Clinical decision making in the selection of analgesia

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.

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Scar Resurfacing

Textbook on Scar Management ◽

10.1007/978-3-030-44766-3_36 ◽

2020 ◽

pp. 311-316

Author(s):

Fiona M. Wood

Keyword(s):

Decision Making ◽

Clinical Decision Making ◽

Healing Process ◽

Clinical Decision ◽

Skin Surface ◽

History Of ◽

Secondary Healing ◽

The Impact ◽

Selection Of

AbstractScar resurfacing is focused on the improvement in the quality of a scar by disruption of the skin surface and reducing the bulk of the scar by control of the secondary healing process. The prerequisite is knowledge of the wound healing and scarring process such that the intervention can be designed to reduce the risk of increasing the scarring.The clinical examination and assessment of the scar will guide the selection of the technique addressing the specific aspects of the scar, such as the pigment restoration and volume reduction, with the aim of blending the scar with the surrounding uninjured skin.Understanding the natural history of the scar, the impact it has on the patient, and the techniques available for improvement provides the clinical decision-making matrix to drive an improved scar outcome. Resurfacing is one opportunity for scar modulation which needs to be taken into context relative to the range of conservative and surgical therapeutic opportunities explored within the chapters of the book.

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Important issues in the justification of a control treatment in paediatric drug trials

Archives of Disease in Childhood ◽

10.1136/archdischild-2016-310644 ◽

2016 ◽

Vol 101 (10) ◽

pp. 962-967 ◽

Cited By ~ 6

Author(s):

Lauren E Kelly ◽

Elin Haf Davies ◽

Agnes Saint-Raymond ◽

Paolo Tomasi ◽

Martin Offringa

Keyword(s):

Decision Making ◽

Clinical Trials ◽

Clinical Decision Making ◽

Clinical Decision ◽

Control Treatment ◽

European Medicines Agency ◽

Drug Dosing ◽

Optimal Dosing ◽

Dosing Strategy ◽

Selection Of

ObjectiveThe value of comparative effectiveness trials in informing clinical and policy decisions depends heavily on the choice of control arm (comparator). Our objective is to identify challenges in comparator reasoning and to determine justification criteria for selecting a control arm in paediatric clinical trials.DesignA literature search was completed to identify existing sources of guidance on comparator selection. Subsequently, we reviewed a randomly selected sample of comparators selected for paediatric investigation plans (PIPs) adopted by the Paediatric Committee of the European Medicines Agency in 2013. We gathered descriptive information and evaluated their review process to identify challenges and compromises between regulators and sponsors with regard to the selection of the comparator. A tool to help investigators justify the selection of active controls and placebo arms was developed using the existing literature and empirical data.ResultsJustifying comparator selection was a challenge in 28% of PIPs. The following challenging paediatric issues in the decision-making process were identified: use of off-label medications as comparators, ethical and safe use of placebo, duration of placebo use, an undefined optimal dosing strategy, lack of age-appropriate safety and efficacy data, and drug dosing not supported by extrapolation of safety/efficacy evidence from other populations.ConclusionsIn order to generate trials that will inform clinical decision-making and support marketing authorisations, researchers must systemically and transparently justify their selection of the comparator arm for their study. This report highlights key areas for justification in the choice of comparator in paediatric clinical trials.

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