METHODS AND DESIGN: TICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged ≥ 18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.
RESULTS: This paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.
DISCUSSION: The SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.
TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN93732214 . Registered on 17 January 2013.
METHOD: This study proposes a combination of decision tree and logistic regression techniques to model crash severity (injury vs. noninjury), because the combined approach allows the specification of nonlinearities and interactions in addition to main effects. Both a scobit model and a random parameters logit model, respectively accounting for an imbalance response variable and unobserved heterogeneities, are tested and compared. The study data set contains a total of 5 years of crash data (2008-2012) on selected mountainous highways in Malaysia. To enrich the data quality, an extensive field survey was conducted to collect detailed information on horizontal alignment, longitudinal grades, cross-section elements, and roadside features. In addition, weather condition data from the meteorology department were merged using the time stamp and proximity measures in AutoCAD-Geolocation.
RESULTS: The random parameters logit model is found to outperform both the standard logit and scobit models, suggesting the importance of accounting for unobserved heterogeneity in crash severity models. Results suggest that proportion of segment lengths with simple curves, presence of horizontal curves along steep gradients, highway segments with unsealed shoulders, and highway segments with cliffs along both sides are positively associated with injury-producing crashes along rural mountainous highways. Interestingly, crashes during rainy conditions are associated with crashes that are less likely to involve injury. It is also found that the likelihood of injury-producing crashes decreases for rear-end collisions but increases for head-on collisions and crashes involving heavy vehicles. A higher order interaction suggests that single-vehicle crashes involving light and medium-sized vehicles are less severe along straight sections compared to road sections with horizontal curves. One the other hand, crash severity is higher when heavy vehicles are involved in crashes as single vehicles traveling along straight segments of rural mountainous highways.
CONCLUSION: In addition to unobserved heterogeneity, it is important to account for higher order interactions to have a better understanding of factors that influence crash severity. A proper understanding of these factors will help develop targeted countermeasures to improve road safety along rural mountainous highways.
METHODS: This cross-sectional study included 346 adult males aged 18 years old to 68 years old. Socio-demographic characteristics, oral hygiene practices, and shammah use history were surveyed by using a structured interview questionnaire. The clinical assessment for the presence or absence of periodontal pockets was assessed on the basis of community periodontal index. The chi-square test was used to assess significant differences in study groups in terms of the presence of periodontal pockets. Multivariable logistic regression was selected to assess potential associated factors with the development of periodontal pockets.
RESULTS: Among the 346 adult males, 248 (71.7 %), 30 (8.6 %), and 68 (19.7 %) males never used shammah, were former shammah users, and were current shammah users, respectively. The significant associated factors with the development of periodontal pocket were age group (30 years old and above) (Adjusted Odds Ratio (AOR) = 2.03, 95 % CI: 1.13, 3.65; P = 0.018), low family income category (AOR = 2.35, 95 % CI: 1.39, 3.99; P = 0.001), former shammah user (AOR = 2.66, 95 %: CI: 1.15, 6.15; P = 0.022), and current shammah user (AOR = 6.62, 95 %: CI: 3.59, 12.21; P = 0.001).
CONCLUSIONS: The results revealed that periodontal pockets were significantly associated with age group (30 years old and above), low family income category, former shammah use, and current shammah use. The findings of the current study highlighted the need to develop comprehensive shammah prevention programs and reduce periodontal disease and other shammah-associated diseases.
METHODS: Data were derived from the Global School-Based Student Health Survey (GSHS). Data from 71176 adolescents aged 12-15 years residing in 23 countries were analyzed. The Centers for Disease Control and Prevention (CDC) 2000 growth charts were used to identify underweight, normal weight, and overweight/ obesity. Weighted age- and gender-adjusted prevalence of weight categories and tobacco use was calculated. Multivariate logistic regression analysis was performed to estimate the association between weight categories and tobacco use for each country, controlling for covariates. Pooled odds ratios and confidence intervals were computed using random- or fixed-effects meta-analyses.
RESULTS: A significant association between weight categories and tobacco use was evident in only a few countries. Adolescents reporting tobacco use in French Polynesia, Suriname, and Indonesia, had 72% (95% CI: 0.15-0.56), 55% (95% CI: 0.24-0.84), and 24% (95% CI: 0.61-0.94) lower odds of being underweight, respectively. Adolescents reporting tobacco use in Uganda, Algeria, and Namibia, had 2.30 (95% CI: 1.04-5.09), 1.71 (95% CI: 1.25-2.34), and 1.45 (95% CI: 1.00-2.12) times greater odds of being overweight/obese, but those in Indonesia and Malaysia had 33% (95% CI: 0.50-0.91) and 16% (95% CI: 0.73-0.98) lower odds of being overweight/obese.
CONCLUSIONS: The association between tobacco use and BMI categories is likely to be different among adolescents versus adults. Associating tobacco use with being thin may be more myth than fact and should be emphasized in tobacco prevention programs targeting adolescents.
METHODS: VKA control was assessed retrospectively by time-in-the-therapeutic range (TTR) (Rosendaal method) and percentage INR-in-range (PINRR) in 991 White, Afro-Caribbean and South-Asian AF patients [overall mean (SD) age 71.6 (9.4) years; 55% male; mean (SD) CHA2DS2-VASc score 3.4 (1.6)] over a median (IQR) follow-up of 5.2 (3.2-7.0) years.
RESULTS: Compared to Whites, mean (SD) TTR and PINRR were significantly lower in South-Asians [TTR 67.9% vs. 60.5%; PINRR 58.8% vs. 51.6%, respectively] and Afro-Caribbeans [TTR 67.9% vs. 61.3%; PINRR 58.8% vs. 53.1%, respectively], despite similar INR monitoring intensity. Logistic regression revealed non-white ethnicity [OR 2.62; 95% Confidence Interval [CI] (1.67-4.10) and OR 3.47 (1.44-8.34)] and anaemia [OR 1.65 (1.00-2.70) and OR 6.27 (1.89-20.94)] as independent predictors of both TTR and PINRR