Purpose: The aim of this study was to compare estimates of adherence to oral endocrine therapy (OET) based on real-world data (RWD) and on clinical evaluation in people diagnosed with breast cancer in the public healthcare system in Catalonia (Spain). Methods: We conducted two retrospective cohort studies. Cohort 1 (RWD) consisted of women diagnosed with breast cancer in 2021 in the public healthcare system of Catalonia (Spain). Sources of RWD were the pharmacy billing register, hospital discharge records, and the Catalan health division’s central insurance registry. Nonadherence was defined as below 80% adherence in the first year of treatment. Data for cohort 2 came from two population-based cancer registries in Girona and Tarragona (Catalonia), with diagnoses from 2007 to 2011. We evaluated the impact of variables missing from RWD, such as stage and hormonal status. Analyses were performed using a chi-square test and logistic regression, with results stratified by age group and drug type. Results: Nonadherence at one year was 10.9% in cohort 1 and 11.3% in cohort 2. When we reviewed the medical records of a selection of nonadherent women from cohort 1, we found only 59.4% had documented treatment interruptions. Reasons for interruptions in the patients from RWD cohort included adverse effects (48.8%), patient decision (40.0%), medical reasons (29.4%), and other clinical causes (14.7%). Women aged under 50 years and those receiving tamoxifen or a sequential regimen had lower adherence. Determinants associated with nonadherence were similar in both approaches used. Conclusions: This study confirms the validity of estimating adherence with RWD from the Spanish national health system, although when combined with reviewing medical records, this may provide more reliable and higher-quality data. The RWD method provides valuable evidence to help oncologists discuss adherence with their patients.
目的：本研究旨在比较基于真实世界数据与临床评估对西班牙加泰罗尼亚公共卫生系统中乳腺癌患者口服内分泌治疗依从性的评估结果。方法：我们进行了两项回顾性队列研究。队列1（真实世界数据组）纳入2021年在西班牙加泰罗尼亚公共卫生系统确诊的乳腺癌女性患者。真实世界数据来源于药房结算记录、住院病历以及加泰罗尼亚卫生部门中央保险登记库。治疗依从性不足定义为治疗第一年内依从性低于80%。队列2数据来源于赫罗纳和塔拉戈纳（加泰罗尼亚地区）的两个基于人群的癌症登记库，纳入2007年至2011年确诊的患者。我们评估了真实世界数据中缺失变量（如分期和激素状态）的影响。采用卡方检验和逻辑回归进行分析，结果按年龄组和药物类型分层。结果：治疗一年后，队列1的依从性不足率为10.9%，队列2为11.3%。当我们审查队列1中部分依从性不足患者的医疗记录时，发现仅有59.4%的患者有明确记录的治疗中断。真实世界数据队列中患者中断治疗的原因包括不良反应（48.8%）、患者自行决定（40.0%）、医疗原因（29.4%）及其他临床原因（14.7%）。50岁以下女性以及接受他莫昔芬或序贯治疗方案的患者依从性较低。两种评估方法确定的依从性不足相关决定因素相似。结论：本研究证实了利用西班牙国家卫生系统真实世界数据评估治疗依从性的有效性，但结合医疗记录审查可获得更可靠、更高质量的数据。真实世界数据方法为肿瘤科医生与患者讨论治疗依从性提供了有价值的证据支持。
肿瘤(癌症)患者之家