Analysis methods and strategies for patient-reported outcomes data in clinical research
- 1Health Statistics Teaching and Research Office,Department of Military Preventive Medicine,Air Force Military MedicalUniversity,Xi'an,Shaanxi 710032,China
Abstract
Patient-reported outcomes(PROs),as an important tool for directly assessing health status,symptom burden,and quality of life from the patient 's perspective,are increasingly valued in modern medical research. However,PROs data possess inherent characteristics such as repeated measurements,multidimensionality,prevalent missingness,and non-normal distribution,which pose numerous challenges to their statistical analysis,including inconsistent method selection,poor comparability of results,and low regulatory recognition. This article systematically reviews the data types derived from PROs in different application scenarios and the corresponding statistical analysis strategies. It also analyzes methodological considerations in visualization,missing data,multiple correction,baseline covariates,and cross-cultural comparisons,aiming to provide methodological references for PROs data analysis.
Related
- Bayesian joint modeling of longitudinal patient-reported outcomes and survival: an application to chronic obstructive pulmonary disease
- Qualitative research - Part 3: Sampling methods and sample size considerations.
- Reported clinical breast examination activity in Bangladesh, 2019–2025: Temporal trends, geographic variation, positivity, and reporting completeness
- Transportability methods for failure-time outcomes under assumptions for relative effect measures
- Influence of continuous predictor modelling methods on prediction stability in clinical prediction model development: an empirical comparison using real clinical data
BibTeX
@article{zhe2026analysis,
title = {{Analysis methods and strategies for patient-reported outcomes data in clinical research}},
author = {YANG Zhe and YUAN Peng and JU Ying and LU Wenjing and SHANG Lei and ZHAI Zhongjie and LIANG Ying and ZHANG Haiyue and WANG Yue and TAN Zhijun},
journal = {Zhongguo linchuang yanjiu},
year = {2026},
month = oct,
doi = {10.13429/j.cnki.cjcr.2026.10.027},
url = {https://doi.org/10.13429/j.cnki.cjcr.2026.10.027},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Analysis methods and strategies for patient-reported outcomes data in clinical research
AU - YANG Zhe
AU - YUAN Peng
AU - JU Ying
AU - LU Wenjing
AU - SHANG Lei
AU - ZHAI Zhongjie
AU - LIANG Ying
AU - ZHANG Haiyue
AU - WANG Yue
AU - TAN Zhijun
PY - 2026
DA - 2026/10/26
JO - Zhongguo linchuang yanjiu
DO - 10.13429/j.cnki.cjcr.2026.10.027
UR - https://doi.org/10.13429/j.cnki.cjcr.2026.10.027
AB - Patient-reported outcomes(PROs),as an important tool for directly assessing health status,symptom burden,and quality of life from the patient 's perspective,are increasingly valued in modern medical research. However,PROs data possess inherent characteristics such as repeated measurements,multidimensionality,prevalent missingness,and non-normal distribution,which pose numerous challenges to their statistical analysis,including inconsistent method selection,poor comparability of results,and low regulatory recognition. This article systematically reviews the data types derived from PROs in different application scenarios and the corresponding statistical analysis strategies. It also analyzes methodological considerations in visualization,missing data,multiple correction,baseline covariates,and cross-cultural comparisons,aiming to provide methodological references for PROs data analysis.
SN - 1674-8182
ER -