OBJECTIVES: Cost-effectiveness analyses have proven highly sensitive to the health state utility value (HSUV) selection. With an uptick in studies eliciting HSUVs, systematic literature reviews (SLRs) and meta-analyses have become essential tools to synthesize these studies in various decision contexts. Therefore, quality appraisal (QA) of HSUV elicitation studies is central to informing new health technology assessments. This study aimed to develop a scientifically grounded, evidence-based QA tool tailored to SLRs of studies eliciting HSUVs.

METHODS: We adopted a comprehensive mixed-methods approach. Initially, a rapid review was performed to identify terminologies related to scientific quality, QA, QA dimensions, QA items, and signaling questions used in SLRs of studies eliciting HSUVs. This was followed by a Delphi consensus process involving an international, multidisciplinary expert panel, which completed two rounds of online questionnaires and an online panel discussion on QA aspects in HSUVs. The consensus was defined a priori at all stages of the Delphi study.

RESULTS: 73 SLRs were included, and seven international experts participated in the Delphic study. Response rates to the questionnaire's first and second rounds and the virtual meeting were 7/7, 6/7 and 5/7, respectively. Consensus was reached on the definitions of scientific quality, QA, three QA dimensions, the scope of the QA tool, QA items for reporting quality, study relevance, methodological limitations and risk of bias. The panel also ranked the most critical items for QA of studies eliciting HSUVs. The first version of the Quality Appraisal Tool - Health Sates Utility Values (QAT-HSUV) was developed.

CONCLUSIONS: The proposed QA tool, specific for studies eliciting HSUVs, discerns between reporting, relevance, and methodological quality. The consensus achieved on definitions, QA dimensions, and the scope of a QA tool marks a significant step towards standardizing the QA process for HSUVs. The next steps will involve the assessments of the tool's usability, validity and discriminant ability.