BackgroundProblematic use of digital technology among children, adolescents, and young adults is associated with adverse health, behavioural, interpersonal, social, academic and vocational outcomes. Most existing research focuses on treatment oriented interventions. Prevention focused interventions are limited. This is especially true for the low- and middle-income countries. There is a need for structured prevention approaches that involve youth, parents, and teachers.ObjectivesThis study aims to develop and validate a comprehensive package of prevention-focused interventions targeted at problematic use of digital technology among youth.MethodsThe study will be conducted across six sites in India. It will use a sequential mixed-methods design. Literature review, stakeholder interviews, and expert consensus shall be used for intervention development. This will be guided by established frameworks for complex interventions. Validation will be carried out using a quasi-experimental pre–post design. Quantitative measures will assess changes in knowledge, skills, confidence, and decision-making, as well as feasibility and acceptability. Qualitative methods will be used to assess engagement, delivery quality, and contextual factors.Expected outcomesThe study will lead to a modular prevention-focused intervention package with evidence of feasibility and acceptability. Findings will inform future larger scale implementation and evaluations.ConclusionThis protocol outlines a structured approach to development of a prevention-focused intervention targeted at problematic digital technology use among youth. The focus on prevention, stakeholder involvement, and real-world settings supports relevance for public health practice and policy.Clinical trial registrationhttps://ctri.nic.in/Clinicaltrials/login.php, identifier CTRI2026/03/105278.
ADOPT model combined with structured health education alleviates the preoperative anxiety of patients undergoing preventive ileostomy
ObjectiveThis study aimed to evaluate the efficacy of the ADOPT (Attitude-Definition-Openmind-Plan-Try it out) model combined with structured health education in alleviating preoperative anxiety in patients undergoing preventive ileostomy for rectal cancer.MethodsThis is a randomized controlled trial. A total of 60 patients scheduled for temporary ileostomy were randomly assigned to either the control group (routine care) or the research group (ADOPT model combined with science popularization interventions). The research group received structured education via a multimedia resource library, including preoperative, intraoperative, and postoperative care guidance, alongside interactive support from a specialized healthcare team. Anxiety levels were assessed with the State-Trait Anxiety Inventory (STAI) at admission and preoperatively.ResultsAt baseline, no significant differences were observed in gender (P = 0.202), age (P = 0.052), or BMI (P = 0.798) between the two groups. Both groups exhibited comparable anxiety levels at admission. However, one hour before surgery, the research group showed significantly lower state anxiety (S-AI) scores and total anxiety scores compared to the control group (20 ± 0.48 vs 23 ± 0.37, p<0.001), while trait anxiety (T-AI) scores remained similar (p<0.05).ConclusionThe integration of the ADOPT model with structured health education effectively reduces preoperative anxiety in ileostomy patients, highlighting its potential as a standardized nursing intervention.
Virtual reality-based inhibition training influences food-related responses: no additional effects of repetitive transcranial magnetic stimulation
Combining cognitive inhibition training with brain stimulation techniques has received increasing attention as a potential approach to modulating maladaptive food craving and food intake. Building on previous work in this line of research, the current study examined whether virtual reality (VR)-based no-go inhibition training paired with repetitive transcranial magnetic stimulation (rTMS) modulates implicit food-related attitudes, craving and food-choice behaviors. Healthy women with high trait food cravings and a preference for high-calorie foods were assigned to one of four groups in a 2 (rTMS: active vs. sham) × 2 (training: no-go vs. neutral) between-subjects design. High-frequency rTMS was applied over the left dorsolateral prefrontal cortex (DLPFC), and no-go training was implemented in a VR environment using food stimuli tailored to participants’ self-reported preferences. Implicit attitudes and food craving were assessed before and after the intervention, while food choice was measured post-intervention only. Following training, the no-go group showed reduced positive implicit attitudes toward high-calorie foods and increased craving for low-calorie foods compared to pre-training levels, whereas no such changes were observed in the neutral group. Moreover, compared to the neutral group, the no-go group made healthier food choices. No-go training effects on food choice were more pronounced among individuals with low-to-moderate baseline preferences for high-calorie foods. In contrast, no significant main effects or additive effects of rTMS were observed. The present study demonstrates that VR-based no-go training can effectively regulate food-related responses and extends earlier work by demonstrating robust inhibition training effects across implicit and explicit measures, while highlighting the importance of considering individual differences in future research.
Why we left the FDA: Six former officials share their stories
A year after U.S. DOGE Service cuts shook up the federal government, STAT’s FDA reporter Lizzy Lawrence has been speaking with former officials about their time at the agency. Two weeks ago, I hit the road with Lizzy to interview six of them about what drew them to the agency, the important work they did during their career there, and, ultimately, why they decided to leave during the second Trump administration.
In a special road-trip edition of STATus Report, Lizzy and I travel around the leafy suburbs of Washington to bring you first-person testimonies, including the former director of the FDA’s Center for Drug Evaluation and Research, Richard Pazdur; Sheryl Lard-Whiteford, a leader in the FDA’s biologics center; and Julie Tierney, who worked on Operation Warp Speed.
Fully Anonymized Digital Health Data Acquisition in a Research Partnership Using a Blinded Deidentification Proxy in the HerzFit App: Implementation Study
Background: The European General Data Protection Regulation (GDPR) strictly regulates the processing of personal and health-related data, posing challenges for digital health research, especially when data are collected using participants’ own devices. Although scientific data can theoretically be anonymized, standard internet communication protocols inevitably expose transmission metadata, preventing true anonymization. Existing solutions, including virtual private networks, reverse proxies, and trust centers, improve confidentiality but do not technically or legally enable fully anonymized data collection. Consequently, large-scale digital health research often requires extensive organizational measures, complex consent procedures, and high regulatory overhead. Objective: This study aimed to develop a GDPR-compliant concept for fully anonymized scientific data collection, ensuring that no entity has simultaneous access to identifying information and donated data. We also implemented and evaluated this concept in a real-world public-private partnership. Methods: We designed a data donation architecture based on a blinded deidentification proxy that decouples identifying transmission metadata from encrypted user data at the time of donation. The concept combines symmetric (Advanced Encryption Standard-128 in Cipher Block Chaining) and asymmetric (Rivest-Shamir-Adleman with Optimal Asymmetric Encryption Padding) encryption, enabling end-to-end encrypted and anonymized data transfer without persistent identifiers. The system was integrated into the HerzFit app, a mobile lifestyle coach for cardiovascular disease prevention available in German-speaking countries, and evaluated for adoption, technical feasibility, and performance. Performance overhead was assessed using round-trip time benchmarks. Duplicate donations were identified and merged to estimate unique data donors. Results: The solution was integrated and tested in the HerzFit app with more than 200,000 downloads between April 2022 and December 2025. Since the introduction of the data donation feature, more than 13,000 donations have been received, translating to more than 9000 individual users contributing anonymized datasets. Proxy-based transmission resulted in an average round-trip time of 143 ms, compared to 58 ms for direct transfer, representing a modest overhead while maintaining usability. The operator of the donation database did not gain access to identifying information at any stage, demonstrating full technical anonymization. The approach can be operated reliably at scale with minimal server resources due to the stateless proxy design. Conclusions: This work introduces a novel system architecture enabling fully anonymized, GDPR-compliant data donation directly from participants’ devices. By decoupling identifying metadata from encrypted health data, the concept minimizes regulatory effort, strengthens privacy protection, and provides a practical framework for large-scale digital health research in research partnerships, for example, between a private company and a research institution. The real-world deployment in HerzFit demonstrates the feasibility, scalability, and scientific utility of this approach. The concept is broadly transferable to other mobile health apps and has the potential to substantially expand ethically and legally compliant data acquisition.
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Impact of a Prototype Combining Recommender Functionality With Structured Documentation on Operator Performance in Calls to Medical Communication Centers: Quasi-Experimental Feasibility Study
<strong>Background:</strong> Management of contacts to medical communication centers relies heavily on clinical judgment, contextual understanding, and communication skills. Decision support systems, intended to complement medical expertise, may, due to their rigidity, impede effective caller interaction and may, together with the obligatory documentation of calls, contribute to a workflow that draws attention away from the communication. Recommender systems have demonstrated potential in supporting decision-making across various domains by nudging individuals toward better choices without undermining autonomy. We built a prototype that combined artificial intelligence–based question recommendations with structured documentation (hereafter: the prototype) and conducted a feasibility study to test its influence on operators’ performance. <strong>Objective:</strong> This study aimed to examine whether the prototype influenced the operators’ performance during telephone triage. We hypothesized that the prototype would affect medical quality without affecting communication quality. <strong>Methods:</strong> A quasi-experimental pre- and posttest feasibility study was conducted in a simulated setting. Twenty-five operators were voluntarily recruited from 5 Norwegian medical communication centers, in which 22 operators contributed to both the pretest (before the prototype) and the posttest (with the prototype). The operators handled the same 15 medical cases presented by simulated callers, with a 5-month interval between the 2 sessions. The question recommender was trained on other data and then fine-tuned on the 15 scenarios used. Audio recordings of the calls were rated using the tool Assessment of Quality in Telephone Triage. Pre- and posttest values were compared, with overall medical and communication quality as the primary outcomes. Secondary outcomes included specific items related to medical content and communication, accuracy of triage, patient safety, call duration, and efficiency. <strong>Results:</strong> A total of 320 paired calls were analyzed. Overall medical quality improved significantly with use of the prototype, from a mean of 6.83 points pretest to 7.16 points posttest rated on a 10-point scale (difference 0.34, 95% CI 0.11-0.57; <i>P</i>=.004). The effect size was small (Cohen <i>dz</i>=0.16). No significant change was observed in overall communication quality, with a mean of 7.06 points pretest and 6.97 points posttest (difference –0.09 points, 95% CI –0.28 to 0.10; <i>P</i>=.35). A significant decrease from pre‑ to posttest was observed in the specific items “Collects information about the patient’s location” (<i>P</i><.001) and “Ensures that the triage decision is understandable and feasible” (<i>P</i>=.002). None of the remaining secondary outcomes showed significant changes. <strong>Conclusions:</strong> The prototype yielded a modest improvement in medical quality within the scenario‑based test environment. Although overall communication quality remained unchanged, aspects of the interaction were negatively affected. Artificial intelligence–based question recommendations combined with structured documentation may serve as useful functionalities within a decision support system, but each functionality requires further testing and development before such technology can be implemented in the triage of unselected, real‑world calls. <strong>Trial Registration:</strong>
Examining the Influence of Social Network Factors on Weight Loss Among Latina and Non-Hispanic White Breast Cancer Survivors: Observational Cohort Study
<strong>Background:</strong> Breast cancer is the most commonly diagnosed cancer among women and is the leading cause of cancer death among Latina individuals. Breast cancer survivors are at increased risk of obesity. Mobile health interventions have been shown to be an effective way of reducing the risk of weight gain. Less studied but also important is the extent to which social networks play a role in supporting or undermining weight loss efforts. <strong>Objective:</strong> We examined the association between 4 kinds of social network interactions and change in BMI among Latina and non-Hispanic White breast cancer survivors engaging in a mobile health app pilot study. <strong>Methods:</strong> Latina and non-Hispanic White breast cancer survivors were randomized to engage in either the <i>Mi Salud</i> or <i>Mi Vida, Mi Salud</i> app. <i>Mi Salud</i> allowed participants to engage in self-monitoring by recording their behaviors and symptoms. <i>Mi Vida, Mi Salud</i> used these same features in addition to a self-discovery feature that would summarize and report back this information to participants. We collected information on BMI and health-related social support; positive and negative health-related social control (which included persuasion and pressure, respectively); and undermining at baseline and after 12 weeks of the intervention. <strong>Results:</strong> While participants (non-Hispanic White n=22 and Latina n=22) in both study arms experienced decreased BMI over the 12-week period, this change in BMI did not differ according to ethnicity. Furthermore, change in social support was not associated with decreased BMI (B=−0.19, <i>P</i>=.12). However, the interaction between change in social support and ethnicity was significant, such that predicted margins were significant for non-Hispanic White individuals (B=−0.57, <i>P</i>=.02) but not for Latina individuals (B=−0.54, <i>P</i>=.72). Change in persuasion was not associated with change in BMI (B=0.072, <i>P</i>=.61); however, increased pressure was associated with increased BMI (B=0.66, <i>P</i>=.02). Finally, change in undermining was not associated with change in BMI (B=0.32, <i>P</i>=.11). <strong>Conclusions:</strong> Latina and non-Hispanic White participants did not differ in weight loss. However, our findings regarding social network involvement and change in BMI show the importance of considering social network processes in weight loss among breast cancer survivors. These findings buttress existing research suggesting the benefits of social support, particularly within specific cultural frameworks, while attempts to increase participants’ healthy behaviors that involve criticism can be detrimental to change efforts. Future research that builds on these findings is needed to elucidate the specific social network processes that may drive health behavior among diverse breast cancer survivors.
A Sustainable Lifestyle Intervention Among Office Workers: Cluster Randomized Pilot and Feasibility Study
Background: Society faces multiple challenges, including lifestyle diseases and global climate change. Framing health education within sustainable development may enhance motivation for behavior change because proenvironmental behaviors, as well as healthy behaviors, often rely on the same behavior change principles. Combining these perspectives may therefore reinforce health behaviors and climate-friendly choices. Objective: This pilot study aims to explore changes in dietary intake, diet-related carbon footprint, and physical activity among office workers receiving sustainable plus healthy lifestyle (sustainable lifestyle arm) or healthy lifestyle education (healthy lifestyle arm) alone. It also aims to assess the feasibility of the intervention functions, including workshop attendance rate, participants’ dietary goals, social support, and facilitators and barriers to behavior change. Methods: A 2-armed participant-blinded cluster randomized study, including an experimental intervention arm (sustainable lifestyle; n=19) and a control intervention arm (healthy lifestyle; n=14), was conducted in Sweden. The study lasted 8 weeks and included 6 workplace-based workshops and was framed by the behavioral change wheel and the socioecological model. Diet, carbon footprint, and physical activity were assessed using the web-based questionnaires Meal-Q and Active-Q. Attendance rate, individual goals, social support, and facilitators and barriers were assessed using printed questionnaires. Results: The reduction of total diet-related carbon dioxide equivalents (COe) was 0.8 kg and 0.4 kg per day for the sustainable and healthy lifestyle arm, respectively. Also, there was a statistically significant interaction between time and lifestyle when the carbon footprint was expressed as a qualitative aspect of diet, that is, COe kg per 1000 kcal per day (=.05). Moreover, the intake of vitamin C, a marker for fruits and vegetables, increased to 8.0 and 12.5 mg per 1000 kcal per day for the sustainable and healthy lifestyle arms, respectively. In addition, total sedentary time decreased by 0.4 hours per day in the sustainable lifestyle arm, but not in the healthy lifestyle arm. This indicates that the educational workshops in respective arms had different impacts on health behavior over time. Minor differences were found in dietary goals, with the sustainable lifestyle arm setting more goals related to ecological and vegetarian foods. No differences were seen between arms regarding barriers or facilitators. Conclusions: This study suggests that embedding healthy lifestyle recommendations within a sustainable development context may be an efficient way to reduce carbon footprint and increase healthy behavior among office workers. Given the ongoing global epidemic of metabolic diseases, climate change, and environmental degradation, promoting a sustainable lifestyle in a workplace context has the potential to counteract these trends. Trial Registration: ClinicalTrials.gov NCT06698094; https://clinicaltrials.gov/study/NCT06698094
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Barriers and Facilitators in the Implementation of the Systematic Medical Appraisal, Referral, and Treatment (SMART) Mental Health Digital Intervention in Rural India: Mixed Methods Process Evaluation Study
<strong>Background:</strong> An estimated 150 million people have mental health care needs in India, but only 15% are able to access care. Depression and anxiety contribute to a large proportion of mental morbidity. The Systematic Medical Appraisal, Referral, and Treatment (SMART) Mental Health trial used a mobile-based clinical decision support system for primary care doctors and community health workers (CHWs) to identify and treat people at risk of depression, anxiety disorders, and self-harm. A community-based antistigma campaign was also delivered. The intervention led to improved remission rates for depression and anxiety and lower stigma scores. <strong>Objective:</strong> A process evaluation assessed (1) implementation fidelity, barriers, and facilitators; (2) perceptions of doctors and CHWs on the use of SMART Mental Health; and (3) the causal pathways that led to trial outcomes. <strong>Methods:</strong> A mixed methods evaluation combining backend program data and qualitative data was conducted. A total of 38 focus group discussions and 37 key informant interviews were conducted with primary doctors, CHWs, government officials, local community leaders, and research project staff. The data were coded and analyzed using a framework analysis approach based on the UK Medical Research Council guidance on process evaluations and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. <strong>Results:</strong> The intervention had high implementation fidelity. Across clusters, the median proportion of participants with at least 1 CHW follow-up was 98% (IQR 96.6%-100%). The referral rate for a psychiatrist was low (224/1697, 13.2%), and only 23.6% (53/224) of those referred visited the psychiatrist. The median exposure to antistigma audiovisual content was 84% (IQR 65.7%-95.9%). At the community level, key implementation barriers included cultural inhibitions in seeking mental health care and the unavailability of patients due to competing demands. Proximity and tight social connections between CHWs and their communities were important facilitators in seeking medical help. Doctor and CHW training, mentoring, and feedback provided by program staff were important facilitators to support the use of the digital health components by the health workforce. <strong>Conclusions:</strong> A complex intervention that included both community-based antistigma and clinical digital health interventions achieved high implementation fidelity. Key areas to consider for maintenance of such interventions include (1) the need for sustained community-based strategies to address stigma and other cultural barriers; (2) health workforce strengthening policies, including supportive supervision for CHWs and doctors to increase capability in the use of mental health digital health tools; and (3) strategies to improve access to specialist care for those with more complex care needs. <strong>Trial Registration:</strong> Clinical Trial Registry India CTRI/2018/08/015355; https://tinyurl.com/5r63suxp
Macrophages Use Cell Volume Changes to Sense Danger and Amplify Inflammation
Macrophages are often described as the immune system’s first responders, but new work suggests they are also remarkably attuned to the physical state of their environment. A study published in the Journal of Cell Biology titled “Disruption of macrophage cell volume drives inflammatory responses and type I interferon signaling” reveals that shifts in cell volume act as a previously underappreciated danger signal—one that can rewire macrophage gene expression, heighten antiviral defenses, and intensify inflammatory responses.
The research, led by Jack Green, PhD, and colleagues at the University of Manchester, centers on the Volume‑Regulated Anion Channel (VRAC), a protein complex that helps cells maintain osmotic balance. When VRAC is missing, macrophages lose the ability to correct swelling under hypo‑osmotic stress. “Cell volume disruption induced type I interferon signaling through a DNA- and TBK1-dependent mechanism, but independent of cGAS and 2′3′-cGAMP transport,” the authors wrote. That loss of control, the team found, is far more consequential than a simple biophysical hiccup. It fundamentally alters how macrophages interpret threats.
Green noted that although earlier studies hinted at a connection between cell volume and inflammatory signaling, the underlying biology remained murky. “Despite the reported indications that cell volume and VRAC are involved in inflammatory signaling, the basic biological mechanisms of how the regulation of cell volume shapes inflammation were unknown,” he said. To probe that gap, the team examined VRAC‑deficient macrophages exposed to mild osmotic stress.
The swelling triggered broad reprogramming of gene expression, including the induction of antiviral and proinflammatory pathways. Many of the most strongly upregulated genes belonged to type I interferon signaling cascades or nucleic acid–sensing systems. First author James Cook frames the finding succinctly: “Together, these findings suggest that cell volume acts as an additional layer of danger sensing in macrophages that shapes and tunes the nature of immune responses to pathogens.”
That prediction held up in functional assays. When challenged with Influenza A virus, VRAC‑deficient macrophages mounted a more potent antiviral response than their wild‑type counterparts. The heightened sensitivity extended beyond viral infection. In mouse models of systemic hyperinflammation, animals lacking VRAC showed elevated levels of a key inflammatory mediator, indicating that dysregulated cell volume can exacerbate cytokine‑driven pathology in vivo.
Rather than responding solely to biochemical cues, these cells appear to fold physical perturbations—such as osmotic imbalance—into their danger‑sensing logic. Green argued that this perspective may help explain why inflammatory diseases can escalate unpredictably when tissue conditions shift. “Understanding disruptions in the tissue microenvironment leading to alterations in cell volume is therefore an important consideration in our understanding of inflammation and disease pathogenesis,” he concluded, adding that “future studies will reveal the potential for regulating VRAC‑dependent cell volume changes in macrophages in disease.”
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