Mangues-Bafalluy Irene, Bernárdez Beatriz, Martínez-Sesmero José Manuel, Navarro-Ruiz Andres, Rubio-Salvador Ana Rosa, Martín-Conde Maria Teresa
Pharmacy Department, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain; Grupo de Farmacoepidemiología y Farmacodinamia, Institut de Recerca Biomèdica, IRBLLeida, Lleida, Spain.
Departamento de Medicina, Universidad de Santiago de Compostela, Santiago, Spain; Unidad de Farmacia Oncológica, Servicio de Farmacia, Hospital Clínico Universitario de Santiago de Compostela, Santiago, Spain; Grupo de Farmacología, Instituto de Investigación Santiago de Compostela (IDIS), Santiago, Spain.
Farm Hosp. 2025 Mar-Apr;49(2):117-121. doi: 10.1016/j.farma.2024.05.016. Epub 2024 Jul 14.
This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain.
This multicenter, observational, prospective study will be conducted by 6 hospital pharmacists from 6 Spanish hospitals. The study will include men and women aged 18 years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3 months, including 4 study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence >80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis.
We expect that our study will provide initial information on key aspects of adherence to OCT (i.e., measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.
本文描述了一项在西班牙对局部晚期或转移性非小细胞肺癌（NSCLC）患者口服化疗（OCT）依从性进行评估的研究方案。
这项多中心、观察性、前瞻性研究将由来自6家西班牙医院的6名医院药剂师开展。研究将纳入年龄在18岁及以上、诊断为局部晚期或转移性NSCLC且正在接受或已被开具OCT治疗的男性和女性。一旦被纳入，患者将被积极随访3个月，包括4次研究访视，以记录社会人口统计学变量、抗肿瘤治疗及依从性、药学服务、临床变量以及患者报告结局（PRO）（EQ-5D的3级版本、欧洲癌症研究与治疗组织核心生活质量问卷、简短疾病认知问卷、药物治疗满意度问卷以及不良事件通用术语标准的PRO版本）。在患者纳入12个月后，我们将记录疾病进展状态和配药处方信息。主要结局是治疗依从性百分比，将通过药丸计数法计算如下：配药数量减去未使用药丸数量的差值除以治疗天数，再乘以肿瘤学家规定的每日药丸数量；该商数将乘以100以获得依从性百分比。基于该药丸计数核对，依从性百分比>80%的患者将主要被归类为依从。其次，治疗依从性还将根据覆盖天数比例和4项Morisky Green Levine药物依从性量表进行计算。为分析患者和治疗特征对依从性的影响，将使用不同的依从性截断点进行双变量分析。为评估依从性对无进展生存期评估的治疗疗效的影响，我们将使用Kaplan-Meier方法，并与对数秩检验和单变量Cox回归分析进行比较。
我们期望我们的研究将提供关于OCT依从性关键方面（即测量、促进因素和障碍）及其与NSCLC患者及临床相关结局关系的初步信息，并且该信息将有助于设计提高依从性的药学干预措施。
