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

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