Treasure trove of data: How starting a trauma registry can boost OMT research

When examined together, the collective records from a group of patients can give physicians a bigger-picture view of treatment outcomes and pave the way for research studies that may ultimately lead to better patient care.

Adrienne McCallister, DO, used patient registries to research the effects of osteopathic manipulative treatment (OMT) on patients with traumatic brain injury (TBI). A patient registry is a roster of information collected on a group of patients, typically those who have the same illness, so their outcomes can be monitored for research or quality control.

Dr. McCallister’s registry enabled to her develop a case report, recently published in The Journal of the American Osteopathic Association, that reviewed two patients with TBI who received OMT. Dr. McCallister found that the use of OMT improved somatic dysfunction for both patients. Following a case report, the next step is a retrospective analysis, which would also use a patient registry.

“Unlike a case study that uses one or two patient cases to review an interesting outcome, a cohort retrospective trial is a research style looking at a group of patients for a given outcome and would be the next step to help answer a research question after you observe an outcome in a case study,” Dr. McCallister says.

Dr. McCallister’s JAOA case report also included a section offering guidance on what to include in a patient registry and tips for using the data in research.

Key data to include

If your hospital does not already maintain a registry, Dr. McCallister says even something simple like keeping a journal to jot down patient data can help physicians track a diagnosis.

“There are ways to code data so what is made public is not identifiable. Research documents should always be kept on a secure computer or in locked drawers, as there has to be one document linking a patient’s name to their codified identification,” Dr. McCallister says.

All research needs to go through an institutional review board in order to make sure these HIPAA protections are in place, she adds.

Whether you DIY or use a formal registry, here are three key data points Dr. McCallister recommends tracking.

• Patient characteristics in the registry should include demographics, injury patterns and severity of injury. This information helps distinguish cohorts and develop appropriate case matches.
• Note what OMT styles or techniques you performed, where on the body you used OMT and any complications from treatment to enable future reproducibility of a study. “Even if an open treatment protocol is used instead of a specific treatment protocol, you should document what styles or techniques were used to allow for meaningful future meta-analyses,” Dr. McCallister says.
• Record patient outcomes, such as length of hospital stay and where the patient went following discharge (i.e., home, rehabilitation facility).

Analyzing trauma registry results

“A trauma registry can be a way to gather subjects for a cohort retrospective trial as a registry gathers together patients based on different variables of interest. Once you have a group of patients, you would investigate that data to try to answer your research question,” Dr. McCallister says.

Here are three tips to keep in mind when combing through trauma registry data.

• Include at least 30 patients per cohort, the case report authors recommend.
• Focus on blunt-trauma patients. Other types of trauma injuries, such as penetrating, occur less frequently and have characteristics different from blunt-trauma injuries.
• When forming patient groups, data used for matching should not be statistically different between cohorts. Once the cohorts are matched, outcomes can be compared based on whether OMT was used, the case report authors say.