PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“Eligible participants were then randomly assigned (1:1) to the intervention or control group via a secure web based randomisation system (Randomiser V.2.0.2) operated by a data manager who was not involved in patient recruitment, centrally at the Institute of Medical Biometry, Heidelberg University.”direct quote[Methods, Randomisation and masking]
“While the patients, GPs, and mental health specialists were aware of the intervention assignment after allocation, the data analysts were masked to the allocation.”direct quote[Methods, Sample size]
“To detect the minimal clinically important difference in the PHQ-ADS score of 3 points (SD 9 points) with a two sided 5% significance level and a power of 80%, a sample size of 160 patients per group was necessary.”PASSReviewer 2· 90% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“Eligible participants were then randomly assigned (1:1) to the intervention or control group via a secure web based randomisation system (Randomiser V.2.0.2) operated by a data manager who was not involved in patient recruitment, centrally at the Institute of Medical Biometry, Heidelberg University.”direct quote[Methods, Randomisation and masking]
“While the patients, GPs, and mental health specialists were aware of the intervention assignment after allocation, the data analysts were masked to the allocation.”direct quote[Methods, Sample size]
“To detect the minimal clinically important difference in the PHQ-ADS score of 3 points (SD 9 points) with a two sided 5% significance level and a power of 80%, a sample size of 160 patients per group was necessary.”