Arnold Katrin, Breuing Jessica, Becker Monika, Nothacker Monika, Neugebauer Edmund, Schmitt Jochen, Deckert Stefanie
Zentrum für Evidenzbasierte Gesundheitsversorgung (ZEGV), Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, 01307, Dresden, Deutschland.
IFOM - Institut für Forschung in der Operativen Medizin, Department für Humanmedizin Universität Witten/Herdecke, 51109, Köln, Deutschland.
Z Evid Fortbild Qual Gesundhwes. 2019 Nov;147-148:34-44. doi: 10.1016/j.zefq.2019.09.001. Epub 2019 Nov 13.
Evidence-based and formally consensus-based clinical practice guidelines (S3-CPGs) are a valuable source for the development of quality indicators (QIs) in Germany. While deriving QIs from guideline recommendations is a mandatory part of the development of S3-CPGs within the National Program for Disease Management Guidelines (DMGP) and the German Guideline Program in Oncology (GGPO), there is no such obligation in the guideline program of the Association of the Scientific Medical Societies in Germany (AWMF) (MS program). Despite that, several S3-CPGs in the MS program have been published with QIs in the last years while some DMGP and one GGPO S3 guidelines have failed to meet this requirement. From the perspective of the guideline authors of all three mentioned programs, the present qualitative study examined why S3-CPGs do or do not contain QIs and explored the factors perceived by authors as either facilitating or hampering in the QI development process.
Semi-structured interviews were conducted with authors of 22 S3-CPGs, 11 of which represented guidelines containing QIs and 11 of which represented guidelines without QIs. Authors of guidelines containing QIs (n=11) were asked about the perceived decisive reasons for formulating QIs and about facilitators and barriers during the QI development process. Authors of guidelines without QIs (n=11) gave reasons for not formulating QIs. Interviews were analyzed using structuring qualitative content analysis.
Within the MS program, not formulating QIs was mainly attributed to the lack of a mandatory requirement and to insufficient funding of guideline projects. Amongst DMGP authors, a low priority of QI development prevailed, which was, for example, due to already existing QIs or to their lacking implementation. In the GGPO guideline examined, not formulating QIs was due to the guideline topic (prevention) - for this topic, there was a lack of suitable evidence and data sources. If QIs were developed, the most important facilitating factor in the development process, across all programs, was the methodological support provided by the guideline program. Important hampering factors included the additional time required for QI development and concerns regarding the implementation of many potential QIs, especially due to a lack of data availability.
For regular development of QIs within S3-CPG projects, the incorporation of such a requirement in the guideline program is a necessary, but not a sufficient, condition. Other pivotal factors include systematic methodological support, adequate financial and staff resources and the perceived meaningfulness and relevance of guideline-based QI development, measured in terms of the actual implementation of already existing QIs.
The study reveals starting points for measures to strengthen the consideration of QI development in German S3-CPG projects, especially within the MS program. Without substantial structural changes, especially of the resources of guideline groups, and without an overall concept covering the entire process from QI development to QI implementation, guideline-based QI development will remain heavily dependent on the (self-)motivation of guideline groups.
循证且基于正式共识的临床实践指南(S3 - CPGs)是德国制定质量指标(QIs)的宝贵来源。虽然从指南建议中推导质量指标是国家疾病管理指南计划(DMGP)和德国肿瘤学指南计划(GGPO)中S3 - CPGs制定的强制性部分,但在德国科学医学协会联合会(AWMF)的指南计划(MS计划)中并无此义务。尽管如此,在过去几年中,MS计划中的一些S3 - CPGs已发布了质量指标,而一些DMGP和一个GGPO S3指南未能满足这一要求。从上述三个计划的指南作者的角度来看,本定性研究探讨了S3 - CPGs为何包含或不包含质量指标,并探究了作者认为在质量指标制定过程中促进或阻碍的因素。
对22份S3 - CPGs的作者进行了半结构化访谈,其中11份代表包含质量指标的指南,11份代表不包含质量指标的指南。包含质量指标的指南的作者(n = 11)被问及制定质量指标的决定性原因以及质量指标制定过程中的促进因素和障碍。不包含质量指标的指南的作者(n = 11)给出了不制定质量指标的原因。采用结构化定性内容分析法对访谈进行分析。
在MS计划中,不制定质量指标主要归因于缺乏强制性要求以及指南项目资金不足。在DMGP作者中,质量指标开发的优先级较低,例如,这是由于已有质量指标或缺乏实施所致。在所研究的GGPO指南中,不制定质量指标是由于指南主题(预防)——对于该主题,缺乏合适的证据和数据源。如果制定了质量指标,在所有计划的制定过程中,最重要的促进因素是指南计划提供的方法学支持。重要的阻碍因素包括质量指标开发所需的额外时间以及对许多潜在质量指标实施的担忧,特别是由于缺乏数据可用性。
为了在S3 - CPG项目中定期开展质量指标开发,在指南计划中纳入这样的要求是必要条件,但并非充分条件。其他关键因素包括系统的方法学支持、充足的资金和人员资源,以及基于指南的质量指标开发在实际实施现有质量指标方面的感知意义和相关性。
该研究揭示了加强德国S3 - CPG项目中质量指标开发考量的措施的起点,特别是在MS计划中。如果没有实质性的结构变化,特别是指南小组资源的变化,以及没有涵盖从质量指标开发到质量指标实施的整个过程的总体概念,基于指南的质量指标开发将严重依赖于指南小组的(自我)积极性。