Utility measurement tools and quality of life assessment of cleft care in Sub-Saharan Africa: A systematic review.

BACKGROUND: In sub-Saharan Africa (SSA), there is a heavy burden on the health-related quality of life (HRQoL) of both people living with cleft lip and/or palate (CL/P) and their families. In these places, there is little to no utility data for cost-effectiveness analysis. The existing condition-specific patient-reported outcome measures (PROMs) and utility instruments were developed and validated in high-income countries (HIC). Therefore, there is a question on the effectiveness of these tools in SSA. This study systematically maps and appraises the utility measurement tools and HRQoL instruments applied in CL/P care across SSA, characterises their psychometric properties, and identifies gaps to inform instrument adaptation and development. METHODS: The Population-Concept-Context framework was used to conduct a systematic review. Searches were performed across four databases. The inclusion criteria were a peer-reviewed quantitative study conducted in SSA with a CL/P population with a named, validated QoL or utility instrument. RESULTS: Twelve studies from five SSA countries were included. While fourteen distinct HRQoL instruments were identified, only one study used a direct utility method. There were three condition-specific PROMs but none was formally validated in SSA. After quality appraisal, five studies were rated low, five were moderate and two had a high risk of bias. Across studies, CL/P had a significant association with low HRQoL. CONCLUSIONS: There is a paucity of utility data and SSA-validated HRQoL instruments for CL/P. The existing instruments when applied, are done without formal cultural adaptation. This is likely to lead to ineffective application, and uninformed conclusions and decision making.