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| Analysis of clinical evaluation outcomes of drug treatment for elderly acute myeloid leukemia |
| Hits 1062 Download times 557 Received:November 25, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2021.03.15 |
| Key Words
elderly acute myeloid leukemia;effectiveness outcomes;safety outcomes;core outcome set;randomized controlled trial |
| Author Name | Affiliation | E-mail | | ZHU Zheng | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | JIN Xinyao | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHENG Wenke | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Mingyan | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | YANG Fengwen | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Hui | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | wangh@tice.com.cn | | ZHANG Junhua | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | zjhtcm@foxmail.com |
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| Abstract
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| [Objective] To analyze the efficasy evaluation outcomes of randomized controlled trials (RCTs) on drug therapy for elderly acute myeloid leukemia (AML), and to establish the basis for core outcome set (COS)about elderly AML.[Methods] CNKI, WanFang, SinoMed, PubMed, Cochrane library, EMbase databases, ChiCTR and ClinicalTrials.gov were searched by computer, and the clinical randomized controlled trial(RCT) for the drug treatment of elderly AML treatment comprehensively collected. The retrieval time was set on January 1, 2015 to November 1, 2020. Literature screening and data extraction were conducted independently by 2 system evaluators according to inclusion and exclusion criteria.[Results] A total of 64 RCTs were included, and the intervention course was observed for 1~4 treatment courses, with treatment duration ranging from 7~63 days. The longest follow-up was 5 years, and the shortest follow-up was 1 month. A total of 168 evaluation outcomes were reported, and 252 of them were used in total, which were normalized to 38 evaluation outcomes and classified into 6 outcomes domains according to functional attributes. In addition, the evaluation outcomes used in this study have inconsistent criteria for the efficacy evaluation, and there are few reports on the measurement of the outcomes.[Conclusion] The evaluation outcomes of clinical research on elderly AML are not reasonable now. Definition of outcomes are not standard. The measurement report is not clear, the choices of outcomes is not reasonable and so on. There is an urgent need to establish core outcome set (COS)about elderly AML durg treating with the characteristics of the disease and the specificity of the intervention, so as to provide reference and basis for the design and implementation of clinical trials. |
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