Acceptable Outcomes Research Articles

Yoga-Based Group Intervention for Inpatients with Schizophrenia Spectrum Disorders-Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial.

The efficacy of yoga as an adjunctive treatment for schizophrenia spectrum disorders (SSD) has garnered interest. While yoga may positively influence various symptom domains, further investigation is needed due to the limited number, quality, and generalizability of studies. This study assessed the feasibility and acceptability (primary outcome) of a yoga-based group intervention (YoGI) developed in a participatory approach and explored its preliminary effectiveness. In addition to the primary outcomes, this preregistered randomized controlled trial examined rater-blinded general psychopathology, positive- and negative symptoms, and self-rated depression, anxiety, stress, body mindfulness, mindfulness, psychological flexibility, cognition, social functioning, quality of life, and medication regime at baseline and postintervention as secondary outcomes. Fifty inpatients with SSD received either TAU (n = 25) or YoGI + TAU (n = 25) for four weeks. Outcomes showed 95% protocol adherence of YoGI, feasibility, and retention rates of 91% and 94%, respectively, and a dropout rate of 6%. ANCOVA revealed significant between-group postintervention improvements for YoGI + TAU in positive symptoms, depression, cognitive fusion, and a mindfulness subscale. Medium-to-large pre- to postintervention effects were found for body mindfulness, positive, negative, and general psychopathology, cognitive fusion, depression, anxiety, stress, quality of life, and attention in YoGI + TAU, while within-group changes were consistently smaller in TAU. No severe adverse events were reported. This trial supports the feasibility and acceptability of YoGI for inpatients with SSD and provides preliminary evidence of YoGI's benefits beyond TAU. Further robust, multicentric RCTs are warranted to deepen our understanding of YoGI's therapeutic potential and inform clinical interventions for SSD.

Efficacy of intravitreal faricimab therapy for polypoidal choroidal vasculopathy: A systematic review and meta-analysis.

Polypoidal choroidal vasculopathy (PCV) is an aneurismal type of macular neovascularization that show similarities with age-related macular degeneration and diseases that are part of the pachychoroid disease spectrum. Exudative changes in PCV can be treated with intravitreal anti-vascular endothelial growth factor monotherapy; however, a combination therapy with photodynamic therapy may be required. In this systematic review and meta-analysis, we evaluated the efficacy of faricimab for PCV. We searched 12 literature databases for eligible studies. All study evaluation and data extraction were made by two authors in duplicate. Studies eligible for analysis were included for a qualitative and quantitative review. We identified seven studies with data from 150 eyes with PCV, five studies were of treatment-naïve eyes who were commenced in faricimab monotherapy, and two studies were of switch-over to faricimab from other anti-VEGF drugs. After faricimab loading dose in treatment-naïve eyes, the best-corrected visual acuity (BCVA) remained stable at -0.09 (95% CI: -0.20-0.03) logMAR, central retinal thickness (CRT) decreased -169 (95% CI: -311--27) μm, and 48.7 (95% CI: 32.5-65.0) % of eyes obtained polyp closure. In switch-over eyes, 57%-67% experienced fluid reduction and 21% were able to extend their treatment interval. In conclusion, faricimab monotherapy for PCV leads to acceptable clinical outcomes in terms of stable BCVA, reduction of CRT, and high incidence of polyp closure. Some cases may benefit from a switch to faricimab. However, long-term efficacy studies and controlled comparative studies are warranted.

Interwoven nitinol stent-assisted arteriovenous fistula maturation: 2 year-outcomes of a single center experience.

The aim of this study was to report 2-year outcomes of interwoven nitinol (SuperaTM) stent-assisted arteriovenous fistula (AVF) maturation in patients who presented with non-matured AVF. We reviewed the clinical data of 20 patients who presented with non-matured AVF (19 patients with brachiocephalic AVF and 1 patient with radiocephalic AVF) and underwent balloon angioplasty followed by SuperaTM stenting in the cephalic vein for long-term hemodialysis between January 2017 and January 2022. The outcomes were evaluated in these patients in terms of technical success, post-intervention complications, reintervention, and cumulative patency (6months, 1year, and 2years). The study included 20 patients who presented with non-matured AVF. The mean age of the patients was 65 years (range, 40-85). The SuperaTM stents of size 6.5mm were used in 15 patients (75%), and those of 7.5mm and 5.5mm were used in 4 (20%) and 1 (5%) patient, respectively. The average stent length was 99.5mm (range, 80-120). Technical success was achieved in all patients. Early use within 1 week by needling at the SuperaTM stent segment (cannulation zone) was successful in all patients without any complications. The mean follow-up time was 24.5 months. During the follow-up period, reinterventions to maintain the function of AVF were performed in 8 patients (40%) (7 patients with juxta-anastomotic stenosis, 1 patient with in-stent restenosis). The reintervention rate was 0.39 procedures per patient per year. The primary patency at 6 months, 1 year, and 2 years were 85.5%, 62.6%, and 54.2%, respectively. The assisted primary patency at 6 months, 1 year, and 2 years were 95%, 84.5%, and 78.8%, respectively. The use of the SuperaTM stent to improve the AVF maturation rate was associated with acceptable outcomes at 2 years. Its benefit over other strategies was the early use of the access for hemodialysis.

HPB SO19 - Comparison of perioperative outcomes of open (CUSA) versus laparoscopic (LOTUS) major hepatectomy – revisited. First evaluation of efficacy and safety of AEONTM stapler

Abstract Background In 2019, preliminary data matching 40 cases demonstrated improved outcomes of laparoscopic major liver resections using the BOWA-LOTUSTM liver blade (Devon, UK). An updated and expanded comparison between open and laparoscopic major hepatectomies is presented as well as evaluating of an endovascular stapler AEON™ (Lexington Medical, Massachusetts, USA). Method January 2020 to June 2023 patients were identified from a prospectively maintained database. Propensity score matching analysis used R statistical tool in SPSS (IBM, New York, USA) to isolate matched open and laparoscopic cases. LOTUSTM ultrasonic energy device was used for parenchymal transection in laparoscopic cases and CUSA (Valleylab, Colorado, USA) in open procedures. AEONTM endovascular stapler was used from early 2021. Results 86 patients constitute the study population after applying propensity score matching analysis in a 1:1 ratio. The median (range) age in the matched sample was 63 (27-83) yrs. Hospital stay (mean 7.8 v 14.7 days; p=0.025) and blood transfusion requirement (0 v 4 units; p=0.035) were all significantly improved when comparing laparoscopic to open. Comparison of the AEONTM stapler with Endo-GIA (Medtronic, MN, USA) showed no significant difference in any outcome measure, although AEONTM demonstrated (non-significantly) a reduced trend in operating time comparing all cases (56 v 69 mins; p=0.300) and laparoscopic (56 v 71 min; p=0.295). Conclusion The LOTUS liver blade continues to be associated with acceptable outcomes in laparoscopic liver resections. The AEONTM endovascular stapler was equivalent to other staplers with a trend towards a shorter operating time in liver transectional surgery.

Percutaneous endoscopic lumbar discectomy versus open fenestration discectomy for lumbar disc herniation: a retrospective propensity score-matched study with more than 5 years of follow-up.

We compared the long-term outcomes of percutaneous endoscopic lumbar discectomy (PELD) with those of open fenestration discectomy (OFD) in treating lumbar disc herniation (LDH). 281 patients were included from January 2013 to December 2018, of whom 228 underwent PELD and 53 underwent OFD. General information of patients was collected and imbalances in covariates between groups were corrected using propensity score matching (PSM). Then, the clinical function scores, imaging data, and complications were compared. Among participants, 102 patients were successfully matched and were followed for 62-128 months. Compared to the OFD group, the PELD group indicated greater improvements in visual analog scale score of low back pain (VAS-BP), Japanese orthopedic association (JOA), and Oswestry disability index (ODI) at 7 days postoperatively and the last follow-up (P < 0.05). At 24 months postoperatively and the last follow-up, the disc height index (DHI), ratio of grays (RVG), and range of motion (ROM) were higher and the compass value was lower (P < 0.05) in the PELD group compared to the OFD group, suggesting that the PELD procedure better maintained the mobility and stability of the responsible segment after surgery. The recurrence rates between the PELD (9.80%) and OFD (7.84%) groups did not reveal statistical differences (P > 0.05). PELD and OFD both provide acceptable clinical outcomes for LDH. However, PELD is superior to OFD in terms of relieving low back pain, delaying disc degeneration, and maintaining segmental stability.

Abstract 4140154: Highly Sensitized Heart Transplant Recipients Who Have Undergone Pre-Transplant Desensitization Therapies Demonstrate Acceptable Medium-Term Outcomes

Introduction/Research Question: Allosensitization, the presence of circulating anti-HLA antibodies, is a barrier in heart transplantation (HT), restricting the donor pool size, and leading to increased waitlist mortality and rejection risk post-HT. Desensitization therapies can be used to broaden the donor pool in highly sensitized patients, defined as pre-HT calculated panel reactive antibodies (cPRA)≥50%, for antibodies with mean fluorescence intensity (MFI)&gt;10,000. There is paucity of data on longer-term outcomes in such high-immunological risk patients. Methods: Sensitized patients with pre-HT cPRA&gt;50%, who were treated with desensitization and then received HT between 2011-2022 at Cedars-Sinai Medical Center were included. Desensitization therapies included bortezomib, rituximab, tocilizumab, obinutuzumab, intravenous immunoglobulin (IVIG), and plasmapheresis. cPRA, donor-specific antibody (DSA) levels, and post-HT clinical outcomes were assessed up to 5-year follow-up, loss to follow-up, or death. Results: 40 patients were analyzed. 77.5% of patients were female, and all had at least 1 risk factor for sensitization. cPRA decreased from 84.5±13.5% at baseline to 74.1±22.4% after completion of desensitization therapy, prior to transplant (p=0.005). Mean follow-up time post-HT was 4.3±2.9 years. 45.0% of patients had antibody-mediated rejection (AMR), 12.5% had CAV. Overall survival was 94.9%, 92.1%, and 87.5% at 1, 3, and 5 years respectively. All patients except 1 had normal left ventricular function at last follow-up. 72.5% of patients were transplanted in the presence of DSA, and 60.0% underwent post-HT induction with eculizumab in addition to antithymocyte globulin (ATG)/IVIG, while the remaining received ATG/IVIG alone. Among HT recipients with pre-formed DSA, 41.4% had high-level DSA (MFI &gt; 10,000) at time of HT. At 6-12 months post-HT, only 17.2% had high-level DSA, and 41.4% had resolution of DSA. Conclusion: Highly sensitized HT candidates who underwent pre-HT desensitization had comparable survival and CAV rates as compared to the general HT population reported in the literature. However, sensitized patients experienced higher rates of AMR which were not associated with graft dysfunction or mortality.

Thibang Diphatlha: a sequential multiple assignment randomized trial designed to increase timely adoption of cervical cancer treatment in Botswana.

Delays and missed opportunities for timely treatment contribute significantly to stark inequities in cervical cancer mortality in low- and middle-income countries (LMICs) compared to high-income countries. The vast majority (approximately 90%) of new cases and deaths occur in LMICs, particularly those with high rates of HIV such as Botswana. To date, most of the implementation and cancer control research in Botswana and other LMICs has focused on cancer prevention and screening, with limited focus on cancer treatment. As such, there is a critical need to identify effective strategies to ensure timely care, and to understand contextual factors that shape the response to strategies. Without this fundamental knowledge, cervical cancer will remain a public health crisis in Botswana and other LMICs. To help fill this known gap, this study tests the effectiveness of adaptive strategies on timely treatment adoption using a hybrid (type III) Sequential Multiple Assignment Randomized Trial (SMART) design and evaluate contextual mechanisms contributing to the success or failure of each adaptive strategy. The adaptive strategies are designed to target contextual determinants identified in our prior work, including delayed communication of results to patients, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics, and are supported by systematic evidence of the effectiveness of nudge strategies in clinical care. The primary implementation outcome is adoption, defined as the initiation of treatment within 90days. Secondary outcomes include fidelity, reach, acceptability, implementation costs, and cancer and HIV-related clinical outcomes. The rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach will both increase timely treatment adoption and be scalable and sustainable after the project is completed. This innovative study seeks to decrease cervical cancer mortality in LMICs by developing and implementing effective and sustainable strategies that can be sustained and adapted to other contexts. Additionally, this study seeks to advance the long-term impact of global implementation science through strong and sustained partnerships in Botswana and other LMICs. ClinicalTrials.govNCT05952141. Registered on July 11, 2023. https://clinicaltrials.gov/study/NCT05952141 PROTOCOL VERSION AND DATE: Version 1 (September 28, 2024).

CTNI-74. SONODYNAMIC THERAPY (SDT) USING INTRAVENOUS 5-AMINOLEVULINIC ACID WITH NON-ABLATIVE FOCUSED ULTRASOUND FOR THE TREATMENT OF DIFFUSE INTRINSIC PONTINE GLIOMAS IN PEDIATRICS: INITIAL SAFETY AND OUTCOMES THE MULTICENTER SDT-201 TRIAL

Abstract Diffuse intrinsic pontine glioma (DIPG) is the leading cause of mortality amongst pediatric neuro-oncologic diseases. Sonodynamic therapy with non-ablative MR-guided focused ultrasound (MRgFUS) is being investigated in multiple clinical trials. We describe safety outcomes and initial efficacy of SDT with 5-ALA for the treatment of pediatric patients with DIPG. Twelve patients with DIPG were treated from August 2022-April 2024 as part of a dose-escalation protocol with SDT in a multicenter Phase 1/2 clinical trial (NCT05123534). MRgFUS was combined with the prodrug SONALA-001 (5-ALA iv) to activate its metabolite, protoporphyrin IX, and thereby induce apoptosis within tumor cells. Treatment is delivered every 4 weeks for up to 12 treatments. Patient ages ranged from 3-23 years and 60% were male. Twelve patients underwent a total of 45 SDT treatments (range 2-9). When enrolled, median tumor volume was 1,337 cm3 (range, 310-2078 cm3) and duration since diagnosis was 5 months. SONALA-001 doses tested were 5 mg/kg and 10 mg/kg. Delivered ultrasonic acoustic energy ranged from 190-444 joules/cm3. After 6 months of median follow-up (range 2-18), 2 partial responses occurred, and 9 of 12 patients had stable or improved baseline symptoms (Lansky Status), including improved mobility and diplopia. One adverse clinical event included a small non-operative epidural hematoma secondary to a stereotactic frame pin. There have been no grade 3 or worse treatment-related adverse events or dose-limiting toxicities. Ten patients are alive a median of 11 months after diagnosis; 2 have deceased; 4 have discontinued treatment. Maximum percent tumor volume changes throughout treatment ranged from a -68% reduction to over 100% enlargement. Preliminary analysis of twelve pediatric patients treated with SDT for DIPG demonstrates acceptable safety outcomes and promising clinical results. Additional patient enrollment and longer follow-up times are required to determine efficacy.

Trends and Outcomes of the Management of Common Bile Duct Stones at KIST Medical College Teaching Hospital

Introduction: Common bile duct (CBD) stones are found in 10% to 15% of patient having cholelithiasis. Various surgical methods including endoscopic, laparoscopic and open surgical techniques are practiced but there is no consensus on the management. This cross-sectional study aims to analyze the demographics and trends un management of CBD stones at KIST Medical College. Methods: Patient undergoing CBD stone management from 15 June 2021 to 31 December 2023 were included in the study. Different treatment methods applied and outcomes were analyzed. Results: Fifty-one patients were included in the study with 18 (25.3 %) males and 33 (64.7%) females. Abdominal pain was the most common symptom. Laparoscopic cholecystectomy(LC) with intraoperative(io)-ERCP was done in 30 (58.8%) patients, while LC + Laparoscopic CBD exploration(LCBDE) was done in 11 (21.6 %) and Endoscopic Retrograde Cholangiopancreatography(ERCP) only was done in 10 (19.6%) patients. The significant difference was observed in the length of hospital stay [5.03 ± 2.13 vs 6.36 ± 2.29, p=0.046] and the number of days the drain was kept [2.20 ±0.45 vs 4 ± 1.90, p=0.037] both favoring LC + io-ERCP group. Stone clearance, post-operative complications and operative time were comparable between the two groups. Conclusion: Single-stage management of cholelithiasis and choledocholithiasis is feasible at our center. Both LC with io-ERCP and LC + LCBDE can be performed selectively with acceptable and comparable outcomes.

Rectal Cancer Watch & Wait Management: Experience of 545 Patients from the U.S. Rectal Cancer Research Group.

The use of a watch and wait management strategy following a complete clinical response to neoadjuvant therapy for rectal cancer is increasing. However, insights into implementation, treatments, and outcomes, on a United States national level, are limited. To investigate and report on watch & wait management practices and outcomes in the US. Retrospective study. Multicenter. Stage II or III rectal cancer patients who underwent intentional watch & wait management between January 2015 and August 2022. Patient and tumor characteristics, neoadjuvant treatment and response, local cancer regrowth and metastasis, salvage surgery, overall and disease-specific survival. Among 545 patients from 33 centers, follow-up was 21 months (range, 9-37). Total neoadjuvant therapy or other types of neoadjuvant were used in 395 (72%) and 150 (28%) of patients, respectively. Estimated 3-year local regrowth rate was 23.8% (95% CI: 19.1-29.4%). Patients with local regrowth had higher distant metastases incidence (14.2% vs. 3.5%, p < 0.001). Salvage surgery was performed in 74/84 (88%) patients with local regrowth and included rectal resection in 66 (89%), and local excision in 8 (11%). Of 64 salvage resections with known pathology results, 58 (91%) were margin-negative. Overall, 3-year overall survival was 94.8% (95% CI: 90.5 - 97.2%) and 3-year disease specific survival 96.2% (95% Cl 91.8 - 98.2%). Patients with and without local regrowth exhibited 3-year overall survival of 83.6% (95% Cl 68.4 - 91.9%), and 97.7% (95% CI: 93.3 - 99.2%), respectively. Retrospective study. This multicenter study indicates that the watch & wait approach for locally advanced rectal cancer is feasible with acceptable outcomes across a variety of geographical regions and practice settings in the US. Local regrowth and distant metastasis rates were within published norms and salvage surgery proved effective. See Video Abstract.

Understanding the purchase intention in live streaming from the perspective of social image

E-commerce live streaming (hereafter, “ELS”) has introduced novel avenues for E-commerce. Driven by commercial goals, ELS streamers work to craft, sustain, and enhance their social images to attract popularity, acceptance, trust, and other beneficial outcomes. This article investigates how various characteristics of a streamer’s social image influence purchase intentions within ELS, using a conceptual model comprising fourteen hypotheses based on the Stimulus-Organism-Response (SOR) framework. This model examines social image through three dimensions that correspond to the intentional behaviors of ELS streamers. The findings indicate that consumers’ purchase intention is significantly influenced by characteristics that benefit the first impression developed by the streamer, namely physical attractiveness. Characteristics that benefit the endorsement of products, namely matchup congruence, authenticity, and expertise, also positively affect consumer purchase intention. Moreover, the effect of streamers’ social image characteristics that benefit communication traits, entertainment, and responsiveness, are tested respectively. However, surprisingly contrary to our expectation, entertainment features have no significant effect on both trust and purchase intention. Responsiveness has significant effects on trust but no significant effects on purchase intention. Potential psychological and regulatory explanations for this finding is provided. The article also offers strategic recommendations for streamers and e-commerce businessmen to refine their live-streaming efforts.

A case study of the development of a valid and pragmatic implementation science measure: the Barriers and Facilitators in Implementation of Task-Sharing Mental Health interventions (BeFITS-MH) measure

BackgroundFew implementation science (IS) measures have been evaluated for validity, reliability and utility – the latter referring to whether a measure captures meaningful aspects of implementation contexts. We present a real-world case study of rigorous measure development in IS that assesses Barriers and Facilitators in Implementation of Task-Sharing in Mental Health services (BeFITS-MH), with the objective of offering lessons-learned and a framework to enhance measurement utility.MethodsWe summarize conceptual and empirical work that informed the development of the BeFITS-MH measure, including a description of the Delphi process, detailed translation and local adaptation procedures, and concurrent pilot testing. As validity and reliability are key aspects of measure development, we also report on our process of assessing the measure’s construct validity and utility for the implementation outcomes of acceptability, appropriateness, and feasibility.ResultsContinuous stakeholder involvement and concurrent pilot testing resulted in several adaptations of the BeFITS-MH measure’s structure, scaling, and format to enhance contextual relevance and utility. Adaptations of broad terms such as “program,” “provider type,” and “type of service” were necessary due to the heterogeneous nature of interventions, type of task-sharing providers employed, and clients served across the three global sites. Item selection benefited from the iterative process, enabling identification of relevance of key aspects of identified barriers and facilitators, and what aspects were common across sites. Program implementers’ conceptions of utility regarding the measure’s acceptability, appropriateness, and feasibility clustered across several common categories.ConclusionsThis case study provides a rigorous, multi-step process for developing a pragmatic IS measure. The process and lessons learned will aid in the teaching, practice and research of IS measurement development. The importance of including experiences and knowledge from different types of stakeholders in different global settings was reinforced and resulted in a more globally useful measure while allowing for locally-relevant adaptation. To increase the relevance of the measure it is important to target actionable domains that predict markers of utility (e.g., successful uptake) per program implementers’ preferences. With this case study, we provide a detailed roadmap for others seeking to develop and validate IS measures that maximize local utility and impact.

Patients Have Acceptable Patient-Reported Outcome Measures After Medial Unicompartmental Knee Arthroplasty Regardless of Age

BackgroundContemporary evidence-based indications no longer consider age regarding eligibility for medial unicompartmental knee arthroplasty (mUKA). This has led to more surgical candidates; however, whether patients still have satisfactory outcomes lacks evidence. This study examined the association between age and change in patient-reported outcome measures (PROMs) after mUKA as well as the achievement of Patient Acceptable Symptom State (PASS) and Minimal Important Change (MIC). MethodsWe included 782 mUKAs performed between February 1, 2016, and April 26, 2023. The mean change from preoperative Oxford Knee Score (OKS), Forgotten Joint Score (FJS), and Activity and Participation Questionnaire (APQ) was assessed at three, 12, and 24 months after surgery. The achievement of 12-month PASS (OKS ≥ 30) and MIC (changes in OKS ≥ 8; FJS ≥ 14) was also assessed. Patients were divided into age groups: < 55, 55 to < 65, 65 to < 75 years (reference group), and ≥ 75 years. There were 432 women (55%), patients had a mean age of 67 years (range, 29 to 93) and a mean BMI of 30 (range, 20 to 53). ResultsMedian OKS, youngest to eldest, were 34, 35, 36, and 35 (three months); 40, 39, 41, and 43 (12 months); 42, 41, 43, and 42 (24 months). We found no differences in change in OKS between groups. Patients aged 55 to < 65 years had lower changes in FJS at 24 months and APQ at 12 and 24 months. Patients ≥ 75 years had lower 24-month change in APQ. We found no association between age and the fraction achieving either PASS or MIC (youngest to eldest, 90, 90, 94, and 95%). ConclusionWe found good PROM improvements and satisfactory outcomes after mUKA in all age groups; however, patients aged 55 to < 65 years had worse changes in FJS and APQ. Results support contemporary indications for mUKA, and applying an age cutoff is unwarranted.

Validation of 2D lateral cephalometric analysis using artificial intelligence-processed low-dose cone beam computed tomography

ObjectivesTraditional cephalometric radiographs depict a three-dimensional structure in a two-dimensional plane; therefore, errors may occur during a quantitative assessment. Cone beam computed tomography, on the other hand, minimizes image distortion, allowing essential areas to be observed without overlap. Artificial intelligence can be used to enhance low-dose cone beam computed tomography images. This study aimed to clinically validate the use of artificial intelligence-processed low-dose cone beam computed tomography for generating two-dimensional lateral cephalometric radiographs by comparing these artificial intelligence-enhanced radiographs with traditional two-dimensional lateral cephalograms and those derived from standard cone beam computed tomography. MethodsSixteen participants who had previously undergone both cone beam computed tomography and plain radiography were selected. Group I included standard lateral cephalometric radiographs. Group II included cone beam computed tomography-produced lateral cephalometric radiographs, and Group III included artificial intelligence-processed low-dose cone beam computed tomography-produced lateral cephalometric radiographs. Lateral cephalometric radiographs of the three groups were analyzed using an artificial intelligence-based cephalometric analysis platform. ResultsA total of six angles and five lengths were measured for dentofacial diagnosis. There were no significant differences in measurements except for nasion-menton among the three groups. ConclusionsLow-dose cone beam computed tomography could be an efficient method for cephalometric analyses in dentofacial treatment. Artificial intelligence-processed low-dose cone beam computed tomography imaging procedures have the potential in a wide range of dental applications. Further research is required to develop artificial intelligence technologies capable of producing acceptable and effective outcomes in various clinical situations. Clinical significanceReplacing standard cephalograms with cone beam computed tomography (CBCT) to evaluate the craniofacial relationship has the potential to significantly enhance the diagnosis and treatment of selected patients. The effectiveness of low-dose (LD)-CBCT was assessed in this study. The results indicated that lateral cephalograms reconstructed using LD-CBCT were comparable to standard lateral cephalograms.

Feasibility, acceptability, and initial outcomes of a psychological adjustment and reintegration program for transitioned military veterans

BackgroundReintegration and adjustment to civilian life after military service is crucial for veterans’ mental and physical health. However, there is a lack of evidence-based interventions in Australia that specifically address the psychological and cultural factors associated with improved adjustment and mental health in this group. The aim of this study was to evaluate the feasibility, acceptability, and initial outcomes of a novel group intervention program, developed to address this gap in supports and services for Australian veterans.MethodsA non-controlled, within-subjects longitudinal design was employed with a feasibility framework including assessment of demand, implementation, integration, experience, perceived effectiveness, and burden or discomfort. The program included eight weekly 2.5-hour group sessions using cognitive-behavioural and acceptance and commitment therapy techniques. Participants included 24 transitioned veterans who completed the Military-Civilian Adjustment and Reintegration Measure, Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form, Depression Anxiety Stress Scale-21, and PTSD Checklist for DSM-5 at pre-intervention, post-intervention, and three-month follow-up.ResultsHigh participant ratings of engagement, experience and usefulness of the program were found, as well as perceived improvement in adjustment to civilian life as a result of the program. Sound program retention (82.8%), completion (87.5%), and manual adherence rates (89.6%) were also found. Significant improvements were found in adjustment and reintegration scores from pre-intervention to post-intervention (p = < 0.001) and from pre-intervention to follow-up (p = < 0.05), with large effect size (ηp2 = 0.344). All participants who completed the program reported they would recommend the program to another veteran.ConclusionThis study demonstrated the feasibility and acceptability of a novel group intervention program designed for military veterans in Australia. The program showed promising initial evidence of effectiveness in improving adjustment and reintegration to civilian life and provides an essential first step towards addressing a substantial gap in services for veterans struggling to adjust to civilian life. A randomised controlled trial may be an appropriate next step.ANZCTR registration numberACTRN12622000172707.Date of registration02/02/2022.Type of registrationRetrospectively registered.

Exploring the Importance of Race and Gender Concordance Between Patients and Physical Therapists in Digital Rehabilitation for Musculoskeletal Conditions: Observational, Longitudinal Study.

Race/ethnicity and gender concordance between patients and providers is a potential strategy to improve health care interventions. In digital health, where human interactions occur both synchronously and asynchronously, the effect of concordance between patients and providers is unknown. This study aimed to evaluate the impact of race/ethnicity or gender concordance between patients and physical therapists (PTs) in engagement and the clinical outcomes following a digital care program (DCP) in patients with musculoskeletal (MSK) conditions. This secondary analysis of 2 prospective longitudinal studies (originally focused on assessing the acceptance, engagement, and clinical outcomes after a remote DCP) examined the impact of both race/ethnicity concordance and gender concordance between patients and PTs on outcomes for a digital intervention for MSK conditions. Outcomes included engagement (measured by the completion rate and communication, assessed by text interactions), satisfaction, and clinical outcomes (response rate, ie, percentage of patients achieving at least a minimal clinically important change in pain, measured by the Numerical Pain Rating Scale [NPRS]; anxiety, measured by the Generalized Anxiety Disorder 7-item scale [GAD-7]; depression, measured by the Patient Health Questionnaire 9-item [PHQ-9]; and daily activity impairment, measured by the Work Productivity and Activity Impairment [WPAI] questionnaire). Of 71,201 patients, 63.9% (n=45,507) were matched with their PT in terms of race/ethnicity, while 61.2% (n=43,560) were matched for gender. Concordant dyads showed a higher completion rate among White (adjusted odds ratio [aOR] 1.11, 95% CI 1.05-1.19, P<.001) and Hispanic (aOR 1.27, 95% CI 1.08-1.54, P=.009) groups, as well as women (aOR 1.10, 95% CI 1.06-1.18, P<.001), when compared to discordant dyads. High and similar levels of interaction between patients and PTs were observed across race/ethnicity and gender dyads, except for Asian concordant dyads (adjusted β coefficient 5.32, 95% CI 3.28-7.36, P<.001). Concordance did not affect satisfaction, with high values (>8.52, 95% CI 8.27-8.77) reported across all dyads. Response rates for pain, anxiety, and daily activity impairment were unaffected by race/ethnicity concordance. An exception was observed for depression, with White patients reporting a higher response rate when matched with PTs from other races/ethnicities (aOR 1.20, 95% CI 1.02-1.39, P=.02). In terms of gender, men had a slightly higher pain response rate in discordant dyads (aOR 1.08, 95% CI 1.01-1.15, P=.03) and a higher depression response rate in concordant dyads (aOR 1.23, 95% CI 1.05-1.47, P=.01). Race/ethnicity and gender concordance between patients and PTs does not translate into higher satisfaction or improvement for most clinical outcomes, aside from a positive effect on treatment completion. These results highlight the importance of other PT characteristics, in addition to race/ethnicity or gender concordance, suggesting the potential benefit of experience, languages spoken, and cultural safety training as ways to optimize care. ClinicalTrials.gov NCT04092946, NCT05417685; https://clinicaltrials.gov/study/NCT05417685, https://clinicaltrials.gov/study/NCT04092946.

Pilot study of a parent-based intervention for functional somatic symptoms in children.

Functional somatic symptoms are associated with significant distress and impairment for children and their families. Despite the central role that families play in their children's care, there is little clinical research to guide how parents can support their children with functional somatic symptoms and promote better functioning. To address this gap, we developed a parent-based intervention for functional somatic symptoms in children and obtained preliminary data on acceptability, feasibility, treatment satisfaction, and clinical outcomes. The intervention was adapted from SPACE (Supportive Parenting for Anxious Childhood Emotions), an evidence-based treatment for anxiety and related disorders in children. The intervention, SPACE-Somatic, was delivered to parents of 16 children (Mage = 14.50 years; 75% girls) with a range of functional somatic symptoms. Parents participated in seven weekly group sessions conducted via telehealth. We found that SPACE-Somatic was acceptable, feasible, and satisfactory to parents. There were significant improvements in several clinical outcomes from baseline to posttreatment, including children's level of functional impairment, with some gains maintained at 3-month follow-up. Parents also reported improvements in their own stress and their accommodation of children's symptoms. This pilot study provides preliminary evidence that a parent-based intervention is viable and beneficial to children with functional somatic symptoms and their parents.

Long-term efficacy of concomitant surgical ablation for atrial fibrillation with cardiac surgery

Abstract Background Concomitant surgical ablation (SA) is recommended at the time of cardiac surgery in patients with atrial fibrillation (AF) but it is only performed in the minority due to perceived barriers such as increased risk, longer procedure duration and additional technical skills required [1,2]. Furthermore, long-term outcome reporting is limited to only a few high-volume centres. Purpose We sought to report on our centre’s 11-year experience with cardiac surgery and concomitant SA. Methods This was a retrospective observational study on 625 patients with AF who underwent SA in addition to other cardiac surgery at our centre between April 2011 and March 2022. Patients undergoing standalone SA were excluded. Complications were recorded up to 30 days post-procedure. Freedom from atrial tachyarrhythmias (ATA) was determined by electrocardiography, Holter monitoring and pacemaker interrogation at various time points, if available, with or without additional therapies for AF. Results Mean age was 69 +/- 9.9 years and the median duration of AF was 1.2 years (interquartile range 0.4-3.8), persistent in 79% of patients. The median left atrial volume index (LAVI) was 55 ml/m2 (interquartile range 43-71). Concomitant surgery included coronary artery bypass grafting (26%), mitral (68%), aortic (27%), tricuspid (21%) and/or other (5%). Biatrial Cox-Maze IV was performed in 51% of patients and the left atrial appendage was occluded in 74%. Major complications included 30-day mortality (3%), stroke (3%) and pacemaker implantation (4%). Freedom from ATAs was 80% (312/391), 64% (154/240), 53% (76/144) and 44% (33/75) at 1, 3, 5 and 7 years, respectively (Figure 1). Cox regression demonstrated diabetes mellitus, AF duration, persistent AF and LAVI as predictors of 7-year ATA recurrence. Conclusion Concomitant SA for AF has good early and acceptable longer-term rhythm outcomes with no significantly increased complication rate, which should encourage greater uptake of the procedure.

Feasibility Trial of an Online Expressive Writing Intervention for Young Adult Cancer Survivors.

Purpose: Many young adult (YA) breast cancer survivors (BCS) experience psychosocial distress during and after treatment, but do not utilize supportive care resources to maximize their health outcomes. The purpose of this pilot study was to test the feasibility and acceptability of a brief, internet-based expressive writing (EW) intervention intended to improve psychosocial health among YA BCS. Methods: Thirty YA BCS were remotely recruited via a hospital patient database and randomly assigned to the EW (n = 20) or neutral writing (n = 10) group. The EW intervention included delivery of positive messages and a weekly 30-minute EW activity for 3 weeks. Feasibility, acceptability, patient-reported satisfaction, and health outcomes were evaluated at baseline and 1-month follow-up. Results: The database-focused recruitment strategies (40% response) appeared to be feasible. Almost all (93%) participants adhered to at least one writing task and 67% to at least two writing tasks. Participants perceived the study as enjoyable and helpful for reducing stress. The difference in QOL of the intervention versus control group was medium to large (d = 0.73). Conclusion: This is the first study to test the feasibility of an internet-based EW for YA BCS. The online EW pilot intervention demonstrated evidence of feasibility and acceptability to YA BCS; its potential to improve health outcomes should be evaluated in an adequately powered prospective randomized controlled trial (RCT). Online EW may be offered to YA BCS in low-resource settings to address their unique physical and psychological challenges.

Long-term outcomes of aortic stenosis patients with different flow/gradient patterns undergoing transcatheter aortic valve implantation

Abstract Background Few data exist on the comparative long-term outcomes of severe aortic stenosis (AS) patients with different flow-gradient patterns undergoing transcatheter aortic valve implantation (TAVI). This study sought to evaluate the impact of the pre-TAVI flow-gradient pattern on long-term clinical outcomes after TAVI. Methods Consecutive patients with severe AS undergoing TAVI in our institution were screened and prospectively enrolled. Patients were divided into four subgroups according to pre-TAVI flow/gradient pattern: (i) low flow—low gradient (LF-LG): stroke volume indexed (SVi) ≤ 35 mL/m2 and mean gradient (MG) &amp;lt; 40 mmHg); (ii) normal flow—low gradient (NF-LG): SVi &amp;gt; 35 mL/m2 and MG &amp;lt; 40 mmHg; (iii) low flow—high gradient (LF-HG): Svi 35 mL/m2 and MG ≥ 40 mmHg and (iv) normal flow—high gradient (NF-HG): SVi &amp;gt; 35 mL/m2 and MG ≥ 40 mmHg. Clinical follow-up was obtained at 12 months, and yearly thereafter until 5-year follow-up was complete for all patients. Results A total of 272 patients with complete echocardiographic and clinical follow-up were included in our analysis. Their mean age was 80 ± 7 years and the majority of patients (N = 138, 50.8%) were women. 62 patients (22.8% of the study population) were distributed in the LF-LG group, 98 patients (36%) were LF-HG patients, 95 patients (34.9%) were NF-HG, and 17 patients (6.3%) were NF-LG. There was a greater prevalence of comorbidities among LF-LG AS patients. One-year all-cause mortality differed significantly between the four subgroups of AS patients (log-rank p: 0.022) and was more prevalent among LF-LG patients (25.8%) compared to LF-HG (11.3%), NF-HG (6.3%) and NF-LG patients (18.8%). At 5-year follow-up, global mortality remained persistently higher among LF-LG patients (64.5%) compared to LF-HG (47.9%), NF-HG (42.9%), and NF-LG patients (58.8%) (log-rank p: 0.029) (Figure 1). At multivariable Cox hazard regression analysis, baseline SVi (HR: 0.951, 95% C.I.; 0.918–0.984), the presence of at least moderate tricuspid regurgitation at baseline (HR: 3.091, 95% C.I: 1.645–5.809) and at least moderate paravalvular leak (PVL) post-TAVI (HR: 1.456, 95% C.I.: 1.106–1.792) were significant independent predictors of late global mortality. Conclusions Patients with LF-LG AS have acceptable 1-year outcomes, but exhibit exceedingly high 5-year mortality following TAVI. The presence of low transvalvular flow and at least moderate tricuspid regurgitation at baseline and significant paravalvular leak post-TAVI were associated with poorer long-term outcomes in the entire cohort of AS patients.