The future of surgical research: the role of the American College of Surgeons Oncology Group.

The American College of Surgeons Oncology Group (ACOSOG) was established in 1997; it is funded by the National Cancer Institute (NCI) and American College of Surgeons (ACS) for the purpose of conducting multicenter phases II and III clinical trials in the field of surgical oncology. After eight years, ACOSOG has successfully completed seven trials and has five studies currently open to accrual for patients with brain, breast, gastrointestinal, head and neck, and lung cancers. The history of randomized controlled trials in surgery and the structure and function of ACOSOG are discussed. ACOSOG is establishing an extensive specimen bank for current and future correlative science studies, providing unique educational opportunities for surgeons in clinical research, and pursuing collaborative relationships in order to conduct trials with private industries. Also, ACOSOG has expanded its membership to include international sites, which contribute to the success of ACOSOG studies and enhance the portfolio of future protocols. The participation of general surgeons and surgical oncologists in clinical trials is essential to the improvement of treatment options for cancer patients.

Influence of panel-reactive antibodies on posttransplant outcomes in lung transplant recipients.

BACKGROUND: Panel-reactive antibody (PRA) is used to estimate the degree of humoral sensitization in the recipient before transplantation. Although pretransplant sensitization is associated with increased complications in other solid organ transplant recipients, less is known about the outcome of sensitized lung transplant recipients. Therefore, we sought to determine the impact of elevated pretransplant PRA on clinical outcomes after lung transplantation. METHODS: The records of the first 200 lung transplant operations performed at Duke University Medical Center were reviewed. The outcomes of sensitized patients, PRA greater than 10% before transplantation (n = 18), were compared with the outcomes of nonsensitized patients. RESULTS: Sensitized patients experienced a significantly greater number of median ventilator days posttransplant (9 +/- 8) as compared with nonsensitized recipients (1 +/- 11; p = 0.0008). There were no significant differences between the number of episodes of acute rejection; however, there was a significantly increased incidence of bronchiolitis obliterans syndrome occurring in untreated sensitized recipients (56%) versus nonsensitized (23%; p = 0.044). In addition, there was a trend towards decreased survival in the sensitized recipients, with a 2-year survival of 58% in sensitized recipients as compared with 73% in the nonsensitized patients (p = 0.31). CONCLUSIONS: Sensitized lung transplant recipients experience more acute and chronic complications after transplantation. These patients probably warrant alternative management strategies.

Mini-circuit cardiopulmonary bypass with vacuum assisted venous drainage: feasibility of an asanguineous prime in the neonate.

Conventional cardiopulmonary bypass (CPB) in neonates results in increased transfusion requirements and hemodilution. There has been little advancement in CPB for the neonatal population. There is evidence that increased priming volumes and blood product transfusion enhances inflammatory response to CPB and increases myocardial and pulmonary dysfunction. We have devised a miniaturized CPB circuit that utilizes vacuum-assisted venous drainage (VAVD) in an effort to decrease priming volume and avoid transfusion requirements. The purpose of this study was to evaluate the safety and efficacy of this miniaturized CPB system and determine the feasibility of an asanguineous prime. Ten 1-week-old piglets were randomized to five mini- and five conventional CPB pump circuits. Subjects were supported with CPB at 100 ml/kg/min, cooled to 28 degrees C, exposed to 10 min aortic crossclamp with cardioplegic arrest, rewarmed to 37 degrees C, weaned from bypass, and subjected to modified-ultrafiltration (MUF) for approximately 10 min. This method was chosen to simulate a situation with all the elements of clinical CPB. Blood transfusion trigger was a hematocrit <15 on CPB. Serum samples were obtained pre-CPB, at 15 min of CPB onset, immediately post-CPB completion, and immediately post-MUF. Indices of hemolysis (SGOT, LDH), production of inflammatory mediators (interleukin (IL)-8, tumor necrosis factor-alpha (TNFalpha)), and physiologic parameters of inflammation were measured. The overall blood requirement was significantly less in the mini-circuit compared to conventional CPB (47.0+/-5.8 ml vs 314.2+/-31.6 ml; p < 0.0001). The only significant blood requirement in the mini-circuit was to replace the volume removed for samples. During the study, mean arterial pressure (MAP) (p = 0.004), static pulmonary compliance (p = 0.04), platelets (p = 0.0003), and white blood cells (p = 0.003) significantly decreased across the groups. Lung water content (p = 0.02), TNFalpha levels (p = 0.05), and SGOT (p = 0.009) increased significantly during the study, across the groups. Among all parameters tested, except for blood requirement and hematocrit post-CPB, there were no significant differences between the two circuits. VAVD makes asanguineous prime in neonates feasible. When used in this study to miniaturize a conventional-CPB circuit, VAVD with a reconfigured neonatal CPB console and circuit resulted in no detrimental effects, and allowed for markedly decreased priming volumes and blood transfusion requirements.

Patient satisfaction in the ambulatory setting. Influence of data collection methods and sociodemographic factors.

To evaluate the impact of patient characteristics and method of data collection on satisfaction results used for the comparison of practice locations, questionnaires were distributed to 1,208 adult outpatients at five medicine clinics, either on-site or by mail. Patient dissatisfaction with three service domains was measured: communication with the provider, courtesy of the office staff, and timeliness of care. Practice location, survey methodology, and patient characteristics were significant predictors of dissatisfaction, and adjustment for the latter two factors affected the rankings of practices by dissatisfaction rates for all three domains. Further study of the impact of patient characteristics and method of data collection should be conducted before the comparison of unadjusted satisfaction results becomes the accepted standard.