Decision Analysis and FDA Drug Review: A Proposal for Shadow Advisory Committees

The FDA seems to acknowledge that sometimes different standards of proof for assessing drug efficacy should be used. Dr. Mendeloff thus proposes a methodology that might illuminate the FDA\u27s decision-making and help better to assess its decisions

The Declining Effects of OSHA Inspections on Manufacturing Injuries: 1979 to 1998

This study compares the impact of OSHA inspections on manufacturing industries using data from three time periods: 1979-85, 1987-91, and 1992-98. We find substantial declines in the impact of OSHA inspections since 1979-85. In the earliest period we estimate that having an OSHA inspection that imposed a penalty reduces injuries by about 15%; in the later periods it falls to 8% in 1987-91 and to 1% (and statistically insignificant) in 1992-98. Testing for different effects by inspection type, employment size, and industry, we find differences across size classes, but these cannot explain the overall decline. In fact, we find reductions in OSHA's impact over time for nearly all subgroups we examine, so shifts across subgroups cannot explain the whole decline. We examine various other hypotheses concerning the declining impact, but in the end we are not able to provide a clear explanation for the decline.

Controlling Violence in Professional Sports: Rule Reform and the Federal Professional Sports Violence Commission

This article addresses the problem of violence in sports and assesses the inability of the traditional legal mechanisms of tort and criminal law to control this violence. The authors also examine the major schemes to stem sports violence that have been considered by Congress. Finally, the authors propose the control of violent behavior through legislatively mandated rule reforms enforced by a Federal Professional Sports Violence Commission

Phlegmonous Enteritis in a Patient with Congestive Heart Failure and Colon Cancer

Phlegmonous enteritis is a rare infective inflammatory disease of the intestine, predominantly involving the submucosal layer. It is difficult to diagnose and often fatal. Its association with alcoholism and various liver diseases, although rarely reported, is well documented. We report a case of phlegmonous enteritis in a male patient with congestive heart failure and colon cancer, and describe the ultrasonographic and CT findings

Long-term survival after perforated diverticulitis

Aim: Short-term survival after emergency surgery for perforated diverticulitis is poor. Less is known about long-term survival. The aims of this study were to evaluate long-term survival after discharge from hospital and to identify factors associated with prognosis. Method: All patients who underwent emergency surgery for perforated diverticulitis in five hospitals in Rotterdam, the Netherlands, between 1990 and 2005, were included. The association between type of surgery (Hartmann's procedure or primary anastomosis) and long-term survival was analysed using multivariate Cox regression analysis, taking into account age American Society of Anesthesiology (ASA) classification, Hinchey score, Mannheim Peritonitis Index (MPI) and surgeon's experience. In addition, survival of the patients was compared with that of the matched general Dutch population. Results Of 340 patients included in the study, 250 were discharged alive from hospital. The overall 5-year survival wa

Bronchial airway anastomotic complications after pediatric lung transplantation: Incidence, cause, management, and outcome

ObjectiveAirway complications are a recognized surgical complication and an important source of morbidity after adult lung transplantation. Little is known about these complications after pediatric lung transplantation.MethodsData of pediatric lung transplants performed between January 1990 and December 2002 in a single pediatric institution were reviewed retrospectively.ResultsA total of 214 patients, with a mean age of 9.8 ± 6.1 years (range 0.01-19.7 years), underwent 239 lung transplants: 231 bilateral and 8 single. Mean follow-up was 3.4 years. Forty-two airway complications requiring interventions (stenosis = 36; dehiscence = 4; malacia = 2) developed in 30 recipients (complication rate: 9% of 470 bronchial anastomoses at risk). There were airway complications in 29 bilateral lung transplants (13%) and 1 single lung transplant (13%). Mean time to diagnosis was 51 ± 27 days (median: 53, range 1-96 days), and diagnoses were made in 90% of patients within the first 3 months after transplantation. Preoperative Pseudomonas cepacia, postoperative fungal lung infection, and days on mechanical ventilator were found to be significant risk factors on multivariate analysis (P = .002, P = .013 and P = .003, respectively). Treatment included rigid bronchoscopic dilatation in 17 patients, balloon dilatation in 13 patients, and stent placement in 12 patients. Other treatments consisted of debridement, fibrin glue application, chest tube placement, and pneumonectomy followed by retransplantation. No patients died as a direct result of airway complications. There was no significant difference in the incidence of bronchiolitis obliterans or overall survival in comparison with patients who did not have airway complications.ConclusionsAirway complications are a significant cause of morbidity after pediatric lung transplantation. The majority are successfully treated, and patient outcomes are not adversely affected

Pediatric And Adult Lung Transplantation For Cystic Fibrosis

AbstractObjective: This paper was undertaken to review the experience at our institution with bilateral sequential lung transplantation for cystic fibrosis.Methods: Since 1989, 103 bilateral sequential lung transplants for cystic fibrosis have been performed (46 pediatric, 48 adult, 9 redo); the mean age was 21 ± 10 years. Cardiopulmonary bypass was used in all but one pediatric (age <18) transplant, and in 15% of adults.Results: Hospital mortality was 4.9%, with 80% of early deaths related to infection. Bronchial anastomotic complications occurred with equal frequency in the pediatric and the adult populations (7.3%). One- and 3-year actuarial survival are 84% and 61%, respectively (no significant difference between pediatric and adult age groups; average follow-up 2.1 ± 1.6 years). Mean forced expiratory volume in 1 second increased from 25% ± 9% before transplantation to 79% ± 35% 1 year after transplantation. Acute rejection occurred 1.7 times per patient-year, with most episodes taking place within the first 6 months after transplantation. The need for treatment of lower respiratory tract infections occurred 1.2 times per patient in the first year after transplantation. Actuarial freedom from bronchiolitis obliterans was 63% at 2 years and 43% at 3 years. Redo transplantation was performed only in the pediatric population and was associated with an early mortality of 33%. Eight living donor transplants (four primary transplants, four redo transplants) were performed with an early survival of 87.5%.Conclusion: Patients with end-stage cystic fibrosis can undergo bilateral lung transplantation with morbidity and mortality comparable to that seen in pulmonary transplantation for other disease entities. (J Thorac Cardiovasc Surg 1998;115:404-14

Phlegmonous colitis: another source of sepsis in cirrhotic patients?

<p>Abstract</p> <p>Background</p> <p>The clinical relevance of phlegmonous colitis (PC), a rare autopsy finding in cirrhotic patients, is poorly documented. We postulated that PC might be a source of sepsis in patients with portal hypertensive colopathy (PHC).</p> <p>Case presentation</p> <p>We report three cirrhotic patients who were admitted with abdominal sepsis and who illustrate, to various degrees, the clinico-pathological sequence of colonic alterations associated with portal hypertension. Two cirrhotic patients with PHC developed gram-negative bacteraemia and quickly responded to intravenous antibiotics. Another cirrhotic patient underwent emergency colectomy for PC, and subsequently died from multiple organ failure. Histological alterations in the operative specimen included: a) mucosal ulcerations; b) disseminated micro-abscesses in the submucosa; and c) a severe vasculopathy leading to complete obliteration of submucosal blood vessels.</p> <p>Conclusions</p> <p>These data suggest that cirrhotic patients with PHC may progress towards PC, which, in turn, may be the cause for life-threatening sepsis.</p

Predictors of postoperative outcome after general surgical procedures in patients with congenital heart disease

This study was undertaken to evaluate factors predictive of postoperative outcome after general surgical (GS) procedures in patients with congenital heart disease (CHD). All patients with a diagnosis of CHD who underwent a GS procedure under general anesthesia during a consecutive 10-year period were considered eligible for the study. The congenital heart defect was classified as either simple (ASD, VSD, PDA) or complex (endocardial cushion defects, transposition of the great vessels, tetralogy of Fallot), and the GS procedure as either major (intraperitoneal, intrathoracic, or vascular reconstructive) or minor (inguinal herniorrhaphy, vascular access). The overall mortality rate for the patient population was 12% (27 deaths among 226 procedures), minor procedures being associated with a 3% mortality rate (2 of 70 procedures), and major procedures with a 16% mortality rate (25 of 156 procedures). Incremental risk factors for mortality included a preoperative American Society of Anesthesiologists' (ASA) physical status class of IV or higher (P = .0003), a preoperative in-hospital stay of 10 or more days (P = .004), birth at a tertiary care center (P = .04), and emergency operations (P = .05). In the subgroup of patients less than 6 months old, weight of less than 2.4 kg at the time of surgery and a 1-minute Apgar score of less than 4 were additional independent risk factors (P = .04 and .01, respectively). By logistic analysis, previous corrective cardiac procedures, whether complete or palliative, did not significantly alter the postoperative outcome. The authors conclude that physiologically well-compensated patients with CHD can undergo elective operations at a low operative risk; however, poorly compensated patients undergoing urgent or emergent operations are at high risk. Previous corrective cardiac procedures may improve the overall outcome if the physiological state of the patient could be improved.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/31485/1/0000407.pd

The social value of a QALY : raising the bar or barring the raise?

Background: Since the inception of the National Institute for Health and Clinical Excellence (NICE) in England, there have been questions about the empirical basis for the cost-per-QALY threshold used by NICE and whether QALYs gained by different beneficiaries of health care should be weighted equally. The Social Value of a QALY (SVQ) project, reported in this paper, was commissioned to address these two questions. The results of SVQ were released during a time of considerable debate about the NICE threshold, and authors with differing perspectives have drawn on the SVQ results to support their cases. As these discussions continue, and given the selective use of results by those involved, it is important, therefore, not only to present a summary overview of SVQ, but also for those who conducted the research to contribute to the debate as to its implications for NICE. Discussion: The issue of the threshold was addressed in two ways: first, by combining, via a set of models, the current UK Value of a Prevented Fatality (used in transport policy) with data on fatality age, life expectancy and age-related quality of life; and, second, via a survey designed to test the feasibility of combining respondents’ answers to willingness to pay and health state utility questions to arrive at values of a QALY. Modelling resulted in values of £10,000-£70,000 per QALY. Via survey research, most methods of aggregating the data resulted in values of a QALY of £18,000-£40,000, although others resulted in implausibly high values. An additional survey, addressing the issue of weighting QALYs, used two methods, one indicating that QALYs should not be weighted and the other that greater weight could be given to QALYs gained by some groups. Summary: Although we conducted only a feasibility study and a modelling exercise, neither present compelling evidence for moving the NICE threshold up or down. Some preliminary evidence would indicate it could be moved up for some types of QALY and down for others. While many members of the public appear to be open to the possibility of using somewhat different QALY weights for different groups of beneficiaries, we do not yet have any secure evidence base for introducing such a system