Parent class: Protocol-concept


Documentation: "The process of assigning participants to interventions, also called treatment allocation."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
blocking-size "Whether the block sizes were variable (as preferred) or fixed." SYMBOL Variable Fixed 0:1  
method-of-assignment-notification "How assignment is communicated to the study staff" SYMBOL Via phone Via schedule Via self administered schedule Via on site computer Via envelope Direct to patient Other 0:1  
matching-description "If matched randomization was used, description of the matching applied." STRING   0:1  
unit-of-randomization "The entity that is subjected to randomization and then treatment allocation." SYMBOL Participant Provider Participant-Group Provider-Group Site Site-Group Other 0:1  
stratification-variables "Variable(s) that is/are controlled for stratified randomization, ie when participants are assigned to interventions in such a way as to ensure that participants with this variable have the same distribution in all intervention groups." STRING   0:1  
matched-randomization? "Was matched randomization used?" SYMBOL Yes No 0:1  
blocking-description   STRING   0:1  
type-of-adaptive-randomization   SYMBOL None Baseline Outcome Number Other 0:1  
type-of-tx-assignment   SYMBOL Randomized Sequential Convenience Cluster Randomized Other 0:1  
allocation-ratio   SYMBOL Uniform Non-uniform 0:1  
comments   STRING   0:1  
sequence-generation   STRING   0:1  
blocked-randomization?   SYMBOL Yes No 0:1  
description-of-adaptive-randomization "Number adaptive: assignment probabilities are modified as a function of observed departures from the desired allocation ratio. e.g., biased coin procedure. Baseline adaptive: assignment probabilities are modified as a function of differences in the observed distribution of baseline characteristics among the intervention groups. Outcome adaptive: a function of observed outcomes in the treatment groups . e.g., Zelen's procedure (Meinert, p. 91)" STRING   0:1  
assignment-masking-method   STRING   0:1  
rationale-for-stratification   STRING   0:1  
cochrane-score   SYMBOL Adequate Inadequate Unclear 0:1  
masked-assignment? "Whether the person assigning the participant to the intervention is masked to what the participant's assignment is." SYMBOL Yes No Unclear 0:1  
delay-enrollment-to-rand   STRING   0:1  
assignment-method   STRING   0:1  
stratified-randomization?   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  

Return to index

Generated on Mon Dec 15 11:40:40 2008