Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study.

BACKGROUND: Despite the extensive use of real-world data for retrospective, observational clinical research, our understanding of how real-world data might increase the efficiency of data collection in patient-level randomized clinical trials is largely unknown. The structure of real-world data is inherently heterogeneous, with each source electronic health record and claims database different from the next. Their fitness-for-use as data sources for multisite trials in the United States has not been established. METHODS: For a subset of participants in the HARMONY Outcomes Trial, we obtained electronic health record data from recruiting sites or Medicare claims data from the Centers for Medicare & Medicaid Services. For baseline characteristics and follow-up events, we assessed the level of agreement between these real-world data and data documented in the trial database. RESULTS: Real-world data-derived demographic information tended to agree with trial-reported demographic information, although real-world data were less accurate in identifying medical history. The ability of real-world data to identify baseline medication usage differed by real-world data source, with claims data demonstrating substantially better performance than electronic health record data. The limited number of lab results in the collected electronic health record data matched closely with values in the trial database. There were not enough follow-up events in the ancillary study population to draw meaningful conclusions about the performance of real-world data for identification of events. Based on the conduct of this ancillary study, the challenges and opportunities of using real-world data within clinical trials are discussed. CONCLUSION: Based on a subset of participants from the HARMONY Outcomes Trial, our results suggest that electronic health record or claims data, as currently available, are unlikely to be a complete substitute for trial data collection of medical history or baseline lab results, but that Medicare claims were able to identify most medications. The limited size of the study population prevents us from drawing strong conclusions based on these results, and other studies are clearly needed to confirm or refute these findings.

Validation of an administrative claims coding algorithm for serious opioid overdose: A medical chart review.

PURPOSE: A standardized definition for serious opioid overdose has not been clearly established for disease surveillance or assessing the impact of risk mitigation strategies. The purpose of this study was to use medical chart review to clinically validate a claims-based algorithm to identify serious opioid overdose events. METHODS: The algorithm for serious opioid overdose required an opioid poisoning or external cause ICD-9-CM code occurring within 1 day of (a) an adverse effect code for serious central nervous system or respiratory depression or (b) a mechanical ventilation or critical care CPT code. The claims coding algorithm identified a sample of 145 individuals 18 years or older among patients that presented to the emergency department of two large hospitals in metropolitan Atlanta, Georgia from January 2014 to August 2015. Claims-defined cases were evaluated against rigorous clinical definitions for serious opioid overdose using (a) literature-based criteria for typical clinical manifestations of opioid overdose and/or (b) clinical response to the opioid-specific reversal agent naloxone. The positive predictive value (PPV) for a serious opioid overdose was calculated as the percentage of clinically confirmed cases (definite or probable). RESULTS: Among 140 evaluable claims-defined cases, 107 fulfilled clinical criteria for a serious opioid overdose [95 definite and 12 probable; PPV of 76.4% (95% CI 69.4%, 83.5%)]. Among 30 nonconfirmed cases, 20 were polyintoxications involving one or more nonopioid psychoactive agents. CONCLUSIONS: An administrative claims coding algorithm for serious opioid overdose had high clinical predictive performance in a medical chart review.

Military movement training program improves jump-landing mechanics associated with anterior cruciate ligament injury risk.

As part of the physical education program at the United States Military Academy, all cadets complete a movement training course designed to develop skills and improve performance in military-related physical tasks as well as obstacle navigation. The purpose of this study was to determine if completion of this course would also result in changes in jump-landing technique that reduce the risk of anterior cruciate ligament (ACL) injury. Analysis of landing mechanics on a two-footed jump landing from a height of 30 cm with a three-dimensional motion capture system synchronized with two force plates revealed both positive and negative changes. Video assessment using the Landing Error Scoring System (LESS) revealed an overall improved landing technique (p=.001) when compared to baseline assessments. The studied military movement course appears to elicit mixed but overall improved lower extremity jump-landing mechanics associated with risk for ACL injury.

Epidemiology of lateral and medial epicondylitis in a military population.

OBJECTIVE: To determine the epidemiology of lateral and medial epicondylitis in the U.S. military. METHODS: The Defense Medical Epidemiology Database was queried for ICD-9 codes 726.32 (lateral epicondylitis) and 726.33 (medial epicondylitis) for the years 1998-2006. Multivariate Poisson regression was used to calculate incidence rates (IR) and rate ratios (RR) among demographic groups. RESULTS: The IRs for lateral and medial epicondylitis were 2.98 and 0.81 per 1000 person-years. For lateral epicondylitis, women had a higher incidence (RR = 1.22, 95% CI 1.19-1.26). In both groups, analysis by age showed higher incidence in the > or = 40-year-old group. White compared with black race was a risk factor for both lateral (RR = 1.68, 95% CI, 1.63-1.74) and medial epicondylitis (RR = 1.11, 95% CI 1.05-1.17). CONCLUSIONS: Female gender was a risk factor for lateral but not medial epicondylitis. Age greater than 40 and white race were significant risk factors for both conditions.

The incidence and characteristics of shoulder instability at the United States Military Academy.

BACKGROUND: The literature provides little information detailing the incidence of traumatic shoulder instability in young, healthy athletes. HYPOTHESIS: Shoulder instability is common in young athletes. STUDY DESIGN: Descriptive epidemiologic study. METHODS: We prospectively captured all traumatic shoulder instability events at the United States Military Academy between September 1, 2004, and May 31, 2005. Throughout this period, all new traumatic shoulder instability events were evaluated with physical examination, plain radiographs, and magnetic resonance imaging. Instability events were classified according to direction, chronicity, and type (subluxation or dislocation). Subject demographics, mechanism of injury, and sport were evaluated. RESULTS: Among 4141 students, 117 experienced new traumatic shoulder instability events during the study period; 11 experienced multiple events. The mean age of these 117 subjects was 20.0 years; 101 students were men (86.3%), and 16 were women (13.7%). The 1-year incidence proportion was 2.8%. The male incidence proportion was 2.9% and the female incidence proportion was 2.5%. Eighteen events were dislocations (15.4%), and 99 were subluxations (84.6%). Of the 99 subluxations, 45 (45.5%) were primary events, while 54 (54.5%) were recurrent. Of the 18 dislocations, 12 (66.7%) were primary events, while 6 (33.3%) were recurrent. The majority of the 117 events were anterior in nature (80.3%), while 12 (10.3%) were posterior, and 11 (9.4%) were multidirectional. Forty-four percent (43.6%) of the instability events experienced were as a result of contact injuries, while 41.0% were a result of noncontact injuries, including 9 subluxations caused by missed punches during boxing; information was unavailable for the remaining 15%. CONCLUSION: Glenohumeral instability is a common injury in this population, with subluxations comprising 85% of instability events.

Incidence of major tendon ruptures and anterior cruciate ligament tears in US Army soldiers.

BACKGROUND: Although a rare event, the prevalence of major tendon rupture has increased in recent decades. Identification of risk factors is important for prevention purposes. HYPOTHESIS: Race is a risk factor for major tendon ruptures. STUDY DESIGN: Cohort study (prevalence); Level of evidence, 2. METHODS: All patients admitted for surgical management of a rupture of a major tendon at Womack Army Medical Center, Fort Bragg, North Carolina, in 1995 and 1996 were identified and evaluated for risk factors. RESULTS: The authors identified 52 major tendon ruptures: 29 Achilles, 12 patellar, 7 pectoralis major, and 4 quadriceps tendon ruptures. All patients were active-duty soldiers, and 1 was a female soldier. Forty-one tendon ruptures occurred among black soldiers, 8 occurred among white soldiers, and 3 occurred among Latino soldiers. The population at risk included 93,224 exposures during the 2-year period, of which 67.1% were white, 24.5% were black, and 8.4% were self-classified as other race. The rate ratio for tendon rupture, adjusted for gender and age, was 13.3 (95% confidence interval, 6.2-28.5) between blacks and whites and 2.9 (95% confidence interval, 0.8-10.9) between Latinos and whites. CONCLUSION: The rate of major tendon rupture was 13 times greater for black men in this study population when compared with whites. Interventions among those at a higher risk for injury should be considered.

Incidence of anterior cruciate ligament injury among active duty U.S. military servicemen and servicewomen.

Although some studies have reported an increased incidence of anterior cruciate ligament (ACL) injuries in women athletes, little is known about the gender differences in injury patterns in the U.S. military. Using the Defense Medical Epidemiology Database, a search was performed for International Classification of Diseases, 9th Revision (ICD-9) codes 717.83 (old disruption of ACL) and 844.2 (sprain, strain cruciate ligament of the knee) among all servicemen and servicewomen between 1997 and 2003. Multivariate Poisson regression analysis was used to estimate the rate of ACL injuries per 1000 person-years, controlling for age and race, for each ICD-9 code. We computed rate ratios and 95% confidence intervals (CIs) by using male as the reference category. The injury rates for code 717.83 were 3.09 cases per 1,000 person-years for men and 2.29 cases per 1000 person-years for women, controlling for age and race (relative risk, 0.74; 95% CI, 0.71-0.76). The injury rates for ICD-9 code 844.2 were 3.79 cases per 1000 person-years for men and 2.95 cases per 1,000 person-years for women, controlling for age and race (relative risk, 0.78; 95% CI, 0.76-0.80). There was not an observed increase in the incidence of ACL injuries among female soldiers in the U.S. military between 1997 and 2003.

History of shoulder instability and subsequent injury during four years of follow-up: a survival analysis.

BACKGROUND: Little is known about the risk factors for glenohumeral joint instability. We hypothesized that a prior history of instability would be a significant risk factor for subsequent injury. METHODS: We conducted a prospective cohort study over a four-year period within a high-risk group of young athletes to address the research hypothesis. Subjects were freshmen entering the U.S. Military Academy in June of 2006. Part of the baseline assessment included documenting a prior history of glenohumeral instability on entry into the study. All subjects were followed for subsequent glenohumeral joint instability events until graduation in May of 2010. The primary outcome of interest in this study was time to glenohumeral instability event during the follow-up period. We examined injury outcomes, looking for any instability, anterior instability, and posterior instability events. Cox proportional-hazards regression models were used to analyze the data. RESULTS: Among the 714 subjects, eight shoulders were excluded from the analyses due to prior surgical stabilization, leaving 1420 shoulders, of which 126 had a self-reported prior history of instability. There were forty-six (thirty-nine anterior and seven posterior) acute instability events documented in the cohort during the follow-up period. Subjects with a prior history of instability were over five times (p < 0.001) more likely to sustain an acute (anterior or posterior) instability event during the follow-up period. Subjects with a history of instability were also 5.6 times (p < 0.001) more likely to experience a subsequent anterior instability event and 4.6 times (p = 0.068) more likely to experience a posterior instability event during follow-up. Similar results were observed in multivariable models after controlling for the influence of demographic and baseline physical examination findings. CONCLUSIONS: Despite meeting the rigorous physical induction standards for military service, subjects with a prior history of glenohumeral joint instability were approximately five times more likely to experience a subsequent instability event, regardless of direction, within this high-risk athletic population.

Pathoanatomy of first-time, traumatic, anterior glenohumeral subluxation events.

BACKGROUND: Relative to dislocations, glenohumeral subluxation events have received little attention in the literature, despite a high incidence in young athletes. The pathoanatomy of first-time, traumatic, anterior subluxation events has not been defined, to our knowledge. METHODS: As part of a prospective evaluation of all cases of shoulder instability sustained during one academic year in a closed cohort of military academy cadets, a total of thirty-eight first-time, traumatic, anterior glenohumeral subluxation events were documented. Clinical subluxation events were defined as incomplete instability events that did not require a manual reduction maneuver. Twenty-seven of those events were evaluated with plain radiographs and magnetic resonance imaging within two weeks after the injury and constitute the cohort studied. Magnetic resonance imaging studies were independently evaluated by a musculoskeletal radiologist blinded to the clinical history. Arthroscopic findings were available for the fourteen patients who underwent arthroscopic surgery. RESULTS: Of the twenty-seven patients who sustained a first-time, traumatic, anterior subluxation, twenty-two were male and five were female, and their mean age was twenty years. Plain radiographs revealed three osseous Bankart lesions and two Hill-Sachs lesions. Magnetic resonance imaging revealed a Bankart lesion in twenty-six of the twenty-seven patients and a Hill-Sachs lesion in twenty-five of the twenty-seven patients. Of the fourteen patients who underwent surgery, thirteen had a Bankart lesion noted during the procedure. Of the thirteen patients who chose nonoperative management, four experienced recurrent instability. Two of the thirteen patients left the academy for nonmedical reasons and were lost to follow-up. The remaining seven patients continued on active-duty service and had not sought care for a recurrent instability event at the time of writing. CONCLUSIONS: First-time, traumatic, anterior subluxation events result in a high rate of labral and Hill-Sachs lesions. These findings suggest that clinical subluxation events encompass a broad spectrum of incomplete events, including complete separations of the articular surfaces with spontaneous reduction. A high index of suspicion for this injury in young athletes is warranted, and magnetic resonance imaging may reveal a high rate of pathologic changes, suggesting that a complete, transient luxation of the glenohumeral joint has occurred.

Incidence of carpal tunnel syndrome in the US military population.

Carpal tunnel syndrome (CTS) is a common disease. Its epidemiology has been evaluated previously, mostly in regional populations or in working groups, with an incidence between 1.5 and 3.5 per 1,000 person-years. We studied this diagnosis in the US military population, with the hypothesis that this young population would have a lower incidence of CTS than previously reported in general populations. The Defense Medical Epidemiology Database notes all medical encounters for all US military personnel and maintains the number of all personnel on active duty each year. We queried the database using the International Classification of Diseases, ninth revision, code 354.0 (CTS) and analyzed the personnel presenting for initial visits for the years 1998-2006. Multivariate Poisson analysis was performed, controlling for rank, gender, age, and race. The raw incidence of CTS in the US military was 3.98 per 1,000 person-years, in a population of 12,298,088 person-years. Females had a significantly higher incidence of CTS than males, with an adjusted incidence rate ratio of 3.29. CTS incidence increased by age, with the age group > or = 40 years having a significantly higher incidence. Additionally, military rank was found to be an independent risk factor for CTS, with rates higher in senior officer and enlisted groups. This suggests that occupational requirements have an effect on CTS within the military. We showed a comparable incidence of CTS between the US military and general population, with a significantly higher female cohort with a diagnosis of CTS. Increased age and advanced rank were risk factors for CTS.

The incidence of primary hip osteoarthritis in active duty US military servicemembers.

OBJECTIVE: Although multiple studies have reported the prevalence of primary hip osteoarthritis (OA), little has been reported on incidence rates of hip OA. We sought to determine the incidence rate and demographic risk factors of hip OA in an ethnically diverse and physically active population of US military servicemembers. METHODS: A query was performed using the US Defense Medical Epidemiology Database for the International Classification of Diseases, Ninth Revision, Clinical Modification code for hip OA (715.95). Multivariate Poisson regression analysis was used to estimate the rate of hip OA per 100,000 person-years, controlling for sex, race, age, rank, and service. RESULTS: The overall unadjusted incidence rate of hip OA was 35 per 100,000 person-years. Women, compared with men, had a significantly increased adjusted incidence rate ratio for hip OA of 1.87 (95% confidence interval [95% CI] 1.73-2.01). The adjusted incidence rate ratio for black servicemembers when compared with white servicemembers was 1.32 (95% CI 1.23-1.41). The adjusted incidence rate ratio for the > or =40-year-old age group compared with the 20-year-old group was 22.21 (95% CI 17.54-28.14). With junior officers as the referent category, junior enlisted, senior enlisted, and senior officers rank groups had a significantly increased adjusted incidence rate ratio for hip OA. With the Air Force as the referent category, each service had a significantly increased adjusted incidence rate ratio for hip OA. CONCLUSION: Female sex; black race; age > or =40 years; junior enlisted, senior enlisted, and senior officer rank groups; and military service in the Navy, Army, or Marines were all risk factors for hip OA.

The incidence of scaphoid fracture in a military population.

BACKGROUND: The rate of occurrence of scaphoid injury is not well known. The incidence of scaphoid fracture has been described mostly in small, injured cohort populations, which may underestimate its frequency. We studied the epidemiology of the scaphoid fracture using a large database in a military population. PATIENTS AND METHODS: The Defense Medical Epidemiology Database (DMED), a comprehensive database which tracks medical care for all four military services of the United States, was queried for the first occurrence of scaphoid fractures using International Classification of Diseases (ICD)-9 code 814.01. Data were evaluated using multivariate Poisson analysis, controlling for co-variate factors. RESULTS: We noted 14,704 scaphoid fractures in a population at a risk of 12,117,749 person-years. The unadjusted incidence of scaphoid fracture was 1.21/1000 person-years. Males were significantly more likely to sustain scaphoid fractures, with an adjusted rate ratio (RR) of 1.55 (95% confidence interval (C.I.), 1.47, 1.64), compared to females. The 20-24-year-old age group had the highest incidence of scaphoid fracture at 1.64/1000 person-years, and showed a significantly higher RR compared to the population aged greater than 40 years (adjusted RR 1.55, 95% C.I., 1.38, 1.66). Whites sustained scaphoid fractures at a significantly higher rate than African Americans (adjusted RR 1.32, C.I., 1.26, 1.38). DISCUSSION/CONCLUSIONS: When compared to the previous data on scaphoid fractures, our study showed a greater incidence of scaphoid fracture at 1.21/1000 person-years in the US military population. These data are derived from a large database which effectively captures the population at risk. Males, the younger age group and the white race were associated with higher rates of scaphoid injury in this specialised military population.

The incidence of plantar fasciitis in the United States military.

BACKGROUND: Although plantar fasciitis is the most common cause of heel pain, little has been reported on the incidence rates of this disorder. We sought to determine the incidence rate and demographic risk factors of plantar fasciitis in an ethnically diverse and physically active population of United States military service members. METHODS: A query was performed with use of the Defense Medical Epidemiology Database for the International Classification of Diseases, Ninth Revision, Clinical Modification, code for plantar fasciitis (728.71). Multivariate Poisson regression analysis was used to estimate the rate of plantar fasciitis per 1000 person-years, while controlling for sex, race, rank, service, and age. RESULTS: The overall unadjusted incidence rate of plantar fasciitis was 10.5 per 1000 person-years. Compared with men, women had a significantly increased adjusted incidence rate ratio for plantar fasciitis of 1.96 (95% confidence interval, 1.94 to 1.99). The adjusted incidence rate ratio for black service members compared with white service members was 1.12 (95% confidence interval, 1.09 to 1.12). With junior officers as the referent category, junior enlisted, senior enlisted, and senior officer rank groups had a significantly increased adjusted incidence rate ratio for plantar fasciitis: 1.20 (95% confidence interval, 1.18 to 1.23), 1.19 (95% confidence interval, 1.17 to 1.22), and 1.56 (95% confidence interval, 1.52 to 1.61), respectively. Compared with service members in the Air Force, those in the Army and Marines had a significantly increased adjusted incidence rate ratio for plantar fasciitis of 1.85 (95% confidence interval, 1.82 to 1.87) and 1.28 (95% confidence interval, 1.25 to 1.30), respectively. The adjusted incidence rate ratio for the age group of forty years old or more compared with the twenty to twenty-four-year-old group was 3.42 (95% confidence interval, 3.34 to 3.51). CONCLUSIONS: Female sex; black race; junior enlisted, senior enlisted, and senior officer rank groups; service in the Army or Marines; and increasing age are all risk factors for plantar fasciitis.

Incidence of glenohumeral instability in collegiate athletics.

BACKGROUND: Glenohumeral instability is a common injury sustained by young athletes. Surprisingly, little is known regarding the incidence of glenohumeral instability in collegiate athletes or the relevant risk factors for injury. A better understanding of the populations most at risk may be used to develop preventive strategies. HYPOTHESIS: The incidence of glenohumeral instability in collegiate athletics is high, and it is affected by sex, sport, type of event, and mechanism of injury. STUDY DESIGN: Descriptive epidemiologic study. METHODS: The National Collegiate Athletic Association injury database was queried for all glenohumeral instability events occurring between the years 1989 and 2004. An analysis of the injuries was performed by sport, activity (competition versus practice), sex, type of event (primary versus recurrent), mechanism of injury, and time loss from athletic performance. Incidence rates and incidence rate ratios were calculated. RESULTS: A total of 4080 glenohumeral instability events were documented for an incidence rate of 0.12 injuries per 1000 athlete exposures. The sport with the greatest injury rate was men's spring football, with 0.40 injuries per 1000 athlete exposures. Overall, athletes sustained more glenohumeral instability events during games than practices (incidence rate ratio [IRR], 3.50; 95% confidence interval [CI], 3.29-3.73). Male athletes sustained more injuries than did female athletes (IRR, 2.67; 95% CI, 2.43-2.93). Female athletes were more likely to sustain an instability event as the result of contact with an object (IRR, 2.43; 95% CI, 2.08-2.84), whereas male athletes were more likely to sustain an event from player contact (IRR, 2.74; 95% CI, 2.31-3.25). Time lost to sport (>10 days) occurred in 45% of glenohumeral instability events. CONCLUSION: Glenohumeral instability is a relatively common injury sustained by collegiate athletes. More injuries occurred during competition and among male athletes.

Patellar tendon versus hamstring tendon autografts for anterior cruciate ligament reconstruction: a randomized controlled trial using similar femoral and tibial fixation methods.

BACKGROUND: Controversy remains over the most appropriate graft for anterior cruciate ligament reconstruction. HYPOTHESIS: There is no significant difference in outcomes after 4-strand hamstring and patellar tendon autograft anterior cruciate ligament reconstructions using similar fixation techniques. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Between August 2000 and May 2003, 64 Keller Army Hospital patients with complete anterior cruciate ligament tears were randomized to hamstring (n = 32) or patellar tendon (n = 32) autograft anterior cruciate ligament reconstruction. Operative graft fixation and rehabilitative techniques were the same for both groups. Follow-up assessments included the Single Assessment Numeric Evaluation score, Lysholm score, International Knee Documentation Committee score, and Knee Injury and Osteoarthritis Outcome Score. Postoperative radiographs were analyzed for tunnel location and orientation. RESULTS: Eleven women and 53 men were randomized. Eighty-three percent of the patients (53 of 64) had follow-up of greater than 2 years, or to the point of graft rupture or removal (average follow-up, 36 months). Four hamstring grafts (12.5%) and three patellar tendon grafts (9.4%) (P = .71) ruptured. One deep infection in a hamstring graft patient necessitated graft removal. Forty-five of the 56 patients with intact grafts had greater than 2-year follow-up. Patients with patellar tendon grafts had greater Tegner activity scores (P = .04). Single Assessment Numeric Evaluation scores were 88.5 (95% confidence interval: 83.1, 93.8) and 90.1 (95% confidence interval: 85.2, 96.1) for the hamstring and patellar tendon groups, respectively (P = .53). Lysholm scores were 90.3 (95% confidence interval: 84.4, 96.1) and 90.4 (95% confidence interval: 84.5, 96.3) for the hamstring and patellar tendon groups, respectively (P = .97). There were no significant differences in knee laxity, kneeling pain, isokinetic peak torque, International Knee Documentation Committee score, or Knee Injury and Osteoarthritis Outcome Scores. Postoperative graft rupture correlated with more horizontal tibial tunnel orientation. CONCLUSION: Hamstring and patellar tendon autografts provide similar objective, subjective, and functional outcomes when assessed at least 2 years after anterior cruciate ligament reconstruction.

A single-institution experience with the AneuRx Stent Graft for endovascular repair of abdominal aortic aneurysm.

We report our experience of endovascular repair of infrarenal abdominal aortic aneurysms (EVAR) using the modular AneuRx Stent Graft System. We retrospectively reviewed the outcomes of 113 patients who underwent EVAR with the AneuRx system performed at our institution between October 1999 and August 2003. The mean age of this group was 72.5 years, with 71% (n = 80) over the age of 70 years and 95% (n = 107) males. Aneurysm diameter ranged 4.0-9.0 cm, with 33% (n = 37) >6.0 cm. The average duration of late follow-up was 32.6 +/- 24.8 months (median = 37). Successful deployment of the modular AneuRx system was noted in all patients. There were no immediate operative conversions, deaths within 24 hr of operation, or type I or III endoleaks observed at the completion of the procedure. Thirty-day mortality was 3.5% (n = 4). Acute deployment-related complications occurred in 10% (n = 13) of patients and included misdeployment, operative bleeding, arterial perforation/dissection, and access site complications. Acute systemic complications were present in nine patients, predominantly renal and cardiac complications. An endoleak noted at any time occurred in 25% of patients, with 40% of those requiring a secondary intervention. Two patients suffered late aneurysm rupture due to a type I endoleak and graft infection. Kaplan-Meier analysis revealed 5-year freedom from secondary intervention of 72.4%; freedom from aneurysm-related death of 93.9%; and probability of survival based on all-cause mortality of 60.1%. Endovascular treatment with the modular AneuRx Stent Graft System is safe and effective, producing acceptable rates of disease-free survival and mid-term clinical outcome.

Gender differences in anterior cruciate ligament injury vary with activity: epidemiology of anterior cruciate ligament injuries in a young, athletic population.

BACKGROUND: Previous studies have shown that women involved in similar activities as men are at increased risk for anterior cruciate ligament injuries. HYPOTHESIS: The incidence rate of complete anterior cruciate ligament tears for men and women in our athletic, college-aged population is similar. STUDY DESIGN: Descriptive epidemiology study. METHODS: Students graduating in class years 1994 to 2003 at our institution who sustained complete anterior cruciate ligament tears were assessed for mechanism of injury and type of sport played at time of injury. We calculated the incidence proportion, an estimation of risk, by gender and class year, and the incidence proportion ratio comparing men and women by class year. We also calculated incidence rates by gender and type of sport played and incidence rate ratios comparing men and women. RESULTS: There were 353 anterior cruciate ligament injuries in the 10 classes studied. We found an overall, 4-year incidence proportion of 3.24 per 100 (95% confidence interval, 2.89-3.63) for men and 3.51 (95% confidence interval, 2.65-4.65) for women (incidence proportion ratio, 1.09 [95% confidence interval, 0.80-1.47]). The overall anterior cruciate ligament injury rate, excluding male-only sports, was significantly greater in women (incidence rate ratio, 1.51 [95% confidence interval, 1.03-2.21]). We found significantly greater injury rates among women in a gymnastics course (incidence rate ratio, 5.67 [95% confidence interval, 1.99-16.16]), indoor obstacle course test (incidence rate ratio, 3.72 [95% confidence interval, 1.25-11.10]), and basketball (incidence rate ratio, 2.42 [95% confidence interval, 1.05-5.59]). CONCLUSION: We found little gender difference in the overall risk of an anterior cruciate ligament tear; however, there were gender differences in injury rates when specific sports and activities were compared and when male-only sports were removed from the overall rate assessment.

Nonsteroidal anti-inflammatory drugs, apoptosis, and colorectal adenomas.

BACKGROUND & AIMS: Observational studies indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) reduce the risk of colorectal neoplasia. The mechanism of this effect could be via modification of apoptotic activity in colonic mucosa. We examined grossly normal rectal mucosa in patients with adenomas and adenoma-free controls to assess the associations between NSAID use, adenomatous polyps, and apoptosis. METHODS: Study participants were drawn from consecutive patients who underwent colonoscopy between August, 1998, and February, 2000. Biopsy specimens were taken from normal-appearing rectal mucosa 10 cm from the anal verge. Apoptosis was scored from coded, H&E-stained sections using morphologic methods. Proliferation was scored using whole crypt mitotic counts. Univariate and multivariate regression analyses were conducted to estimate crude and adjusted odds ratios (ORs). RESULTS: There were 226 patients with adenomas and 493 adenoma-free controls. After adjusting for sex, age, race, and body mass index (BMI), individuals in the highest tertile of regular NSAID use were substantially less likely to have adenomas (OR 0.4; 95% CI: 0.2-0.7) compared with occasional or nonusers. Similarly, compared with the lowest tertile, persons in the highest tertile of rectal mucosal apoptotic activity were much less likely to have adenomas (OR 0.12; 95% CI: 0.07-0.20). NSAID use and apoptotic activity were not correlated (r = 0.10). Mucosal proliferation was not related to adenomas or NSAID use. CONCLUSIONS: Our observations suggest that NSAID use and higher levels of mucosal apoptosis are independently associated with a lower prevalence of adenomas. The study shows a strong field effect for apoptosis.