Objective: Pharmacogenomic-guided dosing has the potential to improve patient outcomes but its implementation has been met with clinical challenges. Our objective was to develop and evaluate a clinical decision support system (CDSS) for pharmacogenomic-guided warfarin dosing designed for physicians and pharmacists.
Methods: Twelve physicians and pharmacists completed 6 prescribing tasks using simulated patient scenarios in two iterations (development and validation phases) of a newly developed pharmacogenomic-driven CDSS prototype. For each scenario, usability was measured via efficiency, recorded as time to task completion, and participants' perceived satisfaction which were compared using Kruskal-Wallis and Mann Whitney U tests, respectively. Debrief interviews were conducted and qualitatively analyzed. Usability findings from the first (i.e. development) iteration were incorporated into the CDSS design for the second (i.e. validation) iteration.
Results: During the CDSS validation iteration, participants took more time to complete tasks with a median (IQR) of 183 (124-247) seconds versus 101 (73.5-197) seconds in the development iteration (p=0.01). This increase in time on task was due to the increase in time spent in the CDSS corresponding to several design changes. Efficiency differences that were observed between pharmacists and physicians in the development iteration were eliminated in the validation iteration. The increased use of the CDSS corresponded to a greater acceptance of CDSS recommended doses in the validation iteration (4% in the first iteration vs. 37.5% in the second iteration, p<0.001). Overall satisfaction did not change statistically between the iterations but the qualitative analysis revealed greater trust in the second prototype.
Conclusions: A pharmacogenomic-guided CDSS has been developed using warfarin as the test drug. The final CDSS prototype was trusted by prescribers and significantly increased the time using the tool and acceptance of the recommended doses. This study is an important step toward incorporating pharmacogenomics into CDSS design for clinical testing.
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http://dx.doi.org/10.4338/ACI-2016-05-RA-0081 | DOI Listing |
Trials
January 2025
Department of Electrical and Computer Engineering, Princeton University, Princeton, 08544, NJ, USA.
Background: Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.
Methods: To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD).
BMJ Open
January 2025
Centre for Health Services Studies, University of Kent, Canterbury, UK.
Background: Older adult care homes in England are required to develop care plans on behalf of each of their residents and to make these documents available to those who provide care. However, there is a lack of formal agreement around the key principles that should inform the development of care plans in care homes for older adults. Using a modified Delphi survey, we intend to generate consensus on a set of key principles that should inform the care planning process.
View Article and Find Full Text PDFMol Cell Proteomics
January 2025
Bavarian Center for Biomolecular Mass Spectrometry (BayBioMS), TUM School of Life Sciences, Technical University of Munich, 85354 Freising, Germany. Electronic address:
Mass spectrometry-based proteomics has revolutionized bacterial identification and elucidated many molecular mechanisms underlying bacterial growth, community formation, and drug resistance. However, most research has been focused on a few model bacteria, overlooking bacterial diversity. In this study, we present the most extensive bacterial proteomic resource to date, covering 303 species, 119 genera, and five phyla with over 636,000 unique expressed proteins, confirming the existence of over 38,700 hypothetical proteins.
View Article and Find Full Text PDFJMIR Res Protoc
January 2025
Division of Services and Interventions Research, National Institute of Mental Health, Bethesda, MD, United States.
Background: Although substantial progress has been made in establishing evidence-based psychosocial clinical interventions and implementation strategies for mental health, translating research into practice-particularly in more accessible, community settings-has been slow.
Objective: This protocol outlines the renewal of the National Institute of Mental Health-funded University of Washington Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness Center, which draws from human-centered design (HCD) and implementation science to improve clinical interventions and implementation strategies. The Center's second round of funding (2023-2028) focuses on using the Discover, Design and Build, and Test (DDBT) framework to address 3 priority clinical intervention and implementation strategy mechanisms (ie, usability, engagement, and appropriateness), which we identified as challenges to implementation and scalability during the first iteration of the center.
PLOS Glob Public Health
January 2025
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, United States of America.
The Quality-of-Care Network (QCN), launched by WHO and partners, links global and national actors across several countries to improve maternal and newborn health. We conducted a prospective qualitative study to examine how QCN in Bangladesh, Ethiopia, Malawi and Uganda facilitated learning, sharing, and innovation within and between network countries. We conducted 227 key informant interviews with QCN actors at global, national, and facility levels iteratively in two to four rounds from June 2019 to March 2022.
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