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) |
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Interventions | Medication: cholinesterase inhibitor 1. Oral rivastigmine (3mg twice daily) for 12 months 2. Placebo (3mg twice daily) for 12 months |
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Outcomes | 1. Rate of falls 2. Number of fallers Other outcomes reported but not included in this review |
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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.” |