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PubMedDate not supplied

[Multicenter evaluation on different analyzers of three methods for direct HDL-cholesterol assay].

Most frequently, in routine laboratories, C-HDL is measured in the supernatant after precipitation of apolipoprotein B-containing lipoproteins by the sodium phosphotungstate/magnesium chloride reagent (PTA). This method involves precipitation, centrifugation and decantation steps which prevent full automation of the measurement and decrease the accuracy of the results. Recently, three direct assays for C-HDL including alpha-cyclodextrin sulphate (alpha-CD), polyanions/detergents (PA-D) or antibodies anti-beta-lipoproteins (AC) have been commercialized, in which all steps are fully managed by automated analyzers. These new methods have been compared to the conventional procedure (PTA), in multicenter studies among six laboratories using different analyzers. The C-HDL values measured by the alpha-CD and PA-D assays correlated well with those of the PTA method (r > 0.98), on most of the analyzers. With the AC assay, only the results obtained with the Hitachi 717 analyzer were correlated with C-HDL values of the PTA method. The linearity and specificity studies were evaluated in the laboratory A on a Kone Specific analyzer. The alpha-CD and PA-D assays were linear for C-HDL values from 0 to 5.56 mmol/l, as observed by increasing amounts of HDL2 + HDL3 or serum without lipoprotein isolated by ultracentrifugation. The specificity of these two methods was evaluated simultaneously, by adding various amounts of lipoproteins isolated by sequential ultracentrifugation. No interference was observed when adding chylomicrons up to 13.4 mmol/l of triglycerides for both methods. Inversely, increased C-HDL values were observed with added VLDL from 6 mmol/l of triglycerides for the PA-D assay and from 8 mmol/l for the alpha-CD assay. No interference was observed with added LDL up to 11.5 mmol/l of C-LDL for the alpha-CD assay and up to 6.7 mmol/l for the PA-D assay. In conclusion, the present multicenter evaluation demonstrates that the new procedures for the direct automation of C-HDL are easy and accurate and most of them correlated well with the classical precipitation method. In addition the study provides arguments for a choice between the different direct C-HDL methods.

Antibodies↗
PubMed1999

Local versus central assessment of venographies in a multicenter trial on the prevention of deep vein thrombosis in neurosurgery.

Venography is the diagnostic method of choice for end-point measurement in multicenter trials on the prevention of postoperative deep vein thrombosis (DVT). The aim of the study was to determine the inter-observer agreement between the local and central assessment of venographies in a multicenter trial comparing enoxaparin and placebo in the prevention of DVT after elective neurosurgery. The study was run in seven centers experienced in venography trials on DVT prevention. The central and local adjudication panels were both blind with respect to the assigned treatment. The central panel was unaware of the local adjudication. Venographies were adjudicated as positive, negative or inadequate for adjudication and positive venographies as proximal or distal DVT. Inter-observer agreement was assessed according to the Cohen's inter-observer variability index (K index). All 266 venographies (8 monolateral) were considered adequate for adjudication by both the central and local panels. A disagreement was found in 25 cases; K index = 0.75. Fourteen venographies adjudicated as negative centrally were considered positive locally (3 were proximal DVT). Eleven venographies adjudicated as positive centrally (1 was a proximal DVT) were considered negative locally. Enoxaparin was found to be more effective than placebo according to both the central and local adjudication: 16.9% versus 32.6% (Relative risk, RR = 0.52; CI 95% 0.33-0.82) according to central adjudication; 18.5% versus 33.3% (RR = 0.56; CI 95% 0.36-0.87) according to local adjudication. We conclude that a good inter-observer agreement in the assessment of venography was observed between the central and local adjudication in a study on DVT prevention run in a restricted experienced study framework. The cost and work overloading of central assessment of venographies in this study framework seems not to be justified.

Anticoagulants↗
PubMed2000

Autologous peripheral blood stem cell transplantation as first line treatment of multiple myeloma: an Italian Multicenter Study.

BACKGROUND AND OBJECTIVE: The outcome of patients with multiple myeloma (MM) has not changed markedly since the introduction of melphalan and prednisone. In recent years several studies have investigated the role of intensive therapy followed by infusion of autologous peripheral blood stem cells (PBSC) together with the administration of hematopoietic growth factors. In this study we evaluated the feasibility and efficacy of a PBSC transplantation program for patients with de novo MM in a multicenter setting. DESIGN AND METHODS: In a non-randomized controlled trial 52 patients with de novo MM from 6 Italian centers underwent a three phase treatment strategy including 3 cycles of VAD-like chemotherapy for initial debulking, followed by high-dose cyclophosphamide (HD-CY) and collection of PBSC, that were transplanted after a conditioning regimen with melphalan plus busulfan. Maintenance treatment was a conventional dose of interferon, given until relapse. Actuarial survival and response duration curves were plotted according to Kaplan and Meier's method; the groups were compared using the log rank test. Response rates were compared by the c(2) test; multivariate analysis was performed according to the stepwise regression model. RESULTS: Overall 39/52 (75%) of patients responded, with a complete remission (CR) rate of 31%. After a median follow-up of 55 months, median duration of event-free survival (EFS) and overall survival (OS) are 21 and 57 months, with 24% and 48% probabilities of being event-free and alive after 6 years, respectively. Among the group of 39 responders, CR was significantly associated with prolonged response and survival (2 deaths and 6 relapses/16 patients) as compared with PR (11 deaths and 15 relapses/23 patients), and remained the only significant variable also in a multivariate analysis. Myelosuppression did not protract beyond one week in transplanted patients; extra-hematologic toxicity was very low. INTERPRETATION AND CONCLUSIONS: This multicenter study confirms the feasibility of an aggressive approach to de novo MM patients. Additional confirmation is given of the increased rate of CR, and the significant prolonged survival observed in complete responders. In this experience the association melphalan plus busulfan was shown to be effective, at least as part of conditioning regimens, in the transplant strategy.

Adult↗
PubMed2000

Antimicrobial resistance in Brazil: comparison of results from two multicenter studies.

To evaluate whether our previous study of the antimicrobial resistance patterns in three centers in Brazil represented the pattern in the country as a whole, the results were compared to new data on 855 isolates from 20 clinical laboratories and 36 hospitals located in different regions of Brazil. Both multicenter studies showed high rates of antimicrobial resistance among Gram-negative bacilli isolated in Brazilian hospitals with the most important problems being: 1) E.coli and K.pneumoniae that produce ESBL; 2) Enterobacter spp. which likely express chromosomally mediated (AmpC) stably derepressed cephalosporinases producing resistance to third-generation cephalosporins and broad spectrum penicillins; 3) carbapenem resistance among Acinetobacter spp. and P.aeruginosa; and 4) fluoroquinolone and aminoglycoside resistance among many Gram-negative species. Our results emphasize the importance of regional antimicrobial resistance surveillance programs in guiding empirical therapy and for focusing intervention controls of antimicrobial resistance. Although the SENTRY Program has only three participating centers in Brazil, its results were validated by a larger Brazilian multicenter study.

Brazil↗
PubMed2000

Consensus strategy to quantitate malignant cells in myeloma patients is validated in a multicenter study. Belgium-Dutch Hematology-Oncology Group.

Recently the Belgium-Dutch Hematology-Oncology group initiated a multicenter study to evaluate whether myeloma patients treated with intensive chemotherapy benefit from additional peripheral stem cell transplantation. To determine treatment response accurately, we decided to quantitate malignant cells. To test a consensus quantitation strategy, 5 centers independently determined the immunoglobulin heavy chain sequences of patient tumor cells and developed allele-specific oligonucleotides (ASO) and ASO-polymerase chain reaction (PCR). We compared the reproducibility of real-time quantitation with quantitation using limiting dilutions. We distributed DNA samples with a 4-log range of tumor cell concentrations and found average quantitation values deviating 74% and 42% from the input values with real-time PCR (1 center) and limiting dilutions (4 centers), respectively. Within single centers we found an average variation coefficient of 0.74, with limiting dilutions not significantly different from the average 0.82 center-to-center variation coefficient. Within a single center, real-time quantitation proved more reproducible (average variation coefficient, 0.36). Quantification was confirmed in 3 patients during treatment in the protocol. This report shows that real-time PCR or limiting dilution assays can be used for quantitation in a single multicenter trial. We present a consensus strategy that allows an accurate comparison of quantitation data generated in independent centers.

Base Sequence↗
PubMed2000

Efficacy, safety and patient satisfaction outcomes of the AMS 700CX inflatable penile prosthesis: results of a long-term multicenter study. AMS 700CX Study Group.

PURPOSE: We performed a long-term multicenter study of the AMS 700CX 3-piece inflatable penile prosthesis, focusing on longevity, morbidity and patient satisfaction in men implanted up to 134 months with a median followup of 47.7 months. MATERIALS AND METHODS: We performed a large scale retrospective multicenter study in 2 phases. Phase 1 was a medical record review of 372 men who underwent implantation with the AMS 700CX penile prosthesis from 1987 to 1996 by 7 frequent penile prosthesis implanters. Phase 2 included a structured telephone interview of 207 patients by a neutral observer. RESULTS: For the 372 men in phase 1 mean device mechanical reliability plus or minus standard deviation was 92.1% + or - 3.3% after 3 and 86.2% + or - 4.6% after 5 years. Patient age was 21 to 79 years (mean 57.6 + or - 11.0) at implantation. The etiology of erectile dysfunction was vascular in 27.7% of the cases, Peyronie's disease in 16.9%, diabetes mellitus in 12.9% and radical surgery in 11.6%. Of the men 55.6% received previous treatment for erectile dysfunction. Postoperative infection and device malfunction developed in 3.2% and 17.5% of the cases, respectively. Of the 207 men interviewed in phase 2, 86% still had an AMS 700CX penile prosthesis implanted, including 87.1% with erection suitable for coitus. Currently 79% of those with a device use it at least twice monthly and 88.2% would recommend an implant to a relative or friend. CONCLUSIONS: The AMS 700CX penile implant produced suitable erection and excellent patient satisfaction at long-term followup in the majority of men. Implant reliability is excellent and postoperative morbidity is low.

Adult↗
PubMed2000

Diagnostic accuracy of 99mTc-sestamibi breast imaging: multicenter trial results.

UNLABELLED: Although mammography is well established as a first-line tool for breast cancer screening and detection, efforts to develop complementary procedures continue. Observation of 99mTc-sestamibi tumor uptake provided the impetus for its evaluation as an adjunctive technique. This trial's objectives were to determine in a multicenter trial the diagnostic accuracy of 99mTc-sestamibi in women with suspected breast cancer and to investigate factors influencing diagnostic accuracy. METHODS: Our multicenter trial enrolled 673 women (387 with nonpalpable abnormalities; 286 with palpable abnormalities) scheduled for excisional biopsy or mastectomy. Blinded and unblinded interpretations of scintigraphic images were compared with core laboratory established histopathologic diagnoses to define the diagnostic accuracy of 99mTc-sestamibi breast imaging. RESULTS: Blinded readers' diagnostic accuracy was 78%-81%. Inter-reader agreement was excellent, ranging from 95% to 100% (kappa = 0.82-0.99). Overall institutional sensitivity and specificity for 99mTc-sestamibi breast imaging were 75.4% and 82.7%, respectively. In this population with a 40.1% disease prevalence, the positive predictive value was 74.5% and the negative predictive value was 83.4%. The negative predictive value was 94% in patients with a 40% or lower mammographic likelihood of breast cancer. Sensitivity was higher for palpable abnormalities; specificity was higher for nonpalpable abnormalities. Sensitivity was decreased for tumors <1 cm in largest dimension but appeared not to be affected by patient's age. CONCLUSION: As an adjunct to current procedures, 99mTc-sestamibi breast imaging may contribute to patient management decisions in selected populations, including women with dense breasts, mammographically indeterminate lesions >1 cm, and palpable abnormalities.

Biopsy↗
PubMed2000

Veterans Affairs Multicenter Low Vision Enhancement System (LVES) study: clinical results. Report 1: effects of manual-focus LVES on visual acuity and contrast sensitivity.

PURPOSE: The Department of Veterans Affairs LVES Study is a multicenter study to determine the effectiveness of the Low Vision Enhancement System (LVES) as a visual rehabilitation device. The purpose of this study was to explore the efficacy of the Beta 1 manual-focus LVES for improving visual acuity and contrast sensitivity. METHODS: Patients whose visual acuity was 20/80 or worse in the better eye from any disease, who did not have significant visual field loss, who had previous low vision experience and were capable of working with the LVES were enrolled in a comprehensive prospective multicenter clinical evaluation. Initially, corrected spectacle visual acuities were measured using a standardized ETDRS chart. Contrast sensitivities were also measured with spectacle correction using a standardized Peli-Robson chart. These results were then compared to the acuities and contrast sensitivity obtained with the LVES at optimal magnification. Also, visual acuities were measured using an Eschenbach 3x spectacle-mounted binocular telescope, then compared to the acuities obtained using the LVES set at the lowest magnification (3x). RESULTS: All patients who completed the study demonstrated an improvement in visual acuity, with a median improvement of six lines of Snellen equivalent acuity using the LVES. Improvement in visual acuity was the same in both ARMD and non-ARMD causes of vision loss. Mean contrast sensitivity improved in 52 of 58 patients tested, with a mean improvement of 0.49 log units. CONCLUSION: The LVES significantly improves both visual acuity and contrast sensitivity in visually impaired patients who fall within the study criteria. Up to 10-fold improvement in visual acuity and up to 1.80 log units improvement in contrast sensitivity were noted in the study group when the LVES was used.

Adult↗
PubMed2001

Ultrastaging of colorectal cancer by sentinel lymph node mapping technique--a multicenter trial.

Sentinel lymph node (SLN) mapping accurately diagnoses the status of nodal basin with >95% accuracy in melanoma and breast cancer. A multicenter trial for SLN mapping was performed on 203 patients with colorectal cancer to determine accuracy, upstaging, skip metastasis, and aberrant drainage. Lymphazurin 1% was injected subserosally around the tumor and 1-4 blue staining nodes were marked as SLNs for detailed histological analysis. SLN mapping was successful in 98% of patients with an average of 1.7 SLNs per patient. SLNs were negative in 63% of the patients and positive in 37% of the patients. Skip metastasis was seen in 8 of the patients. Occult micrometastasis was found in 14% of patients. In 5% of the patients, unusual lymphatic drainage lead to an alteration of the extent of lymphadenectomy. This multicenter trial proved that SLN mapping in patients with colorectal cancer is simple, cost effective, and upstages at least 14% of patients from AJCC stage I/II to stage III. These patients may then benefit from adjuvant chemotherapy.

Adult↗
PubMed2001

Encapsulating peritoneal sclerosis in Japan: prospective multicenter controlled study.

OBJECTIVE: Encapsulating peritoneal sclerosis (EPS) is recognized as a serious complication of peritoneal dialysis. The aim of this study was to determine the incidence, clinical features, and variation in mortality rates for EPS. DESIGN: A prospective multicenter design was used, in which peritoneal dialysis patients were pre-registered by facilities across Japan and the incidence of EPS was observed in the registrants. The registrants were followed for a total of 4 years to accurately observe the onset of EPS. RESULTS: As of April 1999, 2216 peritoneal dialysis patients from 64 facilities were registered. By the end of March 2001, 332 patients had dropped out, and 17 of the dropouts had developed SEP. The incidence was 0.77%. After excluding 110 patients who died, the incidence in 2106 patients was 0.81%. The incidence of EPS increased with the duration of peritoneal dialysis. Of the 17 patients with EPS, 12 developed the condition after discontinuing peritoneal dialysis and changing to hemodialysis. During the 2-year survey period, 6 of the 17 EPS patients died. The interval from onset to death was 10.8 +/- 5.8 months (range: 3-19.5 months). CONCLUSIONS: From this prospective multicenter study, the current incidence of EPS is 0.77% (0.81% when dropout owing to death is censored). After a follow-up of 2 years, we conjecture that the incidence of EPS will increase. The incidence, etiology, and prognosis of EPS will be further clarified by periodic observation of dropouts until the end of March 2003.

Adult↗
PubMed2002

Multicenter comparison of calibration and cross calibration of PET scanners.

UNLABELLED: The purpose of this study was to compare the calibration of PET scanners and their cross calibration to peripheral devices in a multicenter study. METHODS: Twenty-three dedicated PET scanners were investigated, applying standardized protocols. To ensure exact determination of the activity used, dose calibrators were checked using (68)Ge standards. RESULTS: Nine of 19 and 11 of 20 scanners displayed an error of <5% in 3-dimensional and 2-dimensional acquisition modes, respectively. Four and 5 scanners displayed an error of 10% in 3-dimensional and 2-dimensional modes, respectively. All other scanners yielded errors of 5% to <10%. Because of hardware and software problems, the measurements performed on 1 scanner could not be adequately analyzed. CONCLUSION: An investigation of calibration is mandatory. Especially for quantitative analyses in clinical multicenter trials, identification of potentially miscalibrated scanners is necessary.

Calibration↗
PubMed2001

[Differential criteria between papillary and follicular thyroid carcinoma--initial conclusions from a multicenter trial].

Histopathological diagnosis of thyroid cancer is difficult and requires much experience. Pathologists have to know many histopathological variants and be aware of the current diagnostic criteria. The aim of the study was to unify criteria applied all over the country and compare whether the accuracy of diagnosis has changed in the course of the last fifteen years. In a multicenter trial, 36 pathologists from 25 centers reevaluated 232 thyroid tumors operated between 1985-1998. The reference diagnosis was given on the basis of evaluation made by four experienced pathologists. The two-step analysis was performed. At first, the accuracy of the diagnosis of malignant neoplasm was evaluated. Then, the accuracy of the diagnosis of the cancer histotype was analyzed, with estimation of kappa coefficients and their asymptomatic standard error. Comparison of primary and reference diagnoses revealed statistically significant differences--in 17% of cases the primary diagnosis of cancer was not confirmed by experienced pathologists. Kappa coefficient for the diagnosis of cancer histotype was 0.53 + 0.06. On the contrary, the diagnoses made by the participants of the trial did not differ significantly from the reference ones. Kappa coefficient for the diagnosis of cancer histotype was significantly higher than for primary diagnoses with 0.63 +/- 0.10 (p < 0.001). The first results of the multicenter trial indicated that the most frequent diagnostic error made at primary diagnosis was the overdiagnosis of follicular thyroid carcinoma. Thus, a summary of strict criteria for papillary and follicular thyroid carcinoma is also given.

Adenocarcinoma, Follicular↗
PubMed2002

Accuracy of endoscopic ultrasonography in upper gastrointestinal submucosal lesions: a prospective multicenter study.

BACKGROUND: Endoscopic ultrasonography (EUS) is commonly agreed to be the best imaging method for diagnosing and differentiating between submucosal lesions in the gastrointestinal tract. However, most of the current evidence for this derives from retrospective multicenter studies. A prospective multicenter analysis of the performance of EUS in diagnosing submucosal lesions in everyday practice was therefore conducted. METHODS: Over a 2-year period, this study included 150 patients (52% men, mean age 59.8 years) from 23 centers who had a presumptive diagnosis of a submucosal lesion on upper gastrointestinal endoscopy. The patients' symptoms and EUS results were recorded. Endoscopic and endosonographic findings regarding lesion size, layer of origin, and the presumptive diagnosis (benign or malignant) were recorded. The reference methods used were surgery, biopsy, other imaging tests, and a follow-up period of 6 months. RESULTS: Of the 150 patients, 102 had an intramural lesion (84 tumors, 18 other lesions such as cysts, aberrant pancreas, etc.), and 48 had an extraluminal compression--in most cases (n = 35) by normal organs or structures. For differentiating between a submucosal and an extraluminal compression, the sensitivity and specificity of endoscopy were 87% and 29%, whereas those of EUS were 92% and 100%. However, the sensitivity and specificity of EUS for differentiating between malignant and benign submucosal tumors were only 64% and 80%, respectively. CONCLUSIONS: The accuracy of EUS in differentiating between submucosal tumors and extraluminal compressions is substantially superior to that of endoscopy, but EUS is still inadequate for differential diagnosis between benign and malignant submucosal tumors. However, EUS is still the best method of visualizing submucosal lesions precisely. The influence of EUS on the further management in these patients remains to be examined in subsequent studies.

Adolescent↗
PubMed2003

OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Exercise 4: an international multicenter longitudinal study using the RA-MRI Score.

The aim of this multireader, multicenter study was to assess the inter-reader reliability of the score in the assessment of disease status and progression. The exercise involved 10 sets of metacarpophalangeal (MCP, 2nd to 5th) joints and 10 sets of wrist magnetic resonance images that were scored by experienced readers from 5 international centers. Synovitis was scored for each site using a global score (0-3). Bone abnormalities were assessed at 8 MCP joint sites and 15 wrist sites according to proportion of bone volume (0-10 for erosions and defects and 0-3 for edema). Intraclass correlation coefficients (ICC) and smallest detectable differences for synovitis, erosions, and edema were acceptable, although better for status scores than progression scores. The agreement for MCP joints was better than wrists. Limited variation in the images for some findings resulted in low ICC. Bone defects had the poorest agreement and have been omitted from new scoring recommendations. Despite limited training, multicenter readers demonstrated acceptable levels of agreement.

Arthritis, Rheumatoid↗
PubMed2003

Prevalence, clinical characteristics, resource utilization and outcome of patients with acute chest pain in the emergency department. A multicenter, prospective, observational study in north-eastern Italy.

BACKGROUND: The evaluation and triage of patients with suspected myocardial ischemia in the emergency department is challenging and costly. In Italy there are no prospective data neither about the prevalence, clinical characteristics, and outcome of patients with chest pain in the emergency room, nor about the costs of their triage. Therefore, this study was undertaken to evaluate the diagnostic accuracy and costs of the actual emergency department triage modalities of patients with acute chest pain. METHODS: We analyzed the clinical data from a multicenter, prospective study of all patients with chest pain who presented to the emergency department of three hospitals in North-Eastern Italy from April to October 1999. RESULTS: Of 12,375 new medical admissions at the three emergency departments during the study period, 495 (prevalence 4%, mean age 62 +/- 16 years, 50% females) were for chest pain. Thirty-seven percent of the patients with chest pain were hospitalized with a suspected acute coronary syndrome, while 63% were directly discharged from the emergency department. The diagnosis of acute coronary syndrome was confirmed in 79% of hospitalized patients. Among the patients discharged directly from the emergency department 68% were immediately sent back home (69 +/- 60 min from admission) and 32% required a brief clinical observation lasting 10 +/- 6 hours and including serial electrocardiographic and myocardial injury marker assessment. The average cost of the emergency department triage was 189 +/- 237 [symbol: see text]/patient. The 1-month follow-up of the patients directly discharged from the emergency department revealed a 2.5% incidence of acute coronary syndromes (3 acute myocardial infarctions), but no deaths. CONCLUSIONS: Data obtained from our multicenter observational study suggest that present triage modalities for patients with chest pain in the emergency department based on patient history, clinical data, electrocardiography, and myocardial injury marker assessment could be improved in terms of accuracy and efficacy. Our data provide the clinical and economical framework for the designation of trials of new accelerated critical pathways for chest pain evaluation in the emergency department.

Acute Disease↗
PubMedDate not supplied

A prospective 5-year multicenter study of the Cresco implantology concept.

PURPOSE: The purpose of this study was to investigate the clinical and radiographic outcome of a prospective 5-year longitudinal multicenter test of a simplified implantology concept comprising an abutment-free implant system (Cresco) and a new method for fabrication of passively fitting superstructures, the Cresco Ti Precision method. MATERIALS AND METHODS: The tests were carried out at three different centers. Sixty partially or completely edentulous patients were restored by fixed implant-supported superstructures fabricated according to the Cresco Ti Precision method. In all, 215 Cresco implants were placed for the support of the superstructures. For various reasons, eight patients (13%) could not be followed through the 5 years. The radiographic measurements were recorded from radiographs exposed perpendicular to the implants. RESULTS: The initial implant failure rate (during the healing phase) was 2%, and the survival rate after loading was 98%. The mean peri-implant bone loss was 0.29 mm (SD 0.57). Of the measured sites, 71% showed a crestal bone loss of less than 0.5 mm. Very few mechanical complications were observed. This was attributed to the passively fitting superstructures. CONCLUSION: The results from the present multicenter test demonstrated that the abutment-free Cresco implantology concept is a reliable alternative method for implant-supported fixed prosthetic rehabilitation of edentulous and partially edentulous jaws.

Adult↗
PubMed2004

New trends in the epidemiological and clinical features of infective endocarditis: results of a multicenter prospective study.

BACKGROUND: The clinical and epidemiological profiles of infective endocarditis (IE) are continuously evolving. We report the results of a 2-year multicenter prospective survey that investigated new trends in the epidemiology, microbiological and clinical features and the prognosis of IE. METHODS: From January 2000 through December 2001, a prospective multicenter survey on IE was conducted in the region of Piedmont, Italy (4.2 million inhabitants). RESULTS: A total of 267 patients with suspected IE were enrolled, of whom 147 received a definite diagnosis of IE, as confirmed by pathology or follow-up data. The annual estimated incidence of IE was 36 cases per 1 million inhabitants in urban Turin and 30 cases per 1 million inhabitants in the province of Turin. A predisposing heart disease was detected in 70.8% of cases, with prosthetic valve involvement in 27 (18%). The incidence of injection drug use was 10%. Twenty-two cases (15%) were related to invasive procedures. Causative microorganisms included: streptococci 37.4% (oral streptococci 17.7%, group D streptococci 9.5%, pyogenic streptococci 3.4%, enterococci 6.8%), staphylococci 34%, other pathogens 28.5%. Blood cultures were negative in 25% of cases. The mean time between symptom onset and hospital admission was 39.7 days; this interval was shorter and associated with a poorer prognosis in cases of IE due to Staphylococcus aureus infection (p < 0.001). The delay in carrying out echocardiographic and blood culture evaluation often led to a late diagnosis as defined by the Duke criteria (8.2 +/- 7.4 days after admission). Valve surgery was performed in 31% of patients. The in-hospital mortality was 14% and that at 3 months 18%. CONCLUSIONS: In Piedmont, the incidence of IE is similar to the rates reported in other recent series. Still, the diagnosis and management of IE remain a challenge. The variegated clinical manifestations of IE and its changing epidemiology require constant surveillance.

Adolescent↗
PubMed2004

Neuroprotective effect of gacyclidine. A multicenter double-blind pilot trial in patients with acute traumatic brain injury.

The aim of this study was to assess the safety and efficacy of intravenous (IV) injections of gacyclidine, a novel NMDA receptor antagonist, for neurological and functional recovery following acute traumatic brain injury. This multicenter, prospective, randomized, placebo-controlled, double-blind study compared four parallel groups. Two IV doses were administrated (placebo, 2x0.005mg/kg, 2x0.001mg/kg, 2x0.02mg/kg): the first dose was given within 2 hours following the trauma, and the second dose 4 hours after the first. Fifty-one patients were enrolled and 48 studied between March 1995 and June 1997 in France. Evaluation criteria for safety were physical examination, cardiovascular parameters, blood chemistry, hematology, ECG, and neuropsychological changes monitored after medication. Primary evaluation criteria for efficacy was the Glasgow coma scale complemented by the initial CT-scan and Glasgow outcome scale, motor deficiencies, neuropsychological changes, and functional indenpendence at D90 and D365 or endpoint. Intracranial pressure (ICP) monitoring was not taken into account because all the clinical centers participating in this study did not use this technique in daily practice during the inclusion period. Twelve patients died during the follow-up period, none of these deaths being related to the drug. Serious adverse events (181) were reported by most of the patients with no significant differences between groups. Only 10 of these adverse events were considered to be drug-related. Safety-related laboratory tests did not show any relevant changes. Concerning efficacy, the predefined prognostic factors (initial CT-scan score, initial Glasgow Coma Scale and occurrence of low systolic blood pressure during the first 24 hours) largely determinated the patient's outcome. When the prognostic factors were taken into account together with the dose level in a logistic regression model, gacyclidine showed a beneficial long-term effect and a best dose-result in the 0.04mg/kg treated group. Data obtained in this clinical trial appeared sufficient to warrant a European multicenter study on gacyclidine using the same evaluation criteria and ICP monitoring.

Adolescent↗