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.

Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC): A collaborative research infrastructure for intervention and implementation.

AIMS: There is an inadequate portfolio of treatments for Gulf War Illness (GWI), a complex disease involving multiple organ systems, and early-phase clinical trials are hampered by many logistical problems. To address these challenges, the Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC) was formed with the aims of (i) creating a collaborative consortium of clinical and scientific researchers that will rapidly implement rigorous and innovative phase I and II clinical trials for GWI, (ii) perform at least four phase I or II clinical trials, (iii) provide a foundation of scalable infrastructure and management in support of the efficient and successful operation of the GWICTIC, and (iv) partner with the Boston Biorepository, Recruitment & Integrated Network for GWI and other GWI investigators to develop a common data element platform for core assessments and outcomes. MAIN METHODS: The GWICTIC brings together a multidisciplinary team of researchers at several institutions to provide scientific innovation, statistical and computational rigor, and logistical efficiency in the development and implementation of early-phase low-risk clinical trials for GWI. The GWICTIC core trials adhere to a Veteran-centered philosophy and focus on interventions with multiple mechanistic targets to maximize the likelihood of efficacy. To support rapid and efficient study startup and implementation across the GWI research community, the GWICTIC will share infrastructure with investigator-initiated research studies funded under separate mechanisms. SIGNIFICANCE: The GWICTIC will leverage the efficiencies of centralized research support and innovative trial designs to address several longstanding needs in the GWI interventions research community.

Use of standardized patients in, undergraduate medical genetics education.

BACKGROUND AND PURPOSE: To study the effectiveness of a standardized patient (SP) program in increasing the competence of medical students in assessing genetic risks and communicating genetic information to patients. METHODS: Third-year medical students at the Mount Sinai School of Medicine had two encounters from 2001 to 2003 with the same SP, who portrayed a woman at risk for hereditary breast cancer. Assessment instruments included student self-assessment of skills, SP assessment of student communication skills, an observer checklist, grading of the student-drawn pedigree, and a knowledge test. Students also completed an evaluation form after the debriefing session at the end of each of the SP sessions. RESULTS: The SP program was completed by 136 students. The student self-evaluation of skills instrument revealed that students who completed the SP program felt more competent in their ability to draw a pedigree, assess genetic risks based on family history and pedigree information, and communicate genetic risks compared to students at the same level of training who did not participate in the SP program. Of participating students, 90% agreed that the program allowed them to identify areas for improvement in their skills, and 95% agreed that the exercise increased their confidence for having a similar patient interaction in the future. CONCLUSIONS: The use of SPs in undergraduate medical genetics education may be one means for increasing the confidence of medical students in skills that are related to genetic encounters.

The use of standardised patients to assess clinical competence: does practice make perfect?

CONTEXT: The use of standardised patients (SPs) is now an integral component of the United States Medical Licensing Examination (USMLE). This new requirement has caused more schools to include SP examinations (SPEs) in their curricula. This study reviews the effect of prior experience with SPs in a medical school curriculum on SPE pass rates. METHODS: This study reviewed the mean scores and pass rates on a 4-station SPE, comparing the performance of 121 US medical school graduates (USMGs) with that of 228 international medical graduates (IMGs). The analysis of USMGs' performance was based upon whether the resident had had previous exposure to an SPE during medical school, while the analysis of IMGs' performance was based upon whether the IMG had taken the Clinical Skills Assessment (CSA) for certification by the Education Commission for Foreign Medical Graduates. A distinction was made between those who had received prior exposure at Mount Sinai School of Medicine's Morchand Center, where the cases utilised were identical to those of the SPE, and those who had gained exposure elsewhere. RESULTS: Neither the mean scores of the IMGs and the USMGs nor the percentage who failed was significantly different relative to prior exposure to SPs. CONCLUSION: Prior exposure to SPs does not appear to have a positive effect on subsequent performance on an SPE unless similar or identical cases are used. However, the type and site of prior exposure limited the influence of the review. In view of the increased use of SPEs in medical schools, the content of prior exposure needs to be more fully established.

An Assessment of House Staff's Knowledge of Alcohol and Substance Abuse Utilizing Standardized Patients.

Utilizing standardized patients (SPs), house staff knowledge of alcohol and substance abuse was assessed in residents just prior to their starting their first graduate year of training. A total of 345 residents from 13 different residencies in eight institutions participated in this program. Each resident was assigned four SP cases. The reliability of these encounters ranged from 0.63 to 0.74. Of the participating residents, 22% were United States medical graduates (USMGs) and 78% were international medical graduates (IMGs). A considerable proportion of both USMGs and IMGs failed to ask appropriate questions concerning alcohol and drug use or identify the presence of risk factors associated with such use. Residents' scores on cases primarily dealing with general medical issues, as compared to those dealing with substance abuse, were consistently higher. Knowledge of basic information concerning substance abuse and opioids was deficient in over 50% of those tested. These findings suggest that residents about to start their clinical training are not sufficiently prepared to address patients presenting with alcohol and other drug problems.