Improving Decision-Making for Clinical Research and Health Administration

2013 ◽  
pp. 179-200 ◽  
Author(s):  
Alexandra Pomares-Quimbaya ◽  
Rafael A. González ◽  
Wilson-Ricardo Bohórquez ◽  
Oscar Mauricio Muñoz ◽  
Olga Milena García ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Research ◽  
Health Administration

Enhancing Regulatory Decision Making for Postmarket Drug Safety

2021 ◽  
Author(s):  
Vishal Ahuja ◽  
Carlos A. Alvarez ◽  
John R. Birge ◽  
Chad Syverson
Keyword(s):  
Decision Making ◽  
Operations Management ◽  
The United States ◽  
Pharmaceutical Products ◽  
Unintended Consequences ◽  
Surveillance Systems ◽  
Veterans Health ◽  
Health Administration ◽  
Regulatory Decision ◽  
Increased Risk

The U.S. Food and Drug Administration (FDA) regulates the approval and safe public use of pharmaceutical products in the United States. The FDA uses postmarket surveillance systems to monitor drugs already on the market; a drug found to be associated with an increased risk of adverse events (ADEs) is subject to a recall or a warning. A flawed postmarket decision-making process can have unintended consequences for patients, create uncertainty among providers and affect their prescribing practices, and subject the FDA to unfavorable public scrutiny. The FDA’s current pharmacovigilance process suffers from several shortcomings (e.g., a high underreporting rate), often resulting in incorrect or untimely decisions. Thus, there is a need for robust, data-driven approaches to support and enhance regulatory decision making in the context of postmarket pharmacovigilance. We propose such an approach that has several appealing features—it employs large, reliable, and relevant longitudinal databases; it uses methods firmly established in literature; and it addresses selection bias and endogeneity concerns. Our approach can be used to both (i) independently validate existing safety concerns relating to a drug, such as those emanating from existing surveillance systems, and (ii) perform a holistic safety assessment by evaluating a drug’s association with other ADEs to which the users may be susceptible. We illustrate the utility of our approach by applying it retrospectively to a highly publicized FDA black box warning (BBW) for rosiglitazone, a diabetes drug. Using comprehensive data from the Veterans Health Administration on more than 320,000 diabetes patients over an eight-year period, we find that the drug was not associated with the two ADEs that led to the BBW, a conclusion that the FDA evidently reached, as it retracted the warning six years after issuing it. We demonstrate the generalizability of our approach by retroactively evaluating two additional warnings, those related to statins and atenolol, which we found to be valid. This paper was accepted by Vishal Gaur, operations management.

Integrating Supported Decision-Making into the Clinical Research Process

2021 ◽  
Vol 21 (11) ◽  
pp. 32-35
Author(s):  
Barbara E. Bierer ◽  
Ari Ne’eman ◽  
Willyanne DeCormier Plosky ◽  
David H. Strauss ◽  
Benjamin C. Silverman ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Research ◽  
Research Process

scholarly journals Broad concepts and messy realities: optimising the application of mental capacity criteria

2021 ◽  
pp. medethics-2021-107571
Author(s):  
Scott Y H Kim ◽  
Nuala B Kane ◽  
Alexander Ruck Keene ◽  
Gareth S Owen
Keyword(s):  
Decision Making ◽  
Clinical Research ◽  
Functional Capacity ◽  
Functional Model ◽  
Relevant Information ◽  
Mental Capacity ◽  
Capacity Assessment ◽  
Diverse Range ◽  
England And Wales ◽  
Mental Capacity Act

Most jurisdictions require that a mental capacity assessment be conducted using a functional model whose definition includes several abilities. In England and Wales and in increasing number of countries, the law requires a person be able to understand, to retain, to use or weigh relevant information and to communicate one’s decision. But interpreting and applying broad and vague criteria, such as the ability ‘to use or weigh’ to a diverse range of presentations is challenging. By examining actual court judgements of capacity, we previously developed a descriptive typology of justifications (rationales) used in the application of the Mental Capacity Act (MCA) criteria. We here critically optimise this typology by showing how clear definitions—and thus boundaries—between the criteria can be achieved if the ‘understanding’ criterion is used narrowly and the multiple rationales that fall under the ability to ‘use or weigh’ are specifically enumerated in practice. Such a typology-aided practice, in theory, could make functional capacity assessments more transparent, accountable, reliable and valid. It may also help to create targeted supports for decision making by the vulnerable. We also discuss how the typology could evolve legally and scientifically, and how it lays the groundwork for clinical research on the abilities enumerated by the MCA.

Anticoagulation Treatment and Outcomes of Venous Thromboembolism by Weight and Body Mass Index: Insights From the Veterans Health Administration

2021 ◽  
Author(s):  
Alexander C. Perino ◽  
Jun Fan ◽  
Susan Schmitt ◽  
Jennifer D. Guo ◽  
Patrick Hlavacek ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Decision Making ◽  
Venous Thromboembolism ◽  
Shared Decision Making ◽  
Patient Selection ◽  
Veterans Health Administration ◽  
Shared Decision ◽  
Veterans Health ◽  
Health Administration ◽  
Recurrent Vte

Background: Consensus statements have recommended against the use of direct oral anticoagulants (DOACs) in venous thromboembolism (VTE) for patients ≥120 kg and ≥40 kg/m 2 . We sought to determine use and outcomes of DOACs for VTE across weight and body mass index (BMI). Methods: We performed a retrospective cohort study of patients with first-time VTE 2013 to 2018 that were treated with DOAC or warfarin in the Veterans Health Administration. The Veterans Health Administration has implemented system-wide guidance for patient selection and shared decision-making for use of DOACs in VTE at extremes of weight. We stratified patients by weight and BMI and assessed (1) association of weight and BMI category to outcomes in those prescribed DOAC; and (2) association of DOAC, as compared to warfarin, to outcomes by weight and BMI categories. Outcomes of interest included major bleeding, clinically relevant nonmajor bleeding, and recurrent VTE. Results: The analysis cohort included 51 871 patients prescribed DOAC or warfarin within 30 days of index VTE diagnosis (age 64.5±13.1 years; 6.0% female; median weight 93.4 kg [25th–75th: 80.5–108.6 kg]). For patients ≥120 kg (N=6934 patients), 38.4% were treated with DOAC, as compared to 45.4% of those ≥60 to <100 kg (N=30 645; P <0.0001). DOAC prescription was not associated with major bleeds, clinically relevant nonmajor bleeds, or recurrent VTE for those in higher weight and BMI categories as compared to those in average weight and BMI categories. DOAC prescription, as compared to warfarin, was not associated with increased recurrent VTE in any weight or BMI category. Conclusions: Patients ≥120 kg and ≥40 kg/m 2 with VTE are frequently prescribed DOAC by the Veterans Health Administration, without an increase in bleeding or recurrent VTE. These findings suggest DOACs can be safe and effective in this population and may argue for broader adoption of pharmacy policies that promote careful patient selection and shared decision making.

scholarly journals Impact of deliberate practice on evidence-based medicine attitudes and behaviours of health care professionals

2020 ◽  
Author(s):  
Eelco Draaisma ◽  
Lauren A. Maggio ◽  
Jolita Bekhof ◽  
A. Debbie C. Jaarsma ◽  
Paul L. P. Brand
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Clinical Research ◽  
Health Care Professionals ◽  
Evidence Based Medicine ◽  
Deliberate Practice ◽  
Medical Decision ◽  
Evidence Based ◽  
Teaching Activities ◽  
Based Medicine

Abstract Introduction Although evidence-based medicine (EBM) teaching activities may improve short-term EBM knowledge and skills, they have little long-term impact on learners’ EBM attitudes and behaviour. This study examined the effects of learning EBM through stand-alone workshops or various forms of deliberate EBM practice. Methods We assessed EBM attitudes and behaviour with the evidence based practice inventory questionnaire, in paediatric health care professionals who had only participated in a stand-alone EBM workshop (controls), participants with a completed PhD in clinical research (PhDs), those who had completed part of their paediatric residency at a department (Isala Hospital) which systematically implemented EBM in its clinical and teaching activities (former Isala residents), and a reference group of paediatric professionals currently employed at Isala’s paediatric department (current Isala participants). Results Compared to controls (n = 16), current Isala participants (n = 13) reported more positive EBM attitudes (p < 0.01), gave more priority to using EBM in decision making (p = 0.001) and reported more EBM behaviour (p = 0.007). PhDs (n = 20) gave more priority to using EBM in medical decision making (p < 0.001) and reported more EBM behaviour than controls (p = 0.016). Discussion Health care professionals exposed to deliberate practice of EBM, either in the daily routines of their department or by completing a PhD in clinical research, view EBM as more useful and are more likely to use it in decision making than their peers who only followed a standard EBM workshop. These findings support the use of deliberate practice as the basis for postgraduate EBM educational activities.

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