Samolsky Dekel Boaz Gedaliahu, Gori Alberto, Gunnellini Marco, Gioia Angela, Di Marco Mariacristina, Casale Giuseppe, Bevilacqua Marzio, Bersani Pietro, Melotti Rita Maria
Department of Medicine and Surgery Sciences, University of Bologna, via Massarenti n. 9, 40138, Bologna, Italy.
Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi, Via Massarenti n. 9, 40138, Bologna, Italy.
Pain Ther. 2021 Dec;10(2):1171-1188. doi: 10.1007/s40122-021-00274-9. Epub 2021 Jun 6.
The literature lacks formally validated and reliable tools for the diagnosis of breakthrough cancer pain (BTcP). The Italian Questionnaire for BTcP diagnosis (IQ-BTP) is an 11-item questionnaire aimed at detecting potential-BTP and classifying it into three likelihood classes: high, intermediate, and low.
A multicenter, prospective, and observational study was designed to validate the IQ-BTP. In three consecutive visits with each cancer patient, the demographic and clinical details of the patient, the Brief Pain Inventory (BPI) scores, IQ-BTP outcomes, and clinicians' autonomous BTcP diagnosis (gold standard) and the agreement of this diagnosis with IQ-BTP outcomes were recorded. The assessed domains for IQ-BTP validation were: Validity, including content and face validity, construct validity (hypothesis testing, and cross-cultural validity\measurement invariance), and criterion validity; Reliability (internal consistency, reliability, and measurement error); Interpretability, and Responsiveness.
Seven palliative and pain management facilities in Italy recruited 280 patients, yielding 753 evaluations. Using the IQ-BTP, the rate of potential-BTcP was 27.2%, of which its likely presence was high in 52.7% of patients, intermediate in 38.5, and low in 8.8%. The BPI item scores differed significantly between the two IQ-BTP classes (no-BTcP and potential-BTcP classes). The correlation of the latter class with BPI items was significant but low. The IQ-BTcP showed two principal components, accounting for 66.6% of the variance. Cronbach's α was 0.71. The agreement rate between the gold standard and IQ-BTP outcomes was 82%. Cohen's [Formula: see text] was 0.535. The IQ-BTP showed sensitivity and specificity of 69 and 86%, respectively.
The IQ-BTP extensive formal validation showed satisfactory psychometric and validity properties. Its content, face, construct, and criterion validities and its reliability, interpretability, and responsiveness were shown. Its use enabled potential-BTcP to be identified and differentiated into three likelihood classes with direct therapeutic and epidemiological implications. The latter may be confirmed in future studies.
目前文献中缺乏用于诊断爆发性癌痛（BTcP）的经过正式验证且可靠的工具。意大利BTcP诊断问卷（IQ - BTP）是一份包含11个条目的问卷，旨在检测潜在的BTcP并将其分为三个可能性类别：高、中、低。
设计了一项多中心、前瞻性观察性研究来验证IQ - BTP。在对每位癌症患者进行的连续三次就诊中，记录患者的人口统计学和临床详细信息、简明疼痛量表（BPI）评分、IQ - BTP结果、临床医生的自主性BTcP诊断（金标准）以及该诊断与IQ - BTP结果的一致性。用于IQ - BTP验证的评估领域包括：效度，包括内容效度和表面效度、结构效度（假设检验和跨文化效度\测量不变性）以及效标效度；信度（内部一致性、可靠性和测量误差）；可解释性和反应性。
意大利的7家姑息治疗和疼痛管理机构招募了280名患者，共进行了753次评估。使用IQ - BTP，潜在BTcP的发生率为27.2%，其中52.7%的患者其存在可能性高，38.5%为中等，8.8%为低。在IQ - BTP的两个类别（无BTcP和潜在BTcP类别）之间，BPI条目得分存在显著差异。后一类与BPI条目的相关性显著但较低。IQ - BTcP显示出两个主要成分，占方差的66.6%。Cronbach's α为0.71。金标准与IQ - BTP结果之间的一致率为82%。Cohen's κ为0.535。IQ - BTP的敏感性和特异性分别为69%和86%。
IQ - BTP广泛的正式验证显示出令人满意的心理测量学和效度特性。展示了其内容效度、表面效度、结构效度和效标效度以及信度、可解释性和反应性。其使用能够识别潜在的BTcP并将其分为三个可能性类别，具有直接的治疗和流行病学意义。后者可能在未来的研究中得到证实。
