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N C C A M Research Blog

When To Get Pragmatic

January 02, 2014
Josephine P. Briggs, M.D.
Josephine P. Briggs, M.D.

Director
National Center for Complementary and Alternative Medicine

View Dr. Briggs' biographical sketch

“Pragmatic trials” are the new buzz in clinical research. I want to spend this post talking a bit about why—and the reasons for NCCAM’s particular interest in this topic.

Many complementary approaches are readily available in the marketplace. As a consequence, NCCAM sits at the crossroads between research and real-world consumer use. The general public wants to know what works and what doesn’t, and increasingly health care providers also want reliable information. Complementary health approaches are being integrated into the care offered in many nursing homes, hospices, and hospitals, and these health care organizations want good information to drive decisions about which therapies to provide or recommend. NCCAM wants to take on the challenge of meeting this need, but by and large we do not have the kind of rigorous, high-quality data that would help answer these questions.

This unique situation has made us aware of the importance of better methods to do real-world, or pragmatic, research. Driven by this interest, we volunteered about 2 years ago to take on a major administrative and leadership role in an NIH Common Fund initiative called the Health Care Systems Research Collaboratory. This program is engaging health care delivery organizations as research partners, with the goal of building methods to conduct rigorous large-scale clinical trials in real-world settings. Through the Collaboratory, NIH is pioneering the development of approaches to conduct large-scale, cost-effective clinical research studies in the settings where patients already receive their care.

The focus of this activity is pragmatic trials. What makes a pragmatic trial, well … pragmatic? Pragmatic trials, sometimes called effectiveness trials, test an intervention, or compare several interventions, delivered under conditions as close to the “real world” as possible. In contrast, efficacy studies typically test interventions under ideal conditions, with very close monitoring.

The interventions tested in a pragmatic trial should not require a complex structure for implementation. The study design should incorporate rigorous controls, prospectively identified and preferably randomized. The monitoring and outcome assessment should be as simple as possible and potentially use electronic health records. And finally, the research question to be answered should be important—to patients, payers, and health care delivery systems.

Two of the Collaboratory studies will address pain management. The LIRE study, a partnership with the National Institute of Arthritis and Musculoskeletal and Skin Diseases and a number of Health Maintenance Organizations, looks at the impact of more detailed radiology reports for back pain imaging studies on subsequent use of resources. The second partnership, a study called PPACT, which involves a number of Kaiser health systems, with oversight from the National Institute on Drug Abuse and the National Institute of Neurological Disorders and Stroke, will examine the impact of an integrated pain management strategy implemented in primary care practices.

This type of research represents a paradigm shift in clinical research. These trials are rigorous randomized studies, but performed in real-world settings with the practical goal of testing the effectiveness of practical approaches. We at NCCAM, like our colleagues at many other NIH Institutes and Centers, are eagerly watching the progress of the Collaboratory projects, not only because of our involvement, but because we hope the lessons being learned will help us and our grantees move clinical research forward.

Comments

Comments are now closed for this post.

Thanks for sharing, Dr. Briggs.As for the PPACT study, what “integrated pain management” strategies are being utilized and studied?Toward our good health and wellbeing…all the best, John

The more information we record about our lifestyles, medical and alternative treatments, and outcomes in digital medical records, the more opportunity we’ll have to find interventions that work.It will be a new paradigm for health research, but one that will reap huge dividends.

Thank you for this update on complementary medical research.  The concept of pragmatic trials, as you describe it, seems the perfect solution to inform patients and clinicians in order that they may make the best choices between the many alternative and complementary options available.

@John Russo - The integrated pain management strategy that will be used in the Pain Program for Active Coping and Training (PPACT)  is a primary care-based intervention involving the integration of physical therapy and behavioral health. For more information, please see the ClinicalTrials.gov description of PPACT at http://clinicaltrials.gov/show/NCT01888146.

Forgive me for not having full knowledge in this field, but I’m trying to learn. You state that efficacy studies, which are a step in traditional clinical trials, are undertaken in ideal conditions, with strict monitoring. I assume your trials have strict monitoring also in order to draw clear results, so I come to wonder about the one distinction you have made between research practices - ideal conditions. In my limited understanding drug trial patients receive the tested treatment and then go about their lives in as normal a fashion as their illness will allow. I don’t believe they live in labs like study rats. Can you please clarify what you mean by real world? 

Thank you for the insight about pragmatic trials Dr. Briggs. I was wondering how they compare to clinical trials, and how many patients tested with either procedure will be relevant enough to change the paradigm of practicing alternative medicine over traditional alopathic medicine. Are there any statistics that need to be acomplished in order to proove a particular alternative medicine effectiveness?

While I think the studies mentioned above deserve their funding, how are they either complementary or alternative medicine?  Just like nutrition and exercise, they seem to fall right into standard medical care, whereas the usual CAM (acupuncture, chiropracty, homeopathy / placebo, chi, etc.) fail all well-designed trials as well as lacking scientific and common sense.

I am glad to see a distinction made between what happens in a very controlled enviornment and what happens in the general pubic. This type of information will aide providers and the public in ways that make sense.