FDA Advisory Decision Highlights Some Problems Inherent in Pragmatic Trials

BackgroundRandomised controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. However, the outcomes of RCTs often lackclinical utility and usually do not address real-world effectivenessAimsTo review how traditional RCTs may be triangulatedwith other methodologies such as observational studies and pragmatic trials by highlighting recently reported studies, outcomes used and their respective meritsMethodLiterature review focusing on drug treatmentResultsRecently reported observational and some pragmatic studies show a degree of consistency in reported results and use outcomes that have face validity for cliniciansConclusionsNo single experimental paradigm or outcome provides the necessary data to optimise treatment of mental illness in the clinical setting

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A pragmatic view on pragmatic trials

Dialogues in Clinical Neuroscience ◽

10.31887/dcns.2011.13.2/npatsopoulos ◽

2011 ◽

Vol 13 (2) ◽

pp. 217-224 ◽

Cited By ~ 93

Keyword(s):

Clinical Trials ◽

Medical Practice ◽

Real Life ◽

Main Tool ◽

Health Sciences ◽

Routine Practice ◽

Special Focus ◽

Pragmatic Trials ◽

Explanatory Trials

Clinical trials have been the main tool used by the health sciences community to test and evaluate interventions, Trials can fall into two broad categories: pragmatic and explanatory. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-life routine practice conditions, whereas explanatory trials aim to test whether an intervention works under optimal situations. Pragmatic trials produce results that can be generalized and applied in routine practice settings. Since most results from exploratory trials fail to be broadly generalizable, the "pragmatic design" has gained momentum. This review describes the concept of pragmatism, and explains in particular that there is a continuum between pragmatic and explanatory trials, rather than a dichotomy. Special focus is put on the limitations of the pragmatic trials, while recognizing the importance for and impact of this design on medical practice.

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Strategies to increase downloads of COVID–19 exposure notification apps: A discrete choice experiment

PLoS ONE ◽

10.1371/journal.pone.0258945 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0258945

Author(s):

Jemima A. Frimpong ◽

Stéphane Helleringer

Keyword(s):

Decision Making ◽

Discrete Choice Experiment ◽

Discrete Choice ◽

Financial Incentives ◽

Choice Experiment ◽

Real Life ◽

Contact Tracing ◽

Reference Scenario ◽

Pragmatic Trials ◽

The Us

Exposure notification apps have been developed to assist in notifying individuals of recent exposures to SARS-CoV-2. However, in several countries, such apps have had limited uptake. We assessed whether strategies to increase downloads of exposure notification apps should emphasize improving the accuracy of the apps in recording contacts and exposures, strengthening privacy protections and/or offering financial incentives to potential users. In a discrete choice experiment with potential app users in the US, financial incentives were more than twice as important in decision-making about app downloads, than privacy protections, and app accuracy. The probability that a potential user would download an exposure notification app increased by 40% when offered a $100 reward to download (relative to a reference scenario in which the app is free). Financial incentives might help exposure notification apps reach uptake levels that improve the effectiveness of contact tracing programs and ultimately enhance efforts to control SARS-CoV-2. Rapid, pragmatic trials of financial incentives for app downloads in real-life settings are warranted.

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Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

10.21203/rs.3.rs-145261/v1 ◽

2021 ◽

Author(s):

Paulo Cesar Morales Mayer ◽

Caroline Amélia Gonçalves ◽

Franz Porzsolt

Keyword(s):

Cervical Cancer ◽

Clinical Trials ◽

Selection Criteria ◽

Human Subjects ◽

Evidence Based ◽

Inclusion Criteria ◽

Pragmatic Trials ◽

Exclusion Criteria ◽

Policy Makers ◽

Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

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