Parent class: Design-concept
Subclasses:
| Template Slots | |||||
| Slot name | Documentation | Type | Allowed Values/Classes | Cardinality | Default |
| justification-for-one-tailed-test | "If the statistical test is one-tailed, it's use must be explained." | STRING | 0:1 | ||
| margin-of-equivalence | "The margin of equivalence defined for an equivalence or non-inferiority trial." | STRING | 0:1 | ||
| alpha-tails | "also called 'sides'" | SYMBOL | One-tailed Two-tailed | 0:1 | |
| threshold-rate-rationale | STRING | 0:1 | |||
| upper-ci | FLOAT | 0:1 | |||
| estimated-icc | "Estimated intracluster correlation coefficient" | FLOAT | 0:1 | ||
| threshold-exp-group-outcome | STRING | 0:1 | |||
| sample-size-calculation-method | STRING | 0:1 | |||
| comments | STRING | 0:1 | |||
| lower-ci | FLOAT | 0:1 | |||
| confidence-interval-percent | SYMBOL | 90% c.i. 95% c.i. 99% c.i. | 0:1 | ||
| assumptions-underlying-target-enrollment | "Describe assumptions that impact on target enrollment versus sample size. e.g., assumptions on proportion of eligible subjects who will agree, number who will stay in study, etc." | STRING | 0:1 | ||
| alpha-value | "Acceptable probaliity of a false positive for rejecting the null hypothesis. Often 0.05." | FLOAT | 0:1 | ||
| power | "1-the probability of a false negative. Is 1-beta, is a real number between 0 and 1, often 0.80." | FLOAT | 0:1 | ||
| base-rate-rationale | STRING | 0:1 | |||
| baseline-comparison-group-outcome | STRING | 0:1 | |||
| target-sample-size | INTEGER | 0:1 | |||
| referent-outcome | "The outcome on which the sample size requirements for this study were calculated." | Instance | Primary-outcome | 0:1 | |
| estimated-min-cluster-size | "Estimated minimum cluster size" | INTEGER | 0:1 | ||
| target-enrollment | INTEGER | 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