Krister Kristianson, PhD. EDC Scandinavia AB, Stockholm
In a recent study involving several hundreds patients, we decided to offer patients the ability to collect their diary data using their own smartphones instead of the traditional paper diary. The patients who decided to participate in the study downloaded the app to their smartphone or could use their desktop to access the application.
The apps were developed for iPhones and Androids with a reminder function that notified them when to report their symptoms. The data was then transferred to OpenClinica using the RESTful web services immediately upon entry. The patients ID and pin code were tested before data was added to the database to avoid any illegitimate entries.
About 80% of the patients decided to use the electronic diary – 65% using iPhones and 35% using various Android devices. They could also download the app to iPads or other tablets and if they preferred, they could use the application on desktops.
Outcomes:
Of the patients who used the traditional method of reporting diary data on paper, 2.5 times more patients failed to report at scheduled time points compared to the patients using the app.- The app recorded the date and time automatically. When using paper, you can never be sure that the diary has not been completed at the time listed.
- The addition of simple edit checks mitigated data entry errors, greatly contributing to the increased quality of the data.
- It further reduced the manpower needed to manually enter data on to the eCRF and enabled us to monitor the patients in real-time and contact them if anything went wrong.
Although the patient population was relatively young, in this part of the world, even elderly patients are likely to use smartphones or desktops and would to be willing to use electronic data capture (EDC) for reporting diary data. The easy configuration of web services in OpenClinica and the ability to query data upon arrival made it an easy task to set up and validate the study.