Lost in Transposition: Erroneous Conflation of Statistical Certainty with Evidentiary Standards

2013 ◽  
Author(s):  
Leslie Demers
Keyword(s):  
Evidentiary Standards ◽  
Statistical Certainty

scholarly journals Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Theresa M. Coles ◽  
Adrian F. Hernandez ◽  
Bryce B. Reeve ◽  
Karon Cook ◽  
Michael C. Edwards ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Contextual Factors ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Think Tank ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

How procedures shape substance: institutional design and antitrust evidentiary standards

2018 ◽  
Vol 46 (1) ◽  
pp. 143-164 ◽  
Author(s):  
Andreea Cosnita-Langlais ◽  
Jean-Philippe Tropeano
Keyword(s):  
Institutional Design ◽  
Evidentiary Standards

Part VIII Accountability for Displacement and Refugee Rights Violations, Ch.62 Restitution and Other Remedies for Refugees and Internally Displaced Persons

2021 ◽  
Author(s):  
Bradley Megan
Keyword(s):  
Data Collection ◽  
Power Relations ◽  
Internally Displaced Persons ◽  
Court Decisions ◽  
Displaced Persons ◽  
Internally Displaced ◽  
Forced Migrants ◽  
State Of Research ◽  
Evidentiary Standards ◽  
Made In

This chapter explores restitution and other remedies for refugees and internally displaced persons (IDPs). Most refugees and IDPs never receive any formal redress for the wrongs they have suffered. Yet over the past 30 years, significant progress has been made in advancing international norms on remedies for refugees and IDPs, and experiences in countries from Bosnia and Kosovo to Rwanda and Iraq have strengthened understanding of the challenges involved in translating these principles into practice. Efforts have focused predominantly on the restitution of housing, land, and property (HLP), with the assumption that this is the most pertinent remedy for forced migrants, particularly because it may help enable return as the ‘preferred’ solution to displacement. The chapter assesses these developments and the state of research on this pivotal challenge. It reviews the approaches taken in major peace treaties, court decisions, and standards. The chapter then reflects on five intertwined challenges: (i) developing appropriate data collection techniques and evidentiary standards; (ii) balancing the rights of ‘secondary occupants’ and people in protracted displacement; (iii) mitigating risks associated with HLP restitution; (iv) developing a better understanding of how gender, race, class, and other intersecting power relations influence redress; and (v) moving beyond a narrow focus on property restitution to consider the wider range of losses associated with displacement.

scholarly journals Detection of Hazelnut Oil in Virgin Olive Oil by Assessment of Free Sterols and Triacylglycerols

2001 ◽  
Vol 84 (5) ◽  
pp. 1534-1542 ◽  
Author(s):  
Stefania Vichi ◽  
Lorena Pizzale ◽  
Emilio Toffano ◽  
Renzo Bortolomeazzi ◽  
Lanfranco Conte
Keyword(s):  
Olive Oil ◽  
Solid Phase ◽  
Virgin Olive Oil ◽  
Hazelnut Oil ◽  
Phase Extraction ◽  
Silica Column ◽  
Free Sterols ◽  
Oil Fractions ◽  
Triacylglycerol Analysis ◽  
Statistical Certainty

Abstract Free sterols were evaluated as factors for discriminating between genuine virgin olive oil and hazelnut-mixed virgin olive oil. Numeric analyses of the results amplified the differences between groups. The application of this method to virgin olive oil samples and their mixtures with 10% hazelnut oil distinguished between genuine and nongenuine virgin olive oil with statistical certainty. Triacylglycerol analysis was tested for the same purpose by using parameter ΔECN42, but although it possessed a discriminating capacity, it alone could not distinguish the aforementioned groups with sufficient certainty. Free Δ7-sterols data were combined with ΔECN42 data into a single discriminating function to improve differentiation and bring more ruggedness, and for detection of low amounts (10%) of hazelnut oil in virgin olive oil. In fact, the values obtained by addition of Δ7-sterol data and ΔECN42 data showed a higher discriminating capacity than single parameters. In a single operation the method produced all the oil fractions necessary for analysis of free sterols and triacylglycerols with ECN42. Solid-phase extraction was applied in substitution of traditional chromatography on a silica column.

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