We are pleased to announce that the eight adapted methodological guidelines for Relative Effectiveness Assessment (REA) developed in JA1 and revised by WP7 – Subgroup 3 in JA2, are ready for public consultation..
The consultation will take place between 26 August and 9 October 2015.
Aim and method of guidelines´ revision
According to the Grant Agreement for Joint Action 2 (JA2) the methodological guidelines produced during Joint Action 1 to support rapid relative effectiveness assessments of pharmaceuticals were to be updated if necessary.
After their first publication in March 2013 the use of the guidelines has been closely monitored by work package 7 – subgroup 3 members in order to detect any unknown quality problems or shortcomings experienced by experts involved in joint assessment projects of work packages 4 and 5.
As important critical feedback has been rare up to now, the subgroup 3 members could follow a minimalist approach for updating the guidelines. Three reviewers for each guideline consecutively proposed and internally agreed on wording changes aimed to extend the guideline’s scope to non-drug technologies. Only minor wording changes (e.g. rewording of “assessment of pharmaceuticals” into “assessment of health technologies”) or corrections of typos were made. Other changes, e.g. regarding content, language, style or comprehensibility were not supposed to be made at this stage. This will be part of the intended regular updating of all methodological guidelines of EUnetHTA in Joint Action 3 and the future.
Exception “Safety” guideline
For the JA1 guideline for REA on safety outcomes there has been a significant number of changes made in regard to the assessment of medical devices. Updating this guideline therefore requires the usual thorough two-step-review process including internal and SAG / public consultation. This process will start in parallel to the process of updating the eight guidelines – see process description below.
Consultation gives opportunity to check the wording changes
The slightly adapted documents will be presented in a tracked changes mode. This is for transparency reasons and provides an opportunity for everyone (EUnetHTA members and Public) to check that the wording changes proposed are not “substantial” in the sense of altering the content of the recommendations given in the original guideline versions released in March 2013.
Consultation documents
1. Eight adapted methodological guidelines for REA
2. Table of comments Form
How to submit your comments?
Please provide comments on the changes made in the eight guidelines in the attached table of comments template (one table for all 8 documents). Deadline for comments is 12:00 noon CET on 9th of October 2015 at the very latest to the Subgroup 3 coordinator joerg.lauterberg@iqwig.de
The reply should contain complete contact data of the sender (name, title, organisation, postal address, telephone number and e-mail address of the sender)
The sender should indicate if he/she submits the comments as an individual or on behalf of an organisation.
The authors are unable to accept:
– Comments received after the consultation deadline
– Comments that are not provided via the table of comments Form
– Confidential information or other material that you would not wish to be made public
What will happen to your comments?
1. All comments will be formally responded to in a combined document, which will be posted on the EUnetHTA website in November 2015. This document will also contain the names of persons / organisations that properly submitted contributions.
2. No action will be taken upon receipt of late comments.
3. You should receive a response to your email with comments as a confirmation that your comments have been received. If you do not receive this acknowledgement, please contact the coordinator joerg.lauterberg@iqwig.de to ensure your comments have been safely received.
The final adapted eight methodological guidelines will be published together with the comments received on the EUnetHTA website in November 2015.
2015-07-08_table_of_comments_ja1_gls-adaptations_jl
2015-07-07-adap_internal_validity
2015-07-03_adap-choice_of_comparator2015-07-03_adapt_clinical_endpoints
2015-07-03-adap_surrogateendpoints
2015-07-07_adap_composite_endpoints
2015-07-07_adap_direct_and_indirect_comparisons
2015-07-07_adap_hrqol
2015-07-07_adapt-applicability
