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Objective: The relationship between musculoskeletal injuries and anabolic-androgenic steroids is not well understood. The purpose of our study was to investigate the association between self-reported anabolic-androgenic steroids use and the prevalence of musculoskeletal injuries in a unique group of retired professional football players. Design: A general health questionnaire was completed by 2552 retired professional football players. Survey data were collected between May 2001 and April 2003. Results of self-reported musculoskeletal injuries were compared with the use of anabolic-androgenic steroids using frequency distributions and chi2 analyses. Results: Of the retired players, 9.1% reported using anabolic-androgenic steroids during their professional career. A total of 16.3% of all offensive line and 14.8% of all defensive line players reported using anabolic-androgenic steroids. Self-reported anabolic-androgenic steroids use was significantly associated (P < 0.05) with the following self-reported, medically diagnosed, joint and cartilaginous injuries in comparison with the nonanabolic-androgenic steroids users: disc herniations, knee ligamentous/meniscal injury, elbow injuries, neck stinger/burner, spine injury, and foot/toe/ankle injuries. There was no association between anabolic-androgenic steroids use and reported muscle/tendon injuries. Conclusions: Our findings demonstrate that an association may exist between anabolic-androgenic steroids use and the prevalence of reported musculoskeletal injury sustained during a professional football career, particularly ligamentous/joint-related injuries. There may also be an associated predisposition to selected types of injuries in anabolic-androgenic steroids users. [ABSTRACT FROM AUTHOR]

Presents a clinical practice improvement study undertaken to determine how variation in patient characteristics and clinical processes impact patient outcomes. Improvement of outcomes for patients hospitalized with congestive heart failure; Evaluation of care against accepted guidelines; Patient care process variables associated with better outcomes.

The addition of a novel therapeutic agent to an organ preservation solution has the potential to address unmet needs in organ transplantation and enhance outcomes for transplant recipients. However, the development expectations for novel therapeutic agents in this context are unclear because of limited precedence and published regulatory guidance documents. To address these gaps, we have articulated a drug development strategy that leverages expectations for parenteral drug products administered via more conventional routes (eg, intravenous) and provided considerations for when deviations may be justified. We have supplemented this strategy with a comparison to available regulatory guidance from the US Food and Drug Administration to highlight potential areas for further clarification. The strategy articulated here is based on Genentech's internal experience for a program intended for use in kidney transplantation., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Congenital scoliosis (CS) is associated with more rigid, complex deformities relative to adolescent idiopathic scoliosis (AIS) which theoretically increases surgical complications. Despite extensive literature studying AIS patients, few studies have been performed on CS patients. The purpose of this study was to evaluate complications associated with spinal fusions for CS and AIS., Methods: A retrospective review of the Kid's Inpatient Database (KID) years 2000 to 2009 was performed. Inclusion: patients under 20 years with ICD-9 diagnosis codes for idiopathic scoliosis (IS-without concomitant congenital anomalies) and CS, undergoing spinal fusion from the KID years 2000 to 2009. Two analyses were performed according to age below 10 years and 10 years and above. Univariate analysis described differences in demographics, comorbidities, intraoperative complications, and clinical values between groups. Binary logistic regression controlling for age, sex, race, and invasiveness predicted complications risk in CS (odds ratios; 95% confidence interval)., Results: In total, 25,131 patients included (IS, n=22443; CS, n=2688). For patients under age 10, CS patients underwent 1 level shorter fusions (P<0.001), had fewer comorbidities (P<0.001), and sustained similar complication incidence. In the 10 and over age analysis, CS patients similarly had shorter fusions, but greater comorbidities, and significantly more complications (odds ratio, 1.6; confidence interval, 1.4-1.8)., Conclusions: CS patients have higher in-hospital complication rates. With more comorbidities, these patients have increased risk of sustaining procedure-related complications such as shock, infection, and Adult Respiratory Distress Syndrome. These data help to counsel patients and their families before spinal fusion., Level of Evidence: Level III-retrospective review of a prospectively collected database.

Study Design: Retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database years 2010 to 2015., Objective: Investigate which short-term outcomes differ for cervical laminoplasty and laminectomy and fusion surgeries., Summary of Background Data: Conflicting reports exist in spine literature regarding short-term outcomes following cervical laminoplasty and posterior laminectomy and fusion. The objective of this study was to compare the 30-day outcomes for these two treatment groups for multilevel cervical pathology., Methods: Patients who underwent cervical laminoplasty or posterior laminectomy and fusion were identified in National Surgical Quality Improvement Program (NSQIP) based on Current Procedural Terminology (CPT) code: laminoplasty 63,050 and 63,051, posterior cervical laminectomy 63,015 and 63,045, and instrumentation 22,842. Propensity-adjusted multivariate regressions assessed differences in postoperative length of stay, adverse events, discharge disposition, and readmission., Results: Three thousand seven hundred ninety-six patients were included: 2397 (63%) underwent cervical laminectomy and fusion and 1399 (37%) underwent cervical laminoplasty. Both groups were similar in age, sex, body mass index (BMI), American Society of Anesthesiologist Classification (ASA), Charleston Comorbidity Index (CCI), and had similar rates of malnutrition, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, and history for steroid use. Age more than 70 and age less than 50 were not associated with one treatment group over the other (P > 0.05). Compared with laminoplasty patients, laminectomy and fusion patients had increased lengths of stay (LOS) (4.5 vs. 3.7 d, P < 0.01) and increased rates of adverse events (41.7% vs. 35.9%, P < 0.01), discharge to rehab (16.4% vs. 8.6%, P < 0.01), and skilled nursing facilities (12.2% vs. 9.7%, P = 0.02), and readmission (6.2% vs. 4.5%, P = 0.05). Both groups experienced similar rates of death, pulmonary embolus, deep vein thrombosis, deep and superficial surgical site infection, and reoperation (P > 0.05 for all)., Conclusion: Posterior cervical laminectomy and fusion patients were found to have increased LOS, readmissions, and complications despite having similar pre-op demographics and comorbidities. Patients and surgeons should consider these risks when considering surgical treatment for cervical pathology., Level of Evidence: 3.

Background: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections., Methods: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process., Results: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration., Conclusion: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.

In this study, the construct validity of the moisture subscale of the Braden Scale for Predicting Pressure Sore Risk is partially supported by the significant inverse relationships between moisture subscale scores, the number of wet observations and soiled observations, brief changes, and differences among the moisture subscale score groups.

Objective: To understand the use of therapy extenders in stroke rehabilitation., Design: Descriptive analysis of a prospective observational cohort study., Results: Two hundred ninety-eight patients with moderate stroke and 284 with severe stroke from 5 inpatient rehabilitation facilities with complete physical and occupational therapy data are included in the study. Overall, occupational therapists and assistants contributed ∼70% and 21% of all occupational therapy hours, respectively. For physical therapy, these percentages in moderate group (60% vs. 31%) differ from those in severe group (65% vs. 23%). Some variations in the use of therapy extenders are noted in both disciplines across sites. Physical and occupational therapists spend more time in delivering advanced activities that include ongoing integrated evaluation and treatment planning or modification. Their assistants spend more time in delivering lower-level activities, such as bed mobility, transfers, dressing, or nonfunctional activities. Also, therapists are more likely to assign responsibility to assistants to treat moderate motor impairment among patients with stroke., Conclusions: Characterizing therapy practice in stroke rehabilitation is not straightforward. It is multifactorial and takes into account the (1) type of therapy, (2) therapy activity, (3) therapy provider including extender personnel, (4) specific training in stroke, and (5) years of experience. Future research to examine the association between use of therapy extenders and outcomes is recommended.

Peroxisome proliferator-activated receptor gamma (PPARgamma) agonists are highly effective in the treatment of type 2 diabetes. In some patients, PPARgamma ligands are associated with fluid retention/oedema, for which the mechanism is not fully understood. A pharmacogenetic study was undertaken to investigate effects of variations in 21 candidate genes related to epithelial sodium channel (ENaC) pathways on oedema. This study used DNA samples collected from type 2 diabetes phase III clinical trials of the PPARgamma agonist farglitazar (administered alone or in combination with insulin or glyburide) and investigated oedema reported as an adverse event as phenotype. Initial case-control analysis of oedema identified candidate gene single nucleotide polymorphisms with significant associations. These included three polymorphisms in ENaCbeta subunit (SCNN1B) that showed significant associations (P<0.05) with the two combination treatments in discrete regions of the gene, but not farglitazar treatment alone. Sequencing of SCNN1B in 207 Caucasian participants receiving farglitazar plus insulin or glyburide combination therapies, identified additional polymorphisms that were also significantly associated with oedema (P<0.0005) and maintained the treatment-regional associations. Further covariate analysis accounting for clinical factors influencing oedema supported these observations. One of the SCNN1B polymorphisms, at position -405 of the 5' flanking region (rs34241435), was predicted to modify transcriptional interactions and in a transfected COS cell luciferase reporter gene assay exhibited higher promoter activity. These exploratory studies provide clinical pharmacogenetic and functional genomic evidence to support a pivotal role for ENaC regulation in PPARgamma-induced oedema and provide insight into mechanisms and possible management of this side effect.

Objective: To demonstrate that by using the knowledge and skills of the primary care provider and by applying statistical and scientific principles of quality improvement, outcomes can be improved and costs significantly reduced., Design: A before and after quasi-experimentally designed trial using historical controls plus an analysis of costs in areas not influenced by intensive care unit (ICU) practice to control for possible secular changes., Setting: A tertiary ICU., Patients: All patients admitted to the above-mentioned ICU from January 1, 1991, through December 31, 1995., Interventions: a) A focused program that applied statistical and scientific quality improvement processes to the practice of intensive care. b) An organized effort to modify the culture, thinking, and behavior of the personnel who practice in the ICU., Measurements: Severity of illness, ICU and hospital lengths of stay, ICU and hospital mortality rates, total hospital costs as analyzed by the cost center, and measures of improvement in specific areas of care., Main Results: Significant improvement in glucose control, use of enteral feeding, antibiotic use, adult respiratory distress syndrome survival, laboratory use, blood gases use, radiograph use, and appropriate use of sedation. A severity adjusted total hospital cost reduction of $2,580,981 in 1991 dollars when comparing 1995 with the control year of 1991, with 87% of the reduction in those cost centers directly influenced by the intervention., Conclusions: A focused quality improvement program in the ICU can have a beneficial impact on care and simultaneously reduce costs.

Objective: To compare the effectiveness of calf-thigh sequential pneumatic compression devices with the effectiveness of plantar venous intermittent pneumatic compression devices in prevention of venous thrombosis after major trauma., Subjects and Methods: We evaluated 181 consecutive patients after major trauma without lower extremity injuries that precluded the use of pneumatic compression devices. We randomly assigned 149 patients to either calf-thigh sequential pneumatic compression or plantar venous pneumatic compression. After blinding the observers to the method of prophylaxis against deep-vein thrombosis, we performed bilateral compression ultrasonography on or before day 8 after randomization., Results: Among 149 randomized patients, 62 who received calf-thigh sequential pneumatic compression and 62 who received plantar venous intermittent pneumatic compression devices completed the trial. Thirteen patients randomized to plantar venous intermittent pneumatic compression (21.0%) and 4 patients randomized to calf-thigh sequential pneumatic compression (6.5%) had deep-vein thrombosis (p = 0.009). Seven of 13 patients with deep-vein thrombosis after prophylaxis with plantar venous intermittent pneumatic compression had bilateral deep-vein thromboses, whereas all 4 patients with deep-vein thrombosis after prophylaxis with calf-thigh sequential pneumatic compression had unilateral deep-vein thrombosis., Conclusion: Calf-thigh sequential pneumatic compression prevents deep-vein thrombosis more effectively than plantar venous intermittent pneumatic compression after major trauma without lower extremity injuries.

This study was designed to evaluate the relative severity and resource consumption of hospitalized patients with burns in a national cross section of hospitals, both with and without burn centers. We investigated to determine whether clinical variables or severity of illness measures not recorded in the Uniform Hospital Discharge Data Set are significant in explaining variation in length of stay, total cost, and mortality for patients with burns. The ability of the six burn diagnosis-related groups (DRGs) to explain variation in patients' length of stay was 20% and their ability to predict total costs was 24%. For the same patient population, the explanatory power of the DRGs improved to 54% for length of stay and 44% for costs when these variables were adjusted by the Severity of Illness Index. We also investigated whether hospitals with burn centers treated a more severely ill population of patients with burns than did hospitals without such centers. Significantly higher levels of severely ill patients with burns (p less than or equal to 0.0001) were found at burn center hospitals. Other patients or treatment variables, combined with a case-mix severity measure, were evaluated for their ability to further increase the explanatory power of DRGs. We also discuss here the use of the study results for reevaluating reimbursement policy.

To address the question of quantification of severity of illness on a wide scale, the Computerized Severity Index (CSI) was developed by a research team at the Johns Hopkins University. This article describes an initial assessment of some aspects of the validity and reliability of the CSI on a sample of 2,378 patients within 27 high-volume DRGs from five teaching hospitals. The 27 DRGs predicted 27% of the variation in LOS, while DRGs adjusted for Admission CSI scores predicted 38% and DRGs adjusted for Maximum CSI scores throughout the hospital stay predicted 54% of this variation. Thus, the Maximum CSI score increased the predictability of DRGs by 100%. We explored the impact of including a 7-day cutoff criterion along with the Maximum CSI score similar to a criterion used in an alternative severity of illness measure. The DRG/Maximum CSI score's predictive power increased to 63% when the 7-day cutoff was added to the CSI definition. The Admission CSI score was used to predict in-hospital mortality and correlated R = 0.603 with mortality. The reliability of Admission and Maximum CSI data collection was high, with agreement of 95% and kappa statistics of 0.88 and 0.90, respectively.

Two adjuvant techniques for the intraoperative assessment of small intestinal viability were compared with standard clinical judgment in a prospective, controlled study of 71 ischemic bowel segments in 28 consecutive patients operated on for acute intestinal ischemic disease. Each segment was independently assessed 15 minutes after surgical correction of the underlying lesion by: 1) standard clinical judgment; 2) Doppler-detected pulsatile mural blood flow; and 3) fluorescein ultraviolet fluorescence pattern. Viability endpoint for each segment was determined objectively by patient follow-up or "blinded" microscopic evaluation of histologically unequivocal resection specimens using criteria established by previous animal studies. Seventeen histologically equivocal specimens were excluded from the final results. Standard clinical judgment proved moderately accurate overall (89%) but would have led to a relatively high rate (46%) of unnecessary bowel resection. The Doppler technique did not increase accuracy in any category of evaluation. The fluorescein fluorescent pattern was correct in all 54 determinant bowel segments, and proved more sensitive specific, predictive, and significantly more accurate overall than either standard clinical judgment or the Doppler method. This controlled study suggests that the fluorescein technique is the method of choice for the prediction of small intestinal recovery following ischemic injury.

The statewide Burn Prevention Program has demonstrated a significant improvement in testable knowledge of burn prevention and fire safety among children and senior citizens as a result of an effective educational program. Formal evaluation using written examinations was done with the children. The statistical significance of the results of these evaluations was analyzed using chi square tests and two sample t tests. Significant improvements were seen in both mean test scores and the percentage of children answering all the test questions correctly. A much less formal type of evaluation was done with the elderly group. Senior citizens were assisted with a pre-program questionnaire. The results of this questionnaire were compared to the results of "BURN-GO" (copyright 1986), a bingotype game, played immediately after the educational session. Again, the post-implementation results of the program were significantly higher than those achieved prior to the intervention.