Diabetic autonomic neuropathy—part I: Autonomic nervous system data analysis by a computerized central unit in a multicenter trial

Abstract

To determine the feasibility of utilizing a central, computerized unit to analyze autonomic nervous system function tests for a 10-year, multicenter, clinical trial, the Autonomic Nervous System Reading Center was established. The Reading Center selected and standardized testing methods, designed the testing protocol, developed testing equipment, computerized data analysis, and instituted measures to monitor data quality. Three cardiovascular testing methods, RR-variation, Valsalva maneuver, and postural testing, were selected because each is a simple, non-invasive, quantitative, sensitive, and reproducible test. Furthermore, a hierarchy of sensitivity has been established with these cardiovascular autonomic nervous system measurements: RR-variation, Valsalva maneuver, and finally postural testing. Confounding variables were minimized by prescribing eligibility criteria. Testing equipment, designed to record time between RR intervals in a form easily read into a computer, has been in 21 clinics for three years and a total of 54 technicians have been trained. Over 85 percent of the autonomic nervous system tests performed have been usable at initial testing. A central reading center is an efficient and necessary means of collecting and analyzing data for a multicenter clinical trial.