Abstract
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.
Introduction
A health registry has been defined as “an organized system that uses observational study methods … for the collection, storage, retrieval, analysis and dissemination of information on individual persons who have either a particular disease, a condition that predisposes to the occurrence of a health-related event, or prior exposure to substances (or circumstances) known or suspected to cause adverse health effects”; 1 “its purposes may be scientific, political and/or management”.1,2
The aim of this narrative review article was to provide an integrated perspective on how health registries can be used as a bridge between healthcare, research, education, innovation and development. The purpose, relevance, healthcare personnel involvement and perspectives of each of these issues will be discussed.
The focus is on the potential of health registries to enhance the value of healthcare (by reducing healthcare costs, and improving health outcomes and quality of care)3–6 and to improve medical knowledge, while addressing challenging ethical issues. 7 Through effective collaboration and integration with other healthcare stakeholders, health registries can be a powerful tool for promoting better health and well-being.
Finally, this review includes a description of the experience of a registry implemented at our hospital (https://www.hospitalitaliano.org.ar/#!/home/investigacion/inicio). Hospital Italiano de Buenos Aires, Argentina, is an institution that has provided healthcare for 170 years and is committed to support, education and research. In the Research Department we work as a transdisciplinary team that helps researchers to generate original and high quality scientific knowledge by promoting the academic development of health professionals in our region, with special emphasis on enhancing their skills of initiating and leading independent research of the highest scientific quality. Over the last 15 years, we have developed experience in designing and implementing institutional registries for various clinical conditions. Some examples of these registries are Sepsis NCT01403935, Amyloidosis NCT01347047, Thromboembolic Disease NCT01372514, Hemorrhagic Hereditary Telangiectasia NCT01761981, Outpatient and Hospitalized COVID-19 Infected Patients (IRCIP)/NCT04839107, Hip Fracture in the Elderly NCT02279550, Inflammatory Bowel Disease, Breast Cancer, Bicuspid Aortic Valve, Colorectal Liver Metastases, Adult Liver Transplant and Pediatric Liver Transplant.
Healthcare
From a healthcare perspective, the process of systematically documenting longitudinal data for each patient is essential both in generating evidence on individual health and in supporting clinical decision making. Medical records have become a key instrument for these purposes, in addition to being legally important documents. The development and application of the use of information technologies in healthcare data has led to the use of electronic medical records (EMRs). Like older non-electronic records, the purpose of EMRs is to document and record the events of each patient’s healthcare and disease process. This makes it possible to observe, evaluate and make decisions about actions focused on individual health. Beyond this core purpose, the information retrieved from EMRs permits research based on real-world data.
The purpose of health registries is to facilitate research and/or epidemiological surveillance using grouping criteria for the population studied (e.g., pathology, risk and geographic groups). Because registries are configured with a focus on research, they can indirectly facilitate the evaluation of diagnostic methods and treatment results, in terms of both effectiveness and safety. 1
Both registries and EMRs evolve continuously; during this process of development, they influence each other. Our EMRs are modular, patient-centered and problem-oriented, and are widely used by all types of health professionals; 8 we believe that this increasing generation of records has helped to create a culture of research. We also believe that the development of a registry through various stages makes EMR users more flexible, so that they can more easily use registry software improvements and upload data with more awareness and efficiency.
This wide range of uses, of both EMRs and registries, supports informed decision making, facilitates coordination and continuity of care among different healthcare providers, enhances the overall quality of healthcare delivery 9 and provides valuable information about the costs associated with healthcare.1,3 However, it is important to understand the different purposes underlying the construction of EMRs and registries to differentiate them.
Research
The act of research is a reflexive process that allows new insights to be gained on the basis of past and present knowledge. A registry assumes a prior process of conceptual elaboration of the dimensions to be studied to systematize and collect data to be stored. This process organizes and makes information available to answer research questions and thus build knowledge. 1
Each registry has a well-defined purpose that allows researchers to identify patterns and trends in disease occurrence, treatment outcomes and healthcare use. Additionally, data analysis can help identify risk factors for disease, assess treatment effectiveness and monitor adverse events associated with specific interventions or exposures. These new insights make it possible to design tailored interventions that involve all individuals belonging to a particular population.1,7
Generally, registries allow the temporal traceability of processes, so that even if they are designed for purposes other than research, they make available data that can be used for research. An additional benefit of registries is that they can help to identify health disparities, allowing healthcare teams to develop targeted interventions to reduce disparities and improve health outcomes for more people. 10
Registries are powerful tools for tumor disease surveillance; in this field, registries are classified according to the scope of coverage they are designed for. Thus, it is possible to construct hospital or population-based registries. 11 In the words of Jensen, “The population-based cancer registry records all new cases in a defined population (most frequently a geographical area) with the emphasis on epidemiology and public health. The hospital-based cancer registry records all cases in a given hospital, usually without knowledge of the background population; the emphasis is on clinical care and hospital administration”. 11 Many registries and research projects at the Hospital Italiano de Buenos Aires are based on the affiliates of our health management organization, and are convenient for estimating health risk and impact in the population, measuring the effects of possible interventions and obtaining useful information for the management of resources.12–14 The Research Department provides methodological support at the different developmental stages of the population-based registries to collect data on the population of health management organization affiliates, and to identify cases that need reporting in national registries. Although the design and implementation of the registries always precede data loading, the acquisition of data may have occurred prior to these stages. For example, this happens when a secondary database is used as a data source; this can sometimes be very useful and may even be the only source available for a particular research project. Unlike health records, this type of secondary database may have been generated for a different purpose, such as administrative-commercial purposes. Therefore, the timing or purpose of the information collected could affect the quality of the data.1,15
To create or use a registry for research purposes, it is necessary to frame it within an adequate theoretical perspective and follow appropriate methodology that permits validation of the generated information. Therefore, it is essential to formulate a research question and have well-defined objectives and a research protocol that organizes the whole process. 15 The design of registries in each research process shares an essential step that establishes bridges, both between the registries and between the stakeholders (healthcare, education, innovation and research); this stage consists of conceptually and operationally defining the variables. The aim of this definition is to represent the theoretical dimensions in a way that encompasses the information gathered from various sources. The development of operational definitions can be challenging and involves making explicit the entire path that each variable follows, from its conception to its inclusion in a study design. This is a very important and rewarding role for researchers, and is especially challenging when the information was stored for a purpose other than research. Our hospital's Research Department is committed to storing the results of this process so that it is transparent, reproducible, traceable, available for replication or reuse in other scenarios, or even used as a basis for another conceptualization.
Registries provide a framework for the dialogic process and facilitate collaborative work between the disciplines involved. The Research Department advises during all stages of the research process, and the knowledge and skill contributions of the following disciplines are of great value to the registries: health professionals (e.g., medicine, psychology, kinesiology, nursing), information technology, research and education/pedagogy. It is essential that personnel work in multidisciplinary teams and constantly strive for transdisciplinarity; the existence of dialogic skills and heterogeneous viewpoints is essential to construct registries characterized by versatility and continuity that have a broad vision and scope.
It is important to establish well-defined roles in organizing the logistics of a registry. However, these roles can be dynamic; sometimes the same person can perform activities corresponding to different roles. Some of these different types of roles can be classified as follows: healthcare personnel, who use the registries on a daily basis and enter data into them; researchers, who use the data to carry out research work; teachers, who use the data to train others; and innovators, who use the data to propose and design improvements to processes and tools. All members of the team can contribute their ideas, proposals and experiences. Registries thus evolve dynamically to meet the needs of their stakeholders.
The most frequent difficulties with registries comprise the substantial task of maintenance over time and retaining an organized team of professionals who can guarantee quality and continuity of the records. 2 Therefore, motivation is essential to promote research projects that in turn stimulate the development and continuous improvement of registries.
Regarding the financial resources necessary for the development and loading of registries, the hospital has a Research Department for methodological support and a Health Informatics Department that provides software tailored to the needs of stakeholders. The loading of information and the maintenance of the registries is financed by the regular work of researchers in the hospital, as well as by grants and scholarships obtained for this purpose.
Education
This section of the manuscript explores a less conventional aspect of registries by clarifying their pivotal role in research education, particularly as empirical health research models. However, it is essential to elucidate the practical contributions of registries in this context; specifically, in enhancing research education. In addition to serving as models for empirical health research, registries provide substantial value to research education by fulfilling the following roles.
Fostering research skills in medical education
Healthcare registries require a research team; 16 within this team, the role of the clinician-scientist is key to achieving excellence in medical education 17 and within healthcare systems. 18 Clinician-scientists are able to not only answer clinically relevant questions that lead to the development of research projects but also to serve as critical resources in ensuring evidence-based education and acting as role models for students pursuing careers in healthcare and research.19,20 Clinician-scientists thus help to equip students with practical and fundamental research skills, providing them with hands-on experience in formulating research questions, collecting and analyzing data, and presenting findings.
Empowering career development
Registries offer substantial opportunities for career development, particularly for researchers affiliated with institutions like CONICET (Consejo Nacional de Investigaciones Científicas y Técnicas) 21 and PRINUAR (Programa para la Investigación Universitaria Argentina). 22 This not only strengthens individual career paths but also enriches the broader research community.
Cultivating a community of practice
Registries serve as hubs for cultivating communities of practice, in which mentorship, knowledge exchange and collaboration thrive. They connect students and professionals from diverse healthcare disciplines, encouraging a transdisciplinary approach to research.
Bridging the gap between evidence and clinical practice
Clinician-scientists in registries play a central role in bridging the gap between research evidence and clinical care. 23 They equip students pursuing healthcare and research careers with the ability to critically assess and apply scientific findings in real-world healthcare settings.
Enhancing research management
Registries facilitate the management of research groups focused on the registry's theme. This involvement in scientific-technological activities is a valuable aspect of research education, and enables students to develop essential project management skills.
Promoting continuous learning
Registries enable healthcare professionals to engage in continuous learning. Students and professionals can identify best clinical practices and stay up-to-date with the latest research, which further enriches their research education. 3
Developing competencies and skills
Through registries, individuals acquire a diverse set of competencies and skills essential for research and clinical practice. This comprehensive education model equips professionals with skills to navigate the complex landscape of biomedical science. 24
In summary, registries play a dual role as models for empirical health research and as valuable resources for research education. They empower students and professionals by fostering research skills, offering career development opportunities, cultivating collaborative research communities and bridging the gap between research evidence and clinical practice. Additionally, registries provide hands-on experience in research management, equipping the next generation of healthcare researchers and practitioners with comprehensive competencies for the biomedical science landscape.
Innovation and development
The aim of innovation and development in hospitals and healthcare centers is to improve the quality of healthcare and to add value to healthcare system users and society in general by providing real solutions to real problems, with an emphasis on novel and applicable solutions. 25 Bioethics plays an important role in this process, as both efficacy and safety should support innovation in medicine. 26 Registries play an essential role in fueling innovation in healthcare through the identification of patterns and trends that indicate areas that require further research.
One development in healthcare has been the use of technology to enhance the efficiency and effectiveness of healthcare systems. Hospitals and healthcare centers have implemented various technological solutions, ranging from mobile applications for patients to artificial intelligence systems for medical diagnostics. These solutions rely on registries.
The Hospital Italiano de Buenos Aires has implemented telemedicine in almost all medical specialties. Telemedicine systems use administrative records for appointment scheduling and payment of services, and use EMRs. Telemedicine increases access to healthcare for people living in remote or rural areas worldwide. It reduces the time and money spent on the transportation of both healthcare professionals and patients, allowing them to interact from their own homes or a location of their choice. During the COVID-19 pandemic, telemedicine became a vital tool with which to provide safe patient care without the need for physical visits, thus improving disease management and continuity of care.27–29
Another innovative tool developed at our hospital is the personal health record. This uses registries generated by healthcare professionals, information from patients and administrative records. Personal health record data are displayed by focusing on the information that patients need to see, and provide personalized information based on the health issues documented in patients’ medical histories. Each patient can view upcoming appointments, schedule an appointment, check test results, manage prescribed medications, and access health recommendations and healthy lifestyle tips and meal recipes tailored to conditions such as pregnancy, hypertension, diabetes and any other conditions recorded in patients’ medical histories. This promotes patient autonomy, and is possible through the integration of various registries. 30
Artificial intelligence solutions such as machine learning are used to analyze very large amounts of medical data to help doctors make more informed and precise decisions. They are also used for early disease detection, as they can identify patterns that indicate an increased risk of developing certain diseases, and design personalized, effective treatments. Artificial intelligence can help identify errors or inconsistencies in medical records, thus reducing the risk of mistakes in healthcare practice.31,32 At the Hospital Italiano de Buenos Aires, various machine learning projects are currently underway. One of our biggest challenges is the selection of the most appropriate algorithm, which involves achieving an optimal balance between algorithm robustness and efficiency.
Ethical challenges
Ensuring the security of registry data is of utmost importance, as registries contain sensitive and personal health information. Implementing robust security measures is essential to safeguard against unauthorized access, security breaches and misuse. Therefore, adherence to privacy regulations and guidelines is important in ensuring patient confidentiality and preserving public confidence in the registry system. 1
Furthermore, the exchange of data among various parties, such as in multicenter studies, presents challenges owing to privacy concerns and regulatory responsibilities. Achieving a balance between promoting data sharing for enhanced research and collaboration, and safeguarding privacy rights, is a multifaceted undertaking. It is imperative to foster collaboration among key stakeholders, such as healthcare providers, researchers and policymakers, to establish robust data sharing frameworks that adhere to ethical, legal and regulatory principles.
One challenge in this respect is that registries function as a bridge between global and local ethical issues, as well as issues specific to institutions. This challenge must be addressed by research teams, as researchers bear substantial responsibility for ensuring the well-being and rights of research participants in accordance with clinical research ethical regulations. 33
The technological advances that have generated exponential increases in storage capacity and computing power have highlighted previously unexpected possibilities for connecting information stored in distributed forms across multiple locations worldwide. Using these connections, products can be generated that may (positively or negatively) affect population groups similar to registry participants. However, technology, regulation and the capacity to regulate are developing at different rates: progress in regulation is slowest, leading to a lack of ability to respond to the ethical needs of registries. This ethical challenge involves both the privacy of individual participant data in the registry and the broader well-being of all other individuals who may be affected by the processes and results of research conducted using the registry (e.g., the application of algorithms).
Each institution is responsible for formulating regulations that can provide solutions to these issues, taking into account local conditions and the technological capabilities specific to each institution. International regulations also contribute to this task. For instance, the Council for International Organizations of Medical Sciences (CIOMS) has developed international ethical guidelines for health-related research involving human participants, 33 which offer comprehensive standards and principles that researchers, institutions and ethics committees should adhere to when conducting research using personal health data. Additionally, the use of institutional technological platforms for the secure management of research data is now an essential strategy for data protection and proper access management, particularly for multicenter studies.
In our hospital, any research project seeking to use clinical data, either from individuals or from medical records, must undergo a comprehensive review conducted by our institutional research ethics committee. The committee assesses the research design, data collection methods, informed consent procedures, and measures for data protection and confidentiality. The committee also checks the ability of the research team to conduct clinical research under ethical conditions. 1
In our experience, to comprehensively address these ethical challenges it is necessary to foster debate within each institution, with the aim of formulating policies and implementing regulations that effectively govern the structure and processes of research databases. For example, we have developed a recommendation for sharing the research databases requested by scientific journals. The standard was formulated through collaboration among various institutional departments, which jointly analyzed national and international legislations, as well as our own capabilities, to develop a secure and reliable response to journal editors.
This dedication to ethical conduct not only ensures the protection of personal privacy, but also enhances the overall authenticity and reliability of medical research. It is through these collaborative endeavors that we can advance scientific understanding while concurrently preserving the welfare and rights of research participants in an evolving healthcare environment driven by data.
Registries bridge gaps and integrate
In this section, we present concrete examples of success in research using registries. We show how registries bridge the gaps in mutual collaboration among healthcare, education and research. These efforts are focused on addressing the healthcare needs of individuals. However, we also acknowledge and discuss the challenges that accompany these achievements.
The Amyloidosis institutional registry (RIA, NCT01347047) is an ongoing registry that has been actively recruiting incident cases of amyloidosis since 2010. It was created with the
The RIA is used by a multidisciplinary network of medical and non-medical professionals from the Hospital Italiano de Buenos Aires. It serves as a link for interdisciplinary daily work activities, including weekly meetings for collaborative learning lessons (both clinical and methodological), athenaeums, specialized medical offices, congress presentations, organization of symposia, article publication and teaching of courses, with the aim of improving the care of all individuals living with amyloidosis.
The network has published articles, won awards at conferences, taught courses and/or seminars in Latin American countries, presented work at congresses and symposia, developed clinical practice guidelines on the diagnosis and treatment of amyloidosis in our region and published related articles on different aspects of amyloidosis, including documentation of the existence and magnitude of the disease,34–36 the characteristics of the disease,37–39 the understanding of the patterns of diagnosis and treatment,40,41 and the development of strategies that seek to resolve or mitigate these problems and/or monitor their evolution.42–47
The research group supports postgraduate and graduate research projects by guiding and tutoring students conducting doctoral projects in medicine and master’s projects in clinical research. It also involves advanced health-related undergraduate students and health professional graduates (in nursing, medicine, biochemistry and bioengineering) in its research, education, support and innovation/development activities. After a period of standardized training, students can participate in research projects by conducting literature searches, protocol writing, patient recruitment, manuscript writing and conference presentations. Projects comply with local ethical standards and are evaluated by an institutional review board prior to implementation. They require ongoing mentoring from initial design to implementation and dissemination. Research
To address current gaps in knowledge,
The RIA initially involved two people, and gradually grew to include additional healthcare professionals. From an initial resource with the single aim of research, the RIA has now developed into a reference center that provides the following types of support: 1) it offers differential services, because amyloidosis is a complex pathology involving multiple organs, and offers entry-level transdisciplinary care; 2) it includes research in precision medicine, which promotes the typing and identification of patients to permit more personalized health approaches. Such research approaches increasingly permit a much more complete picture of patients that includes medical care access, family history, eating habits, engagement with social media and genetic data; 3) The RIA incorporates different technologies to allow accurate diagnosis, which informs approaches in precision medicine (e.g., the sequencing of the TTR gene, which improves the identification of patients), and uses the generation of machine learning algorithms using the EMR system to develop individualized diagnostic tools and policy interventions that could revolutionize the prevention, diagnosis and treatment of disease. Projects may involve building predictive models for environmental exposures and diseases, creating specific gene therapies for individual patients and issues related to machine learning interpretability and robustness; 4) it has developed a referral network that is a leader in amyloidosis research and care, experience and excellence. Physicians refer patients from across Argentina and from other Latin American countries to the RIA; 5) it generates value-based care of patient records for patient-reported outcomes and community advisory boards. This allows evaluation of research and care in terms that are relevant to patients. Such approaches contribute to the imminent revolution in medical care that rejects the traditional asymmetry of information between consumers and providers, which makes it difficult for patients to assess the quality of the care they receive; and 6) it has developed an alliance network with other societies, institutions and healthcare stakeholders.
One of the biggest challenges to health registries is sustainability. Despite having institutional and political support, as well as a research department for methodological consultancy and honoraria for human resources dedicated to maintaining the registry, securing a consistent stream of funding remains a continuous and resource-intensive effort. The process of fundraising necessitates the building and nurturing of relationships with donors and the community. In our experience, it often takes more than 7 years (and usually several unsuccessful grant proposals) to obtain grants. In fact, for every financial support grant received, approximately 10 proposals are rejected.
Motivation is another challenge linked to sustainability, particularly among key stakeholders, including clinicians, researchers and patients. To address this, we have developed a comprehensive communication plan that involves frequent meetings, mailings, phone calls, web materials and publications. Additionally, we have implemented strategies for academic and financial recognition for researchers and have established mechanisms for sharing research opportunities. This requires ongoing efforts not only to maintain the registry itself but also to sustain its associated infrastructure.
Conclusion
Health registries have the potential to improve health. This article presents one perspective on health registries and uses an example to illustrate their potential and explore how they can be used to address knowledge gaps by bridging healthcare, research, education and innovation and development. It also discusses ethical challenges in promoting progress in scientific understanding while ensuring the welfare and rights of research participants.
Footnotes
Acknowledgements
We thank Jose Navarro Estrada, Silvana Figar, Diego Giunta, Celeste Puga and all the Hospital Italiano de Buenos Aires researchers who participated in the registry experience.
Author contributions
All authors listed contributed sufficiently to the project to be included as authors, drafted the article and revised it critically for important intellectual content, approved the version to be published, and participated sufficiently as follows: Maria Lourdes Posadas-Martinez: idea, introduction, education, example, revision and critical thinking; Jimena Vicens: research, examples, revision; Adriana Ruth Dawidowski: ethics and care, revision; Marcela Alejandra Martinez Von Scheidt: innovation, education, revision; Vanina Laura Pagotto: introduction, care, revision; Gabriela Alejandra Blugerman: revision and critical thinking; Monica Gabriela Schpilberg: research, ethics, revision; Adrian Carlos Gadano: idea, revision and critical thinking.
Declaration of conflicting interest
The authors declare that there is no conflict of interest.
Funding
Journal of International Medical Research: SAGE in the context of a special edition as a guest editor. No fee was paid. This research received no other specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
