Schwartz Stefani M, Barpujari Awinita, Finnerup Nanna Brix, Raja Srinivasa N
Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital, Baltimore, MD, United States.
Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Pain. 2022 Apr 1;163(4):795-804. doi: 10.1097/j.pain.0000000000002426.
Several different reporting biases cited in scientific literature have raised concerns about the overestimation of effects and the subsequent potential impact on the practice of evidence-based medicine and human health. Up to 7% to 8% of the population experiences neuropathic pain (NP), and established treatment guidelines are based predominantly on published clinical trial results. Therefore, we examined published randomized controlled trials (RCTs) of first-line drugs for NP and assessed the relative proportions with statistically significant (ie, positive) and nonsignificant (ie, negative) results and their rates of citation. We determined the relationships between reported study outcome and the frequency of their citations with journal impact factor, sample size, time to publication after study completion, and study quality metrics. We also examined the association of study outcome with maximum study drug dosage and conflict of interest. We found that of 107 published RCTs, 68.2% reported a statistically significant outcome regarding drug efficacy for chronic peripheral and central NP. Positive studies were cited nearly twice as often as negative studies in the literature (P = 0.01), despite similar study sample size, quality metrics, and publication in journals with similar impact factors. The time to publication, journal impact factor, and conflict of interest did not differ statistically between positive and negative studies. Our observations that negative and positive RCTs were published in journals with similar impact at comparable time-lags after study completion are encouraging. However, the citation bias for positive studies could affect the validity and generalization of conclusions in literature and potentially influence clinical practice.
科学文献中提到的几种不同的报告偏倚引发了人们对效应高估以及对循证医学实践和人类健康后续潜在影响的担忧。高达7%至8%的人口患有神经性疼痛(NP),既定的治疗指南主要基于已发表的临床试验结果。因此,我们审查了已发表的NP一线药物随机对照试验(RCT),并评估了具有统计学显著(即阳性)和无显著(即阴性)结果的相对比例及其被引用率。我们确定了报告的研究结果与其被引用频率与期刊影响因子、样本量、研究完成后发表时间以及研究质量指标之间的关系。我们还研究了研究结果与最大研究药物剂量和利益冲突之间的关联。我们发现,在107项已发表的RCT中,68.2%报告了关于慢性外周和中枢NP药物疗效的统计学显著结果。尽管研究样本量、质量指标相似且发表在影响因子相似的期刊上,但阳性研究在文献中的被引用频率几乎是阴性研究的两倍(P = 0.01)。阳性和阴性研究在发表时间、期刊影响因子和利益冲突方面在统计学上没有差异。我们观察到阴性和阳性RCT在研究完成后以相似的时间间隔发表在影响相似的期刊上,这令人鼓舞。然而,阳性研究的引用偏倚可能会影响文献中结论的有效性和普遍性,并可能影响临床实践。