The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website and includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors, in collaboration with the editorial group. External comments received were also considered.
Due to developments in some areas or need for restructuring and clarification, there have been more important changes in the following chapters:
- 3. Development of the study protocol
- 4.6. Research networks
- 5.2. Bias and confounding
- 5.6. Pragmatic trials and large simple trials
- 7. Quality management
- 9.2. Scientific integrity and ethical conduct
The following chapters were newly added:
- 1. Introduction
- 4.3. Patient registries
- 4.1.1. Surveys
Annex 1. to the Guide provides methodological guidance addressing the conduct of systematic reviews and meta-analyses of drug safety endpoints generated in completed (published or unpublished) comparative pharmacoepidemiological studies.
Three new chapters have been added: Introduction, Patient registries, and Surveys.