Gaps in JCA Guidance for Systematic Literature Reviews: A Comparative Review with Cochrane, EUnetHTA, and Major HTA Agencies' Standards
Author(s)
Beata Smela, PhD1, Mondher Toumi, MSc, PhD, MD2, Samuel Aballea, PhD3, Steven Simoens, BA, MA, MSc, PhD4, Laurent Boyer, MD2, Bruno Falissard, MD5, Renato Bernardini, MD6, Stefano Capri, PhD7, Beata Lukiewicz, MSc1, Konrad Gawlik, MSc1, Pascal Auquier, PhD2.
1Clever-Access, Kraków, Poland, 2Health Services Research and Quality of Life Center, Aix-Marseille University, Marseille, France, 3Inovintell, Rotterdam, Netherlands, 4KU Leuven, Leuven, Belgium, 5Université Paris-Saclay, Villejuif, France, 6Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy, 7School of Economics and Management, LIUC University, Castellanza, Italy.
1Clever-Access, Kraków, Poland, 2Health Services Research and Quality of Life Center, Aix-Marseille University, Marseille, France, 3Inovintell, Rotterdam, Netherlands, 4KU Leuven, Leuven, Belgium, 5Université Paris-Saclay, Villejuif, France, 6Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy, 7School of Economics and Management, LIUC University, Castellanza, Italy.
OBJECTIVES: Systematic literature reviews (SLRs) are essential for transparent and reproducible health technology assessments (HTAs). This study assessed the methodological guidance provided by the EU Joint Clinical Assessment (JCA) in relation to the systematic review standards defined by international HTA agencies, the EUnetHTA recommendations and Cochrane.
METHODS: We reviewed the methodological requirements for SLRs presented in the official JCA guidance documents and compared them with standards outlined by Cochrane, EUnetHTA (2015, 2019), and major HTA agencies (NICE, HAS, IQWiG, CADTH, PBAC). Key domains—such as protocol development, search strategy, study selection, appraisal methods, and synthesis—were evaluated.
RESULTS: JCA documents offer only general, high-level references to SLRs, without providing actionable methodological standards. Unlike Cochrane and EUnetHTA, JCA lacks dedicated SLR guidance, does not recommend a specific methodology, and omits key elements such as dual screening, protocol registration, or validated quality assessment tools. Database requirements are limited to MEDLINE and CENTRAL, which falls short of commonly accepted practice that includes Embase.
CONCLUSIONS: Despite referencing evidence-based principles, JCA guidance deviates from established standards and lacks methodological clarity. No dedicated SLR guidance has been developed, and no SLR appears to have been conducted to inform the recommendations themselves. This may risk reduced reproducibility, reliability, and scientific credibility. Endorsing EUnetHTA and Cochrane guidelines would strengthen the transparency and rigor of future joint assessments.
METHODS: We reviewed the methodological requirements for SLRs presented in the official JCA guidance documents and compared them with standards outlined by Cochrane, EUnetHTA (2015, 2019), and major HTA agencies (NICE, HAS, IQWiG, CADTH, PBAC). Key domains—such as protocol development, search strategy, study selection, appraisal methods, and synthesis—were evaluated.
RESULTS: JCA documents offer only general, high-level references to SLRs, without providing actionable methodological standards. Unlike Cochrane and EUnetHTA, JCA lacks dedicated SLR guidance, does not recommend a specific methodology, and omits key elements such as dual screening, protocol registration, or validated quality assessment tools. Database requirements are limited to MEDLINE and CENTRAL, which falls short of commonly accepted practice that includes Embase.
CONCLUSIONS: Despite referencing evidence-based principles, JCA guidance deviates from established standards and lacks methodological clarity. No dedicated SLR guidance has been developed, and no SLR appears to have been conducted to inform the recommendations themselves. This may risk reduced reproducibility, reliability, and scientific credibility. Endorsing EUnetHTA and Cochrane guidelines would strengthen the transparency and rigor of future joint assessments.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
SA45
Topic
Health Policy & Regulatory, Study Approaches
Topic Subcategory
Literature Review & Synthesis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas