Dufka Faustine L, Munch Troels, Dworkin Robert H, Rowbotham Michael C
Research Institute, California Pacific Medical Center, San Francisco, CA, USA Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Pain. 2015 Jan;156(1):72-80. doi: 10.1016/j.pain.0000000000000009.
Evidence-based medicine rests on the assumption that treatment recommendations are robust, free from bias, and include results of all randomized clinical trials. The Repository of Registered Analgesic Clinical Trials search and analysis methodology was applied to create databases of complex regional pain syndrome (CRPS) and central post-stroke pain (CPSP) trials and adapted to create the Repository of Registered Analgesic Device Studies databases for trials of spinal cord stimulation (SCS), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). We identified 34 CRPS trials, 18 CPSP trials, 72 trials of SCS, and 92 trials of rTMS/tDCS. Irrespective of time since study completion, 45% of eligible CRPS and CPSP trials and 46% of eligible SCS and rTMS/tDCS trials had available results (peer-reviewed literature, results entered on registry, or gray literature); peer-reviewed publications could be found for 38% and 39%, respectively. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, post-herpetic neuralgia, migraine, CRPS, CPSP) and types of treatment, no single study characteristic consistently predicts unavailability of results. Results availability is higher 12 months after study completion but remains below 60% for peer-reviewed publications. Recommendations to increase results availability include supporting organizations advocating for transparency, enforcing existing results reporting regulations, enabling all primary registries to post results, stating trial registration numbers in all publication abstracts, and reducing barriers to publishing "negative" trials. For all diseases and treatment modalities, evidence-based medicine must rigorously adjust for the sheer magnitude of missing results in formulating treatment recommendations.
循证医学基于这样一种假设,即治疗建议是可靠的、无偏差的,并且包括所有随机临床试验的结果。应用注册镇痛临床试验库的搜索和分析方法来创建复杂区域疼痛综合征(CRPS)和中风后中枢性疼痛(CPSP)试验的数据库,并进行调整以创建注册镇痛设备研究库数据库,用于脊髓刺激(SCS)、重复经颅磁刺激(rTMS)和经颅直流电刺激(tDCS)试验。我们识别出34项CRPS试验、18项CPSP试验、72项SCS试验和92项rTMS/tDCS试验。无论研究完成后的时间如何,45%的符合条件的CRPS和CPSP试验以及46%的符合条件的SCS和rTMS/tDCS试验有可用结果(同行评审文献、在注册中心录入的结果或灰色文献);分别有38%和39%能找到同行评审出版物。在研究一系列疼痛性疾病(纤维肌痛、糖尿病性疼痛性神经病变、带状疱疹后神经痛、偏头痛、CRPS、CPSP)和治疗类型的近1000项试验时,没有单一的研究特征能始终预测结果不可用。研究完成12个月后结果的可获得性更高,但同行评审出版物的可获得性仍低于60%。提高结果可获得性的建议包括支持倡导透明度的组织、执行现有的结果报告规定、使所有主要注册中心公布结果、在所有出版物摘要中注明试验注册号,以及减少发表“阴性”试验的障碍。对于所有疾病和治疗方式,循证医学在制定治疗建议时必须严格考虑缺失结果的巨大数量。