Class TRIAL-DESIGN

Parent class: Design-concept

Subclasses:

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
stopping-rule "Description of the stopping rule used, if any." Instance Stopping-rule 0:1  
loss-handling   STRING   0:1  
definition-of-intention-to-treat   STRING   0:1  
individual-blinding "Were individuals in a cluster randomized trial blinded to their treatment assignment and/or interim results?" Instance Blinding 0:1  
bayesian-or-classical?   SYMBOL Bayesian Classical 0:1  
nurse-blinding "Were the study nurses blinded to the subjects' assigned treatment and/or interim results?" Instance Blinding 0:1  
provider-blinding "Were care providers blinded to the subjects' assigned treatment and/or interim results?" Instance Blinding 0:1  
investigator-blinding "Were investigators blinded to subjects' assigned treatment and/or interim results? " Instance Blinding 0:1  
intervention-model   SYMBOL Parallel Cluster-randomized Crossover Factorial Single Group 0:1  
participant-blinding "Were trial subjects blinded to their treatment assignment and/or interim results? The subject is the unit of randomization." Instance Blinding 0:1  
definition-of-efficacy-analysis   STRING   0:1  
hypothesis-design   SYMBOL Superiority Non-inferiority Equivalence 0:1  
allocator-blinding "Whether the allocator was blinded to the subjects assignment, or to interim results." Instance Blinding 0:1  
efficacy-analysis? "Whether analyses were performed on the basis of actual intervention received, rather than intervention assigned. A study may have both efficacy and intention-to-treat analyses." SYMBOL Yes No Not specified 0:1  
type-of-trial-design   SYMBOL Fixed-Sample-Size Open-Sequential Closed Sequential Other 0:1  
intention-to-treat-analysis? "Whether analyses were performed on basis of participant's assigned intervention. A study may include both intention-to-treat and efficacy analyses." SYMBOL Yes No 0:1  
protocol-changes   Instance Protocol-change    
roles "Tells which class and slot will take instances of this class depending on the role of the instance. The format is (role OWNER-CLASS |owner-slot|) e.g., if this class is DATE and the instance's role is recruitment-start-date, (recruitment-start-date RECRUITMENT |start-date|) tells us that this instance of date should be the value of the slot |start-date| in an instance of class RECRUITMENT." SYMBOL   0:1  

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Generated on Mon Dec 15 11:40:40 2008