The Bladder Pain/Interstitial Cystitis Symptom Score: Development, Validation, and Identification of a Cut Score
The Bladder Pain/Interstitial Cystitis Symptom Score: Development, Validation, and Identification of a Cut Score
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DOI：
10.1016/j.eururo.2011.10.004
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发表时间：
2012-02-01
期刊：
影响因子：
23.4
通讯作者：
Abraham, Lucy
中科院分区：
文献类型：
--
作者：
Humphrey, Louise;Arbuckle, Rob;Abraham, Lucy
背景资料：有必要开发一种自我报告的措施，可靠地识别中度至重度膀胱疼痛综合征（BPS）患者纳入临床试验，以评估新的BPS治疗的疗效。目的：为了开发和验证一种基于患者报告的膀胱疼痛/间质性膀胱炎症状评分（BPIC-SS）的工具，用于BPS患者的临床试验资格。设计，设置和参与者：第一阶段：对法国（n = 12）、德国（n = 12）和美国（US）（n = 20）的BPS患者和美国的膀胱过度活动症（OAB）（n = 10）患者进行定性概念启发（CE）访谈，以进行比较。第2阶段：对美国BPS患者（n = 20）进行认知报告（CD）访谈。第三阶段：在美国，一项有99名BPS、99名OAB和100名健康受试者的观察性研究被用于进行项目缩减、确定切割评分并验证测量。使用逻辑回归和受试者工作特征曲线定义切割评分。测量：除了BPIC-SS，盆腔疼痛和尿急/尿频患者症状量表，间质性膀胱炎症状指数，临床医生对严重程度的总体印象，以及患者对变化的总体印象都包括在观察性研究中。结果和局限性：在CE中，报告的症状为膀胱疼痛、持续性排尿冲动和尿频。在CD中，删除了13项，保留了15项。基于验证分析、定性结果和临床相关性，该工具被减少到8个项目，这些项目具有较强的灵敏度（0.72）和特异性（0.86），切割分数>= 19，以确定临床试验纳入。Psychometric properties were strongly.Conclusions：BPIC-SS是一个可靠的，有效的，适当的问卷选择BPS/间质性膀胱炎患者的临床试验。(C)2011年欧洲泌尿外科协会。由Elsevier B出版。V.保留所有权利。
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. (C) 2011 European Association of Urology. Published by Elsevier B. V. All rights reserved.