OBJECTIVE: The study aims to examine the effectiveness of a marital self-disclosure intervention for improving the level of fear of cancer recurrence and the dyadic coping ability among gastric cancer survivors and their spouses.
METHODS: This is a quasiexperimental study with a nonequivalent (pretest-posttest) control group design. The study will be conducted at 2 tertiary hospitals in Taizhou City, Jiangsu Province, China. A total of 42 patients with gastric cancer undergoing chemotherapy and their spouses will be recruited from each hospital. Participants from Jingjiang People's Hospital will be assigned to an experimental group, while participants from Taizhou People's Hospital will be assigned to a control group. The participants in the experimental group will be involved in 4 phases of the marital self-disclosure (different topics, face-to-face) intervention. Patients will be evaluated at baseline after a diagnosis of gastric cancer and reassessed 2 to 4 months after baseline. The primary outcome is the score of the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) for patients. The secondary outcomes are the scores of the FoP-Q-SF for partners and the Dyadic Coping Inventory.
RESULTS: Research activities began in October 2022. Participant enrollment and data collection began in February 2023 and are expected to be completed in 12 months. The primary results of this study are anticipated to be announced in June 2024.
CONCLUSIONS: This study aims to assess a marital self-disclosure intervention for improving the fear of cancer recurrence in Chinese patients with gastric cancer and their spouses. The study is likely to yield desirable positive outcomes as marital self-disclosure is formulated based on evidence and inputs obtained through stakeholder interviews and expert consultation. The study process will be carried out by nurses who have received psychological training, and the quality of the intervention will be strictly controlled.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05606549; https://clinicaltrials.gov/study/NCT05606549.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55102.
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.
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.
OBJECTIVE: This paper presents the protocol for a systematic review that aims to provide evidence of the impact of heat waves on health care services in LMICs.
METHODS: We will identify peer-reviewed studies from 3 online databases, including the Web of Science, PubMed, and SCOPUS, published from January 2002 to April 2023, using the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Quality assessment will be conducted using the Navigation Guide checklist. Key search terms include heatwaves, extreme heat, hospitalization, outpatient visit, burden, health services, and morbidity.
RESULTS: This systematic review will provide insight into the impact of heat waves on health care services in LMICs, especially on emergency department visits, ambulance call-outs, hospital admissions, outpatient department visits, in-hospital mortality, and health care operational costs.
CONCLUSIONS: The results of this review are anticipated to help policymakers and key stakeholders obtain a better understanding of the impact of heat waves on health care services and prioritize investments to mitigate the effects of heat waves in LMICs. This entails creating a comprehensive heat wave plan and ensuring that adequate infrastructure, capacity, and human resources are allocated in the health care sector. These measures will undoubtedly contribute to the development of resilience in health care systems and hence protect the health and well-being of individuals and communities.
TRIAL REGISTRATION: PROSPERO CRD42022365471; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=365471.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44702.
OBJECTIVE: This study aims to (1) compare the detection rate of genetically confirmed FH and diagnostic accuracy between the FAMCAT, SB, and DLCC in the Malaysian primary care setting; (2) identify the genetic mutation profiles, including novel variants, in individuals with suspected FH in primary care; (3) explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing in primary care; and (4) evaluate the clinical utility of a web-based FH Identification Tool that includes the FAMCAT, SB, and DLCC in the Malaysian primary care setting.
METHODS: This is a mixed methods evaluation study conducted in 11 Ministry of Health primary care clinics located at the central administrative region of Malaysia. In Work stream 1, the diagnostic accuracy study design is used to compare the detection rate and diagnostic accuracy of the FAMCAT, SB, and DLCC against molecular diagnosis as the gold standard. In Work stream 2, the targeted next-generation sequencing of the 4 FHCGs is used to identify the genetic mutation profiles among individuals with suspected FH. In Work stream 3a, a qualitative semistructured interview methodology is used to explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing. Lastly, in Work stream 3b, a qualitative real-time observation of primary care physicians using the "think-aloud" methodology is applied to evaluate the clinical utility of a web-based FH Identification Tool.
RESULTS: The recruitment for Work stream 1, and blood sampling and genetic analysis for Work stream 2 were completed in February 2023. Data collection for Work stream 3 was completed in March 2023. Data analysis for Work streams 1, 2, 3a, and 3b is projected to be completed by June 2023, with the results of this study anticipated to be published by December 2023.
CONCLUSIONS: This study will provide evidence on which clinical diagnostic criterion is the best to detect FH in the Malaysian primary care setting. The full spectrum of genetic mutations in the FHCGs including novel pathogenic variants will be identified. Patients' perspectives while undergoing genetic testing and the primary care physicians experience in utilizing the web-based tool will be established. These findings will have tremendous impact on the management of patients with FH in primary care and subsequently reduce their risk of premature coronary artery disease.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47911.
OBJECTIVE: This study aims to assess the effectiveness of BIFI in reducing emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of caregivers of patients with TBI at government hospitals in Malaysia.
METHODS: This is a 2-arm, single-blinded, randomized controlled trial. It will be conducted at Hospital Rehabilitasi Cheras and Hospital Sungai Buloh. In total, 100 caregivers of patients with TBI attending the neurorehabilitation unit will be randomized equally to the intervention and control groups. The intervention group will undergo the BIFI program, whereas the control group will receive standard treatment. Caregivers aged ≥18 years, caring for patients who have completed >3 months after the injury, are eligible to participate. The BIFI program will be scheduled for 5 sessions as recommended by the developer of the module. Each session will take approximately 90 to 120 minutes. The participants are required to attend all 5 sessions. A total of 5 weeks is needed for each group to complete the program. Self-reported questionnaires (ie, Beck Depression Inventory, Positive and Negative Affect Schedule, Caregiver Strain Index, Satisfaction With Life Scale, and Family Needs Questionnaire) will be collected at baseline, immediately after the intervention program, at 3-month follow-up, and at 6-month follow-up. The primary end point is the caregivers' emotional distress.
RESULTS: The participant recruitment process began in January 2019 and was completed in December 2020. In total, 100 participants were enrolled in this study, of whom 70 (70%) caregivers are women and 30 (30%) are men. We are currently at the final stage of data analysis. The results of this study are expected to be published in 2024. Ethics approval has been obtained.
CONCLUSIONS: It is expected that the psychological well-being of the intervention group will be better compared with that of the control group after the intervention at 3-month follow-up and at 6-month follow-up.
TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180809040746N1; https://irct.behdasht.gov.ir/trial/33286.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53692.
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.
OBJECTIVE: This study aims to develop and validate "Chance2Act," a new web-based intervention, designed specifically to facilitate behavioral change in adults with T2D with obesity who are not ready to act toward weight loss. Then, the effectiveness of the newly developed intervention will be determined from a nonrandomized controlled trial.
METHODS: A web-based intervention will be developed based on the Transtheoretical Model targeting adults with T2D with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a nonrandomized controlled trial will be conducted in 2 government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (ie, intervention vs control [usual care] with an allocation ratio of 1:1). A total of 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes in an individual's readiness from a stage of not being ready to change (precontemplation, contemplation, or preparation stage) to being ready for weight loss (action stage). The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition.
RESULTS: The phase 1 study will reveal the intervention's validity through the Content Validity Index and Face Validity Index, considering it valid if both indices exceed 0.83. The effectiveness of the intervention will be determined in phase 2, where the differences within and between groups will be analyzed in terms of the improvement of stages of change and all secondary outcomes as defined in the methodology. Data analysis for phase 2 will commence in 2024, with the anticipated publication of results in March 2024.
CONCLUSIONS: If proven effective, the result of the study may give valuable insights into the effective behavioral modification strategies for a web-based intervention targeting adults with T2D with obesity but not yet ready to change for weight loss. This intervention may be replicated or adopted in different settings, focusing on behavioral modification support that patients need. This study offers a deeper understanding of the application of behavior change techniques for a more holistic approach to obesity care in T2D.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48313.
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.
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.
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.
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.
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.
OBJECTIVE: The objectives of this study are (1) to evaluate the feasibility of a brief mindfulness-based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants.
METHODS: We followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers' Sense of Efficacy Scale (TSES), the Self-Compassion Scale-Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations.
RESULTS: Participants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry.
CONCLUSIONS: This study aims to determine the feasibility and efficacy of the BM-MA, a digital mental health intervention developed using an existing mindfulness-based app, and assess its potential for widespread use.
TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300068085; https://tinyurl.com/2d2x4bxk.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56693.
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.
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.
OBJECTIVE: The aim of this study therefore is to determine if improving sleep quality could improve executive functions in medical students with poor sleep quality by comparing cognitive behavioural therapy for insomnia (CBT-I) with sleep hygiene education (SHE) in a randomized controlled trial (RCT).
METHODS: A parallel group, RCT with a target sample of 120 medical students recruited from government-based medical universities in Malaysia. Eligible participants will be randomized to internet group CBT-I or internet group SHE in a 1:1 ratio. Assessments will be performed at baseline, post-intervention, 1 month, 3-months, and 6-months. The primary outcome is between-group differences in sleep quality and executive function post-baseline. The secondary outcomes include pre-sleep worry, attitude about sleep, sleep hygiene and sleep parameters.
RESULTS: This study received approval from the Research Ethics Committee in Universiti Putra Malaysia (JKEUPM-2023-1446) and Universiti Kebangsaan Malaysia (JEP-2024-669). The clinical trial was also registered in Australian New Zealand Clinical Trial Registry (ACTRN1264000243516). As of June 2024, the recruitment process is ongoing and a total of 48 and 49 students have been enrolled from the universities into the CBT-I and ISHE groups, respectively. All the participants provided signed and informed consent to participate in the study. Data collection has been completed for the baseline (pre-treatment assessment), and follow-up assessments for T1 and T2 for all the participants in both groups, while T3 and T4 assessments will be completed by July 2025. Data analysis will be performed by August 2025 and the research will be completed by December 2025.
CONCLUSIONS: This study is the first attempt to design a CBT intervention to ameliorate poor sleep quality and its related negative effects among medical students. This research is also the first large-scale exploring the relationship between health status and CBT-mediated sleep improvement among medical students.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12624000243516; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387030.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/59288.
OBJECTIVE: This scoping review aimed to explore the literature on molecular genetics of obesity in Malaysia. Specifically, we sought to characterize existing studies, identify the genetic determinants of obesity, and assess their association with obesity predisposition in the population.
METHODS: This scoping review followed the methodology of the Joanna Briggs Institute and used the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist as its guiding framework. Searches were conducted using electronic databases such as PubMed, ScienceDirect, and Scopus, filtering for human studies published until March 2024. Eligible studies included peer-reviewed articles on the Malaysian population irrespective of age or sex. This review excluded review articles, book chapters, non-peer-reviewed conference proceedings, gray literature, and preclinical studies, and the reference lists of the retrieved studies were manually examined to ensure thorough inclusion. The articles were subjected to a 2-stage screening process (title/abstract and full text) conducted by 2 reviewers to assess eligibility. Eligible articles were then extracted following a data extraction framework and organized into a charting table. Only studies investigating the genetics of obesity in Malaysian populations were included.
RESULTS: As of March 2024, our extensive search strategy has yielded 572 records. After removing 153 duplicates, 419 records were screened by title and abstract, resulting in 47 selected for full-text review. Of these, 34 were chosen for data extraction and detailed analysis. These studies predominantly involved participants from major ethnic groups (Malay, Chinese, and Indian) recruited from local health centers and university communities. The articles primarily explored the relationship between specific gene variants and obesity or obesity-related health parameters. This ongoing research is expected to be completed with a comprehensive scoping review by April 2025.
CONCLUSIONS: This review provides valuable insights into the genetic determinants of obesity in Malaysia, despite limitations such as no quality appraisal being conducted for the included studies and the search strategy being restricted to selected databases, potentially omitting relevant studies. However, this review ensured reliability and reproducibility by adhering to the Joanna Briggs Institute and PRISMA-ScR guidelines. Ultimately, this study advances the understanding of local research and sets the foundation for future molecular genetic studies to improve obesity risk prediction and management in Malaysia's multiethnic population.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60838.
OBJECTIVE: This study aims to comprehensively analyze existing research on the link between physical activity and mental health and identify the level of physical activity and mental health status, the barriers to physical activity, and SCI's impacts on psychological well-being in individuals with SCI.
METHODS: An electronic search strategy will be used to identify prevalence studies published since 1993 in health-related databases such as PubMed, MEDLINE, COCHRANE Library, and Wiley Library using the following query: "Spinal Cord Injury" OR "Paraplegia" OR "Tetraplegia" AND "Physical Activity" OR "Exercise" AND "Mental Health" OR "Mental Illness" OR "Mental Disorder." Bibliographies of primary studies and review articles meeting the inclusion criteria will be searched manually to identify further eligible studies. The risk of bias in the included studies will be appraised using the Joanna Briggs Institute checklist for prevalence studies by 2 review authors. Any disagreement will be resolved by reaching a consensus.
RESULTS: Funding was received in October 2023, data collection will commence in July 2024, and the results are expected by 2025. We will summarize the selection of the eligible studies using a flowchart. The data from the studies will be extracted and tabulated. This scoping review will be published in a peer-reviewed journal in accordance with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines.
CONCLUSIONS: This scoping review underscores the complex relationship between physical activity and mental health among individuals with SCI, highlighting the level of physical activity and mental health status, barriers to physical activity engagement, and psychological implications. Understanding these dynamics is crucial in devising tailored interventions aimed at enhancing mental well-being. This synthesis of evidence emphasizes the need for personalized strategies to promote physical activity, addressing unique challenges faced by this population to foster improved mental health outcomes and overall quality of life.
TRIAL REGISTRATION: Open Science Framework osf.io/ugx7d; https://osf.io/ugx7d/.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/56081.