A common language for Gulf War Illness (GWI) research studies: GWI common data elements.

AIMS: The Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community. MAIN METHODS: A collective working group of GWI advocates, Veterans, clinicians, and researchers convened to provide consensus on instruments, case report forms, and guidelines for GWI research. A similar initiative, supported by the National Institute of Neurologic Disorders and Stroke (NINDS) was completed for a comparative illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and provided the foundation for this undertaking. The GWI working group divided into two sub-groups (symptoms and systems assessment). Both groups reviewed the applicability of instruments and forms recommended by the NINDS ME/CFS CDE to GWI research within specific domains and selected assessments of deployment exposures. The GWI CDE recommendations were finalized in March 2018 after soliciting public comments. KEY FINDINGS: GWI CDE recommendations are organized in 12 domains that include instruments, case report forms, and guidelines. Recommendations were categorized as core (essential), supplemental-highly recommended (essential for specified conditions, study types, or designs), supplemental (commonly collected, but not required), and exploratory (reasonable to use, but require further validation). Recommendations will continually be updated as GWI research progresses. SIGNIFICANCE: The GWI CDEs reflect the consensus recommendations of GWI research community stakeholders and will allow studies to standardize data collection, enhance data quality, and facilitate data sharing.

Medication Safety in Two Intensive Care Units of a Community Teaching Hospital After Electronic Health Record Implementation: Sociotechnical and Human Factors Engineering Considerations.

OBJECTIVE: The aim of the study was to assess the impact of Electronic Health Record (EHR) implementation on medication safety in two intensive care units (ICUs). METHODS: Using a prospective pre-post design, we assessed 1254 consecutive admissions to two ICUs before and after an EHR implementation. Each medication event was evaluated with regard to medication error (error type, medication-management stage) and impact on patient (severity of potential or actual harm). RESULTS: We identified 4063 medication-related events either pre-implementation (2074 events) or post-implementation (1989 events). Although the overall potential for harm due to medication errors decreased post-implementation only 2 of the 3 error rates were significantly lower post-implementation. After EHR implementation, we observed reductions in rates of medication errors per admission at the stages of transcription (0.13-0, P < 0.001), dispensing (0.49-0.16, P < 0.001), and administration (0.83-0.56, P = 0.011). Within the ordering stage, 4 error types decreased post-implementation (orders with omitted information, error-prone abbreviations, illegible orders, failure to renew orders) and 4 error types increased post-implementation (orders of wrong drug, orders containing a wrong start or stop time, duplicate orders, orders with inappropriate or wrong information). Within the administration stage, we observed a reduction of late administrations and increases in omitted administrations and incorrect documentation. CONCLUSIONS: Electronic Health Record implementation in two ICUs was associated with both improvement and worsening in rates of specific error types. Further safety improvements require a nuanced understanding of how various error types are influenced by the technology and the sociotechnical work system of the technology implementation. Recommendations based on human factors engineering principles are provided for reducing medication errors.

Diffusion, implementation, and use of Research Electronic Data Capture (REDCap) in the Veterans Health Administration (VA).

This case study describes the implementation of the Research Electronic Data Capture (REDCap) software at the United States Department of Veterans Affairs Veterans Health Administration (VA). VA REDCap enables secure and standardized data collection, fosters collaboration with external researchers through use of a widely used data management tool, facilitates multisite studies through use of data forms that can be shared across sites within and outside the VA, is well suited to health services research studies and quality improvement projects, and enables exporting data for analysis in the VA secure computing environment. Using a diffusion of innovation framework approach, authors explore organizational factors that shaped adoption of REDCap technology and constraints on its use within the VA. Lessons learned from the VA experience are discussed.

Characterising the complexity of medication safety using a human factors approach: an observational study in two intensive care units.

OBJECTIVE: To examine medication safety in two intensive care units (ICU), and to assess the complexity of medication errors and adverse drug events (ADE) in ICUs across the stages of the medication-management process. METHODS: Four trained nurse data collectors gathered data on medication errors and ADEs between October 2006 and March 2007. Patient care documents (eg, medication order sheets, notes) and incident reports were used to identify medication errors and ADEs in a 24-bed adult medical/surgical ICU and an 18-bed cardiac ICU in a tertiary care, community teaching hospital. In this cross-sectional study, a total of 630 consecutive ICU patient admissions were assessed to produce data on the number, rates and types of potential and preventable ADEs across stages of the medication-management process. RESULTS: An average of 2.9 preventable or potential ADEs occurred in each admission, that is, 0.4 events per patient-day. Preventable or potential ADEs occurred in 2.6% of the medication orders. The rate of potential ADEs per 1000 patient-days was 276, whereas the rate of preventable ADEs per 1000 patient-days was 9.2. Most medication errors occur at the ordering (32%) and administration stages (39%). In 16-24% of potential and preventable ADEs, clusters of errors occurred either as a sequence of errors (eg, delay in medication dispensing leading to delay in medication administration) or grouped errors (eg, route and frequency errors in the order for a medication). Many of the sequences led to administration errors that were caused by errors earlier in the medication-management process. CONCLUSIONS: Understanding the complexity of the vulnerabilities of the medication-management process is important to devise solutions to improve patient safety. Electronic health record technology with computerised physician order entry may be one step necessary to improve medication safety in ICUs. Solutions that target multiple stages of the medication-management process are necessary to address sequential errors.

Conducting an efficient proactive risk assessment prior to CPOE implementation in an intensive care unit.

PURPOSE: To develop, conduct, and evaluate a proactive risk assessment (PRA) of the design and implementation of CPOE in an ICU. METHODS: We developed a PRA method based on issues identified from documented experience with conventional PRA methods and the constraints of an organization about to implement CPOE in an intensive care unit. The PRA method consists of three phases: planning (three months), team (one five-hour meeting), and evaluation (short- and long-term). RESULTS: Sixteen unique relevant vulnerabilities were identified as a result of the PRA team's efforts. Negative consequences resulting from the vulnerabilities included potential patient safety and quality of care issues, non-compliance with regulatory requirements, increases in cognitive burden on CPOE users, and/or worker inconvenience or distress. Actions taken to address the vulnerabilities included redesign of the technology, process (workflow) redesign, user training, and/or ongoing monitoring. Verbal and written evaluation by the team members indicated that the PRA method was useful and that participants were willing to participate in future PRAs. Long-term evaluation was accomplished by monitoring an ongoing "issues list" of CPOE problems identified by or reported to IT staff. Vulnerabilities identified by the team were either resolved prior to CPOE implementation (n=7) or shortly thereafter (n=9). No other issues were identified beside those identified by the team. CONCLUSIONS: Generally positive results from the various evaluations including a long-term evaluation demonstrate the value of developing an efficient PRA method that meets organizational and contextual requirements and constraints.

Voluntary reporting of health care personnel seasonal influenza vaccination rates and the impact of universal policies in Illinois hospitals.

OBJECTIVE: In 2009, voluntary public reporting of hospital health care personnel (HCP) vaccination rates began in Illinois. We describe our experience over 3 influenza seasons and examine the impact universal policies have had on performance. METHODS: A secure website was used to report monthly HCP vaccination rates by each participating hospital. Overall and individual hospital performance was publicly reported each month. RESULTS: In the first two seasons, there were 11 hospitals reporting with an average end of season rate of 76% (2009-2010) and 81% (2010-2011). In the 2011-2012 season, there were 22 hospitals reporting, 9 of which had a new universal policy for HCP influenza vaccination. The average 2011-2012 end of season rate was 72% for hospitals with a voluntary program and 95% for hospitals with a universal policy. HCP were also vaccinated earlier in the influenza season when a universal policy was in place, providing greater benefit over time. CONCLUSION: Public reporting of HCP influenza vaccination rates may contribute to implementation of universal employee vaccination policies. Hospitals with universal policies have higher vaccination rates than those with voluntary vaccination programs.