Nature Medicine, Published online: 23 April 2026; doi:10.1038/s41591-026-04415-5
Author Correction: High-dose nusinersen for spinal muscular atrophy: a phase 3 randomized trial
Building a Science-Driven Business: How National Institutes of Health Funding Enabled an Evidence-Based Approach to Maternal Mental Health Innovation
The digital mental health (DMH) industry has grown drastically over the last decade; yet, many DMH products have failed to demonstrate meaningful clinical outcomes, in large part due to lack of scientific evidence. This viewpoint paper highlights an example of how early-stage DMH companies can prioritize science as a strategic advantage. We discuss Moment for Parents, an artificial intelligence–driven maternal mental health app built entirely with support from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program. We illustrate the advantages and challenges of building a science-backed product with federal funding. Benefits include credible evidence generation, independence in product development, and enhanced market differentiation. We also discuss the challenges of navigating the SBIR ecosystem, including grant writing and administrative demands, and aligning business objectives with federal research priorities. By showcasing both the promise and complexity of SBIR funding, this viewpoint paper offers actionable insights for founders and chief executive officers who aim to prioritize science in the DMH space.
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Understanding Collaborative CT and MRI Utilization Through Network Analysis: Retrospective Study Using Administrative Claims Data
<strong>Background:</strong> Japan has one of the highest densities of computed tomography (CT) and magnetic resonance imaging (MRI) scanners globally, yet efficient resource allocation remains a challenge amid demographic shifts and regional health care disparities. <strong>Objective:</strong> This study aimed to develop an analytic framework using network analysis techniques to understand the collaborative use of CT and MRI devices across health care facilities in a Japanese prefecture. <strong>Methods:</strong> A retrospective observational study was conducted using outpatient receipt data from Japan’s National Health Insurance and the Late-Stage Elderly Medical System, covering fiscal years 2016 to 2019. Network analysis techniques were used to identify patterns of shared use among medical institutions. Network graphs with community detection were developed to visualize collaborative relationships, and density and reciprocity metrics were calculated to assess interinstitutional cooperation. <strong>Results:</strong> CT examinations increased from 287,782 (2016) to 307,029 (2019), while MRI examinations increased from 107,876 to 115,929 over the same period. Collaborative examinations also increased for both modalities. Network density remained relatively stable (CT: 3.10-3.50×10<sup>-3</sup>; MRI: 3.20-3.70×10<sup>-3</sup>), while reciprocity decreased (CT: 9.74×10<sup>-2</sup> to 7.79×10<sup>-2</sup>; MRI: 2.82×10<sup>-2</sup> to 1.56×10<sup>-2</sup>). Community detection analysis showed differences in the distribution of medical institutions across clusters over time. <strong>Conclusions:</strong> Network analysis revealed structural changes in collaborative CT and MRI use patterns, including declining reciprocity, which suggests a shift toward more unidirectional referral patterns. This analytic framework provides a method for health care planners to assess interinstitutional collaboration and inform resource allocation strategies for shared diagnostic equipment.
Development of a Child Articulation Screening Test Within Digital Therapeutics: Delphi Study
Background: Speech sound disorders are common in children and are associated with an increased risk of academic reading difficulties. The COVID-19 pandemic further highlighted the need for remote and digitalized assessment tools. In South Korea, standardized instruments such as the Urimal Test of Articulation and Phonation and Assessment of Phonology and Articulation for children are widely used but have limitations, including reliance on face-to-face evaluation, and the absence of automated scoring. Objective: This study aimed to develop and establish the content validity of an articulation assessment tool that can overcome these limitations and be integrated into digital therapeutics (DTx). Methods: A 3-round modified Delphi survey was conducted between July and September 2025 with 92% (23/25) of the invited experts, including 52.2% (12/23) physiatrists and 47.8% (11/23) speech-language pathologists, with a mean professional experience of 10.69 (SD 5.09) years. All participants (23/23, 100%) completed all rounds. Panelists evaluated the appropriateness of word lists, phonological environments, and scoring criteria. Quantitative analyses, including calculations of content validity ratio (CVR), content validity index (CVI), and median and IQR, were performed. Consensus thresholds were set at a CVR of ≥0.39, a CVI of ≥0.78, a median of ≥3.5, and an IQR of ≤1.0. Items were retained only when all 4 criteria were satisfied. While formal qualitative analysis was not performed, the research team internally reviewed and synthesized core keywords and themes from the experts’ open-ended responses to guide the refinement of items. Results: These findings were summarized into four key areas: (1) modernization of word stimuli, (2) expansion of phonological coverage, (3) refinement of scoring criteria to reduce ambiguity, and (4) enhancement of result interpretability through visualization. In round 2, a revised 35-word list was evaluated across 25 items, of which 20 (80%) met all consensus criteria. In total, 20% (5/25) of the items failed to meet at least one threshold, including phonological environment adequacy (CVR=0.48; CVI=0.74), scoring redundancy (CVR=0.13; CVI=0.57), usefulness of proportion of whole-word correctness or percentage of word proximity (CVR=0.39; CVI=0.70), contribution of mean phonological length (CVR=0.22; CVI=0.61), and usefulness of feature-based indexes (CVR=0.30; CVI=0.65; IQR 2). Items that reached consensus showed CVR values of 0.57 to 0.91, CVI values of 0.78 to 0.96, a median score of 4, and IQR values of 0 to 1. In round 3, all remaining items achieved consensus. Conclusions: This Delphi study developed a novel articulation assessment tool with robust content validity. This tool includes updated word stimuli, diverse analysis indexes, and visualization features, thereby enhancing its clinical utility and suitability for integration into artificial intelligence–based DTx. By standardizing and digitalizing articulation assessments, this tool has the potential to support personalized and accessible interventions for children with speech sound disorders.
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Exploring the Cultural Adaptation of an Ongoing Evidence-Based Intervention for Chinese and Korean American Dementia Caregivers: Descriptive Study
Background: The aging and caregiving population is becoming increasingly diverse in the United States, leading to a growing need for culturally adapted interventions to address the unique needs of underrepresented groups, such as Asian Americans. However, interventions targeting Asian Americans and exploring cultural adaptation strategies remain limited in dementia caregiving research. Objective: This study aimed to describe the cultural adaptation process of an evidence-based intervention for Chinese and Korean American dementia caregivers, called the New York University Caregiver Intervention–Enhanced Support. Methods: We conducted a deductive content analysis and categorized our adaptation strategies into 5 elements: content, context, relationship fidelity and core elements, engagement, and cultural competence. Timing and types of responses to each adaptation strategy were also observed. Two authors conducted the initial analysis, and additional team members finalized the synthesis through discussion. The Template for Intervention Description and Replication (TIDieR) checklist was used to guide the methodological rigor. Results: Twenty-four major adaptations were identified and categorized. For content, we translated materials, used culturally relevant terms, incorporated ethnic-specific surveys and resources, created social media support groups on platforms widely used by the targeted population, and extended the time allocated to complete the 6 counseling sessions. Context adaptation included expanding the range of individuals eligible for family counseling sessions to include fictive kin, using online and social media apps for communication, cultural matching and training of staff, and partnerships with relevant community organizations. Relationship fidelity and core elements involved consulting with community experts, conducting focus group interviews with caregivers, having regular meetings with the developer of the original intervention and an experienced New York University Caregiver Intervention–Enhanced Support clinician as well as experts in Chinese and Korean culture, and continuing regular counseling supervision. To enhance engagement, we provided clear explanations of the study procedure, which emphasized the benefits in participants’ native languages and matched participants with social workers who shared the same cultural backgrounds. We also used a step-by-step contact approach and prolonged communication, explained staff roles to build rapport, and offered participant compensation. Finally, cultural competence was reflected in tailoring counseling techniques with respect for cultural beliefs, the use of euphemistic language for taboo subjects, and culturally appropriate refreshments to show respect and build interpersonal relationships. Conclusions: We systematically adjusted a counseling-based intervention, an approach less familiar among Asian Americans, to fit the cultural characteristics of the target population. A contribution of this study is using an integrated, theory-driven approach that combines 2 cultural adaptation frameworks while also capturing real-time adaptations informed by external feedback and self-reflection. This work provides a practical model for adapting evidence-based interventions to serve Chinese and Korean American dementia caregivers and may inform future adaptations for other East Asian populations. Trial Registration: ClinicalTrial.gov NCT05461495; https://clinicaltrials.gov/study/NCT05461495
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Medical Students and Clinicians’ Perceptions of Social Media Direct-to-Consumer Advertising and Medication Requests
This study examines how medical students and clinicians report experiencing patient medication requests associated with prescription drug direct-to-consumer advertising on social media; survey data from 98 respondents indicate that those providing both in-person and virtual care encounter more frequent requests for medications advertised online, particularly branded glucagon-like peptide-1 (GLP-1) weight loss drugs.
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Expected Competencies and Personal Attributes of Digital Health Navigators to Support Digital Mental Health Care: Focus Group and Interview Study With Patients and Health Care Professionals
Background: Digital mental health apps (DMHAs), and in particular digital therapeutics (DTx), offer promising opportunities to support mental health care. However, their effective use in outpatient settings in Germany remains limited. To overcome this gap, the role of digital health navigators (DHNs) has been introduced. DHNs are trained individuals who support patients and health care professionals in selecting, using, and integrating DMHAs into care. Despite increasing interest in this role, there is limited evidence on the competencies, knowledge, and personal attributes required for DHNs to work effectively in mental health settings. Objective: The study aims to explore the expected competencies, knowledge areas, and personal attributes that DHNs need to effectively support the implementation and use of DTx in outpatient mental health care. Methods: As part of the prestudy of the Digital Navigators for Acceptance and Competence Development with Mental Health Apps (DigiNavi) study, a qualitative study was conducted involving 35 participants (7 general practitioners, 8 patients in general practice, 11 outpatient psychiatrists/psychologists, and 9 patients in psychiatric outpatient clinics) from different general practices and psychiatric outpatient clinics in Germany. A total of 17 semistructured interviews and 4 focus groups were conducted to explore expectations of DHNs. Data were analyzed using qualitative content analysis. Results: Participants emphasized that DHNs should combine strong interpersonal skills (empathy, patience, and sensitive communication) with technical and basic clinical competencies. Most favored DHNs as integrated clinical team members (eg, medical assistants), citing their existing patient relationships, but noted time and training constraints. Key expectations included the ability to support patients with DTx use, adapt communication to individual needs, and convey data privacy information clearly. Foundational knowledge of mental health conditions and sensitivity to crises were considered important for identifying warning signs and escalating concerns. While DHNs were seen as essential intermediaries between patients, health care professionals, and DTx, participants highlighted the necessity for clearly defined roles, structured training, and realistic expectations to prevent role overload and enable sustainable implementation in outpatient mental health care. Conclusions: DHNs require a specialized skill set that bridges clinical understanding, digital expertise, and interpersonal competence. Our results lay the groundwork for developing training curricula and implementation strategies that align with real-world expectations for the DHN role. Defining these core competencies is essential for supporting the sustainable and effective integration of DMHAs into mental health care. Trial Registration: German Clinical Trials Register DRKS00034327; https://drks.de/search/en/trial/DRKS00034327 and ClinicalTrials.gov NCT06575582; https://clinicaltrials.gov/study/NCT06575582 International Registered Report Identifier (IRRID): RR2-10.2196/67655
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A CAR-T biotech’s dramatic turnaround, and drugmakers’ tactics to drive more scripts
How did a biotech company that almost ran out of money three times get acquired for over $3 billion? Will the M&A streak continue? And why are drugmakers working with a telehealth company called Prescribery?
We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast. Venture capitalist Bryan Roberts joins us to discuss his firm’s investment in Kelonia Therapeutics, the CAR-T biotech that Eli Lilly just said it would buy for $3.25 billion.
Enabling In Vivo Lentiviral Therapies: Manufacturing Strategies to Improve Purity, Scalability, and Clinical Readiness
Lentiviral vectors are gaining momentum not just as ex vivo tools but as potential in vivo therapeutic platforms. But with that shift comes a number of manufacturing challenges, including higher doses, tighter control of impurities, greater batch consistency, and scalable processes to meet both clinical and commercial needs.
In this GEN Podcast, two experts from SK pharmteco, a global CMO, address these challenges and lay out some best practices that guide the manufacture of lentiviral vectors with the requisite purity, robustness, and economic feasibility required for widespread clinical adoption..
Podcast Guests:
Tatiana Nanda, PhD
CTO, Cell and Gene Therapy
SK pharmteco
Mardhani Aparajithan
Director of Manufacturing,
Science and Technology
SK pharmteco
Produced with support from:
The post Enabling <i>In Vivo</i> Lentiviral Therapies: Manufacturing Strategies to Improve Purity, Scalability, and Clinical Readiness appeared first on GEN – Genetic Engineering and Biotechnology News.
STAT+: Trump celebrates closing first round of drug pricing deals, promises more ahead
WASHINGTON — President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.
On the same day, Regeneron also announced Food and Drug Administration approval of Otarmeni, the first gene therapy to be greenlit under the agency’s new National Priority Voucher program. In early trials, the drug provided modest hearing gains for people with a rare type of hearing loss, though its development has received pushback from parts of the Deaf community. Regeneron plans to offer the drug at no cost to American patients.