6-month Assessment Research Articles

Abstract PO2-08-10: Effect of 6 months of bazedoxifene + conjugated estrogens on body composition and insulin resistance

Abstract Menopause transition is often marked by an acceleration of visceral fat accumulation. Excess visceral fat is associated with insulin resistance and increased risk for breast cancer as well as heart disease and diabetes. We measured change in body composition (via iDXA), fasting insulin and glucose as part of an ongoing, Phase IIB trial (NCT04821141) of 6 months of bazedoxifene (BZA) + conjugated estrogen (CE) vs control with primary endpoints of change in mammographic density and breast tissue Ki-67. Participants are women ages 45-60 with vasomotor symptoms at increased risk for development of breast cancer. Methods: Visceral and total fat, lean, and total mass, were measured with iDXA (GE CoreScan™). Fasting plasma was assayed same day as drawn for total insulin using a chemiluminescence assay and glucose using a hexokinase method. Values generated were used to calculate HOMA IR (as a measure of insulin resistance) using the formula insulin µl/ml x glucose mg/dl/405. HOMA %S was calculated as 1/HOMA IR X100 as a measure of insulin sensitivity. Optimal HOMA IR is considered as ≤1; HOMA IR >1.5 is considered abnormal with >2.0 as evidence of insulin resistance. Optimal HOMA %S is 100%. Results: 24 women (12 BZA+CE, 12 Control) have completed baseline and 6-month body composition and insulin resistance assessments. Women randomized to BZA+CE were more likely to experience reduction in insulin resistance and improved insulin sensitivity despite a small weight gain over the initial 6 months. 7/12 randomized to BZA+CE had ≥15% reduction in HOMA IR vs only 2/12 controls. Three participants had HOMA IR >2 at baseline. Of these, one was randomized to BZA+CE and had a normal HOMA IR value at 6 months. The remaining two women were in the control group and saw no improvement in HOMA IR at 6 months. In addition, one woman randomized to control with normal HOMA-IR at baseline had HOMA IR > 2 at 6 months. Next Steps: The improvements in insulin resistance parameters with BZA+CE are similar to those observed in our rodent studies, supporting this combination as promising for use in breast cancer risk reduction in women with vasomotor symptoms at high-risk for metabolic disease. Citation Format: Carol Fabian, Adrian Zelenchuk, Kandy Powers, Amy Kreutzjans, Krystal Pittman, Bill Hendry, Christy Altman, Erin Giles, Katherine L. Cook, Stephen Hursting, Bruce Kimler. Effect of 6 months of bazedoxifene + conjugated estrogens on body composition and insulin resistance [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-08-10.

Abstract PO4-27-08: A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and HormoneTherapy for Treatment of Bone Metastasis in Breast Cancer Patients

Abstract Background: This Phase II study aimed to determine the efficacy and safety of administering palliative radiotherapy (RT) to bone metastases (mets) in patients (pts) receiving concurrent palbociclib and hormone therapy (HT) for hormone receptor positive, Her2/neu negative breast cancer. The primary endpoint was response rate 3 months after RT. Methods: Pts with painful bone mets or asymptomatic bone mets with risk for impending clinical event were treated with RT to 30 Gy in 10 fractions or 20 Gy in 5 fractions with concurrent palbociclib and HT. Change in maximum pain score on the Brief Pain Inventory was used to assess pain response 3 months post RT relative to baseline. Among pts with asymptomatic bone lesions, response was defined as prevention of a clinical event (e.g., bone fracture) without evidence of local tumor growth on surveillance imaging. Patient reported outcomes (PROs) of fatigue, depression, anxiety, and quality of life were collected. Blood-based biomarkers were examined to determine their relationship with response and PROs. Using a non-inferiority study design, a sample size of at least 33 pts was needed to achieve 80% power to detect a non-inferiority proportion of 60% using a one-sided binomial test and assuming a Type I error of 0.05. Results: Among 38 patients enrolled, 79% had painful bone mets. 35 pts completed baseline and 3-month post RT assessments. 61% and 37% of pts received aromatase inhibitors and fulvestrant, respectively, with palbociclib. Median age was 60 years (31-83) and 25% of pts were non-Hispanic Black. The majority (72%) of pts received 5 fraction RT and 69% received RT to one bone region. 29 patients (83%) were responders [95% CI: 66%-93%, p=.003]. Median progression free survival (PFS) was 30.4 months (1.3 - 44.0). Three-year PFS and overall survival were 45.6% and 67.2%, respectively. Grade 3 neutropenia developed in 4 (11%), 4 (11%), and 7 (20%) pts at end of RT, 1 month, and 3 months post RT, respectively. No pts developed Grade 4 neutropenia. One patient developed Grade 3 gastrointestinal toxicity during RT, another developed Grade 3 dyspnea 1 month post XRT, and another developed a bone fracture 6 months after RT. >While patient reported measures of fatigue, depression, and overall quality of life did not significantly change during or after RT relative to baseline, pain scores (i.e., BPI pain severity and interference, BM22 pain characteristics and pain site subscales, EORTC C15 pain) significantly decreased 3 months post XRT relative to baseline. Heightened inflammatory marker levels (e.g., TNFRII, IL1ra, CRP, TNF alpha) were significantly associated with worse symptoms of fatigue (MFI) and depression (HADS), increased pain interference (BPI), and lower overall quality of life (SF-36), controlling for age and time using mixed effect models. Patients with improved pain symptoms and lower pain scores had significantly lower inflammatory marker levels relative to baseline (e.g., interleukin-6). Conclusions: Our study demonstrated high rates of response to concurrent RT with palbociclib and HT with acceptable levels of toxicity. These results suggest that RT to bone mets effectively alleviates pain in patients taking palbociclib and pain response to treatment is associated with decreased inflammatory markers. RT may be given to pts receiving palbociclib and HT for breast cancer. Clinical Trial Identification: NCT03691493 Citation Format: Mylin Torres, Jolinta Lin, Sarah Friend, Canhua Xiao, Yichun Cao, Shannon Kahn, Karen Godette, Sheela Hanasoge, David Yu, Tony Eng, Matthew Cheney, Nancy Wiggers, Andrew Pippas, Keerthi Gogineni, Jane Meisel, David Schuster, Aditya Bardia, Andrew Miller, Jennifer Felger, Jeffrey Switchenko, Amelia Zelnak, Kevin Kalinsky, Manali Bhave. A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and HormoneTherapy for Treatment of Bone Metastasis in Breast Cancer Patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-27-08.

Booster effects and mechanisms of web-based personalised normative feedback alcohol intervention for college students: A pragmatic randomised controlled trial

BackgroundTo evaluate the effects of booster and no booster versions of web-based alcohol Personalised Normative Feedback (PNF) and whether descriptive norms mediated and/or participant motivation moderated the effectiveness of the intervention in real world conditions (i.e. no financial incentives). MethodsPragmatic randomised controlled trial with 1-, 3-, and 6-month assessments. Brazilian college students reporting alcohol use in the last 12 months (N=931) were recruited from May/2020 to December/2022 and allocated to 1) No booster/single PNF(S-PNF); 2) Booster/multiple PNF(M-PNF); or 3) Assessment-only control. We applied Helmert coding [1: Any intervention (S-PNF or M-PNF) vs. Control; and 2: S-PNF vs. M-PNF]. Primary outcomes: typical number of drinks/week and maximum number of drinks/week; secondary outcomes: drinking frequency and number of consequences. Three-months assessment was the primary interval. Descriptive norms were tested as mediator. Interest, importance, and readiness to change were examined as moderators. ResultsCompared to control, any intervention did not influence primary outcomes at 3-months or 6-months, but did at 1-month, when reduced typical drinking (IRR:0.77, 95%CI:0.66;0.90) and maximum number of drinks (IRR:0.69, 95%CI:0.58;0.82). There was an intervention effect on the consequences at 3-months. No differences were observed between S-PNF and M-PNF. No mediation effects were found at 3-months. At 6-months, there was an indirect effect on typical drinking through norms at 3-months (b=-0.82, 95%CI:-2.03;-0.12) and effects on maximum drinks through norms at 1-month (b=-0.54, 95%CI:-1.65;-0.02). No support for moderation was found. ConclusionsIntervention reduced alcohol drinking at 1 month only and was not effective thereafter. Mechanisms of effect remain unclear.

Cognitive Behavior Therapy vs Mindfulness in Treatment of Prolonged Grief Disorder

Although grief-focused cognitive behavior therapies are the most empirically supported treatment for prolonged grief disorder, many people find this treatment difficult. A viable alternative for treatment is mindfulness-based cognitive therapy. To examine the relative efficacies of grief-focused cognitive behavior therapy and mindfulness-based cognitive therapy to reduce prolonged grief disorder severity. A single-blind, parallel, randomized clinical trial was conducted among adults aged 18 to 70 years with prolonged grief disorder, as defined in the International Classification of Diseases, 11th Revision, and assessed by clinical interview based on the Prolonged Grief-13 (PG-13) scale. Those with severe suicidal risk, presence of psychosis, or substance dependence were excluded. Between November 2012 and November 2022, eligible participants were randomized 1:1 to eleven 90-minute sessions of grief-focused cognitive behavior therapy or mindfulness-based cognitive therapy at a traumatic stress clinic in Sydney, Australia, with follow-up through 6 months. Both groups received once-weekly 90-minute individual sessions for 11 weeks. Grief-focused cognitive behavior therapy comprised 5 sessions of recalling memories of the deceased, plus cognitive restructuring and planning future social and positive activities. Mindfulness-based cognitive therapy comprised mindfulness exercises adapted to tolerate grief-related distress. The primary outcome was change in prolonged grief disorder severity measured by the PG-13 scale assessed at baseline, 1 week posttreatment, and 6 months after treatment (primary outcome time point), as well as secondary outcome measures of depression, anxiety, grief-related cognition, and quality of life. The trial included 100 participants (mean [SD] age, 47.3 [13.4] years; 87 [87.0%] female), 50 in the grief-focused cognitive behavior therapy condition and 50 in the mindfulness-based cognitive therapy condition. Linear mixed models indicated that at the 6-month assessment, participants in the grief-focused cognitive behavior therapy group showed greater reduction in PG-13 scale score relative to those in the mindfulness-based cognitive therapy group (mean difference, 7.1; 95% CI, 1.6-12.5; P = .01), with a large between-group effect size (0.8; 95% CI, 0.2-1.3). Participants in the grief-focused cognitive behavior therapy group also demonstrated greater reductions in depression as measured on the Beck Depression Inventory than those in the mindfulness-based cognitive therapy group (mean difference, 6.6; 95% CI, 0.5-12.9; P = .04) and grief-related cognition (mean difference, 14.4; 95% CI, 2.8-25.9; P = .02). There were no other significant differences between treatment groups and no reported adverse events. In this study, grief-focused cognitive behavior therapy conferred more benefit for core prolonged grief disorder symptoms and associated problems 6 months after treatment than mindfulness-based cognitive therapy. Although both treatments may be considered for prolonged grief disorder, grief-focused cognitive behavior therapy might be the more effective choice, taking all factors into consideration. anzctr.org.au Identifier: ACTRN12612000307808.

Fraction Dose Escalation of Hypofractionated Radiotherapy with Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-Small Cell Lung Cancer: A Phase I Study.

This phase I trial aimed to determine the maximum tolerated fraction dose (MTFD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer. Split-course hypo-RT and hypoboost combined with concurrent chemotherapy was administered at three dose levels (DL), using a stepwise dose-escalation protocol. The sophisticated esophagus-sparing technique was implemented to restrict the dose to the esophagus. Patients who did not experience disease progression or unresolved ≥grade 2 (G2+) toxicities after RT received cICI. Each DL aimed to treat six patients. The MTFD was defined as the highest DL at which ≤2 patients of the six who were treated experienced treatment-related G3+ toxicity and ≤1 patient experienced G4+ toxicity within 12 months post-RT. Eighteen patients were enrolled, with six patients in each DL. All patients completed hypo-RT and concurrent chemotherapy, and 16 (88.9%) received at least one infusion of cICI, with a median of 10 infusions. Within the 12-month assessment period, one patient in DL1 experienced G3 pneumonitis, and one patient in DL3 developed G3 tracheobronchitis. The MTFD was not reached. The objective response rate was 100%. With a median follow-up of 20.9 months, the 1-year overall survival and progression-free survival rates were 94.4% and 83.3%, respectively. Utilizing the split-course hypo-RT and hypoboost approach, a fraction dose of 5 Gy to a total dose of 60 Gy, combined with concurrent chemotherapy and subsequent cICI, was well tolerated and yielded a promising objective response rate and survival outcomes.

Characterizing autoimmune uveitis to systemic diseases: a retrospective study from a Syrian tertiary reference center.

Uveitis, a notable cause of severe visual impairment, is frequently characterized as infectious or noninfectious autoimmune uveitis (AU), the latter of which is commonly associated with younger individuals and systemic diseases. Despite the condition's widespread impact, there are substantial gaps in the comprehension of its pathogenesis, clinical presentation, and therapeutic response, particularly concerning systemic disease-associated uveitis. The current study aims to bridge these gaps through an extensive examination of demographic and clinical features in AU patients, thereby informing future research, and therapeutic strategies, and improving patient outcomes. This retrospective observational study analyzed 261 patients with systemic disease-associated uveitis from January 2018 to December 2022 in Damascus, Syria. With diagnoses made using the Standardization of Uveitis Nomenclature Working Group Criteria, the study evaluated tailored treatment efficacy at the 24-month post-treatment mark, alongside comprehensive ophthalmic examinations, laboratory evaluations, and radiographic assessments. In our study, included 87 patients with Systemic Disease-Associated Autoimmune Uveitis (SDA-AU). Women represented 64.36% of this group, and the mean age at diagnosis was 39.8±17.9 years (range 7-71) for men and 43.8±15.4 years (range 11-69). The most reported symptom was a painful red eye (52.87%). The onset of symptoms was sudden for 32.18% of patients, while 67.81% reported gradual development. Complications occurred in 33.33% of patients, including cataracts (41.37% of those with complications) and glaucoma (17.24%). Laboratory evaluations showed elevated inflammation markers in 66.66% of patients. Upon the 24-month assessment, 48.27% of patients achieved complete remission, 37.93% showed significant improvement, while disease worsened in 13.79% of cases. Our findings demonstrated that the presentation of AU in this cohort frequently precedes the diagnosis of systemic diseases, affirming the vital role of an early and accurate diagnosis of uveitis for the detection of underlying systemic conditions. In conclusion, our study underlines the significance of a comprehensive and multidisciplinary approach in the management of SD-AU, leading to improved prognosis and quality of life for patients.

Coping and empowerment preventive intervention buffers early adolescent neuroendocrine-related risk for internalizing problems

There is an absence of mechanism-driven interventions equipped to reduce the large mental health disparities that exist for preadolescent youth living in poverty. Building a Strong Identity and Coping Skills (BaSICS) is a preventive intervention designed to target multiple aspects of poverty-related stress adaptation, including altered neuroendocrine function. The purpose of the current study was to examine whether pre-post shifts in preadolescent hypothalamic-pituitary-adrenal (HPA) activation could longitudinally predict internalizing outcomes and to determine whether BaSICS could buffer such HPA-related risk for psychopathology. Low-income youth (n = 112) ages 11–12 years were randomized to the 16-session intervention or assessment-only control (53% intervention; 54% female; 40% Hispanic, 63% Black, 20% White). Youth completed questionnaires and the Trier Social Stress Test, and provided cortisol via saliva at six timepoints during the 90-minute assessment. Adjusting for pre-intervention Cortisol Area Under the Curve–Ground (CAUCg) scores and internalizing problems, post-intervention CAUCg and intervention main and interactive effects were modeled as predictors of internalizing outcomes across post-intervention, 6-month, and 12-month follow-up assessments using multilevel regression methods. A significant post-intervention CAUCg by intervention interaction emerged (B=1.198, SE=0.433, p = .006). For control youth, baseline-adjusted decreases in cortisol output were associated with increases in internalizing problems that remained stably elevated across follow-up assessments. For BaSICS youth, however, internalizing problems decreased and remained stably low following program delivery, irrespective of post-intervention increases or decreases in cortisol output. Findings illustrate how BaSICS may buffer against HPA-related risk for internalizing psychopathology and provide support for interventions targeting biological mechanisms of risk for low-income preadolescents.

Clinical study reveals the efficacy of sirolimus in treating primary immune thrombocytopenia: findings from a single-center study.

Immune thrombocytopenia (ITP) is an autoimmune disease that arises because of self-destruction of circulating platelets. The mechanism remains complicated and lacks a standard clinical treatment. Current first-line and second-line medications for ITP have shown limited effectiveness, necessitating the exploration of new therapeutic options. Sirolimus is a mammalian target of rapamycin (mTOR) inhibitor that has been demonstrated to inhibit lymphocyte activity, indicating potential for SRL in the treatment of ITP. This study aimed to evaluate the clinical efficacy of sirolimus as a second-line drug in patients with ITP. The starting dose of sirolimus for adults ranged from 2 to 4 mg/day, with a maintenance dose of 1 to 2 mg/day. For children, the starting dose was 1-2 mg/day, with a maintenance dose of 0.5-1 mg/day. The dosage could be adjusted if needed to maintain a specific blood concentration of sirolimus, typically between 5 and 15 ng/ml, throughout the treatment period. After 3 months, the overall response rate was 60% (12/20), with 30% of patients (6/20) achieving a complete response (CR) and 30% (6/20) achieving a partial response (PR). The CR rate at 6 months remained consistent with the 3-month assessment. No major adverse events were reported, indicating that sirolimus was well tolerated and safe. Analysis of peripheral blood Treg cell percentages in both the control and ITP showed no significant difference before treatment. The percentage of Treg cells increased after treatment with sirolimus, suggesting that sirolimus increases Treg cells. These findings suggest that sirolimus serves as an effective second-line treatment option for ITP, demonstrating favorable clinical efficacy.

Implementing good life with osteoArthritis from Denmark (GLA:D®) in australian public hospitals. Part 1: Feasibility

BackgroundLiterature reporting positive outcomes from the Good Life with osteoArthritis in Denmark (GLA:D®) program in Australia mainly involves patients attending private physiotherapy services. ObjectiveEvaluate the feasibility of implementing GLA:D® in Australian public hospitals. DesignImplementation study in three metropolitan tertiary public hospitals over six months. MethodPatients aged ≥18 years with knee or hip joint-related problems deemed appropriate for non-surgical care were invited to participate in GLA:D®. Feasibility was evaluated using RE-AIM framework components (Implementation, Effectiveness, Maintenance) using service-level metrics, patient-level data, and program fidelity assessment. Findings of qualitative interviews with service providers are presented in Part 2. ResultsImplementation: 70 patients (69 with knee osteoarthritis) participated (13 cohorts). 55 (79%) patients attended both education sessions, and 49 patients (70%) attended 10–12 exercises sessions. Fidelity was met based on environmental, therapist, participant- and program-related criteria. Effectiveness: At 3 months, patients reported lower average pain (visual analogue scale [0–100 mm]: effect size −0.56, 95% CI -0.88 to −0.23) and disability (HOOS/KOOS-12 [100-0]: 0.67, 0.28 to 1.05), and improved quality of life (EQ-5D overall score: 0.46, 0.11 to 0.80). No adverse events were reported. All patients who completed 3-month assessment (n = 52) would recommend GLA:D®. Maintenance: All participating services elected to continue delivering GLA:D® beyond the study. ConclusionsImplementing GLA:D® in Australian public hospitals is feasible, safe, and acceptable to patients with knee osteoarthritis. Public hospital patients with knee osteoarthritis reported improvements in pain, disability, and quality of life similar to previous GLA:D® cohorts.

Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial.

Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx. DERR1-10.2196/53301.

Associations between interconnectedness, compassion, and participation in collective action for people with mental illness: A random-intercept cross-lagged panel modeling approach.

The present study aims to prospectively investigate the relationships between interconnectedness, compassion, and participation in private and public forms of collective action for people with mental illness. Public form refers to collective action at the macrolevel such as large-scale protests and demonstrations going on in the communities. Private form refers to collective action happening at the microlevel that targets promoting awareness of social inequalities and positive changes among personal social circles, such as calling out microaggressions or correcting others' stigmatizing language. Eligible responses from 501 participants were collected at baseline, with 345 and 318 participants retained at 6-month and 12-month follow-up assessments, respectively. Random-intercept cross-lagged panel models were conducted to investigate the mediating role of compassion in the relationships between interconnectedness and participation in private and public forms of collective action. Interconnectedness was consistently associated with a higher frequency of participation in private form, but not public form, of collective action at subsequent time points. Contrary to the hypothesis, results showed the nonsignificant mediating effect of compassion between interconnectedness and participation in both forms of collective action. The present study highlights the potential of interconnectedness in promoting a private form of collective action for the rights of people with mental illness. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The Effectiveness of the Chronic Disease Self-Management Program in Improving Patients' Self-Efficacy and Health-Related Behaviors: A Quasi-Experimental Study.

The Stanford Chronic Disease Self-Management Program (CDSMP) is a valuable educational resource for supporting patients' self-management behaviors. However, no evidence supporting its effectiveness in the Saudi Arabian population exists. Therefore, this study aimed to evaluate the effectiveness of the 6-month CDSMP in individuals with chronic conditions in Saudi Arabia within a primary care context. A quasi-experimental design was conducted in 110 adults living with ≥1 chronic disease in Saudi Arabia. The patients in the experimental group (n = 45) participated in a six-session CDSMP, whereas those in the control group (n = 65) continued their usual care. Baseline and 6-month assessments were conducted using relevant questionnaires to assess outcome measures. Analysis of covariance revealed that the participants who underwent the CDSMP had significantly higher self-efficacy levels in managing their conditions (F = 9.80, p < 0.01) and a greater tendency to adopt healthy behaviors to successfully manage their chronic illnesses (F = 11.17, p < 0.01). The participants who underwent the CDSMP also showed significant improvements in all health-related outcomes compared with those in the control group (p < 0.01). These findings indicated that the program had a positive effectiveness in self-efficacy, self-management behaviors, and health-related outcomes among adults with chronic diseases in Saudi Arabia. The CDSMP may be integrated into primary care settings to help patients successfully manage their chronic conditions.

Acute-Onset Acquired Stuttering Secondary to Concussion: A Case Report

Purpose: Acquired stuttering in young adults can present diagnostic and treatment challenges. This single case report documents the diagnosis of acquired, postconcussive, acute-onset stuttering in an 18-year-old man, describes key elements of a person-centered treatment program conducted via a telerehabilitation platform, and reports documented changes in speech production following intervention. Method: Person-centered care principles, disfluency education, strategies for managing stuttering episodes, and a home program were treatment components. Using the Overall Assessment of the Speaker's Experience of Stuttering (OASES) and speech sample analyses, documentation of initial status and changes over time came from initial, 3-month, 6-month, and follow-up evaluations. Results: Initial OASES scores were consistent with moderate–severe impact for General Information, moderate impact to Daily Communication, and mild–moderate impact with respect to Speaker's Reactions, Quality of Life, and Overall Assessment. The initial speech sample analysis revealed severely disrupted speech production with disfluencies occurring on 60.47% of syllables. In contrast, the 6-month assessment revealed mild or mild–moderate OASES impact scores and disfluencies on 1.78% of syllables. Performance during a follow-up evaluation held 3 months following treatment termination confirmed maintenance of fluent speech production both when reading and engaging in conversation. Conclusion: Clear differentiation between neurogenic and functional contributions to acute-onset, acquired stuttering is not always possible. In some cases, a combination of precipitating factors may be evident. Regardless, presenting traditional fluency management strategies within a framework of person-centered care can be an effective treatment approach. Supplemental Material: https://doi.org/10.23641/asha.25463968

Surgical considerations and techniques using intraoperative indocyanine green angiography for ethmoidal dural arteriovenous fistula.

This study aims to investigate the efficacy of microsurgery with intraoperative indocyanine green (ICG) angiography as a treatment approach for ethmoidal dural arteriovenous fistula (DAVF). Between January 2010 and July 2021, our institution encountered a total of eight cases of ethmoidal DAVF. In each of these cases, microsurgical treatment was undertaken utilizing a bilateral sub-frontal interhemispheric approach, with the aid of intraoperative ICG angiography. ICG angiography identified bilateral venous drainage with single dominance in four cases (50%) of ethmoidal DAVF, a finding that eluded detection during preoperative transfemoral cerebral angiography (TFCA). The application of microsurgical treatment, in conjunction with intraoperative ICG angiography, resulted in consistently positive clinical outcomes for all patients, as evaluated using the Glasgow Outcome Scale (GOS) at the 6-month postoperative follow-up assessment; six patients showed GOS score of 5, while the remaining two patients attained a GOS score of 4. The use of intraoperative ICG angiography enabled accurate identification of both dominant and non-dominant venous drainage patterns, ensuring complete disconnection of the fistula and reducing the risk of recurrence.

Treatment for complete extensor tendon rupture: A case report on extensor pollicis longus tendon transfer and tenodesis procedure to radius for a patient with rheumatoid arthritis.

The complete loss of finger extension leads to significant inconvenience in daily life and often requires surgical treatment. Despite some disadvantages, the Boyes method, which uses the flexor digitorum superficialis tendon, is commonly performed for complete extensor rupture. We report the case of a 73-year-old woman living alone diagnosed with a subcutaneous rupture of all extensor tendons from the index to the little finger. The favourable range of motion of her wrist allowed us to perform extensor tenodesis. Additionally, the patient had a dislocated thumb interphalangeal (IP) joint, enabling us to use the extensor pollicis longus tendon for tendon transfer in combination with thumb IP joint fusion. The patient demonstrated favourable finger range-of-motion outcomes at the 6-month postoperative assessment. The case shows that extensor pollicis longus tendon transfer and tenodesis may be a viable treatment option for patients with complete extensor rupture accompanied by thumb IP joint deformity and normal wrist range of motion.

Childhood Sexual Abuse Moderates the Long-Term Effect of an HIV Prevention Intervention Among Men Who Have Sex With Men With Crystal Methamphetamine Use Disorder

Men who have sex with men (MSM) with a history of childhood sexual abuse (CSA) are more likely to report crystal methamphetamine use and condomless anal intercourse (CAI) than MSM without CSA. MSM with CSA may benefit less in HIV prevention interventions due to long-term psychological effects. Data are from a pilot randomized, controlled trial testing an integrated HIV risk reduction and behavioral activation counseling intervention vs standard of care among MSM with methamphetamine use disorder, which showed effects at reducing CAI. We conducted a secondary analysis (N= 38) to preliminarily assess whether CSA moderated the intervention effects on the two primary outcomes: CAI acts with men whose HIV serostatus was either positive or unknown (1) overall (CAI overall) and (2) while under the influence of methamphetamine (CAI with methamphetamine). At the immediate postintervention assessment, the interaction term between CSA and intervention arm was not statistically significant for either outcome, indicating no moderation effect. However, at the 3-month postintervention assessment, the interaction term was significant for both outcomes. At this time point, for those without CSA, there was a significantly lower number of CAI acts in the intervention condition vs the comparison condition for both outcomes. For those with CSA, however, there was no significant difference between the intervention and comparison conditions for CAI overall, although for the outcome CAI with methamphetamine, the intervention condition had higher levels. Future HIV prevention interventions among MSM with methamphetamine use disorder should consider screening for CSA and addressing CSA-related psychological distress, which may potentially preserve intervention effects.

Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial.

Alcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of substance use and for brief intervention to prevent associated problems and the development of substance use disorder. This study tests the effects of a computer-facilitated screening and brief intervention (cSBI) system (the CRAFFT [Car, Relax, Alone, Forget, Family/Friends, Trouble] Interactive System [CRAFFT-IS]) on heavy episodic drinking, riding with a driver who is substance impaired, or driving while substance impaired among adolescents aged 14 to 17 years presenting for a well visit at pediatric primary care practices. We are conducting a cluster randomized controlled trial of the CRAFFT-IS versus usual care and recruiting up to 40 primary care clinicians at up to 20 pediatric primary care practices within the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings network. Clinicians are randomized 1:1 within each practice to implement the CRAFFT-IS or usual care with a target sample size of 1300 adolescent patients aged 14 to 17 years. At study start, intervention clinicians complete web-based modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention counseling. Adolescents receive mailed recruitment materials that invite adolescents to complete an eligibility survey. Eligible and interested adolescents provide informed assent (parental permission requirement has been waived). Before their visit, enrolled adolescents seeing intervention clinicians complete a self-administered web-based CRAFFT screening questionnaire and view brief psychoeducational content illustrating substance use-associated health risks. During the visit, intervention clinicians access a computerized summary of the patient's screening results and a tailored counseling script to deliver a motivational interviewing-based brief intervention. All participants complete previsit, postvisit, and 12-month follow-up study assessments. Primary outcomes include past 90-day heavy episodic drinking and riding with a driver who is substance impaired at 3-, 6-, 9-, and 12-month follow-ups. Multiple logistic regression modeling with generalized estimating equations and mixed effects modeling will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (eg, cannabis and nicotine vaping), potential mediators of intervention effect (eg, self-efficacy not to drink), and effect moderation by baseline risk level and sociodemographic characteristics. The AAP Institutional Review Board approved this study. The first practice and clinicians were enrolled in August 2022; as of July 2023, a total of 6 practices (23 clinicians) had enrolled. Recruitment is expected to continue until late 2024 or early 2025. Data collection will be completed in 2025 or 2026. Findings from this study will inform the promotion of high-quality screening and brief intervention efforts in pediatric primary care with the aim of reducing alcohol-related morbidity and mortality during adolescence and beyond. ClinicalTrials.gov NCT04450966; https://www.clinicaltrials.gov/study/NCT04450966. DERR1-10.2196/55039.

Assessment of patients’ characteristics associated with the efficacy and safety of oral valganciclovir treatment for infants with symptomatic congenital cytomegalovirus disease

IntroductionInsurance coverage for oral valganciclovir (VGCV) began in Japan in April 2023 on the basis of results, including our clinical trials for symptomatic congenital cytomegalovirus (CMV) disease. The VGCV treatment is available throughout Japan, so clinicians must consider the likelihood of hearing improvement and the possibility of neutropenia before dosing. Materials and methodsWe performed a substudy of an investigator-initiated, single-arm, prospective, multicenter, clinical trial in which 24 infants with symptomatic congenital CMV disease were orally administered 16 mg/kg VGCV twice daily for 6 months as an intervention. We examined the infants’ baseline characteristics associated with improved hearing impairment or a severely reduced neutrophil count. ResultsOf the 24 patients, 4 had normal hearing on assessment of their ear with the best hearing. Hearing impairment improved in 14 patients and did not respond to VGCV treatment in 6 patients at the 6-month hearing assessment. CMV DNA levels in plasma at baseline were higher in patients in whom hearing did not respond to treatment. A neutrophil count <500/mm3 occurred in 5 (21%) patients for the first 6 weeks and in 8 (33%) patients for the first 6 months. A neutrophil count at screening and the lowest neutrophil count over the 6 months showed the highest correlation (r = 0.477, p = 0.019). ConclusionsInfants with a low plasma viral load at screening tend to have an improvement in hearing impairment. Clinicians should be aware of neutropenia during VGCV treatment particularly in patients with a low neutrophil count during screening.

Analysis of the Effectiveness of Anterior Septal Reconstruction in Asians.

Background: Although anterior septal reconstruction (ASR) is effective, it is less commonly employed in Asian patients compared with the septal extension graft technique, even in cases of severe antero-caudal septal deviation. Objective: To compare airflow and patient perceptions after ASR in patients of Korean descent with caudal septal deviations and external nasal deformities, we considered the potential tendency of their septal cartilage to be smaller and less robust compared with that of Caucasians. The measurements were conducted using acoustic rhinometry and patient-reported outcomes. Methods: We analyzed 103 patients using preoperative and 3-month postoperative assessments: Korean version of the Standardized Cosmesis and Health Nasal Outcomes Survey (K-SCHNOS), obstructive (SCHNOS-O), and cosmetic (SCHNOS-C) scores, and minimal cross-sectional area (MCA) measured by acoustic rhinometry. Results: Among 103 patients (mean age 33.36 years, median age 32 years, age range 17-70 years, 77 men [75%], and 26 women [25%]), the average follow-up period for the patients was 264.6 days (median 202 days and range 13-1540 days), SCHNOS-O scores improved significantly from 64.02 ± 4.89 to 19.31 ± 4.45 after ASR (p < 0.001), as did SCHNOS-C scores, improving from 60.61 ± 7.71 to 14.25 ± 4.66 (p < 0.001). MCA increased from 0.30 ± 0.16 cm2 to 0.56 ± 0.38 cm2 (p < 0.001). Conclusions: As measured by MCA and SCHNOS scores at 3 months postoperatively, ASR proves valuable for correcting antero-caudal septal deviations and nasal deformities in Asians, despite the tendency of their septal cartilage to be smaller and less strong compared with that of Caucasians.

Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study.

Upadacitinib (UPA), a selective, reversible, oral Janus kinase (JAK)-1 inhibitor, was approved in 2019 in Canada for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). This phase4 prospective study aimed to characterise the effectiveness of UPA in the real-world population of patients with RA. Adults with RA who initiated treatment with once daily UPA (15mg) and enrolled in the Canadian Real-Life post-marketing Observational Study assessing the Effectiveness of UPadacitinib for treating rheumatoid arthritis (CLOSE-UP) and who completed a 6-month assessment as of 28 February 2023 were included. The primary endpoint of the CLOSE-UP study is the proportion of patients achieving a Disease Activity Score-28 Joint Count C-reactive protein (DAS28-CRP) < 2.6 at 6months. Data was collected at routine visits. Data analysed and summarised descriptively for the overall interim population and for subgroups based on prior therapy included remission or low disease activity, patient-reported outcomes (PROs), and adverse events. A total of 392 patients were included in the interim analysis. Overall, 63.5% (191/301) of patients achieved a DAS28-CRP score < 2.6 at month6, with similar rates observed for all subgroups analysed according to prior therapy including those with prior JAK inhibitor exposure (range 57.4-71.0%), and in patients who received UPA monotherapy (71.6% [48/67]). Early (month3) and sustained improvements up to 6months were observed for all PROs. The safety profile was consistent with previous reports. Real-world improvements in disease activity and PROs in response to UPA treatment were consistent with clinical trial data across a range of Canadian patients with prior therapy exposure and with UPA monotherapy, with an overall favourable benefit-risk profile. NCT04574492.