METHODS AND ANALYSIS: This multicentre, parallel, double-blind, placebo-controlled randomised trial involving seven hospitals in six cities from three different countries commenced in May 2016. Three-hundred-and-fourteen eligible Australian Indigenous, New Zealand Māori/Pacific and Malaysian children (aged 0.25 to 5 years) hospitalised for community-acquired, chest X-ray (CXR)-proven pneumonia are being recruited. Following intravenous antibiotics and 3 days of amoxicillin-clavulanate, they are randomised (stratified by site and age group, allocation-concealed) to receive either: (i) amoxicillin-clavulanate (80 mg/kg/day (maximum 980 mg of amoxicillin) in two-divided doses or (ii) placebo (equal volume and dosing frequency) for 8 days. Clinical data, nasopharyngeal swab, bloods and CXR are collected. The primary outcome is the proportion of children without chronic respiratory symptom/signs of bronchiectasis at 24 months. The main secondary outcomes are 'clinical cure' at 4 weeks, time-to-next respiratory-related hospitalisation and antibiotic resistance of nasopharyngeal respiratory bacteria.
ETHICS AND DISSEMINATION: The Human Research Ethics Committees of all the recruiting institutions (Darwin: Northern Territory Department of Health and Menzies School of Health Research; Auckland: Starship Children's and KidsFirst Hospitals; East Malaysia: Likas Hospital and Sarawak General Hospital; Kuala Lumpur: University of Malaya Research Ethics Committee; and Klang: Malaysian Department of Health) have approved the research protocol version 7 (13 August 2018). The RCT and other results will be submitted for publication.
TRIAL REGISTRATION: ACTRN12616000046404.
DESIGN: Cross-sectional study.
SETTING: Adolescent girls at secondary schools in the Klang Valley, Malaysia.
POPULATION: 729 adolescents aged between 13 and 18 years.
METHOD: A questionnaire survey using Menorrhagia Questionnaire and Paediatric Quality of Life-Teen Report Ages 13-18 (PedsQL).
MAIN OUTCOME MEASURES: Self reports of menstrual bleeding patterns, morbidities and effect on quality of life.
RESULTS: The prevalence of menstrual problems among adolescents was 63.9% in the Klang Valley. Adolescents with menstrual problems had significant lower mean total score of PedsQL (70.23±13.53 vs 76.36±14.93, p=0.001), physical health summary score (74.10±16.83 vs 79.00±15.86, p<0.001) and psychosocial health summary score (68.05±14.27 vs 73.21±13.09, p=0.001) compared with those without menstrual problem. Adolescents experiencing heavy menses bleeding had the lowest physical and emotional function. Those with oligomenorrhoea had the lowest social function, whereas those with dysmenorrhoea had the lowest school function. Cigarette smoking, alcohol and medical illness had lower health-related quality of life, whereas taking oral contraceptive pills for menstrual problems was associated with higher scores in these adolescents.
CONCLUSION: Menstrual problems among adolescents have a significant impact on their quality of life. It is probably wise to screen them at the school level, to identify those with low functional scores and to refer them for proper management at a tertiary adolescent gynaecology centre.
METHODS AND ANALYSIS: Hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.
ETHICS AND DISSEMINATION: We obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.
TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.
SETTING: Adults interviewed during house-to-house surveys.
PARTICIPANTS: Women (15-45 years) and men (15-49 years) surveyed in four Nepal Demographic and Health Surveys done in 2001, 2006, 2011 and 2016.
OUTCOME MEASURE: Current tobacco use (in any form).
RESULTS: The prevalence of tobacco use for men declined from 66% in 2001 to 55% in 2016, and declined from 29% to 8.4% among women. Across both education and wealth quintiles for both men and women, the prevalence of tobacco use generally declines with increasing education or wealth. We found persistently larger absolute inequalities by education than by wealth among men. Among women we also found larger educational than wealth-related gradients, but both declined over time. For men, the Slope Index of Inequality (SII) for education was larger than for wealth (44% vs 26% in 2001) and changed very little over time. For women, the SII for both education and wealth were similar in magnitude to men, but decreased substantially between 2001 and 2016 (from 44% to 16% for education; from 37% to 16% for wealth). Women had a larger relative index of inequality than men for both education (6.5 vs 2.0 in 2001) and wealth (4.8 vs 1.5 in 2001), and relative inequality increased between 2001 and 2016 for women (from 6.5 to 16.0 for education; from 4.8 to 12.0 for wealth).
CONCLUSION: Increasing relative inequalities indicates suboptimal reduction in tobacco use among the vulnerable groups suggesting that they should be targeted to improve tobacco control.
METHODS AND ANALYSIS: A serial cross-sectional design will be combined with a two-point in time longitudinal design to measure the levels of stigma among healthcare students from each year of undergraduate and graduate courses in Malaysia and Australia. In the absence of suitable measures, we will carry out a sequential mixed methods design to develop such a tool. The questionnaire data will be analysed using mixed effects linear models to manage the repeated measures.
ETHICS AND DISSEMINATION: We have received ethical approval from the Monash MBBS executive committee as well as the Monash University Human Research Ethics Committee. We will keep the data in a locked filing cabinet in the Monash University (Sunway campus) premises for 5 years, after which the information will be shredded and disposed of in secure bins, and digital recordings will be erased in accordance with Monash University's regulations. Only the principal investigator and the researcher will have access to the filing cabinet. We aim to present and publish the results of this study in national and international conferences and peer-reviewed journals, respectively.
METHOD: To examine potential factors that influence malaria-prevention behaviour in communities exposed to P. knowlesi malaria, 12 malaria experts participated in a modified Delphi study; every participant maintained their anonymity throughout the study. Three Delphi rounds were conducted via different online platforms between 15 November 2021 and 26 February 2022, and consensus was achieved when 70% of the participants agreed on a particular point with a 4-5 median. The results from the open-ended questions were then subjected to thematic analysis, and the dataset generated by this study was analysed using a deductive and inductive approach.
RESULTS: After a systematic, iterative process, knowledge and belief, social support, cognitive and environmental factors, past experience as a malaria patient, and the affordability and feasibility of a given intervention were critical contributors to malaria-prevention behaviour.
CONCLUSION: Future research on P. knowlesi malaria could adapt this study's findings for a more nuanced understanding of factors that influence malaria-prevention behaviour and improve P. knowlesi malaria programmes based on the expert consensus.
METHODS: This observational study was conducted between December 2018 and October 2019 at 25 PHCs in three regions in Malaysia. Each PHC was linked to one or more hospitals, for referral of seropositive participants for confirmatory testing and pretreatment evaluation. Treatment was provided in PHCs for non-cirrhotic patients and at hospitals for cirrhotic patients.
RESULTS: During the study period, a total of 15 366 adults were screened at the 25 PHCs, using RDTs for HCV antibodies. Of the 2020 (13.2%) HCV antibody-positive participants, 1481/2020 (73.3%) had a confirmatory viral load test, 1241/1481 (83.8%) were HCV RNA-positive, 991/1241 (79.9%) completed pretreatment assessment, 632/991 (63.8%) initiated treatment, 518/632 (82.0%) completed treatment, 352/518 (68.0%) were eligible for a sustained virological response (SVR) cure assessment, 209/352 (59.4%) had an SVR cure assessment, and SVR was achieved in 202/209 (96.7%) patients. A significantly higher proportion of patients referred to PHCs initiated treatment compared with those who had treatment initiated at hospitals (71.0% vs 48.8%, p<0.001).
CONCLUSIONS: This study demonstrated the effectiveness and feasibility of a simplified decentralised HCV testing and treatment model in primary healthcare settings, targeting high-risk groups in Malaysia. There were good outcomes across most steps of the cascade of care when treatment was provided at PHCs compared with hospitals.
SETTINGS: Health screening programme conducted in three inland settlements in the east coast of Malaysia and Peninsular Malaysia.
SUBJECTS: 150 Negritos who were still living in three inland settlements in the east coast of Malaysia and 1227 Malays in Peninsular Malaysia. These subjects were then categorised into MS and non-MS groups based on the International Diabetes Federation (IDF) consensus worldwide definition of MS and were recruited between 2010 and 2015. The subjects were randomly selected and on a voluntary basis.
PRIMARY AND SECONDARY OUTCOME MEASURES: This study was a cross-sectional study. Serum samples were collected for analysis of inflammatory (hsCRP), endothelial activation (sICAM-1) and prothrombogenesis [lp(a)] biomarkers.
RESULTS: MS was significantly higher among the Malays compared with Negritos (27.7%vs12.0%). Among the Malays, MS subjects had higher hsCRP (p=0.01) and sICAM-1 (p<0.05) than their non-MS counterpart. There were no significant differences in all the biomarkers between MS and the non-MS Negritos. However, when compared between ethnicity, all biomarkers were higher in Negritos compared with Malays (p<0.001). Binary logistic regression analysis affirmed that Negritos were an independent predictor for Lp(a) concentration (p<0.001).
CONCLUSIONS: This study suggests that there may possibly be a genetic influence other than lifestyle, which could explain the lack of difference in biomarkers concentration between MS and non-MS Negritos and for Negritos predicting Lp(a).
METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.
ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.
METHODS AND ANALYSIS: We outline the rationale and protocol for an international, multicentre, randomised parallel-group trial assessing the impact of the non-calcium-based phosphate binder, lanthanum carbonate, compared with placebo on surrogate markers of cardiovascular disease in a predialysis CKD population-the
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nd-points (IMPROVE)-CKD study. The primary objective of the IMPROVE-CKD study is to determine if the use of lanthanum carbonate reduces the burden of cardiovascular disease in patients with CKD stages 3b and 4 when compared with placebo. The primary end-point of the study is change in arterial compliance measured by pulse wave velocity over a 96-week period. Secondary outcomes include change in aortic calcification and biochemical parameters of serum phosphate, parathyroid hormone and FGF-23 levels.
ETHICS AND DISSEMINATION: Ethical approval for the IMPROVE-CKD trial was obtained by each local Institutional Ethics Committee for all 17 participating sites in Australia, New Zealand and Malaysia prior to study commencement. Results of this clinical trial will be published in peer-reviewed journals and presented at conferences.
TRIAL REGISTRATION NUMBER: ACTRN12610000650099.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: Cochrane Central Register of Controlled Trials, CENTRAL, MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Psychological Information Database (PsycINFO) from inception till December 2019.
STUDY SELECTION: All randomised control trials comparing CoQ10 with placebo or used as an adjunct treatment included in this meta-analysis. Cross-over designs and controlled clinical trials were excluded.
DATA SYNTHESIS: Heterogeneity at face value by comparing populations, settings, interventions and outcomes were measured and statistical heterogeneity was assessed by means of the I2 statistic. The treatment effect for dichotomous outcomes were using risk ratios and risk difference, and for continuous outcomes, mean differences (MDs) or standardised mean difference; both with 95% CIs were used. Subgroup analyses were carried out for dosage of CoQ10 and if CoQ10 combined with another supplementation. Sensitivity analysis was used to investigate the impact risk of bias for sequence generation and allocation concealment of included studies.
RESULTS: Six studies with a total of 371 participants were included in the meta-analysis. There is no statistically significant reduction in severity of migraine headache with CoQ10 supplementation. CoQ10 supplementation reduced the duration of headache attacks compared with the control group (MD: -0.19; 95% CI: -0.27 to -0.11; random effects; I2 statistic=0%; p<0.00001). CoQ10 usage reduced the frequency of migraine headache compared with the control group (MD: -1.52; 95% CI: -2.40 to -0.65; random effects; I2 statistic=0%; p<0.001).
CONCLUSION: CoQ10 appears to have beneficial effects in reducing duration and frequency of migraine attack.
PROSPERO REGISTRATION NUMBER: CRD42019126127.
METHODS: A cross-sectional standardised survey was completed in 2014-2015 by sites providing paediatric HIV care across regions of the International Epidemiology Databases to Evaluate AIDS (IeDEA) consortium. We developed a comprehensiveness score based on the WHO's nine categories of essential services to categorise sites as 'low' (0-5), 'medium', (6-7) or 'high' (8-9). When available, comprehensiveness scores were compared with scores from a 2009 survey. We used patient-level data with site services to investigate the relationship between the comprehensiveness of services and retention.
RESULTS: Survey data from 174 IeDEA sites in 32 countries were analysed. Of the WHO essential services, sites were most likely to offer antiretroviral therapy (ART) provision and counselling (n=173; 99%), co-trimoxazole prophylaxis (168; 97%), prevention of perinatal transmission services (167; 96%), outreach for patient engagement and follow-up (166; 95%), CD4 cell count testing (126; 88%), tuberculosis screening (151; 87%) and select immunisation services (126; 72%). Sites were less likely to offer nutrition/food support (97; 56%), viral load testing (99; 69%) and HIV counselling and testing (69; 40%). 10% of sites rated 'low', 59% 'medium' and 31% 'high' in the comprehensiveness score. The mean comprehensiveness of services score increased significantly from 5.6 in 2009 to 7.3 in 2014 (p<0.001; n=30). Patient-level analysis of lost to follow-up after ART initiation estimated the hazard was highest in sites rated 'low' and lowest in sites rated 'high'.
CONCLUSION: This global assessment suggests the potential care impact of scaling-up and sustaining comprehensive paediatric HIV services. Meeting recommendations for comprehensive HIV services should remain a global priority.
DESIGN: This is a mixed-method (qualitative and quantitative) study. A questionnaire was created and used by three trained research assistants for the quantitative component of the study. The qualitative component of the study included in-depth interviews and focus group interviews.
SETTING: This study was conducted in rural areas of two states in the Northern Peninsular Malaysia.
PARTICIPANTS: Due to the sensitive nature of the study, the study sample was chosen using a snowball sampling method. Two of the three Northern states Mufti's approached consented to participate in the study.
RESULTS: Quantitative: There were 605 participants, most had undergone FGC (99.3%), were in the opinion FGC is compulsory in Islam (87.6%) and wanted FGC to continue (99.3%). Older respondents had FGC conducted by traditional midwives (X2=59.13, p<0.001) and younger age groups preferred medical doctors (X2=32.96, p<0.001) and would permit doctors (X2=29.17, p<0.001) to conduct FGC on their children. These findings suggest a medicalisation trend. Regression analysis showed the odds of FGC conducted by traditional midwives and nurses and trained midwives compared with medical doctors was 1.07 (1.05; 1.09) and 1.04 (1.01; 1.06), respectively. For every 1-year decrease in age, the odds of participants deciding medical doctors should perform FGC as compared with traditional midwives increase by 1.61.Qualitative: Focus group discussions showed most believed that FGC is compulsory in Islam but most traditional practitioners and the Mufti's stated that FGC is not compulsory in Islam.
CONCLUSION: Almost everyone in the community believed FGC is compulsory in Islam and wanted the practice to continue, whereas the traditional practitioners and more importantly the Mufti's, who are responsible in issuing religious edicts, say it is not a religious requirement.
SETTING: Two cohorts of international exchange programme for second year medical students in the UK and Malaysia.
DESIGN: Interpretivist qualitative design using semistructured interviews/focus groups with students and faculty.
METHODS: Participants were asked about their learning experiences during and after the exchange. Data were recorded with consent and transcribed verbatim. Thematic analysis was used to analyse the data.
RESULTS: Four themes were identified: (1) overall benefits of the exchange programme, (2) personal growth and development, (3) understanding and observing a different educational environment and (4) experiencing different healthcare systems.
CONCLUSION: The international exchange programme highlighted differences in learning approaches, students from both campuses gained valuable learning experiences which increased their personal growth, confidence, cultural competence, giving them an appreciation of a better work-life balance and effective time management skills. It is often a challenge to prepare healthcare professionals for work in a global multicultural workplace and we would suggest that exchange programmes early on in a medical curriculum would go some way to addressing this challenge.
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.
PROSPERO REGISTRATION NUMBER: CRD42019131585.
METHODS AND ANALYSIS: This multiphase observational study will employ embedded mixed methods with a qualitative/quantitative priority: corating functional vision and O&M during social inquiry. Australian O&M agencies (n=15) provide the sampling frame. O&M specialists will use quota sampling to generate cross-sectional assessment data (n=400) before investigating selected cohorts in outcome studies. Cultural relevance of the VROOM and OMO tools will be investigated in Malaysia, where the tools will inform the design of assistive devices and evaluate prototypes. Exploratory and confirmatory factor analysis, Rasch modelling, cluster analysis and analysis of variance will be undertaken along with descriptive analysis of measurement data. Qualitative findings will be used to interpret VROOM and OMO scores, filter statistically significant results, warrant their generalisability and identify additional relevant constructs that could also be measured.
ETHICS AND DISSEMINATION: Ethical approval has been granted by the Human Research Ethics Committee at Swinburne University (SHR Project 2016/316). Dissemination of results will be via agency reports, journal articles and conference presentations.
DESIGN: Scoping review, following the Arksey and O'Malley's framework, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
DATA SOURCES: PubMed, Web of Science and Scopus were searched from 1 January 2020 through 31 December 2021.
ELIGIBILITY CRITERIA: Original articles, reviews, case studies and reports written in English were included. Works without full article and articles that did not answer the research questions were excluded.
DATA EXTRACTION AND SYNTHESIS: Data were extracted using a standardised data extraction form in Microsoft Excel. The findings of all included articles were synthesised narratively.
RESULTS: Eighty-five records were reviewed and 25 studies were included. For the field hospital implementation strategies, 'surge capacity', namely space, human resource, supply and system, was discussed in addition to the preparation and workflow of other services such as pharmacy, rehabilitation, food and nutrition. The management of COVID-19 field hospitals is challenging with respect to staff and resource shortages, inability to anticipate patient load and poor communication. The opportunities and recommendations for improvement of management were also highlighted.
CONCLUSIONS: The compilation of lessons learnt may help improve the future management of field hospitals, administratively and clinically.
DESIGN: Retrospective cohort study.
SETTING: Routinely collected primary care data from all government TB clinics in Selangor.
PARTICIPANTS: Data of 24 570 eligible adult PTB patients from 2013 to 2019 were obtained from Selangor's State Health Department surveillance records. We included PTB patients aged at least 15 years old at the time of diagnosis with complete documentation of the dates of diagnosis, treatment initiation, end of treatment/follow-up and treatment outcomes. We excluded patients whose diagnoses were changed to non-TB, post-mortem TB diagnosis and multidrug-resistant TB (MDR-TB) patients.
PRIMARY AND SECONDARY OUTCOME MEASURES: TB-related death, determined from the recorded physicians' consensus during the TB mortality meeting.
RESULTS: TB-related death was significantly associated with far (adjusted HR (aHR) 9.98, 95% CI 4.28 to 23.28) and moderately advanced (aHR 3.23, 95% CI 1.43 to 7.31) radiological findings at diagnosis; concurrent TB meningitis (aHR 7.67, 95% CI 4.53 to 12.98) and miliary TB (aHR 6.32, 95% CI 4.10 to 9.74) involvement; HIV positive at diagnosis (aHR 2.81, 95% CI 2.21 to 3.57); Hulu Selangor (aHR 1.95, 95% CI 1.29 to 2.93), Klang (aHR 1.53, 95% CI 1.18 to 1.98) and Hulu Langat (aHR 1.31, 95% CI 1.03 to 1.68) residing districts; no formal education (aHR 1.70, 95% CI 1.23 to 2.35); unemployment (aHR 1.54, 95% CI 1.29 to 1.84), positive sputum smear acid-fast bacilli (AFB) at diagnosis (aHR 1.51, 95% CI 1.22 to 1.85); rural residency (aHR 1.39, 95% CI 1.13 to 1.72) and advancing age (aHR 1.03, 95% CI 1.02 to 1.03).
CONCLUSIONS: Far and moderately advanced radiological findings, concurrent TB meningitis and miliary TB involvement, HIV positive, Hulu Selangor, Klang and Hulu Langat residing districts, no formal education, unemployment, positive sputum smear AFB, rural residency and advancing age are risk factors of TB-related death. Our findings should assist in identifying high-risk patients requiring interventions against TB-related death.
METHODS AND ANALYSIS: This study will adopt a between-group design. Participants will include Malaysian Malays and Caucasian Australians with and without MDD (N=320). There will be four tasks involved in this study, namely: (1) the facial emotion recognition task, (2) the biological motion task, (3) the subjective experience task and (4) the emotion meaning task. It is hypothesised that there will be cultural differences in how participants with and without MDD respond to these emotion tasks and that, pan-culturally, MDD will influence accuracy rates in the facial emotion recognition task and the biological motion task.
ETHICS AND DISSEMINATION: This study is approved by the Universiti Putra Malaysia Research Ethics Committee (JKEUPM) and the Monash University Human Research Ethics Committee (MUHREC). Permission to conduct the study has also been obtained from the National Medical Research Register (NMRR; NMRR-15-2314-26919). On completion of the study, data will be kept by Universiti Putra Malaysia for a specific period of time before they are destroyed. Data will be published in a collective manner in the form of journal articles with no reference to a specific individual.