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 explore the diagnostic value of a disintegrin-like and metalloproteinase with thrombospondin type 1 motifs (ADAMTS)-9 in acute aortic dissection (AAD). Methods A total of 328 patients with acute onset of chest pain within 24 hours were enrolled in West China Hospital from January 2015 to June 2016 and according to the results of computed tomography angiography they were divided into an AAD group (n=172, 107 males, 65 females, mean age of 50.4±13.1 years) and a control group (n=156, 89 males, 67 females, mean age of 54.9±14.7 years). The enzyme-linked immunosorbent assay (ELISA) test was used to measure the level of ADAMTS-9. Results Patients in two groups had no significant difference in age, gender, smoke history, hypertension history, total cholesterol, triacylglyceride and hemoglobin (P>0.05). But systolic and diastolic blood pressures were significantly higher in the AAD group than those in the control group (P<0.05, respectively). The level of ADAMTS-9 was significantly higher in the AAD group than that in the control group (249.4±186.8 ng/mlvs. 78.2±48.6 ng/ml,t=11.107, P<0.001). Receiver operating characteristic curve analysis showed that ADAMTS-9 (156.7 ng/ml) was predictive in the diagnosis of AAD with sensitivity of 0.942 and specificity of 0.628. Conclusion ADAMTS-9 might be an effective and important biomarker in diagnosis of AAD.
ObjectiveTo compare the predictive value of six thrombotic risk assessment scales, including Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT, for the deep venous thrombosis (DVT) of lower extremity in patients with gastrointestinal tumors. MethodsThe patients with gastrointestinal tumors who received surgical treatment in the General Surgery Department of Lanzhou University Second Hospital from March 2023 to October 2023 were collected. The risk of DVT on day 3 after surgery for the patient with gastrointestinal tumors was prospectively evaluated using the Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT assessment scales. And the DVT was detected by ultrasound examination. The pionts of six thrombotic risk assessment scales were compared between the patient with DVT and without DVT based on the ultrasound examination results. The predictive value of the six thrombotic risk assessment scales for the lower extremity DVT in the patients with gastrointestinal tumors was evaluated by the area under receiver operating characteristic curve (AUC). ResultsA total of 108 patients who met the criteria, including 71 males and 37 females, were enrolled, age ranged from 18 to 85 years old, (58.3±11.2) years old. Fourty-two cases (38.9%) of DVT occurred. The age of patients with DVT was older than that of patients without DVT (P<0.05), but there were no statistical differences in the gender, body mass index, tumor location, comorbidities, and so on (P>0.05). The points of Autar, Padua, and Caprini in the patients with DVT were higher than those in the patients without DVT (P<0.05), while there were no statistical differences in the points of Wells, Khorana, and COMPASS-CAT between the two (P>0.05). The AUC for differentiating the occurrence of DVT in the patients with gastrointestinal tumors using the Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT assessment scales were 0.907, 0.548, 0.636, 0.627, 0.589, and 0.535, respectively; The sensitivities were 97.6%, 14.3%, 52.4%, 83.3%, 47.6%, and 21.4%; The specificities were 2.4%, 85.7%, 47.6%, 16.7%, 52.4%, and 78.6%, respectively. ConclusionAccording to the abilities of Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT to distinguish the occurrence of DVT in patients with gastrointestinal tumors after surgery, only the Autar evaluation scale is found to be more effective, while the other five evaluation scales are generally able to distinguish the occurrence of DVT.
ObjectivesTo explore the characteristics of Chinese methodological studies on patient compliance in clinical trials so as to provide reference for clinical trial of patient compliance in future.MethodsCNKI, VIP, CBM and WanFang Data databases were electronically searched to collect methodological studies on patient compliance in clinical trials published in Chinese language from January 2000 to December 2018. Two reviewers independently screened literature, extracted data and then, qualitative analysis of document characteristics was then performed.ResultsA total of 84 articles were included, in which 68 were studies on Western medicine and 16 were studies on traditional Chinese medicine (TCM). The results showed that: the quantity of studies on patient compliance increased along with time. However, those in TCM field did not increase. All included studies summarized their strategies to improve patient compliance, however key information for quality evaluation were missing.ConclusionsThere is still a lack of research on how to improve patients’ compliance in clinical trials to ensure the reliability of the results. Existing studies have not systematically and comprehensively explored the influencing factors of patients’ compliance. Clinical trials researchers in China have not focused sufficiently to patients’ compliance and lack the proper methodology to frame studies.
Objective To evaluate the predicted value of APACHEⅡ score at admission for deep fungal infection（DFI） in patients with severe acute pancreatitis （SAP）.Methods The clinical data of 132 patients with SAP from January 2006 to June 2011 in our hospital were analyzed retrospectively. The receiver operating characteristic curve （ROC） was used for evaluating the predicted value.Results Thirty-nine patients with SAP infected DFI （29.5%）,of which 36 patients （92.3%） infected with Candida albicans,2 patients （5.1%） with Candida tropicalis,1 patient （2.6%） with pearl bacteria.And,among these 39 patients,27 patients （69.2%） infected at single site,12 patients （30.8%） infected at multi-site. The APACHEⅡ score in 39 patients with DFI was higher than that of 93 patients without DFI （17.1±3.8 versus 9.7±2.1, t=14.316,P=0.000）.The ROC for APACHEⅡ score predicting DFI was 0.745（P=0.000）, 95%CI was 0.641－0.849.When the cut off point was 15,it showed the best forecast performance,with specificity 0.81, sensitivity 0.72,Youden index 0.53. Conclusions The APACHEⅡ score at admission can preferably predict DFI in patients with SAP； when the APACHEⅡ score is greater than 15,it prompts highly possible of DFI,so preventive anti-fungal treatment may be necessary.
ObjectiveTo investigate the feasibility of quantitative detection of WBC count and bacteria count with UF-1000i urinary sediment analyzer in rapid screening for urinary tract infection by receiver operator characteristic (ROC) curve. MethodsFrom August to December 2013, we used quantitative bacterial culture and UF-1000i automatic urine sediment analyzer respectively to examine asepsis urine specimens of 218 patients with suspected urinary tract infection. Among them, there were 95 males and 123 females, with an average age of 54.7 years old. ResultsAmong the 218 urinary samples, 65 were culture positive specimens. With positive urine culture as the gold standard for making ROC curve, the area under ROC curve for WBC count and bacterial numbers by UF-1000i urine sediment analyzer were respectively 0.839 and 0.894. The cut-off values of Youden index for optimal WBC cell count and bacterial count were ≥31.0/μL and 38.8/μL, respectively. When the above numbers were used as cut-off values, the WBC count sensitivity and specificity were 78.3% and 80.4%, the positive likelihood ratio was 3.99, and the negative likelihood ratio was 1.11. And the bacterial count sensitivity and specificity were 84.3% and 80.6%, the positive likelihood ratio was 4.30, and the negative likelihood ratio was 0.80. ConclusionUsing white blood cell count ≥31/μL and bacterial count ≥38.8/μL detected by UF-1000i urine sediment analyzer as the cut off values of noninvasive screening indexes has a very important value in screening for urinary tract infection in the early stage, determining whether there is a need for urine culture, and guiding clinical rational application of antibiotics
Objective To determine whether B-type natriuretic peptide （BNP） levels combined with Spontaneous breathing trial (SBT) could improve the weaning outcome. Methods Eighty-three patients who were ready to undergo a 90-minute weaning trial （low-pressure support level） were enrolled .Weaning was considered to be successful if the patient passed the trial and sustained spontaneous breathing for more than 48 h after extubation. Plasma BNP was measured just before and at the end of the trial. All patients were divided into a weaning success group and a weaning failure group according to the outcomes of weaning. Categorical variables，expressed as percentages，were analyzed with a chi-square test or a Fisher’s exact test. Continuous variables were expressed as median （25th-75th percentile） and were compared using the Wilcoxon paired test （for related samples） or the Kolgomorov-Smirnov test （for independent samples）. A two-tailed p value of less than 0.05 was taken to indicate statistical significance. Receiver operating characteristic （ROC） curve analysis was performed to assess plasma BNP’s ability to discriminate the subjects who weaned succesfully or failed. Results Overall，13 patients （16.7%） failed the weaning process （6 patients passed the trial but failed extubation）. At the end of SBT，the BNP levels of the weaning failure group were significantly higher than the weaning success group. The BNP levels of the weaning failure group were significantly higher than the weaning success group （Plt;0.001）. The area under cure （AUC） of the ROC curve of BNP to predict the failure of weaning was 0.94±0.03 （Plt;0.001）.At a cut-off level of 123 pg/mL,BNP had a predictive efficiency in weaning outcome as Yourdon’s index of 0.837，sensitivity of 92.3%，and specificity of 91.4%. Conclusion Monitoring the change of BNP during a SBT may improve weaning outcome.
Objective To screen the key genes in childhood therapy-resistant asthma by bioinformatic method, and to verify its expression and diagnostic value in peripheral blood of children with therapy-resistant asthma. Methods The transcriptome dataset GSE27011 of peripheral blood mononuclear cells from healthy children (healthy control group), mild asthma (MA) children (MA group) and severe asthma (SA) children (SA group) was downloaded from the Gene Expression Omnibus of the National Center for Biotechnology Information of the United States. Key genes were obtained by using R software for gene differential expression analysis, weighted gene co-expression network analysis (WGCNA) and clinical phenotypic correlation analysis. The differential expression levels of key genes were verified in children with asthma and immune cell transcriptome datasets. Seventy-eight children with asthma and 30 healthy children who were diagnosed in the Department of Pediatrics of Tangshan People’s Hospital between September 2020 and September 2021 were selected and divided into control group, MA group and SA group. Peripheral blood samples from children with asthma and healthy children who underwent physical examination were collected to detect the expression levels of key genes and inflammatory factors interleukin (IL)-4 and IL-17 in peripheral blood of children. Receiver operating characteristic curve was used to evaluate the sensitivity, specificity and accuracy of key genes in predicting childhood therapy-resistant asthma. Results The key gene GNA15 was obtained by bioinformatic analysis. Analysis of asthma validation dataset showed that GNA15 was up-regulated in asthma groups, and was specifically expressed in eosinophils. Clinical results showed that the expression levels of IL-4, IL-17 and GNA15 among the three groups were significantly different (P<0.05). The expression levels of IL-4 and IL-17 in the MA group and the SA group were higher than those in the control group (P<0.05). Compared with the control group and the MA group, the expression level of GNA15 in the SA group was up-regulated (P<0.05). Neither the difference in the expression level of IL-4 or IL-17 between the MA group and the SA group, nor the difference in the expression level of GNA15 between the control group and the MA group was statistically significant (P>0.05). The specificity, sensitivity and accuracy of GNA15 in predicting SA were 92.90%, 80.00% and 86.10%, respectively. Conclusion GNA15 has a significant clinical value in predicting the childhood therapy-resistant asthma, and may become a potential diagnostic marker for predicting the severity of asthma in children.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).