Considerations for Implementation of Cancer Molecular Diagnostics Into Clinical Care

2016 ◽  
pp. 292-296 ◽  
Author(s):  
Daniel F. Hayes
Keyword(s):  
Cancer Biology ◽  
Clinical Utility ◽  
Clinical Care ◽  
Quality Care ◽  
Tumor Biomarker ◽  
Personalized Care ◽  
Fda Approval ◽  
Improve Patient ◽  
Risk Categorization ◽  
Analytic Validity

Physicians have provided personalized care with as much precision as possible for several centuries. However, increasingly sophisticated understanding of the human genome and of cancer biology has permitted identification of genetic and phenotypic distinctions that might permit development of new tumor biomarker tests for risk categorization, screening, differential diagnosis, prognosis, prediction, and monitoring. Both commercial and academic laboratories are offering tests for single analytes, panels of tests of single analytes, multiparameter assays coalesced into a signature, and total genomic, transcriptomic, or proteomic analyses. However, the absence of a consistent regulatory environment has led to marketing of assays without proven analytic validity or clinical utility. U.S. Food and Drug Administration (FDA) approval or clearance does not necessarily imply that use of the test will improve patient outcomes, and FDA discretion to permit laboratory-developed tests results in unknown benefit, or harm, of others. In this regard, a “bad tumor marker is as bad as a bad drug.” Caveat emptor is not a satisfactory approach to delivering high-quality care. Rather, adoption of tumor biomarker tests should be based on high levels of evidence generated in scientifically rigorous studies that demonstrate both analytical validity and clinical utility. Doing so will ensure that clinicians and patients are confident that a tumor biomarker test is likely to improve their outcomes.

Why Hasn't Genomic Testing Changed the Landscape in Clinical Oncology?

2012 ◽  
pp. e52-e55 ◽  
Author(s):  
Daniel F. Hayes ◽  
Muin J. Khoury ◽  
David Ransohoff
Keyword(s):  
Clinical Utility ◽  
Computational Models ◽  
New Technologies ◽  
Clinical Care ◽  
Tumor Biomarker ◽  
False Discovery Rates ◽  
Patients With Cancer ◽  
Slow Progress ◽  
The Difference ◽  
Therapeutic Research

Overview: The “omics” revolution produced great optimism that tumor biomarker tests based on high-order analysis of multiple (sometimes thousands) of factors would result in truly personalized oncologic care. Unfortunately, 10 years into the revolution, the promise of omics-based research has not yet been realized. The factors behind the slow progress in omics-based clinical care are many. First, over the last 15 years, there has been a gradual recognition of the importance of conducting tumor biomarker science with the kind of rigor that has traditionally been used for therapeutic research. However, this recognition has only recently been applied widely, and therefore most tumor biomarkers have insufficiently high levels of evidence to determine clinical utility. Second, omics-based research offers its own particular set of concerns, especially in regard to overfitting computational models and false discovery rates. Researchers and clinicians need to understand the importance of analytic validity, and the difference between clinical/biologic validity and clinical utility. The latter is required to introduce a tumor biomarker test of any kind (single analyte or omics-based), and are ideally generated by carefully planned and properly conducted “prospective retrospective” or truly prospective clinical trials. Only carefully planned studies, which take all three of these into account and in which the investigators are aware and recognize the enormous risk of unintended bias and overfitting inherent in omics-based test development, will ultimately result in translation of the exciting new technologies into better care for patients with cancer.

Evaluating prediction of continuous clinical values: a glucose case study (Preprint)

2021 ◽  
Author(s):  
George Hripcsak ◽  
David J Albers
Keyword(s):  
Predictive Models ◽  
Clinical Utility ◽  
Clinical Care ◽  
Glucose Measurement ◽  
Care Processes ◽  
Low Glucose ◽  
Potential Clinical Utility ◽  
Rms Error ◽  
Error Grid

BACKGROUND Background: It would be useful to be able to assess the utility of predictive models of continuous values before clinical trials are carried out. OBJECTIVE Objective: To compare metrics to assess the potential clinical utility of models that produce continuous value forecasts. METHODS Methods: We ran a set of data assimilation forecast algorithms on time series of glucose measurements from intensive care unit patients. We evaluated the forecasts using four sets of metrics: glucose root mean square error, a set of metrics on a transformed glucose value, the estimated effect on clinical care based on an insulin guideline, and a glucose measurement error grid (Parkes grid). We assessed correlation among the metrics and created a set of factor models. RESULTS Results: The metrics generally correlated with each other, but those that estimated the effect on clinical care correlated with the others the least and were generally associated with their own independent factors. The other metrics appeared to separate into those that emphasized errors in low glucose versus errors in high glucose. The Parkes grid was well correlated with the transformed glucose but not the estimation of clinical care. CONCLUSIONS Discussion: Our results indicate that we need to be careful before we assume that commonly used metrics like RMS error in raw glucose or even metrics like the Parkes grid that are designed to measure importance of differences will correlate well with actual effect on clinical care processes. A combination of metrics appeared to explain the most variance between cases. As prediction algorithms move into practice, it will be important to measure actual effects.

scholarly journals Early discharge and rehabilitation in paediatric acquired brain and neurological injury: a transferable model

2018 ◽  
pp. edpract-2018-315096
Author(s):  
Rachel Keetley ◽  
Laura Kelly ◽  
William P Whitehouse ◽  
Sophie Thomas ◽  
Emily Bennett ◽  
...  
Keyword(s):  
Discharge Planning ◽  
Quality Care ◽  
Acquired Brain Injury ◽  
Early Discharge ◽  
Family Satisfaction ◽  
Neurological Injury ◽  
Children And Young People ◽  
Financial Gain ◽  
Lengths Of Stay ◽  
Improve Patient

Children and young people who require rehabilitation following sustaining an acquired brain injury often experience long lengths of stay (LOS) and potentially poorer recovery outcomes due to limited access to therapy and little proactive discharge planning. After stakeholder enquiry we launched a new team and pathway with a primary aim to reduce LOS. The secondary aims were to pilot an outreach model, reduce cost and improve patient and family satisfaction. We achieved a significantly improved change in quality care with a financial gain and increased patient and family satisfaction.

scholarly journals Does the phthisioophthalmology section of our Ophthalmologic Society contribute in the promotion of quality care for patients with ocular tuberculosis?

2016 ◽  
Vol 9 (1) ◽  
pp. 56-63
Author(s):  
Elena I Ustinova ◽  
Olga P Ilkova
Keyword(s):  
Positive Impact ◽  
Clinical Care ◽  
Quality Care ◽  
Social Activity ◽  
Diagnosis And Treatment ◽  
Treatment Quality ◽  
Medical Society ◽  
Care Process ◽  
System Reform ◽  
Ocular Tuberculosis

The phthisioophthalmology section work over the last 15 years is analyzed. Due to the antituberculous care system reform the number of section members decreased from 27 to 17. Scientific meetings are regular, their frequency decreased up to 5-6/year. Ever and again presentations are made at plenary sessions of the St.Petersburg Scientific Medical Society of Ophthalmology (6 presentations in 15 years) and at the congresses of associations of ophthalmologists and phthisiologists. In 15 years, session members performed and published 102 studies on ocular tuberculosis, including 38 articles in scientific magazines, 5 teaching editions for doctors, 4 monographs. Based on work reports and inspection results of several institutions, it follows that the section makes positive impact on the formation in clinicians of a scientific approach to clinical care process. Some shortcomings are revealed in the application of recommended methods. We believe that for their elimination, besides social activity of the section, it is necessary to publish teaching editions at federal level on ocular tuberculosis diagnosis and treatment, as well as enhancement of diagnosis and treatment quality control by local administration.

scholarly journals Changes among US Cancer Survivors: Comparing Demographic, Diagnostic, and Health Care Findings from the 1992 and 2010 National Health Interview Surveys

ISRN Oncology ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Natasha D. Buchanan ◽  
Jessica B. King ◽  
Juan L. Rodriguez ◽  
Arica White ◽  
Katrina F. Trivers ◽  
...  
Keyword(s):  
Cancer Survivors ◽  
Support Groups ◽  
National Health ◽  
Clinical Care ◽  
Quality Care ◽  
Insurance Coverage ◽  
Cancer Control ◽  
The United States ◽  
Institute Of Medicine ◽  
Health Interview

Background. Differences in healthcare and cancer treatment for cancer survivors in the United States (US) have not been routinely examined in nationally representative samples or studied before and after important Institute of Medicine (IOM) recommendations calling for higher quality care provision and attention to comprehensive cancer care for cancer survivors. Methods. To assess differences between survivor characteristics in 1992 and 2010, we conducted descriptive analyses of 1992 and 2010 National Health Interview Survey (NHIS) data. Our study sample consisted of 1018 self-reported cancer survivors from the 1992 NHIS and 1718 self-reported cancer survivors from the 2010 NHIS who completed the Cancer Control (CCS) and Cancer Epidemiology (CES) Supplements. Results. The prevalence of reported survivors increased from 1992 to 2010 (4.2% versus 6.3%). From 1992 to 2010, there was an increase in long-term cancer survivors and a drop in multiple malignancies, and surgery remained the most widely used treatment. Significantly fewer survivors (<10 years after diagnosis) were denied insurance coverage. Survivors continue to report low participation in counseling or support groups. Conclusions. As the prevalence of cancer survivors continues to grow, monitoring differences in survivor characteristics can be useful in evaluating the effects of policy recommendations and the quality of clinical care.

Development of a Novel Clinician Decision Support Tool for the Management of Acute Diarrhea in Bangladesh: Formative Qualitative Research (Preprint)

2021 ◽  
Author(s):  
Rochelle K Rosen ◽  
Stephanie C Garbern ◽  
Monique Gainey ◽  
Ryan Lantini ◽  
Sabiha Nasrin ◽  
...  
Keyword(s):  
Decision Support ◽  
Focus Group ◽  
Acute Diarrhea ◽  
Clinical Utility ◽  
Qualitative Data ◽  
Care Delivery ◽  
Clinical Care ◽  
Healthcare Providers ◽  
Final Analysis ◽  
Support Tool

BACKGROUND The availability of mobile clinical decision-support (CDS) tools has grown substantially with the increased prevalence of smartphone devices and applications (apps). Though healthcare providers express interest in integrating mobile health (mHealth) technologies into their clinical settings, concerns raised include perceived disagreements between information provided by mobile CDS tools and standard guidelines. Despite their potential to transform health care delivery, there remains limited literature on the provider’s perspective of the clinical utility of mobile CDS tools for improving patient outcomes, especially in low- and middle- income countries. OBJECTIVE The aim of this study is to describe providers’ perceptions about the utility of a mobile CDS tool accessed via a smartphone app for diarrhea management in Bangladesh. In addition, feedback was collected on preliminary components of the mobile CDS tool to address clinicians’ concerns and incorporate their preferences. METHODS From November to December 2020, qualitative data were gathered through eight virtual focus group discussions with physicians and nurses from three Bangladeshi hospitals. Each discussion was conducted in the local language, Bangla, and audio recorded for transcription and translation by the local research team. Transcripts and codes were entered into NVivo12 and applied thematic analysis was used to identify themes that explore the clinical utility of a mHealth app to assess dehydration severity in patients with acute diarrhea. Summaries of concepts and themes were generated from reviews of the aggregated coded data, and thematic memos were written and used for the final analysis. RESULTS Of the 27 focus group participants, 14 were nurses and 13 doctors; 15 worked at a diarrhea specialty hospital and 12 worked in government district or subdistrict hospitals. The participants’ experience in their current position ranged from 2 to 14 years, with an average of 10.3 years. Key themes from the qualitative data analysis, including: current experience with CDS, overall perception of the app utility and its potential role in clinical care, barriers and facilitators to app use, considerations of overtreatment and undertreatment, and guidelines for the app’s clinical recommendations. CONCLUSIONS Participants were positive about the mHealth app and its potential to inform diarrhea management. They provided detailed feedback, which developers used to further the design and programming. Participants felt that the tool would initially take time to use, but once learned could be useful during epidemic cholera. Some felt that clinical experience remains an important part of treatment that can be supplemented, but not replaced, by a CDS tool. Additionally, diagnostic information, including mid-upper arm circumference and blood pressure, might not be available to directly inform programming decisions. These formative qualitative data provided timely and relevant feedback to improve the utility of a CDS tool for diarrhea treatment in Bangladesh.

How to Build Effective Interprofessional Healthcare Teams

2020 ◽  
pp. 1-34
Author(s):  
Stefanie R. Ellison ◽  
Christi L. Bartlett ◽  
Valerie L. Ruehter
Keyword(s):  
Quality Care ◽  
Degree Programs ◽  
Future Health ◽  
Healthcare Teams ◽  
Use Of Resources ◽  
Key Stakeholders ◽  
Professional Degree ◽  
Provide Quality Care ◽  
Interprofessional Healthcare ◽  
Improve Patient

Building effective interprofessional (IP) teams is an important process for healthcare systems across the world. In order to be truly effective, professional degree programs must teach our future health professionals to learn and collaborate on teams during their education. The goal of building effective IP healthcare teams will be achieved when each healthcare system effectively supports IP collaboration, the development of dynamic teams, and the appropriate use of resources. Advancing the effort to build effective IP healthcare teams will take an investment from key stakeholders such as educators, faculty and students, leaders and researchers in academic medicine, hospital and system administrators, policymakers, as well as patients and their families to create a culture of IP collaboration and provide the resources necessary to be sustainable and successful. This chapter will serve to show that effective IP healthcare teams can successfully improve patient outcomes, provide quality care, improve the healthcare team's experience, and reduce costs.

scholarly journals Quality and Clinical Care Development in Spine Surgery—Connecting the Dots: An Expanded Clinical Narrative

2020 ◽  
Vol 10 (1_suppl) ◽  
pp. 10S-16S
Author(s):  
Sarah Hopkins ◽  
Polly Brune ◽  
Jens R. Chapman ◽  
Marc Horton ◽  
Rod Oskouian ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Care ◽  
Quality Care ◽  
Clinical Quality ◽  
Knowledge Process ◽  
Clinical Narrative ◽  
Spine Care ◽  
Evidenced Based ◽  
Connecting The Dots ◽  
Care Development

Our health care system is an evidenced-based quality-centric environment. Pursuit of quality is a process that encompasses knowledge development and care advancements through collaboration and expertise. Depicted here is the foundational knowledge, process, and contributions that hallmark successful clinical quality programs. Beginning with methodology, followed by process and form, we create the foundational knowledge and exemplars demonstrating framework and continuum of process in pursuit and attainment of successful clinical quality and care development for patients. Although our protocol has been devised for complex spine care, this could be implemented across all health care specialties to provide individualized and high-quality care for all current and future patients, all while creating a culture of accountability for physicians.

scholarly journals Targeting Epigenetic Dependencies in Solid Tumors: Evolutionary Landscape Beyond Germ Layers Origin

Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 682 ◽  
Author(s):  
Francesca Citron ◽  
Linda Fabris
Keyword(s):  
Patient Outcomes ◽  
Chromatin Remodeling ◽  
Cancer Biology ◽  
Poor Prognosis ◽  
Molecular Medicine ◽  
Genomic Alteration ◽  
Clinical Settings ◽  
Cellular Processes ◽  
Improve Patient

Extensive efforts recently witnessed the complexity of cancer biology; however, molecular medicine still lacks the ability to elucidate hidden mechanisms for the maintenance of specific subclasses of rare tumors characterized by the silent onset and a poor prognosis (e.g., ovarian cancer, pancreatic cancer, and glioblastoma). Recent mutational fingerprints of human cancers highlighted genomic alteration occurring on epigenetic modulators. In this scenario, the epigenome dependency of cancer orchestrates a broad range of cellular processes critical for tumorigenesis and tumor progression, possibly mediating escaping mechanisms leading to drug resistance. Indeed, in this review, we discuss the pivotal role of chromatin remodeling in shaping the tumor architecture and modulating tumor fitness in a microenvironment-dependent context. We will also present recent advances in the epigenome targeting, posing a particular emphasis on how this knowledge could be translated into a feasible therapeutic approach to individualize clinical settings and improve patient outcomes.

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