Impact of Case Definitions on Efficacy Estimation in Clinical Trials-A Proof-of-Principle Based on Historical Examples.
case definition
clinical trial
efficacy estimation
specificity
Journal
Antibiotics (Basel, Switzerland)
ISSN: 2079-6382
Titre abrégé: Antibiotics (Basel)
Pays: Switzerland
ID NLM: 101637404
Informations de publication
Date de publication:
04 Jul 2020
04 Jul 2020
Historique:
received:
30
05
2020
revised:
24
06
2020
accepted:
01
07
2020
entrez:
9
7
2020
pubmed:
9
7
2020
medline:
9
7
2020
Statut:
epublish
Résumé
Efficacy estimations in clinical trials are based on case definitions. Commonly, they are a more or less complex set of conditions that have to be fulfilled in order to define a clinical case. In the simplest variant, such a case is identical with a single positive diagnostic test result. Frequently, however, case definitions are more complex. Further, their conditions often ignore the inherent logical structure of symptoms and disease: A symptom or a set of symptoms may be necessary but not sufficient for the unambiguous identification of a case. After describing the structure of case definitions and its impact on efficacy estimations, we exemplify this impact using data from two clinical trials dealing with the effectiveness of the vaginal application of tenofovir gel for the prevention of HIV infections and with the therapeutic effects of fecal transplantation on recurrent
Identifiants
pubmed: 32635553
pii: antibiotics9070379
doi: 10.3390/antibiotics9070379
pmc: PMC7400704
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Deutsche Forschungsgemeinschaft
ID : DFG ZA 697/6-1
Organisme : Forschungsförderungsprogramm of the Universitätsmedizin Göttingen (UMG), Germany
ID : not applicable
Organisme : Open Access Support Program of the Deutsche Forschungsgemeinschaft
ID : not applicable
Organisme : publication fund of the Georg-August-Universität Göttingen
ID : not applicable
Déclaration de conflit d'intérêts
The authors declare no conflicts of interest.
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