The Institute for Quality and Efficiency in Health Care (IQWiG) is an establishment of the Foundation for Quality and Efficiency in Health Care. IQWiG is a professionally independent scientific institute. Information on the structure and organization of the Foundation and the Institute is available on the IQWiG website.

The General Methods explain the legal and scientific basis of the Institute. Its tasks are described in this document, as are the scientific tools applied in the preparation of its products. Hence the Institute’s methods paper provides an important contribution towards transparency in the Institute’s mode of operation.

The General Methods are primarily directed at researchers. In order to make the information on the Institute’s mode of operation accessible to as many interested persons as possible, the authors have aimed to produce a comprehensible document. However, as with any scientific text, a certain level of prior knowledge on the topic is assumed.

The General Methods aim to describe the Institute’s procedures in a general manner. What specific individual steps the Institute undertakes in the assessment of specific medical interventions depend, among other things, on the research question posed and the available scientific evidence. The General Methods should therefore be regarded as a kind of framework. How the assessment process is designed in individual cases is presented in detail for each specific project.

The Institute’s methods are usually reviewed annually with regard to any necessary revisions, unless errors in the document or relevant developments necessitate prior updating. Project-specific methods are defined on the basis of the methods version valid at that time.

Contents

• Preamble
• What is new?
• List of abbreviations
• 1. The Institute for Quality and Efficiency in Health Care
  • 1.1 Legal responsibilities
  • 1.2 Evidence-based medicine
  • 1.3 Health economics
  • 1.4 Evidence-based decision-making in health care
• 2. The Institute's products
  • 2.1 Product-specific procedures
  • 2.2 General aspects in the preparation of products
• 3. Benefit assessment of medical interventions
  • 3.1 Patient-relevant medical benefit and harm
  • 3.2 Special aspects of the benefit assessment
  • 3.3 Benefit assessment of drugs
  • 3.4 Non-drug therapeutic interventions
  • 3.5 Diagnostic tests
  • 3.6 Early diagnosis and screening
  • 3.7 Prevention
  • 3.8 Assessment of potential
• 4. Health economic evaluation of medical interventions
  • 4.1 Introduction
  • 4.2 Modelling
  • 4.3 Benefit
  • 4.4 Costs
  • 4.5 Epidemiological data
  • 4.6 Presentation of results as an efficiency frontier
  • 4.7 Uncertainty (sensitivity analyses)
  • 4.8 Budget impact analysis
  • 4.9 Specific aspects of a health economic evaluation according to §35b SGB V
• 5. Clinical practice guidelines and health care analysis
  • 5.1 Background
  • 5.2 Identification of health care standards by means of clinical practice guidelines
  • 5.3 Recommendations on disease management programmes
  • 5.4 Health care analysis
  • 5.5 Validity of clinical practice guideline recommendations
• 6. Evidence-based health information for consumers
  • 6.1 Background and goals
  • 6.2 Patient-centred communication
  • 6.3 Topic selection, gathering of information and evaluation of evidence
  • 6.4 Information products
• 7. Information retrieval
  • 7.1 Information retrieval conducted by the Institute itself
  • 7.2 Evaluation of the information retrieval
• 8. Assessment of information
  • 8.1 Quality assessment of individual studies
  • 8.2 Consideration of systematic reviews
  • 8.3 Specific statistical aspects
  • 8.4 Qualitative methods
• Appendix A Rationale of the methodological approach for determining the extent of added benefit
• References

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This translation is based on the German document Allgemeine Methoden (Version 4.2) of 22 April 2015. Please note: The translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding.