Buy vs. Build?
Buy - Ironically, capturing data can be one of the more challenging aspects of an outcomes collection study. It is important to offer sites data collection options that meet their needs in order to collect patient- and surgeon-reported data. Just as an engineer cannot successfully complete a task by using only one tool from the toolbox, a multitude of components is necessary to create a successful data collection strategy. Today’s data capture software systems can accommodate in-office, web-based data entry, wireless patient data entry, paper data capture and palm or tablet-based data entry. Many systems also offer the ability to capture radiographic images or forward patient follow-up directly to patients via email or paper. Some data collection platforms are also be equipped with a batch entry portal that allows mass amounts of data to be entered in minutes, for pennies per page. Typically, batch data entry can be performed by the site’s research staff or a third-party company.
Due to the variances in healthcare delivery systems, each site requires different support tools to become successful. Since these technology companies provide broad distribution and scale, many of these tools are very affordable and can dramatically improve the success of a study. In addition to potential cost savings, having a non-biased group responsible for all data capture and analysis is beneficial. This can be advantageous when enrolling surgeons who might be concerned about submitting data directly to a device company. It is also common for the data collection vendor to secure any necessary licensing for the use of proprietary forms, such as the SF-12v2™ or similar standardized instruments, which can save the device company time and money.
Build – Building a data capture system in-house can be achieved, but is expensive and requires staff to maintain software. One common challenge is that years into the study, when it is time to update case report forms or security features, or when a law such as the recently enacted HITECH Act impacts data collection efforts, system updates can be quite time consuming and costly. This challenge can be compounded if the staff that created the database is no longer employed at the device company. Another consideration is the willingness of a surgeon to participate in data capture, knowing that all data he collects will be available to the device company. As mentioned earlier, the more data collection options available to the surgeon sites, the more likely the study will be a success. Adding multiple data collection modalities to a homegrown data base can present challenges of its own.
What Data Should We Capture, and How Will It Be Used?
Most data collection efforts are designed to meet the interests of various stakeholders. Before the study begins, it is vital to envision how the data will be used both throughout the study and upon study completion. Today, most data collection technologies allow for real-time report generation. With web-based mobile technology, various stakeholders can generate many different reports to meet their needs anywhere, anytime. For example, Exhibit 1 shows outcomes scores from the Knee Society survey, one of many possible outcomes measurements captured in a Knee Arthroplasty study.
Exhibit 1: Knee Society Scores as seen in a Knee Arthroplasty Outcomes Report