Abstract：
OBJECTIVE: 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.
METHODS: 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.
CONCLUSIONS: 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.
METHODS: 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.
CONCLUSIONS: 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.
摘要：
目的：本文描述了一项评估西班牙局部晚期或转移性非小细胞肺癌（NSCLC）患者口服化疗（OCT）依从性的研究方案。
方法：这个多中心，观察,前瞻性研究将由6家西班牙医院的6名医院药剂师进行。该研究将包括年龄在18岁或以上的男性和女性，诊断为正在接受治疗或已接受OCT处方的局部晚期或转移性NSCLC。一旦包括在内，患者将积极并前瞻性随访3个月，包括4次研究访问，以记录社会人口统计学变量的信息，抗肿瘤治疗和依从性，药学服务,临床变量，和患者报告的结果(PRO)(EQ-5D的3级版本，EORTC核心生活质量问卷，简要的疾病感知问卷，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)。纳入患者后12个月，我们将记录有关疾病进展状况和处方的信息。主要结果是治疗依从性的百分比，将根据药丸计数计算如下：分配的药丸数量减去未使用的药丸数量之间的差异将除以治疗天数乘以肿瘤学家规定的药丸数量/天;该商将乘以100以获得依从性百分比。根据药丸计数和解，依从率>80%的患者将主要归类为依从。其次，治疗依从性也将根据覆盖天数的比例和4项MoriskyGreenLevine药物依从性量表进行计算。分析患者和治疗特点对依从性的影响，将使用不同的坚持截止点进行双变量分析。通过无进展生存期评估依从性对治疗疗效的影响，我们将使用Kaplan-Meier方法，并将其与对数秩检验和单变量Cox回归分析进行比较。
结论：我们希望我们的研究将提供有关遵守OCT的关键方面的初步信息（即，测量,主持人，和障碍)及其与NSCLC患者和临床相关结局的关系，这些信息将有助于设计药物干预措施以提高依从性。
方法：这个多中心，观察,前瞻性研究将由6家西班牙医院的6名医院药剂师进行。该研究将包括年龄在18岁或以上的男性和女性，诊断为正在接受治疗或已接受OCT处方的局部晚期或转移性NSCLC。一旦包括在内，患者将积极并前瞻性随访3个月，包括4次研究访问，以记录社会人口统计学变量的信息，抗肿瘤治疗和依从性，药学服务,临床变量，和患者报告的结果(PRO)(EQ-5D的3级版本，EORTC核心生活质量问卷，简要的疾病感知问卷，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)。纳入患者后12个月，我们将记录有关疾病进展状况和处方的信息。主要结果是治疗依从性的百分比，将根据药丸计数计算如下：分配的药丸数量减去未使用的药丸数量之间的差异将除以治疗天数乘以肿瘤学家规定的药丸数量/天;该商将乘以100以获得依从性百分比。根据药丸计数和解，依从率>80%的患者将主要归类为依从。其次，治疗依从性也将根据覆盖天数的比例和4项MoriskyGreenLevine药物依从性量表进行计算。分析患者和治疗特点对依从性的影响，将使用不同的坚持截止点进行双变量分析。通过无进展生存期评估依从性对治疗疗效的影响，我们将使用Kaplan-Meier方法，并将其与对数秩检验和单变量Cox回归分析进行比较。
结论：我们希望我们的研究将提供有关遵守OCT的关键方面的初步信息（即，测量,主持人，和障碍)及其与NSCLC患者和临床相关结局的关系，这些信息将有助于设计药物干预措施以提高依从性。
