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The Promise of PROMIS: Practitioners Help Build the Functional Medicine Evidence Base

In an effort to continue building the Functional Medicine evidence base, one of IFM’s long-term strategic goals is to catalyze and facilitate research into the effectiveness, as well as the cost-effectiveness, of the Functional Medicine (FM) model. One of the barriers to this work has always been the nature of Functional Medicine itself: a whole-person, systems biology-based model does not lend itself well to study in randomized controlled trials (RCTs), in which only single interventions are under study. The impact of Functional Medicine is much more measurable by evaluating outcomes following whole suites of interventions that encompass the entire model. Until recently, that type of research had little traction within the medical establishment.

One way to systematically examine the effectiveness of a whole suite of interventions together is to rely on patient-reported outcomes, or PROs, as the dependent variable. These measures, self-reported by patients as opposed to being measured by lab test or assessed by trained clinicians, were formerly seen as “soft” and perhaps unreliable, yet recent changes in this perception have brought PROs to the forefront of interest in clinical research. No lesser organizations than the FDA and the NIH are now accepting these measures as important sources of evidence in the pursuit of patient wellness, particularly in patients with multiple chronic conditions where single condition-specific outcomes are less relevant. This change provides entrée for Functional Medicine to prove its worth in mainstream clinical studies and also creates an unprecedented opportunity for Functional Medicine clinicians to actively participate in research demonstrating the effectiveness of the FM model.

The rise of PROs makes it much easier for individual practitioners to contribute to the research base by participating in practice-based research networks that collect data on patient outcomes and pool that data across numerous clinical practices to allow sufficient power to show statistically significant and clinically meaningful effects. Put another way, one clinician working alone collecting PRO data may have a hard time seeing a large enough number of patients with the same condition to show a statistically significant effect on patient outcomes, but many practices working separately (but contemporaneously) are much more likely to have numbers adequate to show an effect.

One such practice network was established last year by IFM collaborating partner LivingMatrix, a cloud-based patient information management system that incorporates interactive versions of IFM’s clinical tools. In August 2018, LivingMatrix added PROMIS-10, a patient-reported outcomes measure, to their interface, allowing clinicians to enter these data into a database that can be used to track outcomes over time. PROMIS-10 is a brief, 10-item questionnaire within the NIH-validated PROMIS (Patient-Reported Outcomes Measurement Information System) suite of PROs that measures patient outcomes by examining mental and physical health as well as quality of life. Also used by Cleveland Clinic Center for Functional Medicine, this simplified PRO form serves both as an incredibly useful clinical tool and an instrument for collecting research data. Instead of adding an onerous extra step in patient intake, PROMIS-10 actually simplifies patient tracking and provides great insight into patient progress for both the patient and the clinician.

We’ve taken a tool that is primarily used for research and made it both clinician and patient friendly. It not only supports the collection of research data; clinicians are actually using it to communicate with patients, set expectations, and engage and motivate them.” – Priya Kamani, MD, on the PROMIS-10 feature included in LivingMatrix

IFM, along with collaborating partners LivingMatrix and researchers at the University of Maryland School of Medicine, are currently conducting a descriptive study including de-identified PROMIS-10 data collected through LivingMatrix. This initial study will define the typical characteristics of Functional Medicine patients, including the most prevalent symptoms and diagnoses as well as the treatments prescribed. In addition to this descriptive study, the collaborating partners plan to examine how patients’ self-reported outcomes change after Functional Medicine treatment in a subsequent study.

Unlike conventional RCTs that require limitations of clinical care, practice-based research networks featuring patient-reported outcomes (PROs) can blend seamlessly into clinical practice. LivingMatrix is setting the stage for a practice-based research network with the potential to produce outcomes data that will provide rigorous evidence of the effectiveness of the Functional Medicine model.” – Chris D’Adamo, PhD, Director of Research, Center for Integrative Medicine, University of Maryland School of Medicine

This new research opportunity promises to help build the published evidence base demonstrating Functional Medicine’s effectiveness at a time when the Functional Medicine model is experiencing unprecedented growth, and with it, increased scrutiny. Currently over 415 Functional Medicine practices have contributed PROMIS-10 data through LivingMatrix, with 7,400 patients having submitted at least one global health form. The more data that are collected, the better, for many reasons, including improving the chances of demonstrating statistically significant effects on patient outcomes.

It’s hard to overstate the importance of collecting this research evidence and outcomes data for the Functional Medicine ecosystem. Luckily, this type of research is a participatory enterprise, and any Functional Medicine provider can help. Unlike a classic RCT or other single-intervention research study that requires participants to adopt a strictly defined treatment protocol for a given condition, this real-world research model instead provides a way to easily collect data in the flow of what Functional Medicine clinicians are already doing.

It is now well accepted that real world data translates to real world evidence. This is truly ‘real world research,’ and IFM can help bring this new research model to the fore as the future of clinical medicine.” – Robert Luby, MD, IFM Executive Director of Medical Education

IFM will continue to provide information on this exciting research and the opportunity for every Functional Medicine clinician to help build the Functional Medicine evidence base. To find out more about LivingMatrix and how you can play a role, visit livingmatrix.com or contact Dr. Priya Kamani (priya@livingmatrix.com).

 

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