Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database

BackgroundBreast cancer is one of the most prevalent tumors worldwide, significantly compromising the survival and quality of life of patients. This study aims to evaluate the global burden and the application of patient-reported outcomes (PROs) in clinical trials of breast cancer.MethodsData of bre...

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Main Authors: Jiaxin Hao, Yijia Gong, Xiaowen Zhang, Minghong Du, Huan Wang, Guolin Guo, Mengqing Zhou, Tian Tian, Hongguo Rong
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Oncology
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Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2025.1557080/full
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author Jiaxin Hao
Jiaxin Hao
Yijia Gong
Yijia Gong
Xiaowen Zhang
Xiaowen Zhang
Xiaowen Zhang
Minghong Du
Minghong Du
Minghong Du
Huan Wang
Huan Wang
Huan Wang
Guolin Guo
Mengqing Zhou
Tian Tian
Hongguo Rong
Hongguo Rong
Hongguo Rong
author_facet Jiaxin Hao
Jiaxin Hao
Yijia Gong
Yijia Gong
Xiaowen Zhang
Xiaowen Zhang
Xiaowen Zhang
Minghong Du
Minghong Du
Minghong Du
Huan Wang
Huan Wang
Huan Wang
Guolin Guo
Mengqing Zhou
Tian Tian
Hongguo Rong
Hongguo Rong
Hongguo Rong
author_sort Jiaxin Hao
collection DOAJ
description BackgroundBreast cancer is one of the most prevalent tumors worldwide, significantly compromising the survival and quality of life of patients. This study aims to evaluate the global burden and the application of patient-reported outcomes (PROs) in clinical trials of breast cancer.MethodsData of breast cancer burden is extracted from the Global Burden of Disease Study (GBD) 2021 database. This study analyzes geographic patterns, temporal trends and age patterns of female breast cancer disease burden globally and explored the association between age standardised rates for disability adjusted life years (ASDR) of female breast cancer and sociodemographic index (SDI). The interventional clinical trials of breast cancer are selected in the WHO International Clinical Trial Register database from January 1, 2010, to December 31, 2022. The application of PROs is classified into three categories: 1) precisely listed PRO instruments as outcomes, 2) mentioned patient subjective feelings without clarifying specified PRO instruments, and 3) not mentioned any PROs as outcomes.ResultsGlobally, in 2021 the age standardised rates for point prevalence of female breast cancer per 100000 population was 450.64 (427.02 to 475.96), the age standardised rates for incidence (ASIR) per 100000 population was 46.40 (43.26 to 49.56), and the ASDR per 100000 population was 455.56 (426.64 to 485.30). Compared with 1990, the ASIR of female breast cancer in 2021 had increased while the ASDR had decreased globally. Trials involving PROs only account for 37.87% (3968/10478). The Visual Analog Scale and Cancer Quality of Life Questionnaire-Core 30 are the most common instruments in these trials.ConclusionsThe disease burden of breast cancer is severe and varied worldwide while the application of PROs in clinical trials remains noteworthy. Increasing population awareness about policy for breast cancer care and the application of specific PRO instruments is warranted to reduce the future burden of disease.
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spelling doaj-art-027eda134d794dd6b2ed25f2ef0a3f502025-08-20T03:44:46ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-06-011510.3389/fonc.2025.15570801557080Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register databaseJiaxin Hao0Jiaxin Hao1Yijia Gong2Yijia Gong3Xiaowen Zhang4Xiaowen Zhang5Xiaowen Zhang6Minghong Du7Minghong Du8Minghong Du9Huan Wang10Huan Wang11Huan Wang12Guolin Guo13Mengqing Zhou14Tian Tian15Hongguo Rong16Hongguo Rong17Hongguo Rong18Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaKey Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaKey Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaInstitute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaInstitute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaInstitute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaInstitute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaBackgroundBreast cancer is one of the most prevalent tumors worldwide, significantly compromising the survival and quality of life of patients. This study aims to evaluate the global burden and the application of patient-reported outcomes (PROs) in clinical trials of breast cancer.MethodsData of breast cancer burden is extracted from the Global Burden of Disease Study (GBD) 2021 database. This study analyzes geographic patterns, temporal trends and age patterns of female breast cancer disease burden globally and explored the association between age standardised rates for disability adjusted life years (ASDR) of female breast cancer and sociodemographic index (SDI). The interventional clinical trials of breast cancer are selected in the WHO International Clinical Trial Register database from January 1, 2010, to December 31, 2022. The application of PROs is classified into three categories: 1) precisely listed PRO instruments as outcomes, 2) mentioned patient subjective feelings without clarifying specified PRO instruments, and 3) not mentioned any PROs as outcomes.ResultsGlobally, in 2021 the age standardised rates for point prevalence of female breast cancer per 100000 population was 450.64 (427.02 to 475.96), the age standardised rates for incidence (ASIR) per 100000 population was 46.40 (43.26 to 49.56), and the ASDR per 100000 population was 455.56 (426.64 to 485.30). Compared with 1990, the ASIR of female breast cancer in 2021 had increased while the ASDR had decreased globally. Trials involving PROs only account for 37.87% (3968/10478). The Visual Analog Scale and Cancer Quality of Life Questionnaire-Core 30 are the most common instruments in these trials.ConclusionsThe disease burden of breast cancer is severe and varied worldwide while the application of PROs in clinical trials remains noteworthy. Increasing population awareness about policy for breast cancer care and the application of specific PRO instruments is warranted to reduce the future burden of disease.https://www.frontiersin.org/articles/10.3389/fonc.2025.1557080/fullbreast cancerglobal burden of diseasepatient-reported outcomesclinical trialssystematic analysisquality of life
spellingShingle Jiaxin Hao
Jiaxin Hao
Yijia Gong
Yijia Gong
Xiaowen Zhang
Xiaowen Zhang
Xiaowen Zhang
Minghong Du
Minghong Du
Minghong Du
Huan Wang
Huan Wang
Huan Wang
Guolin Guo
Mengqing Zhou
Tian Tian
Hongguo Rong
Hongguo Rong
Hongguo Rong
Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database
Frontiers in Oncology
breast cancer
global burden of disease
patient-reported outcomes
clinical trials
systematic analysis
quality of life
title Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database
title_full Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database
title_fullStr Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database
title_full_unstemmed Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database
title_short Global burden of breast cancer and application of patient-reported outcomes in clinical trials: a systematic analysis based on the global burden of disease study 2021 and WHO international clinical trial register database
title_sort global burden of breast cancer and application of patient reported outcomes in clinical trials a systematic analysis based on the global burden of disease study 2021 and who international clinical trial register database
topic breast cancer
global burden of disease
patient-reported outcomes
clinical trials
systematic analysis
quality of life
url https://www.frontiersin.org/articles/10.3389/fonc.2025.1557080/full
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