Translational Science Highlight
- A community-based research evaluation model of consultation services is helping to translate clinical practice observations into research-supported treatment approaches.
For many clinicians, it can be difficult to gather the research data needed to determine how effective a treatment will be for a patient. Ensuring that observations from clinical practice can lead to better therapies is a translational science priority that NCATS seeks to support through its Clinical and Translational Science Awards (CTSA) Program.
Licensed massage therapist (LMT) Diane Mastnardo has demonstrated how challenging this effort in translation can be. She was certain that massage therapy helped her clients by relieving pain, increasing joint flexibility, improving balance and posture and speeding recovery from injuries. Yet medical providers — citing a lack of scientific evidence demonstrating health benefits of massage — often were reluctant to refer their patients to LMTs for therapy. Mastnardo had hit a translational barrier: She needed data about massage therapy, but she couldn’t collect the information without research training or access to resources to carry out a study that could generate the data.
Mastnardo’s situation wasn’t unique. Many community members want to play an active role in research, even undertaking studies themselves. At the same time, investigators supported through the CTSA Program value the role of community participation as they design and conduct studies. They often seek out opportunities to collaborate with community members, patients and clinicians to help guide research that can lead to new treatments to improve health.
These mutual needs and the resulting partnerships are the foundation of community-based research (CBR), which differs from traditional biomedical research approaches. Rather than focusing research on the community, CBR is carried out with the community.
“CTSA Program-supported investigators have implemented a broad range of CBR initiatives to encourage dialogue about health concerns and clinical research,” said Pamela McInnes, D.D.S., M.Sc.(Dent.), NCATS deputy director and the Center’s acting director of the Division of Clinical Innovation. “They often partner with organizations to learn about local health needs, foster mutual trust and provide information about and access to clinical trials.”
Evaluating the Consultation Services’ Impact on CBR
Since 2004, the Center for Reducing Health Disparities of the Clinical & Translational Science Collaborative (CTSC) of Cleveland, based at Case Western Reserve University, has provided a consultation service for academic and community researchers to help them with CBR projects. The consultation team is a multidisciplinary group of experts with diverse academic, medical, research and cultural backgrounds. The consultants help anyone with an interest in CBR, including biomedical researchers, students and trainees but also entities beyond traditional academic research, such as community organizations, health care providers and individuals who, like Mastnardo, want to conduct a study.
Over the years, the CTSC consulting team has advised clients on a wide array of research-related challenges, including research project design, survey development, regulatory matters, recruitment strategies, translation services and focus group design. The CTSC recently evaluated the effectiveness of these consultation services and reported the results in the Journal of Clinical and Translational Science.
Evaluating the impact of consultation services on community engagement and CBR is challenging. “Tracking parameters such as numbers of clients and types of assistance provided is pretty straightforward,” said Clara Pelfrey, Ph.D., director of evaluation for the CTSC. “Discerning trends and obtaining long-term data on the outcomes of research projects is more difficult.”
Those are key reasons why few, if any, such evaluations have been reported — until now.
Pelfrey spoke with consultation service staff in 2014 about capturing data on CBR activities and developing a process to evaluate the service’s effectiveness. First, Pelfrey and the CBR consultants delineated the steps involved in consultation and project completion, resulting in a Stages of Engagement framework. Next, more than 10 years of data were imported into REDCap, a CTSA Program-supported application that helps users capture data, generate reports and detect trends. The evaluation team then developed several survey instruments and interviewed some former clients to fill information gaps and learn about the outcomes of research projects.
Clients from five universities and three hospitals, as well as 14 community members or organizations, requested consultations between January 2011 and July 2015. These clients benefited from the expert knowledge, community connections and project guidance provided by the consultation service team, increasing the likelihood of study completion and achievement of research goals.
The Making of a Citizen-Scientist
Mastnardo’s first encounter with the CBR team happened at a community event that brought together local people and CTSC researchers to foster CBR. There she met Katrice Cain, M.A., program development manager for the Center for Reducing Health Disparities, which is supported through the CTSC Community Research Partnership Core.
“Diane was interested in learning about incorporating research into her massage practice to collect evidence for medical professionals and insurers to give their patients access to therapeutic massage services,” Cain said.
Cain connected Mastnardo to the CBR consultation service and introduced her to Ashwini Sehgal, M.D., co-director of CTSC’s Community Research Partnership Core and a nephrologist with the MetroHealth System, where he treats patients whose kidneys have failed. Sehgal wanted to find a way to alleviate muscle cramps experienced by many patients undergoing dialysis. Unfortunately, when cramps occur, dialysis must stop, depriving patients of the procedure’s full therapeutic benefit. Sehgal wondered whether massage therapy could relieve the cramps, allowing dialysis to proceed.
Sehgal suggested a collaborative pilot study with Mastnardo and other LMTs to see whether massage might help relieve the muscle cramping associated with dialysis. The CBR consultation service helped Mastnardo make the leap from LMT to clinical researcher.
“Through the CBR consultation service, I was able to access research training; learn about study design, regulations and bioethics; and receive grant-writing assistance,” Mastnardo said. “I also was inspired to set up the Massage Northern Ohio Practice-Based Research Network (MNOPBRN), which now has 90 registered LMT members.”
With the support of the core and the consultation service, Mastnardo and her colleagues developed a pilot study and received a grant through CTSC’s Practice-Based Research Network.
“The CBR consultation service helped us frame the research question, develop a stepwise approach to creating a research plan, set up study sites and prepare for protocol review by the institutional review board,” Mastnardo explained.
MNOPBRN partnered with community dialysis centers to conduct a small randomized controlled trial. Research participants who received massages reported fewer cramping episodes during and between dialysis sessions. The results were presented at professional meetings and published in the International Journal of Therapeutic Massage & Bodywork.
In November 2017, at the North American Primary Care Research Group conference in Montreal, Mastnardo presented a poster on perceptions of and barriers to massage therapy. “To build on our momentum, we hope to identify funding sources and collaborators for larger studies on the health outcomes massage therapy affects: pain, stress and anxiety,” she said.
Mastnardo credits her research success to the CBR consultation service and CTSC’s support. “The consult service provides a wealth of resources and expertise,” she said. “Whenever I hit an impasse, the consultants came up with solutions.”
“Her story demonstrates how community members can become productive researchers,” Pelfrey added. “In fact, she is now a contributing member on the CBR consultation service and brings a fresh viewpoint as a true citizen-scientist.”
Posted December 2017