Background
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
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2b | Specific objectives or hypotheses | Specific objectives or hypotheses for embedded recruitment trial
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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
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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
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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
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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
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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
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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)
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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)
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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 |
Methods
Ethics approval
Participant recruitment
Randomisation and blinding
Control group
Intervention group: ‘bespoke user-tested’ PIS
Intervention group: ‘template-developed’ PIS
Primary outcome
Secondary outcomes
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Proportion of patients in each group who were recruited into the REFORM cohort
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Proportion of patients retained in the trial at 3 months post randomisation defined as returning at least the first 3 months’ worth of falls calendars from the date of randomisation.
Sample size
Statistical analysis
Results
Responses to invitation
Randomised to REFORM trial
Characteristic | Control (n = 62) | Template-developed (n = 68) | Bespoke user-tested (n = 63) | Total (n = 193) |
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Gender, n (%) | ||||
Male | 24 (38.7) | 32 (47.8) | 27 (43.6) | 83 (43.5) |
Age | ||||
Mean (SD) | 78.3 (5.8) | 78.6 (6.6) | 77.5 (7.8) | 78.1 (6.8) |
Fallen in previous 6 months? n (%) | ||||
Yes | 23 (37.1) | 29 (43.3) | 27 (42.9) | 79 (41.2) |
No | 39 (62.9) | 36 (53.7) | 36 (57.1) | 111 (57.8) |
Don’t know | 0 (0.0) | 2 (3.0) | 0 (0.0) | 2 (1.0) |
If fallen in previous 6 months, how many times? | ||||
Median (min,max) | 1 (1, 5) | 1 (1, 20) | 1 (1, 6) | 1 (1, 20) |
Worried about having a fall during the previous 4 weeks | ||||
All of the time | 4 (6.5) | 3 (4.5) | 4 (6.4) | 11 (5.7) |
Most of the time | 1 (1.6) | 4 (6.0) | 2 (3.2) | 7 (3.7) |
A good bit of the time | 6 (9.7) | 3 (4.5) | 4 (6.4) | 13 (6.8) |
Some of the time | 19 (30.7) | 13 (19.4) | 9 (14.3) | 41 (21.4) |
A little of the time | 23 (37.1) | 27 (40.3) | 29 (46.0) | 79 (41.2) |
None of the time | 9 (14.5) | 17 (25.4) | 15 (23.8) | 41 (21.4) |
Short Falls Efficacy Scale – International (FES-I)a
| ||||
Mean (SD) | 13.1 (5.0) | 11.7 (4.3) | 12.1 (4.5) | 12.3 (4.7) |
Frenchay Activities Index (FAI)a
| ||||
Mean (SD) | 47.2 (6.7) | 46.5 (7.2) | 46.4 (7.1) | 46.6 (7.0) |