To ascertain the likelihood of composite maternal hemorrhagic outcome (CMHO) among individuals that delivered vaginally with livebirth versus a stillbirth. This was a retrospective cohort study of all parturients greater than 20 weeks gestation who delivered vaginally at a single level IV site within 24 months. Demographic differences and baseline PPH risks were analyzed. CMHO included any of the following: estimated blood loss > 1000 mL, use of uterotonics (beyond prophylactic oxytocin), Bakri balloon, surgical management of postpartum hemorrhage, blood transfusion, hysterectomy, venous thromboembolism (VTE), admission to the intensive care unit (ICU) or maternal death. Statistical analysis included Chi-square, Kruskal-Wallis, and Poisson regression with robust error variance for risk ratios, adjusting for gestational age (GA), bleeding on admission, chorioamnionitis, and prior uterine surgery. Of 8,623 consecutive vaginal births > 20 weeks, 89 (1.9%) were stillbirths. Maternal age, marital status, gestational age (GA) at delivery, and PPH risk stratification at admission differed significantly. Bleeding at admission (p<0.001), prior uterine surgery (p<0.001), magnesium sulfate use (p=0.006), chorioamnionitis (p<0.001), platelet count <100 (p=0.001), platelet count <50 (p<0.001) and retained products of conception (p<0.001) were different in the two groups. CMHO was significantly higher with a stillbirth delivery (32.6% vs 16.8%; aRR 1.56 95%CI 1.01-2.46). After adjustment, the components of the CMHO that differed significantly were estimated blood loss > 1000mL and ICU admission. Tamponade, surgical intervention, VTE, hysterectomy and maternal death did not differ between the two groups. Pregnancies with stillbirth, compared to livebirth, had an increased risk of hemorrhagic related morbidity. In addition to being useful in shared decision making, our results can be nidus for intervention trials to decrease the hemorrhagic morbidity associated with stillbirth.

The role of minimal residual disease (MRD) testing is well defined in curable hematological malignancies like acute lymphoblastic leukemia. However, in chronic lymphocytic leukemia (CLL), which is an incurable low-grade lymphoma, MRD is mostly investigational, especially in the relapsed setting. Newer techniques are trying to get to even deeper levels than before-for instance, 10-6 with sequencing. Here we describe the current techniques of MRD testing in CLL and explore the applications of these modalities in relapsed/refractory CLL in novel targeted therapies, cellular therapy, and other immunotherapies that can lead to deep and durable remissions, especially when used in combinations. More and more prospective interventional trials are now using MRD testing to inform decisions, and the data from these trials will further elucidate the best use of MRD testing in CLL patients. For now, MRD testing is not used for treatment decisions in the real world, although it can be done for monitoring in patients with high-risk genetics.

Self-reported and wearable device derived data on physical activity (PA) differ in burden, transparency, and validity, underscoring the need for comparison in cancer survivorship research. Physical activity and sedentary behavior measured from the ActiGraph, International Physical Activity Questionnaire (IPAQ), and Fitbit Inspire device in women with early-stage breast cancer were compared. Breast cancer survivors participating in a lifestyle intervention trial concurrently provided ActiGraph and IPAQ data at baseline and 6months. Fitbit devices were used for PA self-monitoring after randomization and data were available at follow-up only. Comparisons of PA measurements were estimated via Pearson correlation coefficients and visualized using Bland-Altman plots. Prevalence of meeting moderate to vigorous PA guidelines of ≥150minutes per week were also calculated. At baseline (n = 73), mean vigorous PA was 2 and 5minutes per day for ActiGraph and IPAQ, respectively (r = .22, P = .06), while mean sedentary hours per day were 11.4 and 6.2 for ActiGraph and IPAQ, respectively (r = .29, P = .01). Correlations between ActiGraph and IPAQ at 6-month follow-up (n = 50) were not statistically significant. Six-month comparisons of PA measures between ActiGraph and Fitbit (n = 30) were higher than those between IPAQ and Fitbit (n = 30). Prevalence of meeting moderate to vigorous PA guidelines at baseline was 40% for ActiGraph and 59% for IPAQ (P = .01). At 6months, proportions meeting moderate to vigorous PA guidelines were 50%, 73%, and 67% for ActiGraph, IPAQ, and Fitbit, respectively. Correlations of PA comparing self-report from IPAQ and activity devices from ActiGraph and Fitbit were weak. Strengths and limitations of PA measurement methods should be weighed accordingly in studies of lifestyle interventions for breast cancer survivors.

Bacterial vaginosis, defined by Nugent score (Nugent-BV), has been associated with preterm birth and other adverse pregnancy outcomes. However, few studies have longitudinally described the associations between Nugent-BV and adverse pregnancy outcomes at varying times in pregnancy. We assessed associations between Nugent-BV at two separate time points in pregnancy and preterm birth (<37 weeks of gestation), low birth weight (LBW, <2500 g), and small-for-gestational-age (SGA, <10th percentile) using data from a community-based randomized trial in rural northwestern Bangladesh from 2001 to 2007. Pregnant women provided self-collected vaginal swabs in early (first or second trimester) and late (third trimester) pregnancy for Nugent scoring. Nugent-BV was categorized as 7-10 (ref: 0-6) or 4-10 (ref: 0-3). We used multivariable regression techniques to model relationships between Nugent-BV and incidence of preterm birth, LBW, and SGA, adjusted for the trial intervention and demographic, socioeconomic, and pregnancy history factors. A total of 1243 women provided ≥1 vaginal swab with a Nugent score and had a live birth. Preterm birth incidence was 23.5% (n = 271/1151). Nugent-BV 7-10 in early (adjusted relative risk (aRR): 0.84, 95% confidence interval [CI]: 0.42, 1.66) and late (aRR: 1.04, 95% CI: 0.44, 2.41) pregnancy were not associated with preterm birth. Nugent-BV 4-10 at either time point was not associated with preterm birth in the final adjusted models. From early to late pregnancy, a transition from Nugent score category 4-10 to 0-3, relative to 0-3 at both timepoints, was associated with decreased risk of preterm birth (aRR 0.20, 95% CI: 0.06, 0.63). In early and late pregnancy, neither Nugent-BV categorization was associated with LBW or SGA in the final models. Resolution of Nugent-BV between early and late pregnancy might be associated with a decreased risk of preterm birth. Longitudinal studies with frequent sampling in pregnancy and using molecular techniques are needed to better describe changes in the vaginal microbiota and associated risk for adverse pregnancy outcomes.

Abstract Background: Melanoma is a major cause of skin cancer-related death, and clinical trials are essential for advancing melanoma treatment options. However, many trials either are teminated prematurly or are never published, eaving critical data unreported. These “unfinished stories”, hinder scientific progress, waste resources, and limit informed clinical decision-making. Therefore, understanding how many and what factors predict unpublished or discontinued melanoma trials is key to improving the transparency of research and advancing best care for patients. Objective: To identify the extent, characteristics, and variables related to Discontinuation and Non-Publication melanoma clinical investigations. Methods: We systematically searched ClinicalTrials.gov for Melanoma studies up to March 1, 2025. Studies completed within the past 24 months were excluded to account for potential delays in the peer review process. Publication status was identified using NCT numbers. Data on participant gender, age, study design, funding source, type of intervention, sample size, and trial location were collected and analyzed. Multiple logistic regression was used to identify factors associated with trial discontinuation or non-publication. All statistical analyses were conducted using Jamovi version 2.6.24. Results: In total, there were 2,144 trials, with 712 (33.2%) published, 1,215 (56.7%) non-published, and 217 (10.1%) unknown. Of the discontinued trials (516, 24.1%), just 59 (11.4%) were published. Non-publication status was noted to be significant among trials of genetic interventions (OR = 0.104, 95% CI: 0.027-0.401, p=0.001), procedural interventions (OR = 0.262, 95% CI: 0.121-0.567, p&amp;lt;0.001), and in a multicenter trial (OR = 0.185, 95% CI: 0.123-0.278, p&amp;lt;0.001). Also, a study was considerably more probable to be discontinuation if smaller-sized (≤500 participants, p&amp;lt;0.001) or earlier (Phase 1/2, p&amp;lt;0.001). Conclusions: The high frequency of Discontinuation and Non-Publication trials record highlights the importance of efforts toward completing and/or fully publication melanoma clinical investigations, particularly those for genetic and/or procedural treatments and/or smaller trials. Citation Format: Hadeer Hafez, Abdelrahman Hagag, Mohamed Ashraf. Mohamed, Mohamed Saad. Rakab, Ismail Zakaria. Ismail, Aya Jamal. Elkenani, Nada Elmetwally. Ahmed, Abdelrahman M. Hafez, Doaa Mashaly, Ali Tarek. Lasheen, Mohamed Abdelsalam. Unfinished stories: Consequences of melanoma clinical trial discontinuation and non-publication [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Cancer Evolution: The Dynamics of Progression and Persistence; 2025 Dec 4-6; Albuquerque, NM. Philadelphia (PA): AACR; Cancer Res 2025;85(23_Suppl):Abstract nr A027.

Earlier meta-analyses showing low rates of abstinence in treatments for bulimia nervosa (BN) and binge-eating disorder (BED) have spurred growing efforts to improve outcomes. In response, numerous trials have tested augmented, novel, or streamlined treatment protocols. However, it remains unclear whether these efforts have translated into improvements in meaningful abstinence outcomes. This meta-analysis provided updated estimates of abstinence and examined whether rates have changed over time. Trials of psychological treatments for BN and BED that reported abstinence rates were identified from two prior reviews, with an updated search (January 2018-September 2025). Pooled abstinence rates were calculated using random-effects models. Meta-regressions tested associations between trial year and abstinence. Ninety-ninetrials (18 new) were included, 47 in BN and 52 in BED. For BN, the pooled abstinence rate was 29.4% (95% CI = 26.0, 33.1) among all randomized participants, marginally higher among completers (35.3%) and almost a third higher in all randomized augmented treatment conditions (42.9%). BN abstinence rates showed little change over time. For BED, the abstinence rate was 43.3% (95% CI = 39.2, 47.5), which was slightly higher among treatment completers and stable in various sensitivity analyses. Meta-regressions indicated BED outcomes have declined over time under certain conditions. Many patients do not respond to front-line treatments, with no observable improvement in outcomes over four decades. Moving forward, meaningful progress will require a shift in how treatments are conceptualized and tested to achieve better outcomes, with promise emerging for strategically augmenting standard protocols and offering targted support to gradual responders.

Longitudinal data can be used to study disease progression and are often collected at irregular intervals. When the assessment times are informative about the severity of the disease, regression analyses of the outcome trajectory over time based on Generalized Estimating Equations (GEEs) result in biased estimates of regression coefficients. Inverse-intensity weighted GEEs (IIW-GEEs) are a popular approach to account for informative assessment times and yield unbiased estimates of outcome model coefficients when the assessment times and outcomes are conditionally independent given previously observed data. However, a consequence of irregular assessment times is that some patients may have no follow-up assessments at all, and it is common practice to omit these patients from analyses when studying the outcome trajectory over time. We show mathematically that IIW-GEEs yield biased estimates of regression coefficients when patients with no follow-up assessments are excluded from analyses. We design a simulation study to evaluate how the bias varies with sample size, assessment frequency, follow-up time, and the informativeness of the assessment time process. Using the STAR*D trial of treatments for major depressive disorder, we examine the extent of bias in practice. Our simulation results showed the bias incurred by omitting patients with no follow-up visits increased as visit frequency decreased and as the duration of follow-up decreased. In the STAR*D trial, omitting patients with no follow-up visits led to over-estimation of the rate of improvement in depressive symptoms. Studies should be designed to ensure patients with no follow-up are included in the data. This can be achieved by a) creating inception cohorts; b) when taking sub-samples of existing cohorts, ensuring that patients without follow-up assessments are included; c) dropping exclusion criteria based on availability of follow-up visits.

Sporadic cerebral small vessel disease (SVD) has a heterogeneous underlying pathology, and current SVD magnetic resonance imaging (MRI) markers do not accurately capture this heterogeneity. Novel ultrahigh-field (7T) brain MRI markers provide a window of opportunity to study early changes and potential determinants of SVD. White matter hyperintensity (WMH) shape is a relatively novel MRI marker of SVD and has shown prognostic potential. However, the exact microstructural changes within or surrounding WMHs or potential causes related to WMH shape variations are unknown. Furthermore, impaired brain clearance via the recently discovered brain clearance system may be another early change or potential cause of SVD. In the White Matter Hyperintensity Shape and Brain Clearance (WHIMAS) study, we aim to assess the link between WMHs-their shape in particular-and brain clearance and other MRI markers on ultrahigh-field (7T) brain MRI and show whether these markers are associated with cognitive functioning in older adults with memory complaints. This is a cross-sectional study conducted at the Leiden University Medical Center. A total of 50 outpatients from the memory or geriatric clinic aged ≥65 years will be recruited for a 3T and 7T MRI scan (including clinical structural scans, eg, 3D T1-weighted, 3D fluid-attenuated inversion recovery), and experimental scans such as cerebrospinal fluid (CSF)-selective T2-prepared readout with acceleration and mobility encoding (CSF-STREAM) and the relationship between blood oxygen level-dependent [BOLD] signals and CSF flow) and magnetic resonance fingerprinting, as well as a standardized neuropsychological test battery (domains: memory, executive function, visuoconstruction, and processing speed). We will assess WMH shape markers (solidity, convexity, concavity index, fractal dimension, and eccentricity) and brain clearance markers (CSF mobility and the relationship between blood oxygen level-dependent signals and CSF flow) and study their relationship to other MRI markers and cognitive functioning using multivariable regression analyses. Patient inclusion started in January 2023, and study enrollment of patients is expected to finish in the second quarter of 2027, whereas the main results are expected to be published in the first quarter of 2028. We aim to understand variations in WMH shape and find their relationship to cerebral SVD and markers of brain clearance and cognitive functioning. WMH shape and brain clearance markers early in the disease process of SVD are extremely important as they may represent a basis for future patient selection for lifestyle interventions or for treatment trials aimed at the prevention of dementia. ClinicalTrials.gov NCT06010511; https://clinicaltrials.gov/study/NCT06010511. DERR1-10.2196/77681.

To assess whether automated analysis of retinal arterioles and venules can identify treatment response in papilledema secondary to idiopathic intracranial hypertension (IIH). This retrospective analysis used data from a multicenter, randomized, double-blind, placebo-controlled IIH treatment trial. Participants (n = 165) with mild visual loss were assigned to a dietary/lifestyle modification plus acetazolamide (ACZ) or placebo for 6 months. Color fundus photographs, optical coherence tomography (OCT), and clinical metrics were collected at baseline and at multiple follow-up visits. AutoMorph, a deep learning-based pipeline, quantified venule and arteriole diameters, fractal dimensionality, tortuosity, and vessel density. Venular widths were standardized to arteriolar widths to form a venule-to-arteriole (V:A) ratio, which was correlated with Frisén grade, OCT optic nerve head (ONH) parameters, and cerebrospinal fluid (CSF) opening pressure. Baseline vascular OCT metrics and Frisén grades were similar between groups. At month 1, ACZ significantly reduced venule diameters (-4.59 µm; P = 0.02), and placebo showed no change (+1.21 µm; P = 0.54). The V:A ratio was consistently lower in the ACZ group than placebo from month 1 (1.20 vs. 1.24, respectively; P = 0.03) to month 6 (1.16 vs. 1.23, P = 0.02). Higher Frisén grades correlated strongly with increased mean V:A values (R2 = 0.91, P = 0.011). The V:A ratio was significantly associated with CSF opening pressure at month 6 (R2 = 0.47, P < 0.001). Automated retinal vessel analysis provides a promising, non-invasive method for monitoring treatment response in IIH and may complement traditional imaging and clinical assessments. Deep learning-based retinal vessel metrics may provide an accessible biomarker for monitoring treatment response in papilledema.

GOULD EDU: Cluster-Randomized Trial of an Educational Intervention to Improve Lipid-Lowering Guideline Adherence.

Takotsubo cardiomyopathy is an acute cardiac emergency presenting with severe left ventricular dysfunction. Physical exercise training or cognitive behavioral therapy may enhance myocardial recovery after takotsubo cardiomyopathy. In a prospective multicenter clinical trial conducted between February 2020 and August 2023, patients with acute takotsubo cardiomyopathy were randomized 1:1:1 to physical exercise training, cognitive behavioral therapy, or standard care for 12 weeks after index presentation. The primary end point was resting phosphocreatine/gamma-ATP ratio assessed by 31P-magnetic resonance spectroscopy. Secondary end points were the rate of oxygen consumption at peak exercise on cardiopulmonary exercise testing, 6-minute walk distance, left ventricular global longitudinal strain, and the Minnesota Living With Heart Failure Questionnaire. Twelve-week changes in outcome were compared between allocated trial interventions. Seventy-six participants were recruited: the median age was 66 years, and 91% were women. Compared with standard care, the primary end point of myocardial phosphocreatine/gamma-ATP ratio was improved by physical exercise training (0.4 [95% CI, 0.1-0.8]; P=0.016) and cognitive behavioral therapy (0.3 [0.01-0.7]; P=0.043). Both physical exercise training and cognitive behavioral therapy improved rate of oxygen consumption at peak exercise (4.7 [1.4-8.0] and 4.0 [1.5-6.4] mL/min per kg; P=0.001 and 0.004, respectively) and 6-minute walk distance (92.6 [24.7-160.6] and 73.3 [7.9-138.8] m; P=0.004 and 0.029, respectively) compared with standard care. There were no differences in global longitudinal strain or symptom burden. In patients with acute takotsubo cardiomyopathy, a 12-week intervention with exercise training or cognitive behavioral therapy improved left ventricular myocardial energetics and exercise performance without demonstrable effects on symptoms of heart failure. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04425785.

BackgroundPlantar pressure measurement has become increasingly relevant in fields such as sports performance, rehabilitation, and podiatry. Its outcomes are influenced by factors including foot morphology, body weight, joint mobility, and biological sex, with documented anatomical and physiological differences between men and women potentially affecting load distribution. Morton’s extension, an orthotic device used to restore first ray function, has shown clinical efficacy in managing forefoot pathologies. However, limited research has examined its biomechanical effects with respect to sex. This study aimed to evaluate the differential impact of Morton’s extension on plantar pressure distribution in men and women, under both static and dynamic conditions.MethodsA sex comparing clinical trial intervention study was conducted with 18 men´s feet (38.11 ± 15.49 years) and 32 women´s feet (41.63 ± 15.22 years), who underwent plantar pressure assessments using a calibrated platform before and after the application of a Morton extension. Static and dynamic measurements were recorded under both conditions to evaluate changes in pressure distribution. A mixed models static analysis was done to check that there are differences by sex on foot.FindingsThe following results summarize statistically significant differences observed between sexes under both static and dynamic conditions, with and without Morton’s extension. In static pressures without Morton’s extension, statistically significant results were found in P.Max.Rtp.(kPa) (p = 0.006) and Medium.pressure.Rtp.(kPa) (p < 0.001). With Morton’s extension in static conditions, significant differences were observed in P.Max.1M.(kPa) (p = 0.034), P.Max.Rtp.(kPa) (p = 0.017), and Medium.pressure.Rtp.(kPa) (p = 0.003). In dynamic pressures, before the intervention, statistically significant differences between sexes were observed in P.Max.1M.(kPa) (p = 0.023), Medium.pressure.1M.(kPa) (p = 0.008), Contact.Surfaces.(cm²) (p = 0.008), and Step.duration.(Milliseconds) (p = 0.048). After the intervention, additional significant differences were found in Contact.Surfaces.(cm²) (p = 0.009).ConclusionThe combined evidence indicates that Morton’s extension elicits clinically meaningful, sex-dependent alterations in plantar loading. By applying mixed-effects models we uncovered subtle intra- and interindividual patterns that conventional analyses may overlook. These results support sex-specific orthotic dosing (height/geometry) and argue for individualized prescription to maximize load redistribution, reduce focal overpressure and prevent site-specific pathology. Future work should validate optimal orthotic designs using dynamic 3D gait analysis and computational modelling.

ObjectivesGroup-format, peer-led parenting interventions may be valuable for parents with significant emotional and interpersonal difficulties in improving child behaviour, parenting and parent mental health. This article presents the results of a feasibility pilot randomised controlled trial (RCT) of a novel peer-led group intervention, Being a Parent (BaP)-Enjoying Family Life.DesignTwo-arm, parallel group superiority feasibility RCT, with pre–post intervention (postintervention) and 6-month follow-up (6-month follow-up).SettingCommunity recruitment across four South London boroughs.ParticipantsMain inclusion criteria were (1) primary parental caregivers, (2) aged 18–65 years and (3) significant emotional and interpersonal difficulties (score ≥3 on Standardised Assessment of Personality–Abbreviated Scale screening tool) and had a child (a) aged 2–11 years, (b) living with parent participant and (c) with caregiver-reported behavioural difficulties.InterventionsIntervention arm: BaP-Enjoying Family Life, a 10-session, peer-led, group intervention for parents with significant emotional and interpersonal difficulties. Control arm: BaP-Standard, a nine-session, peer-led group parenting intervention.OutcomesPrimary feasibility criteria were rates of recruitment, retention, intervention acceptability and fidelity. Initial estimates of intervention effect were measured using the Eyberg Child Behaviour Inventory (primary outcome), and the Concerns about my Child scale, Arnold O’Leary Parenting Scale, Parental Reflective Function Questionnaire, Kansas Parent Satisfaction Scale, Brief Parent Self Efficacy Scale, Brief Adjustment Scale-6 and Home Observation Measurement of the Environment (secondary outcomes). Data collection was conducted with the researcher masked to intervention allocation.ResultsPredefined thresholds were met for three of five feasibility indices and partially met for the remaining two. Eligibility criteria were met by 70% (n=77) of 110 interested parents, and 85% (n=66) of those eligible completed baseline data collection and were randomised. Data were collected at postintervention for 91% (n=60) of parents. 75% (n=49) of participants attended at least one session and 50% (n=33) completed 5 or more sessions (intervention completers). The intervention was found to be acceptable by 60.71% of participants in BaP-Enjoying Family Life and 62.50% of participants in BaP-Standard arm, increasing to 93.33% and 88.24%, respectively, among intervention completers. Fidelity was reached for three of five groups in each arm, with missing data and group cancellation contributing to lack of observed fidelity in the remaining two groups. We aimed to obtain estimates of intervention effect and, while underpowered, estimates of effect on the primary outcome (child behaviour) were moderate within each arm (BaP-Enjoying Family Life d=0.73 (95% CI 0.30 to 1.15), BaP-Standard d=0.73 (95% CI 0.34 to 1.12)) from baseline to postintervention. Improvements were maintained at 6-month follow-up. Moderate and large pre–post effects were observed on most secondary outcomes. Effect sizes also indicated no between-arm effect of intervention BaP-Enjoying Family Life and BaP-Standard on most primary and secondary outcomes.ConclusionsFindings indicate that both interventions show promise in supporting parents with significant emotional and interpersonal difficulties with limited differential effects. Further refinements which increase intervention completion, acceptability and fidelity should be conducted prior to progression to a full-scale RCT.Trial registration numberISRCTN10950727.

Respiratory infections and diarrheal diseases are major causes of illness and school absences for school-aged children. Both can be prevented by handwashing with soap. Unfortunately, at most schools in low-resource settings, soap and water are rarely present and, if present, rarely used. As part of a longer-term project, we have been working with the Tamil Nadu school system on improving the hygiene practices of students since 2015. We have designed a handwashing curriculum to educate students at low-resource schools in India to promote behavior change among these students and their teachers. The purpose of this study is to measure how effective this curriculum is in improving handwashing outcomes. From October 2019 through March 2020, we ran a cluster-randomized trial of a school-based hand hygiene intervention for students in grades 3 to 5 in Tamil Nadu public schools. Schools in the treated group implemented a handwashing curriculum to educate students about the importance of handwashing and to create routines within the school. During baseline, midline and endline, enumerators conducted surprise visits at schools to observe whether soap was present in classrooms and whether students were washing their hands with soap before lunch. The intervention occurred at treatment schools between baseline and midline. The observed presence of in-use soap and handwashing before lunch more than doubled at treated schools after the intervention. Both outcomes were also roughly 30 percentage points higher at treated schools than at control schools at midline, providing some indication that a hygiene intervention can succeed in a low-resource setting. Our results indicate that the intervention was successful at improving handwashing with soap. Since the intervention used the school system's own trainers and teachers, it should be scalable. As such, a hygiene intervention like the one we implemented can succeed in a low-resource setting. Longer-term follow-up is important to see what reminders help schools and students sustain the new behavior. AEARCTR-0005182 (AEA RCT Registry, Initial Registration Date was December 15, 2019).

ObjectiveThis reporting guideline was developed to address the gap in methodological reporting standards for trials investigating physical exercise or training in older adults, aiming to enhance the quality, transparency, and replicability of such research. The aim is to improve the reporting of key elements, including population characteristics, intervention components [e.g., Frequency, Intensity, Time, Type (FITT) principles, tailoring, use of technology], study design and methods (e.g., recruitment, randomization, statistical analysis), as well as study results, including outcomes and adherence measures.MethodsA six-stage process was used to develop this guideline. This included a three-round Delphi process involving experts from a large European network (COST Action PhysAgeNet), a comprehensive literature review of existing reporting guidelines, consensus meetings with international experts, and validation with journal editors who evaluated and refined the guideline.ResultsThe final PETIO guideline includes an expanded checklist of items to report in the context of physical exercise interventions in older adults. Experts and editors agreed on essential items for improving quality, transparency, and replicability, such as intervention components (FITT) and setting, tailoring aspects, adverse events, and control group specifications. Notably, it was also emphasized that standardized reporting is critical for future meta-analyses and the implementation of future research protocols.ConclusionThe guideline is expected to support researchers, peer reviewers, and journal editors in improving the quality and transparency of research on physical exercise interventions in older adults. Release date2025 (original version).AvailabilityThe guideline is freely accessible online in the supplemental material.Supplementary InformationThe online version contains supplementary material available at 10.1186/s11556-025-00390-x.

To explore the experiences and opinions of women with breast cancer-related arm lymphoedema (BCRL), a common sequela of breast cancer treatment, and of lymphoedema practitioners regarding current lymphoedema treatment in the UK, priority outcomes and assessment methods, and acceptability of a future trial of lymphoedema treatment and use of intensive-decongestive lymphoedema treatment (DLT) for women presenting with BCRL. Two focus groups were conducted with 13 women and three focus groups with 13 lymphoedema practitioners. Discussions were transcribed and analysed using framework analysis. Usual UK lymphoedema care was self-treatment with hosiery. Women and practitioners supported the notion of early intervention although practitioners reported lack of capacity to provide intensive-DLT. All groups considered arm volume an important outcome but were unsure what treatment outcomes could be expected. Participants supported the need for a trial to identify effective treatment for women with previously untreated BCRL but could not describe criteria for a good clinical outcome. Study findings demonstrate the need and desire of women and practitioners for robust research to determine the most effective treatment for women with early-BCRL, that is, within 12 months of BCRL onset,including intensive-DLT. However, UK lymphoedema services lack capacity to provide intensive-DLT, so the potential to conduct a future trial of effectiveness is likely to be limited. Women with arm BCRL can expect to receive self-treatment with hosiery. There is a need to identify effective treatment for women with arm lymphoedema and criteria for a good clinical outcome.

Abstract OP 23: Mental Health 3, B304 (FCSH), September 4, 2025, 14:45 - 15:45 Aims Latina immigrants in the United States are at high risk for mental health concerns and face barriers to accessing mental health resources. Amigas Latinas Motivando el Alma (ALMA) is a community-based mental health intervention to reduce depression and anxiety among Latina immigrants. The ALMA intervention was originally designed and tested in an intervention trial using mental health and mindfulness professionals to deliver the intervention. Community health workers are increasingly being used to provide culturally relevant mental health care in areas with a limited workforce. The aim of this study was to test the implementation strategy of training community health workers (CHW) to deliver the intervention. Methods The ALMA intervention integrates Latino cultural, mindfulness-based coping strategies and social support to reduce depression and anxiety. We trained five CHWs to deliver the ALMA intervention at two community-based organizations in Central Washington, United States. These CHWs then offered the program to Latina immigrants at each of their organizations (n = 37) with support from our bilingual research team. We collected survey data on CHW and participant characteristics, intervention fidelity, participant attendance, satisfaction, and changes in depression (PHQ-8) and anxiety (GAD-7) pre- and post-intervention. Results CHW completed all training sessions and delivered 94% of the activities in the ALMA sessions. We found high participant engagement and satisfaction with the program. Mean depression scores (PHQ-8) decreased from 7.2 (mild severity) pre-intervention to 4.5 (minimal severity) post-intervention, and anxiety scores (GAD-7) decreased from 6.7 (mild severity) to 3.8 (minimal severity). Conclusions Overall, training and supporting the CHWs to deliver the intervention was feasible. CHWs may be an effective implementation strategy to broaden the reach and sustainability of ALMA. Future research should evaluate this approach in a larger trial with a more rigorous study design.

Proportion of disordered eating among Latin American university students: A multicountry cross-sectional study.

From in-person to virtual: The impact of crisis-enforced delivery change on treatment for low positive affect, depression, and anxiety.

A two-arm cluster randomized controlled trial evaluated the impact of Body Confident Athletes (BCA) on girls' (N = 568, 11-17 years) body image, sports enjoyment, and affect. Sports organizations were randomly allocated (1:1) into either an intervention (BCA; k = 29) or waitlist control condition (k = 33). Girls and coaches in the intervention condition completed three 60-min sessions over three consecutive weeks. Primary outcomes were the immediate and short-term changes in girls' body esteem, with secondary outcomes assessing changes in girls' body appreciation, self-objectification, attuned self-care, sports enjoyment, and affect. Girls in the BCA condition reported significant small improvements in body esteem, body appreciation, attuned self-care, self-objectification, and negative affect at postintervention, with several effects either maintained (attuned self-care at 1-month follow-up [T3], but not at 3-month follow-up [T4]) or reemerging at later follow-up points (body esteem and self-objectification at T4, but not at T3). Effects were not maintained for body appreciation or negative affect, nor did effects emerge for sports enjoyment or positive affect. Coaches were effective interventionists (i.e., 80% accuracy), with most girls comprehending key intervention messages (85.1%). BCA is the first coach-led positive body image intervention designed for girls in sport. The findings of the current trial show that BCA is a scalable body image intervention accurately delivered by sport community members, resulting in immediate and short-term improvements in girls' body image. (PsycInfo Database Record (c) 2025 APA, all rights reserved).