Articles

Platinum Priority – Neuro-urology
Editorial by Antonella Giannantoni on pp. 280–281 of this issue

The Bladder Pain/Interstitial Cystitis Symptom Score: Development, Validation, and Identification of a Cut Score

By: Louise Humphreya lowast , Rob Arbucklea, Rob Moldwinb, Jorgen Nordlingc d, Joop P. van de Merwee, Juliette Meunierf, Tim Crookg and Lucy Abrahamg

European Urology, Volume 61 Issue 1, February 2012, Pages 271-279

Published online: 01 February 2012

Keywords: Bladder pain syndrome, Painful bladder syndrome, Interstitial cystitis, Screener, Qualitative research, Cut score, Receiver operating characteristic (ROC) curve, Questionnaire

Abstract Full Text Full Text PDF (216 KB)

Abstract

Background

There is a need to develop a self-report measure that reliably identifies moderate to severe bladder pain syndrome (BPS) patients for inclusion into clinical trials to assess the efficacy of new BPS treatments.

Objective

To develop and validate a patient-reported symptom-based instrument, the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS), for clinical trial eligibility of BPS patients.

Design, setting, and participants

Stage 1: Qualitative concept elicitation (CE) interviews were conducted with BPS patients in France (n=12), Germany (n=12), and the United States (US) (n=20), and overactive bladder (OAB) (n=10) patients in the US for comparison. Stage 2: Cognitive debriefing (CD) interviews were performed with US BPS patients (n=20). Stage 3: An observational study with 99 BPS, 99 OAB, and 100 healthy participants in the US was used to perform item reduction, identify cut scores, and validate the measure. A cut score was defined using logistic regression and receiver operating characteristic curves. Psychometric properties, including test-retest reliability, were assessed.

Measurements

In addition to the BPIC-SS, the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, the Interstitial Cystitis Symptom Index, a Clinician Global Impression of Severity, and a Patient Global Impression of Change were included in the observational study.

Results and limitations

In CE, reported symptoms were bladder pain, persistent urge to urinate, and high urinary frequency. In CD, 13 items were deleted, and 15 were retained. Based on validation analyses, qualitative findings, and clinical relevance, the instrument was reduced to eight items that had strong sensitivity (0.72) and specificity (0.86) with a cut score ≥19 to determine clinical trial inclusion. Psychometric properties were strong.

Conclusions

The BPIC-SS is a reliable, valid, and appropriate questionnaire to select BPS/interstitial cystitis patients for clinical trials.

Take Home Message

The Bladder Pain/Interstitial Cystitis Symptom Score is a reliable and valid tool for screening moderate to severe bladder pain syndrome patients for clinical trial eligibility. The tool was developed with patient and clinical input using recognized methodology.

Keywords: Bladder pain syndrome, Painful bladder syndrome, Interstitial cystitis, Screener, Qualitative research, Cut score, Receiver operating characteristic (ROC) curve, Questionnaire.

Footnotes

a Mapi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, United Kingdom

b Hofstra University School of Medicine, Pelvic Pain Treatment Center, The Arthur Smith Institute for Urology, North Shore-LIJ Healthcare System, New Hyde Park, NY 11040, USA

c University of Copenhagen, Copenhagen, Denmark

d Department of Urology, Herlev Hospital, Herlev, Denmark

e Department of Immunology and Internal Medicine, Erasmus MC, Rotterdam, The Netherlands

f Mapi Values, Lyon, France

g Pfizer Ltd, Walton Oaks, Walton on the Hill, Tadworth, Surrey KT20 7NS, United Kingdom

lowast Corresponding author. Mapi Values, Adelphi Mill, Bollington, Cheshire SK10 5JB, United Kingdom. Tel. +1 625 577245; Fax: +1 625 5787328.

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