Assessment of Reporting Quality in Randomized Controlled Trials of Acupuncture for Primary Insomnia with CONSORT Statement and STRICTA Guidelines

Table 1

Assessment of reporting quality using items from the CONSORT statement (n = 102 studies).

Criteria	Item	Description	Number of positive trials	%	Cohen’s к coefficient	95% CI
Title and abstract	1a	Identification as a randomized trial in the title	15	14.71	1.00	1.00
	1b	Structured abstract including trial design, methods, results, and conclusions	102	100	1.00	1.00
Background and objectives
Introduction	2a	Scientific background and explanation of rationality	98	96.08	0.85	0.57 to 1.13
	2b	Specific objectives or hypotheses	102	100	1.00	1.00
Trial design
Methods	3a	Description of trial design	102	100	0.66	0.04 to 1.28
	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons	0	0	1.00	1.00
Participants
	4a	Eligibility criteria for participants	102	100	1.00	1.00
	4b	Settings and locations where the data were collected	100	98.04	0.66	0.04 to 1.28
Interventions
	5	Interventions for each group with sufficient details to allow replication	101	99.02	1.00	1.00
	5a	Procedure for tailoring the interventions to participants	102	100	1.00	1.00
	5b	Details of whether and how the interventions were standardized	12	11.76	0.77	0.59 to 0.95
	5c	Adherence of researchers to the protocol: whether they adhere to it and how to assess that	5	4.90	0.7	0.42 to 0.98
	5d	Adherence of participants to the intervention: whether they adhere to it and how to assess that	0	0	1.00	1.00
Outcomes
	6a	Precisely defined prespecified primary and secondary outcome measures	87	85.29	0.84	0.69 to 0.99
	6b	Any changes to trial outcomes after trial commencement with reasons	1	0.98	1.00	1.00
Sample size
	7a	How sample size was determined	14	13.73	0.87	0.73 to 1.01
	7b	Explanation of interim analyses and suspension principles	17	16.67	0.73	0.57 to 0.89
Sequence generation
Randomization	8a	Method used to generate the random allocation sequence	69	67.65	0.87	0.77 to 0.97
	8b	Type of randomization with details of any restriction	4	3.92	0.66	0.22 to 1.10
Allocation concealment mechanism
	9	Description of the method used to implement the random allocation sequence (such as sequentially numbered containers), assuring concealment until interventions were assigned	34	33.33	0.91	0.82 to 1.00
Implementation
	10	Who generated the random allocation sequence, who enrolled participants, and who assigned intervention to participants	10	9.80	0.95	0.86 to 1.04
Blinding
	11a	If done, who was blinded and how	23	22.55	0.89	0.79 to 0.99
	11b	If relevant, description of the similarity of interventions	9	8.82	0.8	0.61 to 0.99
	11c	If blinding was not possible, description of attempts to limit bias	7	6.86	0.82	0.58 to 1.06
Statistical methods
	12a	Statistical methods used to compare groups for primary and secondary outcomes	100	98.04	0.69	0.43 to 0.95
	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses	2	1.96	1.00	1.00
Participant flow
Results	13a	For each group, the numbers of participants randomly assigned, received intended treatment, and analyzed for the outcome indicator	102	100	1.00	1.00
	13b	For each group, the number of losses and exclusions after randomization with reasons	33	32.35	0.91	0.84 to 0.98
	13c	For each group, report of the delay from randomization to the initiation of the intervention	4	3.92	0.85	0.57 to 1.13
Recruitment
	14a	Periods of recruitment and follow-up	55	53.92	0.85	0.75 to 0.95
	14b	Why the trial suspended	0	00	1.00	1.00
Baseline data
	15	A table showing baseline demographic and clinical characteristics for each group	62	60.78	1.00	1.00
Numbers analyzed
	16	The number of participants in each group included in each analysis and whether they were analyzed according to the original grouping	102	100	1.00	1.00
Outcomes and estimation
	17a	The results of primary and secondary outcome indicators, the estimated value of effect size and its accuracy	5	4.90	0.88	0.65 to 1.11
	17b	For dichotomous outcomes, recommendation to provide both absolute and relative effect values	0	0	1.00	1.00
Ancillary analyses
	18	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified analysis from exploratory one	2	1.96	1.00	1.00
Harms
	19	All important harms or unintended effects in each group	45	44.12	0.96	0.91 to 1.01
Limitations
Discussion	20	Report of potential source of bias, imprecision, and multiple analyses	47	46.08	0.9	0.82 to 0.98
Generalizability
	21	Generalizability (external validity, applicability) of the trial findings	65	63.73	0.88	0.79 to 0.97
Interpretation
	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	50	49.02	0.89	0.80 to 0.98
Registration
Other information	23	Registration number and name of trial registry	12	11.76	1.00	1.00
Protocol
	24	Where the full-trial protocol can be accessed, if available	36	35.29	1.00	1.00
Funding
	25	Sources of funding and other support (such as supply of drugs) and role of funders	47	46.08	1.00	1.00