Griffin 2019.
Study characteristics | ||
Methods | RCT, individuals randomised | |
Data | UK, primary care setting. All host trials participants included. Total n = 9375; mean age 77.9 (SD 5.8) years; 52.4% females; 61% married. |
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Comparisons | Participants were randomised allocated participants to receive prospective monthly falls diaries for one simultaneous 4‐month period: · Intervention group 1 received falls diaries from randomisation to 4 months follow‐up. · Intervention group 2 received falls diaries from 5 and 8 months. · Intervention group 3 received falls diaries from or between 9 and 12 months Furthermore, all trial participants received a postal questionnaire at baseline and at 4‐, 8‐, 12‐, and 18‐months post‐randomisation to evaluate data retrospectively. |
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Outcomes | Number of participants who provided falls data on a full set of diaries and on the questionnaire for the corresponding period | |
Notes | Retention period: up to 4 months. Data also available for 5‐8 months and 9‐12 months. | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear | This nested trial design used a separate randomisation strategy to allocate trial participants. However, allocation concealment unclear. |
Adequate sequence generation? | Unclear | This nested trial mentions that the design used a different randomisation strategy to allocate trial participants. However, not reported the sequence generation. The number of people in the control arm was higher compared at the intervention arm. |
Blinding of participants and personnel? | Yes | Not reported in the paper.Unblinding not likely to impact objective outcome |
Blinding of outcome assessment? | Yes | Not reported in the paper.However, objective outcome, staff have no plausible additional opportunity to influence postal response rate once questionnaires sent. |
Incomplete outcome data addressed? All outcomes | Yes | No concerns raised. |
Free of selective outcome reporting? | Yes | No concerns raised. |
Other sources of bias | Yes | No further concerns raised. |
Overall Risk of Bias | Unclear | Unclear |