Search

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.jtcvs.2005.05.052 Byline: Robert James Cerfolio (a), Ayesha S. Bryant (b), Bhavik Patel (c), Alfred A. Bartolucci (d) Abstract: Thoracotomy is associated with significant pain and morbidity. Author Affiliation: (a) Section of Thoracic Surgery, University of Alabama at Birmingham, and the Division of Cardiothoracic Surgery, Department of Surgery, Birmingham Veterans Administration Hospital, Birmingham, Ala (b) Department of Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, Ala (d) Department of Biostatistics, University of Alabama at Birmingham School of Public Health, Birmingham, Ala (c) University of Alabama School of Medicine, Birmingham, Ala Article History: Received 21 January 2005; Revised 20 May 2005; Accepted 24 May 2005

Background: Placing chest tubes to water seal is superior for patients with an air leak, but when a patient has a pneumothorax and an air leak the best chest tube [...]

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.jtcvs.2004.11.007 Byline: Robert James Cerfolio (a), Ayesha S. Bryant (b), Buddhiwardhan Ohja (c), Alfred A. Bartolucci (d) Abstract: We sought to assess whether the standard uptake value of a pulmonary nodule is an independent predictor of biologic aggressiveness. Author Affiliation: (a) Section of Thoracic Surgery, University of Alabama at Birmingham, and the Division of Cardio-Thoracic Surgery, Department of Surgery, Birmingham Veterans Administration Hospital, Birmingham, Ala (b) Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Ala (d) Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, Ala (c) Department of Nuclear Medicine, University of Alabama at Birmingham, Birmingham, Ala. Article History: Received 15 July 2004; Revised 1 November 2004; Accepted 9 November 2004

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.jtcvs.2004.12.042 Byline: Robert James Cerfolio (a)(b), Ayesha S. Bryant (c), Buddhiwardhan Ohja (d), Alfred A. Bartolucci (e), Mohamad A. Eloubeidi (f) Abstract: Patients with esophageal cancer who receive neoadjuvant chemoradiotherapy are restaged with computed tomography (CT), endoscopic ultrasound with fine needle aspiration (EUS-FNA), and integrated positron emission computed tomography (FDG-PET/CT), and the results affect treatment. Author Affiliation: (a) Section of Thoracic Surgery, University of Alabama at Birmingham, Birmingham, Ala (d) Division of Nuclear Radiology, University of Alabama at Birmingham, Birmingham, Ala (f) Department of Medicine, Division of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, Ala (b) Division of Cardio-Thoracic Surgery, Department of Surgery, the Birmingham Veterans Administration Hospital, Birmingham, Ala (c) Department of Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, Ala (e) Department of Biostatistics, University of Alabama at Birmingham School of Public Health, Birmingham, Ala Article History: Received 26 June 2004; Revised 8 November 2004; Accepted 22 December 2004

The prevalence of androgen excess (AE) and the value of preemptive endocrine evaluation in women with minimal unwanted hair growth are studied. The results indicated that patients with minimal unwanted hair growth should be evaluated endocrinologically because approximately 50 percent of subjects demonstrate an AE disorder.

Objectives: We streamlined our care using an algorithm for the postoperative care of patients who undergo Ivor Lewis esophagogastrectomy to try, to reduce hospital stay to 7 days and maintain [...]

Background: Most general thoracic surgeons use double-lumen endotracheal tube (DLET) anesthesia for all video-assisted thoracoscopic surgery, (VATS). We evaluated a single-lumen endotracheal tube (SLET) for VATS for drainage of pleural [...]

The Capacity to Consent to Treatment Instrument may help doctors decide whether a patient with Alzheimer's disease is competent to understand and consent to treatment. This instrument presents the legal standards that have been developed to make such assessments.

Background. In a Phase II trial, surgical adjuvant active specific immunotherapy using a live vaccinia virus-augmented allogeneic polyvalent melanoma cell lysate, vaccinia melanoma oncolysate (VMO), produced a significant disease free interval (DFI) in patients with International Union Against Cancer Stage II melanoma with positive lymph nodes. Therefore, a Phase III randomized prospective, double-blind, multiinstitutional, surgical adjuvant VMO trial was performed to determine the efficacy of VMO to increase the DFI and the overall survival in this group of patients with Stage II disease. Methods. Two hundred and fifty patients with Stage II melanoma were divided into two postsurgical groups. One group received VMO (total protein equals 2 mg/ml) and the other received the placebo of live vaccinia vaccine virus (V) (10[sup 5.4] TCID[sub.50/ml], an adjuvant component of the VMO. Patients initially received these biologics once a week for 13 weeks and then once every 2 weeks for an additional 39 weeks or until recurrence. All surviving patients have been followed for at least 30 months. Results. Statistical analysis of survival data (n = 217) for this first interim analysis shows that there is no statistically significant (P = 0.99) increase in DFI of patients treated with VMO (n = 104) when compared with V (n = 113). The median DFI is 38.0 months for patients treated with VMO and 37.0 months for patients treated with V. At 2- and 4-year intervals, 70 and 38%, respectively, of patients treated with VMO vs. 66 and 36%, respectively, of patients treated with V were free of melanoma. The median overall survival is not available because the patients treated with VMO have not yet reached the 50% mark and the median overall survival is 45.0 months for patients treated with V. At 2- and 4-year intervals, 70 and 38%, respectively, of VMO-treated patients survived when compared with 66 and 36%, respectively, of patients treated with V. Although the overall survival of patients treated with VMO is not statistically significant (P = .88) at this point, there is an increasing trend in the overall survival of patients treated with VMO; a 10% increase at the 4-year time point. Moreover, in the subset analysis, VMO-treated male patients (n = 63) showed a 17% improvement in survival at 4-year time point when compared with male patients treated with V (n = 67) (P = 0.19) at the same time point and male patients (n = 20) between the ages of 44 and 57 having 1-5 positive lymph nodes showed a 37% difference in overall survival at the 4-year time point when compared with those patients treated with V (n = 18) (P = 0.13) at the same time point. Conclusion. In this first interim analysis, active specific immunotherapy with VMO vs. V showed no difference in the disease free interval or overall survival. Subset analyses likewise showed no significant differences in outcome but the data suggest a potential difference in immunoreactivity between male and female patients with melanoma that awaits further follow up and may merit further investigation.

Background. In 1978, the National Prostatic Cancer Project launched two protocols evaluating adjuvant therapy after surgery (Protocol 900) or irradiation (Protocol 1000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy. Methods. After definitive treatment, the patients were randomized either to receive cyclophosphamide 1 g/[m.sup.2] intravenously every 3 weeks for 2 years or estramustine phosphate 600 mg/[m.sup.2] orally daily for up to 2 years or to undergo observation only. Patient accession closed in 1985 and includes 184 patients in Protocol 900 (170 evaluable) and 253 in Protocol 1000 (233 evaluable). Results. Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900 and 63% in Protocol 1000. The median progression-free survival (PFS) and survival were greater for patients in Protocol 900 compared with 1000, regardless of the adjuvant therapy. This reflected the greater proportion of patients with lower pathologic stage disease in the surgically treated group. The median PFS was significantly greater for all patients in Protocol 1000 receiving estramustine phosphate adjuvant (48.2 months) compared with patients randomized to receive cyclophosphamide (35.6 months). The median PFS for patients with nodal involvement in Protocol 1000 who received estramustine phosphate adjuvant was prolonged significantly (37.3 months) compared with no treatment (20.9 months). The median PFS for patients with limited nodal disease in Protocol 1000 was longer (39.9 months), regardless of the adjuvant therapy, compared with those with extensive nodal disease (20.7 months). However, in the latter patient group, those receiving adjuvant estramustine phosphate had a significantly longer median PFS (32.8 months) compared with those receiving adjuvant cyclophosphamide (22.7 months) or no adjuvant therapy (12.9 months). Conclusion. Adjuvant estramustine phosphate was beneficial in patients with prostate cancer and pelvic node involvement who received irradiation as definitive treatment. Cancer 1993; 71:1005-13.

The separate effects of energy restriction and weight loss on serum lipids were studied in 24 postmenopausal moderately obese women before and after weight loss of > 10 kg to normal weight. Fasting serum triglycerides (TGs), total cholesterol (TC), high-density-lipoprotein (HDL) and low-density-lipoprotein (LDL) cholesterol, and insulin were measured a the end of four 10-d in-hospital phases, two before and two after weight loss: phase I, stable weight; phase II, 3350 kJ/d (800 kcal/d). followed by outpatient weight loss; phase III, 3350 kJ/ d (800 kcal/d); and phase IV, stable weight. Diet composition and exercise were constant the entire study. Energy-restriction effect was determined by comparing average values in stable-weight phases (I and IV) with low-energy phases (II and III); weight-loss effect was determined by comparing values in obese phases (I and II) with reduced-weight phases (III and IV). Energy restriction lowered TG, TC, LDL cholesterol, the LDL-HDL cholesterol ratio, and insulin and raised HDL cholesterol (all P < 0.05). Weight loss lowered TG, TC, LDL cholesterol, and insulin (all P < 0.01) but did not change HDL cholesterol or the LDL-HDL cholesterol ratio. The results suggest that reduction to a weight-steady nonobese state significantly lowers TG, TC, and LDL cholesterol but does not improve HDL cholesterol or the LDL-HDL cholesterol ratio. Am J Clin Nutr 1992; 56:44-9.

Methotrexate (MTX), a drug originally used to treat cancer, is also effective in treating rheumatoid arthritis (RA). The mechanism by which MTX improves RA is unclear. RA is an autoimmune disease, in which the body inappropriately makes antibodies against its own tissues. The severity of the disease has been correlated with blood levels of rheumatoid factors (RFs), antibodies directed against part of the structure of immunoglobulin G (IgG). Blood levels of RFs may decline during treatment with certain antirheumatic drugs, indicating that RFs may contribute to the RA disease process. The effect of MTX therapy on RF levels has been disputed. In many previous studies, older, relatively insensitive assays (laboratory tests) have been used for MTX measurement. The effect of MTX on RF levels, using more sensitive measurement techniques, in 30 RA patients was compared with the effect of placebo treatment in 52 RA patients. Approximately one-third of patients improved following MTX treatment. Levels of two RF subtypes, IgM-RF and IgA-RF, both decreased significantly in MTX-treated patients, but not those treated with placebo. However, medical improvement correlated only with changes in IgM-RF levels. These results indicate that MTX treatment in RA patients is associated with decreases in IgM-RF and clinical improvement. IgA-RF levels decrease as well with MTX treatment, but are not necessarily associated with clinical improvement. Further research is needed to determine the relationship between these findings and the disease process underlying RA. (Consumer Summary produced by Reliance Medical Information, Inc.)

Lung cancer is an often fatal, malignant disease that is associated with smoking. Lung cancers are classified by the type of malignant cell present, and the non-small cell type is the leading cause of cancer-related deaths in the United States. The condition has a high mortality because most patients are not good candidates for surgery, either because the tumor is too far advanced or the patient could not withstand the surgery. For the 30 percent of patients with advanced, inoperable non-small cell lung cancer, treatment may involve the use of radiation to kill the cancer cells, but the effectiveness of this strategy is controversial. To assess the effectiveness of local radiation in the treatment of advanced non-small cell lung cancer, 319 patients received either radiation, the cell killing agent vindesine, or the combination. The response rate for radiation therapy was 30 percent and was higher than the 10 percent response rate for vindesine alone. The response rate for the combination of radiation therapy and vindesine was 34 percent. But even though radiation therapy had a higher response rate, no improvement in short or long-time survival occurred. Therefore, this study indicates that patients with inoperable non-small cell lung cancer do not derive meaningful benefit from radiation therapy. These patients should be included in studies assessing the effectiveness of new drug or radiation therapies. (Consumer Summary produced by Reliance Medical Information, Inc.)

Background: Body composition and resting energy expenditure (REE) have not been examined longitudinally during puberty. Objective: The purpose of this longitudinal study was to examine the influence of pubertal maturation on REE relative to body composition in African American and white children. Design: The study included 92 white and 64 African American children (mean age at baseline: 8.3 and 7.9 y, respectively) from Birmingham, AL. The children had 2-5 annual measurements of fat mass (FM), lean mass (LM), and REE. The Tanner stages of the children ranged from 1 to 5. Mixed-model repeated-measures analyses were used to test the change in REE relative to body composition with increasing Tanner stage among ethnic and sex groups. Results: LM increased from Tanner stage 1 to subsequent stages. FM relative to LM decreased from Tanner stage 1 to stages 3, 4, and 5 but not from stage 1 to stage 2. The African American children had relatively higher limb LM and lower trunk LM than did the white children. REE declined with Tanner stage after adjustment for ethnicity, sex, FM, and LM. This decline was significant from Tanner stage 1 to stages 3, 4, and 5 but not to Tanner stage 2. After adjustment for age, Tanner stage, FM, and LM or LM distribution, REE was significantly higher in white than in African American children (by [approximately equals]250 kJ/d). Conclusion: In a large sample of children at various Tanner stages, we found an ethnic difference in REE after adjustment for age, Tanner stage, FM, and LM that was not explained by the difference in LM distribution. Am J Clin Nutr 2001;73:308-15. KEY WORDS Body composition, resting energy expenditure, lean mass distribution, puberty, African American children, white children, Tanner stage

The researchers of the National Prostatic Cancer Treatment Group have followed 212 patients with confirmed stage D-1 prostatic cancer. Fifty-one of these patients were treated with surgery, and 161 with radiotherapy. All patients received some sort of adjuvant chemotherapy. The anatomical locations of involved lymph nodes were tabulated to discover if this information has prognostic value. There has been some controversy regarding the involvement of lymph nodes and the prognosis of prostate cancer; in the present study the involvement of fewer than 20 percent of the examined nodes had a significantly better prognosis than did the involvement of more than 20 percent. It is worth noting that if the data are examined in terms of actual number of nodes involved, there is no prognostic value. That is, if the involvement of one to three nodes is compared with the involvement of more than 3, there is no significant difference in the survival. The data gave no indication that the location of the involved lymph nodes was of any prognostic value. (Consumer Summary produced by Reliance Medical Information, Inc.)

To determine whether early coagulopathy affects the mortality associated with severe civilian pediatric trauma, trauma patients younger than 18 years admitted to a pediatric intensive care unit from 2001 to 2010 were evaluated. Patients with burns, primary asphyxiation, preexisting bleeding diathesis, lack of coagulation studies, or transferred from other hospitals more than 24 h after injury were excluded. Age, sex, race, mechanism of injury, initial systolic blood pressure, Glasgow Coma Scale score, Injury Severity Score, prothrombin time, partial thromboplastin time, platelet count, and international normalized ratio were recorded. An arterial or venous blood gas was performed, if clinically indicated. Coagulopathy was defined as an international normalized ratio greater than 1.2. The primary outcome was in-hospital mortality. Secondary outcomes were lengths of intensive care unit and hospital stay. Eight hundred three patients were included in the study. Overall mortality was 13.4. The incidence of age-adjusted hypotension was 5.4. Early coagulopathy was observed in 37.9 of patients. High Injury Severity Score andor hypotension were associated with early coagulopathy and higher mortality. Early coagulopathy was associated with a modest increase in mortality in pediatric trauma patients without traumatic brain injury (TBI). In contrast, the combination of TBI and early coagulopathy was associated with a fourfold increase in mortality in this patient population. Early coagulopathy is an independent predictor of mortality in civilian pediatric patients with severe trauma. The increase in mortality was particularly significant in patients with TBI either isolated or combined with other injuries, suggesting that a rapid correction of this coagulopathy could substantially decrease the mortality after TBI in pediatric trauma patients.

Abstract: Myelodysplastic syndrome (MDS), sometimes referred to as pre-leukemia or smoldering leukemia, is a group of diseases usually characterized by failure of the bone marrow to produce enough normal blood cells. In about one-third of patients, the disease transforms into acute leukemia. In high-risk MDS, the bone marrow contains too many immature blood cells known as blasts. Patients with high-risk MDS survive for an average of 6–12 months. We have taken data from a large clinical trial and re-examined it considering the pre-leukemia as a random event in a Weibull distribution model. The issue becomes that of examining the affect of the variable on the predictive survival. We have taken the intercept, stress effect and shape parameter of the distribution to be random effects as well with realistic prior distributions based on previous shapes of the survival experience of subjects with this disease. We demonstrate how the model performs under relevant clinical conditions. The conditions are all tested using a Bayesian statistical approach allowing for the robust testing of the model parameters under various stress conditions which we introduce into the model. The convergence of the parameters to stable values are seen in trace plots which follow the convergence patterns This allows for precise estimation for determining clinical conditions under which the survival pattern will change. We give a numerical example of our results. The major platform for the theoretical development follows the Bayesian methodology and the multiple parameter Weibull model with random effects having carefully chosen hyper parameters. We have implemented the basic infrastructure for the analysis using the commercially available WinBugs software employing the Markov Chain Monte Carlo (MCMC) methodology. [Copyright &y& Elsevier]

Optimal experimental design is important for the efficient use of modern high-throughput technologies such as microarrays and proteomics. Multiple factors including the reliability of measurement system, which itself must be estimated from prior experimental work, could influence design decisions. In this study, we describe how the optimal number of replicate measures (technical replicates) for each biological sample (biological replicate) can be determined. Different allocations of biological and technical replicates were evaluated by minimizing the variance of the ratio of technical variance (measurement error) to the total variance (sum of sampling error and measurement error). We demonstrate that if the number of biological replicates and the number of technical replicates per biological sample are variable, while the total number of available measures is fixed, then the optimal allocation of replicates for measurement evaluation experiments requires two technical replicates for each biological replicate. Therefore, it is recommended to use two technical replicates for each biological replicate if the goal is to evaluate the reproducibility of measurements.

To comprehensively investigate the genetic architecture of growth and obesity, we performed Bayesian analyses of multiple epistatic quantitative trait locus (QTL) models for body weights at five ages (12 days, 3, 6, 9 and 12 weeks) and body composition traits (weights of two fat pads and five organs) in mice produced from a cross of the F1 between M16i (selected for rapid growth rate) and CAST/Ei (wild-derived strain of small and lean mice) back to M16i. Bayesian model selection revealed a temporally regulated network of multiple QTL for body weight, involving both strong main effects and epistatic effects. No QTL had strong support for both early and late growth, although overlapping combinations of main and epistatic effects were observed at adjacent ages. Most main effects and epistatic interactions had an opposite effect on early and late growth. The contribution of epistasis was more pronounced for body weights at older ages. Body composition traits were also influenced by an interacting network of multiple QTLs. Several main and epistatic effects were shared by the body composition and body weight traits, suggesting that pleiotropy plays an important role in growth and obesity.

In some population the AIDS/HIV incidence rate θ∈(0,∞) is altered in the middle of a data collection period due to preventive treatments imposed by the health service agencies. The intervened Poisson (IP) model in [Comput. Programs Biomed. 17 (1983) 89; Biometrics 48 (1985) 559] was introduced which is appropriate to analyze data of this type. However, the classical approach leading to the maximum likelihood (ML), moment (M) or minimum variance unbiased (MVU) estimator of θ is mathematically formidable and practically inconvenient as far as sequentially updating the estimate when new data arrive. Previous subjective Bayesian work has been done to overcome these issues. Hence, there is a need to devise a more practical empirical Bayesian technique to estimate θ, and it is done in this article. The results are illustrated using a data on AIDS/HIV incidence in the state of Alabama. Advantages in the Bayesian intervened approach are cited. [Copyright &y& Elsevier]

The purposes of this study are: (1) to determine whether proficiency analytical test (PAT) materials from the American Industrial Hygiene Association can be used to provide quality data for portable X-ray fluorescence analysis (XRF) of lead in dust wipe surface samples; (2) to provide data to determine whether the on-site analysis of field dust wipe samples by XRF and the laboratory method of inductively coupled plasma emission analysis (ICP) are comparable; and (3) to determine if differences exist between different wipe materials. Several wipes meet the ASTM E1792 performance requirements of lead background level less than 5 µg per wipe, be only one layer thick, yield recovery rates of 80–120% from spiked samples, remain damp throughout the sampling procedure, and do not contain aloe. The wipes used in this study were Pace Wipes, which are used for the PAT materials, and, for the field samples, Palintest Wipes, which were supplied by the instrument manufacturer, and Ghost Wipes, which are popular because they digest in hot, concentrated acid, so that chemical analysis is simplified. Twenty PAT wipe samples were obtained from four different proficiency test rounds. Surface wipe samples were taken at three different locations representing different industry types. All samples were analyzed using a portable XRF spectrometer and by ICP. Strong linear relationships were found for the analysis of wipe samples by ICP and by portable XRF. For the PAT samples, the results from the ICP and XRF analysis were not statistically equivalent, which indicates a bias in the ICP analysis. The bias was not excessive, since all ICP analyses fell within the acceptable range for the proficiency samples. The good correlation between the proficiency sample reference values and the XRF determinations is not surprising considering similar proficiency samples were used to calibrate the instrument response. Users of this portable XRF analyzer could enroll in the proficiency test program as part of their quality assurance program. For field samples, the relationship was strongest for Palintest wipes, and the values found for all three industries could be combined. However, the results from the ICP and XRF analysis were not statistically equivalent using the correction factor in the calculation algorithm as supplied with the instrument, and a new coefficient was derived. The mean relative error for the XRF analysis versus the ICP analysis was greater than 25%, such that the method falls within the realm of screening procedures. For Ghost Wipe samples, the precision was different for different industries, and the results could not be pooled. Differences between the two wipe materials may be related to the number of folds required for analysis.

The underlying etiology and pathogenesis of Gulf War veterans' illnesses continue to be under intense investigation. Reports have suggested the basis for these illnesses may be an altered immune system, but compelling evidence is lacking. We sought to determine whether in vitroimmune responses were abnormal in symptomatic Gulf War veterans relative to matched controls. A randomized case-control study was conducted by blinded comparison of laboratory measures of in vitroimmune responses in blood samples obtained from veterans in an outpatient facility of a Veterans Affairs medical center. Symptomatic Gulf War veterans with otherwise undefined illnesses (52 symptomatic subjects), asymptomatic Gulf War veterans (31 asymptomatic controls), and veterans who had applied for disability compensation and had not participated in the Gulf War (21 disability controls) represented the volunteer sample. In vitrocellular and humoral immune responses were measured to detect functional abnormalities in antigen presenting cells (autologous mixed leukocyte reactions and expression of interleukin (IL)-1?, IL-6, IL-10, and tumor necrosis factor-?); T cells (lymphocyte proliferation using the polyclonal T-cell activators phytohemagglutinin and Concanavalin A; primary immune responses in allogeneic mixed leukocyte reactions; secondary immune response using the recall antigens tetanus toxoid, Candida albicans, and anthrax vaccine; and soluble IL-2 receptor expression); type-1 T-helper cells (gamma interferon expression); type-2 T-helper cells (IL-4 and IL-10 expression); and B cells (polyclonal B-cell activator pokeweed mitogen-induced immunoglobulin production). In general, immune response measures did not differ significantly between groups. Heightened responses observed in the disability control group (sporadically greater responses to one mitogen and two antigens) and the Gulf War participation control group (greater recall responses to anthrax vaccine) did not suggest impaired immune cell function in symptomatic veterans when compared with controls. We conclude that in vitroimmunological responses are not abnormal in symptomatic Gulf War veterans.

At some point in time during a post-surgery period, an anesthesiologist may intervene using a medication to quicken a patient’s conscious-recovery time. An assessment of such intervention methods has clinical importance. One performs an extension of the exponential model to address this issue. The model derived is the intervened exponential model (IED). Statistical properties of this new model, expressions to estimate the model parameters, and a test statistic procedure to verify conjectures about the intervention efforts are derived. Other concepts, such as the hazard function and its relevance to this model are introduced and examined. An illustrative example is pursued to demonstrate this procedure. [Copyright &y& Elsevier]

To determine the factors predictive of damage in a multiethnic (Hispanic, African American, and Caucasian) LUMINA (lupus in minority populations, nature versus nurture) cohort of patients with systemic lupus erythematosus (SLE) with disease duration of ≤5 years at enrollment (T0). Variables (socioeconomic/demographic, clinical, immunologic, immunogenetic, behavioral, and psychological) were measured at T0 and annually thereafter. Disease damage was measured with the Systemic Lupus International Collaborating Clinics Damage Index (SDI), and disease activity was measured with the Systemic Lupus Activity Measure. The relationship between the different variables and the SDI at the last visit (TL) was examined (mean followup from diagnosis to TL 61 months; adjusted for disease duration). Poisson regression was used to identify the independent association between the different variables and SDI scores at TL. Seventy-two Hispanics, 104 African Americans, and 82 Caucasians were included. One-half of patients had not accrued any damage. Caucasians had the lowest SDI scores at T0, and Hispanics had the highest scores at TL. Renal damage occurred more frequently among Hispanics and African Americans, while integument damage was more frequent among African Americans. Neuropsychiatric (20%), renal (16%), and ocular (15%) damage occurred most frequently among all patients. Independent predictors of SDI at TL were age, corticosteroid use (maximum dose at T0), number of American College of Rheumatology (ACR) criteria met, disease activity, and abnormal illness-related behaviors. Other variables were less consistently associated with damage accrual (poverty in African Americans, lack of HLA–DRB1*0301 in Hispanics, presence of HLA–DQB1*0201 and acute onset of SLE in Caucasians). Damage in SLE occurs from the outset in some, but not all, patients; Hispanics accrue damage more rapidly. Disease factors (corticosteroid use, number of ACR criteria met, disease activity, and acute-onset type) are important, but age and abnormal illness-related behaviors also contribute to overall damage in SLE.

As individuals with significant functional deficits are discharged earlier from the hospital, health care professionals are challenged to develop cost-effective intervention programmes that will assist family members to manage caregiving problems in the home. The literature suggests that social problem-solving can positively influence the physical and psychological well-being of individuals. This paper describes a social problem-solving training procedure provided primarily by telephone to assist family caregivers to manage caregiving issues in the home.

Chronic pancreatitis remains a debilitating disease with few definitive options for treatment. The purpose of this study was to evaluate the benefit of pancreaticoduodenectomy in the treatment of chronic pancreatitis. The results were evaluated by standard descriptive statistics. In a retrospective study, we reviewed the patients at a single institution undergoing pancreaticoduodenectomy between 1994 and 1997 for complications of chronic pancreatitis. Patients were evaluated for preoperative indication for surgery and perioperative morbidity and mortality, as well as long-term results. Thirty-two patients underwent pancreaticoduodenectomy for chronic pancreatitis; 56 per cent (18) underwent pylorus-preserving and 44 per cent (14) underwent classic pancreaticoduodenectomy. The mean age of these patients was 56 ± 14.7 years (range, 23–79). All patients underwent preoperative CT scan and endoscopic retrograde cholangiopancreatography. The preoperative indication for surgery in 81 per cent (26) of these patients was intractable pain in the setting of a nondilated pancreatic duct. The other 19 per cent were treated for biliary/pancreatic duct stricture and pancreatic head fibrosis (mass suspicious of malignancy). Fifty-three per cent of the patients had a history of previous abdominal surgery. There were no perioperative deaths. The mean postoperative stay was 12.2 ± 7.4 days. The postoperative morbidity rate was 31 per cent (10), consisting of 25 per cent with delayed gastric emptying, 3 per cent with pneumonia, and 3 per cent with wound infections. There was no occurrence of pancreatic fistulas. With a mean follow-up of 40 months (range, 10–52 months), 85 per cent reported a significant improvement in pain with 71 per cent being pain free and not requiring narcotics. Twenty per cent developed new-onset diabetes. The overall event survival rate at 5 years was 97 per cent. Thus, in a selected group of patients with severe chronic pancreatitis, resection of the head of the pancreas achieved relief of symptoms and was a safe and effective treatment for chronic pancreatitis.

Objective: To determine if older patients undergo fewer cardiovascular imaging procedures (CIPs) than younger patients when admitted to a tertiary care academic medical center for an acute myocardial infarction (MI), after adjusting for disease severity and comorbidities.

BackgroundExposure to latex is known to cause an array of symptoms, including pruritus, dermatitis, erythema, and urticaria. Workers at elevated risk for latex exposure include health care personnel whose repeated patient contact or surgical work require extensive use of latex gloves. This study evaluated the prevalence of latex allergies in atopic and non‐atopic intensive care workers and sought to determine the impact of risk factors such as frequency of glove use and hand washing on latex sensitization.

OBJECTIVE:To investigate the agreement of physician judgments of capacity to consent to treatment for normal and demented older adults.

The Southeastern Cancer Study Group conducted a randomized clinical trial in acute myeloblastic leukemia and the blastic phase of chronic myelocytic leukemia to compare: Two induction programs (Schedule A) cytosine arabinoside and 6-thioguanine or (Schedule B) cytosine arabinoside, 6-thioguanine and daunorubicin; two consolidation programs (Schedule C) continuation of induction programs at a reduced dose or (Schedule D) a combination of cyclophosphamide, methotrexate and vincristine; and two maintenance programs — (Schedule E) 1 month of BCG, followed by methotrexate or (Schedule F) methotrexate. Over a 3 year period 372 patients were entered and 295 were judged evaluable. None of 11 patients with blastic phase of chronic myelocytic leukemia responded. There were no significant differences between the schedules in the number of patients with acute myeloblastic leukemia achieving complete remissions (37%, Schedule A vs. 41% Schedule B). The relapse rates on consolidation were similar (43%, Schedule C and 39%, Schedule D). BCG significantly prolonged the duration of first remission following consolidation (P<0.05) from 13.0–23.9 weeks. Survival was not significantly prolonged (92.7 weeks vs. 71.7 weeks). There were no serious complications from BCG therapy.

A randomized controlled trial was initiated in 1972 to compare two chemotherapeutic regimens [1–3-bis (2-chloroethyl) 1-nitrosourea (BCNU), cyclophosphamide, and prednisone versus melphalan and prednisone], to determine whether the two regimens are cross-resistant, and to evaluate the effectiveness of sodium fluoride, vitamin D, calcium gluconate, and fluoxymesterone in the promotion of bone healing. Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same. Patients on either regimen who failed to respond after 6 mo had a very low response rate to the alternative regimen (approximately 10%). Initially responding patients were randomly assigned to either an active drug regimen (sodium fluoride, vitamin D, calcium gluconate, fluoxymesterone) or placebo tablets. There was no significant difference in the low percentage of patients demonstrating bone improvement. Thus, the BCNU, cyclophosphamide, prednisone regimen is as effective as melphalan and prednisone. Fluoride, calcium, vitamin D, and androgenic steroids should not be routinely recommended in myeloma, as they seem to add little to effective chemotherapy and may contribute to morbidity.

In this paper we discuss some moment properties of a symmetric generalized logistic distribution indexed by a shape parameter λ and denoted by GL(λ, λ), and show that it is asymptotically normal as λ s→∞, and asymptotically double exponential as λ s→0. We also show that GL(λ, λ) can be used to approximate the normal distribution. The proposed approximation is illustrated for specific values of λ.

This retrospective study of diffuse mixed (DM) cell lymphoma was undertaken as a collaborative study between the Repository Center for Lymphoma Clinical Studies and four cooperative oncology groups (CALGB, ECOG, SECSG, SWOG), and was based on 62 patients from the files of the Repository Center. We wanted to ascertain whether there were any significant clinical differences among the various morphological subtypes of this lymphoma. All patients were treated according to different protocols of the Cooperative Oncology Groups sponsored by the National Cancer Institute. In 16 patients (26%), the malignant lymphoma (ML) had morphological features consistent with follicular center cell origin (FCC); in 34 patients (55%), the ML did not have features of follicular center cell type (non-FCC), but had morphology described for peripheral T-cell-derived ML. In 8 of the patients (13%), no agreement could be reached by the 7 histopathologists who participated in the study, and these were classified as unresolved; the remaining 4 (6%) were unclassifiable. We compared the survival times of the 16 patients having the morphological features of the FCC subtype with the survival times of the 34 patients with the non-FCC subtype and found that patients with FCC lived longer (p= 0.07 Cox's regression). In the FCC group, all patients who had complete remissions (CR) were alive; however, their survival times were similar to those who had a partial or no response (p= 0.32). In contrast, in the non-FCC group, the median survival was 20 mo, and patients with a CR had a significantly longer survival than did noncomplete responders (p= 0.003). According to these results the non-FCC diffuse mixed cell lymphoma appears to be a high-grade malignant lymphoma, whereas the FCC type is not.

Combination chemotherapy appears superior to single‐agent therapy in treating a wide variety of tumors. Encouraged by this data, we conducted a pilot study using cyclophosphamide, adriamycin, intermediate dose methotrexate and folinic acid rescue (CAMF) in patients with advanced lung cancer. Forty‐eight patients with unresectable tumors were entered on this trial, and treated with 500 mg/m2intravenously administered cyclophosphamide, 50 mg/m2intravenously administered adriamycin, 40 – 200 mg/m2orally administered methotrexate (4 doses/24 hrs), and 5 mg orally administered folinic acid (6 doses/36 hrs); this regimen was repeated every three weeks if tolerable. There were 43 patients evaluable for toxicity and 34 (non‐small cell types) for response. The major toxicities were myelosup‐pression and nausea and vomiting. The overall response rate (complete and partial responses) was 29.4% (10/34) and in 13 patients (38%), the disease was stabilized. Those responding had a median survival time of 10.5 months versus 4 months for nonresponders. Patients in whom the disease was stabilized had a median survival time of 8 months. CAMF is a well‐tolerated drug combination with promising results in patients with advanced lung cancer.

The elderly patient with malignancy is often considered a poor risk for treatment. To assess the effect of age on the treatment of one such disease, multiple myeloma (a disease with increased incidence in the elderly), a study was made of 280 patients treated with 1,3‐bis (2‐chloroethyl)‐1‐nitrosourea (BCNU), cyclophosphamide and prednisone on a Southeastern Cancer Study Group protocol. Initial response rates after six months of treatment were equivalent for the older compared with the younger age groups, with a slightly longer remission duration for those over 70. Likewise, survival was equivalent for the older patients. This was not the result of selection of older patients with less advanced disease, since the proportion with both good and poor risk factors are not significantly different in the various age groups. Moreover, for patients with each of the prognostic factors, older patients responded at least as well as younger patients. There were no significant differences among the age groups in gastrointestinal, skin, hair, or hematologic toxicity, although there was a slightly higher incidence of mild granulocyte and platelet toxicity in patients over 60. These findings are in contrast to the widely held belief that older patients cannot tolerate chemotherapy. On the contrary, they suggest that the elderly patient with myeloma may be expected to respond and survive, without excessive toxicity, at least as well as a younger counterpart with similar prognostic factors.

Although childhood T-cell acute lymphocytic leukemia IT-ALL) and T-cell non-Hodgkin's lymphoma (T-NHL) have certain clinical features in common, T-ALL carries a notably poorer prognosis than does T-NHL. To determine whether the malignant cells from patients with these disorders are distinguishable, we examined bone marrow and/or blood from 51 children with T-ALL and tumor biopsy specimens from 17 with T-NHL, using a panel of monoclonal antibodies directed against T-cell differentiation antigens. We found considerable phenotypic heterogeneity in both T-ALL and T-NHL. Of the TALL (defined by >25% blasts in the bone marrow) patients, 33% demonstrated a surface antigen pattern consistent with the earliest thymocyte stage of T-cell development (T9+and/or T10+. or T6-/ T4-/T8-/T3+), 37% were of a midthymocyte stage (T6+, and/or simultaneous expression of T4-helper and T8-suppressor antigens), and 30% expressed surface antigen patterns found on mature thymocytes (T3+, variable expression of other antigens). In contrast, tumor cell phenotypes in the 17 T-NHL patients were approximately equally distributed between mid- and mature thymocyte phenotypes. No NHL samples were classified as the early thymocyte phenotype. Clinical features as related to specific T-ALL immunophenotypes are presented, and the implications of these findings in regard to the current understanding of the differences in tumor biology between T-ALL and T-NHL are discussed.

• The predictive value of magnetic resonance imaging (MRI) was assessed by a prospective study of 34 patients selected for surgical treatment of temporal lobe epilepsy. The MRIs were interpreted using standardized visual diagnostic criteria and the imaging findings were correlated with the surgical outcome. Lateralized MRI abnormalities were found in 25 (74%) of 34 patients. Significant associations were found between either the presence of a restricted foreign-tissue lesion or hippocampal atrophy and an excellent surgical outcome. An abnormal MRI had an 82% predictive value and a normal MRI had a 56% predictive value for surgical success. A history of febrile convulsions and the presence of hippocampal atrophy best predicted outcome (predictive value, 86%). These results suggest that specific MRI findings in candidates for temporal lobe epilepsy surgery are predictive of surgical outcome. The information provided by MRI may be of value for counseling patients prior to surgical intervention.

• In Alzheimer's disease (AD), the relationship between white-matter changes on magnetic resonance images and behavior are unclear. Therefore, magnetic resonance images, cognition, and psychiatric state were assessed in patients with AD with depression (AD/DEP; n = 18) and without depression (AD; n = 45), older depressed patients (n = 12) and older normal individuals (n = 25). High-intensity signals in the cortex and subcortical regions were similar in number and proportions among all groups, even when hypertensive patients were excluded. No correlations to cognitive or psychiatric state were found. Periventricular signals were categorized using a 1- (absent) to 6- (thick, irregular caps and stripes) point scale. The categories were similar among groups except that patients with AD exhibited more category 5 changes than did normal subjects, neuropsychological performance was significantly worse in patients with AD who had category 5 and 6 changes when compared to those in category 1. These results suggest that periventricular changes may predict poor neuropsychological performance in patients with AD. However, neither deep white-matter lesions nor periventricular changes are useful for diagnostic purposes.

In order to study the effectiveness of the drug combination BCNU, cyclophosphamide, and prednisone (BCP) in myeloma, the Southeastern Cancer Study Group entered 126 previously untreated and 33 previously treated patients in this study. Patients received cyclophosphamide, 400 mg/sq m, BCNU, 75 mg/sq m, and prednisone, 80 mg/sq m, for 7 days, every 4 wk, and were evaluated for response after 6 mo of therapy. Responding patients were continued on therapy and followed for evaluation of survival. Previously untreated patients were evaluated for good and poor risk status as well as clinical stage by calculation of tumor cell mass. These calculated values, as well as the individual components such as blood urea nitrogen (BUN), immunoglobulin (Ig) type, and hemoglobin (Hb), were evaluated for correlation with response and survival. The response rate was approximately 50% for all untreated patients regardless of cell mass or risk status. Toxicity was not excessive, and no case of acute leukemia was seen. Median survival for untreated patients was 27.8 mo; good risk patients, 44 mo; and poor risk, 12 mo. Though cell mass status did not correlate well with survival, individual factors of BUN, IgAλ, and IgGκprotein types had strong predictive value. Using these factors, a model for survival predication was created that had high predictive value in this group of patients. The study indicates that this treatment regimen is effective and could be used as an alternative to standard chemotherapy or in sequential combinations. Since it does not contain melphalan, it might be attractive if melphalan-contain-ing regimens prove to be particularly leuke-mogenic. The survival-predictive model may be useful in assessment of patient prognosis and will be further evaluated in subsequent group studies.

In 35 of 191 patients with acute lymphocytic leukemia (ALL) malignant cells were similar in phenotype to B-lymphocyte precursors. Both these patients’ lymphoblasts and normal pre-B-cells contain cytoplasmic immunoglobulin (Ig) µ heavy chains, but have no surface Ig. In patients with pre-B leukemias, lymphoblasts containing cytoplasmic µ.chains alone were often accompanied by cells of identical morphology that expressed no Ig and less frequently by lymphoblasts bearing scant amounts of surface µ. This spectrum of cellular Ig expression suggests that “null,” pre-B, and intermediate pre-B/B ALLs represent closely related malignancies with complete or partial arrests at different stages of maturation. When pre-B, B, T, and “null” cell categories of ALL were compared for 22 different clinical and laboratory features, including remission rate and short-term remission duration, no statistical differences were observed between the pre-B and “null” groups. These early results suggest that pre-B-cell leukemias represent a relatively good prognostic subclass of ALL, do not require more intensive treatment than that proven to be effective for “null” cell ALL, and should be distinguished from the less common, but more clinically aggressive, B-cell subclass of ALL. Longer follow-up will be required to confirm these preliminary conclusions.

• In this phase la/lb trial, vaccinia melanoma oncolysate (VMO) is a virus-augmented melanoma cell membrane vaccine that has been shown to be safe and to stimulate the production of antimelanoma antibodies in high-risk melanoma patients treated in a surgical adjuvant setting. One patient with stage I and 38 patients with stage II melanoma were entered in the study between December 1984 and October 1985, with a mean follow-up of approximately 17 months. Each patient received a smallpox booster injection followed one week later by the first of 13 weekly intradermal injections of 2.0 mg of VMO. At the end of 13 weeks, injections were given every other week for 12 months or until recurrence. Clinical results show that 25 of the 39 patients had no evidence of disease as of December 1986. Moreover and more importantly, statistical comparison of patients in this study with 39 matched controls shows a significant increase in disease-free survival for the patients treated with VMO. Serum obtained prior to treatment and at three-month intervals during treatment was tested in a Staphylococcus protein A rosette assay for reactivity with melanoma cell lines. All pretreatment samples (39/39) were negative, and 64% became positive by 12 months after appropriate dosage escalations. Moreover, enzyme-linked immunosorbent assay showed a positive correlation between antimelanoma IgG antibody titer and disease-free survival.(Arch Surg 1987;122:1460-1463)

Background:A phase III, randomized, double-blind, multi-institutional trial was performed evaluating active specific immunotherapy using vaccinia melanoma oncolysate (VMO) in the surgical adjuvant setting in patients with stage II melanoma (UICC staging). The first interim analysis showed no significant difference in disease-free and overall survival. The data were further analyzed to identify subsets of patients with improved outcome when treated with VMO.

Summary The Southeastern Cancer Study Group, in a prospectively randomized study involving patients with advanced breast cancer, has compared a low dose intermittently administered five-drug regimen including cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisone (CMFVP) with an aggressively administered three-drug regimen including cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF). CAF induced more responses and more complete responses and a longer duration of disease control. However, only a marginal difference was demonstrated in overall survival between the two regimens (p = <0.10).

Summary Between September 1976 and June 1982, 308 patients with operable breast cancer with 1–3 involved axillary nodes were stratified according to institution, type of mastectomy, and time from surgery to protocol entry, and then randomized to receive either six or 12 months of adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil (CMF). With a median time of follow-up of 33 months, relapse rates among 181 reviewed and evaluable patients are 20/85 (23.5%) for pre- and 23/96 (24%) for postmenopausal patients. Results for premenopausal women, while better than historical controls at a similar time interval, appear inferior to other published adjuvant studies (e.g., NSABP and Milan). Although total relapse rates were 23/100 (23%) for six months and 20/81 (25%) for 12 months of therapy, suggestive differences were encountered by menopausal status with early trends favoring 12 months of treatment for premenopausal patients and six months of treatment for postmenopausal patients. During this same period, 283 patients with four or more involved axillary nodes were randomized to 1–3 treatment arms: six months of CMF, six months of CMF preceded by local-regional x-ray therapy (XRT), or 12 months of CMF. The latter arm was closed in February 1980 while the two six-month chemotherapy arms remain open as of January 1983. Relapse rates for 174 reviewed and evaluable patients on the three arms include: 27/76 (36%) for six months CMF, 15/54 (28%) for XRT and CMF, and 24/44 (45%) for 12 months CMF. Local-regional relapse rates were 12/120 (10%) for the combined two non-XRT arms and 3/54 (6%) for the XRT treatment arm (p = 0.34). Thus, at this early stage of follow-up there are still no statistically significant differences between six or 12 months of adjuvant CMF therapy and neither definite beneficial nor detrimental effects of prechemotherapy adjuvant radiation therapy. Longer follow-up will be needed to provide definitive conclusions.

One hundred and ninety-two evaluable patients were treated on a multicenter protocol for adult acute lymphoid leukemia to determine in a prospective randomized fashion if late intensification chemotherapy beginning after about six months of treatment would improve remission duration and survival. The complete remission rate was 60%. The median remission duration from beginning of maintenance was 18.7 versus 25.9 months (P = 0.36) for standard maintenance therapy and late intensification, respectively, and the median survival from randomization was 25.8 versus 28.5 months (P = 0.94) respectively. There was a suggestion that the late intensification strategy was helpful with respect to remission duration, and this trend was sustained in long-term follow-up. However, relapse proved to be common during the earlier phases of treatment; thus, insufficient numbers of patients were available at the randomization point to conclusively address the possible value of late intensification. Intensive therapy earlier in the course of treatment should be evaluated, including transplantation in selected patients.