Schwalm Anja, Perleth Matthias, Matthias Katja
Abteilung Fachberatung Medizin, Gemeinsamer Bundesausschuss, Berlin.
Z Evid Fortbild Qual Gesundhwes. 2010;104(4):323-9. doi: 10.1016/j.zefq.2009.12.029.
With the aim to study the level of evidence on which coverage decisions of the Federal Joint Committee (G-BA) were made and how the G-BA deals with missing or insufficient evidence, we analysed the final reports of coverage decisions after benefit assessments (outpatient care) between 1.1.1998 and 31.10.2008. A total of 36 decisions were analysed. 12 technologies were adopted for provision in outpatient care, 22 were excluded and two were suspended of assessment procedure until new evidence is provided. The G-BA decided in each case on the basis of the best available evidence. In the majority of negative decisions (16 of 22) no randomised controlled trials (RCTs) were available, the decision was therefore made on the basis of non-randomised studies. Even five of 12 positive decisions lacked evidence based on RCTs. In these cases the G-BA acknowledged that the evaluation of efficacy in randomised clinical trials was, due to the disease characteristic, not feasible. The G-BA uses different ways to deal with missing or insufficient evidence. It should be noted that the concept of missing evidence in the public is often diffuse and should be better defined.
为了研究联邦联合委员会（G-BA）做出医保覆盖决策所依据的证据水平，以及G-BA如何处理缺失或不充分的证据，我们分析了1998年1月1日至2008年10月31日期间效益评估（门诊护理）后医保覆盖决策的最终报告。共分析了36项决策。其中12项技术被批准用于门诊护理，22项被排除，两项在有新证据之前暂停评估程序。G-BA在每种情况下都根据现有最佳证据做出决定。在大多数否定决策（22项中的16项）中，没有随机对照试验（RCT）可用，因此决策是基于非随机研究做出的。甚至12项肯定决策中的5项也缺乏基于RCT的证据。在这些情况下，G-BA承认，由于疾病特征，在随机临床试验中评估疗效不可行。G-BA采用不同方式处理缺失或不充分的证据。应当指出，公众对缺失证据的概念往往模糊不清，需要更好地加以界定。
