In 2016, The People’s Republic of China (PRC) formally passed the blueprint of Healthy China 2030, working toward the national goal of reaching a health standard on par with high-income… Click to show full abstract
In 2016, The People’s Republic of China (PRC) formally passed the blueprint of Healthy China 2030, working toward the national goal of reaching a health standard on par with high-income countries by 2030.1 In 2021, the Chinese government approved its 14th Five-Year Plan for National Economic and Social Development of the PRC, which includes a comprehensive strategy for advancing the quality of health care delivered by its national health system.2 Yet, achieving this goal for China’s diverse population of 1.4 billion people is often complex, depending on employment, insurance type, geodemographic location, socioeconomic status, health care workforce supply, and many other variables.3 In addition, PRC overall health care expenditures as a percentage of gross domestic product have increased by more than 42% since 2010, with the most currently available data showing 7.1% in 2020.4 Over the past several years, patient-reported outcomes (PROs) and derivative standardized patient-reported outcome measures (PROMs) have come into widespread use in other countries, including use, for example, as part of industry-sponsored clinical trials, population outcomes and comparative effectiveness research, health care delivery system program evaluation, and health insurance coverage determinations.5 PROs are intended to provide objective and subjective assessments of a variety of dimensions, for example, health-related quality of life (eg, I do not socialize with friends much anymore), physical capacity (eg, I have difficulty walking 3 city blocks), mental and cognitive changes (eg, I sometimes have trouble concentrating), functional status (eg, I am unable to lift more than 5 pounds on the job), symptoms (eg, I experience moderate pain on most days), and overall well-being (eg, I am in poor health). Data on PROs are usually collected via standardized, psychometrically developed, and validated survey-type instruments that are often used by clinicians and researchers to evaluate health care delivery from the perspectives of individual patients. A PROM is often then generated, which is most typically a summary composite score of the individual PRO item response scores captured by the survey instrument. Using a cross-sectional survey of interventional clinical trials using data from the Chinese Clinical Trial Registry and the ClinicalTrials.gov databases, Chinese researchers have evaluated the current applications of PROMs in clinical trials in the PRC.6 As the authors note, this study documents the major increase from 2010 to 2020 in the number of clinical trials originating in the PRC that include the application and characteristics of PRO instruments and PROMs as primary and secondary outcomes in clinical trials across China. Only 29.7% of the selected 10 093 eligible PRO-related trials were categorized according to those that precisely listed PRO tools as outcomes, and 70.3% did not incorporate PROMs into the analyses. Also documented was a striking use imbalance by regional provincial locations, sponsors, clinical phases, and a relative lack of diversity of PROMs deployed. Most trials were in phase 4, performed in hospitals, and located in the most populous eastern Chinese provinces. The authors accurately conclude that there is a need for more widespread, robust, and correctly targeted use of standardized PROMs in clinical trials across the PRC. In the important context of achieving its goals outlined in Healthy China 2030, the PRC has been aggressively evaluating the new improvements to the Chinese health care delivery system. Much is required to generate better quality of evidence and measurement of cost-effectiveness for guidelinedirected medical therapies indicated for major chronic conditions and other, less common diseases. As such, the discovery of new insights reported by Zhou et al6 requires more widespread and consistent deployment of well-constructed PROMs that provide the best understanding of which + Related article
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