Implementing a prospective study in the system begins just as it would with any electronically managed study, with a thorough examination of the protocol in question. All study outcomes must be identified, as well as whatever supplemental information is necessary to ensure the integrity of the dataset. A study to analyze the effect of an eye drop on progression of geographic atrophy in patients with age-related macular degeneration (AMD) was recently implemented in our system. The main factors being followed are visual acuity, area of geographic atrophy, drusen area, contrast sensitivity, microperimetry, progression of AMD, and drug safety. To collect some of the data, we added the visual acuity, contrast sensitivity, and various other factors to the study-specific screen as described earlier
(Fig. 3) . As this screen was a more recent implementation, we now realized that a new field was needed to establish the presence of a natural lens, to address the need for the pertinent negative. In the past, we had just added the system-wide field, which has an assumed negative rather than an active one. Links were established between the new field and the system-wide field to synchronize the data sets so that the data would be available as part of the overall database for retrospective studies. Because most other data were being collected by a reading center, no additional fields were required with the exception of a field to record which eye had been selected for treatment.
Special screens were built to collect information on protocol compliance (drug accountability) and to screen for adverse events (telephone), and links to those screens were added to the study-specific screen, along with links to study-management screens such as the visit schedule, imaging tracking, termination form, and adverse event form. A study-specific medical history form also had to be created for the pertinent negative and for the management needs of the coordinating center. Links between this screen and the general medical history screens were established so that the data would be available as part of the overall system. Design of these study screens is an iterative process, with interim reviews by both physicians and the coordinating center to check for missing data points, management tools, and compatibility with the coordinating center’s system. Data transfer forms were built by using Impromptu to present the data in the format needed for transfer to the coordinating center. Because of amendments to the protocol and requirements of the coordinating center’s electronic system, small changes had to be made to the screens and data transfer forms along the way, but the ease of customizing the NG EMR makes this a simple process.