A decision support framework for genomically informed investigational cancer therapy.
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ABSTRACT:
SUBMITTER: Meric-Bernstam F
PROVIDER: S-EPMC4651038 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
| S-EPMC4223550 | biostudies-literature
Project description:ContextAdvanced cancer patients have unrecognized gaps in their understanding about palliative radiation therapy (PRT).ObjectivesTo build a video decision aid for hospitalized patients with advanced cancer referred for PRT and prospectively test its efficacy in reducing decisional uncertainty, improving knowledge, increasing treatment readiness and readiness for palliative care consultation, and its acceptability among patients.MethodsForty patients with advanced cancer hospitalized at Memorial Sloan Kettering Cancer Center watched a video decision aid about PRT and palliative care. Patients' conceptual and logistical knowledge of PRT, decisional uncertainty, treatment readiness, and readiness for palliative care consultation were assessed before and after watching the video with a six-item knowledge survey, the decisional uncertainty subscale of the Decisional Conflict Scale, and Likert instruments to assess readiness to accept radiation treatment and/or palliative care consultation, respectively. A postvideo survey assessed the video's acceptability among patients.ResultsAfter watching the video, decisional uncertainty was reduced (28.3 vs. 21.7; P = 0.02), knowledge of PRT improved (60.4 vs. 88.3; P < 0.001), and PRT readiness increased (2.0 vs. 1.3; P = 0.04). Readiness for palliative care consultation was unchanged (P = 0.58). Patients felt very comfortable (70%) watching the video and would highly recommend it (75%) to others.ConclusionAmong hospitalized patients with advanced cancer, a video decision aid reduced decisional uncertainty, improved knowledge of PRT, increased readiness for PRT, and was well received by patient viewers.
| S-EPMC8132595 | biostudies-literature
Project description:An essential component of therapeutic drug/biomarker monitoring (TDM) is to combine patient data with prior knowledge for model-based predictions of therapy outcomes. Current Bayesian forecasting tools typically rely only on the most probable model parameters (maximum a posteriori (MAP) estimate). This MAP-based approach, however, does neither necessarily predict the most probable outcome nor does it quantify the risks of treatment inefficacy or toxicity. Bayesian data assimilation (DA) methods overcome these limitations by providing a comprehensive uncertainty quantification. We compare DA methods with MAP-based approaches and show how probabilistic statements about key markers related to chemotherapy-induced neutropenia can be leveraged for more informative decision support in individualized chemotherapy. Sequential Bayesian DA proved to be most computationally efficient for handling interoccasion variability and integrating TDM data. For new digital monitoring devices enabling more frequent data collection, these features will be of critical importance to improve patient care decisions in various therapeutic areas.
| S-EPMC7080550 | biostudies-literature
Project description:The current treatment paradigm in head and neck cancer does not adequately address its clinical and biological heterogeneity. Data from genomic profiling studies in head and neck squamous cell carcinoma (HNSCC) have revealed the molecular features that are unique to HNSCC subgroups. This progress in the understanding of HNSCC biology provides an opportunity to develop personalized therapies for patients with distinct molecular subtypes to achieve better clinical outcomes including survival. However there are several well-recognized challenges that need to be overcome before genotype-matched therapies make precision medicine a reality for patients with HNSCC. Selection of appropriate patients for biomarker directed clinical trials based on sound scientific rationale will be critical in making cancer genomics more applicable in this malignancy.
| S-EPMC6457141 | biostudies-literature
Project description:ObjectivesPhysician-facing decision support tools facilitate shared decision-making (SDM) during informed consent, but it is unclear whether they are comprehensive in the domains they measure. In this scoping review, we aimed to (1) identify the physician-facing tools used during SDM; (2) assess the patient-centered domains measured by these tools; (3) determine whether tools are available for older adults and for use in various settings (elective vs. emergent); and (4) characterize domains future tools should measure.MethodsUsing the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews, Embase, Medline, and Web of Science were queried for articles published between January 2000 and September 2022. Articles meeting inclusion criteria underwent title and abstract review. Eligible studies underwent data abstraction by two reviewers.ResultsOf 4365 articles identified, 160 were eligible. Tools to aid in surgical SDM focus on elective procedures (79%) and the outpatient setting (71%). Few tools are designed for older adults (5%) or for nonelective procedures (9%). Risk calculators were most common, followed by risk indices, prognostic nomograms, and communication tools. Of the domains measured, prognosis was more commonly measured (85%), followed by alternatives (28%), patient goals (36%), and expectations (46%). Most tools represented only one domain (prognosis, 33.1%) and only 6.7% represented all four domains.Conclusions and implicationsTools to aid in the surgical SDM process measure short-term prognosis more often than patient-centered domains such as long-term prognosis, patient goals, and expectations. Further research should focus on communication tools, the needs of older patients, and use in diverse settings.
| S-EPMC10431347 | biostudies-literature
Project description:BackgroundWith opioid misuse, opioid use disorder (OUD), and opioid overdose deaths persisting at epidemic levels in the U.S., the largest implementation study in addiction research-the HEALing Communities Study (HCS)-is evaluating the impact of the Communities That Heal (CTH) intervention on reducing opioid overdose deaths in 67 disproportionately affected communities from four states (i.e., "sites"). Community-tailored dashboards are central to the CTH intervention's mandate to implement a community-engaged and data-driven process. These dashboards support a participating community's decision-making for selection and monitoring of evidence-based practices to reduce opioid overdose deaths.Methods/designA community-tailored dashboard is a web-based set of interactive data visualizations of community-specific metrics. Metrics include opioid overdose deaths and other OUD-related measures, as well as drivers of change of these outcomes in a community. Each community-tailored dashboard is a product of a co-creation process between HCS researchers and stakeholders from each community. The four research sites used a varied set of technical approaches and solutions to support the scientific design and CTH intervention implementation. Ongoing evaluation of the dashboards involves quantitative and qualitative data on key aspects posited to shape dashboard use combined with website analytics.DiscussionThe HCS presents an opportunity to advance how community-tailored dashboards can foster community-driven solutions to address the opioid epidemic. Lessons learned can be applied to inform interventions for public health concerns and issues that have disproportionate impact across communities and populations (e.g., racial/ethnic and sexual/gender minorities and other marginalized individuals).Trial registrationClinicalTrials.gov (NCT04111939).
| S-EPMC7528750 | biostudies-literature
Project description:ObjectiveTo determine whether a decision aid designed for adults with low education and literacy can support informed choice and involvement in decisions about screening for bowel cancer.DesignRandomised controlled trial.SettingAreas in New South Wales, Australia identified as socioeconomically disadvantaged (low education attainment, high unemployment, and unskilled occupations).Participants572 adults aged between 55 and 64 with low educational attainment, eligible for bowel cancer screening.InterventionPatient decision aid comprising a paper based interactive booklet (with and without a question prompt list) and a DVD, presenting quantitative risk information on the possible outcomes of screening using faecal occult blood testing compared with no testing. The control group received standard information developed for the Australian national bowel screening programme. All materials and a faecal occult blood test kit were posted directly to people's homes.Main outcome measuresInformed choice (adequate knowledge and consistency between attitudes and screening behaviour) and preferences for involvement in screening decisions.ResultsParticipants who received the decision aid showed higher levels of knowledge than the controls; the mean score (maximum score 12) for the decision aid group was 6.50 (95% confidence interval 6.15 to 6.84) and for the control group was 4.10 (3.85 to 4.36; P<0.001). Attitudes towards screening were less positive in the decision aid group, with 51% of the participants expressing favourable attitudes compared with 65% of participants in the control group (14% difference, 95% confidence interval 5% to 23%; P=0.002). The participation rate for screening was reduced in the decision aid group: completion of faecal occult blood testing was 59% v 75% in the control group (16% difference, 8% to 24%; P=0.001). The decision aid increased the proportion of participants who made an informed choice, from 12% in the control group to 34% in the decision aid group (22% difference, 15% to 29%; P<0.001). More participants in the decision aid group had no decisional conflict about the screening decision compared with the controls (51% v 38%; P=0.02). The groups did not differ for general anxiety or worry about bowel cancer.ConclusionsTailored decision support information can be effective in supporting informed choices and greater involvement in decisions about faecal occult blood testing among adults with low levels of education, without increasing anxiety or worry about developing bowel cancer. Using a decision aid to make an informed choice may, however, lead to lower uptake of screening. Trial registration ClinicalTrials.gov NCT00765869 and Australian New Zealand Clinical Trials Registry 12608000011381.
| S-EPMC2965151 | biostudies-literature
Project description:The European Commission's recommendation on the definition of nanomaterial (2011/696/EU) established an applicable standard for material categorization. However, manufacturers face regulatory challenges during registration of their products. Reliable categorization is difficult and requires considerable expertise in existing measurement techniques (MTs). Additionally, organizational complexity is increased as different authorities' registration processes require distinct reporting. The NanoDefine project tackled these obstacles by providing the NanoDefiner e-tool: A decision support expert system for nanomaterial identification in a regulatory context. It provides MT recommendations for categorization of specific materials using a tiered approach (screening/confirmatory), and was constructed with experts from academia and industry to be extensible, interoperable, and adaptable for forthcoming revisions of the nanomaterial definition. An implemented MT-driven material categorization scheme allows detailed description. Its guided workflow is suitable for a variety of user groups. Direct feedback and explanation enable transparent decisions. Expert knowledge is held in a knowledge base for representation of MT performance criteria and physicochemical particle type properties. Continuous revision ensured data quality and validity. Recommendations were validated by independent case studies on industry-relevant particulate materials. Besides supporting material identification and registration, the free and open-source e-tool may serve as template for other expert systems within the nanoscience domain.
| S-EPMC6803960 | biostudies-literature
Project description:UNLABELLED:Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent public health concern. Rapid identification of the resistance genes, their mobilization capacity, and strains carrying them is essential to direct hospital resources to prevent spread and improve patient outcomes. Whole-genome sequencing allows refined tracking of both chromosomal traits and associated mobile genetic elements that harbor resistance genes. To enhance surveillance of CREs, clinical isolates with phenotypic resistance to carbapenem antibiotics underwent whole-genome sequencing. Analysis of 41 isolates of Klebsiella pneumoniae and Enterobacter cloacae, collected over a 3-year period, identified K. pneumoniae carbapenemase (KPC) genes encoding KPC-2, -3, and -4 and OXA-48 carbapenemases. All occurred within transposons, including multiple Tn4401 transposon isoforms, embedded within more than 10 distinct plasmids representing incompatibility (Inc) groups IncR, -N, -A/C, -H, and -X. Using short-read sequencing, draft maps were generated of new KPC-carrying vectors, several of which were derivatives of the IncN plasmid pBK31551. Two strains also had Tn4401 chromosomal insertions. Integrated analyses of plasmid profiles and chromosomal single-nucleotide polymorphism (SNP) profiles refined the strain patterns and provided a baseline hospital mobilome to facilitate analysis of new isolates. When incorporated with patient epidemiological data, the findings identified limited outbreaks against a broader 3-year period of sporadic external entry of many different strains and resistance vectors into the hospital. These findings highlight the utility of genomic analyses in internal and external surveillance efforts to stem the transmission of drug-resistant strains within and across health care institutions. IMPORTANCE:We demonstrate how detection of resistance genes within mobile elements and resistance-carrying strains furthers active surveillance efforts for drug resistance. Whole-genome sequencing is increasingly available in hospital laboratories and provides a powerful and nuanced means to define the local landscape of drug resistance. In this study, isolates of Klebsiella pneumoniae and Enterobacter cloacae with resistance to carbapenem antibiotics were sequenced. Multiple carbapenemase genes were identified that resided in distinct transposons and plasmids. This mobilome, or population of mobile elements capable of mobilizing drug resistance, further highlighted the degree of strain heterogeneity while providing a detailed timeline of carbapenemase entry into the hospital over a 3-year period. These surveillance efforts support effective targeting of infection control resources and the development of institution-specific repositories of resistance genes and the mobile elements that carry them.
| S-EPMC4551976 | biostudies-literature
Project description:The introduction and spread of emerging infectious diseases is increasing in both prevalence and scale. Whether naturally, accidentally or maliciously introduced, the substantial uncertainty surrounding the emergence of novel viruses, specifically where they may come from and how they will spread, demands robust and quantifiably validated outbreak control policies that can be implemented in real time. This work presents a novel mathematical modeling framework that integrates both outbreak dynamics and outbreak control into a decision support tool for mitigating infectious disease pandemics that spread through passenger air travel. An ensemble of border control strategies that exploit properties of the air traffic network structure and expected outbreak behavior are proposed. A stochastic metapopulation epidemic model is developed to evaluate and rank the control strategies based on their effectiveness in reducing the spread of outbreaks. Sensitivity analyses are conducted to illustrate the robustness of the proposed control strategies across a range of outbreak scenarios, and a case study is presented for the 2009 H1N1 influenza pandemic. This study highlights the importance of strategically allocating outbreak control resources, and the results can be used to identify the most robust border control policy that can be implemented in the early stages of an outbreak.
| S-EPMC6379393 | biostudies-literature