return of results
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2021 ◽  
Author(s):  
Steven M. Harrison ◽  
Christina A. Austin‐Tse ◽  
Serra Kim ◽  
Matthew Lebo ◽  
Annette Leon ◽  
...  

2021 ◽  
Author(s):  
Stephanie S Lee ◽  
Michelle Weitz ◽  
Kristin Ardlie ◽  
Amy Bantham ◽  
Michele Fronk Schuckel ◽  
...  

Importance CDC guidance emphasizes the importance of in-person education for students in grades kindergarten to 12 (K-12) during the COVID-19 pandemic. CDC encourages weekly SARS-CoV-2 testing of asymptomatic, unvaccinated students and staff ("screening") to reduce infection risk and provide data about in-school SARS-CoV-2 prevalence where community incidence is high. The financial costs of screening assays have been described, but the human resource requirements at the school and district level to implement a SARS-CoV-2 screening program are not well known. Objective To quantify the resources required to implement a screening program in K-12 schools. Design, Setting, and Participants A consortium of Massachusetts public K-12 schools was formed to implement and evaluate a range of SARS-CoV-2 screening approaches. Participating districts were surveyed weekly about their programs, including: type of assay used, individual vs. pooled screening, approaches to return of results and deconvolution (identification of positive individual specimens) of positive pools, number and type of personnel implementing the screening program, and hours spent on program implementation. Main Outcomes and Measures Costs, resource utilization Results In 21 participating districts, over 21 weeks from January to June 2021, the positivity rate was 0.0%-0.21% among students and 0.0%-0.13% among educators/staff, and 4 out of 21 (19%) districts had at least one classroom transition to remote learning at any point due to a positive case. The average weekly cost to implement a screening program, including assay and personnel costs, was $17.00 per person tested; this was $46.68 for individual screenings and $15.61 for pooled screenings. The total weekly costs by district ranged from $1,644-$93,486, and districts screened between 58 and 3,675 people per week. The reported number of personnel working per week ranged from 1-5 to >50, and the total number of hours worked by all personnel ranged from 5-10 to >50. Conclusion and Relevance The human resources required to implement SARS-CoV-2 screening in Massachusetts public K-12 schools were substantial. Where screening is recommended for the 2021-22 school year due to high COVID-19 incidence (e.g., where vaccination uptake is low and/or more infectious variants predominate), understanding the human resources required to implement screening will assist districts policymakers in planning.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Joseph Ochieng ◽  
Betty Kwagala ◽  
John Barugahare ◽  
Erisa Mwaka ◽  
Deborah Ekusai-Sebatta ◽  
...  

Abstract Background The return of genetics and genomics research results has been a subject of ongoing global debate. Such feedback is ethically desirable to update participants on research findings particularly those deemed clinically significant. Although there is limited literature, debate continues in African on what constitutes appropriate practice regarding the return of results for genetics and genomics research. This study explored perspectives and ethical considerations of Ugandan genomics researchers regarding the return of genetics and genomics research results. Methods This was a qualitative study that employed in-depth interviews. Thirty participants were purposively selected based on their expertise as genomics researchers in Uganda. Data were analysed through content analysis along the main themes of the study using a comprehensive thematic matrix, to identify common patterns arising from the narratives. NVivo software 12 was used to support data analysis. Results The return of genetics and genomics research results was generally acceptable to researchers, and some indicated that they had previously returned individual or aggregate results to participants and communities. The main reasons cited for sharing research results with participants included their clinical utility, actionability and overall benefit to society. Ethical considerations for appropriate return of results included a need for effective community engagement, genetic counselling prior to disclosure of the results, adequate informed consent, and proper assessment of the implications of, or consequences of returning of results. However, the approaches to return of results were perceived as unstandardized due to the lack of appropriate regulatory frameworks. Conclusions The return of genetic and genomic research results is generally acceptable to researchers despite the lack of appropriate regulatory frameworks. Ethical considerations for return of genetics and genomics research results are highly divergent, hence the need for national ethical guidelines to appropriately regulate the practice.


Author(s):  
Eric H. Bernicker ◽  
Yan Xiao ◽  
Denise A. Croix ◽  
Baiyu Yang ◽  
Anup Abraham ◽  
...  

Context.— With multiple therapeutic options available for patients with advanced non–small cell lung cancer, the timely ordering and return of results to determine therapy are of critical importance. Objective.— To assess factors impacting anaplastic lymphoma kinase (ALK) test ordering and time to result delivery. Design.— A retrospective study using a de-identified electronic health record database was performed. Postdiagnosis ALK tests (n = 14 657) were analyzed from 14 197 patients with advanced non–small cell lung cancer diagnosed between January 2015 and May 2019. Time from non–small cell lung cancer diagnosis to ALK sample receipt in the laboratory was a surrogate for test order time. Test ordering was considered delayed if order time was more than 20 days. Turnaround time from sample received to test result was calculated and considered delayed if more than 10 days. Multivariable logistic regression was used to assess factors associated with order time and turnaround time delays. Results.— Median ALK test order time was 15 days, and 36.4% (5342) of all 14 657 orders were delayed. Factors associated with delays were non–fluorescent in situ hybridization testing, send-out laboratories, testing prior to 2018, nonadenocarcinoma histology, and smoking history. Median turnaround time was 9 days, and 40.3% (5906) of all 14 657 test results were delayed. Non–fluorescent in situ hybridization testing, tissue sample, and orders combining ALK with other biomarkers were associated with delayed ALK result reporting. Conclusions.— This study provides a snapshot of real-world ALK test ordering and reporting time in US community practices. Multiple factors impacted both test ordering time and return of results, revealing opportunities for improvement. It is imperative that patients eligible for targeted therapy be identified in a timely fashion.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2197-2197
Author(s):  
Reyka G Jayasinghe ◽  
Annette S. Kim ◽  
Teni Dowdell ◽  
Carrie Cibulskis ◽  
Jennifer Yesil ◽  
...  

Abstract Background: In order to gain a deeper understanding of the clinical, molecular and immune parameters involved in multiple myeloma (MM) disease initiation, progression and response to treatment, the Multiple Myleoma Research Foundation (MMRF) and its partners launched the CureCloud Research Initiative (NCT03657251), a Direct-to-Patient (DTP) effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses are generated from blood specimens and the resulting data aggregated with the correlating clinical information. Methods: To support the molecular characterization of liquid biopsies for CureCloud, a set of myeloma-specific blood-based approaches were developed. The first of such assays is a hybrid selection panel that captures 70 commonly altered MM and Clonal Hematopoiesis of Indeterminate Potential (CHIP) genes detecting somatic variants present in a patient's circulating-free DNA (cfDNA). This MM-70 assay was thoroughly validated to >90% sensitivity for events at 1% variant allele frequency with a specificity of <0.2 FP/Mb when sequenced at 60,000x. A clinical-grade (CLIA) pipeline was established enabling the return of results. Several quality control measures were used to select for CHIP related mutations including filtering out known myeloma driver events, removing high frequency events, and overlapping with previously published CHIP related mutations. Results: 580 subjects were enrolled to the study at abstract submission, including 127 smolderers, 173 newly diagnosed and 265 relapsed participants. 430 cases have been analyzed on the MM-70 assay. A mean cfDNA amount of 31 ng was recovered for input. Mean raw coverage depth of 176,000x was attained, with a mean duplex depth of 1271 (517-2406). 417 cases passed the minimum CLIA validation thresholds. Some of the most frequently mutated genes observed were in the MAPK, DNA repair, epigenetic, cell cycle, and NF-kappaB pathways in agreement with MM retrospective genomic research studies performed on bone marrow aspirates. Of interest, CHIP mutations were detected in a large proportion of cases (174) with their prevalence increasing with age (Figure 1A). 117 of patients had only one CHIP mutation while 57 had two or more with the same genomic loci were recurrently mutated in DNMT3A, TP53, ASXL1, and PPM1D. No significant differences in CHIP were observed between smoldering and overt myeloma subjects (Figure 1B). Interestingly, a greater (>0.1) CHIP Variant Allelic Fraction (VAF) was seen in individuals with higher risk genomic alterations (Figure 1C). Conclusion: This genomic characterization of one of the largest cohorts to date of individuals with myeloma and precursor conditions using a cfDNA-based liquid biopsy assay was able to recapitulate known myeloma-specific mutations and reinforced the importance of CHIP alterations in MM. CHIP mutations are indeed frequent in myeloma, increase with age, and higher burden might be related to disease aggressiveness. Figure 1 Figure 1. Disclosures Ghobrial: AbbVie, Adaptive, Aptitude Health, BMS, Cellectar, Curio Science, Genetch, Janssen, Janssen Central American and Caribbean, Karyopharm, Medscape, Oncopeptides, Sanofi, Takeda, The Binding Site, GNS, GSK: Consultancy.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Alvina G. Lai ◽  
Wai Hoong Chang ◽  
Constantinos A. Parisinos ◽  
Michail Katsoulis ◽  
Ruth M. Blackburn ◽  
...  

Abstract Background An Informatics Consult has been proposed in which clinicians request novel evidence from large scale health data resources, tailored to the treatment of a specific patient. However, the availability of such consultations is lacking. We seek to provide an Informatics Consult for a situation where a treatment indication and contraindication coexist in the same patient, i.e., anti-coagulation use for stroke prevention in a patient with both atrial fibrillation (AF) and liver cirrhosis. Methods We examined four sources of evidence for the effect of warfarin on stroke risk or all-cause mortality from: (1) randomised controlled trials (RCTs), (2) meta-analysis of prior observational studies, (3) trial emulation (using population electronic health records (N = 3,854,710) and (4) genetic evidence (Mendelian randomisation). We developed prototype forms to request an Informatics Consult and return of results in electronic health record systems. Results We found 0 RCT reports and 0 trials recruiting for patients with AF and cirrhosis. We found broad concordance across the three new sources of evidence we generated. Meta-analysis of prior observational studies showed that warfarin use was associated with lower stroke risk (hazard ratio [HR] = 0.71, CI 0.39–1.29). In a target trial emulation, warfarin was associated with lower all-cause mortality (HR = 0.61, CI 0.49–0.76) and ischaemic stroke (HR = 0.27, CI 0.08–0.91). Mendelian randomisation served as a drug target validation where we found that lower levels of vitamin K1 (warfarin is a vitamin K1 antagonist) are associated with lower stroke risk. A pilot survey with an independent sample of 34 clinicians revealed that 85% of clinicians found information on prognosis useful and that 79% thought that they should have access to the Informatics Consult as a service within their healthcare systems. We identified candidate steps for automation to scale evidence generation and to accelerate the return of results. Conclusion We performed a proof-of-concept Informatics Consult for evidence generation, which may inform treatment decisions in situations where there is dearth of randomised trials. Patients are surprised to know that their clinicians are currently not able to learn in clinic from data on ‘patients like me’. We identify the key challenges in offering such an Informatics Consult as a service.


Author(s):  
Drake A. Comber ◽  
Brianna Davies ◽  
Jason D. Roberts ◽  
Rafik Tadros ◽  
Martin S. Green ◽  
...  

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A21-A21
Author(s):  
H Pham ◽  
S Ranganathan ◽  
M Vandeleur

Abstract Background Mental health issues are of increasing burden within the adolescent CF population, with known impacts from sleep disturbance. There are limited studies examining mediators of this relationship. We aimed to investigate the relationship between sleep quality and mood in adolescents with CF alongside a range potential mediating factors including socioeconomic and family influences in adolescents. Study Design Adolescents with CF aged 10–18 and their parents at a Victorian tertiary paediatric CF centre were eligible. Adolescents-parent pairs cross sectionally completed age appropriate online questionnaires assessing sleep (Pediatric Daytime Sleepiness Scale, Sleep Disturbance Scale for Children), mood (Global Anxiety Disorder-7, Patient Health Questionnaire-9, Beck’s Depression Inventory, Brigid Jordan CF screen), health-related quality of life (CF Questionnaire-Revised), family dynamics (Family Assessment Device, Family Management Measure), CF respiratory symptoms (CF Respiratory Symptom Score), and treatment adherence. Socioeconomic status and impacts from pandemic lockdowns were also surveyed. Progress to date 45 CF adolescents-parent pairs have been recruited. Questionnaires have been distributed and awaiting return of results for analysis. Intended outcome and impact We anticipate demonstrating the known association between impaired sleep quality and elevated mood scores. We will also make commentary on associations with a range of social factors (family dynamics, socioeconomic status) as well as parental mental health. Discussion will also include impacts on treatment adherence, HRQOL and respiratory symptom scores. Results from this pilot will inform the upcoming AREST CF prospective longitudinal study where the bidirectional relationships between factors studied can be further explored.


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