Table 2 Variables, measures and methods of analysis
Variable/outcome | Hypothesis | Outcome measure | Methods of analysis |
|---|---|---|---|
1. Primary | Intervention improved outcome from baseline to follow-up period | ||
Relapse rate | Improvement occurred | Questionnaire (binary) | Chi-squared test |
2. Secondary | |||
Time to relapse | Improvement occurred | Questionnaire (time to event) | Log-rank test |
Rebound rate | Improvement occurred | Questionnaire (binary) | Chi-squared test |
PASI | Improvement occurred | Questionnaire (continuous) | t test/ANOVA |
DLQL | Improvement occurred | Questionnaire (continuous) | t test/ANOVA |
VAS | Improvement occurred | Questionnaire (continuous) | t test/ANOVA |
SF-36 | Improvement occurred | Questionnaire (continuous) | T test/ANOVA |
Time to onset | Improvement occurred | Questionnaire (time to event) | Log-rank test |
Cumulative consumption of topical medicine | Improvement occurred | Recorded amount (continuous) | t test/ANOVA |
SAS | Improvement occurred | Questionnaire (continuous) | t test/ANOVA |
SDS | Improvement occurred | Questionnaire (continuous) | t test/ANOVA |
BSA | Improvement occurred | Questionnaire (continuous) | t test/ANOVA |
Direct medical cost | Improvement occurred | Recorded amount (continuous) | t test/ANOVA |
3. Subgroup analyses | |||
Severity of disease | Improvement occurred | Chi-squared/t test/ANOVA | |
Chinese medicine patterns | Improvement occurred | Chi-squared/t test/ANOVA | |
4. Sensitivity analyses | Improvement occurred | All outcomes | |
Per-protocol analysis | Chi-squared/t test | ||
Adjusting for baseline covariates | Multivariable regression/Cox proportional hazards model | ||
clustering among individuals within a hospital | Generalized estimating equations/Cox proportional hazards model | ||
5. Safety analyses | |||
Frequency of adverse events (AEs) | Improvement occurred | Recorded amount (binary) | Chi-squared test |
Cases divided into different degree of AE | Improvement occurred | Recorded amount (binary) | Rank-sum test |
6. Other analyses | |||
Compliance rate | Recorded amount (binary) | Chi-squared test | |
Analysis of drug combinations | Recorded amount (binary) | Descriptive statistics | |
Analysis of shed-off cases | Recorded amount (binary) | Descriptive statistics | |