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癌症疼痛程序性治疗随机临床试验中设计特征和分析细节的报告:ACTTION 系统评价。

Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.

机构信息

From the *Department of Pain Medicine, MD Anderson Cancer Center, Houston, TX; Departments of †Anesthesiology and ‡Biostatistics and Computational Biology, University of Rochester, Rochester, NY; §Johns Hopkins University, Baltimore, MD; and ∥Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA.

出版信息

Reg Anesth Pain Med. 2017 May/Jun;42(3):392-399. doi: 10.1097/AAP.0000000000000553.

DOI:10.1097/AAP.0000000000000553
PMID:28085789
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6784314/
Abstract

BACKGROUND AND OBJECTIVES

The objective of this study was to assess the reporting of randomized clinical trials investigating procedural treatments (eg, nerve blocks, targeted drug delivery) for cancer pain, with a focus on aspects that are particularly challenging in these trials.

METHODS

This article presents results from a systematic review of reporting of randomized clinical trials of procedural interventions for cancer pain. Articles were identified by searching PubMed from 1966 to June 2014. Data related to quality of reporting are presented for early (1985-2004) and late periods (2005-2014).

RESULTS

A total of 35 published trials were included. Approximately two-thirds of the articles clearly indicated the level of blinding. Only 26% reported a primary outcome measure. Less than half explicitly reported the number of patients who completed the trial, and only 1 reported a method that was used to accommodate missing data. Almost one-third of articles included a responder analysis, all of which specified the definition of a responder.

CONCLUSIONS

The goal of highlighting these deficiencies in reporting is to promote transparent reporting of details affecting the completion and interpretation of procedural cancer pain trials so that their quality can be more easily evaluated.

摘要

背景与目的

本研究旨在评估针对癌症疼痛的程序性治疗(如神经阻滞、靶向药物输送)的随机临床试验报告,重点关注这些试验中特别具有挑战性的方面。

方法

本文呈现了对癌症疼痛程序性干预的随机临床试验报告的系统评价结果。通过从 1966 年到 2014 年 6 月在 PubMed 上进行搜索,确定了文章。报告了与报告质量相关的数据,分为早期(1985-2004 年)和晚期(2005-2014 年)。

结果

共纳入 35 项已发表的试验。大约三分之二的文章清楚地指出了盲法的水平。仅 26%的文章报告了主要结局指标。不到一半的文章明确报告了完成试验的患者人数,只有 1 篇文章报告了一种用于处理缺失数据的方法。近三分之一的文章包括应答者分析,所有这些文章都指定了应答者的定义。

结论

强调这些报告缺陷的目的是促进详细报告影响程序性癌症疼痛试验完成和解释的细节,以便更轻松地评估其质量。

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本文引用的文献

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Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system.疼痛强度评分训练:对 ACTTION PROTECCT 系统的探索性研究结果。
Pain. 2016 May;157(5):1056-1064. doi: 10.1097/j.pain.0000000000000502.
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Quality of pain intensity assessment reporting: ACTTION systematic review and recommendations.疼痛强度评估报告的质量:ACTTION系统评价与建议
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Reliability is Necessary but Far From Sufficient: How Might the Validity of Pain Ratings be Improved?可靠性是必要的,但远远不够:如何提高疼痛评分的有效性?
Clin J Pain. 2015 Jul;31(7):599-602. doi: 10.1097/AJP.0000000000000175.
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Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review.近期镇痛药临床试验报告中对 CONSORT 损害报告建议的遵循情况:ACTTION 系统评价。
Pain. 2012 Dec;153(12):2415-2421. doi: 10.1016/j.pain.2012.08.009. Epub 2012 Sep 15.
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