Displaying publications 1 - 20 of 38 in total

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  1. Ab Kadir MA, Abdul Manaf R, Mokhtar SA, Ismail LI
    JMIR Res Protoc, 2023 May 15;12:e43712.
    PMID: 37184897 DOI: 10.2196/43712
    BACKGROUND: Leptospirosis is considered a neglected zoonotic disease in temperate regions but an endemic disease in countries with tropical climates such as South America, Southern Asia, and Southeast Asia. There has been an increase in leptospirosis incidence in Malaysia from 1.45 to 25.94 cases per 100,000 population between 2005 and 2014. With increasing incidence in Selangor, Malaysia, and frequent climate change dynamics, a study on the disease hotspot areas and their association with the hydroclimatic factors would further enhance disease surveillance and public health interventions.

    OBJECTIVE: This study aims to examine the association between the spatio-temporal distribution of leptospirosis hotspot areas from 2011 to 2019 with the hydroclimatic factors in Selangor using the geographical information system and remote sensing techniques to develop a leptospirosis hotspot predictive model.

    METHODS: This will be an ecological cross-sectional study with geographical information system and remote sensing mapping and analysis concerning leptospirosis using secondary data. Leptospirosis cases in Selangor from January 2011 to December 2019 shall be obtained from the Selangor State Health Department. Laboratory-confirmed cases with data on the possible source of infection would be identified and georeferenced according to their longitude and latitudes. Topographic data consisting of subdistrict boundaries and the distribution of rivers in Selangor will be obtained from the Department of Survey and Mapping. The ArcGIS Pro software will be used to evaluate the clustering of the cases and mapped using the Getis-Ord Gi* tool. The satellite images for rainfall and land surface temperature will be acquired from the Giovanni National Aeronautics and Space Administration EarthData website and processed to obtain the average monthly values in millimeters and degrees Celsius. Meanwhile, the average monthly river hydrometric levels will be obtained from the Department of Drainage and Irrigation. Data are then inputted as thematic layers and in the ArcGIS software for further analysis. The artificial neural network analysis in artificial intelligence Phyton software will then be used to obtain the leptospirosis hotspot predictive model.

    RESULTS: This research was funded as of November 2022. Data collection, processing, and analysis commenced in December 2022, and the results of the study are expected to be published by the end of 2024. The leptospirosis distribution and clusters may be significantly associated with the hydroclimatic factors of rainfall, land surface temperature, and the river hydrometric level.

    CONCLUSIONS: This study will explore the associations of leptospirosis hotspot areas with the hydroclimatic factors in Selangor and subsequently the development of a leptospirosis predictive model. The constructed predictive model could potentially be used to design and enhance public health initiatives for disease prevention.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43712.

  2. 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.

  3. Abd Kadir NA, Azzeri A, Jaafar H, Mohd Noor MI, Kefeli Z
    JMIR Res Protoc, 2024 Jan 29;13:e51851.
    PMID: 38285500 DOI: 10.2196/51851
    BACKGROUND: Protected areas are crucial for the maintenance of human health and well-being. They aim to preserve biodiversity and natural resources to secure various ecosystem services that are beneficial to human health. Their ecological characteristics can influence local health literacy. Typically, communities surrounding protected areas have limited economic opportunities due to restriction policies to protect the ecosystem, resulting in socioeconomic disparities. The local community faces obstacles in gaining access to health care facilities and health information due to these limitations. It is difficult for them to locate, comprehend, and apply information and services to make better health-related decisions for themselves and others.

    OBJECTIVE: This study protocol examines the impact of the ecosystem on health literacy among rural communities in protected areas.

    METHODS: This study comprises 5 phases. In phase 1, we conduct a systematic review to identify the issue of health literacy in protected areas. In phase 2, we will collect data from stakeholders in a protected area of Pahang National Park and analyze the results using Net-Map analysis. In phase 3, we will conduct a survey among the adult community in Pahang National Park related to health literacy, socioeconomic status, health expenditure, and quality of life. In phase 4, informed by the results of the survey, we will determine suitable intervention programs to improve health literacy through a focus group discussion. Finally, in phase 5, we will conduct a costing analysis to analyze which intervention program is the most cost-effective.

    RESULTS: This study was funded by Universiti Sains Islam Malaysia (USIM) and strategic research partnership grants, and enrollment is ongoing. The first results are expected to be submitted for publication in 2024.

    CONCLUSIONS: This is one of the first studies to explore health literacy among rural communities in protected areas and will provide the first insights into the overall level of health literacy in the protected community, potential determinants, and a suitable intervention program with expected cost analysis. The results can be used to promote health literacy in other protected areas and populations.

    TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Registry ISRCTN40626062; http://tinyurl.com/4kjxuwk5.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51851.

  4. Abd Rahman A, Abdul Manaf R, Lim PY, Suppiah S, Juni MH
    JMIR Res Protoc, 2021 Aug 13;10(8):e25877.
    PMID: 34398793 DOI: 10.2196/25877
    BACKGROUND: Risk governance involves processes and mechanisms to understand how risk decisions are taken and executed. This concept has gained a reputation over time as being essential for emerging comprehensive management that defines the success of an organization. While guiding documents that explain the use of risk management related to nuclear safety and security are available worldwide, few locally conducted studies have explained risk governance practices in areas where hazard usage is known, such as in radiological emergencies.

    OBJECTIVE: This paper describes a protocol that was used to determine several factors that influence emergency responders' perceptions toward radiological risk practices and visualize the risk radiological framework for emergency preparedness and response.

    METHODS: A mixed methods study with a convergent design was performed. A qualitative analysis was performed using a case study approach where 6 key informants were purposely sampled for in-depth interview, and a cross-sectional study involving a self-administered questionnaire was conducted among approximately 260 emergency respondents from national regulatory, research, and services organizations. NVivo (version 12, QSR International) was used to analyze the interview transcripts and emerging themes were identified through abductive coding. Simultaneously, multiple logistic regression analysis was used to determine significant predictors that form the equation model.

    RESULTS: The study is still underway. Qualitative findings were based on transcript-coding that informed the relevant thematic analysis, while statistical analyses including multiple logistic regression analysis measured the adjusted odds ratio of significant variables for the equation model. The study is expected to conclude in late 2021.

    CONCLUSIONS: Important emerging themes and significant factors that are related to the emergency responders' perceptions regarding radiological governance practices were determined through the convergent design. This potentially facilitated the development of a plausible radiological risk governance framework. Furthermore, our results will provide key insights that can be used in future studies.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25877.

  5. Ahmedy F, Mohamad Hashim N, Lago H, Plijoly LP, Ahmedy I, Idna Idris MY, et al.
    JMIR Res Protoc, 2022 Jan 28;11(1):e27935.
    PMID: 35089146 DOI: 10.2196/27935
    BACKGROUND: Walking recovery post stroke can be slow and incomplete. Determining effective stroke rehabilitation frequency requires the assessment of neuroplasticity changes. Neurobiological signals from electroencephalogram (EEG) can measure neuroplasticity through incremental changes of these signals after rehabilitation. However, changes seen with a different frequency of rehabilitation require further investigation. It is hypothesized that the association between the incremental changes from EEG signals and the improved functional outcome measure scores are greater in higher rehabilitation frequency, implying enhanced neuroplasticity changes.

    OBJECTIVE: The purpose of this study is to identify the changes in the neurobiological signals from EEG, to associate these with functional outcome measures scores, and to compare their associations in different therapy frequency for gait rehabilitation among subacute stroke individuals.

    METHODS: A randomized, single-blinded, controlled study among patients with subacute stroke will be conducted with two groups: an intervention group (IG) and a control group (CG). Each participant in the IG and CG will receive therapy sessions three times a week (high frequency) and once a week (low frequency), respectively, for a total of 12 consecutive weeks. Each session will last for an hour with strengthening, balance, and gait training. The main variables to be assessed are the 6-Minute Walk Test (6MWT), Motor Assessment Scale (MAS), Berg Balance Scale (BBS), Modified Barthel Index (MBI), and quantitative EEG indices in the form of delta to alpha ratio (DAR) and delta-plus-theta to alpha-plus-beta ratio (DTABR). These will be measured at preintervention (R0) and postintervention (R1). Key analyses are to determine the changes in the 6MWT, MAS, BBS, MBI, DAR, and DTABR at R0 and R1 for the CG and IG. The changes in the DAR and DTABR will be analyzed for association with the changes in the 6MWT, MAS, BBS, and MBI to measure neuroplasticity changes for both the CG and IG.

    RESULTS: We have recruited 18 participants so far. We expect to publish our results in early 2023.

    CONCLUSIONS: These associations are expected to be positive in both groups, with a higher correlation in the IG compared to the CG, reflecting enhanced neuroplasticity changes and objective evaluation on the dose-response relationship.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27935.

  6. 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

  7. 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.

  8. Almalki AA, Abdul Manaf R, Hanafiah Juni M, Kadir Shahar H, Noor NM, Gabbad A
    JMIR Res Protoc, 2017 Sep 26;6(9):e185.
    PMID: 28951379 DOI: 10.2196/resprot.8007
    BACKGROUND: Repetition of an image is a critical event in any radiology department. When the repetition rate of routine digital chest radiographs is high, radiation exposure of staff and patients is increased. In addition, repetition consumes the equipment's life span, thus affecting the annual budget of the department.

    OBJECTIVE: The aim of this study is to determine the impact of a printed educational module on reducing the repetition rate of routine digital chest radiography among radiographers in Makkah Region tertiary hospitals.

    METHODS: A quasi-experimental time series with a control group will be conducted in Makkah Region tertiary hospitals for 8 months starting in the second quarter of 2017. Four hospitals out of 5 in the region will be selected; 2 of them will be selected as the control group and the other 2 as the intervention group. Stratification and a simple random sampling technique will be used to sample 56 radiographers in each group. Pre- and postintervention assessments will be conducted to determine the radiographer knowledge, motivation, and skills and repetition rate of chest radiographs. Radiographs of the chest performed by sampled radiographers in the selected hospitals will be collected for 2 weeks before and after the intervention. A piloted questionnaire will be distributed and collected by a researcher in both groups. One-way multivariate analysis of variance and 2-way repeated multivariate analysis of variance will be used to analyze the data.

    RESULTS: It is expected that the repetition rate in the intervention group will decline after implementing the intervention and the change will be statistically significant (P

  9. 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.

  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. Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou Nadal I, et al.
    JMIR Res Protoc, 2022 Sep 08;11(9):e37288.
    PMID: 36074545 DOI: 10.2196/37288
    BACKGROUND: Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM.

    OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.

    METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).

    RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.

    CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.

  12. Chowdhury R, Noh MFM, Ismail SR, van Daalen KR, Kamaruddin PSNM, Zulkiply SH, et al.
    JMIR Res Protoc, 2022 Feb 10;11(2):e31885.
    PMID: 35142634 DOI: 10.2196/31885
    BACKGROUND: Although the burden of premature myocardial infarction (MI) is high in Malaysia, direct evidence on the determinants of MI in this multi-ethnic population remains sparse.

    OBJECTIVE: The Malaysian Acute Vascular Events Risk (MAVERIK) study is a retrospective case-control study established to investigate the genomic, lipid-related, and other determinants of acute MI in Malaysia. In this paper, we report the study protocol and early results.

    METHODS: By June 2019, we had enrolled approximately 2500 patients with their first MI and 2500 controls without cardiovascular disease, who were frequency-matched by age, sex, and ethnicity, from 17 hospitals in Malaysia. For each participant, serum and whole blood have been collected and stored. Clinical, demographic, and behavioral information has been obtained using a 200-item questionnaire.

    RESULTS: Tobacco consumption, a history of diabetes, hypertension, markers of visceral adiposity, indicators of lower socioeconomic status, and a family history of coronary disease were more prevalent in cases than in controls. Adjusted (age and sex) logistic regression models for traditional risk factors indicated that current smoking (odds ratio [OR] 4.11, 95% CI 3.56-4.75; P30 kg/m2; OR 1.19, 95% CI 1.05-1.34; P=.009) were associated with MI in age- and sex-adjusted models.

    CONCLUSIONS: The MAVERIK study can serve as a useful platform to investigate genetic and other risk factors for MI in an understudied Southeast Asian population. It should help to hasten the discovery of disease-causing pathways and inform regionally appropriate strategies that optimize public health action.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/31885.

  13. 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.

  14. 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.

  15. Evans L, Evans J, Fletcher M, Abdullah A, Ahmed Z
    JMIR Res Protoc, 2024 Jan 12;13:e52517.
    PMID: 38214954 DOI: 10.2196/52517
    BACKGROUND: The last 2 decades have been a time of exponential growth and maturation for digital health, while the global burden of respiratory disease continues to grow worldwide. Leveraging digital health interventions (DHIs) to manage and mitigate respiratory disease and its adverse health effects presents itself as an obvious path forward.

    OBJECTIVE: We aimed to understand the current digital landscape and enabling environment around respiratory health to reduce costs, avoid duplication, and understand the comprehensiveness of DHIs.

    METHODS: This study will follow a scoping review methodology as outlined by Arksey and O'Malley, the Joanna Briggs Institute, and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, Web of Science, PakiMedNet, and MyMedR databases will be searched along with key websites, repositories, and gray literature databases. The terms "respiratory health," "digital health," "South Asia," and "Southeast Asia," as well as related terms will be searched. The results will be screened for duplicates and then against the inclusion and exclusion criteria. For the studies included, data will be extracted, collated, and analyzed.

    RESULTS: The scoping review was started in July 2023 and will be finalized by February 2024. Results will be presented following the World Health Organization's classification of DHIs to categorize interventions in a standardized format and the mobile health evidence reporting and assessment checklist to report on the effectiveness of interventions. Further exposition of the evidence extracted will be presented through narrative synthesis.

    CONCLUSIONS: As DHIs continue to proliferate, the need to understand the current landscape becomes more pertinent. In this scoping review, we will seek to more clearly understand what digital health tools and technologies are being used in the current landscape of digital health in South and Southeast Asia for respiratory health and to what extent they are addressing the respiratory health needs of the region. The results will inform recommendations on digital health tools for respiratory health in South and Southeast Asia will help funders and implementers of DHIs leverage existing technologies and accelerate innovations that address documented gaps in the studied countries.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52517.

  16. 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.

  17. Hung HY, Azman A, Jamir Singh PS
    JMIR Res Protoc, 2023 Jun 23;12:e45557.
    PMID: 37272062 DOI: 10.2196/45557
    BACKGROUND: Psychological counseling is perceived as a treatment that could significantly improve older individuals' psychological and behavioral functioning. There is a dearth of information on the impact of psychological counseling on preserving dignity and facilitating good aging among older people in Singapore.

    OBJECTIVE: The objectives of this study are as follows: (1) to assess advance care planning among older people and their perception of life and health, end of life, and end-of-life care; (2) to explore older people's accessibility and receptiveness toward counseling; (3) elucidate older people's perspectives on counseling and its impact on emotional management and decision-making; (4) to assess older people's competencies in emotional management; and (5) to propose an intervention model for enhancing older people's well-being and dignity through psychological counseling in Singapore.

    METHODS: A mixed method study design involving quantitative and qualitative methods will be used. Older individuals receiving some form of preventive, primary, or long-term care in the community through voluntary welfare organizations from the senior activity centers located in eastern Singapore participated in the qualitative phase. Six older individuals from each senior activity center have been enrolled for the interview phase to explore 6 components: the Advanced Care Planning (ACP) booklet, Trait Meta Mood Scale (TMMS), accessibility and receptiveness toward counseling, and emotional management and decision-making. The ACP, an instrument designed to assess advanced care planning among older individuals, and the TMMS, an instrument developed to measure meta-mood experience and emotional management, were used in the quantitative phase among 100 participants. The data will be analyzed thematically using NVivo version 12, whereas descriptive statistics and a 2-tailed, 1-sample t test will be conducted in SPSS (version 25; IBM Corp) for empirical data analyses.

    RESULTS: The qualitative phase, which involves a semistructured interview, has been completed among 20 older individuals aged 66-86 years. Thematic analysis of the data is still ongoing. Meanwhile, the quantitative phase commenced on March 22, 2022, with 100 participants providing signed informed consent to participate in the study. The study is expected to be completed by March 2023.

    CONCLUSIONS: The mixed methods study will document the current awareness of ACP, accessibility and receptiveness toward counseling, and the potential use of psychological counseling in enhancing well-being and dignity among older people in Singapore. The research findings will benefit policy makers in their decision-making when attempting to mitigate the potential barriers to seeking counseling assistance among older people.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45557.

  18. 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.

  19. 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.

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