A consensus statement was developed to address respondent burden in patient-reported outcome (PRO) assessments in healthcare research and clinical practice. The statement includes 19 recommendations aimed at minimizing the burden on respondents. These recommendations were generated through a comprehensive literature review, followed by a two-stage Delphi survey and a consensus meeting involving an international group of stakeholders. The recommendations cover three main areas: rationale and schedule for PRO assessments, measure selection, and measure delivery. Recommendation 1 emphasizes involving patients, clinicians, and other stakeholders in the formulation of PRO research questions to ensure relevance. Recommendation 2 suggests balancing the burden of data collection with the quantity and quality of data required. Recommendation 3 encourages stakeholder involvement in determining the schedule and frequency of assessments. The frequency of PRO administration should consider disease trajectory and balance this with respondent burden. For measure selection, Recommendation 4 recommends reviewing the literature to identify relevant concepts. Recommendation 5 suggests using qualitative and quantitative methods to obtain input from patients and clinicians. Recommendation 6 advises considering the complexity of PRO measures and their instructions. Recommendation 7 emphasizes ensuring that PRO measures are culturally and linguistically relevant. Recommendation 9 suggests considering the length of PRO measures and justifying their use. For measure delivery, Recommendation 12 emphasizes informing respondents about the purpose of data collection and its importance. Recommendation 13 suggests providing clear instructions and support for respondents. Recommendation 14 recommends training for research staff and clinicians to understand the value of PROs. Recommendation 15 suggests specifying the level of support available for respondents. Recommendation 16 recommends offering flexible modes of administration to meet the needs of different populations. Recommendation 17 suggests using ePROs where appropriate, considering the needs and preferences of the target population. Recommendation 18 emphasizes involving patients and clinicians in the co-design of ePRO systems. Recommendation 19 suggests exploring the functionality of ePROs with diverse representatives. The recommendations aim to ensure that PRO data collection is as inclusive and equitable as possible, promoting high-quality data that informs regulatory decisions and patient care. The consensus statement is a valuable resource for stakeholders involved in the implementation of PROs in healthcare research and clinical practice.A consensus statement was developed to address respondent burden in patient-reported outcome (PRO) assessments in healthcare research and clinical practice. The statement includes 19 recommendations aimed at minimizing the burden on respondents. These recommendations were generated through a comprehensive literature review, followed by a two-stage Delphi survey and a consensus meeting involving an international group of stakeholders. The recommendations cover three main areas: rationale and schedule for PRO assessments, measure selection, and measure delivery. Recommendation 1 emphasizes involving patients, clinicians, and other stakeholders in the formulation of PRO research questions to ensure relevance. Recommendation 2 suggests balancing the burden of data collection with the quantity and quality of data required. Recommendation 3 encourages stakeholder involvement in determining the schedule and frequency of assessments. The frequency of PRO administration should consider disease trajectory and balance this with respondent burden. For measure selection, Recommendation 4 recommends reviewing the literature to identify relevant concepts. Recommendation 5 suggests using qualitative and quantitative methods to obtain input from patients and clinicians. Recommendation 6 advises considering the complexity of PRO measures and their instructions. Recommendation 7 emphasizes ensuring that PRO measures are culturally and linguistically relevant. Recommendation 9 suggests considering the length of PRO measures and justifying their use. For measure delivery, Recommendation 12 emphasizes informing respondents about the purpose of data collection and its importance. Recommendation 13 suggests providing clear instructions and support for respondents. Recommendation 14 recommends training for research staff and clinicians to understand the value of PROs. Recommendation 15 suggests specifying the level of support available for respondents. Recommendation 16 recommends offering flexible modes of administration to meet the needs of different populations. Recommendation 17 suggests using ePROs where appropriate, considering the needs and preferences of the target population. Recommendation 18 emphasizes involving patients and clinicians in the co-design of ePRO systems. Recommendation 19 suggests exploring the functionality of ePROs with diverse representatives. The recommendations aim to ensure that PRO data collection is as inclusive and equitable as possible, promoting high-quality data that informs regulatory decisions and patient care. The consensus statement is a valuable resource for stakeholders involved in the implementation of PROs in healthcare research and clinical practice.