How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review.

ABSTRACT:

Introduction

Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.

Method

A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly state

SUBMITTER: Cousins S 

PROVIDER: S-EPMC10660967 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature