Elsevier

Urology

Volume 63, Issue 3, March 2004, Pages 481-486
Urology

Adult urology
Development and validation of a quality-of-life measure for men with nocturia

https://doi.org/10.1016/j.urology.2003.10.019Get rights and content

Abstract

Objectives

To develop and assess the psychometric properties of a short self-report nocturia-specific Quality-of-Life (QOL) questionnaire.

Methods

The Nocturia Quality-of-Life questionnaire (N-QOL) was developed using focus group interviews with men experiencing nocturia. To refine it further and psychometrically validate the questionnaire, 107 men with nocturia (from four urology clinics in the United Kingdom) completed the pilot N-QOL, along with measures of health status and sleep quality. To assess reproducibility, men from one clinic completed the pilot N-QOL again at 1 week.

Results

After standard item reduction analyses, 18 items were dropped from the pilot questionnaire. The psychometric properties of the remaining 13-item instrument were tested in accordance with standard criteria. Factor analysis identified two subscales, sleep/energy and bother/concern, loading at 0.5 and greater. The N-QOL overall score and subscales proved to be internally consistent (alpha = 0.84 to 0.90) and reproducible (intraclass correlation coefficient = 0.74 to 0.82). N-QOL scores correlated with sleep quality (P <0.01) as measured by the Pittsburgh Sleep Quality Index and energy/vitality and social functioning (P <0.01) as measured by the SF-36 Health Survey, demonstrating good convergent validity. The N-QOL also demonstrated statistically significant differences between the scores of those experiencing one, two, and three or more episodes of nocturia on an average night, indicating excellent discriminant validity.

Conclusions

These analyses provide support for the psychometric validity of the N-QOL for use in a male population with nocturia.

Section snippets

Instrument development

The Nocturia Quality-of-Life questionnaire (N-QOL) was developed in accordance with the needs-based model proposed by Hunt et al.,9 which stresses the importance of patient-based information about QOL impacts. This approach has been shown to increase the content validity and overall psychometric performance of the resulting health-related QOL measures. After a review of the literature, focus groups were held with four groups of 7 to 8 men with nocturia to discuss the impact of nocturia on their

Patient characteristics

The study included 107 men with a mean age of 68.2 years (range 32 to 88). Of the 107 men, 85% reported waking up to urinate twice or more per night, and 75.7% had experienced nocturia for more than 1 year. The most common causes of nocturia (as reported by the investigators) were benign prostatic obstruction (36.4%) and overactive bladder (6.5%).

Item reduction

Although by current definition any number of voids during the night is considered nocturia,1 nocturia once per night could be considered normal,

Comment

The N-QOL is the first questionnaire to assess specifically the impact of nocturia on QOL. It was constructed using a needs-based model to elicit subjective evaluations about the impact of nocturia in the words of the patients. The N-QOL is easily self-administered, taking approximately 5 minutes for the average patient to complete, and can be used in the clinical setting to complement clinical measures such as frequency-volume charts to facilitate treatment decision-making. The questionnaire

Conclusions

The N-QOL is a valid and reliable patient-based assessment of the impact of nocturia on the QOL of patients. It facilitates understanding of the impact of nocturia on patients' QOL and can complement clinical measures, aid treatment decision-making, and, potentially, evaluate new treatments for this condition.

Acknowledgements

To Jane Goodman, Jan Svihra, and Mauro Niero for their help in developing the N-QOL, and to Janne Thorp, Debbie Marsh, Wendy Robson, and Suzanne Biers for their help in carrying out the methods study.

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This research was funded by Pfizer Global Pharmaceuticals, Sandwich, United Kingdom.

P. Abrams, M. J. Drake, R. P. MacDonagh, and J. G. Noble are study investigators funded by the sponsor. M. L. Martin is a paid consultant to the sponsor.

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