Some risks affecting the quality of published systematic reviews and in our teaching practice were listed and compared with the correct concept. The current problems include misunderstanding of the relationship of meta-analysis and systematic review, applying meta-analysis and assessing heterogeneity, randomization, allocate concealment, and how to make inclusion and exclusion criteria, etc. This paper aims to help Chinese reviewers improve the quality of their systematic reviews.
Objective To investigate how many hospitals can perform vitrectomy and its relationship to economic development in China.Methods Bibliometric data of retina-vitreous literatures were searched from the China National Knowledge Infrastructure (CNKI) academic databases. We used pars plana vitrectomy (PPV) as a keyword and defined address as mainland China, limited years to 1993 -2009. From those data we analyzed which hospital performed PPV. We also communicated with some hospitals by phone, email to confirm if they were performing PPV. Gross domestic product (GDP), population data and economic development ranking were extracted from the China Statistical Yearbook 2009 (National Bureau of Statistics of China). PPV carry-out rate, PPV-hospital shares and their relationships with the GDP in each regional municipality were analyzed.Results All together this study retrieved 4632 articles meet our requirements. There were 340 hospitals carrying out PPV in mainland China, located in 22 provinces, five autonomous regions and four metropolitan municipalities. The top five provinces with higher PPV carryout rate were Shandong (93,75%), Zhejiang (90,00%), Hebei province (90.00%), Jiangsu (83.33%) and Guangdong (75.00%). There was significant difference in per capita share of PPVhospitals between different cities (chi;2=181,153，P=0,000) and in the PPV carry-out rate between different cities (chi;2=749.217，P=0.000). There were 210 private eye hospitals in China,62 hospitals (18.23%) of them could perform PPV included 39 hospitals located in regionallevel cities. The coefficient correlation between PPV and GDP of different provinces was 0.842 (P=0.000). Conclusions Vitrectomy is widely performed in mainland China, but geographical distribution of PPV-performing hospitals is uneven. PPV performance is closely related with regional economic development,and private hospitals play certain roles in promoting the application of vitrectomy.
Objective To compare the clinical efficacy and safety of thrombolysis with anticoagulation therapy for patients with acute sub-massive pulmonary thromboembolism. Methods The clinical data of 84 patients with acute sub-massive pulmonary thromboembolism were analyzed retrospectively, mainly focusing on the in-hospital efficacy and safety of thrombolysis and/ or anticoagulation. The efficacy was evaluated based on 6 grades: cured, markedly improved, improved, not changed, deteriorated and died. Results Among the 84 patients,49 patients received thrombolysis and sequential anticoagulation therapy( thrombolysis group) , 35 patients received anticoagulation therapy alone( anticoagulation group) . As compared with the anticoagulation group, the thrombolysis group had higher effective rate( defined as patients who were cured, markedly improved or improved, 81. 6% versus 54. 3%, P = 0. 007) , lower critical event occurrence ( defined as clinical condition deteriorated or died, 2. 0% versus 14. 3% , P = 0. 032) . There was no significant difference in bleeding rates between the two groups ( thrombolysis group 20. 4% versus anticoagulation group 14. 3% , P gt; 0. 05) . No major bleeding or intracranial hemorrhage occurred in any of the patients. Conclusions Thrombolysis therapy may be more effective than anticoagulation therapy alone in patients with acute sub-massive pulmonary thromboembolism, and thus warrants further prospective randomized control study in large population.
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
Objective To evaluate the right usage of statistical methods in medical articles. Methods 544 theses from eight medical journalspublished during1998 and 2005 were analyzed. Results 136 theses had obvious statistical errors,accounting for 25.00%. The main types of the errors were: the wrong methods of data analyzing for 61.76%, diagram error for 14.71%, nonstatistical dealing for8.82%, the mixture of rate and ratio for 8.82%, and the other error for 5.88%. Conclusion The statistical methods should be highly valued. Despite handing themanuscript to the specialist in the same field, the statistician checking system should be built through the process of manuscript dealing.
Objective To assess the frequency and the proportion of correct use of statistical analytic methods in five Chinese otorhinolaryngological journals from 2000 to 2002. Methods The statistical methods used in all original articles (n=1 331) published in these journals in three years were evaluated. Results Only 52.0 % of the articles were used statistical analytic methods. And the frequency was higher in basic research (63.5%) than that in clinical research (48.7%) (P＜0.01). The proportions of correct use of statistical analytic methods in the five journals varied from 48.7% to 72.7%, with an average rate of 56.5%. The most frequently used statistical methods were t tests (37.9%), contingency tables (chi-square test) (28.2%) and ANOVAs (14.3%). The most common errors were on the presentation of P values without specifying the test used, using t tests instead of ANOVAs in the comparison among three and more groups, and using unpaired t tests when paired tests were required. Conclusions The rate of application statistical analytic methods is rather high, but incorrect or inappropriate use remain a serious problem.
ObjectiveTo establish an appropriate diabetic retinopathy (DR) risk assessment model for patients with type 2 diabetes mellitus (T2DM).MethodsA retrospective clinical analysis. From January 2016 to December 2017, 753 T2DM patients in the Third Affiliated Hospital of Southern Medical University were analyzed retrospectively. Digital fundus photography was taken in all patients. Fasting plasma glucose (FPG), HbA1c, total bilirubin (TB), blood platelet, total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-c), low density lipoprotein cholesterol (LDL-c), apolipoprotein-A (apoA), apolipoprotein-B (apoB), serum creatinine, blood urea nitrogen (BUN), blood uric acid, fibrinogen (Fg), estimated glomerular filtration (eGFR) were collected. The patients were randomly assigned to model group and testify group, each had 702 patients and 51 patients respectively. Logistic regression was used to screen risk factors of DR and develop an assessment scale that can be used to predict DR. Goodness of fit was examined using the Hosmer-Lemeshow test and the area under the receiver operating characteristic (ROC) curve.ResultsAmong 702 patients in the model group, 483 patients were DR, 219 patients were NDR. The scores for DR risk were duration of diabetes ≥4.5 years, 4 points; total bilirubin ＜6.65 mol/L, 2 points; apoA≥1.18 g/L, 2 points; blood urea≥6.46 mmol/L, 1 points; HbA1c ≥7.75%, 2 points; HDL-c＜1.38 mmol/L, 2 points; diabetic nephropathy, 3 points; fibrinogen, 1 point. The area under the receiver operating characteristic curve was 0.787. The logistic regression analysis showed that the risk factors independently associated with DR were duration of diabetes (β=1.272, OR=3.569, 95%CI 2.283−5.578, P＜0.001), TB (β=0.744, OR=2.104, 95%CI 1.404−3.152, P＜0.001, BUN (β=0.401, OR=1.494, 95%CI 0.996−2.240, P=0.052), HbA1c (β=0.545, OR=1.724, 95%CI 1.165−2.55, P=0.006), HDL-c (β=0.666, OR=1.986, 95%CI 1.149−3.298, P=0.013), diabetic nephropathy (β=1.151, OR=3.162, 95%CI 2.080−4.806, P=0.013), Fg (β=0.333, OR=1.396, 95%CI 0.945−2.061, P=0.094). The risk model was P=1/[1+exp−(−3.799+1.272X1+0.744X2+0.769X3+0.401X4+0.545X5+0.666X6+1.151X7+0.333X8)]. X1= duration of diabetes, X2=TB, X3=apoA, X4=BUN, X5=HbA1c, X6=HDL-c, X7=diabetic nephropathy, X8=Fg. The area under the ROC curve was 0.787 and the Hosmer-Lemeshow test suggested excellent agreement (χ2=10.125, df=8, P=0.256) in model group. The area under the ROC curve was 0.869 and the Hosmer-Lemeshow test suggested excellent agreement (χ2=5.345, df=7, P=0.618) in model group.ConclusionThe area under the ROC curve for DR was 0.787. The duration of diabetes, TB, BUN, HbA1c, HDL-c, diabetic nephropathy, apoA, Fg are the risk factors of DR in T2DM patients.
After the completion of a clinical trial, its conclusion generally depends on the results of statistical analysis of the main outcome, that is, whether the P-value in the hypothesis test is less than the α level of the hypothesis test, usually α=0.05. The size of the P-value indicates the sufficient degree of reason for making the hypothesis judgment, and can be interpreted as to determine whether a conclusion is statistically significant but does not involve the difference in the degree of drug effects or other effects. Fragility index, which is, the minimum number of patients required to change the occurrence of a target outcome event to a non-target outcome event from a statistically significant outcome to a non-significant outcome, can be used to assist in understanding of clinical trial statistical inference results and assisting in clinical decision making This paper discusses the concept, calculation method and clinical application of the fragility index, and recommends that the fragility index be routinely reported in all future randomized controlled trials to help patient clinicians and policymakers make appropriate and optimal decisions.