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At least 397 records · Page 22Linked to original sources
PubMed2001

A closer look at combining data among a small number of binomial experiments.

In a regulatory environment, the regulators and the regulated may not be able to agree on the use of subjective prior information for a clinical trial. The use of a data-based prior offers a greater possibility for agreement, however, the degree of importance given to the prior data may still be contentious. The use of a hierarchical model to link the prior data and the current trial is shown to provide a relatively objective method for assigning weight to the prior data. Using a series of examples combining two binomial experiments, the effect of a hierarchical model on estimating rates, on the degree to which data is combined and on hypothesis testing is illustrated. In addition, the phenomenon in which combining data reduces the precision is explained. Simpler models based on finite mixtures of beta distributions are shown to work as well as the more computationally intensive, continuous mixtures. Lastly, an example combining three concurrent studies is illustrated. Published in 2001 by John Wiley & Sons, Ltd.

Bayes Theorem↗
PubMed2000

[Surgical gowns and patient drapes in routine practice: discrepancy between requirements and reality]].

BACKGROUND: Since the law regulating medical devices was introduced, hospital staff can only use surgical textiles that can guarantee 100% protection against infection. Conventional cotton products have shown themselves to be unsuitable, and must be replaced with barrier textiles. However, the changeover to innovative barrier textiles has turned out to be more difficult than expected. There is uncertainty among the qualified staff regarding the choice of material because of a lack of legal standardization. The objective of our study was to uncover the existing discrepancies between clinical practice and the legal requirements. METHODS: Based on a literature review we examined the suitability of the available surgical textiles with regard to the requirements. We then analyzed the situation based on standardized questionnaires, which were sent out to basic care and maximum care hospitals. RESULTS: According to the currently published data, barrier textiles best fulfill the requirement criteria. In contrast, the hospital staff questioned in our situation analysis noticeably preferred cotton textiles for the surgical gowns. The most common reason given was comfort. The laminates were considered most suitable as coverage material. Forty-four percent of those responding to the survey proved to have large gaps in their knowledge of the law regulating medical devices. Furthermore, only 41% of the hospital personnel were aware of the plan to standardize the requirement criteria. CONCLUSION: We were able to confirm that there is considerable discrepancy between the requirements and practice. The reasons for this are ignorance and lack of enforcement of the existing requirements. In this respect we stress that a quick introduction of the planned European standards is urgently necessary.

Cross Infection↗
PubMed2000

[Dorsal oblique pelvic fixator: development and biomechanical testing].

In haemodynamically unstable patients with an unstable pelvic ring injury the primary stabilisation of the pelvis and thus reduction of pelvic volume is important for the success of the treatment. The pelvic C-clamp is an approved emergency device for these unstable pelvic ring injuries. A secondary procedure though is necessary in most of the cases with a hig rate of wound problems in already traumatized soft tissue areas. The ventrally placed external fixator is a simple and quick procedure with little soft tissue damage. Though primary stability is sufficient even for C-type injuries, biomechanic stability of the posterior pelvic ring is often insufficient for mobilization. Based on biomechanic considerations, a new dorsal oblique pelvic external fixator was developed for pelvic C-type injuries. With the advantages of the supraacetabular fixator and two additional Schanz screws the ventral fixator should stabilize the posterior pelvic ring with comparable stability to the pelvic C-clamp. A primary and already definitive minimal invasive stabilization of the posterior pelvic ring was the aim. In the first series several variations of this asymmetric fixator with two different Schanz screw applications were tested biomechanically. In a second series the favorite version was tested versus the supraacetabular fixator and the pelvic C-clamp. Both of the biomechanic test series were performed with artificial pelves in the one leg stance model in the material testing machine. SI disruption and sacral fracture were the posterior instability types in 6 pelves each. There was no statistically significant difference between the dorsal oblique fixator and the pelvic C-clamp. But the new fixator was significantly more stable than the supraacetabular fixator or the new fixator without pretension.

Biomechanical Phenomena↗
PubMed2004

Sirolimus-eluting stents for percutaneous coronary intervention in acute myocardial infarction Lesson from a case-controlled comparison of bare metal versus drug-eluting stents in thrombus-laden lesions.

BACKGROUND: Given the encouraging results on early restenosis rate with drug-eluting coronary stents, both safety and 6 months outcomes of PCI with sirolimus-eluting stents (SES) in acute myocardial infarction are scarce. METHODS AND RESULTS: Fifty consecutive patients with acute myocardial infarction were subjected to acute PCI with SES and compared to 50 matched control patients who received a bare metal stent (BMS). All patients were followed over 6 months; in addition repeat angiography was obtained in 88.0% of SES and 92.0% of BMS patients. As a result of matching both groups were similar with regard to demographic, clinical, and infarction characteristics, as well as procedural data and adjunctive medication. SES diameter was 3.0 +/- 0.1 versus 3.3 +/- 0.5 mm with BMS, while the length of stented segment was 24 +/- 11 mm with SES versus 16 +/- 8 mm with BMS (p<0.05). No subacute stent thrombosis occurred in either group. At 6 months, all-cause mortality was 2.0% with SES, and 4.0% with BMS (n. s.); reinfarction rate was 2.0% in both groups, but binary restenosis rate (4.0 versus 18.0%; p<0.05) and target vessel revascularization (TVR) were improved with SES (2.0 versus 16.0%; p<0.05) resulting in lower MACE rate of 6.0 versus 22.0% with BMS (p<0.05). CONCLUSION: Placement of SES with PCI for myocardial infarction is feasible and as safe as BMS; 6-month outcome is superior with SES due to the lower rate of both angiographic restenosis and TVR.

Aged↗
PubMed1999

Complex Partial Seizures: Surgical Treatment.

Any patient who continues to have complex partial seizures following an adequate trial of antiepileptic drugs (AEDs) should be considered for evaluation for surgery in a comprehensive epilepsy center. Investigations should include 24-hour electroencephalographic (EEG) monitoring, a high-resolution magnetic resonance imaging (MRI) study, and neuropsychological assessment. Surgery is most effective in patients with unilateral hippocampal atrophy or a structural lesion and concordant EEG findings. With modern microsurgical techniques, surgery is associated with a low rate of major morbidity. The vagal nerve stimulator is a device recently approved by the United States Food and Drug Administration that may offer control equivalent to that of AEDs in patients who are not candidates for surgical resection.

Journal Article↗
PubMed1996

Regulating healthcare technologies and medical supplies in the European Economic Area.

A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of state-centric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create manpower, skills and institutional capacities, or alter governance and administrative practices in the short term. Neither EU directives nor national regulatory adjustments determine the 'man-machine/skills-experience' interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics.

Capital Expenditures↗
PubMed1995

Safety product evaluation: six years of experience.

Safety products to prevent percutaneous injuries are rapidly being developed for health care. Decisions to purchase such products are often made by an institution's infection control committee. We evaluated 30 safety products. These products are most readily accepted when potential users perceive a need, believe they are at risk for injury, and have input into the selection process. Task forces of intended users are invaluable in determining which products to evaluate in high-risk areas. Some new devices may be unsafe if excessive manipulation or in-service education is required. New products may not be well accepted if the devices are a different size or configuration than usual or require changes in established practices or techniques. An adequate supply of new products must be available immediately when the evaluation begins or users will tend to select the older, more familiar product. Removing all similar devices except for the new product can facilitate acceptance. Frequency of use can also influence employees when trying a new product. For instance, nurses who only occasionally draw blood have different perceptions of a new blood-drawing device from those of the phlebotomy team. Key employees were designated as resource persons to complement the manufacturer's in-service education and to support transition to the new product. We recommend that decision making by infection control committees involve the individuals who will eventually directly use the new products, starting with the early phases of safety product evaluation.

Accident Prevention↗
PubMed1995

Clinical investigation of antiarrhythmic devices. A statement for healthcare professionals from a joint task force of the North American Society of Pacing and Electrophysiology, the American College of Cardiology, the American Heart Association, and the Working Groups on Arrhythmias and Cardiac Pacing of the European Society of Cardiology.

The goal of radiofrequency catheter ablation and the criterion for efficacy is the elimination of arrhythmogenic myocardium. The application of radiofrequency current in the heart clearly results in lower morbidity and mortality rates than thoracic and cardiac surgical procedures in general, and comparisons of therapy with radiofrequency catheter ablation and therapy with thoracic and cardiac surgical procedures in randomized clinical trials is unwarranted. Trials of radiofrequency catheter ablation versus medical or implantable cardioverter-defibrillator therapy may be indicated in certain conditions, such as ventricular tachycardia associated with coronary artery disease. Randomized trials are recommended for new and radical departures in technology that aim to accomplish the same goals as radiofrequency catheter ablation. Surveillance using registries and/or databases is necessary in the assessment of long-term safety and efficacy.

American Heart Association↗
PubMed1996

Classification of death in antiarrhythmia trials.

OBJECTIVES: We sought to develop and apply a new scheme for the classification of death to be used in trials of antiarrhythmia treatments. BACKGROUND: Because presently accepted classifications of death do not fully describe or tabulate all significant aspects of terminal events, nor do they consider unique aspects of arrhythmia investigations, a new classification scheme that addresses these issues is desirable. METHODS: A classification scheme of deaths that occur in antiarrhythmia trials was developed using the following categories: 1) primary organ cause (cardiac [arrhythmic, nonarrhythmic or unknown], noncardiac or unknown); 2) temporal course (sudden, nonsudden or unknown); 3) documentation (witnessed, monitored [yes, no or unknown]); 4) operative relation (preoperative, perioperative or postoperative); and 5) system relation (procedure related, pulse generator related and lead related [yes, no or unknown]). RESULTS: The classification scheme was used in a clinical trial of a new implantable cardioverter-defibrillator (1,250 patients, of whom 79 died) and used in an application for device market approval. Application of the classification to data reported using an older classification scheme is demonstrated. CONCLUSIONS: We propose a descriptive classification scheme that 1) fully describes and tabulates all significant aspects of terminal events; 2) incorporates previously used categorizations of death and new categorizations that address unique aspects of arrhythmia investigations; and 3) tabulates sufficient data to allow comparison with other studies. Events in a clinical trial of implantable defibrillator therapy were classified using the new classification scheme.

Arrhythmias, Cardiac↗