An informatics strategy to assure enrollment criteria compliance in studies of the critically ill.

Up to 18% of acutely ill patients randomized into multicenter clinical trials may not satisfy inclusion/exclusion criteria. To improve compliance with such criteria in an ICU-based multicenter international drug trial, we established a novel Internet/telephone-based strategy for providing rapid case approval or disapproval by centralized panels of critical care physicians. We assessed whether these panels could acquire and record accurate patient information, and whether this approach would minimize enrollment of ineligible patients and could be accomplished in a timely fashion. Analysis of the first 1000 submitted patients showed accurate data capture for 98.7% of enrolled and randomized patients. Median response time from case submission to panel member decision was 34.7 min. Over 99% of enrolled patients met critical study criteria. We conclude that, an Internet-based communications strategy appears to be a valuable adjunct to multicenter clinical trials in acutely ill patients when rapid assurance of eligibility is required.

Tracheobronchial adenoid cystic carcinoma: a clinicopathologic study of 14 cases.

STUDY OBJECTIVES: To investigate the clinicopathologic features of primary tracheobronchial adenoid cystic carcinoma (ACC), and to examine kit protein (CD117) expression, and a possible correlation between the histologic grade and Ki-67 positivity. DESIGN: Retrospective 10-year study (from 1992 to 2001). SETTING: Referral center for interventional pulmonology. PATIENTS: Fourteen patients referred to our institution for laser resection of tracheal or endobronchial tumors. INTERVENTIONS: Twelve patients were treated primarily by laser resection via bronchoscopy with subsequent radiation therapy. The remaining two patients had tracheal resection with postoperative radiation and radiation therapy alone. RESULTS: Fourteen patients (5 men and 9 women) had an average age of 44 years at diagnosis (age range, 29 to 57 years). Five of 14 patients were smokers (average smoking history, 28.5 pack-years), 8 were nonsmokers, and the smoking history was unknown in 1 patient. Major symptoms at presentation included cough (57.1%), dyspnea (71.4%), and hoarseness (14.3%). Two patients (14.3%) presented with respiratory failure. Eleven patients (78.6%) had one or more recurrences, and 4 patients (28.6%) had metastases, primarily to the lungs. The average time to either recurrence or metastasis was 4.6 years after the initial diagnosis. Five patients (35.7%), all of whom had recurrences and/or metastasis during the course of their disease, died of their disease (average time, 8.2 years). Thirteen of 13 cases stained for CD117 were positive in the tumor cell cytoplasm with membranous accentuation. Our cases included 8 grade I tumors, 4 grade II tumors, and 2 grade III tumors, which did not correlate with the degree of Ki-67 positivity. CONCLUSIONS: Tracheobronchial ACCs in our study were more common in women and nonsmokers who presented with nonspecific respiratory symptoms and followed a clinical course generally comparable to that of tumors in the salivary glands. CD117 expression was present in all cases tested, and Ki-67 stain results did not correlate with the tumor grade.