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柏林卵巢症状清单(BSCL-O)的开发,用于测量原发性和复发性卵巢癌患者的生活质量:I 期和 II 期研究结果。

Development of the Berlin Symptom Checklist Ovary (BSCL-O) for the measurement of quality of life of patients with primary and recurrent ovarian cancer: results of a phase I and II study.

机构信息

Clinic of Gynecology and Obstetrics, Ernst-Moritz-Arndt University Hospital Greifswald, Greifswald, Germany.

出版信息

Support Care Cancer. 2010 Aug;18(8):931-42. doi: 10.1007/s00520-009-0733-0. Epub 2009 Sep 17.

DOI:10.1007/s00520-009-0733-0
PMID:19760286
Abstract

GOALS OF WORK

Quality of life (Qol) represents a relevant end point in the clinical management of advanced ovarian cancer (AOC). However, there exist only a few specific instruments which have been designed for patients with ovarian cancer. The aim of this study was to develop a systematic checklist (Berlin Symptom Checklist Ovary (BSCL-O)) as an instrument of Qol for patients with AOC and to discriminate between the frequency and the importance of symptoms.

PATIENTS AND METHODS

The main symptoms were identified in a phase I study via free interviews of five patients with ovarian cancer (OC) as well as five medical doctors, family dependent, and care workers. In the phase II study, the capability of BSCL-O was evaluated by questionnaire-guided interviews of 200 patients with primary OC, recurrent OC, metastasized breast cancer, and benign ovarian tumors.

MAIN RESULTS

In phase I, 36 main symptoms were identified. In phase II, 7,200 answers from 98.5% of all patients were evaluable. Of the 36 symptoms of the BSCL-O, 23 revealed clinical relevance. There was a correlation of frequency and importance of symptoms (p < 0.05). The symptoms of the BSCL-O were deemed twice as strenuous in patients with recurrent OC.

CONCLUSIONS

The BSCL-O can measure Qol of patients with OC. The BSCL-O is being validated in a phase III study.

摘要

工作目标

生活质量 (Qol) 是晚期卵巢癌 (AOC) 临床管理的一个重要终点。然而,专门为卵巢癌患者设计的特定工具却为数不多。本研究旨在开发一种系统的检查表(柏林卵巢症状检查表 (BSCL-O))作为 AOC 患者的 Qol 工具,并区分症状的频率和重要性。

患者和方法

在第一阶段研究中,通过对五名卵巢癌 (OC) 患者以及五名医生、家属和护理人员进行自由访谈,确定了主要症状。在第二阶段研究中,通过对 200 名原发性 OC、复发性 OC、转移性乳腺癌和良性卵巢肿瘤患者进行问卷引导访谈,评估了 BSCL-O 的能力。

主要结果

在第一阶段,确定了 36 种主要症状。在第二阶段,可评估来自 98.5%的所有患者的 7200 个答案。BSCL-O 的 36 种症状中有 23 种具有临床相关性。症状的频率和重要性之间存在相关性 (p < 0.05)。复发性 OC 患者的 BSCL-O 症状被认为更为严重。

结论

BSCL-O 可衡量 OC 患者的生活质量。BSCL-O 正在一项 III 期研究中进行验证。

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