PRECISION registry celebrates its 10th anniversary
The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation
(PRECISION Registry) is celebrating its 10th anniversary this year. The registry was
the vision of John Licciardone, DO, MS, MBA, Regents Professor and director of the
Osteopathic Research Center in the Texas College of Osteopathic Medicine at UNT Health
Fort Worth.
The Osteopathic Research Center completed several major initiatives back in 2016,
including training a national network of osteopathic clinical investigators and conducting
the largest randomized controlled trial of osteopathic manipulative treatment. The
trial demonstrated the efficacy of osteopathic manipulative treatment in patients
with chronic low back pain.
“It was time to move beyond our legacy research in osteopathic manipulative treatment
to study other aspects of chronic pain epidemiology and treatment more broadly,” Licciardone
said. “The Precision Medicine Initiative had been recently launched to move away from
a ‘one-size-fits-all’ approach to the provision of health care.”
Precision medicine considers various aspects of an individual’s health, including
genetics, environment, lifestyle and psychological factors. To emulate this approach
in chronic pain patients, the Osteopathic Research Center launched the PRECISION Registry
in 2016.
Registry patients were initially recruited locally and seen on campus at UNT Health,
where they provided clinical research data as well as saliva and blood samples to
study genetics and biomarkers pertaining to chronic pain. In addition to standard
measures, research instruments collected data on biopsychosocial aspects of pain and
its treatment.
“Once we established proof-of-concept, it was time to grow our registry throughout
Texas,” Licciardone said. “We adopted a hybrid model wherein patients could still
be seen locally but were also enrolled across the state using a digital research platform
with electronic data capture. Saliva samples were collected remotely via courier service.”
The registry expanded nationwide and transitioned to an exclusively remote research
model in 2020. Its complex research operation screens potential participants, administers
electronic informed consent, schedules patient encounters at quarterly intervals,
collects data using validated research instruments comprising 250 questions, compensates
patients using digital payments and follows them for 36 months.
Two randomized controlled trials of online eHealth interventions were conducted by
the registry when it expanded. The New England Journal of Medicine had previously
speculated that such “randomized registry trials” may be the next disruptive technology
in clinical research. Registry research is less expensive than traditional research
models, potentially enrolling large numbers of representative patients.
“The advantages of registry research were exhibited during the onset of the Covid
pandemic,” Licciardone said. “While other research operations and laboratories were
locked down, our registry had its highest monthly enrollment numbers by screening
patients remotely throughout the United States.”
The registry currently has data on more than 2,500 patients, including a repository
of genetic data on almost 1,000 patients and a biobank of over 500 biological samples.
About $6 million has been invested in the registry to date through a variety of sources,
including research grants and an endowment from the Osteopathic Heritage Foundation.
“Aside from conducting research, another fundamental reason for establishing the registry
was to have a means for training osteopathic medical students in clinical research
methodology,” Licciardone said.“More than 100 students at the Texas College of Osteopathic Medicine have co-authored
publications in high-impact journals using registry data.”
Students in the Osteopathic Research Center’s Summer Program in Clinical Research
and in the Texas College of Osteopathic Medicine’s Honors Research Practicum have
access to registry data to conduct research projects under Dr. Licciardone’s mentorship.
Student Doctor Naomi Fortier has published articles through both pathways.
“The PRECISION Registry has been a great tool to facilitate student research. Having
access to a lot of data allows students to see entire projects through to completion
without worrying about recruitment and retention of participants,” said Fortier. “I
particularly enjoyed being able to investigate the psychological and socioeconomic
factors that impact chronic lower back pain treatment because it encourages a holistic
approach to care.”
Student Doctor Trevor Ashby recently completed the Summer Program in Clinical Research
and is now working on a project to study the role of patient self-efficacy in predicting
future risk of undergoing lumbar spine surgery for chronic low back pain. The research
involves following a cohort of more than 1,400 registry patients for 36 months.
“The PRECISION Registry is critical to our ability to conduct meaningful research,”
Ashby said. “Because the registry follows patients longitudinally, we can investigate
clinically important questions that would be difficult to answer using cross-sectional
data alone, including identifying factors associated with long-term outcomes and progression
to more invasive treatments.”
The registry’s recruitment goal is 10,000 patients nationwide to enable a greater
number and variety of research questions to be answered. Consequently, artificial
intelligence promises to be an important aspect of registry research in the coming
years.
Subhash Aryal, PhD, is a professor at Johns Hopkins University and director of biostatistics
for the Osteopathic Research Center. He recently presented the annual Goldstein Lecture
sponsored by the Osteopathic Research Center and spoke about the rapid growth of artificial
intelligence and machine learning and their potential applications in pain research.
“The registry dataset has grown and now I see opportunities to apply these machine
learning methods to look at the data,” Aryal said. “The idea would be to determine
if these new algorithms allow us to better separate the signal from the noise, identify
patterns, and learn from the data.
“Our PRECISION Registry will always be a vehicle for research on risk factors and preventive methods for chronic pain, assessment of treatment options to promote better pain management, and training osteopathic medical students in clinical research,” Licciardone said. “Ultimately, our vision is a future for all unbounded by pain.”