Jockey injuries in the United States

Context  In the sport of horse racing, the position of the jockey and speed of the horse predispose the jockey to risk of injury. Objective  To estimate rates of medically treated injuries among professional jockeys and identify patterns of injury events. Design  Cross-sectional survey from data compiled by an insurance broker. Information on the cause of injury, location on the track, and body part injured was evaluated. Setting  Official races at US professional racing facilities (n = 114) from January 1, 1993, through December 31, 1996. Participants  A licensed jockey population of approximately 2700 persons. Main Outcome Measures  Annual injury incidence rates per 1000 jockey-years, as well as injury type, cause, and location on the track. Results  A total of 6545 injury events occurred during official races between 1993 and 1996 (606 per 1000 jockey-years). Nearly 1 in 5 injuries (18.8%) was to the jockey's head or neck. Other frequent sites included the leg (15.5%), foot/ankle (10.7%), back (10.7%), arm/hand (11.0%), and shoulder (9.6%). The most frequent location where injuries occurred was entering, within, or leaving the starting gate (35.1%), including 29.5% of head injuries, 39.8% of arm/hand injuries, and 52.0% of injuries to the leg/foot. Most head injuries resulted from being thrown from the horse (41.8%) or struck by the horse's head (23.2%). Being thrown from the horse was the cause of 55.1% of back and 49.6% of chest injuries. Conclusions  Our data suggest that jockeys have a high injury rate. Efforts are needed to reduce the number of potential injury events on the track and to improve protective equipment so events do not lead to injury.      

Interns' compliance with accreditation council for graduate medical education work-hour limits

Context  Sleep deprivation is associated with increased risk of serious medical errors and motor vehicle crashes among interns. The Accreditation Council for Graduate Medical Education (ACGME) introduced duty-hour standards in 2003 to reduce work hours. Objective  To estimate compliance with the ACGME duty-hour standards among interns. Design, Setting, and Participants  National prospective cohort study with monthly Web-based survey assessment of intern work and sleep hours using a validated instrument, conducted preimplementation (July 2002 through May 2003) and postimplementation (July 2003 through May 2004) of ACGME standards. Participants were 4015 of the approximately 37 253 interns in US residency programs in all specialties during this time; they completed 29 477 reports of their work and sleep hours. Main Outcome Measure  Overall and monthly rates of compliance with the ACGME standards. Results  Postimplementation, 1068 (83.6%; 95% confidence interval [CI], 81.4%-85.5%) of 1278 of interns reported work hours in violation of the standards during 1 or more months. Working shifts greater than 30 consecutive hours was reported by 67.4% (95% CI, 64.8%-70.0%). Averaged over 4 weeks, 43.0% (95% CI, 40.3%-45.7%) reported working more than 80 hours weekly, and 43.7% (95% CI, 41.0%-46.5%) reported not having 1 day in 7 off work duties. Violations were reported during 3765 (44.0%; 95% CI, 43.0%-45.1%) of the 8553 intern-months assessed postimplementation (including vacation and ambulatory rotations), and during 2660 (61.5%; 95% CI, 60.0%-62.9%) of 4327 intern-months during which interns worked exclusively in inpatient settings. Postimplementation, 29.0% (95% CI, 28.7%-29.7%) of reported work weeks were more than 80 hours per week, 12.1% (95% CI, 11.8%-12.6%) were 90 or more hours per week, and 3.9% (95% CI, 3.7%-4.2%) were 100 or more hours per week. Comparing preimplementation to postimplementation responses, reported mean work duration decreased 5.8% from 70.7 (95% CI, 70.5-70.9) hours to 66.6 (95% CI, 66.3-66.9) hours per week (P<.001), and reported mean sleep duration increased 6.1% (22 minutes) from 5.91 (95% CI, 5.88-5.94) hours to 6.27 (95% CI, 6.23-6.31) hours per night (P<.001). However, reported mean sleep during extended shifts decreased 4.5%, from 2.69 (95% CI, 2.66-2.73) hours to 2.57 (95% CI, 2.52-2.62) hours (P<.001). Conclusion  In the first year following implementation of the ACGME duty-hour standards, interns commonly reported noncompliance with these requirements.      

Effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation

Context  Although reperfusion therapy, aspirin, -blockers, and angiotensin-converting enzyme inhibitors reduce mortality when used early in patients with acute myocardial infarction (MI), mortality and morbidity remain high. No antithrombotic or newer antiplatelet drug has been shown to reduce mortality in acute MI. Objective  To evaluate the effects of reviparin, a low-molecular-weight heparin, when initiated early and given for 7 days in addition to usual therapy on the primary composite outcome of death, myocardial reinfarction, or strokes at 7 and 30 days. Design, Setting, and Patients  A randomized, double-blind, placebo-controlled trial (Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation [CREATE]) of 15 570 patients with ST-segment elevation or new left bundle-branch block, presenting within 12 hours of symptom onset at 341 hospitals in India and China from July 2001 through July 2004. Intervention  Reviparin or placebo subcutaneously twice daily for 7 days. Main Outcome Measure  Primary composite outcome of death, myocardial reinfarction, or stroke at 7 and 30 days. Results  The primary composite outcome was significantly reduced from 854 (11.0%) of 7790 patients in the placebo group to 745 (9.6%) of 7780 in the reviparin group (hazard ratio [HR], 0.87; 95% CI, 0.79-0.96; P = .005). These benefits persisted at 30 days (1056 [13.6%] vs 921 [11.8%] patients; HR, 0.87; 95% CI, 0.79-0.95; P = .001) with significant reductions in 30-day mortality (877 [11.3%] vs 766 [9.8%]; HR, 0.87; 95% CI, 0.79-0.96; P = .005) and reinfarction (199 [2.6%] vs 154 [2.0%]; HR, 0.77; 95% CI, 0.62-0.95; P = .01), and no significant differences in strokes (64 [0.8%] vs 80 [1.0%]; P = .19). Reviparin treatment was significantly better when it was initiated very early after symptom onset at 7 days (<2 hours: HR, 0.70; 95% CI, 0.52-0.96; P = .03; 30/1000 events prevented; 2 to <4 hours: HR, 0.81; 95% CI, 0.67-0.98; P = .03; 21/1000 events prevented; 4 to <8 hours: HR, 0.85; 95% CI, 0.73-0.99; P = .05; 16/1000 events prevented; and 8 hours: HR, 1.06; 95% CI, 0.86-1.30; P = .58; P = .04 for trend). There was an increase in life-threatening bleeding at 7 days with reviparin and placebo (17 [0.2%] vs 7 [0.1%], respectively; P = .07), but the absolute excess was small (1 more per 1000) vs reductions in the primary outcome (18 fewer per 1000) or mortality (15 fewer per 1000). Conclusions  In patients with acute ST-segment elevation or new left bundle-branch block MI, reviparin reduces mortality and reinfarction, without a substantive increase in overall stroke rates. There is a small absolute excess of life-threatening bleeding but the benefits outweigh the risks.      

Relation between operator and hospital volume and outcomes following percutaneous coronary interventions in the era of the coronary stent

Context  Studies have found an association between physician and institution procedure volume for percutaneous coronary interventions (PCIs) and patient outcomes, but whether implementation of coronary stents has allowed low-volume physicians and centers to achieve outcomes similar to their high-volume counterparts is unknown. Objective  To assess the relationship between physician and hospital PCI volumes and patient outcomes following PCIs, given the availability of coronary stents. Design, Setting, and Participants  Analysis of data from Medicare National Claims History files for 167 208 patients aged 65 to 99 years who had PCIs performed by 6534 physicians at 1003 hospitals during 1997. Of these procedures, 57.7% involved coronary stents. Main Outcome Measures  Rates of coronary artery bypass graft (CABG) surgery and 30-day mortality occurring during the index episode of care, stratified by physician and hospital PCI volume. Results  Overall unadjusted rates of CABG during the index hospitalization and 30-day mortality were 1.87% and 3.30%, respectively. After adjustment for case mix, patients treated by low-volume (<30 Medicare procedures) physicians had an increased risk of CABG vs patients treated by high-volume (>60 Medicare procedures) physicians (2.25% vs 1.55%; P<.001), but there was no difference in 30-day mortality rates (3.25% vs 3.39%; P = .27). Patients treated at low-volume (<80 Medicare procedures) centers had an increased risk of 30-day mortality vs patients treated at high-volume (>160 Medicare procedures) centers (4.29% vs 3.15%; P<.001), but there was no difference in the risk of CABG (1.83% vs 1.83%; P = .96). In patients who received coronary stents, the CABG rate was 1.20% vs 2.78% for patients not receiving stents, and the 30-day mortality rate was 2.83% vs 3.94%. Among patients who received stents, those treated at low-volume centers had an increased risk of 30-day mortality vs those treated at high-volume centers, whereas those treated by low-volume physicians had an increased risk of CABG vs those treated by high-volume physicians. Conclusion  In the era of coronary stents, Medicare patients treated by high-volume physicians and at high-volume centers experience better outcomes following PCIs.      

Hospital characteristics associated with the management of pediatric splenic injuries

Context  Despite evidence that more than 90% of children with traumatic injuries to the spleen can be successfully managed nonoperatively, there is significant variation in the use of splenectomy. As asplenic children are at increased risk of overwhelming postsplenectomy infection, nonoperative management may be considered a quality of care indicator. Objective  To test the hypothesis that children are more likely to undergo splenectomy in general hospitals than in children’s hospitals. Design  Retrospective cohort study using data from the Kid’s Inpatient Database (KID) for the year 2000. Multivariable regression was used to control for patient and hospital characteristics. Setting and Participants  All children aged 0 to 16 years who were hospitalized with a traumatic (noniatrogenic) spleen injury in nonfederal short-stay hospitals in any of the 27 states participating in KID (N = 2851). Main Outcome Measure  Splenectomy performed within 1 day of arrival. Results  A total of 11 children (3%) with splenic injuries receiving care at children’s hospitals underwent splenectomy compared with 383 children (15.4%) cared for at general hospitals (P<.001). After adjusting for patient characteristics, injury severity, and hospital characteristics, splenectomy was more likely among children treated at general hospitals (odds ratio, 5.01; 95% confidence interval, 2.21-11.36) than among children treated at children’s hospitals. Conclusions  There is considerable variation in the management of pediatric splenic injuries, with significantly lower rates of splenectomy at designated children’s hospitals. Quality improvement interventions, including increased education and training for physicians in general hospitals, may be needed to increase the use of spleen-conserving management practices.      

Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial

Context  Despite many therapeutic advances, mortality in patients with acute ST-segment elevation myocardial infarction (STEMI) remains high. The role of additional antithrombotic agents is unclear, especially among patients not receiving reperfusion therapy. Objective  To evaluate the effect of fondaparinux, a factor Xa inhibitor, when initiated early and given for up to 8 days vs usual care (placebo in those in whom unfractionated heparin [UFH] is not indicated [stratum 1] or unfractionated heparin for up to 48 hours followed by placebo for up to 8 days [stratum 2]) in patients with STEMI. Design, Setting, and Participants  Randomized double-blind comparison of fondaparinux 2.5 mg once daily or control for up to 8 days in 12 092 patients with STEMI from 447 hospitals in 41 countries (September 2003-January 2006). From day 3 through day 9, all patients received either fondaparinux or placebo according to the original randomized assignment. Main Outcome Measures  Composite of death or reinfarction at 30 days (primary) with secondary assessments at 9 days and at final follow-up (3 or 6 months). Results  Death or reinfarction at 30 days was significantly reduced from 677 (11.2%) of 6056 patients in the control group to 585 (9.7%) of 6036 patients in the fondaparinux group (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.77-0.96; P = .008); absolute risk reduction, 1.5%; 95% CI, 0.4%-2.6%). These benefits were observed at 9 days (537 [8.9%] placebo vs 444 [7.4%] fondaparinux; HR, 0.83; 95% CI, 0.73-0.94; P = .003, and at study end (857 [14.8%] placebo vs 756 [13.4%] fondaparinux; HR, 0.88; 95% CI, 0.79-0.97; P = .008). Mortality was significantly reduced throughout the study. There was no heterogeneity of the effects of fondaparinux in the 2 strata by planned heparin use. However, there was no benefit in those undergoing primary percutaneous coronary intervention. In other patients in stratum 2, fondaparinux was superior to unfractionated heparin in preventing death or reinfarction at 30 days (HR, 0.82; 95% CI, 0.66-1.02; P = .08) and at study end (HR, 0.77; 95% CI, 0.64-0.93; P = .008). Significant benefits were observed in those receiving thrombolytic therapy (HR, 0.79; P = .003) and those not receiving any reperfusion therapy (HR, 0.80; P = .03). There was a tendency to fewer severe bleeds (79 for placebo vs 61 for fondaparinux; P = .13), with significantly fewer cardiac tamponade (48 vs 28; P = .02) with fondaparinux at 9 days. Conclusion  In patients with STEMI, particularly those not undergoing primary percutaneous coronary intervention, fondaparinux significantly reduces mortality and reinfarction without increasing bleeding and strokes. Trial Registration  ClinicalTrials.gov Identifier NCT00064428      

Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy

Context  Intraoperative cholangiography (IOC) may decrease the risk of common bile duct (CBD) injury during cholecystectomy by helping to avoid misidentification of the CBD. Objective  To characterize the relationship of IOC use and CBD injury while controlling for patient and surgeon characteristics. Design, Setting, and Patients  Retrospective nationwide cohort analysis of Medicare patients undergoing cholecystectomy from January 1, 1992, to December 31, 1999. Patients were identified using Current Procedural Terminology codes from the Medicare Part B depository. Common bile duct injury was defined by a second surgical procedure to repair the CBD injury within 1 year of cholecystectomy. Surgeon demographic features were obtained from matching the Medicare Part B data to the American Medical Association Physician Masterfile database. Main Outcome Measure  Frequency of CBD injury in patients who did and did not have IOC performed during cholecystectomy, controlling for patient-level (age, sex, race, and case complexity) and surgeon-level (surgeon's age, sex, race, year of surgical procedure, case order, percentage of IOC use in prior surgical procedures, years in medical practice, board certification, and specialization) factors. Results  The database search identified 1 570 361 cholecystectomies and 7911 CBD injuries (0.5%). Common bile duct injury was found in 2380 (0.39%) of 613 706 patients undergoing cholecystectomy with IOC and in 5531 (0.58%) of 956 655 patients undergoing cholecystectomy without IOC (unadjusted relative risk, 1.49; 95% confidence interval, 1.42-1.57). After controlling for patient-level factors and surgeon-level factors, the risk of injury was increased when IOC was not used (adjusted relative risk, 1.71; 95% confidence interval, 1.38-2.28). While surgeons performing IOCs routinely had a lower rate of CBD injuries than those who did not, this difference disappeared when IOC was not used. Conclusions  In this study of Medicare patients undergoing cholecystectomy in the 1990s, the risk of CBD injury was significantly higher when IOC was not used. Although IOCs may not prevent all CBD injuries, this study suggests that the routine use of IOC may decrease the rate of CBD injury.      

National surveillance of emergency department visits for outpatient adverse drug events

Context  Adverse drug events are common and often preventable causes of medical injuries. However, timely, nationally representative information on outpatient adverse drug events is limited. Objective  To describe the frequency and characteristics of adverse drug events that lead to emergency department visits in the United States. Design, Setting, and Participants  Active surveillance from January 1, 2004, through December 31, 2005, through the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project. Main Outcome Measures  National estimates of the numbers, population rates, and severity (measured by hospitalization) of individuals with adverse drug events treated in emergency departments. Results  Over the 2-year study period, 21 298 adverse drug event cases were reported, producing weighted annual estimates of 701 547 individuals (95% confidence interval [CI], 509 642-893 452) or 2.4 individuals per 1000 population (95% CI, 1.7-3.0) treated in emergency departments. Of these cases, 3487 individuals required hospitalization (annual estimate, 117 318 [16.7%]; 95% CI, 13.1%-20.3%). Adverse drug events accounted for 2.5% (95% CI, 2.0%-3.1%) of estimated emergency department visits for all unintentional injuries and 6.7% (95% CI, 4.7%-8.7%) of those leading to hospitalization and accounted for 0.6% of estimated emergency department visits for all causes. Individuals aged 65 years or older were more likely than younger individuals to sustain adverse drug events (annual estimate, 4.9 vs 2.0 per 1000; rate ratio [RR], 2.4; 95% CI, 1.8-3.0) and more likely to require hospitalization (annual estimate, 1.6 vs 0.23 per 1000; RR, 6.8; 95% CI, 4.3-9.2). Drugs for which regular outpatient monitoring is used to prevent acute toxicity accounted for 41.5% of estimated hospitalizations overall (1381 cases; 95% CI, 30.9%-52.1%) and 54.4% of estimated hospitalizations among individuals aged 65 years or older (829 cases; 95% CI, 45.0%-63.7%). Conclusions  Adverse drug events among outpatients that lead to emergency department visits are an important cause of morbidity in the United States, particularly among individuals aged 65 years or older. Ongoing, population-based surveillance can help monitor these events and target prevention strategies.      

Routine upstream initiation vs deferred selective use of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: the ACUITY Timing trial

Context  In patients with moderate- and high-risk acute coronary syndromes (ACS) who undergo an early, invasive treatment strategy, current guidelines recommend administration of platelet glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitors, either upstream to all patients prior to angiography or deferred for selective use in the catheterization laboratory just prior to angioplasty. The preferred approach is undetermined. Objective  To determine the optimal strategy for the use of Gp IIb/IIIa inhibitors in patients with moderate- and high-risk ACS undergoing an early, invasive treatment strategy. Design  Prospective, randomized, open-label trial with 30-day clinical follow-up. Setting  Four hundred fifty academic and community-based institutions in 17 countries. Patients  A total of 9207 patients with moderate- and high-risk ACS undergoing an invasive treatment strategy. Interventions  Patients were randomly assigned to receive either routine upstream (n=4605) or deferred selective (n=4602) Gp IIb/IIIa inhibitor administration, respectively. Main Outcome Measures  The primary outcome was assessment of noninferiority of deferred Gp IIb/IIIa inhibitor use compared with upstream administration for the prevention of composite ischemic events (death, myocardial infarction, or unplanned revascularization for ischemia) at 30 days, using a 1-sided level of .025. Major secondary end points included noninferiority or superiority of major bleeding and net clinical outcomes (composite ischemia or major bleeding). Results  Glycoprotein IIb/IIIa inhibitors were used more frequently (98.3% vs 55.7%, respectively) and for a significantly longer duration (median, 18.3 vs 13.1 hours; P<.001) in patients in the upstream group compared with the deferred group. Composite ischemia at 30 days occurred in 7.9% of patients assigned to deferred use compared with 7.1% of patients assigned to upstream administration (relative risk, 1.12; 95% confidence interval, 0.97-1.29; P = .044 for noninferiority; P = .13 for superiority); as such, the criterion for noninferiority was not met. Deferred use compared with upstream use resulted in reduced 30-day rates of major bleeding (4.9% vs 6.1%, respectively; P<.001 for noninferiority; P = .009 for superiority) and similar rates of net clinical outcomes (11.7% vs 11.7%; P<.001 for noninferiority; P = .93 for superiority). Conclusions  Among patients with moderate- and high-risk ACS undergoing an invasive treatment strategy, deferring the routine upstream use of Gp IIb/IIIa inhibitors for selective administration in the cardiac catheterization laboratory only to patients undergoing percutaneous coronary intervention resulted in a numerical increase in composite ischemia that, while not statistically significant, did not meet the criterion for noninferiority. This finding was offset by a significant reduction in major bleeding. Trial Registration  ClinicalTrials.gov Identifier: NCT00093158      

Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization

Context  Although medical injuries are recognized as a major hazard in the health care system, little is known about their impact. Objective  To assess excess length of stay, charges, and deaths attributable to medical injuries during hospitalization. Design, Setting, and Patients  The Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSIs) were used to identify medical injuries in 7.45 million hospital discharge abstracts from 994 acute-care hospitals across 28 states in 2000 in the AHRQ Healthcare Cost and Utilization Project Nationwide Inpatient Sample database. Main Outcome Measures  Length of stay, charges, and mortality that were recorded in hospital discharge abstracts and were attributable to medical injuries according to 18 PSIs. Results  Excess length of stay attributable to medical injuries ranged from 0 days for injury to a neonate to 10.89 days for postoperative sepsis, excess charges ranged from $0 for obstetric trauma (without vaginal instrumentation) to $57 727 for postoperative sepsis, and excess mortality ranged from 0% for obstetric trauma to 21.96% for postoperative sepsis (P<.001). Following postoperative sepsis, the second most serious event was postoperative wound dehiscence, with 9.42 extra days in the hospital, $40 323 in excess charges, and 9.63% attributable mortality. Infection due to medical care was associated with 9.58 extra days, $38 656 in excess charges, and 4.31% attributable mortality. Conclusion  Some injuries incurred during hospitalization pose a significant threat to patients and costs to society, but the impact of such injury is highly variable.      

Effects of losartan on cardiovascular morbidity and mortality in patients with isolated systolic hypertension and left ventricular hypertrophy: a Losartan Intervention for Endpoint Reduction (LIFE) substudy

Context  Drug intervention in placebo-controlled trials has been beneficial in isolated systolic hypertension. Objective  To test the hypothesis that losartan improves outcome better than atenolol in patients with isolated systolic hypertension and electrocardiographically documented left ventricular hypertrophy (ECG-LVH). Design  Double-blind, randomized, parallel-group study conducted in 1995-2001. Setting and Participants  A total of 1326 men and women aged 55 through 80 years (mean, 70 years) with systolic blood pressure of 160 to 200 mm Hg and diastolic blood pressure of less than 90 mm Hg (mean, 174/83 mm Hg) and ECG-LVH, recruited from 945 outpatient settings in the Nordic countries, the United Kingdom, and the United States. Interventions  Patients were randomly assigned to receive once-daily losartan (n = 660) or atenolol (n = 666) with hydrochlorothiazide as the second agent in both arms, for a mean of 4.7 years. Main Outcome Measure  Composite end point of cardiovascular death, stroke, or myocardial infarction. Results  Blood pressure was reduced by 28/9 and 28/9 mm Hg in the losartan and atenolol arms. The main outcome was reduced by 25% with losartan compared with atenolol, 25.1 vs 35.4 events per 1000 patient-years (relative risk [RR], 0.75; 95% confidence interval [CI], 0.56-1.01; P = .06, adjusted for risk and degree of ECG-LVH; unadjusted RR, 0.71; 95% CI, 0.53-0.95; P = .02). Patients receiving losartan had reductions in the following without a difference in the incidence of myocardial infarction: cardiovascular mortality (8.7 vs 16.9 events per 1000 patient-years; RR, 0.54; 95% CI, 0.34-0.87; P = .01), nonfatal and fatal stroke (10.6 vs 18.9 events per 1000 patient-years; RR, 0.60; 95% CI, 0.38-0.92; P = .02), new-onset diabetes (12.6 vs 20.1 events per 1000 patient-years; RR, 0.62; 95% CI, 0.40-0.97; P = .04), and total mortality (21.2 vs 30.2 events per 1000 patient-years; RR, 0.72; 95% CI, 0.53-1.00; P = .046). Losartan decreased ECG-LVH more than atenolol (P<.001) and was better tolerated. Conclusion  These data suggest that losartan is superior to atenolol for treatment of patients with isolated systolic hypertension and ECG-LVH.      

Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial

Context  The direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI). Objective  To determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications. Design, Setting, and Participants  The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)–2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. Interventions  Patients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. Main Outcome Measures  The primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization. Results  Provisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P = .32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P = .40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001). Conclusions  Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.      

Certificate of need regulations and use of coronary revascularization after acute myocardial infarction

Context  Certificate of need regulations were enacted to control health care costs by limiting unnecessary expansion of services. While many states have repealed certificate of need regulations in recent years, few analyses have examined relationships between certificate of need regulations and outcomes of care. Objective  To compare rates of coronary revascularization and mortality after acute myocardial infarction in states with and without certificate of need regulations. Design, Setting, and Participants  Retrospective cohort study of 1 139 792 Medicare beneficiaries aged 68 years or older with AMI who were admitted to 4587 US hospitals during 2000-2003. Main Outcome Measures  Thirty-day risk-adjusted rates of coronary revascularization with either coronary artery bypass graft surgery or percutaneous coronary intervention and 30-day all-cause mortality. Results  The 624 421 patients in states with certificate of need regulations were less likely to be admitted to hospitals with coronary revascularization services (321 573 [51.5%] vs 323 695 [62.8%]; P<.001) or to undergo revascularization at the admitting hospital (163 120 [26.1%] vs 163 877 [31.8%]; P<.001) than patients in states without certificates of need but were more likely to undergo revascularization at a transfer hospital (73 379 [11.7%] vs 45 907 [8.9%]; P<.001). Adjusting for demographic and clinical risk factors, patients in states with highly and moderately stringent certificate of need regulations, respectively, were less likely to undergo revascularization within the first 2 days (adjusted hazard ratios, 0.68; 95% confidence interval [CI], 0.54-0.87; P = .002 and 0.80; 95% CI, 0.71-0.90; P<.001) relative to patients in states without certificates of need, although no differences in the likelihood of revascularization were observed during days 3 through 30. Unadjusted 30-day mortality was similar in states with and without certificates of need (109 304 [17.5%] vs 90 104 [17.5%]; P = .76), as was adjusted mortality (odds ratio, 1.00; 95% CI, 0.97-1.03; P = .90). Conclusions  Patients with acute myocardial infarction were less likely to be admitted to hospitals offering coronary revascularization and to undergo early revascularization in states with certificate of need regulations. However, differences in the availability and use of revascularization therapies were not associated with mortality.      

Transition of extremely low-birth-weight infants from adolescence to young adulthood: comparison with normal birth-weight controls

Context  Traditionally, educational attainment, getting a job, living independently, getting married, and parenthood have been considered as markers of successful transition to adulthood. Objective  To describe and compare the achievement and the age at attainment of the above markers between extremely low-birth-weight (ELBW) and normal birth-weight (NBW) young adults. Design, Setting, and Participants  A prospective, longitudinal, population-based study in central-west Ontario, Canada, of 166 ELBW participants who weighed 501 to 1000 g at birth (1977-1982) and 145 sociodemographically comparable NBW participants assessed at young adulthood (22-25 years). Interviewers masked to participant status administered validated questionnaires via face-to-face interviews between January 1, 2002, and April 30, 2004. Main Outcome Measures  Markers of successful transition to adulthood, including educational attainment, student and/or worker role, independent living, getting married, and parenthood. Results  At young adulthood, 149 (90%) of 166 ELBW participants and 133 (92%) of 145 NBW participants completed the assessments at mean (SD) age of 23.3 (1.2) years and 23.6 (1.1) years, respectively. We included participants with neurosensory impairments (ELBW vs NBW: 40 [27%] vs 3 [2%]) and 7 proxy respondents. The proportion who graduated from high school was similar (82% vs 87%, P = .21). Overall, no statistically significant differences were observed in the education achieved to date. A substantial proportion of both groups were still pursuing postsecondary education (47 [32%] vs 44 [33%]). No significant differences were observed in employment/school status; 71 (48%) ELBW vs 76 (57%) NBW young adults were permanently employed (P = .09). In a subanalysis, a higher proportion of ELBW young adults were neither employed nor in school (39 [26%] vs 20 [15%], P = .02 by Holm's correction); these differences did not persist when participants with disabilities were excluded. No significant differences were found in the proportion living independently (63 [42%] vs 70 [53%], P = .19), married/cohabitating (34 [23%] vs 33 [25%], P = .69), or who were parents (16 [11%] vs 19 [14%], P = .36). The age at attainment of the above markers was similar for both cohorts. Conclusion  Our study results indicate that a significant majority of former ELBW infants have overcome their earlier difficulties to become functional young adults.      

Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures

Context  Case series demonstrate that bariatric surgery can be performed with a low rate of perioperative mortality (0.5%), but the rate among high-risk patients and the community at large is unknown. Objectives  To evaluate the risk of early mortality among Medicare beneficiaries and to determine the relative risk of death among older patients. Design  Retrospective cohort study. Setting and Patients  All fee-for-service Medicare beneficiaries, 1997-2002. Main Outcome Measures  Thirty-day, 90-day, and 1-year postsurgical all-cause mortality among patients undergoing bariatric procedures. Results  A total of 16 155 patients underwent bariatric procedures (mean age, 47.7 years [SD, 11.3 years]; 75.8% women). The rates of 30-day, 90-day, and 1-year mortality were 2.0%, 2.8%, and 4.6%, respectively. Men had higher rates of early death than women (3.7% vs 1.5%, 4.8% vs 2.1%, and 7.5% vs 3.7% at 30 days, 90 days, and 1 year, respectively; P<.001). Mortality rates were greater for those aged 65 years or older compared with younger patients (4.8% vs 1.7% at 30 days, 6.9% vs 2.3% at 90 days, and 11.1% vs 3.9% at 1 year; P<.001). After adjustment for sex and comorbidity index, the odds of death within 90 days were 5-fold greater for older Medicare beneficiaries (aged 75 years; n = 136) than for those aged 65 to 74 years (n = 1381; odds ratio, 5.0; 95% confidence interval, 3.1-8.0). The odds of death at 90 days were 1.6 times higher (95% confidence interval, 1.3-2.0) for patients of surgeons with less than the median surgical volume of bariatric procedures (among Medicare beneficiaries during the study period) after adjusting for age, sex, and comorbidity index. Conclusions  Among Medicare beneficiaries, the risk of early death after bariatric surgery is considerably higher than previously suggested and associated with advancing age, male sex, and lower surgeon volume of bariatric procedures. Patients aged 65 years or older had a substantially higher risk of death within the early postoperative period than younger patients.      

Improving the use of hospice services in nursing homes: a randomized controlled trial

Context  Hospice care may improve the quality of end-of-life care for nursing home residents, but hospice is underutilized by this population, at least in part because physicians are not aware of their patients’ preferences. Objective  To determine whether it is possible to increase hospice utilization and improve the quality of end-of-life care by identifying residents whose goals and preferences are consistent with hospice care. Design, Setting, and Participants  Randomized controlled trial (December 2003-December 2004) of nursing home residents and their surrogate decision makers (N=205) in 3 US nursing homes. Intervention  A structured interview identified residents whose goals for care, treatment preferences, and palliative care needs made them appropriate for hospice care. These residents’ physicians were notified and asked to authorize a hospice informational visit. Main Outcome Measures  The primary outcome measures were (1) hospice enrollment within 30 days of the intervention and (2) families’ ratings of the quality of care for residents who died during the 6-month follow-up period. Results  Of the 205 residents in the study sample, 107 were randomly assigned to receive the intervention, and 98 received usual care. Intervention residents were more likely than usual care residents to enroll in hospice within 30 days (21/107 [20%] vs 1/98 [1%]; P<.001 [Fisher exact test]) and to enroll in hospice during the follow-up period (27/207 [25%] vs 6/98 [6%]; P<.001). Intervention residents had fewer acute care admissions (mean: 0.28 vs 0.49; P = .04 [Wilcoxon rank sum test]) and spent fewer days in an acute care setting (mean: 1.2 vs 3.0; P = .03 [Wilcoxon rank sum test]). Families of intervention residents rated the resident’s care more highly than did families of usual care residents (mean on a scale of 1-5: 4.1 vs 2.5; P = .04 [Wilcoxon rank sum test]). Conclusion  A simple communication intervention can increase rates of hospice referrals and families’ ratings of end-of-life care and may also decrease utilization of acute care resources.      

Geriatric care management for low-income seniors: a randomized controlled trial

Steven R. Counsell, MD; Christopher M. Callahan, MD; Daniel O. Clark, PhD; Wanzhu Tu, PhD; Amna B. Buttar, MD, MS; Timothy E. Stump, MS; Gretchen D. Ricketts, BSW

JAMA. 2007;298(22):2623-2633.

Context  Low-income seniors frequently have multiple chronic medical conditions for which they often fail to receive the recommended standard of care.

Objectives  To test the effectiveness of a geriatric care management model on improving the quality of care for low-income seniors in primary care.

Design, Setting, and Patients  Controlled clinical trial of 951 adults 65 years or older with an annual income less than 200% of the federal poverty level, whose primary care physicians were randomized from January 2002 through August 2004 to participate in the intervention (474 patients) or usual care (477 patients) in community-based health centers.

Intervention  Patients received 2 years of home-based care management by a nurse practitioner and social worker who collaborated with the primary care physician and a geriatrics interdisciplinary team and were guided by 12 care protocols for common geriatric conditions.

Main Outcome Measures  The Medical Outcomes 36-Item Short-Form (SF-36) scales and summary measures; instrumental and basic activities of daily living (ADLs); and emergency department (ED) visits not resulting in hospitalization and hospitalizations.

Results  Intention-to-treat analysis revealed significant improvements for intervention patients compared with usual care at 24 months in 4 of 8 SF-36 scales: general health (0.2 vs –2.3, P = .045), vitality (2.6 vs –2.6, P < .001), social functioning (3.0 vs –2.3, P = .008), and mental health (3.6 vs –0.3, P = .001); and in the Mental Component Summary (2.1 vs –0.3, P < .001). No group differences were found for ADLs or death. The cumulative 2-year ED visit rate per 1000 was lower in the intervention group (1445 [n = 474] vs 1748 [n = 477], P = .03) but hospital admission rates per 1000 were not significantly different between groups (700 [n = 474] vs 740 [n = 477], P = .66). In a predefined group at high risk of hospitalization (comprising 112 intervention and 114 usual-care patients), ED visit and hospital admission rates were lower for intervention patients in the second year (848 [n = 106] vs 1314 [n = 105]; P = .03 and 396 [n = 106] vs 705 [n = 105]; P = .03, respectively).

Conclusions  Integrated and home-based geriatric care management resulted in improved quality of care and reduced acute care utilization among a high-risk group. Improvements in health-related quality of life were mixed and physical function outcomes did not differ between groups. Future studies are needed to determine whether more specific targeting will improve the program's effectiveness and whether reductions in acute care utilization will offset program costs.

Trial Registration  clinicaltrials.gov Identifier: NCT00182962

     

Long-term outcome of primary percutaneous coronary intervention vs prehospital and in-hospital thrombolysis for patients with ST-elevation myocardial infarction

Context  Whether the superior results of percutaneous coronary intervention (PCI) reported in clinical trials in which patients with ST-segment elevation myocardial infarction (STEMI) received reperfusion treatment can be replicated in daily practice has been questioned, especially whether it is superior to prehospital thrombolysis (PHT). Objective  To evaluate the outcome of different reperfusion strategies in consecutive STEMI patients. Design, Setting, and Patients  A prospective observational cohort study of 26 205 consecutive STEMI patients in the Register of Information and Knowledge about Swedish Heart Intensive Care Admissions (RIKS-HIA) who received reperfusion therapy within 15 hours of symptom onset. The registry includes more than 95% of all Swedish patients, of all ages, who were treated in a coronary intensive care unit between 1999 and 2004. Interventions  Seven thousand eighty-four patients underwent primary PCI; 3078, PHT; and 16 043, in-hospital thrombolysis (IHT). Main Outcome Measures  Mortality, reinfarction, and readmissions as reported in the National Health Registries through December 31, 2005. Results  After adjusting for younger age and less comorbidity, primary PCI was associated with lower mortality than IHT at 30 days (344 [4.9%] vs 1834 [11.4%]; hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.53-0.71) and at 1 year (541 [7.6%] vs 2555 [15.9%]; HR, 0.68; 95% CI, 0.60-0.76). Also primary PCI correlated with lower mortality than PHT at 30 days (344 [4.9%] vs 234 [7.6%]; HR, 0.70; 95% CI, 0.58-0.85) and 1 year (541 [7.6%] vs 317 [10.3%]; HR, 0.81; 95% CI, 0.69-0.94). Prehospital thrombolysis predicted a lower mortality than IHT at 30 days (HR, 0.87; 95% CI, 0.76-1.01) and at 1 year (HR, 0.84; CI 0.74-0.95). Beyond 2 hours' treatment delay, the observed mortality reductions with PHT tended to decrease while the benefits with primary PCI seemed to remain regardless of time delay. Primary PCI was also associated with shorter hospital stay and less reinfarction than either PHT or IHT. Conclusions  In unselected patients with STEMI, primary PCI, which compared favorably with IHT and PHT, was associated with reduced duration of hospital stay, readmission, reinfarction, and mortality.      

Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials

Context  The benefits of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate. Objective  To combine data from all randomized trials conducted with abciximab in STEMI. Data Sources  Formal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004. Study Selection  We examined all completed, published, randomized trials of abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and abciximab. Data Extraction  Information on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus. Data Synthesis  Eleven trials were analyzed, involving 27115 patients (12 602 [46.5%] in the abciximab group, 14 513 [53.5%] in the control group). When compared with the control group, abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36). Conclusions  This meta-analysis shows that, when compared with the control group, adjunctive abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with abciximab in association with fibrinolysis.      

Walking and dementia in physically capable elderly men

Context  Evidence suggests that physical activity may be related to the clinical expression of dementia. Whether the association includes low-intensity activity such as walking is not known. Objective  To examine the association between walking and future risk of dementia in older men. Design  Prospective cohort study. Setting and Participants  Distance walked per day was assessed from 1991 to 1993 in 2257 physically capable men aged 71 to 93 years in the Honolulu-Asia Aging Study. Follow-up for incident dementia was based on neurological assessment at 2 repeat examinations (1994-1996 and 1997-1999). Main Outcome Measures  Overall dementia, Alzheimer disease, and vascular dementia. Results  During the course of follow-up, 158 cases of dementia were identified (15.6/1000 person-years). After adjusting for age, men who walked the least (<0.25 mile/d) experienced a 1.8-fold excess risk of dementia compared with those who walked more than 2 mile/d (17.8 vs 10.3/1000 person-years; relative hazard [RH], 1.77; 95% confidence interval [CI], 1.04-3.01). Compared with men who walked the most (>2 mile/d), an excess risk of dementia was also observed in those who walked 0.25 to 1 mile/d (17.6 vs 10.3/1000 person-years; RH, 1.71; 95% CI, 1.02-2.86). These associations persisted after accounting for other factors, including the possibility that limited amounts of walking could be the result of a decline in physical function due to preclinical dementia. Conclusions  Findings suggest that walking is associated with a reduced risk of dementia. Promoting active lifestyles in physically capable men could help late-life cognitive function.