scholarly journals Challenges and lessons learned from the Pediatric Heart Network Normal Echocardiogram Database study

2020 ◽  
Vol 30 (4) ◽  
pp. 456-461 ◽  
Author(s):  
Dongngan Truong ◽  
Leo Lopez ◽  
Peter C. Frommelt ◽  
Jessica Stelter ◽  
Brenda Ni ◽  
...  
Keyword(s):  
Information Disclosure ◽  
Demographic Data ◽  
Lessons Learned ◽  
Institutional Review Board ◽  
Image Transfer ◽  
Chi Square ◽  
Database Study ◽  
Future Studies ◽  
Institutional Review ◽  
Echocardiographic Images

AbstractBackground:The Pediatric Heart Network Normal Echocardiogram Database Study had unanticipated challenges. We sought to describe these challenges and lessons learned to improve the design of future studies.Methods:Challenges were divided into three categories: enrolment, echocardiographic imaging, and protocol violations. Memoranda, Core Lab reports, and adjudication logs were reviewed. A centre-level questionnaire provided information regarding local processes for data collection. Descriptive statistics were used, and chi-square tests determined differences in imaging quality.Results:For the 19 participating centres, challenges with enrolment included variations in Institutional Review Board definitions of “retrospective” eligibility, overestimation of non-White participants, centre categorisation of Hispanic participants that differed from National Institutes of Health definitions, and exclusion of potential participants due to missing demographic data. Institutional Review Board amendments resolved many of these challenges. There was an unanticipated burden imposed on centres due to high numbers of echocardiograms that were reviewed but failed to meet submission criteria. Additionally, image transfer software malfunctions delayed Core Lab image review and feedback. Between the early and late study periods, the proportion of unacceptable echocardiograms submitted to the Core Lab decreased (14 versus 7%, p < 0.01). Most protocol violations were from eligibility violations and inadvertent protected health information disclosure (overall 2.5%). Adjudication committee reviews led to protocol changes.Conclusions:Numerous challenges encountered during the Normal Echocardiogram Database Study prolonged study enrolment. The retrospective design and flaws in image transfer software were key impediments to study completion and should be considered when designing future studies collecting echocardiographic images as a primary outcome.

scholarly journals Analysis of Ear, Nose and Throat Foreign Bodies in Dhulikhel Hospital

2013 ◽  
Vol 10 (2) ◽  
pp. 4-8 ◽  
Author(s):  
Inku Shrestha ◽  
BL Shrestha ◽  
RCM Amatya
Keyword(s):  
Foreign Body ◽  
Primary Care Physicians ◽  
Foreign Bodies ◽  
Demographic Data ◽  
P Value ◽  
Chi Square ◽  
Cross Sectional ◽  
Male Predominance ◽  
Institutional Review ◽  
Nose And Throat

Background Foreign body in ear nose and throat are commonly encountered by otolaryngologists, pediatricians and primary care physicians. Objective The aim of this study is to analyze different types of foreign bodies and socio-demographic correlates of self-inflicted foreign body insertion in ear–nose–throat. Method This was a two year hospital based cross sectional descriptive study performed in the Department of ear nose and throat (ENT), Dhulikhel Hospital - Kathmandu University from June 2009 to June 2011 after verification from the Institutional Review Committee. Using a predesigned questionnaire, socio-demographic data was collected prospectively by examining clinically all patients attending with foreign body and interviewing the caregivers of pediatric patients after removal of foreign body. The data collected from 312 patients was entered and analyzed by using descriptive and analytical statistical methods using SPSS version 16.0. Results The mean age was 21.26 years with majority between 0-10 years (50.6%). Male predominance was noted (58.97%). Most patients or caregivers were illiterate (35.1%) or literacy up to primary level(21.12%).Foreign body of the ear was found to be most frequent ( 47.4%) and mostly they were non-living (96.1%). Most patients presented late (80%) and had history of prior attempted removal (67%). Pearsons chi square test between education level and duration of time was significant (p value- 0.0000). One way ANOVA test between type of foreign body and age was significant (p value- 0.001). Conclusion Foreign bodies are common in adult and pediatric ear, nose and throat. They can potentially be associated with significant complications if not taken care of immediately. Kathmandu University Medical Journal | Vol.10 | No. 2 | Issue 38 | Apr – June 2012 | Page 4-8 DOI: http://dx.doi.org/10.3126/kumj.v10i2.7334

scholarly journals Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Guillaume Marquis-Gravel ◽  
Holly Robertson ◽  
W. Schuyler Jones ◽  
Danielle Riley ◽  
Daniel E. Ford ◽  
...  
Keyword(s):  
Informed Consent ◽  
Patient Engagement ◽  
Randomized Clinical Trials ◽  
Lessons Learned ◽  
Institutional Review Board ◽  
Ethical Review ◽  
Atherosclerotic Cardiovascular Disease ◽  
Institutional Review ◽  
Patient Centric

Abstract Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)” randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. Main text ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. Conclusion Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

scholarly journals Effect of Arrival Quarantine on Subsequent COVID-19 Testing in a Cohort of Military Basic Trainees

2021 ◽  
Author(s):  
Joseph E Marcus ◽  
Dianne N Frankel ◽  
Mary T Pawlak ◽  
Theresa M Casey ◽  
Erin Enriquez ◽  
...  
Keyword(s):  
Public Health Surveillance ◽  
San Antonio ◽  
Military Training ◽  
Health Surveillance ◽  
Institutional Review Board ◽  
Continuous Variables ◽  
Chi Square ◽  
Institutional Review ◽  
Chi Square Test ◽  
Pharmaceutical Interventions

ABSTRACT Introduction Basic Military Training at Joint Base San Antonio-Lackland implemented several sequential non-pharmaceutical interventions in response to coronavirus disease-2019 (COVID-19). One measure, arrival quarantine, has not been studied as a modern military disease prevention strategy. This study aimed to determine the effect of a 14-day arrival quarantine on symptomatic COVID-19 testing. Material and Methods A retrospective cohort study compared symptomatic COVID-19 testing among all trainees who entered Basic Military Training between March 17, 2020, and April 17, 2020, before the implementation of universal arrival COVID-19 testing, during their first 2 weeks in arrival quarantine compared to the rest of their training. Furthermore, symptomatic COVID-19 testing in the last 5 weeks of training in those who completed arrival quarantine was compared to testing in the last 5 weeks for trainees who arrived between February 16, 2020, and March 16, 2020, and did not undergo arrival quarantine. Nominal variables were compared by chi-square test, and continuous variables were compared by Mann–Whitney U test. This study was approved as a public health surveillance project by the 59th Medical Wing Institutional Review Board. Results Five thousand five hundred and seventy-six trainees started training between February 16, 2020, and April 17, 2020, with 2,573 trainees undergoing an arrival quarantine compared to 3,003 trainees who did not. Trainees who underwent arrival quarantine had higher rates of COVID-19 testing while in arrival quarantine (10.5 tests per 1,000 trainee-weeks vs. 2.3, P ≤ .001) and higher rates of concomitant influenza testing (74% vs. 38%, P = .001) compared to after they completed quarantine. Trainees that completed quarantine had less symptomatic COVID-19 testing after day 14 of training (2.3 tests per 1,000 trainee-weeks vs. 14.3, P ≤ .001) and influenza testing (38% vs. 74%, P = .001) compared to trainees that did not undergo arrival quarantine. Conclusion Arrival quarantine appears to be an effective non-pharmaceutical intervention associated with fewer symptomatic COVID-19 tests, especially after completion of quarantine.

Guiding vacuum-assisted biopsy in prone position: digital breast tomosynthesis vs stereotactic

2021 ◽  
pp. 030089162110161
Author(s):  
Gianfranco P. Scaperrotta ◽  
Giulia Boffelli ◽  
Catherine Depretto ◽  
Giovanni Di Leo ◽  
Alessandro Liguori ◽  
...  
Keyword(s):  
Multivariate Regression ◽  
Digital Breast Tomosynthesis ◽  
Institutional Review Board ◽  
Procedure Time ◽  
Chi Square ◽  
Breast Tomosynthesis ◽  
Institutional Review ◽  
Lower Radiation Dose ◽  
Average Glandular Dose ◽  
Age Range

Purpose: To compare the performance of prone digital breast tomosynthesis (DBT)–vacuum-assisted biopsy (VAB) with prone stereotactic-guided VAB (sVAB), focusing on time of procedure, number of expositions, average glandular dose, and complications. Methods: The institutional review board approved this retrospective study and informed consent was waived. From July 2015 to January 2017, 306 patients with 306 suspicious mammographic findings (BI-RADS ⩾4) underwent mammography-guided biopsy, prone sVAB, or prone DBT-VAB. Student t test, chi-square, and multivariate regression statistics were used. Results: During the study period, 155 prone sVAB procedures in 155 patients (mean age, 56 years; age range, 39–84 years) and 151 DBT-VABs in 151 patients (mean age, 57 years; age range, 33–84 years) were performed. Mean procedure time was shorter with DBT-VAB versus sVAB (14.5 versus 17.4 minutes, respectively; p < 0.001), and fewer images were acquired with DBT-VAB versus sVAB (8 vs 11, respectively; p < 0.001); the average glandular dose was significantly lower in DBT-VAB versus sVAB (11.8 mGy versus 18 mGy, respectively; p < 0.001). There were no differences in the distribution of histologic results ( p = 0.74) or breast density ( p = 0.09) between the two groups. No major complications were observed in either group. Conclusion: Performance of prone DBT-VAB was superior to prone sVAB because it allowed a faster procedure with fewer radiologic expositions and lower radiation dose.

Ontario Cancer Research Ethics Board: Lessons Learned From Developing a Multicenter Regional Institutional Review Board

2008 ◽  
Vol 26 (9) ◽  
pp. 1479-1482 ◽  
Author(s):  
Raphael Saginur ◽  
Susan F. Dent ◽  
Lisa Schwartz ◽  
Ronald Heslegrave ◽  
Sid Stacey ◽  
...  
Keyword(s):  
Lessons Learned ◽  
Institutional Review Board ◽  
Cancer Center ◽  
Roles And Responsibilities ◽  
Clinical Investigator ◽  
Ethics Review ◽  
Institutional Review ◽  
Clear Delineation ◽  
American Society ◽  
Institutional Participation

Purpose We describe issues and outcomes in the development of a specialized, central institutional review board (IRB) for multicenter oncology protocols. Numerous authoritative bodies have called for a change to the ethics review system to better manage multicenter trials in terms of quality, timeliness, and efficiency. In 2003, the American Society of Clinical Oncology proposed a network of regional IRBs for cancer. Previous experience with central IRBs has been met with mixed success. Methods We took a bottom-up approach to organizing a province-wide IRB, which was led by an IRB chair and a clinical investigator at one cancer center. Participation on the part of institutions was voluntary. Results Uptake in the first 2 years was modest and increased from 11 clinical trials in year 1 to 21 in year 2. In the third year, there was an apparent upsurge in the number of involved centers (14) and in the number of submitted clinical protocols (54). Conclusion Sponsors and investigators are loath to risk development of a novel IRB until there is a clear demonstration of quality, efficiency, and timeliness of decision. Development of a regional, specialized IRB requires considerable efforts to develop and maintain the trust of sponsors, investigators, and institutions despite prior demands for more efficient and timely ethics review. Voluntary institutional participation, clear delineation of roles and responsibilities, and effective execution promote development of this trust.

scholarly journals Hysterosalpingography vs Hysteroscopy: Role in Assessment of Uterine Factor during Infertility Workup

2013 ◽  
Vol 4 (3) ◽  
pp. 79-82
Author(s):  
Vani Malhotra ◽  
Meenakshi Barsaul Chauhan ◽  
Pinkey Lakra ◽  
Roopa Sangwan
Keyword(s):  
Predictive Value ◽  
False Negative ◽  
Uterine Cavity ◽  
Institutional Review Board ◽  
Chi Square ◽  
Infertile Women ◽  
Institutional Review ◽  
Chi Square Test ◽  
Student’S T ◽  
Student’S T Test

ABSTRACT Objective Uterine pathologies are the cause of infertility in 15% of infertile couples and their correction is associated with improved pregnancy rates. This prospective study was carried out to compare hysterosalpingography (HSG) with hysteroscopy (HSC) in evaluation of uterine pathology. Study design The research was approved by the institutional review board. A total of 100 infertile women were included in the study. HSC and HSG were performed in the follicular phase and the findings were compared. Student's t test and chi-square test were applied wherever applicable. Degree of agreement between the two procedures was calculated using kappa estimates. Results Thirteen percent of the women had abnormal HSG regarding the uterine cavity while 20% had abnormal HSC findings (chi-square value 1.77, p > 0.05). Out of 10% women who had normal HSG, some abnormality was found on HSC. Similarly 3% women with abnormal HSG had normal findings on HSC. Sensitivity of HSG in detecting uterine cavity abnormality was 50% and specificity 98.1%. Positive predictive value was 76.9% and negative predictive value was 88.5%. Result of HSG was false-negative in 10% of women and false-positive in 3%. Conclusion Hysteroscopy should be considered essential while investigating infertile women., Since HSG provides valuables information about tubes, it may supplement the hysteroscopic assessment. How to cite this article Chauhan MB, Lakra P, Sangwan R, Nanda S, Malhotra V. Hysterosalpingography vs Hysteroscopy: Role in Assessment of Uterine Factor during Infertility Workup. Int J Infertility Fetal Med 2013;4(3):79-82.

scholarly journals Incidental COVID-19 related lung apical findings on stroke CTA during the COVID-19 pandemic

2020 ◽  
Vol 12 (7) ◽  
pp. 669-672 ◽  
Author(s):  
Shingo Kihira ◽  
Javin Schefflein ◽  
Michael Chung ◽  
Keon Mahmoudi ◽  
Brian Rigney ◽  
...  
Keyword(s):  
New York ◽  
New York City ◽  
Head And Neck ◽  
Ct Angiography ◽  
York City ◽  
Demographic Data ◽  
Incidence Rates ◽  
Institutional Review Board ◽  
Rt Pcr ◽  
Institutional Review

BackgroundAuthors have noticed an increase in lung apex abnormalities on CT angiography (CTA) of the head and neck performed for stroke workup during the coronavirus disease 2019 (COVID-19) pandemic.ObjectiveTo evaluate the incidence of these CTA findings and their relation to COVID-19 infection.MethodsIn this retrospective multicenter institutional review board-approved study, assessment was made of CTA findings of code patients who had a stroke between March 16 and April 5, 2020 at six hospitals across New York City. Demographic data, comorbidities, COVID-19 status, and neurological findings were collected. Assessment of COVID-19 related lung findings on CTA was made blinded to COVID-19 status. Incidence rates of COVID-19 related apical findings were assessed in all code patients who had a stroke and in patients with a stroke confirmed by imaging.ResultsThe cohort consisted of a total of 118 patients with mean±SD age of 64.9±15.7 years and 57.6% (68/118) were male. Among all code patients who had a stroke, 28% (33/118) had COVID-19 related lung findings. RT-PCR was positive for COVID-19 in 93.9% (31/33) of these patients with apical CTA findings.Among patients who had a stroke confirmed by imaging, 37.5% (18/48) had COVID-19 related apical findings. RT-PCR was positive for COVID-19 in all (18/18) of these patients with apical findings.ConclusionThe incidence of COVID-19 related lung findings in stroke CTA scans was 28% in all code patients who had a stroke and 37.5% in patients with a stroke confirmed by imaging. Stroke teams should closely assess the lung apices during this COVID-19 pandemic as CTA findings may be the first indicator of COVID-19 infection.

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