The Role of the Clinical Research Coordinator in Multicenter Clinical Trials

The clinical research coordinator plays a crucial role in organizing a site's participation in the expanding arena of multicenter medical and pharmacologic clinical trials. This summary clarifies the role of the clinical research coordinator for inexperienced staff members assuming these responsibilities and outlines planning procedures leading to successful implementation. Emphasis is placed on establishing an interdependent relationship with the principal investigator, careful protocol assessment, team building, and staff feedback. Useful tools such as study manuals and physicians' study orders are described.     

Complement Activation and Cytokine Generation After Modified Fontan Procedure

Background. The modified Fontan procedure separates the systemic and pulmonary circulations in patients born with a functional single ventricle. Delayed recovery is frequently observed after this procedure. It was our hypothesis that complement activation or cytokine generation may contribute to the pathophysiology of this problem.

Methods. We measured activated complement C3, thromboxane B₂, interleukin-6, and tumor necrosis factor- levels by immunoassay in 16 patients undergoing Fontan procedure. Patient plasma samples were obtained preoperatively, on initiation of cardiopulmonary bypass, after administration of protamine, and 1, 4, 8, and 24 hours postoperatively.

Results. There was no early or late mortality in this cohort of patients. Low cardiac output developed in 3 of 16 patients, and pleural effusions developed in 5. The median length of hospital stay was 9 days. Activated complement C3 levels increased from a baseline of 1,486 ± 564 to 4,600 ± 454 ng/mL after cardiopulmonary bypass and administration of protamine, and returned to baseline by 24 hours. The level of interleukin-6 increased from 42 ± 32 to 176 ± 22 pg/mL and at 24 hours remained elevated at 71 ± 15 pg/mL. Neither thromboxane B₂ nor tumor necrosis factor- levels increased significantly.

Conclusions. The data demonstrate threefold to fourfold increases in activated complement C3 and interleukin-6, indicating that both humoral and cellular systems are affected. It is our conclusion that complement and cytokine activation may contribute to the delayed recovery observed after Fontan procedure.     

Rural Hospital Inpatient Surgical Volume: Cutting-edge Service or Operating on the Margin?

Surgical services are an important part of modern health care, but providing them to isolated rural citizens is especially difficult. Public policy initiatives could influence the supply, training, and distribution of surgeons, much as they have for rural primary care providers. However, so little is known about the proper distribution of surgeons, their contribution to rural health care, and the safety of rural surgery that policy cannot be shaped with confidence. This study examined the volume and complexity of inpatient surgery in rural Washington state as a first step toward a better understanding of the current status of rural surgical services. Information about rural surgical providers was obtained through telephone interviews with administrators at Washington's 42 rural hospitals. The Washington State Department of Health's Commission Hospital Abstract Recording System (CHARS) data provided a count of the annual surgical admissions at rural hospitals. Diagnosis-related group (DRG) weights were used to measure complexity of rural surgical cases. Surgical volume varied greatly among hospitals, even among those with a similar mix of surgical providers. Many hospitals provided a limited set of basic surgical services, while some performed more complex procedures. None of these rural hospitals could be considered high volume when compared to volumes at Seattle hospitals or to research reference criteria that have assessed volume-outcome relationships for surgical procedures. Several hospitals had very low volumes for some complex procedures, raising a question about the safety of performing them. The leaders of small rural hospitals must recognize not only the fiscal and service benefits of surgical services--and these are considerable--but also the potentially adverse effect of low surgical volume on patient outcomes. Policies that encourage the proper training and distribution of surgeons, the retention of basic rural surgical services, and the rational regionalization of complex surgery are likely to enhance the convenience and safety of surgery for rural citizens.