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Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials.测量慢性阻塞性肺疾病的呼吸道症状:三项临床试验中EXACT-呼吸道症状工具(E-RS)的性能。
Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
2
The PROactive innovative conceptual framework on physical activity.关于身体活动的积极创新概念框架。
Eur Respir J. 2014 Nov;44(5):1223-33. doi: 10.1183/09031936.00004814. Epub 2014 Jul 17.
3
Measuring respiratory symptoms in clinical trials of COPD: reliability and validity of a daily diary.在 COPD 临床试验中测量呼吸症状:日常日记的可靠性和有效性。
Thorax. 2014 May;69(5):443-9. doi: 10.1136/thoraxjnl-2013-204428. Epub 2014 Mar 4.
4
Item selection, reliability and validity of the Shortness of Breath with Daily Activities (SOBDA) questionnaire: a new outcome measure for evaluating dyspnea in chronic obstructive pulmonary disease.项目选择、日常活动呼吸困难问卷(SOBDA)的信度和效度:一种用于评估慢性阻塞性肺疾病呼吸困难的新的结局测量指标。
Health Qual Life Outcomes. 2013 Nov 14;11:196. doi: 10.1186/1477-7525-11-196.
5
Characteristics, stability and outcomes of the 2011 GOLD COPD groups in the ECLIPSE cohort.2011 GOLD COPD 分组在 ECLIPSE 队列中的特征、稳定性和结局。
Eur Respir J. 2013 Sep;42(3):636-46. doi: 10.1183/09031936.00195212. Epub 2013 Jun 13.
6
Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.报告随机试验中患者报告结局的方法:CONSORT PRO 扩展。
JAMA. 2013 Feb 27;309(8):814-22. doi: 10.1001/jama.2013.879.
7
Clinical COPD Questionnaire score (CCQ) and mortality.临床慢性阻塞性肺病问卷评分(CCQ)与死亡率。
Int J Chron Obstruct Pulmon Dis. 2012;7:833-42. doi: 10.2147/COPD.S38119. Epub 2012 Dec 20.
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Validation of a new questionnaire with generic and disease-specific qualities: the McGill COPD Quality of Life Questionnaire.验证一种具有通用和疾病特异性质量的新问卷:麦吉尔 COPD 生活质量问卷。
Can Respir J. 2012 Nov-Dec;19(6):367-72. doi: 10.1155/2012/914138.
9
Evaluation of Quality of Life instruments for use in COPD care and research: a systematic review.评估用于 COPD 护理和研究的生活质量工具:系统评价。
Int J Nurs Stud. 2013 May;50(5):688-707. doi: 10.1016/j.ijnurstu.2012.07.017. Epub 2012 Aug 24.
10
Proposing a standardized method for evaluating patient report of the intensity of dyspnea during exercise testing in COPD.提出一种评估 COPD 患者运动试验中呼吸困难强度的标准化方法。
Int J Chron Obstruct Pulmon Dis. 2012;7:345-55. doi: 10.2147/COPD.S29571. Epub 2012 May 28.

慢性阻塞性肺疾病中最常见的患者报告结局综述——回顾现有知识并预估未来挑战。

A review of the most common patient-reported outcomes in COPD--revisiting current knowledge and estimating future challenges.

作者信息

Cazzola Mario, Hanania Nicola Alexander, MacNee William, Rüdell Katja, Hackford Claire, Tamimi Nihad

机构信息

University of Rome 'Tor Vergata', Department of Medicine of Systems, Unit of Respiratory Clinical Pharmacology, Rome, Italy.

Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, TX, USA.

出版信息

Int J Chron Obstruct Pulmon Dis. 2015 Apr 7;10:725-38. doi: 10.2147/COPD.S77368. eCollection 2015.

DOI:10.2147/COPD.S77368
PMID:25897216
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4396518/
Abstract

Patient-reported outcome (PRO) measures that quantify disease impact have become important measures of outcome in COPD research and treatment. The objective of this literature review was to comprehensively evaluate psychometric properties of available PRO instruments and the ability of each of them to characterize pharmaceutical treatment effects from published clinical trial evidence. Identified in this study were several PRO measures, both those that have been used extensively in COPD clinical trials (St George's Respiratory Questionnaire and Chronic Respiratory Questionnaire) and new instruments whose full value is still to be determined. This suggests a great need for more information about the patient experience of treatment benefit, but this also may pose challenges to researchers, clinicians, and other important stakeholders (eg, regulatory agencies, pharmaceutical companies) who develop new treatment entities and payers (including but not limited to health technology assessment agencies such as the National Institute for Health and Care Excellence and the Canadian Agency for Drugs and Technologies in Health). The purpose of this review is to enable researchers and clinicians to gain a broad overview of PRO measures in COPD by summarizing the value and purpose of these measures and by providing sufficient detail for interested audiences to determine which instrument may be the most suitable for evaluating a particular research purpose.

摘要

量化疾病影响的患者报告结局(PRO)指标已成为慢性阻塞性肺疾病(COPD)研究和治疗中重要的结局指标。本综述的目的是全面评估现有PRO工具的心理测量特性,以及它们根据已发表的临床试验证据表征药物治疗效果的能力。本研究确定了几种PRO指标,既有在COPD临床试验中广泛使用的指标(圣乔治呼吸问卷和慢性呼吸问卷),也有其全部价值仍有待确定的新工具。这表明非常需要更多关于患者治疗获益体验的信息,但这也可能给开发新治疗实体的研究人员、临床医生和其他重要利益相关者(如监管机构、制药公司)以及支付方(包括但不限于像英国国家卫生与临床优化研究所和加拿大卫生技术评估局这样的卫生技术评估机构)带来挑战。本综述的目的是通过总结这些指标的价值和用途,并为感兴趣的读者提供足够的细节,以便他们确定哪种工具可能最适合评估特定的研究目的,从而使研究人员和临床医生能够全面了解COPD中的PRO指标。