Displaying publications 1 - 20 of 38 in total

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  1. Mohd Hisham MF, Lodz NA, Muhammad EN, Asari FN, Mahmood MI, Abu Bakar Z
    JMIR Res Protoc, 2023 Jul 25;12:e36121.
    PMID: 37490330 DOI: 10.2196/36121
    BACKGROUND: According to the World Bank, Malaysia reported an estimated 97 tuberculosis cases per 100,000 people in 2021. Chest x-ray (CXR) remains the best conventional method for the early detection of pulmonary tuberculosis (PTB) infection. The intervention of artificial intelligence (AI) in PTB diagnosis could efficiently aid human interpreters and reduce health professionals' work burden. To date, no AI studies have been evaluated in Malaysia.

    OBJECTIVE: This study aims to evaluate the performance of Putralytica and Qure.ai software for CXR screening and PTB diagnosis among the Malaysian population.

    METHODS: We will conduct a retrospective case-control study at the Respiratory Medicine Institute, National Cancer Institute, and Sungai Buloh Health Clinic. A total of 1500 CXR images of patients who completed treatments or check-ups will be selected and categorized into three groups: (1) abnormal PTB cases, (2) abnormal non-PTB cases, and (3) normal cases. These CXR images, along with their clinical findings, will be the reference standard in this study. All patient data, including sociodemographic characteristics and clinical history, will be collected prior to screening via Putralytica and Qure.ai software and readers' interpretation, which are the index tests for this study. Interpretation from all 3 index tests will be compared with the reference standard, and significant statistical analysis will be computed.

    RESULTS: Data collection is expected to commence in August 2023. It is anticipated that 1 year will be needed to conduct the study.

    CONCLUSIONS: This study will measure the accuracy of Putralytica and Qure.ai software and whether their findings will concur with readers' interpretation and the reference standard, thus providing evidence toward the effectiveness of implementing AI in the medical setting.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36121.

  2. Kader Maideen SF, Mohd Sidik S, Rampal L, Mukhtar F, Ibrahim N, Phang CK, et al.
    JMIR Res Protoc, 2016;5(2):e112.
    PMID: 27329333 DOI: 10.2196/resprot.4622
    Mental disorders are a major public health problem and are debilitating in many nations throughout the world. Many individuals either do not or are not able to access treatment. The Internet can be a medium to convey to the community accessible evidenced-based interventions to reduce these burdens.
  3. 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.

  4. Shrestha R, Wickersham JA, Khati A, Azwa I, Ni Z, Kamarulzaman A, et al.
    JMIR Res Protoc, 2022 Dec 21;11(12):e43318.
    PMID: 36542425 DOI: 10.2196/43318
    BACKGROUND: Men who have sex with men (MSM) are disproportionately affected by the HIV epidemic in Malaysia and globally. Cross-cutting prevention strategies such as mobile health (mHealth), particularly smartphone apps, hold great promise for HIV prevention efforts among Malaysian MSM, especially when linked to HIV testing and pre-exposure prophylaxis (PrEP).

    OBJECTIVE: This study aims to adapt an existing app to create and test a clinic-integrated app (JomPrEP), a virtual platform to deliver HIV testing and PrEP services for MSM in Malaysia.

    METHODS: The JomPrEP project involves developing and testing an app-based platform for HIV prevention among Malaysian MSM and will be conducted in 2 phases. In phase I (development phase), we will adapt an existing mHealth app (HealthMindr) to create a new clinic-integrated app called "JomPrEP" to deliver holistic HIV prevention services (eg, HIV testing, PrEP, support services for mental health and substance use) among MSM in Malaysia. During phase II (testing phase), we will use a type I hybrid implementation science trial design to test the efficacy of JomPrEP while gathering information on implementation factors to guide future scale-up in real-world settings.

    RESULTS: As of September 2022, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, clinic-integrated JomPrEP app, which provides a virtual platform for MSM in Malaysia to facilitate their engagement in HIV prevention in a fast and convenient manner. Based on participant feedback provided during phase I, we are currently optimizing JomPrEP and the research protocols for a large-scale efficacy trial (phase II), which will commence in January 2023.

    CONCLUSIONS: Scant HIV prevention resources coupled with entrenched stigma, discrimination, and criminalization of same-sex sexual behavior and substance use hamper access to HIV prevention services in Malaysia. If found efficacious, JomPrEP can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT05325476; https://clinicaltrials.gov/ct2/show/NCT05325476.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43318.

  5. Ni Z, Peng ML, Balakrishnan V, Tee V, Azwa I, Saifi R, et al.
    JMIR Res Protoc, 2024 Feb 15;13:e54349.
    PMID: 38228575 DOI: 10.2196/54349
    BACKGROUND: Chatbots have the potential to increase people's access to quality health care. However, the implementation of chatbot technology in the health care system is unclear due to the scarce analysis of publications on the adoption of chatbot in health and medical settings.

    OBJECTIVE: This paper presents a protocol of a bibliometric analysis aimed at offering the public insights into the current state and emerging trends in research related to the use of chatbot technology for promoting health.

    METHODS: In this bibliometric analysis, we will select published papers from the databases of CINAHL, IEEE Xplore, PubMed, Scopus, and Web of Science that pertain to chatbot technology and its applications in health care. Our search strategy includes keywords such as "chatbot," "virtual agent," "virtual assistant," "conversational agent," "conversational AI," "interactive agent," "health," and "healthcare." Five researchers who are AI engineers and clinicians will independently review the titles and abstracts of selected papers to determine their eligibility for a full-text review. The corresponding author (ZN) will serve as a mediator to address any discrepancies and disputes among the 5 reviewers. Our analysis will encompass various publication patterns of chatbot research, including the number of annual publications, their geographic or institutional distribution, and the number of annual grants supporting chatbot research, and further summarize the methodologies used in the development of health-related chatbots, along with their features and applications in health care settings. Software tool VOSViewer (version 1.6.19; Leiden University) will be used to construct and visualize bibliometric networks.

    RESULTS: The preparation for the bibliometric analysis began on December 3, 2021, when the research team started the process of familiarizing themselves with the software tools that may be used in this analysis, VOSViewer and CiteSpace, during which they consulted 3 librarians at the Yale University regarding search terms and tentative results. Tentative searches on the aforementioned databases yielded a total of 2340 papers. The official search phase started on July 27, 2023. Our goal is to complete the screening of papers and the analysis by February 15, 2024.

    CONCLUSIONS: Artificial intelligence chatbots, such as ChatGPT (OpenAI Inc), have sparked numerous discussions within the health care industry regarding their impact on human health. Chatbot technology holds substantial promise for advancing health care systems worldwide. However, developing a sophisticated chatbot capable of precise interaction with health care consumers, delivering personalized care, and providing accurate health-related information and knowledge remain considerable challenges. This bibliometric analysis seeks to fill the knowledge gap in the existing literature on health-related chatbots, entailing their applications, the software used in their development, and their preferred functionalities among users.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54349.

  6. Kim YJ, Qian L, Aslam MS
    JMIR Res Protoc, 2020 Nov 20;9(11):e23112.
    PMID: 33216000 DOI: 10.2196/23112
    BACKGROUND: Workplace cyberbullying harms the psychological and social functioning of professionals working in an organization and may decrease the productivity and efficiency of daily life tasks. A recent study on trainee doctors across 8 different United Kingdom National Health Service trusts found health issues and job dissatisfaction in people who have experienced workplace cyberbullying. This disabling effect is even more noticeable in low-socioeconomic communities within low-income countries. In Malaysia, there is a need to create a personalized mobile mental health intervention program for health care professionals. These programs should be directed to prevent and decrease psychosocial issues and enhance coordination among health care professionals to solve health issues in the community.

    OBJECTIVE: Our main objective is to study the pre-effects and posteffects of the Personalized Mobile Mental Health Intervention (PMMH-I) for workplace cyberbullying in public and private hospitals in Malaysia.

    METHODS: A hospital-based multimethod multi-analytic evidential approach is proposed, involving social and psychological health informatics. The project has been subdivided into 3 stages, starting with Phase 1, a prevalence study, followed by exploratory studies. Phase 2 consists of a quasi-experimental design, whereas the development of a prototype and their testing will be proposed in Phase 3. Each stage includes the use of quantitative and qualitative methods (mixed-method program), using SPSS (version 26.0; IBM Corp) and Stata (version 16.1; StataCorp) as tools for quantitative research, and NVivo (version 1.0; QSR International) and Atlas.ti (version 9.0.16; ATLAS.ti Scientific Software Development GmbH) for qualitative research.

    RESULTS: The results of this study will determine the pre- and posteffectiveness of an integrated PMMH-I for health care professionals. The prototype system platform will be developed and implemented in a public and private hospital. Results from Phase 1 will be published in 2021, followed by the implementation of Phase 2 in subsequent years.

    CONCLUSIONS: This study will provide evidence and guidance regarding the implementation of a personalized mobile mental health intervention for health care professionals into routine public and private hospitals to enhance communication and resolve conflicts.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/23112.

  7. Kim YJ, Qian L, Aslam MS
    JMIR Res Protoc, 2021 Aug 12;10(8):e29582.
    PMID: 34387559 DOI: 10.2196/29582
    BACKGROUND: Cyberbullying is becoming prevalent among health care professionals and may cause a variety of mental health issues. Traditional and complementary medicine practitioners remain an important pillar of the health care system in Malaysia.

    OBJECTIVE: This paper presents a study protocol for an online survey (Cyberbullying Among Traditional and Complementary Medicine Practitioner [TCMPs]) that will collect the first nationwide representative data on cyberbullying behavior among traditional and complementary medicine practitioners in Malaysia. The objectives of the survey are to (1) evaluate the cyberbullying behavior among traditional and complementary medicine practitioners in Malaysia, (2) identify sociodemographic and social factors related to cyberbullying, and (3) evaluate the association between cyberbullying behavior, sociodemographic, and social factors.

    METHODS: A snowball sampling strategy will be applied. Traditional and complementary medicine practitioners who are permanent Malaysian residents will be randomly selected and invited to participate in the survey (N=1023). Cyberbullying behavior will be measured using the Cyberbullying Behavior Questionnaire (CBQ). Data on the following items will be collected: work-related bullying, person-related bullying, aggressively worded messages, distortion of messages, sending offensive photos/videos, hacking computers or sending a virus or rude message, and threatening messages about personal life or family members. We will also collect data on participants' sociodemographic characteristics, social factors, and substance abuse behavior.

    RESULTS: This cross-sectional descriptive study was registered with Research Registry (Unique Identifying Number 6216; November 05, 2020). This research work (substudy) is planned under a phase 1 study approved by the Research Management Centre, Xiamen University Malaysia. This substudy has been approved by the Research Ethics Committee of Xiamen University Malaysia (REC-2011.01). The cross-sectional survey will be conducted from July 01, 2021, to June 30, 2022. Data preparation and statistical analyses are planned from January 2022 onward.

    CONCLUSIONS: The current research can contribute to identify the prevalence of workplace cyberbullying among Malaysian traditional and complementary medicine practitioners. The results will help government stakeholders, health professionals, and education professionals to understand the psychological well-being of Malaysian traditional and complementary medicine practitioners.

    TRIAL REGISTRATION: Research Registry Unique Identifying Number 6216; https://tinyurl.com/3rsmxs7u.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29582.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. Jones K, Basinas I, Kromhout H, van Tongeren M, Harding AH, Cherrie JW, et al.
    JMIR Res Protoc, 2020 Feb 28;9(2):e16448.
    PMID: 32130188 DOI: 10.2196/16448
    BACKGROUND: Exposure to certain pesticides has been associated with several chronic diseases. However, to determine the role of pesticides in the causation of such diseases, an assessment of historical exposures is required. Exposure measurement data are rarely available; therefore, assessment of historical exposures is frequently based on surrogate self-reported information, which has inherent limitations. Understanding the performance of the applied surrogate measures in the exposure assessment of pesticides is therefore important to allow proper evaluation of the risks.

    OBJECTIVE: The Improving Exposure Assessment Methodologies for Epidemiological Studies on Pesticides (IMPRESS) project aims to assess the reliability and external validity of the surrogate measures used to assign exposure within individuals or groups of individuals, which are frequently based on self-reported data on exposure determinants. IMPRESS will also evaluate the size of recall bias on the misclassification of exposure to pesticides; this in turn will affect epidemiological estimates of the effect of pesticides on human health.

    METHODS: The IMPRESS project will recruit existing cohort participants from previous and ongoing research studies primarily of epidemiological origin from Malaysia, Uganda, and the United Kingdom. Consenting participants of each cohort will be reinterviewed using an amended version of the original questionnaire addressing pesticide use characteristics administered to that cohort. The format and relevant questions will be retained but some extraneous questions from the original (eg, relating to health) will be excluded for ethical and practical reasons. The reliability of pesticide exposure recall over different time periods (<2 years, 6-12 years, and >15 years) will then be evaluated. Where the original cohort study is still ongoing, participants will also be asked if they wish to take part in a new exposure biomonitoring survey, which involves them providing urine samples for pesticide metabolite analysis and completing questionnaire information regarding their work activities at the time of sampling. The participant's level of exposure to pesticides will be determined by analyzing the collected urine samples for selected pesticide metabolites. The biomonitoring measurement results will be used to assess the performance of algorithm-based exposure assessment methods used in epidemiological studies to estimate individual exposures during application and re-entry work.

    RESULTS: The project was funded in September 2017. Enrollment and sample collection was completed for Malaysia in 2019 and is on-going for Uganda and the United Kingdom. Sample and data analysis will proceed in 2020 and the first results are expected to be submitted for publication in 2021.

    CONCLUSIONS: The study will evaluate the consistency of questionnaire data and accuracy of current algorithms in assessing pesticide exposures. It will indicate where amendments can be made to better capture exposure data for future epidemiology studies and thus improve the reliability of exposure-disease associations.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16448.

  13. Kumar R, Htwe O, Baharudin A, Ariffin MH, Abdul Rhani S, Ibrahim K, et al.
    JMIR Res Protoc, 2016 Dec 05;5(4):e230.
    PMID: 27919862
    BACKGROUND: Spinal cord injury (SCI) is a devastating condition with limited therapeutic options despite decades of research. Current treatment options include use of steroids, surgery, and rehabilitation. Nevertheless, many patients with SCI remain disabled. MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries and may have a potential role in improving recovery after SCI.

    OBJECTIVE: The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.

    METHODS: Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.

    RESULTS: The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.

    CONCLUSIONS: SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.

    TRIAL REGISTRATION: Clinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG).

  14. 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.

  15. 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.

  16. 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.

  17. Lambraki IA, Majowicz SE, Parmley EJ, Wernli D, Léger A, Graells T, et al.
    JMIR Res Protoc, 2021 Jun 10;10(6):e24378.
    PMID: 34110296 DOI: 10.2196/24378
    BACKGROUND: Antimicrobial resistance (AMR) is an escalating global crisis with serious health, social, and economic consequences. Building social-ecological system resilience to reduce AMR and mitigate its impacts is critical.

    OBJECTIVE: The aim of this study is to compare and assess interventions that address AMR across the One Health spectrum and determine what actions will help to build social and ecological capacity and readiness to sustainably tackle AMR.

    METHODS: We will apply social-ecological resilience theory to AMR in an explicit One Health context using mixed methods and identify interventions that address AMR and its key pressure antimicrobial use (AMU) identified in the scientific literature and in the gray literature using a web-based survey. Intervention impacts and the factors that challenge or contribute to the success of interventions will be determined, triangulated against expert opinions in participatory workshops and complemented using quantitative time series analyses. We will then identify indicators using regression modeling, which can predict national and regional AMU or AMR dynamics across animal and human health. Together, these analyses will help to quantify the causal loop diagrams (CLDs) of AMR in the European and Southeast Asian food system contexts that are developed by diverse stakeholders in participatory workshops. Then, using these CLDs, the long-term impacts of selected interventions on AMR will be explored under alternate future scenarios via simulation modeling and participatory workshops. A publicly available learning platform housing information about interventions on AMR from a One Health perspective will be developed to help decision makers identify promising interventions for application in their jurisdictions.

    RESULTS: To date, 669 interventions have been identified in the scientific literature, 891 participants received a survey invitation, and 4 expert feedback and 4 model-building workshops have been conducted. Time series analysis, regression modeling of national and regional indicators of AMR dynamics, and scenario modeling activities are anticipated to be completed by spring 2022. Ethical approval has been obtained from the University of Waterloo's Office of Research Ethics (ethics numbers 40519 and 41781).

    CONCLUSIONS: This paper provides an example of how to study complex problems such as AMR, which require the integration of knowledge across sectors and disciplines to find sustainable solutions. We anticipate that our study will contribute to a better understanding of what actions to take and in what contexts to ensure long-term success in mitigating AMR and its impact and provide useful tools (eg, CLDs, simulation models, and public databases of compiled interventions) to guide management and policy decisions.

    INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24378.

  18. 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.

  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.

  20. 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.

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