The Randomized Registry Trial: Two Birds, One Stone

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Excerpt

Because healthcare in the United States has become more value-based, patients, providers, and other stakeholders urgently need more high-quality clinical evidence. 1 Such evidence can inform clinical decisions, guide healthcare policies, evaluate care quality, and, ultimately, provide and assess value. Randomized clinical trials (RCTs) represent a criterion standard for evidence because of their ability to remove systematic biases and enhance insights into causality. Their complexity, need for scale, difficulties in patient and provider accrual, and immense costs, however, hamper their performance and completion.
To overcome some of the challenges facing RCTs, trialists have recently begun to seek other ways to attain evidence. One such strategy is to leverage the abundance of clinical registries as data platforms for clinical trials. The registry-based randomized trial, or randomized registry trial (RRT), aims to approach the statistical rigor of randomization, whereas expediting and enhancing patient enrollment, minimizing cost, and addressing the generalizability of findings (Table 1). 2–5
The first published RRT was conducted in Sweden. 3 In less than 3 years, 7244 patients across 3 countries in more than 30 sites were randomized. The trial was estimated to have costed only $50 per patient. 2,3,5 The first RRT in the United States was the Study of Access Site for Enhancement of Percutaneous Coronary Intervention (SAFE-PCI) for Women Trial, 2,6 conducted with the National Institutes of Health National Cardiovascular Data Registry CathPCI Registry platform. 7 In this pragmatic, open-label trial, women were randomized to percutaneous coronary intervention via radial versus femoral access to compare postprocedure bleeding. Using the registry, high-volume hospitals with physicians proficient at both radial and femoral access were identified and recruited. The trial reached 99.2% accrual in only 22 months. 6 Registry data were copied into each participant's electronic trial case report and supplemented with trial-specific data by each site's trial coordinator, reducing the coordinator's workload by approximately 65%. 6 Registry abstractors and site trial coordinators collaborated closely. The registry abstractors accelerated their workflow to ensure timely collection of data for patient safety monitoring. An independent Data and Safety Monitoring Committee reviewed data on a quarterly basis, and all participating sites received approval by their respective institutional review boards.
Significant investments have been made in the development of and participation in registries—and their use has expanded. 8 In surgery, registries focused on quality improvement, such as the American College of Surgeons’ National Surgical Quality Improvement Program (ACS NSQIP), have been developed to evaluate and improve surgical care and outcomes. In addition, research using these registry data has made considerable contributions to clinical practice and health policy. Finally, registries are now playing an increasingly important role in value-based healthcare. The Quality Payment Program of the Medicare Access and CHIP Reauthorization Act relies on Qualified Clinical Data Registries to track the quality of care provided and adjust reimbursement. 9
Recently, the ACS NSQIP and the Americas Hepato-Pancreato-Biliary Association (AHPBA) have designed an RRT for surgical care. As one of the first RRTs in surgery, it aims to test a quality improvement intervention using the ACS NSQIP. Patients undergoing pancreatoduodenectomy at participating centers are randomized to receive 1 of 2 widely available antibiotics as surgical antimicrobial prophylaxis, and then the ACS NSQIP tracks their outcomes to determine which regimen reduces surgical site infections more effectively. 10 This relevant yet unanswered clinical question has garnered broad engagement by the surgical community who performs these procedures. Importantly, there is equipoise. In setting up the trial, we have learned a number of important lessons using this novel trial design that are worth sharing.
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