S06: Conducting Research in Integrative Medicine Clinical Practices: Lessons Learned and Future Directions

Donald Abrams1, Ruth Wolever2,Jeffery Dusek3, Elad Schiff4

1University of California San Francisco, USA; 2Duke Integrative Medicine, USA; 3Penny George Institute for Health and Healing; Center for Healthcare Innovation, Allina Hospital and Clinics, USA; 4Bnai Zion Medical Center, Israel

 

Practice-based research and patient-reported outcome measures will be key factors in demonstrating the effectiveness of integrative medicine interventions in the treatment of a wide variety of conditions. Multicenter participation provides adequate numbers of participants and allows for generalizability of results. Concentrating on patient-reported outcome measures recognizes the importance of the participant’s subjective experience of their IM treatment and the potential for integrative interventions to impact on many different health outcomes. Patient-reported outcome measures are also less expensive to collect than biomedical endpoints when resources are limited. BraveNet is a practice-based research network (PBRN) based in nine diverse IM clinics across the United States that launched its first study in 2008.  Introducing research culture, methodology and tools into clinical practices oriented towards providing patient-centered, multimodality, personalized care was the initial challenge. The first study undertaken was a cross-sectional Registry of information on 4200 patients seeking care at the sites. Data was collected by participants completing a paper questionnaire. Practitioners were only required to provide the patient’s diagnoses at the corresponding clinic visit. Data was entered directly into the central database at the coordinating center by way of a secure website.  Identifying appropriate staff to consent participants, retrieval of questionnaires and engaging clinic practitioners to complete forms in a correct and timely manner were some of the challenges encountered.  Next, the network chose to investigate the effectiveness of an IM intervention for patients with chronic pain, introducing longitudinal prospective follow-up and two laboratory determinations to the network’s clinical trial repertoire. Challenges included the inability to settle on a “standardized” integrative pain intervention and patient retention over time. As the pilot suggests benefit of the intervention, the next challenge involves the selection of a control and perhaps mandating a standardized intervention in a follow-on trial. Building on the Registry and SIMTAP, a pilot Data Repository project collects longitudinal data on clinic patients prospectively to ascertain which conditions respond best to IM interventions. In this effort, the 29-question PROMIS questionnaire has been embedded into an on-line REDCap survey. StatusScope data collection software developed in the integrative surgery department at Ben Zion Medical Center in Israel has been used for the past two years to collect quantitative outcomes and qualitative data on tablet devices. The system is easy to use by patients as well as research-naïve practitioners and could be a valuable tool for capturing data in integrative medicine clinical practices.