Published Sep 26, 2014

Copenhagen, Denmark - Many people experience waking up several times a night to go to the toilet – a condition called nocturia. Some people fall right back to sleep and are not bothered at all, but others experience a chronic, cumulative interference with sleep with a large impact on quality of life. As a result, researchers from Denmark and the United States developed the Nocturia Impact Diary ^© to assess the potential impact of nocturia on quality of life and the benefit of treatment. The Nocturia Impact Diary is a questionnaire that includes questions on energy, productivity, mood, low sleep quality, as well as social self-limitations. The development of this questionnaire followed three steps recommended by the FDA as well as the ISPOR PRO guidelines (concepts and assessment): (1) development of a comprehensive concept pool compiled to reflect the important aspects of nocturia experienced by patients; (2) content validity explored in a series of focus group interviews; and (3) psychometric testing to assess the validity, reliability and sensitivity of the diary in a clinical trial setting. “The Nocturia Impact (NI) Diary is the first nocturia impact assessment tool developed in close dialogue with the FDA and in accordance with new patient-reported outcome (PRO) validation guidelines,” said author Dr. Tove Holm-Larsen, PhD, Managing Director of Pharma Evidence and external lecturer at the University of Copenhagen, Denmark.  “The NI Diary has high validity, reliability and sensitivity. It captures the real-life consequences of nocturia and its treatment and should be used in conjunction with the 3-Day Voiding Diary, commonly used for diagnosis of urological diseases.” The full study, “The Nocturia Impact Diary: A Self-Reported Impact Measure to Complement the Voiding Diary,” is published in Value in Health.