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author:("Wang, duolang")
1.  Predictors for neonatal death in the rural areas of Shaanxi Province of Northwestern China: a cross-sectional study 
BMC Public Health  2015;15:387.
Almost all (99%) neonatal deaths arise in low-income and middle-income countries. Approximately 450 new-born children die every hour, which is mainly from preventable causes. There has been increased recognition of the need for these countries to implement public health interventions that specifically target neonatal deaths. The purpose of this paper is to identify the predictors of neonatal death in Type 4 rural (poorest) counties in Shaanxi Province of northwestern China.
A cross-sectional study was conducted in Shaanxi Province, China. A single-stage survey design was identified to estimate standard errors. Because of concern about the complex sample design, the data were analysed using multivariate logistic regression analysis. Socioeconomic and maternal health service utilization factors were added into the model.
During the study period, a total of 4750 women who delivered in the past three years were randomly selected for interview in the five counties. There were 4880 live births and 54 neonatal deaths identified. In the multiple logistic regression, the odds of neonatal death was significantly higher for multiparous women (OR = 2.77; 95% CI: 1.34, 5.70) and women who did not receive antennal health care in the first trimester of pregnancy (OR = 2.49; 95% CI: 1.41, 4.40). Women who gave birth in a county-level hospital (OR = 0.18; 95% CI: 0.04, 0.86) and had junior high school or higher education level (OR = 0.20; 95% CI: 0.05, 0.84) were significantly protected from neonatal death.
Public health interventions directed at reducing neonatal death should address the socioeconomic factors and maternal health service utilization, which significantly influence neonatal mortality in rural China. Multipara, low educational level of the women, availability of prenatal visits in the first trimester of pregnancy and hospital delivery should be considered when planning the interventions to reduce the neonatal mortality in rural areas.
PMCID: PMC4403673  PMID: 25887409
Predictors; Neonate mortality; Rural China
2.  Randomized Trial of Complete Versus Lesion-Only Revascularization in Patients Undergoing Primary Percutaneous Coronary Intervention for STEMI and Multivessel Disease 
The optimal management of patients found to have multivessel disease while undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction is uncertain.
CvLPRIT (Complete versus Lesion-only Primary PCI trial) is a U.K. open-label randomized study comparing complete revascularization at index admission with treatment of the infarct-related artery (IRA) only.
After they provided verbal assent and underwent coronary angiography, 296 patients in 7 U.K. centers were randomized through an interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization (n = 146). Complete revascularization was performed either at the time of P-PCI or before hospital discharge. Randomization was stratified by infarct location (anterior/nonanterior) and symptom onset (≤3 h or >3 h). The primary endpoint was a composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months.
Patient groups were well matched for baseline clinical characteristics. The primary endpoint occurred in 10.0% of the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45; 95% confidence interval: 0.24 to 0.84; p = 0.009). A trend toward benefit was seen early after complete revascularization (p = 0.055 at 30 days). Although there was no significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups.
In patients presenting for P-PCI with multivessel disease, index admission complete revascularization significantly lowered the rate of the composite primary endpoint at 12 months compared with treating only the IRA. In such patients, inpatient total revascularization may be considered, but larger clinical trials are required to confirm this result and specifically address whether this strategy is associated with improved survival. (Complete Versus Lesion-only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605)
PMCID: PMC4359051  PMID: 25766941
complete revascularization; non-infarct-related lesion; primary percutaneous coronary angioplasty; FFR, fractional flow reserve; HF, heart failure; IRA, infarct-related artery; MACE, major adverse cardiac event(s); MI, myocardial infarction; MPS, myocardial perfusion scintigraphy; N-IRA, non–infarct-related artery; PCI, percutaneous coronary intervention; P-PCI, primary percutaneous coronary intervention; STEMI, ST-segment elevation myocardial infarction
3.  Probiotics in the prevention of eczema: a randomised controlled trial 
Archives of Disease in Childhood  2014;99(11):1014-1019.
To evaluate a multistrain, high-dose probiotic in the prevention of eczema.
A randomised, double-blind, placebo-controlled, parallel group trial.
Antenatal clinics, research clinic, children at home.
Pregnant women and their infants.
Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo.
Main outcome measure
Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years.
The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91).
The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood.
Trial registration Number
PMCID: PMC4215350  PMID: 24947281
Allergy; Microbiology; Dermatology
4.  Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson’s disease (SMART-PD): study protocol for a randomised controlled trial (v7; 15 August 2014) 
Trials  2014;15:374.
Nonadherence to treatment leads to suboptimal treatment outcomes and enormous costs to the economy. This is especially important in Parkinson’s disease (PD). The progressive nature of the degenerative process, the complex treatment regimens and the high rates of comorbid conditions make treatment adherence in PD a challenge. Clinicians have limited face-to-face consultation time with PD patients, making it difficult to comprehensively address non-adherence. The rapid growth of digital technologies provides an opportunity to improve adherence and the quality of decision-making during consultation. The aim of this randomised controlled trial (RCT) is to evaluate the impact of using a smartphone and web applications to promote patient self-management as a tool to increase treatment adherence and working with the data collected to enhance the quality of clinical consultation.
A 4-month multicentre RCT with 222 patients will be conducted to compare use of a smartphone- and internet-enabled Parkinson’s tracker smartphone app with treatment as usual for patients with PD and/or their carers. The study investigators will compare the two groups immediately after intervention. Seven centres across England (6) and Scotland (1) will be involved. The primary objective of this trial is to assess whether patients with PD who use the app show improved medication adherence compared to those receiving treatment as usual alone. The secondary objectives are to investigate whether patients who receive the app and those who receive treatment as usual differ in terms of quality of life, quality of clinical consultation, overall disease state and activities of daily living. We also aim to investigate the experience of those receiving the intervention by conducting qualitative interviews with a sample of participants and clinicians, which will be administered by independent researchers.
Trial registration
ISRCTN45824264 (registered 5 November 2013)
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-374) contains supplementary material, which is available to authorized users.
PMCID: PMC4283131  PMID: 25257518
Long-term conditions; m-health; Mobile application; Parkinson’s disease; Self-management
5.  The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial 
Trials  2014;15:300.
Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation (TAVI).
The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial is a randomized, controlled open-label trial of 310 patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention (PCI - test arm) or no PCI (control arm). Significant coronary disease is defined as ≥1 lesion of ≥70% severity in a major epicardial vessel or 50% in a vein graft or protected left main stem lesion. The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI, with a composite primary outcome of 12-month mortality and rehospitalization. Secondary outcomes include efficacy end-points such as 30-day mortality, safety endpoints including bleeding, burden of symptoms, and quality of life (assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire).
In conclusion, we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the 50% severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique.
Trial registration
ISRCTN75836930, (registered 19 November 2011).
PMCID: PMC4132914  PMID: 25059340
Transcatheter aortic valve implantation; Percutaneous coronary intervention; Aortic stenosis; Coronary
6.  The effect of interleukin-1 receptor antagonist therapy on markers of inflammation in non-ST elevation acute coronary syndromes: the MRC-ILA Heart Study 
European Heart Journal  2014;36(6):377-384.
Acute coronary syndromes (ACSs) are driven by inflammation within coronary plaque. Interleukin-1 (IL-1) has an established role in atherogenesis and the vessel-response to injury. ACS patients have raised serum markers of inflammation. We hypothesized that if IL-1 is a driving influence of inflammation in non-ST elevation ACS (NSTE-ACS), IL-1 inhibition would reduce the inflammatory response at the time of ACS.
Methods and results
A phase II, double-blinded, randomized, placebo-controlled, study recruited 182 patients with NSTE-ACS, presenting <48 h from onset of chest pain. Treatment was 1:1 allocation to daily, subcutaneous IL-1receptor antagonist (IL-1ra) or placebo for 14 days. Baseline characteristics were well matched. Treatment compliance was 85% at 7 days. The primary endpoint (area-under-the-curve for C-reactive protein over the first 7 days) was: IL-1ra group, 21.98 mg day/L (95%CI 16.31–29.64); placebo group, 43.5 mg day/L (31.15–60.75) (geometric mean ratio = 0.51 mg/L; 95%CI 0.32–0.79; P = 0.0028). In the IL-1ra group, 14-day achieved high-sensitive C-reactive protein (P < 0.0001) and IL-6 levels (P = 0.02) were lower than Day 1. Sixteen days after discontinuation of treatment (Day 30) high-sensitive C-reactive protein levels had risen again in the IL-1ra group [IL-1ra; 3.50 mg/L (2.65–4.62): placebo; 2.21 mg/L (1.67–2.92), P = 0.022]. MACE at Day 30 and 3 months was similar but at 1 year there was a significant excess of events in the IL-1ra group.
IL-1 drives C-reactive protein elevation at the time of NSTE-ACS. Following 14 days IL-1ra treatment inflammatory markers were reduced. These results show the importance of IL-1 as a target in ACS, but also indicate the need for additional studies with anti-IL-1 therapy in ACS to assess duration and safety.
Clinical Trial Registration
EUCTR: 2006-001767-31-GB:
PMCID: PMC4320321  PMID: 25079365
Myocardial infarction; Drugs; Interleukins
7.  Local versus general anesthesia for transcatheter aortic valve implantation (TAVR) – systematic review and meta-analysis 
BMC Medicine  2014;12:41.
The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve Implantation (TAVR).
TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported.
This is a systematic review and meta-analysis comparing MAC versus GA in patients undergoing transfemoral TAVR. Trials were identified through a literature search covering publications from 1 January 2005 through 31 January 2013. The main outcomes of interest of this literature meta-analysis were 30-day overall mortality, cardiac-/procedure-related mortality, stroke, myocardial infarction, sepsis, acute kidney injury, procedure time and duration of hospital stay. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.
Seven observational studies and a total of 1,542 patients were included in this analysis. None of the studies were randomized. Compared to GA, MAC was associated with a shorter hospital stay (-3.0 days (-5.0 to -1.0); P = 0.004) and a shorter procedure time (MD -36.3 minutes (-58.0 to -15.0 minutes); P <0.001). Overall 30-day mortality was not significantly different between MAC and GA (RR 0.77 (0.38 to 1.56); P = 0.460), also cardiac- and procedure-related mortality was similar between both groups (RR 0.90 (0.34 to 2.39); P = 0.830).
These data did not show a significant difference in short-term outcomes for MAC or GA in TAVR. MAC may be associated with reduced procedural time and shorter hospital stay. Now randomized trials are needed for further evaluation of MAC in the setting of TAVR.
PMCID: PMC4022332  PMID: 24612945
TAVR; Local anesthesia; General anesthesia; Aortic stenosis
8.  A win ratio approach to comparing ordinal or non-normal outcomes in clinical trials 
Trials  2013;14(Suppl 1):O47.
PMCID: PMC3981646
9.  Sample size determination for clinical research 
Calculating the sample size is a most important determinant of statistical power of a study. A study with inadequate power, unless being conducted as a safety and feasibility study, is unethical. However, sample size calculation is not an exact science, and therefore it is important to make realistic and well researched assumptions before choosing an appropriate sample size accounting for dropouts and also including a plan for interim analyses during the study to amend the final sample size.
PMCID: PMC3838318  PMID: 24367769
randomized control trials; statistics; sample size
10.  Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QTc interval in healthy volunteers 
The study was performed to assess the safety of strontium ranelate in accordance with the ICH, E14 guidelines for QT/QTc studies. Its primary objective was to compare supratherapeutic repeated dosing of strontium ranelate (4 g day−1 for 15 days) with placebo on the largest time-matched mean QTc variation, from baseline to under treatment values, in healthy subjects.
Ninety-six healthy male and female subjects (27.7 ± 7.5 years) were included to receive 1 day of placebo followed by 15 days of supratherapeutic repeated dosing of strontium ranelate (4 g day−1), in a 4 month, randomized, placebo (16 days) and positive-controlled (single dose of moxifloxacin 400 mg preceded by 15 days of placebo), double-blind, double dummy, crossover design. Measurement of QT interval was performed automatically on the ECGs with subsequent manual onscreen over-reading by cardiologists using electronic callipers.
The largest time-matched difference in QTcI (individual QT correction for heart rate) between moxifloxacin 400 mg and placebo was observed at 2 h post dose (mean [95% CI] 10.62 [7.90, 13.35] ms). For strontium ranelate (4 g day−1) the largest time-matched difference in QTcI compared with placebo was observed at 1 h post dose (mean [90% CI] 7.54 [5.17, 9.90] ms). No subject had a QTc greater than 480 ms during the study. Both moxifloxacin and strontium ranelate were well tolerated in healthy subjects.
The findings of this study demonstrate that the administration of supratherapeutic repeated oral doses of strontium ranelate (4 g day−1 for 15 days) does not lead to a prolongation of the QT/QTc interval above the threshold of regulatory concern.
PMCID: PMC3630749  PMID: 22283848
clinical trial; healthy subject; moxifloxacin; QTc; QTcI; strontium ranelate
11.  Assessment of maternal anemia in rural Western China between 2001 and 2005: a two-level logistic regression approach 
BMC Public Health  2013;13:366.
There are multiple adverse effects of anemia on human function, particularly on women. However, few researches are conducted on women anemia in rural Western China. This study mainly aims to investigate the levels and associated factors of maternal anemia between 2001 and 2005 in this region.
6172 and 5372 mothers with children under three years old were selected from 8 provinces in 2001 and from 9 provinces in 2005 respectively in Western China by means of a multi-stage probability proportion to size sampling method (PPS). The blood samples were tested and related socio-demographic information was obtained through questionnaires. A two-level logistic regression model was employed to identify the determinants and provincial variations of women anemia in 2001 and 2005.
The results indicated that the crude prevalence of women anemia in 2005 was higher than the rate in 2001(45.7% vs 33.6%). Based on the nationwide census data in 2000, the age-standardized prevalence of women anemia in the study were obtained as 38.0% in 2001 and 50.0% in 2005 respectively. Two-level logistic model analysis showed that compared to the average, women were more likely to be anemic in Guangxi and Qinghai in 2001 as well as in Chongqing and Qinghai in 2005; that women from Minority groups had higher odds of anemia in contrast with Han; that women with higher parity, longer breastfeeding duration and higher socioeconomic level had a lower rate of anemia, while age of women was positively associated with anemia. The positive correlation between women anemia and altitude was also observed.
The study demonstrated that the burden of maternal anemia in rural Western China increased considerably between 2001 and 2005. The Chinese government should conduct integrated interventions on anemia of mothers in this region.
PMCID: PMC3637149  PMID: 23597320
12.  Oral rehydration salt use and its correlates in low-level care of diarrhea among children under 36 months old in rural Western China 
BMC Public Health  2013;13:238.
Since 2000, there has been a decline in the proportion of oral rehydration salts (ORS) therapy in childhood diarrhea. How to sustain and achieve a high level of ORS therapy continues to be a challenge.
The data of 14112 households and 894 villages in 45 counties across 10 provinces of Western China were collected in 2005. Generalized estimated equation logistic regression models were used to identify the determinants of ORS use in home-based and village-level care.
The therapy rate of ORS was 34.62%. This rate in home-based care (HBC) was significantly lower than that in village-level care (VLC), township-level care or county-level-or-above care. The children in the families with several pre-school-aged children (OR = 0.29 95% CI: 0.10, 0.86) or of the smaller age (12 vs 36 months: OR = 0.10 95% CI 0.02, 0.41; 24 vs 36 months: OR = 0.26 95% CI 0.09, 0.77) were less likely to receive ORS therapy against diarrhea in HBC. The children whose family had the habit of drinking boiled water (OR = 2.77 95% CI 1.30-5.91), or whose caretakers received educational materials about childhood diseases (OR = 3.08 95% CI 1.54, 6.16), or who were living in the villages in which village clinics had the available ORS packages (OR = 3.94 95% CI 2.25, 6.90) were more likely to receive ORS therapy against diarrhea in VLC.
There thus, ORS promoting program should give the highest priority to home care. ORS promoting strategies for low-level care could be strengthened based on children characteristics, the habit of drinking water and the situation of receiving educational material in the families and on the availability of ORS packages in village clinics in rural Western China.
PMCID: PMC3606826  PMID: 23506435
13.  Effect of a plant sterol, fish oil and B vitamin combination on cardiovascular risk factors in hypercholesterolemic children and adolescents: a pilot study 
Nutrition Journal  2013;12:7.
Assessment of cardiovascular disease (CVD) risk factors can predict clinical manifestations of atherosclerosis in adulthood. In this pilot study with hypercholesterolemic children and adolescents, we investigated the effects of a combination of plant sterols, fish oil and B vitamins on the levels of four independent risk factors for CVD; LDL-cholesterol, triacylglycerols, C-reactive protein and homocysteine.
Twenty five participants (mean age 16 y, BMI 23 kg/m2) received daily for a period of 16 weeks an emulsified preparation comprising plant sterols esters (1300 mg), fish oil (providing 1000 mg eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA)) and vitamins B12 (50 μg), B6 (2.5 mg), folic acid (800 μg) and coenzyme Q10 (3 mg). Atherogenic and inflammatory risk factors, plasma lipophilic vitamins, provitamins and fatty acids were measured at baseline, week 8 and 16.
The serum total cholesterol, LDL- cholesterol, VLDL-cholesterol, subfractions LDL-2, IDL-1, IDL-2 and plasma homocysteine levels were significantly reduced at the end of the intervention period (p<0.05). The triacylglycerols levels decreased by 17.6%, but did not reach significance. No significant changes in high sensitivity C-reactive protein, HDL-cholesterol and apolipoprotein A-1 were observed during the study period. After standardisation for LDL cholesterol, there were no significant changes in the levels of plasma γ-tocopherol, β-carotene and retinol, except for reduction in α-tocopherol levels. The plasma levels of n-3 fatty acids increased significantly with the dietary supplementation (p<0.05).
Daily intake of a combination of plant sterols, fish oil and B vitamins may modulate the lipid profile of hypercholesterolemic children and adolescents.
Trial registration
Current Controlled Trials ISRCTN89549017
PMCID: PMC3549748  PMID: 23297818
Cholesterol; Plant sterols; Fish oil; B vitamins; Children; Adolescents
14.  Care-Seeking Pattern for Diarrhea among Children under 36 Months Old in Rural Western China 
PLoS ONE  2012;7(8):e43103.
To explore the caretakers' care-seeking pattern and its determinants among children under 36 months old with diarrhea in rural western China.
The data of 14112 households was collected in 45 counties of 10 provinces of western China from June to August 2005. A generalized estimated equation (GEE) linear model was used to identify the determinants of the care-seeking.
Village-level and township-level care were sought for childhood diarrhea by 67.02% of the caretakers. GEE model analysis shows that compared with the caretakers of the children delivered at county-level or above hospitals, those of the children delivered at home seldom sought a higher level care (−0.23, 95%CI: −0.45,−0.01, p = 0.040); that the age of the children was negatively associated with seeking a higher level care (12 vs 36 months: 0.35, 95%CI: 0.16,0.55, p<0.001; 24 vs 36 months: 0.26, 95%CI: 0.08,0.44, p = 0.004); that the more danger signs of diarrhea the caretakers recognized, the higher level care they sought for their children with diarrhea (0.04, 95%CI: 0.00,0.07, p = 0.037); that the children with breastfeeding were given a higher level care than those without (0.15, 95%CI: 0.01,0.28, p = 0.035); that the mothers with a higher education sought the higher level care than those with only primary education (0.29, 95%CI: 0.03,0.56, p = 0.032); and that the farther the villages where these caretakers lived were from their townships, the lower level care for their children with diarrhea they sought (−0.09, 95%CI: −0.18,−0.01, p = 0.039).
Village-level and township-level care were sought for childhood diarrhea by most of the caretakers. Birth settings, the distance from village to township, maternal education, caretakers' awareness of the danger signs of diarrhea, breastfeeding status and age of children affected the care-seeking. These findings may have some implications for the improvement of health care services and care-seeking intervention against childhood diarrhea in rural western China.
PMCID: PMC3422327  PMID: 22912799
16.  CHAMP: Cognitive behaviour therapy for health anxiety in medical patients, a randomised controlled trial 
BMC Psychiatry  2011;11:99.
Abnormal health anxiety, also called hypochondriasis, has been successfully treated by cognitive behaviour therapy (CBT) in patients recruited from primary care, but only one pilot trial has been carried out among those attending secondary medical clinics where health anxiety is likely to be more common and have a greater impact on services. The CHAMP study extends this work to examine both the clinical and cost effectiveness of CBT in this population.
The study is a randomized controlled trial with two parallel arms and equal randomization of 466 eligible patients (assuming a 20% drop-out) to an active treatment group of 5-10 sessions of cognitive behaviour therapy and to a control group. The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants. Subsequently the control group was to receive whatever care might usually be available in the clinics, which is normally a combination of clinical assessment, appropriate tests and reassurance. Those allocated to the active treatment group were planned to receive between 5 and 10 sessions of an adapted form of cognitive behaviour therapy based on the Salkovskis/Warwick model, in which a set of treatment strategies are chosen aimed at helping patients understand the factors that drive and maintain health anxiety. The therapy was planned to be given by graduate research workers, nurses or other health professionals trained for this intervention whom would also have their competence assessed independently during the course of treatment. The primary outcome is reduction in health anxiety symptoms after one year and the main secondary outcome is the cost of care after two years.
This represents the first trial of adapted cognitive behaviour therapy in health anxiety that is large enough to test not only the clinical benefits of treatment but also whether the cost of treatment is offset by savings from reduced use of other health services in comparison to the control group.
Cognitive behaviour therapy for Health Anxiety in Medical Patients (CHAMP)
Trial registration
Current Controlled Trials ISRCTN14565822
PMCID: PMC3141642  PMID: 21672205
17.  Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers 
To characterize the effects of levofloxacin on QT interval in healthy subjects and the most appropriate oral positive control treatments for International Conference on Harmonization (ICH) E14 QT/QTc studies.
Healthy subjects received a single dose of levofloxacin (1000 or 1500 mg), moxifloxacin (400 mg) or placebo in a four-period crossover design. Digital 12-lead ECGs were recorded in triplicate. Measurement of QT interval was performed automatically with subsequent manual onscreen over-reading using electronic callipers. Blood samples were taken for determination of levofloxacin and moxifloxacin concentrations.
Mean QTcI (QT interval corrected for heart rate using a correction factor that is applicable to each individual) was prolonged in subjects receiving moxifloxacin 400 mg compared with placebo. The largest time-matched difference in QTcI for moxifloxacin compared with placebo was observed to be 13.19 ms (95% confidence interval 11.21, 15.17) at 3.5 h post dose. Prolonged mean QTcI was also observed in subjects receiving levofloxacin 1000 mg and 1500 mg compared with placebo. The largest time-matched difference in QTcI compared with placebo was observed at 3.5 h post dose for both 1000 mg and 1500 mg of levofloxacin [mean (95%) 4.42 ms (2.44, 6.39) in 1000 mg and 7.44 ms (5.47, 9.42) in 1500 mg]. A small increase in heart rate was observed with levofloxacin during the course of the study. However, moxifloxacin showed a greater increase compared with levofloxacin.
Both levofloxacin and moxifloxacin can fulfil the criteria for a positive comparator. The ICH E14 guidelines recommend a threshold of around 5 ms for a positive QT/QTc study. The largest time-matched difference in QTc for levofloxacin suggests the potential for use in more rigorous QT/QTc studies. This study has demonstrated the utility of levofloxacin on the assay in measuring mean QTc changes around 5 ms.
PMCID: PMC2848412  PMID: 20406223
clinical trial; healthy subject; levofloxacin; moxifloxacin; QTc
18.  Utilization of delivery care among rural women in china: does the health insurance make a difference? a cross-sectional study 
BMC Public Health  2010;10:695.
Since 2003, the New Cooperative Medical Scheme (NCMS) has been implemented throughout rural China, usually covering delivery services in its benefit package. The objective of this study was to compare the difference of utilization of delivery services, expenditures, and local women's perceived affordability between women with and without reimbursement from NCMS.
A cross-sectional survey was carried out in two rural counties in Shaanxi province, China, during December 2008-March 2009. Women giving birth from April 2008 to March 2009 were interviewed by a structured questionnaire to collect information on utilization of delivery services. Multivariable analyses were used to compare the differences in outcomes between women with and without reimbursement from NCMS.
Of the total 1613 women interviewed, 747(46.3%) got reimbursement to cover their expenditure on delivery care (NCMS group) and 866(53.7%) paid delivery services entirely out of their own pocket (Non-NCMS group). Compared with the Non-NCMS group, the NCMS group had significantly more women who delivered at hospital. The rate of Caesarean section (CS), proportion of women seeking higher level services, and length of hospitalization were similar between the two groups. The total hospital costs for delivery services in the NCMS group was significantly smaller and after being reimbursed, the out-of-pocket payment in the NCMS group was less than a half of that in the Non-NCMS group. Fewer women in the NCMS group than in the Non-NCMS group considered their payment for delivery services expensive.
There was no evidence of overuse delivery services among the women reimbursed by NCMS. Total hospital costs and women's costs for delivery services were found lower in the NCMS group, subsequently alleviation on women's perceived financial affordability.
PMCID: PMC3091584  PMID: 21073757
19.  The evaluation of "Safe Motherhood" program on maternal care utilization in rural western China: a difference in difference approach 
BMC Public Health  2010;10:566.
Maternal care is an important strategy for protection and promotion of maternal and children's health by reducing maternal mortality and improving the quality of birth. However, the status of maternal care is quite weak in the less developed rural areas in western China. It is found that the maternal mortality rates in some western areas of China were 5.8 times higher than those of their eastern costal counterparts. In order to reduce the maternal mortality rates and to improve maternal care in western rural areas of China, the Chinese Ministry of Health (MOH) and the United Nations Children's Fund (UNICEF) sponsored a program named "Safe Motherhood" in ten western provinces of China from 2001 through 2005. This study mainly aims to evaluate the effects of "Safe Motherhood" program on maternal care utilization.
32 counties were included in both surveys conducted in 2001 and 2005, respectively. Ten counties of which implemented comprehensive community-based intervention were used as intervention groups, while 22 counties were used as control groups. Stratified 3-stage probability-proportion-to-size sampling method was used to select participating women. Two cross-sectional surveys were conducted with questionnaires about the prenatal care utilization in 2001 and 2005, respectively. Difference in difference estimation was used to assess the effect of intervention on the maternal care utilization while controlling for socio-economic characteristics of women.
After the intervention, the proportion of pregnant women who had their first prenatal visit in the first trimester was increased from 38.9% to 76.1%. The proportion of prenatal visits increased from 82.6% to 98.3%. The proportion of women mobilized to deliver in hospitals increased from 62.7% to 94.5%. Hospital delivery was improved greatly from 31.1% to 87.3%. The maternal mortality rate was lowered by 34.9% from 91.76 to 59.74 per 100,000 live births. The community-based intervention had increased prenatal visits rate by 5.2%, first prenatal visit in first trimester rate by 12.0% and hospital delivery rate by 22.5%, respectively. No effect was found on rate of women being mobilized to hospital delivery compared with that of the control group.
The intervention program seemed to have improved the prenatal care utilization in rural western China.
PMCID: PMC2946300  PMID: 20858285
20.  Liver function abnormalities and outcome in patients with chronic heart failure: data from the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) program 
European Journal of Heart Failure  2009;11(2):170-177.
The prevalence and importance of liver function test (LFT) abnormalities in a large contemporary cohort of heart failure patients have not been systematically evaluated.
Methods and results
We characterized the LFTs of 2679 patients with symptomatic chronic heart failure from the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity program (CHARM). We used multivariable modelling to assess the relationships between baseline LFT values and long-term outcomes. Liver function test abnormalities were common in patients with chronic heart failure, ranging from alanine aminotransferase elevation in 3.1% of patients to low albumin in 18.3% of patients; total bilirubin was elevated in 13.0% of patients. In multivariable analysis, elevated total bilirubin was the strongest LFT predictor of adverse outcome for both the composite outcome of cardiovascular death or heart failure hospitalization (HR 1.21 per 1 SD increase, P < 0.0001) and all-cause mortality (HR 1.19 per 1 SD increase, P < 0.0001). Even after adjustment for other variables, elevated total bilirubin was one of the strongest independent predictors of poor prognosis (by global chi-square).
Bilirubin is independently associated with morbidity and mortality. Changes in total bilirubin may offer insight into the underlying pathophysiology of chronic heart failure.
PMCID: PMC2639422  PMID: 19168515
Heart failure; Bilirubin; Liver function tests; Hepatic congestion; Prognosis; Death; Laboratory tests
21.  Serum Aβ Levels as Predictors of Conversion to Mild Cognitive Impairment/Alzheimer Disease in an ADAPT Subcohort 
Molecular Medicine  2009;15(11-12):432-437.
Recent evidence suggests an association of β-amyloid (Aβ) with vascular risk factors and the medications to treat them, which could potentially obfuscate the usefulness of Aβ for prediction of mild cognitive impairment (MCI) or Alzheimer disease (AD). In a subcohort from the Alzheimer’s Disease Anti-inflammatory Prevention Trial (enriched for family history of AD), we investigated whether systolic blood pressure, total cholesterol, triglycerides, serum creatinine, apolipoprotein E, and use of statins and antihypertensives influenced the predictive value of serum Aβ for MCI/AD during a 2-year period. We collected blood samples to quantify serum Aβ from cognitively normal participants (n = 203) at baseline and ascertained the outcome of MCI/AD (n = 24) for a period of approximately 2 years. In an unadjusted model, the lowest quartile of Aβ1–42 (hazard ratio [HR] = 2.93, 95% CI [1.02–8.32], P = 0.04) and of the Aβ1–42/Aβ1–40 ratio (HR = 3.53, 95% CI [1.24–10.07], P = 0.02), compared with the highest quartile, predicted conversion to MCI/AD, but no impact of Aβ1–40 was observed. No relationship between nonsteroidal antiinflammatory drug interventions and Aβ on MCI/AD risk was evident. Once data were adjusted for potential confounders (age, sex, and education), vascular risk factors, and the medications listed above, the lowest quartiles of Aβ1–42 (HR = 4.47, 95% CI [1.39–14.39], P = 0.01), and of the Aβ1–42/Aβ1–40 ratio (HR 4.87, 95% CI [1.50–15.87], P = 0.01) became strong predictors of conversion to MCI/AD. In this subcohort of individuals at risk for AD, the association of Aβ with vascular risk factors and medications to treat these conditions did not interfere with Aβ’s predictive value for MCI/AD.
PMCID: PMC2730348  PMID: 19707525
22.  Hemoglobin levels and anemia evaluation during pregnancy in the highlands of Tibet: a hospital-based study 
BMC Public Health  2009;9:336.
Anemia is regarded as a major risk factor for unfavorable pregnancy outcomes, but there have been no previous studies describing the pattern of hemoglobin concentration during pregnancy in Tibet and the relationship between altitude and Hb concentration in the pregnant women living in Tibet still has not been clearly established. The main objectives of this study were to study the hemoglobin levels and prevalence of anemia among pregnant women living in the highlands of Tibet and to evaluate potential associations of hemoglobin and anemia with women's characteristics.
The hospital-based study was conducted in 380 pregnant women. Their blood samples were tested and related sociodemographic information was collected. Multiple linear regression model and multiple logistic regression model were used to assess the association of pregnant women's characteristics with hemoglobin level and the occurrence of anemia. Centers for Disease Control (CDC), Dirren et al. and Dallman et al. methods were used to adjust the hemoglobin measurements based on altitude for estimating the prevalence of anemia.
The mean hemoglobin concentration was 127.6 g/L (range: 55.0-190.0 g/L). Prevalence rate of anemia in this study was 70.0%, 77.9% and 41.3%, respectively for three altitude-correction methods for hemoglobin (CDC method, Dirren et al. method, and Dallman et al. method). Gestational age, ethnicity, residence and income were significantly associated with the hemoglobin concentration and prevalence of anemia in the study population. Specially, the hemoglobin concentration of pregnant women decreased with increase in gestational age.
The hemoglobin level was low and prevalence rate of anemia was high among pregnant women in Lhasa, Tibet. Gestational age, ethnicity, residence and income were found to be significantly associated with the hemoglobin level and the occurrence of anemia in the study population.
PMCID: PMC2753353  PMID: 19754927
23.  Evaluation of a portable hemoglobin photometer in pregnant women in a high altitude area: a pilot study 
BMC Public Health  2009;9:228.
Anemia is a widespread public health problem associated with an increased risk of morbidity and mortality, especially in pregnant women. This study examined the agreement between a portable hemoglobin photometer and a laboratory analyzer in determining hemoglobin level in pregnant women.
This study recruited 69 pregnant women in Tibet, China. Capillary blood samples were taken to measure hemoglobin concentration using the hemoglobin photometer and the laboratory analyzer. Limit of agreement, concordance and intraclass correlation coefficient were used to evaluate the agreement. Laboratory measurement was considered as the standard reference method. Sensitivity and specificity were calculated to assess the error in screening for anemia.
Mean difference between the two methods was -2.1 g/l. wide 95% limits of agreement were found (-22.6 g/l to 18.4 g/l). The intraclass correlation coefficient was 0.795, and concordance correlation coefficient was 0.793. Sensitivity and specificity were 94.9% and 76.7% respectively. Positive predictive value was 84.1%, and negative predictive value was 92.0%.
This hemoglobin photometer is not recommended for determining hemoglobin concentration in pregnancy in a high altitude area.
PMCID: PMC2717084  PMID: 19591672
24.  A randomised cross-over trial in healthy adults indicating improved absorption of omega-3 fatty acids by pre-emulsification 
Nutrition Journal  2007;6:4.
The health benefits of increased intakes of omega-3 fatty acids are well established but palatability often presents a problem. The process of emulsification is used in the food industry to provide a wider spectrum of use, often with the result of increased consumption. Moreover, as emulsification is an important step in the digestion and absorption of fats, the pre-emulsification process may enhance digestion and absorption. In this study the levels of plasma fatty acid and triacylglycerol (TAG) following the ingestion of either an oil mixture or an emulsified oil mixture have been compared.
In this randomised cross-over study, 13 volunteers received the oil mixture and 11 received the oil emulsion as part of an otherwise fat free meal. Blood samples were collected at 0, 1.5, 3, 4.5, 6, 7.5 and 9 hours after ingestion of oil, separated and stored at -20°C. Plasma triacylglycerols were assessed spectrophotometrically and fatty acids were determined by gas chromatography. Following a washout period of twenty days the procedure was repeated with the assignments reversed.
The postprandial plasma TAG and the C18:3 (n-6), C18:3(n-3), C20:5(n-3) and C22:6 (n-3) polyunsaturated fatty acid (PUFA) levels for the emulsified oil group were increased significantly (P = 0.0182; P = 0.0493; P = 0.0137; P < 0.0001; P = 0.0355 respectively) compared with the non-emulsified oil group. The C16:0 and C18:0 saturated fatty acids, the C18:1 (n-9) monounsaturated fatty acid and the C18:2 PUFA were not significantly different for the oil and emulsified oil groups.
Pre-emulsification of an oil mixture prior to ingestion increases the absorption of longer chain more highly unsaturated fatty acids (especially eicosapentaenoic acid and docosahexaenoic acid) but does not affect absorption of shorter chain less saturated fatty acids, suggesting that pre-emulsification of fish oils may be a useful means of boosting absorption of these beneficial fatty acids.
Trial registration: Current Controlled Trials ISRCTN43202606
PMCID: PMC1796891  PMID: 17254329

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