The Data Co-ordinating Center (DCC) for the Reduction in Mortality and Morbidity Among Hemodialysis Patients Pilot Study will coordinate the scientific and operational aspects of the Study. This study will evaluate the feasibility of carrying out a full-scale randomized clinical trial comparing one or more interventions to reduce the mortality and morbidity of hemodialysis patients. In the planning phase (Phase I), the DCC will design and develop the Pilot Study protocol in conjunction with the Steering Committee. Systems for data acquisition (via distributed data entry) and data management will be established. A major activity of the DCC will be the development of procedures for control of the quality of the data. A detailed manual of operations will be developed describing the data collection procedures and other procedures including forms for the Clinical Centers and the DCC. The randomization schedule for entering patients will be generated. The DCC will provide centralized training of Clinical Center staff in the areas of entry of study subjects, completion of study forms, and use of the distributed data entry system. The DCC will arrange meetings of the Steering Committee and participate in these meetings and report the proceedings. The database management system developed in Phase I will be used to assure accurate and complete collection of study data. A query system will be used to resolve data discrepancies. A major function of the DCC during the recruitment phase of the study will be to monitor patient recruitment and compliance as a whole and by Clinical Center. Study progress will be reported in monthly reports to the Clinical Centers, newsletters, and presentations at the Steering Committee, and External Advisory Committee meetings. Statistical analyses will be performed during the course of the study with final analyses completed and reported during Phase Ill of the study. These analyses will help in the design of the Full-Scale Study. The DCC will develop new statistical methodology as needed to properly analyze the data being collected. Since the Study is a multi-centered effort including several organizational components, the DCC will be proactive in performing its duties so that the goals of the study are met. The DCC will work to foster a spirit of cooperation which is important in this multi-center study.
