Table 7.

Compliance with Items of the CONSORT 2010 Checklist

CONSORT item		Pharmacological n = 82	NPI n = 35
1a	Identification as a randomised trial in the title	65 (79.3%)	34 (97. 1%)
1b	Structured summary of trial design, methods, results, and conclusions	56 (68.3%)	19 (54.3%)
2a	Scientific background and explanation of rationale	82 (100.0%)	35 (100.0%)
2b	Specific objectives or hypotheses	80 (97.6%)	34 (97. 1%)
3a	Description of trial design (such as parallel, factorial) including allocation ratio	48 (58.5%)	23 (65.7%)
3b*	Important changes to methods after trial commencement (such as eligibility criteria), with reasons	-	-
4a	Eligibility criteria for participants	81 (98.8%)	34 (97. 1%)
4b	Settings and locations where the data were collected	55 (67.1%)	31 (88.6%)
5	The interventions for each group with sufficient details to allow replication	77 (93.9%)	33 (94.3%)
5A**	Description of the components of the interventions and, if applicable, the procedure for individualizing treatment	N/A	25 (71.4%)
5B**	Details of how the interventions were standardized	N/A	28 (80.0%)
5C**	Details of how the adherence of care provers with the protocol was assessed or enhanced	N/A	3 (8.6%)
6a	Completely defined pre-specified primary and secondary outcome measures	71 (86.6%)	28 (80.0%)
6b*	Any changes to trial outcomes after the trial commenced, with reasons	-	-
7a	How sample size was determined	52 (63.4%)	25 (71.4%)
7b*	When applicable, explanation of any interim analyses and stopping guidelines	-	-
8a	Method used to generate the random allocation sequence	43 (52.4%)	26 (74.3%)
8b	Type of randomization; details of any restriction (such as blocking and block size)	21 (25.6%)	12 (34.3%)
9	Mechanism used to implement the random allocation sequence	29 (35.4%)	18 (51.4%)
10	Who generated the random allocation sequence, enrolled participants, and assigned participants to interventions	23 (28.0%)	13 (37. 1%)
11a	If done, who was blinded after assignment to interventions and how	30 (36.6%)	14 (40.0%)
11b*	If relevant, description of the similarity of interventions	-	-
12a	Statistical methods used to compare groups for primary and secondary outcomes	80 (97.6%)	34 (97. 1%)
12b*	Methods for additional analyses, such as subgroup analyses and adjusted analyses	-	-
13a	The numbers of participants who were randomised, received treatment, and analysed for the primary outcome	76 (92.7%)	32 (91.4%)
13b	For each group, losses and exclusions after randomisation, together with reasons	62 (75.6%)	21 (60.0%)
14a	Dates defining the periods of recruitment and follow-up	35 (42.7%)	18 (51.4%)
14b*	Why the trial ended or was stopped	-	-
15	A table showing baseline demographic and clinical characteristics for each group	70 (85.4%)	24 (68.6%)
16	For each group, number of participants analyzed and whether the analysis was by original assigned groups	69 (84. 1%)	30 (85.7%)
17a	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision	64 (78.0%)	27 (77. 1%)
17b	For binary outcomes, presentation of both absolute and relative effect sizes is recommended	28 (34. 1%)	14 (40.0%)
18*	Results of any other analyses performed, including subgroup analyses and adjusted analyses	-	-
19	All important harms or unintended effects in each group	61 (74.4%)	25 (71.4%)
20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses	37 (45. 1%)	23 (65.7%)
21	Generalizability (external validity, applicability) of the trial findings	17 (20.7%)	12 (34.3%)
22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	55 (67.1%)	27 (77. 1%)
23	Registration number and name of trial registry	62 (75.6%)	28 (80.0%)
24	Where the full trial protocol can be accessed, if available	2 (2.4%)	2 (5.7%)
25	Sources of funding and other support (such as supply of drugs), role of funders	60 (73. 2%)	27 (77. 1%)

^*indicates a conditional item for which not all manuscripts were scored

^**items relate to nonpharmacological (NPI) RCTs only