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Decision-making in acute viral bronchiolitis: a universal guideline and a publication gap
medRxiv - Pediatrics Pub Date : 2020-05-21 , DOI: 10.1101/2020.05.18.20105320
Jochen Meyburg , Markus Ries

Background: Acute viral bronchiolitis is very common in infants and children up to 2 years. Some patients develop serious respiratory symptoms and need to be hospitalized. In 2014, the American Academy of Pediatrics (AAP) published a guideline on acute bronchiolitis which has gained global acceptance. We hypothesized that a publication gap, which is increasingly perceived in clinical medicine, might have also affected these universal recommendations. Methods: We determined the proportion of published and unpublished studies registered at ClinicalTrials.gov that were marked as completed by October 1st 2018. The major trial and literature databases were used to search for publications. In addition, the study investigators were contacted directly. Results: Of the 69 registered studies on the treatment of acute viral bronchiolitis, only 50 (72%) have been published by November 2019. Published trials contained data from n=9403 patients, whereas n=4687 patients were enrolled in unpublished trials. Median time to publication was 20 months, and only 8 of 50 trials were published within 12 months after completion. Only 40% of the clinical trials that were completed after the release of the AAP guideline were subsequently published as compared to 80% before 2014. Conclusion: There is a significant publication gap regarding therapy of acute viral bronchiolitis that may have influenced certain recommendations of the AAP guideline. In turn, recommendations of the guideline might have discouraged investigators to publish their results after its release.

中文翻译:

急性病毒性毛细支气管炎的决策:通用指南和出版物空白

背景:急性病毒性细支气管炎在2岁以下的婴儿和儿童中非常常见。一些患者出现严重的呼吸道症状,需要住院。2014年,美国儿科学会(AAP)发布了有关急性毛细支气管炎的指南,该指南已获得全球认可。我们假设在临床医学中越来越多地发现出版空白可能也影响了这些普遍建议。方法:我们确定了在ClinicalTrials.gov上注册的已发表和未发表研究的比例,这些研究被标记为已于2018年10月1日完成。使用主要的试验和文献数据库搜索出版物。此外,还直接联系了研究人员。结果:在69项治疗急性病毒性细支气管炎的注册研究中,到2019年11月,仅发表了50篇(72%)。已发表的试验包含来自n = 9403名患者的数据,而n = 4687名患者参加了未发表的试验。发表的中位时间为20个月,在完成后的12个月内仅发表了50个试验中的8个。随后仅发布了AAP指南发布后完成的40%的临床试验,而2014年之前只有80%。结论:关于急性病毒性毛细支气管炎的治疗存在重大的出版空白,可能影响了该指南的某些建议。 AAP准则。反过来,该指南的建议可能会阻止调查人员在该指南发布后发布其结果。而n = 4687名患者参加了未发表的试验。发表的中位时间为20个月,在完成后的12个月内仅发表了50个试验中的8个。随后仅发布了AAP指南发布后完成的40%的临床试验,而2014年之前只有80%。结论:关于急性病毒性毛细支气管炎的治疗存在重大的出版空白,可能影响了该指南的某些建议。 AAP准则。反过来,该指南的建议可能会阻止调查人员在该指南发布后发布其结果。而n = 4687位患者参加了未发表的试验。发表的中位时间为20个月,在完成后的12个月内仅发表了50个试验中的8个。随后仅发布了AAP指南发布后完成的40%的临床试验,而2014年之前只有80%。结论:关于急性病毒性毛细支气管炎的治疗存在重大的出版空白,可能影响了该指南的某些建议。 AAP准则。反过来,该指南的建议可能会阻止调查人员在该指南发布后发布其结果。随后仅发布了AAP指南发布后完成的40%的临床试验,而2014年之前只有80%。结论:关于急性病毒性毛细支气管炎的治疗存在重大的出版空白,可能影响了该指南的某些建议。 AAP准则。反过来,该指南的建议可能会阻止调查人员在该指南发布后发布其结果。随后仅发布了AAP指南发布后完成的40%的临床试验,而2014年之前只有80%。结论:关于急性病毒性毛细支气管炎的治疗存在重大的出版空白,可能影响了该指南的某些建议。 AAP准则。反过来,该指南的建议可能会阻止调查人员在该指南发布后发布其结果。
更新日期:2020-05-21
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