Abstract：
OBJECTIVE: This review aimed to assess the measurement and reporting of time toxicity (i.e., time spent receiving care) within prospective oncologic studies.
METHODS: On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity.
RESULTS: The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric \"days alive and out of the hospital\" was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. \"Time spent at home\" was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care.
CONCLUSIONS: Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.
METHODS: On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity.
RESULTS: The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric \"days alive and out of the hospital\" was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. \"Time spent at home\" was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care.
CONCLUSIONS: Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.
摘要：
目的：这篇综述旨在评估时间毒性的测量和报告(即，在前瞻性肿瘤研究中接受护理的时间)。
方法：2023年7月23日，PubMed，Scopus,和Embase在1984年至2023年的前瞻性或随机对照试验(RCT)中询问了时间毒性作为肿瘤治疗或干预的主要或次要结局.如果RCT报告时间毒性，则包括二次分析。然后评估纳入的研究如何报告和定义时间毒性。
结果：初始查询确定了883条记录，有10项研究(3项随机对照试验，2项前瞻性队列研究，和5次随机对照分析)符合最终纳入标准。治疗干预措施包括手术（n=5），全身治疗（n=4），和专门的姑息治疗（n=1）。80％（n=4）的外科研究使用了度量“存活和出院天数”。其中三项手术研究未包括在时间毒性计算中接受门诊护理的时间。“在家度过的时间”通过三项研究(30%)进行了评估，每个都使用不同的定义。来自RCT的五个次要分析使用了更全面的指标，包括住院和门诊护理所花费的时间。
结论：肿瘤临床试验中很少报道时间毒性，没有标准化的定义，公制，或方法论。需要进一步的研究来确定测量和报告时间毒性的最佳实践，以制定可以实施的策略，以减轻寻求癌症治疗的患者的负担。
方法：2023年7月23日，PubMed，Scopus,和Embase在1984年至2023年的前瞻性或随机对照试验(RCT)中询问了时间毒性作为肿瘤治疗或干预的主要或次要结局.如果RCT报告时间毒性，则包括二次分析。然后评估纳入的研究如何报告和定义时间毒性。
结果：初始查询确定了883条记录，有10项研究(3项随机对照试验，2项前瞻性队列研究，和5次随机对照分析)符合最终纳入标准。治疗干预措施包括手术（n=5），全身治疗（n=4），和专门的姑息治疗（n=1）。80％（n=4）的外科研究使用了度量“存活和出院天数”。其中三项手术研究未包括在时间毒性计算中接受门诊护理的时间。“在家度过的时间”通过三项研究(30%)进行了评估，每个都使用不同的定义。来自RCT的五个次要分析使用了更全面的指标，包括住院和门诊护理所花费的时间。
结论：肿瘤临床试验中很少报道时间毒性，没有标准化的定义，公制，或方法论。需要进一步的研究来确定测量和报告时间毒性的最佳实践，以制定可以实施的策略，以减轻寻求癌症治疗的患者的负担。
