Study Type: Interventional
Study Design: Double Blind Randomized Controlled Trial
Initiator: Albert Dahan, MD, PhD, professor, Leiden University Medical Center
Official Title: Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery (BLISS3)
A lover of technology and a clinical epidemiologist, Bart Torensma (MSc, CRNA, PhD candidate) represents the young, enthusiastic, tech-savvy researchers. While a project manager at a hospital, tired of Microsoft Excel he sought out new technological solutions that could handle a 50-page eCRF (electronic Case Report Form). After using Castor EDC for the Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery (BLISS3) study, we spoke with Bart to learn more about his study.
The BLISS3 study occurred in 3 phases: the operating room, the postoperative recovery care unit and in the ward. In the operating room (OR), the data was collected live every 10 minutes from the surgeon, the hemodynamic-, respiratory- and the muscle relaxant values were measured . After the surgery, the patient number 1 was transferred to the postoperative care room, while the patient number 2 was brought into surgery. On a typical day, there would be between four and five patients. Using Castor enabled live and simultaneous data capture among three different hospital areas and team members.
For a patient to be included in the study it was very important that Bart work with his team to ensure that all data points were collected. If a data was not collected from the patient in the ward (the last phase), the patient would be excluded from the study. From anywhere in the world the study monitor can view and verify the data entered. This ensured that no patients were lost to follow-up, which would have extended the length of the study.
From start to finish the study took 8 months to complete and Bart’s team was able to publish their paper in just two months after the data collection phase finished. No easy feat, considering that this was a randomized, double blind, controlled trial taking place in three hospital units. 159 patients were included in the BLISS3 study and for each patient 367 variables were collected, over 58,000 unique data points.
Bart explained that when building a study in Castor, it becomes easier to visualize the structure and he used the manual to support the building of his study. He recommends using the repeated measures functionality, especially if data is collected longitudinally to save time. Bart also reduced the total study time by working on the data analysis ahead of time by preparing the script and syntax.
Collecting data requires focus and the operating room is a high-stress situation. Working with a colleague in the OR to collect data, Bart constructed the eCRF with built-in checks and validations to prompt data enterers. This allowed him to remain focused during surgery and feedback ensured high quality data was captured.
Creative methods were used to remind staff to complete data entry in the ward and Bart gave demonstrations to his team members. Transitioning to new methods is often met with hesitation and resistance to change, however Bart gave demonstrations of the system and showed that collecting data in a single system was easier and much more efficient for everyone. He also could call his team members to verify that the data entry was completed within the required time. If there was no data entered in the evening by 8:15 pm, Bart would check with his team and motivate them complete the data entry. This could be done from home later and didn’t require him to stay in the ward.
Read the BLISS3 publication here. And good luck completing your PhD, Bart!