ObjectiveTo evaluate changes in operational effectiveness after the implementation of ambulatory surgical management in pars plana vitrectomy (PPV). MethodsA retrospective clinical study. 17 528 surgeries in 10 895 eyes of 10 895 patients who underwent minimally invasive PPV on an ambulatory and/or inpatient basis at Tianjin Medical University Eye Hospital from August 2015 to June 2023 were included in this study. Among them, 5 346 eyes in 5 346 cases were male; 5 549 eyes in 5 549 cases were female. The age ranged from 0 to 95 years, with the mean age of (57.74±13.15) years. 6 381 surgeries in 3 615 eyes from August 2015 to December 2018 (the initial period of day surgery) were used as the control group; 11 147 surgeries in 7 280 eyes from January 2019 to June 2023 (the expanded period of day surgery) were used as the observation group. According to the management mode of ambulatory surgery, the observation group was subdivided into the decentralized management group (January 2019 to December 2020) and the centralized management group (January 2021 to June 2023), with 2 905 and 4 375 eyes and 4 646 and 6 501 surgeries, respectively. Changes in the percentage of day surgery, average hospitalization days, and average unplanned reoperation rate were compared. The Mann-Whitney U test was used to compare numerical variables between groups; the chi-square test or Fisher's exact test was used to compare categorical variables. ResultsThe number of cases of daytime PPV performed in the observation group and control group was 7 852 (70.44%, 7 852/11 147) and 24 (0.38%, 24/6 381) cases, respectively, and the average hospitalization days were 1 (1) and 5 (3) d. Compared with the control group, the observation group had a significantly higher percentage of day surgery (χ2=8 051.01) and a considerably lower mean hospitalization day (Z=4 536 844.50), and the differences were statistically significant (P＜0.000 1). The mean hospitalization days in the decentralized and centralized management groups were 2 (3) and 1 (0) d, respectively, and unplanned reoperations were 34 (0.73%, 34/4 646) and 171 (2.63%, 171/6 501) eyes, respectively. Compared with the decentralized management group, average hospitalization days was significantly lower (Z=1 436.94) and unplanned reoperation rate was significantly higher (χ2=54.10) were significantly lower in the centralized management group, both of which were statistically significant (P＜0.000 1). ConclusionPPV ambulatory management model can significantly reduce the average hospitalization day, but also results in higher rates of unplanned reoperations.
ObjectiveTo systematically reviewed the progress of Zelen’s design and its modifications in clinical research and clarified its methodological elements, advantages, and limitations. MethodsA systematic literature search was conducted for Zelen’s design from databases. The data were extracted. ResultsOne hundred and twenty-four trials were included. The dominant disease in this design was mental disorders, followed by osteoarthrosis diseases, cancer, cardiovascular diseases, and others. Regarding types of consent, more than half of the trials used a double-consent (71, 57.26%), and 42 used a single-consent. Eleven trials used a modified Zelen’s design nested within an observational study. This design used a two-stage informed consent. Stage 1, patients were invited to participate in a cohort study; Stage 2, patients randomized in the experimental group were informed of the allocation result and asked whether they would like to follow the treatment. Five trials used the McNulty-Zelen design, which could be applied in cluster randomized controlled trials and overcome the potential bias of the Hawthorne effect. Intention-to-treat analysis was the main population used in Zelen’s design. ConclusionZelen’s design has a broad application in the foreground in clinical trials. It could also be used to adapt to research needs by combining with various observational studies. Zelen’s design offers unique advantages in reducing recruitment difficulty, improving patient compliance, and minimizing bias. Although the randomization of patients without their prior consent raises potential ethical concerns, these can be addressed through methods such as nested observational studies or supplementary informed consent. In real-world applications of Zelen’s design, it is necessary to design a reasonable informed consent strategy and data statistical analysis method according to the research context. Attention must be paid to the impact of sample size, group shifting and selection of dataset on the results, to improve the interpretability and accuracy of the results.
Diabetic retinopathy (DR), which is a common complication of diabetic and the main cause of blindness, brings not only a heavy economic burden to society, but also seriously threatens to the patients’ quality of life. Clinical researches on the therapies of DR are active at present, but how to perform a good clinical research with scientific design should be considered with high priority. The randomized controlled trial (RCT) is considered to be the gold standard for evidence-based medicine, but RCT is not always perfect. Limitations still exist in certain circumstance and the conclusions from RCTs also need to be interpreted by an objective point of view before clinical practice. Real world study (RWS) bridges the gap between RCT and clinical practice, in which the data can be easily collected without much cost, and results might be obtained within a short period. However, RWS is also faced with the challenge of not having standardized data and being susceptible to confounding bias. The standardized single disease database for DR and propensity score matching method can provide a wide range of data sources and avoid of bias for RWS in DR.
Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.
Traditional randomized controlled trial and real-world study have different advantages in internal validity and external extensibility, respectively. With the development of evidence-based health decisions, randomized controlled trial was no longer the only golden standard of interventional study, the research evidence of the real world was gradually involved in health decisions. This study mainly analyzed the requirements of evidence and actual application of evidence in the evaluation of the effectiveness of NICE in the UK. It was found that NICE still used the results of randomized controlled trials as a primary basis. Although real-world research has developed rapidly in recent years, it was limited used in health decision because of its bias by design and other factors. However, in recent years, real-world evidence has played a significant role in the field of innovative drugs or diseases that lack therapeutic drugs. With the improvement of real-world research in experimental design and data analysis, it is expected that it will play a more important role in health decision-making.
Real-world studies (RWS) can more accurately reflect patient treatment outcomes and long-term prognosis in clinical practice, and they play an increasingly important role in drug effectiveness evaluation and regulatory decision-making. However, due to their non-randomized nature, RWS are susceptible to systematic biases - such as unmeasured (or uncontrolled) confounding bias, information bias (e.g., measurement error or misclassification), and selection bias - which may lead to deviations from the true effect and compromise the reliability of evidence and the rationality of policy decisions. Quantitative bias analysis (QBA) is a methodological approach used to assess the impact of bias on study results, enabling the quantification of the direction, magnitude, and uncertainty of such biases. To promote the standardized application of QBA in real-world research, this paper systematically reviews existing QBA methods and their applicable scenarios, aiming to provide methodological references and practical guidance for researchers and decision-makers in improving the interpretability and credibility of real-world evidence.
Focusing on research quality is a crucial aspect of modern evidence-based medical practice, providing substantial evidence to underpin clinical decision-making. The increase in real-world studies in recent years has presented challenges, with varying quality stemming from issues such as data integrity and researchers’ expertise levels. Although systematic reviews and meta-analyses are essential references for clinical decisions, their reliability is contingent upon the quality of the primary studies. Making clinical decisions based on inadequate research poses inherent risks. With the lack of a specialized tool for evaluating the quality of real-world studies within systematic reviews and meta-analyses, the Gebrye team has introduced a new assessment tool - QATSM-RWS. Comprising 5 modules and 14 items, this tool aims to improve real-world research evaluation. This article aims to elaborate on the tool’s development process and content, using this tool to evaluate a published real-world study as an example and providing valuable guidance for domestic researchers utilizing this innovative tool.
With the boom of information technology and data science, real-world evidence (RWE) which is produced using diverse real-world data (RWD) has become an important source for healthcare practice and policy decisions, such as regulatory and coverage decisions, guideline development, and disease management. The production of high-quality RWE requires not only complete, accurate and usable data, but also scientific and sound study designs and data analyses to enable the questions of interest to be reliably answered. In order to improve the quality of production and use of RWE, China REal world data and studies ALliance (ChinaREAL) has developed the first series of technical guidance for developing real-world data and subsequent studies. The efforts are ongoing which would ultimately inform better healthcare practice and policy decisions.
ObjectiveTo systematically review the difference in 30-day readmission rates among acute heart failure patients between real-world studies vs. randomized controlled trials (RCTs). MethodsPubMed, EMbase, The Cochrane Library, CNKI, CBM, VIP and WanFang Data databases were electronically searched to collect clinical studies on 30-day readmission rates in patients with acute heart failure from inception to April 12th, 2021. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using Stata 16.0 software. ResultsA total of 33 real-world studies and 11 RCTs involving 106 722 subjects were included. The results of meta-analysis showed that the 30-day heart failure-related readmission rates in the real-world studies and RCTs were 10.8% (95%CI 9.3% to 12.3%) and 6.9% (95%CI 5.3% to 8.4%), respectively. The 30-day all-cause readmission rates in real-world studies and randomized controlled studies were 18.6% (95%CI 15.7% to 21.4%) and 14.2% (95%CI 12.0% to 16.3%), respectively. There were statistically significant differences between two kinds of studies (P<0.05). ConclusionsCurrent evidence suggests that the 30-day heart failure-related and all-cause readmission rates in patients of acute heart failure in real-world studies are significantly higher than those in patients of RCTs. Due to the limited quality and quantity of included studies, more high-quality studies are required to verify the above conclusions.
As an important policy tool, real-world evidence is the basis for health insurance catalogue adjustment, and relevant policies and regulations have been issued in foreign countries to guide the use of real-world research for health insurance access, but the field of traditional Chinese medicine (TCM) in China in particular is still in the exploratory stage. Since TCM protocols are widely used in clinical practice and have significant clinical value, this paper takes TCM protocols as an example and systematically constructs a technical pathway based on real-world research to support health insurance access, including clinical needs assessment, basic requirements of protocols, key points for conducting real-world research and evaluating real-world evidence, the process of access, the strategy of access, and the dynamic monitoring of access, with the aim of providing guidance for the application of real-world research in China's health insurance catalogue adjustment. Access to real-world research to provide references for the application of real-world research in China's health insurance.