Plastic Surgery

Protocol: AI-assisted education to improve mental health and QoL after head-and-neck cancer surgery in older adults

This single-center RCT protocol will randomize 100 postoperative HNC patients aged ≥60 to 12 months of AI-assisted personalized education versus standardized SMS education. Planned outcomes include multiple validated patient-reported measures of stress, function, mood, loneliness, fear of progression, and quality of life assessed at five time points to 12 months. Analysis will use intention-to-treat linear mixed models with maximum likelihood to handle missing data. Generalisability may be limited by single-center recruitment and reliance on self-reported outcomes. 1

Systematic review: inconsistent application and handling of discrepant phase 3 trial pairs under the two-trial rule

Among 9,925 phase 3 trials (2010–2024) the authors identified 498 duplicated studies (≈5%). Results were available for 206 trial pairs, with 17% (35 pairs) showing discrepant statistical conclusions between duplicates. The FDA approved 14 drugs despite discrepancies, and required an additional RCT in 8 cases, illustrating regulatory inconsistency. Outcome changes and type I error method modifications were uncommon but present, and these may undermine trial robustness. 2

Preliminary RCT: manual lymph drainage plus standard care reduced breast edema and pain after BCS and radiotherapy

In a small randomized trial (n = 25) MLD added to education, compression, and exercise produced greater improvements in breast pain and breast‑specific edema scores than standard therapy alone at three months. Both groups improved across multiple symptom and quality-of-life measures, but between-group differences favored the MLD arm for several breast-related domains. Limitations include small sample size, lack of objective edema measures, no untreated control, and absence of blinding. Findings are preliminary and require confirmation in larger, blinded trials with objective outcome measures. 3