Your browser doesn't support javascript.
loading
: 20 | 50 | 100
1 - 18 de 18
1.
N Engl J Med ; 389(26): 2446-2456, 2023 Dec 28.
Article En | MEDLINE | ID: mdl-37952133

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).


Anemia , Blood Transfusion , Myocardial Infarction , Humans , Anemia/blood , Anemia/etiology , Anemia/therapy , Blood Transfusion/methods , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/methods , Hemoglobins/analysis , Myocardial Infarction/blood , Myocardial Infarction/complications , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Recurrence
2.
Am Heart J ; 257: 120-129, 2023 03.
Article En | MEDLINE | ID: mdl-36417955

BACKGROUND: 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. METHODS: 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 hemoglobin <10 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 end point is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary end points 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 end points. CONCLUSIONS: The MINT trial will inform RBC transfusion practice in patients with acute MI.


Anemia , Coronary Artery Disease , Myocardial Infarction , Myocardial Ischemia , Humans , Anemia/etiology , Anemia/therapy , Blood Transfusion , Coronary Artery Disease/complications , Hemoglobins/metabolism , Ischemia/etiology , Myocardial Infarction/complications , Myocardial Infarction/therapy , Myocardial Ischemia/complications , Myocardial Ischemia/therapy , Randomized Controlled Trials as Topic
3.
Nurs Rep ; 11(1): 28-35, 2021 Jan 06.
Article En | MEDLINE | ID: mdl-34968309

The role of advanced practice providers has expanded in the hospital setting. However, little data exist examining the impact of these providers. Our purpose was to determine the effect of adding nurse practitioners in a complementary role on the quality and efficiency of care of hospitalized patients. A retrospective cohort study evaluated adult patients admitted by private physicians (without house staff or non-physician providers) to a general medical-surgical unit in an academic medical center. The admissions department allocated patients as beds became available and nurse practitioners were assigned to patients until their caseload was reached. Outcomes included length of hospital stay, in-hospital mortality, admission costs, 30-day readmissions, transfer to a more intensive care level, and discharge order time. Of the 382 patients included in this study, 263 were assigned to the nurse practitioner group. Hospital mortality was lower in the nurse practitioner group [OR 0.11 (95% CI 0.02-0.51)] as was transfer to more intensive care level [OR 0.39 (95% CI 0.20-0.75)]; however, the nurse practitioner group had longer length of stay (geometric mean = 5.80 days for nurse practitioners, 3.63 days for no nurse practitioners; p < 0.0001) and higher cost per patient (geometric mean = USD 6631 vs. USD 5121; p = 0.005). The results were unchanged when models were adjusted for potential confounders. Adding nurse practitioners can yield improved clinical outcomes (lower hospital mortality and fewer transfers to intensive care), but with a potential economic expense (longer hospital stays and higher costs).

4.
Transfusion ; 61(7): 2025-2034, 2021 07.
Article En | MEDLINE | ID: mdl-34058023

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 <40,000/µl, or congenital or acquired coagulation disorders unresponsive to plasma. We randomly allocated patients stratified by hospital and history of cirrhosis to receive plasma transfusion (10-15 cc/kg) or no transfusion. The primary outcome was change in hemoglobin concentration within 2 days of procedure. RESULTS: We enrolled 57 patients, mean age 56.0, 34 (59.6%) with cirrhosis, and mean INR 1.92 (SD = 0.27). In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm (p < .01). The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm (p = .29). Adverse outcomes were uncommon. DISCUSSION: We found no differences in change in hemoglobin concentration in those treated with plasma compared to no treatment. The change in INR was small and corrected to less than 1.5 in minority of patients. Large trials are required to establish if plasma is safe and efficacious.


Blood Component Transfusion , Plasma , Adult , Aged , Ambulatory Surgical Procedures/adverse effects , Blood Component Transfusion/adverse effects , Female , Hemoglobins/analysis , Humans , Inpatients , International Normalized Ratio , Liver Cirrhosis , Male , Middle Aged , Pilot Projects , Postoperative Hemorrhage/prevention & control , Pragmatic Clinical Trials as Topic/methods
5.
Am J Clin Nutr ; 112(3): 613-618, 2020 09 01.
Article En | MEDLINE | ID: mdl-32073599

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 <12 ng/mL, 12 to <20 ng/mL, 20 to <30 ng/mL, or ≥30 ng/mL. GNRI was categorized into major/moderate nutritional risk (<92), some risk (92 to <98), or in good nutritional status (≥98). RESULTS: Of the 290 patients [aged 82 ± 7 y, BMI (kg/m2): 25 ± 5], 73% were women. Compared with patients with <12 ng/mL, those with higher 25(OH)D concentrations had higher rates of walking at 30 d (P = 0.031): 12 to <20 ng/mL (adjusted OR: 2.61; 95% CI: 1.13, 5.99); 20 to <30 ng/mL (3.48; 1.53, 7.95); ≥30 ng/mL (2.84; 1.12, 7.20). In addition, there was also greater mobility at 60 d (P = 0.028) in patients with higher 25(OH)D compared with the reference group (<12 ng/mL). Poor nutritional status (GNRI <92) showed an overall trend to reduce mobility (unadjusted P = 0.044 and adjusted P = 0.056) at 30 but not at 60 d. There was no association of vitamin D or GNRI with mortality at either time. CONCLUSIONS: Vitamin D deficiency (<12 ng/mL) is associated with reduced ambulation after hip fracture surgery, whereas GNRI also contributes to immobility but is a less reliable predictor. Mechanisms that can explain why vitamin D deficiency is associated with mobility should be addressed in future studies.


Hip Fractures/surgery , Recovery of Function , Vitamin D Deficiency/blood , Aged , Aged, 80 and over , Female , Humans , Male , Prospective Studies , Vitamin D/analogs & derivatives , Vitamin D/blood
6.
Int J Qual Health Care ; 30(2): 97-103, 2018 Mar 01.
Article En | MEDLINE | ID: mdl-29385446

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 <100 g/L within 3 days post-surgery. The average age was 82 years and 1527(76%) subjects were females. INTERVENTION: Demographics, health status and health services data were collected up to 60 days post-surgery and mortality to a median of 3 years post-surgery. MAIN OUTCOMES: Mortality, inability to walk and return home. RESULTS: US subjects had higher adjusted mortality than Canadians at 30 days (odds ratio = 1.78; 95% confidence interval: 1.09-2.90), 60 days (1.53; 1.02-2.29) and up to 3 years (hazard ratio = 1.25; 1.07-1.45). There were no differences in adjusted outcomes for walking ability or return home at 30 or 60 days post-surgery. Median hospital length of stay was longer (P < 0.0001) in Canada (9 days; interquartile range: 5-18 days) than the US (3 days; 2-5 days). US subjects (52.9%) were more likely than Canadians (16.8%) to be discharged to nursing homes for rehabilitation (P < 0.001). CONCLUSIONS: Adjusted survival favored Canadians post hip fracture while walking ability and return home were not different between countries. The reason(s) for mortality differences warrant further investigation.


Hip Fractures/mortality , Hip Fractures/surgery , Recovery of Function , Walking , Aged , Aged, 80 and over , Blood Transfusion/statistics & numerical data , Canada/epidemiology , Female , Hip Fractures/rehabilitation , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Nursing Homes/statistics & numerical data , Postoperative Care , Risk Factors , United States/epidemiology
7.
Teach Learn Med ; 28(4): 424-431, 2016.
Article En | MEDLINE | ID: mdl-27141826

PROBLEM: 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. INTERVENTION: 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. CONTEXT: 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. OUTCOME: 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%), χ2(1, N = 225) = 37.70, p < .0001. Significant increases were seen in faculty observation of history taking in pediatrics, surgery, and psychiatry. Direct observation rates also increased on the AAMC GQ items for history taking and physical exam for all clerkships. Failures on the summative OSCE decreased from 12% preintervention to 2% postintervention (p = .0046). LESSONS LEARNED: Institution 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.


Clinical Clerkship , Clinical Competence , Internal Medicine , Child , Educational Measurement , Humans , Physical Examination , Students, Medical
8.
J Am Geriatr Soc ; 63(8): 1640-4, 2015 Aug.
Article En | MEDLINE | ID: mdl-26200232

OBJECTIVES: 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. DESIGN: Cohort study. SETTING: Data were from a randomized clinical trial that compared two blood transfusion protocols after hip fracture. PARTICIPANTS: Individuals with hip fracture (N = 2,016; 489 (24%) male). MEASUREMENTS: 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. RESULTS: 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). CONCLUSION: 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.


Geriatric Assessment/methods , Hip Fractures/physiopathology , Nursing Homes/statistics & numerical data , Recovery of Function , Risk Assessment/methods , Survivors/statistics & numerical data , Walking/physiology , Activities of Daily Living , Aged , Aged, 80 and over , Blood Transfusion/methods , Female , Follow-Up Studies , Hip Fractures/mortality , Hip Fractures/rehabilitation , Humans , Male , Middle Aged , Prognosis , Risk Factors , Sex Distribution , Sex Factors , Surveys and Questionnaires , Time Factors , United States/epidemiology
9.
Lancet ; 385(9974): 1183-9, 2015 Mar 28.
Article En | MEDLINE | ID: mdl-25499165

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.


Blood Transfusion/statistics & numerical data , Hip Fractures/surgery , Postoperative Care/methods , Transfusion Reaction , Aged , Aged, 80 and over , Anemia/blood , Anemia/epidemiology , Anemia/therapy , Canada/epidemiology , Cardiovascular Diseases/mortality , Cardiovascular Diseases/prevention & control , Cause of Death , Female , Hemoglobins/analysis , Humans , Male , Middle Aged , Postoperative Care/adverse effects , Risk Factors , Single-Blind Method , Survival Analysis , United States/epidemiology
10.
Acad Med ; 89(6): 940-3, 2014 Jun.
Article En | MEDLINE | ID: mdl-24871247

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.


Review Literature as Topic , Search Engine , Adult , Cross-Over Studies , Female , Humans , Internal Medicine , Male , Reproducibility of Results , Time Factors
11.
Am Heart J ; 165(6): 964-971.e1, 2013 Jun.
Article En | MEDLINE | ID: mdl-23708168

BACKGROUND: 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. METHODS: We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin <10 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 hemoglobin <8 g/dL. The predefined primary outcome was the composite of death, myocardial infarction, or unscheduled revascularization 30 days post randomization. RESULTS: 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). CONCLUSIONS: 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.


Blood Transfusion/methods , Coronary Artery Disease/therapy , Decision Making , Hemoglobins/metabolism , Cardiac Catheterization , Coronary Artery Disease/blood , Coronary Artery Disease/diagnosis , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/prevention & control , Electrocardiography , Follow-Up Studies , Humans , Incidence , Pilot Projects , Prognosis , Retrospective Studies , Survival Rate/trends , United States/epidemiology
12.
N Engl J Med ; 365(26): 2453-62, 2011 Dec 29.
Article En | MEDLINE | ID: mdl-22168590

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 <8 g per deciliter). The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up. RESULTS: A median of 2 units of red cells were transfused in the liberal-strategy group and none in the restrictive-strategy group. The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal-strategy group, 1.01; 95% confidence interval [CI], 0.84 to 1.22), for an absolute risk difference of 0.5 percentage points (95% CI, -3.7 to 4.7). The rates of in-hospital acute coronary syndrome or death were 4.3% and 5.2%, respectively (absolute risk difference, -0.9%; 99% CI, -3.3 to 1.6), and rates of death on 60-day follow-up were 7.6% and 6.6%, respectively (absolute risk difference, 1.0%; 99% CI, -1.9 to 4.0). The rates of other complications were similar in the two groups. CONCLUSIONS: A liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk. (Funded by the National Heart, Lung, and Blood Institute; FOCUS ClinicalTrials.gov number, NCT00071032.).


Erythrocyte Transfusion , Hip Fractures/surgery , Aged , Aged, 80 and over , Anemia/classification , Anemia/therapy , Blood Transfusion/statistics & numerical data , Female , Follow-Up Studies , Hemoglobins , Humans , Male , Middle Aged , Mortality , Postoperative Complications , Risk Factors , Treatment Outcome , Wound Infection
13.
Transfusion ; 49(7): 1395-9, 2009 Jul.
Article En | MEDLINE | ID: mdl-19389032

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.


Anemia/etiology , Anemia/mortality , Adolescent , Adult , Aged , Anemia/metabolism , Female , Hemoglobins/metabolism , Humans , Male , Middle Aged , Retrospective Studies , Young Adult
14.
Am J Med ; 117(9): 629-35, 2004 Nov 01.
Article En | MEDLINE | ID: mdl-15501199

PURPOSE: 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. METHODS: 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. RESULTS: 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% (P <0.001), whereas the percentage of discounted days that were later reversed ranged from 23.2% to 85.3% (P <0.001). 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). CONCLUSION: 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.


Fee-for-Service Plans/economics , Health Maintenance Organizations/economics , Hospital Charges/statistics & numerical data , Hospital Costs/statistics & numerical data , Hospitals, University/statistics & numerical data , Insurance, Health, Reimbursement/statistics & numerical data , Adult , Aged , Cohort Studies , Diagnosis-Related Groups/economics , Diagnosis-Related Groups/statistics & numerical data , Fee-for-Service Plans/statistics & numerical data , Female , Health Maintenance Organizations/statistics & numerical data , Hospitalization/statistics & numerical data , Humans , Length of Stay , Logistic Models , Male , Middle Aged , Odds Ratio , Retrospective Studies
15.
Transfusion ; 43(12): 1717-22, 2003 Dec.
Article En | MEDLINE | ID: mdl-14641869

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.


Anemia/therapy , Blood Transfusion , Hemoglobins , Hip Fractures/rehabilitation , Hip Fractures/surgery , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Male , Middle Aged , Postoperative Complications/therapy , Recovery of Function , Retrospective Studies , Walking
16.
Arch Intern Med ; 162(18): 2053-7, 2002 Oct 14.
Article En | MEDLINE | ID: mdl-12374513

BACKGROUND: 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. OBJECTIVE: To systematically map incidence and outcomes of a broad spectrum of medical complications after hip fracture repair. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.


Fracture Fixation, Internal/adverse effects , Hip Fractures/complications , Hip Fractures/surgery , Postoperative Complications/epidemiology , Aged , Aged, 80 and over , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Cohort Studies , Female , Hip Fractures/mortality , Humans , Male , Medical Records , Middle Aged , Postoperative Complications/etiology , Prognosis , Respiratory Tract Diseases/epidemiology , Respiratory Tract Diseases/etiology , Retrospective Studies , Risk Factors , Survival Analysis , Time Factors , Treatment Outcome , United States
17.
Transfusion ; 42(7): 812-8, 2002 Jul.
Article En | MEDLINE | ID: mdl-12375651

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 > or = 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 inhospital 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 < or = 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.


Blood Transfusion , Hemoglobins/analysis , Postoperative Complications/blood , Postoperative Complications/mortality , Treatment Refusal , Adolescent , Adult , Aged , Aged, 80 and over , Blood Transfusion/psychology , Cohort Studies , Female , Heart Diseases/blood , Heart Diseases/etiology , Heart Diseases/mortality , Hospital Mortality , Humans , Infections/blood , Infections/etiology , Infections/mortality , Intraoperative Care , Jehovah's Witnesses , Male , Middle Aged , Morbidity , Postoperative Complications/etiology , Retrospective Studies , Surgical Procedures, Operative/mortality
18.
Am J Med ; 112(9): 702-9, 2002 Jun 15.
Article En | MEDLINE | ID: mdl-12079710

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.


Hip Fractures/surgery , Aged , Aged, 80 and over , Bacterial Infections/etiology , Female , Hip Fractures/complications , Hip Fractures/mortality , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Pressure Ulcer/etiology , Retrospective Studies , Survival Rate , Thromboembolism/etiology , Time Factors , Treatment Outcome
...