(Print) Use this randomly generated list as your call list when playing the game. There is no need to say the BINGO column name. Place some kind of mark (like an X, a checkmark, a dot, tally mark, etc) on each cell as you announce it, to keep track. You can also cut out each item, place them in a bag and pull words from the bag.
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State and justify any criteria for excluding any outcome data from the analysis and reporting, or report that no outcome data were excluded
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Describe who assessed the outcome (eg, nurse, parent), and any qualifications or trial-specific training necessary to administer the study instruments to assess the outcome
Important changes to methods after trial commencement (such as eligibility criteria), with reasons
Settings and locations where the data were collected
A table showing baseline demographic and clinical characteristics for each group
Describe any processes used to promote outcome data quality during data collection (eg, duplicate measurements) and after data collection (eg, range checks of outcome data values), or state where details can be found
All important harms or unintended effects in each group
Dates defining the periods of recruitment and follow-up
Eligibility criteria for participants
Provide a description of the study instruments used to assess the outcome (eg, questionnaires, laboratory tests) along with reliability, validity, and responsiveness in a population similar to the study sample
The interventions for each group with sufficient details to allow replication, including how and when they were actually administered (for specific guidance see TIDieR checklist and guide)
Describe methods to assess patterns of missingness (eg, missing not at random), and describe the methods to handle missing outcome items or entire assessments
How sample size was determined
Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory
Provide a rationale for the selection of the domain for the trial’s primary outcome
Type of randomization; details of any restriction (such as blocking and block size)
Specific objectives or hypotheses
Define and justify the target difference between treatment groups (eg, the minimal important difference)
Provide definition of outcome analysis population relating to protocol nonadherence (eg, as randomized analysis)
For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI)
Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
Describe the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, mean, proportion), and the time point for each outcome
Identify any outcomes that were not prespecified in a trial registry or protocol
Participant flow (a diagram is strongly recommended)
Methods for additional analyses, such as subgroup analyses and adjusted analyses
Describe any methods used to account for multiplicity in the analysis or interpretation of the primary and secondary outcomes (eg, coprimary outcomes, same outcome assessed at multiple time points, or subgroup analyses of one outcome)
Description of trial design (such as parallel, factorial) including allocation
Method used to generate the random allocation sequence
Statistical methods used to compare groups for primary and
secondary outcomes
