METHODS: A cross-sectional design method was used to recruit 220 mothers (age=14-25 years) from four communities in the city of Maiduguri, Northeastern Nigeria. Participants were surveyed using a self-developed interviewer-administered questionnaire that assesses maternal and child health indices and sociodemographic characteristics. Logistic regression analysis was used to compute adjusted OR and 95% CI of the associations between motherhood in adolescence (mothers below 18 years old) and maternal and child health indices.
RESULTS: Compared to adult mothers, adolescent mothers were more likely to experience fistula (OR=5.01, 95% CI=3.01 to 14.27), to have postpartum haemorrhage (OR=6.83, 95% CI=2.93 to 15.92), to have sexually transmitted infections (OR=6.29, 95% CI=2.26 to 17.51) and to lose a child within 5 years of birth (OR=3.52, 95% CI=1.07 to 11.60). Children born to adolescent mothers were less likely to have normal weight at birth (OR=0.34, CI=0.15 to 0.73) than those born to adult mothers.
CONCLUSION: Adolescent motherhood was associated with negative maternal and child health indices. The findings can be used by public health professionals including physiotherapists in this role to inform effective primary healthcare practice and community health advocacy to improve maternal and child health indices among adolescent mothers in Maiduguri. Future studies are needed to confirm the evidence at the regional or national level including the rural population in Nigeria.
STUDY DESIGN AND STATISTICAL ANALYSIS: Overall, 5058 respondents from Thailand, Malaysia, the UK, Italy and Slovenia completed the self-administered survey between May and June 2020. Poststratification weighting was applied, and associations between categorical variables assessed. Frequency counts and percentages were used to summarise categorical data. Associations between categorical variables were assessed using Pearson's χ2 test. Data were analysed in Stata 15.0 RESULTS: Among the five countries, Thai respondents reported having been most, and Slovenian respondents least, affected economically. The following factors were associated with greater negative economic impacts: being 18-24 years or 65 years or older; lower education levels; larger households; having children under 18 in the household and and having flexible/no income. Regarding social impact, respondents expressed most concern about their social life, physical health, mental health and well-being.There were large differences between countries in terms of voluntary behavioural change, and in compliance and agreement with COVID-19 restrictions. Overall, self-reported compliance was higher among respondents who self-reported a high understanding of COVID-19. UK respondents felt able to cope the longest and Thai respondents the shortest with only going out for essential needs or work. Many respondents reported seeing news perceived to be fake, the proportion varying between countries, with education level and self-reported levels of understanding of COVID-19.
CONCLUSIONS: Our data showed that COVID-19 and public health measures have uneven economic and social impacts on people from different countries and social groups. Understanding the factors associated with these impacts can help to inform future public health interventions and mitigate their negative consequences.
TRIAL REGISTRATION NUMBER: TCTR20200401002.
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.
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.
CONCLUSION: Our study has revealed a high prevalence of SBHF in T2DM patients without overt cardiac disease in Malaysia that has one of the highest prevalence of TDM in the world.
DESIGN: Single-site, parallel, two-arm randomised controlled feasibility trial.
SETTING: A UK tertiary centre hospital.
PARTICIPANTS: Patients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF.
INTERVENTIONS: The intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team.
PRIMARY AND SECONDARY OUTCOME MEASURES: The feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events.
RESULTS: 241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial.
CONCLUSIONS: There were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial.
TRIAL REGISTRATION NUMBER: ISRCTN16719542.
SETTING: Nationwide data from the Social Security Organisation (SOCSO) of Malaysia.
PARTICIPANTS: A stratified random sample of workers registered with the SOCSO of Malaysia with documentation of eye injury.
PRIMARY AND SECONDARY OUTCOME MEASURES: Characteristics of eye injuries and medical costs related to eye injury (primary) and return-to-work status (secondary).
RESULTS: A total of 884 from 8861 case files workplace accidents involving eye injury registered with Social Security Services (SOCSO) were identified. The mean age was 35±10 years and the highest incidence of work-related eye injury occurred in the age group 30-39 years and among Malay ethnics. Males are affected more than females' workers. The highest cause of eye injury was the impact from a moving object excluding falling objects (89.2%) and anterior segment injuries occurred more than posterior segment injuries. The total direct and Indirect medical cost was RM1 108 098.00 (US$316 599.40) and RM4 150 140.00 (US$1 185 754.20) for 884 cases.
CONCLUSION: The majority of workers suffered from the low level of eye injury. A significant relationship was found between the severity of eye injury and employee work status. The indirect cost of medical and vision rehabilitation was higher than the direct cost. Awareness and vision rehabilitation programmes at the workplace need to be addressed for better prevention and rehabilitative service.
METHODS AND ANALYSIS: SUNRISE is the first international cross-sectional study that aims to determine the proportion of 3- and 4-year-old children who meet the WHO Global guidelines. The study will assess if proportions differ by gender, urban/rural location and/or socioeconomic status. Executive function, motor skills and adiposity will be assessed and potential correlates of 24-hour movement behaviours examined. Pilot research from 24 countries (14 LMICs) informed the study design and protocol. Data are collected locally by research staff from partnering institutions who are trained throughout the research process. Piloting of all measures to determine protocol acceptability and feasibility was interrupted by COVID-19 but is nearing completion. At the time of publication 41 countries are participating in the SUNRISE study.
ETHICS AND DISSEMINATION: The SUNRISE protocol has received ethics approved from the University of Wollongong, Australia, and in each country by the applicable ethics committees. Approval is also sought from any relevant government departments or organisations. The results will inform global efforts to prevent childhood obesity and ensure young children reach their health and developmental potential. Findings on the correlates of movement behaviours can guide future interventions to improve the movement behaviours in culturally specific ways. Study findings will be disseminated via publications, conference presentations and may contribute to the development of local guidelines and public health interventions.
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: Scopus, PubMed, Cochrane, Web of Science and ProQuest will be searched from database inception to February 2023 using PEO search strategy (Population: adults with COPD; Exposure: inflammatory markers; Outcomes: lung function, muscle force and exercise capacity). Four reviewers working in pairs will independently screen articles for eligibility and extract data that fulfilled the inclusion criteria. Depending on the design of the included studies, either Cochrane risk-of-bias version 2 or the Newcastle-Ottawa Scale tools will be used to rate the methodological quality of the included studies. Effect sizes reported in each individual study will be standardised to Cohen's d and a random effects model will be used to calculate the pooled effect size for the association.
ETHICS AND DISSEMINATION: Ethical approval is unnecessary as this study will only use publicly available data. The findings will be disseminated through publication in peer-reviewed journals and conferences.
PROSPERO REGISTRATION NUMBER: CRD42022284446.
PARTICIPANTS: A total of 1210 Japanese lactating women who satisfied the inclusion criteria, were invited across the country at various participating sites, between 2014 and 2019. Finally a total of 1122 women were enrolled in this study.
FINDINGS TO DATE: Among 1122 eligible participants, mean age at delivery was 31.2 (SD 4.4) years and mean prepregnancy BMI was 20.8 (SD 2.7). Among these women, 35% were previously nulliparous and 77.7% had college, university or higher education. The mean gestational period was 39.0 (SD 1.3) weeks. Caesarean section was reported among 11.9%; mean infant birth weight was 3082 (SD 360) g. Of the infants, 53.7% were male. Overall, our participants appeared to be healthier than the general population in Japan. Analyses of the 1079 eligible human milk samples obtained at the first and second months postpartum showed the following composition: carbohydrate, 8.13 (SD 0.32) g/100 mL; fat, 3.77 (SD 1.29) g/100 mL; and crude protein, 1.20 (SD 0.23) g/100 mL. We also analysed osteopontin, fatty acid, vitamin D and phospholipid levels in limited subcohorts of the samples.
FUTURE PLANS: Follow-up surveys will be conducted to obtain milk samples every 2 months for 12 months and to investigate mother and child health until the children reach 5 years of age. These will be completed in 2024. We plan to longitudinally analyse the composition of macronutrients and various bioactive factors in human milk and investigate the lifestyle and environmental factors that influence breastfeeding practices, maternal and child health, and child development.
TRIAL REGISTRATION NUMBER: UMIN000015494; pre-results.
DESIGN: Budget impact analysis. Assumptions and costs in the opportunistic and novel CRC screening scenarios were derived from a previous evaluation of opportunistic CRC screening in community health clinics across Malaysia and the CRC-SIM research project, respectively.
SETTING: National level (with supplement analysis for district level). The BIA was conducted from the viewpoint of the federal government and estimated the annual financial impact over a period of 5 years.
RESULTS: The total annual cost of the current practice of opportunistic screening was RM1 584 321 (~I$1 099 460) of which 80% (RM1 274 690 or ~I$884 587) was expended on the provision of opportunistic CRC to adults who availed of the service. Regarding the implementation of national CRC screening programme, the net budget impact in the first year was estimated to be RM107 631 959 (~I$74 692 546) and to reach RM148 485 812 (~I$103 043 589) in the fifth year based on an assumed increased uptake of 5% annually. The costs were calculated to be sensitive to the probability of adults who were contactable, eligible and agreeable to participating in the programme.
CONCLUSIONS: Results from the BIA provided direct and explicit estimates of the budget changes to when implementing a population-based national CRC screening programme to aid decision making by health services planners and commissioners in Malaysia about whether such programme is affordable within given their budget constraint. The study also illustrates the use and value of the BIA approach in low-income and middle-income countries and resource-constrained settings.
METHODS AND ANALYSIS: This is a 1-year retrospective cohort study of patients with T2DM in 2016. Data will be collected from: (1) hospital databases from public institutions to estimate the cost of diabetes treatment and (2) physician interviews to estimate the cost of management of diabetes in outpatient care. We will perform descriptive and comparative analyses on direct medical costs and healthcare resource utilisation, stratified by the presence of diabetes-associated complications.
ETHICS AND DISSEMINATION: Research ethics board approval has been obtained from the Department of Health Single Joint Research Ethics Board and Cardinal Santos Medical Center Research Ethics Review Committee. Findings from the study will be reported in peer-reviewed scientific journals and local researcher meetings.
DESIGN: Cross-sectional analysis.
SETTING: The Malaysian Health and Adolescents Longitudinal Research Team (MyHeART) study.
PARTICIPANTS: Fifteen-year-old secondary school children who have given consent and who participated in the MyHeART study in 2014.
PRIMARY OUTCOME MEASURE: Muscle strength was measured in relation to dietary intake (energy and macronutrients) and physical activity by using a hand grip dynamometer.
RESULTS: Among the 1012 participants (395 male; 617 female), the hand grip strength of the males was higher than that of the females (27.08 kg vs 18.63 kg; p<0.001). Also, males were more active (2.43vs2.12; p<0.001) and consumed a higher amount of energy (2047 kcal vs 1738 kcal; p<0.001), carbohydrate (280.71 g vs 229.31 g; p<0.001) and protein (1.46 g/kg body weight (BW) vs 1.35 g/kg BW; p<0.168). After controlling for ethnicity, place of residency and body mass index, there was a positive relationship between hand grip strength and the intake of energy (r=0.14; p=0.006), carbohydrate (r=0.153; p=0.002) and fat (r=0.124; p=0.014) and the physical activity score (r=0.170; p=0.001) and a negative relationship between hand grip strength and the intake of protein (r=-0.134; p=0.008), for males. However, this was not observed among females.
CONCLUSIONS: Energy, carbohydrate and fat intakes and physical activity score were positively correlated with hand grip strength while protein intake was negatively correlated with hand grip strength in males but not in females.
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 AND ANALYSIS: This 12-week randomised double-blind, placebo-controlled, parallel-group study aims to evaluate the efficacy of the standardised water extract of EL known as Physta in increasing the quality of life of perimenopausal and postmenopausal women. The study involves 150 women aged 40-55 years who score more than 61 on the Menopause-Specific Quality of Life (MENQOL) assessment. These participants will be randomised into three groups, receiving Physta at either 50 mg or 100 mg or a placebo. The outcomes measures include mood state, quality of life, fatigue, sleep quality, sexual function and pain score assessed using Profile of Mood State, MENQOL, Chalder Fatigue Scale, Pittsburgh Sleep Quality Index, Female Sexual Function Index and the Brief Pain Inventory questionnaires, respectively. The secondary outcome of the study includes full blood analysis, urine analysis, female reproductive hormone profiling, inflammatory and oxidative stress biomarkers analysis.
ETHICS AND DISSEMINATION: The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2021-898). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER: ACTRN12622001341718.
METHODS AND ANALYSIS: The target participants are infants born from January to June 2015 in the South East Asia Community Observatory (SEACO) platform. The SEACO is a Health and Demographic Surveillance System (HDSS) that is established in the District of Segamat in the state of Johor, Malaysia. For the quantitative strand, the sociodemographic data, feeding practices, anthropometry measurement and total nutrient intake will be assessed. The assessment will occur around the time complementary feeding is expected to start (7 Months) and again at 12 months. A 24-hour diet recall and a 2-day food diary will be used to assess the food intake. For the qualitative strand, selected mothers will be interviewed to explore their infant feeding practices and factors that influence their practices and food choices in detail.
ETHICS AND DISSEMINATION: Ethical clearance for this study was sought through the Monash University Human Research and Ethics Committee (application number CF14/3850-2014002010). Subsequently, the findings of this study will be disseminated through peer-reviewed journals, national and international conferences.
DESIGN: Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.
SETTING: Participants were recruited from a tertiary care children's hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.
PARTICIPANTS: Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.
RESULTS: Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.
CONCLUSION: This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.
METHOD AND ANALYSIS: We will conduct a systematic review of randomised controlled trials that investigate the effect and safety of GO for the treatment of patients with AML. We will search for any eligible articles from selected electronic databases. We will follow the Preferred Reporting Items for Systematic reviews and Meta-Analysis for study selection and reporting. We will use The Cochrane Handbook for Systematic Reviews of Interventions and Meta-Analysis as guidance to select eligible studies. All data will be extracted using a standardised data extraction form.
ETHICS AND DISSEMINATION: There was no patient involved in this study, therefore no ethical consideration is needed. The findings of this study will be disseminated in a peer-reviewed journal and any relevant conference presentation.
PROSPERO REGISTRATION NUMBER: CRD42019123286.
STUDY DESIGN: A cross-sectional study, conducted across Punjab, Pakistan.
METHOD: The study deployed a validated survey to evaluate the competencies and practices of the community and hospital pharmacists.
RESULTS: 504 community pharmacists and 279 hospital pharmacists participated in the survey with an overall response rate of 85.5%. Almost half of the respondents 'never' or 'sometimes' made clinical notes in a journal or dispensing software to monitor ongoing opioid use. Generally, pharmacists were reluctant to collaborate with physicians or notify police regarding the abuse/misuse of opioids. Hospital pharmacists achieved significantly higher mean competency scores than chain and independent community pharmacists (p<0.05). In competency evaluation, three priority areas emerged that require additional training, that is, 'opioid overdose management', 'opioid use monitoring' and 'therapeutic uses of opioids'.
CONCLUSION: Both community and hospital pharmacists hold significant positions and potential to contribute meaningfully to the mitigation of harms and risks associated with opioids. Nevertheless, this study underscores notable deficiencies in the competence of pharmacists, whether in hospital or community settings in Punjab, concerning various aspects related to the dispensing and utilisation of opioids. It also highlights the pressing need for the development of strategies aimed at improving several practice areas including the documentation, the quality of patient counselling, the effectiveness of reporting mechanisms for opioid abuse and the stringent enforcement of regulatory policies to curtail opioid misuse. Thus, to mitigate the opioid epidemic in Pakistan, it is imperative to institute opioid stewardship initiatives aimed at rectifying the competency and procedural deficiencies within the pharmacist workforce.
SETTING AND PARTICIPANTS: We are recruiting study participants from 12 tertiary care hospitals in 10 countries on 5 continents.
PARTICIPANTS: We are enrolling patients ≥65 years of age, requiring hospital admission after non-cardiac surgery, who have an anticipated length of hospital stay of at least 2 days after elective non-cardiac surgery that occurs under general or neuraxial anaesthesia.
PRIMARY AND SECONDARY OUTCOME MEASURES: Patients are recruited before elective non-cardiac surgery, and their cognitive function is measured using the Montreal Cognitive Assessment (MoCA) instrument. After surgery, a brain MRI study is performed between postoperative days 2 and 9 to determine the presence of acute brain infarction. One year after surgery, the MoCA is used to assess postoperative cognitive function. Physicians and patients are blinded to the MRI study results until after the last patient follow-up visit to reduce outcome ascertainment bias.We will undertake a multivariable logistic regression analysis in which the dependent variable is the change in cognitive function 1 year after surgery, and the independent variables are acute perioperative covert stroke as well as other clinical variables that are associated with cognitive dysfunction.
CONCLUSIONS: The NeuroVISION study will characterise the epidemiology of covert stroke and its clinical consequences. This will be the largest and the most comprehensive study of perioperative stroke after non-cardiac surgery.
TRIAL REGISTRATION NUMBER: NCT01980511; Pre-results.