scholarly journals Laboratory Workup of Lymphoma in Adults

2020 ◽  
Author(s):  
Steven H. Kroft ◽  
Cordelia E. Sever ◽  
Adam Bagg ◽  
Brooke Billman ◽  
Catherine Diefenbach ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Clinical Pathology ◽  
Cost Effective ◽  
Primary Diagnosis ◽  
Aggressive Lymphoma ◽  
Evidence Based ◽  
Assessment Development ◽  
Evaluation Approach ◽  
Cost Effective Approach ◽  
American Society

Context.— The diagnostic workup of lymphoma continues to evolve rapidly as experience and discovery led to the addition of new clinicopathologic entities and techniques to differentiate them. The optimal clinically effective, efficient, and cost-effective approach to diagnosis that is safe for patients can be elusive, in both community-based and academic practice. Studies suggest that there is variation in practice in both settings. Objective.— To develop an evidence-based guideline for the preanalytic phase of testing, focusing on specimen requirements for the diagnostic evaluation of lymphoma. Design.— The American Society for Clinical Pathology, the College of American Pathologists, and the American Society of Hematology convened a panel of experts in the laboratory workup of lymphoma to develop evidence-based recommendations. The panel conducted a systematic review of literature to address key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, recommendations were derived based on the available evidence, strength of that evidence, and key judgements as defined in the Grading of Recommendations Assessment, Development, and Evaluation Evidence to Decision framework. Results.— Thirteen guideline statements were established to optimize specimen selection, ancillary diagnostic testing, and appropriate follow-up for safe and accurate diagnosis of indolent and aggressive lymphoma. Conclusions.— Primary diagnosis and classification of lymphoma can be achieved with a variety of specimens. Application of the recommendations can guide decisions on specimen suitability, diagnostic capabilities, and correct use of ancillary testing. Disease prevalence in patient populations, availability of ancillary testing, and diagnostic goals should be incorporated into algorithms tailored to each practice environment.

Laboratory Workup of Lymphoma in Adults

2020 ◽  
Vol 155 (1) ◽  
pp. 12-37
Author(s):  
Steven H Kroft ◽  
Cordelia E Sever ◽  
Adam Bagg ◽  
Brooke Billman ◽  
Catherine Diefenbach ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Clinical Pathology ◽  
Cost Effective ◽  
Primary Diagnosis ◽  
Aggressive Lymphoma ◽  
Evidence Based ◽  
Assessment Development ◽  
Cost Effective Approach ◽  
American Society ◽  
Evidence Based Guideline

Abstract Objectives The diagnostic workup of lymphoma continues to evolve rapidly as experience and discovery lead to the addition of new clinicopathologic entities and techniques to differentiate them. The optimal clinically effective, efficient, and cost-effective approach to diagnosis that is safe for patients can be elusive, in both community-based and academic practice. Studies suggest that there is variation in practice in both settings. The aim of this review is to develop an evidence-based guideline for the preanalytic phase of testing, focusing on specimen requirements for the diagnostic evaluation of lymphoma. Methods The American Society for Clinical Pathology, the College of American Pathologists, and the American Society of Hematology convened a panel of experts in the laboratory workup of lymphoma to develop evidence-based recommendations. The panel conducted a systematic review of the literature to address key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, recommendations were derived based on the available evidence, the strength of that evidence, and key judgments as defined in the GRADE Evidence to Decision framework. Results Thirteen guideline statements were established to optimize specimen selection, ancillary diagnostic testing, and appropriate follow-up for safe and accurate diagnosis of indolent and aggressive lymphoma. Conclusions Primary diagnosis and classification of lymphoma can be achieved with a variety of specimens. Application of the recommendations can guide decisions about specimen suitability, diagnostic capabilities, and correct utilization of ancillary testing. Disease prevalence in patient populations, availability of ancillary testing, and diagnostic goals should be incorporated into algorithms tailored to each practice environment.

scholarly journals Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies: Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology

2021 ◽  
Author(s):  
David F. Keren ◽  
Gregary Bocsi ◽  
Brooke L. Billman ◽  
Joan Etzell ◽  
James D. Faix ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Sample Selection ◽  
Analytical Data ◽  
Clinical Pathology ◽  
Clinical Information ◽  
M Protein ◽  
Evidence Based ◽  
Monoclonal Gammopathies ◽  
Assessment Development ◽  
M Proteins

Context.— The process for identifying patients with monoclonal gammopathies is complex. Initial detection of a monoclonal immunoglobulin protein (M protein) in the serum or urine often requires compilation of analytical data from several areas of the laboratory. The detection of M proteins depends on adequacy of the sample provided, available clinical information, and the laboratory tests used. Objective.— To develop an evidence-based guideline for the initial laboratory detection of M proteins. Design.— To develop evidence-based recommendations, the College of American Pathologists convened a panel of experts in the diagnosis and treatment of monoclonal gammopathies and the laboratory procedures used for the initial detection of M proteins. The panel conducted a systematic literature review to address key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, recommendations were created based on the available evidence, strength of that evidence, and key judgements as defined in the Grading of Recommendations Assessment, Development, and Evaluation Evidence to Decision framework. Results.— Nine guideline statements were established to optimize sample selection and testing for the initial detection and quantitative measurement of M proteins used to diagnose monoclonal gammopathies. Conclusions.— This guideline was constructed to harmonize and strengthen the initial detection of an M protein in patients displaying symptoms or laboratory features of a monoclonal gammopathy. It endorses more comprehensive initial testing when there is suspicion of amyloid light chain amyloidosis or neuropathies, such as POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes) syndrome, associated with an M protein.

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 Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology

2017 ◽  
Vol 35 (13) ◽  
pp. 1453-1486 ◽  
Author(s):  
Antonia R. Sepulveda ◽  
Stanley R. Hamilton ◽  
Carmen J. Allegra ◽  
Wayne Grody ◽  
Allison M. Cushman-Vokoun ◽  
...  
Keyword(s):  
Clinical Oncology ◽  
Molecular Pathology ◽  
Targeted Therapies ◽  
Clinical Pathology ◽  
Molecular Biomarkers ◽  
Molecular Testing ◽  
Evidence Based ◽  
Molecular Biomarker ◽  
Biomarker Testing ◽  
American Society

Purpose Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidence-based recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) –targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations Evidence supports mutational testing for genes in the EGFR signaling pathway, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results. Additional information is available at: www.asco.org/CRC-markers-guideline and www.asco.org/guidelineswiki

Guideline for the Management of Fever and Neutropenia in Children With Cancer and/or Undergoing Hematopoietic Stem-Cell Transplantation

2012 ◽  
Vol 30 (35) ◽  
pp. 4427-4438 ◽  
Author(s):  
Thomas Lehrnbecher ◽  
Robert Phillips ◽  
Sarah Alexander ◽  
Frank Alvaro ◽  
Fabianne Carlesse ◽  
...  
Keyword(s):  
Risk Stratification ◽  
Initial Presentation ◽  
Local Context ◽  
Evidence Based ◽  
Children With Cancer ◽  
Level Of Evidence ◽  
Hematopoietic Stem ◽  
Assessment Development ◽  
Patient Advocate ◽  
Evaluation Approach

PurposeTo develop an evidence-based guideline for the empiric management of pediatric fever and neutropenia (FN).MethodsThe International Pediatric Fever and Neutropenia Guideline Panel is a multidisciplinary and multinational group composed of experts in pediatric oncology and infectious disease as well as a patient advocate. The Panel was convened for the purpose of creating this guideline. We followed previously validated procedures for creating evidence-based guidelines. Working groups focused on initial presentation, ongoing management, and empiric antifungal therapy. Each working group developed key clinical questions, conducted systematic reviews of the published literature, and compiled evidence summaries. The Grades of Recommendation Assessment, Development, and Evaluation approach was used to generate summaries, and evidence was classified as high, moderate, low, or very low based on methodologic considerations.ResultsRecommendations were made related to initial presentation (risk stratification, initial evaluation, and treatment), ongoing management (modification and cessation of empiric antibiotics), and empiric antifungal treatment (risk stratification, evaluation, and treatment) of pediatric FN. For each recommendation, the strength of the recommendation and level of evidence are presented.ConclusionThis guideline represents an evidence-based approach to FN specific to children with cancer. Although some recommendations are similar to adult-based guidelines, there are key distinctions in multiple areas. Implementation will require adaptation to the local context.

scholarly journals Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology

2017 ◽  
Vol 141 (5) ◽  
pp. 625-657 ◽  
Author(s):  
Antonia R. Sepulveda ◽  
Stanley R. Hamilton ◽  
Carmen J. Allegra ◽  
Wayne Grody ◽  
Allison M. Cushman-Vokoun ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Oncology ◽  
Molecular Pathology ◽  
Clinical Pathology ◽  
Evidence Based ◽  
Molecular Biomarker ◽  
Egfr Signaling Pathway ◽  
Biomarker Testing ◽  
American Society ◽  
Evidence Based Guideline

Objectives.— To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. Methods.— The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Results.— Twenty-one guideline statements were established. Conclusions.— Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

Abstract TMP49: Yield of Diagnostic Evaluation in Major Stroke Phenoytypes

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Jennifer J Majersik ◽  
Ethem M Arsava ◽  
Robert D Brown ◽  
Raji Grewal ◽  
Christina Jern ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Management Strategies ◽  
Cost Effective ◽  
Considerable Proportion ◽  
Evidence Based ◽  
Large Artery ◽  
Stroke Etiology ◽  
Cardiac Evaluation ◽  
Major Stroke

Background: Considerable disagreement exists among experts regarding the appropriate extent of diagnostic testing after ischemic stroke (IS). Evidence-based data guiding stroke evaluation for individual patients according to the underlying phenotype are unknown. We sought to determine the yield of cardiac and arterial evaluations for identifying an alternative major stroke etiology in patients with a given phenotype in the NINDS Stroke Genetics Network (SiGN). Methods: SiGN is a consortium of IS studies at 22 US and European sites aiming to identify stroke susceptibility genes. Adjudicators certified in Causative Classification of Stroke (CCS) system determined major etiologic stroke phenotypes based on chart review. All diagnostic data entered into the CCS software were stored in a confidential database. We determined the probability of identifying an alternative major abnormality based on cardiac (history, EKG, echocardiography) and arterial [intracranial (IC), extracranial (EC)] evaluations in 3 stroke phenotypes: lacunar infarct (LI), large artery atherosclerosis (LAA), and cardiac embolism (CE). Proportions of alternative major etiologies were calculated in patients with complete evaluations in each phenotype. Results: The analyses included 15720 patients. Among these, 2299 had phenotypic subtype of LI (1660 with cardiac and 1691 with arterial evaluations); 4228 had CE (2451 with arterial evaluation); and 2613 had LAA (2047 with cardiac evaluation). Cardiac evaluation revealed a major cardiac source of embolism in 12.3% of patients with LI and 20.3% with LAA. Echocardiography demonstrated an additional major structural cardiac source not seen by history/examination/EKG in 1.9% and 1.6% in LI and LAA respectively. Arterial evaluation led to the identification of ≥50%ipsilateral stenosis in 13.5% (IC: 8.9%, EC: 5.8%) of patients with LI and 17% (IC: 8.1%, EC: 11.3%) of those with CE. In LI patients with complete cardiac and vascular evaluations, 24.1% had an alternative major stroke etiology. Conclusions: A considerable proportion of IS patients with LI, LAA, and CE harbor an alternative major etiology. In the future, these results can be used to generate evidence-based and cost-effective evaluation and management strategies.

Empirical Antimicrobial Therapy of Neonates with Necrotizing Enterocolitis: A Systematic Review

2021 ◽  
Author(s):  
Daniele Donà ◽  
Andrea Gastaldi ◽  
Elisa Barbieri ◽  
Luca Bonadies ◽  
Jalemba Aluvaala ◽  
...  
Keyword(s):  
Necrotizing Enterocolitis ◽  
Empiric Therapy ◽  
Risk Of Bias ◽  
Current Evidence ◽  
Surgical Approaches ◽  
Evidence Based ◽  
Assessment Development ◽  
Evaluation Approach ◽  
Gentamicin Treatment ◽  
Empiric Antibiotic

Objective Necrotizing enterocolitis (NEC) is an inflammatory disease of the gastrointestinal tract characterized by ischemic necrosis of the intestinal mucosa, mostly affecting premature neonates. Management of NEC includes medical care and surgical approaches, with supportive care and empirical antibiotic therapy recommended to avoid any disease progression. However, there is still no clear evidence-based consensus on empiric antibiotic strategies or surgical timing. This study was aimed to review the available evidence on the effectiveness and safety of different antibiotic regimens for NEC. Study Design MEDLINE, EMBASE, Cochrane CENTRAL, and CINAHL databases were systematically searched through May 31, 2020. Randomized controlled trials (RCTs) and nonrandomized interventions reporting data on predefined outcomes related to NEC treatments were included. Clinical trials were assessed using the criteria and standard methods of the Cochrane risk of bias tool for randomized trials, while the risk of bias in nonrandomized studies of interventions was evaluated using the ROBINS-I tool. The certainty in evidence of each outcome's effects was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results Five studies were included in this review, two RCTs and three observational studies, for a total amount of 3,161 patients. One RCT compared the outcomes of parenteral (ampicillin plus gentamicin) and oral (gentamicin) treatment with parenteral only. Three studies (one RCT and two observational) evaluated adding anaerobic coverage to different parenteral regimens. The last observational study compared two different parenteral antibiotic combinations (ampicillin and gentamicin vs. cefotaxime and vancomycin). Conclusion No antimicrobial regimen has been shown to be superior to ampicillin and gentamicin in decreasing mortality and preventing clinical deterioration in NEC. The use of additional antibiotics providing anaerobic coverage, typically metronidazole, or use of other broad-spectrum regimens as first-line empiric therapy is not supported by the very limited current evidence. Well-conducted, appropriately sized comparative trials are needed to make evidence-based recommendations. Key Points

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 Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology: Guideline Update From the College of American Pathologists in Collaboration With the American Society for Clinical Pathology and the Association for Pathology Informatics

2021 ◽  
Author(s):  
Andrew J. Evans ◽  
Richard W. Brown ◽  
Marilyn M. Bui ◽  
Elizabeth A. Chlipala ◽  
Christina Lacchetti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Expert Panel ◽  
Good Practice ◽  
Digital Pathology ◽  
Clinical Pathology ◽  
Glass Slide ◽  
Whole Slide Imaging ◽  
Assessment Development ◽  
Evaluation Approach ◽  
Diagnostic Concordance

Context.— The original guideline, “Validating Whole Slide Imaging for Diagnostic Purposes in Pathology,” was published in 2013 and included 12 guideline statements. The College of American Pathologists convened an expert panel to update the guideline following standards established by the National Academies of Medicine for developing trustworthy clinical practice guidelines. Objective.— To assess evidence published since the release of the original guideline and provide updated recommendations for validating whole slide imaging (WSI) systems used for diagnostic purposes. Design.— An expert panel performed a systematic review of the literature. Frozen sections, anatomic pathology specimens (biopsies, curettings, and resections), and hematopathology cases were included. Cytology cases were excluded. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, the panel reassessed and updated the original guideline recommendations. Results.— Three strong recommendations and 9 good practice statements are offered to assist laboratories with validating WSI digital pathology systems. Conclusions.— Systematic review of literature following release of the 2013 guideline reaffirms the use of a validation set of at least 60 cases, establishing intraobserver diagnostic concordance between WSI and glass slides and the use of a 2-week washout period between modalities. Although all discordances between WSI and glass slide diagnoses discovered during validation need to be reconciled, laboratories should be particularly concerned if their overall WSI–glass slide concordance is less than 95%.

Sign in / Sign up

Export Citation Format

Share Document