Table 2. CONSORT 2010 checklist of information to include when reporting a randomized trial.
CONSORT: Consolidated Standards of Reporting Trials.
Section/Topic | Item No | Checklist item | |||||
Title and abstract | QL Block for Hip Surgeries | He et al. 2020 [10] | Kukreja et al. 2019 [11] | Brixel et al. 2021 [13] | Abduallah et al. 2020 [12] | Hu et al. 2021 [14] | |
1a | Identification as a randomised trial in the title | 0.5 | 0.5 | 0.5 | 0.5 | 0 | |
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | |
Introduction | |||||||
Background and objectives | 2a | Scientific background and explanation of rationale | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
2b | Specific objectives or hypotheses | 0.5 | 0.5 | 0.5 | 0.5 | 0 | |
Methods | |||||||
Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 0.5 | 0.5 | 0.5 | 0.5 | 0 |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 0.5 | 0.5 | 0.5 | 0 | 0.5 | |
Participants | 4a | Eligibility criteria for participants | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
4b | Settings and locations where the data were collected | 0.5 | 0 | 0.5 | 0.5 | 0.5 | |
Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 1 | 1 | 1 | 1 | 1 |
Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
6b | Any changes to trial outcomes after the trial commenced, with reasons | 0.5 | 0.5 | 0.5 | 0 | 0 | |
Sample size | 7a | How sample size was determined | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
7b | When applicable, explanation of any interim analyses and stopping guidelines | 0.5 Failure of SA block | 0.5 | 0.5 | 0.5 | 0.5 | |
Randomization: | |||||||
Sequence generation | 8a | Method used to generate the random allocation sequence | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
8b | Type of randomization; details of any restriction (such as blocking and block size) | 0.5 Random number table | 0.5 | 0.5 | 0.5 | 1 | |
Allocation concealment mechanism | 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 | 1 Steel cabinet | 1 | 1 | 1 | 1 |
Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 0.5 | 0 | 0.5 | 0.5 | 1 |
Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 0.5 | 0.5 | 0.5 | 0.5 | 1 |
11b | If relevant, description of the similarity of interventions | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | |
Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | 0.5 t-test Chi-Square test ANOVA | 0.5 | 0.5 | 0.5 | 0.5 |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | |
Results | |||||||
Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | 0.5 | 0.5 | 0.5 | 0.5 | 1 |
13b | For each group, losses and exclusions after randomization, together with reasons | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | |
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 0.5 | 0 | 0.5 | 0.5 | 0.5 |
14b | Why the trial ended or was stopped | 0.5 Failed SA Block | 0.5 | 0.5 | 0.5 | 0.5 | |
Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 1 | 1 | 1 | 1 | 1 |
Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 1 | 1 | 1 | 1 | 1 |
Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 0 | 0.5 | 0.5 | 0.5 | 0.5 |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 0 | 0.5 | 0.5 | 0.5 | 1 | |
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 0 | 1 | 1 | 1 | 1 |
Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 1 | 0 | 1 | 1 | 1 |
Discussion | |||||||
Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 1 | 1 | 1 | 1 | 1 |
Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | 1 | 1 | 1 | 1 | 1 |
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 1 | 1 | 1 | 0 | 1 |
Other information | |||||||
Registration | 23 | Registration number and name of trial registry | 1 | 0 | 1 | 1 | 1 |
Protocol | 24 | Where the full trial protocol can be accessed, if available | 1 | 1 | 1 | 1 | 1 |
Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 0 | 1 | 1 | 1 | 1 |
Total (n/25) | 21 | 20.5 | 24 | 22.5 | 24 |