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. 2019 Jul 4;18(2):349–362. doi: 10.1007/s40200-019-00419-w

Table 3.

Quality assessment of included studies according to the CONSORT checklist

Item Asemi et al. [25] Shargorodsky et al. [34] Alizadeh et al. [24] Murer et al. [32] Jamilian et al. [30] Faghihi et al. [27] Farrokhian et al. [28, 40] Bahmani [26] Faure et al. [29] Mohammad Hosseinzadeh et al. [35] Mao [35] Rayman et al. [33]
1a Yes No Yes Yes Yes Yes Yes No No Yes No Yes
1b Yes Yes Yes No Yes No Yes Yes Yes Yes Yes Yes
2a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
2b Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
3a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
3b No No No No No No No No No No No No
4a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
4b Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
5 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
6a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
6b No No No No No No No No No No No No
7a Yes Yes Yes Yes Yes No Yes Yes No Yes No Yes
7b Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
8a Yes No Yes Yes Yes Yes Yes Yes No No Yes Yes
8b No No Yes Yes Yes Yes Yes Yes No No Yes Yes
9 Yes No Yes Yes Yes No Yes Yes No No Yes Yes
10 Yes No No No Yes No Yes Yes No Yes No Yes
11a No No No No Yes No Yes Yes No No No Yes
11b No No No No No No No No No No No No
12a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
12b Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
13a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
13b Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
14a Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
14b No No No No No No No No No No Yes No
15 Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes
16 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
17a Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes
17b Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
18 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
19 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
20 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
21 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
22 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
23 Yes No Yes Yes Yes No Yes Yes No Yes Yes Yes
24 No No No No No No No No No No No Yes
25 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Total 30 25 30 29 32 26 32 31 23 28 29 33

(1a) Identification as a randomized trial in the title; (1b) Structured summary of trial design, methods, results, and conclusions; (2a) Scientific background and explanation of rationale; (2b) Specific objectives or hypotheses; (3a) Description of trial design (such as parallel, factorial) including allocation ratio; (3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons; (4a) Eligibility criteria for participants; (4b) Settings and locations where the data were collected; [5] The interventions for each group with sufficient details to allow replication, including how and when they were actually administered; (6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed; (6b) Any changes to trial outcomes after the trial commenced, with reasons; (7a) How sample size was determined; (7b) When applicable, explanation of any interim analyses and stopping guidelines; (8a) Method used to generate the random allocation sequence; (8b) Type of randomization; details of any restriction (such as blocking and block size); [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; [10] Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions; (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; (12a) Statistical methods used to compare groups for primary and secondary outcomes; (12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses; (13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome; (13b) For each group, losses and exclusions after randomization, together with reasons; (14a) Dates defining the periods of recruitment and follow-up; (14b) Why the trial ended or was stopped; [15] A table showing baseline demographic and clinical characteristics for each group; [16] For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups; 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; [18] Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory; [19] All important harms or unintended effects in each group (for specific guidance see CONSORT for harms); [20] Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses; [21] Generalizability (external validity, applicability) of the trial findings; [22] Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence; [23] Registration number and name of trial registry; [24] Where the full trial protocol can be accessed, if available; [25] Sources of funding and other support (such as supply of drugs), role of funders