探索随机对照试验的报告标准,涉及对外围动脉疾病的内血管干预:系统性审查
Ewa M Zywicka1, Eleanor McNally2, Lucy Elliott1
1Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
概括
对于下肢内血管干预的随机对照试验 (RCT) 往往缺乏详细的报告. 这限制了重复干预措施的能力,并评估它们在对外围动脉疾病 (PAD) 管理中的有效性.
科学领域:
- 血管外科 血管外科
- 干预心脏病学 干预心脏病学
- 医疗器械技术 医疗器械技术
- 临床试验方法论 临床试验方法论
背景情况:
- 通过高质量的随机对照试验 (RCT) 严格评估内血管创新至关重要.
- 针对内血管干预的RCT在设计,实施和报告方面存在独特的方法挑战.
- 下肢外周动脉疾病 (PAD) 的管理依赖于有效的内血管治疗.
研究的目的:
- 系统地审查和评估下肢PAD内血管干预的RCT的报告质量.
- 评估这些RCT是否遵守已确定的报告准则,特别是CONSORT-NPT和TIDieR.
主要方法:
- 对Medline,Embase和Cochrane图书馆数据库的系统审查 (截至2021年12月).
- 包括参与下肢PAD的参与者进行下肢内血管干预的RCT.
- 对研究数据的评估与干预报告质量的CONSORT-NPT和TIDieR检查清单进行比较.
主要成果:
- 确定了112个符合条件的RCT,涵盖了228种内血管器械/技术.
- 只有21%的干预措施被描述得足够详细,可以复制;55%的干预措施被描述得不够好.
- 在81%的试验中提供了干预描述,但细节不尽相同;只有22%的人报告了干预标准化.
结论:
- 下肢内血管治疗的RCT的报告质量显著受到限制.
- 干预措施的描述和标准化不足,阻碍了内血管技术的可复制性和评估.
- 改善报告准则的遵守是必要的,以提高PAD干预措施的证据质量.
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