METHODS AND ANALYSIS: This mixed-method project has two phases. In phase 1, we will identify a list of patient-reported and clinical outcomes through qualitative research and systematic reviews. In phase 2, we will categorise the identified outcomes using the Core Outcome Measures in Effectiveness Trials taxonomy of core domains and the International Classification of Functioning, Disability and Health. We will develop questionnaires from the list of outcomes identified from each domain for the two-round online Delphi exercise, aiming to reach a consensus on the COS. The Delphi process will include patients, carers, researchers and healthcare participants. We will hold an online consensus meeting involving representatives of all key stakeholders to establish the final COS.
ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia and the Research Ethics Committee, National University of Malaysia. This proposed COS in TD will improve the value of data, facilitate high-quality evidence synthesis and evidence-based decision-making. Furthermore, we will present the results to participants, in peer-reviewed academic journals and conferences.
REGISTRATION DETAILS: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1371.
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.
TRIAL REGISTRATION DETAILS: ClinicalTrials.gov identifier: NCT03782792; Pre-results.
METHODS AND ANALYSIS: This study is a single-centre double-blind randomised placebo-controlled trial. Sixty-eight patients will be randomised to receive under ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline. All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist. Outcome data will be collected before intervention (baseline), and thereafter on a weekly basis. The primary outcome measure is the duration to return-to-play. It is defined as the duration (in days) from the date on which the injury occurred until the patients were pain-free, able to perform the active knee extension test and have regained hamstring muscle strength. Secondary outcome measures include assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire. Both the primary and secondary outcomes were assessed at baseline and thereafter once a week until return to play. Also, hamstring injury recurrence within the first 6 months after recovery will be monitored via telephone. The results of this study will provide insights into the effect of LR-PRP in muscle and may help to identify the best PRP application protocol for muscle injuries.
ETHICS AND DISSEMINATION: Ethics approval were obtained from the Medical Research Ethics Committee of the University of Malaya Medical Centre. Results of this trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: ISRCTN76844299.
METHODS AND ANALYSIS: RISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.
ETHICS: Study protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.
TRIAL REGISTRATION NUMBER: ACTRN12618000633280; Pre-results.
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: A focus group and individual interview qualitative study using purposive sampling of participants to obtain diverse views. Data collection was guided by piloted semistructured topic guides. The focus groups and interviews were audiorecorded, transcribed verbatim and analysed using inductive thematic analysis. We completed data collection once data saturation was reached.
SETTING: Stakeholders in education and health sectors in Malaysia.
PARTICIPANTS: Fifty-two participants (40 school staff, 9 healthcare professionals and 3 policy-makers) contributed to nine focus groups and eleven individual interviews.
RESULTS: School staff had limited awareness of asthma and what to do in emergencies. There was no guidance on asthma management in government schools, and teachers were unclear about their role in school children's health. These uncertainties led to delays in the treatment of asthma symptoms/attacks, and suggestions that an asthma education programme and a school plan would improve asthma care. Perceived challenges in conducting school health programmes included a busy school schedule and poor parental participation. A tailored asthma programme in partnerships with schools could facilitate the programme's adoption and implementation.
CONCLUSIONS: Identifying and addressing issues and challenges specific to the school and wider community could facilitate the delivery of a school asthma programme in line with the WHO School Health Initiative. Clarity over national policy on the roles and responsibilities of school staff could support implementation and guide appropriate and prompt response to asthma emergencies in schools.
METHODS: A cross-sectional market survey was conducted in 2017 of 233 sauces sold in Malaysian supermarkets. Information on the sodium content was collected from the product packaging and nutrient information panels of the sauces sold in the seven top supermarkets in the capital of Malaysia.
RESULTS: Of the 233 sauces surveyed, 116 did not include sodium content information on the nutrient information panel (49.8%). Soy sauce (particularly sweet soy sauce) and ketchup (particularly chilli sauce) were found to be the highest number of products surveyed in the analysis (N=54 and N=48, respectively). The highest sodium content information was displayed by fish/prawn sauce (budu/cencalok) (5192±3228 mg/100 g) which was followed by the light/thin soy sauce (5116±2084 mg/100 g), and followed by salty soy sauce (4780±988 mg/100 g). The sodium content information of the imported sauces was higher compared with local products produced in Malaysia. However, for sweet soy sauce, the sodium content information of the local products was higher compared with the imported products. Of the 116 sauces which displayed information regarding their sodium content, only 18.2% of the salty soy sauce and 25% of the light/thin soy sauce were found to be below the 2017 Malaysian sodium guidelines. Furthermore, only 21.7% of chilli ketchup and no tomato ketchup were below the 2017 UK salt guidelines.
CONCLUSIONS: Almost half of the sauces surveyed did not include sodium content information on the nutrient information panel. It is recommended that sodium content information is provided on all sauces sold in Malaysia. Also, manufacturers should be urged to reduce the sodium content level of their sauces to a minimum of 5%.
DESIGN: A systematic review was conducted using electronic databases of CINAHL, PubMed, PsychINFO, Psychology and Behavioural Sciences Collection, SocINDEX and Web of Science for articles published until the 11th of January 2018.
ELIGIBILITY CRITERIA: All observational studies investigating the association between social support and depression among community-dwelling older adults in Asia were included.
PARTICIPANTS: Older adults aged 60 years and more who are living in the community.
EXPOSURE MEASURES: Social support.
OUTCOME MEASURES: Depression.
RESULTS: We retrieved16 356 records and screened 66 full-text articles. Twenty-four observational studies were included in the review. They consisted of five cohort studies and 19 cross-sectional studies. Social support was found to be measured by multiple components, most commonly through a combination of structural and functional constructs. Perceived social support is more commonly measured compared with received social support. Good overall social support, having a spouse or partner, living with family, having a large social network, having more contact with family and friends, having emotional and instrumental support, good support from family and satisfaction with social support are associated with less depressive symptoms among community-dwelling older adults in Asia.
CONCLUSIONS: There were 20 different social support measures and we applied a framework to allow for better comparability. Our findings emphasised the association between good social support and decrease depression among older adults. Compared with western populations, family support has a greater influence on depression among community-dwelling older adults in Asia. This indicates that the family institution needs to be incorporated into designed programmes and interventions when addressing depression in the Asian context. TRIAL : registration number : CRD42017074897.
DESIGN: Cross-sectional study.
SETTING: Primary and secondary schools in Malaysia.
PARTICIPANTS: 11 246 non-smoking school-going adolescents.
OUTCOME MEASURES: The prevalence and factors associated with smoking susceptibility among non-smoking school-going adolescents in Malaysia.
RESULTS: Approximately 14% of non-smokers were susceptible to smoking, and the prevalence of susceptibility was significantly higher among males, ever-smokers and e-cigarette users. The odds of susceptibility to smoking were higher among males, e-cigarette users, those aged 12 years and under and those who had ever smoked or tried cigarettes. Students from schools with educational programmes on the health effects of second-hand smoke (SHS) and who perceived smoking to be harmful were less likely to be susceptible to smoking.
CONCLUSION: Smoking susceptibility is prevalent among school-going adolescents. A comprehensive approach that enhances or reinforces health education programmes on the adverse health effects of smoking and SHS among school children, that considers multiple factors and that involves all stakeholders is urgently needed to reduce the prevalence of smoking susceptibility among vulnerable subgroups, as identified from the present findings.
METHODS: Eligible studies were included if they used any models to assess the impact of COVID-19 disruptions on any health services. Articles published from January 2020 to December 2022 were identified from PubMed, Embase and CINAHL, using detailed searches with key concepts including COVID-19, modelling and healthcare disruptions. Two reviewers independently extracted the data in four domains. A descriptive analysis of the included studies was performed under the format of a narrative report.
RESULTS: This scoping review has identified a total of 52 modelling studies that employed several models (n=116) to assess the potential impact of disruptions to essential health services. The majority of the models were simulation models (n=86; 74.1%). Studies covered a wide range of health conditions from infectious diseases to non-communicable diseases. COVID-19 has been reported to disrupt supply of health services, demand for health services and social change affecting factors that influence health. The most common outcomes reported in the studies were clinical outcomes such as mortality and morbidity. Twenty-five studies modelled various mitigation strategies; maintaining critical services by ensuring resources and access to services are found to be a priority for reducing the overall impact.
CONCLUSION: A number of models were used to assess the potential impact of disruptions to essential health services on various outcomes. There is a need for collaboration among stakeholders to enhance the usefulness of any modelling. Future studies should consider disparity issues for more comprehensive findings that could ultimately facilitate policy decision-making to maximise benefits to all.
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).
CONCLUSION: Only 62% of instant noodles displayed the salt content on their food label. Salt content in instant noodles is very high, with 90% exceeding the daily salt intake recommended by WHO. Prompt action from regulatory and health authorities is needed to reduce the salt content in instant noodles.
METHODS AND ANALYSIS: In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2'-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. 'Intent-to-treat' principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ2 analysis and regression will be used for comparisons.
ETHICS AND DISSEMINATION: This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences.
TRIAL REGISTRATION NUMBER: NCT02058420; results.
METHODS AND ANALYSIS: The systematic review, will be conducted by extensively searching different databases such as PubMed, Web of Science, Scopus, Wiley and ProQuest to identify randomised controlled trials (with no time frame) which relate to the administration of probiotics to patients with colorectal cancer. The search strategy will include words like colorectal cancer, probiotics, Bifidobacterium, clinical trials etc. A systematic search of databases was performed between 17 and 20 January 2020. Two reviewers will independently review the studies and also search the reference lists of the eligible studies to obtain more references. Data will be extracted from the eligible studies using standardised data extraction form. After assessing the risk of bias, qualitative analysis will be used to synthesise the systematic review.
ETHICS AND DISSEMINATION: This is a protocol for a systematic review; therefore, it doesn't require any ethics approval. We intend to disseminate the protocol in a peer reviewed journal.
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: The study, set in Malaysia and the Philippines, builds on two systematic reviews of barriers to effective hypertension management. People with hypertension (pre-existing and newly diagnosed) will be identified in poor households in 24-30 communities per country. Quantitative and qualitative methods will be used to examine their experiences of and pathways into seeking and obtaining care. These include two waves of household surveys of 20-25 participants per community 12-18 months apart, microcosting exercises to assess the cost of illness (including costs due to health seeking activities and inability to work (5 per community)), preliminary and follow-up in-depth interviews and digital diaries with hypertensive adults over the course of a year (40 per country, employing an innovative mobile phone technology), focus group discussions with study participants and structured assessments of health facilities (including formal and informal providers).
ETHICS AND DISSEMINATION: Ethical approval has been granted by the Observational Research Ethics Committee at the London School of Hygiene and Tropical Medicine and the Research Ethics Boards at the Universiti Putra Malaysia and the University of the Philippines Manila. The project team will disseminate findings and engage with a wide range of stakeholders to promote uptake and impact. Alongside publications in high-impact journals, dissemination activities include a comprehensive stakeholder analysis, engagement with traditional and social media and 'digital stories' coproduced with research participants.
METHODS AND ANALYSIS: The methodology draws on Arksey and O'Malley's seminal framework for the scoping review. The literature search will be conducted by using keywords to find suitable published literature. The existing literature will be searched using selected electronic databases such as PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science from the years 2011 and 2021. The selected publications will focus on 10 Southeast Asian countries: Malaysia, Indonesia, Singapore, Thailand, Brunei, Philippines, Laos, Vietnam, Cambodia and Myanmar. Two reviewers will be performing title and abstract screening for the criteria of each publication, in which they will be working independently of each other. The included publication will undergo a full-text review and references cited will be examined for relevance using the same inclusion criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram will guide throughout the process. Data will be extracted, analysed and charted within each category from the selected publications for each Southeast Asian country.
ETHICS AND DISSEMINATION: The results of this scoping review will illustrate an overview of the 3D printing healthcare research in the Southeast Asian context, which can be a guide for the advancement of 3D printing that can be accentuated in future research. The results will undergo dissemination which will be submitted for publication in a scientific journal.