ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.
ObjectiveTo evaluate the complete blood count performance quality of Sysmex-XN automatic hematology analyzer. MethodsWe investigated the precision rate, residual contamination rate, analytic linearity range, and background counting of Sysmex-XN-B3 analyzer. ResultsThe inner and inter-group precision test showed that the inaccuracy of the analyzer was lower than the allowable standard of 1/4 (CLIA'88). The highest level of residual contamination rate was 0.12%, lower than the standard of manufacturer (≤1%). Linearity evaluation showed that the white blood cell count analytic linear range was from 0.51×109/L to 393.40×109/L, the red blood cell count analytic linear range was from 0.51×1012/L to 8.15×1012/L, the hemoglobin analytic linear range from 15.0 g/L to 244.5 g/L, and the platelet count analytic linear range was from 3.0×109/L to 2 072.5×109/L. Background counting was also lower than the standard of manufacturer. Comparison between the two different series of analyzers showed that the inaccuracy rate of Sysmex-XN-B3 was not only lower than the standard of National Center for Clinical Laboratories, but also lower than the standard of 1/2 (CLIA'88). ConclusionSysmex-XN automatic hematology analyzer has a high performance in capability evaluation. It is an excellent tool for routine hematologic blood examination.
Objective To summarize and analyze the working experience of hospital performance evaluation and reporting system in America, so as to provide decision support to China on such work as establishing objective, scientific and effective hospital performance evaluation system, strengthening government’s supervision to health service, and promoting hospitals’ sound development.Methods American official websites and databases were searched to include relative policies, reports and documents on hospitals’ performance evaluation. Results Typical hospital performance evaluation and reporting system in America included National Healthcare Quality Report (NHQR), Consumer Assessment of Healthcare Providers and System (CAHPS), Healthcare Effectiveness Data and Information Set (HEDIS), Leapfrog Group Evaluation System and Thomson Reuters 100 Top Hospitals. Conclusion The enlightenments of American performance performance evaluation systems to China include: a) more attention should be paid to performance evaluation; b) combined evaluation models and results application methods should be considered; c) comparatively scientific evaluation methods and comprehensive evaluation contents should be established.
As an advanced mode of diagnosis and treatment, day surgery is widely carried out in foreign countries. Although it started late in China, it has been gradually valued and vigorously promoted in medical and health field in recent years. The effective implementation of day surgery in hospital cannot be separated from the strong support of performance management system. Through introducing the performance management experiences in promoting day surgery mode in West China Hospital of Sichuan University, this article discusses how to construct an effective whole-course performance management system for day surgery combined with operation management through three mechanisms: the management committee mechanism, the operation management mechanism and the performance assessment mechanism, which are based on the structure-process-outcome dimensions of quality management system, at the three levels of hospital, department and position, so as to provide a reference for developing day surgery in China.
Objective To evaluate the impact of the new performance evaluation system in H hospital on clinical rational blood use and provide a basis for optimizing medical resource management. Methods This study employed a self-controlled before-after design to evaluate the effects of a blood management reform implemented in December 2023. The reform integrated key performance indicator (KPI) assessment with objectives and key results (OKR) methodology. Key interventions included enhancing the information system, strengthening clinical blood management quality control, and promoting alternative therapeutic techniques. Clinical blood utilization data were collected for one year both before and after the reform implementation. The impact of the reform was rigorously assessed using interrupted time series analysis (ITSA). Results A total of 1 032 clinical blood transfusion records were collected from 2023 to 2024, with 977 ultimately included in the analysis. In 2024, the qualified rate of hemoglobin of patients receiving red blood cell suspension transfusions in the whole hospital increased from 67.46% to 76.38%, and the per capita consumption of red blood cell suspension decreased by 11.36% year on year. The number of blood transfusion cases in surgical departments decreased by 26.60%, and that in non-surgical specialist departments decreased by 7.53%. The multi factor model showed that the improvement of the qualified rate in non-surgical departments and the main internal medicine subgroups was statistically significant. Conclusion The new performance evaluation system significantly improves the level of rational blood use and reduces resource waste through mechanism optimization and incentive coordination, providing a reference model for blood management reform in medical institutions.
Objective To evaluate the performance of emergency medical rescue (EMR) within 1 month after Lushan earthquake, and to prove and enrich the experience from Wenchuan earthquake, so as to provide useful references for global earthquake EMR with regard to decreasing death and disability rates. Methods All the following date published within 1 month after 4.20 Lushan earthquake were collected and analyzed, including official information, public documents, news release, relevant information from websites and victims’ medical records in the West China Hospital, then the relevant domestic and foreign literature about EMR (including EMR of Wenchuan earthquake). And then comparative analysis was conducted to evaluate the performance of EMR in Lushan earthquake. Results a) Being 87 km apart from each other, the main seismic zones of Lushan and Wenchuan located in the south west and middle north of Longmenshan fault zone, respectively. Although only 1 earthquake magnitude differed between them, the disaster area, and the number of affected population, deaths, disappearances, injured, severe injured and migration population in Wenchuan earthquake were 40, 23, 353, 853, 27, 14 and 51 times higher than those in Lushan earthquake, respectively. b) Learned from Wenchuan experience, the manpower scheduling in Lushan earthquake was quicker: the assembled medical personnel peak of Lushan vs. Wenchuan was 87.62% vs. 56.06 % in golden 72 hours post-quake. c) Supplies scheduling was more rational: the utilization rate was higher under the guidance of accurate information of demand. d) Medical treatment was more rational and efficient: the critical injured were treated following “Four concentration treatment principles”; saving life and restoring function at the same time; treatment and physical-mental rehabilitation at the same time; treatment and evidence production and implementation at the same time. e) Medical institutions and service returned to normal in time: 96.7% (440/455) of government owned township medical institutions in 21 affected towns returned to normal and provided medical services at their original sites. Conclusion By learning form Wenchuan experience, the following performance is implemented in Lushan earthquake: medical rescue guided by the accurate information; supplies scheduling guided by the accurate demand; both critical injured treatment,and physical-mental rehabilitation guided by the accurate assessment of injuries. So the medical rescue within 1 month after Lushan earthquake is quicker, more rational and efficient. After 20 days post quake zero death of critical injured was achieved. The early physical-mental rehabilitation fastens the functional reconstruction of the injured and helps them return to the society. So it suggests that the Lushan EMR enriches and develops the reference value of EMR experience of Wenchuan earthquake.
ObjectiveTo evaluate the current status of primary healthcare system reform in Xinjin county, in order to provide baseline data for improving the healthcare service system and population health in Chengdu. MethodsPrimary health care services and population health in Xinjin county were quantitatively described and compared. Resultsa) Eleven township hospitals (100%) and 89 village clinics (66.42%) were upgraded according to the national standards. The management of 60 village clinics were integrated with township hospitals. And 417 and 76 essential healthcare services were provided by township hospitals and village clinics, respectively. b) In 2010, the number of outpatients and inpatients in Xinjin county were increased by 24.2% and 46.3% respectively compared to those of 2009, while the costs per outpatient visit and inpatient discharge were reduced by 21.5% and 18.6% respectively. c) In 2010, health records of 98.2% of population in Xinjin county have been established; 96.3% of pregnant women were managed systematically; 98.8% of children immunization programs were implemented; 100% patients with severe mental disorders and about 78% with hypertension and diabetes were in follow-up and treatment; and 28.8% of total population got the free physical exams in 2010. d) The essential medicine accounted for 96.7% of total types of medicines and 97.8% of total expenditure of medicines in primarily healthcare institutions in Xinjin. The cost of medicine management was reduced from 8.5% to 4.2% while the medicine turnover rate was increased by 50%. e) Average life expectancy in Xinjin county was 77.97 years, infant mortality rate was 6.82‰ in 2010; and there was no maternal death in recent 8 years. f) The regional healthcare information system was established covering three-tier rural health care network spanning the county, township and village. Conclusiona) The primary healthcare system reform in Xinjin county improves the infrastructure of primary care system, the utilization of essential medical care, essential public health service, and essential medicines. b) Life expectancy, infant mortality rate and maternal mortality of Xinjin county are better than the average levels in Sichuan province and China. Xinjin county is a representative pilot county for healthcare service system reform in Chengdu city and a nice model to successfully promote healthcare system reform based on regional healthcare information system.
ObjectiveTo explore the parameter selection of different sample size estimation methods and the differences in estimation results in single-group target value clinical trials with rate as the outcome evaluation index. MethodsWe conducted a literature review to assess the method of target value selection for single-group target value clinical trials. Then, different values of target value (P0), clinical expected value (P1), and class II error level (β) were set through numerical simulation. Sample size results estimated using different sample size estimation methods were obtained using PASS software. The coefficient of variation, range/mean, analysis of variance and other methods were used to compare the differences between different methods. ResultsAnalysis of the data simulation results showed: when the expected value P1 was fixed, the sample size first decreased rapidly and then decreased slowly along with the increase or decrease of the targeted value P0 on both sides of the sample size limit value. When the difference between P0 and P1 was within 0.15, the ratio before and after correction could be controlled within 0.9. When the difference between P0 and P1 was more than 0.6, the ratio before and after correction approached 0.5. When P0+P1≈1, the ratio of different standard error choices (Sp0 or Sp1) to the estimated sample size was close to 1. When 0.65<P0+P1<1.35, the ratio of different standard error choices (Sp0 or Sp1) to the estimated sample size was about 3:1. When the confidence was 0.8, P0 and P1 were between 0.25 and 0.75 and between 0.20 and 0.80, respectively. We found little difference among the sample sizes estimated using these five methods (CV<0.10, range/mean<0.2). ConclusionThere are some differences among different sample size estimation methods, however, when P0 and P1 values are around 0.5, the differences between different methods are small, suggesting that appropriate methods should be selected for sample size estimation.
ObjectiveTo describe the current status of the evaluation index for the performance of diagnostic reagents compared with gold standards in systematic reviews and develop the list of evaluation indexes. MethodsPubMed, Embase (OVID), Cochrane Library (OVID), CBM, WanFang Data and CNKI databases were searched for systematic reviews about the performance of diagnostic reagents compared with gold standards from inception to 28th April, 2023. Two reviewers independently screened literature and extracted data. The frequency and ratio were used to describe the current status, while the qualitative synthesis was used to develop the list. ResultsA total of 133 systematic reviews were included. Sensitivity (133/133, 100.0%), specificity (131/133, 98.5%) and AUC (80/133, 60.2%) were used more frequently than 50%. Q index (6/133, 4.5%), false positive rate (3/133, 2.3%), Kappa value (2/133, 1.5%), false negative rate (1/133, 5%) and Youden's index were used less frequently than 5%. In order to evaluate the performance of diagnostic reagents compared with gold standards in systematic reviews comprehensively, a total of 14 index related to validity and predictability could be considered. ConclusionThe evaluation index for the performance of diagnostic reagents in systematic reviews are inconsistent and limited, so there is an urgent need to develop standardized evaluation indicators based on expert consensus.
With the continuous development of health system, more and more countries recognize that the health system performance evaluation is an indispensable part of improving government management and health system. Some developed countries have already set up comparatively perfect evaluation systems. This paper compared and deeply analyzed the history of establishment, evaluation framework, evaluation index, and evaluation data of the health system performance evaluation systems of Britain, Australia and the United State, and some suggestions for improving the evaluation of new medical reform in China were given.