Handling a Surgical Study with Repeated Observation Times

Challenge

While collecting repeated observations of animals using a standardize scale is not in itself a challenge, allowing access to only one scale at a time during the appropriate time frame to the correct individual is a challenge. For this particular study, up to three individuals could conduct the observations around the clock at specific intervals over a minimum of a 72-hour time-frame and were restricted to conducting observations at specific times. The scale needed on-demand functionality as well in case additional observation times were necessary. The clock for the observation period started running off the surgical start time, which also had to be incorporated into the solution. Additionally, if the score was above a certain threshold, the researcher had to be alerted that an alternate procedure (medication or treatment protocol) had to be followed and/or the animal had to be removed from the study.

Proposal

Prelude Dynamics proposed utilization of Prelude EDC, an electronic data collection system, to allow researchers to capture information in real-time, provide the standardized scales in a just-in-time manner, follow the natural work flow of the study process, and ease the data collection process. In order to restrict the scales to the appropriate individuals, form level permissions would be assigned to specific roles. Prelude EDC would be programmed to use custom calculations to automatically start the clock from the surgical start time entered and provide the correct dosing amount of any medications administered.

Background

It is a common study objective to understand how animals respond to a certain surgical procedure, anesthesia, or post-surgery medications. Researchers examine an animal’s response at specific time intervals over a period of time to reach this understanding. When this time period extends over multiple days, it is necessary to utilize multiple observers to complete standardized scales.

When the data is collected on paper, it is difficult to blind current observers from information completed on forms by a previous observer. Access to previously entered information can bias the current observer, regardless of whether he or she collected the prior observation or it was collected by someone else. Reducing bias is important to obtaining reliable information.

Solution

Prelude staff trained the study staff to utilize Prelude EDC to show and provide access to only one scale at a time, restricting access to the individual with the appropriate permission at the designated time. Prelude EDC was programmed to start running the time clock off the entered surgical start time. Permissions were assigned to roles that corresponded with access to particular scale forms as indicated in the study protocol. Some scales could only be filled out by a certain role while others had multiple roles that could fill them out. Once a scale was filled in, reviewed and approval given, that scale became inaccessible or hidden and the next scale became accessible. Based on the initial entered surgical start time, each scale displayed the expected date and time that scale needed to be filled in.

As a standard, Prelude EDC collects full audit trail information on each data point entered into the system, including who entered the information and a date and time stamp. It also allows data entry fields to be augmented with comments or notes, which is an important feature if additional information needs to be added that might otherwise be limited to a selection of choices.

Prelude EDC also contains pre-existing summaries which assist in monitoring the data being collected at the patient level, at each site or for the study as a whole. Using Prelude EDC’s search and filter capacity allows these summaries to display data of only the cases fitting the search criteria. Additionally, Prelude EDC provides users with certain permissions the ability to create ad-hoc reports which they can use for monitoring additional criteria or in order to answer important research questions. The data within the system is available for export 24/7/365 with the appropriate user permission. Export features the ability to export in multiple formats including SAS-ready format.

Results & Benefits

Real-time data is being entered into Prelude EDC, standardized scales are being filled in and signed off on, then the completed form is no longer accessible to the individuals completing forms. Using Prelude EDC eliminates observer bias since current observers cannot view or compare findings entered by a prior observer. There are certain roles designated by the Sponsor to maintain read-only access to view all the scales at any time.

Scale scores are immediately calculated and feedback automatically provided if scores indicate necessity for removal from the study or other treatment. This identifies potential problems quickly and reduces the risk to the participating animal.

Prelude EDC also identifies these animals quickly so they can be taken out of the study and prevent further costs associated with tracking an ineligible subject. Additionally, when an animal is removed from the study, the Prelude EDC Randomization module, which is behind the scenes, will reassign the withdrawn animal’s treatment to a new case to ensure that sufficient cases are enrolled for each treatment group.

The need for data collection on paper CRF has been eliminated. Researchers spend less time entering data after the fact because they are able to enter information directly into the system in real-time. There is also a cost savings and error reduction by eliminating data entry at a later date.

Data is accessible in real time for query, review, analysis and export. Users report the streamlining of the process has helped reduce errors and improved efficiency