Tag: pubmed

Trials. 2025 Jul 11;26(1):241. doi: 10.1186/s13063-025-08915-6.

ABSTRACT

Reports of the results of clinical studies are integral to regulatory decision making. They are used to support marketing authorization, to substantiate labeling information, and to inform academic publications, trial postings, and promotional messages intended to communicate study results to doctors and patients. Therefore, beyond summarizing the study design, methods, and data, study reports should provide clear descriptions of the benefits and risks of an intervention for a given medical condition. The ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials provides a framework aiming for more clarity about the reported “treatment effects.” In practice, stakeholders are still learning how to embrace the estimand framework and how it impacts the reporting of study results in the most value-adding manner. This paper provides recommendations and considerations for implementing the estimand framework in the reporting of results to realize its full potential of increased transparency for interpretation and decision-making. These recommendations are based on practical experiences of working with clinical trial teams through the reporting process following implementation of the estimand framework in the protocol. As illustrated by two case studies, the primary application is in reporting studies for the scientific evaluation of medicines by regulatory agencies, directly impacting clinical study reports and submission documents, and will also extend to publications in scientific journals.

PMID:40640873 | DOI:10.1186/s13063-025-08915-6

Int J Equity Health. 2025 Jul 10;24(1):202. doi: 10.1186/s12939-025-02555-7.

ABSTRACT

BACKGROUND: Transgender and gender-diverse (TGD) individuals face substantial health disparities as a result of discrimination and poor provider competence in understanding their health needs. Relatively little work has been done studying educational interventions targeted toward increasing residents’ knowledge and ability to treat TGD individuals with sensitivity. We studied the effectiveness of implementing a lecture series on transgender health in preparing internal medicine residents to care for the TGD population.

METHODS: Both study and control participants were recruited through their affiliated internal medicine residency programs. The study design was a pre-post controlled educational study. A lecture series was developed at Riverside University Health System as the educational intervention. We used a Transgender Assessment survey developed for the study to determine changes in the residents’ knowledge, self-confidence, and knowledge of barriers to care during the study period from January to June 2022. The data were statistically analyzed to assess the differences between pre- and post- and study and control groups.

RESULTS: Similar demographics were noted between the study and control groups. Compared with the control group, residents in the study group tended to have more exposure to transgender health education prior to the study. Residents in the study group demonstrated increased knowledge and self-confidence after completing the curriculum. The study group’s average knowledge score increased from 4.8 to 6.1 post-intervention (p = 0.004). Self-confidence scores in providing gender-specific care rose from an average of 13.7 to 17.9 post-intervention (p < 0.001). The study group had higher post-intervention scores compared to the control group, particularly in knowledge of gender-affirming therapies (post 4.3 vs. pre 3.4, p = 0.01) and self-confidence in providing gender-specific care (post 17.9 vs. pre 12.3, p=0.004). No significant changes were observed in knowledge of barriers to care for both groups.

CONCLUSIONS: Our study demonstrates the effectiveness of a curriculum focused on TGD health in improving residents’ knowledge and confidence. Further research is needed on the durability of these effects and the curriculum’s impact on awareness of barriers to care. Implementing such curricula at other institutions could reinforce educational programs in medical schools to improve provider competence and address the healthcare needs of TGD individuals.

PMID:40640870 | DOI:10.1186/s12939-025-02555-7

Parasit Vectors. 2025 Jul 10;18(1):277. doi: 10.1186/s13071-025-06921-w.

ABSTRACT

BACKGROUND: The World Health Organization (WHO) recommends mass distribution of insecticide-treated nets (ITNs) to prevent malaria transmission. Unfortunately, resistance to pyrethroids affects the efficacy of standard ITNs. To overcome this resistance and continue to protect the population, the WHO has recommended new types of ITNs that combine a pyrethroid insecticide with either a synergist (PBO) or a second insecticide, such as chlorfenapyr. This study examines the baseline characteristics of malaria vectors prior to the distribution of three types of insecticide-treated nets as part of a three-arm randomised controlled trial: Interceptor G2 (pyrethroid-chlorfenapyr), VEERALIN (pyrethroid-PBO), and MAGNet (pyrethroid only).

METHODS: The study was carried out in 40 villages (grouped into 33 clusters) of Tiébissou district in central Côte d’Ivoire. To assess biting rate and biting behaviour, human landing catches were conducted hourly indoors and outdoors in six randomly selected houses in each cluster, starting at 18:00 and continuing until 08:00 the next morning. Adult mosquitoes collected were morphologically identified, and a subset of Anopheles gambiae sensu lato (s.l.) and An. funestus s.l. were speciated by quantitative PCR (qPCR). Plasmodium sporozoite infections were detected by qPCR to estimate infection rates. The entomological inoculation rate was calculated as the product of the mosquito biting rate and the sporozoite infection rate.

RESULTS: Among the 10,698 mosquitoes collected, An. gambiae s.l. was the predominant species, accounting for 62.5% (n = 6683) of the catch, followed by An. funestus s.s., which accounted for 19.8% (n = 2120). Of the sub-sample of An. gambiae s.l. processed by PCR, 79.0% (n = 1291/1635) were An. coluzzii and the remaining were Anopheles gambiae s.s. Malaria vectors were highly aggressive, with an average of 14.8 bites/person/night for An. coluzzii, 2.0 b/p/n for An. gambiae s.s. and 5.4 b/p/n for An. funestus, representing an overall average of 22.2 b/p/n (95% CI 17.2-27.2 b/p/n). No significant difference was found in biting activity between indoor and outdoor environments (Z = -0.25, P = 0.803). Plasmodium sporozoite infection rate was 2.4% (95% CI 1.3-3.6%) for An. coluzzii, 1.5% (95% CI 0.3-2.6%) for An. gambiae s.s. and 2.7% (95% CI 1.2-4.3%) for An. funestus. The estimated overall entomological inoculation rate was 0.4 infected b/p/n (95% CI 0.3-0.6) and varied between 0.0 and 0.2 infective bites/person/night according to species. There was no difference observed in entomological infection rate (EIR) between capture locations (indoors versus outdoors; Z = 1.521, P = 0.128).

CONCLUSIONS: This study shows that An. coluzzii and An. funestus were the main malaria vectors and showed similar biting patterns both indoors and outdoors. Anopheles funestus was found in high density in a limited number of villages. Malaria transmission was high despite universal distribution of pyrethroid-ITN in the district.

PMID:40640866 | DOI:10.1186/s13071-025-06921-w

Mar Pollut Bull. 2025 Jul 9;220:118394. doi: 10.1016/j.marpolbul.2025.118394. Online ahead of print.

ABSTRACT

Driftwood is a ubiquitous component of coastal environments, yet its functional role in trapping marine litter remains poorly understood, particularly in tropical systems. This study investigates the relationship between driftwood abundance and litter accumulation across seven remote beaches of the central Caribbean coast of Colombia. A standardized quadrant-based field protocol was applied to quantify and classify 12,129 items, including 3990 driftwood pieces and 8139 litter items. Plastics represented 92 % of total litter, with foam sponge, caps, and fragmented packaging as dominant types. Driftwood indices showed strong spatial variation and were positively correlated with total litter and plastic densities. Sites with greater driftwood presence consistently exhibited higher litter accumulation, suggesting a passive retention mechanism. Multivariate ordination and cluster analyses revealed that driftwood-rich beaches formed distinct assemblages dominated by lightweight, floatable plastic items. Although Indicator Species Analysis did not yield statistically significant item-driftwood associations, qualitative patterns supported selective entrapment. These findings position driftwood as a key modulator of litter retention in remote beach systems. Beyond its ecological role, driftwood also holds predictive potential: linear relationships and derived ratios (LDR, PDR) offer scalable metrics for identifying pollution hotspots.

PMID:40638947 | DOI:10.1016/j.marpolbul.2025.118394

N Z Med J. 2025 Jul 11;138(1618):83-95. doi: 10.26635/6965.6887.

ABSTRACT

AIM: To analyse hospital resource utilisation at Christchurch Hospital in New Zealand during two mass-casualty incidents (MCIs) in 2019: the Christchurch mosque shootings and the Whakaari (White Island) volcanic eruption.

METHODS: A cross-sectional retrospective analysis was conducted to assess hospital resource utilisation during the two MCIs.

RESULTS: A total of 45 patients from the mosque MCI and eight patients from the Whakaari MCI were admitted to Christchurch Hospital. The total length of stay was mosque MCI: 15,054 hours (average 335 hours per patient) and Whakaari MCI: 1,841 hours (average 230 hours per patient). Mean surgeon time (operative length multiplied by number of surgical staff) was mosque MCI: 6.5 hours and Whakaari MCI: 14.7 hours. Burns represented a significantly greater surgical workload per operative event. There were notable differences in staffing, investigations, consumables, blood products, theatre time and the number of operative events between the MCI cohorts.

CONCLUSION: The studied MCIs had significant effects on hospital resource utilisation. Burn trauma was more resource intensive than non-burn trauma, despite most patients being repatriated within days of the index event. An analysis of resourcing, surge capacity and funding models in New Zealand is required to ensure trauma centres can effectively respond to future crises.

PMID:40638932 | DOI:10.26635/6965.6887

N Z Med J. 2025 Jul 11;138(1618):48-59. doi: 10.26635/6965.6875.

ABSTRACT

AIM: A facility-specific, prehospital trauma destination matrix has been implemented in the Te Manawa Taki (TMT)/Midland Region of Aotearoa New Zealand to support decisions on the most appropriate destination hospital for injured patients. This study evaluates the implementation of this policy.

METHODS: Injury data obtained from the TMT Trauma Registry were linked with Global Positioning System (GPS) data from Hato Hone St John and Land Information New Zealand Data Service for trauma events within the region from 1 January to 31 December 2023. Analysis of spatial relationships between injury location, specific injuries and hospital admission was performed using ArcGIS and R statistical programming.

RESULTS: A total of 214 trauma events met the TMT Matrix criteria, of which 163 (76.1%) were transported to a hospital consistent with the destination specified. Lowest consistency (43.8%) of prehospital transport was seen with severe traumatic brain injury likely to require neurosurgery among adults aged >15 years. Approximately 32% of patients with matrix conditions requiring direct transport were lower severity (Injury Severity Score [ISS] <13). When the specified destination was that closest to the incident, there was 93.9% TMT Matrix consistency. Patients with a TMT Matrix condition who did not go directly to the defined facility and had a subsequent transfer took a median 10.5 hours to reach the defined facility.

CONCLUSIONS: The majority of trauma patient transports were consistent with the TMT prehospital matrix. A primary influence on compliance was the distance from point of injury to designated facility. This study prompts further exploration of factors associated with appropriate prehospital triage and refinement of TMT prehospital destination policy.

PMID:40638929 | DOI:10.26635/6965.6875

N Z Med J. 2025 Jul 11;138(1618):30-47. doi: 10.26635/6965.6729.

ABSTRACT

AIM: The 1737 Need to Talk telehealth service (mental health call and text helpline) was launched in Aotearoa New Zealand in June 2017, providing the public with the ability to call or text when they need mental health support. The aim of this research is to describe the utilisation of the 1737 Need to Talk telehealth service. We describe the patterns of 1737 contacts over time and describe the contact users, including the most at-risk contacts (defined as those contacts who trigger the “Break Glass” procedure).

METHODS: This is a retrospective observational study analysing 1737 Need to Talk data over 5 years and 7 months from June 2017 through to December 2022. A total of 719,904 contacts to the service were analysed.

RESULTS: This research found that contacts to the 1737 Need to Talk service (by call or text) increased until the end of 2021 and then plateaued from 2022. The average proportion of at-risk service users was 0.43% of 1737 Need to Talk contacts, and this grew minimally over the period investigated. Service users most at risk were found to be of the female gender, in the 13-19-year-old age group, and those residing in Whanganui and MidCentral districts.

CONCLUSION: This study details the growth in the number of specific demographics reaching out for mental health support to 1737 and may be indicative of the need for increasing mental health support.

PMID:40638928 | DOI:10.26635/6965.6729

JMIR Res Protoc. 2025 Jul 10;14:e67511. doi: 10.2196/67511.

ABSTRACT

BACKGROUND: Detained adolescents exhibit high rates of behavioral health needs, yet few receive treatment during detention or community re-entry. Once adolescents are released into the community, caregivers must mobilize significant resources and overcome barriers to facilitate their treatment engagement. Parenting stress is often heightened during this forced separation and the re-entry transition. Parenting stress is associated with greater perceived barriers to treatment and, for adolescents who begin treatment, less therapeutic change and premature treatment dropout. Interventions designed to support caregivers of detained adolescents in managing their stress while navigating the juvenile legal system are urgently needed, and mobile health (mHealth) interventions offer promising, scalable approaches. RAISE (Reducing pArentIng StrEss) is a web-based application co-designed with caregivers of detained adolescents to reduce caregiver stress and promote postrelease adolescent behavioral health services use.

OBJECTIVE: This study will evaluate the effectiveness of RAISE in reducing caregiver stress and promoting adolescent behavioral health services use following release from detention.

METHODS: A randomized controlled trial with 60 caregivers of detained adolescents (ages 12-17 years) across the United States will be conducted. Caregivers will be recruited through passive and active techniques and randomized to receive RAISE (intervention) or an informational brochure (comparison). Self-assessment questionnaires will be completed at baseline and 3- and 6-month follow-up timepoints. The fully automated RAISE intervention includes an 8-week stress reduction intervention, self-monitoring and affirmational SMS text messaging, and resources related to navigating the juvenile legal system. Assessments include empirically validated measures of parenting stress, mindful parenting, parenting self-efficacy, adolescent services use, motivation for youth treatment, caregiver behavioral health, sociodemographics, and RAISE usability (intervention only). Caregivers will also participate in a semistructured qualitative exit interview at the 3-month (postintervention) timepoint. Descriptive statistics will examine recruitment, randomization, assessment, retention, and application usability. Independent samples t tests and chi-square analyses will determine whether randomization was successful based on multiple background variables; group differences will be accounted for in outcome analyses. Regression analyses will be used for outcome analyses, with an intent-to-treat design; analyses will include intervention group as a predictor and control for the baseline level of the outcome, application usage, and demographic characteristics. Potential moderators and mediators of intervention effects will be explored.

RESULTS: We propose the enrollment of 60 caregivers by April 2025, final data collection by September 2025, and submission of main findings for publication in December 2025.

CONCLUSIONS: This study will provide empirical evidence regarding the impact of an mHealth stress reduction intervention co-designed with caregivers of detained adolescents. Findings will be informative for legal systems regarding how best to support caregivers of detained adolescents and the impact of reducing caregiver stress on adolescents’ linkage to behavioral health services following their release into the community.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05032742; https://clinicaltrials.gov/study/NCT05032742.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67511.

PMID:40638918 | DOI:10.2196/67511

Am J Ther. 2025 Jul 11. doi: 10.1097/MJT.0000000000001950. Online ahead of print.

ABSTRACT

BACKGROUND: Hypertension is a serious health problem, and resistant hypertension occurs when blood pressure (BP) is uncontrolled despite at least 3 optimal-dosed agents of different pharmacologic classes. Aprocitentan is a novel pharmacological agent approved in early 2024 for treatment of hypertension, in patients whom BP is not adequately controlled while on other antihypertensive medications.

MECHANISM OF ACTION, PHARMACODYNAMICS AND PHARMACOKINETICS: Aprocitentan acts as a dual endothelin receptor antagonist, inhibiting both ETa and ETb. It is postulated that low-renin models and salt-sensitive models of hypertension, consistent with resistant hypertension, exhibit increased levels of plasma ET-1. Thus, inhibition of ET-1 at ETa receptors inhibits vasoconstriction effects. The oral bioavailability of aprocitentan is currently unknown. Maximum plasma concentrations reaching a Cmax is within 4-5 hours with an effective half-life of 41 hours. Plasma concentrations increase in a dose-proportional manner and reach steady state within 8 days. The volume of distribution is 20 L, highly protein bound, primarily to albumin, and undergoes both renal and hepatic metabolism via UGT1A1- and UGT2B7-mediated N-glycosylation and nonenzymatic hydrolysis.

CLINICAL TRIALS: In a phase 3, multicenter-study in adult patients (N = 730) with systolic blood pressure ≥140 mm Hg with a run-in placebo and standard background BP therapy continued throughout the study, placebo or aprocitentan (12.5, 25 mg) were randomized at various stages. Aprocitentan 12.5 mg was superior to placebo in reducing sitting (sitting systolic blood pressure) at week 4, and a persistence of the BP-lowering effect was demonstrated (sitting systolic blood pressure was maintained and was statistically superior at week 40) when aprocitentan 25 mg were rerandomized to placebo.

THERAPEUTIC ADVANCE: Aprocitentan is a novel endothelin receptor antagonist approved for the treatment of resistant hypertension. It is a welcome development in the arsenal to fight against resistant hypertension for those with difficulty to manage with conventionally available antihypertensive medications.

PMID:40638911 | DOI:10.1097/MJT.0000000000001950

J Med Internet Res. 2025 Jul 10;27:e70674. doi: 10.2196/70674.

ABSTRACT

BACKGROUND: One of the main challenges with COVID-19 has been that although there are known factors associated with a worse prognosis, clinicians have been unable to predict which patients, with similar risk factors, will die or require intensive care unit (ICU) care.

OBJECTIVE: This study aimed to develop a personalized artificial intelligence model to predict the patient risk of mortality and ICU admission related to SARS-CoV-2 infection during the initial medical evaluation before any kind of treatment.

METHODS: It is a population-based, observational, retrospective study covering from February 1, 2020, to January 24, 2023, with different circulating SARS-CoV-2 viruses, vaccinated status, and reinfections. It includes patients attended by the reference hospital in Fuenlabrada (Madrid, Spain). The models used the random forest technique, Shapley Additive Explanations method, and processing with Python (version 3.10.0; Python Software Foundation) and scikit-learn (version 1.3.0). The models were applied to different epidemic SARS-CoV-2 infection waves. Data were collected from 11,975 patients (4998 hospitalized and 6737 discharged). Predictive models were built with records from 4758 patients and validated with 6977 patients after evaluation in the emergency department. Variables recorded were age, sex, place of birth, clinical data, laboratory results, vaccination status, and radiologic data at admission.

RESULTS: The best mortality predictor achieved an area under the receiver operating characteristic curve (AUC) of 0.92, sensitivity of 0.89, specificity of 0.82, positive predictive value (PPV) of 0.35, and mean negative predictive value (NPV) of 0.98. The ICU admission predictor had an AUC of 0.89, sensitivity of 0.75, specificity of 0.88, PPV of 0.37, and NPV of 0.98. During validation, the mortality model exhibited good performance for the nonhospitalized group, achieving an AUC of 0.95, sensitivity of 0.88, specificity of 0.98, PPV of 0.21, and NPV of 0.99, predicting the death of 30 of 34 patients who were not hospitalized. For the hospitalized patients, the mortality model achieved an AUC of 0.85, sensitivity of 0.86, specificity of 0.74, PPV of 0.24, and NPV of 0.98. The model for predicting ICU admission had an AUC of 0.82, sensitivity of 1.00, specificity of 0.59, PPV of 0.05, and NPV of 1.00. The models’ metrics presented stability along all pandemic waves. Key mortality predictors included age, Charlson value, and tachypnea. The worse prognosis was linked to high values in urea, erythrocyte distribution width, oxygen demand, creatinine, procalcitonin, lactate dehydrogenase, heart failure, D-dimer, oncological and hematological diseases, neutrophil, and heart rate. A better prognosis was linked to higher values of lymphocytes and systolic and diastolic blood pressures. Partial or no vaccination provided less protection than full vaccination.

CONCLUSIONS: The artificial intelligence models demonstrated stability across pandemic waves, indicating their potential to assist in personal health services during the 3-year pandemic, particularly in early preventive and predictive clinical situations.

PMID:40638909 | DOI:10.2196/70674