Systematically prepared guideline synopses of the Institute for Quality and Efficiency in Health Care (IQWiG) serve the Federal Joint Committee (G-BA) as a basis for revision of the requirements for the design of disease management programmes (DMPs). Before the G-BA commissions IQWiG to prepare a systematic guideline synopsis, according to its Code of Procedure it evaluates whether there are indications of a possible need for revision of requirements for existing DMPs. DMPs are structured treatment programmes for chronically ill people that are based on the findings of evidence-based medicine. Within these programmes, treatment methods are primarily used that correspond to the current state of scientific knowledge. Patients thus receive health care that aims to prevent as far as possible the risk of late complications and acute deterioration of the disease and increase their quality of life. The goal of DMPs is, among other things, to optimize treatment, promote collaboration with service providers and thus better interlink diagnostic and therapeutic procedures. The requirements for the design of the DMP are regulated in the G-BA’s directives and, according to the Social Code Book (SGB) V, must be regularly examined. The G-BA’s Code of Procedure also stipulates a regular examination of the requirements for the DMP. The regular examination of the requirements of existing DMPs is performed in several steps according to the G-BA’s Code of Procedure. Initially it is examined whether there are indications of a possible need for revision of existing directives. At this point the examination starts. The exploratory examination of the need for revision aims to provide information to the G-BA to support its decision-making as to whether a need for revision exists for a DMP. If, after examining all the necessary information, the G-BA determines that there is a need for revision, it subsequently initiates the procedure for revision of the respective DMP. For the exploratory examination of the need for revision of DMPs, a methodology was tested in a feasibility study (working paper GA14-06) on the basis of which the present project was commissioned. In the working paper GA14-06 “Regular exploratory examination of the need for DMP revision – a feasibility study using the example of the DMP ‘coronary heart disease’ (CHD)” it was tested to what extent a need for revision of DMPs can be determined by means of the exploratory examination of guidelines, safety notices, the (German) Pharmaceutical Directive, IQWiG’s benefit assessments, as well as studies and systematic reviews. In the conclusion of the working paper it was noted, among other things, that the need for revision of a DMP could be estimated with the chosen approach. According to a further result of the working paper, instead of a search in bibliographic databases for studies and systematic reviews, web-based information sources should be used that search for and assess evidence on clinical interventions and make it available in a summarized form (referred to as “tertiary sources” in the following text). Also against this background, when the G-BA commissioned IQWiG with the present report, it noted that the exploratory examination of the need for revision of the DMP CHD should roughly follow the methodology of working paper GA14-06, but that in particular it should dispense with the search for and assessment of studies, as well as systematic reviews. CHD manifests itself as arteriosclerosis (also called atherosclerosis) of the coronary arteries. The starting point of the disease is damage to the endothelial function resulting in pathological lipid accumulation in the vessel wall and in the development of atherosclerotic plaques. In most cases, no clinical symptoms exist in the early stage of disease. In the advanced stage, the increasing stenosis of the vessels leads to an imbalance between the need for oxygen and the oxygen supply in the heart muscle and subsequently to myocardial ischaemia. This commonly manifests itself as angina pectoris (AP), that is, sudden pain in the chest, jaw, arm or other regions, lasting seconds to minutes. The development of heart failure, myocardial infarction, or sudden cardiac death may be consequences of CHD. CHD is a chronic disease. Stable AP is a clinical form of manifestation of CHD that reproducibly occurs under physical or mental stress and is constant over months. In contrast, acute phases of CHD that are directly life-threatening or fatal are summarized under the term “acute coronary syndrome”. This also includes unstable AP occurring under slight or no physical activity, myocardial infarction with or without ST-segment elevations, as well as sudden cardiac death. Risk factors for the development of CHD include increasing age, male sex, smoking, obesity, hypertension, hypercholesterolaemia, and diabetes mellitus. For the present report the term “guidelines” is used according to the definition of the US Institute of Medicine (IOM): “practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” and “include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options”. Guideline authors often award a “Grade of Recommendation” (GoR) and a “Level of Evidence” (LoE). The GoR reflects the strength of a recommendation and is usually based on a weighing of the benefit and risks of treatment, on each specific healthcare context, as well as on the strength of the underlying evidence or the LoE. The LoE represents an assessment of internal validity of the studies underlying the recommendations; in this context, systematic reviews of randomized controlled trials (RCTs) are generally awarded the highest LoE. However, guideline developers use different systems to grade evidence and, within the LoE, acknowledge varying importance of the different clinical and epidemiological studies, as well as of further potentially biasing factors, if applicable.
Z Evid Fortbild Qual Gesundhwes. 2014
Cochrane Database Syst Rev. 2022-2-1
Early Hum Dev. 2020-11
Zhonghua Jie He He Hu Xi Za Zhi. 2024-2-12
Ont Health Technol Assess Ser. 2006
2025-1
Eur J Health Econ. 2008-11