AG Epidemiologie & International Public, Universität Bielefeld, Bielefeld, Germany.
Clin J Pain. 2013 Jul;29(7):591-9. doi: 10.1097/AJP.0b013e31826d6251.
Evidence from randomized controlled trials is regarded as the gold standard in clinical research and yet the quality of the conduct and reporting of trials is variable, even post-Consolidated Standards of Reporting Trials. This study arose from a systematic review and cost-effectiveness analysis of treatment for neuropathic pain. The aim was to provide a description of the included trials and investigate trends in study characteristics and measures of quality over time.
The review provided data regarding study characteristics (patients, place, time, drugs, outcomes), methodological factors (sample size calculations, randomization, reporting baseline patient data, withdrawals, intention-to-treat (ITT), and statistical analysis (completeness and correctness of reporting of results, methods of analysis).
A total of 131 trials from 1969 to 2007 were included. Of these, 63% were parallel-group designs, the remainder were cross-over; 73% were placebo-controlled. Several trial features increased or improved over time: trial size, quality (using Jadad score), presentation of baseline data by group, reporting of power calculations, use of visual analogue score or numerical rating scale scales to assess pain, completeness of reporting of statistical results, use of modeling to allow for baseline pain scores. The proportion of withdrawals was constant over time with a mean of 14.3%. The proportion of studies stating the analysis as ITT, increased over time, but inspection of papers indicated that the proportion confirmed as ITT was unchanged.
There have been a number of improvements regarding the quality and reporting of randomized controlled trials in neuropathic pain, but some failings remain that at best make some results difficult to interpret and at worst lead to bias.
随机对照试验的证据被认为是临床研究的金标准，但即使在 CONSORT 报告标准之后，试验的实施和报告质量仍然存在差异。本研究源于对治疗神经性疼痛的治疗进行的系统评价和成本效益分析。目的是提供纳入试验的描述，并研究研究特征和质量衡量指标随时间的变化趋势。
该综述提供了有关研究特征（患者、地点、时间、药物、结局）、方法学因素（样本量计算、随机化、报告基线患者数据、退出、意向治疗（ITT）和统计分析（结果报告的完整性和正确性、分析方法）的数据。
共纳入 1969 年至 2007 年的 131 项试验。其中，63%为平行组设计，其余为交叉设计；73%为安慰剂对照。随着时间的推移，几个试验特征增加或改善：试验规模、质量（使用 Jadad 评分）、按组呈现基线数据、报告功效计算、使用视觉模拟评分或数字评分量表评估疼痛、报告统计结果的完整性、使用建模允许基线疼痛评分。退出率随时间保持不变，平均为 14.3%。报告 ITT 分析的研究比例随时间增加，但对论文的检查表明，确认为 ITT 的比例没有变化。
在神经性疼痛的随机对照试验的质量和报告方面已经有了一些改进，但仍存在一些不足之处，这些不足之处要么使某些结果难以解释，要么导致偏倚。
