Expansion of Longitudinal Study of Cardiac Defribrilators in Selected Populations (ICD)

THIS NOTICE IS FOR INFORMATION PURPOSES ONLY. THIS IS NOT A SOLICIATION FOR PROPOSALS.

DESCRIPTION OF SERVICES REQUIRED:
The purpose of this task order is to do a power analysis of the benefit of increasing the sample size for selected populations in the "Longitudinal Studies of Implantable Cardiac Defibrillators (ICD)" project and produce a report on the rate of appropriate and inappropriate shocks in the selected populations.

This task order is divided into two phases. In Phase one the baseline data will be analyzed to determine whether there are enough patients available at the sites so that the project will have adequate power for the two strata of interest. The contractor shall submit a report on the power of the study, including information on the actual rates of shocks from patients already enrolled.

An optional Phase may be exercised if it is determined that there are enough patients to continue. In the second phase, the contractor shall produce 3 reports on the rate of appropriate and inappropriate shocks in the additional cohort of patients identified in the first part.

IDENTIFICATION OF THE EXCEPTION TO FAIR OPPORTUNITY:
The task order was issued on a sole-source basis to Harvard Pilgrim Healthcare in the interest of economy and efficiency because it is a logical augmentation of an existing study. The existing task order under the DEcIDE 1 Network entitled "Logitudinal Studies of Implantable Cardiac Defribrillators" has met its proposed precision goal for the estimates in Stratum I, however, due to the characteristics of the patient population at the study sites being different from the original projection, the number of patients in Stratum II and Stratum III are not sufficient to accurately estimate the rates of ICD therapies in these clinical groups. This task order will improve the precision of current parameters' estimates on rates of ICD therapies in the two strata of interest by analyzing data on a greater number of patients. It is therefore most logical to issue this task order as a sole source directly to Harvard Pilgrim Healthcare.