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.
DESIGN AND METHODS: Four PPSs, including headache, chest pain, low back pain, and muscle pain, and subjective depressive symptoms were assessed using the Symptom Checklist-90-Revised.
FINDINGS: Out of 528 participants, 390 (73.9%) had at least one PPS. After adjusting for sex, depression severity, disability, fatigue, physical health status, and mental health status, PPSs were found to be associated with crying easily, blaming oneself, feeling lonely, feeling blue, and worrying too much.
PRACTICAL IMPLICATIONS: Almost three-quarters of Asian patients with MDD experience PPSs. PPSs are associated with some subjective feelings of depression.
METHOD: One hundred RA patients and 50 healthy controls, sex- and age-matched, were recruited. Disease Activity Score of 28 joints and Health Assessment Questionnaire scores were assessed. Baseline serum 25(OH)D3 and IL-6 were measured in all subjects. RA patients who were vitamin D deficient were given loading doses of vitamin D3 and repeated assessments were done.
RESULTS: Vitamin D deficiency (<50 nmol/L) was found in 63% of RA patients and 76% of healthy controls. Chinese RA patients and healthy controls had significantly more sufficient 25(OH)D3 levels compared to Malays and Indians (P
AIMS: We sought to investigate recent trends in stroke outcomes at hospital discharge among first-ever stroke patients.
METHODS: This was an analysis of data from the Malaysia National Stroke Registry. Patients aged 18 years or older documented as having a first episode of stroke in the registry were recruited. Subsequently, the comparison of proportions for overall and sex-specific stroke outcomes between years (from 2009 to 2017) was conducted. The primary outcome was modified Rankin Scale score, which was assessed at hospital discharge, and each patient was categorized as follows: 1) functional independence, 2) functional dependence, or 3) death for analysis.
RESULTS: This study included 9361 first-ever stroke patients. Approximately 36.2% (3369) were discharged in an independence state, 53.1% (4945) experienced functional dependence, and 10.8% (1006) patients died at the time of hospital discharge. The percentage of patients who were discharged independently increased from 23.3% in 2009 to 46.5% in 2017, while that of patients discharged in a disabled state fell from 56.0% in 2009 to 45.6% in 2017. The percentage of death at discharge was reduced from 20.7% in 2009 to 7.8% in 2017. These findings suggest that the proportions of stroke outcomes at hospital discharge have changed significantly over time (p
OBJECTIVE: To estimate mortality, incidence, years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs) for 28 cancers in 188 countries by sex from 1990 to 2013.
EVIDENCE REVIEW: The general methodology of the Global Burden of Disease (GBD) 2013 study was used. Cancer registries were the source for cancer incidence data as well as mortality incidence (MI) ratios. Sources for cause of death data include vital registration system data, verbal autopsy studies, and other sources. The MI ratios were used to transform incidence data to mortality estimates and cause of death estimates to incidence estimates. Cancer prevalence was estimated using MI ratios as surrogates for survival data; YLDs were calculated by multiplying prevalence estimates with disability weights, which were derived from population-based surveys; YLLs were computed by multiplying the number of estimated cancer deaths at each age with a reference life expectancy; and DALYs were calculated as the sum of YLDs and YLLs.
FINDINGS: In 2013 there were 14.9 million incident cancer cases, 8.2 million deaths, and 196.3 million DALYs. Prostate cancer was the leading cause for cancer incidence (1.4 million) for men and breast cancer for women (1.8 million). Tracheal, bronchus, and lung (TBL) cancer was the leading cause for cancer death in men and women, with 1.6 million deaths. For men, TBL cancer was the leading cause of DALYs (24.9 million). For women, breast cancer was the leading cause of DALYs (13.1 million). Age-standardized incidence rates (ASIRs) per 100 000 and age-standardized death rates (ASDRs) per 100 000 for both sexes in 2013 were higher in developing vs developed countries for stomach cancer (ASIR, 17 vs 14; ASDR, 15 vs 11), liver cancer (ASIR, 15 vs 7; ASDR, 16 vs 7), esophageal cancer (ASIR, 9 vs 4; ASDR, 9 vs 4), cervical cancer (ASIR, 8 vs 5; ASDR, 4 vs 2), lip and oral cavity cancer (ASIR, 7 vs 6; ASDR, 2 vs 2), and nasopharyngeal cancer (ASIR, 1.5 vs 0.4; ASDR, 1.2 vs 0.3). Between 1990 and 2013, ASIRs for all cancers combined (except nonmelanoma skin cancer and Kaposi sarcoma) increased by more than 10% in 113 countries and decreased by more than 10% in 12 of 188 countries.
CONCLUSIONS AND RELEVANCE: Cancer poses a major threat to public health worldwide, and incidence rates have increased in most countries since 1990. The trend is a particular threat to developing nations with health systems that are ill-equipped to deal with complex and expensive cancer treatments. The annual update on the Global Burden of Cancer will provide all stakeholders with timely estimates to guide policy efforts in cancer prevention, screening, treatment, and palliation.
METHODS: The study included 2322 nationally represented community-dwelling older persons in Malaysia who participated in the baseline study of Neuroprotective Model for Healthy Longevity. In order to test the moderating effect of emotional support on the association between disability and life satisfaction, a series of hierarchical multiple linear regression models were utilized, after controlling for potential covariates associated with life satisfaction.
RESULTS: Bivariate analyses showed that disability negatively predicted life satisfaction, whereas emotional support positively predicted life satisfaction. Furthermore, the moderated hierarchical regression analysis showed that emotional support moderated the association between disability and life satisfaction, after controlling for potential covariates, such that the negative relationship between disability and life satisfaction was stronger for individuals with lower levels of emotional support.
CONCLUSIONS: The presence of emotional support might reduce the negative effects of disability on life satisfaction. These findings have important clinical implications, especially in developing better strategies to help disabled older persons to cope with their disabilities; with the hope that in the long term, a society with healthy longevity can be established. Geriatr Gerontol Int 2018; 18: 1361-1365.
OBJECTIVE: The present study aims to examine differences in psychological factors, disability and subjective fatigue between subgroups of LBP based on their chronification grade.
METHODS: Twenty-one healthy controls (HC) and 54 LBP patients (categorized based on the grades of chronicity into recurrent LBP (RLBP), non-continuous chronic LBP (CLBP), or continuous (CLBP)) filled out a set of self-reporting questionnaires.
RESULTS: The Hospital Anxiety and Depression Scale (HADS) and Multidimensional Pain Inventory (MPI) scores indicated that anxiety, pain severity, pain interference and affective distress were lower in HC and RLBP compared to non-continuous CLBP. Anxiety scores were higher in non-continuous CLBP compared to RLBP, continuous CLBP and HC. The Pain Catastrophizing Scale for Helplessness (PSCH) was higher in non-continuous CLBP compared to HC. The Survey of Pain Attitudes (SOPA) showed no differences in adaptive and maladaptive behaviors across the groups. The Pain Disability Index (PDI) measured a higher disability in both CLBP groups compared to HC. Moreover, the Rolland Morris Disability Questionnaire (RMDQ) showed higher levels of disability in continuous CLBP compared to non-continuous CLBP, RLBP and HC. The Checklist Individual Strength (CIS) revealed that patients with non-continuous CLBP were affected to a higher extent by severe fatigue compared to continuous CLBP, RLBP and HC (subjective fatigue, concentration and physical activity). For all tests, a significance level of 0.05 was used.
CONCLUSIONS: RLBP patients are more disabled than HC, but have a tendency towards a general positive psychological state of mind. Non-continuous CLBP patients would most likely present a negative psychological mindset, become more disabled and have prolonged fatigue complaints. Finally, the continuous CLBP patients are characterized by more negative attitudes and believes on pain, enhanced disability and interference of pain in their daily lives.
METHODS: Data from the CHInese Medicine NeuroAiD Efficacy on Stroke (CHIMES) and CHIMES-Extension (CHIMES-E) studies were analyzed. CHIMES-E was a 24-month follow-up study of subjects included in CHIMES, a multi-centre, double-blind placebo-controlled trial which randomized subjects with acute ischemic stroke, to either MLC601 or placebo for 3 months in addition to standard stroke treatment and rehabilitation. Subjects were stratified according to whether they received or did not receive persistent rehabilitation up to month (M)3 (non- randomized allocation) and by treatment group. The modified Rankin Scale (mRS) and Barthel Index were assessed at month (M) 3, M6, M12, M18, and M24.
RESULTS: Of 880 subjects in CHIMES-E, data on rehabilitation at M3 were available in 807 (91.7%, mean age 61.8 ± 11.3 years, 36% female). After adjusting for prognostic factors of poor outcome (age, sex, pre-stroke mRS, baseline National Institute of Health Stroke Scale, and stroke onset-to-study-treatment time), subjects who received persistent rehabilitation showed consistently higher treatment effect in favor of MLC601 for all time points on mRS 0-1 dichotomy analysis (ORs 1.85 at M3, 2.18 at M6, 2.42 at M12, 1.94 at M18, 1.87 at M24), mRS ordinal analysis (ORs 1.37 at M3, 1.40 at M6, 1.53 at M12, 1.50 at M18, 1.38 at M24), and BI ≥95 dichotomy analysis (ORs 1.39 at M3, 1.95 at M6, 1.56 at M12, 1.56 at M18, 1.46 at M24) compared to those who did not receive persistent rehabilitation.
CONCLUSIONS: More subjects on MLC601 improved to functional independence compared to placebo among subjects receiving persistent rehabilitation up to M3. The larger treatment effect of MLC601 was sustained over 2 years which supports the hypothesis that MLC601 combined with rehabilitation might have beneficial and sustained effects on neuro-repair processes after stroke. There is a need for more data on the effect of combining rehabilitation programs with stroke recovery treatments.
METHODS: An analysis was conducted among 2237 older adults who participated in a longitudinal study on aging (LRGS TUA). This study involved four states in Malaysia, with 49.4% from urban areas. Respondents were divided into three categories of SES based on percentile, stratified according to urban and rural settings. SES was measured using household income.
RESULTS: The prevalence of low SES was higher among older adults in the rural area (50.6%) as compared to the urban area (49.4%). Factors associated with low SES among older adults in an urban setting were low dietary fibre intake (Adj OR:0.91),longer time for the Timed up and Go Test (Adj OR:1.09), greater disability (Adj OR:1.02), less frequent practice of caloric restriction (Adj OR:1.65), lower cognitive processing speed score (Adj OR:0.94) and lower protein intake (Adj OR:0.94). Whilst, among respondents from rural area, the factors associated with low SES were lack of dietary fibre intake (Adj OR:0.79), lower calf circumference (Adj OR: 0.91), lesser fresh fruits intake (Adj OR:0.91), greater disability (Adj OR:1.02) and having lower score in instrumental activities of daily living (Adj OR: 0.92).
CONCLUSION: Lower SES ismore prevalent in rural areas. Poor dietary intake, lower fitness and disability were common factors associated with low in SES, regardless of settings. Factors associated with low SES identifiedin both the urban and rural areas in our study may be useful inplanning strategies to combat low SES and its related problems among older adults.
AIM: The main aim of the present study was to design a new tool called neck pain functional limitation scale (NPFLS) for measuring disability related to neck pain and observe its reliability, concurrent validity and criterion validity.
SETTING AND DESIGN: This study was performed at the institutional hospital.
MATERIALS AND METHODS: A total of 157 subjects (neck pain group) and 25 control subjects (control group) without neck pain were recruited for this study. NPFLS was framed as a new tool for this study, which consisted of 5 domains - pain intensity, activities of daily living, social activities, functional activities and psychological factors. Neck Bournemouth questionnaire (NBQ) was used as a gold standard to measure the concurrent validity and criterion validity of the NPFLS.
STATISTICAL ANALYSIS: Criterion validity and concurrent validity between the neck Bournemouth questionnaire (NBQ) and NPFLS scores were tested statistically using Mann-Whitney U test and Spearman correlation test. The reliability was tested by examining the internal consistency to calculate the Cronbach's alpha value for each item in NPFLS.
RESULTS: No significant difference between NPFLS and NBQ was observed using Mann-Whitney U Test, with P value greater than 0.05 (P= 0.557). Besides that, NPFLS had a high concurrent validity (r= 0.916) and good internal consistency with high Cronbach's alpha value of (r= 0.948), which demonstrated strong correlation between the items of NPFLS and NBQ.
CONCLUSION: NPFLS demonstrated good reliability, high concurrent validity and criterion validity in this study. NPFLS can be used to assess neck pain and disability among patients with neck pain.