Displaying publications 41 - 60 of 242 in total

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  1. Aljaberi MA, Juni MH, Al-Maqtari RA, Lye MS, Saeed MA, Al-Dubai SAR, et al.
    BMJ Open, 2018 09 12;8(9):e021180.
    PMID: 30209153 DOI: 10.1136/bmjopen-2017-021180
    OBJECTIVE: The current study aimed to investigate the relationships among the perceived quality of healthcare services, satisfaction and behavioural intentions among international students in Kuala Lumpur, Malaysia.

    SETTING: A cross-sectional study on public universities in Kuala Lumpur, Malaysia.

    PARTICIPANTS: All participants in this study were international students joining public universities in Kuala Lumpur, Malaysia.

    PRIMARY INDEPENDENT VARIABLE: Perceived quality of healthcare services measured on a SERVQUAL scale.

    PRIMARY DEPENDENT VARIABLE: Participants' satisfaction of healthcare services assessed using five items.

    SECONDARY DEPENDENT VARIABLE: Behavioural intentions measured on six items.

    RESULTS: Of the 556 international students, 500 (90%) completed the survey. The study used structural equation modelling (SEM) through the AMOS (Analysis of Moment Structures) software to analyse the data. SEM analyses showed that the perceived quality of healthcare services significantly and directly affected satisfaction, with a value of 89% and an effect size of 0.78. It also had a significant indirect impact on the behavioural intentions (0.78) of international students. The results indicated that participants' satisfaction had a statistically significant impact on their behavioural intentions (0.77).

    CONCLUSION: Perceived quality of care is an important driver of international students' satisfaction and their behavioural intention with healthcare services. Such relations of effects among the three investigated factors were also positive and significant.

  2. Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfán E, Sigamani A, et al.
    BMJ Open, 2019 05 01;9(4):e028537.
    PMID: 31048449 DOI: 10.1136/bmjopen-2018-028537
    INTRODUCTION: Annually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.

    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.

    TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.

  3. Mrkobrada M, Chan MTV, Cowan D, Spence J, Campbell D, Wang CY, et al.
    BMJ Open, 2018 07 06;8(7):e021521.
    PMID: 29982215 DOI: 10.1136/bmjopen-2018-021521
    OBJECTIVES: Covert stroke after non-cardiac surgery may have substantial impact on duration and quality of life. In non-surgical patients, covert stroke is more common than overt stroke and is associated with an increased risk of cognitive decline and dementia. Little is known about covert stroke after non-cardiac surgery.NeuroVISION is a multicentre, international, prospective cohort study that will characterise the association between perioperative acute covert stroke and postoperative cognitive function.

    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.

  4. Tan GN, Tan PC, Hong JGS, Kartik B, Omar SZ
    BMJ Open, 2021 05 13;11(5):e046528.
    PMID: 33986063 DOI: 10.1136/bmjopen-2020-046528
    OBJECTIVE: To evaluate four foods in women with hyperemesis gravidarum (HG) on their agreeability and tolerability.

    DESIGN: Prospective, randomised, within-subject cross-over trial.

    SETTING: Single-centre, tertiary, university hospital in Malaysia.

    PARTICIPANTS: 72 women within 24-hour of first admission for HG who were 18 years or above, with confirmed clinical pregnancy of less than 16 weeks' gestation were recruited and analysed. Women unable to consume food due to extreme symptoms, known taste or swallowing disorder were excluded.

    INTERVENTIONS: Each participant chewed and swallowed a small piece of apple, watermelon, cream cracker and white bread in random order and was observed for 10 min after each tasting followed by a 2 min washout for mouth rinsing and data collection.

    OUTCOME MEASURES: Primary outcome was food agreeability scored after 10 min using an 11-point 0-10 Visual Numerical Rating Scale (VNRS). Nausea was scored at baseline (prior to tasting) and 2 and 10 min using an 11-point VNRS. Intolerant responses of gagging, heaving and vomiting were recorded.

    RESULTS: On agreeability scoring, apple (mean±SD 7.2±2.4) ranked highest followed by watermelon (7.0±2.7) and crackers (6.5±2.6), with white bread ranked lowest (6.0±2.7); Kruskal-Wallis H test, p=0.019. Apple had the lowest mean nausea score and mean rank score, while white bread had the highest at both 2 and 10 min; the Kruskal-Wallis H test showed a significant difference only at 10 min (p=0.019) but not at 2 min (p=0.29) in the ranking analyses. The intolerant (gagged, heaved or vomited) response rates within the 10 min study period were apple 3/72 (4%), watermelon 7/72 (10%), crackers 8/72 (11%) and white bread 12/72 (17%): χ2 test for trend p=0.02.

    CONCLUSION: Sweet apple had the highest agreeability score, the lowest nausea severity and intolerance-emesis response rate when tasted by women with HG. White bread consistently performed worst.

  5. Hamzah N, Narayanan V, Ramli N, Mustapha NA, Mohammad Tahir NA, Tan LK, et al.
    BMJ Open, 2019 09 18;9(9):e028711.
    PMID: 31537559 DOI: 10.1136/bmjopen-2018-028711
    OBJECTIVES: To measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.

    SETTING: A single centre study, Malaysia.

    PARTICIPANTS: Adults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen's d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate).

    INTERVENTIONS: Intervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks.

    OUTCOME MEASURES: Primary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).

    RESULTS: Results will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson's correlation coefficient.

    CONCLUSION: This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.

    ETHICS AND DISSEMINATION: The study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928-4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.

    TRIAL REGISTRATION NUMBER: NCT03237676.

  6. Ho KY, Gyanwali B, Dimayuga C, Eufemio EM, Bernardo E, Raju G, et al.
    BMJ Open, 2024 Mar 19;14(3):e080620.
    PMID: 38508619 DOI: 10.1136/bmjopen-2023-080620
    INTRODUCTION: Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

    METHODS AND ANALYSIS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

    ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

  7. Rashid AA, Shariff Ghazali S, Mohamad I, Mawardi M, Roslan D, Musa H
    BMJ Open, 2019 08 10;9(8):e024488.
    PMID: 31401588 DOI: 10.1136/bmjopen-2018-024488
    INTRODUCTION: Being a house officer (HO) is said to be associated with high levels of stress, leading to mental health problems and sometimes to quitting the medical profession altogether. In Malaysia, the number of HOs completing training on time is slowly declining, with increasing annual dropout rates. Feeling incompetent is one of the contributors towards this growing problem. This study aimed to evaluate the effectiveness of a 3-day pre-HO intervention module in addressing participants' confidence, readiness and psychological well-being in preparation for their HO training.

    METHODS AND ANALYSIS: The pre-HO intervention is the 'Medicorp' module that includes clerkship, experience sharing, hands-on skills training, common clinical cases and introduction of the local healthcare system. This is a pre-post quasi-experimental study lasting 1 year, with three assessment time points-at pretraining, immediately after training and 1 month into the participants' HO-ship. The study is currently ongoing and involves 208 participants who attended the course in Malaysia. Participants with known psychiatric illness, working HOs and medical students are excluded. A pretested, self-administered questionnaire that includes baseline sociodemography, adaptation of the International Medical University (IMU) Student Competency Survey and the Depression Anxiety Stress Scale has been adopted, and 1 month follow-up will be conducted by telephone. Data will be analysed using SPSS V.24. The primary outcome is change in confidence level, while the secondary outcomes are changes in the readiness and psychological well-being of the participants.

    ETHICS AND DISSEMINATION: This study protocol has received ethics approval from Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia and the National Medical Research Registry Malaysia. Written informed consent has been obtained from each participant. Results will be disseminated through journals and conferences, especially those involved in medical education specifically looking into the training of medical doctors.

    TRIAL REGISTRATION NUMBER: NCT03510195.

  8. Mariappen U, Chew KT, Zainuddin AA, Mahdy ZA, Abdul Ghani NA, Grover S
    BMJ Open, 2022 Jan 04;12(1):e051896.
    PMID: 34983763 DOI: 10.1136/bmjopen-2021-051896
    OBJECTIVE: To describe the prevalence of menstrual problems (heavy menses bleeding, dysmenorrhoea and oligomenorrhoea) and its impact towards quality of life among adolescents in Klang Valley, Malaysia.

    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.

  9. Leong Bin Abdullah MFI, Mansor NS, Mohamad MA, Teoh SH
    BMJ Open, 2021 Oct 07;11(10):e048446.
    PMID: 34620656 DOI: 10.1136/bmjopen-2020-048446
    OBJECTIVE: This study aimed to evaluate the quality of life (QoL) and determine its association with various factors and social support among university students during the COVID-19 pandemic after the end of movement lockdown.

    DESIGN, SETTING AND PARTICIPANTS: This online cross-sectional study recruited 316 participants. The inclusion criteria were students 18 years and above who were registered with the faculties of medicine at Malaysian public universities located in Klang Valley and in the states of Penang and Kelantan in Peninsular Malaysia. The exclusion criteria were those who presented with psychotic disorders, bipolar mood disorder or a history of illicit drugs.

    OUTCOME MEASURES: Participants were administered a self-reported questionnaire to gather data on demographic, personal, clinical and psychological characteristics. The questionnaire comprised of the 21-item Depression, Anxiety and Stress Scale, the Multidimensional Scale of Perceived Social Support, and the WHO Quality of Life- Brief Version (WHOQoL-BREF).

    RESULTS: The psychological and social QoL scores were lower than the non-pandemic norms of the general population, while the physical health and environmental QoL scores were comparable. After adjusting for relevant demographic, personal and clinical variables, religious coping, greater number of hours of online classes attended, and greater social support from family, friends and significant others were significantly associated with higher QoL among the participants. Frustration due to study disruption, living in areas with a high prevalence of COVID-19 cases, and a higher severity of depressive and stress symptoms were significantly associated with lower QoL.

    CONCLUSION: COVID-19 impaired the QoL of university students even after the movement lockdown was lifted.

  10. Al-Yateem N, Hijazi H, Saifan AR, Ahmad A, Masa'Deh R, Alrimawi I, et al.
    BMJ Open, 2023 Dec 22;13(12):e076326.
    PMID: 38135338 DOI: 10.1136/bmjopen-2023-076326
    OBJECTIVES: To identify language-related communication barriers that expatriate (non-Arabic) healthcare practitioners in the UAE encounter in their daily practice.

    DESIGN: Qualitative study utilising semi-structured in-depth interviews. The interviews were conducted in English language.

    SETTING: Different healthcare facilities across the UAE. These facilities were accessed for data collection over a period of 3 months from January 2023 to March 2023.

    PARTICIPANTS: 14 purposively selected healthcare practitioners.

    INTERVENTION: No specific intervention was implemented; this study primarily aimed at gaining insights through interviews.

    PRIMARY AND SECONDARY OUTCOMES: To understand the implications of language barriers on service quality, patient safety, and healthcare providers' well-being.

    RESULTS: Three main themes emerged from our analysis of participants' narratives: Feeling left alone, Trying to come closer to their patients and Feeling guilty, scared and dissatisfied.

    CONCLUSIONS: Based on the perspectives and experiences of participating healthcare professionals, language barriers have notably influenced the delivery of healthcare services, patient safety and the well-being of both patients and practitioners in the UAE. There is a pressing need, as highlighted by these professionals, for the inclusion of professional interpreters and the provision of training to healthcare providers to enhance effective collaboration with these interpreters.

  11. Zainudeen ZT, Abd Hamid IJ, Azizuddin MNA, Abu Bakar FF, Sany S, Zolkepli IA, et al.
    BMJ Open, 2021 08 11;11(8):e050523.
    PMID: 34380732 DOI: 10.1136/bmjopen-2021-050523
    OBJECTIVE: To investigate the psychosocial impact of COVID-19 on Malaysian families.

    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.

    CONCLUSION: Rates of depression and anxiety during the COVID-19 pandemic were high. Findings suggest that urgent measures to ensure job security among Malaysian families are important to reduce the impact of the COVID-19 pandemic on psychosocial and mental health outcomes.

  12. Azzopardi M, Thomas R, Muruganandan S, Lam DC, Garske LA, Kwan BC, et al.
    BMJ Open, 2016 07 05;6(7):e011480.
    PMID: 27381209 DOI: 10.1136/bmjopen-2016-011480
    INTRODUCTION: Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation.

    METHODS AND ANALYSIS: A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate.

    ETHICS AND DISSEMINATION: The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings.

    TRIAL REGISTRATION NUMBER: ACTRN12615000963527; Pre-results.

  13. Mohan D, Stephan BC, Allotey P, Jagger C, Pearce M, Siervo M, et al.
    BMJ Open, 2017 01 19;7(1):e013635.
    PMID: 28104710 DOI: 10.1136/bmjopen-2016-013635
    INTRODUCTION: There is a growing proportion of population aged 65 years and older in low-income and middle-income countries. In Malaysia, this proportion is predicted to increase from 5.1% in 2010 to more than 15.4% by 2050. Cognitive ageing and dementia are global health priorities. However, risk factors and disease associations in a multiethnic, middle-income country like Malaysia may not be consistent with those reported in other world regions. Knowing the burden of cognitive impairment and its risk factors in Malaysia is necessary for the development of management strategies and would provide valuable information for other transitional economies.

    METHODS AND ANALYSIS: This is a community-based feasibility study focused on the assessment of cognition, embedded in the longitudinal study of health and demographic surveillance site of the South East Asia Community Observatory (SEACO), in Malaysia. In total, 200 adults aged ≥50 years are selected for an in-depth health and cognitive assessment including the Mini Mental State Examination, the Montreal Cognitive Assessment, blood pressure, anthropometry, gait speed, hand grip strength, Depression Anxiety Stress Score and dried blood spots.

    DISCUSSION AND CONCLUSIONS: The results will inform the feasibility, response rates and operational challenges for establishing an ageing study focused on cognitive function in similar middle-income country settings. Knowing the burden of cognitive impairment and dementia and risk factors for disease will inform local health priorities and management, and place these within the context of increasing life expectancy.

    ETHICS AND DISSEMINATION: The study protocol is approved by the Monash University Human Research Ethics Committee. Informed consent is obtained from all the participants. The project's analysed data and findings will be made available through publications and conference presentations and a data sharing archive. Reports on key findings will be made available as community briefs on the SEACO website.

  14. Noor NM, Mustaffa Z, Nizam A, Mohd Zim MA, Ng LWC, Mirza FT
    BMJ Open, 2023 Jul 18;13(7):e068776.
    PMID: 37463801 DOI: 10.1136/bmjopen-2022-068776
    INTRODUCTION: The prevalence of chronic obstructive pulmonary disease (COPD) has been on the rise, with acute exacerbation of COPD associated with the highest burden and multiple pulmonary and systemic consequences. People with COPD have been found to have an abnormal response of systemic inflammation. To date, although limited, there are studies that suggest negative associations between inflammatory markers and important clinical outcomes such as exercise capacity and muscle force. This protocol aims to systematically review the evidence for (i) the associations between inflammatory markers and lung function, muscle force and exercise capacity and (ii) the influence of other factors (eg, hospitalisation, exercise programme) on the level of inflammatory markers in people with COPD.

    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.

  15. Soh YC, Yap KH, McGrattan A, Yasin S, Reidpath D, Siervo M, et al.
    BMJ Open, 2022 Jan 03;12(1):e052175.
    PMID: 34980615 DOI: 10.1136/bmjopen-2021-052175
    INTRODUCTION: Accurate sodium intake estimates in adults with elevated blood pressure are essential for monitoring salt reduction progress and preventing cardiovascular diseases. However, sodium assessments are challenging in this high-risk population because many commonly used antihypertensive drugs alter urinary sodium excretion. Despite the high cost and substantial participant burden of gold-standard 24-hour urine collection, the relative performance of existing spot-urine based equations and dietary self-report instruments have not been well studied in this population, who will benefit from salt restriction. This systematic review aims to describe the current methods of assessing dietary sodium intake in adults with elevated blood pressure and determine what method can provide a valid and accurate estimate of sodium intake compared with the gold standard 24-hour urine collection.

    METHODS AND ANALYSIS: Studies assessing sodium intake in adults aged 18 years and above with reported elevated blood pressure will be included. Five electronic databases (MEDLINE, Embase, Global Health, WoS and Cochrane CENTRAL) will be systematically searched from inception to March 2021. Also, a manual search of bibliographies and grey literature will be conducted. Two reviewers will screen the records independently for eligibility. One reviewer will extract all data, and two others will review the extracted data for accuracy. The methodological quality of included studies will be evaluated based on three scoring systems: (1) National Heart, Lung and Blood Institute for interventional studies; (2) Biomarker-based Cross-sectional Studies for biomarker-based observational studies and (3) European Micronutrient Recommendation Aligned Network of Excellence for validation studies of dietary self-report instruments.

    ETHICS AND DISSEMINATION: As the proposed systematic review will collect and analyse secondary data associated with individuals, there will be no ethical approval requirement. Findings will be disseminated in a peer-reviewed journal or presented at a conference.

    PROSPERO REGISTRATION NUMBER: CRD42020176137.

  16. Mak WY, Ong LM, Goh BL, Bavanandan S, Mushahar L, Leong CT, et al.
    BMJ Open, 2019 03 08;9(3):e024589.
    PMID: 30852538 DOI: 10.1136/bmjopen-2018-024589
    INTRODUCTION: Peritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.

    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.

  17. Sobri NHM, Ismail IZ, Hassan F, Papachristou Nadal I, Forbes A, Ching SM, et al.
    BMJ Open, 2021 08 26;11(8):e044878.
    PMID: 34446477 DOI: 10.1136/bmjopen-2020-044878
    INTRODUCTION: Women who develop gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes, and to reduce this risk the women have to adopt healthy behaviour changes. Although previous studies have explored the challenges and facilitators to initiate behaviour change among women with GDM, there is limited data from Malaysian women. Thus, this study will explore the factors affecting the uptake of healthy behaviour changes and the use of digital technology among women and their healthcare providers (HCPs) to support healthy behaviour changes in women with GDM.

    METHODS AND ANALYSIS: The study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5-8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.

    ETHICS AND DISSEMINATION: The project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.

  18. Balqis-Ali NZ, Saw PS, Jailani AS, Yeoh TW, Fun WH, Mohd-Salleh N, et al.
    BMJ Open, 2020 03 26;10(3):e034128.
    PMID: 32220914 DOI: 10.1136/bmjopen-2019-034128
    INTRODUCTION: Person-centred care (PCC) has become a global movement in healthcare. Despite this, the level of PCC is not routinely assessed in clinical practice. This protocol describes the adaptation and validation of the Person-Centred Practice Inventory-Staff (PCPI-S) tool that will be used to assess person-centred practices of primary healthcare providers in Malaysia.

    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.

    ETHICS AND DISSEMINATION: Study findings will be disseminated to healthcare professionals and academicians in the field through publication in peer-reviewed journals and conference presentations, as well as at managerial clinic sites for practice improvement. The study was approved by the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia (KKM/NIHSEC/ P18-766 (14) and Monash University Human Research Ethics Committee (2018-14363-19627).

  19. Mohan SN, Mukhtar F, Jobson L
    BMJ Open, 2016 Oct 21;6(10):e012774.
    PMID: 27798019 DOI: 10.1136/bmjopen-2016-012774
    INTRODUCTION: Depression is a mood disorder that affects a significant proportion of the population worldwide. In Malaysia and Australia, the number of people diagnosed with depression is on the rise. It has been found that impairments in emotion processing and emotion regulation play a role in the development and maintenance of depression. This study is based on Matsumoto and Hwang's biocultural model of emotion and Triandis' Subjective Culture model. It aims to investigate the influence of culture on emotion processing among Malaysians and Australians with and without major depressive disorder (MDD).

    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.

  20. Sazlina SG, Browning CJ, Yasin S
    BMJ Open, 2012;2(6).
    PMID: 23161092 DOI: 10.1136/bmjopen-2012-002119
    INTRODUCTION: Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care.
    METHODS AND ANALYSIS: A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. ETHICAL AND DISSEMINATION: The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals.
    TRIAL REGISTRATION: This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials.com/ISRCTN71447000/).
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