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EMBO Reports Jan 2020EMBO Press encourages to document or pre-register animal experiments on the new Animal Study Registry to increase reproducibility and efficacy of animal research.
EMBO Press encourages to document or pre-register animal experiments on the new Animal Study Registry to increase reproducibility and efficacy of animal research.
Topics: Animal Experimentation; Animals; Registries; Reproducibility of Results
PubMed: 31867857
DOI: 10.15252/embr.201949868 -
PloS One 2022Mitochondrial diseases are a large group of genetically heterogeneous and clinically diverse disorders. Diagnosis often takes many years for which treatment may not... (Review)
Review
BACKGROUND
Mitochondrial diseases are a large group of genetically heterogeneous and clinically diverse disorders. Diagnosis often takes many years for which treatment may not exist. Registries are often used to conduct research, establish natural disease progression, engage the patient community, and develop best disease management practices. In Canada, there are limited centralized registries for mitochondrial disease patients, presenting a challenge for patients and professionals.
OBJECTIVE
To support the creation of such a registry, a systematic scoping review was conducted to map the landscape of mitochondrial disease patient registries worldwide, with a focus on registry design and challenges. Furthermore, it addresses a knowledge gap by providing a narrative synthesis of published literature that describes these registries.
METHODS
Arksey and O'Malley's methodological framework was followed to systematically search English-language literature in PubMed and CINAHL describing the designs of mitochondrial disease patient registries, supplemented by a grey literature search. Data were extracted in Microsoft Excel. Stakeholder consultations were also performed with patient caregivers, advocates, and researchers to provide perspectives beyond those found in the literature. These data were thematically analyzed and were reported in accordance with the PRISMA-ScR reporting guidelines.
RESULTS
A total of 17 articles were identified describing 13 unique registries located in North America, Europe, Australia, and West Asia. These papers described the registries' designs, their strengths, and weaknesses, as well as their tangible outcomes such as facilitating recruitment for research and supporting epidemiological studies.
CONCLUSION
Based on our findings in this review, recommendations were formulated. These include establishing registry objectives, respecting patients and their roles in the registry, adopting international data standards, data evaluations, and considerations to privacy legislation, among others. These recommendations could be used to support designing a future Canadian mitochondrial disease patient registry, and to further research directly engaging these registries worldwide.
Topics: Humans; Canada; Registries; Research Personnel; Mitochondrial Diseases; Europe
PubMed: 36301904
DOI: 10.1371/journal.pone.0276883 -
Medical Science Monitor : International... Jun 2021Patient registries include data on patient diagnosis, demographics, treatment, and outcomes and are now fundamental to the provision of successful global health systems....
Patient registries include data on patient diagnosis, demographics, treatment, and outcomes and are now fundamental to the provision of successful global health systems. Patient registries include mainly local, regional, and national patient data on general or specific patient groups. Global registries currently exist mainly for rare diseases. Some of the most studied registries include the national Surveillance, Epidemiology, and End Results (SEER) program and the hospital-based Medical Information Mart for Intensive Care (MIMIC-III) dataset. The limitations of registry databases have included lack of feedback from clinical studies to the clinical center, the lack of patient involvement, and limited findings on patient-reported outcomes (PROs). In September 2020, the European Medicines Agency (EMA) published its draft guidelines on registry-based clinical studies. Guidelines for the development and analysis of registry data will improve the quality and registry-based studies and increase the role of registry data to support clinical trials. This Editorial aims to present the current status of registries and population databases in clinical research and practice.
Topics: Clinical Protocols; Databases, Factual; Humans; Practice Guidelines as Topic; Registries
PubMed: 34149048
DOI: 10.12659/MSM.933554 -
Journal of ISAKOS : Joint Disorders &... Oct 2022Sports injuries, trauma and the globally ageing and obese population require increasing levels of knee surgery. Shared decision making has replaced the paternalistic... (Review)
Review
Sports injuries, trauma and the globally ageing and obese population require increasing levels of knee surgery. Shared decision making has replaced the paternalistic approach to patient management. Evidence-based medicine underpins surgical treatment strategies, from consenting an individual patient to national healthcare system design. The evolution of successful knee-related registries starting from specific arthroplasty registries has given rise to ligament reconstruction, osteotomy and cartilage surgery registries developing as platforms for surgical outcome data collection. Stakeholders include surgeons and their patients, researchers, healthcare systems, as well as the funding insurers and governments. Lately, implant manufacturers have also been mandated to perform postmarket surveillance with some hoping to base that on registry data. Aiming to assess the current status of knee-related registries, we performed a comprehensive literature and web search, which yielded 23 arthroplasty, 8 ligament, 4 osteotomy and 3 articular cartilage registries. Registries were evaluated for their scope, measured variables, impact and limitations. Registries have many advantages as they aim to increase awareness of outcomes; identify trends in practice over time, early failing implants, outlier surgeon or institution performance; and assist postmarketing surveillance. International collaborations have highlighted variations in practice. The limitations of registries are discussed in detail. Inconsistencies are found in collected data and measured variables. Potential measurement and selection biases are outlined. Without mandated data collection and with apparent issues such as unverified patient reporting of complications, registries are not designed to replace adverse event recording in place of a proper safety and efficacy study, as demanded by regulators. Registry 'big data' can provide evidence of associations of problems. However, registries cannot provide evidence of causation. Hence, without careful consideration of the data and its limitations, registry data are at risk of incorrectly drawn conclusions and the potential of misuse of the results. That must be guarded against. Looking at the future, registry operators benefit from a collective experience of running registries as they mature, allowing for improvements across specialties. Large-scale registries are not only of merit, improving with stakeholder acceptance, but also are critical in furthering our understanding of our patients' outcomes. In doing so, they are a critical element for our future scientific discourse.
Topics: Humans; Knee Joint; Registries; Plastic Surgery Procedures; Cartilage, Articular; Anterior Cruciate Ligament Reconstruction
PubMed: 34407996
DOI: 10.1136/jisakos-2021-000625 -
Hernia : the Journal of Hernias and... Aug 2018The aim of the international CORE project was to explore the databases of the existing hernia registries and compare them in content and outcome variables. (Comparative Study)
Comparative Study Review
INTRODUCTION
The aim of the international CORE project was to explore the databases of the existing hernia registries and compare them in content and outcome variables.
METHODS
The CORE project was initiated with representatives from all established hernia registries (Danish Hernia Database, Swedish Hernia Registry, Herniamed, EuraHS, Club Hernie, EVEREG, AHSQC) in March 2015 in Berlin. The following categories were used to compare the registries: initiation and funding, data collection and use for certification of hernia centers, patient data and data protection, operative data, registration of complications and follow-up data.
RESULTS
The Danish Hernia Database is the only one to qualify as a genuine national registry where participation is compulsory for entry of all procedures by all surgeons performing a hernia operation. All other registries have to be considered as voluntary and completeness of data depends upon the participating hospitals and surgeons. Only the Danish Hernia Database and the Swedish Hernia Registry are publicly funded. All other registries are reliant on financial support from the medical technology industry. As an incentive for voluntary participation in a hernia registry, hospitals or surgeons are issued a certificate confirming that they are taking part in a quality assurance study for hernia surgery. Due to data protection and privacy regulations, most registries are obliged or have chosen to enter their patient data anonymously or coded. The Danish Hernia Database and Swedish Hernia Registry utilize a national personal patient code. In the Herniamed Registry, patient data are saved in a coded and anonymous format after obtaining the patient's informed consent.
CONCLUSION
Despite the differences in the way data are collected for each of the listed hernia registries, the data are indispensable in clinical research.
Topics: Databases, Factual; Europe; Hernia; Humans; Internationality; Randomized Controlled Trials as Topic; Registries
PubMed: 29307057
DOI: 10.1007/s10029-017-1724-6 -
Human Resources For Health Jan 2022Nigeria's health sector aims to ensure that the right number of health workers that are qualified, skilled, and distributed equitably, are available for quality health...
BACKGROUND
Nigeria's health sector aims to ensure that the right number of health workers that are qualified, skilled, and distributed equitably, are available for quality health service provision at all levels. Achieving this requires accurate and timely health workforce information. This informed the development of the Nigeria Health Workforce Registry (NHWR) based on the global, regional, and national strategies for strengthening the HRH towards achieving universal health coverage. This case study describes the process of conceptualizing and establishing the NHWR, and discusses the strategies for developing sustainable and scalable health workforce registries.
CASE PRESENTATION
In designing the NHWR, a review of existing national HRH policies and guidelines, as well as reports of previous endeavors was done to learn what had been done previously and obtain the views of stakeholders on how to develop a scalable and sustainable registry. The findings indicated the need to review the architecture of the registry to align with other health information systems, develop a standardized data set and guidance documents for the registry including a standard operating procedure to ensure that a holistic process is adopted in data collection, management and use nationally. Learning from the findings, a conceptual framework was developed, a registry managed centrally by the Federal Ministry of Health was developed and decentralized, a standardized tool based on a national minimum data was developed and adopted nationally, a registry prototype was developed using iHRIS Manage and the registry governance functions were integrated into the health information system governance structures. To sustain the functionality of the NHWR, the handbook of the NHWR that comprised of an implementation guide, the standard operating procedure, and the basic user training manual was developed and the capacity of government staff was built on the operations of the registry.
CONCLUSION
In establishing a functional and sustainable registry, learning from experiences is essential in shaping acceptable, sustainable, and scalable approaches. Instituting governance structures that include and involve policymakers, health managers and users is of great importance in the design, planning, implementation, and decentralization stages. In addition, developing standardized tools based on the health system's needs and instituting supportable mechanisms for data flow and use for policy, planning, development, and management is essential.
Topics: Health Workforce; Humans; Nigeria; Organizational Case Studies; Registries; Universal Health Insurance
PubMed: 35033109
DOI: 10.1186/s12960-022-00706-3 -
National and international kidney failure registries: characteristics, commonalities, and contrasts.Kidney International Jan 2022Registries are essential for health infrastructure planning, benchmarking, continuous quality improvement, hypothesis generation, and real-world trials. To date, data... (Review)
Review
Registries are essential for health infrastructure planning, benchmarking, continuous quality improvement, hypothesis generation, and real-world trials. To date, data from these registries have predominantly been analyzed in isolated "silos," hampering efforts to analyze "big data" at the international level, an approach that provides wide-ranging benefits, including enhanced statistical power, an ability to conduct international comparisons, and greater capacity to study rare diseases. This review serves as a valuable resource to clinicians, researchers, and policymakers, by comprehensively describing kidney failure registries active in 2021, before proposing approaches for inter-registry research under current conditions, as well as solutions to enhance global capacity for data collaboration. We identified 79 kidney-failure registries spanning 77 countries worldwide. International Society of Nephrology exemplar initiatives, including the Global Kidney Health Atlas and Sharing Expertise to support the set-up of Renal Registries (SharE-RR), continue to raise awareness regarding international healthcare disparities and support the development of universal kidney-disease registries. Current barriers to inter-registry collaboration include underrepresentation of lower-income countries, poor syntactic and semantic interoperability, absence of clear consensus guidelines for healthcare data sharing, and limited researcher incentives. This review represents a call to action for international stakeholders to enact systemic change that will harmonize the current fragmented approaches to kidney-failure registry data collection and research.
Topics: Benchmarking; Healthcare Disparities; Humans; Nephrology; Registries; Renal Insufficiency
PubMed: 34736973
DOI: 10.1016/j.kint.2021.09.024 -
Chest Apr 2020Regional and/or national severe asthma registries provide valuable country-specific information. However, they are often limited in scope within the broader definitions... (Review)
Review
Regional and/or national severe asthma registries provide valuable country-specific information. However, they are often limited in scope within the broader definitions of severe asthma, have insufficient statistical power to answer many research questions, lack intraoperability to share lessons learned, and have fundamental differences in data collected, making cross comparisons difficult. What is missing is a worldwide registry which brings all severe asthma data together in a cohesive way, under a single umbrella, based on standardized data collection protocols, permitting data to be shared seamlessly. The International Severe Asthma Registry (ISAR; http://isaregistries.org/) is the first global adult severe asthma registry. It is a joint initiative where national registries (both newly created and preexisting) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research purposes. Its strength comes from collection of patient-level, anonymous, longitudinal, real-life, standardized, high-quality data (using a core set of variables) from countries across the world, combined with organizational structure, database experience, inclusivity/openness, and clinical, academic, and database expertise. This gives ISAR sufficient statistical power to answer important research questions, sufficient data standardization to compare across countries and regions, and the structure and expertise necessary to ensure its continuance and the scientific integrity and clinical applicability of its research. ISAR offers a unique opportunity to implement existing knowledge, generate new knowledge, and identify the unknown, therefore promoting new research. The aim of this commentary is to fully describe how ISAR may improve our understanding of severe asthma.
Topics: Asthma; Global Health; Humans; International Cooperation; Registries; Severity of Illness Index
PubMed: 31838187
DOI: 10.1016/j.chest.2019.10.051 -
Journal of Neuro-ophthalmology : the... Sep 2016Medical research registries (MRR) are organized systems used to collect, store, and analyze patient information. They are important tools for medical research with... (Review)
Review
BACKGROUND
Medical research registries (MRR) are organized systems used to collect, store, and analyze patient information. They are important tools for medical research with particular application to the study of rare diseases, including those seen in neuro-ophthalmic practice.
EVIDENCE ACQUISITION
Evidence for this review was gathered from the writers' experiences creating a comprehensive neuro-ophthalmology registry and review of the literature.
RESULTS
MRR are typically observational and prospective databases of de-identified patient information. The structure is flexible and can accommodate a focus on specific diseases or treatments, surveillance of patient populations, physician quality improvement, or recruitment for future studies. They are particularly useful for the study of rare diseases. They can be integrated into the hierarchy of medical research at many levels provided their construction is well organized and they have several key characteristics including an easily manipulated database, comprehensive information on carefully selected patients, and comply with human subjects regulations. MRR pertinent to neuro-ophthalmology include the University of Illinois at Chicago neuro-ophthalmology registry, Susac Syndrome Registry, Intracranial Hypertension Registry, and larger-scale patient outcome registries being developed by professional societies.
CONCLUSION
MRR have a variety of forms and applications. With careful planning and clear goals, they are flexible and powerful research tools that can support multiple different study designs, and this can provide the potential to advance understanding and care of neuro-ophthalmic diseases.
Topics: Biomedical Research; Databases, Factual; Eye Diseases; Humans; Neurology; Ophthalmology; Registries
PubMed: 27389624
DOI: 10.1097/WNO.0000000000000391 -
Acta Obstetricia Et Gynecologica... Dec 2020Medical quality registries have gained popularity as tools for monitoring the quality of medical treatments and they serve as data sources for research. The Norwegian...
INTRODUCTION
Medical quality registries have gained popularity as tools for monitoring the quality of medical treatments and they serve as data sources for research. The Norwegian Female Incontinence Registry (NFIR) was established in 1998 to monitor and improve the quality of surgery for women with stress and mixed urinary incontinence in Norway and to collect data for research. This study aimed to assess the completeness and accuracy of the Norwegian Female Incontinence Registry, and potential differences in data accuracy over time and according to surgical volume of the reporting hospitals.
MATERIAL AND METHODS
A random selection of 300 women from a total of 20 610 operated for urinary incontinence between 1998 and 2016 reported to the Norwegian Female Incontinence Registry from 28 public hospitals were selected for validation. The database completeness was estimated for 2008-2017 by comparing surgical procedures registered both in the Norwegian Female Incontinence Registry and the Norwegian National Patient Registry. Historical data recorded in the Registry for 10 selected key variables were extracted and compared with the patients' individual medical records at the reporting hospitals as reference. The reviewers were blinded to the previously stored information. The intraclass correlation coefficient for continuous variables and Cohen's kappa for categorical variables were calculated.
RESULTS
Primary source data on 285 of the 300 women selected from Norwegian Female Incontinence Registry were successfully retrieved. The completeness of the registry has increased from 61% in 2008 to 99% in 2017. The national coverage has increased from 12 reporting departments in 1998 to all 38 public departments performing female incontinence surgery in 2017. Excellent accuracy was found for both continuous variables (intraclass correlation coefficient >0.94) and categorical variables (Cohen's kappa >0.86). No differences in data accuracy were found comparing high-volume hospitals with low-volume hospitals, or when comparing data accuracy over time.
CONCLUSIONS
The Norwegian Female Incontinence Registry is a reliable tool for quality assessment of incontinence surgery and research. The registry completeness has improved over time and now contains data on nearly all women undergoing incontinence surgery in Norway.
Topics: Data Accuracy; Data Collection; Databases, Factual; Female; Hospitals, Public; Humans; Middle Aged; Norway; Patient Care Management; Quality Improvement; Random Allocation; Registries; Reproducibility of Results; Urinary Incontinence
PubMed: 32640493
DOI: 10.1111/aogs.13951