Integrating Electronic Patient-Reported Outcomes and Palliative Care in Pediatric Advanced Cancer: The PediQUEST Response Multisite Randomized Controlled Trial.

Methods

This multicenter open-label RCT enrolled children 2 years and older with advanced cancer.

这项多中心开放标签的RCT招募了2岁及以上的晚期癌症儿童。

The study was conducted between April 2018 and December 2021 at five US tertiary-level pediatric cancer centers.

该研究于2018年4月至2021年12月在美国五家三级儿科癌症中心进行。

All parents and children 5 years and older answered weekly child HRQOL and symptom surveys over 18 weeks (2-week run-in).

所有5岁及以上的儿童及其父母每周回答一次儿童健康相关生活质量（HRQOL）和症状调查，持续18周（2周试运行期）。

Child-parent dyads were assigned (1:1) to PQ Response (n = 74) or usual care (n = 80) for 16 weeks.

儿童-父母配对被1:1分配到PQ响应组(n = 74)或常规护理组(n = 80)，持续16周。

Primary outcomes were the difference between average 16-week and baseline Pediatric Quality of Life Inventory (PedsQL-4.0) total scores reported by parents and children (range, 0-100; higher = better HRQOL; minimal clinically important difference [MCID], 4.5).

主要结果是父母和儿童报告的平均16周与基线期儿童生活质量评估量表（PedsQL-4.0）总分的差异（范围，0-100；更高=更好的健康相关生活质量；最小临床重要差异[MCID]，4.5）。

Secondary outcomes were PedsQL subscales and symptom scores.

次要结果是PedsQL子量表和症状评分。

Analyses followed an intention-to-treatapproach.

分析遵循了意向治疗分析方法。

Results

Of 154 participants randomly assigned, 50% were girls, 78% were White, 17% were Hispanic, and 45% had brain tumors.

在随机分配的154名参与者中，50%为女孩，78%为白人，17%为西班牙裔，45%患有脑肿瘤。

The mean age was 11 years (standard deviation, 6.1).

平均年龄为11岁（标准差为6.1）。

Parents assigned to PQ Response reported greater improvements in child HRQOL (PedsQL total mean difference 3.45 points [{95% CI, 0.48 to 6.43}; P = .023]; PedsQL physical 4.61 [{95% CI, 0.40 to 8.82}; P = .032]).

被分配到PQ响应的父母报告了孩子HRQOL（PedsQL总平均差异3.45点[{95% CI, 0.48至6.43}; P = .023]; PedsQL身体4.61[{95% CI, 0.40至8.82}; P = .032]）的更大改善。

Children reported similar improvements.

孩子们报告了相似的改善。

Effects did not exceed MCIDs.

效果未超过最小临床重要差异（MCIDs）

No improvements were observed in PedsQL-psychosocial or symptom scores.

在PedsQL心理社会或症状评分中未观察到改善。

Sensitivity analyses showed consistent effects, with most physical HRQOL scores and several child-reported symptom scores exceeding MCIDs.

敏感性分析显示了与主要结果一致的效果，大多数身体健康相关生活质量（HRQOL）评分以及几个儿童自报的症状评分超过了最小临床重要差异（MCIDs）

We observed site-specific variability.

我们观察到了特定部位的变异性。

At the site with the largest adherence, all effects exceeded MCIDs.

在依从性最高的地点，所有效果均超过了最小临床重要差异（MCIDs）

No adverse events reported.

没有报告任何不良事件。

Conclusions

Findings suggest benefits of integrating electronic patient-reported outcome feedback and SPPC into pediatric advanced cancer care.

研究结果表明，将电子患者报告的结果反馈和SPPC整合到儿科晚期癌症护理中具有潜在益处。

Enhanced implementation strategies are needed to optimize clinical impact.

需要加强实施策略以优化临床影响。