Item bank development, calibration and validation for patient-reported outcomes in female urinary incontinence

Current patient-reported outcomes for female urinary incontinence (UI) are limited by their inability to be tailored. Our objective is to describe the development and field testing of seven item banks designed to measure domains identified as important UI in females (UIf).

We also describe the calibration and validation properties of the UIf-item banks, which allow for more efficient computerized adaptive testing (CAT) in the future.

The UIf-measures included 168 items covering seven domains: Stress UI (SUI), overactive bladder (OAB), urinary frequency, physical, social and emotional health impact and adaptation. Items underwent rigorous qualitative development and psychometric testing across two sites. Items were calibrated using item response theory and evaluated for internal consistency, construct validity and responsiveness.

A total of 750 women (249 SUI, 249 OAB and 252 mixed UI) participated. Mean age was 55 ± 14 years, and 23 % were Hispanic and 80 % white. In addition to face and content validity, the measures demonstrated good internal consistency (coefficient alpha 0. 92-0. 98) and unidimensionality. There was evidence for construct validity with moderate-to-strong correlations with the UDI (r's ≥ 0. 6) and IIQ (r's = ≥0. 6) scales. The measures were responsive to change for SUI treatment (paired t test p < . 001, ES range 1. 3-2. 9; SRM range 1. 3-2. 5) and OAB treatment (paired t test p < . 05 for all domains except social health impact and adaptation, ES range 0. 3-1. 5, SRM range 0. 4-1. 0). The measures were responsive based on concurrent changes with the UDI and IIQ (p < 0. 05). CAT versions were developed and pilot-tested.

The UIf-item banks demonstrate good psychometric characteristics and are a sufficiently valid set of customizable tools for measuring UI symptoms and life impact.

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2016 Jan 06 [Epub ahead of print]

Vivian W Sung, James W Griffith, Rebecca G Rogers, Christina A Raker, Melissa A Clark

The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Women and Infants' Hospital/Warren, Alpert Medical School of Brown University, 695 Eddy Street, Lower Level, Providence, RI, 02903, USA. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. , The Division of Urogynecology, Department of Obstetrics and Gynecology and Surgery, University of New Mexico, Albuquerque, NM, USA. , The Division of Research, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA. , Department of Epidemiology and Obstetrics and Gynecology, Alpert Medical School and School of Public Health of Brown University, Providence, RI, USA.