Mohsen Gholami, Mohammad Nami, Fatemeh Shamsi, Khojaste Rahimi Jaberi, Babak Kateb, Abbas Rahimi Jaberi
Effects of transcranial direct current stimulation on cognitive dysfunction in multiple sclerosis
Neurophysiologie clinique = Clinical neurophysiology
informed consent participation rct important ethical legal requirement placebo surgical trials issues raised date explored patient information leaflets pils core component informed consent process study aimed investigate key content pils recently completed placebocontrolled trials invasive procedures including surgery highlight areas good practice identify gaps information provision trials type provide recommendations practice pils sought trials included recent systematic review placebocontrolled trials invasive procedures including surgery trial characteristics data surgical placebo interventions evaluation extracted directed content analysis applied informed published regulatory good practice guidance pil content existing research placebocontrolled surgical trials results analysed using descriptive statistics presented narrative summary 62 eligible rcts authors 59 trials contactable 14 pils received analysis least 50 pils included content general trial design explanations placebo differs similar surgical intervention ie fidelity reported 6 43 included pils half 57 pils included information potential therapeutic benefits surgical intervention one 7 included information potential indirect therapeutic benefits invasive components placebo five 36 presented known risks placebo intervention whilst 8 57 presented information known risks surgical intervention range terms used across pils describe placebo component including control mock sham developers pils placebocontrolled surgical trials carefully consider use language eg sham mock explicit placebo differs similar surgical intervention provide balanced presentations potential benefits risks surgical intervention separately placebo research required determine optimal approaches design deliver information trials