Tag: Academic research

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Development of a Contextualized, Research-Based Flemish Assessment Framework for Digital Care, Assistance, and Support: Delphi Study

<strong>Background:</strong> The rapid evolution of digital technologies has transformed health, mental health, and social care, offering new modalities of digital care, assistance, and support through web-based platforms, mobile apps, extended reality, wearables, and artificial intelligence systems. Despite this proliferation, there is little consensus on what constitutes “high-quality” digital care. Challenges persist regarding data security, interoperability, accessibility, sustainability, and professional competence, whereas existing standards and regulations provide fragmented guidance. <strong>Objective:</strong> This study aimed to develop a contextualized, consensus-based quality assessment framework for digital care, assistance, and support in Flanders, Belgium. For this purpose, perspectives across technology, organizational processes, and professional competencies were integrated. <strong>Methods:</strong> The study used a multiphase design comprising (1) 10 expert interviews with Flemish government officials; (2) a narrative literature review of 303 peer-reviewed and gray literature sources; (3) a 3-round Delphi study with 50 experts across 5 domains (end users, facilitators, technology developers, deontology and ethics experts, and digital inclusion and media literacy experts); and (4) 4 complementary focus groups and 3 interviews with specialists in artificial intelligence, regulation, social work, mental health, and IT. The Delphi rounds gathered iterative feedback through open-ended elicitation, structured rating, and classification of quality criteria. Quantitative data were analyzed using descriptive statistics, whereas qualitative feedback was subjected to thematic analysis. <strong>Results:</strong> A total of 50 experts participated in round 1, a total of 40 (80%) participated in round 2, and 27 (54%) participated in round 3. Round 1 generated 577 unique quality criteria, consolidated into 26 clusters organized under 3 pillars: technology, organization, and professional competencies. The relative importance across pillars was balanced (mean score 37.29, SD 12.38 for technology; 33.33, SD 10.39 for professional competencies; and 29.80, SD 10.45 for organizations). Accessibility, reliability, and safety ranked highest for the technology; vision, quality monitoring, and infrastructure ranked highest for organization; and support, digital competencies, and ethics ranked highest for professional competencies. The finalized framework included 112 criteria, of which 35 (31.3%) were designated as optional and 77 (68.8%) were designated as minimum requirements. Focus groups and interviews validated the framework’s comprehensiveness and usability, emphasizing proportional implementation, user centrality, and alignment with European Union regulations. Stakeholders highlighted the need for tools, training, and governance mechanisms to ensure adoption and sustainability. <strong>Conclusions:</strong> This study produced a codeveloped, context-sensitive quality assessment framework that balances technological robustness, organizational readiness, and professional competence in digital care, assistance, and support. The framework can serve both as a quality safeguard and a developmental road map. Accompanying self-assessment and governance tools enhance practical applicability. Implementation success will depend on governmental support, resource allocation, and structured feedback loops. Future research should pilot the framework in real-world settings, assess its impact, and establish mechanisms for continuous updates to maintain relevance in a rapidly evolving digital landscape. <strong>Trial Registration:</strong>
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<![CDATA[Experts share more on research developments of remternetug for Alzheimer disease.]]>
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STAT+: Pharmalittle: We’re reading about FDA seeking more data on a Lilly obesity pill, a pharma 340B win, and more

Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Our choice today is chocolate raspberry. Meanwhile, we have assembled the latest menu of tidbits to help you along. So please dig in. Have a smashing day, and please feel free to forward any secrets you come across. Our “in basket” is always open. …

The U.S. Food and Drug Administration asked Eli Lilly for more data on liver injury linked to its newly approved ​obesity pill, Reuters says, citing a letter posted on the agency website. The April 1 letter also said Lilly must conduct post-marketing trials to assess risks related to cardiovascular events and delayed gastric emptying. The drugmaker is required to also conduct a milk-only lactation study in ​lactating women who have received a dose of the pill to assess concentrations of the drug ​in breast milk using a validated assay. The weight loss pill, ‌branded Foundayo, a once-daily oral medication that targets the GLP-1 hormone, won approval earlier this month under the Commissioner’s National Priority voucher program, which aims to speed FDA decisions on drugs deemed critical to public health or ​national security.

AbbVie, Novartis, AstraZeneca, and the Pharmaceutical Research & Manufacturers of America, the industry trade group, notched a victory after a U.S. appeals court vacated an order rejecting their request to block a Maryland drug discount law, remanding the decision for review, Bloomberg Law reports. The U.S. Court of Appeals for the Fourth Circuit ruled that a lower court erred when it denied a motion filed by the companies and the trade group for a preliminary injunction against a Maryland law. H.B. 1056, currently in effect, requires manufacturers to distribute discounted drugs to an unlimited number of pharmacies that contract with health providers under the 340B Drug Discount Program. They argued the law improperly forces drug companies to supply so-called contract pharmacies as part of the program, and that the law is illegal because it is preempted by federal law and also violates the U.S. Constitution.

Continue to STAT+ to read the full story…

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Aberrant local and global neural activation patterns in pediatric Prader–Willi syndrome

PurposeAlthough cognitive disorders in children with Prader–Willi syndrome (PWS) are linked to abnormalities in spontaneous neural activation and functional connectivity (FC), the specific neural activation patterns remain uncertain, especially in young children with PWS.MethodsThe current study set out to explore specific local and global neural activation in pediatric PWS using the amplitude of low-frequency fluctuations (ALFF), regional homogeneity (ReHo), and seed-based whole brain FC. Information was gathered from 35 pediatric PWS patients and 33 healthy controls (HC). Both groups’ ALFF and ReHo values were computed, and FC were constructed on the basis of altered ALFF and ReHo regions. The relationships between altered ALFF, ReHo, and FC and the Griffiths Developmental Scales (GDS) of the PWS group were analyzed using partial correlation analysis.ResultsBoth ALFF and ReHo exhibited decreases in occipital lobe, temporal lobe, and cingulate gyrus, and altered ReHo was present in parietal lobe, frontal lobe, and basal ganglia areas. Moreover, ALFF and ReHo also exhibited increases in occipital and temporal lobes. Decreased FC was detected in the visual network (VN), sensorimotor network (SMN), salience network (SAN), and default mode network (DMN). The SMN-, cingulate-, and occipital lobe-related neural activation patterns were significantly positively correlated with the GDS score.ConclusionThe PWS group was characterized mainly by decreased neuronal physiological function and the ReHo was similar to ALFF but more extensive. The decreased local and global brain neural activation patterns may serve as early physiological indicators of cognitive abnormalities.
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Brain-gut communication and potential applications of microecological treatments in stroke

Stroke is a cerebrovascular disease with high incidence rates, serious disability and increased mortality rates, thereby posing a serious threat to human health. The mechanisms of brain-gut communication have gradually emerged in recent times. This article focuses on the gut-brain axis and discusses the bidirectional regulatory pathways between gut microecology and stroke via the neurotransmitter, colony metabolite, endocrine, and immunoregulatory pathways. Additionally, it summarizes the latest applications of gut microecological agents in stroke, which may provide new research ideas and clinical treatment strategies for the microecological diagnosis and therapy of stroke.
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Early tinnitus burden and subjective hearing are candidate markers of 2-year quality of life after cochlear implantation in single-sided deafness

BackgroundCochlear implantation is a common treatment for adults with single-sided deafness (SSD), but patient-reported benefits vary. The relationships among tinnitus burden, perceived hearing ability, psychological distress, disease-specific health-related quality of life, and whether early postoperative outcomes predict later results are not well understood.ObjectiveThis study explores how disease-specific quality of life relates to tinnitus burden, hearing, stress, depression, and anxiety after cochlear implantation in SSD. It also seeks early markers linked to 2-year outcomes.MethodsThis secondary complete-case analysis was based on a previously reported prospective longitudinal SSD cohort. Of 70 adults with postlingual SSD, 36 (51.4%) had complete Nijmegen Cochlear Implant Questionnaire (NCIQ) data at baseline and at 6 months, 1 year, and 2 years after unilateral cochlear implantation and were included. Additional measures included the Tinnitus Questionnaire (TQ), Oldenburg Inventory (OI), PerceivFed Stress Questionnaire (PSQ), General Depression Scale (ADS-L), Generalized Anxiety Disorder 7-item scale (GAD-7), and Freiburg Monosyllable Test (FMT) at 65 dB. Timepoint-specific correlations with the NCIQ were analyzed using Spearman’s rank correlations. Exploratory multivariable analyses employed linear regression on rank-transformed variables to assess whether baseline and 6-month patient-reported profiles were associated with 2-year NCIQ outcomes. Longitudinal within-patient comparisons were conducted as a secondary descriptive analysis.ResultsHigher NCIQ scores were linked to lower tinnitus burden and better hearing across all assessments. Associations with depression and anxiety persisted, while connections with perceived stress emerged after surgery. At baseline, higher tinnitus burden was associated with lower 2-year NCIQ scores. At 6 months, higher tinnitus is still associated with lower 2-year NCIQ scores, whereas better hearing is associated with higher 2-year NCIQ scores. Early postoperative improvement was followed by stabilization over 2 years.ConclusionImprovement in health-related quality of life after cochlear implantation in adults with SSD is complex and extends beyond hearing alone. Tinnitus was the most consistent negative factor, while improved subjective hearing at 6 months was associated with better outcomes at 2 years. These results support a structured, multidimensional approach to patient-reported follow-up after cochlear implantation in SSD and suggest that early postoperative patient-reported status may serve as an early candidate marker for later quality-of-life outcomes.
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Direct and indirect associations of hypochondriasis with suicidality in psychiatric outpatients: mediating roles of anxiety and depression

IntroductionAlthough both hypochondriasis and suicidality are common in psychiatric patients and related to anxiety and depression, their association in psychiatric patients remains unclear. This study investigated the direct association of hypochondriasis with suicidality and the indirect associations via anxiety and depression in psychiatric patients.MethodsClinical records of 5484 psychiatric outpatients were reviewed. Hypochondriasis, Suicidality, Anxiety, and Depression were evaluated using the hypochondriasis item of the Hamilton Depression Rating Scale, the suicidality item of the 17-item Hamilton Depression Rating Scale (HAM-D17), the Hamilton Anxiety Rating Scale (HAM-A), and the 6-item subscale of the Hamilton Depression Rating Scale (HAM-D6), respectively. The associations among Hypochondriasis, Suicidality, Anxiety, and Depression were examined using a parallel mediation model. The model was estimated using the lavaan package in R with 10, 000 bootstrap resamples, adjusted for age and sex. Moderation by age and sex was also investigated.ResultsSignificant positive indirect associations via Anxiety (point estimate = 0.05, 95% CI [0.03, 0.06]) and Depression (point estimate = 0.17, 95% CI [0.15, 0.19]) were observed between Hypochondriasis and Suicidality. Conversely, the direct association between Hypochondriasis and Suicidality was also significant but in a negative direction (B = −0.16, p <.001). As the total indirect association was stronger than the direct association, the total association of Hypochondriasis with Suicidality was significantly positive (B = 0.05, p = 0.002). The negative direct association of Hypochondriasis with Suicidality was significantly stronger in younger patients (interaction term = 0.004, p <.001).ConclusionAnxiety and depression mediated the association between hypochondriasis and increased suicidality. In contrast, hypochondriasis was associated with decreased suicidality after accounting for the mediators. As the indirect association was stronger than the direct association, hypochondriasis was associated with increased suicidality overall. The direct association between hypochondriasis and decreased suicidality was stronger in younger patients.
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Gut microbiota profiles in anorexia nervosa: associations with disease severity, BMI, and history of childhood trauma

Study objectivesEmerging evidence suggests a possible link between anorexia nervosa (AN) and alterations in the gut microbiota. This study aimed to characterize the gut microbiota profile in a cohort of Chinese female patients with AN.MethodA comparative analysis of the gut microbiota was conducted between 30 female patients with AN and 30 sex- and age-matched healthy controls (HCs). Fecal samples were collected for 16S rRNA gene sequencing analysis. All participants were assessed using the Eating Disorder Inventory (EDI) and the Childhood Trauma Questionnaire (CTQ). Bioinformatics analysis was performed using QIIME2, and statistical analyses were carried out with SPSS 26.0 and R software. Correlations between microbiota differences and body mass index (BMI), EDI, and CTQ were further investigated.ResultsThe analysis revealed differences in beta diversity and the abundances of specific microbial taxa between the two groups; however, no significant differences were observed in alpha diversity nor in the associations between gut microbiota and BMI, disease severity, or childhood trauma.ConclusionsThis study identified limited differences in the gut microbiota composition between patients with AN and HCs. Critically, no robust associations between gut microbiota and clinical features were found after rigorous multiple comparison correction. While nominal (uncorrected) correlations were observed between the specific microbiota and psychological traits, these results are exploratory and should be considered hypothesis-generating. They highlight a potential avenue for future research but require validation in larger, longitudinal cohorts to determine their reproducibility and biological significance.
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The conversing military chaplain: time allocation, task salience, and competencies among Swedish military chaplains

Military chaplaincy is an established yet multifaceted practice within military organizations and is exposed to particular stressors such as the use of violence, ethical dilemmas, loss, and existential vulnerability. This study examines how a Swedish normative framework for Military Soul Care (ACCES: advisory role, command and crisis support, ceremonies, education, and soul care conversations) interacts with Swedish military chaplains’ own experiences of what they perceive as most important and meaningful in their mission. The empirical material consists of qualitative questionnaire data collected in 2025 from 50 military chaplains. The material was analyzed using an abductive approach and organized thematically. The results show that conversations constitute the task to which the greatest amount of time is devoted across both main categories of military chaplains, and that conversations are understood broadly, ranging from informal everyday interactions to confidential individual soul care conversations. Various forms of ceremonies and crisis support related to death and grief were experienced as particularly meaningful and reflect a clearly articulated priestly identity. Educational tasks varied between categories, with time constraints and organizational priorities limiting opportunities depending on context. A central finding is that presence within the organization, aimed at building relationships and trust, emerges as a decisive prerequisite and contributes to many chaplains working beyond their contracted hours. The importance of presence is not explicitly articulated in the ACCES framework but rather permeates the mission implicitly. Against the backdrop of a changed security environment, the findings illustrate that ecclesial priestly competencies related to crisis response, death, grief, and funeral expertise constitute a particularly vital resource in situations of crisis and war.
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Preoperative anxiety and depression symptoms are associated with poorer clinical outcomes following corrective surgery for adult equinocavovarus foot

PurposeThis study aimed to investigate the preoperative psychological status of adult patients with equinocavovarus foot deformity and to examine the association between preoperative anxiety/depressive symptoms and the clinical outcomes of corrective surgery in this population.MethodsA retrospective analysis was conducted on 103 adult patients who underwent corrective surgery for equinocavovarus foot at Xi’an Honghui Hospital between March 2014 and July 2023. Baseline data were collected. Patient psychological status, ankle-hindfoot function, pain, and quality of life were assessed preoperatively and at the final follow-up using the Hospital Anxiety and Depression Scale (HADS), the American Orthopedic Foot & Ankle Society (AOFAS) ankle-hindfoot score, the Visual Analog Scale (VAS), and the 36-Item Short Form Health Survey (SF-36). Based on preoperative HADS scores, patients were categorized into an anxiety/depression group (Group A) and a non-anxiety/depression group (Group B). The two groups were compared with respect to baseline characteristics (gender, age, disease duration, BMI, follow-up duration), clinical outcomes, and the degree of improvement in all assessment metrics.ResultsA total of 83 patients completed the follow-up, among whom 38 (45.78%) exhibited preoperative anxiety/depression symptoms. No significant differences were found in baseline characteristics between the two groups (all P > 0.05). At the final follow-up, both groups showed significant improvement in VAS, AOFAS, SF-36 (PCS/MCS), and HADS (A/D) scores compared to their preoperative baselines (all P < 0.001). Intergroup comparisons revealed that Group A had significantly lower AOFAS and SF-36 (PCS/MCS) scores, and significantly higher VAS and HADS (A/D) scores than Group B, both preoperatively and at the final follow-up (all P < 0.001). Regarding the degree of improvement, Group A demonstrated a smaller magnitude of improvement in VAS (P < 0.01), AOFAS (P < 0.01), and SF-36 PCS (P < 0.001) compared to Group B. Conversely, Group A showed a greater improvement in SF-36 MCS and HADS (A/D) scores (all P < 0.001).ConclusionsWhile surgery improved all outcomes, patients with preoperative anxiety/depression exhibited persistently worse clinical scores. Their improvement profile was distinct: smaller gains in pain and physical function but greater mental health improvement. Addressing preoperative psychological status may optimize comprehensive outcomes.