Pan 2018.
Study characteristics | ||
Methods | Study type: interventional (clinical trial) Primary purpose: treatment |
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Participants | 170 participants Country: China Setting: inpatient At randomisation number allocated: 170, paroxetine (n = 85); usual care (n = 85) % male: paroxetine (71.8); usual care (unclear) Age: mean age paroxetine = 65.6 ± 7.56; placebo = unclear Subtype of stroke: not stated. Severity of stroke: NIHSS, Median (IQR): paroxetine 8 (6 – 10); usual care (unclear) Time since stroke onset: within 1 week Inclusion criteria
Exclusion criteria
Withdrawal criteria: not stated |
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Interventions | Experimental: orally administrated paroxetine at dosages of 10 mg/day during week 1 and 20 mg/day thereafter, for a total treatment duration of 3 months Comparator: usual care |
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Outcomes | Outcomes were collected at 15, 90 and 180 days
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Funding source | No grant funding from any grant funding agency, commercial or not‐for‐profit organisations | |
Notes | There is no study protocol/trial register reference Baseline sociodemographic and clinical characteristics are provided only for those who completed the study The authors state that one of the inclusion criteria is MOCA score of < 26 points. In the Results section they state that there were "72 cases of cognitive impairment" (i.e. a MoCA score of < 26 points) in the comparator group and 82 in the experimental group at days 15, 90 and 180. This suggests that either that the inclusion criteria were not strictly adhered to or if 100% of participants had a MoCA score of < 26 points at baseline then 10/82 participants in the comparator group and 3/85 in the experimental group have improved on the MoCA between days 0 and 15 Dates study conducted: participants recruited between January 2012 and June 2014 Declarations of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random number table" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to judge high or low |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to judge high or low |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All scale evaluators were trained and tested by the main investigator and were blind to the group assignment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data available for all participants in the experimental group (n = 85/85) and data available for (n = 82/85) participants in the comparison group for the Fugl–Meyer Motor Scale and the HAMD score For the MoCA (see 'Other bias' below) < 5% overall loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | There is no study protocol/trial register reference, so insufficient information to judge high or low |
Other bias | High risk | The authors state that one of the inclusion criteria is Montreal Cognitive Assessment (MoCA) score of < 26 points. In the Results section they state that there were "72 cases of cognitive impairment" (i.e., a MoCA score of < 26 points) in the comparator group and 82 in the experimental group at days 15, 90 and 180. This suggests that either that the inclusion criteria were not strictly adhered to or, if 100% of participants had a MoCA score of < 26 points at baseline then 10/82 participants in the comparator group and 3/85 in the experimental group have improved on the MoCA between days 0 and 15. The results 'Comparison of MoCA scores' and table 3 suggests otherwise |