Abstract

Background To support evidence-based healthcare appropriately, clinical practice guidelines must reflect what matters most to patients. This requires considering health outcomes that patients value, such as pain, function, or quality of life. These outcomes are captured by researchers using patient-reported outcomes (PROs). Despite their relevance, PROs remain inconsistently used in guideline development. Objective To provide an example-based roadmap for integrating PROs into the development of clinical practice guidelines. Methods We synthesized and organized existing methodological guidance on evidence synthesis and guideline development and structured it according to key decision points informed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Using illustrative dental examples, we describe how guideline developers can incorporate PROs when formulating recommendation questions, summarizing evidence, and assessing benefits, harms, and certainty of evidence. Results We present practical strategies to integrate PROs throughout the guideline development process. We define key concepts, show how to design recommendation questions that reflect patient priorities, describe how to synthesize PRO data when studies use diverse instruments and report outcomes inconsistently, and explain how to incorporate PRO evidence when judging benefits, harms, and certainty of evidence. We also identify common barriers and propose approaches to improve PRO integration. Conclusions Integrating PROs throughout the guideline process increases the likelihood that recommendations are aligned with patient values. Achieving this goal also requires high-quality primary studies and systematic reviews that include and report on PROs.