Table 2.

Checklist of CONSORT items and the non-pharmacological trials extension to CONSORT (with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) extending CONSORT item 5 for acupuncture trials)

Section/topic	Item number	CONSORT 2010 statement* – checklist item10 Describe	Additional items from the non-pharmacological trials extension to CONSORT14 Add
Title and abstract	1a	Identification as a randomised trial in the title	In the abstract, description of the experimental treatment, comparator, care providers, centres and blinding status
	1b	Structured summary of trial design, methods, results and conclusions; for specific guidance, see CONSORT for abstracts58,59
Introduction
Background and objectives	2a	Scientific background and explanation of rationale	–
	2b	Specific objectives or hypotheses
Methods
Trial design	3a	Description of trial design (eg, parallel, factorial) including allocation ratio
	3b	Important changes to methods after trial commencement (eg, eligibility criteria), with reasons
Participants	4a	Eligibility criteria for participants	When applicable, eligibility criteria for centres and those performing the interventions
	4b	Settings and locations where the data were collected
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	Precise details of both the experimental treatment and comparator–see table 1 above for details
Outcomes	6a	Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed	–
	6b	Any changes to trial outcomes after the trial started with reasons
Sample size	7a	How sample size was determined	When applicable, details of whether and how
	7b	When applicable, explanation of any interim analyses and stopping guidelines	the clustering by care providers or centres was addressed
Randomisation
Sequence generation	8a	Method used to generate the random allocation sequence	When applicable, how care providers were
	8b	Type of randomisation; details of any restriction (eg, blocking and block size)	allocated to each trial group
Allocation concealment	9	Mechanism used to implement the random allocation sequence (eg, sequentially numbered containers), 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 (eg, participants, care providers, those assessing outcomes) and how	Whether or not those administering co-interventions were blinded to group assignment
	11b	If relevant, description of the similarity of interventions	If blinded, method of blinding and description of the similarity of interventions
Statistical methods	12a	Statistical methods used to compare groups for primary and secondary outcomes	When applicable, details of whether and how the clustering by care providers or centres was addressed
	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 numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome	The number of care providers or centres performing the intervention in each group and the number of patients treated by each care provider or in each centre
	13b	For each group, losses and exclusions after randomisation, together with reasons
Implementation of intervention	–	–	Details of the experimental treatment and comparator as they were implemented
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	When applicable, a description of care providers (case volume, qualification, expertise, etc) and centres (volume) in 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 (eg, 95% CI)	–
	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 prespecified from exploratory	–
Harms	19	All important harms or unintended effects in each group; for specific guidance see CONSORT for Harms60	–
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	Generalisability (external validity) of the trial findings according to the intervention, comparators, patients and care providers and centres involved in the trial
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	In addition, take into account the choice of the comparator, lack of or partial blinding, unequal expertise of care providers or centres in each group
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 (eg, supply of drugs); role of funders

^*We strongly recommend reading this statement in conjunction with the CONSORT 2010 explanation and elaboration¹¹ for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials,⁶¹ non-inferiority and equivalence trials,⁶² herbal interventions,⁶³ and pragmatic trials.¹⁶ Moreover, additional extensions are forthcoming. See http://www.consort-statement.org (accessed April 2010), for those and also for up-to-date references relevant to this checklist.