F Jenio [1], C Scholes [2], M Marenah [1], J Li [1], M Cowley [2], M Ebrahimi [2], M Harrison-Brown [2], W Murrell [1]. [1] Emirates Integra Medical and Surgical ...
Quality in Practice: Implementation of a Clinical Outcomes Registry in Regenerative Medicine F Jenio [1], C Scholes [2], M Marenah [1], J Li [1], M Cowley [2], M Ebrahimi [2], M Harrison-Brown [2], W Murrell [1] [1] Emirates Integra Medical and Surgical Centre Dubai, United Arab Emirates [2] EBM Analytics, Sydney, Australia
Background A clinical outcomes registry is an organised system for collecting patient The secondary objective of the registry was to use clinical data to record the outcomes and clinical measures as data points relevant to assess the effect of efficacy and safety of approved biological and interventional in order to treatments on pathology or injury. The registry can be used to improve agility improve their performance and direct future improvements in patient care. of care and increase localized specificity to a clinic. Data extracted from patient outcome registries can be used to optimize healthcare value by providing insight into methods for providing care at a lower cost [1] or removing ineffective treatments [2].
Evaluation The registry has completed its implementation phase and is now in a pilot period to confirm data collection processes and user feedback. Initial findings indicate suboptimal data entry compliance in key areas that were rectified by refining data fields, reimaging within existing operating systems, and linkage to external supporting documents.
The feedback provided through registry data can additionally aid in the development of shared baselines (guidelines) for physicians utilizing specific treatments [3]. Many existing registries provide useful evidence about patient outcomes for various treatments, but lack specificity to the clinic’s population [4] and treatment strategies [5]. Implementation of a clinical outcomes registry is associated with challenges such as: costs, coordination amongst multiple practitioners and clinic staff, and managing various cell mediated treatment strategies [6].
Local Problem The clinic lacked an efficient system to incorporate treatment and process feedback into the facility’s patient flow and treatment plans. The primary purpose of implementing the clinical outcomes registry was to objectively assess, analyze, and maximize patient-centered outcomes for surgical and non-surgical management of spine, knee, hip, shoulder and upper limb, and foot and ankle musculoskeletal disorders amongst the patient population. Figure 1: Interaction between limitations overall and local challenges.
Detailed descriptions of each person’s role within the registry documentation process were provided, in-depth training and fine tuning for clinicians, nursing staff, clinical support, admin staff, and the registry support team, and real-world testing was crucial for the success of the final implementation step.
Lessons Learned Implementation Process The first stage of building the registry included the drafting of the design; therefore, registry designers worked extensively with the registry owner to establish the scope and scale of the registry. Figure 2: Overview of implementation process.
The key impacts of the registry implementation have been to i) redefine criteria for treatment success and failure within the area of biologic treatments in musculoskeletal practice, ii) instigate discussion, and document standardised treatment pathways, clinical handover processes and shared decision-making with patients and iii) act as a catalyst to target deficiencies in staff knowledge and skills in the areas of patient management and interaction, clinical documentation and administration processes.
References [1] Jain, N. B., Kuye, I., Higgins, L. D., & Warner, J. J. P. (2013). Surgeon volume is associated with cost and variation in surgical treatment of proximal humeral fractures. Clinical Orthopaedics and Related Research, 471(2), 655–664. [2] Chiauzzi, E., Rodarte, C., & DasMahapatra, P. (2015). Patient-centered activity monitoring in the self-management of chronic health conditions. BMC Medicine, 13, 77.
When developing the scientific rationale for the registry, registry designers needed to know identify the what clinician wanted to know about their treatments so preliminary work was conducted to connect the registry with the current orthobiologics literature and design observational study methods that accurately allow for the purpose to be fulfilled through the uniform data.
[3] James, B.C., & Savvitz, L.A. (2011). How Intermountain trimmeed healthcare costs through robust quality improvement efforts. Health Affairs, 30(6), 1185-1191. [4] Allen, K. D., E. J. Kasarskis, R. S. Bedlack, M. P. Rozear, J. C. Morgenlander, A. Sabet, L. Sams, et al. 2008. “The National Registry of Veterans with Amyotrophic Lateral Sclerosis.” Neuroepidemiology 30 (3): 180–90. [5] Lecluse, L. L. A., L. Naldi, R. S. Stern, and P. I. Spuls. 2009. “National Registries of Systemic Treatment for Psoriasis and the European ‘Psonet’ Initiative.” Dermatology 218 (4): 347–56. [6] Giklich, R.E., Dreyer, N.A., & Leavy, M.B. (Eds).). (2014). Registries for Evaluating Patient OUtcomes: A User’s Guide.
In designing the registry, informed consent, data protection, marketing practices, and the credentials of Investigators were emphasized.
Rockville (MD): Agency for Healthcare Research and Quality (US).
