Table 1 The frequency and adherence of RCTs to individual items of CONSORT 2010 checklist, in order of increasing fulfillment

From: Reporting quality of surgical randomised controlled trials in head and neck cancer: a systematic review

Item Description Frequency Adherence (%)
24 Where the full trial protocol can be accessed, if available 6/41 14.6
4a Eligibility criteria for participants 8/41 19.5
10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 9/41 22.0
17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 12/41 29.3
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 13/41 31.7
3a Description of trial design (such as parallel, factorial) including allocation ratio 16/41 39.0
8b Type of randomisation; details of any restriction (such as blocking and block size) 16/41 39.0
25 Sources of funding and other support (such as supply of drugs), role of funders 17/41 41.5
23 Registration number and name of trial registry 19/41 46.3
14b Why the trial ended or was stopped 21/41 51.2
4b Settings and locations where the data were collected 22/41 53.7
7a How sample size was determined 23/41 56.1
8a Method used to generate the random allocation sequence 24/41 58.5
21 Generalisability (external validity, applicability) of the trial findings 24/41 58.5
14a Dates defining the periods of recruitment and follow-up 26/41 63.4
19 All important harms or unintended effects in each group 26/41 63.4
16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 27/41 65.9
1a Identification as a randomised trial in the title 28/41 68.3
13b For each group, losses and exclusions after randomisation, together with reasons 28/41 68.3
20 Trial limitations, addressing sources of potential bias, imprecision, and if relevant, multiplicity of analyses 28/41 68.3
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 29/41 70.7
11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 32/41 78.0
13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome 33/41 80.5
6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 34/41 82.9
15 A table showing baseline demographic and clinical characteristics for each group 34/41 82.9
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 38/41 92.7
18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 38/41 92.7
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 39/41 95.1
11b If relevant, description of the similarity of interventions 39/41 95.1
12a Statistical methods used to compare groups for primary and secondary outcomes 39/41 95.1
1b Structured summary of trial design, methods, results, and conclusions 40/41 97.6
5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 40/41 97.6
6b Any changes to trial outcomes after the trial commenced, with reasons 40/41 97.6
2a Scientific background and explanation of rationale 41/41 100
2b Specific objectives or hypotheses 41/41 100
7b When applicable, explanation of any interim analyses and stopping guidelines 41/41 100
22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 41/41 100
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