Development and evaluation of a patching treatment questionnaire for Chinese amblyopic children

Background Amblyopia is a common disease for children.The main treatment approach for amblyopia is to patch the normally sighted eye and force the use of the amblyopic eye.However,patching treatment in children may negatively impact psychological well-being of both the child and family.At present,no specific questionnaire is available to assess the health-related quality of life （HRQoL） of amblyopic treatment for children and their families in China.The purpose of our study was to develop a Chinese version of patching treatment questionnaire,and evaluate its reliability and validity.Methods The original patching treatment questionnaire of amblyopia treatment index （ATI） was translated into Chinese.Amblyopic patients aged 4-9 years receiving patching 4-8 hours per day or full-time were recruited.The reliability and validity of the Chinese version of the patching treatment questionnaire were determined by internal consistency,test-retest reliability,item-scale correlations,and construct validity.The associated baseline factors and the questionnaire responses were assessed.Results One hundred and nine children with amblyopia treated with patching were enrolled.Distribution of response options for individual items and correlation with the respective subscale were calculated.Factor analysis revealed that 16 of the 21 items were loaded in the three subscales as follows：＂adverse effects＂ of treatment,“difficulties with compliance＂ and ＂social stigma＂ of treatment.Intemal consistency values measured by Cronbach＇s a coefficient （0.768） and split-half coefficient （0.790） were satisfactory for the total scales.The intra-class correlation coefficient for test-retest reliability was 0.998.No significant difference was found between the overall questionnaire scores and children＇s age,sex,baseline visual acuity of amblyopic eyes,improvement of the amblyopic eye,or patching time.Conclusions We developed a Chinese version of the patching treatment questionnaire with satisfactory reliability and validity.Validation in a patch-treated pediatric amblyopic population indicated that the questionnaire may be useful for Chinese children.     

Reliability and validity of addiction severity index in drug users with methadone maintenance treatment in Guizhou province, China

Objective To evaluate the reliability and validity of the Chinese version of addiction severity index （ASI）-5th version （ASI-C-5）, in illegal drug users receiving methadone maintenance treatment （MMT） in China. Methods One hundred and eighty-six heroin addicts （144 men and 42 women） receivihg MMT at three clinics in Guizhou province, southwest China, were recmited. They were all interviewed with a questionnaire of ASI-C-5 and 35 were re-interviewed at an interval of seven days to assess its test-retest reliability. Results Cronbach＇s alpha for internal consistency of CSs varied from 0.60 to 0.81 in all domains. Test-retest reliability of composite scores （CSs） of ASI-C-5 were satisfactory （r=0.38-0.97）. Based on item analysis and expert＇s suggestions, five items were deleted and one item was modified in ASI-C-5. Criterion validity of ASI-C-5 was found acceptable, as compared to addicts＇ self-rating anxiety scale （SAS） and self-rating depression scale （SDS） （r=0.59 and 0.45） except for social support rating scale （SSRS）. Conclusions ASI-C-5 can be used for heroin addicts receiving MMT with acceptable reliability and validity.     

Original article：A new diagnostic algorithm for vascular cognitive impairment： the proposed criteria and evaluation of its reliability and validity

Background Vascular cognitive impairment （VCI） is considered to be the most common pattern of cognitive impairment. We aimed to devise a diagnostic algorithm for VCI, and evaluate the reliability and validity of our proposed criteria. Methods We based our new algorithm on previous literature, a Delphi consensus method, and preliminary testing. First, successive 100 patients with cerebrovascular disease （CVD） in hospital underwent a structured medical examination. Twenty-five case vignettes fulfilled the proposed criteria of diagnosis for probable or possible VCI were divided into three subtype categories： vascular cognitive impairment, no dementia （VCIND）, vascular dementia （VaD） or mixed VCI/Alzheimer＇s disease （AD）. Inter-raters reliability was assessed using a Fleiss kappa analysis. Convergent validity was also evaluated by correlation coefficients （r） between the proposed key points for each subtype and the currently accepted criteria. Forty-five patients with probable VCI were examined to determine the accuracy of identification for each subtype. Results The proposed criteria showed clinical diagnostic validity for VCI, and were able to define probable, possible and definite VCI, three VCI subtypes, and vascular causes. There was good consensus between experts （Cronbach＇s a=0.96 for both rounds）. Significant moderate to good items-total correlations were found for two questionnaires （50-r range, 0.40-0.97 and 0.41-0.99, respectively）. Significant slight and moderate inter-raters reliability were obtained for VCI （k=0.13） and three VCI subtypes （k=0.45）. Furthermore, good convergent validity was observed in a comparison of significant correlations between criteria： good （4-r range, 0.75-0.92） to perfect （3-r=1.00） validity for the VCIND subtype, and moderate to good validity for the VaD subtype （1-r=0.46; 5-r range, 0.76-0.92） and for the mixed VCI/AD subtype （r=0.92 and 1.00; 4-r range, 0.47-0.70）. Importantly, the area under receiver operating characteristic （ROC） curves for the subtypes of VCIND, VaD and mixed VCI/AD were 0.85, 0.67 and 0.93, respectively. Conclusion Our results suggest that the new VCI diagnostic algorithm might be a suitable clinical approach for assessing stroke patients.     

Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

Objective： The Consolidated Standards for Reporting of Trials （CONSORT） statement has already proved to be an efficient standard for reporting quality of randomized controlled trials （RCTs）. However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods： We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals （Journal type 1） without adoption of CONSORT and Chinese Journal of Evidence-based Medicine （Journal type 2） which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 （pre-adoption period） was compared with that from 2004 to 2006 （post-adoption period）. Results： The average reporting quality of RCTs was moderate （mean score, 15.18）, and the mean score of the 6 core items was low （mean score, 1.09） in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period （2001-2003） and post-adoption period （2004-2006） was statistically significant （P=0.003; P=0.000）. Interaction between journal type and period was not significant （F=0.76; P=0.383）. We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 （P=0.038; P=0.016）. Conclusion： The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.     

Development and Influencing Factors of Compliance Behaviors of Investigators in Clinical Trials

The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cron- bach＇s alpha coefficient and structural equation modeling were adopted to empirically analyze the re- suits. Six variables in the hypothetical model were included： compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality con- trol of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality con- trol of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical in- stitutinn wan only influenced by capability of government regulation.     

Responsiveness of the Chinese Quality of Life Instrument in patients with congestive heart failure

Objective： The Chinese Quality of Life Instrument （ChQOL） was developed as a valid generic health status instrument based on the well-established theory of health in Chinese medicine. Psychometric properties of the ChQOL were good. In the present study, the responsiveness of the ChQOL in patients with congestive heart failure （CHF） were investigated and compared with two generic questionnaires, the Medical Outcomes Study Short Form 36-item Health Survey （SF-36） and World Health Organization Quality of Life Assessment （WHOQOL-BREF）, as well as one disease-specific questionnaire, the Minnesota Living with Heart Failure Questionnaire （MLHF）. Methods： Thirty-nine in-patients with CHF who had undergone treatment with integrative medicine were recruited. The health status measurements were performed at enrolment and after a 4-week treatment. The following responsiveness indices were used： the effect size （ES） and standardized response mean （SRM）. All patients were classified into those groups with stable measures and those groups with changes after a 4-week treatment, based upon both the doctor＇s global rating of changes in heart function tests, and the patient＇s global rating of changes in overall quality of life. Results： All domains of the ChQOL showed significant improvement. In the comparison of the responsiveness indices, the ChQOL was regarded as more responsive than the WHOQOL-BREF or SF-36 utility, but it was less responsive than the MLHF. Conclusions： The ChQOL was better in sensitivity and responsiveness for assessing congestive heart failure as a generic measure than the SF-36 and WHOQOL-BREF. The ChQOL is considered suitable as an outcome measure for clinical trials in patients with congestive heart failure.     

An Evaluation Scale of Medical Services Quality Based on “Patients’ Experience”

An evaluation scale of medical services quality was developed on the basis of ＂patients＇ experience＂. The questionnaires were developed by, among others, searching relevant literature, col- lecting well-established assessment scales, measuring patients＇ experience and satisfaction, brain-storming, literature analysis. Delphi method was adopted for expert consultation. Scale items were screened and revised. The key indexes were converted. Field surveys were conducted for testing the reliability and validity of the scale. Our modified evaluation scale for measuring medical services quality based on ＂patients＇ experience＂ included 6 dimensions （tangibility, reliability, responsiveness, assurance, empathy and continuity）, and 50 items. The novel scale based on ＂patients＇ experience＂ may better serve the purpose of assessin~ medical services quality.     

躯体变形障碍问卷的修订考评

Objective To evaluate the reliability and validity of body dysmorphic disorder questionnaire (BDDQ) Chinese version. Methods A total of 222 participants from a plastic surgery department were enrolled in the study by systematic sampling. They were measured with BDDQ Chinese version and interviewed with Structured Clinical Interview for DSM-]V-TR-Patients( SCID/P) to evaluate the validity. Fifty participants were assessed again after two weeks to evaluate the test-retest reliability. Results The sensitivity of BDDQ Chinese version was 100% and the specificity was 93%. The correlation coefficient of each item was between 0. 808 and 1.000(P＜ 0.001). Conclusion BDDQ Chinese version has fairly high reliability and validity. Thus, it can be used as a screening diagnosis tool for BDD.     

Validation of the Physical Activity Questionnaire for Older Children (PAQ-C) among Chinese Children

Objective This study initially validates the Chinese version of the Physical Activity Questionnaire for Older Children(PAQ-C), which has been identified as a potentially valid instrument to assess moderate-to-vigorous physical activity(MVPA) in children among diverse racial groups. Methods The psychometric properties of the PAQ-C with 742 Hong Kong Chinese children were assessed with the scale's internal consistency, reliability, test-retest reliability, confirmatory factory analysis(CFA) in the overall sample, and multistep invariance tests across gender groups as well as convergent validity with body mass index(BMI), and an accelerometry-based MVPA. Results The Cronbach alpha coefficient(α=0.79), composite reliability value(ρ=0.81), and the intraclass correlation coefficient(α=0.82) indicate the satisfactory reliability of the PAQ-C score. The CFA indicated data fit a single factor model, suggesting that the PAQ-C measures only one construct, on MVPA over the previous 7 days. The multiple-group CFAs suggested that the factor loadings and variances and covariances of the PAQ-C measurement model were invariant across gender groups. The PAQ-C score was related to accelerometry-based MVPA(r=0.33) and inversely related to BMI(r=-0.18). Conclusion This study demonstrates the reliability and validity of the PAQ-C in Chinese children.     

Effects of glucocorticoids on traumatic brain injury related critical illness-related corticosteroid insufficiency

Background Traumatic brain injury （TBI） is a heterogeneous condition that can lead to critical LLLness-related corticosteroid insufficiency （CIRCI） causing a high mortality and morbidity.Glucocorticoids were widely used in the clinical management of TBI,but their benefit has been challenged in some studies and their efficacy,especially for treating CIRCI in TBI patients,remains unclear.Methods We conducted a meta-analysis of published data to determine if the controversy is related to clinical dosing and timing of glucocorticoids （GCs） application.We analyzed published reports in four databases （MEDLINE,EMBASE,the Cochrane Controlled Trials Register,and CBMdisc）.The published data were stratified into not only low-and high-dose GCs group but also short-and long-term GCs group to compare their effectiveness in improving TBI outcomes.Results We totally identified 16 reports.For low-dose patients,the pooled relative risks （RRs） for two clinical outcomes of death or a combination of death and severe disability were 0.95 （95% confidence interval （CI）：0.80 to 1.13） and 0.95 （95% CI：0.83 to 1.09）,respectively.The risks for infection and gastrointestinal bleeding were 0.85 （95% CI：0.50 to 1.45） and 0.64 （95% Cl：0.15 to 2.70）,respectively.For high-dose group,the pooled RR of death is 1.14 （95% Cl：1.06 to 1.21）.The pooled RRs for infection and gastrointestinal bleeding for the high-dose patients were 1.04 （95% CI：0.93 to 1.15） and 1.26 （95% CI：0.92 to 1.75）,respectively.For long-term use group,the pooled RRs for two clinical outcomes of death or a combination of death and severe disability were 0.98 （95% CI：0.87 to 1.12） and 1.00 （95% CI：0.90 to 1.11）,respectively.The risks for infection and gastrointestinal bleeding were 0.88 （95% CI：0.71 to 1.11） and 0.96 （95% CI：0.35 to 2.66）,respectively.For short-term use group,the pooled RR of death is 1.15 （95% CI：1.07 to 1.23）,and importantly the effects on infections were beneficial in terms of TBI patients suffering from CIRCI.Conclusions This meta-analysis suggests an increased risk of death for TBI patients on a high dose and short term of glucocorticoids compared with those on a low dose and long term,for whom a trend towards clinical improvement is evident.In addition,stress-does of GCs further decrease the pneumonia incidence in TBI patients suffering from CIRCI.A large-scale multicenter randomized controlled trial is warranted for testing （1） the efficacy of stress-dose GCs treatment in the sub-acute phase of TBI （4-21 days after initial trauma）,when CIRCI is most likely to occur; （2） the hypothesis that stress-dose GCs could boost patients＇ stress function and ensure survival.     

Association between intervertebral disc degeneration and disturbances of blood supply to the vertebrae

Low back pain is a common public health problem in western industrialized societies and the world as well.Studies indicate that the prevalence rate ranges to 35%, with around 10% of patients from 12% becoming chronically disabled. It also places an enormous economic burden on society. Although the exact cause of low back pain has yet to be defined, intervertebral disc degeneration is considered a major source of it. Since patients with degenerative discs are often asymptomatic, the mechanisms of it are still unclear.     

Diagnosis and treatment of epistaxis caused by non-traumatic pseudoaneurysms of carotid artery

Epistaxis remains one of the most common otolaryngology emergencies. Severe epistaxis may be caused by internal carotid artery （ICA） pseudoaneurysm or cavernous fistula, which is clinically rare but life threatening if it is not diagnosed and treated timely. Most ICA pseudoaneurysms are mainly caused by trauma with few other causes. From January 1998 to December 2005, a total of 8 cases with non-traumatic carotid artery pseudoaneurysm were correctly diagnosed through digital subtraction angiography （DSA） in Ganzhou People＇s Hospital. The patients had suffered from serious nose bleeding repeatedly and had been resistant to routine treatments.     

Saffron （Crocus sativus L.） and major depressive disorder： a meta-analysis of randomized clinical trials

Due to safety concerns and side effects of many antidepressant medications, herbal psychopharmacology research has increased, and herbal remedies are becoming increasingly popular as alternatives to prescribed medications for the treatment of major depressive disorder （MDD）. Of these, accumulating trials reveal positive effects of the spice saffron （Crocus sativus L.） for the treatment of depression. A comprehensive and statistical review of the clinical trials examining the effects of saffron for treatment of MDD is warranted. OBJECTIVE： The purpose of this study was to conduct a meta-analysis of published randomized controlled trials examining the effects of saffron supplementation on symptoms of depression among participants with MDD. SEARCH STRATEGY： We conducted electronic and non-electronic searches to identify all relevant randomized, double-blind controlled trials. Reference lists of all retrieved articles were searched for relevant studies. INCLUSION CRITERIA： The criteria for study selection included the following： （1） adults （aged 18 and older） with symptoms of depression, （2） randomized controlled trial, （3） effects of saffron supplementation on depressive symptoms examined, and （4） study had either a placebo control or antidepressant comparison group. DATA EXTRACTION AND ANALYSIS： Using random effects modeling procedures, we calculated weighted mean effect sizes separately for the saffron supplementation vs placebo control groups, and for the saffron supplementation vs antidepressant groups. The methodological quality of all studies was assessed using the Jadad score. The computer software Comprehensive Meta- analysis 2 was used to analyze the data. RESULTS： Based on our pre-specified criteria, five randomized controlled trials （n = 2 placebo controlled trials, n = 3 antidepressant controlled trials） were included in our review. A large effect size was found for saffron supplementation vs placebo control in treating depressive symptoms （M ES = 1.62, P 〈 0.001）, revealing that saffron supplementation significantly reduced depression symptoms compared to the placebo control. A null effect size was evidenced between saffron supplementation and the antidepressant groups （M ES = -0.15） indicating that both treatments were similarly effective in reducing depression symptoms. The mean Jadad score was 5 indicating high quality of trials. CONCLUSION： Findings from clinical trials conducted to date indicate that saffron supplementation can improve symptoms of depression in adults with MDD. Larger clinical trials, conducted by research teams outside of Iran, with long-term follow-ups are needed before firm conclusions can be made regarding saffron＇s efficacy and safety for treating depressive symptoms.     

高维列联表资料的统计分析与SAS软件实现（六）

非条件logistic回归分析方法的主要算法是采用最大似然法对参数进行估计。最大似然法在大样本前提下进行参数估计是非常有效的,但当处理样本量小的数据,特别是按多个定性变量进行分层且每一层中样本量很小时,     

痘苗病毒天坛株的减毒与其作为疫苗载体研究进展

1痘苗病毒天坛株的历史天花是人类历史上最可怕的传染病之一。天花由天花病毒（variola virus）引起,人是该病毒的惟一宿主。人感染天花病毒后的死亡率达到30%~40%[1]。世界上公认的对天花最早的准确记录来自中国,晋代药学家葛洪于公元430年左右,在《肘后备急方》中对天花有清楚的描述[1]。     

Relevance of muscle biopsy for diagnosing multifocal motor neuropathy

Multifocal motor neuropathy （MMN） is a rare,.focal,inflammatory,demyelinating disease of the peripheral nerves with pure motor involvementJ MMN is clinically characterized by slowly progressive,asymmetric,distal,upper limb predominant weakness,in the absence of sensory disturbances） Weakness is usually multifocal and connected to a distinct motor nerve,such as the musculocutaneous nerve resulting in biceps weakness,the posterior interosseus nerve resulting in finger drop,the median,ulnar,or radial nerve resulting in dexterity problems or grip weakness,or the peroneal nerve resulting in a foot drop.Onset of clinical manifestations is between 20 and 50 years of age.The prevalence of MMN is reported as 1-2 per 100 000.2 MMN is three times more frequent in men as compared to women.     

WHO西太区与世界中医药学会联合会中医名词术语国际标准比较研究：八纲辨证（三）

The Chinese characters 寒 and 热, 虚, and 实 are quite common concepts in Chinese language. However in traditional Chinese medicine （TCM）, they are used as four principles in syndrome differentiation. In terms of translation, 寒 and 热 are very easy to understand and can be simply translated as ＂cold＂ and ＂heat＂. But the transla- tion of 虚 and 实 used to be a problem. For a quite long time in translation practice,     

The role of central nervous system on hypoglycemia and the feasibility of the brain theory in traditional Chinese medicine on treatment of diabetes mellitus

The central nervous system （CNS） plays a key regulatory role in glucose homeostasis. In particular, the brain is important in initiating and coordinating protective counterregulatory responses when blood glucose levels fall. This may due to the metabolic dependency of the CNS on glucose, and protection of food supply to the brain. In healthy subjects, blood glucose is normally maintained within a relatively narrow range. Hypoglycemia in diabetic patients can increase the risk of complications, such as heart disease and diabetic peripheral neuropathy. The clinical research finds that the use of traditional Chinese medicine （TCM） has a positive effect on the treatment of hypoglycemia. Here the authors reviewed the current understanding of sensing and counterregulatory responses to hypoglycemia, and discuss combining traditional Chinese and Western medicine and the theory of iatrogenic hypoglycemia in diabetes treatment. Furthermore, the authors clarify the feasibility of treating hypoglycemia on the basis of TCM theory and CNS and have an insight on its clinical practice.