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Background: Robotic surgery has gained widespread acceptance in elective interventions, yet its role in emergency procedures remains underexplored. While the 2021 WSES position paper discussed limited studies on the application of robotics in emergency general surgery, it recommended strict patient selection, adequate training, and improved platform accessibility. This prospective study aims to define the role of robotic surgery in emergency settings, evaluating intraoperative and postoperative outcomes and assessing its feasibility and safety. Methods: The ROEM study is an observational, prospective, multicentre, international analysis of clinically stable adult patients undergoing robotic surgery for emergency treatment of acute pathologies including diverticulitis, cholecystitis, and obstructed hernias. Data collection includes patient demographics and intervention details. Furthermore, data relating to the operating theatre team and the surgical instruments used will be collected in order to conduct a cost analysis. The study plans to enrol at least 500 patients from 50 participating centres, with each centre having a local lead and collaborators. All data will be collected and stored online through a secure server running the Research Electronic Data Capture (REDCap) web application. Ethical considerations and data governance will be paramount, requiring local ethical committee approvals from participating centres. Discussion: Current literature and expert consensus suggest the feasibility of robotic surgery in emergencies with proper support. However, challenges include staff training, scheduling conflicts with elective surgeries, and increased costs. The ROEM study seeks to contribute valuable data on the safety, feasibility, and cost-effectiveness of robotic surgery in emergency settings, focusing on specific pathologies. Previous studies on cholecystitis, abdominal hernias, and diverticulitis provide insights into the benefits and challenges of robotic approaches. It is necessary to identify patient populations that benefit most from robotic emergency surgery to optimize outcomes and justify costs. [ABSTRACT FROM AUTHOR]

Background: Early language delay is exacerbated by social disadvantage. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. Methods used to achieve successful health outcomes in socially disadvantaged clinical populations may need enhancing. Aims: To compare the impact of standard parent‐based intervention (PBI) to enhanced PBI for young children with speech, language and communication needs (SCLN) and their families living in more socially disadvantaged populations. Methods and Procedures: A multicentre clustered blind randomised controlled trial was used to compare the effect of parent‐based group interventions to improve early language development with children (mean age 27.5 months) from more socially disadvantaged populations with an expressive vocabulary of 40 or less single words. Intervention sessions were delivered by a speech and language therapist, over a 20‐week period. Participants received one of two interventions: (1) Standard Care – indirect group PBI – (PBI) (2) Enhanced Care: indirect group enhanced PBI – (EPBI). Both standardised and non‐standardised measures were used as outcomes. Parent engagement in the intervention was captured through analysis of attendance and the Parent Activation Measure – Speech & Language Therapy (PAM‐SLT) (Insignia Health, 2014). The PAM measures a person's knowledge, skills and confidence to manage their own health and well‐being (NHS England, 2018). In this study, activation referred to parents' knowledge, skills and confidence to manage their child's language development. Outcomes and Results: One hundred fifty‐five participants were randomised at baseline. Children in both groups made significant improvements in the outcome on MacArthur‐Bates Communicative Development Inventories Sentence Length, from pre‐intervention to post‐intervention and 6 months post‐intervention (p < 0.05). Changes in vocabulary and expressive language skills were more equivocal, showing wide variation in confidence intervals for both groups. Where parents attended at least one intervention session almost all effect sizes were in favour of the EPBI intervention. Parents' activation levels significantly increased for both groups (EPBI p < 0.001, PBI p = 0.003), with a moderate effect size in favour of EPBI (Hedges' G 0.37, confidence interval –0.02 to 0.76), although wide variation was found. Conclusions and Implications: This trial provides some evidence of facilitating the language development of children with SLCN from more socially disadvantaged areas through supporting caregivers. However, we found variation in outcomes; some children made excellent progress, whilst others did not. Further exploration of parent engagement and its relationship to child language outcomes will be valuable to understanding more about mechanisms of change in interventions that involve parents. WHAT THIS PAPER ADDS: What is already known on the subject: Speech, language and communication needs (SLCN) have a knock‐on effect on emotional well‐being, school readiness, literacy and school attainment, putting children at increased risk of long‐term consequences such as poor literacy, mental health problems and unemployment. In disadvantaged areas, the prevalence of language difficulties is higher than elsewhere. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. What this paper adds to existing knowledge: Children with SLCN from more socially disadvantaged areas can make improvements in their language development through parent intervention, although wide individual variation was found. There was some evidence that children achieve better outcomes with EPBI, which employed an interagency collaborative approach. Parent's engagement (activation levels) increased significantly over time with intervention, with the increase twice as big for EPBI. What are the potential or actual clinical implications of this work?: This trial provides some evidence that it is possible to facilitate the language development of children from more socially disadvantaged areas through supporting their caregivers. Further research would be useful to determine whether increases in parent engagement are related to adherence to intervention and change in child outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To compare the outcomes of immediate and delayed implant placement with bone-level tapered implants. Materials and Methods: In this post-market, multicenter prospective randomized controlled study with a primary endpoint of 1 year, 53 patients were randomized to receive either immediate implant placement (test group) or delayed implant placement (control group). The mean crestal bone level changes from implant loading to 12 months postloading were measured using standardized digital periapical radiographs. Changes in facial plate thickness (as measured on CBCT images), implant success and survival, implant stability, soft tissue changes, patient-centered outcomes, and adverse events were measured to assess outcomes between the test and control treatments at 12 months postloading. Results: Of the original 53 patients, 46 patients completed the study (23 in each group). Mean bone changes from loading to the 12-month follow-up were recorded with no statistically significant difference (P = .950) between the groups. The hypothesis was confirmed that immediate implant placement (test) in extraction sockets produces in similar outcomes as delayed placement (control). The test group was found to be similar to the control group (P = .022) in terms of mean changes in facial plate thickness. Implant survival and success were 95.8% in the test group and 92% in the control group. Stability in the control group was superior at the time of surgery, but there was no difference between the groups at implant loading, producing a nonsignificant P value of .563). Conclusions: This randomized controlled multicenter study showed comparable outcomes 1 year after prosthetic loading in the immediate and delayed implant placement groups. [ABSTRACT FROM AUTHOR]

Background: Treatment fidelity refers to the degree to which an intervention is implemented as intended. Promoting treatment fidelity is important to achieve a valid comparison in intervention research. However, it is often underreported: few studies detail the use and development of fidelity measures. This study aims to promote the treatment fidelity of a modified version of the Derbyshire Language Scheme (M‐DLS), a manualised intervention for children with language difficulties, by exploring participants' opinions on training and intervention delivery. Results inform development of a checklist and scoring system to monitor and promote treatment fidelity in a comparison trial. Method: Ten student speech and language therapists (SLTs) and two research assistants (RAs) participated in the study. All received training on the M‐DLS, and 10 were video‐recorded completing role‐plays of an M‐DLS session in small groups. Feedback was gathered after training and role‐plays in focus groups and interviews. Feedback was interpreted using the constructs of the Theoretical Domains Framework (TDF). A treatment fidelity checklist was then developed using the feedback. The first author and two RAs rated role‐play videos using the checklist to trial it to inform amendments and to promote interrater reliability. Interrater agreement was calculated using Spearman's test of correlation. Results: Participants discussed the importance of having clear materials and time to practise sessions. They suggested amendments to the materials and training to promote treatment fidelity. The checklist and scoring system accounted for participants' suggestions, with amendments detailed in a log. Spearman's correlation results suggested agreement between the raters was strong. Conclusions: Results emphasise the importance of training quality, practice and reflective opportunities and clear materials to promote treatment fidelity. The construction of the checklist and scoring system was described in detail, informing the development of future checklists. After further trialling, the checklist can be used to ensure the M‐DLS is delivered with high treatment fidelity in the comparison trial. What this paper adds: What is already known on this subject: Treatment fidelity is an essential component of intervention effectiveness and efficacy studies, ensuring the intervention is delivered as intended. It is also an essential component of evidence-based clinical practice. However, few research studies report the treatment fidelity process or publish the checklists used, depriving clinicians of useful information for implementation. What this study adds: This study describes in detail the iterative process of treatment fidelity checklist development, engaging those implementing the intervention in development. This ensured clarity and interrater reliability of the checklist. Furthermore, a novel scoring system was developed so that accuracy of implementation can be easily compared across users and across practice attempts. What are the clinical implications of this work?: The importance of treatment fidelity when implementing effective and efficacious interventions cannot be overstated. The treatment fidelity checklist developed for research can be easily adopted to support accurate implementation in clinical practice through an audit process. [ABSTRACT FROM AUTHOR]

BACKGROUND: Vision impairments affect the ability to navigate environments and gain spatial perception of one's surroundings. Existing navigation aids typically provide close-range information, but not feedback on farther distances (i.e., beyond 5 m from the user). OBJECTIVE: To address this gap, the OptiBand, a custom assistive device, was previously designed with a stakeholder who is blind. The OptiBand uses Lidar sensing and haptic feedback to relay information on objects up to 15 m away. In this paper, we sought to evaluate the efficacy of the OptiBand with an in situ user study. METHODS: N = 9 participants (eight blind and one low-vision) used the OptiBand for a period of three months. Users periodically rated spatial perception workload and trust of their assistive navigation aids (at first as a baseline without the OptiBand, and then with the OptiBand). RESULTS: The OptiBand tended to yield lower workload requirements and similar trust levels compared to existing navigation aids. Interview data demonstrated the usefulness of the OptiBand in selected day-to-day tasks such as navigating outdoors and maintaining appropriate interpersonal spacing. CONCLUSIONS: This work provides evidence on benefits of and potential uses of assistive navigation aids like the OptiBand. Researchers interested in similar devices can benefit from our efforts. [ABSTRACT FROM AUTHOR]

Background: To elucidate the treatment and surgery outcomes with or without perioperative therapies in Japanese patients with clinical stage III non‐small cell lung cancer (NSCLC) in real‐world settings. Methods: We performed subset analyses of the SOLUTION study, a multicenter, noninterventional, observational study of Japanese patients diagnosed with clinical stage III NSCLC, for those who started first‐line treatment (surgery±perioperative therapy) between January 2013 and December 2014 (study registration: UMIN000031385). Follow‐up data were obtained using medical records from diagnosis to March 1, 2018. Results: Of 149 eligible patients, 67 underwent surgery alone (median age 71 years) and 82 underwent surgery+perioperative therapy (median age 63 years). Lung resection was performed in 137 patients and the others underwent exploratory thoracotomy or other procedures. Perioperative therapies included adjuvant therapy only (n = 41), neoadjuvant therapy only (n = 24), and neoadjuvant+adjuvant therapy (n = 17). The median overall survival (OS) and 3‐year OS rate were 29.3 months and 44.0%, respectively, in patients who underwent surgery alone, and not reached and 61.1%, respectively, in patients who underwent surgery+perioperative therapy. The 3‐year progression‐free survival (PFS) and disease‐free survival (DFS) rates were 42.4% and 47.1%, respectively, in patients who underwent surgery+perioperative therapy and 28.5% and 28.9%, respectively, in patients who underwent surgery alone. In multivariable Cox regression, perioperative therapy was associated with improved OS (hazard ratio [95% confidence interval] 0.49 [0.29–0.81]), PFS (0.62 [0.39–0.96]), and DFS (0.62 [0.39–0.97]) versus surgery alone. Conclusions: Our study suggested that perioperative therapy may be associated with better survival among patients undergoing surgical treatment of clinical stage III NSCLC. [ABSTRACT FROM AUTHOR]

Background: In recent years, an increasing number of studies have examined the potential efficacy of cognitive training procedures in individuals with normal ageing and mild cognitive impairment (MCI). Objective: The aims of this study were to (i) evaluate the efficacy of the cognitive Virtual Reality Rehabilitation System (VRRS) combined with anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex compared to placebo tDCS stimulation combined with VRRS and (ii) to determine how to prolong the beneficial effects of the treatment. A total of 109 subjects with MCI were assigned to 1 of 5 study groups in a randomized controlled trial design: (a) face-to-face (FTF) VRRS during anodal tDCS followed by cognitive telerehabilitation (TR) (clinic-atDCS-VRRS+Tele@H-VRRS); (b) FTF VRRS during placebo tDCS followed by TR (clinic-ptDCS-VRRS+Tele@H-VRRS); (c) FTF VRRS followed by cognitive TR (clinic-VRRS+Tele@H-VRRS); (d) FTF VRRS followed by at-home unstructured cognitive stimulation (clinic-VRRS+@H-UCS); and (e) FTF cognitive treatment as usual (clinic-TAU). Results: An improvement in episodic memory was observed after the end of clinic-atDCS-VRRS (p < 0.001). We found no enhancement in episodic memory after clinic-ptDCS-VRRS or after clinic-TAU. Moreover, the combined treatment led to prolonged beneficial effects (clinicatDCS- VRRS+Tele@H-VRRS vs. clinic-ptDCS-VRRS+Tele@H-VRRS: p = 0.047; clinic-atDCS-VRRS+Tele@H-VRRS vs. clinic-VRRS+Tele@H-VRRS: p = 0.06). Discussion: The present study provides preliminary evidence supporting the use of individualized VRRS combined with anodal tDCS and cognitive telerehabilitation for cognitive rehabilitation. [ABSTRACT FROM AUTHOR]

Introduction: Patients experiencing an out-of-hospital cardiac arrest (OHCA) frequently do not receive bystander cardiopulmonary resuscitation (CPR), especially in low- and middle-income countries (LMIC). In this study we sought to determine the prevalence of OHCA patients in Vietnam who received bystander CPR and its effects on survival outcomes. Methods: We performed a multicenter, retrospective observational study of patients (≥18 years) presenting with OHCA at three major hospitals in an LMIC from February 2014-December 2018. We collected data on the hospital and patient characteristics, the cardiac arrest events, the emergency medical services (EMS) system, the therapy methods, and the outcomes and compared these data, before and after pairwise 1:1 propensity score matching, between patients who received bystander CPR and those who did not. Upon admission, we assessed factors associated with good neurological survival at hospital discharge in univariable and multivariable logistic models. Results: Of 521 patients, 388 (74.5%) were men, and the mean age was 56.7 years (SD 17.3). Although most cardiac arrests (68.7%, 358/521) occurred at home and 78.8% (410/520) were witnessed, a low proportion (22.1%, 115/521) of these patients received bystander CPR. Only half of the patients were brought by EMS (8.1%, 42/521) or private ambulance (42.8%, 223/521), 50.8% (133/262) of whom had resuscitation attempts. Before matching, there was a significant difference in good neurological survival between patients who received bystander CPR (12.2%, 14/115) and patients who did not (4.7%, 19/406; P < .001). After matching, good neurological survival was absent in all OHCA patients who did not receive CPR from a bystander. The multivariable analysis showed that bystander CPR (adjusted odds ratio: 3.624; 95% confidence interval 1.629-8.063) was an independent predictor of good neurological survival. Conclusion: In our study, only 22.1% of total OHCA patients received bystander CPR, which contributed significantly to a low rate of good neurological survival in Vietnam. To improve the chances of survival with good neurological functions of OHCA patients, more people should be trained to perform bystander CPR and teach others as well. A standard program for emergency first-aid training is necessary for this purpose. [ABSTRACT FROM AUTHOR]

Background According to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria, both immunohistochemical HER2 (3+) and HER2 (2+)/in situ hybridization (ISH) amplified [HER2 (2+)/ISH+] breast cancers (BCs) fall under the HER2-positive BC category. However, there is a lack of studies exploring the difference of neoadjuvant therapeutic response between patients with HER2 (3+) and HER2 (2+)/ISH+ early BC. We aimed to evaluate the neoadjuvant therapeutic response, long-term outcome, and intrinsic subtype heterogeneity between HER2 (3+) and HER2 (2+)/ISH+ BC. Methods We examined 2 distinct cohorts. Cohort 1 (C1) encompassed 2648 patients with HER2-positive early BC diagnoses, and they received neoadjuvant therapy (NT) and surgery between January 1, 2009 and December 31, 2022, from the Shanghai Jiao Tong University Breast Cancer Data Base. Cohort 2 (C2) comprised 135 patients with early-stage HER2-positive BC who underwent NT and surgery at Henan Cancer Hospital from January 1, 2021, to December 31, 2022. These patients had available genomic and transcriptomic data at their disposal. C1 and C2 were further categorized into 2 patient cohorts as follows: (1) patients with IHC HER2 (3+) early BC [HER2 (3+) group], (2) patients with HER2 (2+)/ISH+ early BC [HER2 (2+)/ISH+ group]. Among those excluded from the analysis were patients < 18 years or >80 years of age. Clinicopathological parameters, long-term outcomes, and intrinsic subtypes were analyzed. Results In the C1 population, 83.7% had HER2 (3+) BC, while 16.3% had HER2 (2+)/ISH+ BC. Patients with HER2 (3+) had a significantly higher pathological complete response (PCR) rate (38.9%) than patients with HER2 (2+)/ISH+ (18.1%; P  < .001), but the disease-free survival (DFS) was comparable after a median follow-up of 29 months (P  = .556). The addition of trastuzumab or trastuzumab plus pertuzumab to neoadjuvant chemotherapy (NAC) improved PCR rates and DFS in HER2 (3+) BC but not in HER2 (2+)/ISH+ BC. In the C2 population, 97.75% HER2 (3+) and 52.17% HER2 (2+)/ISH+ were HER2 enriched (HER2E) subtype (P  < .001). HER2E showed increased PCR rates compared to non-HER2E (P  = .004). Conclusions Compared to HER2 (3+) BC, the limited effectiveness of neoadjuvant trastuzumab and pertuzumab therapy for HER2 (2+)/ISH+ BC is due to subtype heterogeneity. Reassessment of targeted therapy efficacy in patients with HER2 (2+)/ISH+ BC is essential. [ABSTRACT FROM AUTHOR]

Introduction: Metronomic oral cyclophosphamide (MOC) presents many potential advantages, such as significantly less severe side effects than standard regimens, ease of administration, and the delivery of a dose-dense but not necessarily dose-intense treatment. These observations prompted us to evaluate in a retrospective, multicenter study the efficacy and toxicity of MOC in a real-life series of pretreated cancer patients. Methods: The study is a multicenter, retrospective analysis of the activity of single-agent MOC in patients with recurrent or residual epithelial ovarian, fallopian tube, or primary. Eligible patients were continuously treated with MOC at 50 mg/day until progression, toxicity, or death. Overall response rate (ORR), stable disease (SD), and disease control rate (DCR) were reported. Results: The study included 62 patients. Three patients reached a complete response rate (5%), 11 had a partial response rate (18), and 15 had stabilization of disease (24) for an ORR of 23% and a DCR of 47%. Patients with low-grade indolent tumors showed an ORR and an SD rate higher than that observed in non-indolent ones (33% vs. 18% and 28% vs. 14%, respectively). Overall, progression-free survival was 3.5 months (range 1–9 months). Conclusion: Single-agent MOC is active and very well tolerated in a significant fraction of patients with refractory, recurrent, or residual epithelial ovarian, fallopian tube, or primary peritoneal cancer. In the vision of a practical approach, single-agent MOC may be a useful palliative treatment option for patients with poor tolerance to high-dose regimens or widely pretreated. Further studies are needed better to characterize the role of such an approach in clinical practice. [ABSTRACT FROM AUTHOR]

This multi-center study examined the safety and effectiveness of cochlear implantation of children between 9 and 11 months of age. The intended impact was to support practice regarding candidacy assessment and prognostic counseling of pediatric cochlear implant candidates. Data in the clinical chart of children implanted at 9–11 months of age with Cochlear Ltd devices at five cochlear implant centers in the United States and Canada were included in analyses. The study included data from two cohorts implanted with one or two Nucleus devices during the periods of January 1, 2012–December 31, 2017 (Cohort 1, n = 83) or between January 1, 2018 and May 15, 2020 (Cohort 2, n = 50). Major adverse events (requiring another procedure/hospitalization) and minor adverse events (managed with medication alone or underwent an expected course of treatment that did not require surgery or hospitalization) out to 2 years post-implant were monitored and outcomes measured by audiometric thresholds and parent-reports on the IT-MAIS and LittlEARS questionnaires were collected. Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were transitory and resolved. Improved hearing with cochlear implant use was shown in all outcome measures. Findings reveal that the procedure is safe for infants and that they show clear benefits of cochlear implantation including increased audibility and hearing development. [ABSTRACT FROM AUTHOR]

Dystonia is a neurological movement disorder characterised by abnormal involuntary movements and postures, particularly affecting the head and neck. However, current clinical assessment methods for dystonia rely on simplified rating scales which lack the ability to capture the intricate spatiotemporal features of dystonic phenomena, hindering clinical management and limiting understanding of the underlying neurobiology. To address this, we developed a visual perceptive deep learning framework that utilizes standard clinical videos to comprehensively evaluate and quantify disease states and the impact of therapeutic interventions, specifically deep brain stimulation. This framework overcomes the limitations of traditional rating scales and offers an efficient and accurate method that is rater-independent for evaluating and monitoring dystonia patients. To evaluate the framework, we leveraged semi-standardized clinical video data collected in three retrospective, longitudinal cohort studies across seven academic centres. We extracted static head angle excursions for clinical validation and derived kinematic variables reflecting naturalistic head dynamics to predict dystonia severity, subtype, and neuromodulation effects. The framework was also applied to a fully independent cohort of generalised dystonia patients for comparison between dystonia sub-types. Computer vision-derived measurements of head angle excursions showed a strong correlation with clinically assigned scores. Across comparisons, we identified consistent kinematic features from full video assessments encoding information critical to disease severity, subtype, and effects of neural circuit interventions, independent of static head angle deviations used in scoring. Our visual perceptive machine learning framework reveals kinematic pathosignatures of dystonia, potentially augmenting clinical management, facilitating scientific translation, and informing personalized precision neurology approaches. [ABSTRACT FROM AUTHOR]

Background: Evidence for the management of pregnant women with acute hypoxaemic respiratory failure (AHRF) is currently lacking. The likelihood of avoiding intubation and the risks of continuing the pregnancy under invasive ventilation remain undetermined. We report the management and outcome of pregnant women with pneumonia related to SARS-CoV-2 admitted to the ICU of tertiary maternity hospitals of the Paris area. Methods: We studied a retrospective cohort of pregnant women admitted to 15 ICUs with AHRF related to SARS-CoV-2 defined by the need for O2 ≥ 6 L/min, high-flow nasal oxygen (HFNO), non-invasive or invasive ventilation. Trajectories were assessed to determine the need for intubation and the possibility of continuing the pregnancy on invasive ventilation. Results: One hundred and seven pregnant women, 34 (IQR: 30–38) years old, at a gestational age of 27 (IQR: 25–30) weeks were included. Obesity was present in 37/107. Intubation was required in 47/107 (44%). Intubation rate according to respiratory support was 14/19 (74%) for standard O2, 17/36 (47%) for non-invasive ventilation and 16/52 (31%) for HFNO. Factors significantly associated with intubation were pulmonary co-infection: adjusted OR: 3.38 (95% CI 1.31–9.21), HFNO: 0.11 (0.02–0.41) and non-invasive ventilation: 0.20 (0.04–0.80). Forty-six (43%) women were delivered during ICU stay, 39/46 (85%) for maternal pulmonary worsening, 41/46 (89%) at a preterm stage. Fourteen non-intubated women were delivered under regional anaesthesia; 9/14 ultimately required emergency intubation. Four different trajectories were identified: 19 women were delivered within 2 days after ICU admission while not intubated (12 required prolonged intubation), 23 women were delivered within 2 days after intubation, in 11 intubated women pregnancy was continued allowing delivery after ICU discharge in 8/11, 54 women were never intubated (53 were delivered after discharge). Timing of delivery after intubation was mainly dictated by gestational age. One maternal death and one foetal death were recorded. Conclusion: In pregnant women with AHRF related to SARS-CoV-2, HFNO and non-invasive mechanical ventilation were associated with a reduced rate of intubation, while pulmonary co-infection was associated with an increased rate. Pregnancy was continued on invasive mechanical ventilation in one-third of intubated women. Study registration retrospectively registered in ClinicalTrials (NCT05193526). [ABSTRACT FROM AUTHOR]

Introduction: The optimal strategy for differentiated thyroid cancer (DTC) patients treated with radioiodine (RAI) following thyroidectomy remains controversial. Multi-centre clinical studies are essential to identify strategies to improve patient outcomes while minimising treatment-induced toxicity. Materials and Methods: The INSPIRE clinical trial (ClinicalTrials.gov Identifier: NCT04391244) aims to investigate patient-specific dosimetry for DTC patients and to determine the range of absorbed doses delivered to target and nontarget tissues and their relationship with treatment outcome and toxicity. Results: We report here initial results of the first 30 patients enrolled onto the INSPIRE trial. A large range of absorbed doses are observed for both thyroid remnants and salivary glands, with median values of 4.8 Gy (Range 0.2 - 242 Gy) and 0.3 Gy (Range 0.1 to 1.7 Gy), respectively. Discussion: The preliminary study results are encouraging and could help to improve our understanding of absorbed doses to thyroid remnants and normal organs following RAI therapy. Such knowledge could potentially enable patientspecific treatment planning with improved clinical outcomes and quality-of-life of patients. [ABSTRACT FROM AUTHOR]

Aim: This study was conducted to determine the effect of music on the pain, anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy. Methods: This study was conducted on patients with hematological malignancies. Music was used with the intervention group. Patients' pain, anxiety, and comfort levels were measured. In addition, qualitative data were obtained through in-depth interviews with patients. Results: A significant difference (p < 0.05) was found between the experimental and control groups regarding pain, comfort and anxiety levels following the application of music. It was found that there was a negative correlation between comfort and pain (r=-0.442 p < 0.001) and between comfort and anxiety (r=-0.544 p < 0.001). As a result of qualitative interviews, patients mentioned the relaxing effect of music and the reduction of anxiety and pain levels. They also stated that music can be utilized as an alternative method. Conclusion: According to the results of the present study, music reduced the pain and anxiety levels of the patients in bone marrow aspiration and biopsy and increased their comfort levels. We can say that music can be used in the clinic as a non-pharmacological method for pain, anxiety and comfort. Clinical Trials Number: NCT05895357 (Date:08/06/2023). [ABSTRACT FROM AUTHOR]

Purpose: Literature suggests a dependency of the acoustic metrics, smoothed cepstral peak prominence (CPPS) and harmonics-to-noise ratio (HNR), on human voice loudness and fundamental frequency (F0). Even though this has been explained with different oscillatory patterns of the vocal folds, so far, it has not been specifically investigated. In the present work, the influence of three elicitation levels, calibrated sound pressure level (SPL), F0 and vowel on the electroglottographic (EGG) and time-differentiated EGG (dEGG) metrics hybrid open quotient (OQ), dEGG OQ and peak dEGG, as well as on the acoustic metrics CPPS and HNR, was examined, and their suitability for voice assessment was evaluated. Method: In a retrospective study, 29 women with a mean age of 25 years (± 8.9, range: 18–53) diagnosed with structural vocal fold pathologies were examined before and after voice therapy or phonosurgery. Both acoustic and EGG signals were recorded simultaneously during the phonation of the sustained vowels /ɑ/, /i/, and /u/ at three elicited levels of loudness (soft/comfortable/loud) and unconstrained F0 conditions. Results: A linear mixed-model analysis showed a significant effect of elicitation effort levels on peak dEGG, HNR, and CPPS (all p < .01). Calibrated SPL significantly influenced HNR and CPPS (both p < .01). Furthermore, F0 had a significant effect on peak dEGG and CPPS (p < .0001). All metrics showed significant changes with regard to vowel (all p < .05). However, the treatment had no effect on the examined metrics, regardless of the treatment type (surgery vs. voice therapy). Conclusions: The value of the investigated metrics for voice assessment purposes when sampled without sufficient control of SPL and F0 is limited, in that they are significantly influenced by the phonatory context, be it speech or elicited sustained vowels. Future studies should explore the diagnostic value of new data collation approaches such as voice mapping, which take SPL and F0 effects into account. [ABSTRACT FROM AUTHOR]

Simple Summary: It is generally reported that the prognostic factors for ampulla of Vater cancer include T stage, N stage, and lymphovascular invasion and subtype, and the meaning of MUC stain is controversial. This retrospective study by the authors evaluated the significance of various MUC stains in AoV cancer using single-center clinicopathological data. The results showed that MUC5AC was significant for lymph node metastasis and was furthermore valuable as a prognostic factor for predicting overall survival. If this is evaluated in addition to the hematoxylin and eosin stain, which is commonly performed in preoperative biopsy, it is expected to be a method to select groups that require more extensive LN dissection and further prevent locoregional recurrence. Introduction: Mucins play a pivotal role in epithelial carcinogenesis; however, their role remains elusive in ampulla of Vater (AoV) cancer, regardless of histological subtype. Therefore, we investigated the clinical significance of MUC1, MUC2, MUC5AC, and MUC6 expression in AoV cancer. Methods: Using samples from 68 patients with AoV cancer, we performed immunohistochemical staining for MUC1, MUC2, MUC5AC, and MUC6 using a tissue microarray. Subsequently, we analyzed their expression patterns in relation to clinicopathological parameters and patient outcomes. Results: Of the patients, 98.5% exhibited positive expression for MUC1, while MUC2, MUC5AC, and MUC6 were expressed in 44.1%, 47.1%, and 41.2% of the patients, respectively. Correlation analyses between mucin expression and clinicopathological factors revealed no significant associations, except between MUC5AC expression and N stage. Univariate analysis demonstrated significant associations between MUC5AC expression and overall survival (OS). Multivariate analysis further confirmed that MUC5AC expression was a significant predictor of OS, along with the N stage. However, MUC5AC expression was not meaningfully associated with recurrence-free survival (RFS). The patients positive for MUC5AC expression had a considerably shorter OS than those with negative expression. Conclusions: Our study provides insights into the clinical impact of mucins on AoV cancer, regardless of the histological subtype. Although MUC1 expression is universal, MUC5AC expression is a significant prognostic indicator that correlates with lymph node metastasis and poor OS. These results emphasize the possible utility of MUC5AC as a biomarker for extensive lymph node dissection and the prognostic evaluation of patients with AoV cancer. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to explore the impact of internally guided (IG) versus externally guided (EG) adapted tango (AT) dance training (i.e., dancing the IG "Leader" role or the EG "Follower" role), on motor and non-motor functions in individuals with Parkinson's disease and freezing of gait (PD-FOG). The "Leader" role, a proxy for IG movements, conveys direction, timing, and amplitude of steps with tactile cues. The "Follower" role, a proxy for EG movements, detects and responds to the leader's tactile cues. Case description: Six participants were randomly assigned to the IG ("Leader") or EG ("Follower") roles for 20, 90-min AT lessons over 12 weeks. Participants were assessed for PD-specific and non-PD-specific functions before and twice after the end of the 12-week intervention, at 1-week and 1-month post-intervention. Results: EG participants improved and/or maintained performance on more outcomes across all domains than IG participants. Five participants improved in PD motor symptoms, dynamic gait, global cognitive function, and the FOG Questionnaire immediately or 1month after intervention. All participants expressed positive attitudes toward the intervention, including improvements in walking, balance, and endurance. Conclusion: AT training in the follower role may benefit individuals with PD- FOG to a greater extent compared to the leader role. Impact: This case series study could inform additional research with the goal of enhancing physical therapy or music-based therapy approaches for addressing PD-FOG. [ABSTRACT FROM AUTHOR]

Introduction: Chronic non-cancer pain (CNCP) is a lifelong condition with radical consequences, calling for management involving patients' families. Interventions based on the family systems nursing framework by Wright and Leahey have proved beneficial in other populations but require investigation in a CNCP population. This trial assumed that family nursing conversations (FNCs) based on the family systems nursing framework would increase patients' and family members' self-efficacy concerning CNCP management. Objective: To investigate whether an intervention with FNCs as an add-on to the usual multidisciplinary treatment of CNCP would have an effect on patients' and family members' self-efficacy. Additionally, to investigate any impact on family function, health-related quality of life, anxiety, and depression. Methods: The trial applied a prospective non-blinded quasi-experimental design with two comparable groups of patients and family members: a historical control group (HCG) and an intervention group (IG). The intervention was executed by nurses employed at a multidisciplinary pain center in the Capital Region of Denmark. HCG data were collected before the nurses' intervention training. The primary outcome was self-efficacy. Secondary outcomes were family function, health-related quality of life, anxiety, and depression. Results: In total, 58 patients and 85 family members were included. The primary outcome, self-efficacy, detected no statistically significant between-group differences in mean change for patients, p =.990, or family members, p =.765. A statistically significant effect in favor of the IG was found in between-group differences in mean change in patients' behavioral family function, p =.034, and anxiety, p =.031. No statistically significant between-group differences were detected in family members' secondary outcomes. Conclusion: The intervention had no effect on patients' or family members' self-efficacy but a positive effect on patients' behavioral family function and anxiety. The intervention was deeply affected by the COVID-19 pandemic. Hence, any results should be interpreted with caution. [ABSTRACT FROM AUTHOR]

Background: Chronic headache disorders are disabling. The CHESS trial studied the effects of a short non-pharmacological intervention of education with self-management support for people affected by migraine and/or tension type headache for at least 15 days per month for at least three months. There were no statistically significant effects on the Headache Impact Test-6 (HIT-6) at 12-months. However, we observed improvement in pain self-efficacy questionnaire (PSEQ) and short-term HIT-6. We explored the impact of the CHESS intervention on PSEQ, and subsequently, on the HIT-6 and chronic headache quality of life questionnaire (CH-QLQ) at four, eighth and 12 months. Methods: We included all 736 participants from the CHESS trial. We used simple linear regression models to explore the change of HIT-6 and CH-QLQ with treatment and PSEQ at baseline (predictor analysis), and the interaction between treatment and baseline PSEQ (moderator analysis). We considered the change of PSEQ from baseline to four months as a mediator in the mediation analysis. Results: Baseline PSEQ neither predicted nor moderated outcomes. The prediction effect on change of HIT-6 from baseline to 12 months was 0.01 (95% CI, -0.03 to 0.04) and the interaction (moderation) effect was −0.07 (95% CI, -0.15 to 0.002). However, the change of PSEQ from baseline to 4-month mediated the HIT-6 (baseline to 8-, and 12-month) and all components of CH-QLQ (baseline to 8-, and 12-month). The CHESS intervention improved the mediated variable, PSEQ, by 2.34 (95% CI, 0.484 to 4.187) units and this corresponds to an increase of 0.21 (95% CI, 0.03 to 0.45) units in HIT-6 at 12-months. The largest mediated effect was observed on the CH-QLQ Emotional Function, an increase of 1.12 (95% CI, 0.22 to 2.20). Conclusions: PSEQ was not an effective predictor of outcome. However, change of short-term PSEQ mediated all outcomes, albeit minimally. Future behavioural therapy for chronic headache may need to consider how to achieve larger, and more sustained increases level of self-efficacy than that achieved within the CHESS trial. Trial registration: ISRCTN79708100. [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigated whether using virtual reality (VR) could help reduce anxiety in women undergoing gynecological cancer surgery. Participants were split into two groups: one receiving VR therapy alongside usual care and the other receiving only usual care. Results showed that VR significantly decreased anxiety levels before surgery compared to the control group. This suggests that VR could be a valuable tool in preparing patients for surgery, potentially improving their experience and outcomes. Further research is needed to explore VR's benefits in other types of surgery and its long-term effects on patient recovery. Perioperative anxiety is common among patients undergoing surgery, potentially leading to negative outcomes. Immersive virtual reality (VR) has shown promise in reducing anxiety in various clinical settings. This study aimed to evaluate the effectiveness of VR in reducing perioperative anxiety in patients undergoing gynecological oncology surgery and was conducted as a single-center, double-arm, single-blinded randomized controlled trial at the Gold Coast University Hospital, Queensland, Australia. Participants were randomized into the VR intervention + care as usual (CAU) group (n = 39) and the CAU group (n = 41). Anxiety scores were assessed using a six-tier visual facial anxiety scale at baseline, after the intervention/CAU on the same day, and, several days up to weeks later, immediately before surgery. There was no significant difference in baseline anxiety scores, type of operation, or suspected cancer between the two groups. The VR intervention significantly reduced anxiety scores from baseline to preoperative assessment (p < 0.001). The median anxiety score in the VR intervention group decreased from 3 (interquartile range 2 to 5) at baseline to 2 (2 to 3) prior to surgery, while the control group's scores were 4 (2 to 5) and 4 (3 to 5), respectively. Multivariate analysis showed that group assignment was the sole outcome predictor, not age, type of procedure, or the time elapsed until surgery. Thus, VR exposure was effective in reducing perioperative anxiety in patients undergoing gynecological oncology surgery. The use of VR as a preparation tool may improve patient experience and contribute to better surgical outcomes, warranting further research into exploring the potential benefits of VR in other surgical specialties and its long-term impact on patient recovery. [ABSTRACT FROM AUTHOR]

Objective: To evaluate therapeutic footwear expectations and usability of individuals with diabetes and foot complications. Design: A prospective multicenter study was conducted on participants with a high risk of developing a diabetic foot ulcer. Setting: Participants were enrolled in 11 different specialized diabetic foot units in Spain between March 2022 and June 2023. Subjects: Patients with diabetes at moderate to high risk of foot ulceration receiving first therapeutic footwear prescription. Interventions: All the patients included in the research were prescribed with their first pair of therapeutic footwear. Main measures: Primary outcome measures were MOS-pre and MOS-post questionnaires evaluating use and usability of prescribed therapeutic footwear. Secondary outcome measures aimed to evaluate footwear clinical efficacy as ulceration rate and self-reported perceived walking distance per day. Results: The use of therapeutic footwear exceeded the patient's pre-provision prediction of their anticipated use in 94% of people (n = 126). Based on the visual analogic satisfaction scale, the median satisfaction of daily wearing their therapeutic footwear was 7 points, Interquartile Range (IQR) [5–8.25]. During the follow-up period, 39 participants (29.1%) experienced diabetic foot ulcer. Perceived walking distance participants reported an improvement in their perceived walking ability during various daily life activities. Conclusions: Diabetes patients at moderate to high risk of diabetic foot ulcer improved their perception of walking ability after therapeutic footwear prescription. Adherence to the therapeutic footwear prescription resulted in less ulcerations. [ABSTRACT FROM AUTHOR]

Aims and Objectives: To develop a Chinese version of a chronic wound health‐related quality of life (QoL) instrument and to examine the psychometric properties of this instrument. Background: Existing QoL instruments are not tailored to the linguistic and cultural characteristics of Chinese‐speaking patients; a version addressing this gap will increase clinical understanding of their healthcare experience and may help guide chronic wound care. Design: A methodological study. Methods: The method advanced by DeVellis (2017) was used to develop the instrument. An initial pool of 38 items was created. To optimize scale length and test reliability and validity, exploratory and confirmatory factor analyses were conducted. A total of 23 items formed the final pool. After two rounds of expert discussions, the average content validity index of the final 23 items was.89. Results: A total of 226 patients completed the instrument and were divided into two groups for further analysis. Exploratory factor analysis revealed that 15 items remained in four factors (social activity restrictions, physical and psychological disturbance, wound burden and daily life limitation), which accounted for 64.87% of the variance. Confirmatory factor analysis revealed an acceptable fit of the hypothesized factor structure and the convergent and discriminant validities were achieved. Cronbach's α coefficients for each factor were.807,.773,.799 and.713, respectively. Conclusion: The Chinese version of a chronic wound health‐related QoL instrument consists of 15 items in four subscales and demonstrates good reliability and validity. Relevance to Clinical Practice: This instrument can be used intermittently or continuously to evaluate the treatment effect of chronic wounds by assessing health‐related QoL. Scholars in Chinese‐speaking regions may find this culturally compatible instrument useful when conducting studies related to chronic wounds. Patient or Public Contribution: Two hundred twenty‐six participants provided their perspectives on health‐related QoL. [ABSTRACT FROM AUTHOR]

Objective: To present the design and methodology for an actively enrolling comparative effectiveness study of revision palatoplasty versus pharyngoplasty for the treatment of velopharyngeal insufficiency (VPI) Design: Prospective observational multicenter study Setting: Twelve hospitals across the United States and Canada Participants: Individuals who are 3–23 years of age with a history of repaired cleft palate and a diagnosis of VPI, with a total enrollment target of 528 participants Interventions: Revision palatoplasty and pharyngoplasty (either pharyngeal flap or sphincter pharyngoplasty), as selected for each participant by their treatment team Main Outcome Measure(s): The primary outcome is resolution of hypernasality, defined as the absence of consistent hypernasality as determined by blinded perceptual assessment of a standard speech sample recorded twelve months after surgery. The secondary outcome is incidence of new onset obstructive sleep apnea. Statistical analyses will use propensity score matching to control for demographics, medical history, preoperative severity of hypernasality, and preoperative imaging findings. Results: Study recruitment began February 2021. As of September 2022, 148 participants are enrolled, and 78 have undergone VPI surgery. Enrollment is projected to continue into 2025. Collection of postoperative evaluations should be completed by the end of 2026, with dissemination of results soon thereafter. Conclusions: Patients with VPI following cleft palate repair are being actively enrolled at sites across the US and Canada into a prospective observational study evaluating surgical outcomes. This study will be the largest and most comprehensive study of VPI surgery outcomes to date. [ABSTRACT FROM AUTHOR]

Simple Summary: The prevalence of second neoplasms among patients with hairy cell leukemia (HCL) treated with cladribine is not negligible. Immunosuppression, high rate of cure, and aging may have a role in the pathogenesis of second cancers after HCL. We aimed to compare the risk of cancer between patients with HCL treated with cladribine and the general population. Concern has emerged about the prevalence of second cancers among patients with hairy cell leukemia (HCL) treated with purine analogs. We investigated 513 patients with HCL treated with cladribine over the last 30 years at 18 Italian centers and calculated their standardized incidence ratios (SIRs). We identified 24 patients with a second cancer diagnosed at a median time from treatment with cladribine of 59.9 months (range: 9.2–169.7 months). All patients with solid neoplasms presented with a limited-stage disease, except four cases of locally advanced cancer; multiple myeloma patients had a smoldering disease, while lymphoma patients had stage Ie and stage IV diseases. Response to therapy was complete in 19 cases; 1 patient is still receiving treatment for a relapsing bladder disease, while 2 patients progressed during treatment and died. These two patients died from unrelated causes: one from infection and one due to surgery complications. The median OS from HCL was 98.5 months (range: 38.4–409.2 months), while the median OS from second cancer was 27.6 months (range: 1–117.8 months). The SIR was 0.86 (95% CI: 0.54–1.30) for males and 1.13 (95% CI: 0.36–2.73) for females: no statistically significant differences were highlighted. We were not able to demonstrate an excess of second cancer or a significant association with the specific studied neoplasm. [ABSTRACT FROM AUTHOR]

Simple Summary: Transoral Robotic Surgery (TORS) is increasingly used for various conditions, yet its success and failure remain underexplored. In this multicenter study, we assessed 220 TORS interventions across 211 patients. Success criteria differed by condition, including tumor identification for CUP, resection margins for malignancies, and symptom improvement for benign cases like OSA and chronic lingual tonsillitis. Predictors of success varied, with factors such as patient comorbidity, tumor characteristics, and demographics playing roles. Conversely, failure predictors encompassed postoperative complications and pain, linked to patient health and demographics. These insights into TORS outcomes may aid in patient selection and counseling across different conditions, informing clinical practice and enhancing patient care. Transoral Robotic Surgery (TORS) is utilized for treating various malignancies, such as early-stage oropharyngeal cancer and lymph node metastasis of an unknown primary tumor (CUP), and also benign conditions, like obstructive sleep apnea (OSA) and chronic lingual tonsillitis. However, the success and failure of TORS have not been analyzed to date. In this retrospective observational multicenter cohort study, we evaluated patients treated with TORS using the da Vinci surgical system. Success criteria were defined as identification of the primary tumor for CUP, >2 mm resection margin for malignant conditions, and improvement on respiratory polygraphy and tonsillitis complaints for benign conditions. A total of 220 interventions in 211 patients were included. We identified predictors of success, such as low comorbidity status ACE-27, positive P16 status, and lower age for CUP, and female gender and OSA severity for benign conditions. For other malignancies, no predictors for success were found. Predictors of failure based on postoperative complications included high comorbidity scores (ASA) and anticoagulant use, and for postoperative pain, younger age and female gender were identified. This study provides valuable insights into the outcomes and predictors of success and failure in TORS procedures across various conditions and may also help in patient selection and counseling. [ABSTRACT FROM AUTHOR]

Purpose: The transtheoretical model (TTM) has been applied to varying areas of physical health, e.g. diabetes. However, research into its applicability to psychotherapy is mixed. The TTM is applied through the University of Rhode Island Change Assessment (URICA). Investigating the utility of the URICA is needed to improve patient care and outcomes. This study aims to assess whether the URICA scores relate to patient outcomes; patient attendance; practitioner ratings of patient readiness, appropriateness, insight, motivation and potential for improvement; and to explore practitioner's perspectives on the URICA. Design/methodology/approach: Correlational methods were used to assess the relationship between the URICA and therapeutic outcome, attendance and practitioner-rated areas. Content analysis was used to analyse practitioner qualitative data. Findings: The URICA did not correlate with either therapeutic outcome or attendance. A significant negative correlation was found between the URICA and practitioner-rated appropriateness of the referral. This means practitioners perceived individuals with lower URICA scores to be a more appropriate referral, despite the score indicating a reduced readiness to change. Qualitative categories included positive views, negative views, ambivalence and changes to measure and process. To conclude, the URICA does not explain a patient's outcome or attendance. The URICA may not be appropriate to use in its current format in mental health services; therefore, assessing the TTM verbally may be more helpful. Originality/value: This study provides research into suitability of using the URICA to assess the TTM and its applicability to attendance and outcome in psychological therapies. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to investigate the retinal morpho‐functional characteristics of patients with neovascular wet age‐related macular degeneration (nAMD) treated with intravitreal injection (IV) of aflibercept (AFL). Methods: The study was conducted on 35 patients previously diagnosed with type 1 nAMD who received a fixed‐dosing regimen of aflibercept injections over 12 months. The goal was to assess trends in visual abilities over time by measuring visual acuity (VA), contrast sensitivity (CS), visual evoked potentials (VEPs), and spectral domain‐optical coherence tomography (SD‐OCT). The same psychophysical, electro‐functional, and morphological tests administered at baseline (T0) were repeated 4 to 8 weeks after the last aflibercept injection (Tn), resulting in a total of six examinations. Results: At Tn, all subjects exhibited improved VA for both far and near distances compared to values detected at T0. Similarly, VEP amplitude and latency values at Tn showed a greater P100 improvement than those observed at T0. Additionally, the CS examination at Tn demonstrated improvement, particularly at high spatial stimulation frequencies. The Tn SD‐OCT results highlighted a reduction in macular thickness compared to T0 values. Conclusions: This exploratory research indicates that intravitreal injections of AFL, following a fixed‐dosing regimen, represent a valuable therapeutic approach for enhancing visual performance. This conclusion is supported by comprehensive statistical analysis of psychophysical, electro‐functional, and morphological examinations within the same group of patients with nAMD, as demonstrated for the first time. [ABSTRACT FROM AUTHOR]

Background Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases. Objective To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms. Methods This prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events. Results The study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2. Conclusions This first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures. [ABSTRACT FROM AUTHOR]

Introduction: Patients with multimorbidity attend multiple outpatient clinics. We assessed the effects on hospital use of scheduling several outpatient appointments to same-day visits in a multidisciplinary outpatient pathway (MOP). Methods: This study used a quasi-experimental design. Eligible patients had multimorbidity, were aged ≥18 years and attended ≥2 outpatient clinics in five different specialties. Patients were identified through forthcoming appointments from August 2018 to March 2020 and divided into intervention group (alignment of appointments) and comparison group (no alignment). We used patient questionnaires and paired analyses to study care integration and treatment burden. Using negative binomial regression, we estimated healthcare utilisation as incidence rates ratios (IRRs) at one year before and one year after baseline for both groups and compared IRR ratios (IRRRs). Results: Intervention patients had a 19% reduction in hospital visits (IRRR: 0.81, 95% CI: 0.70–0.96) and a 17% reduction in blood samples (IRRR: 0.83, 0.73–0.96) compared to comparison patients. No effects were found for care integration, treatment burden, outpatient contacts, terminated outpatient trajectories, hospital admissions, days of admission or GP contacts. Conclusion: The MOP seemed to reduce the number of hospital visits and blood samples. These results should be further investigated in studies exploring the coordination of outpatient care for multimorbidity. Research question: Can an intervention of coordinating outpatient appointments to same-day visits combined with a multidisciplinary conference influence the utilisation of healthcare services and the patient-assessed integration of healthcare services and treatment burden among patients with multimorbidity? [ABSTRACT FROM AUTHOR]

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non‐healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs. [ABSTRACT FROM AUTHOR]

Objectives: Randomized clinical trials are used to evaluate the efficacy of various pain treatments individually, while a limited number of observational studies have portrayed the overall relief experienced by persons living with chronic pain. This study aimed to describe pain relief in real-world clinical settings and to identify associated factors. Methods: This exploratory web-based cross-sectional study used data from 1,419 persons recruited in the community. Overall pain relief brought by treatments used by participants was assessed using a 0%-100% scale (10-unit increments). Results: A total of 18.2% of participants reported minimal pain relief (0%-20%), 60.0% moderate to substantial pain relief (30%-60%), and 21.8% extensive pain relief (70%-100%). Multivariable multinomial regression analysis revealed factors significantly associated with greater pain relief, including reporting a stressful event as circumstances surrounding the onset of pain, living with pain for ≥10 years, milder pain intensity, less catastrophic thinking, use of prescribed pain medications, use of nonpharmacological pain treatments, access to a trusted healthcare professional, higher general health scores, and polypharmacy. Factors associated with lower pain relief included surgery as circumstances surrounding pain onset, use of over-the-counter pain medications, and severe psychological distress. Discussion: In this community sample of persons living with chronic pain, 8 out of 10 persons reported experiencing at least moderate relief with their treatment. The analysis has enabled us to explore potential modifiable factors as opportunities for improving the well-being of persons living with chronic pain. [ABSTRACT FROM AUTHOR]

Introduction. Due to the significant resources involved in creating HSCT programs there is a significant disparity in the availability of this treatment modality between the developed and developing countries. This manuscript details the process and the outcomes of the first HSCT program in East Africa which was started at Muhimbili National Hospital (MNH) in Dar-es-Salaam, Tanzania. Materials and Methods. Information and data were collected on the processes which had been implemented for starting the HSCT program at MNH. The details of the collaborations, training, infrastructure development, and acquisition of the biomedical equipment, as well as the actual process for HSCT, as well as the outcomes of treatment are described. Observations. The project has been detailed in 4 stages for ease of description: Stage 1: Preparatory work which was performed by the Government of Tanzania, as well as the administrators and clinicians from MNH (July 2017-September 2021). Stage 2: Exploratory gap analysis by the teams from MNH and International Haematology Consortium of HCG Hospital, India (HCG-IHC) in October 2021. Stage 3: Activities for closure of gaps (November 2021). Stage 4: Stem Cell Transplantation Camps (November 2021 to March 2022). 11 peripheral blood stem cell transplants were done in two camps, November 2021 (5 patients), and February 2022 (6 patients). 10 patients underwent autologous peripheral blood stem cell transplantation for multiple myeloma and 1 for lymphoma. The median duration of hospital stay was 19 ± 6 days. The median time for neutrophil engraftment, it was on 8.8 ± 0.8 days, and for platelet engraftment was 9.6 ± 2.4 days. Progression-free survival was 100%, and there was no mortality. Conclusion. Commonalities in the socioeconomic challenges in developing countries can be leveraged to create robust HSCT programs in other developing countries. [ABSTRACT FROM AUTHOR]

Background: Previous research has found that the incidence of neurovascular injury is greatest among multiligamentous knee injuries (MLKIs) with documented knee dislocation (KD). However, it is unknown whether there is a comparative difference in functional recovery based on evidence of a true dislocation. Purpose: To determine whether the knee dislocation-3 (KD3) injury pattern of MLKI with documented tibiofemoral dislocation represents a more severe injury than KD3 MLKI without documented dislocation, as manifested by poorer clinical outcomes at long-term follow-up. Study Design: Cohort study; Level of evidence, 3. Methods: A multicenter retrospective cohort study was performed of patients who underwent surgical treatment for KD3 MLKI between May 2012 and February 2021. Outcomes were assessed using the International Knee Documentation Committee (IKDC) score, Lysholm score, Tegner activity scale, and visual analog scale (VAS) for pain. Documented dislocation was defined as a radiographically confirmed tibiofemoral disarticulation, the equivalent radiology report from outside transfer, or emergency department documentation of a knee reduction maneuver. Subgroup analysis was performed comparing lateral (KD3-L) versus medial (KD3-M) injuries. Multivariable linear regression was conducted to determine whether documented dislocation was predictive of outcomes. Results: A total of 42 patients (25 male, 17 female) were assessed at a mean 6.5-year follow-up (range, 2.1-10.7 years). Twenty patients (47.6%) were found to have a documented KD; they reported significantly lower IKDC (49.9 vs 63.0; P =.043), Lysholm (59.8 vs 74.5; P =.023), and Tegner activity level (2.9 vs 4.7; P =.027) scores than the patients without documented dislocation. VAS pain was not significantly different between groups (36.4 vs 33.5; P =.269). The incidence of neurovascular injury was greater among those with documented dislocation (45.0% vs 13.6%; P =.040). Subgroup analysis found that patients with KD3-L injuries experienced a greater deficit in Tegner activity level than patients with KD3-M injuries (Δ: –3.4 vs −1.2; P =.006) and had an increased incidence of neurovascular injury (41.7% vs 11.1%; P =.042). Documented dislocation status was predictive of poorer IKDC (β = −2.15; P =.038) and Lysholm (β = −2.85; P =.007) scores. Conclusion: Patients undergoing surgical management of KD3 injuries with true, documented KD had significantly worse clinical and functional outcomes than those with nondislocated joints at a mean 6.5-year follow-up. The current MLKI classification based solely on ligament involvement may be obscuring outcome research by not accounting for true dislocation. [ABSTRACT FROM AUTHOR]

Background: Proximal hamstring complex injury (PHCI) is a common injury among professional athletes, particularly those participating in pivot contact sports. Previous studies have suggested that surgery can be effective in restoring function and allowing athletes to return to sport (RTS), but the factors influencing successful RTS have been less clear. Purpose: To assess RTS capabilities after surgical treatment of PHCI in professional athletes and to identify favorable predictors of RTS. Study Design: Case series; Level of evidence, 4. Methods: This study (2002-2022) was conducted on professional athletes who underwent surgical treatment for PHCI at a sports surgery center. The primary outcome of the study was the RTS capability, evaluated based on the rate of athletes' return to their preinjury level of competition, time delay to RTS, and quality of RTS as measured using their level of performance and progression of scores on activity scales such as the Tegner Activity Scale (TAS) and University of California, Los Angeles (UCLA), scale. "Maintained performance" was defined as athletes returning to the same preinjury activity level (per the TAS and UCLA scale) and perceiving themselves to have maintained their performance. Secondary outcomes covered the potential RTS predictors and complication rate. The study distinguished 2 types of PHCI: proximal hamstring tendon avulsion injury (proximal rupture with empty footprint, or having a "positive dropped ice cream sign") and complete proximal hamstring free tendon rupture (PHTR; proximal rupture without empty footprint, or having a "negative dropped ice cream sign"). Results: The study examined 64 professional athletes (mean age, 27.3 years; 82.8% male) undergoing surgery for PHCI. The RTS rate was 98.4%, with 78.1% of the athletes returning to their preinjury level of competition at 6.2 months (SD, 2.5 months). Twelve (19%) patients had returned to sport at an inferior level of competition, and 2 (3.1%) were unable to continue in their preinjury sport. Subgroup analysis revealed variation in RTS based on sport type, with the highest rate of return to preinjury performance found in athletes in handball and sports with splits (fencing, squash, and escalade; 100%) and soccer (95.2%). In the univariate analysis, male sex (hazard ratio [HR], 4.05; 95% CI, 1.45-11.3; P =.008), higher preinjury TAS score (HR, 1.27; 95% CI, 1.06-1.52; P =.011), injury involving the semimembranosus (HR, 4.84; 95% CI, 2.31-10.2; P <.001) or conjoint tendon (HR, 3.12; 95% CI, 1.55-6.25; P =.001), and PHTR (HR, 7.77; 95% CI, 3.54-17.0; P <.001) were significantly associated with a better postoperative level of competition. Multivariate analysis identified 3 favorable predictors of RTS with HRs of 2.91 (95% CI, 1.01-8.35; P =.047) for male sex, 3.86 (95% CI, 1.78-8.37; P <.001) for isolated semimembranosus injury, and 5.18 (95% CI, 2.24-12.0; P <.001) for PHTR. The complication rate was 4.7%. Conclusion: Favorable predictors of early RTS were male sex, isolated semimembranosus injury, and PHTR injuries. Registration: NCT02906865 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

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Background and objectives: Chronic headaches are a frequent cause of pain and disability. The purpose of this randomized trial was to examine whether transcranial direct current stimulation (tDCS) applied to the primary motor cortex, reduces pain and increases daily function in individuals suffering from primary chronic headache. Materials and methods: A prospective, randomized, controlled trial, where participants and assessors were blinded, investigated the effect of active tDCS vs. sham tDCS in chronic headache sufferers. Forty subjects between 18 and 70 years of age, with a diagnosis of primary chronic headache were randomized to either active tDCS or sham tDCS treatment groups. All patients received eight treatments over four consecutive weeks. Anodal stimulation (2 mA) directed at the primary motor cortex (M1), was applied for 30 min in the active tDCS group. Participants in the sham tDCS group received 30 s of M1 stimulation at the start and end of the 30-minute procedure; for the remaining 29 min, they did not receive any stimulation. Outcome measures based on data collected at baseline, after eight treatments and three months later included changes in daily function, pain levels, and medication. Results: Significant improvements in both daily function and pain levels were observed in participants treated with active tDCS, compared to sham tDCS. Effects lasted up to 12 weeks post-treatment. Medication use remained unchanged in both groups throughout the trial with no serious adverse effects reported. Conclusion: These results suggest that tDCS has the potential to improve daily function and reduce pain in patients suffering from chronic headaches. Larger randomized, controlled trials are needed to confirm these findings. Trial registration: The study was approved by the local ethics committee (2018/ 2514) and by the Norwegian Centre for Research Data (54483). [ABSTRACT FROM AUTHOR]

Purpose: Skilled nursing facility (SNF) care has historically been influenced by systemic issues that could impact speech-language pathology (SLP) service provision. However, there has been little study specifically on factors associated with SLP service provision in SNFs. Large administrative data sets are rarely analyzed in SLP research but can be used to understand real-world SLP services. This study investigated associations between patient and facility characteristics and SLP services. Method: Mixed-effects logistic regression models were used to evaluate factors associated with SLP service provision in 2018 Medicare administrative data representing 833,653 beneficiaries. Results: Beneficiaries had higher odds of receiving SLP services when they had neurologic diagnosis (odds ratio [OR] = 3.32), had SLP-related functional impairments (ORs = 1.19-3.41), and received other rehabilitative services (ORs = 3.11- 3.78). Beneficiaries had lower odds of receiving SLP services when they received care from SNFs located in hospitals versus freestanding (OR = 0.45), with need for interpreter services (OR = 0.76) and with thresholding (OR = 0.68), a financially motivated practice. Direction of association varied across racial and ethnic groups and measures of location. Odds of being provided SLP services decreased with increasing communication impairment severity. Conclusions: The results suggest that clinicians are identifying patients with diagnoses most likely to warrant SLP services. However, association disparities and weakening association of service provision with increasing impairment severity have concerning clinical implications. Health services research methods can be used to further explore SLP practices in SNFs to support equitable service provision. [ABSTRACT FROM AUTHOR]

Psychotherapy is expected to be effective in the treatment of patients with medically unexplained physical symptoms (MUPS). However, evidence is scarce. The aim of this study was to examine the effectiveness of a multicomponent treatment based on group therapy in patients with MUPS in a naturalistic setting and to explore potential predictors of the outcomes. A multisite naturalistic uncontrolled effectiveness study. A total of 290 patients with MUPS participated in group psychotherapy across seven clinical sites. Somatic symptoms, depression, anxiety, general psychotherapy outcomes operationalized as the Outcome Rating Scale (ORS) score, well-being, role functioning interference, as well as a number of pretreatment predictors were measured using a battery of self-report measures. Multilevel modeling and lasso regression with bootstrapping were used for the analysis. Medium to large pre-post effects were found for somatic symptoms, ORS, depression, anxiety, well-being, role functioning interference found in completers after controlling for site and group effects, pretreatment outcome values, and treatment length. Changes reported at 6- and 12-month follow-up were higher for most variables. No substantial pretreatment predictors of the patients' posttreatment status were found in addition to the pretreatment level of outcome variables. Somatic symptoms seem to be less malleable in psychotherapy than psychological outcome variables. However, there was a trend of further improvement after treatment completion. Registration: This study was retrospectively registered with ISRCTN (Identifier 13532466). [ABSTRACT FROM AUTHOR]

International research suggests that increasing numbers of autistic people are entering higher education. Currently, very little is known about this population. For example, the rates of autistic people enrolling at UK-based higher education institutions, the demographics of this population, the subjects they study and particularly their graduate outcomes are unknown. This study is an exploratory analysis of autistic graduate outcomes. We compare outcomes between autistic students, other disabled students and non-disabled students, by sex. The article draws upon population data collected by the Higher Education Statistical Agency in the United Kingdom (N = 1,326,416) across the years 2012–2018. Our findings indicate that the academic programmes studied at university by autistic students are more diverse than typically assumed. We also found that graduates make the transition into a range of employment sectors following graduation, but experience persistent and disparities in economic activity and income. We argue that higher education institutions must focus greater attention on developing more robust and effective employment transition support for autistic students and graduates. International research suggests that more autistic people are entering higher education. Currently, very little is known about this group in the United Kingdom, for example, we have little information about how many autistic people enrol at UK-based higher education institutions, their backgrounds, the academic programmes they study and what they do once they have graduated. Our study tries to explore these issues by comparing outcomes between autistic students, other disabled students and non-disabled students. We use population data collected by the Higher Education Statistical Agency in the United Kingdom, which included 1,326,416 graduates across the years 2012–2018. Our findings indicate that the degree subjects studied at university by autistic students are more diverse than often people think. We also found that graduates go on to work in a range of employment sectors following graduation but often experience worse outcomes in terms of access to full-time work and worse pay. We argue that universities and colleges must focus greater attention on developing better employment transition support for autistic students and graduates. [ABSTRACT FROM AUTHOR]

Simple Summary: The location of the primary tumor in the right colon, left colon, or rectum affects the efficacy of biological drugs used in the treatment of metastatic colorectal cancer, but how? We examined how the primary tumor location affects disease characteristics, treatability, quality of life, and outcome in a real-life study population of 1080 Finnish patients in the RAXO study. The primary tumor location correlates with the location of metastases, the frequency of gene mutations, how often metastases can be operated upon, long-term survival after curative surgery or palliative chemotherapy, and the quality of life during the disease trajectory. The primary tumor location is a helpful surrogate for clinicians working with metastatic colorectal cancer patients in estimating the clinical course of the disease. This study cannot identify the reasons for the associations, i.e., whether it is the primary location per se, the different mutations, or other reasons. The primary tumor location (PTL) is associated with the phenotype, metastatic sites, mutations, and outcomes of metastatic colorectal cancer (mCRC) patients, but this has mostly been studied according to sidedness (right vs. left sided). We studied right colon vs. left colon vs. rectal PTL in a real-life study population (n = 1080). Health-related quality of life (HRQoL) was assessed multi-cross-sectionally with QLQ-C30, QLQ-CR29, EQ-5D, and 15D. A chi-square, Kaplan–Meier, and Cox regression were used to compare the groups. The PTL was in the right colon in 310 patients (29%), the left colon in 396 patients (37%), and the rectum in 375 patients (35%). The PTL was associated with distinct differences in metastatic sites during the disease trajectory. The resectability, conversion, and resection rates were lowest in the right colon, followed by the rectum, and were highest in the left colon. Overall survival was shortest for right colon compared with left colon or rectal PTL (median 21 vs. 35 vs. 36 months), with the same trends after metastasectomy or systemic therapy only. PTL also remained statistically significant in a multivariable model. The distribution of symptoms varied according to PTL, especially between the right colon (with general symptoms of metastases) and rectal PTL (with sexual- and bowel-related symptoms). mCRC, according to PTL, behaves differently regarding metastatic sites, resectability of the metastases, outcomes of treatment, and HRQoL. [ABSTRACT FROM AUTHOR]

Simple Summary: Nowadays: minimal invasive distal pancreatectomy is becoming the standard approach for this procedure. Nevertheless, empirical evidence is still needed to validate the advantages associated with the various surgical approaches. This international retrospective multicenter cohort study conducted at three high-volume centers for HPB surgery attempted to compare the perioperative and oncological outcomes of the three primary surgical techniques—open, laparoscopic, and robotic—using propensity score matching analysis. The laparoscopic approach demonstrated notable benefits, including shorter operative times, lower blood loss, and reduced duration of both ICU and hospital stays. Furthermore, the robotic approach exhibited a significantly lower incidence of POPF. Notably, all three techniques demonstrated comparable levels of oncological safety, morbidity, and mortality. Background: Minimally invasive surgery is increasingly preferred for left-sided pancreatic resections. The SIMPLR study aims to compare open, laparoscopic, and robotic approaches using propensity score matching analysis. Methods: This study included 258 patients with tumors of the left side of the pancreas who underwent surgery between 2016 and 2020 at three high-volume centers. The patients were divided into three groups based on their surgical approach and matched in a 1:1 ratio. Results: The open group had significantly higher estimated blood loss (620 mL vs. 320 mL, p < 0.001), longer operative time (273 vs. 216 min, p = 0.003), and longer hospital stays (16.9 vs. 6.81 days, p < 0.001) compared to the laparoscopic group. There was no difference in lymph node yield or resection status. When comparing open and robotic groups, the robotic procedures yielded a higher number of lymph nodes (24.9 vs. 15.2, p = 0.011) without being significantly longer. The laparoscopic group had a shorter operative time (210 vs. 340 min, p < 0.001), shorter ICU stays (0.63 vs. 1.64 days, p < 0.001), and shorter hospital stays (6.61 vs. 11.8 days, p < 0.001) when compared to the robotic group. There was no difference in morbidity or mortality between the three techniques. Conclusion: The laparoscopic approach exhibits short-term benefits. The three techniques are equivalent in terms of oncological safety, morbidity, and mortality. [ABSTRACT FROM AUTHOR]

Simple Summary: Outcomes for high-risk myeloma patients are still poor, despite many advances in treatment. In addition, scarce data exist on double maintenance in transplant-eligible high-risk newly diagnosed multiple myeloma (NDMM) patients. We present the results of a prospective study on 120 transplant-eligible NDMM patients with prolonged cytogenetic risk-based all-oral maintenance with lenalidomide + ixazomib (IR) for high-risk patients and lenalidomide (R) alone for non-high-risk patients after ixazomib–lenalidomide–dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation. We found that high-risk cytogenetics had no impact on the proportion of patients achieving sustained undetectable minimal residual disease or on the rate of progression-free survival with IR maintenance. Our data suggest that prolonged use of all-oral double maintenance with IR with reasonable adverse effects would be a potential option for high-risk myeloma patients. Scarce data exist on double maintenance in transplant-eligible high-risk (HR) newly diagnosed multiple myeloma (NDMM) patients. This prospective phase 2 study enrolled 120 transplant-eligible NDMM patients. The treatment consisted of four cycles of ixazomib–lenalidomide–dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation and cytogenetic risk-based maintenance therapy with lenalidomide + ixazomib (IR) for HR patients and lenalidomide (R) alone for NHR patients. The main endpoint of the study was undetectable minimal residual disease (MRD) with sensitivity of <10−5 by flow cytometry at any time, and other endpoints were progression-free survival (PFS) and overall survival (OS). We present the preplanned analysis after the last patient has been two years on maintenance. At any time during protocol treatment, 28% (34/120) had MRD < 10−5 at least once. At two years on maintenance, 66% of the patients in the HR group and 76% in the NHR group were progression-free (p = 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10−5. Altogether 95% of the patients with sustained MRD <10−5, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (p < 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients. [ABSTRACT FROM AUTHOR]

Background: Beta-blocker (BB) therapy plays a central role in the treatment of cardiovascular diseases. An increasing number of patients with cardiovascular diseases undergoe noncardiac surgery, where opioids are an integral part of the anesthesiological management. There is evidence to suggest that short-term intravenous BB therapy may influence perioperative opioid requirements due to an assumed cross-talk between G-protein coupled beta-adrenergic and opioid receptors. Whether chronic BB therapy could also have an influence on perioperative opioid requirements is unclear. Methods: A post hoc analysis of prospectively collected data from a multicenter observational (BioCog) study was performed. Inclusion criteria consisted of elderly patients (≥ 65 years) undergoing elective noncardiac surgery as well as total intravenous general anesthesia without the use of regional anesthesia and duration of anesthesia ≥ 60 min. Two groups were defined: patients with and without BB in their regular preopreative medication. The administered opioids were converted to their respective morphine equivalent doses. Multiple regression analysis was performed using the morphine-index to identify independent predictors. Results: A total of 747 patients were included in the BioCog study in the study center Berlin. 106 patients fulfilled the inclusion criteria. Of these, 37 were on chronic BB. The latter were preoperatively significantly more likely to have arterial hypertension (94.6%), chronic renal failure (27%) and hyperlipoproteinemia (51.4%) compared to patients without BB. Both groups did not differ in terms of cumulative perioperative morphine equivalent dose (230.9 (BB group) vs. 214.8 mg (Non-BB group)). Predictive factors for increased morphine-index were older age, male sex, longer duration of anesthesia and surgery of the trunk. In a model with logarithmised morphine index, only gender (female) and duration of anesthesia remained predictive factors. Conclusions: Chronic BB therapy was not associated with a reduced perioperative opioid consumption. Trial registration: This study was registered at ClinicalTrials.gov (NCT02265263) on the 15.10.2014 with the principal investigator being Univ.-Prof. Dr. med. Claudia Spies. [ABSTRACT FROM AUTHOR]

Background: Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN. Methods: This study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment. Discussion: This study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect. Trial registration: ClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b]. [ABSTRACT FROM AUTHOR]

Cochlear implantation successfully improves hearing in most adult recipients. However, in rare cases, post-implant rehabilitation is required to maximize benefit. The primary aim of this investigation was to test if self-reports by cochlear implant users indicate the need for post-implant rehabilitation. Listening performance was assessed with the Speech, Spatial and Qualities short-form SSQ12, which was self-administered via a web-based survey. Subjects included over 2000 adult bilateral or unilateral cochlear implant users with at least one year of experience. A novel application of regression tree analysis identified core SSQ12 items that serve as first steps in establishing a plan for further rehabilitation: items 1, 8, and 11 dealing with single-talker situations, loudness perception, and clarity, respectively. Further regression and classification tree analyses revealed that SSQ12 item scores were weakly related to age, degree of tinnitus, and use of bilateral versus unilateral implants. Conversely, SSQ12 scores were strongly associated with self-rated satisfaction and confidence in using their cochlear implant. The SSQ12 total scores did not vary significantly over 1–9 or more years' experience. These findings suggest that the SSQ12 may be a useful tool to guide rehabilitation at any time after cochlear implantation. Identification of poor performance may have implications for timely management to improve the outcomes, through various techniques such as device fitting adjustments, counseling, active sound exposure, and training spatial hearing. [ABSTRACT FROM AUTHOR]

Simple Summary: Local therapies (LTs) are suggested by most experts and guidelines for the treatment of advanced ACC. However, there are only a few published studies on LTs, and there are no clear recommendations regarding which patients benefit from which treatments. Therefore, this multicentre cohort study aimed to investigate the outcomes and factors associated with LTs (n = 132) when used as a therapeutic approach in 66 patients with metastatic ACC. These patients were treated with local thermal ablation (LTA, n = 84) therapies, transarterial (chemo)embolisation (TA(C)E, n = 40), and transarterial radioembolisation (TARE, n = 8). In 21% of the treated tumoural lesions, complete remission was achieved. Time to progression of the treated lesion was particularly long in patients treated with LTA (median not yet reached), whereas it was only 8.3 months after TA(C)E and 8.2 months after TARE. Thus, this study provides clear evidence that LTs can be quite efficient in a subgroup of patients with advanced ACC. International guidelines recommend local therapies (LTs) such as local thermal ablation (LTA; radiofrequency, microwave, cryoablation), transarterial (chemo)embolisation (TA(C)E), and transarterial radioembolisation (TARE) as therapeutic options for advanced adrenocortical carcinoma (ACC). However, the evidence for these recommendations is scarce. We retrospectively analysed patients receiving LTs for advanced ACC. Time to progression of the treated lesion (tTTP) was the primary endpoint. The secondary endpoints were best objective response, overall progression-free survival, overall survival, adverse events, and the establishment of predictive factors by multivariate Cox analyses. A total of 132 tumoural lesions in 66 patients were treated with LTA (n = 84), TA(C)E (n = 40), and TARE (n = 8). Complete response was achieved in 27 lesions (20.5%; all of them achieved by LTA), partial response in 27 (20.5%), and stable disease in 38 (28.8%). For the LTA group, the median tTTP was not reached, whereas it was reached 8.3 months after TA(C)E and 8.2 months after TARE (p < 0.001). The median time interval from primary diagnosis to LT was >47 months. Fewer than four prior therapies and mitotane plasma levels of >14 mg/L positively influenced the tTTP. In summary, this is one of the largest studies on LTs in advanced ACC, and it demonstrates a very high local disease control rate. Thus, it clearly supports the guideline recommendations for LTs in these patients. [ABSTRACT FROM AUTHOR]

Background: Serving as a stop signal of inflammation, the role of lipoxin A4 (LXA4) in periodontitis remains to be clarified. This study is aimed to examine the changes in LXA4 levels in gingival crevicular fluid (GCF) after scaling and root planing (SRP) and to determine the relationship between LXA4 levels and treatment outcomes and periodontal pathogens in severe periodontitis. Methods: A total of 74 GCF samples were collected from 21 severe periodontitis participants at the deepest affected sites. These sites were re-sampled at 1, 3, and 6 months after SRP. Besides, GCF samples were also collected from 25 periodontally healthy participants. Clinical parameters including probing depth (PD) and clinical attachment level (CAL) in periodontitis group were recorded. LXA4 levels and periodontal pathogens in the GCF were analyzed by ELISA and PCR, respectively. Correlations between GCF LXA4 levels and treatment effect and periodontal pathogens were assessed. Results: LXA4 levels in GCF significantly increased after SRP (p < 0.05), but remained lower than those observed in healthy individuals (p < 0.05). Sites with lower baseline LXA4 concentrations were more likely to experience greater improvements in PD at 6 months post-SRP (area under the curve [AUC] = 0.792), and the improvements were positively correlated with the increase of LXA4 at these sites post-treatment (p < 0.05). Furthermore, more elevated LXA4 levels were observed in sites that became negative for Prevotella intermedia or Tannerella forsythia after SRP. Conclusion: Baseline LXA4 in GCF has the potential to predict the site-specific response of severe periodontal lesions to SRP. The increase of LXA4 levels after treatment was positively correlated with clinical improvements and negatively correlated with the presence of Prevotella intermedia or Tannerella forsythia. [ABSTRACT FROM AUTHOR]

Background: Twice weekly sessions of cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) for major depressive disorder (MDD) lead to less drop-out and quicker and better response compared to once weekly sessions at posttreatment, but it is unclear whether these effects hold over the long run. Aims: Compare the effects of twice weekly v. weekly sessions of CBT and IPT for depression up to 24 months since the start of treatment. Methods: Using a 2 × 2 factorial design, this multicentre study randomized 200 adults with MDD to once or twice weekly sessions of CBT or IPT over 16–24 weeks, up to a maximum of 20 sessions. Main outcome measures were depression severity, measured with the Beck Depression Inventory-II and the Longitudinal Interval Follow-up Evaluation. Intention-to-treat analyses were conducted. Results: Compared with patients who received once weekly sessions, patients who received twice weekly sessions showed a significant decrease in depressive symptoms up through month 9, but this effect was no longer apparent at month 24. Patients who received CBT showed a significantly larger decrease in depressive symptoms up to month 24 compared to patients who received IPT, but the between-group effect size at month 24 was small. No differential effects between session frequencies or treatment modalities were found in response or relapse rates. Conclusions: Although a higher session frequency leads to better outcomes in the acute phase of treatment, the difference in depression severity dissipated over time and there was no significant difference in relapse. [ABSTRACT FROM AUTHOR]