirium psychomotor subtypes in patients undergoing surgical repair of hip fracture.

Summary Background Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. Methods In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. Findings Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4–4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95–1·25]; p=0·21). Interpretation Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20–25% or cause of death. Funding National Heart, Lung, and Blood Institute.

One might not have anticipated that lower hematocrit level is associated with bleeding in patients with hypoproliferative thrombocytopenia as suggested in a secondary analysis by Uhl et al in this issue of Blood . 1 However, patients with hematocrit ≤25% were reported to have a fivefold higher risk of grade ≥3 bleeding (odds ratio [OR], 5.09; 95% confidence interval [CI], 2.65-9.79) and a 1.2-fold higher risk of grade ≥2 bleeding (OR, 1.20; 95% CI, 1.03-1.39) compared with patients with hematocrit ≥29%.

Substantial progress has been made in our understanding of the risks and benefits of RBC transfusion through the performance of large clinical trials. More than 7000 patients have been enrolled in trials randomly allocating patients to higher transfusion thresholds (∼9-10 g/dL), referred to as liberal transfusion, or lower transfusion thresholds (∼7-8 g/dL), referred to as restrictive transfusion. The results of most of the trials suggest that a restrictive transfusion strategy is safe and, in some cases, superior to a liberal transfusion strategy. However, in patients with myocardial infarction, brain injury, stroke, or hematological disorders, more large trials are needed because preliminary evidence suggests that liberal transfusion might be beneficial or trials have not been performed at all.

Background Blood conservation strategies have been shown to be effective in decreasing red blood cell (RBC) utilization in specific patient groups. However, few data exist describing the extent of RBC transfusion reduction or their impact on transfusion practice and mortality in a diverse inpatient population.

Anemia is extremely common following hip fracture. Consistent data from randomized trials show that transfusion of less blood, with a transfusion threshold around 8 g/dL hemoglobin concentration, is preferable to a traditional threshold of 10 g/dL. Adoption of a lower threshold leads to at least equivalent clinical outcomes, with much less exposure to transfusion costs and risks. The most common complication of transfusion is circulatory overload. Future research may elucidate the optimal transfusion threshold for these elderly patients and address the specific needs of subgroups of patients, including those with acute coronary syndrome or chronic kidney disease.

Introduction: The analysis of published clinical trial results is essential for the evidence base of patient blood management (PBM). In addition, an evidence-based way of developing guidelines and recommendation is indispensable for high quality patient-centred hemotherapy. The international Consensus Conference (ICC) was set up in order to develop evidence-based clinical and research recommendations for preoperative anemia, red blood cell (RBC) transfusion thresholds in adult patients and implementation of PBM programmes. Methods: An international scientific committee (SC) defined 17 population-intervention-comparison-outcome (PICO) questions for the three topics preoperative anemia, red blood cell (RBC) transfusion thresholds in adult patients and implementation of PBM. From these 17 PICO questions, literature search was conducted in four biomedical databases. Several meta-analyses, forest plots, the GRADE methodology (= grading of recommendations, assessment, development and evaluation), GRADEpro, the open source online database for GRADE as well as the Evidence-to-Decision (EtD) framework were used in order to keep the development of recommendations as evidence-based and transparent as possible. Three expert panels (EP) consisting of clinicians, scientists, nurses, patient representatives and methodologists were established and used the methods described above in order to develop recommendations driven by published evidence. Results: Out of more than 17,500 literature citations, data from 145 studies (63 randomised trials including more than 23,000 patients (pts.) & 82 observational studies including more than 4 million pts.) was incorporated into the final analysis. The expert panel for preoperative anemia developed 4 clinical and 3 research recommendations. A strong recommendation advocates for early detection and management of preoperative anemia before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations came out of the process. Two strong clinical recommendations for PBC transfusion thresholds advocate a hemoglobin level (hb) of < 7 g/dL for critical ill, but clinical stable adult intensive care patients independent of septic shock and < 7.5 g/dL for adults undergoing cardiac surgery. For implementation of PBM programmes, 2 clinical and 3 research recommendations were defined. Research recommendations define open fields in PBM and try to initiate additional studies in order to answer still open questions. Conclusion: This is the first ICC for PBM defining the evidence base for three clinically important hemotherapy topics. The relative paucity of strong evidence in current PBM literature underscores the ongoing struggle to a.) find internationally accepted definitions e.g. for anemia and b.) execute internationally planned meaningful multicentre trials in the still open fields of PBM. The clinical recommendations found here however should be considered and accepted in clinical practice. Disclosures Seifried: Medac: Other: BSD owns IP and is contract manufacturer; Uniqure BV: Research Funding.

In this episode of Annals On Call, Dr. Centor discusses patient outcomes following changes in recommendations about the management of anemia in hospitalized patients with Dr. Jeff Carson.

Blood product transfusion has not been subject to rigorous clinical study, and great practice variations exist. Of particular concern to hospitalists is the use of red blood cells, plasma, and platelets prior to invasive procedures to correct anemia or perceived bleeding risk. We summarize the known risks associated with periprocedural anemia, prolonged international normalized ratio (INR), and thrombocytopenia, as well as the effects of blood product administration on clinical outcomes. Clinical trial evidence argues for a restrictive red blood cell transfusion threshold (a hemoglobin level of 7-8 g/dL or symptomatic anemia) for most perioperative patients. There are no high-quality data to guide plasma and platelet transfusions around the time of procedures. Available data do not support the use of prothrombin time/INR to guide prophylactic administration of plasma, and there are scarce data to guide platelet use around the time of an invasive procedure. Therefore, we rely on current consensus expert opinion, which recommends administration of plasma in moderate- to high-risk procedures when INR is >1.5. We recommend platelet transfusion in low-risk procedures when platelet count is

Objectives: To determine whether a higher blood transfusion threshold would prevent new or worsening delirium symptoms in the hospital after hip fracture surgery. Design: Ancillary study to a randomized clinical trial. Setting: Thirteen hospitals in the United States and Canada. Participants: One hundred thirty-nine individuals hospitalized with hip fracture aged 50 and older (mean age 81.5 ± 9.1) with cardiovascular disease or risk factors and hemoglobin concentrations of less than 10 g/dL within 3 days of surgery recruited in an ancillary study of the Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair. Intervention: Individuals in the liberal treatment group received one unit of packed red blood cells and as much blood as needed to maintain hemoglobin concentrations at greater than 10 g/dL; those in the restrictive treatment group received transfusions if they developed symptoms of anemia or their hemoglobin fell below 8 g/dL. Measurements: Delirium assessments were performed before randomization and up to three times after randomization. The primary outcome was severity of delirium according to the Memorial Delirium Assessment Scale (MDAS). The secondary outcome was the presence or absence of delirium defined according to the Confusion Assessment Method (CAM). Results: The liberal group received a median two units of blood and the restrictive group zero units of blood. Hemoglobin concentration on Day 1 after randomization was 1.4 g/dL higher in the liberal group. Treatment groups did not differ significantly at any time point or over time on MDAS delirium severity (P = .28) or CAM delirium presence (P = .83). Conclusion: Blood transfusion to maintain hemoglobin concentrations greater than 10 g/dL alone is unlikely to influence delirium severity or rate in individuals with hip fracture after surgery with a hemoglobin concentration less than 10 g/dL.

Background There is considerable uncertainty regarding the optimal haemoglobin threshold for the use of red blood cell (RBC) transfusions in anaemic patients. Blood is a scarce resource, and in some countries, transfusions are less safe than others because of a lack of testing for viral pathogens. Therefore, reducing the number and volume of transfusions would benefit patients. Objectives The aim of this review was to compare 30-day mortality and other clinical outcomes in participants randomized to restrictive versus liberal red blood cell (RBC) transfusion thresholds (triggers) for all conditions. The restrictive transfusion threshold uses a lower haemoglobin level to trigger transfusion (most commonly 7 g/dL or 8 g/dL), and the liberal transfusion threshold uses a higher haemoglobin level to trigger transfusion (most commonly 9 g/dL to 10 g/dL). Search methods We identified trials by searching CENTRAL (2016, Issue 4), MEDLINE (1946 to May 2016), Embase (1974 to May 2016), the Transfusion Evidence Library (1950 to May 2016), the Web of Science Conference Proceedings Citation Index (1990 to May 2016), and ongoing trial registries (27 May 2016). We also checked reference lists of other published reviews and relevant papers to identify any additional trials. Selection criteria We included randomized trials where intervention groups were assigned on the basis of a clear transfusion 'trigger', described as a haemoglobin (Hb) or haematocrit (Hct) level below which a red blood cell (RBC) transfusion was to be administered. Data collection and analysis We pooled risk ratios of clinical outcomes across trials using a random-effects model. Two people extracted the data and assessed the risk of bias. We conducted predefined analyses by clinical subgroups. We defined participants randomly allocated to the lower transfusion threshold as 'restrictive transfusion' and to the higher transfusion threshold as 'liberal transfusion'. Main results A total of 31 trials, involving 12,587 participants, across a range of clinical specialities (e.g. surgery, critical care) met the eligibility criteria. The trial interventions were split fairly equally with regard to the haemoglobin concentration used to define the restrictive transfusion group. About half of them used a 7 g/dL threshold, and the other half used a restrictive transfusion threshold of 8 g/dL to 9 g/dL. The trials were generally at low risk of bias .Some items of methodological quality were unclear, including definitions and blinding for secondary outcomes. Restrictive transfusion strategies reduced the risk of receiving a RBC transfusion by 43% across a broad range of clinical specialties (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.49 to 0.65; 12,587 participants, 31 trials; high-quality evidence), with a large amount of heterogeneity between trials (I² = 97%). Overall, restrictive transfusion strategies did not increase or decrease the risk of 30-day mortality compared with liberal transfusion strategies (RR 0.97, 95% CI 0.81 to 1.16, I² = 37%; N = 10,537; 23 trials; moderate-quality evidence) or any of the other outcomes assessed (i.e. cardiac events (low-quality evidence), myocardial infarction, stroke, thromboembolism (high-quality evidence)). Liberal transfusion did not affect the risk of infection (pneumonia, wound, or bacteraemia). Authors' conclusions Transfusing at a restrictive haemoglobin concentration of between 7 g/dL to 8 g/dL decreased the proportion of participants exposed to RBC transfusion by 43% across a broad range of clinical specialities. There was no evidence that a restrictive transfusion strategy impacts 30-day mortality or morbidity (i.e. mortality at other points, cardiac events, myocardial infarction, stroke, pneumonia, thromboembolism, infection) compared with a liberal transfusion strategy. There were insufficient data to inform the safety of transfusion policies in certain clinical subgroups, including acute coronary syndrome, myocardial infarction, neurological injury/traumatic brain injury, acute neurological disorders, stroke, thrombocytopenia, cancer, haematological malignancies, and bone marrow failure. The findings provide good evidence that transfusions with allogeneic RBCs can be avoided in most patients with haemoglobin thresholds above 7 g/dL to 8 g/dL.

Over the past three decades, our knowledge regarding the optimal use of red blood cell transfusions has greatly expanded. The risk of contracting chronic viral infections has significantly decreased; elderly transfusion recipients are much more likely to experience harm from noninfectious complications of transfusion, particularly circulatory overload. The traditional goal of maintaining hemoglobin levels at 10 g/dl or greater has been abandoned in the face of increasing evidence favoring a more restrictive transfusion strategy targeting hemoglobin levels of 7–8 g/dl. We do not yet know the optimal transfusion strategy for all geriatric patients, and data addressing the transfusion needs of important patient subgroups is still quite limited.

Background The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial. We conducted a randomized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture. Methods We enrolled 2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery. We randomly assigned patients to a liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion for a hemoglobin level of

ObjectivesLower extremity percutaneous transluminal angioplasty (LE PTA) is currently performed by a variety of endovascular specialists. We hypothesized that cardiologists (CRD) and vascular surgeons (VAS) may have different practice patterns, indications for intervention, and hospital resource utilization.MethodsUsing the State Inpatient Databases for New Jersey (2003-2007), patients with elective admission undergoing PTA procedures with indications of claudication, rest pain, and gangrene/ulceration were examined. Physician specialty was determined based on all procedures performed. We contrasted by specialty, the indication for LE PTA for the procedure, volume, and hospital resource utilization.ResultsOf the 1887 cases of LE PTA, VAS performed 866 (45.9%) and CRD 1021 (54.1%) procedures. The mean patient age was 68.0 years (CRD) vs 70.7 years (VAS), P = .0163. Indications for intervention were compared for CRD vs VAS: claudication 80.7% vs 60.7%, (P < .002); rest pain 6.2% vs 16.0%, (P < .002); gangrene/ulceration 13.1% vs 23.3%, (P < .002). Stents (64.8% of cases) were utilized similarly among physicians (P = .18), and mean hospital length of stay were similar (2.38 days vs 2.41 days, P = .85). Hospital charges by indication varied between CRD vs VAS (all procedures: $49,748 vs $42,158 [P < .0001]). Revenue center charges were different between CRD vs VAS: medical surgical supply $19,128 vs $12,737, (P < .0001); pharmacy $1,959 vs $1,115, (P < .0001). Only 10.7% of CRD were high volume practitioners, compared with 36.8% among VAS (P < .05). High volume practitioners had significantly lower hospital charges ($41,730 vs $51,014, P < .001).ConclusionsCardiologists performing lower extremity angioplasty were more likely to treat patients with claudication than those with rest pain or gangrene/ulceration. Despite treating younger patients with less severe peripheral vascular disease, cardiologists used significantly greater hospital resources. High practitioner volume, regardless of specialty, was associated with lower hospital resource utilization. Reducing variations in indication and practitioner volume may offer substantial cost savings for lower extremity endovascular interventions.

SUMMARY Bloodless surgery refers to performing surgery without the use of blood. Such programs were developed to support Jehovah's Witness patients but the principles of care that have been established should be used in the care of all patients. However, there are limits to the ability of patients to tolerate anemia. Animal experiments show that myocardial ischemia develops around 5 g/dL and death at 3 g/dL. Studies in humans undergoing surgery demonstrate a linear relationship between death and anemia and poor outcome is extremely common below 5–6 g/dL. Patients with cardiovascular disease appear less tolerant of anemia. The care of the bloodless surgery patient involves careful preoperative planning, correction of anemia, use of erythropoietin, prompt surgery to stop bleeding, and meticulous surgical technique.

There is no available evidence from randomized trials that early detection of prostate cancer improves health outcomes, but the prostate-specific antigen (PSA) test is commonly used to screen men for prostate cancer.The objective of the study is to see if screening with PSA decreases mortality from prostate cancer.This is a case-control study using one-to-one matching on race, age, and time of availability of exposure to PSA screening. Decedents, 380, from New Jersey Vital Statistics 1997 to 2000 inclusive, 55-79 years of age at diagnosis were matched to living controls without metastatic prostate cancer. Medical records were obtained from all providers, and we abstracted information about PSA tests from 1989 to the time of diagnosis in each index case.Measurements consist of a comparison of screening (yes, no) between cases and controls. Measure of association was the odds ratio.Eligible cases were diagnosed each year from 1989 to 1999 with the median year being 1993. PSA screening was evident in 23.2-29.2% of cases and 21.8-26.1% of controls depending on the screening criteria. The unadjusted, matched odds ratio for dying of prostate cancer if ever screened was 1.09 (95% CI 0.76 to 1.60) for the most restrictive criteria and 1.19 (95% CI, 0.85 to 1.66) for the least restrictive. Adjustment for comorbidity and education level made no significant differences in these values. There were no significant interactions by age or race.PSA screening using an ever/never tabulation for tests from 1989 until 2000 did not protect New Jersey men from prostate cancer mortality.

To compare risk-adjusted differences between men and women 30 and 60 days after hip fracture surgery in not walking, ability to return home in a community-dwelling subset, not walking in a nursing home resident subset, and mortality within 60 days.Cohort study.Data were from a randomized clinical trial that compared two blood transfusion protocols after hip fracture.Individuals with hip fracture (N = 2,016; 489 (24%) male).Walking, dwelling, and mortality were determined in telephone follow-up 30 and 60 days after randomization, which occurred within 3 days of surgery. Sex differences for each outcome were compared using univariate and multivariate regression adjusting for potential confounders.Men were younger (P.001) and more likely to have comorbidity (P = .003) than women at the time of hip fracture and to die within 60 days, even after risk adjustment (odds ratio (OR) = 1.76, 95% confidence interval (CI) = 1.15-2.69). After risk adjustment, male survivors were as likely as female survivors not to walk (OR = 1.03, 95% CI = 0.78-1.34) and no less likely to return home (OR = 0.90, 95% CI = 0.69-1.17) 60 days after hip fracture. No differences were noted between male and female nursing home residents in not walking within 60 days (OR = 0.95, 95% CI = 0.32-2.86).Although men experience higher mortality, male survivors can expect recovery of walking ability similar to that of female survivors and are as likely to return to community living.

)Department of Intensive Care, Rigshospitalet, University ofCopenhagen, Copenhagen, Denmarke-mail: anders.perner@regionh.dkL. B. Holste-mail: lars.broksoe.holst@regionh.dkJ. L. CarsonDivision of General Internal Medicine, Department of Medicine,Rutgers Robert Wood Johnson Medical School, New Brunswick,NJ, USAe-mail: jeffrey.carson@rutgers.edu

The prevalence of anemia in elective surgical patients may be as frequent as 75% in certain populations. A national audit demonstrated that 35% of patients scheduled for joint replacement therapy have a hemoglobin

This article discusses the impact of anemia in the context of the perioperative setting. Relevant data from animal and human studies, the adaptive mechanisms in anemia, and current views on transfusion triggers are evaluated. Recommendations are provided for the anesthesiologist for transfusion of red blood cells.

Blood transfusion is a widely used treatment that is expensive and carries a small degree of risk. The level of anemia that patients tolerate and the indications for blood transfusion are controversial.Review of pertinent English language literature.The risk of blood transfusion from viral transmission is very low. The risk of anemia increases as hemoglobin concentration decreases. The risk is very high when the hemoglobin concentration is below 6 g/dL. The risk of death or serious morbidity increases more rapidly in patients with cardiovascular disease than patients without cardiovascular disease. There is only one adequately powered clinical trial that demonstrates that a 7 g/dL transfusion threshold is as safe, and in some subgroups, safer than a 10 g/dL threshold.A restrictive transfusion threshold (7 g/dL) is recommended in most patients. In patients with cardiovascular disease, a 9-10 g/dL may be advisable, but definitive guidelines await further clinical trials. However, as with all such treatments, the decision to transfuse should be based on individual assessment of patients' signs, symptoms, and co-morbidity.

BACKGROUND: Guidelines for allogeneic transfusion emphasize minimizing use to avoid transmission of serious illness. However, there is little information on the risks associated from withholding transfusion. STUDY DESIGN AND METHODS: A retrospective cohort study of patients who declined RBC transfusions for religious reasons was performed. This analysis was restricted to consecutive patients ≥18 years old, who underwent surgery in the operating room from 1981 to 1994 and had a postoperative Hb count of 8 g per dL or less. The primary outcome was defined as any in-hospital death occurring within 30 days of the surgery. Secondary outcome was 30-day mortality or in-hospital 30-day morbidity. Morbidity was defined as myocardial infarction, arrhythmia, congestive heart failure, or infection. RESULTS: Of 2083 eligible patients, 300 had postoperative Hb counts of 8 g per dL or less. The study population was predominantly female (70.3%) with a mean age of 57 years (SD, ± 17.7). In patients with a postoperative Hb level of 7.1 to 8.0, 0 died (upper 95% CI, 3.7%), and 9.4 percent (95% CI, 4.4-17.0%) had a morbid event. In patients with a postoperative Hb level of 4.1 to 5.0, 34.4 percent (95% CI, 18.6-53.2%) died and 57.7 percent (95% CI, 36.9-76.6%) had a morbid event or died. After adjusting for age, cardiovascular disease, and Acute Physiology and Chronic Health Evaluation II score, the odds of death in patients with a postoperative Hb level of ≤8 g per dL increased 2.5 times (95% CI, 1.9-3.2) for each gram decrease in Hb level. CONCLUSIONS: The risk of death was low in patients with postoperative Hb levels of 7.1 to 8.0 g per dL, although morbidity occurred in 9.4 percent. As postoperative blood counts fall the risk of mortality and/or morbidity rises and becomes extremely high below 5 to 6 g per dL.

Purpose There is a perception that the standard of care is to repair hip fractures surgically within 24 hours of hospitalization. However, it is unclear whether this reduces mortality or morbidity. Subjects and methods We performed a retrospective study in consecutive hip fracture patients, aged 60 years or older, who underwent surgical repair. Patients with metastatic cancer, trauma, or a fracture occurring >48 hours before admission were excluded. The primary outcome was long-term (up to 18 years) mortality. Secondary outcomes included 30-day mortality and decubitus ulcers, serious bacterial infections, myocardial infarction, and thromboembolism. Analyses were adjusted for medical conditions; the comparison group comprised patients who underwent surgery for hip fracture repair within 24 to 48 hours because there were no patients with active medical problems who underwent surgery within 24 hours. Results Of the 8383 patients, surgery was delayed for more than 24 hours in 2464 patients (29%) for medical reasons and in 1341 patients (16%) without active medical problems. Compared with those who underwent surgery 24 to 48 hours after admission to the hospital, patients who underwent surgery more than 96 hours after admission did not have increased long-term mortality (hazard ratio=1.07; 95% confidence interval [CI]: 0.95 to 1.21), although the risk of decubitus ulcer was increased (odds ratio=2.2; 95% CI: 1.6 to 3.1). There were no associations between time-to-surgery and the other secondary outcomes. Conclusion Time-to-surgery in hip fracture patients was not associated with short- or long-term mortality after adjusting for active medical problems. Other than increasing the risk of decubitus ulcer formation, waiting did not appear to affect patients' outcomes adversely.

Holst and colleagues1 now provide definitive evidence in the Journal that a restrictive approach to blood transfusion not only reduced blood use by half but also did not cause harm to 998 critically ill patients with septic shock. It has been 15 years since the publication of the results of the Transfusion Requirements in Critical Care (TRICC) trial in the Journal.2 In that Canadian Critical Care Trial Group study, 838 critically ill patients were randomly assigned to receive blood transfusions on the basis of a threshold of 7 g per deciliter or 10 g per deciliter while also agreeing . . .

The elderly population is growing rapidly, and the prevalence of anemia is approximately 11 % in the elderly. Observational data demonstrates poor outcome in patients with even mild anemia, but this may reflect the patients’ underlying disease rather than the anemia itself. Clinical trials evaluating transfusion thresholds in the elderly suggest that a restrictive transfusion approach is safe in most clinical settings. Transfusion guidelines do not recommend specific transfusion thresholds in the elderly but rather focus on the hemoglobin level in relation to patients’ comorbidities; thus, transfusion decisions may be affected by the higher prevalence of underlying medical problems in the elderly but not by age itself.

Blood conservation strategies effectively decrease red blood cell (RBC) use in specific patient groups.1-3 However, the impact of RBC transfusion reduction on mortality in a diverse inpatient population remains poorly described. We detail the impact of declining RBC use on 30-day mortality within Kaiser Permanente Northern California (KPNC), an integrated health care delivery system serving 3.5 million members at 21 hospitals.

We examined physical restraint use among 1856 nursing home residents hospitalized with hip fracture using a data set of hip fracture patients in 20 U. S. hospitals from 1983-1993. Mean age of patients was 85.2 years, 81.7% were women, and 91.3% were white. Rate of physical restraint use was 59.4%. Pre-operative physical restraint use was predicted by younger age, confusion, dementia, and needing assistance or dependency in activities of daily living (ADL). Physical restraint use following surgery was predicted by pre-operative physical restraint use, confusion, dementia, and lower co-morbidity of illness. At hospital discharge, restrained patients were more likely to be dependent in ADL and continence. The reduction of physical restraints among hospitalized nursing home residents will require attention to a multiplicity of factors that contribute to restraint use.

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: 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.

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.