PASSReviewer 1· 95% conf
The trial design is rigorous with clear randomization, blinding of statisticians, a priori power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomization and masking]
“Participants were allocated to intervention or control groups using a mixed minimization and randomization approach to balance the groups with respect to the participant-selected dominant LC symptom (fatigue, breathlessness, pain, anxiety/depression or other), sex (male, female and other), age (<50 and 50+), ethnicity (white, South Asian and other) and IMD (postcode-based, deciles 1–5 and 6–10).”direct quote[Methods, Randomization and masking]
“Statisticians analyzing the data remained blinded until the statistical analysis plan was completed and the primary analysis database was locked.”direct quote[Methods, Statistical analysis]
“For 90% power at 5% statistical significance, 86 participants per group with outcome data were calculated as necessary.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, blinding of statisticians, a priori power calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomization and masking]
“Participants were allocated to intervention or control groups using a mixed minimization and randomization approach to balance the groups with respect to the participant-selected dominant LC symptom (fatigue, breathlessness, pain, anxiety/depression or other), sex (male, female and other), age (<50 and 50+), ethnicity (white, South Asian and other) and IMD (postcode-based, deciles 1–5 and 6–10).”direct quote[Methods, Randomization and masking]
“Statisticians analyzing the data remained blinded until the statistical analysis plan was completed and the primary analysis database was locked.”direct quote[Methods, Statistical analysis]
“For 90% power at 5% statistical significance, 86 participants per group with outcome data were calculated as necessary.”