Category: Statistics

JMIR Res Protoc. 2026 Jun 3;15:e97781. doi: 10.2196/97781.

ABSTRACT

BACKGROUND: Approximately 80% of individuals with Parkinson disease (PD) experience impaired balance and mobility, contributing to freezing of gait, an increased risk of falls, and reduced health-related quality of life. Mind-body interventions, such as mindfulness and yoga, may address both motor and nonmotor symptoms by enhancing mind-body coordination and reducing stress, thereby offering a scalable approach to balance rehabilitation in PD.

OBJECTIVE: This study aims to evaluate the effects and acceptability of Mindfulness Yoga-Practice Awareness through Cognitive-Based Exercise (MY-PACE), a mobile health-delivered, home-based intervention, on balance, mobility, and psychological well-being in individuals with PD and balance impairment.

METHODS: This assessor-blinded, 2-arm, randomized waitlist-controlled trial enrolled 132 individuals with PD and balance impairment, randomized to either the MY-PACE group (n=66, 50%) or the control group receiving routine outpatient care (n=66, 50%). The MY-PACE group will complete a 12-week, Zoom-delivered program incorporating mindfulness, yoga, and mindful walking practices. The control group will receive the intervention after study completion. The primary outcome is functional balance, as measured by the Berg Balance Scale. Secondary outcomes include functional mobility, gait patterns, balance confidence, freezing of gait severity, motor symptoms, anxiety and depressive symptoms, cognitive function, mindfulness, health-related quality of life, and fall incidence. Assessments will occur at baseline, 3 months (T1), and 6 months (T2). Data will be analyzed using linear mixed-effects models under the intention-to-treat principle.

RESULTS: Ethics approval was obtained on September 18, 2019. A preliminary feasibility study with 10 participants was conducted between May and June 2020. The full randomized controlled trial was funded in January 2022 by the Early Career Scheme 2021-2022 of the Research Grants Council, Hong Kong. The trial was prospectively registered on December 10, 2021. Recruitment began in April 2022. As of manuscript submission, 132 participants have been enrolled. Data analysis has not yet commenced. The study protocol and statistical analysis plan follow the original prespecified design. The results are expected to be published in 2026.

CONCLUSIONS: This trial will evaluate a telehealth-delivered mindful yoga intervention for improving balance and mobility in individuals with PD. By integrating cognitive-based mindful awareness and motor training, MY-PACE targets both motor and nonmotor contributors to balance impairment. If effective, it may represent a scalable intervention for individuals with PD and other populations with mobility limitations.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100054145; https://tinyurl.com/4j8f8zvn.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/97781.

PMID:42235054 | DOI:10.2196/97781

J Drugs Dermatol. 2026 Jun 1;25(6):83251s3-83251s10. doi: 10.36849/JDD.83251.

ABSTRACT

Hair loss is a widespread condition with a potentially severe psychological burden, especially among women. The chance of suffering from female alopecia increases with menopause, and topical treatments beyond minoxidil are scarce. Over the past several years, new combinations of natural ingredients and patented mixtures have shown promising results to improve hair shedding, thus helping recover self-esteem and confidence. In this work, results of a prospective, open-label clinical trial conducted in women of predominantly menopausal age provides evidence that the dual cosmetic serum system developed by KilgourMD displays statistically significant and clinically meaningful effects on female hair loss, measured through an objective combing test, modified hair wash test, and clinical expert evaluation, after an application period of 4 months.

PMID:42235052 | DOI:10.36849/JDD.83251

J Drugs Dermatol. 2026 Jun 1;25(6):523-529. doi: 10.36849/JDD.9346.

ABSTRACT

BACKGROUND: Acne is the most prevalent skin disease globally, with a significant burden and limited therapeutic innovation. Although it has a multifactorial etiology, Cutibacterium acnes (C acnes) overgrowth is a key factor in driving inflammation in acne. Bacteriophages are a novel mechanism that can specifically target C acnes and are found in greater abundance on healthy skin compared to acne-prone skin.

OBJECTIVES: To study the safety and efficacy of phages and salicylic acid (SA) in acne, and to analyze their mode of action and effect on microbiome diversity.

METHODS: A randomized double-blind placebo-controlled study was conducted on 90 participants for 8 weeks. Males and females 12 to 35 years old with mild to moderate acne were enrolled in placebo, phage, and phage + SA arms. Clinic visits at baseline, week 4, and week 8 collected safety data, VISIA imaging, lesion counts, IGA scores, and microbiome samples.

RESULTS: Phage treatment demonstrated an excellent safety profile. Participants in both phage and phage + SA arms showed significant improvement (P<0.05) over baseline at 8 weeks. Phage application resulted in a statistically significant (P<0.05) decrease of C acnes on the skin compared to placebo. Notably, phage use over 8 weeks significantly increased microbiome diversity, a marker of long-term skin health.

CONCLUSION: This study shows the potential of bacteriophages to be a highly promising modality with a unique mode of action for the treatment of acne. Beyond short-term lesion improvement, phage-induced enhancement of microbiome diversity suggests potential for durable, long-term skin health benefits. &nbsp.

PMID:42235049 | DOI:10.36849/JDD.9346

Cutan Ocul Toxicol. 2026 Jun 3:1-6. doi: 10.1080/15569527.2026.2680300. Online ahead of print.

ABSTRACT

BACKGROUND: Large language models (LLMs) are increasingly used for the dissemination of health-related information. However, data regarding the accuracy and adequacy with which they present information on the safety, contraindications, and adverse effects of botulinum toxin (BoNT) applications remain limited.

METHODS: In this study, the performance of the ChatGPT-5 mini (OpenAI), DeepSeek-V3.2, and Gemini 3 Flash LLMs in presenting safety and risk-related information on BoNT applications was comparatively evaluated using 10 categorized and structured questions. Responses were independently scored by three dermatologists using a predefined four-point evaluation scale.

RESULTS: ChatGPT-5 mini (OpenAI) and DeepSeek-V3.2 achieved higher and more consistent scores in the domains of general safety, contraindications, and adverse effects. In contrast, the Gemini 3 Flash model demonstrated lower performance, particularly in patient safety-critical areas such as systemic spread and toxicity, as well as drug interactions. A statistically significant difference was observed in the distribution of response quality among the models (p < 0.05).

CONCLUSION: The findings suggest that the level at which LLMs present information related to BoNT applications may vary. Therefore, these tools should be considered supportive aids under physician supervision rather than independent sources of clinical decision-making.

PMID:42235011 | DOI:10.1080/15569527.2026.2680300

Neuroradiol J. 2026 Jun 3:19714009261456600. doi: 10.1177/19714009261456600. Online ahead of print.

ABSTRACT

BackgroundArterial calcification is commonly found in patients with cerebrovascular disease and may negatively affect outcomes following endovascular thrombectomy (EVT) for acute ischemic stroke (AIS). This systematic review and meta-analysis aimed to evaluate the impact of intracranial or aortic arch calcification on procedural success and functional outcomes in AIS patients undergoing anterior circulation EVT.MethodsWe systematically searched the PubMed, EMBASE, and Cochrane databases to identify studies comparing EVT outcomes between AIS patients with and without arterial calcification. Outcomes assessed included first-pass effect (FPE), successful reperfusion at the end of the procedure, modified Rankin scale (mRS), mortality, and symptomatic intracerebral hemorrhage (sICH). Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random effects models, with heterogeneity evaluated with I² statistics.ResultsA total of six observational studies were included, with a total of 3834 patients (2303 with calcification and 1531 controls). Arterial calcification was associated with a lower chance of achieving FPE (RR: 0.50, 95% CI: 0.36-0.69, p < 0.001) and successful reperfusion (RR: 0.90, 95% CI: 0.86-0.94, p < 0.001). Patients with calcification had a greater risk of poor outcome (mRS 3-6) (RR: 1.29, 95% CI: 1.16-1.43, p < 0.001), mortality (RR: 1.51, 95% CI: 1.14-2.00, p < 0.001), and sICH (RR: 1.29, 95% CI: 1.16-1.43, p < 0.001). Heterogeneity was low, with I² ≤ 34%.ConclusionArterial calcification may be indicative of advanced vascular disease, potentially leading to diminished technical success and worse functional outcomes following EVT for AIS. These findings underscore that vascular calcification acts as an associative marker of procedural complexity and advanced vascular disease in EVT candidates.

PMID:42234997 | DOI:10.1177/19714009261456600

Aging Dis. 2026 Jun 2. doi: 10.14336/AD.2025.1653. Online ahead of print.

ABSTRACT

While chronological age is an important risk factor for osteoporosis, biological aging measures may better capture nuances in systemic and bone-tissue aging among same-age individuals. This review aims to summarize the associations between DNA methylation/telomere dysfunction (mainly telomere shortening) and bone health. We searched for human epidemiological studies that examined the associations between blood-based epigenetic aging clocks or leukocyte telomere length (LTL) and osteoporosis-related outcomes on PubMed and Embase. Five epigenetic aging-related studies and 14 LTL-related studies were eventually included, from which data on study design, population, bone health-related outcomes, and statistically significant effect estimates were extracted. Risk of bias was assessed using the Newcastle-Ottawa Scale for observational studies. Findings were summarized narratively due to heterogeneity in study design, biomarkers, and outcome definitions. This review concludes that while laboratory-based studies often provide evidence of aging biomarkers’ association with bone outcomes, population-level epidemiological studies provide inconclusive evidence, highlighting limited studies on epigenetic aging clocks and bone health, and inconsistent findings regarding the association between LTL and bone health. Challenges many of the human studies faced include small sample sizes, inadequate study designs, non-diverse cohorts, and heterogeneity in epigenetic clock selection and/or bone health outcomes. Future research should focus on conducting prospective studies with larger, independent cohort sizes and comprehensive adjustment for intervening factors to paint a clearer picture of the biological aging markers’ associations with osteoporosis and provide guidance on their potential clinical relevance in bone health.

PMID:42234964 | DOI:10.14336/AD.2025.1653

Neurology. 2026 Jul 14;107(1):e218053. doi: 10.1212/WNL.0000000000218053. Epub 2026 Jun 3.

ABSTRACT

BACKGROUND AND OBJECTIVES: Rural residence is linked to poor access to neurologists and specialized epilepsy centers, yet its impact on clinical epilepsy outcomes remains unclear. To address this knowledge gap, we assessed the association between rurality and epilepsy outcomes in a nationally representative cohort in the United States.

METHODS: We conducted a retrospective cohort study using the National Inpatient Sample (2016-2021), including patients with a primary diagnosis of epilepsy and recurrent seizures. The primary exposure was patient rurality, defined using the National Center for Health Statistics Urban-Rural Classification Scheme for Counties. Logistic regression models were used to study the effect of rurality on in-hospital mortality, presenting in status epilepticus, prolonged length of stay, nonroutine discharge, and receipt of EEG. Models were adjusted for demographic, socioeconomic, and hospital-related characteristics and Elixhauser comorbidities. Subanalyses examined patients presenting in status epilepticus, those with private insurance, and those admitted to urban teaching hospitals.

RESULTS: A total of 841,445 epilepsy admissions were included (median age 56 years, 47.2% female). After adjusting for covariates, patients from the most rural counties experienced significantly higher odds of in-hospital mortality (odds ratio [OR] 1.93 [95% CI 1.56-2.39], p < 0.001), presenting in status epilepticus (OR 1.32 [95% CI 1.24-1.41], p < 0.001), and prolonged length of stay (OR 1.29 [95% CI 1.19-1.41], p < 0.001), relative to patients from the most urban counties. The most rural patients also experienced lower odds of receiving EEG (OR 0.88 [95% CI 0.77-1.00], p = 0.047) and nonroutine discharge (OR 0.90 [95% CI 0.85-0.96], p = 0.001). When subanalyzing only patients with private insurance, the associations between rurality and mortality, presenting in status epilepticus, and prolonged length of stay were no longer observed.

DISCUSSION: Increasing rurality was associated with markedly worse epilepsy outcomes, including nearly double the odds of in-hospital mortality. The attenuation of these disparities among privately insured patients suggests that modifiable structural barriers drive rural-urban disparities, rather than geography alone. Inherent to observational studies, residual confounding and limited clinical granularity remain important considerations. These findings underscore the urgent need for targeted public health interventions to improve outcomes for rural epilepsy populations.

PMID:42234954 | DOI:10.1212/WNL.0000000000218053

Blood Adv. 2026 Jun 3:bloodadvances.2026019765. doi: 10.1182/bloodadvances.2026019765. Online ahead of print.

ABSTRACT

Children and adolescents with early-stage nodular lymphocyte-predominant Hodgkin lymphoma (nLPHL) have a 5-year event-free survival (EFS) of about 77% after complete lymph node resection and around 89% with anthracycline-containing chemotherapy. We investigated whether patients with early-stage nLPHL can be successfully treated with surgical resection alone or with low-intensity, anthracycline-free CVP chemotherapy for those with unresectable nodal disease. EuroNet-PHL-LP1 was a prospective phase III trial enrolling patients under 18 years with stage IA/IIA nLPHL. Completely resected lymph nodes led to active surveillance. Patients with unresectable disease received three cycles of CVP (cyclophosphamide, vinblastine, prednisone). In CVP-cohort-1, treatment cessation required a negative 18F -FDG-PET. An amendment in 2014 omitted PET for end-of-treatment response; CT and/or MRI alone defined response in CVP-cohort-2. The primary endpoint was 5-year EFS, with death, relapse, second malignancy and PET-positivity counting as events; for CVP-cohort-2, progression-free survival (PFS) was primary. Among 267 registered patients (2009-2018), 247 were evaluable. Seventy-eight underwent resection only; their 5-year EFS/PFS was 79.5%. Six of 18 patients who relapsed after surgical resection re-entered the CVP arm. In CVP-cohort-1, 51/82 (62%) achieved a complete metabolic response (CMR). 5-year EFS was 56.4%, while 5-year PFS in the CMR group was 91.3%. In contrast, PFS in 84 CVP-cohort-2 patients was 64.7%. During CVP, 68.3% of patients experienced grade 3-4 neutropenia. No treatment-related deaths were reported. Excellent outcomes were achieved after complete resection and with low-intensive, anthracycline-free chemotherapy if 18F-FDG-PET showed CMR after chemotherapy. This strategy now constitutes the EuroNet-PHL standard of care for early-stage nLPHL. The trial was registered under EudraCT-No.: 2007-004092-19.

PMID:42234940 | DOI:10.1182/bloodadvances.2026019765

J Clin Oncol. 2026 Jun 3:JCO2501896. doi: 10.1200/JCO-25-01896. Online ahead of print.

NO ABSTRACT

PMID:42234933 | DOI:10.1200/JCO-25-01896

Blood Adv. 2026 Jun 3:bloodadvances.2025019356. doi: 10.1182/bloodadvances.2025019356. Online ahead of print.

ABSTRACT

We report outcomes of the phase 2 study combining carfilzomib (CFZ) plus vincristine, dexamethasone, asparaginase, and daunorubicin (CFZ-VXLD) in heavily pre-treated, pediatric patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL). We investigated whether post-induction complete remission (CR) rates after CFZ-VXLD induction are superior to an external real-world control (EC). Patients aged ≥1 month to <21 years with R/R ALL received CFZ-VXLD induction, followed by optional consolidation (experimental arm). EC arm included similar patients receiving real-world, curative-intent regimens at Therapeutic Advances in Childhood Leukemia sites between 2000-2023. Primary endpoint was CR after induction; overall response rate (ORR; CR/CR with partial/incomplete hematologic recovery/CR without platelet recovery) was a secondary endpoint. Comparative analyses used inverse probability of treatment weighting. Experimental and EC arms included 105 and 140 patients, respectively. CR rates after induction were 14.8% vs 7.8% (odds ratio [OR] 2.04; 95% CI, 0.54-7.66) in patients with B-ALL and 13.6% vs 9.1% (OR 1.58; 95% CI, 0.47-5.31) in patients with T-ALL. There was no statistically significant increase in post-induction CR for the CFZ-VXLD arm vs the EC arm and the study did not meet its primary endpoint. In patients with B-ALL, ORR was 42.6% vs 26.3% favoring the CFZ-VXLD arm vs the EC arm. Adverse event rates with CFZ were consistent with previous reports. Taken together, the CFZ-VXLD regimen may be an option for some selected pediatric patients with R/R ALL and this study highlights that novel treatments for R/R ALL remain an area of unmet medical need. NCT02303821.

PMID:42234929 | DOI:10.1182/bloodadvances.2025019356