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A new study published in Lancet Rheumatology reports the results from a multinational database study on knee replacement. The largest study of its kind to date, it assessed data from over 250,000 individuals in the US and UK who had undergone either partial (unicompartmental) or total knee replacement to compare the clinical outcomes for patients. Partial knee replacements were shown to reduce the risk of complications after surgery, in particular venous thromboembolism, and a reduction in the use of potent painkillers (opioids), possibly indicating a reduced risk of persistent pain after surgery. Total knee replacement was however associated with a lower risk of revision procedures.
The study builds on the Total or Partial Knee Arthroplasty Trial (TOPKAT), led by researchers at the University of Oxford, which found that after 5 years, partial knee replacement showed similar, if not better, outcomes than total replacement. This new study explored whether those results translate into effectiveness in real-world settings and investigated safety outcomes that were too rare to study in detail in TOPKAT due to fewer patient numbers.
Researchers belonging to the global Observational Health Data Sciences and Informatics (OHDSI) network, and the IMI European Health Data & Evidence Network (EHDEN), came together with in Oxford in December 2018 to plan and perform the study. The analyses were designed and conducted in a week-long "study-a-thon". This collaborative endeavour was facilitated by the use of previously mapped real-world data and the availability of previously validated analytical tools.
"We brought together experts with knowledge of the data sources, methodological approaches, or the clinical area," said Ed Burn, Research Associate in real world health economics at NDORMS at the University of Oxford, and one of the joint first authors of the paper, "with the application of a common data model and open-source tools allowing us to quickly design a robust study and run it on both primary care data from the UK and insurance claims data from the US."
Professor Daniel Prieto-Alhambra, one of the senior authors of the paper, is a workpackage lead of the European Health Data & Evidence Network (EHDEN), an EU Innovative Medicines Initiative (IMI2) project. "EHDEN will stimulate the further development of the research ecosystem that this study utilised in Europe," explained Professor Prieto-Alhambra. "By doing so, EHDEN will increase our ability to generate reliable, reproducible and top-quality evidence from real-world data in Europe and globally."
"This is exactly what EHDEN is setting out to do in terms of good quality evidence that informs clinical practice across many domains, but importantly it also demonstrates the efficacy of our collaboration with OHDSI," said Associate Professor Rijnbeek, Academic Coordinator of EHDEN.
The findings of this study will help to inform shared decision making for individuals eligible for knee replacement surgery, and the approach used for this study provides a template for future analyses of real-world data.
