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Biomedical subjects

R Golub

Publications and source records attributed to R Golub.

33 records · Page 2Linked to original sources
PubMed1997

Economic analyses of phase III cooperative cancer group clinical trials: are they feasible?

Both economic and clinical evaluations of new pharmaceutical agents are important to physicians who practice in the current health care environment. While cooperative cancer groups carry out large-scale phase III clinical evaluations of these agents, few cooperative group studies incorporate economic analyses because of concerns over overburdening of data management, investigators, and statistical center personnel. In this study, we describe the results and operational considerations of one of the first completed economic analyses of a phase III cooperative group trial of the Eastern Cooperative Oncology Group (ECOG). We developed an economic model estimating economic benefits of yeast-derived granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy for adult patients (56-70 years) with acute myelogenous leukemia. Clinical data were based on prospectively collected information from a recently reported double-blind phase III multi-institutional study carried out by ECOG. Retrospective economic data were obtained from financial information systems at our hospital, one of the study sites. The cost-minimization analyses were based on the perspective of a third-party payer. Indirect costs related to loss of earnings by patients and caregivers as well as quality-of-life adjustments were not incorporated into the model. Clinical trial results indicated that patients treated with GM-CSF had shorter times to recovery of absolute neutrophil count of 500 cells/mm3 and 1000 cells/mm3 and fewer serious infections than patients who received placebo following induction chemotherapy, while no significant differences were noted in red blood cell and platelet transfusion dependency, toxicities, and duration of hospitalization. The economic model estimated that the group treated with GM-CSF was estimated to have lower costs of care, associated with lower frequencies of serious infections and lower overall infection-related costs. Sensitivity analyses indicated that these results held true over a wide range of estimates of costs and infection rates. Prospective economic analyses of phase III cooperative cancer group clinical trials have not been completed to date. Strategies that are not likely to overburden data managers and statistical center personnel are possible to devise. However, these studies require careful planning and coordination between clinical trialists, economists, and health services researchers.

Adult↗
PubMed1997

A multivariate analysis of factors contributing to leakage of intestinal anastomoses.

BACKGROUND: The study of anastomotic leaks is critically important to surgeons because morbidity and mortality increase many fold in the aftermath of an anastomotic disruption. Previous studies that have attempted to identify significant factors contributing to leakage of intestinal anastomoses used animal models or have analyzed retrospective data using univariate analysis. Our objective was to identify factors contributing to leakage of intestinal anastomoses. STUDY DESIGN: We conducted a retrospective, multivariate analysis of 764 patients who underwent 813 intestinal anastomoses. RESULTS: The overall rate of anastomotic leakage was 3.4 percent. No difference was found in rates of leakage among different techniques of anastomosis or among different anastomotic locations. Colonic anastomoses leaked no more frequently than anastomoses of the small intestine. Proximal fecal diversion did not decrease the frequency of leaks. Multivariate analysis identified six significant predictive variables: a serum albumin level of less than 3.0 g/L, use of corticosteroids, peritonitis, bowel obstruction, chronic obstructive pulmonary disease, and perioperative transfusion of more than 2 U packed red blood cells. The in-hospital mortality rate in patients with and without leaks was 39.3 percent and 7 percent, respectively. Multivariate analysis showed that anastomotic leaks were an independent predictor of mortality. CONCLUSIONS: Factors predictive of anastomotic leaks include chronic obstructive pulmonary disease, peritonitis, bowel obstruction, malnutrition, use of corticosteroids, and perioperative blood transfusion.

Adult↗
PubMed1994

Gallstone shrapnel contamination during laparoscopic cholecystectomy.

The fate of lost gallstones in the peritoneal cavity following laparoscopic cholecystectomy is unknown. We report a case of microabscesses and granuloma formation in the peritoneal cavity and abdominal wall caused by infected gallstone shrapnel due to rupture of the gallbladder during extraction.

Abdominal Abscess↗
PubMed1994

Efficacy of albumin supplementation in the surgical intensive care unit: a prospective, randomized study.

OBJECTIVE: To determine the efficacy of supplemental 25% albumin in reducing morbidity and mortality rates in the surgical intensive care unit (ICU). DESIGN: Prospective, randomized, unblinded clinical study. SETTING: Surgical ICU in a community hospital. PATIENTS: Two hundred nineteen patients with admission circulating albumin concentrations of < 3.0 g/dL (< 30 g/L). The groups were well matched regarding age, sex, Acute Physiology and Chronic Health Evaluation II scores and initial circulating albumin concentrations. INTERVENTIONS: The treatment group (n = 116) received 37.5 g/day of albumin until the circulating albumin concentration increased to > 3.0 g/dL (> 30 g/L). The control group (n = 103) received no supplemental albumin. Both groups received standard nutritional support. MEASUREMENTS AND MAIN RESULTS: The complication rate was 44% in the albumin group vs. 36.9% in the controls (p = .29). The albumin patients had a mortality rate of 10.3% vs. 5.8% in the control group (p = .22). There were no significant differences between the groups in the number of days spent receiving mechanical ventilation or in the tolerance to tube feedings. CONCLUSIONS: Routine supplemental administration of 25% albumin is expensive and offers no apparent outcome advantage and should be abandoned in the treatment of patients in the surgical ICU.

Aged↗
PubMed1993

Complication of the intracolonic bypass. Report of a case.

The intracolonic bypass has been used both experimentally and clinically to avoid high-risk primary colonic anastomosis in the face of peritonitis. Experimental and clinical data have established the Coloshield as safe, with few clinical complications reported. This is a review of the literature and a case report of a complication of an intracolonic bypass that was found to have eroded through the colon in the early postoperative period.

Colitis↗
PubMed1993

[The effect of stress and personality structure on the onset and severity of the clinical picture of psoriasis].

On a sample of 38 psoriatic patients we tried to determine the relationship between neurotic disorders (operationalized MMPI) and the number and hazardous effects of stressful events on the one hand and the severity of the clinical picture and the time of the onset of psoriasis on the other. In our sample neurotic disorders are much commoner than in the general population indicating that they might represent one of the most significant factor of etiology, complications and prevention. The last hypothesis is based on the results showing that neurotic psoriatics develop psoriasis significantly later than non-neurotics. We haven't attained a profile of a typical neurotic person because neurotic disorders are manifested through different symptoms. The average number of stressful events was found significantly higher in more severe forms of psoriasis compared to the milder forms. Finally, a remark has been made about benefits of a multidisciplinary approach to the study of psoriasis and the inclusion of psychotherapy in the treatment of psoriatic patients.

Adult↗
PubMed1992

Efficacy of preadmission testing in ambulatory surgical patients.

A retrospective study was done with 325 patients who had preadmission testing prior to ambulatory surgery. At least one laboratory abnormality was noted in 84% of the patients. The serial multiple analysis (SMA)-7 was abnormal 63% of the time. Abnormalities were seen in 54% of the SMA-12 panels and 38% of the urinalyses performed. Twenty-four percent of the patients treated had an abnormal electrocardiogram (ECG). An abnormal chest roentgenogram was found in 19% of the patients. Only three (1%) patients potentially benefited from preadmission testing. Ninety-six percent of the abnormal laboratory results were ignored by the attending physicians. Therefore, we conclude that preadmission testing should be done on a selective basis. Patients older than 50 years of age should have an ECG. A hematocrit should be obtained only if major blood loss is anticipated. All other tests should be ordered based on the history and physical examination.

Adolescent↗
PubMed1983

Modulation of human granulocyte and monocyte chemiluminescence responses: evidence for distinct free radical generating systems.

Using a previously described luminol-dependent photometric chemiluminescence (CL) assay we have investigated the relative significance of the free radicals in the CL phenomenon associated with the respiratory burst of granulocytes and monocytes. The O-2 scavenger, superoxide dismutase, quenches approximately 50% of CL emission from resting and stimulated cells of both types. CL production from granulocytes and monocytes, in the presence of catalase, indicates that H2O2 plays a much less significant role in monocyte light emission than in that of granulocytes. Sodium azide, an 1O2 scavenger and potent inhibitor of peroxidase, and sodium benzoate, an OH. scavenger, both induced 90% reductions of light output from both cell types in resting or stimulated states. The distinct effects of cytochalasins on granulocytes and monocytes further suggest distinct CL generating mechanisms for each cell type. No difference was observed between granulocyte and monocyte CL response in chronic granulomatous disease (CGD) and other clinically related but unknown phagocyte metabolic disorders, whereas selective CL response abnormalities were observed in patients with severe isolated phagocyte chemotaxis defects.

Concanavalin A↗
PubMedDate not supplied

Role of antibiotics in acute pancreatitis: A meta-analysis.

In an attempt to decrease the infectious complications of acute pancreatitis and its high mortality, many investigators have conducted randomized prospective trials on the efficacy of prophylactic antibiotics. The results of these studies are conflicting, and many have called for a large multicenter study. Because multicenter trials are costly and difficult to organize, we believe that meta-analysis is a reasonable alternative. A meta- analysis of all eight previously published trials of prophylactic antibiotics in acute pancreatitis was performed. The end point was death. The Mantel-Haenszel statistic was used to summarize odds ratios across studies in a fixed effects model, after homogeneity was assessed. Sensitivity analysis was performed as appropriate. The meta-analysis of all eight trials showed a positive benefit for antibiotics in reducing mortality. Sensitivity analysis showed that the advantage was limited to patients with severe pancreatitis who received broad- spectrum antibiotics that achieve therapeutic pancreatic tissue levels. It is recommended that all patients with severe pancreatitis be treated with broad- spectrum antibiotics that achieve therapeutic levels in pancreatic tissue.

Acute Disease↗
PubMedDate not supplied

[Modern psychosomatic aspects of dermatology].

Concerning their origin most diseases are multifactorial and that goes for skin diseases too. Emphasizing just one must not exclude further research and other aspects of etiopathogenetic mechanisms. It has been known for along time that psychological factors have a certain influence on the start, aggravation and maintenance on skin changes and that cosmetic defects of this kind disturb the psychological peace of the sick person and his capacity of establishing satisfactory social relations. Psychosomatic approach in dermatology cannot be reduced to investigation of specific etiology in the field of psyche without physical or social spheres. It unites all of them and in that way the old question what cause and what the consequence is has no importance, because there is no time or distance limit among them. They act simultaneously, holistically.

Humans↗