Optimizing clinical trial design using prospective cohort study data: a case study in neuro-urology.

ABSTRACT:

Study design

Simulations using data from a prospective cohort study.

Objectives

To illustrate how prospective cohort data can be employed in randomized controlled trial (RCT) planning to assess feasibility and operational challenges, using TASCI (Transcutaneous tibial nerve stimulation in patients with Acute Spinal Cord Injury to prevent neurogenic detrusor overactivity: a nationwide randomized, sham-controlled, double-blind clinical trial) as a case study.

Setting

Spinal cord injury (SCI) rehabilitation centers in Switzerland.

Methods

TASCI is nested in the multicenter Swiss Spinal Cord Injury Cohort Study (SwiSCI), which prospectively includes patients with acute SCI. In simulations, data from 640 patients, collected by SwiSCI, were used to investigate differ

SUBMITTER: Anderson CE 

PROVIDER: S-EPMC7611589 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature