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利用真实世界数据研究长期乳腺癌幸存者的医疗服务利用情况和合并症(SURBCAN研究):一项基于人群的纵向队列研究方案

Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study.

作者信息

Jansana Anna, Del Cura Isabel, Prados-Torres Alexandra, Sanz Cuesta Teresa, Poblador-Plou Beatriz, Gimeno Miguel A, Lanzuela Manuela, Ibañez Berta, Tamayo Ibai, Moreno-Iribas Conchi, Padilla-Ruiz María, Redondo Maximino, Comas Mercè, Domingo Laia, Díaz-Holgado Antonio, Salamanca Francisco Javier, Castells Xavier, Sala Maria

机构信息

Department of Epidemiology and Evaluation, Hospital del Mar Institute for Medical Research, Barcelona, Barcelona, Spain.

Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Madrid, Spain.

出版信息

BMJ Open. 2020 Sep 9;10(9):e040253. doi: 10.1136/bmjopen-2020-040253.

DOI:10.1136/bmjopen-2020-040253
PMID:32912957
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7482495/
Abstract

INTRODUCTION

Breast cancer has become a chronic disease due to survival improvement and the need to monitor the side effects of treatment and the disease itself. The aim of the SURBCAN study is to describe comorbidity, healthcare services use and adherence to preventive recommendations in long-term breast cancer survivors and to compare them with those in women without this diagnosis in order to improve and adapt the care response to this group of survivors.

METHODS AND ANALYSIS

Population-based retrospective cohort study using real-world data from cancer registries and linked electronic medical records in five Spanish regions. Long-term breast cancer survivors diagnosed between 2000 and 2006 will be identified and matched by age and administrative health area with women without this diagnosis. Sociodemographic and clinical variables including comorbidities and variables on the use of health services between 2012 and 2016 will be obtained from databases in primary and hospital care. Health services use will be assessed through the annual number of visits to primary care professionals and to specialists and through annual imaging and laboratory tests. Factors associated with healthcare utilisation and comorbidities will be analysed using multilevel logistic regression models. Recruitment started in December 2018.

ETHICS AND DISSEMINATION

This study was approved by the Ethics Committee of Parc de Salut Mar. The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations.

TRIAL REGISTRATION NUMBER

This protocol is registered in Clinical Trials.gov (identifier: NCT03846999).

摘要

引言

由于生存率的提高以及监测治疗副作用和疾病本身的需要,乳腺癌已成为一种慢性病。SURBCAN研究的目的是描述长期乳腺癌幸存者的合并症、医疗服务使用情况以及对预防性建议的依从性,并将其与未患此病的女性进行比较,以便改进和调整针对这组幸存者的护理应对措施。

方法与分析

基于人群的回顾性队列研究,使用来自西班牙五个地区癌症登记处的真实世界数据以及关联的电子病历。将识别出2000年至2006年间确诊的长期乳腺癌幸存者,并按年龄和行政区将其与未患此病的女性进行匹配。2012年至2016年间的社会人口统计学和临床变量,包括合并症以及医疗服务使用变量,将从基层医疗和医院护理数据库中获取。医疗服务使用情况将通过每年拜访基层医疗专业人员和专科医生的次数以及每年的影像学和实验室检查来评估。将使用多水平逻辑回归模型分析与医疗服务利用和合并症相关的因素。招募工作于2018年12月开始。

伦理与传播

本研究已获得圣保禄医院伦理委员会的批准。研究结果将发表在同行评审期刊上,并将在国内和国际科学会议以及患者协会上公布。

试验注册号

本方案已在ClinicalTrials.gov注册(标识符:NCT03846999)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e92/7482495/0548108f21d3/bmjopen-2020-040253f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e92/7482495/d3bcfdb88a00/bmjopen-2020-040253f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e92/7482495/0548108f21d3/bmjopen-2020-040253f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e92/7482495/d3bcfdb88a00/bmjopen-2020-040253f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e92/7482495/0548108f21d3/bmjopen-2020-040253f02.jpg

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