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Table 1 Target trial characteristics (information elements)

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