Randomized Controlled Trial of Paper-Based at a Hospital versus Continual Electronic Patient-Reported Outcomes at Home for Metastatic Cancer Patients: Does Electronic Measurement at Home Detect Patients' Health Status in Greater Detail?
Randomized Controlled Trial of Paper-Based at a Hospital versus Continual Electronic Patient-Reported Outcomes at Home for Metastatic Cancer Patients: Does Electronic Measurement at Home Detect Patients' Health Status in Greater Detail?
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DOI：
10.1177/0272989x211010171
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发表时间：
2021-04-24
影响因子：
3.6
通讯作者：
Shimozuma, Kojiro
中科院分区：
文献类型：
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作者：
Shiroiwa, Takeru;Hagiwara, Yasuhiro;Shimozuma, Kojiro
目的本研究旨在确定在家中连续电子患者报告结果 (ePRO) 测量是否可以捕捉两次就诊之间健康相关生活质量 (HRQOL) 分数的波动。方法我们进行了一项随机对照试验，将标准实践（医院纸质测量）获得的分数与在家中连续测量 ePRO 获得的分数进行比较。转移性癌症患者被随机分配到纸质组 (n = 50) 或 ePRO 组 (n = 52)。纸质组在 3 个不同化疗日获得 EQ-5D-5L 和 EORTC QLQC-30 评分。同时，ePRO组在2个周期的化疗当天以及第3、7、10和14天获得评分。我们研究的第一个假设是，尽管测量频率、地点或测量方式不同，但同一时间点的两个分数将是相等的。第二个假设是 PRO 分数调整时间在各组之间会有所不同。为了等效，终点是门诊治疗前化疗日的平均 EQ-5D-5L 指数值。仅当显示等效性时，才考虑使用所有数据进行质量调整生命天数 (QALD)。 结果 EQ-5D-5L 指数的调整平均差异确定为 -0.013（95% 置信区间 [CI]：-0.049 至 0.022）； 95% CI 未超过等效裕度。同样，全球健康状况的平均差异 (2.28 [95% CI: -2.55 至 7.11]) 也显示出相同性。然而，ePRO 组中 EQ-5D-5L 的 QALD 显着降低，每 30 天降低 1.36（95% CI：-2.22 至 -0.51；P = 0.0021）。 结论 通过 ePRO 在家持续测量 HRQOL 可能会产生更详细的 HRQOL 概况。
PurposeThis study aimed to determine whether continual electronic patient-reported outcome (ePRO) measurements at home can capture the fluctuations in health-related quality of life (HRQOL) scores between visits.MethodsWe performed a randomized controlled trial to compare the scores obtained by standard practice (paper-based measurements in the hospital) to scores by continuous measurement of ePRO at home. Metastatic cancer patients were randomly assigned to either the paper-based (n = 50) or the ePRO group (n = 52). EQ-5D-5L and EORTC QLQ C-30 scores were obtained on 3 different chemotherapy days in the paper-based group. Meanwhile, scores were obtained on the chemotherapy day and on days 3, 7, 10, and 14 in the ePRO group during 2 cycles. The first hypothesis of our study was that both scores at the same time points would be equivalent despite different measurement frequency, place, or mode of measurement. The second hypothesis was that PRO score-adjusted time would be different between the groups. For equivalence, the endpoint was the mean EQ-5D-5L index value on the chemotherapy day before the outpatient treatment. Only if equivalence was shown, quality-adjusted life-days (QALDs) were considered using all the data.ResultsThe adjusted mean difference in the EQ-5D-5L index was determined to be -0.013 (95% confidence interval [CI]: -0.049 to 0.022); the 95% CI did not exceed the equivalence margin. Similarly, the mean difference in global health status (2.28 [95% CI: -2.55 to 7.11]) also showed equivalence. However, the QALD by EQ-5D-5L was significantly lower in the ePRO group by 1.36 per 30 d (95% CI: -2.22 to -0.51; P = 0.0021).ConclusionsContinual measurements of the HRQOL at home by ePRO may yield more detailed profiles of the HRQOL.