| Study characteristics |
| Methods |
RCT (within participants cross‐over design) |
| Participants |
Setting: specialist falls and syncope facility, Newcastle upon Tyne, United Kingdom
N = 34
Sample: consecutive patients presenting to A&E or syncope service (79% women)
Age (years): mean 76.8 (SD 9.0)
Inclusion criteria: aged over 55; carotid sinus hypersensitivity as sole attributable cause of ≥ 3 falls in preceding 6 months
Exclusion criteria: moderate to severe cognitive impairment; stroke or myocardial infarction within 3 months; any history of syncope |
| Interventions |
1. Dual chamber permanent pacemaker switched on
2. Control: dual chamber permanent pacemaker switched off |
| Outcomes |
1. Rate of falls
2. Number of fallers |
| Duration of the study |
6 months in each mode |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "At 1 month, subjects were randomised (by table of random numbers) in double‐blind fashion to either continue in DDD/RDR mode, or for the pacing to be turned off (ODO mode). Six months later, patients crossed over to the opposite mode for the remaining 6 months of the study." |
| Allocation concealment (selection bias) |
Low risk |
Quote: "At 1 month, subjects were randomised (by table of random numbers) in double‐blind fashion to either continue in DDD/RDR mode, or for the pacing to be turned off (ODO mode)." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Placebo‐controlled. Quote: "Following pacemaker implantation, all subjects' pacemakers were programmed to on (ie, in DDD/RDR mode) for a 1‐month run‐in period in order to ensure that they were unaware of pacing intervention. At 1 month, subjects were randomised (by table of random numbers) in double‐blind fashion to either continue in DDD/RDR mode,or for the pacing to be turned off (ODO mode). Six months later, patients crossed over to the opposite mode for the remaining 6 months of the study." |
| Blinding of outcome assessment (detection bias)
Falls and fallers |
Unclear risk |
Insufficient information to judge whether person phoning participants was blind to pacemaker status (on or off) |
| Blinding of outcome assessment (detection bias)
Fractures |
Unclear risk |
Fractures recorded in events diary throughout, but no mention of blinded radiology assessment |
| Incomplete outcome data (attrition bias)
Falls |
Low risk |
SeeAppendix 3 for method of assessment |
| Incomplete outcome data (attrition bias)
Fallers |
Low risk |
SeeAppendix 3 for method of assessment |
| Risk of bias in recall of falls |
Low risk |
Quote: "All subjects completed daily fall diaries returned at weekly intervals using prepaid postage to avoid confounding due to inaccurate recall of falls. Information from the falls diaries was held at a central database; failure of diary return initiated a telephone prompt to keep diary returns contemporaneous" |
