Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations.
Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations.
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DOI：
10.1097/j.pain.0000000000000458
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发表时间：
2016-04
期刊：
影响因子：
7.4
通讯作者：
Whiteside G
中科院分区：
文献类型：
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作者：
Andrews NA;Latrémolière A;Basbaum AI;Mogil JS;Porreca F;Rice ASC;Woolf CJ;Currie GL;Dworkin RH;Eisenach JC;Evans S;Gewandter JS;Gover TD;Handwerker H;Huang W;Iyengar S;Jensen MP;Kennedy JD;Lee N;Levine J;Lidster K;Machin I;McDermott MP;McMahon SB;Price TJ;Ross SE;Scherrer G;Seal RP;Sena ES;Silva E;Stone L;Svensson CI;Turk DC;Whiteside G
改进的报告标准，以及强调控制实验偏差的实验方案的采用，可能会提高对疼痛生物学的理解和信心。人们越来越担心在许多临床前生物学研究领域缺乏科学严谨性和透明的报告。糟糕的实验设计和缺乏透明的报告可能会导致有意识或无意识的实验偏见，产生不可复制的结果。止痛药、麻醉剂和成瘾临床试验翻译、创新、机会和网络(ACTTION)与美国食品和药物管理局(FDA)的公私合作伙伴关系赞助了临床前疼痛研究联盟调查安全性和有效性(PPRECISE)工作组的共识会议。来自大学、资助机构、政府机构、行业和患者权益倡导组织的国际参与者参加了会议。具体讨论了减少发表偏见、增加其他人忠实地重复实验方法的能力以及增加数据报告的透明度。在已发表的文献中，被认为对增加信心至关重要的参数是明确、具体的先验假设报告和主要结果衡量标准的定义。能量计算以及测量最小有意义的效应大小以确定这些是否应该成为临床前研究工作的核心组成部分引起了相当大的讨论，许多人但不是所有人都同意。报告的更大透明度应该由科学家、期刊编辑、审查员和赠款资助者推动。充分报道的高质量科学的开展不应排除临床前疼痛研究的新颖性和创新，实际上，任何限制此类创新的努力都将是误导的。我们认为，为了实现为疼痛患者找到有效的新治疗方法的目标，疼痛领域需要处理这些具有挑战性的问题。
Improved reporting standards, and adoption of experimental protocols that emphasize control of experimental bias, are likely to improve understanding and confidence in pain biology. There is growing concern about lack of scientific rigor and transparent reporting across many preclinical fields of biological research. Poor experimental design and lack of transparent reporting can result in conscious or unconscious experimental bias, producing results that are not replicable. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership with the U.S. Food and Drug Administration sponsored a consensus meeting of the Preclinical Pain Research Consortium for Investigating Safety and Efficacy (PPRECISE) Working Group. International participants from universities, funding agencies, government agencies, industry, and a patient advocacy organization attended. Reduction of publication bias, increasing the ability of others to faithfully repeat experimental methods, and increased transparency of data reporting were specifically discussed. Parameters deemed essential to increase confidence in the published literature were clear, specific reporting of an a priori hypothesis and definition of primary outcome measure. Power calculations and whether measurement of minimal meaningful effect size to determine these should be a core component of the preclinical research effort provoked considerable discussion, with many but not all agreeing. Greater transparency of reporting should be driven by scientists, journal editors, reviewers, and grant funders. The conduct of high-quality science that is fully reported should not preclude novelty and innovation in preclinical pain research, and indeed, any efforts that curtail such innovation would be misguided. We believe that to achieve the goal of finding effective new treatments for patients with pain, the pain field needs to deal with these challenging issues.