Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.
Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.
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DOI：
10.1097/j.pain.0000000000000191
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发表时间：
2015-07
期刊：
影响因子：
7.4
通讯作者：
Walco GA
中科院分区：
文献类型：
--
作者：
Gewandter JS;Dworkin RH;Turk DC;Farrar JT;Fillingim RB;Gilron I;Markman JD;Oaklander AL;Polydefkis MJ;Raja SN;Robinson JP;Woolf CJ;Ziegler D;Ashburn MA;Burke LB;Cowan P;George SZ;Goli V;Graff OX;Iyengar S;Jay GW;Katz J;Kehlet H;Kitt RA;Kopecky EA;Malamut R;McDermott MP;Palmer P;Rappaport BA;Rauschkolb C;Steigerwald I;Tobias J;Walco GA
虽然某些风险因素可以识别最有可能发展为慢性疼痛的个体，但很少有预防慢性疼痛的干预措施。为了促进预防性干预措施的确定，召开了IMMPACT会议，讨论研究慢性疼痛预防的临床试验的研究设计考虑因素。我们提出了在慢性疼痛风险相对较高的人群中进行预防试验的一般设计考虑。具体的设计考虑因素包括受试者识别、治疗时间和持续时间、结局、评估时间以及分析中的风险因素调整。我们提供了4种慢性疼痛预防模型的详细检查（即，慢性手术后疼痛、带状疱疹后神经痛、慢性腰痛和疼痛性化疗诱导的周围神经病变）。在许多情况下，所讨论的问题可以外推到其他慢性疼痛状况。选择这些实施例是因为它们是一级和二级预防的代表性模型，反映了由多次损伤引起的持续性疼痛（即，手术、病毒感染、损伤和有毒/有害元素暴露），并且是用一系列干预治疗的慢性疼痛病症。慢性疼痛预防试验设计的改进可以提高检测灵敏度，从而加快有效干预措施的识别。这些干预措施有可能降低慢性疼痛在人群中的患病率，此外，预防临床试验结果的标准化将促进荟萃分析和系统评价，并改善临床试验中出现的预防策略的检测。
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (i.e., chronic post-surgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (i.e., surgery, viral infection, injury, and toxic/noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.
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影响因子：
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作者：
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