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PubMed2005

Treatment intensity and outcome of patients aged 80 and older in intensive care units: a multicenter matched-cohort study.

OBJECTIVES: To determine whether patients aged 80 and older have similar treatment intensity to that of younger patients in the intensive care unit (ICU). DESIGN: Multicenter, matched-cohort study. SETTING: Data were extracted from a multicenter database with 36 ICUs in the Paris area (France) during a 4-year period (1997-2000). PARTICIPANTS: Three thousand one hundred seventy-five patients aged 80 and older (oldest-old) were retrospectively matched to 3,175 patients aged 65 to 79 (young-old). MEASUREMENTS: The matching criteria were severity status on admission (+/-2) (assessed using a corrected Simplified Acute Physiology Score II leaving out age points), Charlson Comorbidity Index, type of admission (surgical vs medical), sex, admission to same ICU, and year of ICU admission. The underlying condition was classified using the McCabe classification. The functional status was assessed using the Knaus classification. The ICU workload was assessed using the OMEGA scoring system. RESULTS: Total and daily workload were lower in the oldest-old than in matched young-old patients. Estimated mean direct medical cost per stay was approximately 1,280 dollars lower for oldest-old patients. Older patients received less mechanical ventilation (adjusted odds ratio (AOR)=0.69, 95% confidence interval (CI)=0.61-0.78), less tracheostomy (AOR=0.37, 95% CI=0.28-0.50), and less renal support (AOR=0.52, 95% CI=0.41-0.66) than matched young-old patients. Oldest-old patients had a shorter length of ICU stay than matched young-old patients and the same length of post-ICU stay. CONCLUSION: Oldest-old patients receive less treatment in the ICU than young-old patients even after adjustment for severity of illness.

Aged↗
PubMed1988

[Chemotherapy of chronic myelocytic leukemia. Status of the German Multicenter Study on busulfan versus hydroxyurea versus alpha interferon, October 1897].

For palliative therapy during the chronic phase of CML busulfan has proved to be the drug of choice. During the past years hydroxyurea and also interferon-alpha have gained increasing significance since they might prolong the duration of the chronic phase. In a multicenter study it is being determined, whether the use of hydroxyurea or of interferon-alpha instead of busulfan prolongs the duration of the chronic phase of Philadelphia-positive CML. Additional goals are the examination, whether the types of disease evolution and the terminal phases differ between the treatment groups, and the prospective recognition of prognostic criteria for the duration of the chronic phase of CML. By November 26, 1987, 321 CML-patients had been randomized, 147 for busulfan, 149 for hydroxyurea and 25 for interferon-alpha. The average age is about 50 years. 59 patients reached the end of the chronic phase, 55 died. The mean observation time of all patients is 1.34 years. At present no significant difference in survival is recognizable between the busulfan and hydroxyurea groups. Fewer adverse effects have been observed in the hydroxyurea group. Philadelphia chromosome-negative patients show a higher average age and tend to have lower white blood cell and platelet counts. The number of patients having received interferon-alpha is still too small to allow evaluation. This report intends to document organization and progress of this study which to our knowledge is, at present, the largest ongoing prospective multicenter study on the therapy of CML.

Busulfan↗
PubMed1987

Multicenter clinical trials. Potential influence of consumer education.

Multicenter therapeutic trials have demonstrated clearly the efficacy and safety of antihypertensive therapy. Such studies were designed initially to demonstrate the effectiveness of antihypertensive therapy in preventing complications and fatalities from hypertensive disease. Over the three decades since these studies were instituted, succeeding trials have become more sophisticated in design, and those of us who observe and interpret their results have similarly become more sophisticated and more demanding. However, we should not expect more from the studies than their designers intended. Let us neither overinterpret the results nor ascribe failure to studies simply because they do not answer the questions that remain. This discussion concerns primarily three recent multicenter clinical trials: the Hypertension Detection and Follow-up Program (1979), the Australian National Blood Pressure Study (1980), and the Multiple Risk Factor Intervention Trial (1982).

Blood Pressure↗
PubMed2006

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery.

BACKGROUND: Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. METHODS/DESIGN: CLIVIT (Clips versus Ligatures in Thyroid Surgery) is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min) when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. DISCUSSION: As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

Journal Article↗
PubMed1998

Pediatric pneumococcal bone and joint infections. The Pediatric Multicenter Pneumococcal Surveillance Study Group (PMPSSG).

OBJECTIVE: To describe the clinical and microbiological characteristics of infants and children with bone and joint infections caused by penicillin-susceptible and penicillin-nonsusceptible strains of Streptococcus pneumoniae. DESIGN: Multicenter, prospective patient accrual; retrospective chart review of identified patients. SETTING: Eight children's hospitals in the United States. PARTICIPANTS: Forty-two children with bone and/or joint infections prospectively enrolled in the United States Pediatric Multicenter Pneumococcal Surveillance Study from September 1, 1993 to August 31, 1996. OUTCOME MEASURES: Data were collected on multiple variables, including age, gender, race, days of symptoms before and during hospitalization, antibiotic and surgical therapy, laboratory and imaging studies. RESULTS: Of the 42 children enrolled (21 bone, 21 joint infections), 14 had isolates that were not susceptible to penicillin. Eight of 16 (50%) strains isolated from children who received antibiotics within 4 weeks before hospitalization were not susceptible to penicillin, compared with 4 of 15 (27%) strains isolated from children without previous antibiotic exposure. Clinical response to therapy was similar between children infected by penicillin-susceptible strains compared with those infected by penicillin-nonsusceptible strains, including duration of hospitalization (9.1 days vs 11.2 days), days of intravenous antibiotic therapy (25.3 days vs 24.6 days), days of fever (3.6 days vs 3.1 days), and sequelae (14% vs 7%). The most commonly prescribed single agents for parenteral therapy in definitive treatment were ceftriaxone (36%), penicillin (15%), and clindamycin (15%). Oral therapy followed parenteral therapy in 56% of children. The mean (+/- standard deviation) duration of total antibiotic therapy in children with osteomyelitis was 57.5 +/- 48.6 days (range, 23-196 days) and 29.2 +/- 11.8 days (range, 12-67 days) for arthritis. Late sequelae (long-term destructive changes of the bone or joint) were documented in 5 (12%) children, 4 with osteomyelitis, and 1 with arthritis. Sequelae occurred in 30% of children with long bone osteomyelitis associated with infection in the adjacent joint. The age of children with sequelae was younger than those without sequelae (6.4 months vs 18.6 months). CONCLUSIONS: The demographic characteristics and anatomic sites of infection in our patients were similar to previously published series collected from single institutions before the emergence of significant antibiotic resistance in S pneumoniae. Our analysis suggests that children infected by penicillin-nonsusceptible strains have a similar clinical response to therapy when compared with children infected by penicillin-susceptible strains.

Anti-Bacterial Agents↗
PubMed1998

Myths and reality concerning hypertension in peritoneal dialysis patients: results of a multicenter study.

OBJECTIVES: To evaluate the prevalence of hypertension, the average blood pressure level, the 24 h blood pressure profile, and the efficacy of antihypertensive therapy for a large population of peritoneal dialysis patients.DESIGN: A cross-sectional, observational multicenter study. METHODS: From 504 peritoneal dialysis patients (18% of the Italian peritoneal dialysis population) involved in a multicenter observational study, we selected 414 who had undergone successful ambulatory blood pressure monitoring (i.e. no hours with data absent, >/= 75% successful readings and monitoring duration >/= 24 h). Office blood pressure measurements and ambulatory blood pressure monitoring were performed for each patient on the same day with a standard mercury sphygmomanometer and a SpaceLabs 90207 device, respectively.RESULTS: According to World Health Organization/International Society of Hypertension criteria, 44 peritoneal dialysis patients (10.6%) were normotensive and 370 patients (89.4%) were hypertensive, 304 (82.1%) of whom were being administered antihypertensive therapy. Daytime systolic and diastolic blood pressures were both significantly lower than office systolic and diastolic blood pressures (140.7 +/- 19.7/72.1 +/-11.1 versus 148.3 +/- 23.6/85.6 +/- 12 mmHg; P < 0.001). The difference between office blood pressure and daytime blood pressure was significantly correlated to office blood pressure (P < 0.001 for systolic and P < 0.001 for diastolic). The diurnal blood pressure rhythm evaluated by visual inspection of hourly mean plots was not influenced by sex, age, antihypertensive treatment, and peritoneal dialysis modality. Systolic and diastolic blood pressures exhibited a day-night mean decreases of 8.6 +/- 11.7 and 7.7 +/- 6.9 mmHg, respectively, and daytime blood pressure values were significantly higher than night-time ones (P < 0.001). Two hundred and twenty patients (53.1%) were nondippers according to O'Brien's criteria, 247 patients (59.7%) were nondippers according to Verdecchia's criteria, and 269 patients (65.0%) were nondippers according to Staessen's criteria. Only 39 patients (9.4%) had a reversed circadian rhythm. The day-night differences of systolic and diastolic blood pressures were in a unimodal distribution. Among hypertensive patients not being administered antihypertensive therapy, only six patients ( five women and one man) had white-coat hypertension. Among hypertensive patients being administered antihypertensive therapy, 235 patients (77.3%) had 24 h blood pressure loads > 30%.CONCLUSION: There is a high prevalence of hypertension among peritoneal dialysis patients. White-coat hypertension is very rare in this population. Despite the extensive use of antihypertensive therapy, control of blood pressure is maintained in a large number of our peritoneal dialysis patients. Any classification of patients into dipers and nondippers must be interpreted cautiously.

Journal Article↗
PubMed1998

Office versus Ambulatory (OvA) recording of blood pressure, a European multicenter study: inclusion and early follow-up characteristics.

Only a few large prospective trials intended to address the question of whether management of hypertensive patients should be guided by office (OBP) or ambulatory blood pressure (ABP) and whether fatal and nonfatal cardiovascular events are better predicted by ABP than they are by OBP are going on. Office versus Ambulatory (OvA) recording of blood pressure, a European multicenter study, is a multicenter prospective, 10 000 patient-years follow-up study of treated essential hypertension designed to correlate blood pressure to prognosis, blood pressure being defined either by ABP or OBP. Early in 1997, inclusion was stopped (n = 2224 inclusions, 48.3% women, aged 56.8 +/- 13.1 years) because the required number had been exceeded. Inclusion data reveal that OBP (152.9 +/-21.2/92.7 +/- 10.9 mmHg) of a large portion of patients remains high, although patients had been treated for at least 3 months with antihypertensive drugs. Mean 24 h ABP averaged 133.3 +/-15.9/84.0 +/-11.0 mmHg and 24 h blood pressure and heart rate profiles, large differences in drug treatment, apparatus, type of patients, and patients' activities notwithstanding, were like those expected from well-controlled studies. Risk profile was not particularly high. Evolution of OBP, ABP and electrocardiographic and echocardiographic indices of left ventricular hypertrophy indicate that reeductions of the OBP, ABP, and electrocardiographic indices of left ventricular hypertrophy had occurred after 12 months, after 24 months follow-up there was no longer any further change for most parameters. In conclusion, analysis of inclusion and preliminary follow-up data indicates that the OvA study is running well and that it is likely that final analysis of the data and events from the OvA study will lead to an answer to the study question of whether ABP monitoring is better suited than is OBP to deal with management of the treated hypertensive patient.

Journal Article↗
PubMed2000

Pisa syndrome (pleurothotonus): report of a multicenter drug safety surveillance project.

BACKGROUND: Pisa syndrome is usually regarded as a rare adverse event of neuroleptic medication. However, its frequency and predisposing factors have yet to be defined. Here, we investigated risk factors of Pisa syndrome occurring in a large population of psychiatric patients surveyed during a multicenter drug safety project. METHOD: Twenty episodes of Pisa syndrome were documented in 17 patients within a population of 45,000 psychiatric patients monitored by a multicenter drug safety surveillance project (Projekt zur Uberwachung der Arzneimittelsicherheit in der Psychiatrie) between 1990 and 1997. All results were related to the epidemiologic data provided for this population and systematically analyzed regarding history of medication, current medication, comedication, and clinical course. RESULTS: A constellation of putative risk factors was found in the majority of patients: previous treatment with classical neuroleptics, combined pharmacologic treatment, female gender, old age, and the presence of an organic brain disorder. Given these risk factors, Pisa syndrome was also documented with atypical neuroleptic drugs such as clozapine, olanzapine, and sertindole. CONCLUSION: We conclude that Pisa syndrome is a very rare adverse event occurring with neuroleptic treatment. In patients exhibiting the reported constellation of risk factors, neuroleptic drugs should be administered with particular caution.

Adult↗
PubMed2002

Multicenter evaluation of a new immunoassay for intact PTH measurement on the Elecsys System 2010 and 1010.

BACKGROUND AND OBJECTIVE: The determination of parathyroid hormone (PTH) is of great clinical relevance in the assessment of calcium metabolic disorders. Although PTH was one of the first hormones measured by immunoassays, there are still many difficulties in its determination due to the low concentration of the hormone in blood and due to the heterogeneity of PTH resulting from different circulating hormone fragments. The aim of our multicenter-study was to evaluate the technical performance and the clinical validity of a new immunoassay for intact PTH measurement on the Elecsys Systems 2010 and 1010. METHODS AND RESULTS: The multicenter evaluation was performed in 11 clinical laboratories. The Elecsys PTH assay is a one step sandwich electrochemiluminescence immunoassay based upon the streptavidin-biotin technology. Two monoclonal antibodies are used in the assay providing detection of intact PTH. The imprecision study yielded within-run and between-days coefficients of variation of 3.1% - 6.6% and 3.4% - 15.6%, respectively using a three level control (PreciControl Bone, Roche Diagnostics) and human pool sera at two different concentrations (HS-low: 20 - 60 pg/ml, HS-high > 65 pg/ml). The analytical sensitivity calculated as the mean value plus 2 standard deviations of a within-run imprecision was below 2.70 pg/ml using zero calibrator matrix. Dilution linearity was observed up to 4890 pg/ml using zero calibrator matrix or human pool sera. Recoveries ranged between 85% - 115%. Serum, EDTA- and heparin plasma were evaluated for PTH measurement. Due to a better analyte stability (48h at 21 degrees C; 3d at 4 degrees C) EDTA plasma was recommended for PTH measurement. Results of the Elec sys PTH immunoassay correlated well (r = 0.926 - 0.994) with three different immunoradiometric assays (N-tact PTH SP, DiaSorin; Nichols Allegro Intact PTH, Nichols Institute Diagnostics; ELSA-PTH, CISBio International) and two different immunochemiluminometric assays (PTH-Intact-Immulite, DPC Biermann; Nichols Advantage Intact PTH, Nichols Institute Diagnostics) in technical and clinical method comparisons. The Passing/Bablok regression analysis yielded slopes of 0.692 - 1.729 and intercepts of -13.982 - +15.763 pg/ml. Deviations from slope 1.0 and intercept 0.0 were not unexpected due to differences in immunoassay standardization and probably due to the presence of different PTH fragments and a variable affinity of the used antibodies to these PTH fragments. Highly similar PTH concentration pattern of the Elecsys immunoassay and the Quick-Intraoperative Intact PTH immunoassay (Nichols Institute Diagnostics) obtained from specimens taken intraoperatively support the applicability of the Elecsys immunoassay to monitor the success of parathyroid resection. A reference range of 12.3 - 56.0 pg/ml calculated from PTH values of 43 apparently healthy individuals confirms reference limits published in the literature. The partition of collectives according to age showed, that individuals > 50 years have slightly higher PTH concentrations, independently of gender. This shift could be due to age itself or to an increased prevalence of individuals without obvious calcium metabolic disorders in this collective. CONCLUSION: The Elecsys PTH assay is a useful and reliable tool for determination of intact PTH. Our data support the intended use of the assay in clinical applications related to disorders of calcium metabolism.

Adolescent↗
PubMed1987

Feasibility of centralized measurements of glycated hemoglobin in the Diabetes Control and Complications Trial: a multicenter study. The DCCT Research Group.

A method for measuring glycated hemoglobin (Hb A1c) and an accompanying method of specimen transport to a central laboratory were developed for the multicenter Diabetes Control and Complications Trial (DCCT). In the DCCT, results for Hb A1c are used to assess chronic glycemic control for data collection and patient management. During the feasibility phase of the trial, central (CHL) and backup laboratories using automated, "high-performance" ion-exchange liquid-chromatographic methods were established. Whole-blood samples were stored (4 degrees C) at each of the 21 clinical centers for up to 72 h before air-express shipment to the CHL. Quality-control procedures included daily analyses of three calibration specimens. A pooled hemolysate was assayed frequently over time as a long-term quality control (LTQC). After 18 months, within- and between-run CVs were less than 6%. Mean values for split duplicate samples assayed in a masked fashion at the CHL were nearly identical. LTQC results indicated no significant assay drift over time. More than 6000 samples were assayed (mean interval between obtaining the blood sample and completing the assay: less than six days). Hb A1c evidently can be precisely and reliably measured in the context of a long-term, multicenter trial such as the DCCT.

Adult↗
PubMed1985

Indications for coronary artery bypass surgery in patients with chronic angina pectoris: implications of the multicenter randomized trials.

The three major randomized studies of medical vs surgical therapy in patients with coronary artery disease have had a major impact in the management of patients with this disease. For the most part, these multicenter trials have provided concordant information regarding the influence of surgery on survival in asymptomatic or mildly symptomatic patients. It has been demonstrated that coronary artery bypass surgery improves survival in patients with stenosis of the left main coronary artery. Bypass surgery probably should be performed in most patients with this lesion, although studies have identified low-risk subgroups in whom surgery may not improve survival. There are also concordant data that survival is not enhanced by surgery in mildly symptomatic patients with either one- or two-vessel disease. The important discrepancies regarding the role of surgery in three-vessel disease have been resolved to a major extent. Long-term follow-up studies in the Veterans Administration Cooperative Study and the Coronary Artery Surgery Study (CASS) demonstrate improved survival with surgical management in patients with three-vessel disease and left ventricular dysfunction. The remaining controversy regards management of patients with three-vessel disease and normal left ventricular function; this may be resolved by studies indicating that inducible left ventricular ischemia in patients with three-vessel disease and preserved left ventricular function at rest identifies patients at higher risk during medical management. Different proportions of such patients entered into the multicenter studies may explain the discordant results in three-vessel disease and normal left ventricular function reported by the European trial and CASS.(ABSTRACT TRUNCATED AT 250 WORDS)

Angina Pectoris↗
PubMed1985

A multicenter comparison of related pharmacologic features of cephalexin and dicloxacillin given for two months to young children with cystic fibrosis.

Twenty-one cystic fibrosis patients under 3 years of age were enrolled in an open multicenter study to assess the feasibility of the study design and to compare selected pharmacologic features of cephalexin or dicloxacillin administered orally for 2 months. Patient tolerance and compliance were significantly less for dicloxacillin (p less than .01 and p less than .001, respectively). Superficial Candida infections were more common in the cephalexin group (p = 0.02), however increased stool frequency and nonspecific diaper rashes were more prevalent in patients receiving dicloxacillin (p less than .05). Staphylococcus aureus was isolated from respiratory secretions after 2 months from two dicloxacillin and no cephalexin patients. Areas under the curve and peak serum concentrations were higher for cephalexin (p less than .05 and p = .02), but antistaphylococcal activity in serum was higher for dicloxacillin (p less than .05) due to a lower mean MIC compared to cephalexin. Deep pharyngeal plus routine throat culture yielded more pathogens than either method alone. Express mail and central processing of respiratory specimens was efficient for most organisms, however there was some loss of Streptococcus pneumoniae and Haemophilus influenzae. Cephalexin was associated with better patient acceptance and compliance despite higher rates of superficial fungal infections as compared to dicloxacillin. Cephalexin, routine bacteriologic throat swabs processed locally or centrally, mail-in urine compliance assessment and a multicenter design are feasible components for a long-term prospective evaluation of antibiotic prophylaxis in patients with cystic fibrosis.

Administration, Oral↗
PubMed1982

Cefotaxime treatment in patients with osteomyelitis and septic arthritis: a multicenter study.

The effectiveness of parenteral cefotaxime in the treatment of adults with acute septic arthritis or acute or chronic osteomyelitis was evaluated in a multicenter trial. The drug was given to 47 patients admitted to the University of Texas Medical Branch Hospitals or Hahnemann Medical College and Hospital (UT-H study) and to 40 patients in other medical centers using an identical protocol. In the UT-H study, cefotaxime was effective in 15 of 16 patients (94%) with acute osteomyelitis, in 24 of 27 patients (89%) with chronic osteomyelitis, and in four of four patients (100%) with acute septic arthritis. In the multicenter study, the success rates were as follows: acute osteomyelitis, six of six (100%); chronic osteomyelitis, 14 of 19 (74%); and septic arthritis, 12 of 15 (80%). The antibiotic was well tolerated in most patients. The most serious side effect was significant neutropenia, which occurred in three patients. Cefotaxime appears to be a clinically useful, broad-spectrum antibiotic for bone and joint infections.

Adult↗
PubMed1983

A multicenter study on timolol in secondary prevention after myocardial infarction.

Patients who survive the acute phase of myocardial infarction have a high mortality in the following years. The mortality is largely due to sudden cardiac death or recurrent myocardial infarction. The main purpose of the present study was to clarify whether long-term treatment with the beta-adrenergic blocking agent timolol would improve prognosis in such patients. In order to recruit the sufficient number of patients to resolve this question a multicenter study was performed. This study, named "The Norwegian Multicenter Study On Timolol After Myocardial Infarction" was designed as a randomized, double-blind, placebo controlled trial. Twenty hospitals in Norway collaborated within an organizational structure aiming to achieve a maximum of standardization of study procedures. From a representative population of patients less than 75 years of age surviving the acute episode of infarction 52% were recruited for the study. The recruitment rate was high at all hospitals. The 1884 patients included were stratified into 3 risk groups before randomization. Risk Group I (18%) were patients with a recurrent infarction. Risk Group II (58%) were patients with a first infarction considered to be at high risk of sudden cardiac death. The rest, Risk Group III (22%) were patients at low risk. The placebo and timolol groups were similar with respect to most of the important baseline characteristics. Minor differences in a few characteristics did not affect the overall results as was shown by various statistical procedures including the Cox's proportional hazards regression model. The patients were followed 12 - 33 months after discharge from hospital with regular clinical examinations performed by the study investigators at the hospitals. Compliance was very good and no patient was lost to follow-up although 23.3% in the placebo group and 29.1% in the timolol group were withdrawn from the study regimen. The study demonstrated that long-term treatment with timolol improved prognosis in survivors of acute myocardial infarction. The most important finding was a highly statistically significant difference in life table mortality of 39.3% between the placebo group (21.9%) and the timolol group (13.3%) (p=0.0003). This difference was first of all due to a lower rate of sudden cardiac death in the timolol group (7.7%) compared to the placebo group (13.9%) (p=0.0001) when including events in the so-called "per protocol period".(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1990

Hypertensive black men and women. Quality of life and effects of antihypertensive medications. Black Hypertension Quality of Life Multicenter Trial Group.

A multicenter, randomized double-blind clinical trial was conducted among 306 black men and women with mild to moderate hypertension to determine effects of atenolol, captopril, and verapamil SR on measures of quality of life. Patients were randomly assigned to a stable or forced-dose titration sequence. After an 8-week treatment period, the rate of withdrawal from treatment because of adverse effects was low and did not differ by drug treatment group or titration level. Patients taking verapamil SR showed a significantly greater reduction in mean blood pressures than patients treated with atenolol or captopril. Along with absence of worsening on any quality of life total scale scores examined over the treatment period, we found either improvement or no change in the total scale scores for all three treatment groups. Among both male and female patients, comparisons between drug treatment groups showed no differences in degree of change on the total scale scores. In comparisons within each treatment group, improvement in scores of male patients after 8 weeks appeared among those taking atenolol in general well-being and physical symptoms reduction; among male patients taking captopril in general well-being, physical symptoms, and sexual performance; and among male patients receiving verapamil SR in scores in irritability, sleep, and the Digit Span test. Improvement in scores among female patients taking atenolol was found in scores on general well-being, physical symptoms, and sleep; among women taking captopril on general well-being, physical symptoms, and irritability; and among women taking verapamil SR on general well-being. Patients in all treatment groups improved on measures of visuomotor functioning. The research shows that with the three newer generation antihypertensive medications studied, blood pressure control was achieved during the treatment period without negative effects on quality of life scales, along with findings of improvement on some measures. Given the special clinical features of hypertension in black patients, the study underlines as well the potential and utility of systematic tracking of measures of quality of life, while monitoring blood pressures in this patient population.

Black or African American↗
PubMed2003

Prevalence and risk factors for carriage of methicillin-resistant Staphylococcus aureus at admission to the intensive care unit: results of a multicenter study.

BACKGROUND: Detection of methicillin-resistant Staphylococcus aureus (MRSA) carriers on admission to the intensive care unit (ICU) is an important component of strategies for controlling the spread of MRSA. METHODS: A prospective multicenter study was conducted in 14 French ICUs for 6 months. All patients were screened within 24 hours after admission, using nasal and cutaneous swabs In addition, clinical samples were obtained. Patient data collected on ICU admission included presence of immunosuppression; history of hospital stay, surgery, antimicrobial treatments, or previous colonization with MRSA; chronic health evaluation and McCabe scores; reason for admission; whether the patient was transferred from another ward; severity of illness; presence of skin lesions; and invasive procedures. Risk factors for MRSA carriage at ICU admission were estimated, and significantly associated variables were used to develop a predictive score for MRSA carriage. A cost-benefit analysis was then performed. RESULTS: Of the 2347 admissions with MRSA screening, 162 (6.9%; range, 3.7%-20.0% among ICUs) were positive for MRSA, of whom 54.3% were detected through screening specimens only. Of the 2310 first admissions (vs repeat admissions) to the ICU, 96 were newly identified MRSA carriers. Factors associated with MRSA carriage in the multivariate analysis were age older than 60 years, prolonged hospital stay in transferred patients, history of hospitalization or surgery, and presence of open skin lesions in directly admitted patients. Only universal screening detected MRSA carriage with acceptable sensitivity. A cost-benefit analysis confirmed that universal screening and preventive isolation were beneficial. CONCLUSIONS: The prevalence of MRSA carriage on admission to the ICU is high in this endemic setting. Screening for MRSA on admission is useful to identify the imported cases and should be performed in all ICU-admitted patients.

Aged↗
PubMed1990

Multicenter trial of cryotherapy for retinopathy of prematurity. Three-month outcome. Cryotherapy for Retinopathy of Prematurity Cooperative Group.

We report the results of the national multicenter trial of cryotherapy for retinopathy of prematurity, as determined 3 months after randomization. The threshold severity of retinopathy required for entry into the clinical trial was defined as five or more contiguous or eight cumulative 30 degree sectors (clock hours) of stage 3+ retinopathy of prematurity in zone 1 or 2. Transscleral cryotherapy to the avascular retina was applied in one eye when there was threshold retinopathy in both eyes, or in half the eyes when the threshold severity existed in only one eye (18% of patients). Of the 279 infants who survived 3 months following randomization, 273 returned for outcome examination at that time. Of these infants, 260 had fundus photographs taken that could be graded for anatomic outcome. An unfavorable outcome was defined as posterior retinal detachment, posterior retinal fold (usually involving the macula), or retrolental tissue that obscured the view of the posterior pole. Whereas 51.4% of control eyes had an unfavorable outcome, this was significantly less frequent in the eyes that received cryotherapy (31.1%). No deaths were attributed to the cryotherapy procedure. These data, together with numerous additional ocular findings and preliminary 12-month postrandomization outcome results reported herein, support the efficacy of cryotherapy in reducing the risk of unfavorable ocular outcome from threshold retinopathy of prematurity. We have previously recommended cryotherapy for at least one eye in all patients with threshold retinopathy of prematurity. Now we add the recommendation cryotherapy be considered for both eyes whenever stage 3+ retinopathy of prematurity involves the posterior retina (zone 1) of both eyes.

Analysis of Variance↗
PubMed2002

A prospective multicenter study of patient factors associated with hospital admission from the emergency department among children with acute asthma.

BACKGROUND: Recent studies show that objective measures such as peak flow rates are strongly associated with asthma admission among adults. OBJECTIVE: To identify factors associated with admission among children. METHODS: We performed a prospective cohort study as part of the Multicenter Airway Research Collaboration. Patients aged 2 to 17 years who presented to the emergency department (ED) with acute asthma underwent a structured interview in the ED and another by telephone 2 weeks later. The study was performed at 44 EDs in 18 US states and 4 Canadian provinces. The decision to admit was made at the discretion of the treating physician. Univariate analysis of risk factors for admission was followed by multivariate logistic regression. RESULTS: Of the 1178 eligible subjects, 275 (23%; 95% confidence interval, 21%-26%) were admitted or placed into ED observation units. A multivariate model that included 12 characteristics measured at presentation and during the ED stay was associated with an area under the receiver operating characteristic curve of 0.91. Demographic factors were not independently associated with admission. Severity of symptoms (odds ratio, 1.3) and intensity of therapy both before and during ED visit correlated with the likelihood of admission. Previous admission for asthma (P =.02) and recent use of inhaled corticosteroids (P =.04) also were associated with admission. Peak flows were associated with admission but were infrequently (23% overall) measured. CONCLUSION: Hospitalization for asthma exacerbation in children is primarily associated with clinical indicators in the ED and with historical factors such as previous asthma admission or intubation, recent use of corticosteroids, and comorbidity.

Adolescent↗