Browsing by Subject "Clinical Decision-Making"

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    Caveat emptor: the combined effects of multiplicity and selective reporting.
    (Trials, 2018-09-17) Li, Tianjing; Mayo-Wilson, Evan; Fusco, Nicole; Hong, Hwanhee; Dickersin, Kay
    Clinical trials and systematic reviews of clinical trials inform healthcare decisions. There is growing concern, however, about results from clinical trials that cannot be reproduced. Reasons for nonreproducibility include that outcomes are defined in multiple ways, results can be obtained using multiple methods of analysis, and trial findings are reported in multiple sources ("multiplicity"). Multiplicity combined with selective reporting can influence dissemination of trial findings and decision-making. In particular, users of evidence might be misled by exposure to selected sources and overly optimistic representations of intervention effects. In this commentary, drawing from our experience in the Multiple Data Sources in Systematic Reviews (MUDS) study and evidence from previous research, we offer practical recommendations to enhance the reproducibility of clinical trials and systematic reviews.
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    Consideration of Out-of-Office Blood Pressure Monitoring in Hypertension Management.
    (Journal of clinical hypertension (Greenwich, Conn.), 2016-05) Goldstein, Karen M; Zullig, Leah L; Bosworth, Hayden B; Oddone, Eugene Z
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    Global guideline for the diagnosis and management of the endemic mycoses: an initiative of the European Confederation of Medical Mycology in cooperation with the International Society for Human and Animal Mycology.
    (The Lancet. Infectious diseases, 2021-12) Thompson, George R; Le, Thuy; Chindamporn, Ariya; Kauffman, Carol A; Alastruey-Izquierdo, Ana; Ampel, Neil M; Andes, David R; Armstrong-James, Darius; Ayanlowo, Olusola; Baddley, John W; Barker, Bridget M; Lopes Bezerra, Leila; Buitrago, Maria J; Chamani-Tabriz, Leili; Chan, Jasper FW; Chayakulkeeree, Methee; Cornely, Oliver A; Cunwei, Cao; Gangneux, Jean-Pierre; Govender, Nelesh P; Hagen, Ferry; Hedayati, Mohammad T; Hohl, Tobias M; Jouvion, Grégory; Kenyon, Chris; Kibbler, Christopher C; Klimko, Nikolai; Kong, David CM; Krause, Robert; Lee Lee, Low; Meintjes, Graeme; Miceli, Marisa H; Rath, Peter-Michael; Spec, Andrej; Queiroz-Telles, Flavio; Variava, Ebrahim; Verweij, Paul E; Schwartz, Ilan S; Pasqualotto, Alessandro C
    The global burden of the endemic mycoses (blastomycosis, coccidioidomycosis, emergomycosis, histoplasmosis, paracoccidioidomycosis, sporotrichosis, and talaromycosis) continues to rise yearly and these infectious diseases remain a leading cause of patient morbidity and mortality worldwide. Management of the associated pathogens requires a thorough understanding of the epidemiology, risk factors, diagnostic methods and performance characteristics in different patient populations, and treatment options unique to each infection. Guidance on the management of these infections has the potential to improve prognosis. The recommendations outlined in this Review are part of the "One World, One Guideline" initiative of the European Confederation of Medical Mycology. Experts from 23 countries contributed to the development of these guidelines. The aim of this Review is to provide an up-to-date consensus and practical guidance in clinical decision making, by engaging physicians and scientists involved in various aspects of clinical management.
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    Imaging biomarker roadmap for cancer studies.
    (Nature reviews. Clinical oncology, 2017-03) O'Connor, James PB; Aboagye, Eric O; Adams, Judith E; Aerts, Hugo JWL; Barrington, Sally F; Beer, Ambros J; Boellaard, Ronald; Bohndiek, Sarah E; Brady, Michael; Brown, Gina; Buckley, David L; Chenevert, Thomas L; Clarke, Laurence P; Collette, Sandra; Cook, Gary J; deSouza, Nandita M; Dickson, John C; Dive, Caroline; Evelhoch, Jeffrey L; Faivre-Finn, Corinne; Gallagher, Ferdia A; Gilbert, Fiona J; Gillies, Robert J; Goh, Vicky; Griffiths, John R; Groves, Ashley M; Halligan, Steve; Harris, Adrian L; Hawkes, David J; Hoekstra, Otto S; Huang, Erich P; Hutton, Brian F; Jackson, Edward F; Jayson, Gordon C; Jones, Andrew; Koh, Dow-Mu; Lacombe, Denis; Lambin, Philippe; Lassau, Nathalie; Leach, Martin O; Lee, Ting-Yim; Leen, Edward L; Lewis, Jason S; Liu, Yan; Lythgoe, Mark F; Manoharan, Prakash; Maxwell, Ross J; Miles, Kenneth A; Morgan, Bruno; Morris, Steve; Ng, Tony; Padhani, Anwar R; Parker, Geoff JM; Partridge, Mike; Pathak, Arvind P; Peet, Andrew C; Punwani, Shonit; Reynolds, Andrew R; Robinson, Simon P; Shankar, Lalitha K; Sharma, Ricky A; Soloviev, Dmitry; Stroobants, Sigrid; Sullivan, Daniel C; Taylor, Stuart A; Tofts, Paul S; Tozer, Gillian M; van Herk, Marcel; Walker-Samuel, Simon; Wason, James; Williams, Kaye J; Workman, Paul; Yankeelov, Thomas E; Brindle, Kevin M; McShane, Lisa M; Jackson, Alan; Waterton, John C
    Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.
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    Linked Sensitivity Analysis, Calibration, and Uncertainty Analysis Using a System Dynamics Model for Stroke Comparative Effectiveness Research.
    (Medical decision making : an international journal of the Society for Medical Decision Making, 2016-11) Tian, Yuan; Hassmiller Lich, Kristen; Osgood, Nathaniel D; Eom, Kirsten; Matchar, David B

    Background

    As health services researchers and decision makers tackle more difficult problems using simulation models, the number of parameters and the corresponding degree of uncertainty have increased. This often results in reduced confidence in such complex models to guide decision making.

    Objective

    To demonstrate a systematic approach of linked sensitivity analysis, calibration, and uncertainty analysis to improve confidence in complex models.

    Methods

    Four techniques were integrated and applied to a System Dynamics stroke model of US veterans, which was developed to inform systemwide intervention and research planning: Morris method (sensitivity analysis), multistart Powell hill-climbing algorithm and generalized likelihood uncertainty estimation (calibration), and Monte Carlo simulation (uncertainty analysis).

    Results

    Of 60 uncertain parameters, sensitivity analysis identified 29 needing calibration, 7 that did not need calibration but significantly influenced key stroke outcomes, and 24 not influential to calibration or stroke outcomes that were fixed at their best guess values. One thousand alternative well-calibrated baselines were obtained to reflect calibration uncertainty and brought into uncertainty analysis. The initial stroke incidence rate among veterans was identified as the most influential uncertain parameter, for which further data should be collected. That said, accounting for current uncertainty, the analysis of 15 distinct prevention and treatment interventions provided a robust conclusion that hypertension control for all veterans would yield the largest gain in quality-adjusted life years.

    Conclusions

    For complex health care models, a mixed approach was applied to examine the uncertainty surrounding key stroke outcomes and the robustness of conclusions. We demonstrate that this rigorous approach can be practical and advocate for such analysis to promote understanding of the limits of certainty in applying models to current decisions and to guide future data collection.
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    Point-of-care diagnostics for invasive aspergillosis: nearing the finish line.
    (Expert review of molecular diagnostics, 2020-10) Jenks, Jeffrey D; Hoenigl, Martin

    Introduction

    The spectrum of disease caused by Aspergillus spp. is dependent on the immune system of the host, with invasive aspergillosis (IA) its most severe manifestation. Early and reliable diagnosis of Aspergillus disease is important to decrease associated morbidity and mortality from IA.

    Areas covered

    The following review searched Pub Med for literature published since 2007 and will give an update on the current point-of-care diagnostic strategies for the diagnosis of IA, discuss needed areas of improvement for these tests, and future directions.

    Expert opinion

    Several new diagnostic tests for IA - including point-of-care tests - are now available to complement conventional galactomannan (GM) testing. In particular, the Aspergillus-specific Lateral Flow Device (LFD) test and the sōna Aspergillus GM Lateral Flow Assay (LFA) are promising for the diagnosis of IA in patients with hematologic malignancy, although further evaluation in the non-hematology setting is needed. In addition, a true point-of-care test, particularly for easily obtained specimens like serum or urine that can be done at the bedside or in the Clinic in a matter of minutes is needed, such as the lateral flow dipstick test, which is under current evaluation. Lastly, improved diagnostic algorithms to diagnose IA in non-neutropenic patients is needed.
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    Quality of Life and Recommendations for Further Care.
    (Crit Care Med, 2016-11) Putman, Michael S; Tak, Hyo Jung; Curlin, Farr A; Yoon, John D
    OBJECTIVES: Physician recommendations for further medical treatment or palliative treatment only at the end of life may influence patient decisions. Little is known about the patient characteristics that affect physician-assessed quality of life or how such assessments are related to subsequent recommendations. DESIGN, SETTING, AND SUBJECTS: A 2010 mailed survey of practicing U.S. physicians (1,156/1,878 or 62% of eligible physicians responded). MEASUREMENTS AND MAIN RESULTS: Measures included an end of life vignette with five experimentally varied patient characteristics: setting, alimentation, pain, cognition, and communication. Physicians rated vignette patient quality of life on a scale from 0 to 100 and indicated whether they would recommend continuing full medical treatment or palliative treatment only. Cognitive deficits and alimentation had the greatest impacts on recommendations for further care, but pain and communication were also significant (all p < 0.001). Physicians who recommended continuing full medical treatment rated quality of life three times higher than those recommending palliative treatment only (40.41 vs 12.19; p < 0.01). Religious physicians were more likely to assess quality of life higher and to recommend full medical treatment. CONCLUSIONS: Physician judgments about quality of life are highly correlated with recommendations for further care. Patients and family members might consider these biases when negotiating medical decisions.
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    Reframing Hospital to Home Discharge from "Should We?" to "How Can We?": COVID-19 and Beyond.
    (Journal of the American Geriatrics Society, 2021-03) Gustavson, Allison M; Toonstra, Amy; Johnson, Joshua K; Ensrud, Kristine E