Lessons Learned about Clinical Data Registries

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The specialty of otolaryngology is committing increasing resources toward cultivating large clinical datasets. The promise of using “big data” to revolutionize healthcare has captivated the minds of clinicians, researchers, and myriad other stakeholders. During the past five years, a group of cochlear implant surgeons and audiologists have been methodically collecting clinical data surrounding cochlear implant care. Our experience with this database has highlighted important pearls—both inspiring and cautionary—that can hopefully inform future data science efforts within otolaryngology. A few of these pearls are highlighted below.

What Is a Registry?

A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition. There are many types of clinical data registries. For example, some registries are very focused and contain information about specific diseases, conditions, or interventions. Other registries recruit patients with broad health conditions that can later be used to address a specific disease. Registries can also be used in multiple ways, including clinical research, quality improvement, cost effectiveness, policy making, or government-mandated quality reporting. Each type of registry has specific considerations that should be weighed before embarking on data collection. Some of these considerations include:

• What is the purpose of data collection?
• How will the data be collected?
• Who is going to benefit from the registry data?
• Who will pay to build and maintain the registry?
• Is the financial model sustainable?
• Who will be able to access the data?

The value that can be derived from a specific registry will largely depend on the answers to the above questions. Our experience with cochlear implant data collection has taught us that the devil is truly in the details. Proper planning can make the difference between powerful clinical insights and frustrating failure. The following lessons are just a few of the insights we have learned.

Lesson 1: There Is Power in Numbers

Otolaryngology is a diverse and creative specialty with dozens of hyperspecialized areas of clinical interest. While this makes for a fascinating career, it also means that generating studies with large sample sizes can be challenging. In a world where everything (clinical practice, policy, etc.) depends on good data, the curse of small, single-institution studies can threaten progress for niche areas of otolaryngology. This is certainly true with cochlear implants. By combining data from multiple institutions, we have been able to investigate clinical scenarios with statistical power that has previously not been possible.

For example, one group recently utilized our database to explore how cochlear implant testing conditions (i.e., using backgrounds of noise versus quiet) influence patient selection and outcomes. By combining data from many institutions, this study evaluated the experience of more than 2,000 patients. Additionally, the data used in this study came from real-world clinical practices. Without such a registry, data from these community-based practices would likely never be found in research studies.