A comparative effectiveness study of eSource used for data capture for a clinical research registry.

OBJECTIVE: This pilot study compared eSource-enabled versus traditional manual data transcription (non-eSource methods) for the collection of clinical registry information. The primary study objective was to compare the time spent completing registry forms using eSource versus non-eSource methods The secondary objectives were to compare data quality associated with these two data capture methods and the flexibility of the workflows. This study directly addressed fundamental questions relating to eSource adoption: what time-savings can be realized, and to what extent does eSource improve data quality. MATERIALS AND METHODS: The study used time and motion methods to compare eSource versus non-eSource data capture workflows for a single center OB/GYN registry. Direct observation by industrial engineers using specialized computer software captured keystrokes, mouse clicks and video recordings of the study team in their normal work environment completing real-time data collection. RESULTS: The overall average data capture time was reduced with eSource versus non-eSource methods (difference, 151s per case; eSource, 1603s; non-eSource, 1754s; p=0.051). The average data capture time for the demographic data was reduced (difference, 79s per case; eSource, 133s; non-eSource, 213s; p<0.001). This represents a 37% time reduction (95% confidence interval 27% to 47%). eSourced data field transcription errors were also reduced (eSource, 0%; non-eSource, 9%). CONCLUSION: The use of eSource versus traditional data transcription was associated with a significant reduction in data entry time and data quality errors. Further studies in other settings are needed to validate these results.

Leveraging a Statewide Clinical Data Warehouse to Expand Boundaries of the Learning Health System.

Learning Health Systems (LHS) require accessible, usable health data and a culture of collaboration-a challenge for any single system, let alone disparate organizations, with macro- and micro-systems. Recently, the National Science Foundation described this important setting as a cyber-social ecosystem. In 2004, in an effort to create a platform for transforming health in South Carolina, Health Sciences South Carolina (HSSC) was established as a research collaboration of the largest health systems, academic medical centers and research intensive universities in South Carolina. With work beginning in 2010, HSSC unveiled an integrated Clinical Data Warehouse (CDW) in 2013 as a crucial anchor to a statewide LHS. This CDW integrates data from independent health systems in near-real time, and harmonizes the data for aggregation and use in research. With records from over 2.7 million unique patients spanning 9 years, this multi-institutional statewide clinical research repository allows integrated individualized patient-level data to be used for multiple population health and biomedical research purposes. In the first 21 months of operation, more than 2,800 de-identified queries occurred through i2b2, with 116 users. HSSC has developed and implemented solutions to complex issues emphasizing anti-competitiveness and participatory governance, and serves as a recognized model to organizations working to improve healthcare quality by extending the traditional borders of learning health systems.

Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents.

BACKGROUND: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. PURPOSE: The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow. METHODS: The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. RESULTS: An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. LIMITATIONS: There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. CONCLUSIONS: We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.

An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting.

PURPOSE: Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system - an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. METHODS: This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. RESULTS: The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. DISCUSSION: The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences.

Challenges that limit meaningful use of health information technology.

PURPOSE: Health information technology (HIT) is perceived as an essential component for addressing inefficiencies in healthcare. Without understanding the challenges that limit meaningful use of HIT, there is a high chance that institutions will convert complex paper-based systems to expensive digital chaos. RECENT FINDINGS: Clinical information systems do not communicate with each other automatically because integration of existing data standards is lacking. Data standards for medical specialties need further development. Database architectures are often designed to support single clinical applications and are not easily modified to meet the enterprise-wide needs desired by all end-users. Despite the improvements in charge capture and better access to health information the realized savings and impact on patient throughput is not enough to cover the cost of the technology, maintenance, and support. HIT is necessary for improved quality of care but it increases the cost of doing business. Poor user interface and system design hinders clinical workflow and can result in wasted time, poor data collection, misleading data analysis, and potentially negative clinical outcomes. Healthcare organizations have little recourse if a vendor fails to deliver as intended once the vendor's system becomes embedded into the organization. Decisions on technology acquisitions and implementations are often made by individuals or groups that lack clinical informatics expertise. SUMMARY: Government incentives to increase HIT will likely result in a more computerized clinical environment. Understanding the challenges can help avoid costly mistakes. The future looks promising but caution is warranted, as achievement of full benefits of HIT requires addressing significant challenges.

A Biomedical Research Permissions Ontology: Cognitive and Knowledge Representation Considerations.

In designing a comprehensive mechanism for managing informed consents and permissions for biomedical research involving human participants, a significant effort is dedicated to the development of standardized classification of these consents and permissions. In this paper, we describe the considerations and implications of this effort that should be addressed during the development of a Biomedical Research Permissions Ontology (RPO). It is hoped that this standardization will allow disparate research institutions to pool research data and associated consents and permissions in order to facilitate collaborative translational research projects across multiple institutions and subsequent new breakthroughs in medicine while providing: 1) essential built in protections for privacy and confidentiality of research participants and 2) a mechanism for insuring that researchers adhere to patient's intent whether to participate in research or not.