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生物标志物、临床病程和初级保健中 COPD 患者的个体需求:斯德哥尔摩 COPD 炎症队列(SCOPIC)研究方案。

Biomarkers, Clinical Course, and Individual Needs in COPD Patients in Primary Care: The Study Protocol of the Stockholm COPD Inflammation Cohort (SCOPIC).

机构信息

Academic Primary Health Care Centre, Stockholm County Council, Stockholm, Sweden.

Division of Family Medicine and Primary Care, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.

出版信息

Int J Chron Obstruct Pulmon Dis. 2022 May 2;17:993-1004. doi: 10.2147/COPD.S358056. eCollection 2022.

Abstract

BACKGROUND

To facilitate effective personalized medicine, primary health care needs better methods of assessing and monitoring chronic obstructive pulmonary disease (COPD).

AIM

This cohort study aims to investigate how biomarkers relate to clinical characteristics and COPD patients' subjective needs over time.

METHODS

Patients (n=750) in different COPD severity according to the GOLD criteria and age- and sex-matched controls (n=750) will be recruited over a period of 5 years from 15 primary health care centers in Region Stockholm, Sweden, and followed for 10 years in the first instance. Data on patients' subjective needs will be collected via telephone/email, data on clinical/physiological variables (eg, symptoms, exacerbations, comorbidities, medications, smoking habits, lung function) from existing databases that are based on medical records, and data on biomarkers via repeated blood sampling. Quantitative and qualitative methods will be used. Initial results are expected after 2 years (feasibility test), and a larger body of evidence after 5 years.

DISCUSSION

The study is expected to provide definitive and clinically useful scientific evidence about how biomarkers relate to clinical variables and patients' subjective needs. This new evidence will facilitate accurate, and personalized COPD management by the use of valid biomarkers. It will provide useful tools for primary care professionals and may facilitate optimal self-management.

摘要

背景

为了促进有效的个体化医学,基层医疗需要更好的方法来评估和监测慢性阻塞性肺疾病(COPD)。

目的

本队列研究旨在探讨生物标志物与临床特征以及 COPD 患者主观需求随时间的变化关系。

方法

根据 GOLD 标准,将不同 COPD 严重程度的患者(n=750)和年龄、性别匹配的对照者(n=750)在瑞典斯德哥尔摩地区的 15 个基层医疗中心招募,为期 5 年,并在最初的 10 年内进行随访。将通过电话/电子邮件收集患者主观需求的数据,通过基于病历的现有数据库收集临床/生理变量(如症状、加重、合并症、药物、吸烟习惯、肺功能)的数据,并通过重复采血收集生物标志物数据。将使用定量和定性方法。预计在 2 年后(可行性测试)将获得初步结果,在 5 年后将获得更多的证据。

讨论

该研究有望提供关于生物标志物与临床变量和患者主观需求之间关系的明确和临床有用的科学证据。这种新的证据将通过使用有效的生物标志物促进 COPD 的准确和个体化管理。它将为基层医疗专业人员提供有用的工具,并可能促进最佳的自我管理。

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