scholarly journals HER2 testing of gastro-oesophageal adenocarcinoma: a commentary and guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee

2018 ◽  
Vol 71 (5) ◽  
pp. 388-394 ◽  
Author(s):  
Newton A C S Wong ◽  
Fernanda Amary ◽  
Rachel Butler ◽  
Richard Byers ◽  
David Gonzalez ◽  
...  
Keyword(s):  
Molecular Pathology ◽  
Clinical Decision Making ◽  
Growth Factor Receptor ◽  
Clinical Pathology ◽  
Clinical Decision ◽  
Oesophageal Adenocarcinoma ◽  
Guidance Document ◽  
Her2 Testing ◽  
American Society ◽  
The Uk

The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinical Pathology and the American Society of Clinical Oncology jointly published guidelines for HER2 testing and clinical decision making in gastro-oesophageal adenocarcinoma. The Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee has issued the following document as a commentary of these guidelines and, in parallel, to provide guidance on HER2 testing in National Health Service pathology departments within the UK. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such HER2 testing.

scholarly journals HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology

2016 ◽  
Vol 140 (12) ◽  
pp. 1345-1363 ◽  
Author(s):  
Angela N. Bartley ◽  
Mary Kay Washington ◽  
Christina B. Ventura ◽  
Nofisat Ismaila ◽  
Carol Colasacco ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Clinical Pathology ◽  
Clinical Decision ◽  
Evidence Based ◽  
Her2 Testing ◽  
Gastroesophageal Adenocarcinoma ◽  
American Society ◽  
Evidence Based Guideline ◽  
Selection Of

Context.— ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. Objectives.— To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. Design.— The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. Results.— The panel is proposing 11 recommendations with strong agreement from the open-comment participants. Recommendations.— The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. Conclusions.— This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

scholarly journals HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology

2017 ◽  
Vol 35 (4) ◽  
pp. 446-464 ◽  
Author(s):  
Angela N. Bartley ◽  
Mary Kay Washington ◽  
Carol Colasacco ◽  
Christina B. Ventura ◽  
Nofisat Ismaila ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Clinical Pathology ◽  
Clinical Decision ◽  
Evidence Based ◽  
Her2 Testing ◽  
Gastroesophageal Adenocarcinoma ◽  
American Society ◽  
Evidence Based Guideline ◽  
Selection Of

Context ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. Objectives To establish an evidence-based guideline for HER2 testing in patients with GEA, formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. Design The College of American Pathologists (CAP), American Society for Clinical Pathology (ASCP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. Results The Panel is proposing 11 recommendations with strong agreement from the open comment participants. Recommendations The Panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and an HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. Conclusion This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

scholarly journals Haematological and biochemical reference intervals in healthy racing and retired Italian Greyhounds

2020 ◽  
Vol 68 (1) ◽  
pp. 71-78
Author(s):  
Paola Scarpa ◽  
Beatrice Ruggerone ◽  
Sara Gironi ◽  
Tiziana Vitiello ◽  
Saverio Paltrinieri
Keyword(s):  
Clinical Decision Making ◽  
Haemoglobin Concentration ◽  
Clinical Pathology ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Specific Reference ◽  
Canine Population ◽  
Mean Corpuscular Haemoglobin ◽  
American Society ◽  
Advia 120

AbstractIn view of the enormous variability of dog breeds, breed-specific reference intervals (RIs) are recommended for use in veterinary clinical decision-making. The aim of this study was to determine whether RIs of the general canine population may be applied to the Italian Greyhound (Piccoli Levrieri Italiani or PLI), and to generate breed-specific RIs, where appropriate. Sixty-three privately owned clinically healthy fasted dogs were examined. Routine haematology and biochemistry were performed on 58 enrolled patients using the ADVIA 120 haematology analyzer and the Cobas Mira system, respectively. Changes in haematological and biochemical parameters depending on sex, age and attitude (resting vs. running dogs) were investigated. The results of PLI were compared with the RIs of the general canine population. In those cases in which these RIs were not validated, new RIs were generated according to the guidelines of the American Society of Veterinary Clinical Pathology. Pre-existing RIs were considered valid based on the recommendations by the Clinical & Laboratory Standards Institute (CLSI). RIs were higher for mean corpuscular haemoglobin (MCH), mean cell haemoglobin concentration (MCHC), cell haemoglobin concentration mean (CHCM) and lower for large unstained cells (LUC). A wider discrepancy between pre-existing and newly established RIs was found for some ADVIA parameters regarding red blood cell (RBC) or reticulocyte morphology. For total protein and cholesterol the new RIs were wider than the pre-existing ones, while albumin, calcium and iron were higher. This study suggests that most of the RIs published in veterinary textbooks cannot be validated for PLIs.

scholarly journals Contextualizing genetic risk score for disease screening and rare variant discovery

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Dan Zhou ◽  
Dongmei Yu ◽  
Jeremiah M. Scharf ◽  
Carol A. Mathews ◽  
Lauren McGrath ◽  
...  
Keyword(s):  
Complex Traits ◽  
Genetic Basis ◽  
Clinical Decision Making ◽  
Genetic Risk Score ◽  
Sufficient Conditions ◽  
Clinical Decision ◽  
Generative Models ◽  
Variant Discovery ◽  
Models Of Disease ◽  
The Uk

AbstractStudies of the genetic basis of complex traits have demonstrated a substantial role for common, small-effect variant polygenic burden (PB) as well as large-effect variants (LEV, primarily rare). We identify sufficient conditions in which GWAS-derived PB may be used for well-powered rare pathogenic variant discovery or as a sample prioritization tool for whole-genome or exome sequencing. Through extensive simulations of genetic architectures and generative models of disease liability with parameters informed by empirical data, we quantify the power to detect, among cases, a lower PB in LEV carriers than in non-carriers. Furthermore, we uncover clinically useful conditions wherein the risk derived from the PB is comparable to the LEV-derived risk. The resulting summary-statistics-based methodology (with publicly available software, PB-LEV-SCAN) makes predictions on PB-based LEV screening for 36 complex traits, which we confirm in several disease datasets with available LEV information in the UK Biobank, with important implications on clinical decision-making.

The value of a consultant physiotherapist within a primary care musculoskeletal interface service: part of the spinal multidisciplinary team

2021 ◽  
Vol 28 (1) ◽  
pp. 1-10
Author(s):  
Michelle L Angus ◽  
Victoria Dickens ◽  
Naveed Yasin ◽  
James Greenwood ◽  
Irfan Siddique
Keyword(s):  
Primary Care ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Tertiary Referral Centre ◽  
Allied Health Professionals ◽  
Convenience Sample ◽  
Surgical Services ◽  
Pain Pathway ◽  
The Uk ◽  
Case Based

Background/aims The national low back pain pathway in the UK suggests practitioners managing patients with spinal pathology should be specifically trained to do so and have the ability to link with tertiary spinal services when required. The aim of this study was to ensure referrals through to a tertiary spinal surgical centre are appropriate and patients get the correct advice early in their management pathway. Methods A retrospective review of 700 cases were discussed at a spinal case-based discussion meeting in a primary care interface service, compared to services without this model. A convenience sample of cases were analysed with the consultant physiotherapist and those referred from other allied health professionals into the tertiary spinal surgical centre. Case-based team discussion took place before every referral into the tertiary spinal service, with spinal surgical discussion where required. Results Patients referred from other interface services were more likely to require further work-up such as investigations, or be discharged from clinic on their first attendance than those who had been through the case-based discussion. Conclusions A consultant physiotherapist working as part of the spinal team of a tertiary referral centre can help advanced practitioners with their clinical decision making to help prevent unnecessary referrals to spinal surgical services.

scholarly journals Precision Approaches in the Management of Colorectal Cancer: Current Evidence and Latest Advancements towards Individualizing the Treatment

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3481
Author(s):  
Rebecca A. Shuford ◽  
Ashley L. Cairns ◽  
Omeed Moaven
Keyword(s):  
Colorectal Cancer ◽  
Growth Factor ◽  
Metastatic Colorectal Cancer ◽  
Mismatch Repair ◽  
Clinical Decision Making ◽  
Growth Factor Receptor ◽  
Clinical Decision ◽  
Current Evidence ◽  
Therapeutic Modalities ◽  
Clinically Significant

The genetic and molecular underpinnings of metastatic colorectal cancer have been studied for decades, and the applicability of these findings in clinical decision making continues to evolve. Advancements in translating molecular studies have provided a basis for tailoring chemotherapeutic regimens in metastatic colorectal cancer (mCRC) treatment, which have informed multiple practice guidelines. Various genetic and molecular pathways have been identified as clinically significant in the pathogenesis of metastatic colorectal cancer. These include rat sarcoma (RAS), epithelial growth factor receptor (EGFR), vascular endothelial growth factor VEGF, microsatellite instability, mismatch repair, and v-raf murine sarcoma viral oncogene homolog b1 (BRAF) with established clinical implications. RAS mutations and deficiencies in the mismatch repair pathway guide decisions regarding the administration of anti-EGFR-based therapies and immunotherapy, respectively. Furthermore, there are several emerging pathways and therapeutic modalities that have not entered mainstream use in mCRC treatment and are ripe for further investigation. The well-established data in the arena of targeted therapies provide evidence-based support for the use or avoidance of various therapeutic regimens in mCRC treatment, while the emerging pathways and platforms offer a glimpse into the future of transforming a precision approach into a personalized treatment.

OP143 Assessment Of mHealth Apps: Is Current Regulation Policy Adequate?

2019 ◽  
Vol 35 (S1) ◽  
pp. 33-33
Author(s):  
Magdalena Moshi ◽  
Jacqueline Parsons ◽  
Rebecca Tooher ◽  
Tracy Merlin
Keyword(s):  
Medical Device ◽  
Clinical Evaluation ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
International Standards ◽  
Regulatory Agencies ◽  
Guidance Document ◽  
Regulatory Bodies ◽  
Mhealth Apps

IntroductionAustralians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.MethodsA policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.ResultsAll included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.ConclusionsNone of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.

scholarly journals Clinical decision making in the provision of audiovisual care for upper limb trauma: a survey of UK experiences

Hand Therapy ◽  
2020 ◽  
pp. 175899832097213
Author(s):  
Emily McMullen ◽  
Megan Robson ◽  
Mark Paul Brewin ◽  
Poonam Valand ◽  
Leela Sayed ◽  
...  
Keyword(s):  
Decision Making ◽  
Upper Limb ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Service Planning ◽  
Cross Sectional Survey ◽  
Visual Technology ◽  
Limb Trauma ◽  
The Uk ◽  
Decision Making Tool

Introduction For many patients, audio-visual appointments have provided a timely and efficient way of seeking advice, assessment and treatment for their hand injuries during the NHS response to COVID-19. This study aimed to explore the experience of hand units across the UK in determining the safe and judicious use of audio-visual outpatient care for the management of acute upper limb trauma. Methods An online cross-sectional survey was sent to the therapy leads of hand units across the UK. Questions focused on the experience of using audio-visual technology in the management of upper limb trauma, and the relevant factors in determining its appropriate use. A deductive mixed methods analysis was used to identify both common themes and capture community experience and characteristics. Results A total of 51 out of 76 hand therapy units completed the survey; a response rate of 67%. Of these, 82% (42/51) reported using audio-visual technology to manage upper limb trauma during the UK COVID-19 lockdown. When determining patient suitability for audio-visual consultations, 73% (37/51) of respondents reported the use of COVID-19 guidelines, but only 35% (18/51) reported the use of a clinical decision-making tool. In agreement with our experience at Salisbury Hospital Foundation Trust, 92% (47/51) had concerns relating to the use of audio-visual care. Conclusion The choice of safely managed remote care or in-person consultation has, to date, largely relied on the discretion of the clinician. A carefully designed clinical decision-making tool for the management of upper limb trauma is needed for use both in clinical practice and in future service planning.

scholarly journals A user guide to the American Society of Hematology clinical practice guidelines

2020 ◽  
Vol 4 (9) ◽  
pp. 2095-2110
Author(s):  
Ariel Izcovich ◽  
Adam Cuker ◽  
Robert Kunkle ◽  
Ignacio Neumann ◽  
Julie Panepinto ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Immune Thrombocytopenia ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Cell Disease ◽  
Presentation Formats ◽  
American Society ◽  
The Many

Abstract Since November 2018, Blood Advances has published American Society of Hematology (ASH) clinical practice guidelines on venous thromboembolism, immune thrombocytopenia, and sickle cell disease. More ASH guidelines on these and other topics are forthcoming. These guidelines have been developed using consistent processes, methods, terminology, and presentation formats. In this article, we describe how patients, clinicians, policymakers, researchers, and others may use ASH guidelines and the many related derivates by describing how to interpret information and how to apply it to clinical decision-making. Also, by exploring how these documents are developed, we aim to clarify their limitations and possible inappropriate usage.

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