Ocelot TRIAL-DESIGN Class Documentation

Class TRIAL-DESIGN

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

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