OBJECTIVES: The Pediatric Economic Database Evaluation (PEDE) Project features a database of 787 pediatric economic evaluations published between 1980 and 1999. A goal of the PEDE Project is to appraise the quality of pediatric economic evaluations published over this period. The objective of this research was to develop a valid and reliable quality appraisal instrument applicable to economic evaluations in the pediatric population. METHODS: A draft instrument was constructed from published checklists and questionnaires. New questions pertaining to the pediatric population were incorporated. An expert panel reviewed the draft instrument and the proposed scoring scheme for face and content validity. A revised version was pilot-tested by three independent appraisers. After addressing discrepancies in scores, a final version was created and subjected to inter-rater and test-retest reliability assessment. RESULTS: The 57 items in the final questionnaire were mapped onto fourteen domains: economic evaluation, comparators, target population, time horizon, perspective, costs and resource use, outcomes, quality of life, analysis, discounting, incremental analysis, sensitivity analysis, conflict of interest, and conclusions. Among the 57 items, 46 have response options that are scored from 0 to 1. Inter-rater reliability was 0.75 (95% CI 0.66-0.81) and test-retest reliability was 0.92 (95% CI 0.71-0.98). CONCLUSIONS: The Pediatric Quality Appraisal Questionnaire is a comprehensive instrument demonstrating face and content validity and very good reliability for application in the appraisal of pediatric economic evaluations. The instrument is currently being used in a quality appraisal of a random sample of 150 publications from the PEDE database.