Tag: statistics

PLoS One. 2025 May 15;20(5):e0323557. doi: 10.1371/journal.pone.0323557. eCollection 2025.

ABSTRACT

Fencing has gained global popularity, with athletes often competing on hard surfaces, especially at United States national tournaments in convention centre with concrete floors. These surfaces may contribute to overuse injuries from high-impact movements like the fencing lunge. This study aimed to investigate tibial accelerations, a measure of impact shock, experienced by fencers during lunges on various surface materials placed beneath standard aluminium fencing pistes. The aim was to identify a material that could reduce injury risk by mitigating impact shock. Sixty-nine fencers (35 female) performed five lunges on six different surfaces (A-F: A-E composed of various materials placed between the aluminium piste and the concrete floor; F was only the concrete floor), during the 2024 US Senior National Championships. A triaxial accelerometer mounted on the tibia was used to measure tibial accelerations as a marker of impact shock. The accelerometer was aligned to measure acceleration along the longitudinal axis of the tibia and set to record at 1000 Hz with a sensitivity range of ± 100 g. Data acquisition was carried out via a logging system (Biometrics DL1001, Gwent, UK), which was attached to the participant using a tightly fitted backpack. The peak positive axial tibial acceleration was extracted for each lunge and the average was calculated from three lunges after discarding the highest and lowest values from each surface. Statistical analysis revealed that Surface E (a non-absorbent vinyl loop material; 12.7 ± 7.6g), significantly reduced tibial accelerations compared to the standard concrete setup (Surface F; 13.6 ± 8.4g). These findings suggest that modifying competition surfaces by incorporating cushioning materials may help reduce the impact shock of the fencing lunge, potentially lowering the risk of overuse injuries, such as tendonitis and tenosynovitis, commonly reported by fencers. Future research should investigate optimal material properties, including thickness and softness, for maximizing injury prevention while maintaining performance standards in competitive fencing environments.

PMID:40373100 | DOI:10.1371/journal.pone.0323557

PLoS One. 2025 May 15;20(5):e0322852. doi: 10.1371/journal.pone.0322852. eCollection 2025.

ABSTRACT

The Thai version of the 12-item Zarit Burden Interview (ZBI) is valid for measuring caregiver burden in psychiatric caregivers. Nevertheless, it has not been verified in a larger palliative care (PC) context. The aim of this study was to validate the 12-item ZBI in PC among caregivers of palliative care patients. A methodological study examining the validity of the 12-item ZBI was carried out with informal caregivers of palliative care patients of two district health service networks. The data were gathered using self-administered questionaries, and then all participants were randomly split into two sub-samples for exploratory factor analysis (EFA) (n = 150) and confirmatory factor analysis (CFA) (n = 155). After utilizing statistical approaches for reducing items, EFA was used with group 1 to analyze the factor structure of the 12-item ZBI. Finally, CFA was employed with group 2 to confirm the amended structure indicated by the EFA and to evaluate the construct validity of the 12-item ZBI. A total of 305 palliative caregivers were enrolled. The principal component analysis of the 12 items yielded a loading based on a two-factor model of personal strain and role strain accounting for 61.4% of the variance. Cronbach’s alpha (0.83) and item-total correlations (rho = 0.38-0.70) showed that the 12-item Zarit had acceptable reliability. For convergent validity, the average variance extracted (AVE) values revealed that all 12-item ZBI subscales had a convergence effect, with AVEs ranging from 0.50-0.53. Additionally, this tool had a significant positive correlation with depressive symptoms (r = 0.48), anxiety (r = 0.38), and stress (r = 0.56). The 12-item ZBI is a brief, precise, and valid instrument for assessing burden among Thai palliative caregivers. We discovered high evidence of reliability in this sample, along with convergent and construct validity. Likewise, EFA revealed that the 12-item ZBI was a two-dimensional scale. Thus, health care practitioners may utilize the ZBI in research and clinical settings to determine burden in palliative caregivers.

PMID:40373099 | DOI:10.1371/journal.pone.0322852

PLoS One. 2025 May 15;20(5):e0323486. doi: 10.1371/journal.pone.0323486. eCollection 2025.

ABSTRACT

INTRODUCTION: Urban vegetable farmers in Ghana face multiple health risks, including soil-transmitted helminths (STHs), which may contribute to morbidities that threaten urban food security. Additionally, infected farmers may act as persistent sources of disease transmission within urban populations. There is the need to assess the burden of STH among these farmers using more sensitive molecular assays.

METHODS: This was a cross-sectional study involving 168 urban farmers from Accra and Tamale in Ghana’s Greater Accra and Northern regions, respectively. Participants completed semi-structured questionnaires, and stool samples were collected for analysis. A qualitative Polymerase Chain Reaction (QPCR) assay was employed to detect STH prevalence, targeting the ITS1, ITS2, and 18S genes of Ascaris lumbricoides, Ancylostoma duodenale and Strongyloides stercoralis, respectively.

RESULTS: While no positives were found in Tamale, 5.1%, 2.5%, and 0.8% of participants in Accra tested positive for A. lumbricoides, A. duodenale and S. stercoralis, respectively. Inadequate use of Personal Protective Equipment (PPEs) and STH infection status were strongly correlated among risk factors (Odds ratio; 4.3, 95% Cl: 1.03-18.00, p-value = 0.04). Overall, 72% of participants in Tamale wore PPEs, compared to 43% in Accra.

CONCLUSIONS: Even though STH was not common, inadequate PPE use was a major factor in STH transmission in urban vegetable farms. Therefore, the key to drastically lowering the STH burden in urban farms is education and behaviour changes. Using more sensitive molecular diagnostic assays is crucial in low prevalence environments.

PMID:40373097 | DOI:10.1371/journal.pone.0323486

JAMA Netw Open. 2025 May 1;8(5):e259591. doi: 10.1001/jamanetworkopen.2025.9591.

ABSTRACT

IMPORTANCE: There are significant gaps in the research on ethnic disparities in mental health status among adults nationwide in China. Evidence is needed to fill these gaps.

OBJECTIVE: To examine the mental health status by ethnic group in China and to explore the sociodemographic and health-related factors associated with these mental health disparities.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from a multicenter, population-based survey conducted from June to August 2023. Participants were required to be aged 18 years or older and Chinese nationals and permanent residents. After quota sampling based on Chinese population statistics, 30 054 questionnaires were included in final analyses. Data were analyzed from March to April 2024.

EXPOSURES: Ethnicity, categorized as Han or minority group (ie, Achang, Bai, Blang, Bonan, Buyei, Dai, Daur, Deang, Derung, Dong, Dongxiang, Ewenki, Gaoshan, Gelao, Gin, Hani, Hezhen, Hui, Jingpo, Jino, Kazak, Kirgiz, Korean, Lahu, Lhoba, Li, Lisu, Man, Maonan, Miao, Monba, Mongol, Mulao, Naxi, Nu, Oroqen, Pumi, Qiang, Russ, Salar, She, Sui, Tajik, Tatar, Tibetan, Tu, Tujia, Uyghur, Uzbek, Va, Xibe, Yao, Yi, Yugur, and Zhuang), as well as unrecognized ethnic groups in China, ie, populations in the People’s Republic of China that have been assimilated into the Han or other recognized ethnic groups but have not yet been officially identified).

MAIN OUTCOMES AND MEASURES: Depression and anxiety symptoms were assessed using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7-item scale. Any positive (≥1) response to the ninth item of Patient Health Questionnaire-9 was considered as having suicidal ideation.

RESULTS: Among the 30 054 eligible participants (median [IQR] age, 43 [29-54] years; 15 043 [50.1%] female), 27 299 (90.8%) were from the Han ethnic group and 2755 (9.2%) were from ethnic minority groups. Compared with Han participants, participants from ethnic minority groups had significantly higher prevalence of moderate to major depression symptoms (25.5% vs 19.0%; P < .001), moderate to severe anxiety symptoms (17.4% vs 12.3%; P < .001), and suicidal ideation (29.4% vs 20.9%; P < .001). Participants from ethnic minority groups had higher odds of these outcomes even after adjusting for sociodemographic and behavioral factors (moderate to major depression symptoms: adjusted odds ratio [aOR], 1.18; 95% CI, 1.07-1.29; moderate to severe anxiety symptoms: aOR, 1.23; 95% CI, 1.10-1.37; suicidal ideation: aOR, 1.34; 95% CI, 1.22-1.46]). For members of ethnic minority groups, having 2 or more chronic conditions was associated with a higher likelihood of moderate to severe anxiety symptoms (aOR, 1.57; 95% CI, 1.13-2.18) and suicidal ideation (aOR, 1.73; 95% CI, 1.30-2.29).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study in China, significant disparities of mental health were observed between Han and ethnic minority populations. Members of ethnic minority groups were at a significantly higher risk for experiencing moderate to major depression symptoms, moderate to severe anxiety, and suicidal ideation, particularly when exposed to specific risk factors, such as chronic health conditions and social stressors. Targeted public health interventions are needed to address the mental health needs of ethnic minority populations.

PMID:40372758 | DOI:10.1001/jamanetworkopen.2025.9591

JAMA Netw Open. 2025 May 1;8(5):e2510319. doi: 10.1001/jamanetworkopen.2025.10319.

ABSTRACT

IMPORTANCE: Although individual prosociality, defined as voluntary behavior intended to benefit another, is known to promote help-seeking behaviors among adolescents, it remains unclear whether a prosocial community, such as the classroom, also facilitates these behaviors.

OBJECTIVE: To investigate the associations of classroom-level and individual-level prosociality with help-seeking behaviors, considering age and gender, and to examine moderation effects of being bullied.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, annual surveys were conducted via questionnaire among students in Japanese junior and senior high schools from 2020 to 2023. The first wave was administered from October 1 to November 7, 2020, followed by the second wave from June 4 to July 13, 2021, the third wave from June 17 to July 19, 2022, and the fourth wave from June 19 to July 28, 2023.

EXPOSURE: Classroom-level prosociality was defined as the mean prosociality of all students within a classroom, while individual-level prosociality was measured as the deviation from this classroom mean. Prosociality was assessed using the prosocial subscale of the self-reported Strengths and Difficulties Questionnaire.

MAIN OUTCOMES AND MEASURES: Generalized mixed-effects models estimated the associations of classroom-level and individual-level prosociality with help-seeking behaviors (including poor help-seeking and seeking help from friends, family members, homeroom teachers, and physicians) while considering subgroups based on grades and gender, as well as the moderation effect of being bullied. Help-seeking behaviors were evaluated by a question about seeking help for one’s mental health problems (“Are you currently consulting anyone to discuss your psychological stress or mental health problems?”), with multiple options. The robustness of the main findings were tested by models stratified by survey year.

RESULTS: The analysis included 21 845 participants (mean [SD] school grade, 10.4 [1.2]; 16.6% junior high school students and 83.4% senior high school students; 53.3% boys). Classroom-level prosociality was associated with a higher rate of help-seeking from friends among senior high school students (odds ratio [OR], 1.26, 95% CI, 1.17-1.35), which confirmed the robustness. No moderation effect of being bullied was found in this association. Higher individual-level prosociality was associated with increased help-seeking from various sources across nearly all models and subgroups, regardless of being bullied (friends: OR, 1.15 [95% CI, 1.13-1.17]; P < .001; family members: OR, 1.09 [95% CI, 1.07-1.11]; P < .001; homeroom teachers: OR, 1.15 [95% CI, 1.10-1.19]; P < .001; school nurses: OR, 1.19 [95% CI, 1.12-1.28]; P < .001; and physicians: OR, 1.14 [95% CI, 1.07-1.20]; P < .001).

CONCLUSIONS AND RELEVANCE: This cross-sectional study of 21 845 students found that both classroom-level and individual-level prosociality were associated with higher rates of help-seeking from peers among senior high school students, while accounting for individual characteristics. Enhancing classroom prosociality could foster help-seeking behaviors through reciprocal peer support, benefiting even those who experienced bullying.

PMID:40372756 | DOI:10.1001/jamanetworkopen.2025.10319

JAMA Netw Open. 2025 May 1;8(5):e2510325. doi: 10.1001/jamanetworkopen.2025.10325.

ABSTRACT

IMPORTANCE: Patient demographic and socioeconomic characteristics are associated with differential delays in access to emergency care. However, less is known about the association between demographic, socioeconomic, and emergency medical services (EMS) agency factors and ambulance patient offload times (APOT), a critical measure of timely access to emergency care.

OBJECTIVE: To determine the association between ambulance offload times and demographic, socioeconomic, and EMS agency factors, uncover disparities in offload delays, and investigate factors associated with long APOT.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted using offload data from the California EMS Authority and local EMS agencies (LEMSA), population data from the US Census Bureau, and demographic and socioeconomic data from the Centers for Disease Control and Prevention’s Social Vulnerability Index. California local EMS agencies participated from January 1, 2021, to June 30, 2023.

EXPOSURE: A total of 30 community demographic, socioeconomic, and LEMSA factors were assessed.

MAIN OUTCOMES AND MEASURES: The main outcome was weighted mean APOT, calculated from APOT measures obtained from the California Emergency Medical Services Authroity and LEMSAs. The association between APOT and area demographic and socioeconomic characteristics was assessed using linear regression.

RESULTS: In this retrospective study from January 1, 2021, to June 30, 2023, 5 913 399 offloads were observed across 34 California LEMSAs with median (IQR) of 0.3% (0.2%-0.4%) American Indian or Alaska Native residents, 7.1% (4.7%-1.5%) Asian residents, 2.2% (1.6%-4.9%) Black residents, 33.1% (22.5%-48.7%) Hispanic or Latino residents, 0.3% (0.2%-0.4%) Native Hawaiian or Pacific Islander residents, 4.1% (3.1%-4.9%) multiracial, and 0.4% (0.4%-0.5%) residents in the additional race category; 17.2% (14.7%-22.8%) residents living below 150% of the poverty line; and 15.7% (13.5%-20.1%) aged 65 years or older. The weighted mean (SD) APOT across California was 42.8 (27.3) minutes; the median (IQR) across LEMSAs was 27.0 (15.5-48.3) minutes. Sequential unadjusted linear regressions of the 30 characteristics revealed 11 that were significantly associated with APOT. Least absolute shrinkage and selection operator penalization identified Black race, being aged 65 years or older, and total offloads (all log-transformed) as the variables most associated with APOT. A 3.3% absolute increase in Black residents, from 1.6% (25th percentile) to 4.9% (75th percentile), was associated with an unadjusted 17.4-minute (95% CI 10.3-24.5) increase in APOT. This increase remained significant, at 11.75 (95% CI 1.9-21.6) minutes, after adjustments for demographic, socioeconomic, and LEMSA characteristics.

CONCLUSIONS AND RELEVANCE: This cohort study of 5.9 million ambulance offloads found that the proportion of Black residents was the factor most significantly associated with longer APOT. These findings have direct implications for patients, EMS systems, and hospitals, as APOT may be an important component of health disparities in emergency care.

PMID:40372755 | DOI:10.1001/jamanetworkopen.2025.10325

JAMA Netw Open. 2025 May 1;8(5):e2510386. doi: 10.1001/jamanetworkopen.2025.10386.

ABSTRACT

IMPORTANCE: Digital health technologies include patient portals, telehealth, mobile health, and web-based resources; they have the potential to expand health care access, increase quality of care, and improve health outcomes. An emerging literature describes factors associated with disparities between Spanish and English speakers with the use of digital health tools and documents.

OBJECTIVE: To characterize barriers and facilitators and to inform hypothesis-generating questions and intervention planning associated with digital health technology use among Spanish-speaking populations in the US.

EVIDENCE REVIEW: Between January 2023 and April 2024, PubMed, Scopus, Web of Science, and Google Scholar were searched for publications between January 2013 and April 2024. Systematic reviews, protocols, editorials, abstracts, unpublished literature, non-peer-reviewed literature, and non-US-based and non-English studies were excluded. The Covidence platform was used to avoid duplicate records, and an abstract and full-text screening were then conducted for exclusions. Unstructured text in the final dataset was thematically analyzed.

FINDINGS: Of 688 publications searched, 192 were excluded as duplications, 277 were excluded from abstract screenings, and 113 were excluded from full-text screenings. Among the 106 included studies (68% of which were published between 2019 and 2024), 73 (69%) used quantitative methods, 15 (14%) used qualitative methods, and 18 (17%) used applied mixed methods. The primary technologies studied were characterized as portal (21% [n = 22]), telehealth (42% [n = 45]), mobile health (16% [n = 17]), web-based resources (9% [n = 10]), and mixed (studies reporting >1 technology; 11% [n = 12]). Compared with English speakers, studies revealed consistently lower portal account activation, portal use, telehealth adoption, and online resource use among Spanish speakers. Barriers to use across all technologies included limited access to technology and Wi-Fi, low literacy, and limited digital literacy. Barriers to portal and telehealth use included lack of awareness of digital tools, limited patient-facing instructions in Spanish, and interpreter-related challenges. Facilitators cited across multiple technologies included use of text messaging and social media interventions, interventions involving care partners and/or interpreters, and culturally and linguistically tailored Spanish materials.

CONCLUSIONS AND RELEVANCE: The results of this scoping review suggest that Spanish-speaking persons in the US faced technology, language, and literacy-related barriers to digital technology use. Embracing support for care partners, facilitating text message or social media-oriented workflows, and ensuring that materials are linguistically and culturally tailored represent approaches for health systems, electronic health record vendors, and community health organizations to mitigate these disparities.

PMID:40372754 | DOI:10.1001/jamanetworkopen.2025.10386

JAMA Netw Open. 2025 May 1;8(5):e2510512. doi: 10.1001/jamanetworkopen.2025.10512.

ABSTRACT

IMPORTANCE: Despite receiving postacute rehabilitation services, many older women with a recent hip fracture repair are unable to return to their prefracture level of function. Whether testosterone therapy can enhance recovery after hip fracture in older women with persistent mobility impairments has not been fully examined.

OBJECTIVE: To evaluate the effects of a supervised exercise program combined with topical testosterone therapy on functional outcomes in older women with a recent hip fracture.

DESIGN, SETTING, AND PARTICIPANTS: This phase 3 double-blind, placebo-controlled randomized clinical trial, Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI), was conducted at 8 US sites between December 2018 and August 2023. Participants were women aged 65 years or older with a recent surgical repair of a nonpathologic femur fracture, met objective criteria for mobility impairment, and were community dwelling after discharge from rehabilitation. During the first 14 months of the trial, participants were randomly assigned to 1 of 3 treatment groups: exercise plus topical testosterone gel, exercise plus placebo gel, or enhanced usual care. Statistical analysis, using a modified intention-to-treat approach, was performed from November 2023 to November 2024.

INTERVENTIONS: For 24 weeks, the 2 exercise groups underwent a supervised, multimodal high-intensity exercise program that included progressive resistance training with trained and certified exercise interventionists. Testosterone was provided in the form of a topical gel (generic 1.0% testosterone), and the placebo gel was chemically identical but without testosterone. The enhanced usual care group was prescribed a self-administered low-intensity home-based exercise program and a staff-led monthly health education session.

MAIN OUTCOMES AND MEASURES: The primary outcome was the between-group difference in the change in the 6-minute walking distance (6MWD) from baseline to 24 weeks.

RESULTS: Among the 129 women randomized (54 to the exercise plus testosterone group, 55 to the exercise plus placebo group, and 20 to the enhanced usual care group; mean [SD] age, 79.3 [8.4] years) included in the STEP-HI trial (122 (94.6%) provided primary outcome data for baseline and at least 1 time point (12 or 24 weeks). The mean (SD) change in the 6MWD between baseline and 24 weeks was not significantly different for exercise plus topical testosterone gel (n = 53; 42.7 [8.2] m) compared with exercise plus placebo gel (n = 51; 40.5 [8.4] m) and enhanced usual care (n = 18; 37.7 [14.8] m).

CONCLUSIONS AND RELEVANCE: In the STEP-HI randomized clinical trial, supervised exercise training combined with testosterone therapy conducted in older women recovering from a hip fracture did not lead to significant improvement in 6MWD compared with supervised exercise alone. Adding testosterone therapy to exercise may not provide further benefits for long-distance mobility. Whether it can improve physical performance and mobility for short distances in this patient population warrants further study.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02938923.

PMID:40372752 | DOI:10.1001/jamanetworkopen.2025.10512

JAMA Ophthalmol. 2025 May 15. doi: 10.1001/jamaophthalmol.2025.1080. Online ahead of print.

ABSTRACT

IMPORTANCE: The optimal timing for secondary intraocular lens (IOL) implantation in children with bilateral aphakia remains uncertain, with important implications for long-term visual outcomes and the risk of complications such as glaucoma. Determining when to implant to achieve the best visual outcomes while minimizing complications is critical for improving clinical decision-making in pediatric cataract management.

OBJECTIVE: To report the visual acuity (VA) and complications in children with bilateral aphakia after lensectomy for pediatric cataracts, undergoing secondary IOL implantation at different ages.

DESIGN, SETTING, AND PARTICIPANTS: This single-center prospective observational cohort study, conducted from 2014 to 2023, is a 7-year follow-up study. A total of 251 children met the inclusion criteria. After exclusion, 158 children were enrolled in this study. These 158 children (316 eyes) underwent lensectomy before the age of 2 years, followed by secondary IOL implantation between the ages of 2 and younger than 6 years in bilateral pediatric cataracts.

EXPOSURE: Study participants were categorized into 4 groups based on the timing of secondary IOL implantation (2 to <3 years, 3 to <4 years, 4 to <5 years, and 5 to <6 years).

MAIN OUTCOME AND MEASURE: Best-corrected VA (BCVA) outcomes at age 7 years after secondary IOL implantation in children with bilateral pediatric cataracts.

RESULTS: Among the 158 children included in the study, 103 (65.2%) were male. At age 7 years, the mean (SD) BCVA for children who underwent secondary IOL implantation was 0.49 (0.35) logMAR (Snellen equivalent, 20/62) at 2 to younger than 3 years, 0.59 (0.36) logMAR (Snellen equivalent, 20/78) at 3 to younger than 4 years, 0.60 (0.30) logMAR (Snellen equivalent, 20/80) at 4 to younger than 5 years, and 0.65 (0.34) logMAR (Snellen equivalent, 20/89) at 5 to younger than 6 years (P = .20). Glaucoma-related adverse events occurred in 47 eyes in total: 6 eyes (8.8%), 7 eyes (9.0%), 10 eyes (15.6%), and 24 eyes (22.6%) across the groups, respectively, with a statistical difference among the groups (P = .03).

CONCLUSIONS AND RELEVANCE: These findings suggest that secondary IOL implantation performed between the ages of 2 and younger than 6 years following bilateral pediatric cataract lensectomy can achieve comparable visual outcomes; however, the risk of glaucoma increases with older implantation age.

PMID:40372731 | DOI:10.1001/jamaophthalmol.2025.1080

JAMA Oncol. 2025 May 15. doi: 10.1001/jamaoncol.2025.1059. Online ahead of print.

ABSTRACT

IMPORTANCE: Postoperative radiotherapy remains underused for men with biochemical recurrence or adverse pathological features after radical prostatectomy (RP). Stereotactic body radiotherapy (SBRT) may improve utilization and poses potential radiobiological advantages.

OBJECTIVE: To evaluate physician-reported late toxic effects and 2-year patient-reported outcomes (PROs) following post-RP SBRT.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2, single-arm trial was conducted in 2 academic centers in the US and included a comparator cohort. Men with post-RP prostate-specific antigen greater than 0.03 ng/mL or adverse pathologic features were included. Data were collected from February 2018 to March 2021, and data were analyzed from January to October 2024.

INTERVENTIONS: SBRT delivered at 30 to 34 Gy in 5 fractions to the prostate bed. Nodal irradiation, boost to gross disease, and/or hormonal therapy were delivered per physician discretion.

MAIN OUTCOMES AND MEASURES: Late toxic effects (more than 90 days after treatment) were graded according to Common Terminology Criteria for Adverse Events version 4.03. PROs were measured using Expanded Prostate Cancer Index-26. The proportion of men whose PROs had decrements greater than twice the threshold for minimal clinically important difference (MCID) at any point during the first 2 years were evaluated. The longitudinal PROs for men receiving SBRT was compared with a cohort of 200 men receiving postoperative conventionally fractionated radiotherapy (CFRT) using logistic regression, while adjusting for baseline scores, age, and receipt of nodal irradiation.

RESULTS: Of 100 patients treated with post-RP SBRT, the median (IQR) age was 68.5 (63.9-71.4) years, and the median (IQR) follow-up was 43 (37-53) months. Cumulative incidence of late grade 2 and 3 genitourinary toxic effects was 25% and 4%, respectively, and of late grade 2 and 3 gastrointestinal tract toxic effects was 3% and 3%, respectively. The proportion of patients with decrements more than 2-fold the MCID in PROs was 38.9% (37 of 95) for urinary incontinence, 17.9% (17 of 95) for urinary irritation, and 34.1% (31 of 91) for bowel function. Compared with the CFRT cohort, the adjusted odds ratio for patients receiving SBRT experiencing decrements more than 2-fold the MCID was 1.55 (95% CI, 0.87-2.76; P = .14) for urinary incontinence, 0.94 (95% CI, 0.46-1.94; P = .87) for urinary irritation, and 1.03 (95% CI, 0.57-1.84; P = .93) for bowel function.

CONCLUSIONS AND RELEVANCE: In this nonrandomized clinical trial, post-RP SBRT was well-tolerated, with no measurably different decline in urinary or bowel PROs through 2 years compared with CFRT. Randomized studies and longer follow-up will better define the toxic effects and efficacy profile of post-RP SBRT.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03541850.

PMID:40372727 | DOI:10.1001/jamaoncol.2025.1059