Tag: statistics

JMIR Res Protoc. 2026 Aug 25;15:e100104. doi: 10.2196/100104.

ABSTRACT

BACKGROUND: Systemic lupus erythematosus (SLE) presents substantial life challenges, reflecting the complex and heterogeneous nature of the disease. Pain is common and often one of the earliest manifestations. Skill-based behavioral pain treatments are often inaccessible to patients with SLE, and no SLE-specific evidence exists to guide patient and clinician treatment choices. To fill a pressing evidence gap for SLE pain treatment, the Lupus PROGRESS (Pain Relief With Online Groups That Empower Skill-Based Symptom Reduction) trial will compare a lower-burden evidence-based behavioral pain treatment with online multisession cognitive behavioral therapy (CBT; the gold standard behavioral treatment for chronic pain) while also enhancing diversity and representativeness among patient advisors and study participants.

OBJECTIVE: Lupus PROGRESS is a national, pragmatic, randomized noninferiority trial comparing the effectiveness of 2 evidence-based behavioral pain treatments (online 8-session CBT vs 1 session the Empowered Relief program; Stanford University) in adults with SLE and chronic pain in the United States for reducing pain intensity and pain interference at 3 months after treatment (multiple primary end points).

METHODS: In total, 150 adults with SLE and pain (≥3 months, intensity of ≥3/10) will be enrolled from academic medicine, community health network, and insurance payer study sites. Participants are randomized 1:1 to either 1-session Empowered Relief or 8-session CBT, with both treatments delivered online to groups. Mixed-model repeated measures and intention-to-treat analytic approaches will be used to test comparative effectiveness aims from baseline to 3 months after treatment (the primary end point). Multiple primary outcomes are pain intensity and pain interference; priority secondary outcomes are sleep disturbance, pain catastrophizing, pain bothersomeness, and anxiety; and other secondary outcomes are satisfaction with roles and responsibilities and global impression of change, anger, fatigue, and depression. Durability of effects will be tested at 6 months after treatment. Empowered Relief is hypothesized to have superior treatment completion and adherence and lower treatment burden ratings than CBT. In exploratory analyses, we will compare health care use through medical record and claims data 3 months prior to enrollment to the last 3 study months, hypothesizing reduced noninferiority in reduced use. The study also incorporates a multilevel patient engagement infrastructure to improve accessibility, recruitment, and study relevance.

RESULTS: As of May 2026, we have enrolled 130 participants. Enrollment is anticipated to end in November 2026, with treatments completed by April 2027 and full analyses completed by February 2028.

CONCLUSIONS: Lupus PROGRESS will provide real-world pragmatic evidence on whether a 1-session online group skill-based treatment is noninferior to 8-session CBT. Results from this patient-centered study will inform more accessible, equitable, and patient-centered chronic pain care for people living with lupus.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05612750; https://clinicaltrials.gov/study/NCT05612750.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/100104.

PMID:42641149 | DOI:10.2196/100104

Inquiry. 2026 Jan-Dec;63:469580261469829. doi: 10.1177/00469580261469829. Epub 2026 Aug 25.

ABSTRACT

IntroductionPeople with a low socio-economic position (SEP) are disproportionally affected by both chronic diseases and with reduced access to, use of, and perceived benefits from e-health. People with one or more chronic diseases are likely to experience a greater burden of disease and have more frequent interactions with the healthcare system and e-health. This study provides insights in whether socio-economic differences in e-health use exist in a Dutch population of people with one or more chronic diseases.MethodsIn 2023 a questionnaire was sent out to 2,113 members of a Dutch panel consisting of people with one or more chronic diseases. Participants were asked about the use of five e-health applications and their inclination to use e-health. E-health applications included: websites, apps, wearables, patient portal and digital communication. Educational attainment was used as a proxy for SEP. Results were stratified by level of educational attainment.ResultsThe response rate was 1,543/2,113, 73%, the final study sample was 1,517. Results show that participants with a lower educational attainment used significantly less websites (OR 4.78, 95% CI, 3.50-6.53), apps (OR 2.88, 95% CI, 2.00-4.16), wearables (OR 2.12, 95% CI, 1.52-2.95) and patient portals (OR 3.24, 95% CI, 2.38-4.41) compared to higher educational attainment groups. Participants with a high educational attainment were more likely to be inclined (RRR 2.21, 95% CI 1,48-3,31) and less likely to be uncertain about e-health use (RRR 0.56, 95% CI 0,39-0.81) compared to participants with a low educational attainment.ConclusionDifferences in e-health use and positive inclination towards e-health use also exist between socio-economic groups in a population of people with a chronic disease. These findings show that current practice and implementation of e-health for people with chronic disease does not serve all patients equally, demanding more attention towards inclusive organization of e-health.

PMID:42641147 | DOI:10.1177/00469580261469829

Surg Laparosc Endosc Percutan Tech. 2026 Aug 24. doi: 10.1097/SLE.0000000000001499. Online ahead of print.

NO ABSTRACT

PMID:42641142 | DOI:10.1097/SLE.0000000000001499

Rev Esc Enferm USP. 2026 Aug 24;60:e20260155. doi: 10.1590/1980-220X-REEUSP-2026-0155en. eCollection 2026.

ABSTRACT

OBJECTIVE: To explore sexual violence in Indonesian higher education and the psychological impact on women who intend to speak up.

METHOD: This mixed-methods study combined an online survey of 472 respondents, including students, lecturers, officials, and staff from two universities, with follow-up interviews to enrich and validate the survey.

RESULTS: Sexual violence occurred in various forms on campus, with 12% of respondents reporting victimization and 18% choosing not to disclose the experiences. Some contributing factors to sexual violence on campuses include peer pressure, power abuse, lower moral values, and the ability to conduct sexual violence. The victims dealt with significant psychological problems, such as trauma, fear, depression, a desire to self-harm, and a decline in academic performance.

CONCLUSION: Campuses must have comprehensive interventions for sexual violence survivors to create a safer and more responsive academic environment.

PMID:42641141 | DOI:10.1590/1980-220X-REEUSP-2026-0155en

JMIR Form Res. 2026 Aug 25;10:e102681. doi: 10.2196/102681.

ABSTRACT

BACKGROUND: Rural communities continue to experience behavioral health disparities associated with workforce shortages, digital exclusion, and fragmented coordination between trusted community-based supports and formal behavioral health systems. Although telehealth has expanded opportunities for care, less is known about how key implementation factors interact within hybrid behavioral health systems-coordinated systems that integrate trusted community-based support with formal digital behavioral health services-or how these interactions influence implementation and engagement across community and formal care settings.

OBJECTIVE: This exploratory pilot study examined implementation domains relevant to hybrid behavioral health systems in rural communities using the hybrid community care model (HCCM) as the conceptual framework for survey development and interpretation of the findings.

METHODS: A cross-sectional survey was administered to professionals and community stakeholders attending a rural community workshop in the Midwestern United States, with a 46.3% (38/82) response rate. Survey items operationalized 4 theoretically informed implementation domains: relational trust, digital system capacity, coordination, and perceived feasibility of hybrid care models. Descriptive statistics and Spearman rank-order analyses were conducted to examine preliminary associations among individual survey items.

RESULTS: Spearman rank-order correlations indicated that coordination-related items demonstrated the strongest and most consistent associations, particularly among referral knowledge, collaboration between the community and behavioral health providers (BHPs), and continuity of care (ρ=0.383-0.633; P≤.02). Perceived hybrid care feasibility demonstrated more variable associations, with respondents perceiving more limited BHP and appointment availability reporting stronger support for community-BHP partnerships (ρ=-0.471 and -0.648, respectively; P=.004 and P<.001).

CONCLUSIONS: Preliminary findings suggest that coordination warrants further investigation as an implementation process within hybrid behavioral health systems. The HCCM served as a conceptual framework for interpreting the observed perception patterns and provides a foundation for future hypothesis-driven implementation research. Additional studies using validated measures are needed to further evaluate the implementation domains represented within the HCCM and examine their applicability across diverse rural settings.

PMID:42641127 | DOI:10.2196/102681

J Clin Oncol. 2026 Aug 25:JCO2502234. doi: 10.1200/JCO-25-02234. Online ahead of print.

ABSTRACT

PURPOSE: To compare hypofractionated radiotherapy (RT) with conventional RT for treating biochemical recurrence following radical prostatectomy.

METHODS: Between 2019 and 2021, 316 patients with intermediate- to high-risk prostate cancer were randomly assigned to receive salvage RT with either 65 Gy in 26 fractions (hypofractionated RT, HYPO) or 66 Gy in 33 fractions (conventional RT, CONV). RT was delivered to the prostate bed, with elective pelvic nodal irradiation performed at the discretion of radiation oncologists. Intensity-modulated RT with daily image guidance was used. The primary end point was biochemical progression-free survival (bPFS). Secondary end points included distant metastasis-free survival (DMFS), prostate cancer-specific survival (CSS), toxicity profiles, and patient-reported quality-of-life.

RESULTS: One hundred fifty-one patients (51.2%) received androgen deprivation therapy, and 202 (68.5%) underwent elective nodal irradiation. Endorectal balloons were used in 186 men (63.1%). The median pre-RT prostate-specific antigen level was 0.36 ng/mL (IQR, 0.24-0.49 ng/mL). After a median follow-up of 52.6 months, the 4-year bPFS rates were 80.1% and 78.1% in the HYPO and CONV arms, respectively. There were no significant differences in DMFS (91.7% v 91.0%) and CSS (100% v 100%). The 4-year cumulative incidence of grade ≥2 GI toxicity was higher in the HYPO arm (7.9% v 0.7%), predominantly among patients without an endorectal balloon; all cases were resolved by the last follow-up. Patient-reported quality-of-life outcomes were comparable.

CONCLUSION: bPFS was not superior in the HYPO arm at 4 years. However, given the comparable oncologic outcomes, toxicity profiles, and quality-of-life measures, hypofractionated RT may be considered a viable alternative in the salvage setting. Further research is needed to determine whether the use of an endorectal balloon reduces GI toxicity.

PMID:42641124 | DOI:10.1200/JCO-25-02234

J Gerontol Nurs. 2026 Sep;52(9):6-12. doi: 10.3928/00989134-20260806-03. Epub 2026 Sep 1.

ABSTRACT

PURPOSE: To identify the prevalence of polypharmacy and its association with age, sex, body mass index (BMI), comorbidity, and medication categories in Irish residential health care settings for older adults.

METHOD: This quantitative retrospective study was conducted in a residential health care setting for older adults, with 30 participants aged ≥65 years.

RESULTS: Prevalence of hyper-polypharmacy (60%) and polypharmacy (37%) was high. Of participants, 97% were taking medications for central nervous system disorders. The three leading medication classes included analgesics (90%), antidepressants (66%), and laxatives (66%). Due to a relatively small sample size, no statistically detectable association was found between the number of medications and age, sex, BMI, and comorbidities.

CONCLUSION: Provision of education for health care professionals and raising awareness among older adults to reduce polypharmacy and associated risks is important. Although the study is limited by insufficient statistical power due to the small sample size, the study design and methods provide preliminary evidence to inform future large-scale research. Further research in Ireland using larger sample sizes is recommended to determine the significance of polypharmacy in relation to these variables.

PMID:42641120 | DOI:10.3928/00989134-20260806-03

JMIR Mhealth Uhealth. 2026 Aug 25;14:e94070. doi: 10.2196/94070.

ABSTRACT

BACKGROUND: AI-powered digital mental health interventions (DMHIs) are a promising approach to address barriers to traditional mental health care. However, real-world evidence of their immediate and sustained benefits remains limited.

OBJECTIVE: The purpose of this real-world, retrospective study is to explore patterns of perceived mood and stress change associated with the use of Yuna, an AI-powered DMHI. We aimed to (1) describe user demographics and session characteristics, (2) quantify the magnitude of mood and stress change within sessions and over time with continued Yuna use, and (3) identify session-level factors associated with changes in mood and stress.

METHODS: Adult Yuna users (aged ≥18 y) who initiated at least one session with the Yuna app were included in this study. Users self-reported mood and stress on Visual Analog Scales (VASs; range 0-1) before and after sessions. Linear mixed effects models were used to explore the immediate, within-session improvements in mood and stress, and the sustained, between-session changes in symptoms of mood and stress. Linear mixed effects models were also used to examine session-level predictors of within-session improvements, including baseline symptom severity, session duration, total number of unique therapeutic approaches used, safety guardrail activation, and gender.

RESULTS: A total of 5549 real-world users were included (2901/5549, 52.3% female; mean sessions 3.44, SD 9.83). Users demonstrated significant, immediate within-session improvements in both mood (d=0.55) and stress (d=0.56), with sensitivity analyses yielding consistent results. Between-session analyses revealed gradual improvements in baseline mood (d=-0.009) and stress (d=-0.011). Baseline symptom severity was the strongest predictor of immediate, within-session change (mood: β=.118, SE 0.003; P<.001; stress: β=.131, SE 0.004; P<.001), followed by session duration (mood: β=.027, SE 0.003; P=.003; stress: β=.029, SE 0.003; P<.001). A greater number of unique therapeutic approaches used was associated with smaller improvements in both outcomes (mood: β=-0.007, SE 0.003; P=.043; stress: β=-0.011, SE 0.003; P=.002).

CONCLUSIONS: Use of Yuna, an AI-powered DMHI, was associated with perceived within-session improvements in mood and stress, with preliminary evidence of gradual improvements in mood and stress across repeated sessions. However, the absence of a control group and potential selection bias preclude causal conclusions. These findings offer promising, real-world evidence for AI-powered DMHIs as accessible, on-demand support tools. Prospective, controlled designs are needed to establish causal effects and evaluate the sustainability of observed improvements.

PMID:42641108 | DOI:10.2196/94070

J Indian Soc Pedod Prev Dent. 2026 Jul 1;44(4):462-470. doi: 10.4103/jisppd.jisppd_216_26. Epub 2026 Aug 25.

ABSTRACT

BACKGROUND: Dental caries is a chronic microbial disease, characterized by progressive enamel demineralization. Improved understanding of its pathogenesis has shifted dentistry toward minimally invasive biomimetic strategies such as Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP). Chitosan, a natural polysaccharide with antibacterial and biomimetic mineralization properties, has recently emerging as a promising alternative. Hence, this study compared the remineralization efficacy of CPP-ACP and chitosan hydrogel on artificially induced enamel lesions on primary enamel.

METHODOLOGY: Thirty-six extracted human molars were sectioned into four parts: sound enamel (control), demineralized enamel, and two experimental groups – Group A (CPP-ACP) and Group B (chitosan hydrogel). Demineralization was carried out for 96 h followed by remineralization using a 21-day pH-cycling model with twice-daily application of the respective agents. Energy-dispersive X-ray spectroscopy was used for Ca/P ratio analysis in all specimens. Surface microhardness (SMH) was assessed using Vickers microhardness testing for all the samples. A separate subset of three samples from each group evaluated under the scanning electron microscopy (SEM) for surface morphological assessment. Statistical analysis was performed using the Kruskal-Wallis and pairwise Mann-Whitney U -tests ( P < 0.05).

RESULTS: Group B demonstrated higher SMH (211.2 ± 32.5) and Ca/P ratio (1.74 ± 0.08) compared to Group A. Significant differences were observed among the groups. Pairwise analysis showed both CPP-ACP and chitosan hydrogel significantly improved the Ca/P ratio compared to demineralized enamel ( U = 66.5, P < 0.001), while the chitosan group demonstrated Ca/ P values comparable to sound enamel. SEM analysis revealed more uniform enamel-like crystal deposition in Group B.

CONCLUSION: Chitosan hydrogel demonstrated superior remineralization compared to CPP-ACP, highlights its potential as a nonfluoridated, biomimetic, clinically translatable material for enamel remineralization.

PMID:42641100 | DOI:10.4103/jisppd.jisppd_216_26

J Indian Soc Pedod Prev Dent. 2026 Jul 1;44(4):455-461. doi: 10.4103/jisppd.jisppd_206_26. Epub 2026 Aug 25.

ABSTRACT

BACKGROUND AND AIM: Changes in lifestyle and food habits have led to increased consumption of processed foods by children. These foods contain additives which may affect primary teeth enamel. This study aimed to assess the erosive potential of various condiments on primary teeth enamel.

MATERIALS AND METHODS: Freshly extracted sound primary teeth were decoronated and sectioned mesiodistally to give 105 tooth sections. They were coated with acid resistant nail varnish, leaving a 5 mm × 5 mm window, and stored in 0.9% sodium chloride solution. Fifteen enamel specimens served as baseline controls and were assessed for surface roughness, surface hardness, and calcium content. The remaining 90 specimens were allocated to six groups ( n = 15) and subjected to the exposure protocol. Six condiments were evaluated for pH, titratable acidity (TA), and viscosity and used to expose enamel specimens ( n = 15/group) twice daily for 15 days, with storage in artificial saliva between exposures. Following this, samples were reassessed and data were statistically analyzed.

RESULTS: All six condiments were acidic, with the lowest mean pH and highest TA observed for imli sauce, while chocolate syrup showed the highest pH and lowest TA. Veg mayonnaise showed the highest viscosity. Significant changes in enamel surface roughness, surface hardness and apparent calcium content were observed following exposure ( P < 0.05).

CONCLUSIONS: Exposure to all six condiments demonstrated erosive potential on primary tooth enamel. Frequent consumption may increase the risk of dental erosion in children, particularly in those with altered salivary characteristics or enamel defects.

PMID:42641099 | DOI:10.4103/jisppd.jisppd_206_26