Category: Statistics

Nutr J. 2025 Apr 21;24(1):63. doi: 10.1186/s12937-025-01106-8.

ABSTRACT

BACKGROUND: Animal proteins (APs) and plant proteins (PPs) seem to exhibit different thermic and metabolic effects, which may be attributed to differences in amino acid profiles, bioavailability, and digestibility.

OBJECTIVES: In this study, we aimed to investigate and compare the postprandial effects of AP and PP meals on energy metabolism parameters, including resting energy expenditure (REE) and substrate oxidation (SO), in overweight and obese men.

METHODS: This acute randomized crossover clinical trial involved forty-eight overweight and obese men, with a mean age of 33.48 ± 8.35 years and an average BMI of 29.15 ± 2.33 kg/m². Participants consumed two high-protein test meals with different protein sources (AP and PP) on separate days, with a washout period of 7 to 10 days between them. On each test day, energy metabolism parameters were measured in both the fasting state and postprandial phase using indirect calorimetry. Statistical analysis was conducted using SPSS version 25 and R programs, evaluating the effects of carry-over, treatment, time, and treatment × time interaction through generalized estimating equations (GEE) analysis.

RESULTS: After controlling for baseline values, there was a significant effect of time (P < 0.05), protein source (P < 0.05), and protein source × time (P < 0.05) on REE, TEF, and carbohydrate oxidation. REE showed an increase following the consumption of both meals; however, the rise observed after AP (14.2%) was greater than that of PP (9.55%). The trends in TEF changes were similar to those of REE. The mean carbohydrate oxidation after consuming PP remained relatively stable throughout the test, whereas the AP meal gradually increased, reaching its peak at the 180th minute. The decline in carbohydrate oxidation was more pronounced following the AP meal than the PP meal by the end of the test.

CONCLUSION: This clinical trial demonstrates that animal-based protein results in higher energy expenditure and carbohydrate oxidation than plant-based protein.

PMID:40259349 | DOI:10.1186/s12937-025-01106-8

BMC Rheumatol. 2025 Apr 21;9(1):45. doi: 10.1186/s41927-025-00487-x.

ABSTRACT

BACKGROUND: Early initiation of effective treatment is associated with positive long-term prognosis for patients with rheumatoid arthritis (RA). Currently, there are no biomarkers in clinical use to predict treatment response. A predictor of treatment response may be the B-cell compartment, as this is altered in RA patients, making it a potential candidate for predicting treatment response. In this study, we sought to identify B-cell subset(s) at diagnosis that might be associated with Clinical Disease Activity Index (CDAI) remission at 24-week follow-up.

METHODS: Seventy early RA patients from the NORD-STAR trial, recruited from two Swedish sites, and 28 matched healthy controls, were included in this spin-off study. In NORD-STAR, all patients were randomized to methotrexate (MTX) combined with 1) prednisolone, 2) anti-TNF (certolizumab-pegol), 3) CTLA4-Ig (abatacept), or 4) anti-IL-6R (tocilizumab). Circulating B-cell subsets at diagnosis were assessed by flow cytometry. The primary outcome measure was remission according to CDAI ≤ 2.8. A multivariate two-part discriminant analysis was performed to assess whether B-cell subpopulations at diagnosis could predict remission at 24 weeks. Subsequent univariable statistical analyses were performed using t-tests, Mann-Whitney U, or Kruskal-Wallis tests, as appropriate. Correlations were analyzed using Spearman or Pearson tests, depending on data type. The impact of specific B-cell populations on remission at week 24 was assessed using logistic regression models. The logistic regression model was also used to simultaneously visualize the sensitivity and specificity of the model for all possible values of the exposure (B-cell subpopulations) in predicting the outcome.

RESULTS: Patients who achieved CDAI remission at 24 weeks had higher proportions of transitional (p < 0.01) and CD21^– PD-1⁺ (p < 0.01) B cells at diagnosis compared to those who did not. When the two B-cell populations were combined, the sensitivity and specificity for remission, including all treatment arms, were 59% and 86%, respectively. Stratification of the patients by treatment arm revealed a significant negative correlation between the proportion of transitional B cells at baseline and disease activity after 24 weeks of treatment with either MTX and prednisolone or anti-IL-6R.

CONCLUSIONS: Our results indicate that transitional and CD21^– PD-1⁺ B cells are associated with remission in early RA.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:40259340 | DOI:10.1186/s41927-025-00487-x

BMC Health Serv Res. 2025 Apr 21;25(1):571. doi: 10.1186/s12913-025-12753-2.

ABSTRACT

BACKGROUND: Sickle cell disease (SCD) is a chronic hematologic disease associated with increased morbidity and mortality. The study aims to investigate the suggested socio-economic and clinical factors and their contribution to the frequency of pain episodes among sickle cell patients in Uganda.

METHOD: We used pre-existing secondary data from sickle cell clinic records at Mulago referral hospital collected in 2019, with a sample of 2532 sickle cell patients. In support of the outcome being count data, the Negative Binomial Regression model was utilized to estimate how the independent factors affected the frequency of pain episodes among the patients.

RESULTS: The frequency of pain episodes was different among age groups as age group (16/24) experienced the highest number of pain episodes on average (Incidence Rate Ratio = 1.39; 95% CI = 1.277-1.522; p = 0.000) compared to young children because as individuals age, pain management declines, and repeated episodes can lead to increased sensitivity, making them more prone to pain. While increased temperature (°C) (fever) increased the frequency of pain episodes by 24% (Incidence Rate Ratio = 1.243; 95% CI = 1.147-1.348; p = 0.000), infection by 27% (Incidence Rate Ratio = 1.27; 95% CI = 1.191-1.354; p < 0.000), other chronic diseases by 11% (Incidence Rate Ratio = 1.11; 95% CI = 1.038-1.188; p < 0.002), malaria by 38% (Incidence Rate Ratio = 1.38; 95% CI = 1.036-1.836; p < 0.027). The rate of hydroxyurea usage was very high at 90%. The intake of the drug reduced the frequency of pain episodes by 34% (Incidence Rate Ratio = 0.662; 95% CI = 0.584-0.750; p < 0.000). According to the observations, there is a high chance that hydroxyurea also had a strong protective against malaria in SCD patients. Nevertheless, there was no evidence that being a male or female would influence the frequency of pain episodes among sickle cell patients.

CONCLUSIONS: These findings are expected to add to the body of knowledge in the health sector, assist in advocacy programs, inform policy, and aid in tailored interventions.

PMID:40259337 | DOI:10.1186/s12913-025-12753-2

Eur J Public Health. 2025 Apr 21:ckaf043. doi: 10.1093/eurpub/ckaf043. Online ahead of print.

ABSTRACT

Improving the quality of the most basic health behavior among youth may contribute to short-term body composition management with long-term implications for noncommunicable disease regression. This investigation aimed to assess the impact of primary school physical activity (PA), dietary, or dual approach interventions on pupils’ body weight (BW) and body mass index (BMI). A systematic review and meta-analysis was completed following a study protocol and a trial registration (PROSPERO: CRD4202347770) with the PRISMA approach. Publications in English or German were included with school-based randomized controlled trials on diet and/or PA. Pupils of primary schools (aged 5-10) with no major nutritional deficiency or unstable health condition were included. The Boolean search strategy revealed a total of 9479 articles, qualifying 39 studies with 20 462 pupils (including 10 211 girls and 10 251 boys) for quantitative synthesis. The interventions were mostly PA (n = 31), several were dietary (n = 6), and some were dual approach (n = 5). Random effects meta-analyses revealed PA intervention (n = 20) to have an effect size of +0.07 kg (95% CI: -0.01 to 0.15) and -0.12 kg/m2 (95% CI: -0.23 to -0.01). Low statistical heterogeneity was found for BW (I2 = 0%; P = 1.000) and BMI (I2 = 0%; P = .9688), respectively. The findings indicate a scarcity of top-quality scientific research performed on healthy diet for body weight management in primary schools. PA intervention for elementary school pupils provides support for a healthier body composition profile amidst the current world health crisis.

PMID:40258297 | DOI:10.1093/eurpub/ckaf043

Retina. 2025 Apr 16. doi: 10.1097/IAE.0000000000004488. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the efficacy of autologous retinal graft (ARG) surgery using a novel technique of Viscoat as a graft adherent and stabilizer for large, refractory macular holes (MHs) without postoperative face-down positioning.

METHODS: This retrospective interventional case series included 13 patients with refractory MHs who underwent ARG surgery. The surgical technique involved retinal graft placement stabilized with Viscoat, without postoperative positioning. Preoperative, 6 months and 12 months postoperative outcomes, including MH closure rates and visual acuity (VA) were analyzed.

RESULTS: Pre-op mean MH size was 821.69 ± 180.65 µm (range: 563-1200 µm). Anatomical closure was achieved in 76.9% (10/13) of cases. Median VA improved from 1.7 logMAR (20/1000) preoperatively to 1.3 logMAR (20/400) at 6 months and at 12 months postoperatively, although this change was not statistically significant (p = 0.106 and p = 0.311 respectively). No major complications were reported. Larger MH size and chronicity might limit functional improvement despite successful closure.

CONCLUSION: This is the first study to demonstrate that ARG surgery with Viscoat can achieve high closure rates without postoperative head positioning. The technique offers a patient-friendly alternative for refractory MH management, reducing postoperative burden while maintaining promising anatomical outcomes. Further studies with larger cohorts are warranted to validate these findings.

PMID:40258292 | DOI:10.1097/IAE.0000000000004488

Retin Cases Brief Rep. 2025 Apr 16. doi: 10.1097/ICB.0000000000001765. Online ahead of print.

ABSTRACT

PURPOSE: Evaluate the safety and efficacy of membrane rich in growth factors (mPRGF) and its effects on retinal vasculature and anatomy in refractory and poor-prognosis macular holes.

METHODS: Retrospective, interventional, longitudinal, case series and single-center study conducted at Dr. Elías Santana Hospital, Dominican Republic. Patients with macular hole larger than 400 microns, refractory or with poor prognosis were treated with posterior pars plana vitrectomy (PPV) plus adjuvant therapy mPRGF. A total of seven eyes were included: refractory MH (n=6) and traumatic MH (n=1). The anatomical closure was evaluated by optical coherence tomography (OCT) and foveal avascular zone (FAZ), and foveal density (FD) was measured with optical coherence tomography angiography (OCT-A) pre- and post-surgery. Also, the corrected visual acuity (CVA) was compared pre- and post-intervention.

RESULTS: A total of seven eyes were intervened with a surgical-anatomic closure rate was 85.7%. The average CVA resulted in an improvement of over six lines in Snellen notation which was statistically significant (p=0.036). FAZ and FD showed a decrease (p=0.002) and increase (p=0.043), respectively after surgery.

CONCLUSIONS: In conclusion, this clinical research provides compelling evidence supporting the efficacy and safety of mPRGF in achieving the anatomical closure of refractory or traumatic macular holes larger than 400 microns. Notably, mPRGF treatment demonstrated significant improvements in patients’ visual acuity and contributed to the restoration of normal retinal vasculature. These exciting results pave the way for the potential utilization of mPRGF as a reproducible and cost-effective adjuvant therapy in the surgical management of macular holes.

PMID:40258274 | DOI:10.1097/ICB.0000000000001765

J Med Internet Res. 2025 Apr 21;27:e60681. doi: 10.2196/60681.

ABSTRACT

BACKGROUND: Identifying patients with inherited colorectal cancer (CRC) syndromes offers many potential benefits. However, individuals often experience decisional conflict regarding genetic testing for CRC, and the uptake rate remains low. Given the growing popularity of genetic testing and the increasing demands on genetic service providers, strategies are needed to promote informed decision-making, increase genetic testing uptake among at-risk individuals, and ensure the rational use of genetic service resources.

OBJECTIVE: This study aims to determine whether a decision aid (DA) tool could promote informed decision-making among family members regarding the genetic testing of a patient with CRC.

METHODS: A single-center, parallel-group, randomized controlled trial was conducted. We randomized 82 family members of patients with CRC, who were involved in major medical decision-making for the patient, to either a DA intervention or usual care. The primary outcome was informed decision-making, assessed through measures of knowledge, decisional conflict, decision self-efficacy, and preparation for decision-making. Secondary outcomes included patients’ uptake of genetic counseling and testing, participants’ CRC screening behavior, healthy lifestyle scores, anxiety and depression levels, quality of life, and satisfaction with the intervention. Data were collected at baseline (T0), after the intervention (T1), and 3 months after the baseline survey (T2). The DA intervention and outcome assessments at T1 and T2 were delivered via WeChat. The effects of the intervention were analyzed using generalized estimating equation models.

RESULTS: Statistically significant improvements were observed in knowledge (T1: β=2.049, P<.001; T2: β=3.317, P<.001), decisional conflict (T1: β=-11.660, P<.001; T2: β=-17.587, P<.001), and decision self-efficacy (T1: β=15.353, P<.001; T2: β=22.337, P<.001) in the DA group compared with the usual care group at both T1 and T2. Additionally, the DA group showed significantly greater improvement in processed and red meat intake (β=-1.494, P<.001) at T1 and in healthy lifestyle scores (β=1.073, P=.03) at T2. No differences were found between the groups for other outcomes.

CONCLUSIONS: A DA tool may be a safe, effective, and resource-efficient approach to facilitate informed decision-making about genetic testing. However, the current DA tool requires optimization and further evaluation-for example, by leveraging more advanced technology than WeChat to develop a simpler and more intelligent DA system.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100048051; https://www.chictr.org.cn/showproj.html?proj=129054.

PMID:40258273 | DOI:10.2196/60681

J Med Internet Res. 2025 Apr 21;27:e71684. doi: 10.2196/71684.

ABSTRACT

BACKGROUND: Breast cancer is one of the most prevalent cancers among women and significantly impacts psychological well-being and health-related quality of life (HR-QoL) during the perioperative period. Mobile health interventions offer a promising approach to providing education and psychosocial support, yet their effectiveness in this context remains underexplored.

OBJECTIVE: This study aimed to develop and evaluate the effectiveness of an innovative, mobile-based, perioperative care program for women undergoing breast cancer surgery (iCareBreast). The assessment focused on perioperative self-efficacy, anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction.

METHODS: A two-group randomized control trial was conducted at a tertiary hospital in Singapore. The intervention group used the iCareBreast app, offering four main resources: perioperative care guidance, breast cancer and surgery education, psychological support, and social support. The control group received standard hospital care. Participants in the intervention group engaged with the fully automated app daily for 29 days (two weeks before surgery, on the day of surgery, and two weeks after surgery). Data were collected face-to-face or on the web at three time points: baseline, immediately after the intervention (T1; two weeks after surgery), and at a 2.5-month follow-up (T2; three months after surgery). The primary outcome was perioperative care self-efficacy, while secondary outcomes included anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction.

RESULTS: A total of 123 patients with early-stage breast cancer scheduled for breast surgery were enrolled in the study, with 62 patients assigned to the iCareBreast group and 61 patients to the control group. The results showed no significant differences between the groups in the primary outcome-perioperative self-efficacy-at any time point. Baseline scores were similar (P=.80), and while the iCareBreast group showed slightly lower scores at T1 (mean difference [MD] -1.63, 95% CI -3.43 to 0.18; P=.08) and T2 (MD -1.90, 95% CI -4.06 to 0.26; P=.09), the differences were not statistically significant. Similarly, secondary outcomes, including anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction, showed no significant changes between groups (all P>.05). However, the iCareBreast group reported higher perioperative care satisfaction during the postintervention assessment. Satisfaction scores were comparable at T1 (P=.68), while at T2, the iCareBreast group showed a slight increase compared to the control group (MD 0.35, 95% CI 0.04-0.73; P=.08), though the difference was not statistically significant.

CONCLUSIONS: The mobile-based psychosocial intervention, although satisfied by users, did not demonstrate significant benefits compared to standard care. This highlights the need to refine the iCareBreast app in future iterations to enhance its effectiveness in addressing the targeted health outcomes. Future mobile health research should prioritize optimizing user engagement strategies and incorporating personalized approaches to better address the perioperative care needs of patients with breast cancer.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04172350; https://clinicaltrials.gov/study/NCT04172350.

PMID:40258266 | DOI:10.2196/71684

JMIR Res Protoc. 2025 Apr 21;14:e59511. doi: 10.2196/59511.

ABSTRACT

BACKGROUND: The evolving global health landscape highlights the importance of travel medicine, making it necessary for health care professionals to understand the epidemiologic profiles among varied traveler populations and keep themselves updated in this rapidly changing field. However, in Italy, travel medicine clinics have significant gaps in resource allocation, staff training, and infrastructure.

OBJECTIVE: This protocol of a cross-sectional study aims to create and validate a questionnaire to assess the knowledge, attitudes, and practices of health care professionals in travel medicine in Italy. The final goal is to provide a tool to evaluate the state of travel medicine, guide training initiatives, and be able to monitor trends over time.

METHODS: The study population consists of health care professionals who practice travel medicine in Italy. The questionnaire will be developed by adapting an existing English survey and conducting a scoping review to align the questionnaire with contemporary scientific discourse. The validation process includes face validity, content validity, and expert evaluation. The sample size, determined through power analysis, ranges from 218 to 278 participants. The questionnaire will undergo a pilot test on a smaller sample size (10% of the total) to identify and address any issues. Statistical analysis will include central tendency and dispersion measures, categorical summaries, group comparisons, and regressions. This research received ethical approval, and informed consent will be obtained from all participants.

RESULTS: As of July 2024, we completed the questionnaire validation involving 9 experts. The validated version of the questionnaire includes 86 items. Furthermore, we conducted a pilot test on 53 individuals during the SIMVIM (Italian Society of Travel Medicine and Migrations) course on travel medicine held in Lucca, Italy, on June 14, 2024.

CONCLUSIONS: This cross-sectional study will guide strategic planning and targeting training and awareness activities in areas deemed most critical or lacking. The study’s structured approach and periodic assessments will facilitate the identification of educational gaps, the dissemination of best practices, and the overall improvement of health care services for travelers in Italy.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59511.

PMID:40258265 | DOI:10.2196/59511

Gen Dent. 2025 May-Jun;73(3):73-77.

ABSTRACT

The use of mouthwash is a practical approach to decreasing bacteria during orthodontic treatment. This study aimed to investigate the antibacterial effect of 0.2% curcumin mouthwash on Streptococcus mutans in individuals undergoing fixed orthodontic treatment. For this double-blinded clinical study, 22 orthodontic patients aged 15 years or older with no systemic or periodontal diseases were selected and randomly divided into 2 groups of 11 individuals. One group received 0.2% curcumin mouthwash (intervention), while the other group received 0.2% chlorhexidine mouthwash (control) to use twice daily. Orthodontic elastics were collected from the patients’ mouth immediately before the first use of the mouthwash, immediately after the first use, and after 20 days of mouthwash use. The elastics were stored in normal saline, and the samples were transferred to a microbiology laboratory for serial dilution, plating, and incubation. After 48 hours, the number of colony-forming units (CFUs) of S mutans were counted and compared. The Friedman and Wilcoxon tests were used for statistical analysis of intragroup data, while the Mann-Whitney U test was used for intergroup comparisons. A difference of P < 0.05 was considered statistically significant. Both the curcumin and chlorhexidine groups demonstrated a statistically significant decrease in CFUs of S mutans immediately after the initial use as well as after 20 days’ use (P < 0.05). After the first use, there was no statistically significant difference between the groups in the reduction of CFUs (P = 0.071). However, after 20 consecutive days of mouthwash use, the curcumin group had a significantly greater decrease in CFUs of S mutans than the chlorhexidine group (P < 0.001). Both chlorhexidine and curcumin mouthwashes significantly reduced the number of S mutans colonies when used regularly. The results of the present study suggest that curcumin herbal mouthwash is a superior choice to chlorhexidine for orthodontic patients due to its long-term antibacterial properties.

PMID:40258261