NUQUEST-NUtrition QUality Evaluation Strengthening Tools: Development of tools for the evaluation of risk of bias in nutrition studies.

Background Dietary exposure assessments are a critical issue in evaluating human nutrition studies; however, nutrition-specific criteria are not consistently included in existing bias assessment tools. Objective Our objective was to develop a set of Risk of Bias (RoB) tools that integrated nutrition-specific criteria into validated generic assessment tools to address RoB issues, including those specific to dietary exposure assessment. Methods Nutrition QUality Evaluation Strengthening Tools (NUQUEST) development and validation process included eight steps. The first steps identified: 1) a development strategy; 2) generic assessment tools with demonstrated validity; and 3) nutrition-specific appraisal issues. This was followed by: 4) generation of nutrition-specific items, and 5) development of guidance to aid users of NUQUEST. The final steps used established ratings of selected studies and feedback from independent raters to: 6) assess reliability and validity; 7) assess formatting and usability; and 8) finalize NUQUEST. Results NUQUEST is based on the Scottish Intercollegiate Guidelines Network checklists for randomized controlled trials, cohort studies and case-control studies. Using a purposive sample of 45 studies representing the three study designs, inter-rater reliability was high (Cohen's kappa 0.73, 95% confidence interval (CI) 0.52, 0.93) across all tools and at least moderate for individual tools (range 0.57 to 1.00). The use of a worksheet improved usability and consistency of overall inter-rater agreement across all study designs (40% without worksheet, 80-100% with worksheet). When compared to published ratings, NUQUEST ratings for evaluated studies demonstrated high concurrent validity (93% perfect or near-perfect agreement). Where there was disagreement, the nutrition-specific component was a contributing factor in discerning exposure methodological issues. Conclusion NUQUEST integrates nutrition-specific criteria with generic criteria from assessment tools with demonstrated reliability and validity. NUQUEST represents a consistent and transparent approach for evaluating RoB issues related to dietary exposure assessment commonly encountered in human nutrition studies.