Category: Statistics

JMIR Public Health Surveill. 2025 May 22;11:e66921. doi: 10.2196/66921.

ABSTRACT

BACKGROUND: Sexual and gender minority (SGM) individuals represent 2%-5% of the US population, yet continue to account for more than two-thirds of new HIV infections annually.

OBJECTIVE: This study seeks to identify multilevel (ie, structural, psychological, and social) and biobehavioral (ie, rectal cytokines or chemokines) determinants of amplified HIV seroconversion risk for SGM individuals, including those who use methamphetamine.

METHODS: The American Transformative HIV Study is an ongoing web-based cohort study of 5364 SGM individuals from all 50 US states and Puerto Rico, enrolled in 2022 and 2023, and will be followed through 2027. We oversampled persons who use methamphetamine (2846/5364, 53.1%). We used established web-based strategies to enroll individuals aged 16-49 years at high risk of HIV acquisition via sexual networking apps. To be eligible, participants had to report meeting objective criteria for HIV pre-exposure prophylaxis (PrEP) care, but not be taking PrEP. Participants complete annual web-based surveys (baseline, 12, 24, and 36 months) and are asked to provide self-collected oral fluid samples for HIV testing and 2 rectal swabs (the Aptima Multitest Swab and the Zymo DNA/RNA Shield swab) following each assessment. Oral fluid samples are analyzed immediately, while rectal swabs are banked for a future nested case-cohort analysis to assess changes in inflammatory markers following a new infection.

RESULTS: Nearly all participants (4542/5364, 84.7%) were cisgender men, 3.7% (201/5364) were transgender women, and 1.1% (61/5364) were transgender men who have sex with men. There were also 560 (10.4%) individuals who self-identified outside of the gender binary-all reported being assigned male sex at birth. In total, 56.5% (3031/5364) were persons of color, and 31.8% (1714/5365) were aged 16 to 29 years. In total, 4054 baseline HIV test kits were returned, including 371 HIV reactive samples-3.3% (69/2210) were HIV-positive among those who did not report methamphetamine use, and 15.5% (302/1944) were HIV-positive among those reporting methamphetamine use. Based on participant’s HIV results as well as self-reporting when their most recent prior HIV-negative test was, we estimated that the incidence rate in this cohort in the 12-month period leading up to study enrollment was 10.06 (95% CI 8.65-11.64) per 100 person-years among those reporting methamphetamine use compared with 2.04 (95% CI 1.49-2.73) among those not reporting methamphetamine use per 100 person-years.

CONCLUSIONS: A large, US national, and racially diverse web-based cohort of SGM individuals at high risk for HIV has been successfully enrolled and will be followed through 2027. Persons who use methamphetamine have been oversampled and demonstrated an exceptionally greater risk for HIV. Our study will offer insight into the development and implementation of new interventions, which aim to have a meaningful impact on HIV transmission.

PMID:40402549 | DOI:10.2196/66921

JAMA Ophthalmol. 2025 May 22. doi: 10.1001/jamaophthalmol.2025.1262. Online ahead of print.

ABSTRACT

IMPORTANCE: The accuracy of the predicted risk of malignant transformation of a large choroidal nevus or indeterminate melanocytic tumor (IMT) is not known.

OBJECTIVE: To estimate the risk of malignant transformation (predicted risk) in a cohort of patients with IMT of known outcomes (observed status; benign [large nevus] or malignant [small melanoma]).

DESIGN, SETTING, AND PARTICIPANTS: This was a cohort study of patients from a single center. Patients diagnosed with IMTs that were benign (large nevus) or malignant (small melanoma) were included in the analysis. Those lesions classified as large nevus (benign; 0% risk) had documented stability over 24 or more months. IMTs classified as small melanoma (malignant; 100% risk) had quantified growth or confirmatory pathology. Data were analyzed from October to December 2024.

EXPOSURES: Prediction of malignant transformation of a large choroidal nevus or IMT.

MAIN OUTCOMES AND MEASURES: The primary outcome included the predicted 5-year Kaplan-Meier probability of malignant transformation using combinations of risk factors of predictive models, the Collaborative Ocular Melanoma Study (COMS) and Wills Eye Hospital (WEH) model.

RESULTS: A total of 123 patients (median [IQR] age, 63 [56-67] years; 89 male [72%]), 62 with large nevus and 61 with small malignant melanoma, were included in this study. The mean predicted 5-year Kaplan-Meier probability of melanoma for observed melanoma was 0.39 (95% CI, 0.32-0.46) by the COMS model and 0.44 (95% CI, 0.39-0.49) by the WEH model. The difference of -0.05 (95% CI, -0.14 to 0.04) was not statistically significant. However, the mean predicted 5-year Kaplan-Meier probability of melanoma for observed nevus was 0.18 (95% CI, 0.12-0.23) by the COMS model and 0.31 (95% CI, 0.24-0.38) by the WEH model. The difference of -0.13 (95% CI, -0.22 to -0.05) was statistically significant. There was a significant difference in mean 5-year Kaplan-Meier probability of melanoma between observed melanoma and nevus of 0.21 (95% CI, 0.12-0.31) by the COMS model and 0.13 (95% CI, 0.05-0.21) by the WEH model. Optimal cut points of 0.18 and 0.34 for the COMS model and the WEH model, respectively, were identified using the Youden index. The sensitivity was lower for the COMS model than the WEH model (-15.2% difference; 95% CI, -25.6% to -4.8%), and the specificity was higher for the COMS model than the WEH model (11.7% difference; 95% CI, 2.0%-21.4%).

CONCLUSIONS AND RELEVANCE: Findings of this cohort study suggest that predicted risk for malignant transformation estimated by 2 different models based on combinations of risk factors was suboptimal and may lead to overtreatment in approximately 30% of patients. These findings support pursuing other methods for prediction that should be validated before use in clinical practice.

PMID:40402510 | DOI:10.1001/jamaophthalmol.2025.1262

JAMA Netw Open. 2025 May 1;8(5):e2511764. doi: 10.1001/jamanetworkopen.2025.11764.

ABSTRACT

IMPORTANCE: Respiratory viral infections (RVIs) are associated with elevated cardiovascular risk; however, less is known about cardiac complications after hospitalization for respiratory syncytial virus (RSV) vs other vaccine-preventable RVIs (COVID-19 or influenza).

OBJECTIVE: To compare the risk of acute cardiovascular complications in adults hospitalized for RSV vs COVID-19 or influenza.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cross-sectional study, conducted before RSV vaccination rollout in Singapore, assessed all adults hospitalized for RSV or influenza (January 1, 2017, to June 30, 2024) and all adults hospitalized for COVID-19 during Omicron XBB/JN.1 transmission (January 1, 2023, to June 30, 2024).

EXPOSURE: Hospitalization for RSV, influenza (vaccinated or unvaccinated), or COVID-19 (boosted [≥3 vaccine doses] or unboosted [<3 vaccine doses]).

MAIN OUTCOMES AND MEASURES: Cardiovascular events during RSV, influenza, or COVID-19 hospitalization, defined as any cardiac, cerebrovascular, or thrombotic event, occurring from admission until discharge or death. Odds of any cardiovascular event (RSV vs COVID-19 or RSV vs influenza) and severe RVI (intensive care unit admission) with or without an acute cardiovascular event were estimated using multivariate logistic regression, adjusted for sociodemographic and clinical characteristics.

RESULTS: A total of 32 960 RVI hospitalizations (mean [SD] patient age, 66.58 [18.99] years; 17 056 [51.7%] female) were included (2148 for RSV, 14 389 for influenza, and 16 423 for COVID-19). Of the 2148 patients hospitalized for RSV, 234 (10.9%) had an acute cardiovascular event. Higher odds of any acute cardiovascular event (adjusted odds ratio [AOR], 1.31; 95% CI, 1.12-1.54) as well as other individual cardiac events were observed in RSV hospitalizations vs boosted COVID-19 (dysrhythmia: AOR, 1.52; 95% CI, 1.19-1.94; heart failure: AOR, 1.75; 95% CI, 1.30-2.35). Similarly, higher odds of any acute cardiovascular event (AOR, 1.58; 95% CI, 1.24-2.01) as well as dysrhythmias or heart failure were observed in patients hospitalized for RSV vs unboosted COVID-19. Odds of a cardiovascular event were not significantly different in RSV vs influenza, except among contemporaneous hospitalizations after the pandemic (2023-2024), where odds of heart failure (AOR, 2.09; 95% CI, 1.21-3.59) were significantly higher in RSV hospitalizations vs vaccine-breakthrough influenza hospitalizations. Occurrence of a cardiovascular event was associated with greater odds of severe RSV requiring intensive care unit admission (AOR, 2.36; 95% CI, 1.21-4.62).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, 1 in 10 patients hospitalized for RSV had a concurrent acute cardiovascular event. Odds of cardiac events were significantly higher in RSV vs COVID-19 hospitalizations in both vaccine-boosted and unboosted individuals. In contemporaneous hospitalizations for RSV or influenza after the pandemic (2023-2024), odds of heart failure were significantly higher in RSV hospitalizations vs vaccine-breakthrough influenza hospitalizations. These findings suggest that patients with preexisting cardiovascular risk should consider vaccination against RVIs.

PMID:40402498 | DOI:10.1001/jamanetworkopen.2025.11764

JAMA Netw Open. 2025 May 1;8(5):e2512032. doi: 10.1001/jamanetworkopen.2025.12032.

ABSTRACT

IMPORTANCE: An estimated half of all long-term care facility (LTCF) residents are colonized with antimicrobial-resistant organisms, and early identification of these patients on admission to acute care hospitals is a core strategy for preventing intrahospital spread. However, because LTCF exposure is not reliably captured in structured electronic health record data, LTCF-exposed patients routinely go undetected. Large language models (LLMs) offer a promising, but untested, opportunity for extracting this information from patient admission histories.

OBJECTIVE: To evaluate the performance of an LLM against human review for identifying recent LTCF exposure from identifiable patient admission histories.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional, multicenter study used the history and physical (H&P) notes from unique, randomly sampled adult admissions occurring between January 1, 2016, and December 31, 2021, at 13 hospitals in the University of Maryland Medical System (UMMS) and the John Hopkins (Hopkins) health care system to compare the performance of an LLM (GPT-4-Turbo) using zero-shot learning and prompting against humans in identifying patients with recent LTCF exposure. LLM analyses were conducted from August to September 2024.

EXPOSURE: Recent (≤12 months) LTCF exposure documented in the H&P note, as adjudicated by (1) humans and (2) an LLM.

MAIN OUTCOMES AND MEASURES: LLM sensitivity and specificity with Clopper-Pearson 95% CIs. Secondary outcomes were note review time and cost. The LLM was also prompted to provide a rationale and supporting note-text for each classification.

RESULTS: The study included 359 601 eligible adult admissions, of which 2087 randomly sampled H&P notes were manually reviewed at UMMS (1020 individuals; median [IQR] age, 58 [41-71] years; 493 [48%] male) and Hopkins (1067 individuals; median [IQR] age, 58 [48-67] years; 561 [53%] male) for LTCF residence. Compared with human review, the LLM achieved a sensitivity of 97% (95% CI, 91%-100%) and a specificity of 98% (95% CI, 97%-99%) at UMMS, and 96% (95% CI, 86%-100%) and 93% (95% CI, 92%-95%) sensitivity and specificity, respectively, at Hopkins; specificity at Hopkins improved with prompt revision (96% [95% CI, 95%-97%]). Of 117 manually reviewed LLM rationales, all were factually correct and quoted note-text accurately, and some demonstrated inferential logic and external knowledge. The LLM identified 37 (1.8%) human errors. Human review time had a mean of 2.5 minutes and cost $0.63 to $0.83 per note vs a mean of 4 to 6 seconds and $0.03 per note for LLM review.

CONCLUSIONS AND RELEVANCE: In this 13-hospital study of 2087 adult admissions, an LLM accurately identified LTCF residence from H&P notes and was more than 25 times faster and 20 times less expensive than human review.

PMID:40402496 | DOI:10.1001/jamanetworkopen.2025.12032

JAMA Netw Open. 2025 May 1;8(5):e2512075. doi: 10.1001/jamanetworkopen.2025.12075.

ABSTRACT

IMPORTANCE: Women experiencing more severe menopausal symptoms exhibit poorer quality of life, and those with early menopause have a higher risk of developing chronic diseases. However, the extent to which neighborhood disadvantage contributes to menopause onset and symptom severity remains understudied.

OBJECTIVE: To examine the association of Social Vulnerability Index (SVI) with age of natural menopause onset and menopausal symptom severity.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from a prospective cohort of women participating in Project Viva who were initially enrolled in eastern Massachusetts and followed up from pregnancy to midlife between April 1999 and August 2021. Participant inclusion required geocoded residential addresses at enrollment (1999-2002), 8-year follow-up (2006-2010), and 13-year follow-up (2012-2016); age at natural menopause; and menopausal symptoms. Data were analyzed between March 1 and June 30, 2024.

EXPOSURES: SVI grouped into 5 categories: very low (<20th percentile), low (20th to <40th percentile), moderate (40th to <60th percentile), high (60th to <80th percentile), or very high (≥80th percentile) vulnerability.

MAIN OUTCOMES AND MEASURES: Age at natural menopause and self-reported menopausal symptoms based on the presence and severity of 11 symptoms over the past year. These symptoms were assessed using the Menopause Rating Scale (total score range: 0-44, with higher scores indicating greater severity).

RESULTS: Of the 691 women included in the study (mean [SD] enrollment age, 33.7 [3.8] years; 41 with Asian [6.0%], 79 with Black [11.5%], 39 with Hispanic [5.7%], 507 with White [73.6%], and 23 with other [3.3%] race and ethnicity), 87 (12.6%) resided in neighborhoods with very high SVI at enrollment, 38 of 635 (6.0%) at 8-year follow-up, and 41 of 660 (6.2%) at 13-year follow-up. The Kaplan-Meier estimate for median age of natural menopause was earlier in women residing in neighborhoods with very high vs very low SVI at enrollment (52.0 [95% CI, 51.0-53.0] years vs 53.0 [95% CI, 53.0-54.0] years), 8-year follow-up (51.0 [95% CI, 50.0-53.0] years vs 53.0 [95% CI, 53.0-54.0] years), and 13-year follow-up (51.0 [95% CI, 50.0-53.0] years vs 53.0 [95% CI, 53.0-54.0] years). After adjusting for covariates, residence in neighborhoods with very high (but not low, moderate, or high) vs very low SVI at enrollment (adjusted hazard ratio [AHR], 1.36; 95% CI, 0.90-2.06), 8-year follow-up (AHR, 2.23 (95% CI, 1.29-3.85), and 13-year follow-up (AHR, 2.18 (95% CI, 1.30-3.66) was associated with higher risk of earlier natural menopause. SVI was not associated with menopausal symptoms.

CONCLUSIONS AND RELEVANCE: In this cohort study, women who resided in neighborhoods with very high vulnerability within 10 years of the perimenopause period exhibited higher risk of earlier natural menopause. Future research is warranted to explore whether initiatives to improve neighborhood conditions could mitigate the association of neighborhood disadvantage with earlier menopause onset.

PMID:40402495 | DOI:10.1001/jamanetworkopen.2025.12075

JAMA Netw Open. 2025 May 1;8(5):e2512405. doi: 10.1001/jamanetworkopen.2025.12405.

ABSTRACT

IMPORTANCE: Housing instability and homelessness have wide-ranging health and social effects. Health systems increasingly recognize the importance of addressing these needs to make progress toward health equity goals and reduce health care costs. State Medicaid programs are uniquely positioned to support the housing needs of their members but are relatively new to the housing space and need to understand how to most effectively partner with the housing sector to improve health outcomes.

OBJECTIVE: To evaluate the implementation and initial outcomes of a housing benefit pilot program, including participant characteristics, needs, and service utilization.

DESIGN, SETTING, AND PARTICIPANTS: This was a cohort study involving a pilot program that provided temporary rental assistance, housing navigation, and additional supports to Medicaid members between May 2022 and October 2024. The pilot took place in the Portland, Oregon, metropolitan area involving Medicaid members of Health Share of Oregon, a large coordinated care organization. Individuals were referred to the program primarily from foster care, substance use disorder residential programs, and corrections facilities. Data were analyzed from October 2024 to March 2025.

EXPOSURE: Enrolled participants received services, including temporary rental assistance, housing navigation, and other supports, for up to 12 months, with modifications made mid-pilot due to capacity challenges.

MAIN OUTCOMES AND MEASURES: Participant demographic characteristics, baseline needs, service utilization, and costs associated with the housing benefit program.

RESULTS: Of 716 referrals, 517 individuals (mean [SD] age, 37.8 [11.1] years; 295 [57.1%] male) enrolled; including 14 American Indian or Alaskan Native individuals (2.7%), 7 Asian individuals (1.4%), 67 Black individuals (13.0%), 22 Hispanic individuals (4.3%), 6 Native Hawaiian or Pacific Islander individuals (1.2%), and 308 White individuals (59.6%); 513 individuals (99.2%) spoke English. Participants had substantial housing needs, with rent (383 individuals [74.1%]) and utility (282 individuals [54.5%]) support being the most frequently reported needs and used services. The mean (SD) cost per member per month was $2225 ($1586). Frequently reported nonhousing needs included employment (154 individuals [42.3%]), food (152 individuals [41.8%]), mental health (94 individuals [25.8%]), and transportation (86 individuals [23.6%]).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study provide critical insights into the types of services needed and associated costs for supporting housing as a Medicaid benefit. Significant needs were observed, emphasizing the necessity of cross-sector collaboration and clear role definitions between health care and housing organizations. The findings offer valuable lessons for the design and implementation of housing support programs under Medicaid; these insights are crucial as Oregon and other states consider similar initiatives to address housing as a health-related social need.

PMID:40402494 | DOI:10.1001/jamanetworkopen.2025.12405

JAMA Otolaryngol Head Neck Surg. 2025 May 22. doi: 10.1001/jamaoto.2025.0903. Online ahead of print.

ABSTRACT

IMPORTANCE: The De-escalated Adjuvant Radiation Therapy (DART) phase 3 randomized clinical trial (RCT) showed that in patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma, postoperative minimal residual disease (MRD), detected through circulating tumor HPV DNA (ctHPVDNA), was associated with a higher risk of disease progression. When considered along with pathologic factors, postoperative ctHPVDNA assessment may improve patient selection for adjuvant treatment de-escalation; however, more data are needed to demonstrate how it may be used in personalizing treatment intensity.

OBJECTIVE: To determine the association of postoperative MRD status with progression-free survival (PFS) after surgery for HPV-associated oropharyngeal squamous cell carcinoma.

DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of the DART RCT, which was conducted from October 2016 to August 2020 in multiple sites in the US. Participants from the de-escalated adjuvant radiation therapy group and the standard of care group with available blood specimen data were included. Reports from 3-month posttreatment surveillance visits were used to assess associations and outcomes. Data analyses were performed from March 2023 to March of 2025.

INTERVENTIONS: The DART group received 30 to 36 Gy of radiation therapy in 1.5 to 1.8 Gy twice daily, plus docetaxel, 15 mg/m2, on days 1 and 8. The standard of care group received 60 Gy with or without weekly cisplatin, 40 mg/m2.

MAIN OUTCOME AND MEASURE: PFS.

RESULTS: The analysis included 140 patients (mean [SD] age, 59.1 [8.4] years; 12 [8.6%] females and 128 [91.4%] males; 97 [69.3%] with no smoking history); characteristics were similar to the overall DART RCT population. Of these, 17 patients (12.1%) had postoperative MRD (13 of 96 [13.5%] receiving DART and 4 of 44 [9.1%] receiving standard of care). For all patients, postoperative MRD positivity was strongly associated with worsened PFS at 24 months (MRD positivity, 69.5%; MRD negativity, 95.9%; hazard ratio [HR], 0.19; 95% CI, 0.06-0.59). MRD positivity was associated with PFS when evaluating only those patients in the DART group, where 24-month PFS was 68.4% compared to 92.6% for MRD-negative patients (HR, 0.28; 95% CI, 0.08-0.93). Three months after completion of all treatment, 8 of 117 patients (6.8%) had detectable ctHPVDNA, whereas 109 of 117 (93.2%) did not, and detection was highly associated with PFS (HR, 20.48; 95% CI, 6.91-60.67).

CONCLUSIONS AND RELEVANCE: This secondary analysis of the DART RCT found that patients with detectable ctHPVDNA after surgery had a higher risk of disease progression. When added to the pathologic factors considered, ctHPVDNA assessment may improve selection of patients for treatment de-escalation. In addition, the 3-month posttreatment time point, early in surveillance, may identify a sizable portion of patients with progression and may guide intervention and surveillance after surgery for HPV-associated oropharyngeal squamous cell carcinoma.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02908477.

PMID:40402484 | DOI:10.1001/jamaoto.2025.0903

Am J Drug Alcohol Abuse. 2025 May 22:1-9. doi: 10.1080/00952990.2025.2502743. Online ahead of print.

ABSTRACT

Background: US smoke shop prevalence is growing and stores are diversifying products beyond nicotine vape supplies, often selling non-regulated psychoactive substances.Objectives: Investigate health claims and safety information provided by smoke shop employees regarding hemp-derived tetrahydrocannabinol (THC) and kratom.Methods: Secret shopper visits were conducted at 100 San Antonio and Austin, Texas smoke shops. Using scripted questions, shoppers assessed whether the shop sold THC and kratom, what these products could be used for, and adverse effects. Shoppers documented product availability, disease states referenced, health claims made, adverse effects mentioned, and guidance for use related to pregnancy. Descriptive statistics were calculated to characterize shopper reports.Results: THC (100%) and kratom (94%) were routinely stocked by smoke shops. Most employees made at least one health claim regarding THC (50%) or kratom (81%). Claims regarding pain (50%), insomnia (31%), and mental health disorders (27%) were most commonly discussed for THC, while drug withdrawal/cravings (76%), pain (69%), and mental health conditions (31%) were most frequent for kratom. When specifically asked about adverse effects, 22% and 24% of smoke shop employees, respectively, did not disclose any risks about THC or kratom; most others provided minimal information. The most common risks discussed were sedation (36%) and psychiatric (31%) adverse effects for THC, and dependence (59%) and gastrointestinal (24%) adverse effects for kratom.Conclusion: Efforts to develop evidence-based consumer information regarding kratom and hemp-derived THC, improve health information provided by smoke shop employees, and incentivize store owners to devote resources to employee education are needed.

PMID:40402475 | DOI:10.1080/00952990.2025.2502743

AIDS Behav. 2025 May 22. doi: 10.1007/s10461-025-04736-5. Online ahead of print.

ABSTRACT

Pre-Exposure Prophylaxis (PrEP) with Tenofovir-Disoproxil/Emtricitabine (TDF/FTC) is efficacious for HIV prevention. PrEP users might be more exposed to other sexually transmitted infections (STIs) and toxicities. Our aim was to evaluate the trend of STIs and toxicities in an Italian PrEP cohort. A retrospective multicentre cohort study (Modena, Genova and Padova) including TDF/FTC-PrEP users followed from Jan-2019 to Jul-2022. Data collection included demographics, toxicities and STIs detection: N.gonorrhoeae (NG), C.trachomatis (CT), M.genitalium (MG), T.vaginalis (TV), T.pallidum (TP), HAV, HBV and HCV. Two-hundred-forty-four persons included: 97% males; median age 39 years (IQR 33-47). A nearly incremental trend was recorded in NG and MG incidences, especially after 2020: from 5.7% to 2.3% in 2020, to 10.3% and 6.5% in 2021 and to 9.6% and 4.8% in the first 7 months of 2022. CT and TP presented a variable trend, while only two TV diagnoses were done. The test for trend for ordered groups across years showed no statistical significance for all the STIs and the annual proportions of subjects with multiple STIs varied. At logistic regression, only history of STIs was associated to risk of new STIs. Twenty cases of nephrotoxicity were recorded, leading to PrEP interruption in 1 case only. Concluding, STIs incidence and nephrotoxicity in our cohort were consistent with other data from literature. In 2020 we observed a lower STIs incidence, probably as consequence of COVID-19 restrictions. An incremental trend could be hypothesized regarding NG, MG and CT incidence. Thus, we suggest STIs monitoring, prophylaxis and treatment to contain their spread among PrEP users.

PMID:40402466 | DOI:10.1007/s10461-025-04736-5

Drug Deliv Transl Res. 2025 May 22. doi: 10.1007/s13346-025-01882-0. Online ahead of print.

ABSTRACT

This study aimed to design and evaluate the clinical efficacy of a new patented portable multifunctional medical nebulizer. The portable multifunctional nebulizer, constructed using medical-grade PVC, incorporates four main systems: a nebulization system, a particle size adjustment mechanism, a heating unit, and a power storage system. This study employed a comparative experimental design. A conventional medical nebulizer, commonly used in a tertiary hospital, was selected as the control group, while the newly developed portable multifunctional nebulizer served as the experimental group. Each group underwent 30 experimental runs, with controlled variables across all tests. Key parameters assessed included initial mist emission time, nebulization rate, particle size distribution, medication splash loss, residual drug volume, and noise levels. The particle size distribution was measured using dynamic light scattering (DLS) technology, while medication loss was calculated by capturing mist spillover and measuring residual drug volume. Noise levels during stable nebulization were recorded using a sound level meter. The experimental group demonstrated the production of smaller, more uniform nebulized particles, reduced medication splash loss, decreased residual drug volume, and lower noise emissions. Statistically significant differences (P < 0.05) were observed across all parameters when compared to the control group. The multifunctional medical nebulizer consistently generates particles within a size range of 120-160 nm, improving drug delivery to target organs, minimizing medication loss, and reducing operational noise. This innovative design represents a significant advancement in the clinical application of respiratory therapy.

PMID:40402464 | DOI:10.1007/s13346-025-01882-0