Recommended data elements for health registries: a survey from a German funding initiative.

BACKGROUND: The selection of data elements is a decisive task within the development of a health registry. Having the right metadata is crucial for answering the particular research questions. Furthermore, the set of data elements determines the registries' readiness of interoperability and data reusability to a major extent. Six health registries shared and published their metadata within a German funding initiative. As one step in the direction of a common set of data elements, a selection of those metadata was evaluated with regard to their appropriateness for a broader usage. METHODS: Each registry was asked to contribute a 10%-selection of their data elements to an evaluation sample. The survey was set up with the online survey tool "LimeSurvey Cloud". The registries and an accompanying project participated in the survey with one vote for each project. The data elements were offered in content groups along with the question of whether the data element is appropriate for health registries on a broader scale. The question could be answered using a Likert scale with five options. Furthermore, "no answer" was allowed. The level of agreement was assessed using weighted Cohen's kappa and Kendall's coefficient of concordance. RESULTS: The evaluation sample consisted of 269 data elements. With a grade of "perhaps recommendable" or higher in the mean, 169 data elements were selected. These data elements belong preferably to groups' demography, education/occupation, medication, and nutrition. Half of the registries lost significance compared with their percentage of data elements in the evaluation sample, one remained stable. The level of concordance was adequate. CONCLUSIONS: The survey revealed a set of 169 data elements recommended for health registries. When developing a registry, this set could be valuable help in selecting the metadata appropriate to answer the registry's research questions. However, due to the high specificity of research questions, data elements beyond this set will be needed to cover the whole range of interests of a register. A broader discussion and subsequent surveys are needed to establish a common set of data elements on an international scale.

Data Quality and Data Quantity: Complements or Contradictions?

Although data quality is well defined, the relationship to data quantity remains unclear. Especially the big data approach promises advantages of volume in comparison with small samples in good quality. Aim of this study was to review this issue. Based on the experiences with six registries within a German funding initiative, the definition of data quality provided by the International Organization for Standardization (ISO) was confronted with several aspects of data quantity. The results of a literature search combining both concepts were considered additionally. Data quantity was identified as an umbrella of some inherent characteristics of data like case and data completeness. The same time, quantity could be regarded as a non inherent characteristic of data beyond the ISO standard focusing on the breadth and depth of metadata, i.e. data elements along with their value sets. The FAIR Guiding Principles take into account the latter solely. Surprisingly, the literature agreed in demanding an increase in data quality with volume, turning the big data approach inside out. A usage of data without context - as it could be the case in data mining or machine learning - is neither covered by the concept of data quality nor of data quantity.

Cross-Registry Benchmarking of Data Quality: Lessons Learned.

Feedback of data quality measures to study sites is an established procedure in the management of registries. Comparisons of data quality between registries as a whole are missing. We implemented a cross-registry benchmarking of data quality within the field of health services research for six projects. Five (2020) and six (2021) quality indicators were selected from a national recommendation. The calculation of the indicators was adjusted to the registries' specific settings. Nineteen (2020) and 29 results (2021) could be included in the yearly quality report. Seventy-four per cent (2020) and 79% (2021) of the results did not include the threshold in their 95%-confidence-limits. The benchmarking revealed several starting points for a weak-point analysis through a comparison of results with a predefined threshold as well as through comparisons among each other. In the future, a cross-registry benchmarking might be part of services provided through a health services research infrastructure.

Patient Characteristics in the Recording Courses of Vascular Diseases (Reccord) Registry: Comparison with the Voyager Pad Endovascular Cohort.

BACKGROUND: To compare the characteristics of a "real world" population included in a prospective registry to patients enrolled in a randomized, controlled trial (RCT) after endovascular revascularization (EVR) for symptomatic peripheral artery disease (PAD). METHODS: The RECcording COurses of vasculaR Diseases (RECCORD) registry is an observational registry prospectively recruiting patients undergoing EVR for symptomatic PAD in Germany. VOYAGER PAD was an RCT which demonstrated the superiority of rivaroxaban and aspirin versus aspirin to reduce major cardiac and ischemic limb events following infrainguinal revascularization for symptomatic PAD. For this exploratory analysis, the clinical characteristics of 2.498 patients enrolled in RECCORD and of 4.293 patients from VOYAGER PAD who underwent EVR were compared. RESULTS: The rate of patients aged ≥ 75 years was considerably higher in the registry (37.7 vs. 22.5%). More patients in the registry had undergone previous EVR (50.7 vs. 38.7%) or suffered from critical limb threatening ischemia (24.3 vs. 19.5%). Registry patients were more commonly active smokers (51.8 vs. 33.6%), but less frequently suffered from diabetes mellitus (36.4 vs. 44.7%). While statins (70.5 vs. 81.7%) were less frequently used, antiproliferative catheter technologies (45.6 vs. 31.4%) and postinterventional dual antiplatelet therapy (64.5 vs. 53.6%) were more commonly applied in the registry. CONCLUSIONS: There were many similarities but some clinically meaningful differences in clinical characteristics between PAD patients who underwent EVR and were included in a nationwide registry and PAD patients from the VOYAGER PAD trial.

Clinical Characteristics and Current Practice of Endovascular Revascularization in Aorto-Iliac, Femoropopliteal and Infra-Popliteal Lower Extremity Artery Disease-Insights from the RECCORD Registry.

BACKGROUND: Endovascular revascularization (EVR) is a pillar of therapeutic management in patients with symptomatic lower extremity artery disease (LEAD). Due to lack of scientific evidence, the approach of EVR type and the devices used at the different anatomic vascular segments of the lower limbs vary substantially between operators and centers. We analyzed data from the RECcording COurses of vasculaR Diseases (RECCORD) registry to assess the current real-world EVR treatment patterns in relation to anatomic vascular segments in symptomatic LEAD patients in Germany. PATIENTS AND METHODS: RECCORD is an ongoing, prospective, multicenter, all-comers and entirely web-based registry platform. Baseline demographic and periprocedural data of patients undergoing EVR for symptomatic LEAD were assessed and performed EVRs were grouped according to the intervened anatomic vascular segment. We analyzed four EVR groups comprising either the aorto-iliac, femoropopliteal, or infrapopliteal segments (all these EVRs with or without a further intervention in another anatomic segment) or the infrapopliteal segment alone. RESULTS: A total of 2210 EVR segments (in 1639 patients) were analyzed. Of those 616 (27.9%) were aorto-iliacal, 1346 (60.9%) femoropopliteal, 248 (11.2%) infrapopliteal and 104 (4.7%) only infrapopliteal segments. Aorto-iliac EVR was associated with younger age, smoking, claudication and simple lesions, while the distal infrapopliteal EVRs were related to advanced age, diabetes, multiple comorbidities, limb threatening ischemia and complex lesions. The use of different EVR devices at the aorto-iliac, femoropopliteal, infrapopliteal and only infrapopliteal segments were: only ballon-angioplasty: 8.3%, 12.9%, 58.1% and 63.5%; stenting: 82.3%, 45.3%, 16.9% and 12.5%; drug-coated balloon: 11.2%, 55.0%, 19.4% and 19.2%. CONCLUSION: The RECCORD registry data demonstrate that in LEAD clinical and lesion characteristics are related to anatomic vascular segments. Despite the clear relationship between vascular segments and the current use of device types, prospective, segment-specific clinical studies are warranted to establish a consistent, evidence-based path for EVR in LEAD.

ICT Tools for Registry Research: A Market Survey.

Registries in health research are complex systems requiring a diverse infrastructure with information and communications technology tools (ICT tools) for manifold tasks. Those tools should support not only data management but also several core and accompanying processes. Recent trends in registry research also need to be taken into account. Thirty-five vendors, suppliers, and experts were included in a survey on ICT tools for registries and cohorts. Information from 28 tools was available for a preliminary analysis. In comparison to 2015 and 2018, coverage of core processes such as registry development or data analysis and utilization increased from below 40% to 39% and higher. Recording patient-reported information and linkage to other data collections was well covered. However, near-patient trends were less supported. The market offers a rich selection of commercial and non-commercial ICT tools for registry research. Due to the manifold offers available from the market, in-house developed software should be an absolute exception.

Metadata Definition in Registries: What Is a Data Element?

Observational research benefits from a rich methodological foundation of registry development and operation published in international and national guidelines. Metadata management is an essential part of registry implementation based on concepts of data elements and value sets. The metadata from six German registries revealed vastly divergent interpretations of the concept of data elements. The different perspectives of research questions, data acquisition and data storage were all represented in the registries' catalogs of data elements. Consequently, the whole life cycle of a registry needs to be accompanied by a catalog of data elements, which has to be continuously adapted to the changing perspectives. A standard for the representation of those metadata is still missing. The FAIR Guiding Principles introduce important methodological requirements, but the tools for their fulfillment in respect to the management of metadata are still in its infancy.

Safety and Effectiveness of Endovascular Therapy for the Treatment of Peripheral Artery Disease in Patients with and without Diabetes Mellitus.

This study investigated the distribution of risk factors, lesion characteristics and endovascular revascularization (EVR) strategies in patients with peripheral arterial disease (PAD) with vs without diabetes mellitus (DM). Data were collected within the RECcording COurses of vasculaR Diseases (RECCORD) registry. Demographic data, lesion localization (iliac vs femoropopliteal vs below-the-knee (BTK)) and lesion complexity score (LCS) based on number of affected segments, and lesion length (< 10 vs 10-20 vs > 20 cm), EVR strategies and peri-procedural complications were analysed in 786 patients with and 1337 without diabetes mellitus. Patients with diabetes mellitus were older (71.6 ± 9.6 vs 69.4 ± 10.5 years, P < .001) and had higher LCS and more often BTK lesions (P < .05 for all). Lesions were treated less frequently with stents (48.7 vs 59.6%, P < .001) in patients with diabetes mellitus, whereas a non-significant trend was noticed for higher DCB treatment rates (48.3 vs 44.4%, P = .07). Post-interventional ankle-brachial index (ABI) increase was similar (from .77 ± .28 to .92 ± .25 with diabetes mellitus and from .74 ± .21 to .90 ± .20 without diabetes mellitus, P < .001 for both). Peri-/post-procedural complications were low in both groups (4.6%). Patients with diabetes mellitus, who undergo endovascular revascularization are older, have more comorbidities and higher target lesion complexity. However, treatment success rates are similar and complication rates are low.

FAIR and Quality Assured Data - The Use Case of Trueness.

The FAIR Guiding Principles do not address the quality of data and metadata. Therefore, data collections could be FAIR but useless. In a funding initiative of registries for health services research, trueness of data received special attention. Completeness in the definition of recall was selected to represent this dimension in a cross-registry benchmarking. The first analyses of completeness revealed a diversity of its implementation. No registry was able to present results exactly as requested in a guideline on data quality. Two registries switched to a source data verification as alternative, the three others downsized to the dimension integrity. The experiences underline that the achievement of appropriate data quality is a matter of costs and resources, whereas the current Guiding Principles quote for a transparent culture regarding data and metadata. We propose the extension to FAIR-Q, data collections should not only be findable, accessible, interoperable, and reusable, but also quality assured.

Understanding the Nature of Metadata: Systematic Review.

BACKGROUND: Metadata are created to describe the corresponding data in a detailed and unambiguous way and is used for various applications in different research areas, for example, data identification and classification. However, a clear definition of metadata is crucial for further use. Unfortunately, extensive experience with the processing and management of metadata has shown that the term "metadata" and its use is not always unambiguous. OBJECTIVE: This study aimed to understand the definition of metadata and the challenges resulting from metadata reuse. METHODS: A systematic literature search was performed in this study following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for reporting on systematic reviews. Five research questions were identified to streamline the review process, addressing metadata characteristics, metadata standards, use cases, and problems encountered. This review was preceded by a harmonization process to achieve a general understanding of the terms used. RESULTS: The harmonization process resulted in a clear set of definitions for metadata processing focusing on data integration. The following literature review was conducted by 10 reviewers with different backgrounds and using the harmonized definitions. This study included 81 peer-reviewed papers from the last decade after applying various filtering steps to identify the most relevant papers. The 5 research questions could be answered, resulting in a broad overview of the standards, use cases, problems, and corresponding solutions for the application of metadata in different research areas. CONCLUSIONS: Metadata can be a powerful tool for identifying, describing, and processing information, but its meaningful creation is costly and challenging. This review process uncovered many standards, use cases, problems, and solutions for dealing with metadata. The presented harmonized definitions and the new schema have the potential to improve the classification and generation of metadata by creating a shared understanding of metadata and its context.

Value of the Electronic Medical Record for Hospital Care: Update From the Literature.

BACKGROUND: Electronic records could improve quality and efficiency of health care. National and international bodies propagate this belief worldwide. However, the evidence base concerning the effects and advantages of electronic records is questionable. The outcome of health care systems is influenced by many components, making assertions about specific types of interventions difficult. Moreover, electronic records itself constitute a complex intervention offering several functions with possibly positive as well as negative effects on the outcome of health care systems. OBJECTIVE: The aim of this review is to summarize empirical studies about the value of electronic medical records (EMRs) for hospital care published between 2010 and spring 2019. METHODS: The authors adopted their method from a series of literature reviews. The literature search was performed on MEDLINE with "Medical Record System, Computerized" as the essential keyword. The selection process comprised 2 phases looking for a consent of both authors. Starting with 1345 references, 23 were finally included in the review. The evaluation combined a scoring of the studies' quality, a description of data sources in case of secondary data analyses, and a qualitative assessment of the publications' conclusions concerning the medical record's impact on quality and efficiency of health care. RESULTS: The majority of the studies stemmed from the United States (19/23, 83%). Mostly, the studies used publicly available data ("secondary data studies"; 17/23, 74%). A total of 18 studies analyzed the effect of an EMR on the quality of health care (78%), 16 the effect on the efficiency of health care (70%). The primary data studies achieved a mean score of 4.3 (SD 1.37; theoretical maximum 10); the secondary data studies a mean score of 7.1 (SD 1.26; theoretical maximum 9). From the primary data studies, 2 demonstrated a reduction of costs. There was not one study that failed to demonstrate a positive effect on the quality of health care. Overall, 9/16 respective studies showed a reduction of costs (56%); 14/18 studies showed an increase of health care quality (78%); the remaining 4 studies missed explicit information about the proposed positive effect. CONCLUSIONS: This review revealed a clear evidence about the value of EMRs. In addition to an awesome majority of economic advantages, the review also showed improvements in quality of care by all respective studies. The use of secondary data studies has prevailed over primary data studies in the meantime. Future work could focus on specific aspects of electronic records to guide their implementation and operation.

[Cross-Project Support of Registries in Development, Implementation and Operation]. / Projektübergreifende Unterstützung von Registern in Entwicklung, Umsetzung und Betrieb.

OBJECTIVE: The German Federal Ministry of Education and Research funded a project accompanying a funding initiative for registries in health services research. The aim was to provide cross-registry support initially for 16 and later 6 projects with regard to methodological, technical and structural standards. METHODS: The 16 projects were initially guided in concept development, e. g., providing a template for a registry protocol. Furthermore, an expert consultation was organized and carried out. To assist in the selection of an IT solution, a challenge workshop was hosted where different vendors presented their software for registries. The catalogs of data elements of the projects were migrated into a metadata catalog and transferred to the standard model of ISO/IEC 11179. A set of quality indicators was defined for a cross-registry quality management approach to be implemented during the operational phase. To improve data quality, the indicators were to be transmitted and evaluated on a regular basis. RESULTS: The template for a registry protocol was used by the majority of projects when applying for funding of their operational phase. At the workshop on IT solutions, 12 products for registry software were presented; however, the projects opted for other solutions for different reasons. Transferring the catalogs of data elements into a standard model enabled a comparison of attributes and value sets, which in turn enabled formulation of recommendations for important elements. A set of five quality indicators was defined for quality management, for which an initial evaluation was carried out for 2020. CONCLUSION: The template of a registry protocol serves a systematic development of a concept. The use of a uniformly structured catalog of data elements supports compliance with the FAIR principles. Monitoring of data quality can be achieved by regularly identifying quality indicators across registries.

Metadata of Registries: Results from an Initiative in Health Services Research.

Metadata management is an essential condition to follow the FAIR principles. Therefore, metadata management was one asset of an accompanying project within a funding scheme for registries in health services research. The metadata of the funded projects were acquired, combined in a database compatible with the metamodel of ISO/IEC 11179 "Information technology - Metadata registries" third edition (ISO/IEC 11179-3), and analyzed in order to support the development and the operation of the registries. In the second phase of the funding scheme, six registries delivered a complete update of their metadata. The mean number of data elements increased from 245.7 to 473.5 and the mean number of values from 569.5 to 1,306.0. The conceptual core of the database had to be extended by one third to cover the new elements. The reason for this increase remained unclear. Constraints from the grant might be causal, a deviation from an evidence-based development process as well. It is questionable, whether the revealed quality of the metadata is sufficient to fulfill the FAIR principles. The extension of the metamodel of ISO/IEC 11179-3 is in agreement with the literature. However, further research is needed to find workable solutions for metadata management.