Research Unit, Galdakao-Usansolo Hospital [Osakidetza] - Health Services Research on Chronic Patients Network [REDISSEC], Barrio Labeaga s/n, 48960, Galdakao, Bizkaia, Spain.
Research Unit, Universitario Donostia Hospital - REDISSEC, BioDonostia Health Research Institute, Donostia, Gipuzkoa, Spain.
BMC Cancer. 2018 Jan 8;18(1):54. doi: 10.1186/s12885-017-3926-9.
Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis.
Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study.
Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment.
Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system.
The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications.
NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .
尽管乳腺癌仍是一个主要的健康问题，但对于该疾病患者所接受的医疗保健服务及其相关费用，我们知之甚少。此外，西班牙还需要更新和验证风险分层工具。我们的目的是评估西班牙的乳腺癌卫生服务，从筛查和诊断到治疗和预后。
这是一项涉及西班牙 13 家医院的前瞻性队列研究，随访时间最长为诊断性活检后 5 年。纳入标准：2013 年 4 月至 2015 年 5 月期间诊断为乳腺癌且同意参与研究的患者。
将收集以下数据：干预前的病史、生物学、临床和社会人口统计学特征、癌症检测方式、住院、治疗和初始治疗后 5 年内的结局。患者在开始初始治疗前和随访结束时（2 年后）填写有关生活质量的问卷（欧洲五维健康量表（EQ-5D-5L）、欧洲癌症研究与治疗组织核心调查问卷（EORTC QLQ-C30）联合乳腺癌特定模块（QLQ-BR23），以及医院焦虑和抑郁量表）。研究的终点是健康相关生活质量的变化、复发、并发症和初始治疗后 2 年和 5 年的再入院情况。
将计算描述性统计数据，并在适当情况下使用多变量模型来调整潜在的混杂因素。为了创建和验证预测模型，将进行拆分验证和引导抽样。将从国家卫生系统的角度进行成本分析。
该协作项目的结果预计将产生具有科学依据且具有临床和社会重要意义的信息，为管理者和负责确保平等护理过程和健康结局的当局的决策提供信息。对于临床医生，将制定临床预测规则，预计这些规则将为软件开发应用程序提供基础。
NCT02439554。注册日期：2015 年 5 月 8 日（回溯性注册）。
