gms | German Medical Science

G-I-N Conference 2012

Guidelines International Network

22.08 - 25.08.2012, Berlin

The experience with GRADE in a national clinical practice guideline: practical issues around risk of bias and safety

Meeting Abstract

  • J. López-Alcalde - Health Technology Assessment Unit (UETS), Laín Entralgo Agency, Madrid, Spain
  • B. Nieto - Health Technology Assessment Unit (UETS), Laín Entralgo Agency, Madrid, Spain
  • J. Gracia - Health Technology Assessment Unit (UETS), Laín Entralgo Agency, Madrid, Spain
  • M. Miravitlles - Institut d'Investigacions Biomèdiques August Pi i Sunyer. Hospital Clínic, Barcelona, Spain
  • J.A. Blasco - Health Technology Assessment Unit (UETS), Laín Entralgo Agency, Madrid, Spain

Guidelines International Network. G-I-N Conference 2012. Berlin, 22.-25.08.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. DocP046

doi: 10.3205/12gin158, urn:nbn:de:0183-12gin1581

Veröffentlicht: 10. Juli 2012

© 2012 López-Alcalde et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen ( Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.



Background: We used GRADE to develop a clinical practice guideline (CPG) on chronic obstructive pulmonary disease in the context of the National CPG Program in Spain (GuiaSalud).

Objectives: To identify methods used in the development of a CPG with GRADE for assessment of the risk of bias (RoB) of clinical trials (CTs) and the safety of interventions in systematic reviews (SRs).

Methods: A descriptive study of the process used when developing the guideline.

Results: The preliminary results show that around 70% of the identified SRs didn’t use the Cochrane tool for assessing RoB (for example, the Jadad scale was used). The beneficial and adverse effects of the interventions were evaluated in each SR using the same method, that is, common eligibility criteria (same study designs, participants, and interventions) and a single search strategy.

Discussion: There was a heterogeneous methodology for the assessment of RoB of included studies and we decided to use the Cochrane RoB tool for all of them, which was time consuming. Although the identified SRs assessed beneficial and adverse effects with the same methodology, a standardised strategy to address safety in SRs is lacking, and other approaches could have been used, such as performing a separate review for adverse effects.

Implications for guideline developers: When using GRADE, guidance is needed on assessing the RoB of studies identified by systematic reviews that have not used the Cochrane RoB tool. Guidance is also needed concerning safety issues arising from SRs.