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The term "intercurrent events" has recently been used to describe events in clinical trials that may complicate the definition and calculation of the treatment effect estimand. This paper focuses on the use of an attributable estimand to address intercurrent events. Those events that are considered to be adversely related to randomized treatment (eg, discontinuation due to adverse events or lack of efficacy) are considered attributable and handled with a composite estimand strategy, while a hypothetical estimand strategy is used for intercurrent events not considered to be related to randomized treatment (eg, unrelated adverse events). We explore several options for how to implement this approach and compare them to hypothetical "efficacy" and treatment policy estimand strategies through a series of simulation studies whose design is inspired by recent trials in chronic obstructive pulmonary disease (COPD), and we illustrate through an analysis of a recently completed COPD trial.
This article was published in the following journal.
Name: Pharmaceutical statistics
There is a key problem in randomised clinical trials as outcomes can be distorted due to informative post-randomisation events. This is inadequately addressed by the use of traditional intention-to-tr...
The aim of the study is to evaluate the cost-effectiveness of alectinib for first-line treatment of ALK+ advanced non-small-cell lung cancer compared to crizotinib in the French setting. This study us...
In our discussion of environmental and ecological catastrophes or disasters resulting from extreme weather events, we unite disparate literatures, the biological and the physical. Our goal is to tie t...
Many daily life events, from lotteries to coincidental encounters, occur partly or entirely randomly or "by chance." Six experiments, in two different languages, explored how perceptions of randomness...
Tourism contributes substantially to municipal solid waste generation, yet the waste from tourism systematically remains hidden behind residential waste flows. As a result, municipal fees are set with...
To describe the magnitude and duration of changes in HIV-1 RNA levels during and after an acute febrile illness. To identify factors associated with increases, i.e., type of illness ultima...
The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disea...
This will be an exploratory study, using semi-structured interviews to explore patients' experiences of undergoing investigations for Sciatica (leg pain referred from the lower back). Inte...
The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allost...
To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure pa...
Works consisting of an account of the events, works, and achievements, personal and professional, during a person's life. It includes articles on the activities and accomplishments of living persons as well as the presentation of an obituary.
An article or portion of an article giving an account of past events or circumstances significant in a field of study, a profession, a discovery, an invention, etc. The concept of history is very wide, ranging from the dawn of time to the present. This publication type is often checked in conjunction with BIOGRAPHY.
A series of progressive, overlapping events, triggered by exposure of the PLATELETS to subendothelial tissue. These events include shape change, adhesiveness, aggregation, and release reactions. When carried through to completion, these events lead to the formation of a stable hemostatic plug.
Persons who experienced traumatic events during childhood.
Any situation where an animal or human is trained to respond differentially to two stimuli (e.g., approach and avoidance) under reward and punishment conditions and subsequently trained under reversed reward values (i.e., the approach which was previously rewarded is punished and vice versa).
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...
COPD (chronic obstructive pulmonary disease)
COPD (chronic obstructive pulmonary disease) is used for a number of conditions including chronic bronchitis and emphysema, which all lead to the airways in the lungs becoming damaged and thus narrower, making inhalation and exhalation harder...