. 2021 Apr 29;11(4):e049093. doi: 10.1136/bmjopen-2021-049093

Table 1.

Consensus meeting discussions and advisory decisions for the checklist items

Section/topic	CONSORT 2010 item	CONSORT ext. item	CONSORT 2010 item	Suggested modified or additional extension items	Consensus status (Delphi)	Summary of the discussion, decisions and suggestions made during the CONSORT-ROUTINE in-person consensus meeting	Final checklist item to be included in CONSORT-ROUTINE
Title and abstract
	1a	1a	Identification as a randomised trial in the title.	Identification as a randomised trial in the title, including that it was a trial conducted using a cohort or routinely collected source of data (modified).	Not reached.	Discussed the need for a modification to the original item. It was noted that multiple databases or types of databases could be used to conduct a trial and stating all would not be feasible as journals might have title length restrictions. Decision: do not include the modification and retain the CONSORT 2010 item; expand the E&E text for clarification.	Identification as a randomised trial in the title.
	1b	1b	Structured summary of trial design, methods, results and conclusions (for specific guidance see CONSORT for abstracts).			No suggested modification. Decision: retain the CONSORT 2010 item. Note: additional item 1c was later merged with this item (see further).	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).
				The source(s) of data used to conduct the trial should be specified in the abstract (additional).	Reached for inclusion.	Noted the importance of stating the cohort or routinely collected database(s) used to conduct the trial in the abstract, if not in the title. Decision: include the suggested new item with revisions. Note: the item was later merged with item 1b from CONSORT 2010.
				If linkage between multiple sources of data was conducted for the study, this should be clearly stated in the abstract (additional).	Not reached.	Mixed views on the necessity of reporting the suggested new item in the abstract. Agreed that linkage is important to report in the body of the paper but not necessarily the abstract. Decision: do not include the suggested new item.
				The proportion of participants offered and the proportion that accepted the intervention should be reported (for trials conducted using the cohort multiple RCT design) (additional).	Reached for inclusion.	Mixed views on the necessity of reporting the suggested new item in the abstract. Agreement that the information is important to report but not essential for the abstract due to word count restrictions. In addition, this applies to one trial design used in cohorts but not all cohort trials and not trials using other types of data. The item was merged with CONSORT 2010 item 13a (14a in the final extension checklist) pertaining to participant flow. Decision: do not include the suggested new item in the abstract but include in item 14a in the final extension checklist.
Introduction
Background and objectives	2a	2a	Scientific background and explanation of rationale.			Discussed the importance of reporting the rationale for conducting the trial using a cohort or routinely collected database but decided against modifying original CONSORT 2010 item. Decision: retain the CONSORT 2010 item.	Scientific background and explanation of rationale.
Background and objectives	2b	2b	Specific objectives or hypotheses			No suggested modification. Decision: retain the CONSORT 2010 item.	Specific objectives or hypotheses.
Methods
Trial design	3a	3a	Description of trial design (such as parallel, factorial) including allocation ratio.	Description of trial design (such as parallel and factorial) including allocation ratio, the source(s) of data used to conduct the trial (such as cohort and registry) and how the data are used within the trial (such as identification of eligible trial participants, trial outcomes) (modified).		Noted that key elements of the study design and cohort or database(s) used for the trial should be stated early in the methods section, as well as the extent to which the database was used in the trial. Decision: include the modified item.	Description of trial design (such as parallel and factorial) including allocation ratio, that a cohort or routinely collected database(s) used to conduct the trial (such as electronic health record and registry) and how the data were used within the trial (such as identification of eligible trial participants and trial outcomes).
Trial design	3b	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons.			No suggested modification. Decision: retain the CONSORT 2010 item.	Important changes to methods after trial commencement (such as eligibility criteria), with reasons.
Cohort or routinely collected database (additional header)		ROUTINE-1		Description of the source(s) of data used to conduct the trial, including the setting, locations, relevant dates, periods of recruitment, follow-up and data collection (additional).	Reached for inclusion	Agreed on the importance of reporting the item. Decision: include the suggested new item.	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).
				Describe indicators of the quality of the source(s) of data used to conduct the trial including what types of quality checks have been performed and the entity responsible for the data (additional).	Reached for inclusion.	Mixed views on the necessity of the suggested new item. There were concerns that ‘quality’ is vague and the term ‘accuracy and completeness’ may better clarify the intent of the item. It was acknowledged that the accuracy and completeness of the cohort or database is important to report while (1) selecting participants and (2) ascertaining outcomes. Decision: do not include the suggested new item as a standalone item. The item was merged with extension items 5a and 7b (pertaining to participant selection and outcome ascertainment) in the finalised checklist.
				Describe modifications to the data collected in the source(s) of data used to conduct the trial, such as adding data items, if applicable (additional).	Reached for inclusion	Agreed that the suggested item is not necessarily unique to trials conducted using cohorts and routinely collected data. Decision: do not include the suggested new item; expand the E&E text for clarification.
				Describe additional sources of data used to conduct the trial, if any (additional).	Reached for inclusion.	Mixed views on the necessity of the suggested new item as it is not unique to trials conducted using cohorts and routinely collected data. Decision: do not include the suggested new item; expand the E&E text for clarification.
		ROUTINE-2		Give the eligibility criteria, the sources and methods of selection of participants, and methods of follow-up (for trials conducted using cohorts or registries) (additional).	Reached for inclusion	Discussed the importance of reporting the eligibility criteria for inclusion in the cohort or routinely collected database(s), but there was concern that elements related to follow-up are not specific to trials conducted using cohorts and routinely collected data. Decision: include the suggested new item with revisions; expand the E&E text for clarification of other aspects.	Eligibility criteria for participants in the cohort or routinely collected database(s).
		ROUTINE-3		Detail any use of record linkage across sources of data, the methods of linkage and methods of quality evaluation, if applicable (additional).	Reached for inclusion.	Suggestion to integrate wording from RECORD checklist for clarity. Decision: include the suggested new item adapted from RECORD.	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.
				Describe if (and how) participants were informed about the potential use of their data in randomised trials (additional).	Not reached	Mixed views on the necessity of the item as some believed that ethics considerations are beyond the scope of CONSORT, and ethics does not appear in CONSORT 2010. The group agreed to include the item as consent is an important issue with unique aspects in these trials, but that this should be presented as part of trial participants section. Decision: include the suggested new item with revisions and move to section ‘Trial participants’ as item 5c.
Trial participants (modified header)	4a	4a	Eligibility criteria for participants.	Eligibility criteria for trial participants (modified).		Agreed to merge with suggested new item (see next row). Decision: merge with suggested new item, ‘Provide details of how eligible clusters/participants were identified from the source(s) of data used to conduct the trial’.	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.
				Provide details of how eligible clusters/participants were identified from the source(s) of data used to conduct the trial (additional).	Reached for inclusion.	Suggested merging with CONSORT 2010 item 4a (5a in final checklist) and address accuracy and completeness of data. Decision: merge the suggested new item with CONOSRT 2010 item 4a (5a in the final checklist).
	4b	4b	Settings and locations where the data were collected.	Settings and locations where the trial data were collected (modified).	Reached for inclusion.	The word ‘trial’ was dropped as the header ‘Trial participants’ clarifies the intent of the item. Decision: retain the CONSORT 2010 item; expand the E&E text for clarification.	Settings and locations where the data were collected.
		ROUTINE-4		Details of information provided to participants from the source(s) of data who are selected for recruitment or inclusion in the trial, including any differences in information provided across trial arms (additional).	Not reached.	Extended discussions on the importance of the item as it might only be applicable to the controlled multiple RCT design. Agreement to formulate as a general item on consent as item 5 c. Decision: do not include the suggested new item. The consent item was simplified and moved to this section. Expand the E&E text for clarification of consent issues.	Describe whether and how consent was obtained.
Interventions	5	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered.			No suggested modification. Decision: retain the CONSORT 2010 item; expand the E&E text for clarification.	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered.
				Describe how the source(s) of data was used to implement the intervention, if applicable (eg, for trials conducted using electronic health records) (additional).	Reached for inclusion.	Debated the necessity of the new item as it is only applicable to trials conducted using electronic health records that may be used as intervention tools. Decision: do not include the suggested new item; expand the E&E text for clarification.
Outcomes	6a	6a	Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed.			Suggestion to merge with proposed new item, ‘Provide source(s) of data for each outcome’ (see below). Decision: item merged with suggested new item and included in the final checklist.	Completely defined prespecified 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.
				Provide source(s) of data for each outcome (additional).	Reached for inclusion.	Suggestion to merge with CONSORT 2010 item 6a. Decision: item merged with CONSORT 2010 item 6a (7a in the final checklist).
		ROUTINE-5		Provide a list of codes and algorithms used to define (and/or derive) the outcomes as online supplemental information, including validation, if applicable (additional).	Not reached.	Acknowledged the importance of reporting the list of codes and algorithms for ascertaining outcomes along with the accuracy and completeness of data and validation. Decision: include the suggested new item with revisions.	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.
				Detail any adjudication or external validation of data items from the source(s) of data used to conduct the trial, if applicable (additional).	Reached for inclusion.	Acknowledged the importance of reporting the item. There was agreement that validation should be reported while selecting participants and ascertaining outcomes and included as part of items 5a and 7b of extension checklist. Decision: address elements of proposed item as part of items 5a and 7b in the final checklist.
	6b	6b	Any changes to trial outcomes after the trial commenced, with reasons.			No suggested modification. Decision: retain the CONSORT 2010 item.	Any changes to trial outcomes after the trial commenced, with reasons.
Sample size	7a	7a	How sample size was determined.			No suggested modification. Decision: retain the CONSORT 2010 item.	How sample size was determined.
Sample size	7b	7b	When applicable, explanation of any interim analyses and stopping guidelines.			No suggested modification. Decision: retain the CONSORT 2010 item.	When applicable, explanation of any interim analyses and stopping guidelines.
Randomisation
Sequence generation	8a	8a	Method used to generate the random allocation sequence.			No suggested modification. Decision: retain the CONSORT 2010 item; expand the E&E text for clarification.	Method used to generate the random allocation sequence.
Sequence generation	8b	8b	Type of randomisation; details of any restriction (such as blocking and block size).			No suggested modification. Decision: retain the CONSORT 2010 item.	Type of randomisation; details of any restriction (such as blocking and block size).
Allocation concealment mechanism	9	9	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.	Mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned, such as using automated random sequence generation concealed within source(s) of data (modified).	Reached for inclusion.	Discussion to clarify wording of the item. Decision: include the modified item with revisions.	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	10	Who generated the random allocation sequence, who enrolled participants and who assigned participants to interventions.			No suggested modification. Decision: retain the CONSORT 2010 item.	Who generated the random allocation sequence, who enrolled participants and who assigned participants to interventions.
Blinding	11a	11a	If done, who was blinded after assignment to interventions (eg, participants, care providers, those assessing outcomes) and how.			No suggested modification. Decision: retain the CONSORT 2010 item.	If done, who was blinded after assignment to interventions (eg, participants, care providers, those assessing outcomes) and how.
Blinding	11b	11b	If relevant, description of the similarity of interventions.			No suggested modification. Decision: retain the CONSORT 2010 item.	If relevant, description of the similarity of interventions.
Statistical methods	12a	12a	Statistical methods used to compare groups for primary and secondary outcomes.			No suggested modification. Decision: retain the CONSORT 2010 item.	Statistical methods used to compare groups for primary and secondary outcomes.
Statistical methods	12b	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses.			No suggested modification. Decision: retain the CONSORT 2010 item.	Methods for additional analyses, such as subgroup analyses and adjusted analyses.
Results
Participant flow (a diagram is strongly recommended)	13a	13a	For each group, the numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome.	Describe in detail the numbers of clusters/participants in the source(s) of data used to conduct the trial, number screened for eligibility, randomly assigned, offered and accepted interventions (eg, cohort multiple RCTs), received intended treatment and analysed for the primary outcome (modified).	Reached for inclusion.	Suggestion to form a committee to draft example flow diagram and oversee the E&E. Decision: include the modified item; committee to oversee the E&E development.	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.
				Describe any linkage of multiple sources of data, including the number of clusters/participants successfully linked (additional).	Reached for inclusion.	Debated the necessity of the item as a stand-alone item as linkage was addressed in item 4c. Suggested to include the number of clusters/participants successfully linked as part of the flow diagram. Decision: do not include the suggested new item; expand the E&E text for clarification.
	13b	13b	For each group, losses and exclusions after randomisation, together with reasons.			No suggested modification. Discussed that the item should be tied to data accuracy and completeness, and linkage. Decision: retain the CONSORT 2010 item; expand the E&E text for clarification.	For each group, losses and exclusions after randomisation, together with reasons.
Recruitment	14a	14a	Dates defining the periods of recruitment and follow-up.			No suggested modification. Decision: retain the CONSORT 2010 item.	Dates defining the periods of recruitment and follow-up.
Recruitment	14b	14b	Why the trial ended or was stopped.			No suggested modification. Decision: retain the CONSORT 2010 item.	Why the trial ended or was stopped.
Baseline data	15	15	A table showing baseline demographic and clinical characteristics for each group.			No suggested modification. Decision: retain the CONSORT 2010 item.	A table showing baseline demographic and clinical characteristics for each group.
				A table showing baseline demographic and clinical characteristics for eligible participants who participated in the trial and those who did not (additional).	Reached for inclusion.	Agreement to not include the suggested new item as a stand-alone item. The information should be reported if possible, but not necessary, and implications should be addressed as part of ‘Generalisability’ (item 21). Decision: do not include the suggested new item.
Numbers analysed	16	16	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups.			No suggested modification. Decision: retain the CONSORT 2010 item.	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups.
Outcomes and estimation	17a	17a	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI).			No suggested modification. Decision: retain the CONSORT 2010 item.	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI).
	17b	17b	For binary outcomes, presentation of both absolute and relative effect sizes is recommended.			No suggested modification. Decision: retain the CONSORT 2010 item.	For binary outcomes, presentation of both absolute and relative effect sizes is recommended.
Ancillary analyses	18	18	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory.			No suggested modification. Decision: retain the CONSORT 2010 item.	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory.
				If outcomes for eligible patients in the existing source(s) of data who were not included in the trial are known, they should be reported (additional).	Not reached.	Agreement to not include the suggested new item as a stand-alone item. The information should be reported if possible, but not necessary, and implications should be addressed as part of ‘Generalisability’. Decision: do not include the suggested new item; expand the E&E text for clarification in the ‘Generalisability’ section.
Harms	19	19	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms).			No suggested modification. Decision: retain the CONSORT 2010 item.	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms).
Discussion
Limitations	20	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.			No suggested modification. Decision: retain the CONSORT 2010 item.	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.
				Discuss the implications of using data that were not created or collected to answer the specific research question(s) (additional).	Reached for inclusion.	Discussed that using routinely collected data is not necessarily a limitation, and the content of this item should be addressed in the ‘Interpretation’ section. Decision: do not include the suggested new item; merge with CONSORT 2010 item 22 (23 in the final checklist); expand the E&E text for clarification in the ‘Generalisability’ section.
Generalisability	21	21	Generalisability (external validity and applicability) of the trial findings.			No suggested modification. Agreement to elaborate on the representativeness of the cohort or routinely collected database(s) used for the trial, including issues related to characteristics of eligible cohort or database participants who do not agree to participate in trial. Decision: retain the CONSORT 2010 item; expand the E&E text for clarification.	Generalisability (external validity and applicability) of the trial findings.
Interpretation	22	22	Interpretation consistent with results, balancing benefits and harms and considering other relevant evidence.			Item merged with the proposed new item ‘Discuss the implications of using data that were not created or collected to answer the specific research question(s)’. Decision: include the modified item.	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	23	Registration number and name of trial registry.			No suggested modification. Decision: retain the CONSORT 2010 item.	Registration number and name of trial registry.
Protocol	24	24	Where the full trial protocol can be accessed, if available.			No suggested modification. Decision: retain the CONSORT 2010 item; expand the E&E text for clarification.	Where the full trial protocol can be accessed, if available.
Funding	25	25	Sources of funding and other support (such as supply of drugs), role of funders.	Sources of funding and other support for the trial and the existing source(s) of data, role of funders (modified).	Reached for inclusion.	Suggested minor revision to the item. Decision: include the modified item with revision.	Sources of funding and other support for both the trial and the cohort or routinely collected database(s), role of funders

CONSORT, Consolidated Standards of Reporting Trials; E&E, Explanation & Elaboration; RCT, randomised controlled trial; ROUTINE, Extension for Trials Conducted Using Cohorts and Routinely Collected Data.