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. 2022 Jun 6;2022(6):CD011574. doi: 10.1002/14651858.CD011574.pub2

Li 2015a.

Study characteristics
Methods RCT
Participants Setting: China
N = 89 (subgroup with cognitive impairment only as they were given the intervention)
Sample: recruited from the PD collaborative study carried out in the neurology department of Weihai Municipal Hospital (37% women)
Age (years): Mean (95% CI) intervention group 67.5 (52.7‐71.1) control group 66.9 (53.8‐70.3)
Inclusion criteria: diagnosis of PD in accordance with the UK Brain Bank criteria; cognitive impairment, including PD dementia
Exclusion criteria: the presence of other conditions that can lead to cognitive dysfunction, such as delirium, stroke, severe depression, metabolic abnormalities, drug side effects, and head trauma
Disease severity at baseline: HY stage 1 to 5; MDS‐UPDRS motor score mean 20.6 (SD not reported)
Interventions Medication: cholinesterase inhibitor
1. Oral rivastigmine (3mg twice daily) for 12 months
2. Placebo (3mg twice daily) for 12 months
Outcomes 1. Rate of falls
2. Number of fallers
Other outcomes reported but not included in this review
Duration of the study 12 months
Funding source Development Plan of Medical and Health Sciences of Shandong Province (No. 2007HW020)
Notes Fall data collected: at baseline and every week by phone calls or follow‐up evaluations for 12 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of generating randomisation list not described.
Quote: "The trial was a randomized, double‐blind, placebo‐controlled study of 12 months duration.”
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information to permit judgement. No details provided relating to how double blinding to group allocation (medication/placebo) was performed.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Outcomes were recorded/confirmed in all allocated groups using the same method and the personnel recording/confirming outcomes were blind to group allocation.
Incomplete outcome data (attrition bias)
Falls Unclear risk Data not available to assess.
Incomplete outcome data (attrition bias)
Fallers Unclear risk Data not available to assess.
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement as unable to find a published protocol or trial registration.
Method of ascertaining falls (recall bias)
Falls and fallers Unclear risk It appears that retrospective recall was required over a short period (one week).
Quote: "Phone calls or follow‐up evaluations were conducted every week to record the data related to falls.”