Graphical representations of patient tolerability data: Recommendations from the National Cancer Institute (NCI) Cancer Moonshot Standardization Working Group.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18612-e18612
Author(s):  
Gillian Gresham ◽  
Gina L. Mazza ◽  
Blake Langlais ◽  
Bellinda King-Kallimanis ◽  
Lauren J. Rogak ◽  
...  
Keyword(s):  
Working Group ◽  
Best Practice ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Section 508 ◽  
Graphical Displays ◽  
Patient Reported ◽  
Tolerability Data ◽  
Survey Results ◽  
Data Incorporate

e18612 Background: Effective communication of treatment tolerability data is essential for clinical decision making and improved patient outcomes, yet standardized approaches to the analysis and visualization of tolerability data in cancer clinical trials are currently limited. To address this need, the Standardization Working Group (SWG) was established within the NCI Cancer Moonshot Tolerability Consortium. This abstract describes the SWG’s initiative to develop a publicly accessible online toolkit with a comprehensive set of guidelines, references, and resources for graphical displays of tolerability data. Methods: A multidisciplinary group of PRO researchers including biostatisticians, clinicians, epidemiologists, and representatives from the NCI and FDA convened monthly to discuss toolkit development and content. Considerations for standardization of graphical displays of tolerability data included (1) types of graphical displays, (2) incorporation of missing data, (3) labeling and color schemes, and (4) software to produce graphical displays. For consistency, considerations of tolerability relied on the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE), which includes 124 items assessing the frequency, severity, interference, and/or presence of 78 symptomatic adverse events. Graphical displays were generated using simulated PRO-CTCAE data and summarized by composite score (range 0-3).Color schemes that were Section 508 compliant and color blindness accessible were created. Surveys were distributed to 68 consortium members to assess preferences and interpretability of the graphical displays. Results: The SWG created graphical displays for PRO-CTCAE data, including bar charts, butterfly plots, and Sankey diagrams and compiled SAS macros and R functions to do so. Graphical displays made available in the toolkit maximize the use of PRO-CTCAE data, incorporate missingness, support between-arm comparisons, and present data longitudinally over treatment cycles or study timepoints. Survey results for labeling and color schemes were summarized and informed a list of short labels for PRO-CTCAE items (e.g., “radiation burns” for “skin burns from radiation”) and standardized color schemes for use in graphical displays. Survey results were also summarized to provide insight into PRO researchers’ ability to accurately interpret the graphical displays. Conclusions: Standardizinggraphical displays is important for improving the communication and interpretation of tolerability data. The type of graphical display used depends on the purpose of the analysis and should be tailored to the intended audience, including patients. This toolkit will provide a comprehensive resource with best practice recommendations.

scholarly journals Standard set of patient-reported outcomes for personality disorder

2021 ◽  
Author(s):  
Valentina Prevolnik Rupel ◽  
Beth Jagger ◽  
Luz Sousa Fialho ◽  
Lisa-Marie Chadderton ◽  
Timea Gintner ◽  
...  
Keyword(s):  
Mental Health ◽  
Personality Disorder ◽  
Outcome Measures ◽  
Working Group ◽  
Clinical Decision Making ◽  
Outcome Measurement ◽  
Clinical Decision ◽  
Case Mix ◽  
Patient Reported ◽  
Standard Set

Abstract Purpose The purpose of the article is to present standard set of outcomes for people with personality disorder (PD), in order to facilitate patient outcome measurement worldwide. Methods The International Consortium for Health Outcomes Measurement (ICHOM) gathered a multidisciplinary international working group, consisting of 16 experts, including clinicians, nurses, psychologists, methodologists and patient representatives, to develop a standard set of outcome measures for people with PD. The Delphi method was used to reach consensus on the scope of the set, outcome domains, outcome measures, case-mix variables and time points for measuring outcomes in service users. For each phase, a project team prepared materials based on systematic literature reviews and consultations with experts. Results The working group decided to include PD, as defined by International Classification of Diseases 11th revision (ICD-11). Eleven core outcomes and three optional outcomes across four health domains (mental health, behaviour, functioning and recovery) were defined as those relevant for people with PD. Validated measures for the selected outcomes were selected, some covering more than one outcome. Case-mix variables were aligned to other ICHOM mental health standard sets and consisted of demographic factors and those related to the treatment that people received. The group recommended that most outcomes are measured at baseline and annually. Conclusion The international minimum standard set of outcomes has the potential to improve clinical decision making through systematic measurement and comparability. This will be key in improving the standard of health care for people with PD across the world.

Between a logic of disruption and a logic of continuation: Negotiating the legitimacy of algorithms used in automated clinical decision-making

2021 ◽  
pp. 136345932199674
Author(s):  
Rikke Torenholt ◽  
Henriette Langstrup
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Patient Reported Outcomes ◽  
Patient Involvement ◽  
Clinical Decision Making ◽  
Diagnostic Procedures ◽  
Clinical Decision ◽  
Patient Reported ◽  
Pro Tools

In both popular and academic discussions of the use of algorithms in clinical practice, narratives often draw on the decisive potentialities of algorithms and come with the belief that algorithms will substantially transform healthcare. We suggest that this approach is associated with a logic of disruption. However, we argue that in clinical practice alongside this logic, another and less recognised logic exists, namely that of continuation: here the use of algorithms constitutes part of an established practice. Applying these logics as our analytical framing, we set out to explore how algorithms for clinical decision-making are enacted by political stakeholders, healthcare professionals, and patients, and in doing so, study how the legitimacy of delegating to an algorithm is negotiated and obtained. Empirically we draw on ethnographic fieldwork carried out in relation to attempts in Denmark to develop and implement Patient Reported Outcomes (PRO) tools – involving algorithmic sorting – in clinical practice. We follow the work within two disease areas: heart rehabilitation and breast cancer follow-up care. We show how at the political level, algorithms constitute tools for disrupting inefficient work and unsystematic patient involvement, whereas closer to the clinical practice, algorithms constitute a continuation of standardised and evidence-based diagnostic procedures and a continuation of the physicians’ expertise and authority. We argue that the co-existence of the two logics have implications as both provide a push towards the use of algorithms and how a logic of continuation may divert attention away from new issues introduced with automated digital decision-support systems.

Music Therapy Pre-internship Education and Training: Support for a Methods-Based Approach

2021 ◽  
Author(s):  
Susan C Gardstrom ◽  
James Hiller ◽  
Annie Heiderscheit ◽  
Nancy L Jackson
Keyword(s):  
Music Therapy ◽  
Best Practice ◽  
Clinical Decision Making ◽  
Well Being ◽  
Clinical Decision ◽  
Education And Training ◽  
Population Based ◽  
Music Therapists ◽  
Training Support ◽  
And Training

Abstract As music therapists, music is our primary realm of understanding and action and our distinctive way of joining with a client to help them attain optimal health and well-being. As such, we have adopted and advocate for a music-focused, methods-based (M-B) approach to music therapy pre-internship education and training. In an M-B approach, students’ learning is centered on the 4 music therapy methods of composing, improvising, re-creating, and listening to music and how these music experiences can be designed and implemented to address the health needs of the diverse clientele whom they will eventually encounter as practicing clinicians. Learning is highly experiential, with students authentically participating in each of the methods and reflecting on these self-experiences as a basis for their own clinical decision-making. This is differentiated from a population based (P-B) approach, wherein students’ attention is directed at acquiring knowledge about the non-musical problems of specific “clinical populations” and the “best practice” music interventions that are presumed to address these problems. Herein, we discuss both approaches, identifying the limitations of a P-B perspective and outlining the benefits of an M-B curriculum and its relevance to 21st-century music therapy practice.

scholarly journals Call for action: how to improve use of patient-reported outcomes to guide clinical decision making in rheumatoid arthritis

2018 ◽  
Vol 38 (6) ◽  
pp. 935-947 ◽  
Author(s):  
Bruno Fautrel ◽  
Rieke Alten ◽  
Bruce Kirkham ◽  
Inmaculada de la Torre ◽  
Frederick Durand ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Decision Making ◽  
Patient Reported Outcomes ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Patient Reported

No incentives, no innovation

2009 ◽  
Vol 91 (1) ◽  
pp. 10-12
Author(s):  
Jon Hackett
Keyword(s):  
Decision Making ◽  
Best Practice ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Bottom Up ◽  
High Profile ◽  
No Innovation

While the NHS has expressed a commitment to innovation with a succession of dedicated 'arms length bodies,' there are numerous high-profile cases in which advances on the ground have not received as much support as they might. In his recent Next Stage Review report, Lord Darzi has emphasised a commitment to clinical decision-making at all levels of the NHS but whether this will involve embracing best practice from the bottom up remains to be seen. For this article I spoke to two surgeons, whose sometimes controversial innovations were admired by many, about the obstacles they faced.

scholarly journals Treatment Discontinuation and Disease Progression with Injectable Disease-Modifying Therapies

2013 ◽  
Vol 15 (4) ◽  
pp. 194-201 ◽  
Author(s):  
Robert J. Fox ◽  
Amber R. Salter ◽  
Tuula Tyry ◽  
Jennifer Sun ◽  
Xiaojun You ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Clinical Decision Making ◽  
Medication Compliance ◽  
Clinical Decision ◽  
Research Committee ◽  
The North ◽  
Disease Modifying Therapies ◽  
Patient Reported ◽  
Disease Modifying

Injectable first-line disease-modifying therapies (DMTs) for multiple sclerosis (MS) are generally prescribed for continuous use. Accordingly, the various factors that influence patient persistence with treatment and that can lead some patients to switch medications or discontinue treatment may affect clinical outcomes. Using data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database, this study evaluated participants' reasons for discontinuation of injectable DMTs as well as the relationship between staying on therapy and sustained patient-reported disease progression and annualized relapse rates. Participants selected their reason(s) for discontinuation from among 16 possible options covering the categories of efficacy, safety, tolerability, and burden, with multiple responses permitted. Both unadjusted data and data adjusted for baseline age, disease duration, disability, and sex were evaluated. Discontinuation profiles varied among DMTs. Participants on intramuscular interferon beta-1a (IM IFNβ-1a) and glatiramer acetate (GA) reported the fewest discontinuations based on safety concerns, although GA was associated with reports of higher burden and lower efficacy than other therapies. Difficulties with tolerability were more often reported as a reason for discontinuing subcutaneous (SC) IFNβ-1a than as a reason for discontinuing IM IFNβ-1a, GA, or SC IFNβ-1b. In the persistent therapy cohort, less patient-reported disability progression was reported with IM IFNβ-1a treatment than with SC IFNβ-1a, IFNβ-1b, or GA. These findings have relevance to clinical decision making and medication compliance in MS patient care.

scholarly journals What is the role of technology in improving patient safety? A French, German and UK healthcare professional perspective

2020 ◽  
Vol 25 (6) ◽  
pp. 219-224
Author(s):  
Alain Astier ◽  
Jean Carlet ◽  
Torsten Hoppe-Tichy ◽  
Ann Jacklin ◽  
Annette Jeanes ◽  
...  
Keyword(s):  
Patient Safety ◽  
Working Group ◽  
Clinical Decision Making ◽  
Point Of Care ◽  
Clinical Decision ◽  
Cultural Changes ◽  
Use Of Technology ◽  
Patient Pathways ◽  
Professional Perspective ◽  
Enhance Patient Safety

Patient safety in hospitals can be compromised by preventable adverse events (AE). Among the preventable AEs, hospital-acquired infections (HAIs) are one of the most burdensome, contributing to not only poorer patient outcomes but institutional burden through direct financial losses and increased patient length of stay.  Technological innovations can enhance patient safety by automating tasks, introducing medication alerts, clinical reminders, improved diagnostic and consultation reports, facilitating information sharing, improving clinical decision-making, intercepting potential errors, reducing variation in practice, and managing workforce shortages as well as making complete patient data available.  A multidisciplinary working group from three European countries was convened to discuss how to optimise the use of technology to reduce preventable AEs in acute care hospitals. The working group identified examples where they felt there were opportunities to streamline patient pathways, including antimicrobial stewardship, point of care testing, microbiology test reporting to streamline time from sample-taking to clinical decision and mobile automated dispensing systems, which can reduce the burden on overworked staff. The working group also discussed key factors that were critical to ensuring different stakeholders, both within and outside the hospital, could meaningfully contribute to improving patient safety. They agreed that technological approaches and advances would have limited impact without meaningful cultural changes at all levels of healthcare infrastructure to implement the benefits offered by current or future technologies.

scholarly journals Novel Neurotechnological Interventions for Pediatric Drug-Resistant Epilepsy: Physician Perspectives

2020 ◽  
pp. 088307382096693
Author(s):  
Patrick J. McDonald ◽  
Viorica Hrincu ◽  
Mary B. Connolly ◽  
Mark J. Harrison ◽  
George M. Ibrahim ◽  
...  
Keyword(s):  
Decision Making ◽  
Best Practice ◽  
Clinical Decision Making ◽  
Qualitative Content Analysis ◽  
Scientific Evidence ◽  
Clinical Decision ◽  
Drug Resistant ◽  
Ethical Considerations ◽  
Pediatric Drug ◽  
Drug Resistant Epilepsy

This qualitative study investigated factors that guide physicians’ choices for minimally invasive and neuromodulatory interventions as alternatives to conventional surgery or medical management for pediatric drug-resistant epilepsy. North American physicians were recruited to one of 4 focus groups at national conferences. Discussions were analyzed using qualitative content analysis. A pragmatic neuroethics framework was applied to interpret results. Discussions revealed 2 major thematic branches: (1) clinical decision making and (2) ethical considerations. Under clinical decision making, physicians emphasized scientific evidence and patient candidacy when assessing neurotechnologies for patients. Ongoing seizures without intervention was important for safety and neurodevelopment. Under ethical considerations, resource allocation, among other financial considerations for technology adoption, were considerable sources of pressure on decision making. Access to neurotechnology was a salient theme differentiating Canadian and American contexts. When assessing novel neurotechnological interventions for pediatric drug-resistant epilepsy, physicians balance clinical and ethical factors to guide decision making and best practice.

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