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The nocturia impact diary: A self-reported impact measure to complement the voiding diary

Tove Holm-Larsen, PhD, Fredrik Andersson, PhD, Egbert van der Meulen, PhD, Vladimir Yankov, MD, Raymond C. Rosen, PhD, Jens Peter Nørgaard, MD

Value in Health, Volume 17, Issue 6, September 2014, Pages 696–706

Editor’s comments:
When assessing nocturia, it is important to adopt valid tools to adequately investigate the patient-reported bother, the impact on Quality of Life and the effect of a treatment. In the present study, the authors developed and validated the Nocturia Impact Diary - an enlarged form of the Nocturia Quality of Life questionnaire, produced to be completed in conjunction with a 3-day voiding diary.

In the development process, three steps were included: 1) development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; 2) content validity study; 3) psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo-controlled study in patients with nocturia. The first draft of the diary included 14 items and 4 domains. Then twenty-three patients with nocturia participated in the cognitive debriefing study where items were adjusted accordingly, and the content validity was high. Finally, the Nocturia Impact diary was administered to fifty-six patients, who were randomized to desmopressin orally disintegrating tablet or placebo.

The results showed high construct validity, with good sensitivity and high internal consistency, discriminatory ability, and acceptable sensitivity to change of the diary. Thus, the Nocturia Impact Diary appeared to be a useful, validated patient-reported outcome measure in the assessment of nocturia.

The novel finding of the study is that the questionnaire should be used together with a voiding diary, which allows to better understand the real-life consequences of nocturia and its treatment.

ABSTRACT

Background
Nocturia is a chronic, fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life. Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment, but the available tools are suboptimal.

Objectives
This study reports the development and validation of the Nocturia Impact Diary—an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary.

Methods
The process comprised three steps: Step 1: Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; Step 2: Content validity study; Step 3: Psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo-controlled study in patients with nocturia.

Results
Step 1: Fourteen items and 4 domains were included in the first draft of the diary. Step 2: Twenty-three patients with nocturia participated in the cognitive debriefing study. Items were adjusted accordingly, and the content validity was high. Step 3: Fifty-six patients were randomized to desmopressin orally disintegrating tablet or placebo. The diary demonstrated high construct validity, with good sensitivity and a good fit to Rasch model, as well as high internal consistency, discriminatory ability, and acceptable sensitivity to change. Results indicated that the diary was unidimensional.

Conclusions
The Nocturia Impact Diary is a convenient, validated patient-reported outcome measure. It should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment.