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