Tag: statistics

Eur J Med Res. 2025 Sep 2;30(1):834. doi: 10.1186/s40001-025-03007-2.

ABSTRACT

BACKGROUND: The rising incidence of cancer has highlighted the need for effective treatment strategies, particularly for bone tumors like distal femoral tumors. These tumors are among the most prevalent types of bone malignancies, often necessitating extensive surgical intervention to achieve optimal outcomes. Limb-salvage surgery, which involves resecting the tumor and reconstructing the limb with prosthetic devices, has become the standard approach for managing both malignant and aggressive benign tumors of the distal femur. This technique has largely replaced amputation, allowing patients to retain limb function and improve their quality of life. Despite advancements in surgical methods and prosthetic designs, complications such as aseptic loosening, periprosthetic fractures, and infections remain common, frequently requiring revision surgeries. The choice between cemented and uncemented prostheses in these revision procedures is crucial, as it significantly impacts patient outcomes and long-term functional recovery. This study aims to compare clinical outcomes between cemented and uncemented prostheses in distal femoral tumor revision surgeries, addressing existing gaps in the literature and providing guidance for clinical decision-making.

METHODS: This retrospective study analyzed data from 46 patients who underwent revision surgery for distal femoral tumor prostheses at Shanghai Sixth People’s Hospital from 2019 to 2024. Patients were divided into two groups: 22 in the cemented prosthesis group (control) and 24 in the uncemented prosthesis group (experimental). Inclusion criteria required patients to be aged 20-50 years, with confirmed epiphyseal closure and clinical diagnosis of aseptic loosening after distal femoral tumor prosthesis replacement. Patients with severe systemic conditions or infections were excluded to ensure a homogeneous study population. Key parameters evaluated included operation time, intraoperative blood loss, length of hospital stay, and postoperative drainage duration. Functional outcomes were assessed using the Musculoskeletal Tumor Society (MSTS) scoring system and the Karnofsky Performance Status (KPS) scale. Statistical analyses were performed using SPSS software, with significance set at a P value of ≤ 0.05, ensuring robust comparisons of clinical, radiological, and functional outcomes between the two prosthesis types.

RESULTS: The uncemented prosthesis group demonstrated superior clinical outcomes compared to the cemented group. Operation time was significantly shorter (124.75 ± 12.54 min vs. 162.67 ± 19.17 min, P < 0.001), and intraoperative blood loss was markedly lower (412.45 ± 32.12 mL vs. 647.56 ± 37.45 mL, P < 0.001). Postoperative recovery indicators also favored the uncemented group, with shorter hospital stays (16.64 ± 2.67 days vs. 19.78 ± 2.86 days, P = 0.004) and reduced drainage duration (9.85 ± 3.52 days vs. 13.47 ± 3.17 days, P = 0.007). Functional outcomes, measured by MSTS scores, were significantly higher in the uncemented group (70.24 ± 7.35 vs. 56.70 ± 4.98, P < 0.001), and KPS scores showed similar trends (78.32 ± 3.87 vs. 62.45 ± 4.12, P < 0.001).

CONCLUSION: In conclusion, this study demonstrates that uncemented prostheses provide superior clinical outcomes in revision surgeries for distal femoral tumors compared to cemented prostheses. The significant advantages include shorter operation times, reduced intraoperative blood loss, faster recovery, and improved functional outcomes, as indicated by higher MSTS and KPS scores. The biological fixation mechanism of uncemented prostheses promotes osseointegration, enhancing long-term stability and minimizing complications, such as aseptic loosening and infections. Although oncological outcomes, including disease-free survival and overall survival, were comparable between both groups, uncemented prostheses were particularly beneficial for younger patients with adequate bone stock. Despite limitations such as a small sample size and insufficient long-term follow-up, these findings offer valuable insights into the clinical application of uncemented prostheses and underscore the importance of personalized treatment strategies tailored to individual patient needs. Future research should involve larger, multicenter studies to validate these results and further explore the mechanisms behind the observed differences in outcomes.

PMID:40890832 | DOI:10.1186/s40001-025-03007-2

Eur J Med Res. 2025 Sep 2;30(1):832. doi: 10.1186/s40001-025-03112-2.

ABSTRACT

PURPOSE: Aseptic loosening remains a leading cause of revision in medial unicompartmental knee arthroplasty (UKA). This imaging study aimed to identify recurrent patterns of coronal alignment deviation in patients undergoing revision to total knee arthroplasty (TKA) to explore whether subtle malalignment may contribute to biomechanical failure.

METHODS: Imaging of patients who underwent revision surgery of a medial UKA to TKA for aseptic loosening of the tibial or femoral component was retrieved. Lower limb axes were evaluated using anteroposterior plain radiographs of the leg using the software MediCAD Knie 2D (mediCAD Hectec GmbH, Altdorf, Germany). The radiographic axes of revised patients were compared with established reference values, as defined by the MediCAD Knie 2D software and published literature, to identify common alignment patterns potentially associated with aseptic loosening.

RESULTS: Data from 62 patients were analysed. Before the revision surgery, the joint line convergence angle (JLCA, P = 0.002) and the anatomical-mechanical angle (AMA, P < 0.0001) were statistically significantly greater than the corresponding reference values. In contrast, the mechanical lateral distal femoral angle (mLDFA, P < 0.0001), the mechanical and anatomical medial proximal tibial angle (mMPTA and aMPTA, P < 0.0001), and the mechanical and anatomical lateral distal tibial angle (mLDTA and aLDTA, P < 0.0001) were significantly lower than reference. No statistically significant difference was found in the mechanical lateral proximal femoral angle (mLPFA, P = 0.9) or in the mechanical axis deviation (MAD, P = 0.5) when compared to normative data.

CONCLUSION: Our cohort of patients revised from medial UKA to TKA for aseptic loosening frequently exhibited consistent deviations in lower limb alignment, particularly increased AMA and JLCA, and reduced mLDFA, mMPTA, and mLDTA. These subtle but recurrent patterns may alter load distribution across the medial compartment, contributing to implant micromotion and loosening. A detailed preoperative axis assessment may help identify patients at a higher biomechanical risk.

PMID:40890827 | DOI:10.1186/s40001-025-03112-2

BMC Health Serv Res. 2025 Sep 2;25(1):1173. doi: 10.1186/s12913-025-13376-3.

ABSTRACT

INTRODUCTION: Earthquakes are recognized as one of the most dangerous and destructive types of natural disasters. Therefore, decision-making and crisis management are of great importance in these circumstances. The aim of the present study was to investigate the effect of the crisis management training intervention in earthquake simulation conditions in prehospital emergency and incident management center personnel in Chaharmahal Bakhtiari, Iran in 2024.

METHODOLOGY: The present study was a semi-experimental pre-test-post-test type. The statistical population was 64 emergency medical personnel at emergency bases in Iran, who were selected from the study population by simple random method and according to the inclusion criteria and were randomly assigned to two intervention and control groups based on a lottery. The educational-operational intervention program was presented to the intervention group in four two-hour sessions. A crisis management questionnaire was used to collect data. Data were analyzed using SPSS26 software, t-test, and structural equation modeling.

RESULTS: The mean age of the participants was 38.6±1.33. The crisis management score before training the crisis management model in the intervention group was 37.03±3.63 and in the control group was 37.34±4.22; there was no statistically significant difference (p=0.761). The crisis management score after training the crisis management model in the intervention group was 43.45±6.00 and in the control group was 37.91±4.31, which was statistically significant (p<0.001).

CONCLUSION: Considering the positive effect of crisis management training in earthquake simulation conditions on emergency medical personnel at emergency bases, it seems that this method can improve the performance of emergency medical personnel. Therefore, it can be suggested that crisis management training intervention in earthquake incidents with simulated training (maneuver) be used to increase the performance of emergency medical personnel.

PMID:40890815 | DOI:10.1186/s12913-025-13376-3

BMC Med. 2025 Sep 1;23(1):510. doi: 10.1186/s12916-025-04328-z.

ABSTRACT

BACKGROUND: The International Committee of Medical Journal Editors (ICMJE) recommends that trial authors must specify data sharing plans when trials are registered and published, yet this uptake remains unclear. We aimed to assess the practice of data sharing plans in trial registration platforms and the concordance between registered and published data sharing plans.

METHODS: We included clinical trials published between 2021 and 2023 in six high-profile journals (The Lancet, The New England Journal of Medicine, JAMA, BMJ, JAMA Internal Medicine, and Annals of Internal Medicine) that enrolled participants no earlier than 2019 and registered on clinical trial platforms. One study outcome was data sharing plans in the trial registration platform, where trials clearly responding a “yes” to “Plan to share” were considered as planning to share data (including study protocols, statistical analysis plans, analytic codes, and individual participant data). The concordance between registered and published plans to share data was also assessed, which included plans to either share data (Yes/Yes) and not to share data (No/No) in both registration and publications. Univariate analyses were used to assess associations between trial characteristics and registered plans to share data and between trial characteristics and concordance.

RESULTS: Of the 383 included registration IDs, only 44.6% (171/383) planned to share data in registration. Trials with drug versus non-drug interventions had increased odds of registering plans to share data (OR = 2.71, 95% CI: 1.63, 4.63). There were seven trial publications, each pooling two trials and having two registration IDs. We selected the registration IDs with a later start date, resulting in 376 trial publications for concordance assessment. Over half (216/376, 57.4%) had discordance between registration and publications. COVID-19-related trials were associated with decreased odds of data sharing concordance (OR = 0.59, 95% CI: 0.37, 0.91). Additionally, significant discordance was consistently found in statistical analysis plans or study protocols, analytic codes, and individual participant data.

CONCLUSIONS: Most registered trials do not specify plans to share data. More than half of published trials have data sharing discordance between registration and publication. Efforts are required to improve the reporting and reliability of plans to share clinical trial data.

TRIAL REGISTRATION: This study was registered on the Open Science Framework ( https://osf.io/k6etb ).

PMID:40890807 | DOI:10.1186/s12916-025-04328-z

BMC Res Notes. 2025 Sep 1;18(1):377. doi: 10.1186/s13104-025-07428-4.

ABSTRACT

OBJECTIVE: The aim of this study was to determine CD4 cell count and viral load count association and its joint clinical risk factors among adult TB/HIV co-infected patients. The purpose of this research was leads to contribute improved planning and execution of screening programs, regular follow-ups, and prevention measures.

RESULT: The baseline variability for viral load ([Formula: see text]) was higher than CD4 cell (819.797). Furthermore, the correlation matrix (R) shows that the baseline subject-specific CD4 cell and viral load were negatively correlated (- 0.[Formula: see text]). There was also a negative relationship between the subject-specific change CD4 cell and baseline viral load (-[Formula: see text]), subject-specific baseline CD4 cell, and the patient-specific change of viral load (-0.6513), longitudinal trajectory (association of evolution) for the two random slopes [Formula: see text]-0.9413). Then, there was very strong negative relationship between subject-specific change CD4 cell and viral load over time. Visit time[Formula: see text], white blood cell[Formula: see text], good[Formula: see text] and fair[Formula: see text]) adherence, hemoglobin ≥ 11 g/dl[Formula: see text], baseline CD4 cell ≥ 200 cells/mm³[Formula: see text], and baseline viral load < 10,000 copies/mL[Formula: see text]hematocrit[Formula: see text]and monocytes of patients[Formula: see text] were a joint determinates for viral load and CD4 cell, respectively.

PMID:40890806 | DOI:10.1186/s13104-025-07428-4

Trials. 2025 Sep 1;26(1):333. doi: 10.1186/s13063-025-09060-w.

ABSTRACT

BACKGROUND: Hip fractures are common in older people and are associated with high perioperative mortality. Prompt surgical intervention within the first 48 h of fraction reduces complications; however, surgical urgency often precludes a comprehensive preoperative cardiac evaluation. Preliminary data suggests that performing a focused cardiac ultrasound (FCU) before surgery may reduce postoperative complications. We therefore propose to test the primary hypothesis that FCU reduces a 30-day composite of mortality and serious complications.

METHODS: We plan a definitive multicenter pragmatic randomized trial that will enroll 2000 adults with hip fractures. Participants will be randomized before surgery to either receive FCU as part of their preoperative assessment or to routine care without FCU. FCU is a brief, 10-min, goal-directed echocardiography performed at the patient’s bedside. FCU will be conducted by physicians trained in FCU and the information gathered will be shared immediately with all clinicians involved in the patient’s care (anesthesiologists, orthopedic surgeons, geriatricians). The primary outcome will be a 30-day composite of all-cause mortality, hospital readmission, acute kidney injury, cardiac failure, and myocardial injury after noncardiac surgery. Secondary and exploratory outcomes include hospital length of stay, days to return to original residence, postoperative recovery, and quality of life. Additionally, a health cost analysis will be conducted to weigh costs against benefits.

DISCUSSION: Our large RCT aims to determine whether preoperative focused ultrasound examinations of hip fracture patients reduce serious postoperative complications, improves the quality of recovery, improves life quality, and is cost-effective.

TRIAL REGISTRATION: Registration number: ACTRN12622001546741. Date registered 14/12/2022.

PMID:40890796 | DOI:10.1186/s13063-025-09060-w

BMC Health Serv Res. 2025 Sep 1;25(1):1170. doi: 10.1186/s12913-025-13401-5.

ABSTRACT

BACKGROUND: Healthcare staff are among the most vulnerable groups at risk of HIV infection. The present study aims to evaluate the impact of theory of planned behavior (TPB)-based educational intervention on HIV screening among healthcare staff in Firouzabad.

METHODS: This quasi-experimental study was conducted on 160 healthcare staff in Firouzabad, 2024. Participants were selected using multistage sampling method (cluster and random) and randomly assigned to either the intervention or control group (n = 80 per group). The intervention group received TPB-based educational intervention in five in-person sessions, each lasting 60 min. Data were collected using a standardized questionnaire based on TPB, which was completed by both groups before and two months after the intervention. Data were analyzed using SPSS 27.0 through statistical tests, including paired t-test, independent samples t-test, Chi-squared and McNemar test.

RESULTS: After the educational intervention, 72 individuals (90%) from the intervention group and 27 individuals (33.75%) from the control group intended to perform HIV screening. The McNemar test results indicated that this difference was statistically significant (P = 0.001). Furthermore, the results revealed that 64 individuals (80%) from the intervention group and 22 individuals (27.5%) from the control group performed HIV screening two months after the educational intervention, and a statistically significant difference was observed between the two groups (P = 0.001).

CONCLUSION: The current study demonstrated that an educational intervention based on the Theory of Planned Behavior significantly improved the intention of undergoing HIV screening among Firouzabad healthcare professionals, in addition to the actual conduct of screening behaviors. The intervention resulted in statistical significance in terms of changes in attitudes, subjective norms, and perceived behavioral control, all of which together resulted in a noticeable rise in the participants’ screening activity. These results suggest that the Theory of Planned Behavior can be a helpful construct in the creation of focused educational efforts directed at the promotion of essential preventive health behaviors, like HIV screening, among key risk occupational groups. While the results are promising in terms of the population of this study, further investigations are needed in order to determine the long-term durability of the acquired behaviors as well as the broader generalizability of the intervention in different healthcare settings.

PMID:40890789 | DOI:10.1186/s12913-025-13401-5

Trials. 2025 Sep 1;26(1):334. doi: 10.1186/s13063-025-09012-4.

ABSTRACT

BACKGROUND: “Difficult-to-treat” depression – here operationalized as either chronic or treatment-resistant depression – encompasses about one third of all patients with depression. Despite its considerable size, the patient group is understudied, and evidence-based psychotherapeutic treatment options are currently limited. The DEPRE-ST trial therefore seeks to investigate beneficial and harmful effects of schema therapy for difficult-to-treat depression.

METHODS: This is a randomized multicenter parallel-group superiority clinical trial. A total of 129 patients will be randomized to receive either 30 sessions of individual schema therapy or psychotherapy according to Treatment As Usual, along with psychopharmacological treatment. Participants are assessed before randomization and at 6, 12, and 24 months after randomization. The primary outcome is depression symptoms (6-item Hamilton Rating Scale for Depression), assessed at 12 months. Secondary outcomes include health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version), functional impairment (Work and Social Adjustment Scale), psychological wellbeing (WHO-5 Well-being Index), and negative effects of treatment (Negative Effects Questionnaire), alongside a range of patient-relevant exploratory outcomes. Blinding of treatment allocation is ensured for primary outcome assessors, statisticians, and the data safety and monitoring committee. The primary outcome will be analyzed with multilevel linear regression, with conservative multiple imputation for missing data, and presented as the covariate-adjusted difference between treatments’ change scores with its 95% confidence intervals. Further, a health economic analysis will be performed.

DISCUSSION: This statistical analysis plan was developed and submitted before unblinding of data to ensure transparency and diminish bias in selection, analysis, and reporting of results.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05833087. Registered on 15th April 2023. https://clinicaltrials.gov/study/NCT05833087?term=depre-st&checkSpell=false&rank=1.

PMID:40890784 | DOI:10.1186/s13063-025-09012-4

Trials. 2025 Sep 1;26(1):324. doi: 10.1186/s13063-025-09077-1.

ABSTRACT

BACKGROUND: Acute cholangitis (AC) frequently presents as a community-acquired infection and is associated with a high prevalence of antibiotic use among infectious diseases. The Tokyo Guidelines 2018 (TG18) recommend 4-7 days of antibiotic administration after biliary drainage. However, this recommendation lacks strong evidence of its effectiveness and is primarily based on heterogeneous clinical findings and expert opinions. Recent retrospective studies have advocated a shorter 1- to 3-day antibiotic course as effective for AC treatment, prompting the need to reassess the treatment duration to achieve therapeutic efficacy while minimizing resistance and adverse effects.

METHODS: We designed a multicenter, non-blinded, randomized trial to evaluate the efficacy of short-course therapy compared to standard-course therapy for AC management. The short-course therapy group will receive 1-3 days of intravenous (IV) antibiotic treatment after successful biliary drainage compared to 4-7 days of IV antibiotics after successful biliary drainage for the standard-course therapy group. The primary outcome is the clinical cure rate within 14 days from the endoscopic retrograde cholangiopancreatography (ERCP) procedure. Participants will be allocated to either treatment course using a minimization method in a non-blinded, randomized manner, with stratification factors including condition severity and facility. We determined that 210 participants would be required to achieve a statistical power of 90% with a one-sided significance threshold of 2.5% and a non-inferiority limit of 10%.

DISCUSSION: This phase 3 trial aims to determine the non-inferiority of short-course therapy over standard-course therapy. Shortening the duration of antibiotic administration may mitigate the emergence of resistant bacteria, adverse events, and reduce hospital stay length and healthcare costs. https://jrct.niph.go.jp/re/reports/detail/73862 TRIAL REGISTRATION: This study was registered at the Japan Registry of Clinical Trials under registry number jRCT1031230709. Registered on 14 March 2024, https://jrct.niph.go.jp/re/reports/detail/73862.

PMID:40890775 | DOI:10.1186/s13063-025-09077-1

Reprod Biol Endocrinol. 2025 Sep 1;23(1):120. doi: 10.1186/s12958-025-01453-5.

ABSTRACT

BACKGROUND: This retrospective cohort study aimed to evaluate the impact of insulin resistance (IR) on clinical outcomes in polycystic ovary syndrome (PCOS) patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.

METHODS: A total of 1,768 PCOS patients undergoing IVF/ICSI cycles at Shenzhen Zhongshan Obstetrics & Gynecology Hospital between October 2010 and November 2024 were stratified into two cohorts: non-IR group (HOMA index < 2.69, n = 867) and IR group (HOMA index ≥ 2.69, n = 901). Baseline characteristics and clinical outcomes were compared between the groups. Linear logistic regression and multivariate logistic regression analysis were conducted to assess the independent impact of IR on fertilization efficiency and pregnancy outcomes.

RESULTS: Patients with IR exhibited significantly higher BMI (25.44 ± 3.55 vs. 21.59 ± 3.20, p < 0.001), longer infertility duration (3.74 ± 2.75 vs. 3.25 ± 2.43, p < 0.001), increased antral follicle counts (26.74 ± 10.74 vs. 25.05 ± 9.79, p < 0.001) and lower basal follicle-stimulating hormone (FSH) level (9.78 ± 3.25 vs. 10.64 ± 3.83, p < 0.001) compared to those without IR. Additionally, the fertilization rate (82.02% vs. 83.86%, p = 0.005) and 2PN rate (81.07% vs. 83.96%, p < 0.001) were significantly lower in PCOS patients with IR. Linear regression indicated that IR had a more pronounced inverse effect on 2PN rate (B: -2.540, p = 0.009) than on fertilization rate (B: -0.664, p = 0.490). Subgroup analysis and interaction analysis demonstrated that IR functioned as an independent risk factor for impaired oocyte fertilization in normal-weight PCOS patients (B: -22.694, p = 0.011). No statistically significant associations between IR status and clinical or live birth pregnancy outcomes were observed in the regression models.

CONCLUSIONS: IR adversely affects oocyte fertilization competence and early embryonic development in normal-weight PCOS patients undergoing assisted reproductive technology (ART). These effects may be attributable to IR-induced metabolic dysregulation, which compromises folliculogenic and cytoplasmic maturation processes critical to gamete competence. These findings underscore the importance of addressing metabolic dysfunction in IR-affected PCOS populations to optimize ART outcomes.

TRIAL REGISTRATION: This is a retrospective study.

PMID:40890764 | DOI:10.1186/s12958-025-01453-5