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.
SUBJECTS/METHODS: Nested within the European Prospective Investigation into Cancer and Nutrition (EPIC-IBD), incident UC and CD cases and matched controls where included. At recruitment, participants completed validated food frequency and lifestyle questionnaires. Alcohol consumption was classified as either: non-use, former, light (⩽0.5 and 1 drink per week), below the recommended limits (BRL) (⩽1 and 2 drinks per day), moderate (⩽2.5 and 5 drinks per day), or heavy use (>2.5 and >5 drinks per day) for women and men, respectively; and was expressed as consumption at enrolment and during lifetime. Conditional logistic regression was applied adjusting for smoking and education, taking light users as the reference.
RESULTS: Out of 262 451 participants in six countries, 198 UC incident cases/792 controls and 84 CD cases/336 controls were included. At enrolment, 8%/27%/32%/23%/11% UC cases and 7%/29%/40%/19%/5% CD cases were: non-users, light, BRL, moderate and heavy users, respectively. The corresponding figures for lifetime non-use, former, light, BRL, moderate and heavy use were: 3%/5%/23%/44%/19%/6% and 5%/2%/25%/44%/23%/1% for UC and CD cases, respectively. There were no associations between any categories of alcohol consumption and risk of UC or CD in the unadjusted and adjusted odds ratios.
CONCLUSION: There was no evidence of associations between alcohol use and the odds of developing either UC or CD.
METHODS: All 5616 patients, diagnosed with breast cancer in University Malaya Medical Centre from 1999 to 2013 were included. In 945 elderly patients (aged 65 years and above), multivariable logistic regression was performed to identify factors associated with treatment, following adjustment for age, ethnicity, tumor, and other treatment characteristics. The impact of lack of treatment on survival of the elderly was assessed while accounting for comorbidities.
RESULTS: One in five elderly patients had comorbidities. Compared to younger patients, the elderly had more favorable tumor characteristics, and received less loco-regional treatment and chemotherapy. Within stage I-IIIa elderly breast cancer patients, 10 % did not receive any surgery. These patients were older, more likely to be Malays, have comorbidities, and bigger tumors. In elderlies with indications for adjuvant radiotherapy, no irradiation (30 %) was associated with increasing age, comorbidity, and the absence of systemic therapy. Hormone therapy was optimal, but only 35 % of elderly women with ER negative tumors received chemotherapy. Compared to elderly women who received adequate treatment, those not receiving surgery (adjusted hazard ratio: 2.30, 95 %CI: 1.10-4.79), or radiotherapy (adjusted hazard ratio: 1.56, 95 %CI: 1.10-2.19), were associated with higher mortality. Less than 25 % of the survival discrepancy between elderly women receiving loco-regional treatment and no treatment were attributed to excess comorbidities in untreated patients.
CONCLUSION: While the presence of comorbidities significantly influenced loco-regional treatment decisions in the elderly, it was only able to explain the lower survival rates in untreated patients up to a certain extent, suggesting missed opportunities for treatment.
METHODS: Participants comprised 1912 college students (16-28 years old, 47.2% female) from three universities in Jilin Province, China, who completed the self-report assessments of psychological strains (40 items Psychological Strains Scale) and suicidal behaviors (Suicidal Behaviors Questionnaire-Revised). The demographic characteristics included four variables: health status, psychological status, academic status and economic status.
RESULTS: Approximately 15.0% (286/1912) of participants were classified as having suicide risk, based on the cut-off scores of the SBQ-R. The prevalence of suicidal behaviors among males and females was 11.9% (120/1009) and 18.4% (166/903), respectively. Value strain (OR = 1.075, 95%CI: 1.057-1.094), aspiration strain (OR = 1.082, 95%CI: 1.064-1.101), deprivation strain (OR = 1.073, 95%CI: 1.052-1.093), and coping strain (OR = 1.095, 95%CI: 1.075-1.116) were risk factors for suicidality in college students. Coping strain (OR = 1.050, 95%CI: 1.023-1.077) was still positively associated with suicide risk in multivariate logistic regression. Logistic regression analysis indicated that coping strain had the highest correlation with suicidal behaviors.
LIMITATIONS: The directionality of the relationships cannot be deduced because this study is cross-sectional.
CONCLUSION: This study confirms a strong association between psychological strains and suicidal behaviors in college students. Some measures can be taken to reduce psychological strains to mitigate suicide risk among college students. More studies investigating coping strain among college students are warranted.
METHODS: In this single-centre retrospective study, comparative analysis on clinical presentations and laboratory findings was performed between confirmed leptospirosis versus non-leptospirosis cases.
RESULTS: In multivariate logistic regression evidenced by a Hosmer-Lemeshow significance value of 0.979 and Nagelkerke R square of 0.426, the predictors of a leptospirosis case are hypocalcemia (calcium <2.10mmol/L), hypochloremia (chloride <98mmol/L), and eosinopenia (absolute eosinophil count <0.040×109/L). The proposed diagnostic scoring model has a discriminatory power with area under the curve (AUC) 0.761 (p<0.001). A score value of 6 reflected a sensitivity of 0.762, specificity of 0.655, a positive predictive value of 0.38, negative predictive value of 0.91, a positive likelihood ratios of 2.21, and a negative likelihood ratios of 0.36.
CONCLUSION: With further validation in clinical settings, implementation of this diagnostic scoring model is helpful to manage presumed leptospirosis especially in the absence of leptospirosis confirmatory tests.
DESIGN: An analysis of the English Longitudinal Study of Ageing (ELSA) cohort.
SETTING: United Kingdom community-based.
PARTICIPANTS: 5197 community-dwelling older adults recruited to a prospective longitudinal cohort study.
MEASUREMENTS: Data on the occurrence of falls and number of falls, which occurred during a 12-month follow-up period, were assessed against the specific cognitive domains of memory, numeracy skills, and executive function. Binomial logistic regression was performed to evaluate the association between each cognitive domain and the dichotomous outcome of falls in the preceding 12 months using unadjusted and adjusted models.
RESULTS: Of the 5197 participants included in the analysis, 1308 (25%) reported a fall in the preceding 12 months. There was no significant association between the occurrence of a fall and specific forms of cognitive dysfunction after adjusting for self-reported hearing, self-reported eyesight, and functional performance. After adjustment, only orientation (odds ratio [OR]: 0.80; 95% confidence intervals [CI]: 0.65-0.98, p = 0.03) and verbal fluency (adjusted OR: 0.98; 95% CI: 0.96-1.00; p = 0.05) remained significant for predicting recurrent falls.
CONCLUSIONS: The cognitive phenotype rather than cognitive impairment per se may predict future falls in those presenting with more than one fall.
OBJECTIVES: To determine the prevalence of depression, anxiety and stress among HO in Sarawak General Hospital (SGH), Kuching, Sarawak. The socialdemographic factors were also evaluated to identify the high-risk groups.
MATERIALS AND METHODS: This is a descriptive cross-sectional study involving 227 house officers in SGH over a period of three months. The social-demographic data such as age, sex, marital status, current posting, duration of posting, place of graduate and state of origin were obtained from interviews with the respondents. The Depression, Anxiety and Stress scale (DASS) questionnaire was completed to assess the psychological morbidities.
RESULTS: HO were found to have high prevalence of psychiatric morbidities such as depression (42%), anxiety (50%) and stress (42.7%). Foreign graduates showed a significantly higher odds of depression (odds ratio, OR: 3.851; 95% confidence interval, 95%CI: 2.165, 6.851), anxiety (OR: 2.427; 95%CI: 1.394, 4.225) and stress (OR: 2.524; 95%CI: 1.439, 4.427) as compared to local graduates.. Further, non-Sarawakians were observed to have higher odds of developing anxiety (OR: 1.772; 95%CI: 1.022, 3.073) as compared to the Sarawakians.
CONCLUSION: HO in SGH had high prevalence of depression, anxiety and stress. Therefore, psychiatric morbidities should be screened regularly amongst the HOs in Malaysia.
Objective: The objective of this study was to investigate the prevalence and pattern of medications associated with geriatric syndromes (MAGSs) among the discharged elderly patients (≥65 years old).
Materials and Methods: This is a cross-sectional study that was conducted at a Malaysian teaching hospital from October to December 2018. The discharge medications of geriatric patients were reviewed to identify MAGSs using Beers criteria, Lexicomp drug information handbook, and the United States Food and Drug Administration (USFDA) drug inserts. Chi-square test was used to compare MAGS prescribed between categories. Spearman's rank-order correlation was used to test the correlation between the presence of MAGS and the number of discharge medications. A binomial logistic regression was applied to determine the predictors of prescribing MAGSs.
Results: A total of 400 patients (mean ± standard deviation [SD] age, 72.0 ± 5.0 years) were included, and 45.3% of them were females. The most common diseases were hypertension followed by diabetes mellitus. The mean ± SD number of discharge medications per patient was 4.2 ± 2.5. The MAGSs were prescribed in 51.7% of the patients, and 54 patients were discharged with more than one MAGSs. The most commonly prescribed MAGSs were opioid analgesics, vasodilators, and β-blockers, which are associated with falls, depression, and delirium. Polypharmacy was found in 138 patients, and it was significantly associated with the presence of MAGSs (P < 0.001). No significant differences were found in prescribing MAGSs based on the patients' gender, race, and age.
Conclusion: The prescribing of MAGSs occurred in half of the discharged elderly patients. Physicians should be aware of the medications that are associated with special side effects in the elderly patients, and should switch to safer alternatives when possible.
METHODS: We established a multi-country cross-sectional dataset of first available quantitative HCV RNA linked to demographic and clinical data. We excluded individuals on HCV treatment. We analyzed the distribution of HCV RNA and determined critical thresholds for detection of HCV viraemia. We then performed logistic regression to evaluate factors associated with LLV, and derived relative sensitivities for significant covariates.
RESULTS: The dataset included 66,640 individuals with HCV viraemia from Georgia (44.4%), Canada (40.9%), India (8.1%), Cambodia (2.6%), Egypt (1.6%), Pakistan (1.3%), Cameroon (0.4%), Indonesia (0.2%), Thailand (0.2%), Vietnam (0.1%), Malaysia (0.05%), and Mozambique (0.02%). The 97% LOD was 1,318 IU/mL (95% CI 1298.4, 1322.3). Factors associated with LLV were younger age 18-30 vs. 51-64 years (OR 2.56 95% CI 2.19, 2.99), female vs. male sex (OR 1.32, 95% CI 1.18, 1.49), and advanced fibrosis stage F4 vs. F0-1 (OR 1.44, 95%CI 1.21, 1.69). Only the younger age group had a decreased relative sensitivity below 95% at 93.3%.
CONCLUSIONS: In this global dataset, a test with an LOD of 1,318 IU/mL would identify 97% of viraemic HCV infections among almost all populations. This LOD will help guide manufacturers in the development of affordable POC diagnostics to expand HCV testing and linkage to care in LMICs.
LAY SUMMARY: We created and analyzed a dataset from 12 countries with 66,640 participants with chronic hepatitis C virus infection. We determined that about 97% of those with viraemic infection had 1300 International Units/mL or more of circulating virus at the time of diagnosis. While current diagnostic tests can detect as little as 12 International Units/mL of virus, our findings suggest that increasing the level of detection closer to 1300 would maintain good test accuracy and will likely allow for more affordable portable tests to be developed for use in low and middle income countries.
OBJECTIVE: We aimed to identify the prevalence and risk factors of genitourinary C.trachomatis infection among patients attending STD clinics in northern Peninsular Malaysia.
METHODS: A hospital-based cross-sectional study was conducted in STD clinics of Hospital Pulau Pinang and Hospital Sultanah Bahiyah, Kedah from January to November 2014. Participants were individually interviewed using a structured data collection form followed by a physical examination and laboratory tests. Nucleic Acid Amplification Test (NAAT) was used to detect C.trachomatis infection. Analysis was carried out using SPSS Version 15.
RESULTS: Eighty-three sexually active patients were enrolled, consisting of 51 males and 32 females. The median age was 28.0 years. In general, 32.5% patients were asymptomatic, the remaining presented with genital discharge (41.0%), genital warty lesion (25.3%), genital ulcer (13.3%), dysuria (13.3%), dyspareunia (2.4%), urine hesistancy (1.2%) and genital swelling (1.2%). The prevalence of genitourinary C.trachomatis infection was 21.7% in the study population; 17.6% in males and 28.1% in females. Among the infected females, 44.4% were pregnant. Of those infected 56.6% did not show any symptoms of genital infection, and 77.8% were aged between 18 and 30 years, of which most were females. Among newly diagnosed HIV patients, the prevalence was 14.3%. From multivariable logistic regression analysis, age under 28 years, being married and engagement in oral sex had significantly increased odds of C.trachomatis infection.
CONCLUSIONS: C.trachomatis infection was common among patients attending STD clinics in northern Penisular Malaysia especially in the younger age groups. Majority of the infected patients were asymptomatic.
METHODS: This was a nationwide cross-sectional study using two-stage stratified random sampling. In total, 3977 older adults aged ≥60 years were involved in this study. Socio-demography characteristics were obtained using self-administered questionnaire. AO was measured using waist circumference and classified according to the cut-off values of ≥90 cm for men and ≥80 cm for women based on the WHO recommendation. Descriptive and multiple logistic regression analysis using a complex sample design were performed for data analysis.
RESULTS: Our findings showed that 2371 (67.3%) older adults had AO. Older adults who were from urban areas (69.7%), of women (78.4%), married (66.7%), with tertiary education (73.6%) and unemployed (70.9%) had the highest prevalence of AO. Those from urban areas (adjusted odds ratio [aOR] = 1.29), women (aOR = 3.12), unemployed (aOR = 1.14), diagnosed with hypertension (aOR = 1.56) and diabetes mellitus (aOR = 2.08) were also significantly associated with a higher risk of AO.
CONCLUSIONS: This study identified several risk factors that are associated with AO among older adults in Malaysia. Such information is important and needed to improve the healthcare system systematically, enable nutrition screening and appropriate intervention to combat the growing AO in Malaysia. Geriatr Gerontol Int 2020; 20: 68-72.