Additional File 5. Data Extraction Items

Additional file 5. Data extraction items Domain Extraction Item Entry type Options Analyzed? Design Inclusion criteria Free text -- Yes Design Exclusion criteria Free text -- Yes Design Funding source Check boxes  Government Yes with free  Industry text option (multiple  Academic or choice Hospital allowed)  Foundation etc.  Named entity of an unclear category (free text for name)  No funding (explicitly stated)  Not reported Design No. centers Radio  Single center Yes buttons with  Multicenter (how free text many centers? option (single  Not answer reported/unclear allowed) Design Followup duration (maximum or Free text -- Yes mean) Design Randomization technique Radio  Yes Yes reported? buttons  No Design Allocation concealment method Radio  Yes Yes reported? buttons  No Design Intention-to-treat analysis reported Radio  Yes Yes for any outcome (either in methods buttons  No or results sections) Design Power calculation reported for any Radio  Yes Yes outcome buttons  No Design Subject blinding explicitly reported Radio  Yes Yes (for any outcome) buttons  No Design Caregiver blinding explicitly Radio  Yes Yes reported (for any outcome) buttons  No Design Outcome assessor blinding Radio  Yes Yes explicitly reported (for any buttons  No outcome) Design Double blinded(for any outcome) Radio  Yes Yes buttons  No Design Single blinded(for any outcome) Radio  Yes Yes buttons  No

1 Domain Extraction Item Entry type Options Analyzed? Design Select all outcomes reported from Check boxes  Different Yes a given list of about 12 outcomes (multiple outcomes for choices each language allowed) culled from the articles  None of these outcomes found Intervention / Study arm title Free text -- No Comparator Intervention / Study arm description Free text -- No (inadequate Comparator nonredundant data were extracted) Intervention / Dose (individually for each Free text -- Yes (for 1 or 2 Comparator outcome) preselected outcomes only) Intervention / Frequency (individually for each Free text -- Yes (for 1 or 2 Comparator outcome) preselected outcomes only) Intervention / Route (individually for each Free text -- Yes (for 1 or 2 Comparator outcome) preselected outcomes only) Intervention / Duration (individually for each Free text -- Yes (for 1 or 2 Comparator outcome) preselected outcomes only) Intervention / No. randomized into each study Free text -- Yes (for 1 or 2 Comparator arm (for all interventions) preselected outcomes only) Outcome Outcome title Free text -- No (1 preselected continuous and/or 1 preselected categorical outcome) Outcome Outcome units Free text -- No (inadequate meaningful data were extracted) Outcome Outcome description Free text -- Yes Results Continuous: No. analyzed (per Free text -- Yes intervention) Results Continuous: Mean or median Free text “Mean” or “Median” Yes reported†† (not the value) Results Continuous: Net difference (or Free text (calculate if Yes difference between final) necessary) Results Continuous: Standard error of net Free text (calculate if Yes difference necessary) Results Categorical: No. analyzed (per Free text -- Yes intervention)

2 Domain Extraction Item Entry type Options Analyzed? Results Categorical: No. events (counts) Free text -- Yes (combined with reported odds ratio and confidence interval) Results Categorical: Odds ratio and 95% Free text (calculate if Only if there were confidence interval necessary) no counts data (only reported data; calculations not analyzed) Results Both: Reported P value of Free text -- Yes difference or odds ratio Results Both: What analysis adjusted for Free text -- No (insufficient data) Study Quality What is the risk of selection bias Pull down  Low Yes (biased allocation to interventions) menu  Unclear due to inadequate generation of a randomized sequence?  High Study Quality What is the risk of selection bias Pull down  Low Yes (biased allocation to interventions) menu  Unclear due to inadequate concealment of allocations before assignment?  High Study Quality For the preselected categorical Pull down  Low Yes outcome (or continuous outcome if menu  Unclear there is no categorical outcome), what is the risk of performance bias  High due to knowledge of the allocated interventions by participants and personnel during the study (lack of study participant and personnel blinding)? Study Quality For the preselected categorical Pull down  Low Yes outcome (or continuous outcome if menu  Unclear there is no categorical outcome), what is the risk of detection bias  High due to knowledge of the allocated interventions by outcome assessment (lack of outcome assessor blinding)? Study Quality For the preselected categorical Pull down  Low Yes outcome (or continuous outcome if menu  Unclear there is no categorical outcome), what is the risk of attrition bias due  High to amount, nature, or handling of incomplete outcome data? Miscellaneous For TRANSLATED articles: How Free text  <5 minutes extra Yes much additional time do you time estimate the extraction of the  6-30 min extra translated article took compared to time an extraction of a similar English article?  >30 min extra time

3 Domain Extraction Item Entry type Options Analyzed? Miscellaneous For TRANSLATED articles: How Free text  I have little Yes confident are you in the accuracy confidence and completeness of the  I have a moderate translation of the original article? confidence *  I have strong confidence Miscellaneous For TRANSLATED articles: Please Free text -- C provide examples of poor translations that made extraction difficult