• App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial

    stage 1

    Background: People of color (POC) who experience race-related stress are at risk of developing mental health problems, including high levels of stress, anxiety, and depression. Mindfulness meditation may be especially well suited to help POC cope, given its emphasis on gaining awareness and acceptance of emotions associated with discriminatory treatment. However, mindfulness meditation rarely reaches POC, and digital approaches could reduce this treatment gap by addressing traditional barriers to care. Objective: This study will test the effectiveness of a self-directed app-based mindfulness meditation program among POC who experience elevated levels of race-related stress. Implementation outcomes such as treatment acceptability, adherence, and satisfaction will be examined. Methods: Participants (n=80) will be recruited online by posting recruitment materials on social media and sending emails to relevant groups. In-person recruitment will consist of posting flyers in communities with significant POC representation. Eligible participants will be block randomized to either the intervention group (n=40) that will complete a self-directed 4-week mindfulness meditation program or a wait-list control condition (n=40) that will receive access to the app after study completion. All participants will complete measures at baseline, midtreatment, and posttreatment. Primary outcomes include changes in stress, anxiety, and depression, and secondary outcomes constitute changes in mindfulness, self-compassion, rumination, emotion suppression, and experiential avoidance. Exploratory analyses will examine whether changes in the secondary outcomes mediate changes in primary outcomes. Finally, treatment acceptability, adherence, and satisfaction will be examined descriptively. Results: Recruitment began in October 2021. Data will be analyzed using multilevel modeling, a statistical methodology that accounts for the dependence among repeated observations. Considering attrition issues in self-directed digital interventions and their potential effects on statistical significance and treatment effect sizes, we will examine data using both intention-to-treat and per-protocol analyses. Conclusions: To our knowledge, this will be the first study to provide data on the effectiveness of a self-directed app-based mindfulness meditation program for POC recruited based on elevated race-related stress, a high-risk population. Similarly, meaningful clinical targets for POC affected by stressors related to race will be examined. Findings will provide important information regarding whether this type of intervention is an acceptable treatment among these marginalized groups. Trial Registration: ClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113

    Giovanni Ramos, Adrian Aguilera, Amanda Montoya, Anna Lau, Chu Yin Wen, Victor Cruz Torres, Denise Chavira·2022·JMIR Research Protocols
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  • Determining the Feasibility and Usability of a Co-Designed Culturally Appropriate Conversational Agent (DESI-Heart) to Support Self-Care in People With Cardiovascular Diseases: Protocol for a Single-Arm Pilot Trial

    stage 1

    Background: Cardiovascular diseases (CVDs) are a leading cause of death and disability worldwide. For people living with CVD, clinical guidelines recommend ongoing self-care such as symptom monitoring, medication adherence, and lifestyle modifications. However, many people struggle to engage in this due to the complexity of disease management, limited understanding, and a lack of cultural support. Conversational agents (CAs) offer a solution by providing artificial intelligence–driven, voice-based support that enables human-like communication. While many CAs and digital interventions are good for people with CVDs, they are for mainstream populations and overlook culturally and linguistically diverse communities. Objective: This study outlines the protocol for pilot testing the feasibility and usability of Diaspora Engaged Self-Care Intervention and Heart (DESI-Heart) program, to support self-care management among Indian diaspora populations with CVDs in Australia over an 8-week intervention period. The formative development of DESI-Heart is also described. Methods: We integrated the Double Diamond Model and the ecological validity model to develop our DESI-Heart program. First, we co-designed the program with end users, who identified 4 key goals for engagement with self-care through culturally and linguistically appropriate approaches. Based on these priorities and ideas, we developed specific goals, including (1) medication reminders, (2) daily exercise guidance, (3) diet buddy, and (4) guided meditation. Participants will access the DESI-Heart program through a web-based CA, available on smartphones, laptops, or PCs. Based on their preferred timing, individuals will receive links to access specific components of the program corresponding to each goal. These links will be sent to participants via SMS or email, depending on their preference. A single-arm prepost pilot trial (N=28) will be conducted to evaluate the feasibility and usability of the DESI-Heart program among Indian adults living in Australia with CVDs. The primary outcome will assess feasibility indicators, including recruitment, engagement, and usability, while secondary outcomes will examine changes in self-care behaviors and quality of life. Results: The DESI-Heart program received ethics approval in July 2024. Recruitment for the pilot trial is scheduled to begin in June 2025 and conclude by September 2025, with participant follow-up expected to be completed by the end of December 2025. All 28 participants have been recruited, and data analysis will be conducted once follow-up is finalized. Conclusions: We have co-designed and developed the DESI-Heart program, a culturally and linguistically appropriate self-care intervention aimed at supporting Indian adults with CVD living in Australia. The next step is to conduct a pilot study to assess the feasibility and usability of DESI-Heart, which will inform the design of a larger evaluation trial. DESI-Heart has the potential to complement existing health services by helping individuals with CVD manage their condition within the community, while acknowledging their cultural backgrounds and language preferences.

    Ann Tresa Sebastian, Paul Jansons, Ee Ling Ng, Samantha David, Ralph Maddison·2025·JMIR Research Protocols
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  • Behavioral Intervention to Prevent HIV/AIDS Among Young Adults Using Motivational Culture-Based Communication: Protocol for a Research and Development Study

    stage 1

    Background: HIV/AIDS is an epidemic in 190 countries, with Indonesia having more than half a million people living with the virus. Risk factors include risky sexual activity and alternating needle usage. The majority of cases are young adults (18-30 years old). The Indonesian National HIV/AIDS strategy aims to reduce new cases to less than a thousand per year. Nowadays, effective prevention involves avoiding free sex and adopting healthier lifestyles. Objective: This research aims to explore young adults’ needs, perceptions, and cultural aspects of HIV/AIDS prevention, develop the intervention model, analyze its effectiveness, and examine its effect on HIV prevention behavior. Methods: We will conduct the study in three phases: qualitative research, model development, and quantitative research. In the first phase, we will use descriptive phenomenology and forum group discussion (FGD) to collect data from young adults and stakeholders in Batang and Pekalongan regencies. The second phase will develop a motivation model for HIV/AIDS prevention using culture-based communication (MK-U) through website media. We will design the model in consultation with an IT team and experts to ensure its suitability. The third phase will involve a pre-post-test with a control group quasi-experiment involving young adults aged 20–30 years old in Batang and Pekalongan districts. The intervention group will receive culture-based motivational interviewing, while the control group will receive standard counseling. We will analyze the data using a generalized linear model (GLM) and multivariate analysis of variance (MANOVA). Results: We expect to develop the MK-U model for HIV prevention behavior among young adults. In 2025, we will implement a community-based nursing research program for the MK-U model to prevent HIV/AIDS. Conclusions: In this research, we will compare the results with similar studies, which will benefit program implementers and policymakers in both regions and enhance the effectiveness of HIV prevention programs.

    Moh Khotibul Umam, Agus Setiawan, Henny Permatasari, Muchtaruddin Mansyur·2025·JMIR Research Protocols
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  • Improving Work-Related Challenges in Psychiatric-Psychosomatic Clinics: Study Protocol for an Internet-Based Needs Assessment and Co-Design of a Training

    stage 1

    Background: Medical, psychiatric-psychosomatic facilities are confronted with a variety of daily challenges that affect working conditions, the mental health of employees and the quality of patient care. This project focuses on the work-related challenges faced by healthcare professionals in psychiatric-psychosomatic clinics in Germany. Objective: Therefore, the aim of the current research is to investigate the interactions between individuals and their social environment, identify psychological and organizational challenges and job demands to use these findings to inform the development of a participatory, evidence-based intervention. Methods: This two-phase research is grounded in the job demands-resources model (JD-R). Study phase one (needs assessment) employs a cross-sectional online survey with healthcare professionals in German psychiatric-psychosomatic clinics to assess job demands, resources, and outcomes in a target sample of 600 participants (power analysis). Study phase two (co-design of a training) involves co-creatively designing an intervention based on survey findings through participatory workshops with at least 20 participants. Analyses include regression and moderation tests (SPSS), and qualitative data analysis to co-design training. Results: The recruitment of participants is planned to be finished by October 2025. The co-designing of workshops (phase two) will be started in February 2026. As this is a study protocol, results are not available yet. Conclusions: This current research examines the work-related challenges faced by healthcare professionals in psychiatric-psychosomatic clinics. It is expected that burnout, engagement, and psychological safety will likely emerge as central mediating and moderating variables. As the findings of phase one serve as a basis for the development of an intervention this research seeks to improve the well-being of healthcare professionals in psychiatric-psychosomatic institutions sustainably. Clinical Trial: ClinicalTrials.gov NCT06867601; https://clinicaltrials.gov/study/NCT06867601

    Katharina Schiffer, Sonia Lippke·2025·JMIR Research Protocols
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  • Trust Dynamics and Equity in Public Health in Canada: Protocol for a Mixed Methods Project in the Postpandemic Era

    stage 1

    Background: The COVID-19 pandemic impacted trust in public health, medical care, scientific, and governmental institutions; this influenced health, health-seeking behaviors, and adherence to public health measures. Understanding how trust evolves is necessary for informing future public health crisis management and strategies. Rebuilding public trust is key to pandemic preparedness worldwide. This research protocol examines these trust dynamics, their determinants, and their implications. Objective: This study aimed to investigate the evolution of public trust in scientists, public health and medical care institutions, governments, and social and personal networks during the COVID-19 pandemic. It sought to identify key factors contributing to trust maintenance or erosion, particularly in marginalized and minority communities, and understand the impact of trust level on public health adherence. Methods: A sequential, explanatory mixed methods approach was implemented, consisting of an initial quantitative survey followed by qualitative interviews. The nationwide representative survey included 5607 Canadian residents as of May 2024. The questionnaire assessed trust in 6 key trust sources before and during the pandemic: provincial and federal governments, public health authorities, medical care providers, health scientists, and social and personal networks. To complement, 41 qualitative interviews were conducted to understand participants’ lived experiences, perceptions, and how trust played into both. Data have been analyzed using quantitative statistical techniques and qualitative phenomenological analysis, and the results have been integrated to derive comprehensive insights. All phases of data collection and analysis were finalized by early 2025. The project then advanced to paper preparation, dissemination at national conferences, and knowledge-translation activities, including the report development and public-facing outputs, scheduled for completion in end-2025. Results: This Canadian survey included participants from all 10 provinces and 2 territories; the provinces and territories’ samples matched the proportions of each in the overall Canadian population. Age and sex or gender were well distributed across the sample. Additionally, 18.6% (1040/5607) identified as an ethnic minority, 12.7% (710/5607) identified as Indigenous, including 7.2% (403/5607) First Nations, 4.8% (270/5607) Métis, and 0.4% (25/5607) Inuit. Fifty-five percent (3094/5607, 55.2%) had received at least 1 dose and planned to stay up to date with booster recommendations, while 36.6% (2052/5607) were vaccinated but did not intend to receive additional doses. A small percentage, 0.7% (39/5607), had not yet been vaccinated but were open to it, whereas 6.4% (359/5607) had not received a vaccine and did not plan to take a vaccine. Conclusions: The COVID-19 pandemic has underscored the critical role of trust in public health behavior and crisis response. This study explores how consistent, transparent communication and equity-driven policies may contribute to maintaining public trust, particularly among marginalized communities. By examining trust dynamics and identifying potential disparities, this study aims to inform evidence-based public health strategies and improve preparedness for future health emergencies. Trial Registration:

    Nazeem Muhajarine, Cory Neudorf, Khatira Mehdiyeva, Fionnuala Braun, Syed Jafar Raza Rizvi, Zili Zhou, Thilina Bandara, Katrina Baudelaire, Sohana Sadique, Daniel A. Adeyinka, Sahana Ramamoorthy, Ninan Abraham, Kimberly Huyser, Claire Betker, Mary Jessome, Tamara Chavez, Kim L. Lavoie, Ève Dubé·2025·JMIR Research Protocols
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  • COVID-19 Pandemic Experiences Among Adults, Youth, and Childcare Providers: Protocol for a Mixed Methods Study

    stage 1

    Background: The COVID-19 pandemic challenged families, youth, and frontline workers, including childcare providers. Studying lived experiences before, during, and near the pandemic’s end from multiple perspectives provides a more holistic and deeper understanding of its effects and impacts. Objective: This study investigated how parental, childcare provider, and youth stress, mental health, and role overload relate to individual coping and family functioning, as well as vaccine attitudes and uptake patterns among youth, parents, and childcare providers. Information learned from this investigation will inform policy and messaging for future public health crises. Methods: This study is an explanatory sequential mixed methods study designed to capture the voices of parents of children younger than 18 years of age, childcare providers, and youth aged 12-17 years through surveys and interviews. This retrospective cross-sectional study began with a web-based survey that included demographic questions and validated scales to assess personal well-being, household and family dynamics, behavioral problems, and vaccination-related perceptions, attitudes, and behaviors. Open-ended responses about pandemic experiences for themselves and their families were included. A subsample of parents, youth, and childcare providers was selected for in-depth interviews about their pandemic-related experiences. Descriptive statistics were used to summarize demographic characteristics, and internal consistency was assessed for all survey measures using Cronbach α. Future studies will use inferential statistical techniques to analyze survey measures, thematic analysis for open-ended survey responses and interview data, and mixed methods data integration to synthesize quantitative and qualitative findings. Results: Data collection for the study began in August 2022 and finished in August 2023. Data analysis is currently in progress to address research questions, and study preparation and dissemination efforts are underway. A total of 506 adults and 93 youths answered a study survey, and 45 adults and 21 youths completed in-depth interviews. Among the 506 adults, 166 were childcare providers. The adult sample had a mean age of 42.8 (SD 9.15) years and was predominantly female (467/506, 92.3%), with 9.7% (49/506) identifying as Black, 4.7% (24/506) as Hispanic, and 81.2% (411/506) being parents of children aged 17 years or younger. The youth sample had a mean age of 14.5 (SD 1.63) years, and 55.9% (52/93) were female, 6.4% (6/93) were Black, and 17.2% (16/93) were Hispanic. Several dyads and triads participated. The sample included 42 parent-child dyads, 3 parent-parent dyads, 2 parent-parent-child triads, and 21 parent-child-child triads. Conclusions: These data will be used to understand the diverse experiences of families, youth, and childcare providers during and after the COVID-19 pandemic. This includes successful and unsuccessful adaptations, responses to policies and mandates, and the unmet needs for health messaging, programs, policies, and services. This research aims to guide the development of effective policies and public health communication, fostering scalable and sustainable messaging resources.

    Jacinda K. Dariotis, Dana A. Eldreth, Chunyuan Xi, Iffat Noor, Rebecca Lee Smith·2025·JMIR Research Protocols
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  • An Open-Road Driving Performance Task to Examine Long-Term Medical Marijuana Use and Prescription Opioid Positivity Among Adults Aged 50 Years and Older: Protocol for an Observational Trial

    stage 1

    Background: Driving performance involves multiple underlying components of psychomotor functioning, such as attention, executive functions, and vehicle control. While the effects of acute medical marijuana and prescription opioid intoxication are known, how long-term use of medical marijuana under real-world conditions affects driving performance is unknown. Additionally, there are numerous ongoing physical and cognitive changes that affect driving performance with age. Given the proliferation of medical marijuana and prescription opioid use in adults aged 50 years and older, the prevalence of polypharmacy, and declining functional abilities, it is imperative to understand the long-term effects of daily medical marijuana use. Further, we need to understand how co-occurring use of medical marijuana and prescription opioids, in the presence of comorbidities such as chronic pain, affects real-world driving outcomes. Objective: This study aims to document the observational trial protocol. The primary goal of this study is to identify the effects of daily long-term (ie, use for >12 months daily or most days of the week) medical marijuana use on driving performance outcomes using an open-road driving performance task under real-world conditions in adults aged 50 years and older who endorse chronic or severe nonmalignant pain and to examine the combined effect of daily long-term medical marijuana use and prescription opioid use on driving outcomes. A secondary goal is to qualitatively explore self-regulation of medical marijuana and prescription opioid use in this population. Methods: We plan to test medical marijuana use as the exposure variable in adults aged 50 years and older on an open-road driving task performance as the primary outcome. The study will detail tetrahydrocannabinol exposure through ecological momentary assessment and urinalysis and will compare performance with a race-sex–matched group of non–marijuana users. Results: This study is funded by a grant from the National Institute on Drug Abuse (5R01DA057965). Recruitment began on May 19, 2025. As of November 2025, a total of 30 participants had been enrolled. Recruitment is anticipated to be completed by 2029. Publication of the complete results and data from this study is expected by 2030. Conclusions: Data from this study will identify the effects of long-term medical marijuana use and the combined effect of that use with prescription opioids to develop risk screening protocols and intervention targets for this population. The development and dissemination of screening and intervention guidelines will be the next step in this work. Trial Registration: ClinicalTrials.gov NCT06995937; https://www.clinicaltrials.gov/study/NCT06995937

    Nicole Ennis, Sherrilene Classen·2025·JMIR Research Protocols
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  • Challenges in Developing a Patient-Reported Symptom-Based Risk Stratification System for Suspected Head and Neck Cancer: Protocol for a Qualitative Case Study

    stage 1

    Background: Background: The Symptom iNput Clinical (SYNC) system was developed to enhance the timely reporting of Head and Neck Cancer (HNC) symptoms and to ensure that high-risk patients receive faster diagnoses. A key feature of the system is a digital questionnaire co-designed with patient representatives to accommodate varying levels of digital literacy. The system integrates a validated algorithm that assigns risk scores to categorise cases as low or high risk, and a dashboard that supports clinicians by providing them with patient reports. However, the development process encountered challenges that necessitates a systematic evaluation of the process, roles, and experiences of team members. Objective: Objective: This study aims to identify challenges faced during development, how these challenges were addressed, and the implications for future digital health innovations. Methods: Methods: A qualitative single-case study approach will be employed, focusing on individuals involved in the SYNC system’s development. Participants will be selected using a combination of purposive and snowball sampling to ensure diverse perspectives, using meeting minutes and recommendations from key stakeholders. A total of 8 to 12 participants will be interviewed, representing clinical, research, and IT roles. Data collection will involve semi-structured interviews which will be conducted through Microsoft Teams. The interviews are expected to last between 40–60 minutes each. These interviews will be audio-recorded, transcribed, and analysed using framework analysis in Dedoose. Actor-Network Theory (ANT) will guide the analysis by mapping interactions between human and non-human actors, such as developers, clinicians, and technological tools, to understand how they influenced the project’s outcomes. Participant confidentiality will be maintained through data encryption, de-identification, and secure storage. Results: Expected Results: The study anticipates identifying key barriers and facilitators in the SYNC system’s development, including technical, organisational, and collaboration-related challenges. The findings are expected to provide a detailed account of the challenges encountered, such as delays, security concerns, and coordination issues, an insight into how these challenges were mitigated and lessons learned and recommendations for improving digital health technology development, including best practices for co-design, technical integration, and stakeholder engagement. Conclusions: Conclusion: This case study will provide valuable insights into the complexities of developing digital health technologies, particularly in collaborative, multi-stakeholder environments. Documenting the challenges encountered in the SYNC system’s development will contribute to best practices in digital health innovation.

    Chinasa Odo, Joanne Patterson, Nikki Rousseau, Vinidh Paleri, Rebecca Randell·2025·JMIR Research Protocols
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  • Platelet Indices as Unequivocal Markers of Active Disease in Patients With Nonradiographic Axial Spondyloarthritis: Protocol for a Cross-Sectional Study

    stage 1

    Background: Spondyloarthritis is divided into axial and peripheral subtypes. The axial subtype is further divided into ankylosing spondylitis (AS) or radiographic axial spondyloarthritis and nonradiographic axial spondyloarthritis (nr-axSpA). Although AS and nr-axSpA share some common features, nr-axSpA lacks X-ray–based sacroiliitis as defined by the modified New York criteria, that is, the presence of either bilateral grade 2 sacroiliitis or unilateral grade 3 sacroiliitis, which is present in AS. Disease activity in either of them is measured via C-reactive protein (CRP) levels or magnetic resonance imaging (MRI) of the pelvis showing sacroiliitis due to the presence of bone marrow edema. A person with active disease can have normal CRP and MRI findings, especially in nr-axSpA. Immune system activation during inflammation has been shown to alter platelet maturation and morphology, as reflected by platelet indices. These platelet indices have been studied in the past in various autoimmune diseases, such as psoriatic arthritis, AS, and rheumatoid arthritis, and have been correlated with disease activity. Particularly, in spondyloarthritis, platelet indices are more central to the pathology of sacroiliitis, and CRP, which is currently used, is a generalized marker of inflammation. Therefore, platelet indices can provide a better understanding of inflammation, particularly in patients with sacroiliitis. Objective: This study aims to investigate whether platelet indices can be better markers of inflammation in patients with nr-axSpA. We will determine whether platelet indices are reliable biomarkers for measuring disease activity in patients with nr-axSpA. Methods: All patients who are classified as having axial spondyloarthritis as per the Assessment of Spondylarthritis International Society criteria will be included in this study. Patients will be divided into 2 case groups: group A (patients without radiographic sacroiliitis [nr-axSpA]) and group B (patients with radiographic sacroiliitis [AS]). Healthy individuals will be enrolled as controls to compare and correlate platelet indices such as platelet count, plateletcrit, mean platelet volume, and platelet distribution width with CRP, erythrocyte sedimentation rate, and MRI findings in patients with AS and nr-axSpA. Results: This is a nonfunded study. The data collection started on February 1, 2025, and we expect to complete the study by December 2027. As of July 2025, 7 individuals had been enrolled in groups A and B, respectively, and 5 individuals had been included in the control group. At the end of the study, we will be able to correlate whether platelet indices are trustworthy biomarkers of active disease in patients with nr-axSpA. Conclusions: If platelet indices prove to be better markers of active disease in patients with nr-AxSpA, then these markers should be included in the routine evaluation of these patients.

    Abhijeet Kumar Agrawal, Sourya Acharya, Jahnabi Bhagawati, Shivali Kashikar, Nishant Raj·2025·JMIR Research Protocols
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  • Gender of loan officers and loan performance: A pre-registered report

    stage 1

    This pre-registered study tries to explore whether female loan officers maintain their advantage in credit quality in unsecured lending markets, as observed in secured lending markets. The study addresses three key research questions: (1) Whether female loan officers exhibit higher or lower loan performance compared to their male colleagues in unsecured lending; (2) The underlying factors driving the performance gap between male and female loan officers in this market; and (3) How digital lending models influence the credit quality of loans underwritten by female officers. This research provides empirical evidence on the performance differentials of female loan officers across secured and unsecured lending markets. The findings offer valuable insights for commercial banks seeking to optimize the credit assessment efficiency of loan officers and inform their digital transformation strategies.

    Mingwei Chen, Kangyi Xu, Di Gong, Hongyu Guo·2025·Pacific-Basin Finance Journal
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  • The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence to Statins and Blood Pressure–Lowering Medication in Adolescents with Familial Hypercholesterolemia or Hypertension: Protocol for a Pre-Post Cohort Study

    stage 1

    Background: Cardiovascular disease (CVD) is a leading cause of mortality and morbidity in the United States, with risk factors such as hypertension and elevated low-density lipoprotein (LDL) cholesterol originating in childhood. While statins and blood pressure–lowering medications can mitigate these risks, adherence is often poor, particularly among youth. Innovative solutions, such as monetary incentives via smartphone apps, may enhance adherence, but evidence in youth is lacking. Objective: This study aims to evaluate the efficacy of a smartphone app (Wellth) offering financial incentives to improve adherence to statins and blood pressure–lowering medications among youth aged 12 to 19 years at risk for cardiovascular disease. Methods: We initially designed a randomized controlled trial to compare the efficacy of 2 different incentive structures in youth treated with a statin for familial hypercholesterolemia with inadequate adherence. After facing recruitment challenges, the study protocol was changed to evaluating a single incentive in a pre-post design. The primary outcome was the change in adherence rate over the 60-day incentive period compared to the adherence rate during the 14-day run-in period. The secondary outcome was a change in LDL cholesterol level. Adjustments to the protocol were made in response to recruitment challenges during the COVID-19 pandemic, simplifying the incentive structure and expanding eligibility criteria. Results: The study is currently undergoing recruitment and collection of data from the first participants. The study has faced recruitment challenges exacerbated by the COVID-19 pandemic, necessitating protocol modifications. Detailed analysis of adherence rates and LDL cholesterol changes is ongoing. Conclusions: This study explores the efficacy of monetary incentives delivered through a smartphone app to improve medication adherence in youth at risk for CVD. The findings will be used to build upon the existing literature in an effort to improve medication adherence throughout the life course and ultimately reduce CVD. Trial Registration: ClinicalTrials.gov NCT04458766; https://clinicaltrials.gov/study/NCT04458766

    Jacob Hartz, Hannah Chiert, Sarah de Ferranti, Tiffany Powell-Wiley·2025·JMIR Research Protocols
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  • Post–Critical Illness Dysphagia in the Intensive Care Unit (the Dysphagia-ICU Study): Protocol for a Prospective Cohort Study

    stage 1

    Background: Post–critical illness dysphagia occurs in about 10% to 62% of patients in the intensive care unit (ICU). Studies focusing on risk factors for dysphagia following endotracheal intubation are scarce and provide conflicting results. More research is required to determine the true prevalence of dysphagia, possible mechanisms, and risk factors. Objective: The aims of the study are to determine (1) risk factors associated with post–critical illness dysphagia, (2) the prevalence of post–critical illness dysphagia, (3) outcomes of patients with post–critical illness dysphagia, and (4) the diagnostic accuracy of the water sip test compared to fiber-optic endoscopic evaluation of swallowing (FEES). Methods: We plan to undertake a single-center prospective cohort study of patients with post–critical illness dysphagia admitted to the ICU at Prince Sultan Military Medical City, Saudi Arabia. Our inclusion criteria are as follows: (1) being an adult (age 18 years and older), (2) having undergone invasive mechanical ventilation for >24 hours, (3) having been extubated for >24 hours, (4) being able to participate in a FEES, and (5) being hemodynamically stable. Each day, the research coordinator will screen all patients in the ICU for enrollment in the study. The research coordinator will collect daily data on the use of advanced life support, the need for mechanical ventilation, and outcomes (mortality, duration of mechanical ventilation, ICU length of stay, and hospital length of stay). Enrolled patients will undergo a water sip test in the ICU and FEES performed by a certified speech-language pathologist. Patients will then be followed during a hospital stay truncated for analysis at 30 days as two cohorts: (1) patients that have dysphagia, that is, abnormal FEES results; and (2) patients who have normal FEES results. Logistic regression will identify dysphagia risk factors (eg, age, Acute Physiology and Chronic Health Evaluation II score, and ventilation duration), while sensitivity and specificity tests will be used to compare the results of the water sip test to the FEES. Survival analysis will be used to evaluate 30-day outcomes. Results: The study anticipates enrolling 200 patients over 18 months. Key outcomes include dysphagia prevalence and risk factors. Final results will be analyzed and reported upon completion of the 30-day follow-up for all participants. As of July 13, 2025, a total of 45 patients had been enrolled, with an average recruitment rate of 7.5 patients per month. Conclusions: The study findings will promote early intervention for patients with post–critical illness dysphagia, improve multidisciplinary care, and inform policymakers for better resource allocation. This study lays the groundwork for future research and clinical guidelines tailored to Saudi Arabia’s health care context.

    Waleed Alhazzani, Kimberley Lewis, Jamala Selan, Haifa F. Alotaibi, Sara Alnasser, Afaf Alrwais, Atheer Alhomoud, Rawabi M. Alsayer, Hani Tamim·2025·JMIR Research Protocols
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  • Honey as a Wound Care Modality in Treating Deep Neck Space Abscesses: Protocol for a Randomized Controlled Trial

    stage 1

    Background: Deep neck abscesses are a disease in the field of otorhinolaryngology-head and neck surgery that causes significant morbidity, death, and expenditures. Treatment length, whether inpatient or outpatient, is also prolonged. Deep neck abscesses are managed with incision and drainage, abscess exploration, systemic broad-spectrum antibiotic treatment, comorbidity control, and postoperative wound care through recovery. Standard dressings for wound treatment have proven time-consuming and expensive. Honey is one type of dressing that has long been used in wound treatment for a number of body areas and disorders. Objective: The purpose of this study is to investigate the use of honey as a potential substitute for standard dressings for deep neck abscesses. Methods: This is a single-blind randomized controlled trial. Randomization will be done through simple random sampling. The population and sample of the study include all patients with deep neck abscesses treated at Dr Sardjito General Hospital, which is equipped with board-certified otorhinolaryngologists. Patients with deep neck abscesses who were given ethical clearance and meet the inclusion criteria were recruited as study participants until the sample size was reached. There are 18 participants in each group. Participants in the intervention group received standard dressings in addition to honey dressings, whereas those in the control group received standard dressings alone. Proinflammatory cytokines and growth factors, wound size, Bates-Jensen Wound Assessment Tools scoring, and quantitative bacterial colony identification will be all evaluated and assessed. The gathered data will be documented and subjected to statistical analysis. Results: This manuscript presents a study protocol for a randomized controlled trial investigating honey as a wound care modality in patients with deep neck space abscesses. Ethical approval and partial funding for the study were obtained in May 2024. Recruitment and data collection commenced in June 2024 and were successfully completed as of June 2025. Conclusions: We hypothesize that honey may serve as a safe, effective, and affordable alternative wound dressing for the management of deep neck abscesses, with potential benefits in both clinical and health care system outcomes. Trial Registration: ClinicalTrials.gov NCT06562257; https://clinicaltrials.gov/study/NCT06562257.

    Dian Paramita Wulandari, Yanri Wijayanti Subronto, Agus Surono·2025·JMIR Research Protocols
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  • Hospital at home digital twin for the management of patients with frailty: a scoping review protocol

    stage 1

    Introduction Patients with frailty are at risk of adverse outcomes such as mortality, falls, deconditioning and hospital readmissions. With an increasingly ageing population and a greater likelihood of frailty, there is a significant need to ensure that patients are managed in the right place and at the right time. There has been a focus on offering hospital-level care at home as a way to meet this need, incorporating strategies to integrate care and use digital solutions. Digital twin (DT) technology is one advancement, offering a virtual replica of an object/environment, which has the potential to make use of real-time data personalised for an individual patient and/or setting to inform and support patient management decisions. We are yet to realise the full potential of this new way of integrated working and technological advancements. This scoping review aims to ascertain the current evidence for the components of the DT architecture to enable the monitoring and management of patients with frailty living at home. Methods This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews and will be reported following the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews guidelines. The following electronic databases will be searched: Medline, Embase, CINAHL, Cochrane CENTRAL, Web of Science and Scopus. Relevant websites will be searched for grey literature or case reports to capture the required information, as well as any documents provided by stakeholders. Primary studies, published in the English language from 2019 to the present day, which report on the monitoring or management of patients with long-term conditions and frailty within their home environment, will be included. Screening will be conducted by at least two independent reviewers against eligibility criteria, and a piloted data extraction form will be used to align with the research questions. Qualitative content analysis will be used. Data will be presented in tabular form, as well as descriptive and illustrative formats, to address the objectives of this review. Ethics and dissemination This scoping review does not require ethical approval. The findings of this review will be disseminated through peer-reviewed journals and conferences and will support the development of a conceptual model of a hospital-at-home DT for the management of patients with frailty.

    Faiza Yahya, Matthew Cooper, Mohamad Kassem, Hamde Nazar·2025·BMJ Open
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  • How air pollution influences corporate credit spreads: A pre-registered report

    stage 1

    This pre-registered study aims to explore the impact of air pollution, an environmental factor, on corporate bond credit spreads. We are going to investigate three questions in this study: (1) whether air pollution exhibits a causal effect on corporate bond risk premiums? (2) what are the underlying mechanisms driving this relationship? (3) how firm-level heterogeneity modulates environmental risk sensitivity? To explore these questions, we collect corporate bonds that have traded in China's exchange markets from 2014 to 2022 to conduct an empirical analysis. These findings underscore the importance of environmental considerations, such as air pollution, in shaping corporate financial risks and investment decisions.

    Yunbiao Ma, Jingcong Shao, Beibei Shi·2025·Pacific-Basin Finance Journal
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  • Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial

    stage 1

    Background: Voice-controlled smart speakers and displays have a unique but unproven potential for delivering eHealth interventions. Many laptop- and smartphone-based interventions have been shown to improve multiple outcomes, but voice-controlled platforms have not been tested in large-scale rigorous trials. Older adults with multiple chronic health conditions, who need tools to help with their daily management, may be especially good candidates for interventions on voice-controlled devices because these patients often have physical limitations, such as tremors or vision problems, that make the use of laptops and smartphones challenging. Objective: The aim of this study is to assess whether participants using an evidence-based intervention (ElderTree) on a smart display will experience decreased pain interference and improved quality of life and related measures in comparison with participants using ElderTree on a laptop and control participants who are given no device or access to ElderTree. Methods: A total of 291 adults aged ≥60 years with chronic pain and ≥3 additional chronic conditions will be recruited from primary care clinics and community organizations and randomized 1:1:1 to ElderTree access on a smart display along with their usual care, ElderTree access on a touch screen laptop along with usual care, or usual care alone. All patients will be followed for 8 months. The primary outcomes are differences between groups in measures of pain interference and psychosocial quality of life. The secondary outcomes are between-group differences in system use at 8 months, physical quality of life, pain intensity, hospital readmissions, communication with medical providers, health distress, well-being, loneliness, and irritability. We will also examine mediators and moderators of the effects of ElderTree on both platforms. At baseline, 4 months, and 8 months, patients will complete written surveys comprising validated scales selected for good psychometric properties with similar populations. ElderTree use data will be collected continuously in system logs. We will use linear mixed-effects models to evaluate outcomes over time, with treatment condition and time acting as between-participant factors. Separate analyses will be conducted for each outcome. Results: Recruitment began in August 2021 and will run through April 2023. The intervention period will end in December 2023. The findings will be disseminated via peer-reviewed publications. Conclusions: To our knowledge, this is the first study with a large sample and long time frame to examine whether a voice-controlled smart device can perform as well as or better than a laptop in implementing a health intervention for older patients with multiple chronic health conditions. As patients with multiple conditions are such a large cohort, the implications for cost as well as patient well-being are significant. Making the best use of current and developing technologies is a critical part of this effort. Trial Registration: ClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196

    David H. Gustafson, Marie-Louise Mares, Darcie C. Johnston, Gina Landucci, Klaren Pe-Romashko, Olivia J. Vjorn, Yaxin Hu, Adam Maus, Jane E. Mahoney, Bilge Mutlu·2022·JMIR Research Protocols
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  • Registered Report: How does Art Impact Pain and Stress? Exposure to Multimodal Art (Music + Visual) and Music Alone Enhances Pain Tolerance More Than Visual Art, but Neither Art Form Impacts Autonomic or Endocrine Markers

    stage 1

    While the pain- and stress-reducing effects of music are well investigated, effects of visual art and the combination of both modalities (music and visual art) are much less explored. We tested the (1) pain- and (2) stress-reducing effects of a multimodal (music + visual art) aesthetic experience—expecting stronger effects than single modal aesthetic experiences (music or visual art)—and, in an exploratory manner, (3) investigated underlying mechanisms of aesthetic experience and (4) individual differences. In a repeated-measures design (music, visual art, multimodal aesthetic experience, control), 42 female participants submitted their self-selected movingly beautiful visual artworks and music pieces to the lab, where pain and stress were induced by a cold pressor test. Pain (global pain perception, pain intensity, pain affect, pain tolerance) and stress responses (subjective reports, autonomic [electrocardiography, electrodermal activity, salivary alpha-amylase] and endocrine activity [salivary cortisol]) were measured. Individual differences of the experience, trait empathy and absorption were investigated. Exposure to multimodal art resulted in longer pain tolerance than single modality of visual art, but no difference was found for music. Other measures of pain intensity, stress intensity, and pain affect did not differ across the conditions. Regarding the mechanisms, exposure to all types of art distracted participants’ attention from pain, prompted mind wandering, and elicited greater enjoyment than the control condition. Physiological measures of electrocardiography and electrodermal activity validated our design: participants were more stressed during the cold pressor test, but no differences were observed across the four conditions. Also, no differences were found regarding cortisol and alpha-amylase. Regarding individual differences, higher trait absorption was associated with longer pain tolerance in the multimodal condition and with lower pain intensity in the music-only condition, compared to the other conditions. In conclusion, exposure to art can influence pain; however, the underlying mechanisms require further research.

    Anna Fekete, Rosa Maidhof, Eva Specker, Andreas Gartus, Urs Nater, Helmut Leder·2025
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  • A Head-to-Head Comparison of the Incremental Validity of Four Major Mentalizing Tests Against Mentalizing Self-Reports: A Preregistered Study in Adults

    stage 1
    open materials

    Mentalizing, the ability to attribute mental states to oneself and others, is commonly assessed using a variety of neuropsychological tests. However, whether these tools capture unique aspects of mentalizing or primarily reflect reasoning and language abilities remains unclear. This pre-registered study examines the incremental validity of four widely used mentalizing assessments: the Hinting Task, the Faux-Pas test, the Reading the Mind in the Eyes Test, and Frith–Happé Animations. We aim to determine whether these tests uniquely predict self-reported mentalizing abilities in daily life (using various self-reported indices of mentalizing) beyond general reasoning and language skills. Beyond testing the incremental validity of each test, we will also conduct several exploratory analyses, including head-to-head comparisons between the performance-based tests and multimodal associations between tests and self-report questionnaires. This study will clarify the relevance of mentalizing assessments, offering valuable implications for research and clinical practice.

    Léa Guignette, Serge Caparos, François Quesque, Bastien Trémolière, Kim Nimon, Corentin J. Gosling·2025·Assessment
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  • Registered Report Stage I: Prioritizing sociability over morality: Preferring false empathic over truthful unempathic emotion communication

    stage 1

    Literature on person perception suggests the primacy of morality over sociability in interactions. While theories of emotion highlight the importance of adhering to socially acceptable display rules, a contentious debate surrounds whether individuals prioritize moral or sociable communication of emotions. We investigated how people perceive and react to others who falsely communicate empathic versus truthfully communicate unempathic emotions related to others' (mis)fortunes. Through three preregistered studies, we examined participants' perceptions (sociability and morality) and behavioral reactions (in a Dictator Game) by employing various paradigms (vignette and retrospective recall) and situations (e.g., promotion and lottery). Consistently across our studies, we found that participants perceived targets who truthfully communicated unempathic emotions as higher on morality and lower on sociability compared to those who falsely communicated empathic emotions. Moreover, Studies 2 and 3 revealed that participants formed more favorable impressions of, and were more willing to interact with, the target who falsely communicated empathic emotions, as opposed to those who truthfully communicated unempathic emotions. This preference was explained by perceived morality and sociability attributed to the targets. Building on these findings, we propose two follow-up studies aimed at replicating our results and extending them to a laboratory setting – a Gamble Game where participants will directly encounter an actual (mis)fortune, and a Dictator Game with an allegedly real interaction partner. Our expected findings indicate that falsely communicating empathic emotions is favored over truthfully communicating unempathic emotions, suggesting the primacy of sociability over morality in the context of communicating emotions related to others' (mis)fortunes.

    Zi Ye, Feiteng Long, Roujia Feng, Yi Zhang, Wilco W. van Dijk·2026·Journal of Experimental Social Psychology
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  • A study of the effect of AI usage on students' self-efficacy and academic performance in business education: Moderating effect of teacher support [Registered report - stage I]

    stage 1

    The integration of artificial intelligence (AI) in business education marks a significant shift in pedagogical approaches, yet the psychological mechanisms and contextual factors influencing its effectiveness are not yet fully understood. This registered report-stage I study aims to contribute to the field by examining the impact of AI usage on college students' academic self-efficacy and performance in business courses, with a particular focus on the role of teacher support. Drawing on self-efficacy theory, the study proposes a theoretical framework with 4 hypotheses, and employes field and online experiments to test these hypotheses. By addressing the current gaps in research, this study seeks to contribute to the academic literature on the integration of AI in business education, with a focus on self-efficacy and teacher support. The study not only deepens our understanding of the impact of AI in business education but also underscores the critical role of teacher support in shaping student outcomes in the context of AI integration.

    Yong Zhu·2026·Acta Psychologica
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  • Layperson-Friendly AI Translation of Medical Documents to Improve Doctor–Patient Communication: Protocols for the AI-INFOCARE and AI-MEDTALK Randomized Controlled Trials

    stage 1

    Background: Many patients struggle to understand referral letters and discharge summaries; low health literacy is prevalent, and short consultations limit explanations. Large language models (LLMs) can translate clinical jargon into layperson language, but their impact on doctor–patient communication in real care remains untested.

    Elida Hasani, Sven Richter, Tareq Adnan Juratli, Clara Helene Buszello, Markus Georg Prem, Sophia Willkommen, Sahr Sandi-Gahun, Ilker Yasin Eyüpoglu, Witold Henryk Polanski·2025·JMIR Research Protocols
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  • ESG disclosure, ESG rating disagreement and firm valuation in China: A pre-registered report

    stage 1

    As corporate attention to ESG issues continues to grow, the disagreement in ratings for the same company by different ESG rating agencies have sparked widespread discussion and concern. This report aims to explore how corporate efforts in ESG information disclosure can effectively reduce rating disagreements from the perspective of information asymmetry. Using a 2008–2022 sample of Chinese listed firms, we measure corporate ESG disclosure from annual reports and construct a metric of ESG rating divergence from ratings provided by domestic and international agencies. We examine the underlying mechanisms, including information asymmetry, analyst attention, and media oversight. We also investigate the sources of the change in ESG rating disagreement by examining whether the shift stems from domestic versus international agencies, or from incumbent versus new entrants. Besides, we examine how ESG disagreement affects corporate valuation (proxied by Tobin's Q) and how policy-driven changes in disclosure influence firm value, using a portfolio analysis approach. This report sheds light on the economic consequences of voluntary ESG information disclosure, providing support for the future establishment of unified ESG information disclosure standards.

    Xiaoquan Zhu, Yifan Yang, Huijia Hua·2026·Pacific-Basin Finance Journal
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  • Current strategies for improving osseointegration of mesoporous silica drug delivery systems: A scoping review protocol

    stage 1

    Mesoporous silica (MS) is widely recognized as a local drug delivery system in bone-related diseases. Although MS enables controlled or sustained release and improved bioavailability of therapeutic agents, its limited native osseointegration capacity remains a critical barrier to effective bone regeneration. Numerous engineering strategies have therefore been proposed to enhance its biological performance. This scoping review protocol aims to collect studies, published from January 2015 onwards, that report evidence on the osseointegration potential (i.e., osteoconductive, osteoinductive, or proangiogenic properties) of MS bone drug delivery systems. Studies indexed in PubMed, Scopus, and Embase will be screened to identify the strategies used to improve MS-mediated bone regeneration, including structural modifications, formulation into composites, and incorporation of bioactive molecules. A structured analytical framework will be applied to explore how specific design approaches relate to biological outcomes across experimental models in vitro, in vivo, or ex vivo. The resulting scoping review will identify trends and knowledge gaps in strategies intended to enhance the osseointegration of MS bone drug delivery systems, supporting their future development and rational optimization for bone repair.

    Adrianna Skwira-Rucińska, Jakub Ruszkowski, Adrian Szewczyk, Magdalena Prokopowicz·2026·PLOS ONE
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  • How do registered reports work? Evidence from a funding initiative

    stage 1

    A recommendation of: Sigrid H. Ingvaldsen, Ida Svege, Jan-Ole Hesselberg Evaluation of a Funder-Driven Registered Report Initiative https://osf.io/6ynbq/files/kt2qg

    Veli-Matti Karhulahti·2026·Peer Community in Registered Reports
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  • Cross-border data flow regulation and multinational enterprise financing constraints: A pre-registered report

    stage 1

    Using the 2021 enforcement of China's Data Security Law and Personal Information Protection Law as an external shock, this pre-registered study seeks to explore whether—and through which channels—cross-border data flow restrictions are associated with changes in multinational enterprises' financing constraints. Employing a difference-in-differences framework combined with propensity score matching and entropy-balancing matching, we aim to examine whether the regulatory shock affects multinational enterprises' financing constraints through channels related to operational efficiency and information asymmetry. We further explore how firm characteristics, such as foreign sales intensity and state ownership, may condition these effects, with the former potentially intensifying frictions and the latter possibly providing institutional resilience.

    Shixin Li, Boyu Liu, Ziran Qu, Dan Zhu·2026·Pacific-Basin Finance Journal
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  • Caries Detection in Primary Teeth Using Intraoral Scanners Featuring Fluorescence: Protocol for a Diagnostic Agreement Study

    stage 1verified

    Background: Digital methods that enable early caries identification can streamline data collection in research and optimize dental examinations for young children. Intraoral scanners are devices used for creating 3D models of teeth in dentistry and are being rapidly adopted into clinical workflows. Integrating fluorescence technology into scanner hardware can support early caries detection. However, the performance of caries detection methods using 3D models featuring color and fluorescence in primary teeth is unknown. Objective: This study aims to assess the diagnostic agreement between visual examination (VE), on-screen assessment of 3D models in approximate natural colors with and without fluorescence, and application of an automated caries scoring system to the 3D models with fluorescence for caries detection in primary teeth. Methods: The study sample will be drawn from eligible participants in a randomized controlled trial at the Royal Children’s Hospital, Melbourne, Australia, where a dental assessment was conducted, including VE using the International Caries Detection and Assessment System (ICDAS) and intraoral scan using the TRIOS 4 (3Shape TRIOS A/S). Participant clinical records will be collected, and all records meeting eligibility criteria will be subject to an on-screen assessment of 3D models by 4 dental practitioners. First, all primary tooth surfaces will be examined for caries based on 3D geometry and color, using a merged ICDAS index. Second, the on-screen assessment of 3D models will include fluorescence, where caries will be classified using a merged ICDAS index that has been modified to incorporate fluorescence criteria. After 4 weeks, all examiners will repeat the on-screen assessment for all 3D models. Finally, an automated caries scoring system will be used to classify caries on primary occlusal surfaces. The agreement in the total number of caries detected per person between methods will be assessed using a Bland-Altman analysis and intraclass correlation coefficients. At a tooth surface level, agreement between methods will be estimated using multilevel models to account for the clustering of dental data. Results: Automated caries scoring of 3D models was completed as of October 2023, with the publication of results expected by July 2024. On-screen assessment has commenced, with the expected completion of scoring and data analysis by March 2024. Results will be disseminated by the end of 2024. Conclusions: The study outcomes may inform new practices that use digital models to facilitate dental assessments. Novel approaches that enable remote dental examination without compromising the accuracy of VE have wide applications in the research environment, clinical practice, and the provision of teledentistry. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001237774; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384632

    Bree Jones, Stavroula Michou, Tong Chen, Margarita Moreno-Betancur, Nicky Kilpatrick, David Burgner, Christoph Vannahme, Mihiri Silva·2023·JMIR Research Protocols
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  • Does MFIs reduce poverty through entrepreneurship? Evidence from the Microfinance poverty alleviation policy in China: A pre-registered report

    stage 1

    This pre-registered report aims to explore the interaction between entrepreneurship and poverty alleviation based on a microfinance policy perspective, trying to answer three questions: 1) whether the microfinance policy implementation will improve poor entrepreneurs' access finance? 2) If it does, what is the underlying mechanism? 3) what is the impact of the microfinance policy on local entrepreneurial vitality? To explore such three questions, we utilize microfinance poverty alleviation policy issued in China as an exogenous policy shock to conduct a triple difference-in-difference analysis. This pre-registered report expands the understanding on microfinance poverty alleviation through entrepreneurship, and provides a new perspective for consolidating the poverty alleviation performance of finance and preventing a return to poverty.

    Yinglin Liu, Yuning Zhang·2026·Pacific-Basin Finance Journal
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  • Investor behaviors and heuristics based on lunar superstition beliefs: A pre-registered report

    stage 1

    This pre-registered report examines how Lunar Superstitions from the traditional Almanac affect investors' behavior in stock markets across the major Asian economies, including Mainland China, Hong Kong SAR, and Taiwan. We are going to investigate four questions in this study: 1) Do the Lunar superstition beliefs affect stock market returns and trading volumes in the stock markets where Chinese investors participate? 2) What are the mechanisms underlying these effects? 3) If so, under what circumstances will these effects be more pronounced? 4) What are the economic consequences of these effects? This research improves the understanding of how heuristics from superstition beliefs shape investors' decision-making when trading risky assets.

    Li Zhuohan, Qiao Minjian·2026·Pacific-Basin Finance Journal
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  • Cocreation of Integrated Interventions Addressing Noncommunicable Diseases and Environmental Degradation: Protocol for a Participatory Qualitative Study

    stage 1

    Background: Addressing the adverse impacts of climate change on human health requires a global effort across multiple sectors. People living in low- and middle-income countries are particularly vulnerable to the health crises induced by climate change. Therefore, context specific solutions to tackle such challenges are essential to ensure preventive measures are in place for mitigating such risks. Objective: This protocol aims to outline an integrated, participatory approach to cocreate multisectoral interventions tailored to specific environmental and health challenges in Bangladesh, India, and Indonesia. This work is done as part of the Global Health Research Centre for Non-Communicable Diseases and Environmental Change, funded by the National Institute for Health and Care Research. The overall aim is to collaboratively design and assess interventions that deliver dual benefits for planetary and human health. Methods: To address the multisectoral nature of the challenges, this study will adopt a cocreation methodology that blends co-design and coproduction approaches. While the problem areas are specific to each context—tackling air pollution due to plastic burning in Indonesia, improving dietary diversity of public food procurement systems and managing extreme heat in India, and mitigating drinking water salinity in Bangladesh—the underlying cocreation framework is consistent and can be adapted to the needs of each study setting. The workflow consists of 4 key stages guided by an existing cocreation framework: planning, developing, evaluation, and reporting, with the 6 core elements of the Medical Research Council’s complex intervention development framework embedded throughout the process. Drawing on the Double Diamond design process, the cocreation stage involves the following phases: codevelopment of a theory of change to explore potential context-specific interventions, short-listing of intervention components through gap analysis and prioritization, co-designing and coproducing selected intervention components, and assessing appropriateness and feasibility of intervention implementation. The cocreation process will be evaluated using the Research Quality Plus for Co‑Production framework to ensure methodological rigor and quality. Results: Cocreation will take place over 6 months. Sampling and recruitment of cocreators (key stakeholders across sectors) have been completed in all 3 countries, with each cocreator group consisting of 20-30 members. We have developed the tools for the cocreation phase, informed by the findings from formative research, and received the necessary ethics approval to conduct these activities. We will generate a series of academic and nonacademic outputs on the cocreation process to disseminate the findings, as well as training materials for implementers to facilitate future adoption in similar settings. Conclusions: The cocreation of multisectoral interventions to tackle both environmental change and health is a comparatively new domain of implementation research. This protocol addresses the complex, multidimensional, and unique nature of such interventions by developing a structured and scientifically sound approach to be implemented in real-life settings.

    Nushrat Khan, Paraskevi Seferidi, Kristine Belesova, Nantu Chakma, Laura Downey, Noshin Farzana, Sarada Satyamoorthy Garg, Suparna Ghosh-Jerath, Renu John, Maroof Khan, P. K. Latha, Asri Maharani, Sabhya Pritwani, Sekar Aqila Salsabilla, Haryani Saptaningtyas, Vidisha Sharma, Sujarwoto Sujarwoto, Aliya Naheed, Vidhya Venugopal, Christopher Millett, Vivekanand Jha, Devarsetty Praveen·2025·JMIR Research Protocols
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  • Scaling European Citizen Driven Transferable and Transformative Digital Health: Protocol for an Effectiveness-Implementation Hybrid Trial of a Digital Health Platform to Support Multimorbidity Self-Management

    stage 1

    Background: Multimorbidity, the presence of 2 or more chronic conditions, is becoming increasingly prevalent worldwide, resulting in significant impacts on health care systems. For people with multimorbidity, self-management is challenging, requiring engagement in several tasks. Digital health platforms have been widely acknowledged as having the potential to enhance self-management practices for those with chronic conditions. However, limited longitudinal studies have explored the effectiveness of digital health platforms that support multimorbidity self-management or issues relating to their implementation and scalability in practice. Objective: The aim of this study is to determine the effectiveness and implementation of a digital health platform, ProACT, with support services including clinical triage and a care network (consisting of informal and formal caregivers and health care professionals) compared to the use of the platform alone and compared to standard care. Methods: An effectiveness-implementation type 1 hybrid study will be conducted across 3 European countries. A total of 720 older adults aged 65 years or older with multimorbidity (2 or more of the following: diabetes, a chronic respiratory disease, chronic heart failure, and chronic heart disease) will be recruited and randomized into 1 of 3 trial arms. Those in trial arm 1 will be invited to have up to 5 care network members participate with them, resulting in a maximum of 1500 care network participants. Effectiveness will be assessed through a 3-arm pragmatic randomized controlled trial, while implementation issues will be addressed via a process evaluation. Primary outcomes for participants with multimorbidity are quality of life and health care use, while secondary outcomes focus on the potential of the ProACT platform to support multimorbidity self-management (eg, self-efficacy, usability, engagement, and symptom stabilization). Primary outcomes for informal caregivers in the care network include caring burden, while secondary outcomes for all care network members include usability, engagement, satisfaction, and overall experiences with ProACT. Additional outcomes related to the process evaluation include the reach, uptake, and fidelity of implementation of ProACT and the way organizations implement and deliver ProACT; how they differ in this regard; and the factors underpinning these differences. A range of qualitative and quantitative data will be collected and analyzed to assess these outcomes. Results: Enrollment in the trial began in September 2022, and the trial is anticipated to end by March 2026. Trial outcomes will be submitted for publication in 2026. Conclusions: The generation of evidence-based support for the routine use of the ProACT platform in applied settings would represent considerable impact. With health care services under increasing strain and traditionally designed to support those with single morbidities, it is more important than ever to develop actionable insights and resources to empower persons with multimorbidity to self-manage their complex care needs at home, with support from their caregivers. Trial Registration: ISRCTN Registry ISRCTN34134007; https://www.isrctn.com/ISRCTN34134007

    Julie Doyle, Séamus Harvey, Sara Polak, Myriam Sillevis Smitt, Jane Murphy, Áine Teahan, Jessica Ferreira Morais, Suzanne Smith, Orla Moran, Gordon Boyle, An Jacobs, Sarah Anne Tighe, John Dinsmore·2025·JMIR Research Protocols
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  • A Novel Digital Platform to Support Child and Family Mental Health in Australia (Child and Family eHub): Protocol for a Mixed Methods Evaluation

    stage 1

    Objective: This study aims to evaluate the feasibility, acceptability, appropriateness, and preliminary impact of the eHub digital platform for caregivers of children aged 0-12 years, particularly those experiencing adversity. The evaluation will assess implementation outcomes, caregiver and child mental health outcomes, and help-seeking behaviors over a 6-month period. Methods: A prospective cohort of 270 caregivers of children aged 0-12 years will be recruited from 3 socioeconomically diverse Australian sites (Wyndham Vale in Victoria and Marrickville and Fairfield in New South Wales). Participants will be recruited through local community hubs, health and social service providers, and social media, and will enroll via the REDCap (Research Electronic Data Capture; Vanderbilt University) survey platform. A mixed methods type 3 implementation impact evaluation will be undertaken, which tests an implementation strategy while observing and gathering information on the intervention’s impact on relevant outcomes. In this protocol, implementation will be assessed as a primary outcome using Proctor’s outcomes for the implementation framework, and secondary outcomes will include caregiver access and use of the eHub and associated child and parent mental health outcomes. Data will be collected at baseline and 6 months. Quantitative data will be analyzed using descriptive statistics and regression models; repeated measures will be analyzed using generalized estimating equations. Qualitative data will be analyzed using framework analysis. Results: The study was funded in December 2021. Participant enrollment for the study began in February 2024, with participants involved in the eHub evaluation for 6 months. Conclusions: The results of this study will be instrumental in refining the intervention for future scaling to other Australian sites. This study has the potential to offer an accessible, cost-effective, and scalable digital solution to improve service navigation and mental health outcomes for children and families experiencing adversity.

    Suzy Honisett, Raghu Lingam, Valsamma Eapen, Brian Oldenburg, Naomi Hackworth, Harriet Hiscock, George Charalambous, Lisa Minton, Glenn Pringle, Kim Dalziel, John Eastwood, Sharon Goldfeld·2025·JMIR Research Protocols
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  • Deciphering the link between sleep and the human gut microbiome – A Registered Report.

    stage 1

    Hosted on the Open Science Framework

    Sarah Schoch, Martin Dresler, Nils Kohn, Isabella Wagner·2025
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  • Noninvasive Neuromodulation of Visual Perception and Neural Connectivity in Body Dysmorphic Disorder: A Registered Report

    stage 1
    Joel P. Diaz-Fong, Madison Lewis, Jessica Qian, Wan-Wa Wong, Andrew F. Leuchter, Reza Tadaynnejad, Daphne Voineskos, Gerasimos Konstantinou, Eileen Lam, Daniel M. Blumberger, Jamie D. Feusner·2025·Peer Community in Registered Reports
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  • The impact of cash out availability on online betting behavior Stage 1 Registered Report

    stage 1
    Barnabas Szaszi, Wei Yue Hung, Peter Szecsi, Pal Kolumban, Marton Kolozsvari, Miklos Bognar, Arife Yesilöz, Mark D. Griffiths, Zsolt Demetrovics·
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  • The consideration of cost in evaluations of moral praiseworthiness among Chinese children

    stage 1
    Xin Zhao··Infant and Child Development
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  • Clinical Nurse Educators’ Job Satisfaction and Turnover Intentions: Protocol for a Scoping Review

    stage 1
    Kateryna Metersky, Emily Richard, Yasin Yasin, Areej Al-Hamad, Valerie Tan·2025·JMIR Research Protocols
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  • Testing Intuition-Based and Market-Based Forecasting: A Stage 1 Registered Report Using Financial Prediction Tasks

    stage 1verified

    This Stage 1 Registered Report proposes a preregistered replication and extension of prior exploratory work comparing an Intuition Market (IM) with a traditional Prediction Market (PM) in forecasting binary financial outcomes. Previous exploratory analyses suggested that IM performance may equal or exceed that of PM under specific conditions, particularly when predictions are expressed with moderate-to-high confidence and when both methods converge on the same outcome. However, these findings require confirmation using independent data and preregistered analyses. The present study evaluates these patterns using a new set of 30 future financial events. Primary objectives are to test whether (i) IM predictions exceed chance accuracy when confidence is ≥60%, (ii) concordant IM–PM predictions yield higher-than-chance accuracy. All hypotheses, inclusion criteria, outcome measures, and analyses are specified a priori. Primary outcomes are predictive accuracy percentages. This study aims to assess whether intuition-based forecasting provides reliable information beyond standard prediction markets, while ensuring full transparency, reproducibility, and protection against analytical flexibility.

    Patrizio Tressoldi, Riccardo Boscariol·2026·PsychArchives
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  • Visual Mirror Therapy for Children with Cerebral Visual Impairment and an Atelic Profile A Registered Report Stage 1 Clinical Feasibility Study Protocol

    stage 1
    Edwige Smague·
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  • Emotional Coherence under Hypoxia and Aging: A Registered Report on Subjective–Physiological Coupling

    stage 1

    Emotional episodes involve partially coordinated changes in experience and autonomic activity, and subjective–physiological coherence appears to vary with aging and physiological stress. Physiological accounts of emotional aging propose that age-relat

    Pierrick Laulan, Grégoire Millet, Ulrike Rimmele·
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  • The Rhythm of Episodic Memory – Multimodal Investigation and Data-Driven Modulation of Memory Impairments across EEG Signatures

    stage 1

    Background and Aim: In healthy aging, there is a decline of cognitive functions such as episodic memory, i.e., long-term memories of events in one’s life. This process is exacerbated in neurodegenerative diseases such as Alzheimer’s disease. Therefore, developing interventions to maintain memory functions in old age is essential, but requires the identification of the underlying neuronal processes of this decline. However, the neuronal processes underlying age-related memory decline have been inconclusively investigated, particularly regarding the temporal dynamics of memory content integration within brain networks. Here, electroencephalography (EEG) and transcranial alternating current stimulation (tACS) provide methods for investigating and modulating brain oscillations and their association with memory. However, methodological advancements are still required for more practicable and better-tolerated assessments of the neuronal mechanisms of memory impairments and their effective neuromodulation, e.g., in clinical populations. Therefore, this dissertation aims to provide a comprehensive picture of oscillatory processes during memory performance, their age-related changes, and new methods for investigation and potential intervention in healthy older adults and patients. Methods: To this end, I investigated and compared the neuronal correlates of episodic memory in young and older adults using EEG in paper 1. Paper 2 is a Stage 1 Registered Report aiming to investigate the effect of tACS on memory performance and oscillatory activity in healthy older adults. Here, I used EEG, functional magnetic resonance imaging (fMRI) and computational modeling of electric fields of older adults to determine the appropriate stimulation frequency, the exact stimulation sites, and the appropriate electrode set-up to target the identified regions. Paper 2 also includes a pilot study with young adults to ensure the feasibility of the stimulation protocol and involvement of subcortical activity in stimulation effects. In paper 3, I compared memory-relevant measures between conventional and newer dry electrodes (dry EEG) to test whether dry EEG provides a reliable method for investigations in groups or environments where conventional EEG would not be possible, e.g., patient populations in their home. Results: Analyses showed disturbed oscillatory processes in healthy older adults, compared to younger adults, related to age-related memory impairments (paper 1). To target the disturbed memory network in older adults, I developed a multimodal, data-driven approach analyzing EEG, fMRI and electric field modeling pilot data of healthy older adults to identify suitable tACS parameters for modulation of memory and network functioning. An additional pilot study showed the feasibility of the protocol. It also showed that despite the lack of effect on memory performance in a small, high-performing sample of young adults, the stimulation changed this group’s oscillatory processes in cortical and subcortical regions of the memory network (paper 2). The memory-relevant processes investigated in papers 1 and 2 could also be detected with dry EEG, especially using global network measures (paper 3). Conclusion: Together, this dissertation presents a comprehensive account of oscillatory processes during memory performance and the changes they undergo in healthy aging. It introduces novel methods for investigation and possible intervention in healthy older adults and patients. In future work, these findings could be extended to investigate memory- relevant EEG signatures and their modulation in patient groups to develop effective interventions in memory-impaired populations in a home-based setting.

    Nina Marie Ehrhardt·2025
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  • Risk and protective factors associated with perinatal psychopathology in mothers and fathers: Registered report of an umbrella review of meta-analyses

    stage 1

    PsychArchives is a disciplinary repository for psychological science and neighboring disciplines.

    Davide Giusino, Gloria Lagetto, Eleonora Bevacqua, Simone Rollo, Linda Antonella Antonucci, Carmela Mento, Gabriele Lo Buglio, Tommaso Boldrini, Giorgio Falgares, Ivan Formica, Maria Rita Infurna, Omar Carlo Gioacchino Gelo·2025
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  • Exclusive Effects of Moxibustion on Gut Microbiota: Protocol for a Focused Systematic Review and Meta-Analysis

    stage 1

    Background: The gut microbiota (GM) plays a critical role in systemic health, influencing immune, metabolic, and neurological functions. Emerging evidence suggests that moxibustion, a traditional thermal therapy, may modulate GM to restore microbial homeostasis, yet its exclusive effects remain undifferentiated from combined therapies like acupuncture. Prior meta-analyses lack mechanistic specificity, necessitating a focused evaluation of moxibustion’s impact on microbial ecology. Objective: This systematic review and meta-analysis protocol aims to quantify moxibustion-induced changes in GM diversity, taxonomic composition, and functional metabolites (e.g., short-chain fatty acids [SCFAs]). Methods: We will systematically search PubMed, Web of Science, Cochrane Library, CNKI, Wanfang, and VIP databases from inception through December 31, 2024, using keywords such as “moxibustion,” “gut microbiota,” and “intestinal flora.” Eligible preclinical (animal) and clinical (human) studies evaluating standalone moxibustion interventions on gut microbiota will be included. Primary outcomes include microbial α-diversity indices (Shannon, Simpson) and relative abundance of key taxa (e.g., Firmicutes, Bacteroidetes). Risk of bias will be assessed using SYRCLE for animal studies and modified CAMARADES criteria for human trials. Pooled effect estimates for continuous outcomes (e.g., diversity indices, taxa ratios) will be calculated using the ratio of means (ROM) with 95% confidence intervals. Statistical analyses will be conducted in RevMan 5.4 and R (metafor package), with data archived on Figshare for reproducibility. Results: As of March 2025, the literature search and screening have been completed, and 31 studies meeting the inclusion criteria have been identified. The comprehensive analysis is scheduled to be completed by October 2025, with results anticipated to be published in late 2025. The anticipated findings suggest that moxibustion may reduce pathogenic genera such as Ruminococcus while enhancing beneficial genera, effects that are expected to be associated with improved intestinal barrier integrity and anti-inflammatory responses. Conclusions: This protocol provides a rigorous framework to evaluate moxibustion’s unique role in GM modulation, bridging traditional medicine with microbiome science. Results will inform optimized, non-pharmacological strategies for managing microbiome-associated chronic diseases and guide future research priorities. Clinical Trial: Prospero CRD42025639714.

    Xiaotao Zhang, Yueyue Guo, Jia Shi, Qianli Zang, Ying Li·2025·JMIR Research Protocols
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  • Effectiveness of Transcutaneous Spinal Cord Stimulation for Lower Limb Rehabilitation in Spinal Cord Injury: Protocol for a Systematic Review and Meta-Analysis

    stage 1

    Background: Spinal cord injury (SCI) affects millions of people worldwide and often results in impaired lower limb function and reduced mobility. Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique that shows potential for enhancing motor recovery and walking ability in individuals with SCI. However, the effectiveness of tSCS for lower limb rehabilitation in this population remains unclear due to limited evidence from small sample sizes, heterogeneous protocols, and lack of long-term follow-up data. Objective: The primary objective of this systematic review and meta-analysis is to determine the effectiveness of tSCS, compared to sham stimulation, no intervention, or other active interventions, for improving lower limb motor function in individuals with SCI. Secondary objectives are to evaluate the effects of tSCS on walking ability (including speed, distance, and independence), spasticity, quality of life, and safety outcomes. Methods: This systematic review will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported following the PRISMA 2020 statement. We will search electronic databases (PubMed, Web of Science, Embase, CINAHL, MEDLINE, Cochrane Library, PEDro, and Scopus) from inception to August 2025, along with grey literature, trial registries, and hand-searching of key journals. We will include randomized controlled trials, quasi-RCTs, and non-randomized studies (case series with ≥5 participants) that evaluate the effects of tSCS applied over the spinal region on lower limb rehabilitation outcomes in adults with traumatic or non-traumatic SCI. The primary outcome will be lower limb motor function assessed by validated measures such as the Lower Extremity Motor Score (LEMS). Secondary outcomes will include walking ability, balance, functional independence, spasticity, quality of life, and adverse events. Two reviewers will independently screen studies, extract data, and assess risk of bias using the RoB 2 and ROBINS-I tools. Data will be synthesized using random-effects meta-analysis if appropriate, with planned subgroup analyses examining injury level (cervical vs. thoracic vs. lumbosacral), injury completeness (AIS A vs. B-D), stimulation site (cervical vs. thoracic vs. lumbosacral), and co-intervention effects (tSCS alone vs. tSCS plus training), along with sensitivity analyses to explore heterogeneity. The certainty of evidence will be evaluated using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). Results: This is a protocol paper describing the planned methodology for the systematic review. The search strategy has been developed and the protocol has been registered with PROSPERO (CRD420250652270), with results expected by October 2025. Conclusions: This comprehensive systematic review and meta-analysis will address an important gap in the current literature by providing the first focused evaluation of tSCS effectiveness for lower limb rehabilitation in individuals with SCI. The results will inform clinical practice guidelines and guide future research directions in tSCS for SCI rehabilitation. Clinical Trial: Prospero CRD420250652270

    Ravi Shankar, Wei Wen Kevin Sim, Gobinathan Chandran·2025·JMIR Research Protocols
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  • The Effect of Maternal Choline Intake on Offspring Cognition in Adolescence: Protocol for a 14-year Follow-Up of a Randomized Controlled Feeding Trial

    stage 1

    Background: Choline is an essential micronutrient crucial for fetal neurodevelopment. Numerous rodent studies reveal that compared to maternal consumption of standard chow, maternal prenatal choline deficiency produces lifelong offspring cognitive deficits, and maternal choline supplementation produces lifelong improvements in offspring cognition. Few studies have evaluated this question in humans, with mixed results. Nonetheless, the available data raise concerns about the low choline intakes of pregnant women and highlight the need for knowledge of the functional consequences of various choline intakes during pregnancy. Objective: This study will evaluate the cognitive and affective functioning of adolescents born to women who participated in a randomized controlled trial (RCT) of 2 levels of choline intake during pregnancy, with the primary aim of assessing offspring attention and spatial memory. Methods: In a double-blind, randomized controlled choline feeding trial 26 women beginning their third trimester of pregnancy were randomly assigned to 2 groups: daily choline consumption at 480 or 930 mg/day. In this 14-year follow-up, the offspring (n=21) of these women will complete cognitive tests proctored over videoconferencing software. Cognitive function domains will be assessed using web-based software from the Cambridge Neuropsychological Test Automated Battery (CANTAB Connect). We will also assess facets of mental health using the Achenbach System of Empirically Based Assessment (ASEBA). These assessments will test the hypothesis that third-trimester maternal choline intake exerts lasting effects on offspring attention, memory, executive function, and mental health. Results: Between January 2009 and October 2010, 26 women beginning their third trimester of pregnancy from the Ithaca area were enrolled in the original controlled feeding study. We successfully re-recruited 21 (80%) of the original 26 offspring to this 14-year remote follow-up study. Recruitment started in August 2023 and was concluded in October 2023. Analysis is ongoing, and the first results are expected to be submitted for publication in the fall of 2025. We hypothesize that adolescent offspring born to women in the 930 mg/day group will perform better in domains of attention, memory, executive function, and mental health than offspring of women in the 480 mg/day group. This study is unique because the total maternal choline intake is precisely known, and the offspring are followed into adolescence, a time when group differences are indicative of lifelong effects of prenatal intervention. Conclusions: The findings will provide important new information concerning the lasting functional consequences of maternal choline intake during pregnancy for offspring neurobehavioral health, thereby informing dietary recommendations and supplementation policies for pregnant women. Clinical Trial: ClinicalTrials.gov: NCT05859126; https://clinicaltrials.gov/study/NCT05859126

    Sophie A. Roth, Angie E. Lam, Barbara J. Strupp, Richard L. Canfield, Elisabeth Anne Larson·2025·JMIR Research Protocols
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  • Boosting Human Papillomavirus Vaccination Rates: Protocol for a Randomized Controlled Trial of Awareness Interventions in Réunion Island

    stage 1

    Background: Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide and imposes a significant public health burden. In 2019, HPV was responsible for approximately 620,000 cancer cases in women, 70,000 in men, and more than 300,000 deaths globally. Despite the proven efficacy of the vaccine, vaccination rates remain alarmingly low in certain regions of France. In Réunion Island, only 16% of girls and 9% of boys under 16 years old were fully vaccinated in 2024. This underscores the need for increased awareness, education, and outreach programs. Peer learning is well-established in health education, whereas serious game–style card games are newer and require further research. Both methods have been shown to improve knowledge on specific topics. Objective: The main objective of this study is to assess the impact of 2 awareness-raising strategies on increasing HPV vaccination rates among middle school students by actively involving them in the process. Methods: This protocol describes the design of a randomized, open-label, controlled trial aimed at evaluating the effectiveness of 2 awareness-raising interventions—peer learning and a card-based serious game—in improving HPV vaccination rates among middle school students in Réunion Island. The study will span an entire school year, beginning in August. Approximately 3600 students from 24 middle schools in Réunion Island will be included, with schools randomized into 3 groups of 8 each: (1) a control group receiving the existing national vaccination campaign initiated by the French public health institute; (2) ambassador classes, whose students will receive education about the HPV vaccine and later educate other students in the same school; and (3) serious game card group, where students can play and learn about HPV during a science class. The primary outcome will be the proportion of teenagers who initiate the vaccination process, compared across the 3 groups using appropriate statistical methods. Anonymized data will be collected at the end of the school year using social security records. Teenagers’ knowledge of HPV will be assessed both before and 3 months after each intervention, and satisfaction will also be evaluated after the intervention in each group. Results: As of May 2025, a preliminary result enrolling 124 students showed an increase in vaccination coverage after students played a serious game. We expect higher vaccination rates in the intervention groups compared with the control group, although it is difficult to predict which strategy will be more effective. The estimated target vaccination coverage for groups b and c is 45%. Conclusions: This study aims to improve HPV vaccination rates among teenagers in Réunion Island by evaluating the impact of 2 awareness-raising strategies using innovative and engaging tools. If successful, this approach could be adapted and implemented in other regions of France or internationally.

    Julie Duclaud, Antoine Bertolotti, Emmanuel Chirpaz, Jessica Sambourg, Kevin Diallo, Vincent Balaya, Phuong Lien Tran·2025·JMIR Research Protocols
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  • The Good Start Matters mHealth Parenting Program: Protocol for a Randomized Controlled Trial

    stage 1

    Background: The family plays a critical role in shaping children’s health behaviors during early childhood. Family-based interventions are a cornerstone of childhood obesity prevention but often yield modest effects and have several limitations, including a focus on a single caregiver and insufficient attention to coparenting dynamics. Mobile health (mHealth) interventions that include multiple caregivers and target coparenting practices are rare, but have the potential to amplify parenting intervention effects, leading to stronger child health outcomes. Objective: This protocol aims to describe a randomized controlled trial designed to evaluate the efficacy of the Good Start Matters mHealth Parenting Program in improving parenting and coparenting practices (primary outcomes) and child health behaviors (secondary outcomes) among 2.5- to 6-year-olds. Methods: This randomized controlled trial will recruit 118 two-parent families (ie, families with 2 caregivers participating in the trial) from childcare centers across British Columbia, Canada. To promote inclusivity, one-parent families (ie, only one parent participating) will also be eligible but will not count toward the target sample size for recruitment purposes. Eligibility criteria include at least one parent having primary custody of a child aged 2.5-6 years, both parents being fluent in English, and each caregiver owning a smartphone device. In addition, children must not have severe limitations that prevent adherence to general nutritional and 24-hour Movement Guidelines, nor can they be undergoing weight management treatment. After baseline data collection, families will be randomized into either the intervention group, which will receive immediate access to the app, or a waitlist control group, which will gain access to the app after the follow-up assessment, approximately 2 months later. Baseline and follow-up assessments will collect data on food, physical activity, and media parenting practices, coparenting agreement, and child eating, active play, and screen time behaviors. To analyze the data while accounting for its nested structure, multilevel mixed-effects models, integrating intention-to-treat principles and imputation techniques when deemed necessary, will be used. Sensitivity dose-response analyses will assess the extent to which differential adherence/exposure to the intervention influences the study’s outcomes. Results: The trial was registered in March 2023. Recruitment took place from November 2023 to January 2025, with 121 two-parent families and 62 one-parent families recruited. Data collection took place between November 2023 and April 2025. Data cleaning and analyses started in May 2025. Results are expected to be published in 2026. Conclusions: This study will provide critical insights into the efficacy of mHealth interventions to improve parenting and coparenting practices while promoting healthier child behaviors during early childhood. The Good Start Matters mHealth Parenting Program has the potential to strengthen the foundation of family-centered interventions and set a new standard for systemic approaches to early childhood obesity prevention. Trial Registration: ClinicalTrials.gov NCT05802160; https://clinicaltrials.gov/study/NCT05802160

    Olivia De-Jongh González, Claire N. Tugault-Lafleur, Janet W. T. Mah, Louise C. Mâsse·2025·JMIR Research Protocols
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  • Impact of the Exposome in Type 1 Diabetes: Protocol for a Scoping Review

    stage 1

    Background: The recent increase in the incidence of type 1 diabetes (T1D) over the past few decades has been too rapid to be explained solely by genetic factors. It is likely influenced by environmental factors as well. Understanding these environmental factors, the exposome, is essential for identifying new disease prevention and management strategies. Objective: This paper aims to present a protocol for a scoping review to gather current knowledge on the various dimensions of the exposome relevant to the development and outcomes of T1D, highlight existing knowledge gaps, and provide a foundation for future research. Methods: We will follow principles from the Joanna Briggs Institute (JBI) methodology for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines. We will search for relevant publications in 5 databases: PubMed, Embase (Elsevier), CINAHL (EBSCO), Web of Science (Clarivate), and Google Scholar. All studies on the impact of environmental exposures on T1D development or acute (hypoglycemia or hyperglycemia) and chronic (cardiovascular disease, retinopathy, neuropathy, and others) T1D complications will be collected. Two independent reviewers will then use the CADIMA (Client-Server Application for Documentation and Integrated Management of All Steps of a Systematic Review) web tool to screen records for titles, abstracts, and full texts. Data will be extracted from eligible studies by 2 independent reviewers by using a data extraction sheet, including relevant information from the eligible studies helping to answer the research question. The data extraction sheet will be completed together with a quality assessment by using JBI and other relevant tools before the synthesis of all the relevant results. Numerical and visual results will be presented using descriptive summaries to organize, describe, and interpret the findings. We will also provide a narrative synthesis of the main results focused on our objectives. This scoping review is registered with the Open Science Framework. Results: The scoping review started in November 2024. The analysis is expected to be completed and the results submitted for publication in November 2025. The final review will report on all the studies identified and synthesized in accordance with the predefined protocol. Concerning all types of exposure, we expect to find more aspects of the specific external exposome (eg, pollutants, diet, infectious agents), particularly in young populations (children, adolescents) and possibly in utero exposition, linked to the trigger of the disease rather than in developing diabetes complications. Conclusions: By covering the different aspects and stages of the disease, this literature review aims to provide a comprehensive overview of the different effects of the components from the exposome in relation to T1D. This scoping review will help the scientific community understand the various aspects of the exposome in the development of T1D and its consequences. The results will be released as a peer-reviewed open-access publication and during congresses and conferences to reach the scientific community and the general public. Clinical Trial: OSF Registries 10.17605/OSF.IO/UJ5KM; https://osf.io/uj5km

    Maurane Rollet, Gloria A. Aguayo, Jean-Pierre Riveline, Emmanuel Cosson, Guy Fagherazzi·2025·JMIR Research Protocols
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  • Comparing Artificial Intelligence and manual methods in systematic review processes: protocol for a systematic review

    stage 1

    Objectives: This systematic review aims to evaluate the effectiveness of automated methods using artificial intelligence (AI) in conducting systematic reviews, with a focus on both performance and resource utilization compared to human reviewers. Study Design and Setting: This systematic review and meta-analysis protocol follows the Cochrane Methodology protocol and review guidance. We searched five bibliographic databases to identify potential studies published in English from 2005. Two independent reviewers will screen the titles and abstracts, followed by a full-text review of the included articles. Any discrepancies will be resolved through discussion and, if necessary, referral to a third reviewer. The risk of bias (RoB) in included studies will be assessed at the outcome level using the revised Cochrane risk-of-bias tool for randomized trials and the RoB In Non-randomized Studies - of Interventions for nonrandomized studies. Where appropriate, we plan to conduct meta-analysis using random-effects models to obtain pooled estimates. We will explore the sources of heterogeneity and conduct sensitivity analyses based on prespecified characteristics. Where meta-analysis is not feasible, a narrative synthesis will be performed. Results: We will present the results of this review, focusing on performance and resource utilization metrics. Conclusion: This systematic review will evaluate the effectiveness of automated methods, especially AI tools in systematic reviews, aiming to synthesize current evidence on their performance, resource utilization, and impact on review quality. The findings will inform evidence-based recommendations for systematic review authors and developers on implementing automation tools to optimize review efficiency while maintaining methodological rigor. In addition, we will identify key research gaps to guide future development of AI-assisted systematic review methods. Ó 2025 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

    Xuenan Pang, Km Saif-Ur-Rahman, Sarah Berhane, Xiaomei Yao, Kavita Kothari, Petek Eylül Taneri, James Thomas, Declan Devane·2025·Journal of Clinical Epidemiology
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  • Cybersecurity legislation and corporate AI adoption: Evidence from China—A pre-registered report

    stage 1

    This pre-registered report tries to investigate whether and how cybersecurity legislation affects corporate AI adoption. Drawing on textual analysis to construct firm-level AI adoption measures, we are going to use the implementation of the Cybersecurity Law as a quasi-natural experiment and conduct a difference-in-differences (DID) analysis. We further explore potential mechanisms, including cost driven channel, risk mitigation channel, and managerial adaptation channel. We also assess heterogeneity across firm characteristics and regional law enforcement. This study contributes to the emerging literature on the institutional determinants of AI adoption and offers new insights into how data governance frameworks shape firm-level technology decisions in emerging economies.

    Zhuoyan Lao, Yimeng Guan·2026·Pacific-Basin Finance Journal
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  • Semiautomated screening in living guideline maintenance: a simulation study of 90 machine learning–prioritized screening system configurations (protocol)

    stage 1

    Background: Living guidelines are an emerging approach to ensuring guideline recommendations remain relevant to the needs of stakeholders and frontline clinical care. However, development and maintenance remain manual. Single-database workflows involving an overarching search and triage of articles by a single-guideline development team have emerged in this context to improve the efficiency of evidence synthesis. However, there has been limited investigation in how technological enablers such as machine learning (ML)-prioritized screening may be integrated to further compound work savings. This stage I registered report details the protocol for a retrospective simulation study aiming to simulate and evaluate 90 ML-prioritized screening system configurations to streamline the title and abstract screening phase of living guideline development. Methods: A total of five feature extraction techniques (Term frequency inverse document frequency, Word2Vec, SentenceBERT, Specter2, and BioLinkBERT), two classification algorithms (logistic regression, support vector machines), three training strategies (no retraining, adaptive retraining, and incremental retraining) and three stopping rules (data driven, time-driven, and statistical base criteria) will be simulated and evaluated. Each combination will be evaluated based on capacity to save work over sampling, at a target recall of 95%. Computation bottlenecks within the system that may adversely affect user experience and limit adoption by guideline development teams will also be investigated. Lastly, risk-calibrated threshold values targeting recall of 95% for various stopping rules will be investigated. The study will be conducted on a dataset generated from the International 2023 Polycystic Ovary Syndrome (PCOS) guidelines, and the simulation will be conducted on consumer level hardware to better simulate real world scenarios. Conclusion: This study will inform ongoing work transitioning the International 2023 PCOS guidelines into a living format. The results will also provide guideline development teams at large with empirically derived guidance for adopting pragmatic, single database MLprioritized screening into their own guideline maintenance or development workflows. It will also provide a realistic estimate for potential work savings. With these insights, the study will advance both the theoretical understanding and practical implementation of ML-assisted evidence synthesis, informing how living guidelines can remain sustainable into the future. � 2026 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

    Darren Rajit, Steve McDonald, Aya Mousa, Chau Thien Tay, Lan Du, Helena Teede, Joanne Enticott·2026·Journal of Clinical Epidemiology
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