Set Of Common Data Elements Research Articles

Core Outcomes and Common Data Elements in Chronic Subdural Hematoma: A Systematic Review of the Literature Focusing on Baseline and Peri-Operative Care Data Elements.

Chronic subdural hematoma (CSDH) is an increasingly common subtype of head injury, especially in the elderly population. The optimization of treatment strategies has been hampered by the collection of heterogeneous outcome measures and data elements, precluding cross-study comparisons. This study aimed to quantify the heterogeneity of data elements in the pre-operative, operative, and post-operative phases of care, and build the basis for the development of a set of common data elements (CDEs) for CSDH. This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was registered with the PROSPERO register of systematic reviews (CRD42014007266). All full-text English studies with more than 10 patients (prospective) or more than 100 patients (retrospective) published after 1990 examining clinical outcomes in CSDH were eligible for inclusion. One hundred two eligible studies were found. Only 40 studies (39.2%) reported the main presenting symptom/feature and 24 (23.5%) reported additional symptoms/features. Admitting neurological/functional status was classified by the Glasgow Coma Scale (25 studies; 24.5%), the Markwalder Score (26 studies; 25.5%) and the modified Rankin Scale (three studies; 2.9%). Fifty-four studies (52.9%) made some mention of patient comorbidities and 58 studies (56.9%) reported the proportion or excluded patients on anticoagulant medication. Eighteen studies (17.6%) reported baseline coagulation status. Sixty-four studies (62.7%) stratified or assessed severity based on radiological findings, although the methods used varied widely. There was variable reporting of surgical technique and post-operative care; 32 studies (31.4%) made no mention of whether the operations were performed under general or local anesthetic. This study, a part of the Core Outcomes and Common Data Elements in CSDH (CODE-CSDH) project, confirms and quantifies the heterogeneity of data elements collected and reported in CSDH studies to date. It establishes the basis for the consensus-based development of a set of common data elements, facilitating robust cross-study comparisons and resulting improvements in patient outcomes.

The National Athletic Treatment, Injury and Outcomes Network (NATION): Methods of the Surveillance Program, 2011–2012 Through 2013–2014

Previous epidemiologic researchers have examined time-loss (TL) injuries in high school student-athletes, but little is known about the frequency of non-time-loss (NTL) injuries in these athletes. To describe the methods of the National Athletic Treatment, Injury and Outcomes Network (NATION) Surveillance Program and provide descriptive epidemiology of TL and NTL injuries across athletes in 27 high school sports. Descriptive epidemiology study. Aggregate injury and exposure data collected from 147 high schools in 26 states. High school student-athletes participating in 13 boys' sports and 14 girls' sports during the 2011-2012 through 2013-2014 academic years. Athletic trainers documented injuries and exposures using commercially available injury-tracking software packages. Standard injury-tracking software was modified by the software vendors to conform to the surveillance needs of this project. The modified software exported a set of common data elements, stripped of personally identifiable information, to a centralized automated verification and validation system before they were included in the centralized research database. Dependent measures were injury and exposure frequencies and injury rates with 95% confidence intervals stratified by sport, sex, and injury type (TL or NTL). Over the 3-year period, a total of 2337 team seasons across 27 sports resulted in 47 014 injuries and 5 146 355 athlete-exposures. The NTL injuries accounted for 38 765 (82.45%) and TL injuries for 8249 (17.55%) of the total. The NTL injuries accounted for a substantial amount of the total number of injuries sustained by high school student-athletes. This project demonstrates the feasibility of creating large-scale injury surveillance systems using commercially available injury-tracking software.

NIH/NCATS/GRDR® Common Data Elements: A leading force for standardized data collection

The main goal of the NIH/NCATS GRDR® program is to serve as a central web-based global data repository to integrate de-identified patient clinical data from rare disease registries, and other data sources, in a standardized manner, to be available to researchers for conducting various biomedical studies, including clinical trials and to support analyses within and across diseases. The aim of the program is to advance research for many rare diseases. One of the first tasks toward achieving this goal was the development of a set of Common Data Elements (CDEs), which are controlled terminologies that represent collected data. A list of 75 CDEs was developed by a national committee and was validated and implemented during a period of 2 year proof of concept. Access to GRDR CDEs is freely available at: https://grdr.ncats.nih.gov/index.php?option=com_content&view=article&id=3&Itemid=5. The GRDR CDEs have been the cornerstone of the GRDR repository, as well as of several other national and international patient registries. The establishment of the GRDR program has elevated the issue of data standardization and interoperability for rare disease patient registries, to international attention, resulting in a global dialog and significant change in the mindset of registry developers, patient advocacy groups, and other national and international organizations.

Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project.

To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. International Working Groups. Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team before release. The NINDS SCI CDEs and supporting documents are publically available on the NINDS CDE website and the ISCoS website. The CDEs span the continuum of SCI care and the full range of domains of the International Classification of Functioning, Disability and Health. Widespread use of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence is obtained.

Development of the International Thymic Malignancy Interest Group International Database: An Unprecedented Resource for the Study of a Rare Group of Tumors

Our knowledge of thymic malignancies has largely been derived from small, single-institution series. Recognition of the need for broad collaboration led to the creation of the International Thymic Malignancy Interest Group (ITMIG) and the development of a large, centralized database to advance knowledge of these rare tumors. A multidisciplinary Database Committee was convened to define a common set of data elements a priori. Retrospective data were solicited from ITMIG members and collated using standardized fields. Patients with thymoma, thymic carcinoma, or thymic carcinoid were included. Over a 6-month period, 47 institutions spanning 15 countries contributed a total of 6097 cases (mean, 129 [range, 10-1209]). The sex distribution was equal for thymomas, but there was a greater proportion of men with thymic carcinoma and thymic carcinoid (p < 0.0001). Nearly all cases (99%) were treated surgically. WHO type B2 was the most frequent histologic classification among thymomas, whereas squamous was the most common among thymic carcinomas. In total, 38% of patients with thymoma had myasthenia gravis compared with less than or equal to 5% for thymic carcinoma and thymic carcinoid. Median overall survival was 18.9 years (95% confidence interval [CI], 17.4-20.3) for thymoma, 6.8 years (95% CI, 5.5-7.9) for thymic carcinoma, and 7.5 years (95% CI, 6.5-8.5) for thymic carcinoid. The rapid creation of the ITMIG database demonstrates the feasibility of international collaboration for this rare set of malignancies and attests to the engagement of its membership. This database represents the largest collective data set ever assembled and provides an unprecedented resource for research of these tumors.

Improving the quality of cancer care in America.

Thomas Feeley is the Helen Shafer Fly Distinguished Professor of Anesthesiology, and the Head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center (TX, USA), which he has led since its formation in 2008. He received his undergraduate degree and M.D. from Boston University (MA, USA) and trained in anesthesiology and critical care medicine at Harvard’s Beth Israel Hospital in Boston. He was a faculty member at Stanford University (CA, USA) for 19 years prior to moving to The University of Texas MD Anderson Cancer Center in 1997 to lead the then newly created Division of Anesthesiology and Critical Care. Dr Feeley served on the Institute of Medicine’s Committee on Improving the Quality of Cancer Care: Addressing the Challenges of an Aging Population that published its report in September of 2013. He was recently appointed by Texas Governor Rick Perry to the board of directors of the Texas Institute for Health Care Quality and Efficiency. In addition to his research and administrative roles, Dr Feeley provides patient care services in the delivery of anesthesia.

Assessing the impact of patient navigation: prevention and early detection metrics.

The lack of comparable metrics to evaluate prevention and early detection patient navigation programs impeded the ability to identify best practices. The Prevention and Early Detection Workgroup of the Patient Navigation Leadership Summit was charged with making recommendations for common clinical metrics specific to the prevention and early detection phase of the cancer care continuum. The workgroup began with a review of existing literature to characterize variability in published navigation metrics; then developed a list of priority recommendations that would be applicable to the range of navigation settings (clinical, academic, or community-based). Recommendations for researchers and program evaluators included the following: 1) Clearly document key program characteristics; 2) Use a set of core data elements to form the basis of your reported metrics; and 3) Prioritize data collection using methods with the least amount of bias. If navigation programs explicitly state the context of their evaluation and choose from among the common set of data elements, meaningful comparisons among existing programs should be feasible.

Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements

Thurmond VA, Hicks R, Gleason T, Miller AC, Szuflita N, Orman J, Schwab K. Advancing integrated research in psychological health and traumatic brain injury: common data elements. In civilian, military, and veteran populations, there is increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders and the need to better understand the relationships by integrating research for these topics. The use of different measures to assess similar study variables and/or assess outcomes may limit important advances in PH and TBI research. Without a set of common data elements (CDEs; to include variable definitions and recommended measures for the purpose of this discussion), comparison of findings across studies is challenging. The federal agencies involved in PH and TBI research, the National Institute of Neurological Disorders and Stroke, Department of Veterans Affairs, National Institute on Disability and Rehabilitation Research, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, and Defense and Veterans Brain Injury Center, therefore cosponsored a scientific initiative to develop CDEs for PH and TBI research. Scientific experts were invited to participate in 1 of 8 working groups to develop recommendations for specific topic-driven CDEs. Draft recommendations were presented and discussed in the workshop “Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements (CDE)” held on March 23–24, 2009, in Silver Spring, MD. The overall process leading to the workshop and subsequent recommendations by the working groups are presented in this article. Topic-driven recommendations for CDEs are presented in individual reports in this edition.

An informatics supported web-based data annotation and query tool to expedite translational research for head and neck malignancies.

BackgroundThe Specialized Program of Research Excellence (SPORE) in Head and Neck Cancer neoplasm virtual biorepository is a bioinformatics-supported system to incorporate data from various clinical, pathological, and molecular systems into a single architecture based on a set of common data elements (CDEs) that provides semantic and syntactic interoperability of data sets.ResultsThe various components of this annotation tool include the Development of Common Data Elements (CDEs) that are derived from College of American Pathologists (CAP) Checklist and North American Association of Central Cancer Registries (NAACR) standards. The Data Entry Tool is a portable and flexible Oracle-based data entry device, which is an easily mastered web-based tool. The Data Query Tool helps investigators and researchers to search de-identified information within the warehouse/resource through a "point and click" interface, thus enabling only the selected data elements to be essentially copied into a data mart using a multi dimensional model from the warehouse's relational structure.The SPORE Head and Neck Neoplasm Database contains multimodal datasets that are accessible to investigators via an easy to use query tool. The database currently holds 6553 cases and 10607 tumor accessions. Among these, there are 965 metastatic, 4227 primary, 1369 recurrent, and 483 new primary cases. The data disclosure is strictly regulated by user's authorization.ConclusionThe SPORE Head and Neck Neoplasm Virtual Biorepository is a robust translational biomedical informatics tool that can facilitate basic science, clinical, and translational research. The Data Query Tool acts as a central source providing a mechanism for researchers to efficiently find clinically annotated datasets and biospecimens that are relevant to their research areas. The tool protects patient privacy by revealing only de-identified data in accordance with regulations and approvals of the IRB and scientific review committee.

The Clinical Document Architecture and the Continuity of Care Record: A Critical Analysis

Health care provides many opportunities in which the sharing of data between independent sites is highly desirable. Several standards are required to produce the functional and semantic interoperability necessary to support the exchange of such data: a common reference information model, a common set of data elements, a common terminology, common data structures, and a common transport standard. This paper addresses one component of that set of standards: the ability to create a document that supports the exchange of structured data components. Unfortunately, two different standards development organizations have produced similar standards for that purpose based on different information models: Health Level 7 (HL7)'s Clinical Document Architecture (CDA) and The American Society for Testing and Materials (ASTM International) Continuity of Care Record (CCR). The coexistence of both standards might require mapping from one standard to the other, which could be accompanied by a loss of information and functionality. This paper examines and compares the two standards, emphasizes the strengths and weaknesses of each, and proposes a strategy of harmonization to enhance future progress. While some of the authors are members of HL7 and/or ASTM International, the authors stress that the viewpoints represented in this paper are those of the authors and do not represent the official viewpoints of either HL7 or of ASTM International.

Computer-based data collection boosts productivity, regulatory compliance.

Computer-based data collection boosts productivity, regulatory compliance.

The tissue microarray data exchange specification: a community-based, open source tool for sharing tissue microarray data.

BackgroundTissue Microarrays (TMAs) allow researchers to examine hundreds of small tissue samples on a single glass slide. The information held in a single TMA slide may easily involve Gigabytes of data. To benefit from TMA technology, the scientific community needs an open source TMA data exchange specification that will convey all of the data in a TMA experiment in a format that is understandable to both humans and computers. A data exchange specification for TMAs allows researchers to submit their data to journals and to public data repositories and to share or merge data from different laboratories. In May 2001, the Association of Pathology Informatics (API) hosted the first in a series of four workshops, co-sponsored by the National Cancer Institute, to develop an open, community-supported TMA data exchange specification.MethodsA draft tissue microarray data exchange specification was developed through workshop meetings. The first workshop confirmed community support for the effort and urged the creation of an open XML-based specification. This was to evolve in steps with approval for each step coming from the stakeholders in the user community during open workshops. By the fourth workshop, held October, 2002, a set of Common Data Elements (CDEs) was established as well as a basic strategy for organizing TMA data in self-describing XML documents.ResultsThe TMA data exchange specification is a well-formed XML document with four required sections: 1) Header, containing the specification Dublin Core identifiers, 2) Block, describing the paraffin-embedded array of tissues, 3)Slide, describing the glass slides produced from the Block, and 4) Core, containing all data related to the individual tissue samples contained in the array. Eighty CDEs, conforming to the ISO-11179 specification for data elements constitute XML tags used in the TMA data exchange specification. A set of six simple semantic rules describe the complete data exchange specification. Anyone using the data exchange specification can validate their TMA files using a software implementation written in Perl and distributed as a supplemental file with this publication.ConclusionThe TMA data exchange specification is now available in a draft form with community-approved Common Data Elements and a community-approved general file format and data structure. The specification can be freely used by the scientific community. Efforts sponsored by the Association for Pathology Informatics to refine the draft TMA data exchange specification are expected to continue for at least two more years. The interested public is invited to participate in these open efforts. Information on future workshops will be posted at (API we site).

Design and implementation of a national clinical trials registry.

The authors have developed a Web-based system that provides summary information about clinical trials being conducted throughout the United States. The first version of the system, publicly available in February 2000, contains more than 4,000 records representing primarily trials sponsored by the National Institutes of Health. The impetus for this system has come from the Food and Drug Administration (FDA) Modernization Act of 1997, which mandated a registry of both federally and privately funded clinical trials "of experimental treatments for serious or life-threatening diseases or conditions." The system design and implementation have been guided by several principles. First, all stages of system development were guided by the needs of the primary intended audience, patients and other members of the public. Second, broad agreement on a common set of data elements was obtained. Third, the system was designed in a modular and extensible way, and search methods that take extensive advantage of the National Library of Medicine's Unified Medical Language System (UMLS) were developed. Finally, since this will be a long-term effort involving many individuals and organizations, the project is being implemented in several phases.

Deliberations on the dissemination of PORT products: translating research findings into improved patient outcomes.

This report outlines the activities undertaken by the Inter-PORT Dissemination work group during its first 2 years of operation. The work group's initial purpose was to assist the individual PORTs in developing their plans for both disseminating research findings and evaluating the effectiveness of these strategies. However, it became quickly apparent that in a discipline little more than a decade old, a commonly understood vocabulary had yet to be adopted. Even the term "dissemination" held different meaning for different constituencies. Consequently, the work group has tried to encourage the development of both a definitional framework and a set of common data elements of importance to all dissemination programs. The work group has analogously attempted to agree on minimum standards of methodologic rigor as a starting point for coordination of evaluations across PORTs. To help determine the potential for further coordination, a matrix of each individual PORT's target audiences, intervention strategies, and evaluation designs has been constructed. Much remains to be learned before we can know with any certainty how best to translate research findings into useful behavior change and improved patient outcomes. Our goal is that the efforts of the work group will serve to catalyze this process.