Category: Statistics

Ital J Pediatr. 2024 Feb 27;50(1):34. doi: 10.1186/s13052-024-01609-w.

ABSTRACT

BACKGROUND: The effect of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus in the neonatal period on developing brain is still unknown. This study aims to investigate the long-term neurodevelopmental outcomes of newborns exposed to SARS-CoV-2 & Delta variant.

METHODS: At a tertiary referral center, a prospective observational cohort research was carried out. All babies who were equal to or more than 34 gestational weeks gestation and were admitted to the NICU between January 2021 and January 2022 due to SARS-CoV-2 infection (Delta – or Delta +) were included in the study. Infants who were hospitalized for non-SARS-CoV-2 reasons at similar dates and who had no history of invasive mechanical ventilation were incorporated as a control group using a 2:1 gender and gestational age match. Thirty infants were assigned to the study group and sixty newborns to the control group based on the sample size calculation. These toddlers’ neurodevelopment was evaluated between the ages of 18 and 24 months using the Bayley-II scale.

RESULTS: We enrolled 90 infants. SARS-CoV-2-positive infants had poorer psychomotor development index (PDI) scores and significantly greater mildly delayed performances (MDPs) at 18-24 months (PDI p = 0.05, MDPs p = 0.03, respectively). Delta variant showed statistically significant lower MDI and PDI scores (MDI p=0.03, PDI p=0.03, respectively). A smaller head circumference of SARS-CoV-2-positive toddlers was detected in the first year (p < 0.001), which improved at the second age.

CONCLUSION: SARS-CoV-2-positive neonates revealed lower PDI scores and greater MDPs at 18th-24th months. The effect is most noticeable in Delta variant. Longer-term examination of neurodevelopmental outcomes and reevaluation of these children between the ages of 5 and 12 are critical.

PMID:38413995 | DOI:10.1186/s13052-024-01609-w

Orphanet J Rare Dis. 2024 Feb 27;19(1):91. doi: 10.1186/s13023-024-03095-z.

ABSTRACT

BACKGROUND: Over the last twenty years of orphan drug regulation in Europe, the regulatory framework has increased its complexity, with different regulatory paths and tools engineered to facilitate the innovation and accelerate approvals. Recently, the proposal of the new Pharmaceutical Legislation for the European Union, which will replace at least three Regulations and one Directive, was released and its new framework is raising many questions. The aim of this study was to present a characterisation of the Orphan Medicinal Products (OMPs) authorised by the European Commission (EC), between 2010 and 2022, looking into eighteen variables, contributing to the ongoing discussion on the proposal and implementation of the new Pharmaceutical Legislation proposed.

METHODS: Data of the OMPs identified and approved between 2010 and 2022 were extracted from the European Public Assessment Reports (EPARs) produced by the European Medicines Agency. Information regarding legal basis of the application, applicant, protocol assistance received, type of authorization, registration status, type of molecule, ATC code, therapeutic area, target age, disease prevalence, number of pivotal clinical trials supporting the application, clinical trial designs, respective efficacy endpoints and number of patients enrolled in the pivotal clinical trials were extracted. A descriptive statistical analysis was applied.

RESULTS: We identified 192 OMPs approved in the period between 2010 and 2022. 89% of the OMPs have legal basis of “full application”. 86% of the sponsors received protocol assistance whereas 64% of the MAA benefited from the accelerated assessment. 53% of the active substances are small molecules; about 1 in 5 molecules are repurposed. 40% of the OMPs have oncological therapeutic indications and 56% of the OMPs are intended to treat only adults. 71% of the products were approved based on a single pivotal trial.

CONCLUSIONS: This analysis of OMPs approved between 2010 and 2022 shows that a shift has occurred in the rare disease medicine development space. Through the period studied we observe an increase of non-small molecules approved, accelerated assessment received and non-standard MA’s granted.

PMID:38413985 | DOI:10.1186/s13023-024-03095-z

BMC Oral Health. 2024 Feb 27;24(1):279. doi: 10.1186/s12903-024-04008-z.

ABSTRACT

BACKGROUND: Several methods were introduced for enamel biomimetic remineralization that utilize a biomimetic analogue to interact and absorb bioavailable calcium and phosphate ions and induce crystal nucleation on demineralized enamel. Amelogenin is the most predominant enamel matrix protein that is involved in enamel biomineralization. It plays a major role in developing the enamel’s hierarchical microstructure. Therefore, this study was conducted to evaluate the ability of an amelogenin-inspired peptide to promote the remineralization potential of fluoride and a supersaturated calcium phosphate solution in treating artificially induced enamel carious lesions under pH-cycling regimen.

METHODS: Fifty enamel slices were prepared with a window (4*4 mm² ) on the surface. Five samples were set as control healthy enamel and 45 samples were subjected to demineralization for 3 days. Another 5 samples were set as control demineralized enamel and 40 enamel samples were assigned into 8 experimental groups (n=5) (P/I, P/II, P/III, P/AS, NP/I, NP/II, NP/III and NP/AS) according to peptide treatment (peptide P or non-peptide NP) and remineralizing solution used (I; calcium phosphate solution, II; calcium phosphate fluoride solution, III; fluoride solution and AS; artificial saliva). Samples were then subjected to demineralization/remineralization cycles for 9 days. Samples in all experimental groups were evaluated using Raman spectroscopy for mineral content recovery percentage, microhardness and nanoindentation as healthy, demineralized enamel and after pH-cycling. Data were statistically analysed using two-way repeated measures Anova followed by Bonferroni-corrected post hoc test for pairwise multiple comparisons between groups. Statistical significance was set at p= 0.05. Additionally, XRD, FESEM and EDXS were used for crystal orientation, surface morphology and elemental analysis after pH-cycling.

RESULTS: Nanocrystals clumped in a directional manner were detected in peptide-treated groups. P/II showed the highest significant mean values in mineral content recovery (63.31%), microhardness (268.81±6.52 VHN), elastic modulus (88.74±2.71 GPa), nanohardness (3.08±0.59 GPa) and the best crystal orientation with I₀₀₂/_I300 (1.87±0.08).

CONCLUSION: Despite pH changes, the tested peptide was capable of remineralizing enamel with ordered crystals. Moreover, the supplementary use of calcium phosphate fluoride solution with peptide granted an enhancement in enamel mechanical properties after remineralization.

PMID:38413983 | DOI:10.1186/s12903-024-04008-z

J Ethnobiol Ethnomed. 2024 Feb 27;20(1):27. doi: 10.1186/s13002-024-00671-2.

ABSTRACT

BACKGROUND: Plants deliver livelihood and food for millions of people in the world. Indeed, wild edible plants support rural communities in developing countries to overcome seasonal unfavorable conditions. In rural areas of Ethiopia, wild edible plants play an indispensable role in fighting food insecurity as emergency or supplementary foods. Hence, this research was aimed at studying the ethnobotanical assessment of wild edible plants in Dibatie district, Metekel zone, western Ethiopia.

METHODS: Ethnobotanical data was collected using a semi-structured interview, field observation, focus group discussions, a market survey, and the ranking of selected plants. Besides, voucher specimens were collected and stored at the National Herbarium of Ethiopia. Descriptive statistics, preference ranking, direct matrix ranking, and familiarity index were computed for data analysis.

RESULTS: This study has documented 54 wild edible plant species belonging to 33 plant families and 46 genera. Of these, most (38.90%) had tree growth habits. Wild edible plants bear mostly fruits (72.20%) as edible parts. Local people usually consume these plants freshly raw as complementary foods, though some wild edibles require processing. They were mostly harvested in the January (31.48%) and May (27.78%) months, with the least collected in September (7.41%). Most wild edible plants (78.57%) were available in uncontrolled habitats, while others (21.43%) live in farmlands, home gardens, and as live fences. Out of the recorded plants, about 98% had additional uses besides their nutritional values.

CONCLUSION: Wild edible plants assist the livelihoods of the local people in food security, agriculture, energy sources, construction, medicines, ecological services, aesthetics, income generation, and household utensils. Nevertheless, wild edible plants are recently threatened due to various anthropogenic factors in the study area. Thus, they need wise use and in-situ and ex-situ conservation measures from all the concerned bodies for sustainable use in the future.

PMID:38413982 | DOI:10.1186/s13002-024-00671-2

BMC Med Educ. 2024 Feb 27;24(1):197. doi: 10.1186/s12909-024-05174-y.

ABSTRACT

BACKGROUND: French medical graduates undertake a national examination at the end of their studies with a subsequent national ranking. Specialty is then chosen by each candidate according to their ranking. This study aims to describe the attractiveness of surgical specialties and the evolution of the male-female distribution among French medical graduates (FMG) from 2017 to 2022.

METHODS: Our database included the candidates’ ranking, sex and choice of specialty from 2017 to 2022. It included all French medical graduates from 2017 to 2022 and all French medical schools. A linear regression was performed to predict future trends. Dependent variables were mean rankings and the percentage of women. The independent variable was year of application. A Pearson correlation was performed to examine any relationship with mean workweek.

RESULTS: A total number of 5270 residents chose a surgical programme between 2017 and 2022. The number of residents who were assigned their desired surgical programme held stable at 878 surgical residents per year. Plastic and reconstructive surgery remained the most frequently chosen surgical programme. Thoracic and cardiovascular surgery was the least frequently chosen surgical programme between 2017 and 2022. The mean ranking for a candidate choosing a surgical programme rose significantly by 9% from 2017 to 2022 (p < 0.01). Neurosurgery exhibited the greatest fall as a surgical specialty as its rankings decreased by 163.6% (p < 0.01). Maxillo-facial surgery was the only specialty with a statistically significant increase in its rankings by 35.9% (p < 0.05). The overall proportion of women was 51.1%. Obstetrics-and-gynecology was the highest represented specialty among female candidates, with a mean of 83.9% of women. Orthopedic surgery was the lowest represented, being composed of a mean of 28.6% of women. The number of female surgical residents increased significantly over the six-year period, by 7.6% (p < 0.01).

CONCLUSIONS: More and more medical school graduates decide not to choose surgery for their residency programme. Some specialties continue to be attractive while many are losing their appeal. While there does appear to be progress towards gender equity, further investigation is necessary to assess its actual implementation.

PMID:38413964 | DOI:10.1186/s12909-024-05174-y

Malar J. 2024 Feb 27;23(1):60. doi: 10.1186/s12936-024-04871-9.

ABSTRACT

BACKGROUND: When integrated with insecticide-treated bed nets, larval control of Anopheles mosquitoes could fast-track reductions in the incidence of human malaria. However, larval control interventions may deliver suboptimal outcomes where the preferred breeding places of mosquito vectors are not well known. This study investigated the breeding habitat choices of Anopheles mosquitoes in southern Nigeria. The objective was to identify priority sites for mosquito larval management in selected urban and periurban locations where malaria remains a public health burden. METHODS: Mosquito larvae were collected in urban and periurban water bodies during the wet-dry season interface in Edo, Delta, and Anambra States. Field-collected larvae were identified based on PCR gel-electrophoresis and amplicon sequencing, while the associations between Anopheles larvae and the properties and locations of water bodies were assessed using a range of statistical methods.

RESULTS: Mosquito breeding sites were either man-made (72.09%) or natural (27.91%) and mostly drainages (48.84%) and puddles (25.58%). Anopheles larvae occurred in drainages, puddles, stream margins, and a concrete well, and were absent in drums, buckets, car tires, and a water-holding iron pan, all of which contained culicine larvae. Wild-caught Anopheles larvae comprised Anopheles coluzzii (80.51%), Anopheles gambiae sensu stricto (s.s.) (11.54%), and Anopheles arabiensis (7.95%); a species-specific PCR confirmed the absence of the invasive urban malaria vector Anopheles stephensi among field-collected larvae. Anopheles arabiensis, An. coluzzii, and An. gambiae s.s. displayed preferences for turbid, lowland, and partially sunlit water bodies, respectively. Furthermore, An. arabiensis preferred breeding sites located outside 500 m of households, whereas An. gambiae s.s. and An. coluzzii had increased detection odds in sites within 500 m of households. Anopheles gambiae s.s. and An. coluzzii were also more likely to be present in natural water bodies; meanwhile, 96.77% of An. arabiensis were in man-made water bodies. Intraspecific genetic variations were little in the dominant vector An. coluzzii, while breeding habitat choices of populations made no statistically significant contributions to these variations.

CONCLUSION: Sibling malaria vectors in the An. gambiae complex display divergent preferences for aquatic breeding habitats in southern Nigeria. The findings are relevant for planning targeted larval control of An. coluzzii whose increasing evolutionary adaptations to urban ecologies are driving the proliferation of the mosquito, and An. arabiensis whose adults typically evade the effects of treated bed nets due to exophilic tendencies.

PMID:38413961 | DOI:10.1186/s12936-024-04871-9

BMC Health Serv Res. 2024 Feb 27;24(1):247. doi: 10.1186/s12913-024-10697-7.

ABSTRACT

BACKGROUND: Emergency psychiatric care, unplanned hospital admissions, and inpatient health care are the costliest forms of mental health care. According to Statistics Canada (2018), almost 18% (5.3 million) of Canadians reported needing mental health support. However, just above half of this figure (56.2%) have reported their needs were fully met. In light of this evidence there is a pressing need to provide accessible mental health services in flexible yet cost-effective ways. To further expand capacity and access to mental health care in the province, Nova Scotia Health has launched a novel mental health initiative for people in need of mental health care without requiring emergency department visits or hospitalization. This new service is referred to as the Rapid Access and Stabilization Program (RASP). This study evaluates the effectiveness and impact of the RASP on high-cost health services utilization (e.g. ED visits, mobile crisis visits, and inpatient treatments) and related costs. It also assesses healthcare partners’ (e.g. healthcare providers, policymakers, community leaders) perceptions and patient experiences and satisfaction with the program and identifies sociodemographic characteristics, psychological conditions, recovery, well-being, and risk measures in the assisted population.

METHOD: This is a hypothesis-driven program evaluation study that employs a mixed methods approach. A within-subject comparison (pre- and post-evaluation study) will examine health services utilization data from patients attending RASP, one year before and one year after their psychiatry assessment at the program. A controlled between-subject comparison (cohort study) will use historical data from a control population will examine whether possible changes in high-cost health services utilization are associated with the intervention (RASP). The primary analysis involves extracting secondary data from provincial information systems, electronic medical records, and regular self-reported clinical assessments. Additionally, a qualitative sub-study will examine patient experience and satisfaction, and health care partners’ impressions.

DISCUSSION: We expect that RASP evaluation findings will demonstrate a minimum 10% reduction in high-cost health services utilization and corresponding 10% cost savings, and also a reduction in the wait times for patient consultations with psychiatrists to less than 30 calendar days, in both within-subject and between-subject comparisons. In addition, we anticipate that patients, healthcare providers and healthcare partners would express high levels of satisfaction with the new service.

CONCLUSION: This study will demonstrate the results of the Mental Health and Addictions Program (MHAP) efforts to provide stepped-care, particularly community-based support, to individuals with mental illnesses. Results will provide new insights into a novel community-based approach to mental health service delivery and contribute to knowledge on how to implement mental health programs across varying contexts.

PMID:38413957 | DOI:10.1186/s12913-024-10697-7

BMC Med Educ. 2024 Feb 27;24(1):198. doi: 10.1186/s12909-024-05177-9.

ABSTRACT

BACKGROUND: Creating an inclusive interprofessional teaching and learning community can enhance student engagement and ultimately develop essential graduate attributes (GA) (also known as generic, transferable, core, soft, work-ready or nontechnical skills). The early practical development of GA within a diverse space is essential in health profession education, as students experience the transition to clinical training as challenging.

AIM: This paper describes the conceptualization and implementation of an inclusive interprofessional curriculum focused on GA development in the preclinical years.

METHODS: A phased multimethod research design was applied. Phase 1 focused on the conceptualization of a preclinical GA development curriculum through a consensus-seeking process among all staff in the School of Health and Rehabilitation Sciences (N = 36). Subsequently, in Phase 2, quantitative and qualitative data were gathered from participating first-year students (N = 135) as an early curricular implementation review. Descriptive statistical analyses for quantitative and thematic analyses for qualitative data were performed.

RESULTS: During Phase 1, five themes were identified (Ethics, Professionalism, General principles for interventions, Organizations and institutions, Management) informing preclinical curriculum development. Forty-one first-year students (30%) participated in Phase 2. The majority of participants (87%) indicated that they had a positive learning experience during Phase 2. Students expressed that engagement was encouraged (83%) within a space of mutual respect (83%), with interprofessional groups assisting in building “a trusting environment and a supportive one”. Students indicated they “liked that it [module] wasn’t just about one topic”, as it concretized that “there is more to being a healthcare professional that just treating people”.

CONCLUSION: GA development provides an invaluable opportunity for interprofessional engagement. Creating a diverse and inclusive curricular space through multimodal and interprofessional training, GA training was transformed to be more practical and future-focused, creating a positive learning experience. Future research should focus on the longer-term impact of this practical, preclinical GA development during the transition of these students into the clinical training space.

PMID:38413950 | DOI:10.1186/s12909-024-05177-9

BMC Vet Res. 2024 Feb 28;20(1):78. doi: 10.1186/s12917-024-03930-2.

ABSTRACT

BACKGROUND: Due to the increasing prevalence of equine non-infectious respiratory disease, the air contamination in equine housing (Stables A-C) and training facilities (indoor riding arenas A – C) was investigated. The aim of the study was to monitor gaseous pollutants, bioaerosols, and dust concentrations at three different sites (stables and riding halls), where different floor materials were used in the riding halls.

MATERIALS AND METHODS: Air quality was monitored in housing for horses and in riding halls in terms of dust concentration, the presence of gaseous chemical pollutants, and concentrations of biological aerosol. Statistical analysis was performed using analysis of variance (ANOVA). The levels obtained were compared with acceptable limits.

RESULTS: Among the gaseous pollutants identified, the highest concentration was obtained for ammonia in stables B and C (16.37 and 22.39 mg/m³, respectively). Standards for total dust were exceeded in stables B and C and in riding halls B and C. The highest numbers of bacteria and fungi were recorded in stables A and C and in riding hall B. Ulocladium sp. had the highest percentage share among the moulds identified.

CONCLUSIONS: The results confirm that the wrong choice of bedding in the stable and indoor riding arenas may contribute, even in short training periods, to equine non-infectious respiratory disease (equine asthma). Bioaerosol suspended in the air together with released gaseous pollutants can exacerbate this phenomenon, which even in the case of short training periods can lead to equine asthma of varying degrees of severity. For this reason, the choice of floor material in riding halls should be treated as a priority, as the wrong decision can shorten the period during which the horse can be used for recreational purposes.

PMID:38413934 | DOI:10.1186/s12917-024-03930-2

BMC Med. 2024 Feb 27;22(1):85. doi: 10.1186/s12916-024-03275-5.

ABSTRACT

BACKGROUND: For patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD), effective second-line regimens are urgently needed. Mesenchymal stromal cells (MSCs) have been used as salvage regimens for SR-aGVHD in the past. However, clinical trials and an overall understanding of the molecular mechanisms of MSCs combined with basiliximab for SR-aGVHD are limited, especially in haploidentical haemopoietic stem cell transplantation (HID HSCT).

METHODS: The primary endpoint of this multicentre, randomized, controlled trial was the 4-week complete response (CR) rate of SR-aGVHD. A total of 130 patients with SR-aGVHD were assigned in a 1:1 randomization schedule to the MSC group (receiving basiliximab plus MSCs) or control group (receiving basiliximab alone) (NCT04738981).

RESULTS: Most enrolled patients (96.2%) received HID HSCT. The 4-week CR rate of SR-aGVHD in the MSC group was obviously better than that in the control group (83.1% vs. 55.4%, P = 0.001). However, for the overall response rates at week 4, the two groups were comparable. More patients in the control group used ≥ 6 doses of basiliximab (4.6% vs. 20%, P = 0.008). We collected blood samples from 19 consecutive patients and evaluated MSC-derived immunosuppressive cytokines, including HO1, GAL1, GAL9, TNFIA6, PGE2, PDL1, TGF-β and HGF. Compared to the levels before MSC infusion, the HO1 (P = 0.0072) and TGF-β (P = 0.0243) levels increased significantly 1 day after MSC infusion. At 7 days after MSC infusion, the levels of HO1, GAL1, TNFIA6 and TGF-β tended to increase; however, the differences were not statistically significant. Although the 52-week cumulative incidence of cGVHD in the MSC group was comparable to that in the control group, fewer patients in the MSC group developed cGVHD involving ≥3 organs (14.3% vs. 43.6%, P = 0.006). MSCs were well tolerated, no infusion-related adverse events (AEs) occurred and other AEs were also comparable between the two groups. However, patients with malignant haematological diseases in the MSC group had a higher 52-week disease-free survival rate than those in the control group (84.8% vs. 65.9%, P = 0.031).

CONCLUSIONS: For SR-aGVHD after allo-HSCT, especially HID HSCT, the combination of MSCs and basiliximab as the second-line therapy led to significantly better 4-week CR rates than basiliximab alone. The addition of MSCs not only did not increase toxicity but also provided a survival benefit.

PMID:38413930 | DOI:10.1186/s12916-024-03275-5