RESTORE Trial

Uses

Comparisons

Evidence quality

Highlighted claims

• No randomised controlled trial has previously compared corrective surgery against conservative management for pectus excavatum. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• RESTORE is a pragmatic, multicentre, superiority randomised controlled trial with an embedded observational cohort. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• The central research question of RESTORE is whether corrective pectus surgery is superior to no surgery as measured by change in SF-36v2 physical function score at 1 year. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• The RESTORE trial targets enrolment of 200 RCT participants plus 100 in an embedded observational cohort. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• Blinding of participants and clinical teams is not feasible in the RESTORE trial. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• The RESTORE trial uses 1:1 randomisation stratified by surgical technique, age group, and baseline CPET result. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• The primary statistical analysis uses an intention-to-treat population with a linear mixed-effects regression model adjusting for baseline PF score, site, and stratification variables. — Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial
• The RESTORE trial was stopped early for futility after 115 patients were enrolled because the observed delirium incidence was far below the anticipated rate and no significant difference between groups was detected. — Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)
• The overall five-day delirium incidence in RESTORE was 2.75%, far below the 55% rate assumed in the sample size calculation. — Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)
• There was no statistically significant difference in delirium incidence between the melatonin group (3.64%) and the placebo group (1.85%), with a p-value of 1.000. — Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)