Skip to main content

Table 8 Outcomes and methods of analysis

From: Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial

Outcome/variable Hypothesis Measures Methods of analysis
Baseline balance test   Quantitative outcomes (age, disease duration, body temperature, heart/respiratory rate, blood pressure) T-test/Wilcoxon rank sum test
Qualitative outcomes (gender, marriage, race, previous treatment) Chi-squared test/Fisher exact test/rank-sum test
Adherence at post-intervention   Percent and cases of adherence in previous 10/14 days < 80 %, > 120 % and 80 %-120 % Chi-squared test/Fisher exact test
Concomitant treatments   Percent and cases of concomitant treatments Chi-squared test/Fisher exact test
Intervention duration   Formula: the last day using test drugs-the first day using test drugs + 1 T-test/Wilcoxon rank sum test
Primary    
Time to cough resolution improvement occurred   Kaplan-Meier method/Log-rank test
Cough symptom score improvement occurred   T-test/Wilcoxon rank sum test
Secondary    
VAS score improvement occurred   T-test/Wilcoxon rank sum test
TCM symptom score improvement occurred   T-test/Wilcoxon rank sum test
TCM curative effect improvement occurred Percent and cases of four grades: complete recovery, excellent effect, modest effect and no effect Cochran-Mantel-Haenszel Chi-squared test
CQLQ score improvement occurred Questionnaire T-test/Wilcoxon rank sum test
Cough disappearance rate improvement occurred   CMH Chi-squared test
Time to cough relief improvement occurred   Kaplan-Meier method/Log-rank test