Seroprevalence of hospital staff in a province with zero COVID-19 cases

Background COVID-19 seroprevalence data, particularly in less developed countries with a relatively low incidence, has been scant. We aimed to explore the seroprevalence of hospital staff in the area with zero confirmed COVID-19 case to shed light on the situation of COVID-19 infection in zero or low infection rate countries where mass screening was not readily available. Methods A locally developed rapid immunoglobulin M (IgM)/immunoglobulin G (IgG) test kit was used for hospital staff screening of Ranong hospital which is located in a province with zero COVID-19 prevalence in Thailand from 17th April to 17th May 2020. All staff was tested, 100 of which were randomly invited to have a repeating antibody test in one month. (Thai Clinical Trials Registry: TCTR20200426002) Results Of 844 hospital staff, 82 were tested twice one month apart (response rate for repeating antibody test 82%). Overall, 0.8% of the participants (7 of 844) had positive IgM, none had positive IgG. Female staff had 1.0% positive IgM (95% CI: 0.5–2.1%) while male had 0.5% positive IgM (95% CI: 0.1–2.6%). No participants with a history of travel to the high-risk area or close contact with PCR-confirmed COVID-19 case developed SARS-CoV-2 antibodies. Among 844 staff, 811 had no symptoms and six of them developed IgM seropositive (0.7%) while 33 had minor symptoms and only one of them developed IgM seropositive (3.0%). No association between SARS-CoV-2 IgM status and gender, history of travel to a high-risk area, close contact with PCR-confirmed or suspected COVID-19 case, presence of symptoms within 14 days, or previous PCR status was found. None of the hospital staff developed SARS-CoV-2 IgG. Conclusions COVID-19 antibody test could detect a considerable number of hospital staff who could be potential silent spreaders in a province with zero COVID-19 cases. Accurate antibody testing is a valuable screening tool, particularly in asymptomatic healthcare workers. Trial registration: This study was approved by the Institutional Review Board of Chulalongkorn University (IRB No.236/63) and the Institutional Review Board of Ranong Hospital. (Thai Clinical Trials Registry: TCTR20200426002).

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Seroprevalence of Hospital Staff in Province with Zero COVID-19 cases

10.1101/2020.07.13.20151944 ◽

2020 ◽

Author(s):

Tanawin Nopsopon ◽

Krit Pongpirul ◽

Korn Chotirosniramit ◽

Wutichai Jakaew ◽

Chuenkhwan Kaewwijit ◽

...

Keyword(s):

High Risk ◽

Close Contact ◽

Hospital Staff ◽

Developed Countries ◽

Immunoglobulin M ◽

Risk Area ◽

High Risk Area ◽

Test Kit ◽

Seroprevalence Data ◽

History Of

BACKGROUND. COVID-19 seroprevalence data has been scarce, especially in less developed countries with a relatively low infection rate. METHODS. A locally developed rapid IgM/IgG test kit was used for screening hospital staff in Ranong hospital which located in a province with zero COVID-19 prevalence in Thailand from April 17 to May 17, 2020. A total of 844 participants were tested; 82 of which were tested twice with one month apart. (Thai Clinical Trials Registry: TCTR20200426002) RESULTS. Overall, 0.8% of the participants (7 of 844) had positive immunoglobulin M (IgM), none had positive immunoglobulin G (IgG). Female staffs seemed to have higher IgM seropositive than male staffs (1.0% vs. 0.5%). None of the participants with a history of travel to the high-risk area or a history of close contact with PCR-confirmed COVID-19 case had developed antibodies against SARS-CoV-2. Among 844 staff, 811 had no symptom and six of them developed IgM seropositive (0.7%) while 33 had minor symptoms and only one of them developed IgM seropositive (3.0%). No association between IgM antibody against SARS-CoV-2 status and gender, history of travel to a high-risk area, history of close contact with PCR-confirmed COVID-19 case, history of close contact with suspected COVID-19 case, presence of symptoms within 14 days, or previous PCR status was found. None of the hospital staff developed IgG against SARS-CoV-2. CONCLUSION. COVID-19 antibody test could detect a substantial number of hospital staffs who could be potential silent spreaders in a province with zero COVID-19 case. Antibody testing should be encouraged for mass screening, especially in asymptomatic healthcare workers.

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PS1-03: Expanding the Functional Scope of Institutional Review Board Review of Multi-Site Research in the HMO Research Network: from Data-Only Studies, to Non-Clinical Interventions, to Clinical Trials

Clinical Medicine & Research ◽

10.3121/cmr.2011.1020.ps1-03 ◽

2011 ◽

Vol 9 (3-4) ◽

pp. 175-176 ◽

Cited By ~ 1

Author(s):

J. Braff

Keyword(s):

Clinical Trials ◽

Institutional Review Board ◽

Research Network ◽

Clinical Interventions ◽

Institutional Review ◽

Institutional Review Board Review ◽

Board Review

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Bone Mineral Density in Gravida: Effect of Pregnancies and Breast-Feeding in Women of Differing Ages and Parity

Journal of Osteoporosis ◽

10.1155/2014/897182 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Ehud Lebel ◽

Yuri Mishukov ◽

Liana Babchenko ◽

Arnon Samueloff ◽

Ari Zimran ◽

...

Keyword(s):

Bone Mineral Density ◽

Bone Mineral ◽

Institutional Review Board ◽

Mineral Density ◽

X Ray ◽

Normal Limits ◽

Institutional Review Board Approval ◽

Institutional Review ◽

History Of ◽

Breast Fed

Changes of bone during pregnancy and during lactation evaluated by bone mineral density (BMD) may have implications for risk of osteoporosis and fractures. We studied BMD in women of differing ages, parity, and lactation histories immediately postpartum for BMD,T-scores, andZ-scores. Institutional Review Board approval was received. All women while still in hospital postpartum were asked to participate. BMD was performed by dual-energy X-ray absorptiometry (DXA) machine at femoral neck (FN) and lumbar spine (LS) by a single technician. Of 132 participants, 73 (55.3%) were ≤30 years; 27 (20.5%) were primiparous; 36 (27.3%) were grand multiparous; 35 (26.5%) never breast fed. Mean FNT-scores andZ-scores were higher than respective mean LS scores, but all means were within the normal limits. Mean LST-scores andZ-scores were highest in the grand multiparas. There were only 2 (1.5%) outliers with lowZ-scores. We conclude that, in a large cohort of Israeli women with BMD parameters assessed by DXA within two days postpartum, meanT-scores andZ-scores at both the LS and FN were within normal limits regardless of age (20–46 years), parity (1–13 viable births), and history of either no or prolonged months of lactation (up to 11.25 years).

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The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

Clinical Trials ◽

10.1177/1740774518807888 ◽

2018 ◽

Vol 16 (1) ◽

pp. 3-10 ◽

Cited By ~ 3

Author(s):

Michael P Diamond ◽

Esther Eisenberg ◽

Hao Huang ◽

Christos Coutifaris ◽

Richard S Legro ◽

...

Keyword(s):

Clinical Trials ◽

Child Health ◽

Clinical Research ◽

Human Development ◽

Reproductive Medicine ◽

Institutional Review Board ◽

Institutional Review Boards ◽

Institutional Review ◽

The Impact ◽

Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

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1109. Factors Impacting the Decision to Order Stool Diagnostic Testing in Patients With Acute Gastroenteritis Among Primary Care Providers

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy210.943 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S332-S333

Author(s):

Sean O’Leary ◽

Mandy Allison ◽

Cristina V Cardemil ◽

Laura Hurley ◽

Lori Crane ◽

...

Keyword(s):

Primary Care ◽

Acute Gastroenteritis ◽

Pathogen Detection ◽

Immunocompromised Patient ◽

Diagnostic Testing ◽

Primary Care Providers ◽

Care Providers ◽

Risk Area ◽

High Risk Area ◽

History Of

Abstract Background Diagnostic options for stool pathogens are evolving and expanding rapidly. The majority of acute gastroenteritis (AGE) patients seeking medical care are seen by primary care providers (PCPs), and stool testing may not be performed as AGE is generally self-limited. Little is known about how PCPs decide for which patients to order testing. Our objective was to describe among PCPs factors affecting the decision of whether to order stool diagnostic testing for pathogen detection in patients with AGE symptoms in the outpatient setting. Methods A national survey was conducted from January to March 2018 among primary care pediatricians (Peds), family physicians (FP), and internists (GIM). Results The response rate was 50% (689/1,383; Peds 59% [275/466], FP 49% [226/461], GIM 41% [188/456]). Factors most often reported as greatly increasing the likelihood of testing that did not differ significantly between specialties included patient history of travel to a high-risk area (75% Peds, 71% FP, 72% GIM), immunocompromised patient (Peds 67%, FP 60%, GIM 69%), and clinical suspicion of a pathogen that can be treated with antibiotics or antiparasitics (Peds 63%, FP 56%, GIM 65%). Factors with significant differences between specialties that were most often reported as greatly increasing likelihood of testing included presence of blood in stool (Peds 76%, FP 58%, GIM 48%, P < 0.0001), history of recent antibiotic use (Peds 31%, FP 66%, GIM 72%, P < 0.0001), history of recent hospitalization (Peds 29%, FP 61%, GIM 64%, P < 0.0001), consideration of inpatient admission (Peds 36%, FP 57%, GIM 56%, P < 0.0001), and fever ≥38.5 C (Peds 13%, FP 27%, GIM 40%, P < 0.0001). Factors most often reported as greatly decreasing the likelihood of testing included presence of vomiting without diarrhea (Peds 49%, FP 43%, GIM 50%) and presence of vomiting and diarrhea together (Peds 12%, FP 7%, GIM 9%). Conclusion Physicians rely on a variety of factors when considering diagnostic testing for stool pathogens in AGE, with recent travel, caring for an immunocompromised patient, and antibiotic/antiparasitic treatment decisions often reported as increasing the likelihood of testing. Consideration of the clinical presentation and most common AGE pathogens by age group may be driving some of the differences between specialties. Disclosures All authors: No reported disclosures.

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Institutional Review Board Basics for Pedagogy Research

Pedagogy in Health Promotion ◽

10.1177/2373379918793400 ◽

2018 ◽

Vol 4 (3) ◽

pp. 172-177

Author(s):

Whitney Boling ◽

Kathryn Berlin ◽

Rhonda N. Rahn ◽

Jody L. Vogelzang ◽

Gayle Walter

Keyword(s):

United States ◽

Participatory Research ◽

Community Based Participatory Research ◽

The United States ◽

Institutional Review Board ◽

Community Based ◽

Institutional Review ◽

History Of ◽

Conducting Research ◽

Human Participants

The institutional review board (IRB) process is often protracted and can be a source of frustration, especially when you want your research and publications to move apace. However, because of historical events, the IRB is an important requirement for conducting research with human participants and is regulated by federal oversite. When conducting research as part of a pedagogical study, it is important to identify which level of IRB review (exempt, expedited, or full board) is required. The purpose of this article is to highlight IRB basics within the United States for pedagogy research. Although there are guidelines internationally, this article specifically focuses on U.S. IRBs, including a brief history of the IRB, pedagogical and community-based participatory research, IRB review, tips for IRB submissions, and example case studies.

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