Background
Methods/design
Aim
Design
Participants
Inclusion criteria
Exclusion criteria
Recruitment procedures
Randomization
Interventions and comparison
Treatment group
Measurements | baseline | 1 week | 2 weeks | 3 weeks | 4 weeks | 5 weeks | 6 weeks | 7 weeks | 8 weeks | 20 weeks | 32 weeks |
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NIH-CPSI total score |
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×
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×
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×
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×
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×
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×
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×
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×
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×
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×
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NIH-CPSI subscales score |
×
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×
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×
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×
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×
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IPSS total score |
×
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×
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×
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×
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×
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Global response assessment |
×
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×
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×
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×
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×
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Degree of expectation |
×
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Satisfation |
×
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×
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×
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Control group
Outcome measures
Primary outcome measures
Safety assessment
Data collection and quality control
Sample size calculation and statistical analysis
Outcomes | Time frame | Statistics |
---|---|---|
Primary outcome | ||
NIH-CPSI total score and change from baseline | baseline, week 1-8 | Covariance analysis or generalized estimating equations |
Secondary outcomes | ||
NIH-CPSI subscales score | Baseline, week 4,8,20,32 | Covariance analysis or generalized estimating equations |
NIH-CPSI total score in follow-up | week 20,32 | Covariance analysis or generalized estimating equations |
IPSS total score and change from baseline | baseline, week 4,8,20,32 | Covariance analysis or generalized estimating equations |
Global response assessment improvement | week 4,8,20,32 | CMH test or nonparametric test |
Degree of expectation | baseline | linear regress |
Degree of satisfaction | week 8,20,32 | CMH test or nonparametric test |