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PubMed1998

Regulatory perspective on characterization and testing of orthopedic bone cements.

This paper provides a general regulatory background of acrylic bone cements, chemical composition information on several commercially available bone cements, physical and chemical methods of analyses, mechanical test methods, and risks and failure mechanisms of acrylic bone cements. Suggestions and recommendations presented in Tables 2 and 3 are not mandatory requirements but reflect data and methodologies which the FDA's Orthopedic Devices Branch (ORDB) believes to be acceptable to evaluate most pre-clinical data. FDA may require information in addition to that contained in this paper. In some instances, a sponsor may be able to sufficiently justify the omission of some tests. Although this paper describes certain administrative requirements, it does not take the place of the requirements contained in Title 21 of the Code of Federal Regulations (21 CFR) Parts 801, 807, 812, and 814 or those found in the statute.

Animals↗
PubMed1997

Residual abnormalities of pulmonary function in asymptomatic young adult asthmatics with childhood-onset asthma.

We investigated the pulmonary function of male asthmatics with childhood-onset asthma. Our results revealed that adult asthmatics with mild symptoms apparently have abnormal pulmonary function. On the other hand, after a 3-6-month symptom-free period, and even after inhalation of bronchodilator, they still showed significant residual abnormalities in pulmonary function. Pulmonary function tests are very sensitive tools for the assessment of airway limitations during an acute asthmatic attack. However, these tests are not sensitive enough to detect residual abnormalities in asymptomatic asthmatics. Although the positive predictive rate for detecting small airway dysfunction in asymptomatic asthmatics is not high, FEF25-75 proved to be the best (63.2%) among the conventional pulmonary function parameters. We therefore suggest using FEF25-75 instead of FEV1 or peak flow rate in clinical practice for the conventional assessment of effectiveness of treatment, especially in the follow-up of asthmatic patients. More sensitive and simple tests are required in the future for detection of small airway dysfunction in asymptomatic asthmatics. Moreover, strict and early treatment of this abnormality with steroids is mandatory to prevent the formation of sequelae.

Adult↗
PubMed2006

[Laboratory tests and therapeutic strategies for the porphyrias].

The porphyrias are a heterogeneous group of predominantly hereditary metabolic diseases resulting from a dysfunction of heme biosynthesis. Most of the porphyrias can manifest with a broad range of cutaneous symptoms on the sun-exposed areas of the body, whereas other variants reveal life-threatening acute neurological attacks. Further, mixed types of porphyrias exist. Besides the skin, other organs can be affected, such as the liver and the central nervous system. Therefore, interdisciplinary supervision of these patients is mandatory. In this review we will first present the clinical picture and diagnosis of the porphyrias, including the specific biochemical laboratory tests and a diagnostic algorithm. Thereafter, the current therapeutic concepts will be briefly addressed. Finally, we introduce the European Porphyria Initiative (EPI), an association of various European porphyria centers that is aiming at gathering the broad experience of internationally renowned porphyria experts for the development of European consensus guidelines for diagnosis and treatment of these metabolic disorders.

Algorithms↗
PubMed1992

[Analytical study of the Abbott and Ortho tests for screening and confirmation of anti-HCV antibodies. Le groupe de Travail "Hépatites virales" de la Société Française de Transfusion Sanguine].

Anti-HCV systematic screening on blood donation was mandatory in France since first of March 1991. Two laboratories (Ortho-Chiron and Abbott) have introduced in Europe successively two kinds of hepatitis C positive diagnosis with 1st and 2nd generation ELISA screening and confirmatory assays. The aim of this multicentric study was to evaluated the sensibility and specificity of these tests. For that, they used 10,090 blood sera. As a result we have seen that the new "second generation" screening assays have a higher sensitivity without less of specificity for the confirmatory tests.

Antigens, Viral↗
PubMed1989

A comparison of body mechanic usage in employees participating in three back injury prevention programmes.

Fifty-eight subjects, 23 female and 35 male, 19-62 years of age employed by four local industries, participated in one of three different Back Injury Prevention Programmes offered by a community hospital. Group A, 31 males, received two 1.5 hr classes of informational and exercise instruction plus mandatory 10-min daily exercise participation. Group B received three 1-hr mandatory classes of informational and exercise instruction with no follow-up daily exercise, and Group C received 1 hr of information and exercise demonstration only. Differences in body mechanic performance between the three groups were examined using Body Mechanic Questionnaire (BMQ) scores. The BMQ consists of 11 Likert-type questions developed by the researcher which were administered pre-, 1-week post-, and 3-months post-class instruction. At final post-testing, Group A showed a 12.9% improvement over pre-test scores; Group B, a 5.1% increase; and Group C, a 13.3% increase. These findings are discussed in terms of mandatory, continued reinforcement and Pender's Health Promotion Model.

Adult↗
PubMed1993

Stepwise development of a clinical expert system in rheumatology.

The evaluation of computer expert systems, a promising diagnostic tool for future application in clinical medicine, is of great importance. We present here the evaluation of our expert system, "RHEUMA". It is stressed, that repeated retrospective testing and updating of an expert system and its subsequent repeated assessment in clinical use and surroundings is mandatory. This increases the diagnostic accuracy of the system. For our system this is demonstrated under three separate conditions. In the first study the information available for the computer system (mainframe) came from medical histories only. Here an error rate of about 25%--similar to that of physicians themselves using the same information--was observed in 358 outpatients, compared to the final diagnoses of physicians also relying solely on information from medical histories. In a second step a completely new system on a personal computer was developed with all relevant diagnostic information. The error rate of this system (0.4%) was much too optimistic because the knowledge base was changed during the study, affecting about 30% of the 282 prospectively recruited outpatients. In a third step the efficacy of the expert system was tested in an additional hospital without the diagnostic involvement of the first testing clinic. The error rate of the system without changing the knowledge base reached 11% in 51 outpatients in this rheumatology clinic. This result reflects the diagnostic accuracy of the system today. Its ability to specify the same diagnoses which clinical experts reached approached 90%. Considerable time is needed for such prospective testing, with repeated updating of the knowledge base--in our case for both the two systems and field studies of 2 years each.(ABSTRACT TRUNCATED AT 250 WORDS)

Computers↗
PubMed1975

Normal coronary angiography in an aircrewman with serial exercise test changes.

A 45-year-old asymptomatic aircrewman is presented who developed an abnormal ST segment response to maximal treadmill testing after normal responses for 3 previous years. Coronary angiography performed after his abnormal stress test reveled no change from a previously normal study. It has been demostrated that serially performing exercise tests can increase the sensitivity of detecting latent coronary artery disease. The importance of the case report is to demonstrate that the change from a normal exercise test to an abnormal one does not absolutely indicate that an individual has a coronary artery disease and that it is mandatory to search for other possible causes. Further studies will be required to determine the significance of such serial changes.

Aerospace Medicine↗
PubMed2006

Self-assessment in neurological surgery: the SANS wired white paper.

OBJECTIVE: Periodic self-assessment is an important component of postgraduate medical education and certification. The Self-assessment in Neurological Surgery (SANS) examination has a history of usefulness for neurosurgical written and oral board examination preparation. The SANS Wired test represents a recreation of the original SANS test using an Internet-based platform. Advanced functionality and contemporary content have been added to meet the increasing requirements for demonstration of lifelong learning and self-assessment as part of the Maintenance of Certification (MOC) process. METHODS: A needs assessment was performed before the development of SANS Wired. Postexamination surveys for users obtaining continuing medical education credit were analyzed for user satisfaction with the platform and content. Test-item performance metrics were analyzed based on first-attempt responses. The economic value of SANS Wired as a component of the mandatory MOC process was evaluated. RESULTS: The needs assessment identified a deficiency of available content and mechanisms for neurosurgery-specific self-assessment. As of October 15, 2005, a total of 588 individuals had subscribed to SANS Wired (28 institutional licenses accounted for 229 users). Eighty-eight post-test surveys were analyzed for user satisfaction. Ninety-four percent of responses indicated that learning objectives had been met. Initial performance metrics show an average point-biserial discrimination index of +0.18 for all test items. CONCLUSION: The SANS Wired system seems to be an effective platform for neurosurgical self-assessment and is acceptable to users. The system satisfies, in part, two of the four required components of MOC, namely, periodic self-assessment and demonstration of cognitive expertise. It is endorsed by the American Board of Neurological Surgeons for MOC.

Certification↗
PubMed1995

Piedmont region (Italy): setting quality standards and testing.

In this report we describe the two years (1991-1992) EQA programmes organized by the health committee of the Piedmont region (Italy). This programme was mandatory for all public and private laboratories. The parameters analysed were: PT and APTT (for coagulation); Hb, RBC, WBC, platelets and MCV (for haematology); glucose, urea, creatinine, total proteins, cholesterol, uric acid, triglycerides, AST, ALT, LDH, GGT, amylase, alkaline phosphatase, sodium, potassium, calcium, chloride, phosphorus and iron (for clinical chemistry). For haematology, the comparison between the first and the second year shows a significant decrease of imprecision, especially for platelets, WBC and MCV.

Hematologic Tests↗
PubMed1994

Physical examination and arteriography in patients with penetrating zone II neck wounds.

OBJECTIVE: To review the management of patients with penetrating zone II neck wounds to discern the value of physical examination and proximity arteriography for predicting arterial injury. DESIGN: A retrospective chart review of 178 patients treated for penetrating wounds to the neck. SETTING: A level I trauma facility in Dallas, Tex. PATIENTS: All patients seen from 1987 to 1991 with platysma penetration in zone II of the neck. INTERVENTION: Physical examination, arteriography, and surgical exploration were used to identify patients with arterial injuries in the neck after penetrating trauma. MAIN OUTCOME MEASURES: To identify the presence or absence of an arterial injury. RESULTS: Negative findings on physical examination ruled out an arterial injury in 99% of all patients. Patients with any sign of arterial injury had a 26% incidence of arterial injury confirmed at operation. Of 71 arteriograms in patients without signs or symptoms of arterial injury, only one had an arterial injury requiring operative intervention. CONCLUSIONS: Findings on physical examination are good predictors of arterial injury in patients with penetrating neck wounds and can exclude injury in over 99% of patients. Arteriography is a sensitive test but has a very low yield (1.4%). These findings question whether the current practice of mandatory neck exploration or proximity arteriography is necessary for patients without signs or symptoms of injury who have penetrating wounds of the neck.

Adolescent↗
PubMed2005

[Congenital hearing loss. Molecular genetic diagnosis of connexin genes and genetic counselling].

BACKGROUND: About 50% of congenital non-syndromic hearing impairment is caused by genetic factors. Research on the genetics of deafness has revealed a vast number of relevant genes. Mutations in the GJB2 gene have been shown to be the most common in several populations. METHODS: Mutation analysis of the genes for connexin 26, 30 and 31 (GJB2, GJB6 and GJB3) was performed in 67 patients with profound hearing loss. RESULTS: Of the participants, 9% had two pathogenic mutations in the GJB2 gene. Pedigree information indicates that in these families further offspring have a 25% to a 100% chance of having hearing impairment. CONCLUSIONS: Patients with non-syndromic hearing impairment should be offered molecular diagnostics of the GJB2 gene. Genetic counseling is mandatory for mutation carriers in order to advise them on the individual consequences of the gene test results.

Connexin 26↗
PubMed2005

[Risk factors for substance abuse and dependence in opioid therapy for chronic noncancer-related pain].

Opioids are valuable analgesics, capable of providing pain relief and functional improvement not only in patients with cancer-related pain, but also in chronic noncancer-related pain patients. However, recent data have shown that the increasing prescription of opioids is associated with a rise in aberrant drug-related behaviour. The causes of this behaviour are multifactorial. Some pharmacotherapeutic, but in particular psychosocial risk and etiologic pain factors have been identified. The indication for the prescription of opioids must be very carefully weighed in the presence of any risk factors. In these cases the integration into a multimodal, interdisciplinary therapy programme is mandatory. A contractual agreement on the opioid therapy including goals, side effects, controls including urine drug testing and criteria to finish the opioid therapy are advisable. Assessment of the progress of therapy is based on the following factors: analgesic efficacy, adverse side effects, functional status and aberrant drug-related behaviour. In the absence of a successful opioid therapy, the treatment must be discontinued to avoid iatrogenic damage, substance abuse and illegal diversion. After discontinuation of the therapy, a comprehensive interdisciplinary re-evaluation is required.

Analgesics, Opioid↗
PubMed2005

Assessment of hepatic reserve for the indication of hepatic resection: how I do it.

Despite the careful selection of cirrhotic patients with hepatic neoplasms, liver resection for these patients remains associated with greater risk than in patients without underlying liver disease. The most rational indications for resective surgery in patients with hepatic neoplasms and cirrhosis are nonprogressive cirrhosis and good functional reserve. Therefore, evaluation of hepatic reserve is mandatory for hepatectomy candidates. Because of the complexity of hepatic function, a single, reliable liver function test is not yet available. However, a good multifactorial system that combines several elements (clinical, laboratory, functional, and volumetric evaluation) does provide sufficient data for determining the safe limits of hepatectomy.

Algorithms↗
PubMed2001

Brain abscess in patients with hereditary hemorrhagic telangiectasia: case report and literature review.

Hereditary hemorrhagic telangiectasia (HHT), or Osler-Weber-Rendu disease, affects multiple organ systems. Brain abscess is a potential complication, and this disease carries a high mortality. In the setting of HHT the abscess most likely results from paradoxical septic emboli or bacterial seeding of an ischemic portion of the brain after paradoxical sterile emboli. Brain abscess is the diagnosis that must be ruled out in patients with HHT presenting with new onset neurologic symptoms. The clinician can be misled by seemingly benign and nonspecific symptoms, signs, and laboratory test results. Appropriate diagnostic imaging with computed tomography or magnetic resonance imaging of the head is mandatory. We present a case of brain abscess in a patient with HHT presenting to the Emergency Department. The review of the literature deals with the pathophysiology and manifestations of HHT with particular focus on the pathologic and clinical features, and management of cerebral abscess in this setting. Differences between patients with brain abscess with or without HHT are highlighted.

Brain Abscess↗
PubMed1997

Bioavailability of antisense oligonucleotides in neuroblastoma cells: comparison of efficacy among different types of molecules.

To evaluate the real effectiveness of various chemical modifications in enhancing the ability of antisense molecules to inhibit gene expression, the toxicity, stability, uptake, and intracellular localization of an identical sequence, synthetized either with a phosphodiester or a phosphorothioate backbone, with or without a cholesteryl moiety linked to the 3'-end, were compared in three different human neuroblastoma cell lines. The toxicity, assessed by inhibition of cell viability, greatly depend on the presence of the lipid moiety and to a less extent on the cell line used. At high doses all the antisenses caused a necrotic lysis of plasma membranes. Typical features of apoptotic cell death were never observed. The presence of the lipid moiety enhanced the uptake of antisense molecules while the phosphorothioate backbone, as expected, conferred higher stability. At late times, therefore, the combination of lipid conjugation and phosphorothioate backbone seems to be the most effective in obtaining a consistent antisense accumulation inside the cells. The presence of the cholesteryl moiety also caused a stronger association of the antisense to membraneous compartments, so that a quite different biodistribution occurred among the four antisenses tested. However, the actual amount of antisense molecules found inside NB cells was low in all the conditions tested. Only following cellular permeabilization a significant uptake was obtained, making the use of delivery system mandatory to achieve an efficient inhibition of highly expressed genes.

Autoradiography↗
PubMed2003

Assessment of HER-2/neu overexpression and/or gene amplification in breast carcinomas: should in situ hybridization be the method of choice?

AIMS: Since the release of Herceptin, pathology laboratories have been requested to test breast carcinomas for HER-2/neu overexpression and/or gene amplification. Standardized IHC and FISH are mandatory in order to get reliable results, but there are problems even with standardized procedures. We decided to evaluate the two methods to determine which, or possibly if both, should be the primary investigation method(s). METHODS AND RESULTS: The material consisted of 215 primary invasive breast carcinomas with complete clinical follow-up of 15 years. HER-2/neu protein expression was determined for all specimens, whereas FISH for assessing HER-2/neu gene signal number was done in 165 cases. IHC was double-checked with two or three different antibodies in 35 tumours, including all cases with discrepancies between IHC and FISH. Among these, there were discrepancies in a third. IHC overexpression of HER-2/neu was found in 13% and gene amplification in 18%. Discordance between IHC and FISH was found in 11 cases (8%). Five tumours were IHC+/FISH- and six were IHC-/FISH+. IHC and FISH positive cases as well as FISH only positive tumours had the same prognosis respecting survival. Tumours with >2 but 4 gene signals per nucleus. In contrast, cases with IHC overexpression without gene amplification had a prognosis similar to that of IHC-/FISH- tumours. CONCLUSIONS: From our data, it seems to be more important to assess HER-2/neu gene amplification than IHC overexpression. Failure to detect FISH-amplified (IHC-negative) cases would have an adverse effect on the survival of these patients. On the other hand, IHC overexpression tumours without gene amplification appear to belong to a better prognostic group, and failure to detect them would probably not have a negative effect on the survival of these women. Even though FISH is a more complex and expensive procedure, it should be considered the method of choice for primary assessment of HER-2/neu status in breast cancer patients.

Antibodies, Monoclonal↗