Application of bayesian statistics to decision making during a clinical trial

1992 ◽  
Vol 11 (1) ◽  
pp. 23-35 ◽  
Author(s):  
Laurence S. Freedman ◽  
David J. Spiegelhalter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Bayesian Statistics

Is the Deductive Falsification Approach a Better Basis for Clinical Trial Appraisal?

2019 ◽  
Vol 14 (3) ◽  
pp. 224-228
Author(s):  
Steffen Mickenautsch
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Empirical Evidence ◽  
Clinical Decision Making ◽  
Inductive Reasoning ◽  
Clinical Decision ◽  
Future Trial ◽  
Grading Systems ◽  
Component Scores ◽  
Current Clinical Trial

Background: Inductive reasoning relies on an infinite regress without sufficient factual basis and verification is at any time vulnerable to single contrary observation. Thus, appraisal based on inductive verification, as applied in current clinical trial appraisal scales, checklists or grading systems, cannot prove or justify trial validity. Discussion: Trial appraisal based on deductive falsification can identify invalid trials and give evidence for the recommendation to exclude these from clinical decision-making. Such appraisal remains agnostic towards corroborated trials that pass all appraisal criteria. The results of corroborated trials cannot be considered more robust than falsified trials since nothing within a particular set of complied trial criteria can give certainty for trial compliance with any other appraisal criterion in future. A corroborated trial may or may not reflect therapeutic truth and may thus be the basis for clinical guidance, pending results of any future trial re-appraisal. Conclusion: Trial grading following appraisal based on deductive falsification should be binary (0 = Invalid or 1 = Unclear) and single component scores should be multiplied. Appraisal criteria for the judgment of trial characteristics require a clear rationale, quantification of such rationale and empirical evidence concerning the effect of trial characteristics on trial results.

Adolescent-Parent Dyads' Decision-Making About Adolescent Participation in a Reproductive Health Clinical Trial

2018 ◽  
Vol 62 (2) ◽  
pp. S55-S56
Author(s):  
Jenny K. Rodriguez Francis ◽  
Sara Landers ◽  
Jane Chang ◽  
Marina Catallozzi ◽  
Carmen Radecki Breiktkopf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Reproductive Health ◽  
Adolescent Parent ◽  
Adolescent Participation

scholarly journals The Opioid Analgesic Reduction Study (OARS): A Comparison of Opioid vs. Non-Opioid Combination Analgesics for Management of Post-Surgical Pain Study Protocol for a Double-Blind Randomized Multi-Center Clinical Trial

2021 ◽  
Author(s):  
Cecile A. Feldman ◽  
Janine Fredericks-Younger ◽  
Shou-En Lu ◽  
Paul J. Desjardins ◽  
Hans Malmstrom ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Pain Management ◽  
Opioid Analgesic ◽  
Third Molar ◽  
The United States ◽  
Double Blind ◽  
Post Operative Pain ◽  
Decision Making Tool ◽  
Molar Extraction

Abstract Background: Everyday people die unnecessarily from opioid overdose-related addiction. Dentists are among the leading prescribers of opioid analgesics. Opioid seeking behaviors have been linked to receipt of initial opioid prescriptions following the common dental procedure of third molar extraction. With each opioid prescription a patient’s risk for opioid misuse or abuse increases. With an estimated 56 million tablets of 5 mg hydrocodone annually prescribed after third molar extractions in the United States, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are inadvertently increasing their patient’s risk for addiction.Methods: A double blind, stratified randomized, multi-center clinical trial has been designed to evaluate whether a combination of over-the-counter non-opioid containing analgesics is not inferior to the most prescribed opioid analgesic. The impacted 3rd molar extraction model is being used due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients are randomized to receive either OPIOID (hydrocodone/acetaminophen 5/300 mg) or NON-OPIOID (ibuprofen/acetaminophen 400/500 mg). Outcome data include pain levels, adverse events, overall patient satisfaction, ability to sleep, and ability to perform daily functions. To develop clinical guidelines and a clinical decision making tool, pain management, extraction difficulty and number of tablets taken is being collected enabling an experimental decision making tool to be developed. Discussion: The proposed methods address the short comings of other analgesic studies. Although prior studies have tested short-term effects of single doses of pain medications, patients and their dentists are interested in managing pain for the entire post-operative period, not just the first 12 hours. After surgery, patients expect to be able to perform normal daily functions without feeling nauseous or dizzy and they desire a restful sleep at night. Parents of young people are concerned with the risks of opioid use and misuse, either related to treatments received or to subsequent use of leftover pills. Upon successful completion of this clinical trial, dentists, patients, and their families will be better able to make informed decisions regarding post-operative pain management.Trial registration: ClinicalTrials.gov NCT04452344. Registered on June 20, 2020

scholarly journals ACTA A Tool for Argumentative Clinical Trial Analysis

2019 ◽  
Author(s):  
Tobias Mayer ◽  
Elena Cabrio ◽  
Serena Villata
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Online Discussion ◽  
Trial Analysis ◽  
Persuasive Essays

Argumentative analysis of textual documents of various nature (e.g., persuasive essays, online discussion blogs, scientific articles) allows to detect the main argumentative components (i.e., premises and claims) present in the text and to predict whether these components are connected to each other by argumentative relations (e.g., support and attack), leading to the identification of (possibly complex) argumentative structures. Given the importance of argument-based decision making in medicine, in this demo paper we introduce ACTA, a tool for automating the argumentative analysis of clinical trials. The tool is designed to support doctors and clinicians in identifying the document(s) of interest about a certain disease, and in analyzing the main argumentative content and PICO elements.

scholarly journals Strategies to facilitate shared decision-making about pediatric oncology clinical trial enrollment: A systematic review

2018 ◽  
Vol 101 (7) ◽  
pp. 1157-1174 ◽  
Author(s):  
Eden G. Robertson ◽  
Claire E. Wakefield ◽  
Christina Signorelli ◽  
Richard J. Cohn ◽  
Andrea Patenaude ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Decision Making ◽  
Shared Decision Making ◽  
Pediatric Oncology ◽  
Shared Decision ◽  
Oncology Clinical Trial ◽  
Clinical Trial Enrollment
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