Understanding why restrictive trial eligibility criteria are inappropriate.
Explanatory trials
Iatrogenic morbidity
Pragmatic trials
Randomized trials
Selection criteria
Trial methodology
Journal
Neuro-Chirurgie
ISSN: 1773-0619
Titre abrégé: Neurochirurgie
Pays: France
ID NLM: 0401057
Informations de publication
Date de publication:
07 Sep 2024
07 Sep 2024
Historique:
received:
07
08
2024
accepted:
03
09
2024
medline:
8
9
2024
pubmed:
8
9
2024
entrez:
8
9
2024
Statut:
aheadofprint
Résumé
An important difference between explanatory and pragmatic clinical trials concerns eligibility criteria. Eligibility criteria are restrictive in explanatory trials, while pragmatic trials are more inclusive or even all-inclusive. To better understand the diverging views regarding eligibility criteria, we examine the contrast between theoretical and clinical medicine, and 3 different research contexts: laboratory research, population studies and clinical trials. In each context we review the purpose for selecting study subjects or research material, as well as the type of inductive inference or generalization that is sought by such selection. In each context, selection concerns different things and serves different purposes: In the laboratory, selection concerns the homogenous research material that will help isolate a causal signal. In the epidemiological context selection concerns the (random) sampling method, designed to produce a representative sample of the population. In the clinical trial setting, selection concerns patients in need of care. Restrictive eligibility criteria become inappropriate in the care setting because the aim of the trial is not to represent a population nor to isolate a causal signal, but to find out which patients benefit from treatment. The idea of selecting patients comes from methods that belong to theoretical medicine. In the care setting, most clinical trials should be pragmatic and as inclusive as possible.
Sections du résumé
BACKGROUND
BACKGROUND
An important difference between explanatory and pragmatic clinical trials concerns eligibility criteria. Eligibility criteria are restrictive in explanatory trials, while pragmatic trials are more inclusive or even all-inclusive.
METHODS
METHODS
To better understand the diverging views regarding eligibility criteria, we examine the contrast between theoretical and clinical medicine, and 3 different research contexts: laboratory research, population studies and clinical trials. In each context we review the purpose for selecting study subjects or research material, as well as the type of inductive inference or generalization that is sought by such selection.
RESULTS
RESULTS
In each context, selection concerns different things and serves different purposes: In the laboratory, selection concerns the homogenous research material that will help isolate a causal signal. In the epidemiological context selection concerns the (random) sampling method, designed to produce a representative sample of the population. In the clinical trial setting, selection concerns patients in need of care. Restrictive eligibility criteria become inappropriate in the care setting because the aim of the trial is not to represent a population nor to isolate a causal signal, but to find out which patients benefit from treatment.
CONCLUSION
CONCLUSIONS
The idea of selecting patients comes from methods that belong to theoretical medicine. In the care setting, most clinical trials should be pragmatic and as inclusive as possible.
Identifiants
pubmed: 39244816
pii: S0028-3770(24)00060-2
doi: 10.1016/j.neuchi.2024.101589
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
101589Informations de copyright
Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.