Researchers in the field of orthotics and prosthetics face a unique set of challenges in planning, recruiting and conducting clinical trials. Along with practitioners, technicians, educators, administrators and industry representatives, researchers are a vital component of the field and their work enables the other components to succeed.
To help O&P professional navigate these challenges, O&P News has launched Research Trials in O&P. The new section is intended to help researchers recruit O&P patients to participate in research or clinical trials, as well as to provide O&P practitioners with a resource to find trials for their participation and patients.
“Recruitment of research subjects is a significant problem and a constant struggle,” Steven A. Gard, PhD, executive director of the Northwestern University Prosthetics-Orthotics Center, director of Jesse Brown Veterans Affairs Medical Center Motion Analysis Research Laboratory and associate professor in the Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, told O&P News.
Gard said the studies he works with typically include 10 to 15 participants and are conducted during a 2-year to 3-year period.
“This generally represents the minimum number of subjects required to demonstrate statistically significant differences in outcome measures,” Gard said. “Ideally, our studies would be considered much stronger if we were able to include 30 to 50 subjects, but this number probably is not feasible due to the cost of conducting research and issues with recruitment.”
How practitioners can help
Mark D. Geil, PhD, of Georgia State University, wrote in his Editor’s Comments in the July 2016 issue Journal of Prosthetics and Orthotics (JPO), “It is vital that clinicians work closely with researchers, not only in generating ideas for studies and analyzing results but also during subject recruitment. Those largest studies in JPO were conducted by clinicians, so many of the barriers to recruitment and testing were likely removed. For researchers doing their work outside of a clinical setting, clinical cooperation is essential.”
According to Gard, practitioners can help recruitment efforts in a few different ways. Practitioners can distribute fliers provided by researchers to help recruit patients. They can also suggest research projects.
“Researchers in the prosthetics and orthotics field should be in regular communication with practitioners and rely on their input to help drive research direction,” Gard said.
Practitioners also can join a research team. While Gard acknowledged this is a time commitment, he said, “When planned in advance, we can usually budget in a practitioner’s time on our grant proposals and compensate them for their involvement.”
Gard said research benefits practitioners and patients, as study findings can aid practitioners in making clinical decisions and help provide evidence for reimbursement claims.
“When we present evidence based on 10 subjects, we all understand that for O&P that is a good number. But outsiders who might be reviewing the rigor of the evidence on a certain subject, and therefore making funding decisions, might be accustomed to seeing sample sizes in the hundreds or thousands. I am not suggesting we need numbers that large, but increasing sample sizes would typically help our cause,” Geil told O&P News.
Practitioners should pay attention to inclusion and exclusion criteria when recruiting patients, and should be on the lookout for patients who recognize the value of research, Gard said.
“Sometimes we ask our subjects to wear different [prosthetic or orthotic] devices that they may not like or perform different activities without much explanation, and I think it helps tremendously when the subjects feel that they are helping to advance both research and clinical care,” he said.
Practitioners and researchers should build a strong relationship in order to help each study succeed and each patient have a positive outcome.
“I think researchers and practitioners need to develop a certain trust in which researchers respect and recognize the importance of the care being provided by the practitioner, and the practitioner values research and is willing to help move the field forward by encouraging participation by their clients,” Gard said. – by Amanda Alexander and Kristine Houck
- Geil MD. Journal of Prosthetics and Orthotics. 2016;doi:10.1097/JPO.0000000000000100.
- For more information:
- Visit OandPNews.com/Research for the ongoing list of clinical and research trials.
Disclosures: Gard and Geil reports no relevant financial disclosures.