Towards a Responsible Transition to Learning Healthcare Systems in Precision Medicine: Ethical Points to Consider

Learning healthcare systems have recently emerged as a strategy to continuously use experiences and outcomes of clinical care for research purposes in precision medicine. Although it is known that learning healthcare transitions in general raise important ethical challenges, the ethical ramifications of such transitions in the specific context of precision medicine have not extensively been discussed. Here, we describe three levers that institutions can pull to advance learning healthcare systems in precision medicine: (1) changing testing of individual variability (such as genes); (2) changing prescription of treatments on the basis of (genomic) test results; and/or (3) changing the handling of data that link variability and treatment to clinical outcomes. Subsequently, we evaluate how patients can be affected if one of these levers are pulled: (1) patients are tested for different or more factors than before the transformation, (2) patients receive different treatments than before the transformation and/or (3) patients’ data obtained through clinical care are used, or used more extensively, for research purposes. Based on an analysis of the aforementioned mechanisms and how these potentially affect patients, we analyze why learning healthcare systems in precision medicine need a different ethical approach and discuss crucial points to consider regarding this approach.

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Metrics of Patient, Public, Consumer, and Community Engagement in Healthcare Systems: How Should We Define Engagement, What Are We Measuring, and Does It Matter for Patient Care? Comment on "Metrics and Evaluation Tools for Patient Engagement in Healthcare Organization- and System-Level Decision-Making: A Systematic Review"

International Journal of Health Policy and Management ◽

10.15171/ijhpm.2018.94 ◽

2018 ◽

Vol 8 (1) ◽

pp. 49-50

Author(s):

Zackary Berger

Keyword(s):

Systematic Review ◽

Decision Making ◽

Patient Care ◽

Clinical Outcomes ◽

Patient Engagement ◽

Clinical Care ◽

Healthcare Systems ◽

System Level ◽

Patient Representatives ◽

Conceptual Foundations

In a rigorous systematic review, Dukhanin and colleagues categorize metrics and evaluative tools of the engagement of patient, public, consumer, and community in decision-making in healthcare institutions and systems. The review itself is ably done and the categorizations lead to a useful understanding of the necessary elements of engagement, and a suite of measures relevant to implementing engagement in systems. Nevertheless, the question remains whether the engagement of patient representatives in institutional or systemic deliberations will lead to improved clinical outcomes or increased engagement of individual patients themselves in care. Attention to the conceptual foundations of patient engagement would help make this systematic review relevant to the clinical care of patients.

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Faculty Opinions recommendation of My46: a Web-based tool for self-guided management of genomic test results in research and clinical settings.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.726740805.793523978 ◽

2016 ◽

Author(s):

Marc S Williams

Keyword(s):

Clinical Settings ◽

Test Results ◽

Web Based ◽

Genomic Test

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Strategies to Integrate Genomic Medicine into Clinical Care: Evidence from the IGNITE Network

Journal of Personalized Medicine ◽

10.3390/jpm11070647 ◽

2021 ◽

Vol 11 (7) ◽

pp. 647

Author(s):

Nina R. Sperber ◽

Olivia M. Dong ◽

Megan C. Roberts ◽

Paul Dexter ◽

Amanda R. Elsey ◽

...

Keyword(s):

Precision Medicine ◽

Program Implementation ◽

Clinical Care ◽

Genomic Medicine ◽

Implementation Strategies ◽

Clinical Decision ◽

Implementing Change ◽

Implementation Outcomes ◽

Planning Framework

The complexity of genomic medicine can be streamlined by implementing some form of clinical decision support (CDS) to guide clinicians in how to use and interpret personalized data; however, it is not yet clear which strategies are best suited for this purpose. In this study, we used implementation science to identify common strategies for applying provider-based CDS interventions across six genomic medicine clinical research projects funded by an NIH consortium. Each project’s strategies were elicited via a structured survey derived from a typology of implementation strategies, the Expert Recommendations for Implementing Change (ERIC), and follow-up interviews guided by both implementation strategy reporting criteria and a planning framework, RE-AIM, to obtain more detail about implementation strategies and desired outcomes. We found that, on average, the three pharmacogenomics implementation projects used more strategies than the disease-focused projects. Overall, projects had four implementation strategies in common; however, operationalization of each differed in accordance with each study’s implementation outcomes. These four common strategies may be important for precision medicine program implementation, and pharmacogenomics may require more integration into clinical care. Understanding how and why these strategies were successfully employed could be useful for others implementing genomic or precision medicine programs in different contexts.

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Apixaban concentration variability and relation to clinical outcomes in real-life patients with atrial fibrillation

Scientific Reports ◽

10.1038/s41598-021-93372-9 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Alenka Mavri ◽

Nina Vene ◽

Mojca Božič-Mijovski ◽

Marko Miklič ◽

Lisbeth Söderblom ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Outcomes ◽

Thromboembolic Event ◽

Real Life ◽

Individual Variability ◽

Blood Samples ◽

Chromatography Tandem Mass Spectrometry ◽

Significant Difference ◽

Liquid Chromatography Tandem Mass ◽

Peak Blood

AbstractIn some clinical situations, measurements of anticoagulant effect of apixaban may be needed. We investigated the inter- and intra-individual apixaban variability in patients with atrial fibrillation and correlated these results with clinical outcome. We included 62 patients receiving either 5 mg (A5, n = 32) or 2.5 mg (A2.5, n = 30) apixaban twice-daily. We collected three trough and three peak blood samples 6–8 weeks apart. Apixaban concentration was measured by liquid chromatography-tandem mass-spectrometry (LC–MS/MS) and by anti-Xa. Patients on A2.5 were older, had lower creatinine clearance, higher CHA2DS2VASc (4.7 ± 1.0 vs. 3.4 ± 1.7) and lower trough (85 ± 39 vs. 117 ± 53 ng/mL) and peak (170 ± 56 vs. 256 ± 91 ng/mL) apixaban concentrations than patients on A5 (all p < 0.01). In patients on A5, LC–MS/MS showed a significant difference between through levels and between peak levels (p < 0.01). During apixaban treatment, 21 patients suffered bleeding (2 major). There was no association between bleeding and apixaban concentrations or variability. Four patients who suffered thromboembolic event had lower peak apixaban concentrations than patients without it (159 ± 13 vs. 238 ± 88 ng/mL, p = 0.05). We concluded, that there was a significant intra- and inter-individual variability in apixaban trough and peak concentrations. Neither variability nor apixaban concentrations were associated with clinical outcomes.

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Perspectives and experiences of patients and healthcare professionals with geriatric assessment in chronic kidney disease: a qualitative study

BMC Nephrology ◽

10.1186/s12882-020-02206-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Carlijn G. N. Voorend ◽

Noeleen C. Berkhout-Byrne ◽

Yvette Meuleman ◽

Simon P. Mooijaart ◽

Willem Jan W. Bos ◽

...

Keyword(s):

Kidney Disease ◽

Qualitative Study ◽

Clinical Outcomes ◽

Geriatric Assessment ◽

Clinical Care ◽

Treatment Options ◽

Routine Care ◽

Treatment Team ◽

Dutch Hospital ◽

Additional Support

Abstract Background Older patients with end-stage kidney disease (ESKD) often live with unidentified frailty and multimorbidity. Despite guideline recommendations, geriatric assessment is not part of standard clinical care, resulting in a missed opportunity to enhance (clinical) outcomes including quality of life in these patients. To develop routine geriatric assessment programs for patients approaching ESKD, it is crucial to understand patients’ and professionals’ experiences with and perspectives about the benefits, facilitators and barriers for geriatric assessment. Methods In this qualitative study, semi-structured focus group discussions were conducted with ESKD patients, caregivers and professionals. Participants were purposively sampled from three Dutch hospital-based study- and routine care initiatives involving geriatric assessment for (pre-)ESKD care. Transcripts were analysed inductively using thematic analysis. Results In six focus-groups, participants (n = 47) demonstrated four major themes: (1) Perceived characteristics of the older (pre)ESKD patient group. Patients and professionals recognized increased vulnerability and (cognitive) comorbidity, which is often unrelated to calendar age. Both believed that often patients are in need of additional support in various geriatric domains. (2) Experiences with geriatric assessment. Patients regarded the content and the time spent on the geriatric assessment predominantly positive. Professionals emphasized that assessment creates awareness among the whole treatment team for cognitive and social problems, shifting the focus from mainly somatic to multidimensional problems. Outcomes of geriatric assessment were observed to enhance a dialogue on suitability of treatment options, (re)adjust treatment and provide/seek additional (social) support. (3) Barriers and facilitators for implementation of geriatric assessment in routine care. Discussed barriers included lack of communication about goals and interpretation of geriatric assessment, burden for patients, illiteracy, and organizational aspects. Major facilitators are good multidisciplinary cooperation, involvement of geriatrics and multidisciplinary team meetings. (4) Desired characteristics of a suitable geriatric assessment concerned the scope and use of tests and timing of assessment. Conclusions Patients and professionals were positive about using geriatric assessment in routine nephrology care. Implementation seems achievable, once barriers are overcome and facilitators are endorsed. Geriatric assessment in routine care appears promising to improve (clinical) outcomes in patients approaching ESKD.

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Consumer Wearables for Patient Monitoring in Otolaryngology: A State of the Art Review

Otolaryngology ◽

10.1177/01945998211061681 ◽

2021 ◽

pp. 019459982110616

Author(s):

Shaan N. Somani ◽

Katherine M. Yu ◽

Alexander G. Chiu ◽

Kevin J. Sykes ◽

Jennifer A. Villwock

Keyword(s):

Health Care ◽

Clinical Outcomes ◽

Behavioral Interventions ◽

Early Recognition ◽

Clinical Care ◽

The United States ◽

Major Surgery ◽

Inpatient Setting ◽

Biometric Data ◽

Pubmed Search

Objective Consumer wearables, such as the Apple Watch or Fitbit devices, have become increasingly commonplace over the past decade. The application of these devices to health care remains an area of significant yet ill-defined promise. This review aims to identify the potential role of consumer wearables for the monitoring of otolaryngology patients. Data Sources PubMed. Review Methods A PubMed search was conducted to identify the use of consumer wearables for the assessment of clinical outcomes relevant to otolaryngology. Articles were included if they described the use of wearables that were designed for continuous wear and were available for consumer purchase in the United States. Articles meeting inclusion criteria were synthesized into a final narrative review. Conclusions In the perioperative setting, consumer wearables could facilitate prehabilitation before major surgery and prediction of clinical outcomes. The use of consumer wearables in the inpatient setting could allow for early recognition of parameters suggestive of poor or declining health. The real-time feedback provided by these devices in the remote setting could be incorporated into behavioral interventions to promote patients’ engagement with healthy behaviors. Various concerns surrounding the privacy, ownership, and validity of wearable-derived data must be addressed before their widespread adoption in health care. Implications for Practice Understanding how to leverage the wealth of biometric data collected by consumer wearables to improve health outcomes will become a high-impact area of research and clinical care. Well-designed comparative studies that elucidate the value and clinical applicability of these data are needed.

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Test genetici e consenso informato

SALUTE E SOCIETÀ ◽

10.3280/ses2012-003005 ◽

2012 ◽

pp. 68-95

Author(s):

Marco Seri ◽

Claudio Graziano ◽

Daniela Turchetti ◽

Juri Monducci

Keyword(s):

Dna Sequencing ◽

Human Genetics ◽

Ethical Issues ◽

Clinical Care ◽

Genomic Medicine ◽

Genome Project ◽

Ethical Challenges ◽

Sequencing Technologies ◽

The Human Genome Project

The pace of discovery in the field of human genetics has increased exponentially in the last 30 years. We have witnessed the completion of the Human Genome Project, the identification of hundreds of disease-causing genes, and the dawn of genomic medicine (clinical care based on genomic information). Reduction of DNA sequencing costs, thanks to the so-called "next generation sequencing" technologies, is driving a shift towards the era of "personal genomes", but scientific as well as ethical challenges ahead are countless. We provide an overview on the classification of genetic tests, on informed consent procedures in the context of genetic counseling, and on specific ethical issues raised by the implementation of new DNA sequencing technologies.

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NCOG-18. RELATIONSHIP BETWEEN RANO-PRO WORKING GROUP STANDARDIZED PRIORITY CONSTRUCTS AND DISEASE PROGRESSION AMONG MALIGNANT GLIOMA PATIENTS AS MEASURED THROUGH CLINICAL OUTCOMES ASSESSMENTS

Neuro-Oncology ◽

10.1093/neuonc/noab196.609 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi155-vi156

Author(s):

Elizabeth Vera ◽

Tito Mendoza ◽

Alvina Acquaye ◽

Nicole Briceno ◽

Anna Choi ◽

...

Keyword(s):

Malignant Glioma ◽

Disease Progression ◽

Clinical Outcomes ◽

Stable Disease ◽

Working Group ◽

Karnofsky Performance Status ◽

Clinical Care ◽

Self Care ◽

Work Activity ◽

Core Symptoms

Abstract Recognizing the importance of clinical outcomes assessments (COA), the RANO-PRO Working Group recommends inclusion of core symptoms/functions in clinical care/research for malignant glioma patients. This study evaluated the association between the recommended symptoms (pain, perceived cognition, seizures, aphasia, treatment-specific symptoms) and functions (physical: weakness, walking; and role/social: work, usual activities) and disease progression in these patients. MDASI-Brain Tumor and EQ-5D-3L scores, Karnofsky Performance Status (KPS), and Neurologic Function Score (NFS) were evaluated in relation to disease progression by chi-square tests, independent- and paired-samples t-tests, adjusted for multiple comparisons. Our sample included 336 patients with malignant glioma; 82% white, 64% male, median age=52 (21-79). Imaging study revealed disease progression for 46% of patients. All symptoms except seizures and difficulty concentrating were worse in the group whose imaging showed disease progression versus stable disease, as well as the functions of walking, work, activity, and self-care (0.8 < difference < 1.8). Patients with disease progression were 4 times more likely to have a poor KPS (≤ 80) and worse NFS. Among patients with disease progression (n=112), all symptoms, except seizures, worsened from first assessment to time of progression. Up to 22% of patients reported worsening mobility, self-care, and usual activity; 46% and 35% had worsened KPS and NFS, respectively. Seven symptoms and functions were each individually reported by at least 10% of patients as having worsened the most. Worsening of symptoms and functions was not observed among patients with stable disease, except in difficulty understanding. Identified core symptoms/functions worsen at the time of progression demonstrating the relationship between priority constructs and a traditional tumor response measure while highlighting the importance of longitudinal collection of COA. The pattern of worsening was observed via both patient- and clinician-reported outcomes, emphasizing the utility of COA in clinical care and clinical trials.

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