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Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (8% g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy.We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary endpoint is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary endpoints include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary endpoints.The MINT trial will inform RBC transfusion practice in patients with acute MI.

The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported.To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia.Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505).46 U.S. and Canadian hospitals.Patients aged 50 years or older undergoing hip fracture surgery.Spinal or general anesthesia.Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care.A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups.Missing outcome data and multiple outcomes assessed.Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.Patient-Centered Outcomes Research Institute

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

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

Summary Engaging patients—defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them—as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

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

Direct observation of medical students performing clinical tasks, such as eliciting a patient history or examining a patient, and the provision of feedback, are foundational to student improvement but have been reported to occur infrequently. The mini clinical evaluation exercise (mini-CEX) is a tool that can facilitate direct observation and feedback. This study assessed the impact of a mini-CEX requirement across all 3rd-year clerkships on student report of direct observation by faculty and objectively measured clinical skills.A mini-CEX requirement across all 3rd-year clerkships was implemented in the 2012-2013 academic year. The impact of the mini-CEX requirement on student report of direct observation was assessed by end-of-clerkship surveys and Association of American Medical Colleges (AAMC) Graduation Questionnaire (GQ) items on direct observation. The impact on students' clinical skills was assessed by a summative Objective Structured Clinical Examination (OSCE). Pre/post comparisons were assessed with chi-square and Fisher's exact tests.A mini-CEX requirement had been in place for the internal medicine clerkship, and student reports of direct observation were historically higher for the internal medicine clerkship than for other clerkships. Faculty, residents, and students at each of the clinical sites across all 6 clerkships were oriented to the use of the mini-CEX; the feasibility of its use during usual patient interaction settings and the importance of direct observation and feedback for student improvement were emphasized during these sessions.Adherence to the mini-CEX requirement was high: 92% of required forms were completed, and 78% of completed forms indicated that specific feedback was given. The proportion of students reporting direct observation of physical examination significantly increased in all clerkships, with the largest relative increase occurring in surgery (from 49% to 87%), χInstitution of a mini-CEX requirement was feasible across all 3rd-year clerkships and was associated with a significant increase in student report of direct observation by faculty and a decrease in summative OSCE failure rates.

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.

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

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.

Denial and downgrading of reimbursement for hospital days are two strategies utilized by health plans to maintain profitability. The goal of this study was to describe patterns of discounted reimbursement at a university hospital.We performed a retrospective cohort study of consecutive per diem patients hospitalized in 1999. We defined a discounted day as a day fully denied or downgraded and a reversal day as a day reimbursed at a higher level after appeal. The study outcomes included the probability of a discounted day and the probability of a discounted day to be later reversed. Covariance logistic regression was used to compare these outcomes by plan and physician specialty after adjusting for age, sex, race, length of stay, and diagnosis. Correlations with plan characteristics were analyzed.Of 59,265 hospital days, 6074 days (10.2%) were initially denied or downgraded. On appeal, 1755 discounted days (28.9%) were reversed. The percentage of days discounted per plan ranged from 1.2% to 18.8% (P0.001), whereas the percentage of discounted days that were later reversed ranged from 23.2% to 85.3% (P0.001). The qualitative magnitude of these associations and statistical significance were unchanged in adjusted models. Strong correlations were found between the adjusted odds ratio for a discounted day and net profit margin (R = 0.81) and medical loss ratio (R = -0.77).Denials and downgrades are frequent, with marked variation by health plan. More profitable plans had higher denial and discount rates. Evidence-based standards for denials and downgrades are needed to maintain optimal patient care and the fiscal health of hospitals and health plans.

BACKGROUND: The benefits and indications for blood transfusion are controversial. One possible reason to transfuse is to improve functional recovery after major surgery. However, the data linking improved function with higher Hb concentration are limited. STUDY DESIGN AND METHODS: A retrospective cohort study was performed in 5793 patients at least 60 years old undergoing hip fracture repair at 20 academic and community hospitals. The primary outcome was distance walked at the time of discharge from the hospital. The mean postoperative Hb concentration was the main exposure variable and was defined as the average value from Day 1 after surgery to discharge. We used robust regression to assess the association between postoperative Hb level with distance walked, controlling for other preoperative variables that could influence functional recovery. RESULTS: On bivariate analysis, the predicted distance walked at discharge in feet (95% CI) increased with higher Hb levels (7 g/dL, 56 feet [42-70]; 8 g/dL, 61 feet [54-68]; 9 g/dL, 67 feet [64-70]; 10 g/dL, 74 feet [72-77]; 11 g/dL, 83 feet [80-85]; 12 g/dL, 92 feet [87-96]). After adjustment for other factors associated with ability to walk, higher average postoperative Hb level was independently associated with walking greater distance (p < 0.001). CONCLUSIONS: Higher postoperative Hb level may improve functional recovery after hip fracture repair. If confirmed with clinical trials, this finding would provide a rationale to maintain higher Hb concentrations in elderly patients recovering from surgery.

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.

PURPOSE To compare the speed and accuracy of answering clinical questions using Google versus summary resources. METHOD In 2011 and 2012, 48 internal medicine interns from two classes at Rutgers University Robert Wood Johnson Medical School, who had been trained to use three evidence-based summary resources, performed four-minute computer searches to answer 10 clinical questions. Half were randomized to initiate searches for answers to questions 1 to 5 using Google; the other half initiated searches using a summary resource. They then crossed over and used the other resource for questions 6 to 10. They documented the time spent searching and the resource where the answer was found. Time to correct response and percentage of correct responses were compared between groups using t test and general estimating equations. RESULTS Of 480 questions administered, interns found answers for 393 (82%). Interns initiating searches in Google used a wider variety of resources than those starting with summary resources. No significant difference was found in mean time to correct response (138.5 seconds for Google versus 136.1 seconds for summary resource; P = .72). Mean correct response rate was 58.4% for Google versus 61.5% for summary resource (mean difference -3.1%; 95% CI -10.3% to 4.2%; P = .40). CONCLUSIONS The authors found no significant differences in speed or accuracy between searches initiated using Google versus summary resources. Although summary resources are considered to provide the highest quality of evidence, improvements to allow for better speed and accuracy are needed.

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.

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.

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: 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.

The benefits and indications for blood transfusion are controversial. One possible reason to transfuse is to improve functional recovery after major surgery. However, the data linking improved function with higher Hb concentration are limited.A: retrospective cohort study was performed in 5793 patients at least 60 years old undergoing hip fracture repair at 20 academic and community hospitals. The primary outcome was distance walked at the time of discharge from the hospital. The mean postoperative Hb concentration was the main exposure variable and was defined as the average value from Day 1 after surgery to discharge. We used robust regression to assess the association between postoperative Hb level with distance walked, controlling for other preoperative variables that could influence functional recovery.On bivariate analysis, the predicted distance walked at discharge in feet (95% CI) increased with higher Hb levels (7 g/dL, 56 feet [42-70]; 8 g/dL, 61 feet [54-68]; 9 g/dL, 67 feet [64-70]; 10 g/dL, 74 feet [72-77]; 11 g/dL, 83 feet [80-85]; 12 g/dL, 92 feet [87-96]). After adjustment for other factors associated with ability to walk, higher average postoperative Hb level was independently associated with walking greater distance (p0.001).Higher postoperative Hb level may improve functional recovery after hip fracture repair. If confirmed with clinical trials, this finding would provide a rationale to maintain higher Hb concentrations in elderly patients recovering from surgery.

Most evidence guiding perioperative medical risk management of patients undergoing hip fracture repair focuses on cardiac and thromboembolic risk. Little is known of the relative clinical importance of other complications.To systematically map incidence and outcomes of a broad spectrum of medical complications after hip fracture repair.Retrospective cohort study of patients 60 years or older in 20 academic, community, and Veterans Affairs hospitals. Data on complications and mortality were abstracted from medical records by trained abstractors using standardized, pretested forms or the National Death Index.Of 8930 patients, 1737 (19%) had postoperative medical complications. Cardiac and pulmonary complications were most frequent (8% and 4% of patients, respectively). Similar numbers of patients had serious cardiac or pulmonary complications (2% and 3%, respectively). Other complications were gastrointestinal tract bleeding (2%), combined cardiopulmonary complications (1%), venous thromboembolism (1%), and transient ischemic attack or stroke (1%). Renal failure and septic shock were rare. After the index complication, 416 patients had 587 additional complications. Mortality was similar for serious cardiac or pulmonary complications (30 day: 22% and 17%, respectively; 1 year: 36% and 44%, respectively) and highest for patients with multiple complications (30 day: 29%-38%; 1 year: 43%-62%). Complications and death occurred significantly earlier for serious cardiac than for serious pulmonary complications (1 vs 4 days, 2 vs 8 days, P.001); length of stay for patients surviving these complications was similar.Most patients had no medical complications after hip fracture repair. Serious cardiac and pulmonary complications were equally important in frequency, mortality, and survivors' length of stay. Patients with multiple complications had especially poor prognosis.

[Graphic][1] Introduction There are a large number of randomized clinical trials comparing short-term mortality between liberal and restrictive transfusion strategies. However, transfusion is thought to have long-term consequences related to alteration of immune function. These effects have been hypothesized to increase the risk of subsequent infections and recurrence of cancer. Thus, it is possible that transfusion will increase the risk of long-term mortality by increasing the deaths due to infections and recurrent cancer. Alternatively, more liberal transfusion might reduce cardiac complications by increasing oxygen to vulnerable myocardium and reduce deaths from cardiovascular disease. We hypothesized that liberal transfusion would affect cause specific mortality and might affect all-cause mortality, depending on the predominant impact of transfusion. Methods We performed a secondary analysis of the FOCUS trial that randomly allocated patients undergoing hip fracture repair with postoperative hemoglobin concentrations below 10 g/dL within 3 days of surgery. Patients were eligible for the trial if they had underlying cardiovascular disease (coronary artery disease, congestive heart failure, stroke, peripheral vascular disease) or cardiovascular risk factors (diabetes mellitus, hypertension, hyperlipidemia, tobacco use, or renal insufficiency). We randomly allocated patients to liberal transfusion where patients received blood transfusion to maintain hemoglobin 10 g/dL or greater, or restrictive transfusion where patients received blood transfusion when hemoglobin level was less than 8 g/dL or for symptoms. Long-term mortality was determined by linking the study subjects to national death registries in US and Canada. We compared survival time between the two transfusion treatment strategies using the unadjusted log-rank test and Cox proportional hazard models. The underlying cause of death was identified by the national death registries and grouped into seven categories: cardiovascular disease, cancer, infection, stroke, dementia, pulmonary, and other. Results There were 1007 subjects randomly allocated to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The baseline clinical status was similar between the two groups; mean age of the study population was 81.6 years (range, 51 to 103). The liberal transfusion group were transfused a total of 1866 units and restrictive transfusion group 652 units. We established long-term survival for 2002 (99.3%) of the study population. The median follow-up was 3.1 years (interquartile range, 2.4 to 4.1 years) and there were 841 (42.0%) deaths. There was no difference in the long-term mortality between the liberal transfusion strategy (N=432 deaths) and restrictive transfusion strategy (N= 409 deaths); hazard ratio =1.09; 95% confidence interval 0.95 to 1.25 (Figure). The results were consistent across all subgroups including demographics and multiple co-morbidities. There was also no difference in the underlying cause of death between the transfusion strategies (p=0.99) (Table); Cardiovascular disease (liberal-32.6%, restrictive-33.5%), Cancer (liberal-12.5%, restrictive-12.0%), Infection (liberal-9.5%, restrictive 9.0%). Conclusions Liberal transfusion of 10 g/dL did not reduce or increase long-term mortality compared to restrictive transfusion strategy using an 8 g/dL threshold or symptoms in a high risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death were similar in both arms of the trial and liberal transfusion did not appear to increase risk of death from infection or cancer or reduce the risk of death from cardiovascular disease. These results do not support the hypotheses that transfusion leads to long-term immunosuppression that is severe enough to influence mortality or cause of death. Our findings suggest that clinicians should primarily consider short-term effects of transfusion when deciding whom to transfuse. | | | | | | | || | | | Total N (%) | Liberal N (%) | Restrictive N (%) | | | | Cardiovascular Disease | 278 (33.1) | 141 (32.6) | 137 (33.5) | | | | Cancer | 103 (12.2) | 54 (12.5) | 49 (12.0) | | | | Infection | 78 (9.3) | 41 (9.5) | 37 (9.0) | | | | Stroke | 57 (6.8) | 27 (6.3) | 30 (7.3) | | | | Dementia | 108 (12.8) | 56 (13.0) | 52 (12.7) | | | | Pulmonary | 58 (6.9) | 29 (6.7) | 29 (7.1) | | | | Other | 147 (17.5) | 79 (18.3) | 68 (16.6) | | | | Unknown | 12 (1.4) | 5 (1.2) | 7 (1.7) | | | | Totals | 841 | 432 | 409 | | Table ![Figure 1][2] Figure 1 Disclosures Magaziner: Ammonett : Consultancy; Sanofi: Consultancy; Regeneron: Consultancy; Novartis: Consultancy; Eli Lilly: Consultancy; American Orthopedic Association: Consultancy. [1]: /embed/inline-graphic-2.gif [2]: pending:yes

Background The impact of anesthetic choice on postoperative mortality and morbidity has not been determined with certainty. Methods The authors evaluated the effect of type of anesthesia on postoperative mortality and morbidity in a retrospective cohort study of consecutive hip fracture patients, aged 60 yr or older, who underwent surgical repair at 20 US hospitals between 1983 and 1993. The primary outcome was defined as death within 30 days of the operative procedure. The secondary outcomes were postoperative 7-day mortality, postoperative myocardial infarction, postoperative pneumonia, postoperative congestive heart failure, and postoperative change in mental status. Numerous comorbid conditions were controlled for individually and by several comorbidity indices using logistic regression. Results General anesthesia was used in 6,206 patients (65.8%) and regional anesthesia in 3,219 patients (3,078 spinal anesthesia and 141 epidural anesthesia). The 30-day mortality rate in the general anesthesia group was 4.4%, compared with 5.4% in the regional anesthesia group (unadjusted odds ratio = 0.80; 95% confidence interval = 0.66-0.97). However, the adjusted odds ratio for general anesthesia increased to 1.08 (0.84-1.38). The adjusted odds ratios for general anesthesia versus regional anesthesia for the 7-day mortality was 0.90 (0.59-1.39) and for postoperative morbidity outcomes were as follows: myocardial infarction: adjusted odds ratio = 1.17 (0.80-1.70); congestive heart failure: adjusted odds ratio = 1.04 (0.80-1.36); pneumonia: adjusted odds ratio = 1.21 (0.87-1.68); postoperative change in mental status: adjusted odds ratio = 1.08 (0.95-1.22). Conclusions The authors were unable to demonstrate that regional anesthesia was associated with better outcome than was general anesthesia in this large observational study of elderly patients with hip fracture. These results suggest that the type of anesthesia used should depend on factors other than any associated risks of mortality or morbidity.

Purpose: Utilization report cards are commonly used to assess hospitals. However, in practice, they rarely account for differences in patient populations among hospitals. Our study questions were: (1) How does transfusion utilization for hip fracture patients vary among hospitals? (2) What patient characteristics are associated with transfusion and how do those characteristics vary among hospitals? (3) Is the apparent pattern of variation of utilization among hospitals altered by controlling for these patient characteristics? Subjects and Methods: We included consecutive hip fracture patients aged 60 years or older who underwent surgical repair between 1982 and 1993 in 19 hospitals from four states, excluding those who refused blood transfusion, had multiple trauma, metastatic cancer, multiple myeloma, an above the knee amputation, or were paraplegic or quadriplegic. The outcome of interest was postoperative blood transfusion. "Trigger hemoglobin" was the lowest hemoglobin recorded before transfusion or recorded at any time during the week before or after surgery for patients who were not transfused. Results: There was considerable variation in transfusion among hospitals postoperatively (range 31.2% to 54.0%, P = 0.001). Trigger hemoglobin also varied considerably among hospitals. In unadjusted analyses, four of nine teaching and two of nine nonteaching hospitals had postoperative transfusion rates significantly higher than the reference (teaching) hospital, while one nonteaching hospital had a lower rate. In an analysis controlling for trigger hemoglobin and multiple clinical variables, one of nine teaching and four of nine nonteaching hospitals had rates higher than the reference hospital, while four teaching hospitals and one nonteaching hospital had lower rates. Conclusions: The apparent pattern of variation of transfusion among hospitals varies according to how one adjusts for relevant patient characteristics. Utilization report cards that fail to adjust for these characteristics may be mixleading.

Context.—The risks of blood transfusion have been studied extensively but the benefits and the hemoglobin concentration at which patients should receive a transfusion have not.Objective.—To determine the effect of perioperative transfusion on 30- and 90-day postoperative mortality.Design.—Retrospective cohort study.Setting.—A total of 20 US hospitals between 1983 and 1993.Participants.—A total of 8787 consecutive hip fracture patients, aged 60 years or older, who underwent surgical repair.Main Outcome Measures.—Primary outcome was 30-day postoperative mortality; secondary outcome was 90-day postoperative mortality. The "trigger" hemoglobin level was defined as the lowest hemoglobin level prior to the first transfusion during the time period or, for patients in the nontranfused group, as the lowest hemoglobin level during the time period.Results.—Overall 30-day mortality was 4.6% (n=402; 95% confidence interval [CI], 4.1%-5.0%); overall 90-day mortality was 9.0% (n=788; 95% CI, 8.4%-9.6%). A total of 42% of patients (n=3699) received a postoperative transfusion. Among patients with trigger hemoglobin levels between 80 and 100 g/L (8.0 and 10.0 g/dL), 55.6% received a transfusion, while 90.5% of patients with hemoglobin levels less than 80 g/L (8.0 g/dL) received postoperative transfusions. Postoperative transfusion did not influence 30- or 90-day mortality after adjusting for trigger hemoglobin level, cardiovascular disease, and other risk factors for death: for 30-day mortality, the adjusted odds ratio (OR) was 0.96 (95% CI, 0.74-1.26); for 90-day mortality, the adjusted hazard ratio was 1.08 (95% CI, 0.90-1.29). Similarly, 30-day mortality after surgery did not differ between those who received a preoperative transfusion and those who did not (adjusted OR, 1.23; 95% CI, 0.81-1.89).Conclusions.—Perioperative transfusion in patients with hemoglobin levels 80 g/L (8.0 g/dL) or higher did not appear to influence the risk of 30- or 90-day mortality in this elderly population. At hemoglobin concentrations of less than 80 g/L (8.0 g/dL), 90.5% of patients received a transfusion, precluding further analysis of the association of transfusion and mortality.