Objective To investigate the Chinese version of Self-perceived Burden Scale(SPBS) for cancer patients.Methods Established the psychometric properties of the Chinese version of SPBS,a convenience sample of 220 patients were recruited for evaluation.Results The Chinese version of SPBS comprised 8 items.Exploratory analysis showed that the most interpretable solution consisted of 2 factors.The accumulative variance contribution which explained 61.004％ of variance of the total scale.Meanwhile,the Cronbach's α coefficient was 0.874.Conclusions It suggests that the 8-item Chinese version of the SPBS has good reliability and validity,which could be used as a tool for measuring cancer patients' burden.

ABSTRACT: Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.

Objective To explore the correlation of mimecan/osteoglycin withnuclear factor koppa B(NF-κB) and P53 in peripheral arterial disease (PAD) and PAD combined with type 2 diabetes in the elderly.Methods 120 patients with PAD and 60 healthy controls were enrolled in this study.PAD patients were divided into PAD group (n=60) and PAD combined with type 2 diabetes group (n =60) according to clinical diagnostic criteria.Patients in PAD group were divided into class Ⅰ (n=15),class Ⅱ (n=15),class Ⅲ (n=15) and class Ⅳ (n=15),and patients in PAD combined with type 2 diabetes group were divided to class Ⅰ (n=14),class Ⅱ (n=15),class Ⅲ (n=16) and class Ⅳ (n=15) according to Fontaine's classification.The levels of NF-κB,P53 and mimecan in peripheral blood were measured by enzyme-linked immunosorbent assay (ELISA).Results The levels of NF-κB,P53 and mimecan were significantly increased in PAD combined with type 2 diabetes group as compared with PAD and control groups [NF-κB..(32.8±5.3) mg/L vs.(19.8±4.2) mg/L,(26.3 ±4.8) mg/L; P53:(3.4±1.3) mg/Lvs.(2.5±1.1) mg/L,(1.4±0.8) mg/L; mimecan:(16.4 ±0.8) mg/L vs.(10.3±0.8) mg/L,(4.8±0.6) mg/L; all P＜0.05].There were significant differences in the levels of NF-κB,P53 and mimecan in class Ⅰ,class Ⅱ,class Ⅲ and class Ⅳ in PAD group [NF-κB:(20.3±3.1) mg/L,(24.5±3.4) mg/L,(28.2±4.6) mg/L and (34.2±5.3) mg/L; P53:(2.2 ±1.8) mg/L,(2.6±1.8) mg/L,(3.3±1.9) mg/L and (3.7±2.7) mg/L;mimecan (8.9±2.6) mg/L,(12.4±1.8) mg/L,(15.6±1.5) mg/L and (17.7±1.6) mg/L; all P ＜0.05].There were significant differences in the levels of NF-κB,P53 and mimecan in class Ⅰ,class Ⅱ,class Ⅲ and class Ⅳ in PAD group combined with type 2 diabetes group [NF-κB:(25.5±4.2) mg/L,(28.8±3.7) mg/L,(33.4±5.6) mg/L and (38.5±4.7) mg/L; P53:(2.5±1.1)mg/L,(2.9±1.0)mg/L,(3.7±1.2)mg/L and(4.6±1.3)mg/L; mimecan:(11.7±2.4)mg/L,(14.9± 1.8)mg/L,(17.4±2.5)mg/L and(20.7±2.8)mg/L; all P＜0.05].The levels of NF-κB,P53 and mimecan was increased with the aggravation of PAD (all P＜0.05).Conclusions The increased levels of NF-κB and P53 are correlated with the increase in mimecan level and Fontaine's classification.

In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.

Objectives To study the predictive value of Toll-like receptors 3,4(TLR3,TLR4),fructosamine(FMN)and glycated hemoglobin A1c(HbA1c)in the in-stent restenosis and re-occlusion after primary percutaneous coronary intervention(PCI)in patients aged 70-85 years with old myocardial infarction.Methods 51 patients aged 70-85 years with in-stent restenosis after primary PCI from Jan 2007 to Sep 2016 were selected.Serum level changes in TLR3,TLR4 were detected by flow cytometry.The levels of FMN and HbA1c were tested by colorimetric endpoint reaction and high-pressure liquid chromatography respectively.Results The levels of TLR3,TLR4,FMN and HbA1c were gradually elevated along with the increases of artery numbers(0,1,2,>2)and percentage(0%,70-89%,90-99%,100%)of in-stent restenosis,LVEF(%)decrease and NYHA(Ⅰ,Ⅱ,Ⅲ,Ⅳ)increase(all P<0.01).The examples of data were selected in the following groups of artery numbers(0,1,2,>2)of in-stent restenosis in TLR3,and group of percentage(0%,70-89%,90-99%,100%)in the in-stent restenosis in TLR4,group of LVEF(%)in FMN,and group of NYHAⅠ,Ⅱ,Ⅲ,Ⅳ in HbA1c(%)(all P<0.01).The levels of TLR3(%)in artery numbers of restenosis(0,1,2,>2)groups were(7.6±0.5),(18.9±0.6),(32.0±0.9),(51.3±0.8),respectively(all P<0.01).The levels of TLR4(%)in the in-stent restenosis percentage(0%,70-89%,90-99%,100%)groups were(10.5±7.0),(20.1±7.2),(33.3±9.7),(69.0±11.3%)respectively(all P<0.01).The levels of FMN(mmol/L)in LVEF[(49~59%),(37~48%),(25~36%)]groups were(0.6±0.4),(9.4±0.6),(18.1±0.8),respectively(all P<0.01).And the level of HbA1c(%)in groups of NYHA Ⅰ,NYHA Ⅱ,NYHA Ⅲ,NYHA Ⅳ were(6.1±0.4),(5.9±0.6),(8.9±0.9),(12.0±0.8),respectively(all P<0.01).Conclusions Serum level changes in TLR3,TLR4,FMN and HbA1c may become the new indicators to forecast the degree of in-stent restenosis in very old patients with old myocardial infarction after primary coronary intervention.

Electronic data management has the advantages of saving cost and research time and improving the data quality, which has gradually been the mainstream form of clinical data collection and management. It is important to improve the quality of Traditional Chinese Medicine (TCM) clinical researches. This paper introduces the function, general style, developing principles and processes, management and training of Standard Operating Procedure (SOP) for electronic clinical data management. The characteristics and difficulties of electronic data management of TCM clinical researches are discussed and suggested solutions are proposed in the end.

Objective To study the changes in expression of high-sensitivity C-reactive protein (hsCRP),glutathione S-transferase Pi(GSTPi)and annexin A5 (AnxA5)in elderly patients with old myocardial infarction and the clinical significance.Methods Serum levels of GSTPi and AnxA5 were measured by ELISA and the level of hs-CRP was measured by immunoturbidimetry in elderly patients with old myocardial infarction (n =185)from December 2012 to November 2015.Results Along with the increasing coronary artery stenosis,GSTPi level was decreased and AnxA5/hs-CRP levels were increased in elderly patients with old myocardial infarction.In comparison between coronary artery stenosis ＞ 95％ group versus stenosis of 55％-65％ group,GSTPi was(190.0±37.0)μg/L vs.(289.0 ±86.0)μg/L,AnxA5 was(33.9±4.0)μg/L vs.(8.1 ± 2.9) μg/L,and hs-CRP was (15.3 ± 1.3) mg/L vs.(5.9 ± 0.8) mg/L with statistically significant differences(all P＜0.01).There were significant differences between LVEF 30％ group[GSTPi(198.0±39.0) μg/L,AnxA5(38.9±5.1)μg/L and hs-CRP(17.9± 1.9)mg/L]and LVEF 40％-54％ group[GSTPi(219.0± 61.0)μg/L,AnxA5 (12.9±3.9)μg/L and hs-CRP(10.1 ± 1.0) mg/L] (all P＜0.01).There were significant differences between NYHA Ⅳ group [GSTPi (171.0 ± 43.0) μg/L,AnxA5 (18.1 ± 5.0) μg/L and hs-CRP (16.9±2.1)mg/L]and NYHAⅠgroup[GSTPi(295.0±91.0)μg/L,AnxA5(7.3±3.1)μg/L and hs-CRP (7.8± 1.3)mg/L](all P＜0.01).Conclusions The expression of GSTPi,AnxA5 and hs-CRP in elderly patients with old myocardial infarction may become the new indicators to forecast the degrees of coronary artery stenosis and heart failure.

Objective:To explore the relationship of risk factors and clinical features to assessments of children with cerebral palsy (CP ) using a magnetic resonance imaging classification system (MRICS).Methods:Medical records of CP patients under 18 years old were reviewed retrospectively. Data including high-risk factors, cranial MRI results and clinical characteristics were collected. The cranial MRI results were classified according to the MRICS.Results:Of 1357 patients studied, 1112 (82%) had received cranial MRI scans. Among them, 962 (86.5%) showed MRI-identified brain abnormalities, 489 in the periventricular white matter. Subjects with different weeks of gestation, birth weights, delivery times, neonatal hypoxic-ischemic encephalopathy, and neonatal cerebral hemorrhage had significantly different MRI classifications according to the system. Premature birth, low birth weight and multiple births correlated with the incidence of white matter brain injury. Only 4 of the subjects with neonatal cerebral hemorrhage were classified as having normal brain structures using the MRICS. However, gender, birth method, and pathological jaundice had no significant relationship with MRICS ratings. Significant differences in MRICS classifications were observed between patients with different CP subtypes, gross motor function scores, as well as with or without epilepsy, speech or language impairment. But degrees of mental retardation were not significantly related with MRICS classifications.Conclusion:MRICS classifications relate closely with risk factors and the clinical characteristics of CP patients. The system can play an important role in finding pathogenesis and predicting clinical outcomes. It is worthy of applying and promoting in the clinic.

Objective To understand the current situation of quality management and implementation of risk-based quality management in clinical trial institutions.Methods In the form of questionnaires,Questionnaire Star was used to create the questionnaire,which was sent to clinical trial organisations in all provinces and cities to fill in through emails and institutional WeChat groups.Results The questionnaire results from 123 clinical trial institutions from 25 provinces were included for analysis.The quality management status was as follows:104(84.6%)institutions of the main quality management mode were the internal quality control by GCP department.On average,each institution had 3、4 full-time staff for quality management,with an average of 1 full-time staff to manage 16.8 projects and 10.9 specialties.In the last three years,65(52.8%)institutions conducted training for researchers 2-3 times/year.Ninety-five(77.2%)institutions had established a clinical trial funding allocation system.Forty-nine(39.2%)institutions had established GCP informatization management system and 44(35.2%)institutions had established risk-based quality management model.In the case of coordination between the clinical trial institution and the sponsor,47(41.2%)institutions did not not aware of the sponsor's/CRO's quality management plan in their collaboration with the sponsor.Conclusion The surveyed institutions have weaknesses,such as insufficient dedicated personnel for quality management,low utilization rate of GCP information systems.The collaborative capacity between clinical trial institutions and sponsors needs to be improved,and the implementation rate of risk-based quality management is also low.