DESIGN: MRI substudy nested within the double-blind randomised controlled Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 trial (ISRCTN93732214).

SETTING: International multicentre hospital-based study.

PARTICIPANTS: Eligible adults consented and randomised in the TICH-2 trial who were also able to undergo MRI scanning. To address the primary hypothesis, a sample size of n=280 will allow detection of a 10% relative increase in prevalence of diffusion-weighted imaging (DWI) hyperintense lesions in the TXA group with 5% significance, 80% power and 5% imaging data rejection.

INTERVENTIONS: TICH-2 MRI substudy participants will undergo MRI scanning using a standardised protocol at day ~5 and day ~90 after randomisation. Clinical assessments, randomisation to TXA or placebo and participant follow-up will be performed as per the TICH-2 trial protocol.

CONCLUSION: The TICH-2 MRI substudy will test whether TXA increases the incidence of new DWI-defined ischaemic lesions or reduces perihaematomal oedema or final ICH lesion volume in the context of SICH.

ETHICS AND DISSEMINATION: The TICH-2 trial obtained ethical approval from East Midlands - Nottingham 2 Research Ethics Committee (12/EM/0369) and an amendment to allow the TICH-2 MRI sub study was approved in April 2015 (amendment number SA02/15). All findings will be published in peer-reviewed journals. The primary outcome results will also be presented at a relevant scientific meeting.

METHODS: We searched CENTRAL, MEDLINE, EMBASE and trial registries for randomised controlled trials that evaluated metoprolol for preventing the occurrence of POAF after surgery against other treatments or placebo. Random-effects model was used for estimating the risk ratios (RRs) and mean differences with 95% CIs.

RESULTS: Nine trials involving 1570 patients showed metoprolol reduced POAF compared with placebo (416 patients; RR 0.46, 95% CI 0.33 to 0.66; I²=21%; risk difference (RD) -0.19, 95% CI -0.28 to -0.10). However, metoprolol increased the risk of POAF compared with carvedilol (159 patients; RR 1.59, 95% CI 1.20 to 2.12; I²=4%; RD 0.13, 95% CI 0.06 to 0.20). There was no difference when compared with sotalol or amiodarone. The occurrence of cardiovascular conditions after drugs administration or death between the groups was not different. The overall quality of evidence was moderate to high. Subgroup analysis and funnel plot were not performed.

CONCLUSIONS: Metoprolol is effective in preventing POAF compared with placebo and showed no difference with class III antiarrhythmic drugs. Death and thromboembolism are associated with open heart surgery, but not significant in relation to the use of metoprolol.

DESIGN: A cross-sectional study.

SETTING: 11 manufacturing factories in Malaysia.

PARTICIPANTS: 177 night-shift workers aged 40-65 years old were compared with 317 non-night-shift workers.

PRIMARY AND SECONDARY OUTCOMES: Participants completed a self-administered questionnaire on socio-demographics and lifestyle factors, 12-item Short Form Health Survey V.2 (SF-12v2) and the Pittsburgh Sleep Quality Index (PSQI). The Baron and Kenny's method, Sobel test and multiple mediation model with bootstrapping were applied to determine whether PSQI score or its components mediated the association between night-shift work and HRQoL.

RESULTS: Night-shift work was associated with sleep impairment and HRQoL. Night-shift workers had significantly lower mean scores in all the eight SF-12 domains (p<0.001). Compared with non-night-shift workers, night-shift workers were significantly more likely to report poorer sleep quality, longer sleep latency, shorter sleep duration, sleep disturbances and daytime dysfunction (p<0.001). Mediation analyses showed that PSQI global score mediated the association between night-shift work and HRQoL. 'Subjective sleep quality' (indirect effect=-0.24, SE=0.14 and bias corrected (BC) 95% CI -0.58 to -0.01) and 'sleep disturbances' (indirect effect=-0.79, SE=0.22 and BC 95% CI -1.30 to -0.42) were mediators for the association between night-shift work and physical well-being, whereas 'sleep latency' (indirect effect=-0.51, SE=0.21 and BC 95% CI -1.02 to -0.16) and 'daytime dysfunction' (indirect effect=-1.11, SE=0.32 and BC 95% CI -1.86 to -0.58) were mediators with respect to mental well-being.

METHODS AND ANALYSIS: We will recruit non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.

METHODS AND ANALYSIS: The IPEN Adolescent observational, cross-sectional, multicountry study involves recruiting adolescent participants (ages 11-19 years) and one parent/guardian from neighbourhoods selected to ensure wide variations in walkability and socioeconomic status using common protocols and measures. Fifteen geographically, economically and culturally diverse countries, from six continents, participated: Australia, Bangladesh, Belgium, Brazil, Czech Republic, Denmark, Hong Kong SAR, India, Israel, Malaysia, New Zealand, Nigeria, Portugal, Spain and USA. Countries provided survey and accelerometer data (15 countries), GIS data (11), global positioning system data (10), and pedestrian environment audit data (8). A sample of n=6950 (52.6% female; mean age=14.5, SD=1.7) adolescents provided survey data, n=4852 had 4 or more 8+ hours valid days of accelerometer data, and n=5473 had GIS measures. Physical activity and sedentary behaviour were measured by waist-worn ActiGraph accelerometers and self-reports, and body mass index was used to categorise weight status.

METHODS AND ANALYSIS: This biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.

ETHICS AND DISSEMINATION: This study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.

METHODS AND ANALYSIS: To ensure conceptual and item equivalence, the original version of the PCPI-S will be reviewed and adapted for cultural context by an expert committee. The instrument will subsequently be translated into Malay language using the forward-backward translation method by two independent bilingual speaking individuals. This will be pretested in four primary care clinics and refined accordingly. The instrument will be assessed for its psychometric properties, such as test-retest reliability, construct and internal validity, using exploratory and confirmatory factor analysis.

DESIGN: Observational study.

SETTING: A single-centre study in which eligible patients were recruited from T2DM clinic. Following consent, patients completed a questionnaire and underwent physical examinations. Patients had blood drawn for laboratory investigations and had a transthoracic echocardiography.

PARTICIPANTS: A total of 305 patients who were not known to have CVD were recruited. Patients with deranged liver function tests and end stage renal failure were excluded.

MAIN OUTCOME MEASURES: Echocardiographic parameters such as left ventricular ejection fraction, left ventricular mass index (LVMI), left ventricular hypertrophy, left atrial enlargement and diastolic function were examined.

RESULTS: A total of 305 patients predominantly females (65%), with mean body mass index of 27.5 kg/m2 participated in this study. None of them had either a history or signs and symptoms of CVD. Seventy-seven percent of patients had a history of hypertension and 83% of this study population had T2DM for more than 10 years. Mean HbA1c of 8.3% was recorded. Almost all patients were taking metformin. Approximately, 40% of patients were on newer anti-T2DM agents such as sodium-glucose cotransporter-2 and dipeptidyl peptidase 4 inhibitors. Fifty-seven percent (n=174) of the study population had SBHF at the time of study: diastolic dysfunction, increased LVMI and increased left atrial volume index (LAVI) were noted in 51 patients (17%), 128 patients (42%) and 98 patients (32%), respectively. Thirty-seven patients (12%) had both increase LVMI and LAVI.

METHODS: A scoping review was conducted using six databases, including Econlit, Embase, Global Health, Medline, PsycINFO and Social Policy and Practice. Studies were eligible for inclusion if they were conducted in Malaysia, peer-reviewed, focused on a health dimension according to the Bay Area Regional Health Inequities Initiative (BARHII) framework, and targeted the vulnerable international migrant population. Data were extracted by using the BARHII framework and a newly developed decision tree to identify the type of study design and corresponding level of evidence. Modified Joanna Briggs Institute checklists were used to assess study quality, and a multiple-correspondence analysis (MCA) was conducted to identify associations between different variables.

RESULTS: 67 publications met the selection criteria and were included in the study. The majority (n=41) of studies included foreign workers. Over two-thirds (n=46) focused on disease and injury, and a similar number (n=46) had descriptive designs. The average quality of the papers was low, yet quality differed significantly among them. The MCA showed that high-quality studies were mostly qualitative designs that included refugees and focused on living conditions, while prevalence and analytical cross-sectional studies were mostly of low quality.

METHODS AND ANALYSIS: HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.

ETHICS AND DISSEMINATION: All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.

STUDY DESIGN: A cross-sectional survey was done involving 707 different flavours and packaging of instant noodles sold in six hypermarkets and retailer chains in Malaysia and the corresponding brand's official websites in 2017.

METHODS: The salt content (gram per serving and per 100 g) was collected from the product packaging and corresponding brand's official website.

RESULTS: Of the 707 different packaging and flavours of instant noodles, only 62.1% (n=439) provided the salt content in their food label.The mean (±SD) salt per 100 g of instant noodles was 4.3±1.5 g and is nearly four times higher than the salt content of food classified in Malaysia as a high salt content (>1.2 g salt per 100 g). The salt content for instant noodle per packaging ranged from 0.7 to 8.5 g. 61.7% of the instant noodles exceeded the Pacific Salt Reduction Target, 11.8% exceeded the WHO recommended daily salt intake of <5.0 per day and 5.50% exceeded Malaysia Salt Action Target. 98% of instant noodles will be considered as high salt food according to the Malaysia Guidelines.The probability of the instant noodles without mixed flavour (n=324) exceeding the Pacific Salt Reduction Target was tested on univariate and multivariate analysis. Instant noodles with soup, Tom Yam flavour, pork flavour and other flavours were found to be predictors of instant noodles with the tendency to exceed Pacific Salt Reduction Target when compared with instant noodles without mixed flavours (p<0.05).

DESIGN: A retrospective analysis of STEMI patients from 18 hospitals across Malaysia contributing to the Malaysian National Cardiovascular Database-acute coronary syndrome) registry (NCVD-ACS) year 2006-2013.

PARTICIPANTS: 16 517 patients diagnosed of STEMI from 18 hospitals in Malaysia from the year 2006 to 2013.

PRIMARY OUTCOME MEASURES: In-hospital and 30 day post-discharge mortality.

RESULTS: CS complicates 10.6% of all STEMIs in this study. They had unfavourable premorbid conditions and poor outcomes. The in-hospital mortality rate was 34.1% which translates into a 7.14 times mortality risk increment compared with STEMI without CS. Intravenous thrombolysis remained as the main urgent reperfusion modality. Percutaneous coronary interventions (PCI) in CS conferred a 40% risk reduction over non-invasive therapy but were only done in 33.6% of cases. Age over 65, diabetes mellitus, hypertension, chronic lung and kidney disease conferred higher risk of mortality.

DESIGN: Data were extracted from the Malaysian Thalassaemia Registry, a web-based system accessible to enrolled users through www.mytalasemia.net.my.

SETTING: The Malaysian Thalassaemia Registry data was recorded from reports obtained from 110 participating government and university hospitals in Malaysia.

PARTICIPANTS: The patients were those attending the 110 participating hospitals for thalassaemia treatment.

INTERVENTION: Data were collected from the Malaysian Thalassaemia Registry from 2007 until the fourth quarter of 2018.

PRIMARY OUTCOME MEASURE: 7984 out of 8681 patients with thalassaemia registered in the Malaysian Thalassaemia Registry were reported alive.

RESULTS: Majority of the patients were reported in the state of Sabah (22.72%); the largest age group affected was 5.0-24.9 years old (64.45%); the largest ethnic group involved was Malay (63.95%); and the major diagnosis was haemoglobin E/β-thalassaemia (34.37%). From the 7984 patients, 56.73% were on regular blood transfusions and 61.72% were on chelation therapy. A small fraction (14.23%) has undergone splenectomy, while the percentage of patients with severe iron overload (serum ferritin ≥5000 µg/L) reduced over time. However, cardiac complications are still the main cause of death in patients with thalassaemia.

DESIGN: This post hoc descriptive exploration of data from the large international very early rehabilitation trial (A Very Early Rehabilitation Trial (AVERT)) examined the four common post acute rehabilitation pathways (inpatient rehabilitation, home with community rehabilitation, inpatient rehabilitation then community rehabilitation and home with no rehabilitation) experienced by participants in the 3 months post stroke and describes their 12-month outcomes.

SETTING: Hospital stroke units in AUS, UK and SE Asia.

PARTICIPANTS: Patients who had an acute stroke recruited within 24 hours who were ≤65 years.

RESULTS: 668 participants were ≤65 years; 99% lived independently, and 88% no disability (modified Rankin Score (mRS)=0) prior to stroke. We had complete data for 12-month outcomes for n=631 (94%). The proportion receiving inpatient rehabilitation was higher in AUS than other regions (AUS 52%; UK 25%; SE Asia 23%), whereas the UK had higher community rehabilitation (UK 65%; AUS 61%; SE Asia 39%). At 12 months, 70% had no or little disability (mRS 0-2), 44% were depressed, 28% rated quality of life as poor or worse than death. For those working prior to stroke (n=228), only 57% had returned to work. A noteworthy number of working age survivors received no rehabilitation services within 3 months post stroke.

CONCLUSIONS: There was considerable variation in rehabilitation pathways and post acute service use across the three regions. At 12 months, there were high rates of depression, poor quality of life and low rates of return to work.

METHODS AND ANALYSIS: This randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019-169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.

METHODS AND ANALYSIS: We will conduct a scoping review according to the framework proposed by Arksey and O'Malley (2005). We will search MEDLINE, EMBASE, Web of Science and Google Scholar using a combination of terms such as "colorectal cancer", "screening" and "low-middle-income countries". Studies of CRC screening interventions/programmes conducted in the general adult population in LMICs as well as policy reviews (of interventions in LMICs) and commentaries on challenges and opportunities of delivering CRC screening in LMICs, published in the English language before February 2020 will be included in this review. The title and abstract screen will be conducted by one reviewer and two reviewers will screen full-texts and extract data from included papers, independently, into a data charting template that will include criteria from an adapted template for intervention description and replication checklist and implementation considerations. The presentation of the scoping review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews guidance.

DESIGN: Retrospective cohort study.

SETTING: Singapore's nationwide claims database.

PARTICIPANTS: Singaporeans and permanent residents.

OUTCOMES: Patients were identified by International Classification of Disease, Ninth Revision, Australian Modification (ICD-9-AM) and ICD-10-AM codes from all admissions between 2000 and 2017, and categorised according to aetiology: venous, arterial, diabetic and pressure. Comorbidities were extracted from a national database of Charlson Comorbidity Index scores.

RESULTS: Between 2000 and 2017, 124 023 wound-related claims among 86 631 patients were identified. Age-specific rate (ASR) and age-adjusted incidence rates of all wounds increased over 18 years, with greatest increases among those aged ≥80. In 2017, the median age of patients was 74 (IQR 63-84). Half were male (51%). 70% were ethnic Chinese, 15% Malay and 9% Indian. In 2017, the crude incidence rate (CIR) was 15 per 100 000 persons (95% CI 14 to 16) for venous wounds, 56 (95% CI 53 to 58) for arterial, 168 (95% CI 164 to 173) for diabetic and 183 (95% CI 179 to 188) for pressure wounds. The CIR of any chronic wound was 296 (95% CI 291 to 301). ASRs were greatest in patients aged ≥80: 92 (95% CI 74 to 112) for venous, 478 (95% CI 436 to 522) for arterial, 1791 (95% CI 1710 to 1876) for diabetic, 3647 (95% CI 3530 to 3766) for pressure and 4277 (95% CI 4151 to 4407) for any wound. Compared with the Chinese, Indians had thrice the ASRs of venous and arterial wounds and double the ASR of diabetic wounds. Malays had double the ASRs of arterial and diabetic wounds.

DESIGN: A cross-sectional study was designed using a survey conducted by the Directorate of Health and Family in 2015.

SETTING: Households, community-based health centres and health committees were surveyed.

PARTICIPANTS: 285 children aged under 2 years with vaccination cards and data on households, health centres and health committees were included.

OUTCOMES: Variables indicating whether a child received each of bacillus calmette-guérin (BCG), diphtheria-tetanus-pertussis (DTP3), oral polio (OPV3) and measles vaccination and all of them were outcome variables. Associated factors were identified using multilevel logistic regressions.

RESULTS: Antenatal care at least three times was significantly associated with BCG, DTP3, OPV3 and full vaccination with adjusted ORs ranging from 2.4 (95% CI 1.1 to 5.1) to 3.3 (1.1 to 9.9). The availability of bus to health centre was slightly significant for BCG and OPV3 with the adjusted ORs of 2.0 (0.9 to 4.5) and 2.1 (0.9 to 4.8), respectively. Health committees' budget provision to health centres was significant for OPV3 and full vaccination with the respective adjusted ORs of 15.7 (1.0 to 234.1) and 15.9 (1.2 to 214.7), the wide 95% CIs of which were driven by a small sample size. Health committees' review of expenditure of health centres was significant for measles and full vaccination with the adjusted ORs of 4.0 (1.4 to 11.4) and 5.2 (1.4 to 19.4), respectively.

METHODS AND ANALYSIS: At least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.

ETHICS AND DISSEMINATION: The study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation's Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.

DESIGN: A cross-sectional study performed using an anonymous online questionnaire distributed through social media, email and the Department of Social Welfare.

SETTING: Malaysian families were invited to answer the questionnaires. The sampling was performed between 12 May 2020 and 9 June 2020.

INTERVENTION: The psychological impact was assessed using the Impact of Event Scale-Revised (IES-R) and Children's Revised Impact of Event Scale (CRIES). The mental health status was assessed using the Depression, Anxiety and Stress Scale (DASS) 21.

MAIN OUTCOME MEASURE: (1) Psychological impact on Malaysian families. (2) Prevalence of mental health status of Malaysian families during COVID-19 pandemic.

RESULT: A total of 409 Malaysian families have responded (409 parents and 348 children), 154 respondents (38%) reported high psychological impact (score 14) for psychological construct and 189 respondents (46%) reported high psychological impact (score 6) for behavioural construct. A significantly higher proportion of respondents with not permanent employment status of the family lead reported high psychological impact. The prevalence of anxiety reported from family respondents was 23%. Forty-five children answered the DASS-21 questionnaire; 28.5% reported anxiety, 31.4% reported depression and 13.3% reported stress. The job security status of the family lead was found to be the predictive factor for the mean total IES-R score (psychological construct) and ethnicity for mean total CRIES-8 and CRIES-13.