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PubMed2004

Lessons from epidemiologic studies in clinical trials of traumatic brain injury.

Lessions from epidemiological studies. The Clinical Trial Group for Neurosurgery of the University of California San Diego (UCSD) is involved in epidemiological studies and trials of new pharmacological agents in traumatic brain injury. A great number (> 10,000) of patients has been prospectively analyzed forming an integrated database for further purposes. The development of these databases is based on earlier work by the European Neurosurgeons Jennett and Braakmann and the US-Traumatic Coma Data Bank Study. These studies allowed for the development of sophisticated data collection instruments which were used in the international Tirilizad Trials which enrolled over 1,100 patients. A major observation from that trial was that pretreatment hypotension or hypoxia could be unbalanced even in a large two arm blinded study. Another issue of the tirilazad trial was the influence of gender affecting not only outcome but also drug metabolism. Similar experiences were gathered with the phase-III trial on the competitive NMDA-receptor antagonist selfotel, which interferes with the excitotoxic amino acid glutamate as mediator of secondary brain damage, as ischemia-induced neuronal degeneration. Unfortunately, the trial, already underway, had to be prematurely aborted, since concurrent stroke studies with enrollment of nonintubated patients on low-dose selfotel revealed an increased number of deaths and other adverse events. A retrospective analysis did not confirm that Selfotel was associated with an increased mortality in TBI, but there was also no evidence that the drug was efficacious. A problem here was that a major portion of patients did not have intracranial mass lesions (contusion, subdural haematoma) on CT, questioning whether these had a treatment responsive brain injury. Both studies on tirilazad or selfotel underscore the significance of well designed and conducted phase-I and -II trials to characterize the pharmacokinetics of the agent, to confirm availability of drug in the brain, and to identify a sufficient number of patients with lesions responding to the drug. A major issue is the blood-brain barrier permeability of the agent under study. Further, the phenomenon of secondary deterioration - neurological worsening - turned out as a powerful predictor of poor outcome. The findings and conclusions of both clinical trials (tirilazad, selfotel) were utilized for a subsequent patient study on CP101-606 in consultation with the Pfizer company, the US Brain Injury Consortium, and the San Diego Clinical Trial Group. The patient population was a priori selected towards responsiveness of the brain lesions to the treatment. The major conclusions are: I Development of therapeutic regimens targeted towards the mechanisms of brain injury. II Availability of adequate preclinical data. III Directing treatment towards an appropriate patient population. IV Central gathering and interpretation of the neuroradiological findings. V Monitoring of trial center performance. VI Stratification and pre-trial prognostic analysis for identification of subgroups.

Brain Injuries↗
PubMed2002

Electrical stimulation as an adjunct to spinal fusion: a meta-analysis of controlled clinical trials.

This study was a meta-analysis to examine whether electrical stimulation has a specific effect on spinal fusion. Little evidence exists on the efficacy of electrical stimulation for improving fusion rate of spinal fusion surgery. Using MEDLINE (1966-2000) and EMBASE (1985-1999), a search for articles was carried out using the Medical Subject Headings: (1) electric stimulation or electromagnetic fields, (2) spinal fusion, (3) controlled or clinical trial, and (4) human. Data were extracted from all the hit articles and additionally collected from appropriate journal lists. A total of five randomized controlled trials (RCT) on bones assessing healing of spinal fusion were identified and scored on methodological quality. All the identified studies reported positive findings, but the quality score of each trial showed wide flaws. Because of relatively homogenous subjects who had spine fusion and radiographic assessment from these studies, pooling of the data was able to be performed. Excluding one trial with the lowest score, the combined results of four trials, whose major endpoints were the success rate of the fusion, revealed a statistically significant effect of electrical stimulation with various techniques, but the selected trials still showed wide variation in view of stimulation modalities and treatment protocol. The pooled result of the studies in this review revealed the efficacy of electrical stimulation based on proved methodological quality. As problems on therapeutic modality and protocol remain, there is a further need for improvement in design to constitute acceptable proof and to establish treatment programs that better demonstrate electrical stimulation effects on spinal fusion.

Combined Modality Therapy↗
PubMed2006

Transdisciplinary studies of surgical oncology trial accrual: A National Institutes of Health/National Cancer Institute Roadmap-affiliated project update.

BACKGROUND: A key objective of the National Institutes of Health Roadmap Initiative during the past 2 years has been to address scientific problems and issues through innovative research collaborations that cut across disciplines, traditions, and agendas. METHODS: Recognizing an opportunity to focus on the growing problem of low accrual to cancer surgical trials, the authors organized a multidisciplinary network of 21 clinical researchers and social/behavioral scientists to meet, review the issues, and organize working groups to study the problem. The authors, as representatives of the Karmanos Cancer Institute (Detroit, MI) and the American College of Surgeons Oncology Group, were awarded a Roadmap-affiliated grant from the National Cancer Institute under the "Meetings and Networks for Methodological Development in Interdisciplinary Research" funding mechanism. RESULTS: The overarching objective that guided the methodological developments of this network was to apply state-of-the-science methodologies and analytical strategies to examine the biobehavioral and interpersonal factors that facilitate or impede patients' treatment decision-making. CONCLUSIONS: In this brief report, the authors describe the objectives of their multidisciplinary network and their progress to date.

Advisory Committees↗
PubMed2005

Further steps towards data standardisation: the Proteomic Standards Initiative HUPO 3(rd) annual congress, Beijing 25-27(th) October, 2004.

The increasing volume of proteomics data currently being generated by increasingly high-throughput methodologies has led to an increasing need for methods by which such data can be accurately described, stored and exchanged between experimental researchers and data repositories. Work by the Proteomics Standards Initiative of the Human Proteome Organisation has laid the foundation for the development of standards by which experimental design can be described and data exchange facilitated. The progress of these efforts, and the direct benefits already accruing from them, were described at a plenary session of the 3(rd) Annual HUPO congress. Parallel sessions allowed the three work groups to present their progress to interested parties and to collect feedback from groups already implementing the available formats.

China↗
PubMed2005

Report on the first congress of the Spanish Proteomics Society.

This report describes the first congress of the Spanish Proteomics Society (SEProt) and the Foundation Meeting of the European Proteomics Association (EuPA), which were held in Cordoba, Spain, February 13-17, 2005. The EuPA meeting joined together thirty European representatives from 17 national European proteomics organisations to discuss the opportunity of creating a supranational association aimed to promote all aspects of proteomics as a scientific discipline throughout Europe. The main subjects of the SEProt congress, which was attended by over 350 researchers mainly from Spain and other European countries, were the current status and applications of proteomics in medical and biological sciences.

Congresses as Topic↗
PubMedDate not supplied

The European acamprosate trials: conclusions for research and therapy.

In an excellent methodological approach, the European acamprosate study project showed that acamprosate increases sobriety times. In one randomized prospective study (n = 260) comparing acamprosate and placebo, with a 1-year treatment phase and 1-year follow-up phase, the authors found that acamprosate is effective only in Lesch type I and type II patients. To investigate the possible influence of diagnostic subgrouping, we applied the Lesch typology in a co-work with the main researchers of the UK study. The UK results concerning acamprosate's effects in the types do not mirror the Vienna results, but the numbers of type I and type II patients, retrospectively found as included in the UK centers, were too small for any conclusions. The distribution of the types points to the fact that too many type III and IV patients had been included to give acamprosate the chance to be effective. Following our typology and also these studies, we developed special treatment approaches. For relapse prevention studies, the cumulative abstinence duration together with the Lesch typology seems to be promising.

Acamprosate↗
PubMed2001

An inventory of Canadian anesthesiology. Human research from 1995 through 1999.

PURPOSE: The year 2000 provides a symbolic opportunity to assess the past initiatives in anesthesia research. As in many other fields, medical research has benefited from utilizing computerized data bases to facilitate enumerating areas of interest. We have created a baseline survey of past research in the fields of anesthesia, anesthetics, analgesia, and analgesics to highlight Canadian studies. METHODS: The survey was undertaken using the Medical Literature Analysis and Retrieval System (MEDLARS) medical literature archive for the years 1995 through 1999. The principal categories and sub-categories of MEDLARS' anesthesia classifications were counted for 70 countries contributing to the archive. RESULTS: Canadian contributions ranged from 141 (1992) to 185 (1999) and represented annually 3% of the world total in the anesthesia categories. The greatest number of studies (30-38%) were about adults aged 19 to 44 yr, and there were between 4% and 14% more studies of females than males. "Pharmacology" and "therapeutic use" were the most frequent topics, lidocaine, fentanyl, and propofol were the most studied anesthetics, and non-steroidal anti-inflammatories, opium, morphine, and fentanyl were the most studied analgesics. Among the types of studies, those classified as "quality of health care" occurred most frequently (16%). Canadian trends closely follow world trends. CONCLUSION: The collected counts provide a comprehensive overview of research trends for the past five years.

Adult↗
PubMed2004

The Dutch National Atlas of Public Health.

The Dutch National Atlas of Public Health (http://www.zorgatlas.nl) maps the regional distribution of demand and usage of health care, public health status and influencing factors. The Atlas provides answers to locational questions, e. g. 'Where are the highest mortality rates?', 'Where are the longest waiting lists?' and 'Where are hospitals located?' Maps play a pivotal role in the Atlas. Texts, graphics and diagrams support the interpretation of the maps. The information in the Atlas specifically targets policy makers at the Ministry of Health, Welfare and Sport. For them, the Atlas is a tool for problem detection, policy making and policy evaluation. The Atlas is also aimed at all professionals in health care. In practice, also the general public appears to access and use the Atlas. The Atlas is part of the Dutch Public Health Status and Forecasts (PHSF). The PHSF is made by the National Institute of Public Health and the Environment mandated by the Ministry of Health, Welfare and Sport.

Atlases as Topic↗
PubMed2005

[Approval of clinical trials of immunobiological medicinal products at the Paul Ehrlich Institute].

The GCP Directive 2001/20/EG has been implemented in Germany by the 12th Law Amending the Drug Law of 6 August 2004, thereby introducing new regulations for the performance of clinical trials. The amount of the required documentation has increased, but the assessment and the approval of clinical trials as well as scientific advice procedures (national or by the EMEA) allow the early discussion of many details of the development and the non-clinical and clinical testing of the medicinal product with the experts of the Paul Ehrlich Institute (PEI). This might shorten the times required for later marketing authorisation procedures. To facilitate these new tasks, the PEI has created a new central section "Approval of Clinical Trials", which is responsible for the assessment of the clinical trial applications and will coordinate the procedures within the institute. The main topics of clinical trial applications and the particularities of biological/biotechnological medicinal products such as allergens, blood products, vaccines, sera/mAb and products for cell and gene therapy as well as the differences from chemically defined products are discussed.

Academies and Institutes↗
PubMed2005

[Evidence-based medicine for the public].

The methods of evidence-based medicine demand high quality and up-to-date medical information. Ideally, this information is based on data from controlled clinical trials. When such external evidence is available, it provides a base for an effective patient-physician consultation, and is also essential for the consumer friendly presentation of medical information. This article sketches the international and German developments and approaches to preparing and maintaining evidence-based patient information and its influences on the models of physician-patient communication.

Access to Information↗
PubMed1987

Experience with the use of generalized data base management systems in cooperative group clinical trials (a project of the Gynecologic Oncology Group).

Roswell Park Management Information System (RPMIS) is a formatted video-based system of programs for file creation, data entry, editing, updating, retrieval, and report generation. It has been utilized in more than 800 intrainstitutional research studies at Roswell Park. The Gynecologic Oncology Group (GOG) is a multiinstitutional, multidisciplinary cooperative group. Its clinical trials encompass the planning, initiation, execution, analysis, and presentation of results of management and treatment of patients with gynecologic cancer. The GOG Statistical Office, located at Roswell Park Memorial Institute, is responsible for data management and analysis of all patients entered into GOG protocols. Present annual accrual is approximately 2000 patients per year; 38 protocols are actively accruing patients while follow-up continues on 14 studies that are closed to patient entry. A previous paper (J Med Syst 7:235-242, 1983) described a time study comparing use of RPMIS and a paper batch processing system in GOG data management. The time study results and potential advantages of RPMIS warranted a gradual total conversion to this system. Presently GOG maintains 43 separate, self-contained applications of RPMIS and routinely develops a new system in conjunction with each new study initiated. This paper documents GOG experience with RPMIS during the past 4 years.

Clinical Trials as Topic↗
PubMed1992

Practice and communications systems: a word processor based communications system.

The majority of computerized systems currently available for the orthodontic office have been designed for and aimed at those offices that have a volume practice and frequently have multiple practitioners. The stand-alone practitioner and the small office have been grossly ignored. Systems designed for large practices are frequently too complex, too involved in business administration, and too costly for the small office to use effectively. This article describes how an office communications system can be assembled by using commercially available programs. For background information and definition of terms used in this article, I suggest referring to "An Introduction to the Computerization of the Orthodontic Practice," in the Oct. issue of this Journal.

Communication↗