Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

Missing data is a common but unavoidable issue in clinical trials. It not only lowers the trial power, but brings the bias to the trial results. Therefore, on one hand, the missing data handling methods are employed in data analysis. On the other hand, it is vital to prevent the missing data in the trials. Prevention of missing data should take the first place. From the perspective of data, firstly, some measures should be taken at the stages of protocol design, data collection and data check to enhance the patients' compliance and reduce the unnecessary missing data. Secondly, the causes of confirmed missing data in the trials should be notified and recorded in detail, which are very important to determine the mechanism of missing data and choose the suitable missing data handling methods, e.g., last observation carried forward (LOCF); multiple imputation (MI); mixed-effect model repeated measure (MMRM), etc.
Clinical Trials as Topic ; Data Collection ; methods ; standards ; Humans ; Models, Theoretical ; Research Design

Objective To investigate the ability of T2 mapping in early detection of the change of cartilage collagen by quantitative analysis.Methods 20 porcine patellae were randomly assigned into 4 groups,3 treated groups and 1 control group.The samples of 3 treated groups were respectively immersed in PBS with 100 mg/100 mL,1 50 mg/100 mL and 200 mg/100 mL typeⅡ collagenase for 4 h,whereas control group samples in PBS for 4 h.T2 relaxation times of superficial,deep and full layers of cartilage and mean densi-ty after Van Gieson stain were measured.The correlation of T2 relaxation times and mean density were statistically analyzed.Results Gross pathology showed all articular cartilages maintained intact after treatment.T2 relaxation times of superficial and full layers and mean density increased significantly in any treated group in comparison with control group(P <0.05).Significant differences in T2 relaxation times of superficial layers and mean density were found between any two treated groups,whereas no difference of T2 re-laxation time of full layers was found between 100 mg/100 mL and 1 50 mg/100 mL treated groups(P >0.05).Pearson correlation analysis showed a close correlation(r=-0.837)between T2 relaxation times of full layers and mean density.Conclusion T2 map-ping can adequately detect the change of cartilage collagen in the early stage of osteoarthritis,and shows a good clinical application prospect.

Humans ; Child ; Triage ; Magnetic Resonance Imaging ; Head ; Brain/diagnostic imaging* ; Artificial Intelligence

INTRODUCTIONThe aim of this study was to determine the prevalence and characteristics of benzodiazepine (BZD) abuse among intravenous opioid users in Singapore.

MATERIALS AND METHODSEligibility criteria for inclusion in this study were all intravenous buprenorphine abusers, who presented to the Community Addictions Management Programme (CAMP) over a 1-year period from February 2005 to January 2006. One hundred and twenty subjects, who consented to the study, completed an interviewer-administered questionnaire and underwent blood test for blood-borne viral infections.

RESULTSThe age of the 120 subjects ranged from 20 to 64 years, with a mean age of 39.0 (SD 8.0) years. The majority of the participants were male (90.0%); 48.3% were Chinese. Ninety-eight (81.7%) patients were using BZDs concomitantly. Midazolam was the most commonly used BZD. Buprenorphine abusers who were concomitantly using BZDs were significantly younger and reported an earlier age of onset of illicit drug abuse as compared to those not using BZDs. Those abusing BZDs were more likely to share syringes (x 2 = 5.8, P = 0.02), and were more likely to be seropositive for hepatitis C virus (x 2 = 4.3, P = 0.04).

CONCLUSIONSThis study highlights the extreme caution that needs to be exercised in prescribing BZDs to all patients in general and patients with injecting drug use or histories of drug abuse in particular. At a public health level, general practitioners (GPs) who prescribe buprenorphine should have compulsory training which highlights the potential dangers of abuse and concomitant abuse of BZDs.

Adult ; Buprenorphine ; pharmacology ; Female ; Humans ; Hypnotics and Sedatives ; pharmacology ; Male ; Midazolam ; pharmacology ; Middle Aged ; Narcotics ; pharmacology ; Prevalence ; Retrospective Studies ; Singapore ; epidemiology ; Substance-Related Disorders ; epidemiology

INTRODUCTIONThe US Food and Drug Administration (FDA) approved buprenorphine or Subutex for the treatment of opiate dependence in October 2002. Buprenorphine is a partial agonist of the mu-opioid receptor; although initial animal research suggested a low abuse potential for buprenorphine, it was subsequently shown to have an abuse potential similar to that of morphine or hydromorphone. The objectives of this study were to establish the sociodemographic profile and help-seeking behaviour of buprenorphine abusers attending the deaddiction treatment clinics of the Community Addictions Management Programme.

MATERIALS AND METHODSOne hundred and twenty subjects, all buprenorphine abusers fulfilling the diagnostic criteria for opiate dependence, who consented to the study, completed an interviewer-administered questionnaire.

RESULTSThe mean age of those participating in the study was 39.2 [standard deviation (SD) 8.0] years. The majority of the participants were male (90%), 52.5% were currently employed and 98% had at least primary education. A family history of drug abuse was reported by 27% of the subjects. Illicit drug abuse occurred at an early age with mean age of onset of illicit drug abuse being 16.9 (SD 4.8) years with gateway drugs like marijuana and glue.

CONCLUSIONSIt is vital for our medical profession to be aware of the trend in the local population to move from the abuse of illicit substances, to the abuse of prescriptive medications. It makes it necessary to increase the understanding of addictions both amongst our practising medical fraternity, and amongst those training to enter the profession. At the hospital level, it necessitates a higher level of vigilance among our emergency room physicians and those treating infectious diseases.

Adult ; Buprenorphine ; Female ; Humans ; Male ; Middle Aged ; Narcotic Antagonists ; Opioid-Related Disorders ; rehabilitation ; Patient Acceptance of Health Care ; Singapore ; Socioeconomic Factors

Background and objectives The recent joint ACCF/AHA clinical competence statement on cardiac imaging with multi-detector computed tomography recommended a minimum of 6 months training and 300 contrast examinations, of which the candidate must be directly involved in at least 100 studies. Whether this is adequate to become proficient in interpretation of coronary computed tomogsignificant coronary stenosis in a center with 1 year's experience using a 64-row scanner. Methods A total of 778 patients underwent contrast-enhanced CTA between January and December 2005. Out of these patients, 301 patients also underwent contrast-enhanced conventional coronary angiography (CCA). These patients were divided into 4 groups according to the time the examination was underwent. Group Q1: first quarter of the year (n=20), Group Q2: second quarter (n=128), Group Q3: third quarter (n=134), and Group Results The sensitivity, specificity, positive, and negative predictive values were Q1 - 64%, 89%, 49% and 94%, respectively; Q2 -79%, 96%, 74% and 97%, respectively; Q3 - 78%, 96%, 74%, 97%, respectively, and Q4 - 100% for all. Conclusions In a center with formal training and high caseload, our accuracy in CTA analysis reached a plateau after 6 months experience. Test-bolus protocols produce better image quality and can improve accuracy. New centers embarking on CTA will need to overcome an initial 6-month learning curve depending upon the caseload during which time they should consider correlation with CCA.

Objectives To compare left ventricular ejection fraction (LVEF) determined from 64-row multi-detector computed tomography (64-row MDCT) with those determined from two dimensional echocardiography (2D echo) and cardiac magnetic resonance imaging (CMR). Methods Thirty-two patients with coronary artery disease underwent trans-thoracic 2D echo, CMR and contrast-enhanced 64-row MDCT for assessment of LVEF within 48 hours of each other. 64-row MDCT LVEF was derived using the Syngo Circulation software; CMR LVEF was by Area Length Ejection Fraction (ALEF) and Simpson method and 2D echo LVEF by Simpson method.Results The LVEF was 49.13 ± 15.91% by 2D echo, 50.72 ± 16.55% (ALEF method) and 47.65 ± 16.58%(Simpson method) by CMR and 50.00 ± 15.93% by 64-row MDCT. LVEF measurements by 64-row MDCT correlated well with LVEF measured with CMR using either the ALEF method (Pearson correlation r = 0.94, P ＜0.01) or Simpson method (r = 0.92, P＜0.01). It also correlated well with LVEF measured using 2D echo (r = 0.80, P ＜ 0.01). Conclusion LVEF measurements by 64-row MDCT correlated well with LVEF measured by CMR and 2D echo. The correlation between 64-row MDCT and CMR was better than the correlation between 2D echo with CMR. Standard data set from a 64-row MDCT coronary study can be reliably used to calculate the LVEF.

After bathing at a hot spring resort, a 75-year-old man presented to the emergency department because of seizure-like attack with loss of conscious. This is the first case of primary amebic meningoencephalitis (PAM) caused by Naegleria fowleri in Taiwan. PAM was diagnosed based on detection of actively motile trophozoites in cerebrospinal fluid using a wet-mount smear and the Liu's stain. The amoebae were further confirmed by PCR and gene sequencing. In spite of administering amphotericin B treatment, the patient died 25 days later.
Aged ; Amebiasis/*diagnosis/parasitology/*pathology ; Central Nervous System Protozoal Infections/*diagnosis/parasitology/*pathology ; Cerebrospinal Fluid/parasitology ; DNA, Protozoan/chemistry/genetics ; Fatal Outcome ; Humans ; Male ; Microscopy ; Naegleria fowleri/classification/genetics/*isolation & purification ; Polymerase Chain Reaction ; Sequence Analysis, DNA ; Taiwan