Faculty Bibliography

Diagnostics are a cornerstone of the practice of infectious diseases. However, various limitations frequently lead to unmet clinical needs. In most other domains, diagnostics focus on narrowly defined questions, provide readily interpretable answers, and use true gold standards for development. In contrast, infectious diseases diagnostics must contend with scores of potential pathogens, dozens of clinical syndromes, emerging pathogens, rapid evolution of existing pathogens and their associated resistance mechanisms, and the absence of gold standards in many situations. In spite of these challenges, the importance and value of diagnostics cannot be underestimated. Therefore, the Antibacterial Resistance Leadership Group has identified diagnostics as 1 of 4 major areas of emphasis. Herein, we provide an overview of that development, highlighting several examples where innovation in study design, content, and execution is advancing the field of infectious diseases diagnostics.

The Antibacterial Resistance Leadership Group (ARLG) Laboratory Center (LC) leads the evaluation, development, and implementation of laboratory-based research by providing scientific leadership and supporting standard/specialized laboratory services. The LC has developed a physical biorepository and a virtual biorepository. The physical biorepository contains bacterial isolates from ARLG-funded studies located in a centralized laboratory and they are available to ARLG investigators. The Web-based virtual biorepository strain catalogue includes well-characterized gram-positive and gram-negative bacterial strains published by ARLG investigators. The LC, in collaboration with the ARLG Leadership and Operations Center, developed procedures for review and approval of strain requests, guidance during the selection process, and for shipping strains from the distributing laboratories to the requesting investigators. ARLG strains and scientific and/or technical guidance have been provided to basic research laboratories and diagnostic companies for research and development, facilitating collaboration between diagnostic companies and the ARLG Master Protocol for Evaluating Multiple Infection Diagnostics (MASTERMIND) initiative for evaluation of multiple diagnostic devices from a single patient sampling event. In addition, the LC has completed several laboratory-based studies designed to help evaluate new rapid molecular diagnostics by developing, testing, and applying a MASTERMIND approach using purified bacterial strains. In collaboration with the ARLG's Statistical and Data Management Center (SDMC), the LC has developed novel analytical strategies that integrate microbiologic and genetic data for improved and accurate identification of antimicrobial resistance. These novel approaches will aid in the design of future ARLG studies and help correlate pathogenic markers with clinical outcomes. The LC's accomplishments are the result of a successful collaboration with the ARLG's Leadership and Operations Center, Diagnostics and Devices Committee, and SDMC. This interactive approach has been pivotal for the success of LC projects.

The Antibacterial Resistance Leadership Group (ARLG), with funding from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, was created in June 2013. Its mission is to develop, prioritize, and implement a clinical research agenda that addresses the public health threat of antibacterial resistance. This article reports on the progress that the ARLG has made to date in fulfilling its mission. Since inception, the ARLG has received and reviewed >70 study proposals, initiated >30 studies, executed >300 agreements, included data from >7000 subjects, published >45 manuscripts, and provided opportunities for 26 mentees. Despite this substantial progress, there remains significant work to be accomplished. This article also describes the considerable challenges that lie ahead.

OBJECTIVES: As Asian Americans are dis- proportionately affected by the hepatitis B virus (HBV), we explored predictors of HBV screening and vaccination among Chinese and Korean Americans. METHODS: We used cross-sectional data from a com- munity-based sample of Chinese Americans (N = 502) and Korean Americans (N = 487) residing in the metropolitan New York City area during 2008-2009. Logistic regression models were stratified by Asian-American subgroup and sex to predict HBV screening (for the entire sam- ple) and HBV vaccination (among those not HBV positive). RESULTS: Overall, screening rates were high (71.3% among Chinese and 70.1% among Koreans). The majority of respondents were aware of HBV; however, knowledge about HBV transmission was low. In logistic regression, a physician recommendation was consistently associated with HBV screening and vaccination outcomes across all groups; having heard of HBV was significantly associated with screening and vaccination among Chinese males and screening among Korean males and females. Screening and vaccination barriers were reported among all groups, and included lack of knowledge and feeling well/having no health issues. CONCLUSIONS: Targeted efforts in these at-risk communities are necessary to improve HBV knowledge, address misinformation about HBV, and eliminate provider-, patient-, and resource-related barriers to HBV screening and vaccination.

We developed a multidisciplinary initiative, "Lose the Tube," focused on a Choosing Wisely recommendation to decrease catheter-associated urinary tract infection (CAUTI) rates and catheter days. Through an electronic health record catheter identification tool, daily interdisciplinary query, and clinician education, our multifaceted intervention reduced mean per-person catheter days from 3.3 to 2.9, decreased CAUTI rates from 2.85 to 0.32 per 1,000 catheter days, and reduced cost by $32,245.