Sawada H, Oeda T. Protocol for a randomised controlled trial: efficacy of donepezil against psychosis in Parkinson's disease (EDAP). BMJ Open 2013;3:e003533.
1) In the section ‘Methods and analysis’, subheading ‘Primary outcome measure and statistical analysis,’ the following sentence has a typographical error: ‘Primary outcome measure is the time to the occurrence of psychosis from V2 during 48 weeks.’ This should be ‘Primary outcome measure is the time to the occurrence of psychosis from V2 during 96 weeks.’ The study was designed as 96-week of observation period, as described elsewhere in the manuscript, and this was due to a typographical error.
2) In table 1 ‘Multiplicative Parkinson Psychosis Questionnaire score’, the structure is disarranged. The corrected table 1 is below.
Table 1.
Severity | Frequency |
||
---|---|---|---|
A Early symptoms /sleep disturbance | Up to once per week | Several times per week | Once or more per day |
Not or slightly affecting well-being | 1 | 2 | 3 |
Moderately affecting well-being | 2 | 4 | 6 |
Severely affecting well-being | 3 | 6 | 9 |
B. Hallucinations /illusions | Only during the night | During the night and occasionally during the day | Almost every day & night |
Insight retained | 1 | 2 | 3 |
No full insight | 2 | 4 | 6 |
Lacking insight | 3 | 6 | 9 |
C. Der day | Up to once per week | Several times per week | Once or more per day |
Without affecting the social environment | 1 | 2 | 3 |
Affecting the patient by emotional distress | 2 | 4 | 6 |
Affecting the patient by accusation, aggression, or lack of cooperation | 3 | 6 | 9 |
D. Orientation | Up to once per week | Several times per week | Once or more per day |
No requirement of supervision | 1 | 2 | 3 |
Temporal requirement of supervision | 2 | 4 | 6 |
Permanent requirement of supervision | 3 | 6 | 9 |