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Abstract：
There is strong evidence of under-reporting of harms in manuscripts on randomized controlled trials (RCTs) compared with the volume of raw data retrieved from these trials. Many guidelines have been developed to tackle this, but they have failed to address some important issues that would allow for standardization and transparency. As a consequence, harms reporting in manuscripts remains suboptimal.
The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) aimed to deliver accurate recommendations for better reporting of harms in clinical trials manuscripts on anti-osteoarthritis (OA) drugs. These could help to better inform clinicians on harms recorded in RCTs and further help researchers conducting meta-analyses.
Using the outcomes of several systematic reviews on the safety of anti-OA drugs, we summarized the ways in which harms have been reported in OA RCT manuscripts to date. Next, we drafted some recommendations and initiated a modified Delphi process that involved a panel of clinicians and clinical researchers to build an expert consensus on recommendations from the ESCEO for the reporting of harms in future manuscripts on RCTs assessing anti-OA drugs.
These recommendations emphasize that all treatment-emergent adverse events (AEs) should always be taken into account for harms reporting, with no frequency threshold, and describe how specific AEs should be reported; they also provide a list of the most relevant organ systems to be considered according to each class of drug for reporting of harms within the results section of a manuscript. Irrespective of the drug, the ESCEO recommends that total, severe and serious AEs and withdrawals due to AEs should always be reported; guidance on the reporting of specific events pertaining to each category is provided. The ESCEO also recommends the reporting of information on drug effect on biological parameters, with specific guidance.
These recommendations may contribute to improve transparency in the field of safety of anti-OA medications. Pharmaceutical companies developing drugs for OA, and researchers conducting clinical trials, are encouraged to comply with them when reporting harms-related results in manuscripts on RCTs. The ESCEO also encourages journals to refer to the ESCEO recommendations in their instructions to authors for the publication of manuscripts on trials of anti-OA medications.
The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) aimed to deliver accurate recommendations for better reporting of harms in clinical trials manuscripts on anti-osteoarthritis (OA) drugs. These could help to better inform clinicians on harms recorded in RCTs and further help researchers conducting meta-analyses.
Using the outcomes of several systematic reviews on the safety of anti-OA drugs, we summarized the ways in which harms have been reported in OA RCT manuscripts to date. Next, we drafted some recommendations and initiated a modified Delphi process that involved a panel of clinicians and clinical researchers to build an expert consensus on recommendations from the ESCEO for the reporting of harms in future manuscripts on RCTs assessing anti-OA drugs.
These recommendations emphasize that all treatment-emergent adverse events (AEs) should always be taken into account for harms reporting, with no frequency threshold, and describe how specific AEs should be reported; they also provide a list of the most relevant organ systems to be considered according to each class of drug for reporting of harms within the results section of a manuscript. Irrespective of the drug, the ESCEO recommends that total, severe and serious AEs and withdrawals due to AEs should always be reported; guidance on the reporting of specific events pertaining to each category is provided. The ESCEO also recommends the reporting of information on drug effect on biological parameters, with specific guidance.
These recommendations may contribute to improve transparency in the field of safety of anti-OA medications. Pharmaceutical companies developing drugs for OA, and researchers conducting clinical trials, are encouraged to comply with them when reporting harms-related results in manuscripts on RCTs. The ESCEO also encourages journals to refer to the ESCEO recommendations in their instructions to authors for the publication of manuscripts on trials of anti-OA medications.
摘要：
有强有力的证据表明，与从这些试验中检索到的原始数据相比，随机对照试验（RCT）手稿中的危害报告不足。已经制定了许多指导方针来解决这个问题，但是他们未能解决一些允许标准化和透明度的重要问题。因此,手稿中的危害报告仍然欠佳。
欧洲骨质疏松症临床和经济方面的学会，骨关节炎和肌肉骨骼疾病（ESCEO）旨在提供准确的建议，以更好地报告抗骨关节炎（OA）药物的临床试验手稿中的危害。这些可以帮助更好地告知临床医生RCT中记录的危害，并进一步帮助研究人员进行荟萃分析。
使用一些关于抗OA药物安全性的系统评价的结果，我们总结了迄今为止在OARCT手稿中报道的危害的方式.接下来,我们起草了一些建议,并启动了一个改良的Delphi流程,该流程由一组临床医生和临床研究人员参与,就ESCEO的建议达成专家共识,以便在未来RCT评估抗OA药物的手稿中报告危害.
这些建议强调，所有因治疗引起的不良事件（AE）在报告危害时应始终予以考虑。没有频率阈值，并描述应如何报告特定的AE;他们还提供了一份最相关的器官系统的列表,根据每类药物报告的危害在手稿的结果部分.不管药物，ESCEO建议，应始终报告严重和严重的不良事件以及因不良事件导致的退出;提供了与每个类别相关的具体事件报告的指导.ESCEO还建议报告有关药物对生物学参数的影响的信息，有具体的指导。
这些建议可能有助于提高抗OA药物安全性领域的透明度。制药公司为OA开发药物，和进行临床试验的研究人员，鼓励在RCT手稿中报告与危害相关的结果时遵守这些规定。ESCEO还鼓励期刊在其对作者的说明中参考ESCEO建议，以发表有关抗OA药物试验的手稿。
欧洲骨质疏松症临床和经济方面的学会，骨关节炎和肌肉骨骼疾病（ESCEO）旨在提供准确的建议，以更好地报告抗骨关节炎（OA）药物的临床试验手稿中的危害。这些可以帮助更好地告知临床医生RCT中记录的危害，并进一步帮助研究人员进行荟萃分析。
使用一些关于抗OA药物安全性的系统评价的结果，我们总结了迄今为止在OARCT手稿中报道的危害的方式.接下来,我们起草了一些建议,并启动了一个改良的Delphi流程,该流程由一组临床医生和临床研究人员参与,就ESCEO的建议达成专家共识,以便在未来RCT评估抗OA药物的手稿中报告危害.
这些建议强调，所有因治疗引起的不良事件（AE）在报告危害时应始终予以考虑。没有频率阈值，并描述应如何报告特定的AE;他们还提供了一份最相关的器官系统的列表,根据每类药物报告的危害在手稿的结果部分.不管药物，ESCEO建议，应始终报告严重和严重的不良事件以及因不良事件导致的退出;提供了与每个类别相关的具体事件报告的指导.ESCEO还建议报告有关药物对生物学参数的影响的信息，有具体的指导。
这些建议可能有助于提高抗OA药物安全性领域的透明度。制药公司为OA开发药物，和进行临床试验的研究人员，鼓励在RCT手稿中报告与危害相关的结果时遵守这些规定。ESCEO还鼓励期刊在其对作者的说明中参考ESCEO建议，以发表有关抗OA药物试验的手稿。
