The Bladder Pain/Interstitial Cystitis Symptom Score: Development, Validation, and Identification of a Cut Score
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 freq…
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The same MADRS ≤12 definition has been used previously in clinical studies of MDD patients selected irrespective of prior treatment response.
“Nevertheless, the same definition has also been used previously in clinical studies 20,21 of patients with MDD who were selected irrespective of response to previous treatment.”
From Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression (2020) · cites this paper as [20]
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“The measure has been developed with patient and clinical input and using methods that meet standards for patient-completed measures [9–12].”
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Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression
Wajs, E., Aluisio, L., Holder, R., Daly, E. J., Lane, R., Lim, P., George, J. E., Morrison, R. L., Sanacora, G., Young, A. H., et al. (2020) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.19m12891 · Cited by 299 · see citing works
- Authors
- Humphrey, L., Arbuckle, R., Moldwin, R., Nordling, J., van de Merwe, J. P., Meunier, J., Crook, T., & Abraham, L.
- Affiliations
- Adelphi Group (United Kingdom) (GB)
- Pfizer (United Kingdom) (GB)
- Corresponding author
- Humphrey, Louise
- Venue
- European Urology
- Publisher
- Elsevier BV
- Published
- 2012-02
- Volume
- 61
- Issue
- 2
- Pages
- 271-279
- ISSN
- 0302-2838 (ISSN-L)
- OpenAlex
- W2133112335
- Cited by
- 73
- References
- 3
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 10 · 2023: 5 · 2022: 7 · 2021: 4 · 2020: 4 · 2019: 2 · 2018: 6 · 2017: 4 · 2016: 5 · 2015: 5 · 2014: 2 · 2013: 4
- FWCI
- 2.91
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Urology (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
- Keywords
- interstitial cystitis, overactive bladder, patient-reported outcome measures, symptom-based questionnaire, inclusion and exclusion criteria, cut-off values, psychometric validation, test-retest reliability, concept elicitation, cognitive debriefing
- MeSH terms
- Adult, Urinary Bladder, Clinical Trials as Topic, Female, Humans, Male, Middle Aged, Surveys and Questionnaires, ROC Curve, Sensitivity and Specificity, Severity of Illness Index, Reproducibility of Results, Pelvic Pain, Patient Selection, Cystitis, Interstitial, Urinary Bladder, Overactive, Self Report
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