IQWiG publishes new version of its General Methods

December 02, 2013

The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed the first step in the revision of its methods paper and published the version "General Methods 4.1" on the Internet on 28 November 2013. From now on the new document forms the basis for the scientific work of the Institute and its external experts and for collaboration with the commissioning agencies (the Federal Joint Committee and the Federal Ministry of Health).

Instead of preparing, as previously, a full update of the methods paper, the Institute is revising the General Methods 4.0 in several steps. The first changes primarily affect Chapter 3 on benefit assessment and Section 7.3.8 on meta-analyses.

What is new?

The levels of certainty of conclusions for different situations of evidence in benefit assessments - proof, indication and hint - are now described in more detail. For this purpose, in the chapter on benefit assessment IQWiG has split former Section 3.1.4 into two sections, namely the new section "Outcome-related assessment" (now 3.1.4) and the former section "Summarizing assessment" (now 3.1.5). In Section 3.1.4 the Institute has extended criteria describing in which exceptional cases proof of benefit, i.e., the highest level of certainty of conclusions, can also be inferred from only one study. IQWiG follows suggestions from the commenting procedure here.

Section 3.3.3 on the early benefit assessment of new drugs now contains a detailed description of how IQWiG operationalizes the determination of the extent of added benefit. A new appendix contains a comprehensive rationale for the underlying methodological approach.

The use of prediction intervals in meta-analyses with random effects was added to Section 7.3.8 on meta-analyses. Prediction intervals are an important instrument in assessing whether and how clearly effects observed in studies are in the same direction. According to the new Section 3.1.4, this again plays an important role when deriving conclusions on the available evidence.

Transparent procedure

IQWiG published the draft containing the first step of the updates of General Methods 4.0 and the new sections of General Methods 4.1 on 19 April 2013 and invited interested parties to submit comments in a commenting procedure. These comments have been considered in the present Version 4.1.

Together with its methods paper IQWiG has published a "Documentation and evaluation of comments", which contains the full verbatim written comments as well as their evaluation, that is, IQWiG's responses to all the main arguments presented in the comments.

The next step

The draft of the next updates and additions are planned for publication in the first quarter of 2014. This will again be followed by a commenting procedure and the final revision of the corresponding sections of the methods paper, resulting in General Methods 4.2. This document will as usual be published on the Institute's website.

The second step involves, among other things, new sections on the assessment of the potential of non-drug interventions in accordance with the testing regulation (Erprobungsregelung). This type of assessment has been conducted by IQWiG since the Health Care Structure Law (Versorgungsstrukturgesetz, GKV-VStG) became effective in 2013.
The English-language version of the General Methods Version 4.1 will be available soon. If you would like to be informed when this document is available, please send an e-mail to

Institute for Quality and Efficiency in Health Care

Related Health Care Articles from Brightsurf:

Study evaluates new World Health Organization Labor Care Guide for maternity care providers
The World Health Organization developed the new Labor Care Guide to support clinicians in providing good quality, women-centered care during labor and childbirth.

Six ways primary care "medical homes" are lowering health care spending
New analysis of 394 U.S. primary care practices identifies the aspects of care delivery that are associated with lower health care spending and lower utilization of emergency care and hospital admissions.

Modifiable health risks linked to more than $730 billion in US health care costs
Modifiable health risks, such as obesity, high blood pressure, and smoking, were linked to over $730 billion in health care spending in the US in 2016, according to a study published in The Lancet Public Health.

Spending on primary care vs. other US health care expenditures
National health care survey data were used to assess the amount of money spent on primary care relative to other areas of health care spending in the US from 2002 to 2016.

MU Health Care neurologist publishes guidance related to COVID-19 and stroke care
A University of Missouri Health Care neurologist has published more than 40 new recommendations for evaluating and treating stroke patients based on international research examining the link between stroke and novel coronavirus (COVID-19).

Large federal program aimed at providing better health care underfunds primary care
Despite a mandate to help patients make better-informed health care decisions, a ten-year research program established under the Affordable Care Act has funded a relatively small number of studies that examine primary care, the setting where the majority of patients in the US receive treatment.

International medical graduates care for Medicare patients with greater health care needs
A study by a Massachusetts General Hospital research team indicates that internal medicine physicians who are graduates of medical schools outside the US care for Medicare patients with more complex medical needs than those cared for by graduates of American medical schools.

The Lancet Global Health: Improved access to care not sufficient to improve health, as epidemic of poor quality care revealed
Of the 8.6 million deaths from conditions treatable by health care, poor-quality care is responsible for an estimated 5 million deaths per year -- more than deaths due to insufficient access to care (3.6 million) .

Under Affordable Care Act, Americans have had more preventive care for heart health
By reducing out-of-pocket costs for preventive treatment, the Affordable Care Act appears to have encouraged more people to have health screenings related to their cardiovascular health.

High-deductible health care plans curb both cost and usage, including preventive care
A team of researchers based at IUPUI has conducted the first systematic review of studies examining the relationship between high-deductible health care plans and the use of health care services.

Read More: Health Care News and Health Care Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to