Changes in the use of commercial and lab-developed IVD assays in the clinical setting for PD-L1 expression testing in NSCLC in the United States.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 154-154
Author(s):  
Ayse Levent ◽  
Pieter De Richter ◽  
William H Angel ◽  
Ciny Edathanal ◽  
Christophe Homer
Keyword(s):  
United States ◽  
Clinical Practice ◽  
Practice Guidelines ◽  
Stage Iv ◽  
The United States ◽  
Subsequent Treatment ◽  
Trial Data ◽  
Clinical Practices ◽  
The Us ◽  
One Year

154 Background: In 2016 we observed a lack of standardization in the use of cut-off points to define positivity when testing for PD-L1 expression in NSCLC, despite these being specified by assay manufacturers or recommended based on trial data. One year on we look at how clinical practice has changed in light of new approvals for PD-(L)1 inhibitors, availability of new IVD assays and changes in clinical practice guidelines recommending the use of immunotherapy for stage IV NSCLC. Here we explore how the variety of test brands and cut-off points used in the US has changed since 2016 by examining real-world clinical usage data. Methods: Between June and August 2016 and June and August 2017, a panel of pathologists in the US (n = 21 in 2016 and n = 28 in 2017) was asked to report on their practices relating to PD-L1 expression testing in NSCLC, through the submission of online de-identified record forms (n = 167 and n = 224 PD-L1-tested samples in 2016 and 2017 respectively). Results: Of the 224 samples gathered in 2017, 187 (84%) were tested with the Dako 22C3 pharmDx assay (vs 67% in 2016), 16 (7%) with the Dako 28-8 pharmDx assay (vs 22% in 2016) and 11 (5%) with a lab-developed test (LDT). An increase in the use of 1% staining as the cut-off was observed for both 22C3 and 28-8 pharmDx. The full distribution of cut-offs used is shown in the table below. Conclusions: Following initial fragmentation of clinical practices in 2016, PD-L1 expression testing has seen consolidation towards greater use of the Dako 22C3 assay and higher conformity in testing at the recommended cut-off points. While greater standardization simplifies testing, the choice of assay has potential implications on subsequent treatment: current PD-L1 assays allow physicians to confirm whether a specific PD-(L)1 inhibitor is appropriate for a patient, but there is no single PD-L1 expression test that supports oncologists in making treatment decisions for the PD-(L)1 inhibitor class as a whole.[Table: see text]

scholarly journals 779. Impact of updated IDSA practice guidelines on the treatment of Clostridium difficile infections in the United States

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S346-S346 ◽  
Author(s):  
Cornelius J Clancy ◽  
Minh-Hong Nguyen
Keyword(s):  
United States ◽  
Practice Guidelines ◽  
Randomized Clinical Trials ◽  
The United States ◽  
Prescription Data ◽  
Recommended Treatment ◽  
The Us ◽  
Before And After ◽  
Dosing Regimens ◽  
National Pact

Abstract Background IDSA published updated practice guidelines for C. difficile infections (CDI) in February 2018. Since publication of previous CDI guidelines in2010, randomized clinical trials (RCTs) have demonstrated benefit of oral (po) vancomycin or fidaxomicin over metronidazole in at least some types of CDI. Updated guidelines endorsed vancomycin or fidaxomicin as recommended treatment for initial and recurrent nonfulminant CDI episodes, and vancomycin as treatment for fulminant CDI. We studied the use of po vancomycin, fidaxomicin and metronidazole in the United States before and after publication of updated guidelines. Methods We obtained US antibiotic prescription data (IQVIA, Durham, NC) since 2013, and used standard dosing regimens for treatment of initial CDI to estimate numbers of infections treated with different agents. Po vancomycin and fidaxomicin are used exclusively against known or suspected CDI. Metronidazole is used to treat CDI and other infections. IQVIA data do not capture indications for prescriptions. Results Treatment courses of po vancomycin and fidaxomicin increased by 45% (n = 126,729 increase) and 44% (n = 11,243 increase), respectively, over the 12 months after publication of the updated CDI guidelines compared with 12 months before publication (Figure, second arrow; Table). Increased use of both agents was evident in the first month after guidelines were published. Over the same 12 month periods, treatment courses of po metronidazole decreased by 3% (190,430 decrease). In comparison, treatment courses of po vancomycin increased by 24% (n = 47,219 increase) over the 12 months after publication of the multi-national PACT study in August 2014 (Figure, first arrow), which demonstrated superiority of vancomycin over metronidazole. Since 2013, there were no significant increases in the use of fidaxomicin until publication of the updated guidelines. Conclusion Updated IDSA guidelines have had a major impact on treatment of CDI in the US. RCT data used for guideline updates have been available since 2007–14 and 2011–12 for po vancomycin and fidaxomicin, respectively. IDSA should provide more timely updates to practice guidelines as new data emerge. Annual or bi-annual updates posted in electronic or other nontraditional formats may be more efficient than publishing long-form articles. Disclosures All authors: No reported disclosures.

Gastric Cancer Clinical Practice Guidelines in Oncology

2003 ◽  
Vol 1 (1) ◽  
pp. 28 ◽  
Keyword(s):  
United States ◽  
Gastric Cancer ◽  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
The United States ◽  
Major Health Problem ◽  
Major Health ◽  
Recent Version ◽  
Upper Gastrointestinal

Carcinomas originating in the upper gastrointestinal tract constitute a major health problem around the world. In fact, experts estimate that approximately 34,700 new cases of upper gastrointestinal carcinomas and 25,000 deaths will have occurred in the United States in 2002. This article summarizes the NCCN clinical practice guidelines for managing gastric cancer, which portray uniformity in the systemic approach to cancer in the United States. The article also discusses anticipated future advances in the treatment of gastric carcinoma. For the most recent version of the guidelines, please visit NCCN.org

scholarly journals A changing climate of skepticism: The factors shaping climate change coverage in the US press

2015 ◽  
Vol 26 (4) ◽  
pp. 498-513 ◽  
Author(s):  
Hannah Schmid-Petri ◽  
Silke Adam ◽  
Ivo Schmucki ◽  
Thomas Häussler
Keyword(s):  
Climate Change ◽  
United States ◽  
Content Analysis ◽  
Mass Media ◽  
Media Coverage ◽  
Print Media ◽  
The United States ◽  
Quantitative Content ◽  
The Us ◽  
One Year

Skepticism toward climate change has a long tradition in the United States. We focus on mass media as the conveyors of the image of climate change and ask: Is climate change skepticism still a characteristic of US print media coverage? If so, to what degree and in what form? And which factors might pave the way for skeptics entering mass media debates? We conducted a quantitative content analysis of US print media during one year (1 June 2012 to 31 May 2013). Our results show that the debate has changed: fundamental forms of climate change skepticism (such as denial of anthropogenic causes) have been abandoned in the coverage, being replaced by more subtle forms (such as the goal to avoid binding regulations). We find no evidence for the norm of journalistic balance, nor do our data support the idea that it is the conservative press that boosts skepticism.

Anal Canal Cancer Clinical Practice Guidelines in Oncology

2005 ◽  
Vol 3 (4) ◽  
pp. 510 ◽  
Keyword(s):  
United States ◽  
Clinical Practice ◽  
Anal Canal ◽  
Practice Guidelines ◽  
Digestive System ◽  
The United States ◽  
Anal Canal Cancer ◽  
Nccn Guidelines ◽  
Recent Version

An estimated 3,990 new cases of anal cancer will occur in 2005, accounting for approximately 1.6% of digestive system cancers in the United States. Prognosis directly depends on the size of the primary tumor and the likelihood of lymphatic spread, with tumors 2 cm or smaller cured in 80% of cases. The NCCN guidelines recommend a thorough evaluation for any patient with a suspicious lesion in the anal canal and include additional recommendations for diagnosis, treatment, and follow up for anal canal cancer. For the most recent version of the guidelines, please visit NCCN.org

Impact of Revised Infectious Diseases Society of America and Society for Healthcare Epidemiology of America Clinical Practice Guidelines on the Treatment of Clostridium difficile Infections in the United States

2020 ◽  
Author(s):  
Cornelius J Clancy ◽  
Deanna Buehrle ◽  
Michelle Vu ◽  
Marilyn M Wagener ◽  
M Hong Nguyen
Keyword(s):  
United States ◽  
Clinical Practice ◽  
Clostridium Difficile ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Day Treatment ◽  
The United States ◽  
Prescription Data ◽  
Oral Vancomycin ◽  
Oral Metronidazole

Abstract Background Our objective was to determine if oral vancomycin, fidaxomicin, and oral metronidazole use in the United States changed after publication of revised clinical practice guidelines for Clostridium difficile infection (CDI) in February 2018. Methods We obtained US antibiotic prescription data (IQVIA) from 2006–August 2019 and used guideline-recommended dosing regimens to estimate monthly numbers of 10-day treatment courses of vancomycin, fidaxomicin and metronidazole. Interrupted time-series analyses were performed, adjusted by month. We compared linear trends for monthly numbers of treatment courses in different time periods. Results Cumulative treatment courses of oral vancomycin and fidaxomicin increased by 54% (n = 226 166) and 48% (n = 18 518), respectively, in 18 months following guidelines compared with 18 months before; those of oral metronidazole decreased by 3% (n = 238 372). Monthly vancomycin and fidaxomicin use significantly increased throughout the period following revised guidelines (P < .0001 and P = .0002, respectively), whereas that of metronidazole decreased significantly (P < .0001). Monthly vancomycin use increased and metronidazole use decreased to a significantly greater extent after publication of revised guidelines than after publication of clinical trials establishing superiority of vancomycin over metronidazole (P < .0001). Conclusions Revised practice guidelines have had a significant impact on CDI treatment in the US. Clinical trial data used for the revised guidelines were available since 2007–2014 and 2011–2012 for oral vancomycin and fidaxomicin, respectively. Guidelines or guidance documents for treating CDI and other infections should be updated in more timely fashion.

scholarly journals Utilization of the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative electronic mailing list (listserv) by healthcare professionals

2020 ◽  
pp. 1-3
Author(s):  
Christopher C. McPherson ◽  
Zachary A. Vesoulis ◽  
Talene A. Metjian ◽  
Mirela Grabic ◽  
Summer Reyes ◽  
...  
Keyword(s):  
United States ◽  
Clinical Practice ◽  
Retrospective Study ◽  
Clinical Practice Guidelines ◽  
Antimicrobial Stewardship ◽  
Practice Guidelines ◽  
Healthcare Professionals ◽  
The United States ◽  
Mailing List

Abstract Optimizing pediatric antimicrobial stewardship is challenging. In this retrospective study, we evaluated 515 original e-mails to 482 members of the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative electronic mailing list ([email protected]). The plurality of threads discussed clinical practice guidelines, and pharmacists were most likely to initiate and respond. Representation was geographically diverse within and outside the United States.

Ovarian Cancer Clinical Practice Guidelines in Oncology

2004 ◽  
Vol 2 (6) ◽  
pp. 526 ◽  
Keyword(s):  
United States ◽  
Ovarian Cancer ◽  
Clinical Practice ◽  
Practice Guidelines ◽  
Advanced Disease ◽  
Gynecologic Cancer ◽  
The United States ◽  
Common Cause ◽  
Recent Version ◽  
Eighth Decade

Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the country's fourth most common cause of cancer mortality in women. In the year 2004, there will be an estimated 25,580 new diagnoses and an estimated 16,090 deaths from this neoplasm. The incidence increases with age and is most prevalent in the eighth decade of life, with an incidence rate of 57/100,000 women. The median age at the time of diagnosis is 63 years, and 70% of patients present with advanced disease. For the most recent version of the guidelines, please visit NCCN.org

scholarly journals Continuum of the United States military’s traumatic brain injury care: adjusting to the changing battlefield

2018 ◽  
Vol 45 (6) ◽  
pp. E15 ◽  
Author(s):  
Rachel Lazarus ◽  
Katherine Helmick ◽  
Saafan Malik ◽  
Emma Gregory ◽  
Yll Agimi ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Clinical Practice ◽  
Brain Injury ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Clinical Care ◽  
The United States ◽  
Us Military ◽  
Combat Casualty ◽  
The Us

Over the past 8 years, advances in the US Military Health System (MHS) have led to extensive changes in the way combat casualty care is provided to deployed service members with a traumatic brain injury (TBI). Changes include the application of cutting-edge Clinical Practice Guidelines, use of pioneering technologies, and advances in evacuation procedures. Compared with previous engagements, current operations occur on a much smaller scale, and more frequently in austere environments, such that effective medical support is increasingly challenging. In this paper, the authors describe key aspects of the current continuum of TBI care in the US military, from the point of injury through rehabilitation, with an emphasis on how emerging technologies and evidence-based Clinical Practice Guidelines assist MHS clinicians with providing the best clinical care possible in the changing battlefield.

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