Table 1 Assessment of the quality of RCTs of CP/CPPS based on the CONSORT statement
Section/Topic | Item No | Checklist item | n | % |
|---|---|---|---|---|
Title and abstract | ||||
1a | Identification as a randomised trial in the title | 42 | 54.55 | |
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 67 | 87.01 | |
Introduction | ||||
Background and objectives | 2a | Scientific background and explanation of rationale | 76 | 98.70 |
2b | Specific objectives or hypotheses | 71 | 92.21 | |
Methods | ||||
Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 22 | 28.57 |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 0 | 0 | |
Participants | 4a | Eligibility criteria for participants | 77 | 100 |
4b | Settings and locations where the data were collected | 66 | 85.71 | |
Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 75 | 97.40 |
Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 60 | 77.92 |
6b | Any changes to trial outcomes after the trial commenced, with reasons | 0 | 0 | |
Sample size | 7a | How sample size was determined | 12 | 15.58 |
7b | When applicable, explanation of any interim analyses and stopping guidelines | 0 | 0 | |
Randomisation: | ||||
Sequence generation | 8a | Method used to generate the random allocation sequence | 26 | 33.77 |
8b | Type of randomisation; details of any restriction (such as blocking and block size) | 0 | 0 | |
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 | 6 | 7.79 |
Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 8 | 10.39 |
Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 26 | 33.77 |
11b | If relevant, description of the similarity of interventions | 25 | 32.47 | |
Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | 77 | 100 |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 15 | 19.48 | |
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 analysed for the primary outcome | 36 | 46.75 |
13b | For each group, losses and exclusions after randomisation, together with reasons | 34 | 44.16 | |
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 18 | 23.38 |
14b | Why the trial ended or was stopped | 1 | 1.30 | |
Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 57 | 74.03 |
Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 57 | 74.03 |
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) | 49 | 63.64 |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 19 | 24.68 | |
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 7 | 9.09 |
Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 67 | 87.01 |
Discussion | ||||
Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 57 | 74.03 |
Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | 61 | 79.22 |
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 57 | 74.03 |
Other information | ||||
Registration | 23 | Registration number and name of trial registry | 16 | 20.78 |
Protocol | 24 | Where the full trial protocol can be accessed, if available | 3 | 3.90 |
Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 6 | 7.79 |