1.Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions (1): to improve the validity of real-world evidence
Zuoxiang LIU ; Zilin LONG ; Zhirong YANG ; Shuyuan SHI ; Xinran XU ; Houyu ZHAO ; Zuyao YANG ; Zhu FU ; Haibo SONG ; Tengfei LIN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(2):286-293
Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.
2.Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions(2): to improve the extrapolation of efficacy
Zuoxiang LIU ; Zilin LONG ; Zhirong YANG ; Shuyuan SHI ; Xinran XU ; Houyu ZHAO ; Zuyao YANG ; Zhu FU ; Haibo SONG ; Tengfei LIN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(4):579-584
Objective:Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics.Conclusions:Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.
3.Prediction of premature mortality of major chronic and non-communicable diseases and exploration of influencing factors in Anhui Province
Qin HE ; Yan ZHANG ; Xiuya XING ; Dan DAI ; Qianyao CHENG ; Wei XU ; Zhenqiu ZHA ; Rui LI ; Yeji CHEN ; Huadong WANG ; Zhirong LIU
Chinese Journal of Epidemiology 2024;45(5):700-707
Objective:To analyze and predict the future trend of the premature mortality of major chronic and non-communicable diseases in Anhui Province, evaluate the implementation of the "Healthy China 2030" Plan, and explore its influencing factors.Methods:Using data from death-cause surveillance and statistical yearbooks in Anhui, the trend prediction and analysis on influencing factors were conducted by using methods such as time series accumulation and logarithmic linear Joinpoint regression, principal component regression.Results:In Anhui, 28.10% of the deaths were premature ones, of which 84.40% were attributed to chronic and non-communicable diseases. In premature deaths attributed to chronic and non-communicable diseases, the deaths caused by malignant tumor and cardiovascular disease accounted for 45.88% and 41.65% respectively. The prediction results showed that the premature mortality of major chronic and non-communicable diseases would decrease in Anhui in the future, and by 2030, the goal in the "Healthy China 2030" Plan would be reached only in rural area. To reduce premature death, it is necessary to pay attention to the prevention and control of malignant tumor and cardiovascular disease. Men in urban area are the key population. Factors that reflect urban infrastructure had a significant impact on premature mortality of major chronic non-communicable diseases, such as garden and green space area per capita. Factors such as concentration of PM 2.5 had a negative impact on premature mortality of chronic non-communicable diseases, while factors such as garden and green space area per capita had a positive impact. Conclusions:Disease burden caused by chronic and non-communicable diseases, such as malignant tumor, exits in Anhui. Men in urban area are key population in the prevention and control of chronic and non-communicable diseases in the future.
4.Decision-making experience of patients with abdominoplasty: a qualitative study
Hui WENG ; Chenzi XU ; Ming PANG ; Jinzhen REN ; Zhen WEI ; Handou LI ; Xuan HAO ; Zhirong LIU
Chinese Journal of Plastic Surgery 2024;40(11):1221-1227
Objective:To explore the decision-making experience of patients undergoing abdominoplasty in our country.Methods:A semi-structured interview was conducted with patients suffering from postpartum abdominal wall laxity who were treated at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from June to August 2023. The data were sort and analyzed using the Clolaizzi 7-step analysis method for thematic description.Results:A total of 15 patients, aged 29-53 years, were included in the study. 11 had a college education or higher, while 4 had less than a college education.Thirteen were married and two were divorced. According to the interview data, four themes were extracted: (1) negative perceptual experiences; (2) decision-making dilemmas; (3) peer support; (4) a physician-led decision-making model. According to the interview, the main decision-making dilemma faced by patients with postpartum abdominal wall laxity was lack of information and family support, and the support they get was mostly from information exchange among patients, and they had insufficient cognition of surgical knowledge, improvement degree and risk, and low participation in clinical decision making.Conclusion:Patients with postpartum abdominal wall laxity in China have an urgent psychological need for abdominoplasty, but there are many factors that have adverse effects on their decision-making experience.
5.Correlation between pen-holding posture, grip strength and myopia in school-aged children
Yuxiao WU ; Zhengyang TAO ; Zhirong XU ; Yu LIN ; Hongwei DENG ; Jun ZHAO
Chinese Journal of Experimental Ophthalmology 2024;42(9):827-833
Objective:To investigate the correlation between pen-holding posture, grip strength and myopia.Methods:A cross-sectional study was performed.A total of 496 school-aged children in grades 1-6, who underwent eye examinations at Shenzhen Eye Hospital from November 2021 to May 2022 were consecutively enrolled as subjects.The subjects' age, grade, sex, refractive error and age of school enrollment were recorded.Subjects' grip strength and pen-holding posture were obtained with an electronic grip strength meter and a tool pen, and subjects were divided into correct pen-holding posture group and incorrect pen-holding posture group according to their pen-holding posture.Propensity scores for sex, grade, age at school entry, and grip strength in the two groups were matched using the nearest neighbor matching method.Multifactorial binary logistic regression analysis was performed with binocular myopia, monocular myopia, and emmetropia as dependent variables and grip strength, grade, refractive error, and pen-holding posture as independent variables.The correlation between grip strength and spherical equivalent was examined by Spearman rank correlation analysis and partial correlation analysis.This study protocol adhered to the Declaration of Helsinki and was approved by the Ethics Committee of Shenzhen Eye Hospital (No.2022KYPJ032).Results:After matching propensity scores, there were 101 cases and 197 cases in the correct pen-holding posture group and incorrect pen-holding posture group, respectively.There was no statistical significance in sex, grade, age at enrollment, and grip strength between the two groups (all at P>0.05).Multinomial logistic regression results showed that using emmetropia as a reference, higher grade (4 versus 1∶7.601[1.307-44.206]; 5 versus 1∶4.392[1.039-18.562]), presence of anisometropia (21.366[5.750-79.397]) were relative risk factors for monocular myopia (all at P<0.05), and higher grade (3 versus 1∶4.389[1.783-10.800]); 4 versus 1∶15.398[3.267-72.574]; 5 versus 1∶7.447[2.232-24.851]; 6 versus 1∶6.462[2.116-19.734]) were relative risk factors for binocular myopia (all at P<0.05).Taking monocular myopia as a reference, higher grade (6 versus 1∶4.582[1.193-17.589]), presence of anisometropia (0.141[0.069-0.289]), and irregular pen-holding posture (2.608[1.340-5.075]) were associated factors for binocular myopia (all at P<0.05).According to partial correlation analysis, the spherical equivalent of the right eye of children with incorrect pen-holding posture was negatively correlated with the grip strength ( rs=-0.141, P=0.047). Conclusions:There is an association between pen-holding posture and myopia in school-aged children.Children with greater grip strength and incorrect pen-holding posture may have higher degrees of right eye refractive error.
6.Decision-making experience of patients with abdominoplasty: a qualitative study
Hui WENG ; Chenzi XU ; Ming PANG ; Jinzhen REN ; Zhen WEI ; Handou LI ; Xuan HAO ; Zhirong LIU
Chinese Journal of Plastic Surgery 2024;40(11):1221-1227
Objective:To explore the decision-making experience of patients undergoing abdominoplasty in our country.Methods:A semi-structured interview was conducted with patients suffering from postpartum abdominal wall laxity who were treated at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from June to August 2023. The data were sort and analyzed using the Clolaizzi 7-step analysis method for thematic description.Results:A total of 15 patients, aged 29-53 years, were included in the study. 11 had a college education or higher, while 4 had less than a college education.Thirteen were married and two were divorced. According to the interview data, four themes were extracted: (1) negative perceptual experiences; (2) decision-making dilemmas; (3) peer support; (4) a physician-led decision-making model. According to the interview, the main decision-making dilemma faced by patients with postpartum abdominal wall laxity was lack of information and family support, and the support they get was mostly from information exchange among patients, and they had insufficient cognition of surgical knowledge, improvement degree and risk, and low participation in clinical decision making.Conclusion:Patients with postpartum abdominal wall laxity in China have an urgent psychological need for abdominoplasty, but there are many factors that have adverse effects on their decision-making experience.
7.Coexistence of Subcutaneous Panniculitis-Like T-Cell Lymphoma and Dermatomyositis in a 12-Year-Old Boy
Ruoqu WEI ; Haifei LIU ; Zhen ZHANG ; Fuying CHEN ; Jiawen CHEN ; Qianyue XU ; Hong YU ; Jianying LIANG ; Zhirong YAO
Annals of Dermatology 2023;35(Suppl1):S79-S83
Subcutaneous panniculitis-like T-cell lymphoma (SPTL) is an extremely rare, indolent skin malignancy that can be difficult to distinguish from autoimmune disease-associated panniculitides. Here, we describe a 12-year-old boy who was diagnosed at age 7 years with dermatomyositis with classical manifestations, including poikiloderma, Gottron’s sign, and symmetric muscle weakness. Recently, the boy presented multiple subcutaneous nodules and fever. Histopathological examination and immunohistochemical staining revealed coexistence of SPTL. To our knowledge, this is the first case of dermatomyositis accompanied with SPTL. This case alert clinical physicians of the possibility of SPTL should be considered when a patient with dermatomyositis has new lesions presenting as nodules and unknown fever.
8.Anatomy of rectus femoris muscle flap and anterolateral thigh muscle flap and their application in reconstruction of postoperative defects of oral malignant tumour
Hongrong ZHANG ; Weihong WANG ; Biao XU ; Jin ZHU ; Zhirong ZOU ; Yu LIU ; Yemei QIAN ; Lei LUO ; Jingyi LI
Chinese Journal of Microsurgery 2023;46(3):247-253
Objective:To investigate the anatomy of rectus femoris muscle flap and the anterolateral thigh muscle flap and their clinical application in reconstruction of large soft tissue defects after the removal of oral malignant tumour.Methods:From December 2006 to June 2009, 8 specimens of Chinese adult cadavers fixed in 10% formaldehyde were dissected to perform anatomy of anterolateral thigh region at the School of Basic Medical Sciences, Kunming Medical University. Anatomical images were analysed using Image-Pro Plus 6.0. Then, a retrospective study was performed on 19 patients who had postoperative defects after oral malignant tumour surgery and the defects were reconstructed with the rectus femoris muscle flap and the anterolateral thigh muscle flap from March 2020 to July 2022 at the Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital, Kunming Medical University. The postoperative defects of the 19 patients ranged from 3.0 cm×6.0 cm to 5.0 cm×10.0 cm. Ten rectus femoris muscle flaps, 8 anterolateral thigh muscle flaps and 1 combined rectus femoris muscle flap and anterolateral thigh muscle flap were used. The muscular flaps sized from 4.0 cm × 8.0 cm to 6.0 cm × 11.0 cm. Regular postoperative outpatient follow-ups were conducted.Results:The lengths of vessels of the harvested rectus femoris muscle flap and anterolateral thigh muscle flap were 63.4 mm± 12.9 mm and 112.5 mm± 19.6 mm, respectively. The starting outer diameters of the lateral circumflex thigh artery, the oblique branch of the lateral circumflex thigh artery and the descending branch of the lateral circumflex thigh artery were 2.92 mm±0.72 mm, 1.88 mm±0.23 mm and 2.29 mm±0.43 mm, respectively. Postoperative follow-up lasted for 7 to 32 months, with 17.5 months in average. Seventeen flaps were completely survived and the rectus femoris muscle flap was completely mucosalised 5 weeks after surgery. However, 2 rectus femoris muscle flaps had necrosis of which one was changed to a tongue flap reconstruction and the other encountered flap necrosis during postoperative radiotherapy and healed after debridement and dressing changes. There was no postoperative complication in the donor sites. Other than the 2 patients, all other 17 patients had satisfactory clinical outcomes.Conclusion:Both of the starting outer diameters and length of vessels of the femoris muscle flap and the anterolateral thigh muscle flap meet the requirements for reconstruction of maxillofacial defects, and both muscular flaps are simple to prepare, in good reconstructive results with few complication, as well as an excellent outcome. They are feasible approaches for reconstruction of large soft tissue defects left after the removal of an oral malignant tumour.
9.Effects of the enriched environment on pyroptosis in rats with cerebral ischemia-reperfusion injury
Xiaohui YANG ; Tao TAO ; Wenmei ZHOU ; Zhirong HUI ; Yaqi LI ; Hongliang XU ; Hongpei JI ; Ying ZHANG ; Wenfeng YU
Chinese Journal of Geriatrics 2023;42(11):1343-1349
Objective:To explore the effect of the enriched environment(EE)on pyroptosis in rats with cerebral ischemia-reperfusion injury(CIRI).Methods:45 male Sprague-Dawley rats were randomly divided into three groups: a sham surgery(Sham)group, a cerebral ischemia-reperfusion(CIR)group and an enriched environment(EE)group, with 15 rats in each group.Except for the Sham group, the right middle cerebral artery occlusion model was established in the other two groups.After surgery, the EE group was fed in EE, and the other two groups were fed in standard environment.All the rats were assessed using the modified neurological severity score(mNSS)before modeling and on the 1st day, 7th day and 14th day following surgery.On the 14th day after surgery, 2, 3, 5-triphenyltetrazolium chloride(TTC)staining was used to evaluate the infarct volume, hematoxylin and eosin(HE)staining was used to examine pathomorphological changes of the hippocampal CA1 region on the ischemic side of the rats in each group, immunohistochemical assay was used to detect the expression of nucleotide-binding oligomerization domain-like receptor protein 3(NLRP3)and cysteinyl aspartate specific proteinase-1(caspase-1)proteins in the CA1 region, and ultrastructural changes in neurons in the CA1 region were observed under transmission electron microscopy.Results:Compared with the Sham group, the mNSS scores of the CIR group and the EE group were significantly higher on the 1st day and 7th day after surgery( P<0.05), but there was no significant difference between the CIR and EE groups( P>0.05). On the 14th day after surgery, compared with the CIR group, the EE group showed a decrease in the mNSS score and the cerebral infarct volume( P<0.05), alleviated pathomorphological changes, decreased expression of NLRP3 and caspase-1 proteins( P<0.05), and alleviated pathological changes of pyroptosis in the ultrastructure of neurons. Conclusions:EE can reduce the damage of neurological function, reduce the cerebral infarct volume, and play a protective role for the brain in CIRI rats.The mechanism may be related to the down-regulation of the expression of NLRP3 and caspase-1 proteins related to the classical pyroptosis pathway, leading to the inhibition of pyroptosis.
10.Association between serum uric acid and metabolic syndrome among adult residents in Anhui province
Wei XU ; Huadong WANG ; Xiuya XING ; Jingqiao XU ; Dan CAO ; Qianyao CHENG ; Yili LYU ; Zhirong LIU
Chinese Journal of Endocrinology and Metabolism 2023;39(10):865-869
Objective:To investigate the prevalence of metabolic syndrome(MS) among adult residents with different characteristics and the relationship between serum uric acid(SUA) level and MS using the data of Chinese Adult Chronic Diseases and Nutrition Surveillance(2018) program in Anhui.Methods:Multi-stage stratified cluster random sampling was used to select participants aged 18 and over for questionnaires, physical measurements, and laboratory tests. The complex weighted method was used to estimate the prevalence of MS among residents with different characteristics. Logistic regression model based on complex sampling data was used to analyze the relationship between SUA and MS. Receiver operating characteristic(ROC) curve was used to evaluate the reliability of SUA in diagnosing MS and determine the optimal cutoff point.Results:A total of 7 182 participants were included and the prevalence of MS among adult residents was 29.46%. The prevalence of MS was higher in females(33.76%) than that in males(25.28%), and the difference was statistically significant( P<0.05). After adjusting for other factors, for every 10 μmol/L increase in SUA, the risk of MS increased by 4% in males( OR=1.040, 95% CI 1.019-1.061) and 7% in females( OR=1.070, 95% CI 1.059-1.082). The area under the curve(AUC) for SUA in diagnosing MS was 0.816(95% CI 0.806-0.826), with a sensitivity of 0.761 and specificity of 0.727. The optimal cutoff point for SUA was 450 μmol/L. Conclusion:The prevalence of MS among adult residents in Anhui Province is 29.46%. SUA is a risk factor for MS, and increasing SUA level indicated a higher risk of MS. The optimal cutoff value of SUA may be helpful in diagnosing MS.

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