Epidemic West Nile encephalitis, New York, 1999: results of a household-based seroepidemiological survey.

BACKGROUND: In the summer of 1999, West Nile virus was recognised in the western hemisphere for the first time when it caused an epidemic of encephalitis and meningitis in the metropolitan area of New York City, NY, USA. Intensive hospital-based surveillance identified 59 cases, including seven deaths in the region. We did a household-based seroepidemiological survey to assess more clearly the public-health impact of the epidemic, its range of illness, and risk factors associated with infection. METHODS: We used cluster sampling to select a representative sample of households in an area of about 7.3 km(2) at the outbreak epicentre. All individuals aged 5 years or older were eligible for interviews and phlebotomy. Serum samples were tested for IgM and IgG antibodies specific for West Nile virus. FINDINGS: 677 individuals from 459 households participated. 19 were seropositive (weighted seroprevalence 2.6% [95% CI 1.2-4.1). Six (32%) of the seropositive individuals reported a recent febrile illness compared with 70 of 648 (11%) seronegative participants (difference 21% [0-47]). A febrile syndrome with fatigue, headache, myalgia, and arthralgia was highly associated with seropositivity (prevalence ratio 7.4 [1.5-36.6]). By extrapolation from the 59 diagnosed meningoencephalitis cases, we conservatively estimated that the New York outbreak consisted of 8200 (range 3500-13000) West Nile viral infections, including about 1700 febrile infections. INTERPRETATION: During the 1999 West Nile virus outbreak, thousands of symptomless and symptomatic West Nile viral infections probably occurred, with fewer than 1% resulting in severe neurological disease.

Mail-in questionnaire for monitoring nausea and vomiting in oncology outpatients.

A patient questionnaire designed to help pharmacists monitor nausea and vomiting in outpatients receiving cancer chemotherapy was studied. A 12-item questionnaire was designed by combining items from the Morrow Assessment of Nausea and Emesis (MANE) and the Functional Living Index-Emesis (FLIE). Items included number of vomiting episodes, duration of nausea, number of antiemetics, severity of nausea and vomiting, impact on quality of life, and adverse effects. The questionnaire was printed on an addressed, postage-paid card. Over an eight-week period, outpatients in a hospital's oncology clinic were asked to complete the questionnaire at home during the three days after chemotherapy. Of 48 patients asked, 42 (88%) agreed to complete the questionnaire, and 36 (86%) of these patients mailed it back to the clinic. Of the respondents, 11 reported at least one episode of vomiting, and 22 reported nausea. Thirteen respondents logged nausea ratings of 3 or higher on a 7-point scale. Twenty respondents used antiemetics. Responses given by the patients in follow-up telephone interviews did not differ significantly from the responses collected with the questionnaire. More than 90% of patients who returned the questionnaire rated it as simple to complete. Pharmacists used the self-reports of nausea or vomiting in 7 (17%) of 42 cases to recommend alternative antiemetic regimens. A mail-in questionnaire for monitoring nausea and vomiting in outpatients undergoing chemotherapy was completed and returned by a high percentage of patients and was useful to clinic pharmacists.

Effect of hyaluronidase on mortality and morbidity in patients with early peaking of plasma creatine kinase MB and non-transmural ischaemia. Multicentre investigation for the limitation of infarct size (MILIS).

A multicentred, randomised, blind study was started in 1978 to compare propranolol or hyaluronidase with placebo in patients with acute myocardial infarction admitted within 18 hours of onset of symptoms. Patients were randomised to group A and received hyaluronidase, propranolol, or placebo, or, if propranolol was contraindicated, to group B and received hyaluronidase or placebo. Hyaluronidase (500 U/kg given every six hours for 48 hours) had no effect on mortality or infarct size in the overall population. Because spontaneous reperfusion was more common in patients with early peaking of plasma creatine kinase MB or non-transmural electrocardiographic changes or both, the results were reanalysed for two subgroups: those in whom plasma creatine kinase peaked less than 15 hours after the onset of symptoms (early peak, n = 184) and those with a peak greater than 15 h after the onset of symptoms (late peak, n = 546). The distribution of time to peak activity of creatine kinase MB was similar in the hyaluronidase and placebo groups. In the early peak patients who were given hyaluronidase (groups A and B) total mortality and cardiac-specific four year mortality were significantly lower. This was most pronounced in group B in which the total mortality was 45% and cardiovascular mortality was 47% less than in the placebo group. Similarly, mortality from cardiovascular disease in patients (groups A and B) with nontransmural ischaemia (ST-T changes) given hyaluronidase was significantly lower, with group B showing a 50% reduction. In the subsets of patients with late peaking of creatine kinase MB or those presenting with transmural electrocardiographic changes there was no difference in total mortality or deaths from cardiac disease between those given hyaluronidase and those given placebo. Hyaluronidase was associated with improved survival in patients with early peaking of plasma creatine kinase MB, suggesting the possibility of salvage of myocardium in patients who have early spontaneous reperfusion and possibly after therapeutic reperfusion.

Sex differences in early and long-term results of coronary angioplasty in the NHLBI PTCA Registry.

To assess whether gender influenced the outcome of percutaneous transluminal coronary angioplasty (PTCA), we analyzed data from the NHLBI PTCA Registry. Early results were compared in 705 women and 2374 men. Women were older (p less than .01) and had more unstable angina (p less than .01), and class 3 or 4 angina (p less than .01). Men had more multivessel disease (p less than .01), prior bypass surgery (p less than .01), and abnormal left ventricular function (p less than .05). Women had a lower angiographic success rate (60.3 vs 66.2%; p less than .01) and had a lower clinical success rate (56.6% vs 62.2%; p less than .01). More women had complications (27.2% vs 19.4%; p less than .01), but overall frequency of major complications (death, myocardial infarction, emergency surgery) was not different (9.8% vs 9.3%). Women had a higher incidence of coronary dissection (p less than .05) and higher in-hospital mortality (1.8% vs 0.7%; p less than .01). PTCA-related mortality was nearly six times higher in women (1.7% vs 0.3%; p less than .001) and mortality with emergency surgery was more than five time higher (17.4% vs 3.2%; p less than .001). Multivariate analysis indicated that female gender was an independent predictor for lower success (p less than .05) and early mortality (p less than .05) and was the only baseline predictor for PTCA-related mortality.(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of propranolol on myocardial-infarct size in a randomized blinded multicenter trial.

A multicenter randomized single-blind study was performed to evaluate the effects of propranolol administered during the evolution of myocardial infarction. Five centers enrolled a total of 269 patients, with 134 receiving propranolol and 135 placebo. Propranolol or placebo was given intravenously upon randomization (0.1 mg per kilogram of body weight) and then orally for nine days to keep the heart rate between 45 and 60 beats per minute. Less than 2 per cent of patients were treated within 4 hours after the onset of symptoms, but 50 per cent received therapy within 8 hours of onset of chest pain, and the remainder between 8 and 18 hours. The heart rates in the propranolol-treated group were significantly lower than those in the placebo group (P less than 0.001). Base-line characteristics, including the mean heart rate (79.6 vs. 81.3) and the left ventricular ejection fraction (49.0 vs. 49.5), were similar in the two groups. The primary end point evaluated--infarct size as estimated from plasma MB creatine kinase activity--was virtually identical in the two groups, averaging 13.3 and 13.6 gram-equivalents of MB creatine kinase per square meter of body-surface area. Peak plasma levels of the enzyme were also similar in the two groups. No significant difference was observed between the propranolol and placebo groups in the change in left ventricular ejection fraction, extent of area involved in pyrophosphate uptake, R-wave loss on electrocardiograms, or mortality (after three years). These results do not support the use of propranolol administered four or more hours after the onset of symptoms to limit infarct size.

An acute intervention trial: the research nurse coordinator's role.

A multicenter randomized clinical trial can offer exciting and challenging opportunities to the clinical coordinators and other health professionals who participate in the conduct of a clinical trial at the clinical units. This article will address an acute intervention trial, the Multicenter Investigation of the Limitation of Infarct Size, and demonstrate some of the important responsibilities of the clinical unit research nurse coordinators in the conduct and operation of this trial.

In-hospital mortality rate in the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry.

Twenty-nine patients died among the first 3,079 patients enrolled in the NHLBI PTCA Registry. The overall morality rate was 0.9%; the mortality rate was 0.8% in patients with 1-vessel CAD, 1.0% in those with multivessel CAD (excluding left main CAD), and 3.8% in those with left main CAD (p less than 0.01). The in-hospital morality rate was significantly higher among women (p less than 0.01), in patients older than 60 years, in patients with previous CABG (p less than 0.01), the presence of left main CAD, (p less than 0.01), in patients who required dilatation of a vein graft stenosis (p less than 0.05), and in patients who had had angina for longer than 6 months (p less than 0.01).

Effect of investigator experience on percutaneous transluminal coronary angioplasty.

The NHLBI PTCA Registry collected clinical data on 3,101 PTCA procedures performed at 105 clinical centers between September 1977 and September 1981. To investigate the "learning curve" from introduction through the early application of this new therapy for revascularization, success rates and complication rates were examined by calendar year and according to investigator experience. Success rates improved by calendar year, from 54% in 1979 to 66% in 1981. Investigators with fewer than 50 cases had a success rate of 55%. After an investigator had performed 150 procedures, the success rate was 77%. The increase in success rate was largely the result of a dramatic increase in the ability to cross the narrowing with the catheter, and was accounted for by experience and improved equipment. Patient selection for PTCA was characterized by sex, age, previous CABG, number of diseased coronary arteries and stable Canadian Heart classification over time. Reflecting the increase in the success rate was the decrease in the need to perform elective CABG. Emergency CABG, death and MI rates were low (1% mortality, 5% nonfatal MI) and did not change significantly with time or with investigator experience.

Percutaneous transluminal coronary angioplasty: report of complications from the National Heart, Lung, and Blood Institute PTCA Registry.

The complications reported in the first 1500 patients enrolled in the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry are analyzed. Data were contributed from 73 centers between September 1977 and April 1981. PTCA was successful in 63% of attempts. Five hundred forty-three in-hospital complications occurred in 314 patients (21%). The most frequent complications were prolonged angina in 121, myocardial infarction (MI) in 72, and coronary occlusion in 70. One hundred thirty-eight patients (9.2%) had major complications (MI, emergency surgery or in-hospital death). One hundred two patients (6.8%) required emergency surgery, usually for coronary dissection or coronary occlusion. Sixteen patients (1.1%) died in-hospital; the mortality rate was 0.85% in patients with one-vessel disease and 1.9% in those with multivessel disease. The mortality rate was significantly higher in patients who had had bypass surgery (p less than 0.001). Nonfatal complications were significantly influenced by the presence of unstable angina (p less than 0.001) and initial lesion severity greater than 90% diameter stenosis (p less than 0.001). This report delineates and assesses the complications encountered with PTCA during its initial 3 1/2-year clinical experience. These results support the relative safety of PTCA as a method of nonsurgical myocardial revascularization in carefully selected patients.

Percutaneous transluminal coronary angioplasty: report from the Registry of the National Heart, Lung, and Blood Institute.

Data have been collected from 34 centers in the United States and Europe performing percutaneous transluminal coronary angioplasty since September 1977. The procedure was carried out in 631 patients, with an average age of 51 years (range 23 to 76), of whom 80 percent had single vessel coronary disease, 17 percent had double or triple vessel disease and 3 percent had stenosis of the left main coronary artery. Coronary angioplasty was successful (greater than 20 percent decrease of coronary stenosis) in 59 percent of the stenosed arteries. The mean degree of stenosis was reduced from 83 to 31 percent. Emergency coronary bypass operation was required in 40 patients (6 percent). Myocardial infarction occurred in 29 patients (4 percent). In-hospital death occurred in six patients (1 percent), three with single vessel and three with multivessel disease. Ninety-one patients have been followed up for at least 1 year after coronary angioplasty. Of the 65 patients with an initially successful angioplasty, 83 percent were in improved condition compared with their status before angioplasty. Thus, the initial satisfactory results obtained in a few centers have now been confirmed in many centers using transluminal coronary angioplasty.