There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
A survey was done to identify how pediatric intensivists determine brain death in children. Forty-nine pediatric intensive-care units (PICUs) were surveyed. The questionnaire explored the following areas: 1) clinical and confirmatory studies performed, 2) types of physicians involved, and 3) reevaluation intervals. Thirty-four centers responded to the questionnaire. Sixty-nine percent were children's hospitals, and 94% were university affiliates. The mean number of PICU beds was 17, with a mean admission rate of 890 patients per year, and the mean mortality rate for these units was 6%. There was general agreement on the sufficiency of clinical examination to determine cortical and brain-stem function. All the pediatric intensivists noted that a positive apnea test, absent cephalic reflexes, fixed and dilated pupils, and no motor response to pain were reliable signs of brain death. Radionuclide cerebral-flow scan and EEG were the confirmatory tests routinely used. Most physicians (77%) felt a second clinical examination was required within 12 to 24 hours. The opinion of more than one physician, one of whom was a neurospecialist, was required in 80% of the surveyed institutions.
The National Heart, Lung, and Blood Institute, along with the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases, convened a panel to develop recommendations for treatment, prevention, and research for respiratory failure from severe acute respiratory syndrome (SARS) and other newly emerging infections. The clinical and pathological features of acute lung injury (ALI) from SARS appear indistinguishable from ALI from other causes. The mainstay of treatments for ALI remains supportive. Patients with ALI from SARS who require mechanical ventilation should receive a lung protective, low tidal volume strategy. Adjuvant treatments recommended include prevention of venous thromboembolism, stress ulcer prophylaxis, and semirecumbent positioning during ventilation. Based on previous experience in Canada, infection control resources and protocols were recommended. Leadership structure, communication, training, and morale are an essential aspect of SARS management. A multicenter, placebo-controlled trial of corticosteroids for late SARS is justified because of widespread clinical use and uncertainties about relative risks and benefits. Studies of combined pathophysiologic endpoints were recommended, with mortality as a secondary endpoint. The group recommended preparation for studies, including protocols, ethical considerations, Web-based registries, and data entry systems.
BACKGROUND: The Stockholm and Gotland region in Sweden has a common management protocol for the treatment of colon cancer. The aim of this study was to assess the management and treatment of colon cancer in the region and to try to identify ways to improve the outcome further. METHODS: Clinical data on all patients diagnosed with colon cancer in the region's nine hospitals between January 1996 and December 2000 were prospectively collected. Patients were followed until December 2004, and their management and outcome analysed. RESULTS: Colon cancer was diagnosed in 2775 patients. An elective operation was performed in 2116 (76.3 per cent) patients and an emergency procedure in 590 (21.3 per cent). Emergency surgery was an independent risk factor for death. The crude overall cumulative 5-year survival was 46.2 per cent. A multivariable analysis of risk of dying and risk of local recurrence showed significant differences between hospitals. The number of lymph nodes examined in the specimens also differed between hospitals. CONCLUSION: Differences in the management and outcome of colon cancer in the nine hospitals, despite a common management protocol, indicate a need for improving collaboration between hospitals and multidisciplinary management.
BACKGROUND: Colorectal cancer is the second most common cancer among both men and women in Norway. The quality of the information given in the histopathological report is crucial for staging and treatment, and standardised reports are recommended. Such standardised schemes for histopathological reporting and surgical specimen handling were introduced from 1 July 1996 and 1 January 1998, respectively. The present study was undertaken in order to evaluate these schemes and to investigate to what extent the procedures complied with international recommendations. MATERIAL AND METHODS: An evaluation of all histopathological reports from 390 patients operated for colorectal carcinomas and registered at the Department of Pathology of the Central Hospital of Rogaland 1 July 1996 to 30 June 1999. RESULTS: The standardised schemes were used in 184 of 193 cases of surgical specimen handling (95%) and in 381 of 390 cases of histopathological reporting (98%). The quality of the histopathological reports, was in good agreement with international recommendations with respect to most data items. However, the average number of 9.0 lymph nodes sampled was below the minimum of 12 recommended by the International Union Against Cancer. In 29% of the cases, less than six lymph nodes were found. INTERPRETATION: Although the standardised schemes were used almost uniformly, the schemes did not ensure by themselves that all data items were in accordance with international recommendations. The fact that too few lymph nodes were sampled, was only detected during the present evaluation. Thus, any introduction of standardised schemes should include a regular follow-up to ensure that predefined goals are attained.
In the era of chronic disease, we are challenged to find therapies that provide symptomatic relief and ideally, alter the course of the underlying disease. In Alzheimer's disease (AD), these issues are complicated by the disease itself, which affects the subject's decision-making capacity for participation in the research. According to established ethical guidelines it is clear that individuals with impaired capacity may participate in research and their risk should be no greater than that which the individual would have in day to day activities with anticipation of benefits within that realm. Decision making processes are complex and involve proxies who themselves have biases about their loved one and the potential for participating in the research. Newer disease-modifying approaches such as immunotherapy have potential for affecting the course of the underlying disease but with greater risk of more significant side effects. Ideally the health care of the subjects is not disadvantaged by research participation. At the same time, trials of potentially riskier therapy are relevant in subjects with the disease. Research for subjects with AD must have appropriate safeguards in place to enable effective progress in innovative therapy for a vulnerable, often elderly population. Recommendations are made which could further our capacity to undertake ethical research in the AD population.
The aim of this study was to assess the costs and cost-effectiveness of intravenous thrombolysis treatment with alteplase (Actilyse) of acute ischemic stroke with 24-hour in-house neurology coverage and use of magnetic resonance imaging.
A health economic model was designed to calculate the marginal cost-effectiveness ratios for time spans of 1, 2, 3 and 30 years. Effect data were extracted from a meta-analysis of six large-scale randomized and placebo-controlled studies of thrombolytic therapy with alteplase. Cost data were extracted from thrombolysis treatment at Aarhus Hospital, Denmark, and from previously published literature.
The calculated cost-effectiveness ratio after the first year was $55,591 US per quality-adjusted life-year (base case). After the second year, computation of the cost-effectiveness ratio showed that thrombolysis was cost-effective. The long-term computations (30 years) showed that thrombolysis was a dominant strategy compared with conservative treatment given the model premises.
A high-quality thrombolysis treatment with 24-hour in-house neurology coverage and magnetic resonance imaging might not be cost-effective in the short term compared with conservative treatment. In the long term, there are potentially large-scale health economic cost savings.