EUnetHTA JA2 Methodology Archive (2012 – 2015)

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a) Updated EUnetHTA JA (2010 – 2012) Methodological Guidelines for rapid relative effectiveness assessment (REA)

The EUnetHTA JA2 Work Package 7 Member organisations reviewed the contents of the EUnetHTA JA (2010-2012) methodological guidelines on REA of pharmaceuticals (see below). They decided to extend the scope of the text and recommendations from pharmaceuticals only to the assessment of all health technologies. Content and recommendations remained unchanged.

1. Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness  (Published)
2. Guideline on the Critical assessment of economic evaluations (ongoing)
3. Guideline on the Critical assessment of clinical evaluations (planned)

1.  Endpoints used for Relative Effectiveness Assessment Clinical Endpoints_Amended JA1 Guideline_Final Nov 2015
2.  Endpoints used for Relative Effectiveness Assessment Composite endpoints Amended JA1 Guideline Final Nov 2015
3.  Endpoints used in Relative Effectiveness Assessment Surrogate Endpoints Amended JA1 Guideline Final Nov 2015
4.  Endpoints used in Relative Effectiveness Assessment Safety Amended JA1 Guideline Final Nov 2015
5.  Endpoints used for Relative Effectiveness Assessment Health related quality of life and utility measures Amended JA1 Guideline Final Nov 2015
6. Comparators & Comparisons Criteria for the choice of the most appropriate comparator(s) Amended JA1 Guideline 2015
7. Comparators & Comparisons  Direct and indirect comparisons Amended JA1 Guideline Final Nov 2015
8. Internal validity of randomised controlled trials
9. Levels of Evidence – Applicability of evidence for the context of a relative effectiveness assessment Amended JA1 Guideline Final Nov 2015

b) Newly developed Methodological Guidelines

10. Meta-analysis of diagnostic test accuracy studies
11. Methods for health economic evaluations  – A guideline based on current practices in Europe
12. Internal validity of non-randomised studies (NRS) on interventions
13. Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness
14. Therapeutic medical devices 

c) Reflection Paper on Personalised Medicine and Co-Dependent Technologies

The draft reflection paper was delivered to the European Commission among the outputs of the EUnetHTA JA2 WP7 by the end of EUnetHTA JA2 (March 2016). The draft paper was put to undergo further public consultation with an intent to continue the work on the subject in EUnetHTA.  

d) Documents on Additional Evidence Generation (AEG)

15. Position Paper on research recommendations for AEG
16. Position Paper on study design for AEG
17. Core Protocol Pilot for AEG