Accrual in supportive care trials in pediatric oncology, a challenge!
Accrual in supportive care trials in pediatric oncology, a challenge!
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DOI：
10.1007/s00520-012-1447-2
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发表时间：
2012-12
影响因子：
3.1
通讯作者：
van de Wetering, M. D.
中科院分区：
文献类型：
--
作者：
Schoot, R. A.;van Ommen, C. H.;Caron, H. N.;Tissing, W. J. E.;van de Wetering, M. D.
儿童肿瘤学的治疗方案历来具有较高的应计率，高达94%。另一方面，支持治疗研究的应计收益似乎是一个挑战。本研究的目的是寻找解释这种不良累积的原因，并寻求可能的干预措施来提高患者的入组率。我们分析了支持性护理研究（贵族研究）的失败筛选日志，随后进行了文献检索。文献检索（1985-2011）揭示了影响应计收益的三个因素。首先，通过在所有参与中心指定一名专门的临床调查员和促进临床研究护士，可以促进研究的实施和患者的登记。此外，需要充分和量身定制的信息，以便家庭在参与学习方面做出明智的决定。最后，应保证有足够的时间进行决策过程，特别是因为合格的研究报告数量正在迅速增加。关于我们的研究，所有三个因素都得到了满足，但最引人注目的发现是大多数家长（82%）认为参与研究的负担是反对随机化的主要论据。儿科肿瘤患者在支持性护理研究中的收益是具有挑战性的。然而，在支持性治疗中精心设计的随机对照试验对于改善儿童癌症治疗至关重要。因此，我们需要通过（国际）国家支持性护理工作组提高对支持性护理试验的必要性的认识，并在此类试验开放时刺激累积。
Treatment protocols in pediatric oncology have historically known high accrual rates, up to 94 %. Accrual for supportive care studies on the other hand appears to be a challenge. The aim of this study was to search for reasons explaining this poor accrual and for possible interventions to improve patient enrolment. The failure screen log of our supportive care study (the Aristocaths study) was analyzed, and subsequently, a literature search was performed. The literature search (1985–2011) revealed three factors that can influence accrual. Firstly, study implementation and patient enrolment can be facilitated by appointing a dedicated clinical investigator in all participating centers and by facilitating clinical research nurses. Furthermore, adequate and tailor-made information is required for families to make a well-informed decision regarding study participation. Lastly, sufficient time should be assured for the process of decision making, especially since the number of eligible studies is increasing rapidly. Concerning our study, all three elements were met, but the most striking finding was the presumed burden of study participation by the majority of parents (82 %) as the main argument against randomization. Accrual of pediatric oncology patients in supportive care studies is challenging. Nevertheless, well-designed randomized controlled trials in supportive care will be essential for the improvement of pediatric cancer care. Therefore, we will need to increase awareness through (inter)national supportive care working groups regarding the need for supportive care trials and stimulate accrual when such trials are open.
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