The German Institute for Quality and Efficiency in Health Care (IQWiG) revised its methods paper and published the version "General Methods 5.0" on 10 July 2017 on iqwig.de. An English translation of the methods paper is now available. With its publication, the document became the basis for the scientific work of the Institute and its external experts as well as for cooperation with the contracting agencies, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and the Federal Ministry of Health. The updated version includes, among others, new chapters on HTA reports addressing topics proposed by the public ("ThemenCheck Medizin") and on the assessment of new examination and treatment methods largely based on high-risk medical devices.
The General Methods summarize the scientific standards applied by the Institute. To reflect the extension of the Institute's legal tasks and the further development of standards in scientific disciplines, this manual is updated on a regular basis - partly in smaller steps, partly by means of fundamental revision resulting in a new version number.
Milestone for the tenth event of "IQWiG in Dialogue"
Ralf Bender, Head of the Institute's Medical Biometry Department noted: "In mid-June 2017 our scientific event for methodologists 'IQWiG in Dialogue' took place for the tenth time. In the introduction part, we looked back on the development of the General Methods. We prepared the first version in 2004 after the Institute's establishment. Since then, there have been four major changes in the law, which in each case required a new version. In addition, we incorporated several improvements based on the experiences gained from the daily work on our commissions. We are glad that with Version 5.0, we are up to date again. But of course the further development of the methods never stops."
New chapter on ThemenCheck Medizin ("Topic Check Medicine")
One of the reasons for the fundamental revision was the new task awarded to the Institute with the Statutory Health Insurance Act to Strengthen the Provision of Health Care, which became effective in 2015: According to §139b (5) of Social Code Book V, insurants and other interested individuals can propose assessments of medical examination and treatment methods. It is the Institute's task to select topics from these proposals that are of particular importance for health care and to publish health technology assessment (HTA) reports in this regard.
The new Section 2.1.10 and the new Chapter 6 of the General Methods describe the process from the submission of topics to the production of the report. The selection process comprises 3 steps: the evaluation and weighting of the topic proposals submitted, the assessment and nomination of 15 topics per year by a Selection Committee, and finally the selection of up to 5 topics per year by the Institute Management. The new chapter also describes how to process the topics and how to ensure the quality of the HTA reports. Besides containing a benefit assessment, depending on the research question, the report should also consider health economic, ethical, social, legal, and organizational aspects.
Assessments of high-risk medical devices
Also in 2015, in Social Code Book V §137h the legislator created the option for IQWiG to assess high-risk medical devices under certain circumstances. These assessments are addressed in the new Section 2.1.6 and considered in Chapters 3 and 8 in the corresponding sections. The procedure largely corresponds to assessments of potential (acc. to §137e); however, in assessments according to §137h neither the topics nor the key documents are confidential.
As in assessments according to §137e, essentially the potential is assessed of a new examination and treatment method ("neue Untersuchungs- und Behandlungsmethode", NUB) that is primarily based on the use of a high-risk medical device. This assessment is based on documents submitted by a hospital to the G-BA, which are supplemented by further documents submitted by other hospitals and the medical device manufacturers concerned. If required, the Institute can also conduct its own literature search and involve external medical expertise. As the G-BA is legally obliged to decide on the benefit or potential of a method within 3 months, the Institute produces its assessments within 6 weeks.
The Institute fundamentally revised the sections on guideline synopses and health care analysis (Chapter 5), on health information (Chapter 7), and on information retrieval (Chapter 8).
The new information in Chapter 5 mainly comprises amendments to explanations on the applicability of clinical practice guidelines to the German health care system and the primary deduction of recommendations from so-called Grades of Recommendation (GoR). Chapter 7 is based on the German-language position paper "Good Practice Health Information 2.0", which the German Network for Evidence-based Medicine passed in July 2016. Finally, the chapter on information retrieval was specified and adapted according to the changes in the other chapters. The Institute now distinguishes more clearly between comprehensive and focused information retrieval as well as exploratory literature searches.
Further amendments and updates
In addition, the sections on the involvement of affected persons, on the provision of scientific advice to study sponsors, and on the handling of dependent data were amended. Changes and amendments were also made in the chapter addressing the benefit assessment of medical interventions, for example, on overdiagnosis and on assessments of potential. In the chapter addressing the assessment of information, among others, the explanations on the risk of bias, on subgroup analyses, on meta-analyses, on indirect comparisons and on qualitative methods were updated. Important changes in this chapter refer to the significance level for interaction and heterogeneity tests as well as to the use of the Knapp-Hartung method for meta-analyses with random effects.
An overview of the main changes in the nearly 300-page methods paper is provided in the section "What is new?" at the beginning of the document.
IQWiG published the draft of the new version of the General Methods at the beginning of December 2016 and invited interested parties to submit comments. After the deadline for comments, a well-attended hearing took place at IQWiG in Cologne. The comments and proposals from the hearing were considered in the present version.
Together with the methods paper IQWiG published a documentation and evaluation of the hearing in which on the one hand, all written comments are fully documented. On the other hand, the document contains the Institute's comments, which address all important arguments presented in the comments.
IQWiG will publish information on the next revision of the methods paper at an early stage.