1.Consistency evaluation for quantitative measurements by Bland-Altman method and its clinical application
Journal of Medical Postgraduates 2015;28(10):1107-1111
The Bland-Altman method has been widely used for consistency evaluation in the field of medicine .However, fre-quent errors in the application of the method seriously affect the quality of researches .This review focuses on the studies of the Bland-Altman method , the status quo and common problems in its application , and standards for related reports .
2.MedDRA and its applications in statistical analysis of adverse events.
Acta Pharmaceutica Sinica 2015;50(11):1396-401
Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
3.Using random allocation book for random allocation concealment in a clinical trial
Weihua ZHONG ; Mengjie LU ; Yuxiu LIU ; Tiantian LIU ; Minlin ZHOU
Journal of Medical Postgraduates 2017;30(1):91-94
Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial.In this paper , we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method . Methods According to the randomized sequence , a two-couplet random allocation should be prepared for every subject and bound into a book in order , which named random assignment book with cover and instructions .The first couplet is to collect the enroll information and the second couplet is to show the allocation informa -tion.The serial numbers of the two couplets which around sealant are the same , and leave blank at the same areas of the two couplets for signing the enter information .The content of the first couplet can be completely copied to the second couplet .In order to avoid expo-sing the allocation information in advance , the back of the second couplet should be black-printed. When the subjects are sure qualified, the researchers selected the corresponding two couplet in a sequential order .Exposing the allocation infromation in the second couplet, and the subjects will be allocated to the group designated on the second couplet .This random allocation book should be entrusted to professional printing mechanism ,printing according to the random assignment sequence table and in the strict quality control .For the multicenter clinical trials , it can be printed in parts . Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise . Conclusion The random allocation book method is easy to produce , simple operation and convenient in monitoring , which can effectively achieve the random allocation concealment in a clinical trial as well as having a sig -nificantly practical value in ensuring the quality of randomization .
4.A case of fructose-1, 6-bisphosphatase deficiency with delayed diagnosis for 7 years and review of literature
Mengjie YANG ; Yili LU ; Huiping WU ; Xiaoou SHAN
Chinese Journal of Endocrinology and Metabolism 2021;37(5):457-461
To report a case of fructose-1, 6-bisphosphatase deficiency child with delayed diagnosis for seven years, and review the literature. A 13-year-old boy presented with recurrent episodes of hypoglycemia after infection since 6 years old, he also had convulsion and short stature. The laboratory finding revealed ketotic hypoglycemia, lactic acidosis, transient elevated ALT and UA. The genetic analysis showed compound heterozygous mutations of c. 960-961insG and c. 355G> A in FBP1 gene. Among eighteen patients reported in China, 88.9% had convulsion, 16.7% had growth retardation, the average delayed diagnosis spent 2.8 years, which could result in permanent brain damage and high death risk. The most common mutation was c. 960-961insG, followed by c. 355G>A and c. 490G>A, these mutations maybe hot spot sites of FBPl gene in China.
5.Correlation between sleep quality and brachial-ankle pulse wave velocity of physical examination people
Mengjie LU ; Min HE ; Jinran GAN ; Guijun XUE ; Xinxiao LI ; Youjuan WANG
Journal of Chinese Physician 2016;18(9):1325-1328
Objective To investigate the sleep quality state of people who did physical examination,and its correlation with brachial-ankle Pulse Wave Velocity (baPWV).Methods The indexes of Pittsburgh sleep quality index (PSQI) and baPWV were used.The people who did physical examination were divided into sleep disorders group (284 cases) and normal sleep group (608 cases) according to the results of PSQI survey.Results (1) There were 31.84% of the people who had sleep quality problems.(2) The PSQI total score and the score of subjective sleep quality (SSQ),sleep duration (Sdu),daytime dysfunction (DD) of females were higher than males (t =6.71,3.46,2.45,3.96,P <0.05).The PSQI total score and the score of sleep latency (SL),habitual sleep efficiency (HSE),use of sleeping medication (USM) among different age groups were statistically analyzed (F =12.23,8.31,7.50,7.11,P < 0.05).(3) The score of baPWV of sleep disorders group was higher than normal sleep group (t =5.14,P < 0.05).There were significantly positive correlation between baPWV and total PSQI score,subjective sleep quality,sleep time,daytime dysfunction (r =0.28,0.45,0.30,0.36,0.35,P < 0.05).Conclusions 1/3 of the physical examination people have sleep quality problems.Sleep quality of females is worse than males.There are different styles among different age groups.There is significantly positive correlation between sleep quality and baPWV.
6.Verification of the clinical applicability of the published standard reference interval based on health examination results of Han and Uygur populations
Zhaohui DENG ; Mengjie LIANG ; Yinbo SONG ; Xue SONG ; Weidong YI ; Xinhong LU ; Xin ZHANG
International Journal of Laboratory Medicine 2015;(17):2487-2489
Objective To verify the clinical applicability of the published standard intervals of routine clinical chemistry (WS/T404 .1‐2012 ,WS/T404 .2‐2012) based on the health examination results of Han and Uygur populations in Urumqi .Methods This was a retrospective study .The results of serum TP ,ALB ,ALT ,AST ,ALP ,GGT from healthy examination individuals of Han and Uygur populations (from 2013 August to 2015 January) were collected and the healthy cases (age range:20 -79 years old) were chosen to calculate the 2 .5% and 97 .5% percentiles ,excluding the significant abnormal results according to the Medical Deciding Level 2 recommended by Staland .The percents of health cases not falling in the published standard interval were calculated to meet the judgment criterion of verification (<10% ) .Results The test of normality revealed that the Han and Uygur's results of all veri‐fied items were skewed distributions .The 2 .5% and 97 .5% percentiles of the results of two populations were as follows ,TP(Han 65 -81 g/L ;Uygur 64-81 g/L) ,ALB(Han 41-53 g/L ;Uygur 40-52 g/L) ,ALT(Han:male 9-51 U/L and female 7-42 U/L ;Uygur:male 9-53 U/L and female 6-43 U/L) ,AST(Han:male 14-42 U/L and female 12-37 U/L ,Uygur:male 12-42 U/L and female 12-38 U/L) ,ALP(Han:male 45-119 U/L ;Uygur:male 47-122 U/L) ,ALP(female 20-49 years old:Han 35-95 U/L and Uygur 40-104 U/L) ,ALP(female 50-79 years old:Han 43-131 U/L and Uygur 51-132 U/L) ,GGT(Han:male 11-71 U/L and female 8-54 U/L ;Uygur :male 11 -73 U/L and female 7 -55 U/L ) .The percents of AST results for Han's male , Uygur's male and Uygur's female not falling in the published standard reference interval were slightly over 10% ,but AST results o‐ver 10% were mainly under the lower limit of the published standard reference interval .The health case percents for the other veri‐fied items of Han and Uygur populations not falling in the published standard reference interval were under 10% .Conclusion The published standard reference intervals of routine clinical chemistry (WS/T404 .1‐2012 ,WS/T404 .2‐2012) are applicable in our la‐boratory for the detection of Han and Uygur population .
7.Preliminary study of distribution and age-related changes of iron-content in the brain using MR quantitative susceptibility mapping
Shuang XIA ; Chao CHAI ; Wen SHEN ; Shuo YAN ; Mengjie ZHANG ; Guangming LU
Chinese Journal of Radiology 2014;48(9):730-735
Objective To evaluate the distribution and age-related changes of brain iron content in healthy people using MR quantitative susceptibility mapping (QSM).Methods Sixty three healthy right-handed volunteers underwent the routine MRI and SWI scan to get SWI-unfiltered phase images and magnitude images.QSM were reconstructed from the SWI-unfiltered phase images and magnitude images using SMART software.The regions of interest at the bilateral frontal white matter and nuclei (caudate nuclews,globus pallidus,putamen,substantia nigra,dorsal thalamus,red nucleus and dental nucleus) were drawn manually,and the susceptibility was measured.The linear correlation between the susceptibility and iron concentration cited from Hallgren and Sourander's post-mortem brain study was calculated.Wilcoxon test were applied to calculate the difference between the bilateral frontal white matter and bilateral nuclei.The correlation of age with susceptibility of bilateral frontal white matter and bilateral nuclei were analyzed by Spearman correlation analysis.Results The median susceptibility (extent) of frontal white matter,caudate nucleus,globus pallidus,putamen,dorsal thalamus,substantia nigra,red nucleus and dentate nucleus of 63 healthy people were-12.81 (-31.56,8.72),39.27 (22.35,75.13),93.99 (19.19,158.75),29.16 (4.11,81.53),2.91 (-27.80,27.95),83.14 (38.57,185.79),63.49 (13.83,142.09),63.30 (36.78,128.53) ppb (× 10-9),respectively.There was high consistency with Hallgren and Sourander's study (r=0.91,P<0.05).The susceptibility of globus pallidus was the highest,followed by substantia nigra.The least susceptibility was seen in the frontal white matter.The susceptibility of right caudate nucleus,substantia nigra,red nucleus and dental nucleus was higher than that of left side (Z value was-3.18,-4.44,-3.70 and-2.64,respectively,P<0.05).The susceptibility of bilateral globus pallidus of the male was significantly different from that of the female (Z value was-2.27 and-2.42,respectively,P<0.05).There was positive correlation between age and the susceptibility of bilateral caudate nucleus,putamen,red nucleus and dental nucleus (r value was 0.30 to 0.49,P<0.05).Conclusions QSM based on the SWI-unfiltered phase and magnitude images can clearly display the cerebral nuclei and evaluate the brain iron content accurately,which is consistent with the histopathological results.Iron content of bilateral caudate nucleus,putamen,red nucleus and dental nucleus increase with aging.
8.Comparative analysis of stat test turnaround times between emergency department and intensive care unit
Zhaohui DENG ; Yinbo SONG ; Hongbing JIANG ; Mengjie LIANG ; Xinhong LU ; Xin ZHANG
Chongqing Medicine 2014;(35):4760-4763
Objective To provide the objective evidence for reducing stat test turnaround time (TAT) reasonably through the comparative analysis of different intervals of stat test TAT between emergency department (ED) and intensive care unit (ICU ) . Methods Laboratory information system was used to collect data about blood cell analysis and biochemical profiles of department of emergency and ICU from 1st January to 31th March ,2014 ,then comparatively analyzing different intervals of stat test TAT be‐tween two departments .Results TAT outlier rates of stat CBC tests ordered by ED and ICU were 2 .4% and 15 .1% ,and that of stat biochemical profiles ordered by ED and ICU were 12 .3% and 24 .5% ,respectively .there were no significant differences in mean times between order‐to‐receipt of stat CBC tests and biochemical profiles ordered by ED and collection‐to‐receipt of stat CBC tests and biochemical profiles ordered by ICU [(11 .2 ± 4 .0) min vs .(11 .2 ± 4 .5) min ,P>0 .05 ;(13 .2 ± 14 .1)min vs .(13 .8 ± 9 .8) min ,P>0 .05] .ED had significantly shorter mean time of receipt‐to‐report than ICU for stat CBC tests and biochemical profile [(5 .8 ± 4 .4) min vs .(19 .3 ± 12 .5) min ,P<0 .01 ;(34 .4 ± 10 .9) min vs .(35 .5 ± 13 .2) min ,P>0 .01] .The TAT mean times of stat CBC tests and biochemical profiles ordered by ED were shorter than those ordered by ICU [(17 .0 ± 6 .2) min vs .(30 .5 ± 14 .9) min ,P<0 .01 ;(46 .9 ± 17 .2) min vs .(49 .3 ± 16 .5) min ,P<0 .01] .Conclusion The ED TATs for CBC tests and biochemical pro‐files are reasonably set ,and each interval of the ED TATs is well controlled .The ICU TATs for CBCs and biochemical profiles should be reset ,and the process of stat test for ICU should be optimized .
9. HIV infection rate in people aged 50 years and older in China: a Meta-analysis
Hanxi ZHANG ; Mengjie HAN ; Yu ZHOU ; Xiangfei XIU ; Fang XU ; Lu WANG
Chinese Journal of Epidemiology 2020;41(1):96-102
Objective:
The prevalence of HIV/AIDS in people aged ≥50 years is increasing in China, resulting in another focus for AIDS prevention and control. A Meta-analysis was conducted to evaluate the HIV infection, its area and time distributions in people aged ≥50 years in China to provide evidence for the prevention and control of HIV/AIDS.
Methods:
Information on HIV infection rate in people aged ≥50 years in China were collected from Wanfang digital database, China National Knowledge Infrastructure (CNKI), PubMed and Embase. The R Studio1.1.456 software was used to calculate the pooled infection rate, and assessed the publication bias.
Results:
A total of 30 studies which covered 13 provinces were selected. From 2010 to 2018, the pooled HIV infection rate in people aged ≥50 years was 1.68
10.The effects of sensorimotor training on the risk of falls in hospitalized elderly patients with schizophrenic
Jiangbo LU ; Wei QIAN ; Jianqin PEI ; Jufang JIANG ; Mengjie YAO ; Jinzhi DAI
Chinese Journal of Practical Nursing 2022;38(15):1141-1149
Objective:To explore the intervention effect of sensorimotor training on cognitive function, balance and fall risk of elderly patients with schizophrenia.Methods:The 60 hospitalized elderly schizophrenic patients in Wuxi Mental Health Center were randomly divided into experimental group and control group from June to September 2021, with 30 cases in each group. The control group implemented traditional exercise on the basis of routine nursing. The experimental group received 8-week and 24 times sensorimotor training on the basis of the routine nursing. The Chinese version of the Mini Mental State Examination (MMSE) was used to assess the cognitive level of patients, the Modified Morse Fall Scale (MMFS) was used to assess the risk of falls, and the Berg Balance Scale (BBS) was used to assess the balance function.Results:After 8 weeks of intervention, the total score of MMSE was (26.72 ± 1.71), higher than the total score of the control group (22.36 ± 1.93), the factor scores of temporal orientation, spatial orientation, recollection, attention and calculation, memory and language ability in the experimental group were (4.90 ± 0.31), (4.72 ± 0.53), (2.86 ± 0.35), (4.66 ± 0.61), (2.83 ± 0.47), (6.76 ± 1.09), higher than scores of the control group (4.36 ± 0.56), (3.93 ± 0.66), (2.57 ± 0.50), (3.64 ± 1.03), (2.18 ± 0.67), (5.68 ± 1.02), and the difference was statistically significant( t values were 2.53-9.06, all P< 0.05). The total score of MMFS in the experimental group was (5.93 ± 1.49), which was lower than that in the control group (8.75 ± 2.30). The difference was statistically significant ( t=-5.51, P<0.01). The total score of BBS in the experimental group was (38.83 ± 1.71), which was higher than that in the control group (30.89 ± 1.93). The difference was statistically significant ( t=16.43, P<0.01). Conclusions:Sensorimotor training can improve the level of balance, cognitive function and reduce the risk of falls in elderly patients with schizophrenia.