Table 2.

Combined CONSORT 2010 and CONSORT-ROUTINE checklist

Section/topic	Item No	CONSORT extension for trials conducted using cohorts or routinely collected data item	Reported on page No
Title and abstract
	1a	Identification as a randomised trial in the title
	1b	Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts). Specify that a cohort or routinely collected data were used to conduct the trial and, if applicable, provide the name of the cohort or routinely collected database(s)
Introduction
Background and objectives	2a	Scientific background and explanation of rationale
	2b	Specific objectives or hypotheses
Methods
Trial design	3a	Description of trial design (such as parallel, factorial) including allocation ratio, that a cohort or routinely collected database(s) was used to conduct the trial (such as electronic health record, registry) and how the data were used within the trial (such as identification of eligible trial participants, trial outcomes)
	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons
Cohort or routinely collected database	ROUTINE-1	Name, if applicable, and description of the cohort or routinely collected database(s) used to conduct the trial, including information on the setting (such as primary care), locations, and dates (such as periods of recruitment, follow-up, and data collection)
	ROUTINE-2	Eligibility criteria for participants in the cohort or routinely collected database(s)
	ROUTINE-3	State whether the study included person-level, institutional-level, or other data linkage across two or more databases and, if so, linkage techniques and methods used to evaluate completeness and accuracy of linkage
Trial participants	4a	Eligibility criteria for trial participants, including information on how to access the list of codes and algorithms used to identify eligible participants, information on accuracy and completeness of data used to ascertain eligibility, and methods used to validate accuracy and completeness (eg, monitoring, adjudication), if applicable
	4b	Settings and locations where the data were collected
	ROUTINE-4	Describe whether and how consent was obtained
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
Outcomes	6a	Completely defined pre-specified primary and secondary outcome measures, including how and when they were ascertained and the cohort or routinely collected database(s) used to ascertain each outcome
	ROUTINE-5	Information on how to access the list of codes and algorithms used to define or derive the outcomes from the cohort or routinely collected database(s) used to conduct the trial, information on accuracy and completeness of outcome variables, and methods used to validate accuracy and completeness (eg, monitoring, adjudication), if applicable
	6b	Any changes to trial outcomes after the trial commenced, with reasons
Sample size	7a	How sample size was determined
	7b	When applicable, explanation of any interim analyses and stopping guidelines
Sequence generation	8a	Method used to generate the random allocation sequence
	8b	Type of randomisation; details of any restriction (such as blocking and block size)
Allocation concealment mechanism	9	Mechanism used to implement the random allocation sequence (such as embedding an automated randomiser within the cohort or routinely collected database(s)), describing any steps taken to conceal the sequence until interventions were assigned
Implementation	10	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Blinding	11a	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
	11b	If relevant, description of the similarity of interventions
Statistical methods	12a	Statistical methods used to compare groups for primary and secondary outcomes
	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses
Results
Participant flow (a diagram is strongly recommended)	13a	For each group, the number of participants in the cohort or routinely collected database(s) used to conduct the trial and the numbers screened for eligibility, randomly assigned, offered and accepted interventions (eg, cohort multiple RCTs), received intended treatment, and analysed for the primary outcome
	13b	For each group, losses and exclusions after randomisation, together with reasons
Recruitment	14a	Dates defining the periods of recruitment and follow-up
	14b	Why the trial ended or was stopped
Baseline data	15	A table showing baseline demographic and clinical characteristics for each group
Numbers analysed	16	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups
Outcomes and estimation	17a	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
	17b	For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Ancillary analyses	18	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Harms	19	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
Discussion
Limitations	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalisability	21	Generalisability (external validity, applicability) of the trial findings
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence, including the implications of using data that were not collected to answer the trial research questions
Other information
Registration	23	Registration number and name of trial registry
Protocol	24	Where the full trial protocol can be accessed, if available
Funding	25	Sources of funding and other support for both the trial and the cohort or routinely collected database(s), role of funders

RCT=randomised controlled trial.

This checklist is also presented separately in web table 1.