Skip to main content

Advertisement

Table 1 Checklist of items for reporting embedded recruitment trials

From: An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

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