Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting.

Stacie Hudgens Amy Howerter Ela Polek Fredrik L Andersson

Published in: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation (2021)

The NI Diary is a reliable and valid patient-reported psychometric instrument which is fit-for-purpose to evaluate the impact of nocturia on patient quality of life in the clinical trial setting. Trial registration number and registration date NCT03201419; June 28, 2017.

Keyphrases

clinical trial
patient reported
phase ii
phase iii
study protocol
open label
lower urinary tract symptoms
double blind
case report
benign prostatic hyperplasia
randomized controlled trial
patient reported outcomes
placebo controlled