1 Medical Oncology, Guy's Hospital, London, UK 2 AstraZeneca, Macclesfield, Cheshire, UK 3 Evanston Northwestern Healthcare, Evanston, Illinois, USA.
Patient. 2008 Apr 1;1(2):105-13. doi: 10.2165/01312067-200801020-00006.
Hand-held electronic devices may provide a simple reproducible means by which quality of life (QOL) may be documented in patients with cancer. However, the QOL scales that are routinely used were originally validated when used with paper and pencil data collection. Patient-reported outcomes acquired using hand-held electronic devices (electronic patient-reported outcomes [e-PRO]) may not be the same as those acquired using paper and pencil, so validation of this method of data collection is needed.
This study aimed to compare the results of e-PRO and paper and pencil collection of Functional Assessment of Cancer Therapy-Lung (FACT-L) and EuroQol-5 Dimension (EQ-5D) QOL data in patients with advanced non-small cell lung cancer (NSCLC), and to ascertain patients' preferences for the different modes of collection.
This randomized, single-cohort, crossover study was performed in a tertiary referral hospital cancer center. Fifty patients with previously treated locally advanced or metastatic NSCLC were randomized in a 1 : 1 ratio to complete either paper versions of the questionnaires (FACT-L and EQ-5D) followed by the e-PRO versions, or the e-PRO questionnaire followed by the paper versions.
The majority (88%) of the FACT-L and all (100%) of the EQ-5D individual question responses were within ±1 point of each other when data collection via e-PRO and via pencil and paper were compared. There was no significant difference between the mean total FACT-L scores obtained using the two methods; however, 29% of patients had a difference between FACT-L total scores obtained with the two methods that was greater than ±6 points. The mean completion time was shorter for the paper and pencil method than the e-PRO method (p < 0.0001). However, most patients stated that they preferred the e-PRO method over paper and pencil (60% vs 12%).
This study suggests that the mode of administration of the FACT-L and EQ-5D had a relatively small effect on the mean responses given to the questionnaires in patients with advanced NSCLC. However, at the individual patient level, data varied considerably between the different modes of administration. Therefore, the group results obtained using the e-PRO should be similar to the originally validated paper method, with the advantages of improved patient acceptability and ease of reliable interfacing with trial databases.
手持式电子设备可能提供了一种简单、可重复的方法，可用于记录癌症患者的生活质量（QOL）。然而，常规使用的 QOL 量表最初是在使用纸笔数据收集时进行验证的。使用手持式电子设备获得的患者报告结果（电子患者报告结果[e-PRO]）可能与使用纸笔获得的结果不同，因此需要对这种数据收集方法进行验证。
本研究旨在比较使用手持式电子设备和纸笔收集晚期非小细胞肺癌（NSCLC）患者的功能性评估癌症治疗-肺（FACT-L）和欧洲五维健康量表（EQ-5D）QOL 数据的结果，并确定患者对不同采集模式的偏好。
这是一项在三级转诊癌症中心进行的随机、单队列、交叉研究。50 例先前接受过局部晚期或转移性 NSCLC 治疗的患者以 1：1 的比例随机分为两组，一组先完成纸质问卷（FACT-L 和 EQ-5D），再完成电子问卷；另一组先完成电子问卷，再完成纸质问卷。
当比较通过 e-PRO 和纸笔收集的数据时，大多数（88%）FACT-L 和所有（100%）EQ-5D 个体问题的答案相差在±1 个点内。两种方法获得的 FACT-L 总分平均值之间无显著差异；然而，29%的患者两种方法获得的 FACT-L 总分差值大于±6 分。纸笔法的平均完成时间短于 e-PRO 法（p<0.0001）。然而，大多数患者表示他们更喜欢 e-PRO 法而不是纸笔法（60%比 12%）。
本研究表明，在晚期 NSCLC 患者中，FACT-L 和 EQ-5D 的管理模式对问卷的平均应答影响相对较小。然而，在个体患者层面，不同管理模式之间的数据差异很大。因此，使用 e-PRO 获得的组结果应与最初验证的纸质方法相似，具有提高患者接受度和易于与试验数据库可靠对接的优势。
