Methodological Quality On Health Economic Evaluation Of Cancer Based On Real-World Data

Objective: As the second leading cause of death in the world and an important cause of death for urban and rural residents in our country,cancer has become a major public health problem in our country.Therefore,it has become a hot research field to provide cost-effectiveness evaluation of cancer health for decision-makers.However,the study design gold standard,the traditional Randomized Controlled Trial,is characterized by strictly included standard,small sample size and short follow-up period.In order to make up for the lack of extrapolation in the traditional Randomized Controlled Trial,using a variety of Real-World Data collected on a daily basis that are relevant to the health status of patients or to diagnosis,treatment,and health care can yield more realistic and reliable research results to reduce the risk of decision-making errors.So now it is favored by the policy-makers of health insurance,medicine and medical treatment in the world.However,the Real-World Data itself has limitations in controlling risk of bias and missing data,so it is necessary for decision-makers to evaluate the methodological quality before using this kind of evidence.At present,there are few studies on methodological quality assessment of economic evaluation of cancer health based on Real-World Data,and the overall characteristics and methodological quality of this kind of research are unknown.Moreover,the quality assessment tools of general health economic evaluation still focus only on health economic evaluation itself.Whether these tools are applicable to the methodological quality assessment of this kind of literature is still unknown.This paper focuses on three purposes.The first purpose is to master the basic characteristics and methodological quality of the literature on the evaluation of cancer health economic based on Real-World Data.The second one is to explore the key factors affecting the methodological quality of economic evaluation of cancer health based on Real-World Data.And the third one is to put forward suggestions for improving the methodological quality of economic evaluation of cancer health.Methods: In this study,cross-sectional survey of literature 、 methodological quality assessment and multiple linear regression were used to obtain the basic characteristics,methodological quality and influencing factors of the literature on the economic evaluation of cancer health based on Real-World Data by qualitative and quantitative analysis.In this paper,The CHEERS2022(Consolidated Health Economic Evaluation Reporting Standards)was used to evaluate the reporting quality.And the CHEC(The Consensus on Health Economic Criteria list)was used to evaluate the methodological quality.Risk of bias was assessed by Rob 2(Risk of Bias 2)and descriptive analysis of reporting and controlling of risk of bias.Results:The study found that the 95 included evaluations of cancer health economic based on Real-World Data were of moderate quality overall,with an average score of66.56%,a maximum score of 89.47% and a minimum score of 26.32%.29.47% were good-quality studies(n=28),54.74% were moderate-quality studies(n=52),and 15.79%were poor-quality studies(n=15).Of the included studies,the item “ Are ethical and distributional issues discussed appropriately? ” had the lowest quality.The reporting quality of CHEERS was poor in general,and the results of risk of bias evaluation showed high risk in general,which indicated that nearly 87.37% of the included studies had high risk,and this would directly affect the overall quality of the studies.The reporting quality of CHEERS、the source of funding and the management of confounding bias were the significant factors that affected the methodological quality of CHEC.And the management of confounding bias had the greatest impact on the methodological quality.The more rigorous control of confounding bias was,the higher the methodological quality would be.Compared with other funding sources,the methodological quality of non-industry-funded research was significantly improved.The higher the reporting quality of CHEERS was,the higher the methodological quality of CHEC would be.Conclusion: The methodological quality of the economic evaluation of cancer health based on Real-World Data was generally of moderate quality.The reporting quality of CHEERS and the results of risk of bias evaluation were better than those of the CHEC tool,and the evaluation results of the three methods were not completely consistent.CHEC itself had a broad entry and limited coverage to measure methodological quality.In addition,CHEC had more potential to exert its performance than as an ex-post quality control tool,which leaded to a lower sensitivity of CHEC to affect the quality of original research methodology.The combined effect of the two factors resulted in that CHEC could not distinguish the included literature clearly.In another words,it could not specifically evaluate the methodological quality of the included literature.The reporting quality of CHEERS、funding sources and the management of confounding bias were significant factors affecting the quality of CHEC methodological quality.For studies with positive results,controlling for confounding bias might be the most effective way to improve methodological quality.When the results were not positive,increasing the treatment of drop-out rate and missing data would be a very effective way to improve the methodological quality.Suggestions for improving the methodological quality of the economic evaluation of cancer health based on Real-World Data were as follows.The first one is to strengthen the reporting and controlling of confounding bias、selection bias and information bias,and try to report on the direction of the risk of bias,as well as to use a variety of methods to deal with missing data.The second one is to specify the subgroups that will be preset in the analysis plan,but also to report the details of the subgroups in advance in the article.The third one is to encourage and mobilize the participation of multiple stakeholders,including patients and communities involved in the study,in the design of the study so that it can better support the formulation of local policies or decisions.The fourth one is to strengthen reporting on data conversion,outcome extrapolation,and model validation.The fifth one is not only to reflect the major findings,limitations,and omissions of ethics and fairness in the discussion,but also to explore how these factors will affect patients,policy,and practice.And the study should link research findings to research questions and explain how the findings will affect readers’ understanding of the questions.This study suggested that future development of methodological quality assessment tools for cancer health economic evaluations based on Real-World Data could be considered in the following ways.The first way is to add the evaluation index to the research plan whether to formulate the health economics evaluation plan beforehand in the evaluation tool.The second one is that,the evaluation tools should increase the risk of bias control evaluation indicators.The third one is that,the evaluation tool should increase the evaluation cycle which can observe the outcome of cancer patients indicators of the evaluation index.The fourth one is that,whether the evaluation tool can specifically reflect the outcome of patients with cancer should be added to the evaluation tool.