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Table 1 The instrument used to extract data on CONSORT variables (items)

From: A multiyear systematic survey of the quality of reporting for randomised trials in dentistry, neurology and geriatrics published in journals of Spain and Latin America

CONSORT item # Description and definition Scoring
Title 1a Identification as a randomised trial in the title 1 = word random appears in the title
0 = no word "random" appears
Abstract 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 1 = Structured abstract
0 = No structured abstract
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio (ex-split-mouth) 1 = well described design
0 = not well-described design
Participants 4a Eligibility criteria for participants 1 = specified
0 = not specified
4b Settings (A) and locations (B) where the data were collected 2 = A and B
1 = A or B
0 = not specified
Interventions 5 The interventions for each group (A) with sufficient details to allow replication, including how and when they were actually administered (B) (i.e. "usual care" for control group not enough)] 2 = A and B
1 = A, but only one group with details
0 = only A or only one group without details
Outcomes 6a Completely defined pre-specified primary (A) and secondary outcome (B) measures, including how and when they were assessed (C) 2 = A and B and C
1 = A or B (no distinction) + C
0 = A or B, no C
Sample size 7a How sample size was determined 1 = specified
0 = not specified
Sequence generation 8a The method used to generate the random allocation sequence 1 = specified
0 = not specified
Allocation concealment mechanism 9 The 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 1 = steps for concealment specified
0 = concealment not specified
Implementation 10 Who generated the random allocation sequence (A), who enrolled participants (B), and who assigned participants to interventions (C) 2 = A and B and C
1 = (A and B) or (A and C)
0 = A missing
Blinding 11a If done, who was blinded (A) after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how (B) 2 = (A and B) OR reason why the study is open label
1 = declares who is blinded but no details as how
0 = declares the study blind but no who nor how
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 2 = states full stats method for each outcome
1 = states stats methods for primary outcome
0 = states stats methods vaguely
Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned (A), received intended treatment (B) and were analysed for the primary outcome (C) 2 = A and B and C (narrative in text OR complete flow diagram)
1 = A or B or C missing (only one missing)
0 = only one reported or no info at all
13b For each group, losses (A) and exclusions (B) after randomisation, together with reasons (C) 2 = A and B and C
1 = A or B or C missing (only one missing)
0 = only one reported, or no info at all
Recruitment 14a Dates defining the periods of recruitment (A) and follow-up (B) 2 = A and B reported
1 = A or B reported
0 = none reported
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 1 = "Table 1" present
0 = "Table 1" not present
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis (A) and whether the analysis was by original assigned groups (B) [ITT or Per Protocol] 2 = A and B
1 = A or B
0 = not stated
Outcomes and estimation 17a For each primary and secondary outcome, results for each group (A), and the estimated effect size (B) and the precision (confidence interval) (C) [only for primary outcome] 2 = A and B and C
1 = A or B or C missing (only one missing)
0 = only one reported or none
Harms 19 All important harms or unintended effects in each group 1 = harms described
0 = harms not described
Registration 23 Registration number and name of trial registry 1 = present
0 = absent
Protocol 24 Where the full trial protocol can be accessed, if available 1 = present
0 = absent
Funding 25 Sources of funding and other support (such as the supply of drugs) 1 = present
0 = absent
Additional item AIa Total number of patients randomised Annotate sample size
Additional item AIb Conflict of interest statement 1 = present
0 = absent
Additional item AIc Ethics review 1 = present
0 = absent
Additional item AId Language of article Spanish/English/Portuguese