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PubMed1999

Early chemoprophylaxis with trimethoprim-sulphamethoxazole for HIV-1-infected adults in Abidjan, Côte d'Ivoire: a randomised trial. Cotrimo-CI Study Group.

BACKGROUND: In sub-Saharan Africa, various bacterial diseases occur before pneumocystosis or toxoplasmosis in the course of HIV-1 infection, and are major causes of morbidity and mortality. We did a randomised, double blind, placebo-controlled clinical trial at community-health centres in Abidjan, Côte d'Ivoire, to assess the efficacy of trimethoprim-sulphamethoxazole (co-trimoxazole) chemoprophylaxis at early stages of HIV-1 infection. METHOD: 843 HIV-infected patients were screened and 545 enrolled in the study. Eligible adults (with HIV-1 or HIV-1 and HIV-2 dual seropositivity at stages 2 or 3 of the WHO staging system) received co-trimoxazole chemoprophylaxis (trimethoprim 160 mg, sulphamethoxazole 800 mg) daily or a matching placebo. The primary outcome was the occurrence of severe clinical events, defined as death or hospital admission irrespective of the cause. Analyses were by intention to treat. FINDINGS: Four of the randomised patients were excluded (positive for HIV-2 only). 120 severe events occurred among 271 patients in the co-trimoxazole group and 198 among 270 in the placebo group. Significantly fewer patients in the co-trimoxazole group than in the placebo group had at least one severe event (84 vs 124); the probability of remaining free of severe events was 63.7% versus 45.8% (hazard ratio 0.57 [95% CI 0.43-0.75], p=0.0001) and the benefit was apparent in all subgroups of initial CD4-cell count. Survival did not differ between the groups (41 vs 46 deaths, p=0.51). Co-trimoxazole was generally well tolerated though moderate neutropenia occurred in 62 patients (vs 26 in the placebo group). INTERPRETATION: Patients who might benefit from co-trimoxazole could be recruited on clinical criteria in community clinics without knowing the patients CD4-cell count. This affordable measure will enable quick public-health intervention, while monitoring bacterial susceptibility and haematological tolerance.

AIDS-Related Opportunistic Infections↗

PubMedDate not supplied

Ceftazidime and ciprofloxacin as empiric therapy in febrile neutropenic patients undergoing hematopoietic stem cell transplantation.

This pilot study was done to assess the efficacy and toxicity of intravenous ceftazidime and ciprofloxacin in patients developing febrile neutropenia while undergoing high-dose myeloablative therapy and hematopoietic stem cell transplantation (HSCT). All patients undergoing high-dose chemoradiotherapy and HSCT for leukemias, lymphomas, multiple myeloma, and solid tumors received open-label ceftazidime 2 g intravenously every 8 hours and ciprofloxacin 400 mg intravenously every 12 hours if they developed fever while they were neutropenic. Success with or without modification of this regimen was defined as survival through the neutropenic period; failure was defined as death secondary to infection. Among 45 patients treated with this regimen, the success rate was 98%. Sixty-two percent (28 of 45) of the patients achieved defervescence within 48 to 72 hours and remained afebrile without regimen modification. In 16 patients (36%) the regimen was modified because of persistent fever. The combination of ceftazidime and ciprofloxacin as initial empiric antibacterial therapy in febrile neutropenic patients undergoing myeloablative therapy and HSCT appears to be highly effective and is associated with minimal toxicity.

Adult↗

PubMed1998

Tritiated-naloxone binding to brainstem opioid receptors in the sudden infant death syndrome.

The sudden infant death syndrome (SIDS) is defined as the sudden death of an infant under 1 year of age that remains unexplained after a thorough case investigation, including a complete autopsy. We hypothesized that SIDS is associated with altered 3H - naloxone binding to opioid receptors in brainstem nuclei related to respiratory and autonomic control. We analyzed 3H - naloxone binding in 21 regions in SIDS and control brainstems using quantitative tissue receptor autoradiography. Three groups were analyzed: SIDS (n = 45); acute controls (n = 14); and a chronic group with oxygenation disorders (n = 15). Opioid binding was heavily concentrated in the caudal nucleus of the solitary tract, nucleus parabrachialis medialis, spinal trigeminal nucleus, inferior olive, and interpeduncular nucleus in all cases analyzed (n = 74). The arcuate nucleus on the ventral medullary surface contained negligible binding in all cases (n = 74), and therefore binding was not measurable at this site. We found no significant differences among the three groups in the age-adjusted mean 3H - naloxone binding in 21 brainstem sites analyzed. The only differences we have found to date between SIDS and acute controls are decreases in 3H - quinuclidinyl benzilate binding to muscarinic cholinergic receptors and in 3H - kainate binding to kainate receptors in the arcuate nucleus in alternate sections of this same data set. The present study suggests that there is not a defect in opioid receptor binding in cardiorespiratory nuclei in SIDS brainstems.

Autoradiography↗

PubMed2000

Prognostic value of serum hyaluronan in patients with compensated HCV cirrhosis.

BACKGROUND/AIM: Serum hyaluronan (HA) levels increase according to the degree of liver fibrosis in patients with chronic viral hepatitis C. Patients with liver disease and markedly high serum HA levels have cirrhosis with typical signs of hepatic sinusoidal capillarization, a factor of aggravation of cirrhosis The aim of this study was to evaluate the prognostic value of serum HA for severe complications in asymptomatic patients with HCV cirrhosis. METHODS: Six hundred and sixty-eight patients with anti-HCV antibodies and increased serum alanine aminotransferase were referred to our hospital for evaluation, including liver biopsy. At entry, serum HA levels were measured in 91 patients (64 men, 27 women, 56 +/-11 years old) out of 103 who had asymptomatic, biopsy-proven cirrhosis According to the criteria of Child-Pugh, 82 were classified A and 9 B. The follow-up period was 6 to 82 months (median: 38 months), and 51 of these patients received alpha-interferon therapy during the first year. Severe complications were defined as death or liver transplantation, ascites, bleeding from esophageal varices, encephalopathy, or hepatocellular carcinoma. RESULTS: Serum HA levels at entry were higher in the cirrhotic patients in whom severe complications occurred during the follow-up period (520+/-426 microg/l vs 197+/-146 microg/l, p<0.0001). The patients with serum hyaluronan levels >350 microg/l displayed higher probabilities of occurrence of severe complications (p<0.0001). Other factors associated with the occurrence of complications or death were: serum bilirubin >18mol/l (p = 0.03), platelet count <112x10(9)/l (p= 0.02), prothrombin time <63% (p<0.0001), serum albumin <36 g/l (p=0.002), alkaline phosphatase >81 IU/l (p=0.01), and no interferon treatment (p= 0.0003). Multivariate analysis identified five independent factors predictive of severe clinical complications, namely: hyaluronan (p=0.006), prothrombin time (p=0.04), bilirubin (p=0.04), albumin (p=0.04), and no therapy (p=0.03). CONCLUSION: Serum HA level is predictive for occurrence of severe complications in HCV cirrhosis, and can be used as a prognostic marker, in addition to the parameters of the Child-Pugh score, particularly in patients with compensated cirrhosis.

Aged↗

PubMed1998

Ursodeoxycholic acid therapy for primary sclerosing cholangitis: results of a 2-year randomized controlled trial to evaluate single versus multiple daily doses.

BACKGROUND/AIMS: Ursodeoxycholic acid has been reported to be of potential benefit for primary sclerosing cholangitis but little is known about the long-term biochemical, histological and radiological efficacy or the optimum frequency of ursodeoxycholic acid administration. METHODS: A 2-year multicentre randomised controlled trial was initiated to assess the effects of ursodeoxycholic acid (10 mg kg(-1).d(-1), given in either single or multiple daily doses, on symptoms, serum liver tests, cholangiographic and histological findings and the occurrence of treatment failure. Liver biopsies were taken and endoscopic retrograde cholangiography was performed at entry and after 2 years; follow-up examinations were at 3-month intervals. Treatment failure was defined as death, liver transplantation, 4-fold increase in serum bilirubin, variceal bleeding, de novo ascites or cholangitis. Actuarial survival was compared with predicted survival using the revised Mayo natural history model for primary sclerosing cholangitis. RESULTS: Forty-eight patients were enrolled. In one case, ursodeoxycholic acid had to be discontinued because of gastro-intestinal complaints. No other side-effects were observed. After 2 years of follow-up, treatment was not associated with a beneficial effect on either symptoms or liver histology. Serum liver tests (alkaline phosphatase, y-glutamyl transferase, aspartate aminotransferase) improved significantly in both groups, while serum bilirubin (which was near normal at entry) and IgG remained stable. No major changes in radiographic bile duct appearance seemed to be present. After 2 years, actuarial survival was 91% (95 CI 83%-99%), which is comparable to the predicted 97% survival rate. Treatment failure occurred in 15% of cases. No significant differences in any of the study endpoints (symptoms, serum liver tests, cholangiographic findings, histology, disease progression) were found between the two groups. CONCLUSIONS: Ursodeoxycholic acid is well tolerated in primary sclerosing cholangitis. Significant effects on biochemical parameters were found and symptoms, bilirubin and histology did not deteriorate. No advantage of a multiple daily dose over a single dose was observed.

Adult↗

PubMed2003

Outcome after treatment of coronary in-stent restenosis; results from a systematic review using meta-analysis techniques.

AIMS: To evaluate the clinical outcome after treatment of coronary in-stent restenosis. METHODS AND RESULTS: For identification of the relevant literature a specific search strategy was conducted and explicit inclusion criteria were defined to avoid selection bias. Based on the selected literature, a systematic review using descriptive statistics and meta-analysis methods regarding the outcome after treatment of coronary in-stent restenosis was performed. The proportion of patients experiencing a major adverse cardiac event (MACE) as defined by death, myocardial infarction, and target lesion revascularization was the main outcome measure. A total of 1304 citations were identified. Among these, 28 studies (six different treatment modalities) including a total of 3012 patients met the inclusion criteria and were incorporated into this analysis. The estimated average probability of experiencing a major cardiac adverse event after treatment for in-stent restenosis with a follow-up period of 9+/-4 months was 30.0% (25.0-34.9%, 95% confidence interval) with strong evidence for heterogeneity between study specific results (P=0.0001). The clinical outcome was not significantly different between treatment modalities. After adjustment for confounding factors (i.e. lesion length), however, patients undergoing intracoronary radiation showed an estimated advantage of 16.9% (-37.7+/-4.0%, 95% confidence interval) in MACE free survival, as compared to balloon angioplasty. The post-interventional diameter stenosis was the only independent predictor for the long-term outcome after treatment of in-stent restenosis. CONCLUSIONS: Treatment of in-stent restenosis is associated with an overall 30% rate of major adverse cardiac events. Currently, repeat angioplasty is the treatment option of choice, especially when a sufficient acute procedural result can be achieved. Intracoronary radiation should be considered in cases with therapy refractory forms of diffuse in-stent restenosis.

Coronary Restenosis↗

PubMed2003

Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events: six month results of a randomized trial.

STUDY OBJECTIVE: To compare the long-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation. PATIENT POPULATION AND METHODS: Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. RESULTS: Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185+/-25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10 mg l(-1)was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045). CONCLUSIONS: Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.

Angina Pectoris↗

PubMed1998

Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations (SCCOPE): rationale and design of an equivalence trial. Veterans Administration Cooperative Trials SCCOPE Study Group.

The Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations Trial (SCCOPE) was a randomized, double-blind, placebo-controlled, multicenter trial sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program. Its principal purpose was to determine whether withholding systemic corticosteroids in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD) who were treated with other usual therapy resulted in a clinically significant increase in the rate of treatment failure. Because placebo was compared to a standard therapy, the study was designed as an equivalence trial. If corticosteroids proved effective, the study would also determine whether a short course was as effective as a long one. SCCOPE was to enroll up to 1100 subjects from more than 20 Veterans Administration Medical Centers over 3 years. Patients were screened shortly after hospital admission for acute exacerbation of COPD. Principal criteria for eligibility were age of 50 years or older, smoking history of 30 pack-years or more, clinical diagnosis of COPD as opposed to asthma, nonuse of systemic corticosteroids in the previous 30 days, and forced expiratory volume in 1 sec (FEV1) of 1500 ml or less. Eligible subjects were randomized to one of three treatment arms: (1) short course (2 weeks) of systemic corticosteroids, (2) long course (8 weeks) of systemic corticosteroids, or (3) placebo. We standardized most other aspects of care. We followed patients for 6 months. The primary endpoint of the study was treatment failure, defined as death, intubation with mechanical ventilation, hospital readmission for COPD, or intensification of pharmacologic therapy. Secondary endpoints included length of hospital stay, changes in FEV1, and changes in dyspnea score. We also evaluated possible adverse effects from systemic corticosteroids.

Double-Blind Method↗

PubMed2002

Long-term outcome of patients with ventricular septal defect considered not to require surgical closure during childhood.

OBJECTIVES: The purpose of the study was to assess the long-term outcome of patients with small ventricular septal defects (VSDs) considered not to require surgical closure during childhood. BACKGROUND: Although patients with small VSDs have generally been considered not to require surgery, more recent data suggest that a significant percentage of these patients develop serious problems during adult life. METHODS: A total of 229 consecutive patients (115 females) with a VSD considered too small to require surgery during childhood as defined by normal pulmonary artery pressure, less than 50% shunt, pulmonary vascular resistance < or =200 dynes x s cm(-5), no VSD-related aortic regurgitation (AR), and no symptoms and who had no additional hemodynamically relevant heart defect were followed in an adult congenital heart disease program. Physical examination, electrocardiography, and echocardiography were performed in all patients in one- to three-year intervals; exercise tests and Holter monitoring were performed in 140 and 127 patients, respectively. RESULTS: Follow-up was completed in 222 patients (97%). Mean age at last visit was 30 +/- 10 years. Spontaneous VSD closure was observed in 14 patients (6%). No patients died, four patients (1.8%) had an episode of endocarditis, of whom two required aortic valve replacement, and one additional patient (0.4%) had surgical closure for hemodynamic reasons. For 118 patients who entered the study between 1993 and 1996 and were prospectively followed for 7.4 +/- 1.2 years, event-free survival with end points defined as death, endocarditis or heart surgery was 99.1 +/- 0.8% at three years, 96.5 +/- 1.7% at six years and 95.5 +/- 1.9% at eight years. At last visit, 94.6% of all patients studied were symptom free. Left ventricular (LV) size by echocardiography was normal in 198 (89%) patients, borderline in 23 patients and definitely enlarged in only one patient. None had systolic LV dysfunction, and pulmonary artery pressure (PAP) was normal in all patients. Mean exercise capacity was 92 +/- 21% of expected, and 87% of patients had no arrhythmias on Holter monitoring, with the remainder showing benign rhythm disorders. CONCLUSIONS: Outcome in well-selected patients with a small VSD is good. Surgical closure does not appear to be required during childhood as long as left-to-right shunt is <50% and signs of LV volume overload are absent, when PAP is not elevated, and no VSD-related AR or symptoms are present.

Adolescent↗

PubMed2002

Women do have an improved long-term outcome after non-ST-elevation acute coronary syndromes treated very early and predominantly with percutaneous coronary intervention: a prospective study in 1,450 consecutive patients.

OBJECTIVES: This study sought to assess gender-based differences in long-term outcome after very early aggressive revascularization for non-ST-elevation acute coronary syndromes (NSTACS). BACKGROUND: The Fragmin and fast Revascularization during InStability in Coronary artery disease (FRISC) II study suggested that women have less to gain from an early invasive strategy. METHODS: We conducted a prospective cohort study in 1,450 consecutive patients with NSTACS undergoing coronary angiography and subsequent coronary stenting of the culprit lesion as the primary revascularization strategy within 24 h of admission. The combined primary end point was defined as death or nonfatal myocardial infarction (MI) and recorded for a mean of 20 months. RESULTS: Percutaneous coronary intervention was performed in more than 50% of patients in women and men and accompanied with stenting in 80%. The percutaneous coronary intervention:coronary artery bypass grafting ratio was 4:1 in men and 5:1 in women. The primary end point occurred in 29 (7.0%) women as compared with 108 (10.5%) men (hazard ratio for women, 0.65; 95% confidence interval [CI] 0.42 to 0.99; p = 0.045). Backward-stepwise multivariate Cox regression analysis identified female gender as an independent predictor of death or MI (hazard ratio for female gender, 0.51; 95% CI, 0.28 to 0.92; p = 0.024). Kaplan-Meier analysis showed that women had consistently lower event rates during the entire follow-up period (p = 0.037 by log-rank for death or MI). CONCLUSIONS: Women treated with very early aggressive revascularization with coronary stenting of the culprit lesion as the primary revascularization strategy have a better long-term outcome as compared with men.

Acute Disease↗

PubMed1998

A clinical trial comparing primary stenting of the infarct-related artery with optimal primary angioplasty for acute myocardial infarction: results from the Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO) trial.

OBJECTIVES: This study sought to compare stenting of the primary infarct-related artery (IRA) with optimal primary percutaneous transluminal coronary angioplasty (PTCA) with respect to clinical and angiographic outcomes of patients with an acute myocardial infarction. BACKGROUND: Early and late restenosis or reocclusion of the IRA after successful primary PTCA significantly contributes to increased patient morbidity and mortality. Coronary stenting results in a lower rate of angiographic and clinical restenosis than standard PTCA in patients with angina and with previously untreated, noncomplex lesions. METHODS: After successful primary PTCA, 150 patients were randomly assigned to elective stenting or no further intervention. The primary end point of the trial was a composite end point, defined as death, reinfarction or repeat target vessel revascularization as a consequence of recurrent ischemia within 6 months of randomization. The secondary end point was angiographic evidence of restenosis or reocclusion at 6 months after randomization. RESULTS: Stenting of the IRA was successful in all patients randomized to stent treatment. At 6 months, the incidence of the primary end point was 9% in the stent group and 28% in the PTCA group (p=0.003); the incidence of restenosis or reocclusion was 17% in the stent group and 43% in the PTCA group (p=0.001). CONCLUSIONS: Primary stenting of the IRA, compared with optimal primary angioplasty, results in a lower rate of major adverse events related to recurrent ischemia and a lower rate of angiographically detected restenosis or reocclusion of the IRA.

Adult↗

PubMed1999

Does angiography six months after coronary intervention influence management and outcome? Benestent II Investigators.

OBJECTIVES: This study was performed to assess whether angiography six months after coronary balloon angioplasty or stent implantation has an influence on clinical management and one-year outcome. BACKGROUND: The Benestent II study randomized 827 patients to balloon angioplasty or stent implantation. A subrandomization was undertaken allocating patients to six-month clinical follow-up (CF) or clinical and angiographic follow-up (AF). METHODS: Seven hundred and six patients (349 CF and 357 AF) had no intercurrent angiography, so that restenosis and disease progression elsewhere remained unknown until the time of six-month follow-up. These two groups, which were well matched at enrolment, were compared with respect to symptoms, medication and major cardiac events defined as death, myocardial infarction and need for revascularization at six and 12 months. RESULTS: At six-month follow-up, 53 (15%) of the CF and 76 (21%) of the AF patients had stable angina (p = 0.041), while 5 (1%) and 4 (1%) had symptoms of unstable angina. At 12-month follow-up, 44 (13%) patients in both groups had stable angina, and only 1 patient in the CF group had unstable angina. Seventy-seven patients (27 CF and 50 AF; p < 0.01) had major cardiac events between 6 and 12 months. Of the 349 patients in the CF group, 21 underwent repeat percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery between 6 and 12 months, compared with 44 of the 357 patients in the AF group (relative risk 2.05 [1.24 to 3.37], p = 0.003). CONCLUSIONS: Patients who had AF six months after balloon angioplasty or stent implantation experienced more repeat revascularization procedures than those who had CF. They also had significantly more angina at six-month follow-up but this may be due to bias.

Angina Pectoris↗

PubMed2003

Short-term risk after initial observation for chest pain.

Few studies have evaluated the necessity of immediate stress testing after observation for chest pain. The purpose of this study was to assess the safety of outpatient stress testing after discharge from a chest pain unit. We hypothesized that discharge from a chest pain unit before stress testing is associated with a low rate of short-term adverse outcomes. This was a retrospective chart review of managed care patients discharged from the chest pain unit before the performance of stress testing. Records were reviewed for the occurrence of adverse cardiac outcomes before an outpatient stress test up to 60 days post-discharge. Primary outcomes were defined as death or myocardial infarction, and secondary outcomes as readmission for chest pain evaluation, unstable angina, or congestive heart failure. Three hundred forty-four patients were identified. One hundred sixty-six patients had either a recent prior stress test (17) or an outpatient test (149) performed within 60 days of discharge. During that time, 2 patients (0.6%) had a fatal out-of-hospital cardiac event, and there were 27 subsequent chest pain visits to the Emergency Department by 24 patients (7.0%). Nine patients (2.6%) were admitted to the hospital and 10 (2.9%) were readmitted to the observation unit for chest pain. We conclude that patients who have negative serial electrocardiograms and enzyme testing in a chest pain unit are at low risk for short-term cardiac events. Appropriately selected patients may be discharged for subsequent outpatient testing.

Aged↗

PubMed2006

The Toronto Risk Score for adverse events following cardiac surgery.

OBJECTIVE: To develop and validate an objective and reliable measure of acuity that will identify high-risk patients and predict length of stay following all cardiac surgery procedures. METHODS: Logistical regression analysis of 12,683 patients undergoing cardiac surgery between 1996 and 2000 was used to identify the independent predictors of postoperative adverse events (AEs, defined as death, myocardial infarction, low cardiac output syndrome, postoperative renal failure, stroke or deep sternal wound infection). The rounded ORs for each of the 18 predictors of AEs were summed to calculate the Toronto Risk Score (TRS) for each patient. Weighted linear regression was used to determine the relationship between TRS and length of stay in the 4378 patients who underwent cardiac surgery between 2001 and 2002. RESULTS: TRS was significantly associated with cardiovascular intensive care unit length of stay (R2=0.85, slope=0.42, intercept=0.4; P<0.001). For each unit increase in TRS, cardiovascular intensive care unit length of stay increased by 0.4+/-0.05 days. TRS was also significantly associated with total postoperative length of stay (R2=0.88, slope=0.71, intercept=4.9; P<0.001). TRS captured a significant increase in acuity from 1996 and 2000 (5.12+/-3.5) to 2001 and 2002 (5.54+/-3.5; P<0.001). Despite increased acuity, AEs were reduced in 2001 and 2002 (8.1%) compared with 1996 to 2000 (9.8%; P=0.012). CONCLUSIONS: The TRS is a valid measure of acuity that can identify patients who are at high risk of experiencing an AE and having prolonged length of stay after any cardiac surgery procedure, capture changes in acuity over time and allow for continuous quality performance evaluation.

Aged↗

PubMed2002

Comparison of prediction models for adverse outcome in pediatric meningococcal disease using artificial neural network and logistic regression analyses.

The objective of this study was to compare artificial neural network (ANN) and multivariable logistic regression analyses for prediction modeling of adverse outcome in pediatric meningococcal disease. We analyzed a previously constructed database of children younger than 20 years of age with meningococcal disease at four pediatric referral hospitals from 1985-1996. Patients were randomly divided into derivation and validation datasets. Adverse outcome was defined as death or limb amputation. ANN and multivariable logistic regression models were developed using the derivation set, and were tested on the validation set. Eight variables associated with adverse outcome in previous studies of meningococcal disease were considered in both the ANN and logistic regression analyses. Accuracies of these models were then compared. There were 381 patients with meningococcal disease in the database, of whom 50 had adverse outcomes. When applied to the validation data set, the sensitivities for both the ANN and logistic regressions models were 75% and the specificities were both 91%. There were no significant differences in any of the performance parameters between the two models. ANN analysis is an effective tool for developing prediction models for adverse outcome of meningococcal disease in children, and has similar accuracy as logistic regression modeling. With larger, more complete databases, and with advanced ANN algorithms, this technology may become increasingly useful for real-time prediction of patient outcome.

Adolescent↗

PubMed2003

Major adverse outcomes after percutaneous transluminal coronary angioplasty: a clinical prediction rule.

In this study, we developed and internally validated a clinical model for predicting major adverse outcomes in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) using a multi-institutional prospective cohort study involving all adult patients who underwent PTCA at 12 participating institutions from August 1993 to October 1995. A major adverse outcome, defined as death, renal failure, myocardial infarction, cardiac arrest, stroke, or coma, occurred in 3.3 and 3.2% of patients in the derivation and validation sets, respectively. Death occurred in 1.5% in both sets. Fourteen variables were independently correlated with major adverse outcomes. The rule, which stratifies PTCA patients into six levels of risk based on the severity score, showed excellent discrimination (receiver-operating characteristic curve area 0.82) and calibration (Hosmer-Lemeshow chi-square statistic P =.90) and performed well on internal validation. This rule allows accurate preprocedure stratification of PTCA candidates according to their risk of suffering a major adverse outcome.

Angioplasty, Balloon, Coronary↗

PubMed1999

Empiric antimicrobial therapy of febrile neutropenic patients undergoing haematopoietic stem cell transplantation.

This study was conducted to assess the efficacy and toxicity of intravenous (i.v.) ceftazidime and ciprofloxacin in neutropenic febrile patients undergoing high dose myeloablative therapy and hematopoietic stem cell transplantation (HSCT). All patients undergoing HSCT for leukaemia, lymphoma, multiple myeloma and solid tumours received open-label ceftazidime 2 g i.v. every 8 h and ciprofloxacin 400 mg i.v. every 12 h if they developed fever while they were neutropenic. Success with or without modification of this regimen was defined as survival through the neutropenic period; failure was defined as death secondary to infection. Of 106 patients treated with this regimen, the success rate was 99%. Sixty-one of the patients (57.5%) defervesced within 48-72 h and remained afebrile without regimen modification. In 41.5% of the cases (44/106), the regimen was modified because of persistent fever. One patient died secondary to sepsis. The combination of ceftazidime and ciprofloxacin as initial empiric antibacterial therapy in febrile neutropenic patients undergoing myeloablative therapy and HSCT is highly effective and is associated with minimal toxicity.

Adolescent↗

PubMed1995

Lewis rats of the inbred strain LEW/Han: life expectancy, spectrum and incidence of spontaneous neoplasms.

Although Lewis rats are frequently used in biomedical research, little is known about their life-data and spontaneous pathology. Therefore, it was the aim of this study to determine the life expectancy, spectrum and incidence of spontaneous neoplasms of the inbred rat strain LEW/Han. A total of 629 LEW/Han rats (305 females and 324 males) from a specified pathogen-free breeding colony were kept from weaning up to their natural death under defined environmental conditions. A complete histological examination was performed on all organs and macroscopically altered tissues of all animals which died during the first three years of the study. These were 296 female (98%) and 213 male (66%) rats. The mean lifespan of the females (27.7 +/- 5.1 months) was significantly shorter than that of the males (32.5 +/- 6.6 months). In both sexes, the lifespan was mainly determined by the occurrence of neoplasms. Of the large spectrum of 52 histologically different tumour types, the highest incidences were observed for adenomas of the pituitary gland and adenomas/adenocarcinomas of the adrenal cortex in both sexes, mammary gland tumours and endometrial carcinomas in females, and C-cell adenomas/adenocarcinomas of the thyroid gland and tumours of the haemopoietic system in males. Of these, the high incidences of tumours of the haemopoietic system in males (27.7%) and of endometrial carcinomas in females (45.2%) should be considered as characteristic features of the strain.

Animals↗