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治疗儿童血液系统癌症随机对照治疗试验中需要治疗的人数的效用：系统评价。

Utility of the number needed to treat in paediatric haematological cancer randomised controlled treatment trials: a systematic review.

机构信息

Epi Methods Consulting, Toronto, Ontario, Canada.

Department of Radiation Oncology, BC Cancer Agency, Vancouver, British Columbia, Canada.

出版信息

BMJ Open. 2019 Feb 20;9(2):e022839. doi: 10.1136/bmjopen-2018-022839.

DOI:10.1136/bmjopen-2018-022839
PMID:30787076
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6398916/
Abstract

OBJECTIVES

The primary objective was to assess the utility of the number needed to treat (NNT) to inform decision-making in the context of paediatric oncology and to calculate the NNT in all superiority, parallel, paediatric haematological cancer, randomised controlled trials (RCTs), with a comparison to the threshold NNT as a measure of clinical significance.

DESIGN

Systematic review DATA SOURCES: MEDLINE, EMBASE and the Cochrane Childhood Cancer Group Specialized Register through CENTRAL from inception to August 2018.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES

Superiority, parallel RCTs of haematological malignancy treatments in paediatric patients that assessed an outcome related to survival, relapse or remission; reported a sample size calculation with a delta value to allow for calculation of the threshold NNT, and that included parameters required to calculate the NNT and associated CI.

RESULTS

A total of 43 RCTs were included, representing 45 randomised questions, of which none reported the NNT. Among acute lymphoblastic leukaemia (ALL) RCTs, 29.2% (7/24) of randomised questions were found to have a NNT corresponding to benefit, in comparison to acute myeloid leukaemia (ALM) RCTs with 50% (3/6), and none in lymphoma RCTs (0/13). Only 28.6% (2/7) and 33.3% (1/3) had a NNT that was less than the threshold NNT for ALL and AML, respectively. Of these, 100% (2/2 ALL and 1/1 AML) were determined to be possibly clinically significant.

CONCLUSIONS

We recommend that decision-makers in paediatric oncology use the NNT and associated confidence limits as a supportive tool to evaluate evidence from RCTs while placing careful attention to the inherent limitations of this measure.

摘要

目的

主要目的是评估需要治疗的人数（NNT）在儿科肿瘤学中的决策中的效用，并计算所有优势、平行、儿科血液恶性肿瘤的 NNT，随机对照试验（RCT），并与作为临床意义衡量标准的阈值 NNT 进行比较。

设计

系统评价

数据来源

从建库到 2018 年 8 月，通过 CENTRAL 在 MEDLINE、EMBASE 和 Cochrane 儿童癌症组专业注册库中进行检索。

研究选择的资格标准

在儿科患者中评估与生存、复发或缓解相关的结局的血液恶性肿瘤治疗的优势、平行 RCT；报告了样本量计算值，并带有差值，以允许计算阈值 NNT，并包括计算 NNT 和相关置信区间所需的参数。

结果

共纳入 43 项 RCT，代表 45 个随机问题，其中没有一项报告了 NNT。在急性淋巴细胞白血病（ALL）RCT 中，29.2%（7/24）的随机问题被发现具有相应受益的 NNT，而急性髓细胞性白血病（ALM）RCT 为 50%（3/6），淋巴瘤 RCT 中没有（0/13）。只有 28.6%（2/7）和 33.3%（1/3）的 NNT 小于 ALL 和 AML 的阈值 NNT。其中，100%（2/ALL 和 1/AML）被认为可能具有临床意义。

结论

我们建议儿科肿瘤学的决策者使用 NNT 和相关置信区间作为评估 RCT 证据的辅助工具，同时要注意该措施的固有局限性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/06d5ecbc9a36/bmjopen-2018-022839f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/9337029126b9/bmjopen-2018-022839f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/ef5ad50993fa/bmjopen-2018-022839f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/06d5ecbc9a36/bmjopen-2018-022839f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/9337029126b9/bmjopen-2018-022839f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/ef5ad50993fa/bmjopen-2018-022839f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1584/6398916/06d5ecbc9a36/bmjopen-2018-022839f03.jpg

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