In the past decade, real-world data (RWD) research has undergone significant transformations due to data aggregation and processing technologies. However, there is still a lack of consensus regarding the scope of RWD applications and the value of real-world evidence (RWE). This study briefly outlined the origins of the concept of RWD study and its early research scope to promote further development in this area. We also reviewed the understanding of RWD applications and research models from the five perspectives of healthcare professionals, medical institutions, decision-making departments, cross-regional cooperation model, and the practice of the One-Health model. Finally, we systematically summarized the renewed understanding of the value of RWE while looking ahead to the challenges and future developments in this field.

In the past decade, real-world data (RWD) research has undergone significant transformations due to data aggregation and processing technologies. However, there is still a lack of consensus regarding the scope of RWD applications and the value of real-world evidence (RWE). This study briefly outlined the origins of the concept of RWD study and its early research scope to promote further development in this area. We also reviewed the understanding of RWD applications and research models from the five perspectives of healthcare professionals, medical institutions, decision-making departments, cross-regional cooperation model, and the practice of the One-Health model. Finally, we systematically summarized the renewed understanding of the value of RWE while looking ahead to the challenges and future developments in this field.

Under the structural pressure of aging acceleration and increased chronic disease burden,in order to implement the reform tasks of"promoting healthcare,insurance and pharmaceutical sectors coordinated develop-ment and governance"proposed by the 20th National Congress of the Communist Party of China,it is urgent to build a medical insurance governance system that is adapted to the"Synergistic goverance on healthcare,insurance and pharmaceutical sectors".In order to break the single,fragmented,and passive medical insurance management methods in the past,according to the theoretical framework of system theory,it proposes the"chain-net"gover-nance system of hospital medical insurance built by the policy responsibility chain,information process chain,col-laborative consensus chain,inspection evaluation chain,and performance value chain,and analyzes,the implemen-tation path,necessity and completeness and support elements of this system.

Under the structural pressure of aging acceleration and increased chronic disease burden,in order to implement the reform tasks of"promoting healthcare,insurance and pharmaceutical sectors coordinated develop-ment and governance"proposed by the 20th National Congress of the Communist Party of China,it is urgent to build a medical insurance governance system that is adapted to the"Synergistic goverance on healthcare,insurance and pharmaceutical sectors".In order to break the single,fragmented,and passive medical insurance management methods in the past,according to the theoretical framework of system theory,it proposes the"chain-net"gover-nance system of hospital medical insurance built by the policy responsibility chain,information process chain,col-laborative consensus chain,inspection evaluation chain,and performance value chain,and analyzes,the implemen-tation path,necessity and completeness and support elements of this system.

Under the structural pressure of aging acceleration and increased chronic disease burden,in order to implement the reform tasks of"promoting healthcare,insurance and pharmaceutical sectors coordinated develop-ment and governance"proposed by the 20th National Congress of the Communist Party of China,it is urgent to build a medical insurance governance system that is adapted to the"Synergistic goverance on healthcare,insurance and pharmaceutical sectors".In order to break the single,fragmented,and passive medical insurance management methods in the past,according to the theoretical framework of system theory,it proposes the"chain-net"gover-nance system of hospital medical insurance built by the policy responsibility chain,information process chain,col-laborative consensus chain,inspection evaluation chain,and performance value chain,and analyzes,the implemen-tation path,necessity and completeness and support elements of this system.

Under the structural pressure of aging acceleration and increased chronic disease burden,in order to implement the reform tasks of"promoting healthcare,insurance and pharmaceutical sectors coordinated develop-ment and governance"proposed by the 20th National Congress of the Communist Party of China,it is urgent to build a medical insurance governance system that is adapted to the"Synergistic goverance on healthcare,insurance and pharmaceutical sectors".In order to break the single,fragmented,and passive medical insurance management methods in the past,according to the theoretical framework of system theory,it proposes the"chain-net"gover-nance system of hospital medical insurance built by the policy responsibility chain,information process chain,col-laborative consensus chain,inspection evaluation chain,and performance value chain,and analyzes,the implemen-tation path,necessity and completeness and support elements of this system.

Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.

Objective:Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics.Conclusions:Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.

Under the structural pressure of aging acceleration and increased chronic disease burden,in order to implement the reform tasks of"promoting healthcare,insurance and pharmaceutical sectors coordinated develop-ment and governance"proposed by the 20th National Congress of the Communist Party of China,it is urgent to build a medical insurance governance system that is adapted to the"Synergistic goverance on healthcare,insurance and pharmaceutical sectors".In order to break the single,fragmented,and passive medical insurance management methods in the past,according to the theoretical framework of system theory,it proposes the"chain-net"gover-nance system of hospital medical insurance built by the policy responsibility chain,information process chain,col-laborative consensus chain,inspection evaluation chain,and performance value chain,and analyzes,the implemen-tation path,necessity and completeness and support elements of this system.

Under the structural pressure of aging acceleration and increased chronic disease burden,in order to implement the reform tasks of"promoting healthcare,insurance and pharmaceutical sectors coordinated develop-ment and governance"proposed by the 20th National Congress of the Communist Party of China,it is urgent to build a medical insurance governance system that is adapted to the"Synergistic goverance on healthcare,insurance and pharmaceutical sectors".In order to break the single,fragmented,and passive medical insurance management methods in the past,according to the theoretical framework of system theory,it proposes the"chain-net"gover-nance system of hospital medical insurance built by the policy responsibility chain,information process chain,col-laborative consensus chain,inspection evaluation chain,and performance value chain,and analyzes,the implemen-tation path,necessity and completeness and support elements of this system.