From: ExaCT: automatic extraction of clinical trial characteristics from journal publications
Element | Description |
---|---|
Eligibility criteria | logical conditions for being included in the trial, usually split into inclusion and exclusion criteria |
Sample size | the total number of participants actually enrolled (randomized) in the trial |
Start date of enrolment | date the enrolment actually started, including day, month, year or as much as presented |
End date of enrolment | date the enrolment actually ended, including day, month, year or as much as presented |
Name of experimental treatment | name of experimental intervention |
Name of control treatment | name of control intervention |
Dose | dosage of experimental/control intervention |
Frequency of treatment | frequency of administration of experimental/control intervention |
Route of treatment | route of administration of experimental/control intervention |
Duration of treatment | duration of administration of experimental/control intervention |
Primary outcome name | the outcome(s) of greatest importance, where outcome is a "component of a participant's clinical and functional status after an intervention has been applied, that is used to assess the effectiveness of an intervention" (source: Glossary of Terms in the Cochrane Collaboration) |
Primary outcome time point | point in time when a primary outcome was assessed |
Secondary outcome name | outcome(s) used to evaluate additional effects of the intervention deemed a priori as being less important than the primary outcomes (source: Glossary of Terms in the Cochrane Collaboration) |
Secondary outcome time point | point in time when a secondary outcome was assessed |
Funding organization name | name of a funding source |
Funding number | funding grant number |
Early stopping | whether the trial was stopped earlier |
Registration identifier of trial | trial registration ID, often ClinicalTrials.gov NCT number |
Author name | first and last name of the first author |
Date of publication | year the article was published |
DOI | digital object identifier for the publication |