Patient-centered registries offer efficient, effective infrastructure for real world evidence generation to guide clinical practice and device assessment.
FORCE-TJR merges patient-generated data with administrative and clinical data to serve clinical and policy evaluations of devices, surgical practice, and timing and use of orthopedic interventions. For example, we have established the infrastructure for collection and review of clinical records and radiologic studies. In addition, the University of Massachusetts Medical School has new facilities to support gait evaluations and collection and storage of biological samples. Ancillary research is ongoing using each of these resources with patients from select FORCE sites. Together with patient-reported data, these refined clinical information allow FORCE to support randomized clinical trials, prospective device surveillance studies, and translational research.
Our methods assure consistent measurement of key risk factors before, during, and after treatment to support precision medicine and outcome prediction analyses. FORCE practices engage patients to assure patient values and outcome assessments are included in analyses and to monitor long-term patient outcomes- beyond data captured in any one healthcare system electronic record or payer database.
FORCE illustrates Learning Healthcare System Principles
FORCE-TJR was highlighted in a discussion paper ‘Clinician Engagement for Continuous Learning’ published by the National Academy of Medicine, as an example of learning healthcare system. At the conclusion of the original cohort in late 2015, FORCE-TJR and its methods (patient enrollment, reporting, and benchmarking system) opened to all US surgeons through enrollment into FORCE Quality Improvement. QI FORCE supports the ongoing shared data for comparative effectiveness and outcomes research while simultaneously providing point of care information, periodic risk-adjusted, comparative outcome reports, and data to support success in the bundled payment environment. Interested hospitals and physicians, including those participating in the new CMS value-based payment models for TJR, are joining. Pre-operative and post-surgical data collection follows the same timeline and metrics of the initial FORCE cohort. The risk-adjusted outcome data returned to member sites foster quality improvement activities and allow clinical systems to anticipate outcomes to be reported on CMS public sites (e.g., hospitalcompare.gov) and in value payment programs. In addition, participation meets maintenance of certification requirements of the American Board of Orthopedic Surgeons. Thus, the FORCE system is one model for implementing the learning healthcare system.
LPlatt R, Blake K, Franklin PD, Gaziano M, Hernandez Adrian, Kaushai R, Masica A, NevinJ, Rumsfeld J, Hamilton Lopez M. “Clinician Engagement for Continuous Learning” Perspectives – Expert Voices in Health & Health Care. National Academy of Medicine. Accessed 3/7/2017 at https://nam.edu/wp-content/uploads/2017/03/Clinician-Engagement-for-Continuous-Learning.pdf
Framework for Patient-reported data capture; Lessons learned
As the value of measuring and collecting patient reported outcomes is consistently recognized, lessons learned from the FORCE-TJR experience, in particular, served to guide a much needed framework to PRO implementation. The proposed PRO implementation model stemmed from a recent workshop including experts from various background, who analyzed how PROs are valuable to different stakeholders (i.e., clinicians, hospital leaders, insurers, and researchers), as well as optimal timing, measures selection, costs, and other considerations.
Franklin PD, Chenok KE, Lavallee D, et al. Framework to Guide the Collection and Use of Patient-Reported Outcomes in the Learning Healthcare System (Accepted eGEMS).
Lavallee D, Chenok K, Love R, et al. Incorporating Patient-Reported Outcomes in Healthcare to Engage Patients and Enhance Care. Health Aff (Millwood). 2016 Apr 1;35(4):575-82. doi: 10.1377/hlthaff.2015.1362
Defining an international outcome measure set for Total Joint Replacement
FORCE leaders chaired (Franklin) and participated (Ayers) in the international consensus panel to define an outcome measure set to support international outcomes research. Of note, the FORCE measure set parallels the final recommendation assuring that FORCE data will contribute to future international comparison efforts.
Rolfson O, Wissig S, van Maasakkers L, et al. Defining an International Standard Set of Outcomes Measures for Patients with Hip or Knee Osteoarthritis: Consensus of the International Consortium of Health Outcome Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res (Hoboken). 2016 Feb 16. doi: 10.1002/acr.22868. PMID: 26881821
Development and implementation of web reporting system to return data to surgeons
FORCE-TJR provides quarterly reports to enrolled surgeons that include summaries of their patients outcomes and national benchmarks to improve care and decision-making. Lessons learned from the development and implementation of this web reporting are depicted in a couple of publications.
Zheng H, Rosal M, Li W, Ayers DC, Franklin PD. Evaluation of user interface and content design of a decision support tool for patients with advanced knee arthritis considering total joint replacement. (Manuscript submitted)
Zheng H, Li W, Harrold L, Ayers DC, et al. Web-Based Comparative Patient-Reported Outcome Feedback to Support Quality Improvement and Comparative Effectiveness Research in Total Joint Replacement. eGEMs (Generating Evidence & Methods to improve patient outcomes). 2014(2);Iss. 1, Article 21. doi: http://dx.doi.org/10.13063/2327-9214.1130. Available at: http://repository.academyhealth.org/egems/vol2/iss1/21
Patient-reported adverse events improve postdischarge surveillance
Reinforcing the value of patient-reported outcomes, including adverse events within the FORCE-TJR cohort, we reported that almost one-third of patients sought care from facilities others than the hospital where the TJR occurred. We were able to confirm the validity of the self-reports, which improved postdischarge surveillance and decreased missing data.
Harrold L, Pascal S, Lewis C, et al. Patient Report Improves Posthospital Discharge Event Capture in Total Joint Replacement: A Novel Approach to Capturing All Posthospital Event Data. eGEMS (Generating Evidence & Methods to improve patient outcomes). 2014 Oct 22;2(1):1107. doi: 10.13063/2327-9214.1107. Available at: http://repository.edm-forum.org/egems/vol2/iss1/13/