Registries as a Knowledge-Development Tool: The Experience of Sweden and England

© 2013, The Urban Institute Health Policy Center • www.healthpolicycenter.org page 1 Registries as a Knowledge-Development Tool: The Experience of Sweden and England July 2013 Bradford H. Gray, Ph.D. INTRODUCTION A series of articles by Barry Meier in the New York Times since 2010 told the story of a medical disaster—a rapidly growing number of failures of artificial hips that had been implanted in a surgical procedure called arthroplasty. The initial article reported that a particular artificial hip—the Articular Surface Replacement or ASR—that had been introduced in the early 2000s as a breakthrough in design and that was supposed to last 15 years or more was being recalled by the DePuy Orthopaedics subsidiary of Johnson & Johnson, because of a high rate of failure.1 Failure was indicated by severe pain, soft tissue and bone destruction, the need for repeat surgery, and, in some cases, long-term disability. The ball and cup that comprised the device were both metal, unlike earlier ceramic devices. In a subsequent article, Meier reported that an estimated 500,000 patients in the United States had received an all-metal replacement hip and that the Food and Drug Administration had received 5,000 complaints about metal-on-metal hips in the first six months of 2011.2 This was believed to be a substantial undercount of serious problems because only manufacturers, not doctors or hospitals, are required to file reports of device failures, and manufacturers may not know when one of their devices has been replaced. The financial and legal consequences of these events are currently playing out, including investigations into when the maker of the ASR became aware of their high failure rates.3 What has gained less attention is the fact that research bodies in several other countries, including Sweden, England, and Australia, identified the danger of these devices before they were brought to light in the United States.4,5 They were enabled to do so by their use of registries – databases for tracking the long-term health trajectory of patients with a certain condition or who have received a particular treatment.6 In the case of the ASR, data from registries sounded early alarms in several countries, forestalling untold expense and patient suffering. About 250,000 hip replacement operations are performed in the United States each year using devices made by multiple manufacturers, but there is no source of information about rates of complications and repeat surgery either with particular devices or in total. REGISTERS AS TOOLS FOR IMPROVING CARE The Agency for Healthcare Research and Quality’s user’s guide for patient registries defines a registry as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specific outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.”7 By following patients over time and place, medium- and long-term outcomes can be observed. Registry-based information can be used for a variety of purposes, including tracking epidemics (as with HIV/AIDS or SARS), documenting the life course of and assessing treatment outcomes in patients with rare diseases, tracking the use of certain procedures, comparing the performance of service providers, and assessing outcomes of interventions as they occur in ordinary patient care settings. Their use has also improved outcomes in chronic disease patients.8 Registries have a long history in many countries, including the United States, and there has been a recent surge of interest in the creation and use of registries as evidenced by such developments as the creation of a “register of registries” by the Agency for Healthcare Research and Quality;9 the proposal by an American Medical Association Committee of a National Quality Registry Network;10 the Food and Drug Administration’s sponsorship of The International Consortium of Orthopaedic Registries;11 and the Centers for Medicare and Medicaid Services’ “Summit to Advance the Use of Registries.”12 © 2013, The Urban Institute Health Policy Center • www.healthpolicycenter.org page 2 Although interest has never been higher, registries in the U.S. are typically limited to the patients of particular organizations (such as Kaiser Permanente), of multiple organizations that voluntarily make data available to a coordinating organization (as with cancer registries), or people in a particular geographic locations, as with the New York City diabetes registry.13 An important limitation of such registers is that they can lose track of patients who move, change insurers, or obtain care from a new source. This problem has been overcome in some countries, including Sweden and England—two countries with highly developed systems of registries that are used for planning, public health, quality improvement, technology ass