Category: Statistics

JTCVS Open. 2025 May 22;26:234-241. doi: 10.1016/j.xjon.2025.05.005. eCollection 2025 Aug.

ABSTRACT

OBJECTIVE: To evaluate whether results of the JCOG0802/WJOG4607L trial, which demonstrated the superiority of segmentectomy over lobectomy in terms of overall survival for patients with peripheral small-sized lung cancer, are applicable to clinical practice.

METHODS: In this single-center retrospective analysis, we categorized patients who underwent lobectomy or segmentectomy during the enrollment period of the JCOG0802/WJOG4607L trial into 3 groups: patients enrolled in the trial (Cohort A), patients who were eligible but not enrolled (Cohort B), and ineligible patients (Cohort C). We assessed whether trial participants reflected typical patients seen in clinical practice (representativeness) and whether trial results could be applied in routine practice (generalizability) by comparing patient characteristics and survival between cohorts, using Cohort A as the reference.

RESULTS: Cohorts A, B, and C included 91, 163, and 81 patients, respectively. Overall survival at 5 years was 91.2% (95% confidence interval [CI], 83.1%-95.5%), 93.9% (95% CI, 88.5%-96.8%), and 87.7% (95% CI, 77.7%-93.4%), respectively, with no significant different among the 3 cohorts (P = .269). Hazard ratios for segmentectomy over lobectomy were 0.125 (95% CI, 0.015-0.987) in Cohort A, 0.281 (95% CI, 0.036-2.147) in Cohort B, and 1.806 (95% CI, 0.573-5.690) in Cohort C, indicating that the results observed in Cohort A were not replicated in Cohort B.

CONCLUSIONS: In this single-center retrospective study, segmentectomy was associated with numerically improved overall survival rates than lobectomy in JCOG0802-eligible patients not enrolled in the trial, although the difference was not statistically significant. Given the study’s retrospective nature and underpowered statistics with a small sample size, these findings should be interpreted cautiously.

PMID:40923055 | PMC:PMC12414405 | DOI:10.1016/j.xjon.2025.05.005

Trauma Surg Acute Care Open. 2025 Sep 5;10(Suppl 5):e001592. doi: 10.1136/tsaco-2024-001592. eCollection 2025.

ABSTRACT

INTRODUCTION: Developing and implementing trauma clinical guidance is integral to providing quality care to all trauma patients while maintaining a minimum standard of treatment. A mixed-methods novel consensus-building approach was used to identify the current barriers to developing and implementing trauma clinical guidance and highlight the priority areas for change to better support end users.

METHODS: As part of year 1 of the Design for Implementation: The Future of Trauma Clinical Guidance and Research Conference Series, preconference participant surveys and hybrid, professionally facilitated, structured dialogue were used to define the ideal future state of trauma clinical guidance development and dissemination. Novel to this context, in-person and virtual “user stories”, a form of structured focus group, were generated, and a “minimum viable product” (MVP), a form of brokered dialogue, was developed. Descriptive statistics and thematic analysis were used to evaluate preconference survey and “user story” results.

RESULTS: 72 in-person and up to 35 virtual attendees participated. The majority (92%) of in-person attendees and nearly half (48%) of virtual attendees completed the preconference survey. Participants identified barriers along the continuum of clinical guidance development, dissemination, and adoption. Areas for improvement centered around the creation, storage, and use of guidance. Across the survey and user stories, participants expressed the need for clinical guidance that is comprehensive, evidence-based, coordinated, and easily accessible by all clinicians both domestically and abroad. The MVP targeted the risks and objectives to improved guidance. A prominent theme throughout this consensus-building assessment was the imperative for collaboration between professional societies for clinical guidance development and dissemination.

DISCUSSION: Trauma clinical guidance must be current, consolidated, and coordinated with patient-centered outcomes prioritized. Next steps include turning the MVP produced into a prototype and refining it to inform a national redesign of trauma clinical guidance.

LEVEL OF EVIDENCE: Level III.

PMID:40923036 | PMC:PMC12414228 | DOI:10.1136/tsaco-2024-001592

Drug Des Devel Ther. 2025 Sep 3;19:7707-7718. doi: 10.2147/DDDT.S529526. eCollection 2025.

ABSTRACT

BACKGROUND: The dopamine D2/D3 antagonist amisulpride has demonstrated its superiority and efficacy in prophylaxis of postoperative nausea and vomiting (PONV). Given the branded intravenous amisulpride (Barhemsys^®) has not been approved in China, there is unmet clinical need for amisulpride. Our primary objective was to ascertain the efficacy and safety of the generic intravenous amisulpride (QLG2069) in the prophylaxis of PONV.

METHODS: In this phase III, multicenter, randomized, double-blind, placebo-controlled study, 551 adult Chinese patients (with ≥2 Apfel risk factors for PONV) undergoing elective laparoscopic gynecological or abdominal surgery were randomly allocated in a 1:1 ratio to receive either generic intravenous amisulpride or placebo. The primary endpoint was the complete response (CR) rate, defined as the proportion of patients demonstrating neither emetic episodes (vomiting/retching) nor requiring rescue antiemetics throughout the 24-hour postoperative window.

RESULTS: Totally, 542 patients (amisulpride group: n=275; placebo group: n=267) were included in the full analysis set. Amisulpride demonstrated significantly higher CR rate compared to placebo (53.82% vs 40.07%; P=0.0011) within 24-h postoperative period. Patients treated with intravenous amisulpride exhibited significantly lower incidence of moderate-to-severe nausea (28.36% vs 37.08%; P=0.0266) and emesis (44.73% vs 57.30%; P=0.0030) compared to the incidence in the placebo group. The proportion of patients without nausea was numerically higher (45.09%) in the amisulpride group compared to that in the placebo group (37.45%), although the difference did not reach statistical significance (P=0.0685). No significant difference in the proportions of patients receiving rescue medication was noticed between the two groups (21.09% vs 28.09%; P=0.0569). The incidence of adverse events were comparable in two groups.

CONCLUSION: The generic intravenous amisulpride was safe and effective in prophylaxis of PONV in Chinese patients with moderate-to-high risk of PONV to were undergoing laparoscopic gynecological or abdominal surgery.

PMID:40923005 | PMC:PMC12414449 | DOI:10.2147/DDDT.S529526

Stat Med. 2025 Sep;44(20-22):e70255. doi: 10.1002/sim.70255.

ABSTRACT

This article addresses the problem of determining whether the dose response relationships between subgroups and the full population in a multiregional trial are similar. Similarity is assessed in terms of the maximal deviation between the dose response curves. We consider a parametric framework and develop two powerful bootstrap tests: one for assessing the similarity between the dose response curves of a single subgroup and that of the full population, and another for comparing the dose response curves of multiple subgroups with that of the full population. We prove the validity of these tests, investigate their finite sample properties through a simulation study and illustrate the methodology with a case study.

PMID:40922064 | DOI:10.1002/sim.70255

Matern Child Nutr. 2025 Sep 8:e70105. doi: 10.1111/mcn.70105. Online ahead of print.

ABSTRACT

Despite economic growth and poverty reduction, child undernutrition is still widespread in Bangladesh. This study aimed to evaluate both the burden and correlates of undernutrition among children under five in Bangladesh using the Composite Index of Anthropometric Failure (CIAF). Data were obtained from the 2019 Multiple Indicator Cluster Survey (MICS), comprising a weighted sample of 21,885 children collected through a nationally representative cross-sectional survey between January and June 2019. The study applied a two-stage stratified cluster sampling technique. To determine the factors influencing CIAF, a generalized linear mixed model (GLMM) was employed, accounting for clustering effects. The adjusted odds ratio (AOR) was derived, accompanied by its corresponding 95% CI, and a significance threshold of p < 0.05 was used to identify significant predictors of CIAF. The study revealed an overall CIAF prevalence of 37.2% (95% CI: 36.6%-37.9%). The prevalence of combined stunting and underweight was 11.9%, wasting and underweight 4.2%, and concurrent stunting, wasting and underweight 3.3%. Children aged 24-59 months, multiple births, birth size smaller than average, children of mothers with below primary education (AOR: 2.02; 95% CI: 1.59-2.57), received no ANC visits (AOR: 1.23; 95% CI: 1.04-1.46), children delivered at home, and children from lower socio-economic families had significantly higher odds of undernutrition compared with other counterparts (AOR: 1.70; 95% CI: 1.37-2.11). In Bangladesh, more than one-third of under-five children suffer from undernutrition, hindering the potential of millions. Urgent policy action is needed to address undernutrition, particularly among socio-economically disadvantaged children and those in the Sylhet division. Strengthening nutritional programs, maternal education, financial stability and healthcare access is crucial. The study recommends adopting CIAF as a national indicator to measure child undernutrition and guide comprehensive strategies to achieve the Sustainable Development Goals.

PMID:40922060 | DOI:10.1111/mcn.70105

Influenza Other Respir Viruses. 2025 Sep;19(9):e70152. doi: 10.1111/irv.70152.

ABSTRACT

BACKGROUND: Few studies have evaluated COVID-19 vaccine effectiveness (VE) in middle-income countries, particularly in eastern Europe. We aimed to estimate COVID-19 VE against SARS-CoV-2-confirmed hospitalizations and severe outcomes in Kosovo.

METHODS: We conducted a test-negative case-control study using data from Kosovo’s severe acute respiratory infection (SARI) sentinel surveillance system from January 2022 to June 2024. We enrolled adult patients aged ≥ 18 years hospitalized with SARI. From all patients, we collected clinical data, vaccination history, and a nasopharyngeal specimen, which was tested for SARS-CoV-2 using RT-PCR. SARS-CoV-2-positive patients were cases; those testing negative were controls. We estimated VE overall and against severe outcomes (requiring oxygen, intensive care admission, or in-hospital death) using logistic regression, adjusting for age, sex, and comorbidities, calculating VE as (1-adjusted odds ratio) × 100.

RESULTS: We included 564 SARI patients; 218 (39%) tested positive for SARS-CoV-2. Overall, 24% of SARI patients had received at least one COVID-19 vaccine dose in the previous 12 months. VE against SARS-CoV-2-confirmed SARI hospitalization among all adults was 72% (95% CI: 30%-89%) at 14-179-day postvaccination, and 26% (95% CI: -33%-59%) at 180-364 days. In adults ≥ 60 years, VE was 52% (95% CI:-31%-82%) at 14-179-day postvaccination, and -36% (95% CI: -190%-36%) at 180-364 days. VE against severe outcomes was 67% (95% CI: -14%-91%) at 14-179 days, and 17% (95% CI:-111%-67%) at 180-364 days.

CONCLUSIONS: Our findings suggest that COVID-19 vaccination in Kosovo offered substantial protection against hospitalization and severe outcomes within 6 months, though confidence intervals were wide for some subgroups. Effectiveness waned after 6 months, highlighting the need for periodic booster doses.

PMID:40922048 | DOI:10.1111/irv.70152

Int J Health Plann Manage. 2025 Sep 8. doi: 10.1002/hpm.70018. Online ahead of print.

ABSTRACT

BACKGROUND: Since 2017, Japan has been establishing a community-based integrated mental health care system, which includes first-line consultations provided by local authorities (i.e., municipalities). This study aimed to (1) investigate factors related to the challenge municipalities encounter when providing mental health consultations, and (2) identify collaboration patterns between municipalities and public health agencies.

METHODS: Data were obtained from a nationwide municipal survey and publicly available government statistics. Municipal staff difficulty in providing mental health consultations was measured using a four-point scale, and its association with local psychiatric and social care resources and collaboration activities across local institutions was examined by ordinal logistic regression analysis. Latent class analysis was also conducted based on how the municipality collaborated with public health agencies.

RESULTS: Lower difficulty providing mental health consultations was associated with the existence of municipally established public health centres (OR 0.22, 95% CI 0.09 to 0.53, p = 0.001), which minimises the organisational barrier between the two entities, and frequent meetings with local service providers (OR 0.65, 95% CI 0.44 to 0.96, p = 0.032). Variables indicating local psychiatric and social care resources showed no significant associations. Municipalities were classified into four latent classes based on collaboration patterns: Overall frequent (18.1%), Overall infrequent (22.0%), Frequent for individual support (49.1%), and Infrequent for individual support (10.8%).

CONCLUSIONS: The difficulty faced by local authorities in providing mental health consultations may be reduced by fostering collaboration with other institutions, specifically public health agencies, and by hosting frequent meetings with local service providers.

PMID:40922045 | DOI:10.1002/hpm.70018

J Obstet Gynaecol Res. 2025 Sep;51(9):e70068. doi: 10.1111/jog.70068.

ABSTRACT

AIM: This study aimed to compare short- and long-term surgical outcomes between robotic sacrocolpopexy (RSC) and laparoscopic sacrocolpopexy (LSC), performed with concomitant total hysterectomy, in patients with symptomatic pelvic organ prolapse (POP).

METHODS: This retrospective cohort study included 167 women who underwent RSC (n = 113) or LSC (n = 54) with hysterectomy for uterine prolapse at Kawasaki Medical University between March 2020 and December 2024. Perioperative parameters, complications (Clavien-Dindo classification), and POP recurrence were assessed. The POP-Q was used for anatomical evaluation. Long-term outcomes such as recurrence, urinary incontinence, and mesh erosion were monitored over a median follow-up of 30 (RSC) and 52.5 (LSC) months.

RESULTS: The patients in the RSC group were significantly younger and had a higher incidence of diabetes. RSC had longer operative times (median 175 min vs. 152 min; p < 0.01) but comparable blood loss, complication rates, and hospital stay. POP-Q showed greater cervical elevation in the RSC group at one month (p < 0.05). The long-term recurrence rate was low and similar between the groups (RSC, 2.7%; LSC, 3.7%; p = 0.71). Mesh erosion, urinary incontinence, and organ prolapse were rare and did not differ significantly between the groups.

CONCLUSIONS: RSC with concomitant hysterectomy is a safe and effective alternative to LSC with comparable short- and long-term outcomes. Despite longer operative times, RSC offers anatomical benefits without increasing the risk of postoperative complications or recurrence.

PMID:40922044 | DOI:10.1111/jog.70068

Int J Epidemiol. 2025 Aug 18;54(5):dyaf140. doi: 10.1093/ije/dyaf140.

ABSTRACT

BACKGROUND: Coinciding with the SARS-CoV-2 pandemic, malaria cases and malaria-related deaths increased globally between 2020 and 2022. However, evidence linking the pandemic to increased malaria burden remains ambiguous. We assessed the extent to which an observed malaria resurgence in Lambaréné, Gabon, can be associated with pandemic-related disruptions in malaria control programmes.

METHODS: Using observational data from two tertiary referral hospitals, spanning 2018 to early 2023, we applied autoregressive integrated moving average (ARIMA) models in an interrupted time series (ITS) framework to test for changes in trends and levels following the onset of the pandemic. The primary outcome is the monthly malaria diagnosis rate (per 1000 all-cause hospital diagnoses). As a sub-analysis, we focused on monthly maternal malaria incidence.

RESULTS: Following an initial drop (-47.32, P = 0.031), potentially due to risk-averse behaviours, the malaria diagnosis rate gradually and concavely increased (linear term: 7.32, P = 0.001; squared term: -0.19, P = 0.001) to a peak above pre-pandemic levels. Additional analyses suggest that this resurgence was likely driven by disruptions to malaria control activities and a waning efficacy of malaria control tools administered pre-pandemic. Conversely, a resurgence in maternal malaria incidence was not estimated.

CONCLUSION: Findings align with several national and global descriptive reports, but add a more detailed understanding of underlying dynamics, therefore reinforcing the importance of maintaining malaria control in the general population. The absence of a meaningful increase in maternal malaria provides some reassurance that malaria in pregnancy-specific control remained unchanged during the SARS-CoV-2 pandemic. However, observed peaks in post-pandemic maternal malaria incidence should raise concerns given the risks that malaria poses to this group.

PMID:40922028 | DOI:10.1093/ije/dyaf140

Radiat Oncol. 2025 Sep 8;20(1):139. doi: 10.1186/s13014-025-02719-3.

ABSTRACT

BACKGROUND: Stereotactic Body Radiotherapy (SBRT) has been proven to be a safe and effective alternative to surgery in patients with metastatic primary sarcoma. However, data describing tumor response in relation to the given radiotherapy dose is lacking. Therefore, this study aims at analyzing efficacy and dose-response relationship in a retrospective cohort.

METHODS: Patients with metastatic sarcoma treated with ablative SBRT and followed up at the Karolinska University Hospital between 2008 and 2021 were included. SBRT was delivered using an inhomogeneous dose distribution resulting in higher median doses within the planning target volume (PTV) than the dose prescribed. Local control (LC), progression-free survival (PFS), overall survival (OS), adverse events and dose-response relationship were assessed. Statistical analysis was performed to identify variables that correlate to outcome.

RESULTS: Forty-three patients with a total of 83 lesions were treated. The most frequent histology was leiomyosarcoma (44%). The most common site of metastases was the lung (84%), followed by the liver (11%). The median prescription dose was 45 Gy (range 30-56 Gy) delivered in 3 fractions (range 2-8) with a planned median CTV mean dose of 309 Gy in EQD₂ with α/β = 3 Gy. The local control at 1-year, 2-year and 5-year from SBRT treatment was 97, 93 and 84%, respectively. For tumors with a planned mean CTV dose above EQD₂ 278.8 Gy (corresponding to 60.3 Gy in 3 fractions) the 1, 2 and 5-year local control was 100, 100 and 93%, respectively. Tumors planned with a lower dose than EQD₂ 278.8 Gy (α/β = 3 Gy) had a 1, 2 and 5-year local control of 90, 70 and 52%, respectively. The difference in local control between the high dose and low dose groups was statistically significant (p < 0.001). The median OS for all patients was 43 months. When respecting dose constraints, there were only limited number of mild side effects.

CONCLUSION: In this analysis a strongly significant dose-response relationship with excellent LC rates and limited side effects for patients with metastatic lesions of sarcoma were seen. These results could be related to the inhomogeneous dose distribution of SBRT treatments utilized in this study.

PMID:40922018 | DOI:10.1186/s13014-025-02719-3