Table 1 Checklist of items for reporting embedded recruitment trials
Section/topic and item no. | CONSORT 2010 (standard) checklist item | Extension for embedded recruitment trials |
|---|---|---|
Title and abstract | ||
1a | Identification as a randomised trial in the title | Identification as an embedded randomised recruitment trial in the title |
1b | Structured summary of trial design, methods, results and conclusions (for specific guidance see CONSORT for abstracts) | Structured summary of embedded recruitment trial design, methods, results and conclusions (for specific guidance see CONSORT for abstracts) |
Introduction | ||
Background and objectives | ||
2a | Scientific background and explanation of rationale | Scientific background and explanation of rationale for embedded recruitment trial including a brief description of the host trial(s) as appropriate |
2b | Specific objectives or hypotheses | Specific objectives or hypotheses for embedded recruitment trial |
Methods | ||
Trial design | ||
3a | Description of trial design (such as parallel, factorial) including allocation ratio | Description of embedded recruitment trial design (such as parallel, factorial, cluster) including allocation ratio |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | Important changes to methods of the embedded recruitment trial after commencement (such as eligibility criteria), with reasons |
Participants | ||
4a | Eligibility criteria for participants | Eligibility criteria for participants for embedded recruitment trial, including any differences from those for the host trial(s) |
4b | Settings and locations where the data were collected | Settings and locations where the embedded recruitment trial was carried out, including a brief description of the host trial(s) as appropriate |
Interventions | ||
5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | The interventions for each group (including control group) within the embedded recruitment trial with sufficient details to allow replication, including how, where and when they were actually administered |
Outcomes | ||
6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | Completely defined pre-specified primary and secondary outcome measures for the embedded recruitment trial, including how and when they were assessed |
6b | Any changes to trial outcomes after the trial commenced, with reasons | Any changes to embedded recruitment trial outcomes after the embedded recruitment trial commenced, with reasons |
Sample size | ||
7a | How sample size was determined | How sample size for embedded recruitment trial was determined |
7b | When applicable, explanation of any interim analyses and stopping guidelines | When applicable, explanation of any interim analyses and stopping guidelines for embedded recruitment trial |
Randomisation | ||
Sequence generation | ||
8a | Method used to generate the random allocation sequence | Method used to generate the random allocation sequence for embedded recruitment trial |
8b | Type of randomisation; details of any restriction (such as blocking and block size) | Type of randomisation; details of any restriction (such as blocking and block size) in embedded recruitment trial |
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 | Mechanism used in the embedded recruitment trial to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned |
Implementation | ||
10 | Who generated the random allocation sequence, who enrolled participants and who assigned participants to interventions | Who generated the random allocation sequence(s), who enrolled participants and who assigned participants to embedded recruitment interventions |
Blinding | ||
11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | If done, who was blinded after assignment to embedded recruitment interventions (for example, participants, care providers, those assessing outcomes) and how |
11b | If relevant, description of the similarity of interventions | If relevant, description of the similarity of interventions in the embedded recruitment trial |
Statistical methods | ||
12a | Statistical methods used to compare groups for primary and secondary outcomes | Statistical methods used to compare groups for primary and secondary outcomes of the embedded recruitment trial |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | Methods for additional analyses, such as subgroup analyses and adjusted analyses for embedded recruitment trial |
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 | For each group in the embedded recruitment trial, the numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome |
13b | For each group, losses and exclusions after randomisation, together with reasons | For each group, losses and exclusions after randomisation to embedded recruitment trial, together with reasons |
Recruitment | ||
14a | Dates defining the periods of recruitment and follow-up | Dates defining the periods of recruitment and follow-up for both embedded recruitment trial and host trial(s) |
14b | Why the trial ended or was stopped | Why the embedded recruitment trial ended or was stopped |
Baseline data | ||
15 | A table showing baseline demographic and clinical characteristics for each group | If possible a table showing baseline characteristics of each arm of the embedded recruitment trial |
Numbers analysed | ||
16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | For each group in the embedded recruitment trial, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups |
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) | For each primary and secondary outcome, results for each group in the embedded recruitment trial, 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 | For binary outcomes in the embedded recruitment trial, presentation of both absolute and relative effect sizes is recommended |
Ancillary analyses | ||
18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | Results of any other analyses performed for embedded recruitment trial, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory |
Harms | ||
19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | All important harms or unintended effects in each group for both the embedded recruitment trial and host trial(s) (for specific guidance see CONSORT for harms) |
Discussion | ||
Limitations | ||
20 | Trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analyses | Embedded recruitment trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analyses |
Generalisability | ||
21 | Generalisability (external validity, applicability) of the trial findings | Generalisability (external validity, applicability) of the embedded recruitment trial findings |
Interpretation | ||
22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | Interpretation consistent with results of the embedded recruitment trial, balancing benefits and harms, and considering other relevant evidence |
Other information | ||
Registration | ||
23 | Registration number and name of trial registry | Registration number and name of trial registry (for all host trials and embedded recruitment trial if available) |
Protocol | ||
24 | Where the full trial protocol can be accessed, if available | Where the embedded recruitment trial protocol can be accessed, if available |
Funding | ||
25 | Sources of funding and other support (such as supply of drugs), role of funders | For embedded recruitment trial, sources of funding and other support, role of funders and collaborators |