Displaying publications 1 - 20 of 38 in total

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  1. Al-Jaberi MA, Juni MH, Kadir Shahar H, Ismail SIF, Saeed MA, Ying LP
    JMIR Res Protoc, 2020 Feb 27;9(2):e12950.
    PMID: 32130180 DOI: 10.2196/12950
    BACKGROUND: Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students' attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular.

    OBJECTIVE: This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities.

    METHODS: A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed.

    RESULTS: The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as P

  2. Hu S, Anschuetz L, Huth ME, Sznitman R, Blaser D, Kompis M, et al.
    JMIR Res Protoc, 2019 Jan 09;8(1):e12270.
    PMID: 30626571 DOI: 10.2196/12270
    BACKGROUND: Electroencephalography (EEG) studies indicate possible associations between tinnitus and changes in the neural activity. However, inconsistent results require further investigation to better understand such heterogeneity and inform the interpretation of previous findings.

    OBJECTIVE: This study aims to investigate the feasibility of EEG measurements as an objective indicator for the identification of tinnitus-associated neural activities.

    METHODS: To reduce heterogeneity, participants served as their own control using residual inhibition (RI) to modulate the tinnitus perception in a within-subject EEG study design with a tinnitus group. In addition, comparison with a nontinnitus control group allowed for a between-subjects comparison. We will apply RI stimulation to generate tinnitus and nontinnitus conditions in the same subject. Furthermore, high-frequency audiometry (up to 13 kHz) and tinnitometry will be performed.

    RESULTS: This work was funded by the Infrastructure Grant of the University of Bern, Bern, Switzerland and Bernafon AG, Bern, Switzerland. Enrollment for the study described in this protocol commenced in February 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019.

    CONCLUSIONS: This study design helps in comparing the neural activity between conditions in the same individual, thereby addressing a notable limitation of previous EEG tinnitus studies. In addition, the high-frequency assessment will help to analyze and classify tinnitus symptoms beyond the conventional clinical standard.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/12270.

  3. Ali R, Wan Mohamad Ali WN, Wilson Putit P
    JMIR Res Protoc, 2023 Mar 06;12:e39798.
    PMID: 36877567 DOI: 10.2196/39798
    BACKGROUND: Malaria is still a public health threat. From 2015 to 2021, a total of 23,214 malaria cases were recorded in Malaysia. Thus, effective intervention and key entomological information are vital for interrupting or preventing malaria transmission. Therefore, the availability of malaria vector information is desperately needed.

    OBJECTIVE: The objective of our study is to update the list of human and zoonotic malaria vectors in Malaysia. This work will include (1) the characterization of the key behavioral traits and breeding sites of malaria vectors and (2) the determination of new and potential malaria vectors in Malaysia. The findings of our scoping review will serve as decision-making evidence that stakeholders and decision makers can use to strengthen and intensify malaria surveillance in Malaysia.

    METHODS: The scoping review will be conducted based on the following four electronic databases: Scopus, PubMed, Google Scholar, and Science Direct. A search strategy was conducted for articles published from database inception to March 2022. The criteria for article inclusion were any malaria vector-related studies conducted in Malaysia (with no time frame restrictions) and peer-reviewed studies. The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) will be used to guide our systematic approach. Data from published research literature will be extracted by using a standardized data extraction framework, including the titles, abstracts, characteristics, and main findings of the included studies. To assess the risk of bias, articles will be screened independently by 2 reviewers, and a third reviewer will make the final decision if disagreements occur.

    RESULTS: The study commenced in June 2021, and it is planned to be completed at end of 2022. As of early 2022, we identified 631 articles. After accessing and evaluating the articles, 48 were found to be eligible. Full-text screening will be conducted in mid-2022. The results of the scoping review will be published as an open-access article in a peer-reviewed journal.

    CONCLUSIONS: Our novel scoping review of malaria vectors in Malaysia will provide a comprehensive evidence summary of updated, relevant information. An understanding of the status of Anopheles as malaria vectors and the knowledge generated from the behavioral characteristics of malaria vectors are the key components in making effective interventions for eliminating malaria.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39798.

  4. Thai JY, McCaffrey T, Ramadas A, Chandrasekara D, Koh SGM, Choi TST, et al.
    JMIR Res Protoc, 2022 Dec 05;11(12):e39238.
    PMID: 36469407 DOI: 10.2196/39238
    BACKGROUND: Chronic diseases and the associated risk factors are preventable with lifestyle changes such as eating a healthier diet and being more physically active. In Malaysia, the prevalence of chronic diseases, including diabetes, hypertension, and heart diseases, has risen. In the present study, we explore the potential of co-designing and implementing a digital wellness intervention to promote socially-driven health knowledge and practices in the workplace in Malaysia, drawing on social cognitive theory, social impact theory, and social influence theory.

    OBJECTIVE: This study aims to co-design and assess the feasibility of a socially-driven digital health intervention to promote healthy behavior and prevent chronic diseases in a workplace in Malaysia.

    METHODS: This study involves two phases: (i) identifying the barriers and facilitators to healthy behaviors at work and co-designing the intervention activities with the employees, (ii) implementing and evaluating the intervention's feasibility. Phase 1 will involve qualitative data collection and analysis through semi-structured, in-depth interviews and co-design workshops with the employees, while Phase 2 will consist of a feasibility study employing quantitative measurements of health behaviors through accelerometers and questionnaires.

    RESULTS: This study was funded in June 2021 and ethics approval for Phase 1 was obtained from the Monash University Human Research Ethics Committee in January 2022. As of August 2022, qualitative interviews with 12 employees have been completed and the data has been transcribed and analyzed. These results will be published in a future paper with results from all Phase 1 activities.

    CONCLUSIONS: The study will help us to better understand the mechanisms through which digital technologies can promote socially-driven health knowledge and behaviors. This research will also result in a scalable wellness intervention that could be further tailored and expanded to other employers and social groups across the region.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39238.

  5. Sapari H, Selamat MI, Isa MR, Ismail R, Wan Mahiyuddin WR
    JMIR Res Protoc, 2023 Oct 16;12:e44702.
    PMID: 37843898 DOI: 10.2196/44702
    BACKGROUND: Heat waves significantly impact ecosystems and human health, especially that of vulnerable populations, and are associated with increased morbidity and mortality. Besides being directly related to climate-sensitive health outcomes, heat waves have indirectly increased the burden on our health care systems. Although the existing literature examines the impact of heat waves and morbidity, past research has mostly been conducted in high-income countries (HICs), and studies on the impact of heat waves on morbidity in low- or middle-income countries (LMICs) are still scarce.

    OBJECTIVE: This paper presents the protocol for a systematic review that aims to provide evidence of the impact of heat waves on health care services in LMICs.

    METHODS: We will identify peer-reviewed studies from 3 online databases, including the Web of Science, PubMed, and SCOPUS, published from January 2002 to April 2023, using the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Quality assessment will be conducted using the Navigation Guide checklist. Key search terms include heatwaves, extreme heat, hospitalization, outpatient visit, burden, health services, and morbidity.

    RESULTS: This systematic review will provide insight into the impact of heat waves on health care services in LMICs, especially on emergency department visits, ambulance call-outs, hospital admissions, outpatient department visits, in-hospital mortality, and health care operational costs.

    CONCLUSIONS: The results of this review are anticipated to help policymakers and key stakeholders obtain a better understanding of the impact of heat waves on health care services and prioritize investments to mitigate the effects of heat waves in LMICs. This entails creating a comprehensive heat wave plan and ensuring that adequate infrastructure, capacity, and human resources are allocated in the health care sector. These measures will undoubtedly contribute to the development of resilience in health care systems and hence protect the health and well-being of individuals and communities.

    TRIAL REGISTRATION: PROSPERO CRD42022365471; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=365471.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44702.

  6. Andiesta NS, Hamid MA, Lee K, Pau A
    JMIR Res Protoc, 2018 Jun 06;7(6):e10053.
    PMID: 29875086 DOI: 10.2196/10053
    BACKGROUND: In 2012, nearly 4000 children in Malaysia were referred to hospital pediatric dental services due to dental caries. Recent research has reported the effectiveness of dental home visits in preventing caries development in young children. Dental home visits (DHVs) are described as an ongoing relationship between the dentist and their patients, providing all aspects of a preventive oral health care program in the presence of the parents at home.

    OBJECTIVE: The objective of this study is to evaluate the cost-effectiveness of dental home visits and oral health information, in the form of educational leaflets, in preventing new caries development in young children, compared to those receiving only educational leaflets over a period of two years. Cost-effectiveness analysis will be used to evaluate the cost-effectiveness of dental home visits.

    METHODS: This is a collaborative project with the Oral Health Division of the Ministry of Health Malaysia. The Oral Health Division will provide access to a subsample from the National Oral Health of Preschoolers Survey which was carried out in 2015. The population of interest is children aged 5 and 6 years from kindergartens in the Selangor state of Malaysia. The study adopted a societal perspective for cost-effectiveness analysis and all types of resources that are of value to society will be included in analyzing the costs; such as cost to the patient, cost to the provider or institution, and indirect costs because of loss of productivity.

    RESULTS: The trial has been approved by the International Medical University Malaysia's Joint Research and Ethics Committee (Project ID: IMU R157-2014 [File III - 2016]). This trial is currently recruiting participants.

    CONCLUSIONS: The number of young children in Malaysia who have been referred to the hospital children's dentistry service for severe caries is disturbing. The cost of dental treatment in young children is high due to the severity of the caries which require an aggressive treatment, and the need for general anesthesia or sedation. This study will provide information on the cost and effectiveness of DHVs in caries prevention of young children in Malaysia.

    REGISTERED REPORT IDENTIFIER: RR1-10.2196/10053.

  7. Ramli AS, Qureshi N, Abdul-Hamid H, Kamal A, Kanchau JD, Shahuri NS, et al.
    JMIR Res Protoc, 2023 Jun 02;12:e47911.
    PMID: 37137823 DOI: 10.2196/47911
    BACKGROUND: Familial hypercholesterolemia (FH) is predominantly caused by mutations in the 4 FH candidate genes (FHCGs), namely, low-density lipoprotein receptor (LDLR), apolipoprotein B-100 (APOB-100), proprotein convertase subtilisin/kexin type 9 (PCSK9), and the LDL receptor adaptor protein 1 (LDLRAP1). It is characterized by elevated low-density lipoprotein cholesterol (LDL-c) levels leading to premature coronary artery disease. FH can be clinically diagnosed using established clinical criteria, namely, Simon Broome (SB) and Dutch Lipid Clinic Criteria (DLCC), and can be identified using the Familial Hypercholesterolemia Case Ascertainment Tool (FAMCAT), a primary care screening tool.

    OBJECTIVE: This study aims to (1) compare the detection rate of genetically confirmed FH and diagnostic accuracy between the FAMCAT, SB, and DLCC in the Malaysian primary care setting; (2) identify the genetic mutation profiles, including novel variants, in individuals with suspected FH in primary care; (3) explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing in primary care; and (4) evaluate the clinical utility of a web-based FH Identification Tool that includes the FAMCAT, SB, and DLCC in the Malaysian primary care setting.

    METHODS: This is a mixed methods evaluation study conducted in 11 Ministry of Health primary care clinics located at the central administrative region of Malaysia. In Work stream 1, the diagnostic accuracy study design is used to compare the detection rate and diagnostic accuracy of the FAMCAT, SB, and DLCC against molecular diagnosis as the gold standard. In Work stream 2, the targeted next-generation sequencing of the 4 FHCGs is used to identify the genetic mutation profiles among individuals with suspected FH. In Work stream 3a, a qualitative semistructured interview methodology is used to explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing. Lastly, in Work stream 3b, a qualitative real-time observation of primary care physicians using the "think-aloud" methodology is applied to evaluate the clinical utility of a web-based FH Identification Tool.

    RESULTS: The recruitment for Work stream 1, and blood sampling and genetic analysis for Work stream 2 were completed in February 2023. Data collection for Work stream 3 was completed in March 2023. Data analysis for Work streams 1, 2, 3a, and 3b is projected to be completed by June 2023, with the results of this study anticipated to be published by December 2023.

    CONCLUSIONS: This study will provide evidence on which clinical diagnostic criterion is the best to detect FH in the Malaysian primary care setting. The full spectrum of genetic mutations in the FHCGs including novel pathogenic variants will be identified. Patients' perspectives while undergoing genetic testing and the primary care physicians experience in utilizing the web-based tool will be established. These findings will have tremendous impact on the management of patients with FH in primary care and subsequently reduce their risk of premature coronary artery disease.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47911.

  8. Omar SA, Zulkefly NS, Mukhtar F
    JMIR Res Protoc, 2024 Mar 14;13:e53692.
    PMID: 38483466 DOI: 10.2196/53692
    BACKGROUND: Globally, traumatic brain injury (TBI) is recognized as one of the most significant contributors to mortality and disability. Most of the patients who have experienced TBI will be discharged home and reunited with their families or primary caregivers. The degree of severity of their reliance on caregivers varies. Therefore, the task of delivering essential care to the patients becomes demanding for the caregivers. A significant proportion of caregivers expressed considerable burden, distress, and discontentment with their lives. Therefore, it is critical to comprehend the dynamic of TBI and caregivers to optimize patient care, rehabilitation, and administration. The effectiveness of the Brain Injury Family Intervention (BIFI) program tailored for caregivers of patients with TBI has been widely proven in Western countries. However, the impact is less clear among caregivers of patients with TBI in Malaysia.

    OBJECTIVE: This study aims to assess the effectiveness of BIFI in reducing emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of caregivers of patients with TBI at government hospitals in Malaysia.

    METHODS: This is a 2-arm, single-blinded, randomized controlled trial. It will be conducted at Hospital Rehabilitasi Cheras and Hospital Sungai Buloh. In total, 100 caregivers of patients with TBI attending the neurorehabilitation unit will be randomized equally to the intervention and control groups. The intervention group will undergo the BIFI program, whereas the control group will receive standard treatment. Caregivers aged ≥18 years, caring for patients who have completed >3 months after the injury, are eligible to participate. The BIFI program will be scheduled for 5 sessions as recommended by the developer of the module. Each session will take approximately 90 to 120 minutes. The participants are required to attend all 5 sessions. A total of 5 weeks is needed for each group to complete the program. Self-reported questionnaires (ie, Beck Depression Inventory, Positive and Negative Affect Schedule, Caregiver Strain Index, Satisfaction With Life Scale, and Family Needs Questionnaire) will be collected at baseline, immediately after the intervention program, at 3-month follow-up, and at 6-month follow-up. The primary end point is the caregivers' emotional distress.

    RESULTS: The participant recruitment process began in January 2019 and was completed in December 2020. In total, 100 participants were enrolled in this study, of whom 70 (70%) caregivers are women and 30 (30%) are men. We are currently at the final stage of data analysis. The results of this study are expected to be published in 2024. Ethics approval has been obtained.

    CONCLUSIONS: It is expected that the psychological well-being of the intervention group will be better compared with that of the control group after the intervention at 3-month follow-up and at 6-month follow-up.

    TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180809040746N1; https://irct.behdasht.gov.ir/trial/33286.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53692.

  9. Mohamad ZA, Bakon SK, Jamilan MAJ, Daud N, Ciric L, Ahmad N, et al.
    JMIR Res Protoc, 2022 Nov 21;11(11):e37663.
    PMID: 36409546 DOI: 10.2196/37663
    BACKGROUND: Antimicrobial resistance is a known global public health threat. In addition, it brings serious economic consequences to agriculture. Antibiotic resistance in humans, animals, and environment is interconnected, as proposed in the tricycle surveillance by the World Health Organization. In Malaysia, research and surveillance of antimicrobial resistance are mainly performed in clinical samples, agricultural settings, and surface waters, but no surveillance of the drinking water systems has been performed yet. Hence, this policy-driven study is a combined effort of microbiologists and engineers to provide baseline data on the magnitude of antimicrobial resistance in the drinking water systems of Malaysia.

    OBJECTIVE: The aim of this study was to study the baseline level of antibiotic-resistant bacteria in the drinking water distribution systems of Malaysia by collecting samples from the pretreatment and posttreatment outlets of water treatment plants in a selected state of Malaysia. We aimed to determine the prevalence of antibiotic-resistant bacteria, the occurrence of antibiotic-resistant genes, and the level of antibiotics present in the drinking water systems.

    METHODS: This is a laboratory-based, cross-sectional study in a selected state of Malaysia. Water samples from 6 drinking water treatment plants were collected. Samples were collected at 3 sampling points, that is, the intake sampling station, service reservoir outlet station, and the distribution system sampling station. These were tested against 7 types of antibiotics in triplicates. Samples were screened for antibiotic-resistant bacteria and antibiotic-resistant genes and quantified for the level of antibiotics present in the drinking water treatment plants.

    RESULTS: We will show the descriptive statistics of the number of bacterial colonies harvested from water samples grown on Reasoner's 2A agar with or without antibiotics, the occurrence of antibiotic-resistant genes, and the level of antibiotics detected in the water samples. The sampling frame was scheduled to start from November 2021 and continue until December 2022. Data analysis is expected to be completed by early 2023, and the results are expected to be published in mid-2023.

    CONCLUSIONS: This study provides baseline information on the status of the antimicrobial-resistant bacteria, the presence of resistance genes as contaminants, and the level of antibiotics present in the drinking water systems of Malaysia, with the aim of demonstrating to policymakers the need to consider antimicrobial resistance as a parameter in drinking water surveillance.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37663.

  10. Bakon SK, Mohamad ZA, Jamilan MA, Hashim H, Kuman MY, Shaharudin R, et al.
    JMIR Res Protoc, 2023 May 29;12:e39022.
    PMID: 37247207 DOI: 10.2196/39022
    BACKGROUND: Antimicrobial resistance (AMR) has emerged as a major global public health challenge due to the overuse and misuse of antibiotics for humans and animals. Hospitals are among the major users of antibiotics, thereby having a large contribution to AMR.

    OBJECTIVE: The aim of this study is to determine the prevalence of antibiotic-resistant pathogenic bacteria and the level of antibiotic residues in the hospital effluents in Selangor, Malaysia.

    METHODS: A cross-sectional study will be performed in the state of Selangor, Malaysia. Tertiary hospitals will be identified based on the inclusion and exclusion criteria. The methods are divided into three phases: sample collection, microbiological analysis, and chemical analysis. Microbiological analyses will include the isolation of bacteria from hospital effluents by culturing on selective media. Antibiotic sensitivity testing will be performed on the isolated bacteria against ceftriaxone, ciprofloxacin, meropenem, vancomycin, colistin, and piperacillin/tazobactam. The identification of bacteria will be confirmed using 16S RNA polymerase chain reaction (PCR) and multiplex PCR will be performed to detect resistance genes (ermB, mecA, blaNDM-L, blaCTX-M, blaOXA-48, blaSHV, VanA, VanB, VanC1, mcr-1, mcr-2, mcr-3, Intl1, Intl2, and qnrA). Finally, the level of antibiotic residues will be measured using ultrahigh-performance liquid chromatography.

    RESULTS: The expected outcomes will be the prevalence of antibiotic-resistant Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter (ESKAPE) bacterial species from the hospital effluents, the occurrence of antibiotic resistance genes (ARGs) from the isolated ESKAPE bacteria, and the level of antibiotic residues that may be detected from the effluent. Sampling has been conducted in three hospitals. Data analysis from one hospital showed that as of July 2022, 80% (8/10) of E. faecium isolates were resistant to vancomycin and 10% (1/10) were resistant to ciprofloxacin. Further analysis will be conducted to determine if the isolates harbor any ARGs and effluent samples are being analyzed to detect antibiotic residues. Sampling activities will be resumed after being suspended due to the COVID-19 pandemic and are scheduled to end by December 2022.

    CONCLUSIONS: This study will provide the first baseline information to elucidate the current status of AMR of highly pathogenic bacteria present in hospital effluents in Malaysia.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39022.

  11. Ibrahim Y, Basri NI, Nordin N, Mohd Jamil AA
    JMIR Res Protoc, 2024 Mar 26;13:e53722.
    PMID: 38530345 DOI: 10.2196/53722
    BACKGROUND: Vitamin D deficiency has been associated with hypertensive disorders in pregnancy (HDP). The risk of developing HDP was reported to be further augmented among individuals with a vitamin D receptor (VDR) genetic variant. However, the reported roles of VDR variants in hypertensive disorders are inconsistent among different populations. Given the relatively higher incidence of vitamin D deficiency among Malaysian pregnant women and the high incidence of HDP in this population, we hypothesize that there may be associations between the risk of vitamin D deficiency and HDP with VDR genetic variants.

    OBJECTIVE: This paper outlines the protocol for a study to determine the association of vitamin D status and VDR sequence variants among Malaysian pregnant women with HDP.

    METHODS: This prospective study consists of two phases. The first phase is a cross-sectional study that will entail gathering medical records, a questionnaire survey, and laboratory testing for vitamin D status, with a planned recruitment of 414 pregnant women. The questionnaire will be utilized to assess the risk factors for vitamin D deficiency. The vitamin D status will be obtained from measurement of the vitamin D (25-hydroxyvitamin D3) level in the blood. The second phase is a case-control study involving a Malay ethnic cohort with vitamin D deficiency. Participants will be divided into two groups with and without HDP (n=150 per group). Genomic DNA will be extracted from the peripheral blood monocytes of participants using the Qiagen DNA blood kit, and VDR sequence variants will be determined using polymerase chain reaction-high-resolution melting (PCR-HRM) analysis. Sanger sequencing will then be used to sequence randomly selected samples corresponding to each identified variant to validate our PCR-HRM results. The VDR genotype and mutation frequencies of BsmI, ApaI, TaqI, and FokI will be statistically analyzed to evaluate their relationships with developing HDP.

    RESULTS: As of December 2023, 340 subjects have been recruited for the phase 1 study, 63% of whom were determined to have vitamin D deficiency. In the phase 2 study, 50 and 22 subjects have been recruited from the control and case groups, respectively. Recruitment is expected to be completed by March 2024 and all analyses should be completed by August 2024.

    CONCLUSIONS: The outcome of the study will identify the nonmodifiable genetic components contributing to developing vitamin D deficiency leading to HDP. This will in turn enable gaining a better understanding of the contribution of genetic variability to the development of HDP, thus providing more evidence for a need of customized vitamin D supplementation during pregnancy according to the individual variability in the response to vitamin D intake.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT05659173; https://clinicaltrials.gov/study/NCT05659173.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53722.

  12. Abang Abdullah AF, Muhamad NA, Ab Ghani RM, Maamor NH, Leman FN, Too CL, et al.
    JMIR Res Protoc, 2023 Jun 26;12:e46816.
    PMID: 37358892 DOI: 10.2196/46816
    BACKGROUND: Allergic diseases affect around 40% of the pediatric population worldwide. The coexistence of asthma, allergic rhinitis, eczema, and food allergy renders allergy treatment and prevention challenging. Infant feeding strategies recommend avoiding allergenic foods to prevent allergy development and anaphylaxis. However, recent evidence suggests that early consumption of food allergens during weaning in infants aged 4-6 months could result in food tolerance, thus reducing the risk of developing allergies.

    OBJECTIVE: The aim of this study is to systematically review and carry out a meta-analysis of evidence on the outcome of early food introduction for preventing childhood allergic diseases.

    METHODS: We will conduct a systematic review of interventions through a comprehensive search of various databases including PubMed, Embase, Scopus, CENTRAL, PsycINFO, CINAHL, and Google Scholar to identify potential studies. The search will be performed for any eligible articles from the earliest published articles up to the latest available studies in 2023. We will include randomized controlled trials (RCTs), cluster RCTs, non-RCTs, and other observational studies that assess the effect of early food introduction to prevent childhood allergic diseases.

    RESULTS: Primary outcomes will include measures related to the effect of childhood allergic diseases (ie, asthma, allergic rhinitis, eczema, and food allergy). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for study selection. All data will be extracted using a standardized data extraction form and the quality of the studies will be assessed using the Cochrane Risk of Bias tool. A summary of findings table will be generated for the following outcomes: (1) total number of allergic diseases, (2) rate of sensitization, (3) total number of adverse events, (4) improvement of health-related quality of life, and (5) all-cause mortality. Descriptive and meta-analyses will be performed using a random-effects model in Review Manager (Cochrane). Heterogeneity among selected studies will be assessed using the I2 statistic and explored through meta-regression and subgroup analyses. Data collection is expected to start in June 2023.

    CONCLUSIONS: The results acquired from this study will contribute to the existing literature and harmonize recommendations for infant feeding with regard to the prevention of childhood allergic diseases.

    TRIAL REGISTRATION: PROSPERO CRD42021256776; https://tinyurl.com/4j272y8a.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46816.

  13. Omar N, Shafiee SI, Nor'hisham SH, Ibrahim Z, Jamaluddin R, Rahamat S, et al.
    JMIR Res Protoc, 2023 Jan 31;12:e42496.
    PMID: 36719732 DOI: 10.2196/42496
    BACKGROUND: Geriatric malnutrition in hospitals is common and can be affected by many things, including poor satisfaction toward hospital foodservice. Hospital foodservice plays an important role in a patient's recovery process by providing adequate nutrients. On top of that, patients' foodservice satisfaction can easily be afflicted by the quality of food served and the overall foodservice experience. Furthermore, malnutrition can occur from poor foodservice quality, especially among geriatric patients.

    OBJECTIVE: This study aims to assess the effectiveness of the Malaysian Geriatric Patients' Hospital Foodservice Protocol (MYGERYFS).

    METHODS: The protocol comprises 3 phases. Phase One is a cross-sectional study that took place at public hospitals with geriatric wards in the Klang Valley. Univariate data from Phase One were analyzed descriptively. Pearson correlation and chi-square were conducted to find factors associated with foodservice satisfaction. Phase Two involves the collaboration of health care professionals in the geriatric field. In Phase Three, a feasibility study will be conducted to determine the feasibility of the MYGERYFS protocol in a hospital among 60 geriatric patients. These patients will be randomized into control and intervention groups, respectively. Intervention care will be done to ensure the safety of the protocol.

    RESULTS: Data collection for Phase One of the study has been completed. A total of 233 geriatric respondents with the mean age of 71.39 (SD 7.99) years were gathered. Approximately 51.5% (n=120) of the respondents were female, while 48.5% (n=113) were male, with a mean BMI of 24.84 (SD 6.05) kg/m2. Their mean energy and protein intakes were 1006.20 kcal (SD 462.03 kcal) and 42.60 (SD 22.20) grams, respectively. Based on the Mini Nutritional Assessment, older patients who scored 12-14 (normal) were 27.9% (n=65), those who scored 8-11 (at risk) were 54.9% (n=128), and those who scored 0-7, which is the lowest (malnutrition), were 17.2% (n=40) of the study population. Hence, most patients were at risk of malnutrition. Although a majority of the patients claimed to have good foodservice satisfaction 26.2% (n=61), they also experienced at least 3 barriers during mealtimes. It was found that dietary intake and mealtime barriers were significantly associated with the respondent's foodservice satisfaction. Data for Phase Two and Phase Three are yet to be collected and analyzed.

    CONCLUSIONS: This study protocol could potentially benefit the hospital foodservice system and aid in improving geriatric nutritional status.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT04858165; https://clinicaltrials.gov/ct2/show/NCT04858165.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/42496.

  14. Mohd Saad N, Mohamad M, Mat Ruzlin AN
    JMIR Res Protoc, 2024 Jan 31;13:e48313.
    PMID: 38294848 DOI: 10.2196/48313
    BACKGROUND: In adults with type 2 diabetes (T2D), weight loss can improve hemoglobin A1c, blood pressure, and triglycerides, and reduce the frequency of medications needed. Unfortunately, a large proportion of these individuals are not ready to initiate weight efforts, making existing obesity management strategies less effective. Many digital health interventions aim at weight loss, but there is still limited evidence on their effectiveness in changing weight loss behavior, especially in adults with T2D.

    OBJECTIVE: This study aims to develop and validate "Chance2Act," a new web-based intervention, designed specifically to facilitate behavioral change in adults with T2D with obesity who are not ready to act toward weight loss. Then, the effectiveness of the newly developed intervention will be determined from a nonrandomized controlled trial.

    METHODS: A web-based intervention will be developed based on the Transtheoretical Model targeting adults with T2D with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a nonrandomized controlled trial will be conducted in 2 government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (ie, intervention vs control [usual care] with an allocation ratio of 1:1). A total of 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes in an individual's readiness from a stage of not being ready to change (precontemplation, contemplation, or preparation stage) to being ready for weight loss (action stage). The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition.

    RESULTS: The phase 1 study will reveal the intervention's validity through the Content Validity Index and Face Validity Index, considering it valid if both indices exceed 0.83. The effectiveness of the intervention will be determined in phase 2, where the differences within and between groups will be analyzed in terms of the improvement of stages of change and all secondary outcomes as defined in the methodology. Data analysis for phase 2 will commence in 2024, with the anticipated publication of results in March 2024.

    CONCLUSIONS: If proven effective, the result of the study may give valuable insights into the effective behavioral modification strategies for a web-based intervention targeting adults with T2D with obesity but not yet ready to change for weight loss. This intervention may be replicated or adopted in different settings, focusing on behavioral modification support that patients need. This study offers a deeper understanding of the application of behavior change techniques for a more holistic approach to obesity care in T2D.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48313.

  15. Oakley-Girvan I, Watterson JL, Jones C, Houghton LC, Gibbons MP, Gokal K, et al.
    JMIR Res Protoc, 2021 Jul 30;10(7):e28147.
    PMID: 34328445 DOI: 10.2196/28147
    BACKGROUND: Social cohesion is associated with healthier behaviors and better health outcomes, and therefore may offer a mechanism for promoting better health. Low socioeconomic status (SES) communities face higher rates of chronic disease due to both community- and individual-level factors.

    OBJECTIVE: The aim of this study is to leverage social cohesion to promote healthier behaviors and prevent chronic disease in a low SES community. This protocol outlines the methodology for a pilot study to assess the feasibility of an intervention (Free Time For Wellness [FT4W]) using a social networking platform (Nextdoor) with mothers living in an urban, low-income community to improve social cohesion and promote healthy behaviors.

    METHODS: The study will involve three phases: (I) co-designing the intervention with mothers in the neighborhoods of interest, (II) implementing the intervention with community leaders through the social networking platform, and (III) evaluating the intervention's feasibility. Phase I of the study will include qualitative data collection and analysis from in-depth, semistructured interviews and a co-design group session with mothers. Phases II and III of the study include a pre- and postintervention survey of participating mothers. Neighborhood-level data on social cohesion will also be collected to enable comparison of outcomes between neighborhoods with higher and lower baseline social cohesion.

    RESULTS: As of March 2021, recruitment and data collection for this study are complete. This protocol outlines our original study plan, although the final enrollment numbers and intervention implementation deviated from our initial planned methodology that is outlined in this protocol. These implementation learnings will be shared in subsequent publications of our study results.

    CONCLUSIONS: Ultimately, this study aims to: (1) determine the barriers and facilitators to finding free time for wellness among a population of low-income mothers to inform the co-design process, and (2) implement and study the feasibility of an intervention that leverages social cohesion to promote physical activity in a community of low-income mothers. The results of this study will provide preliminary feasibility evidence to inform a larger effectiveness trial, and will further our understanding of how social cohesion might influence well-being.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/28147.

  16. Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, et al.
    JMIR Res Protoc, 2019 Sep 27;8(9):e13176.
    PMID: 31573942 DOI: 10.2196/13176
    BACKGROUND: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus.

    OBJECTIVE: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes.

    METHODS: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)-marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported.

    RESULTS: This study protocol was approved by the Tallaght University Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020.

    CONCLUSIONS: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13176.

  17. Jinah N, Abdullah Sharin I, Bakit P, Adnan IK, Lee KY
    JMIR Res Protoc, 2024 Jan 08;13:e52938.
    PMID: 38190235 DOI: 10.2196/52938
    BACKGROUND: The global shortage and maldistribution of health care workers, especially medical doctors, pose a significant threat to achieving the United Nations' sustainable development goal 3 of ensuring well-being and healthy lives for all. Low- and middle-income countries (LMICs) are disproportionately affected by this crisis, with a high rate of brain drain from rural to urban areas, as well as to high-income countries. Various retention strategies have been implemented in different settings and organizations. However, their effectiveness remains underexplored, particularly in LMICs.

    OBJECTIVE: We aim to review the available retention strategies for medical doctors in LMICs and to determine the effectiveness of the various strategies. This review aims to compile relevant research findings on this issue to generate a thorough summary of all the retention strategies practiced in LMICs and, more importantly, to provide the current state of evidence of the effectiveness of these strategies in retaining medical doctors in countries with limited resources and high disease burden.

    METHODS: The structured framework given by Arksey and O'Malley will serve as the basis for conducting this scoping review. A comprehensive search strategy will be conducted across 4 electronic databases (PubMed, EBSCOHost, Scopus, and ScienceDirect). A systematic approach following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines will be executed to search, screen, review, and extract data from studies that meet predefined inclusion criteria. Data encompassing bibliographical information, study location, retention strategies, influencing factors, and outcomes (effectiveness) will be obtained from the selected studies using standardized data extraction. Endnote and Microsoft Excel will be used for reference management and removal of duplicate studies. A narrative synthesis will be performed after categorizing and analyzing all the extracted data to identify recurrent themes.

    RESULTS: This ongoing review will generate a comprehensive compilation of retention strategies implemented in LMICs to prevent brain drain among medical doctors. Data extraction is currently in progress, and completion is expected by early 2024. Themes regarding the types of strategies, influencing factors, and outcomes will be synthesized. The findings will highlight effective retention strategies, gaps, and challenges in implementation for the benefits of future research. By identifying common barriers and facilitators, this review will provide insights into enhancing the policies and initiatives for doctor retention in LMICs.

    CONCLUSIONS: This scoping review explores the retention strategies practiced in LMICs and attempts to identify effective strategies from existing research. By evaluating the barriers and challenges that influence the effectiveness of these strategies, policymakers and health care leaders can strive to obtain balanced and optimal health human resources in their respective organizations and countries.

    TRIAL REGISTRATION: Malaysian National Medical Research Register (NMRR) ID-23-01994-OGW; https://nmrr.gov.my/research-directory/ac4f5b88-8619-4b2b-b6c7-9abcef65fdcd.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52938.

  18. Cooper H, Nadzri FZM, Vyas S, Juhari R, Ismail N, Arshat Z, et al.
    JMIR Res Protoc, 2024 Apr 26;13:e55491.
    PMID: 38669679 DOI: 10.2196/55491
    BACKGROUND: The United Nations' Sustainable Development Goal 4, and particularly target 4.2, which seeks to ensure that, by 2030, all children have access to quality early childhood development, care, and preprimary education so that they are ready for primary education, is far from being achieved. The COVID-19 pandemic compromised progress by disrupting education, reducing access to well-being resources, and increasing family violence. Evidence from low- and middle-income countries suggests that in-person parenting interventions are effective at improving child learning and preventing family violence. However, scaling up these programs is challenging because of resource constraints. Integrating digital and human-delivered intervention components is a potential solution to these challenges. There is a need to understand the feasibility and effectiveness of such interventions in low-resource settings.

    OBJECTIVE: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components.

    METHODS: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers' use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders.

    RESULTS: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024.

    CONCLUSIONS: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention.

    TRIAL REGISTRATION: OSF Registries; https://osf.io/f32ky.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55491.

  19. Whitton C, Healy JD, Collins CE, Mullan B, Rollo ME, Dhaliwal SS, et al.
    JMIR Res Protoc, 2021 Dec 16;10(12):e32891.
    PMID: 34924357 DOI: 10.2196/32891
    BACKGROUND: The assessment of dietary intake underpins population nutrition surveillance and nutritional epidemiology and is essential to inform effective public health policies and programs. Technological advances in dietary assessment that use images and automated methods have the potential to improve accuracy, respondent burden, and cost; however, they need to be evaluated to inform large-scale use.

    OBJECTIVE: The aim of this study is to compare the accuracy, acceptability, and cost-effectiveness of 3 technology-assisted 24-hour dietary recall (24HR) methods relative to observed intake across 3 meals.

    METHODS: Using a controlled feeding study design, 24HR data collected using 3 methods will be obtained for comparison with observed intake. A total of 150 healthy adults, aged 18 to 70 years, will be recruited and will complete web-based demographic and psychosocial questionnaires and cognitive tests. Participants will attend a university study center on 3 separate days to consume breakfast, lunch, and dinner, with unobtrusive documentation of the foods and beverages consumed and their amounts. Following each feeding day, participants will complete a 24HR process using 1 of 3 methods: the Automated Self-Administered Dietary Assessment Tool, Intake24, or the Image-Assisted mobile Food Record 24-Hour Recall. The sequence of the 3 methods will be randomized, with each participant exposed to each method approximately 1 week apart. Acceptability and the preferred 24HR method will be assessed using a questionnaire. Estimates of energy, nutrient, and food group intake and portion sizes from each 24HR method will be compared with the observed intake for each day. Linear mixed models will be used, with 24HR method and method order as fixed effects, to assess differences in the 24HR methods. Reporting bias will be assessed by examining the ratios of reported 24HR intake to observed intake. Food and beverage omission and intrusion rates will be calculated, and differences by 24HR method will be assessed using chi-square tests. Psychosocial, demographic, and cognitive factors associated with energy misestimation will be evaluated using chi-square tests and multivariable logistic regression. The financial costs, time costs, and cost-effectiveness of each 24HR method will be assessed and compared using repeated measures analysis of variance tests.

    RESULTS: Participant recruitment commenced in March 2021 and is planned to be completed by the end of 2021.

    CONCLUSIONS: This protocol outlines the methodology of a study that will evaluate the accuracy, acceptability, and cost-effectiveness of 3 technology-enabled dietary assessment methods. This will inform the selection of dietary assessment methods in future studies on nutrition surveillance and epidemiology.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000209897; https://tinyurl.com/2p9fpf2s.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32891.

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