Dusek Jeffery A, Abrams Donald I, Roberts Rhonda, Griffin Kristen H, Trebesch Desiree, Dolor Rowena J, Wolever Ruth Q, McKee M Diane, Kligler Benjamin
Integrative Health Research Center, Penny George Institute for Health and Healing, Allina Health, 2925 Chicago Avenue South, Mail Route 10039, Minneapolis, MN, 55407-1321, USA.
Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, USA.
BMC Complement Altern Med. 2016 Feb 4;16:53. doi: 10.1186/s12906-016-1025-0.
Integrative medicine (IM) provides patient-centered care and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person's health. IM is a "whole systems" approach that employs multiple modalities as opposed to an isolated complementary therapy. Thus, studying outcomes of IM is more challenging than evaluating an isolated intervention. Practice-based research networks (PBRNs) allow for clinicians/investigators at multiple diverse sites using common methodology to pool their data, increase participant sample size and increase generalizability of results. To conduct real-world, practice-based research, the Bravewell Collaborative founded BraveNet in 2007 as the first national integrative medicine PBRN.
Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) is a prospective, non-randomized, observational evaluation conducted at fourteen clinical sites. Participants receive a non-standardized, personalized, multimodal IM approach for various medical conditions. Using the REDCap electronic platform, an anticipated 10,000 study participants will complete patient-reported outcome measures including Patient Reported Outcomes Measurement Information System (PROMIS)-29, Perceived Stress Scale-4, and the Patient Activation Measure at baseline, 2, 4, 6, 12, 18 and 24 months. Extractions from participants' electronic health records include IM services received, as well as ICD diagnostic codes, and CPT billing codes associated with each IM visit. Repeated-measures analyses will be performed on data to assess change from baseline through 24 months with planned subgroup analyses to include specific clinical population and specific IM intervention or combinations.
As the PRIMIER registry grows, we anticipate that our results would provide an indication of the promise of PBRN research efforts in IM. Analyses will incorporate a large sample of participants and an expected 10-year observation period and will provide the ability to evaluate the effect of IM on outcomes for specific clinical populations and specific IM interventions or combinations. As such, PRIMIER will serve as a national platform for future evaluations of IM best practices.
Clinical Trials.gov NCT01754038.
整合医学（IM）提供以患者为中心的护理，并应对影响个人健康的全方位身体、情感、心理、社会、精神和环境因素。整合医学是一种“全系统”方法，采用多种方式，而非单一的补充疗法。因此，研究整合医学的结果比评估单一干预措施更具挑战性。基于实践的研究网络（PBRN）允许多个不同地点的临床医生/研究人员使用共同方法汇总数据，增加参与者样本量并提高结果的普遍性。为了开展基于现实世界实践的研究，Bravewell协作组织于2007年创立了BraveNet，作为首个全国性整合医学PBRN。
接受整合医学有效性登记（PRIMIER）的患者是在14个临床地点进行的一项前瞻性、非随机观察性评估。参与者针对各种医疗状况接受非标准化、个性化、多模式的整合医学方法。使用REDCap电子平台，预计10000名研究参与者将在基线、2、4、6、12、18和24个月完成患者报告的结局测量，包括患者报告结局测量信息系统（PROMIS）-2九项量表、感知压力量表-4以及患者激活量表。从参与者电子健康记录中提取的数据包括接受的整合医学服务，以及与每次整合医学就诊相关的国际疾病分类（ICD）诊断代码和现行程序编码（CPT）计费代码。将对数据进行重复测量分析，以评估从基线到24个月的变化，并计划进行亚组分析，以纳入特定临床人群以及特定的整合医学干预措施或组合。
随着PRIMIER登记的发展，我们预计我们的结果将表明PBRN在整合医学研究方面的努力前景。分析将纳入大量参与者样本以及预计为期10年的观察期，并将能够评估整合医学对特定临床人群以及特定整合医学干预措施或组合的结局的影响。因此，PRIMIER将作为未来评估整合医学最佳实践的全国性平台。
ClinicalTrials.gov NCT01754038
