Dataset Information

A decision support framework for genomically informed investigational cancer therapy.

ABSTRACT: Rapidly improving understanding of molecular oncology, emerging novel therapeutics, and increasingly available and affordable next-generation sequencing have created an opportunity for delivering genomically informed personalized cancer therapy. However, to implement genomically informed therapy requires that a clinician interpret the patient's molecular profile, including molecular characterization of the tumor and the patient's germline DNA. In this Commentary, we review existing data and tools for precision oncology and present a framework for reviewing the available biomedical literature on therapeutic implications of genomic alterations. Genomic alterations, including mutations, insertions/deletions, fusions, and copy number changes, need to be curated in terms of the likelihood that they alter the function of a "cancer gene" at the level of a specific variant in order to discriminate so-called "drivers" from "passengers." Alterations that are targetable either directly or indirectly with approved or investigational therapies are potentially "actionable." At this time, evidence linking predictive biomarkers to therapies is strong for only a few genomic markers in the context of specific cancer types. For these genomic alterations in other diseases and for other genomic alterations, the clinical data are either absent or insufficient to support routine clinical implementation of biomarker-based therapy. However, there is great interest in optimally matching patients to early-phase clinical trials. Thus, we need accessible, comprehensive, and frequently updated knowledge bases that describe genomic changes and their clinical implications, as well as continued education of clinicians and patients.

SUBMITTER: Meric-Bernstam F

PROVIDER: S-EPMC4651038 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A decision support framework for genomically informed investigational cancer therapy.

Meric-Bernstam Funda F Johnson Amber A Holla Vijaykumar V Bailey Ann Marie AM Brusco Lauren L Chen Ken K Routbort Mark M Patel Keyur P KP Zeng Jia J Kopetz Scott S Davies Michael A MA Piha-Paul Sarina A SA Hong David S DS Eterovic Agda Karina AK Tsimberidou Apostolia M AM Broaddus Russell R Bernstam Elmer V EV Shaw Kenna R KR Mendelsohn John J Mills Gordon B GB

Journal of the National Cancer Institute 20150411 7

Rapidly improving understanding of molecular oncology, emerging novel therapeutics, and increasingly available and affordable next-generation sequencing have created an opportunity for delivering genomically informed personalized cancer therapy. However, to implement genomically informed therapy requires that a clinician interpret the patient's molecular profile, including molecular characterization of the tumor and the patient's germline DNA. In this Commentary, we review existing data and tool ...[more]

PMID: 25863335

Similar Datasets

Project description:ObjectiveTo introduce a visual clinical decision support tool to assist with individualizing first-line antidepressant pharmacotherapy for adults with major depressive disorder (MDD) in a Canadian context.Sources of informationA literature review was conducted with Google Scholar, PubMed, the Cochrane Database of Systematic Reviews, and Trip Pro using the MeSH headings depression, antidepressive agents, primary care, practice patterns, medication adherence, and decision making, shared.Main messageMajor depressive disorder affects about 4.7% of Canadians annually and is a prevalent condition encountered and diagnosed in primary care. Untreated depression is associated with decreased quality of life, increased risk of suicide, and worsening physical health outcomes when depression co-occurs with other chronic medical conditions. In a network meta-analysis, antidepressant medications (such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, bupropion, and vortioxetine) reduced depressive symptoms by 50% or more when compared with placebo in acute treatment of adults with moderate to severe MDD. Poor treatment adherence and high discontinuation rates limit MDD treatment success. Factors such as strong therapeutic alliances between patients and prescribers, collaborative care, patient education, and supportive self-management have been shown to enhance treatment adherence. The most recent Canadian Network for Mood and Anxiety Treatments depression treatment guidelines (published in 2016) suggest 15 different first-line antidepressant medication options for the treatment of MDD. There is a need for evidence-informed decision support aids to individualize antidepressant therapy to treat patients diagnosed with MDD.ConclusionRecent studies on antidepressants have indicated no single antidepressant is superior to others in treating patients with MDD. This suggests there may be opportunities to enhance treatment adherence and success by tailoring antidepressant therapy to align with each patient's preferences. The Antidepressant Decision Support Tool was developed to help prescribers and adult patients engage in shared decision making to select an individualized and optimal first-line antidepressant for the treatment of acute MDD.

Project description:BackgroundPublic health professionals are increasingly expected to engage in evidence-informed decision making to inform practice and policy decisions. Evidence-informed decision making involves the use of research evidence along with expertise, existing public health resources, knowledge about community health issues, the local context and community, and the political climate. The National Collaborating Centre for Methods and Tools has identified a seven step process for evidence-informed decision making. Tools have been developed to support public health professionals as they work through each of these steps. This paper provides an overview of tools used in three Canadian public health departments involved in a study to develop capacity for evidence-informed decision making.MethodsAs part of a knowledge translation and exchange intervention, a Knowledge Broker worked with public health professionals to identify and apply tools for use with each of the steps of evidence-informed decision making. The Knowledge Broker maintained a reflective journal and interviews were conducted with a purposive sample of decision makers and public health professionals. This paper presents qualitative analysis of the perceived usefulness and usability of the tools.ResultsTools were used in the health departments to assist in: question identification and clarification; searching for the best available research evidence; assessing the research evidence for quality through critical appraisal; deciphering the 'actionable message(s)' from the research evidence; tailoring messages to the local context to ensure their relevance and suitability; deciding whether and planning how to implement research evidence in the local context; and evaluating the effectiveness of implementation efforts. Decision makers provided descriptions of how the tools were used within the health departments and made suggestions for improvement. Overall, the tools were perceived as valuable for advancing and sustaining evidence-informed decision making.ConclusionTools are available to support the process of evidence-informed decision making among public health professionals. The usability and usefulness of these tools for advancing and sustaining evidence-informed decision making are discussed, including recommendations for the tools' application in other public health settings beyond this study. Knowledge and awareness of these tools may assist other health professionals in their efforts to implement evidence-informed practice.

Project description:BackgroundSuccessful implementation and utilization of Computerized Clinical Decision Support Systems (CDSS) in hospitals is complex and challenging. Implementation science, and in particular the Nonadoption, Abandonment, Scale-up, Spread and Sustainability (NASSS) framework, may offer a systematic approach for identifying and addressing these challenges. This review aimed to identify, categorize, and describe barriers and facilitators to CDSS implementation in hospital settings and map them to the NASSS framework. Exploring the applicability of the NASSS framework to CDSS implementation was a secondary aim.MethodsElectronic database searches were conducted (21 July 2020; updated 5 April 2022) in Ovid MEDLINE, Embase, Scopus, PyscInfo, and CINAHL. Original research studies reporting on measured or perceived barriers and/or facilitators to implementation and adoption of CDSS in hospital settings, or attitudes of healthcare professionals towards CDSS were included. Articles with a primary focus on CDSS development were excluded. No language or date restrictions were applied. We used qualitative content analysis to identify determinants and organize them into higher-order themes, which were then reflexively mapped to the NASSS framework.ResultsForty-four publications were included. These comprised a range of study designs, geographic locations, participants, technology types, CDSS functions, and clinical contexts of implementation. A total of 227 individual barriers and 130 individual facilitators were identified across the included studies. The most commonly reported influences on implementation were fit of CDSS with workflows (19 studies), the usefulness of the CDSS output in practice (17 studies), CDSS technical dependencies and design (16 studies), trust of users in the CDSS input data and evidence base (15 studies), and the contextual fit of the CDSS with the user's role or clinical setting (14 studies). Most determinants could be appropriately categorized into domains of the NASSS framework with barriers and facilitators in the "Technology," "Organization," and "Adopters" domains most frequently reported. No determinants were assigned to the "Embedding and Adaptation Over Time" domain.ConclusionsThis review identified the most common determinants which could be targeted for modification to either remove barriers or facilitate the adoption and use of CDSS within hospitals. Greater adoption of implementation theory should be encouraged to support CDSS implementation.

Project description:BackgroundPatients with atrial fibrillation (AF) must decide between warfarin and direct oral anticoagulants (DOACs), a decision involving important tradeoffs. Our objective was to understand whether physicians engage patients in informed decision making for anticoagulants.DesignWe performed an analysis of recorded conversations between physicians and anticoagulation-naïve patients in the Verilogue Point-of-Practice database. We assessed the presence of 7 elements of informed decision making, as well as a discussion of financial costs.ResultsOf 37 encounters with 21 physicians, 92% resulted in a DOAC prescription and 8% resulted in a warfarin prescription. Seventy percent met criteria for discussion of pros and cons, 70% for discussion of the alternatives, 43% presented the decision, 30% included an assessment of patient understanding, 22% included an explanation of the patient's role in decision making, 22% included an assessment of patient preferences, and 19% included a discussion of uncertainty. Two encounters (5%) included all 7 elements and 9 (24%) included none. Physicians discussed treatment costs with patients in 43% of encounters.LimitationsWe assessed informed decision making in a single encounter. Physicians and patients may have had other discussions that were not captured in our data.ConclusionsPhysicians often presented the alternatives but did not generally engage patients in informed decision making. The high rate of DOAC prescriptions is likely the result of physician preferences, as patient preferences were rarely assessed.ImplicationsStrategies to support physicians in engaging patients in informed decision making for anticoagulation are needed.HighlightsWhile physicians discussed the alternatives and presented pros and cons with patients, they rarely assessed patient preferences, explained the patient's role in decision making, or addressed uncertainty.The cost of treatment with DOACs versus warfarin was discussed by physicians in less than half of encounters, limiting patients' ability to make informed decisions for anticoagulation.Only 2 encounters (5%) fulfilled all 7 elements of informed decision making.

Dataset Information

A decision support framework for genomically informed investigational cancer therapy.

Publications

A decision support framework for genomically informed investigational cancer therapy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets