Parent class: Protocol-concept
Subclasses:
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: ...as 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 |
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Generated on Mon Dec 15 11:40:40 2008