There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Eustachian Tube ; abnormalities ; surgery ; Humans ; Laser Therapy ; Male ; Middle Aged ; Prosthesis Implantation ; Stents ; Tympanoplasty

Objective To assess the aorta elastic properties in the procession of atherosclerosis by ultra‐high frequency ultrasound ,and to detect the relationship between the aorta elastic properties and the atherosclerotic plaque burden .Methods Mice deficient for the apolipoprotein E (ApoE‐/‐) with high‐cholestrol diet were studied as an age‐dependent model of atherosclerosis .At 8 ,16 ,24 and 32 weeks of age , the blood pressure in the ascending aorta was measured by catheter ,and the aorta mechanical properties were assessed by measuring aortic elastic modulus of the ascending aorta with ultra‐high frequency ultrasound .The plaque burden was assessed by high‐frequency ultrasound and Masson′s trichrome stain , separately .Results Vessel thickness at the lesion‐prone sites of the lesser curvature of the aorta and the proximal brachiocephalic artery increased with age ,consistent with the Masson′s trichrome staining which showed age‐dependent worsening of atherosclerosis in the mice model .Elastic modulus of the aorta significantly increased from 8 to 32 weeks of age in E‐/‐mice .There was a statistically difference between any two groups .Conclusions With the progression of atherosclerosis and the increased plaque burden ,aorta mechanical properties deteriorated in Apo E‐/‐mice .Ultra‐high frequency ultrasound was a potential tool for assessment of plaque burden and aorta mechanical properties in mouse model .

CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research ; standards ; China ; Clinical Trials as Topic ; standards ; Data Collection ; standards

Objective To evaluate the relationship between carotid plaque neovascularization and coronary heart disease using contrast-enhanced ultrasound. Methods We studied carotid plaques in 312 patients with coronary artery disease by contrast-enhanced ultrasound [51 patients with acute coronary syndrome (ACS) and 261 patients with stable coronary artery disease (sCAD) ]. We analyzed sonographic features of each plaque, including the enhancement intensity of plaque (A value), the ratio of plaque to carotid artery lumen in enhancement intensity (Ratio), plaque thickness and plaque echo (soft plaque, hard plaque, mixed plaque, calcified plaque). Results The average thickness of plaque in patients with ACS and in patients with sCAD had no significant difference in statistics [(2.6±0.4) mm vs (2.9±0.8) mm, t=-1.903, P=0.058) ]. The group with ACS:soft plaque 43 (84.3%, 43/51), mixed plaque 8 (15.7%,8/51), no hard plaque and calcified plaque. And the group with sCAD:soft plaque 174 (66.7%,174/261), hard plaque 19 (7.3%,19/261), mixed plaques 16 (6.1%,16/261), calcified plaque 52 (19.9%,52/261). The percentage of soft plaque in the acute coronary syndrome group was significantly higher than that in stable coronary artery disease group (χ2=6.274,P=0.012). The A value and Ratio in patients with ACS were prominently larger than those in patients with sCAD [ (11.3±3.2) vs (8.9±3.3) dB, t=7.150,P<0.01;0.6±0.2 vs 0.4±0.2, t=7.419,P<0.01].Conclusion Carotid artery plaque neovascularization density was significantly higher in patients with ACS than that in patients with sCAD by using contrast-enhanced ultrasound, revealing that the neovascularization density is closely related to clinical symptoms of patients with coronary heart disease.

Objective To investigate the prevalence and incidence of Keshan disease (KD) and the selenium concentration of food and hair in residents of Yongjin Village, Fuyu County, Heilongjiang Province, national monitoring site, in 2007. Methods According to the Standard of Keshan Disease Surveillance and the Standard of Diagnosis of Keshan Disease(GB 17021-1997), the residents living in the monitoring site were surveyed by clinical examination and electrocardiography. For individuals whose hearts showed abnormalities, a chest X-ray photograph was taken. The selenium concentrations of the residents' food (flour) and hair were assayed by flowing injection hydride generation atomic fluoremetric method(FI-HG-AFM). Results Nineteen KD patients were found from 282 residents in 2007 KD surveillance. The prevalence of KD, latent KD and chronic KD were 6.7%(19/282), 2.8%(8/282) and 3.9%(11/282), respectively. Five of the 8 latent KD cases were newly found. In addition, there were 5 the suspected KD cases, including 2 suspected chronic KD cases. No acute KD or sub-acute KD patients were found in Yongjin Village at this monitoring site this year. The average selenium concentration of children hair and residents food were (0.3197±0.0586)mg/kg and (0.0210±0.0062)mg/kg, respectively. Conclusions New cases of KD continued to emerge, indicating that etiological factors still exist. Therefore, the emphasis of monitoring KD in furore is founding the consummate report of infectious disease system and training the personnel to increase the reliability of monitoring.

OBJECTIVETo evaluate the effect of meatoplasty with the pedicle flap in the treatment of meatal stenosis secondary to chronic balanitis.

METHODSWe retrospectively analyzed 32 cases of meatal stenosis secondary to chronic balanitis treated by meato- plasty with the pedicle flap. All the patients had a history of chronic balanitis and had received meatal dilatation or simple ventral mea- totomy without significant effect. Their mean maximum urinary flow rate (Qmax) was (4.3 ± 2.4) ml/s. During the operation, A "/\"-shaped incision was made in the healthy epidermis and a flap was harvested from the frenulum. After complete removal of the scar, the flap was placed into the urethral wall, followed by reconstruction of the external urethral orifice.

RESULTSThe patients were fol- lowed up for 6 to 30 months, which revealed smooth urination in all the patients with Qmax of (26.7 ± 4.5) ml/s and normal erectile function and uresiesthesis.

CONCLUSIONWith little invasiveness and few complications, meatoplasty with the pedicle flap is an ideal surgical method for the treatment of meatal stenosis secondary to chronic balanitis. However, there might be some change in the normal appearance of the balanus postoperatively, and its long-term effect needs further observation.

Balanitis ; complications ; Constriction, Pathologic ; etiology ; surgery ; Dilatation ; Humans ; Male ; Postoperative Period ; Reconstructive Surgical Procedures ; Retrospective Studies ; Surgical Flaps ; Urethra ; surgery ; Urethral Stricture ; etiology ; surgery ; Urination

BACKGROUNDPostural orthostatic tachycardia syndrome (POTS) is a common clinical problem in children and adolescents. The previous diagnostic approach to POTS of children and adolescents is based on a series of tests to exclude all other causes, which is time and medical resource consuming. Recently, a new diagnostic approach has been developed. The present study was designed to statistically analyze the results of clinical investigation items and the cost for the diagnosis of POTS in children patients, and evaluate cost changes in the diagnosis of POTS.

METHODSA total of 315 children patients were divided into two groups according to diagnosis period, including group I diagnosed in 2002 - 2006 (100 cases) and group II in 2007 - 2010 (215 cases) and the diagnostic item-based distribution of the cost was analyzed. The diagnostic costs were compared between two groups using SPSS17.0.

RESULTSThe per-capita cost of diagnosis in group I was (621.95 ± 21.10) Yuan, costs of diagnostic tests (head-up tilt test, standing test, etc) accounted for 8.68% and the exclusive tests for 91.32%. The per-capita cost of diagnosis in group II was (542.69 ± 23.14) Yuan, diagnostic tests accounted for 10.50% and exclusive tests for 89.50%. Comparison of the total cost of diagnostic tests between the two groups showed significant differences (P < 0.05).

CONCLUSIONThe cost of POTS diagnosis has been declined in recent years, but the cost of exclusive diagnosis is still its major part.

Adolescent ; Asian Continental Ancestry Group ; Child ; Child, Preschool ; Diagnostic Tests, Routine ; economics ; Female ; Humans ; Male ; Postural Orthostatic Tachycardia Syndrome ; diagnosis ; economics ; Public Health ; economics

OBJECTIVETo observe effects of acupuncture plus acupoint sticking of Migudan on bone mass density (BMD) and pain in the patient of primary osteoporosis.

METHODSBy computer random number generating method, the patients were randomly divided into a treatment group treated with acupuncture plus acupoint sticking of Migudan, and a control group treated with Gaitianli, 48 cases in each group. Changes of their BMD and cumulative scores of pain after treatment were investigated.

RESULTSAcupuncture plus acupoint sticking of Migudan could relieve cumulative score of bone pain in the patient of primary osteoporosis as compared with the control group (P 0.01), with 95% CI= 4.05 to approximately 4. 31 points; acupuncture plus acupoint sticking of Migudan could increase significantly BMD in the patients as compared with the control group (P < 0.05), L2 to approximately L4 BMD 95% CI = 0.029 to approximately 0.073 g/cm2, the neck of femur BMD 95% CI = 0.013 to approximately 0.047 g/cm2.

CONCLUSIONAcupuncture plus acupoint sticking of Migudan has definite therapeutic effect on primary osteoporosis.

Acupuncture Points ; Acupuncture Therapy ; Femur ; Humans ; Musculoskeletal Pain ; Osteoporosis

OBJECTIVETo assessment result with multi-measures operation for adhering otitis media.

METHODSA retrospective review of 108 cases (male 45, female 63), double ears 12, all was 120 ears. Of 20 ears had been radical operated for cholesteatoma some years ago. Of 46 ears had incorporate cholesteatoma now. Of 54 ears had only adhering in middle ear but no had been radical or incorporate cholesteatoma who underwent operation from January 1999 to May 2003 for chronic ear disease as well as ossiculoplasty with multi-technique measures (for example auto-bone cup-pole or gung-pole as total and partial ossicular replacement prostheses; scute rebuild by auto-bone; absorbable Metrogel; tympanic chorda nerve as a spring press prostheses etc) were used in operation, and were followed up mean (26.11 +/- 11.31) months (range 12 approximately 53 months).

RESULTSOne hundred and twenty ears mean AB gap was (38.60 +/- 12.70) dB pre-operation. It was (15.28 +/- 11.69) dB post-operation. Partnership t test, t = 21.24, t 0.01 = 2.60 < 21.24, P < 0.01. The air-bone gap (AB gap) closure to within 20 dB as succeed achieved in 70% (84 ears). AB gap closure in 10 dB as best result in 40% (48 ears). Air conduction was under 40 dB in 70% (83 ears). AB gap closure not enough 10 dB and Air conduction over 40 dB as no effect was 6% (7 ears) .

CONCLUSIONSAs long as technique measures is right, even though adhering middle ear had much difficult in operation, it still can gain succeed to 70%. But had still 30% no succeed, more study is necessary.

Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Otitis Media with Effusion ; pathology ; surgery ; Retrospective Studies ; Tissue Adhesions ; pathology ; surgery ; Treatment Outcome ; Tympanoplasty ; Young Adult