PASSReviewer 1· 95% conf
The cluster-randomized design is rigorous with adequate randomization, power analysis, and pre-specified analysis methods.
Evidence
direct quote[Methods, Randomization]
“FQHC clinics were randomized in a 1:1 ratio to either a multifaceted team-based implementation strategy or enhanced usual care based on a random allocation sequence generated using SAS software, with stratification by FQHC organization.”direct quote[Methods, Statistical Analysis]
“This sample size provided 80% statistical power to detect a 5.0 mmHg difference in mean systolic blood pressure change over 18 months at a two-sided significance level of 0.05, with a follow-up rate of 85%.”direct quote[Methods, Randomization]
“Due to the nature of the cluster design and intervention program, study participants, healthcare providers, health coaches, and research staff who collected study data were unblinded.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, sample size calculation, and pre-specified outcomes.
Evidence
direct quote[Methods, Randomization]
“FQHC clinics were randomized in a 1:1 ratio to either a multifaceted team-based implementation strategy or enhanced usual care based on a random allocation sequence generated using SAS software, with stratification by FQHC organization.”direct quote[Methods, Randomization]
“Due to the nature of the cluster design and intervention program, study participants, healthcare providers, health coaches, and research staff who collected study data were unblinded.”direct quote[Methods, Statistical Analysis]
“This sample size provided 80% statistical power to detect a 5.0 mmHg difference in mean systolic blood pressure change over 18 months at a two-sided significance level of 0.05, with a follow-up rate of 85%.”