Sherlock博士要求澄清欧洲高压医学委员会(ECHM)采用的方法,以评估建立高压氧治疗(HBOT)适应症的证据。首先,无论上述出版物中包含的表格的编辑和校对过程如何严格,我们收到了一些读者的评论,他们发现表1的布局不完善和表2的布局不正确,这极大地改变了从中得出的结论。这涉及所使用方法的细节和ECHM建议的描述以及相关的证据水平。因此,这些表格在本期中以正确的形式重新发布,希望这至少能解释一些疑虑和误解。编辑和我们自己都为这些出版错误道歉。其次,在ECHM共识会议方法中,我们将需要双盲随机对照试验(RCT)的临床研究的证据评分为A级和B级,同时,一些评分量表只需要“RCT”,正如夏洛克博士正确指出的那样。在组织循证医学(EBM)会议和讨论方面的长期经验告诉我们,没有双盲的RCT经常被批评为具有严重的潜在偏见,因此被拒绝作为A级证据。尽管我们承认HBOT临床研究的双重致盲是一个困难的来源,为了避免无休止地讨论这种潜在的偏倚,我们选择了先验的方法,在我们的评分量表中仅考虑双盲RCT.我们很清楚,这样做意味着A级证据对高压社区来说是一个困难的目标。我们同意,许多证据评分系统的观察员之间的协议水平很低。这就是为什么我们将共识会议视为一个有价值的工具,它提供了一个更好的机会来讨论证据,而不是由一小群“专家”进行分析。这是因为整个过程是透明的,对所有参与者的评论和输入都是可用的。因此,在一般性讨论之后,听众投票的最终过程真正反映了欧洲专业高压社区对已发布建议的立场。通过这两种机制,可以避免盲目应用有争议的证据评分系统,至少,decreased.第三,高压研究中的“假”治疗问题已经被提出。虽然这在过去已经讨论过很多次,高压研究并不是这种假治疗带来一些困难的唯一领域。手术可能是最好的例子,其中使用假外科手术(可能包括麻醉)进行控制臂的RCT很少见,并且可能引起重大的道德问题。然而,从EBM的角度来看,在评估临床研究时,从未考虑设计双盲研究的困难.最后,Sherlock博士指出,她对ECHM针对特发性突发性感音神经性听力损失(ISSHL)的建议表示怀疑。虽然这里不可能引用会议期间提交的关于该问题的完整专家报告,据我们了解,会议正在编写一份详细的报告供出版。简而言之,证据强度被评为B级,与上一次Cochrane审查和UHMS委员会报告基本一致。基于这一级别的证据,第1类建议是在绝大多数共识会议与会者的同意下发布的。
Dr Sherlock asks for clarification on the approach adopted by the European Committee on Hyperbaric Medicine (ECHM) to assessing evidence for establishing indications for hyperbaric oxygen treatment (HBOT). Firstly, regardless of the strict process of editing and proof-reading of tables included in the above-mentioned publication, we received comments from some readers that identified imperfect layout of Table 1 and incorrect layout of Table 2 which significantly changed the conclusions to be drawn from them. This concerned both the details of the methodology used and description of the ECHM recommendations and associated levels of evidence. Therefore, those tables are republished in their correct forms in this issue, hoping that this will explain at least some of the doubts and misunderstandings. Both the Editor and ourselves apologise for these errors of publication. Secondly, in the ECHM
Consensus Conference methodology, we scored the evidence for clinical studies requiring double-blind randomised controlled trials (RCT) as Level A and B when, at the same time, some scoring scales require simply \'RCT\', as correctly pointed out by Dr Sherlock. Long experience in organising evidence based medicine (EBM) meetings and discussions has taught us that RCTs that are not double blinded are often criticised as having serious potential bias and so are denied as level A evidence. Although we acknowledge that double blinding a clinical study in HBOT is a source of difficulty, we chose a priori to consider only double-blinded RCTs in our grading scale to avoid endless discussions about this potential bias. We are well aware that doing so means that Level A evidence is a difficult target for the hyperbaric community. We agree that many evidence scoring systems have a low level of inter-observer agreement. This is why we treat the
Consensus Conference as a valuable tool that provides a better opportunity for discussing the evidence than analysis by a small group of \'experts\'. This is because the whole process is transparent and available to all participants\' comments and input. The final process of voting by the audience after the general discussion thus truly reflects the position of the professional hyperbaric community in Europe on the issued recommendations. By these two mechanisms, the blind application of disputable evidence scoring systems may be avoided or, at least, decreased. Thirdly, the problem of \'sham\' treatments in hyperbaric research has been raised. While this has been discussed many times in the past, hyperbaric research is not the sole field where such sham treatment raises some difficulty. Surgery is probably the best example where RCTs with control arms utilising sham surgical procedures (possibly including the administration of anaesthesia) are rare and can raise major ethical problems. Nevertheless, from an EBM viewpoint, the difficulty of designing a double-blind study is never taken into account during evaluation of clinical studies. Finally, Dr Sherlock pointed out her doubts on the recommendations issued by the ECHM on idiopathic sudden sensorineural hearing loss (ISSHL). While there is no possibility to cite here the full experts\' report on that issue presented during the conference, we understand that a detailed report from the Conference is being prepared for publication. In brief, the strength of evidence has been scored as Level B, in general agreement with the last Cochrane review and the UHMS Committee report. Based on this level of evidence, the Type 1 recommendation was issued with the agreement of the large majority of the
Consensus Conference participants.