Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form.

Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form.
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DOI:
10.1016/j.urology.2014.08.044
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发表时间:
2015-01
期刊:
影响因子:
2.1
通讯作者:
PROSTQA Consortium
PROSTQA Consortium
中科院分区:
医学4区
文献类型:
--
作者:
Skolarus TA;Dunn RL;Sanda MG;Chang P;Greenfield TK;Litwin MS;Wei JT;PROSTQA Consortium

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建立一个评分阈值,该阈值构成扩展前列腺癌指数复合-简短形式(EPIC-26)的每个域的临床相关变化。虽然它在临床实践和临床试验中的应用在世界范围内越来越多,但对局限性前列腺癌男性患者报告的26项疾病特异性生活质量问卷的临床解释将通过临床相关变化(最小重要差异,或MID)的评分阈值特征来促进。我们采用了基于分布和锚定的方法来建立每个EPIC-26结构域(泌尿、性器官、肠道、激素)的MID范围,该研究基于一项前瞻性、多机构队列研究,该队列在2003年至2006年期间接受前列腺癌治疗的1,201名男性,并在治疗后随访3年。对于基于锚点的方法,我们将每个领域的受试者评分变化与总体癌症治疗满意度的外部“锚点”测量进行了比较。我们发现肠道和活力/激素领域的MID范围最低(4-6点的变化应被认为是临床相关的),而性领域的MID值最高(10-12)。与尿刺激/梗阻区(5-7)相比,尿失禁似乎有更大的MID范围(6-9)。使用两种独立的方法,我们建立了每个EPIC-26域的最小重要差异。这些MID值的定义对于研究人员或临床医生了解前列腺癌幸存者症状负担的变化何时具有临床相关性至关重要。
To establish a score threshold that constitutes a clinically relevant change for each domain of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26). While its use in clinical practice and clinical trials has increased worldwide, the clinical interpretation of this 26-item disease-specific patient-reported quality of life questionnaire for men with localized prostate cancer would be facilitated by characterization of score thresholds for clinically relevant change (the minimally important differences, or MID). We used distribution- and anchor-based approaches to establish the MID range for each EPIC-26 domain (urinary, sexual, bowel, hormonal) based on a prospective, multi-institutional cohort of 1,201 men treated for prostate cancer between 2003 and 2006 and followed for 3 years after treatment. For the anchor-based approach, we compared within/between subject score changes for each domain to an external “anchor” measure of overall cancer treatment satisfaction. We found the bowel and vitality/hormonal domains to have the lowest MID range (a 4–6 point change should be considered clinically relevant), while the sexual domain had the greatest MID values (10–12). Urinary incontinence appeared to have a greater MID range (6–9) compared with the urinary irritation/obstruction domain (5–7). Using two independent approaches, we established the minimally important differences for each EPIC-26 domain. Definition of these MID values is essential for the researcher or clinician to understand when changes in symptom burden among prostate cancer survivors are clinically relevant.
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