Background
Methods
Generating items for inclusion in the checklist
Consensus meetings and pilot testing
Post-meeting activities
Recommendations 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 the embedded recruitment trial including a brief description of the host trial(s) as appropriate
|
2b | Specific objectives or hypotheses | Specific objectives or hypotheses for the 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 the 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 the 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 the embedded recruitment trial
|
Randomisation | ||
Sequence generation | ||
8a | Method used to generate the random allocation sequence | Method used to generate the random allocation sequence for the 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 the 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 the 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 the 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 the 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 the embedded recruitment trial, sources of funding and other support, role of funders and collaborators
|
Title and abstract
Item 1a
Item 1b
Introduction: background and objectives
Item 2a
Item 2b
Methods: trial design
Item 3a
Item 3b
Participants
Item 4a
Item 4b
Interventions
Item 5
Outcomes
Item 6a
Item 6b
Item 7a
Item 7b
Randomisation: sequence generation
Item 8a
Item 8b
Allocation concealment mechanism
Item 9
Example:
Explanation:
Implementation
Item 10
Blinding
Item 11a
Item 11b
Statistical methods
Item 12a
Item 12b
Results: participant flow (a diagram is strongly recommended)
Item 13a
Item 13b
Item 14a
Item 14b
Baseline data
Item 15
Intervention | Control | |
---|---|---|
(n = 356) | (n = 347) | |
Mean age | 41.11 | 41.53 |
(SD = 10.9) | (SD = 10.7) | |
Gender | ||
Male | 116 (32.6 %) | 104 (30.0 %) |
Female | 240 (67.4 %) | 243 (70.0 %) |
Number of episodes of sick leave | ||
One episode in the last 2 years | 168 (47.2 %) | 179 (51.6 %) |
Two or more episodes in the last 2 years | 188 (52.8 %) | 168 (48.4 %) |
Diagnosis | ||
Mental health problems | 163 (45.8 %) | 160 (46.1 %) |
Muscle-skeletal problems | 154 (43.3 %) | 147 (42.4 %) |
Other diagnosis | 39 (11.0 %) | 40 (10.5 %) |
Numbers analysed
Item 16
Outcomes and estimation
Item 17a
Interventions | Recruitment in intervention group | Recruitment in control group | Difference in recruitment intervention minus control (95 % CI) adjusted for the clustering effect of household (395 households) | OR (95 % CI) for recruitment into study adjusted for clustering effect of household (395 households) |
---|---|---|---|---|
Telephone (groups 3 + 4 versus control (groups 1 + 2) | 134/280 (47.9 %) | 106/280 (37.9 %) | 10.0 % (0.2–19.8 %) | 1.5 (1.0–2.3) |
P = 0.046 | ||||
Questionnaire (groups 2 + 4) versus control (groups 1 + 3) | 116/280 (41.4 %) | 124/280 (44.3 %) | −2.9 % (−12.7–7.0 %) | 0.9 (0.6–1.3) |
P = 0.570 |