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美国国立卫生研究院慢性前列腺炎症状指数:一种新结局指标的制定与验证。慢性前列腺炎协作研究网络。

The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network.

作者信息

Litwin M S, McNaughton-Collins M, Fowler F J, Nickel J C, Calhoun E A, Pontari M A, Alexander R B, Farrar J T, O'Leary M P

机构信息

Department of Urology, University of California, Los Angeles, USA.

出版信息

J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x.

DOI:10.1016/s0022-5347(05)68562-x
PMID:10411041
Abstract

PURPOSE

Chronic abacterial prostatitis is a syndrome characterized by pelvic pain and voiding symptoms, which is poorly defined, poorly understood, poorly treated and bothersome. Research and clinical efforts to help men with this syndrome have been hampered by the absence of a widely accepted, reliable and valid instrument to measure symptoms and quality of life impact. We developed a psychometrically valid index of symptoms and quality of life impact for men with chronic prostatitis.

MATERIALS AND METHODS

We conducted a structured literature review of previous work to provide a foundation for the new instrument. We then conducted a series of focus groups comprising chronic prostatitis patients at 4 centers in North America, in which we identified the most important symptoms and effects of the condition. The results were used to create an initial draft of 55 questions that were used for formal cognitive testing on chronic prostatitis patients at the same centers. After expert panel review formal validation testing of a revised 21-item draft was performed in a diverse group of chronic prostatitis patients and 2 control groups of benign prostatic hyperplasia patients and healthy men. Based on this validation study, the index was finalized.

RESULTS

Analysis yielded an index of 9 items that address 3 different aspects of the chronic prostatitis experience. The primary component was pain, which we captured in 4 items focused on location, severity and frequency. Urinary function, another important component of symptoms, was captured in 2 items (1 irritative and 1 obstructive). Quality of life impact was captured with 3 items about the effect of symptoms on daily activities. The 9 items had high test-retest reliability (r = 0.83 to 0.93) and internal consistency (alpha = 0.86 to 0.91). All but the urinary items discriminated well between men with and without chronic prostatitis.

CONCLUSIONS

The National Institutes of Health chronic prostatitis symptom index provides a valid outcome measure for men with chronic prostatitis. The index is psychometrically robust, easily self-administered and highly discriminative. It was formally developed and psychometrically validated, and may be useful in clinical practice as well as research protocols.

摘要

目的

慢性非细菌性前列腺炎是一种以盆腔疼痛和排尿症状为特征的综合征,其定义不明确、理解不足、治疗效果不佳且令人困扰。由于缺乏一种被广泛接受、可靠且有效的工具来测量症状及对生活质量的影响,帮助患有该综合征男性的研究和临床工作受到了阻碍。我们为患有慢性前列腺炎的男性开发了一种在心理测量学上有效的症状及生活质量影响指数。

材料与方法

我们对先前的研究进行了结构化文献综述,为新工具奠定基础。然后我们在北美4个中心组织了一系列由慢性前列腺炎患者组成的焦点小组,在这些小组中我们确定了该疾病最重要的症状和影响。结果用于创建一个包含55个问题的初稿,该初稿在相同中心的慢性前列腺炎患者中进行了正式的认知测试。经过专家小组评审后,对修订后的21项草案在不同组的慢性前列腺炎患者以及2组良性前列腺增生患者和健康男性的对照组中进行了正式的验证测试。基于这项验证研究,该指数最终确定。

结果

分析得出一个包含9个项目的指数,该指数涵盖了慢性前列腺炎经历的3个不同方面。主要组成部分是疼痛,我们通过4个关注疼痛部位、严重程度和频率的项目来体现。排尿功能是症状的另一个重要组成部分,通过2个项目(1个刺激性项目和1个梗阻性项目)来体现。生活质量影响通过3个关于症状对日常活动影响的项目来体现。这9个项目具有较高的重测信度(r = 0.83至0.93)和内部一致性(α = 0.86至0.91)。除了排尿项目外,所有项目在慢性前列腺炎患者和非慢性前列腺炎患者之间都有很好的区分度。

结论

美国国立卫生研究院慢性前列腺炎症状指数为患有慢性前列腺炎的男性提供了一种有效的结局测量方法。该指数在心理测量学上很稳健,易于自我管理且具有高度区分性。它经过了正式开发和心理测量学验证,可能在临床实践以及研究方案中有用。

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