Role Of Registries Research Articles

The role of registries in improving health and bridging healthcare, research, education, innovation and development: a research department perspective.

Health registries are organized systems that collect data on individuals with a particular disease, condition or exposure. The aim of this narrative review was to provide an integrated perspective from the Research Department at the Hospital Italiano de Buenos Aires, Argentina, on how health registries can be used as a bridge between healthcare, research, education, innovation and development while addressing ethical challenges. The review includes a description of the experience of a registry implemented at our institution, which has provided healthcare for 170 years, and is committed to support, education and research. We focus on the potential of health registries to provide better value healthcare by reducing healthcare costs and improving health outcomes and quality of care, and to improve medical knowledge. However, we also acknowledge and discuss the challenges that accompany these achievements, such as that of ethical issues. Through effective collaboration and integration with other healthcare stakeholders, health registries can be a powerful tool to promote better health.

Tracing data flows in Norway and Austria

The increased importance of datafication in different domains of society, and health in particular, has generated much attention in STS, specifically in the Nordic context. While much of this literature tackles newly emerging forms of data governance, we focus on a historically established and mundane data practice: that of recording vaccinations in vaccine registries. We mobilise the concept of data flows to compare the link between registry practices and governance in two countries: Norway – a data intensive welfare state - and Austria, which we label ‘data hesitant’. We ask: What is the role of registries in vaccination governance? How do data practices shape and reflect relations between citizens, health providers and the state? We show that the governance of immunity is interlocked with the material and political circumstances that make data flow. The paper makes visible the benefits of doing situated comparisons for better understandings of data practices across countries.

Role of Registries in Medicare Coverage of New Alzheimer Disease Drugs

This Viewpoint discusses how the design of the Centers for Medicare & Medicaid Services (CMS) registry could impact Medicare’s ability to evaluate whether monoclonal antibodies are reasonable and necessary for patients with Alzheimer disease and help physicians understand when the drug is most beneficial.

Guidelines "Medical registries. Role in evidence-based medicine. Recommendations for creation": a brief review

The article provides a brief review of the guidelines on medical registries. The methodological recommendations are based on the accumulated clinical and scientific experience, data from domestic and foreign literature, expert consensus on the management of medical registers. The main types and goals of medical registers are described in detail. The issues of planning, management, development of documentation, conducting registers, preliminary preparation of data for statistical analysis are considered. The problems of quality and limitations of registries are highlighted, and the role of registries in the assessment of real clinical practice is defined.

The Role of Registries in Neurotrauma Research: Translating Data Into Health Policy That Enhances Patient Care Comment on "Neurotrauma Surveillance in National Registries of Low- and Middle-Income Countries: A Scoping Review and Comparative Analysis of Data Dictionaries".

The paucity of robust neurotrauma data is felt most in regions that experience a higher burden of traumatic brain injury (TBI). The scoping review done by Barthélemy et al provides insight into the current state of national registries in low- and middle-income countries (LMICs) while also exploring the tools required to standardize data collection. In this commentary, we reflect on the barriers to data collection (ie, creation and maintenance of a TBI registry) and explore how registries can aid both scientific output and preventative public awareness campaigns that may pave the way to improved health policy and social change that avert mortality and morbidity from TBI.

The French Cochlear Implant Registry (EPIIC): Place and role of registries in post-registration studies of medical devices

The French Cochlear Implant Registry (EPIIC): Place and role of registries in post-registration studies of medical devices

Research methodology and practical issues relating to the conduct of a medical device registry

The postmarket research goal is to assess "generalizability" or "external validity" to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal. Although registries are common, in practice they follow the regulatory processes that appear designed primarily for pharmaceutical clinical trials and confirmatory studies. We review the literature to assess different definitions and the role of registries in the hierarchy of scientific evidence. We analyze common characteristics affecting registry design, implementation, and governance as well as safety reporting and off-label use while describing the experience of setting up an international, prospective registry for an endovascular device used to treat abdominal aortic aneurysms. Key areas in which to distinguish registries from trials are as follows: eligibility, setting (patients and institutions), device configurations and iterations, the use of design and quality "spaces," a focus on systematic quality checks (rather than source data monitoring), open-ended follow-up, flexibility in the definition of end points and sample sizes, data sharing, and publishing commitments. Both clinical trials and registries are essential and complementary research methods and the strengths and weaknesses of each need to be recognized. The specific characteristics of registry research deserve to be acknowledged and safeguarded in the regulations governing clinical investigations with medical devices.

The role of registries and genetic databases in familial hypercholesterolemia.

To review how leveraging familial hypercholesterolemia registries can impact molecular genetic research and precision medicine. Familial hypercholesterolemia is both much more common and more phenotypically heterogeneous than previously thought with some evidence for significant genotype to phenotype correlations. Genetic testing for familial hypercholesterolemia is becoming both more widely available and cheaper, spurring conversations about its clinical utility. In most countries, familial hypercholesterolemia is underdiagnosed and diagnosed later in life, often after the onset of coronary heart disease (CHD). Familial hypercholesterolemia is undertreated; low goal attainment and additional modifiable risk factors further increase CHD risk. Familial hypercholesterolemia epitomizes the goal of precision medicine to define a subset of individuals with a high risk of morbidity and mortality through genetic diagnosis to manage and treat the risk accordingly. Genetic cascade screening can be used to identify familial hypercholesterolemia patients at a younger age and start timely treatment to prevent CHD. Familial hypercholesterolemia registries are tools for clinical research and improving healthcare planning and patient care. As genotype and phenotype correlations in familial hypercholesterolemia become increasingly understood, this information will likely play a more important role in diagnosis and treatment especially as the cost of genetic testing continues to decline.

Health technology assessment in Australia: a role for clinical registries?

Objective Health technology assessment (HTA) is a process of assessing evidence to inform policy decisions about public subsidy of new drugs and medical procedures. Where evidence is uncertain but the technology itself is promising, funders may recommend funding on an interim basis. It is unknown whether evidence from clinical registries is used to resolve uncertainties identified in interim-funded decisions made by Australian HTA bodies. Therefore, the present study evaluated the role of evidence from clinical registries in resolving evidence uncertainties identified by the Medical Services Advisory Committee (MSAC). Methods All HTAs considered by MSAC between 1998 and 2015 were reviewed and assessments that recommended interim funding were identified. The MSAC website was searched to identify reassessments of these recommendations and sources of evidence used to resolve the uncertainties were identified. Results Of 173 HTA reports considered by MSAC, 17 (10%) contained an interim funding recommendation. Eight recommendations cited uncertainty around safety, 15 cited uncertainty around clinical effectiveness and 13 cited uncertainty around economics (cost-effectiveness and/or budget impact). Of the 17 interim funding recommendations, 11 (65%) have been reassessed. Only two reassessments relied on clinical registry evidence to resolve evidence gaps identified at the time of the interim funding recommendation. Conclusions Clinical registries are underused as a source of evidence for resolving uncertainties around promising new health technologies in Australia. An open dialogue between stakeholders on the role of registries in this context is needed. What is known about the topic? HTA is a process of assessing the evidence to inform policy decisions about public subsidy of new health technologies (e.g. pharmaceuticals, diagnostic tests, medical procedures). Where evidence is uncertain but the technology under evaluation is promising, funders may recommend the funding of the technology on a temporary basis while additional evidence is collected. Clinical registries have been suggested as a means of collecting additional evidence in these situations. What is does this paper add? It is currently unknown whether evidence from clinical registries is used to resolve uncertainties identified at the time that temporary (interim) funding decisions are made by Australia's HTA bodies, in particular MSAC. The present study found that MSAC rarely relies on the interim funding mechanism (17/173 assessments). Of the 11 subsequent reassessments of interim recommendations, two relied on registry evidence to provide Australian-specific data for addressing uncertainties around long-term safety, effectiveness and cost-effectiveness. These findings suggest that clinical registries, although a feasible source of evidence for HTAs, are rarely used for this purpose. What are the implications for practitioners? Given the registries' ability to resolve both a wider range of questions than those typically addressed by randomised control trials and applicability to a wider group of patients (and, hence, providing estimates of outcomes that are more generalisable), the potential of clinical registries to resolve HTA issues needs more attention from both researchers and decision makers. Stakeholder collaboration to define the evidence requirements for new technologies early in their development phase would be valuable to determine the potential role for clinical registries.

Bridging the Knowledge Gaps in Arrhythmogenic Cardiovascular Conditions: The Critical Role of Registries

Cardiac registries have filled many gaps in knowledge related to arrhythmogenic cardiovascular conditions. Despite the less robust level of evidence available in registries when compared with clinical trials, registries have contributed a range of clinically useful information. In this review, the authors discuss the role that registries have played – related to diagnosis, natural history, risk stratification, treatment, and genetics of arrhythmogenic cardiovascular conditions – in closing knowledge gaps, and their role in the future.

The Role of Registries and Tumor Banking in Rare Pediatric Tumors

Rare pediatric tumors are a heterogenous group of tumors that are rare at any age, or rare in children and common in adults. These are orphan diseases which have not benefitted from the significant advances seen in other pediatric malignancies. To improve our understanding of these tumors, rare tumor registries and tissue repositories have been established. The development of registries has followed two different models: in Europe, the focus has been on large co-operative group registries that enroll the breath of rare tumors, while in the USA, individual rare tumor registries have predominated. Both types of registries have significantly improved our understanding of these tumors. The co-operative group registries have provided valuable information on some very rare tumors, leading to the development of therapeutic guidelines, with the goal of standardizing treatment. On the other hand, the individual rare tumor registries have focused on single tumors, providing granular clinical and molecular information. They have defined the molecular pathogenesis of these tumors and provided new models to understanding carcinogenesis. We discuss the important contributions made by these registries.

The next critical role of orthopedic registries

The next critical role of orthopedic registries

Iliac arteries: how registries can help improve outcomes.

There are many publications reporting excellent short and long-term results with endovascular techniques. Patients included in trials are often highly selected and may not represent real world practice. Registries are important to interventional radiologists for several reasons; they reflect prevailing practice and can be used to establish real world standards of care and safety profiles. This information allows individuals and centers to evaluate their outcomes compared with national norms. The British Iliac Angioplasty and Stenting (BIAS) registry is an example of a mature registry that has been collecting data since 2000 and has been reporting outcomes since 2001. This article discusses the evidence to support both endovascular and surgical intervention for aortoiliac occlusive disease, the role of registries, and optimal techniques for aortoiliac intervention.

Diagnosis and management of thrombotic microangiopathy: The role of registries

Diagnosis and management of thrombotic microangiopathy: The role of registries

Safety in Surgery: The Role for Registries

Safety in Surgery: The Role for Registries

Clinical trial registries: from an omen to a common and disclosed practice

Clinical trials registries are important for guaranteeing trustworthy scientific knowledge. Despite international initiatives promoting trial registration, however, complete and high quality disclosure of trial information in such registries is not routine. The role of registries in also increasing transparency is fundamental, and these databases could be contemplated by research organizations, even at more local levels. A rare initiative was set up at the IRCCS-Mario Negri Institute for Pharmacological Research in Milan in order to make the institute's ongoing research accessible to anyone. The register currently includes 112 studies in which the institute participates. Work still needs to be done to improve the registry, but it is up and functional. Could, or should, such registries be routine for all scientific institutions?

Registries and their role in management of patients with coronary artery disease undergoing revascularization surgery

The paper reviews the role of registries in clinical practice and their difference from randomized clinical trials. The article focuses on the use of registries and databases in the management of patients undergoing revascularization surgery, and on the particular need for the registry of patients who underwent planned bypass surgery.

Quality improvement in heart rhythm care: the path forward

The drastic changes in the American health-care environment have brought forward several major quality improvement initiatives including performance measurement, the demand for transparency to be implemented, at least in part, through public reporting, and the need to demonstrate appropriate use of interventions. Despite the great potential of these initiatives to improve the quality of health care and patient outcomes, the average clinician has not been engaged in or educated about these initiatives. This is particularly true of specialists like electrophysiologists. Given that participation in these initiatives will become mandatory in the next few years, it is critically important to prepare our community for these programs. To that end, electrophysiologists should be educated about the potential strengths and pitfalls of these quality improvement programs, and they should be engaged more effectively in the development and testing of such programs. Indeed, electrophysiologists face unique challenges that deserve attention. Some of these challenges relate to the scarcity of performance measures that are specific to heart rhythm care and the scarcity of registries that could be used for performance measures and public reporting. This article provides an overview of performance measures and public reporting, the role of registries in quality improvement, and appropriate use criteria. It then concludes with recommendations regarding the proper implementation of these quality improvement initiatives to ensure a high likelihood of success.

Improving Quality of Care and Outcomes for Heart Failure - Role of Registries -

Heart failure (HF) results in substantial morbidity, mortality, and costs, yet quality of care varies widely and is frequently inadequate. Performance improvement registries have been developed to improve the quality of care and outcomes for patients with HF in both the inpatient and outpatient settings. HF registries in the United States include ADHERE, OPTIMIZE-HF, GWTG-HF, and IMPROVE HF. These registries collect data on clinical characteristics, admission, hospital, discharge, and/or outpatient care, as well as outcomes. Web-based tools that provide real-time feedback of performance and other quality measures benchmarked to other sites and national data are frequently utilized. Process-of-care improvement tools, including evidence-based clinical decision support, customizable order sets, and patient education are also used. Participation in performance improvement registries has been associated with substantial improvements in the use of guideline-recommended therapies for HF in both the inpatient and outpatient settings. Conformity with HF quality measures has also been shown to improve and disparities in care have also been reduced or eliminated. There have also been improvements in clinical outcomes. This paper reviews the evidence that participation in HF performance improvement registries is associated with improved use of guideline-recommended HF therapies, better conformity with quality measures, and improved outcomes in patients with HF.

Victorian Spleen Registry's role in the management of trauma patients undergoing splenectomy and splenic artery embolisation

Victorian Spleen Registry's role in the management of trauma patients undergoing splenectomy and splenic artery embolisation