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Table 2 Data elements by tab in each abstraction form used in the trial

From: Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial

Tab Data element
Design Study eligibility criteria
Number of study centers
Region of study participant recruitment
Start year of study participant recruitment
End year of study participant recruitment
End year of randomized study participant follow-up
Length of planned (or stated) randomized study participant follow-up
Report of a study sample size/power calculation
Report of conduct of an intention-to-treat analysis
Presence of a participant flow diagram in the article
Study method to generate the random sequence
Risk of bias related to random sequence generation
Study method to conceal the random allocation sequence
Risk of bias related to concealment of the random allocation sequence
Masking (or blinding) of study participants to treatment assigned
Masking (or blinding) of healthcare providers to treatment assigned
Masking (or blinding) of outcome assessors to treatment assigned
Report of “single,” “double,” or “triple” masking without clarification
Report of absence of any masking during the study
Sources of monetary or material support for the study
Financial relationships for any author of the study article
Total number of randomized study arms (or groups)
Number of study participants randomized, by group (or arm)
Number of study participants followed up, by group (or arm)
Whether reasons to follow up were similar between the groups (or arms)
How much time the abstractor spent abstracting data for the Design Tab
Baseline Sample size at baseline, by group (or arm)
Age at baseline, by group (arm)
Sex at baseline, by group (arm)
Other baseline characteristics as appropriate (e.g., body mass index), by group (arm)
Outcomes Each outcome from a pre-defined list of outcomes with time-points specific to articles from each review
Results For each dichotomous outcome at the relevant time-point:
 Number of participants analyzed, by group (arm)
 Number of participants with the outcome, by group (arm)
 Percentage of participants with the outcome, by group (arm)
 Measure of association (e.g., relative risk, odds ratio), by between arm comparison
 95% CI for the measure of association, by between arm comparison
P-value for the measure of association, by between arm comparison
For each continuous outcome at the relevant time-point:
 Number of participants analyzed, by group (arm)
 Mean of outcome, by group (arm)
 Standard deviation of outcome, by group (arm)
 Mean difference, by between arm comparison
 95% CI for the mean difference, by between arm comparison
P value for the mean difference, by between arm comparison