Economic evaluation used alongside clinical trials has become a hot spot in the development of clinical studies. The definition and classification of the cost were introduced in this article. The ways to conduct cost analysis in clinical trials were introduced systematically, including the identification, collection and analysis of the data of costs, and the concern of the analysis.
The calculation of sample size is a critical component in the design phase of clinical trials incorporating health economic evaluations. A reasonable sample size is essential to ensure the scientific validity and accuracy of trial results. This paper summarizes the sample size calculation methods in the frequentist framework based on two health economic evaluation indicators: incremental cost-effectiveness ratio (ICER) and net benefit and examines these methods in terms of their applicable conditions, advantages, and limitations. The ICER method derives the sample size calculation formula by computing the ratio of incremental cost to incremental effect, while the net benefit method determines the economic viability of interventions by calculating incremental net benefit, subsequently leading to the formulation of the sample size calculation. Furthermore, this paper briefly discusses other sample size calculation methods, such as the classical Bayesian approach and the value of information analysis, providing a reference for calculating sample size in clinical trials with integrated health economic evaluations.
This article aims to explore the application of health economics evidence in the development of clinical practice guidelines and evidence recommendations, and to provide better references for clinical decision-making. By reviewing the use of health economics evidence in domestic and international clinical practice guidelines, the difficulties in the application of health economics evidence in the development of clinical practice guidelines and evidence recommendations were summarized. It was found that there were significant differences in the use of health economics evidence in clinical practice guidelines in different countries, and these differences were affected by the goals of clinical practice guidelines and limitations of health economics evidence itself, lacking standardized methodological guidance, resulting in limited use of health economics evidence in clinical practice guidelines. Therefore, further research is needed to optimize the integration of health economics and clinical practice guidelines, and develop standardized methodological guidance.
ObjectivesTo conduct a bibliometric analysis to research the status of disease burden domestically and overseas so as to understand the status of diseases burden, and to provide scientific and reasonable reference for health disease prevention, control strategies formulation and future research.MethodsPubMed, Web of Science, EMbase, The Cochrane Library, WanFang Data, CBM and CNKI databases were electronically searched to collect literature on disease burden from inception to October, 2018. Two reviewers independently screened literature and extracted data. EndNote X7 software was used for literature management, Excel 2016 software and VOS viewer software were also used to analyze data. Literature was classified by the aspects of literature publication characteristics, diseases, background areas, influencing factors, evaluation indicators and poverty caused by illness.ResultsA total of 325 studies were included in the bibliometric analysis. 41 articles (12.6%) were published in journals indexed by SCIE; original research evidence accounted for 97.0% (315 articles); 272 articles were from China (83.7%). The main diseases involved were malignant tumors (58 articles, 17.8%), diabetes (29 articles, 8.9%) and hypertension (24 articles, 7.4%). Factors affecting the disease burden primarily included hospitalization days (9 articles, 2.8%), complications (5 articles, 1.5%), delays in treatment (5 articles, 1.5%), and economic income (4 articles, 1.2%). Sixity-one articles (18.8%) reported poverty due to illness, and related diseases were chronic obstructive pulmonary disease (12 articles, 3.7%), hypertension (10 articles, 3.1%), diabetes (10 articles, 3.1%), malignant tumors (9 articles, 2.8%) and hepatitis B (6 articles, 1.8%).ConclusionsAt present, the disease burden research are focusing more on the burden of chronic non-communicable diseases such as malignant tumors, hypertension, diabetes, cardiovascular and cerebrovascular diseases in developing countries and regions. Medical costs vary from different diseases and treatment, different demographic characteristics of patients, and the coverage medical security of different population are the primary reasons for the " expensive in medical treatment” of current residents and the heavy burden of disease. DALY and total direct medical expenses are the main evaluation indexes of epidemiological burden and economic burden of disease, respectively. Future researches should focus on strengthening the scientific nature of study design to improve the quality of research, as well as paying more attention to diseases and aspects that are rarely involved, such as major diseases caused by poverty due to illness, comprehensive analysis of multiple diseases and aspects of health investment measurement, and comprehensively use the evaluation indicators of disease burden to strengthen the research on the comparability index of disease economic burden.
Objective From the viewpoint of health economics, to analyse the cost-utility of Coflex interspinous dynamic reconstruction and 360° fusion in the treatment of single level lumbar degenerative disease, so as to provide references to doctors and patients for making the best solution. Methods From October 2008 to November 2010, a prospective non-randomized controlled study was carried out on the patients diagnosed as L4-L5 degenerative lumbar spinal disorders, of whom Group A were treated by posterior decompression combined with Coflex interspinous dynamic reconstruction and Group B accepted lumbar 360° fusion treatment. The SF-36 questionnaire was used to survey the life quality of patients and to calculate the quality-adjusted life year (QALY); meanwhile, the costs of the treatment were collected to compare the cost-utility ratio between the two groups. Results A total of 60 patients were included, among whom 29 patients including 20 males and 9 females were in Group A, and the other 31 patients including 16 males and 15 females were in Group B; and the mean time of follow-up was 16.4 months (12-23 months). The average age of Group A and Group B was 45.1 years (21-67 years) and 56.2 years (32-86 years), respectively; the medical costs were 51 509.9±2 422.9 yuan and 57 409.7±9 072.9 yuan, respectively; the life quality compared with that of pre-operation improved by 42.60% and 42.82%, respectively; the cost-utility ratios were 69165.6±4716.0 yuan/QALY and 77 976.7±12 757.4 yuan/QALY, respectively. For each increase of one QALY, Group A could save 12.74% of the cost compared with Group B. Conclusion Coflex interspinous dynamic reconstruction has the equal short-term effects to lumbar 360° fusion in the treatment of L4-L5 degenerative lumbar spinal disorders, but it has lower costs than the latter, and is more in line with the requirements of health economics.
Objective To systematically review the health economic evaluations of using long-term rhythm-control antiarrhythmic drugs (AAD) for patients with paroxysmal or persistent atrial fibrillation (AF). Methods Databases including PubMed, EMbase, Scopus, CNKI, SinoMed, WanFang Data, and official websites of well-established health technology assessment (HTA) institutions were electronically searched to present the economic evaluations of AAD and the recommendations of HTA institutions based on drug economy from inception to April 23rd, 2022. Two reviewers independently screened the literature, extracted data and systematic review was then performed. Results A total of 19 studies were included, including 11 cost-effectiveness or cost-utility analysis studies and 8 official documents from HTA institutions. Only 5 (45.5%) economic evaluations were of relatively high quality, and English language studies were of higher quality than Chinese language studies ones. The included studies lacked elements that CHEERS 2022 concerns, such as health economics analysis plans, equity and distributional effects, engagement with patients and other stakeholders and the impact on the study. Dronedarone and amiodarone were the main focus of the evaluation, and the study results showed that dronedarone was cost-effective compared with other drugs in different study designs and national settings. However, there were differences between the recommendations of HTA agencies and the results of economic evaluation studies. Conclusion The completeness of health economics evaluations needs to be improved, along with the quality of clinical evidence in the field of AF-AAD for Chinese patients. Additionally, the informational value of drugs should be thoroughly investigated through budget impact analysis and distributional cost-effectiveness analysis to provide evidence of high-quality studies for decision-makers in China.
Objective To evaluate the ambulatory surgery mode by using health economical mothods and provide reference for optimization and decision of surgical operation mode. Methods The patients who underwent unilateral flexible ureteroscopic holmium laser lithotriphy for ureteral calculi in Xiangya Hospital, Central South University between January 1st to December 31th, 2015 were selected in this study, including 59 with ambulatory surgery mode (the ambulatory group) and 65 with special in-hospital surgery mode (the special group). The differences in average bed occupancy time, cost, therapeutic effect, and satisfaction between the two operation modes were compared. Results The average bed occupancy time in the ambulatory group and the special group was (1.03±0.18) and (6.35±0.74) days, respectively, and the difference was statistically significant (P<0.05). The patients in both groups were followed up for one month after the operation, and the incidence of complications was 6.8% (4/59) in the ambulatory group and 6.2% (4/65) in the special group, without significant difference (P>0.05). The satisfaction score in the ambulatory group and the special group was 96.48±0.23vs. 96.53±0.18 without significant difference (P>0.05). The differences in direct medical cost [(17 738.28±1 027.85)vs. (21 307.67±554.41) yuan], direct non-medical cost [(103.39±18.25) vs. (630.76±78.90) yuan], indirect cost[ (266.93±47.12) vs. (1 640.44±190.55) yuan], and total cost [(18 128.10±1 037.76) vs. (23 558.29±619.20) yuan] between the ambulatory group and the special group were all statistically significant (P<0.05). The treatment effect index in the ambulatory group and the special group was 0.96 and 1.05, respectively; the cost-effect ratio was 18 883.44 and 22 436.47, respectively. Sensitivity analysis showed that the adjusted cost-effect ratio in the ambulatory group (16 629.64) was still lower than that in the special group (20 534.91). Conclusions The cost-effect ratio of ambulatory surgery mode is superior than that of special in-hospital surgery mode, and there is no obvious difference in patients satisfaction between the two modes. Ambulatory surgery mode can be recommended to patients who meet the indications of day surgery.
Objective To systematically review the current situation of health economics evaluation of gastric cancer screening. Methods The PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect the health economics evaluation studies on gastric cancer screening from January 1st, 1975 to September 30th, 2021. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Then, qualitative analysis was performed. Results A total of 44 studies were included. Most of the targeted populations of the study were high-risk groups in areas with a high incidence of gastric cancer. Screening methods such as endoscopy and Helicobacter pylori infection detection were mainly evaluated in those studies. According to the results, about 47% of the studies evaluated a single screening method. A total of 35 studies showed that they established models, however, only a few calibrated the models. Conclusion Most studies of gastric cancer screening reviews neither calibrate the results nor consider the effect of smoking on the progression of gastric cancer. Those evaluated screening programs are limited.
ObjectiveTo evaluate the effect of health economics of census versus high-risk population screening for tuberculosis in Mianyan city, in order to provide references for the selection of suitable tuberculosis screening method in western region of China. MethodsWe included active tuberculosis patients by residents health screening of 21 villages and towns in Mianyan city from June 2013 to March 2013. Relevant data was analyzed by referencing the National Assessment of Tuberculosis Control Program in 2001-2010. Results184047 residents were screened by tuberculosis census and 128 active tuberculosis patients were diagnosed while 61045 residents were screened by high-risk population screening and 76 active tuberculosis patients were diagnosed. The cost-utility ratio and benefit-cost ratio of tuberculosis census were 6174.17 and 3.84, respectively. The cost-utility ratio and benefit-cost ratio of high risk population screening were 3106.16 and 7.62, respectively. ConclusionHigh-risk population screening has higher cost-utility ratio and benefit-cost ratio than tuberculosis census with higher missed diagnosis. Benefits and harms of tuberculosis detection rate and cost should be fully balanced before tuberculosis screening method were chosen in western underdeveloped region of China.