Tag: statistics

Pilot Feasibility Stud. 2025 Jun 21;11(1):87. doi: 10.1186/s40814-025-01668-8.

ABSTRACT

BACKGROUND: Currently, there is insufficient evidence supporting geriatric home rehabilitation after hospital discharge. Some studies demonstrate a positive effect, but meta-analytic evidence demonstrates uncertainty on the magnitude of the expected effect. Yet, evidence from other populations indicates that home rehabilitation could also be an effective strategy for older persons. Therefore, we aim to evaluate the effectiveness of geriatric home rehabilitation in older persons discharged from the hospital with disability. Given the potential challenges in recruiting participants delivering the intervention, and executing other study procedures in a multi-centre study, we will first carry out a pilot study.

METHODS: The pilot study will commence with an initial start-up phase at two centres: UZ Leuven and CHU UCL Namur, Belgium. Up to three participants per centre will be included to test the procedures and assessments, excluding randomisation and intervention delivery. The study then progresses to the full pilot phase to evaluate and confirm the feasibility of the proposed trial. This pilot study will take place at the same two centres. The pilot study aligns with the design of the envisioned full trial, i.e. a pragmatic, multicentre, individually randomised superiority trial. A 1 to 1 allocation ratio will be used for the pilot. A total of 24 participants from the two centres will be recruited to investigate the pilot study objectives. The pilot endpoints will be used to determine the feasibility of recruitment and study procedures including data collection, assessments and delivery of the intervention (a 6-week program consisting of exercise sessions 3 times per week, 45 min each). The results from the pilot study will be discussed within the pilot study steering group. Progression criteria will be reviewed to determine if the study progresses to a full trial, and which adaptations are needed.

DISCUSSION: In case of a successful pilot, the study will progress to a full trial. The ambition of the full trial is to recruit 333 participants across 8 centres in Belgium, and to investigate the effectiveness of home rehabilitation for older persons discharged from the hospital with disability.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT06404138 on 08 May 2024.

PMID:40544287 | DOI:10.1186/s40814-025-01668-8

Infect Agent Cancer. 2025 Jun 21;20(1):41. doi: 10.1186/s13027-025-00665-z.

ABSTRACT

OBJECTIVE: Bladder cancer (BCa) has become a growing concern worldwide, highlighting the importance of early detection and new treatment methods. Recent studies have shown that viruses from the HERV family play a significant role in the development of various cancers and can act as early diagnostic biomarkers. Although hypomethylation of HERV-K has been proven in bladder cancer, no studies have yet explored the role of HERV-K oncogenes such as env, gag, np9, and rec. In this study, for the first time, we investigate the expression of these genes and their relationship with each other, aiming to shed light on their potential role in bladder cancer progression and diagnosis.

METHODS AND MATERIALS: We collected a total of 42 samples, comprising 21 bladder transitional cell carcinoma (TCC) samples and 21 adjacent normal tissue samples. Following RNA extraction, the expression levels of HERV-K (HML-2) genes (env, gag, np9, and rec) were evaluated using quantitative real-time PCR (qRT-PCR). For statistical analysis, GraphPad software was employed, utilizing the Kruskal-Wallis test, Mann-Whitney U test, and correlation tests to assess the data.

RESULTS: We found that env and np9 were significantly upregulated in BCa tissues compared to normal tissues (p < 0.0001 and p = 0.022, respectively). While env showed strong associations with tumor grade (low-grade: p = 0.0006; high-grade: p = 0.0011) and stage (early stage: p = 0.0002; invasive stage: p = 0.0047), np9 exhibited consistent associations across all grades (low-grade: p = 0.017; high-grade: p = 0.042) but was exclusively linked to invasive stages (p = 0.001). Although gag expression did not differ significantly overall, it was elevated in the invasive stages of tumors (p = 0.0021). Interestingly, while rec expression showed an increase in cancerous tissues compared to normal tissues, this change was not statistically significant. However, it exhibited significant correlations with other HERV-K genes in cancerous tissue (r = 0.63, p < 0.0001 with env; r = 0.80, p < 0.0001 with gag; and r = 0.39, p = 0.015 with np9). Age-stratified analysis revealed tumor-specific env (p = 0.0272) and rec (p = 0.0017) variations, whereas normal tissues showed only marginal rec age-dependence (p = 0.0494).

CONCLUSION: The results of our study highlight the potential role of HERV-K genes, particularly env and np9, in BCa progression and demonstrate their promising utility as diagnostic biomarkers.

PMID:40544283 | DOI:10.1186/s13027-025-00665-z

J Ovarian Res. 2025 Jun 21;18(1):136. doi: 10.1186/s13048-025-01723-1.

ABSTRACT

BACKGROUND: Studies have shown that vitrified-thawed blastocyst re-expansion capacity is a good predictor of implantation. However, whether assisted hatching (AH) influences re-expansion is currently unstudied. Also, whether AH improves subsequent implantation rate remains highly uncertain.

OBJECTIVES: To investigate the impact of AH on re-expansion and subsequent implantation in vitrified-thawed blastocysts transfer cycles.

METHOD: The absolute initial single vitrified-thawed blastocyst cycles of patients between August 2019 and April 2024 in our center were included in this retrospective cohort study, totaling 4637 cycles. Grouping was performed according to laser-AH or not. Stratified analyses according to different trophoblastic ectoderm (TE) grades were applied (TE were categorized into three different grades (A-C) according to their number and cohesiveness), with specific focus on blastocysts with TE grade of C. Subgroup analyses were then carried out based on blastocyst stage (Day5 or Day6), in which AH and Non-AH were compared separately. Multifactorial regression analyses were performed on the main outcomes to clarify the effect of laser-AH.

RESULTS: There were no differences in pregnancy outcomes between AH group and Non-AH group, though the blastocyst stage proportions differed. Subgroup analysis based on blastocyst stage still revealed no statistically significant differences in pregnancy outcomes regarding AH or not (both in Day5 and Day6 blastocysts); while AH group had a lower re-expansion rate than Non-AH group in Day6 blastocysts (78.9% vs. 84.0%, P = 0.006). Multifactorial regression showed that AH had no effect on biochemical pregnancy rate in all cycles (aOR: 1.064, 95% CI: 0.938-1.206, P = 0.337), but increased the probability of implantation in TE grade = C cycles (aOR: 1.340, 95% CI: 1.017-1.766, P = 0.038). In the binary regression analysis on re-expansion rate, AH presented a negative effect both in all cycles and in TE grade = C cycles (all cycles: aOR: 0.774, 95% CI: 0.646-0.827, P = 0.005; TE = C cycles: aOR: 0.688, 95% CI: 0.481-0.984, P = 0.040).

CONCLUSION: Laser-AH negatively affects the ability of vitrified-thawed blastocysts to re-expand. Laser-AH had no significant effect on implantation in all blastocysts. AH may only be beneficial for the implantation of blastocysts with TE grade C.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:40544282 | DOI:10.1186/s13048-025-01723-1

Ann Gen Psychiatry. 2025 Jun 21;24(1):40. doi: 10.1186/s12991-025-00576-8.

ABSTRACT

OBJECTIVES: This study aimed to investigate the association between sleep problems and suicidal behaviors as well as healthcare utilization in Canadian adults with chronic diseases, while also examining the mediating role of mental illness.

METHODS: Data were drawn from the 2015-16 cycle of the Canadian Community Health Survey, specifically from Ontario, Manitoba, and Saskatchewan – the provinces that included the optional sleep module. A total of 22,700 participants aged ≥ 18 years and diagnosed with at least one chronic disease were included in the analysis. Sleep problems were defined as extreme sleep durations (either < 5 or ≥ 10 h) and insomnia. Mental illness was classified as a self-reported mood or anxiety disorder.

RESULTS: Participants with extreme sleep durations (compared to 7 to < 8 h) and those with insomnia (compared to no insomnia) showed a higher prevalence of suicidal ideation, suicidal plans, and increased healthcare utilization. After adjusting for multiple covariates, both extreme sleep durations and insomnia remained significantly associated with increased odds of suicidal ideation, suicidal plans, and healthcare utilization. Mediation analyses indicated that mental illness partially mediated these associations.

CONCLUSIONS: Both extreme sleep durations and insomnia were independently associated with higher odds of suicidal behaviors and increased healthcare utilization in adults with chronic diseases, with mental illness playing a partial mediating role in these relationships.

PMID:40544278 | DOI:10.1186/s12991-025-00576-8

J Health Popul Nutr. 2025 Jun 21;44(1):221. doi: 10.1186/s41043-025-00970-8.

ABSTRACT

BACKGROUND: Evidence from behavioral economics has shown that framing health information can impact the demand for screening. We examined the effect of promotional message framing on mammography demand by estimating willingness to pay (WTP).

METHODS: This experimental study was conducted in 2024 over a period of 3 months. The interesting outcome was a WTP for mammography. 354 women were randomly selected and randomly assigned between the two study arms. The intervention involved the presentation of health information in two frames of gain and loss. The mammography demand has been estimated using robust standard error Logistic regression. Demand rate of mammography has been compared between two types of information framing using the chi-square test. Finally, the monetary value of willingness to pay (WTP) for mammography was estimated using the methodology developed by López-Feldman. All analyses were done using STATA 17.

RESULTS: The price and income elasticity of mammography demand were estimated as – 0.19 and 0.24, respectively (P < 0.01). The higher demand rate in the loss frame compared to the gain frame (38.7% vs. 25.1%) was statistically significant, and its effect size was estimated to be 0.282 (p < 0.01). The value of WTP in the loss frame (10.68 US$) was estimated to be more significant than in the gain frame (4.74 US$) (p < 0.01).

CONCLUSION: This study suggests that health educators consider the message’s persuasiveness with the type of health action before designing health messages. Moreover, health practitioners should use health messages with a loss frame to increase the demand for screening services such as mammography.

PMID:40544270 | DOI:10.1186/s41043-025-00970-8

AIDS Res Ther. 2025 Jun 21;22(1):64. doi: 10.1186/s12981-025-00761-5.

ABSTRACT

BACKGROUND: Weight gain has been associated with the use of antiretrovirals in people with HIV, especially with integrase inhibitors or tenofovir alafenamide, and among women. In 2018, doravirine became the latest non-nucleoside reverse transcriptase inhibitor to be approved in the US. We assessed changes in weight over time among virologically suppressed individuals who switched to a regimen containing doravirine (DOR).

METHODS: From the US-based OPERA cohort, treatment-experienced adults with HIV who switched to a DOR-containing regimen between 30AUG2018-30NOV2022 with a viral load < 50 copies/mL were included (followed through 31MAY2023). The study population was characterized and a linear mixed model was used to estimate rates of weight change on DOR. Results were stratified by sex, by patterns of efavirenz (EFV) and/or tenofovir disoproxil fumarate (TDF) use before/after switch to DOR, and by integrase inhibitor (INSTI) & tenofovir alafenamide (TAF) use combination (restricted to individuals who maintained the same combination before/after switch).

RESULTS: Of 388 included individuals, 21% were women, 33% were Black, and 78% were obese or overweight at DOR switch. Overall, people who switched to DOR lost an average of 0.80 kg/year (95% CI: -1.32, -0.28). Both women and men experienced statistically significant weight loss; women (70% Black, 70% aged ≥ 40 years) lost weight at a rate of -1.67 kg/year (95% CI: -3.32, -0.02) and men at a rate of -0.60 kg/year (95% CI: -1.12, -0.08). When EFV and TDF were absent before and after switch to DOR, statistically significant weight loss was observed. Among those who had the same INSTI and TAF combination throughout and had any INSTI or TAF use, a statistically non-significant trend toward weight loss was observed.

CONCLUSIONS: In one of the first real-world analyses of weight changes among virologically suppressed individuals who switched to a DOR-containing regimen in the US, DOR was associated with statistically significant weight loss. Patterns of use of other antiretrovirals did not fully explain the observed weight loss. These findings are clinically meaningful given that most individuals included were overweight or obese at switch to DOR and that women were predominantly of perimenopausal or menopausal age.

PMID:40544263 | DOI:10.1186/s12981-025-00761-5

J Health Popul Nutr. 2025 Jun 21;44(1):218. doi: 10.1186/s41043-025-00862-x.

ABSTRACT

BACKGROUND: This study investigates the role of economic growth, healthcare investment, immunization coverage, and malnutrition in reducing under-five mortality rates (U5MR) in Sri Lanka. Understanding how these factors interact within socio-economic ecosystems is essential to formulating sustainable strategies to improve child survival outcomes.

METHODS: This study employs multiple linear regression to analyze the statistical associations between economic growth, healthcare investment, immunization, malnutrition, and under-five mortality in Sri Lanka. Using secondary data from the World Bank and UNICEF (2000-2021), U5MR was modeled against economic growth (per capita GDP), government healthcare expenditure (GHE), immunization coverage (DTP1), and malnutrition (MLN), with significance assessed through p-values and model fit via R².

RESULTS: The multiple linear regression model demonstrated strong explanatory power, accounting for 85% of the variation in under-five mortality (R² = 0.85). Economic growth and immunization coverage were negatively associated with U5MR and found to be statistically significant (p < 0.05 and p < 0.10 respectively), indicating their potential role in reducing child mortality. Malnutrition showed a strong positive association (p < 0.01), emphasizing its continued threat to child health. Although government healthcare expenditure had a negative association, it was not statistically significant, suggesting possible inefficiencies in resource utilization.

CONCLUSION: The study highlights the significant role of economic growth, healthcare expenditure, immunization coverage, and nutrition in shaping U5MR trends in Sri Lanka. The findings emphasize the need for targeted policy interventions to enhance child health outcomes and ensure sustainable progress in reducing child mortality.

PMID:40544255 | DOI:10.1186/s41043-025-00862-x

BMC Prim Care. 2025 Jun 21;26(1):200. doi: 10.1186/s12875-025-02881-3.

ABSTRACT

BACKGROUND: Managing patients with chronic non-cancer pain (CNCP) in outpatient healthcare is challenging. Long-term opioid therapy is an option for treatment responders with guideline recommended indications. However, opioid use poses risks of severe side effects, including misuse, and therefore needs to be integrated into a high-quality healthcare process. This analysis evaluates the association between healthcare quality according to the evidence-based Chronic Care Model (CCM) in the treatment process of patients receiving long-term opioid therapy for chronic back and/or arthrosis pain, and patient-related or healthcare related variables.

METHODS: A cross-sectional patient survey was sent to a random sample of 3,037 individuals with long-term opioid therapy and chronic back and/or arthrosis pain insured by a large nationwide German statutory health insurance. Healthcare quality according to the CCM was assessed by the Patient Assessment of Chronic Illness Care (PACIC-5A) questionnaire. Internal reliability of the assessment instrument was determined using Cronbach’s α. Descriptive analysis of the outcome scales were conducted, alongside subgroup analyses considering patient characteristics, patient’s health situation, and pain treatment aspects. Testing for statistical significance was performed by Mann-Whitney U test and Kruskal-Wallis test. Effect sizes, namely Eta and Spearman’s Rank correlation coefficient, were calculated.

RESULTS: The analysis included 661 individuals. Participants were predominantly female (76%) with an average age of 69 years (SD 12.5). PACIC-5A score ratings across all (sub)scales were low, with a summary score rating of 2.4 (on a scale ranging from 1 (worst) to 5 (best)). Positive correlations with treatment quality were observed in the subgroup analysis concerning guideline-compliant pain treatment aspects such as setting therapy goals or a comprehensive treatment concept. Patient characteristics showed little to no correlations, except for a positive correlation between higher PACIC-5A rating and both lower age and higher education. Patient’s health situation presented a mixed picture, with no clear correlation between pain intensity/impairment, and PACIC-5A scores.

CONCLUSIONS: The provision of healthcare for patients with long-term opioid therapy for CNCP seems to be inadequate according to the CCM. Guideline-recommended pain treatment aspects exhibited a positive correlation with healthcare quality according to CCM. Enhancing the implementation of the CCM in the outpatient healthcare process may improve healthcare quality.

TRIAL REGISTRATION: German Clinical Trials Register, DRKS00024854. Registered 04/28/2021.

PMID:40544254 | DOI:10.1186/s12875-025-02881-3

BMC Oral Health. 2025 Jun 21;25(1):955. doi: 10.1186/s12903-025-06345-z.

ABSTRACT

OBJECTIVES: This study aims to evaluate the quality and quantity of gained and maintained bone width after Ridge splitting utilizing autogenic bone wedge versus mixed bone particles for horizontal ridge augmentation in the anterior aesthetic zone.

MATERIALS AND METHODS: This randomized clinical trial included 20 patients with horizontally deficient anterior maxillary alveolar ridges. Patients were divided equally into two groups. Group I received an autogenous bone wedge harvested from the chin area to be placed intercotically after ridge splitting (intervention group). Group II received mixed bone particles of autogenic and xenogeneic bone placed intercortically after ridge splitting (control group). Radiographic assessment of gained and maintained alveolar bone width at three vertical levels was performed using CBCT at three-time intervals (preoperative, immediate postoperative, and 6 months postoperative). Histologic and histomorphometric analysis of core biopsy harvested immediately before implant placement was also performed to assess bone quality and % of newly formed bone area using H&E and Mansons trichrome stains. Collected data were conducted for statistical analysis.

RESULTS: The outcome of the studied grafts showed a significant increase of the immediate postoperative bone width in the control group more than the intervention group, with a mean difference from the preoperative bone width (2.17 ± 1.10) mm for the control group and only (1.44 ± 0.66) for the intervention group. In contrast, the 6-month postoperative bone width was decreased in both groups with a mean difference from the immediate postoperative bone width (1.21 ± 0.54) in the control group (p-value < 0.001) compared to only (0.41 ± 0.50) in the intervention group (p value = 0.135); this statistical data revealed that the bone wedge technique of the intervention group helped to maintain the gained bone width more than the packed bone particles of the control group. Moreover, the intervention group showed higher value and quality of newly formed mature bone with well-formed havarsian canals than the control group, which showed lower bone quality of osteoid and fibrous tissue with remnants of xenogenic bone particles microscopically.

CONCLUSIONS: The two-stage ridge-splitting procedure using an interposition bone wedge is an effective method for horizontal ridge augmentation in the horizontally deficient anterior maxilla.

CLINICAL RELEVANCE: The two-stage Ridge splitting with an inter-positional bone wedge ensures better bone width maintenance and quality.

TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov on 24/07/2024 under the registry number “NCT06529653”. It adhered to the Declaration of Helsinki on medical research ethics and received approval from the Institutional Research Ethics Committee of the Faculty of Dentistry, Cairo University (IRB number: 161022).

PMID:40544250 | DOI:10.1186/s12903-025-06345-z

Diabetol Metab Syndr. 2025 Jun 21;17(1):237. doi: 10.1186/s13098-025-01801-w.

ABSTRACT

BACKGROUND AND AIMS: Nonalcoholic fatty liver disease (NAFLD) is strongly associated with dietary habits and the gut microbiota. The dietary index for the gut microbiota (DI-GM) is a newly proposed index that reflects gut microbial diversity based on dietary intake. However, its relationship with NAFLD remains unclear. This study aimed to explore the association between DI-GM and the risk of NAFLD.

METHODS: In this cross-sectional study, we utilized data from the NHANES 2009-2018. Multivariable logistic regression, restricted cubic spline curves (RCS), subgroup analysis, and mediation analysis were used to evaluate the association between DI-GM and the risk of NAFLD.

RESULTS: A total of 4,923 participants were included in the study. According to the fully adjusted model, a significant inverse association was observed between DI-GM and NAFLD (OR = 0.883, 95% CI: 0.835-0.932, P < 0.001). After stratification by quartiles, compared with participants in the first quartile of DI-GM score, those in the fourth quartile had a 36.5% lower odds of developing NAFLD (OR = 0.635, 95% CI: 0.481-0.839, P = 0.002). Mediation analysis revealed that 72.69% of the association between DI-GM and NAFLD was mediated by BMI (P < 0.001). Subgroup analysis suggested that the association between DI-GM and NAFLD might be influenced by race (P for interaction < 0.05). RCS analysis revealed a linear correlation between DI-GM and NAFLD (P for nonlinear = 0.883).

CONCLUSIONS: DI-GM is negatively associated with NAFLD risk, with BMI mediating this relationship and race being a significant influencing factor.

PMID:40544245 | DOI:10.1186/s13098-025-01801-w