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Manufacturer's Recommendations (manufacturer + recommendation)
Selected AbstractsClinical Judgment Versus Decision Analysis for Managing Device AdvisoriesPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 10 2008MITESH S. AMIN M.D. Introduction: Implantable cardioverter-defibrillator (ICD) and pacemaker (PM) advisories may have a significant impact on patient management. Surveys of clinical practice have shown a great deal of variability in patient management after a device advisory. We compared our management of consecutive patients in a single large university practice with device advisories to the "best" patient management strategy predicted by a decision analysis model. Methods: We performed a retrospective review of all patients who had implanted devices affected by an advisory at our medical center between March 2005 and May 2006 and compared our actual patient management strategy with that subsequently predicted by a decision analysis model. Results: Over 14 months, 11 advisories from three different manufacturers affected 436 patients. Twelve patients (2.8%) were deceased and 39 patients (8.9%) were followed at outside facilities. Management of the 385 remaining patients varied based on type of malfunction or potential malfunction, manufacturer recommendations, device dependency, and patient or physician preferences. Management consisted of the following: 57 device replacements (15.2%), 44 devices reprogrammed or magnets issued (11.7%), and 268 patients underwent more frequent follow-up (71.3%). No major complications, related to device malfunction or device replacement, occurred among any patient affected with a device advisory. Concordance between the decision analysis model and our management strategy occurred in 57.1% of cases and 25 devices were replaced when it was not the preferred treatment strategy predicted by the decision model (43.9%, 37.3% when excluding devices replaced based on patient preference). The decision analysis favored replacement for all patients with PM dependency, but only for four patients with ICDs for secondary prevention. No devices were left implanted that the decision analysis model predicted should have been replaced. Conclusions: We found that despite a fairly conservative device replacement strategy for advisories, we still replaced more devices when it was not the preferred device management strategy predicted by a decision analysis model. This study demonstrates that even when risks and benefits are being considered by experienced clinicians, a formal decision analysis can help to develop a systematic evidence based approach and potentially avoid unnecessary procedures. [source] Nicotine replacement therapy in patients with cardiovascular disease: guidelines for health professionalsADDICTION, Issue 11 2001Hayden McRobbie The causal relationship between cigarette smoking and cardiovascular disease (CVD) is well known and it is of great importance that smokers with CVD are encouraged to stop. Nicotine replacement therapy (NRT) is an effective aid to smoking cessation. However, its use in patients with CVD is often avoided because of warnings on product labelling. This is not justified, as NRT use in dependent smokers is much safer than smoking. Arguments are presented for the following guidelines which may be used when recommending NRT to patients with CVD; (i) NRT can normally be recommended to smokers with CVD who tried and failed to quit without such help; (ii) in patients who have experienced a serious cardiovascular event within the past 4 weeks, involve the patient's consulting physician. In less acute cases this is not needed; (iii) ensure dosing does not exceed the manufacturer's recommendation; (iv) warn patients to stop using NRT if they relapse to smoking; and (v) target motivated smokers (i.e. those seeking help), and where possible provide or arrange intensive behavioural support to accompany NRT. This advice is conservative, but will hopefully remove some obstacles faced by smoking cessation counsellors and other health professionals when considering the use of NRT in people with history of CVD. [source] Serum Immunoglobulin G Concentrations in Calves Fed Fresh Colostrum or a Colostrum SupplementJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 2 2002Nicole M. Holloway This study compared serum immunoglobulin G (IgG) concentrations in calves fed colostrum with those of calves fed a colostrum supplement containing spray-dried serum. Twenty-four Holstein calves were randomly assigned to 1 of 2 treatment groups (fresh colostrum or colostrum supplement). Each calf was fed 4 L of colostrum (n1= 12) or 4 L of colostrum supplement (n2= 12) via oroesophageal intubation at 3 hours of age. The concentration of the colostrum supplement fed to calves was twice the manufacturer's recommendation. The median and range values for colostral IgG concentration were 6,430 mg/dL and 1,400-17,000 mg/ dL, respectively. Median serum IgG concentrations at 2 days of age differed significantly (P= .001) between calves receiving fresh colostrum (3,350 mg/dL) and the colostrum supplement (643 mg/dL). Eight percent of calves force fed colostrum had serum IgG concentrations <1,000 mg/dL, whereas 75% of calves force-fed supplement had IgG concentrations below this threshold. The calculated population relative risks for mortality associated with passive transfer for calves force-fed colostrum and calves force-fed colostrum supplement were 1.09 and 1.90, respectively. Force-fed fresh colostrum is superior to the colostrum supplement studied, but the colostrum supplement has similar efficacy to routine colostrum administration practices. [source] In vivo determination of root canal length: a preliminary report using the Tri Auto ZX apex-locating handpieceINTERNATIONAL ENDODONTIC JOURNAL, Issue 7 2002F. Grimberg Abstract Aim The aim of this study was to assess the clinical perfomance of a cordless handpiece with a built-in apex locator , the Tri Auto ZX , designed for root canal preparation with nickel-titanium rotary files. Methodology Twenty-five human maxillary incisor and canine teeth scheduled for extraction with mature apices were selected for the study. Informed written consent was obtained from each patient before treatment. After administration of local anaesthesia, the teeth were isolated and the pulp cavities accessed. The Tri Auto ZX along with a size 15 K-file was used in its electronic apex locating function based on the manufacturer's recommendations. A periapical radiograph with the file at the electronically determined constriction was taken, the file removed and the measurement registered as the electronic length (EL). To test the auto reverse function, a size 20 ProFile .04 taper NiTi rotary instrument was mounted in the handpiece. The point for the auto apical reverse function was preset on the panel at the 0.5 mm level. After the file was introduced into the canal and reached the predetermined level, the file automatically stopped and rotated in the opposite direction. A reference point was marked and this measurement was registered as the auto reverse length (ARL). All measurements were made twice by two different investigators. Teeth were then extracted and immersed in a 20% formalin solution for 48 h. After fixation, a size 15 file was inserted into the canal to measure the actual root canal length from the same reference point obtained with the Tri Auto ZX to the apical foramen, as seen in the stereo microscope. When the file tip was visible at the anatomical end of the canal it was withdrawn 0.5 mm and this measurement was registered as the actual length (AL). All measurements were expressed in mm and the measuring accuracy was set to 0.5 mm. The significance of the mean differences between EL and ARL and between EL and AL measurements at the 5% confidence level was evaluated. Results EL measurements were coincident to ARL in all instances. EL and ARL were coincident to AL in 10 (40%) canals, in the remaining 15 canals (60%) the AL measurements were longer than EL and ARL (+0.5 mm) in 14 instances and shorter (,0.5 mm) in one case. Overall, the AL was longer than the EL or ARL, the mean difference being ,0.23 mm ± 0.32 (P < 0.05). Conclusions It was concluded that the Tri Auto ZX was useful and reliable. The Tri Auto ZX measurements protected against overpreparation. [source] Compatibility of a natural enemy, Coleomegilla maculata lengi (Col., Coccinellidae) and four insecticides used against the Colorado potato beetle (Col., Chrysomelidae)JOURNAL OF APPLIED ENTOMOLOGY, Issue 3 2004É. Lucas Abstract:, ,The toxicity of four insecticides used to control the Colorado potato beetle, Leptinotarsa decemlineata (Say) (Coleoptera: Chrysomelidae), imidacloprid (Admire®), cryolite (Kryocide®), cyromazine (Trigard®), and Bacillus thuringiensis var. tenebrionis (Novodor®), to one of its natural enemies, the 12-spotted lady beetle, Coleomegilla maculata lengi Timberlake (Coleoptera: Coccinellidae) was determined in the laboratory. Toxicity assays against C. maculata adults and larvae consisted of (1) topical applications and (2) exposures to treated foliage and prey, using concentrations up to 10 times the manufacturer's recommendations. Over a 6-day period, cyromazine (insect growth regulator) and B. t. var. tenebrionis (microbial insecticide) had no lethal effects on first and third instars C. maculata. For both larval and adult stages, cryolite (inorganic insecticide) caused very low predator mortality when topically applied and moderate mortality when ingested through contaminated eggs of Colorado potato beetles. Imidacloprid (systemic organic insecticide) was highly toxic to adult and larval C. maculata. Its estimated LD50 at 6 days following treatment, corresponded to 0.02,0.09 times the recommended field concentration, depending on the developmental stage and mode of contamination. These results indicate that integrated pest management programmes for Colorado potato beetles using imidacloprid or, to a lesser degree, cryolite, would be detrimental to C. maculata. Cyromazine and B. t. var. tenebrionis seem to present a better compatibility with the protection of C. maculata populations. [source] Microstructural and crystallographic surface changes after grinding zirconia-based dental ceramicsJOURNAL OF BIOMEDICAL MATERIALS RESEARCH, Issue 2 2006I. L. Denry Abstract The purpose of this study was to evaluate microstructural and crystallographic phase changes after grinding 3Y-TZP dental ceramics. Ceramic blanks were sintered according to manufacturer's recommendations and divided into four groups: (A) as-sintered control, (B) diamond-ground manually under water, (C) ground and polished, and (D) ground and annealed at 1000°C for 1 h. Bulk specimens were analyzed by X-ray diffraction to characterize the crystalline phases. The microstructure was investigated by SEM. XRD analyses showed that the control group and the group that was ground and annealed contained only tetragonal zirconia. However, after grinding or after grinding followed by polishing, rhombohedral zirconia and strained tetragonal zirconia were present, without any detectable amount of monoclinic zirconia. Annealing led to the disappearance of both residual lattice strain and the rhombohedral phase. The microstructure of the ground and polished specimens was characterized by significant residual surface damage associated with grain pullout to a depth of about 20 ,m. This type of damage could have an impact on the long-term fatigue behavior of 3Y-TZP. © 2005 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2006 [source] Child booster seats and lethal seat belt injuryJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 11 2004RW Byard Abstract: A 7-year-old boy travelling in the rear seat of a sedan car was wearing a lap-shoulder seat belt and sitting on a booster seat. Following a collision the boy ,submarined' under the seat belt sustaining trauma to the anterior aspect of his neck, cardiac arrest and subsequent death from hypoxic-ischaemic encephalopathy. This case demonstrates a potential problem with unsecured older-style booster seats. Movement of a seat in a collision may cause a child to slip under a seat belt and sustain significant neck injuries. Seatbelts for children must be correctly fitted, booster seats or capsules must be securely fastened and manufacturer's recommendations for size and weight limits should be followed. Unfortunately older booster seats may not have attached instructions for installation and use, may not fit later model vehicles, may not conform to current safety recommendations and may have worn webbing. For these reasons their use should be discouraged. [source] Infliximab safety profile and long-term applicability in inflammatory bowel disease: 9-year experience in clinical practiceALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2010Y. ZABANA Aliment Pharmacol Ther,31, 553,560 Summary Background, Most available data on infliximab therapy come from large, short-term, pivotal RCTs and concerns about long-term safety profile still remain. Aim, To evaluate the long-term safety profile of infliximab in inflammatory bowel disease (IBD) in a clinical practice setting. Methods, Since 1999, all IBD patients treated with infliximab were registered and clinical outcomes prospectively recorded up to March 2008, loss of follow-up or patient's death. Infliximab regimens and preventive measures were in accordance with the prevalent guidelines or with the manufacturer's recommendations. Results, One hundred fifty-two patients were included (121 Crohn's disease, 24 ulcerative colitis, 7 indeterminate colitis), with a median of 5 infliximab infusions (IQR 3,8) and 87% of patients received at least three infusions. Seventy-nine per cent of them received concomitant immunomodulators and 70% were pre-medicated with hydrocortisone from the first infusion. After a median follow-up of 142 weeks, 13% presented infusion reactions, 13% viral or bacterial infections and two patients developed neoplasia. The mortality rate was 2.6% (four patients). Conclusions, Infliximab therapy is safe when the recommended preventive measures are implemented, with a rate of serious adverse events less than 10%. No new safety signals were found. [source] Flexural properties of glass fibre reinforced acrylic resin polymersAUSTRALIAN DENTAL JOURNAL, Issue 1 2006IH Tacir Abstract Background: In recent years, glass fibres have been used to strengthen denture base resins. A major difficulty in using reinforcing fibres with multiphase acrylic resins, such as powder liquid resins, is inadequate impregnation of the fibres with the resin. Methods: This investigation examined the reinforcing effect of glass fibres on the fracture resistance and flexural strength of acrylic denture base resins. Eighty identical specimens were formed in specially designed moulds in accordance with the manufacturer's recommendations. The four experimental groups were prepared and these consisted of conventional acrylic resin and the same resin reinforced with glass fibres. Ten specimens were fabricated in a standardized fashion for each experimental group. Flexural strength was tested using a 3-point universal testing machine. Results: In this study, statistically significant differences were found in the flexural strength of the specimens (P<0.05). The injection-moulded, fibre-reinforced group had significantly lower flexural strength than the injection-moulded group (P<0.001), and the microwave-moulded, fibre-reinforced group had lower flexural strength than the microwave-moulded group. The fracture resistance was significantly higher in the injection-moulded, fibre-reinforced group than in the injection-moulded group (P<0.05), and the fracture resistance was significantly higher in the microwave-moulded, fibre-reinforced group than in the microwave-moulded group. Conclusion: Within the limitations of this study, the flexural strength of heat-polymerized PMMA denture resin was improved after reinforcement with glass fibres. It may be possible to apply these results to distal extension partial and complete denture bases. [source] Variability in the upper limit of normal for serum alanine aminotransferase levels: A statewide study,HEPATOLOGY, Issue 6 2009Anand Dutta We conducted a study to characterize the variability in the upper limit of normal (ULN) for alanine aminotransferase (ALT) across different laboratories (labs) in Indiana and to understand factors leading to such variability. A survey was mailed to all eligible labs (n = 108) in Indiana, and the response rate was 62%. The survey queried for ALT ULN, the type of chemical analyzer used, five College of American Pathologists (CAP) sample results, and methods used to establish the reference interval. There was a wide variability in the ALT ULN for both men and women. Eighty-five percent of labs used chemical analyzers belonging to one of the four brands. For all five CAP samples, there was a statistically significant difference in ALT values measured by different analyzers (P < 0.0001), but these differences were not clinically significant. The majority of labs used the manufacturers' recommendations for establishing their ALT ULN rather than in-house healthy volunteer testing (only 17%). When healthy volunteers were tested, the process for testing was haphazard in terms of the number of individuals tested, frequency of testing, and criteria for choosing the reference population. After controlling for chemical analyzer type, there was no significant relationship between ALT ULN values and the method used for its establishment. Conclusion: Wide variability in ALT ULN across different labs is more likely due to variable reference intervals of different chemical analyzers. It may be possible to minimize variability in ALT ULN by (1) each lab solely following the manufacturers' recommendations and (2) manufacturers of different analyzers following consistent and rigorous methodology in establishing the reference range. Alternatively, studies should be undertaken to identify outcome-based reference intervals for ALT. (HEPATOLOGY 2009.) [source] Paediatric antibiotic prescribing by general dental practitioners in EnglandINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 4 2001N.O.A. Palmer Objectives. The inappropriate use of antibiotics is known to be a major contributory factor to the problem of antimicrobial resistance. No information is available on how practitioners prescribe antibiotics for children. This study investigated the prescribing of liquid-based antibiotics for children by general dental practitioners in England. Design. Analysis of National Health Service liquid-based prescriptions issued by general dental practitioners in England. Sample and methods. All prescriptions issued by practitioners in 10 Health Authorities in England for February 1999 were collected. All the liquid-based antibiotic prescriptions for children were selected and we investigated the type of antibiotic prescribed, whether sugar free, the dose, frequency and duration. Results. A total of 18614 prescriptions were issued for antibiotics. Of the 1609 liquid-based paediatric prescriptions 88·3% were for generic and 11·7% for proprietary antibiotics, of which 75·5% were for amoxicillin, 15·2% for phenoxymethylpenicillin, 6·6% for erythromycin, 1·7% for metronidazole. Cephalexin, ampicillin, cephadrine and combinations of two antibiotics were also prescribed. There was a wide variation in dosages for all the antibiotics prescribed. A significant proportion of practitioners prescribed at frequencies inconsistent with manufacturers' recommendations and for prolonged periods, with some practitioners prescribing for periods up to 10 days. Only 29·1% of all the prescriptions issued were sugar free. Conclusions. The results of this study show that some practitioners prescribe liquid-based antibiotics inappropriately for children. This may contribute to the problem of antimicrobial resistance. Clear guidelines on the choice of antibiotic, dose, frequency and duration along with educational initiatives for GDPs might reverse this trend. [source] Biaxial Flexural Strength and Microstructure Changes of Two Recycled Pressable Glass CeramicsJOURNAL OF PROSTHODONTICS, Issue 3 2004Mohammad Albakry BSc Purpose: This study evaluated the biaxial flexural strength and identified the crystalline phases and the microstructural features of pressed and repressed materials of the glass ceramics, Empress 1 and Empress 2. Materials and Methods: Twenty pressed and 20 repressed disc specimens measuring 14 mm × 1 mm per material were prepared following the manufacturers' recommendations. Biaxial flexure (piston on 3-ball method) was used to assess strength. X-ray diffraction was performed to identify the crystalline phases, and a scanning electron microscope was used to disclose microstructural features. Results: Biaxial flexural strength, for the pressed and repressed specimens, respectively, were E1 [148 (SD 18) and 149 (SD 35)] and E2 [340 (SD 40), 325 (SD 60)] MPa. There was no significant difference in strength between the pressed and the repressed groups of either material, Empress 1 and Empress 2 (p > 0.05). Weibull modulus values results were E1: (8, 4.7) and E2: (9, 5.8) for the same groups, respectively. X-ray diffraction revealed that leucite was the main crystalline phase for Empress 1 groups, and lithium disilicate for Empress 2 groups. No further peaks were observed in the X-ray diffraction patterns of either material after repressing. Dispersed leucite crystals and cracks within the leucite crystals and glass matrix were features observed in Empress 1 for pressed and repressed samples. Similar microstructure features,dense lithium disilicate crystals within a glass matrix,were observed in Empress 2 pressed and repressed materials. However, the repressed material showed larger lithium disilicate crystals than the singly pressed material. Conclusions: Second pressing had no significant effect on the biaxial flexural strength of Empress 1 or Empress 2; however, higher strength variations among the repressed samples of the materials may indicate less reliability of these materials after second pressing. [source] | ||||||||||