Is OpenSDE an alternative for dedicated medical research databases? An example in coronary surgery.

BACKGROUND: When using a conventional relational database approach to collect and query data in the context of specific clinical studies, a study with a new data set usually requires the design of a new database and entry forms. OpenSDE (SDE = Structured Data Entry) is intended to provide a flexible and intuitive way to create databases and entry forms for the collection of data in a structured format. This study illustrates the use of OpenSDE as a potential alternative to a conventional approach with respect to data modelling, database creation, data entry, and data extraction. METHODS: A database and entry forms are created using OpenSDE and MSAccess to support collection of coronary surgery data, based on the Adult Cardiac Surgery Data Set of the Society of Thoracic Surgeons. Data of 52 cases are entered and nine different queries are designed, and executed on both databases. RESULTS: Design of the data model and the creation of entry forms were experienced as more intuitive and less labor intensive with OpenSDE. Both resulting databases provided sufficient expressiveness to accommodate the data set. Data entry was more flexible with OpenSDE. Queries produced equal and correct results with comparable effort. CONCLUSION: For prospective studies involving well-defined and straight forward data sets, OpenSDE deserves to be considered as an alternative to the conventional approach.

Computerized endoscopic reporting is no more time-consuming than reporting with conventional methods.

BACKGROUND: Endoscopists use different methods for reporting their findings after a gastrointestinal endoscopy. These may result in handwritten, dictated, or computerized reports. The time needed to create the report is an important parameter for acceptance of the method used. It is also important to be aware of the possible advantages and disadvantages of these different methods. The aim of this study was to compare time aspects of different methods of report writing. METHODS: Three different methods of report writing, i.e., handwritten, dictated, and computerized, were compared. In three different endoscopy departments, one investigator recorded the time needed to compose the report and to send it to the referring doctor. The time needed to describe different diagnoses at endoscopy was compared between the systems. RESULTS: Handwritten reports were completed in an average time of 113 s, free text dictated reports by the endoscopist in 65 s with an additional 172 s allowed for the typist, and computerized, pre-defined reports were completed in 86 s. The incidences of abnormalities found in the reports of the different hospitals were comparable. CONCLUSION: To a large extent, computerized, pre-defined reports could be composed in almost the same amount of time as handwritten and dictated reports. Free text dictated and computerized, pre-defined reports are both stored in the hospital information system, but only computerized, pre-defined reports including endoscopic pictures are stored in a structured database, which makes statistical analysis possible.

Structured data entry for narrative data in a broad specialty: patient history and physical examination in pediatrics.

BACKGROUND: Whereas an electronic medical record (EMR) system can partly address the limitations, of paper-based documentation, such as fragmentation of patient data, physical paper records missing and poor legibility, structured data entry (SDE, i.e. data entry based on selection of predefined medical concepts) is essential for uniformity of data, easier reporting, decision support, quality assessment, and patient-oriented clinical research. The aim of this project was to explore whether a previously developed generic (i.e. content independent) SDE application to support the structured documentation of narrative data (called OpenSDE) can be used to model data obtained at history taking and physical examination of a broad specialty. METHODS: OpenSDE was customized for the broad domain of general pediatrics: medical concepts and its descriptors from history taking and physical examination were modeled into a tree structure. RESULTS: An EMR system allowing structured recording (OpenSDE) of pediatric narrative data was developed. Patient history is described by 20 main concepts and physical examination by 11. In total, the thesaurus consists of about 1800 items, used in 8648 nodes in the tree with a maximum depth of 9 levels. Patient history contained 6312 nodes, and physical examination 2336. User-defined entry forms can be composed according to individual needs, without affecting the underlying data representation. The content of the tree can be adjusted easily and sharing records among different disciplines is possible. Data that are relevant in more than one context can be accessed from multiple branches of the tree without duplication or ambiguity of data entry via "shortcuts". CONCLUSION: An expandable EMR system with structured data entry (OpenSDE) for pediatrics was developed, allowing structured documentation of patient history and physical examination. For further evaluation in other environments, the tree structure for general pediatrics is available at the Erasmus MC Web site (in Dutch, translation into English in progress) 1. The generic OpenSDE application is available at the OpenSDE Web site 2.

Paper versus computer: feasibility of an electronic medical record in general pediatrics.

BACKGROUND: Implementation of electronic medical record systems promises significant advances in patient care, because such systems enhance readability, availability, and data quality. Structured data entry (SDE) applications can prompt for completeness, provide greater accuracy and better ordering for searching and retrieval, and permit validity checks for data quality monitoring, research, and especially decision support. A generic SDE application (OpenSDE) to support documentation of patient history and physical examination findings was developed and tailored for the domain of general pediatrics. OBJECTIVE: To evaluate OpenSDE for its completeness, uniformity of reporting, and usability in general pediatrics. METHODS: Four (trainee) pediatricians documented data for 8 first-visit patients in the traditional, paper-based, medical record and immediately thereafter in OpenSDE (electronic record). The 32 paper records obtained served as the common data source for data entry in OpenSDE by the other 3 physicians (transcribed record). Data entered by 2 experienced users, with all patient information present in the paper record, served as the control record. Data entry times were recorded, and a questionnaire was used to assess users' experiences with OpenSDE. RESULTS: Clinicians documented 44% of all available patient information identically in the paper and electronic records. Twenty-five percent of all patient information was documented only in the paper record, and 31% was present only in the electronic record. Differences were found in patient history and physical examination documentation in the electronic record; more information was missing for patient history (38%) than for physical examination (15%). Furthermore, physical examination contained more additional information (39%) than did patient history (21%). The interobserver agreement of documentation of patient information from the same data source was fair to moderate, with kappa values of 0.39 for patient history and 0.40 for physical examination. Data entry times in OpenSDE decreased from 25 minutes to <15 minutes, indicating a learning effect. The questionnaire revealed a positive attitude toward the use of OpenSDE in daily practice. CONCLUSION: OpenSDE seems to be a promising application for the support of physician data entry in general pediatrics.

Extracting data recorded with OpenSDE: possibilities and limitations.

PURPOSE: OpenSDE is an application intended to support structured data entry in a variety of settings, such as routine care and clinical research. The past years development has focused on data entry to support expressiveness and flexibility. The focus is now shifting to data extraction: what are the possibilities for extracting the data and does the adopted strategy pose limitations? METHODS: Data extraction is supported by presenting the concepts for extraction in the same tree structure as for data entry. Users can select all or a sub selection of these concepts for extraction. Selected concepts are extracted and converted to a table format that can be queried using conventional tools. RESULTS: The extraction tool (entity export) provides a successful technical solution for data extraction. Using the extracted data, however, leads to obstacles that are a result of a fundamental design principle of OpenSDE.

OpenSDE: a strategy for expressive and flexible structured data entry.

PURPOSE: This description focuses on the expressiveness and flexibility of OpenSDE: an application that supports recording of structured narrative data. METHODS: OpenSDE enables data entry with (customizable) forms based on trees of medical concepts. The relevant scope for data entry can be tailored per medical domain by construction of a domain-specific tree. OpenSDE is intended for structuring narrative data to make these available for both care and research. RESULTS: The OpenSDE application is currently in use at several departments in our academic hospital, including radiology, neurology, pediatrics, and child psychiatry. OpenSDE is available for all in open source.

Why are structured data different? Relating differences in data representation to the rationale of OpenSDE.

OpenSDE is an application that supports clinicians with structured recording of narrative patient data to enable use of data in both clinical practice and research. OpenSDE is based on a rationale and requirements for structured data entry. In this study, we analyse the impact of the rationale and the requirements on data representation using OpenSDE. Three paediatricians transcribed 20 paper patient records using OpenSDE. The transcribed records were compared; the findings that were the same in content but differed in representation (e.g. recorded as free text instead of in a structured manner) were categorized in one of three categories of difference in representation. The transcribed records contained 1764 findings in total. The medical content of 302 of these findings was represented differently by at least one clinician and was thus included in this study. In OpenSDE, clinicians are free to determine the degree of detail at which patient data are described. This flexibility accounts for 87% of the differences in data representation. Thirteen per cent of the differences are due to clinicians interpreting and translating phrases from the source text and transcribing these to (different) concepts in OpenSDE. The differences in data representation largely result from initial design decisions for OpenSDE.

Generic computer-based questionnaires: an extension to OpenSDE.

Development of computer-based questionnaires (CQs) has been an ongoing challenge since the 1960s. The added value of such CQs for data collection and the acceptance by patients have been well documented. Many questionnaire projects, however, were temporary due to dedicated software, limited funding, and lack of integration with medical information systems. Also, the use of a fixed dedicated database makes integration cumbersome, as change in content requires change to the data model. Since much of the functional requirement of CQs is not dependent on content, the challenge is to both separate functionality and database structure from content. Following these principles, we extended OpenSDE, a generic application for structured data entry, with a tool to construct and run CQs as an alternative way of data input. We propose the combination of a generic building tool and a content-independent data model as an effective strategy to tackle the above-mentioned problems in CQ development.

OpenSDE: Row modeling applied to generic structured data entry.

Clinicians generally record medical narrative data, such as current complaints, physical examination, and progress notes, as free text in paper-based medical records. The medical narrative involves heterogeneous and detailed data that include the description of (multiple) occurrences of medical findings or symptoms that may progress over time. Structured, electronic recording of narrative data would facilitate the use of these data for research. The authors' OpenSDE application supports clinicians with the structured recording of narrative data in both research and care settings. Data entry is enabled using forms that are generated using domain-specific trees of medical concepts. For data storage, the authors have expanded the traditional row modeling methodology with additional columns that allow structured representation of medical narratives including descriptions of findings, multiple occurrences of findings, and the progression of findings over time.

The computerized patient record: balancing effort and benefit.

PROMISE AND REALITY: this review addresses two questions. First, why is the introduction of the computerized patient record (CPR) so slow, while its potential for improved quality of care and reduction of cost is well recognized? Second, what, in this respect, is the role of record architecture and standardization? BARRIERS: the impediments for CPR adoption are put in a larger context by addressing the relationship among effort, benefit, and the parties involved. An important financial impediment is insufficient return of investment. Other hurdles related to the use of CPRs are lack of integration and flexibility, which cause clinicians to experience insufficient reward to motivate them for data entry and changes in working style. Effort and benefit have to be balanced for each party involved. REQUIREMENTS FOR IMPROVEMENT: lack of standardization impedes exchange and sharing of medical data, and new developments cause fear of applications to become outdated. Flexibility in content and use, integration, and adaptability to change, are key requirements for CPR systems. These requirements can most effectively be met through an architecture that separates content and structure, such that the road to standardization is not paved with frequent expensive adaptations. STRATEGIES FOR IMPLEMENTATION: successful implementation and acceptance require reliable evaluation of applications by independent professional groups. Users need to be involved in setting priorities and planning for actual implementation.