Delayed Treatment Group Research Articles

Study protocol for the Heads-Up trial: a phase II randomized controlled trial investigating head-up tilt sleeping to alleviate orthostatic intolerance in Parkinson’s Disease and parkinsonism

BackgroundIn persons with Parkinson’s Disease (PD) or certain forms of atypical parkinsonism, orthostatic hypotension is common and disabling, yet often underrecognized and undertreated. About half of affected individuals also exhibit supine hypertension. This common co-occurrence of both orthostatic hypotension and supine hypertension complicates pharmacological treatments as the treatment of the one can aggravate the other. Whole-body head-up tilt sleeping (HUTS) is the only known intervention that may improve both. Evidence on its effectiveness and tolerability is, however, lacking, and little is known about the implementability.MethodsIn this double-blind multicenter randomized controlled trial (phase II) we will test the efficacy and tolerability of HUTS at different angles in 50 people with PD or parkinsonism who have both symptomatic orthostatic hypotension and supine hypertension. All participants start with one week of horizontal sleeping and subsequently sleep at three different angles, each maintained for two weeks. The exact intervention will vary between the randomly allocated groups. Specifically, the intervention group will consecutively sleep at 6°, 12° and 18°, while the delayed treatment group starts with a placebo angle (1°), followed by 6° and 12°. We will evaluate tolerability using questionnaires and compliance to the study protocol. The primary endpoint is the change in average overnight blood pressure measured by a 24-hour ambulatory blood pressure recording. Secondary outcomes include orthostatic blood pressure, orthostatic tolerance, supine blood pressure, nocturia and various other motor and non-motor tests and questionnaires.DiscussionWe hypothesize that HUTS can simultaneously alleviate orthostatic hypotension and supine hypertension, and that higher angles of HUTS are more effective but less tolerable. The Heads-Up trial will help to clarify the effectiveness, tolerability, and feasibility of this intervention at home and can guide at-home implementation.Trial registrationClinicalTrials.gov NCT05551377; Date of registration: September 22, 2022.

Outcomes in Early Versus Delayed Management of Pediatric Femoral Shaft Fractures.

There is a paucity of literature regarding the timing of treatment for pediatric femur fractures. The purpose of this study was to analyze whether early versus delayed management of pediatric femoral shaft fractures would impact outcomes regarding time to union and return to baseline function. Pediatric patients presenting with femoral shaft fractures, from January 1, 2010 to January 1, 2021, were identified using the Pediatric Trauma Database at a single Level One Trauma Center and retrospectively reviewed. Demographic information, surgical details, associated injuries, length of follow-up, time to union, and return to baseline function were collected. Patients were then divided into 2 groups; the early intervention group underwent treatment within 24 hours of admission versus the delayed group, which underwent treatment after 24 hours. Patients with neuromuscular disease, pathologic fracture, slipped capital femoral epiphysis, nonambulatory, younger than 6 months old, or had follow-up of <8 weeks posttreatment were excluded. χ 2 and unpaired Student t tests were used to compare outcomes. A P value ≤0.05 was used as the threshold of statistical significance. Of the 169 cases reviewed, 137 met the inclusion criteria. The mean age was 8.0 ± 5.0 (6mo to 16y). The average follow-up time was 1.4 ± 1.4 years. Thirty-two (19%) patients did not meet the inclusion criteria and were excluded from the study. One hundred twenty-two (89%) patients were in the early intervention group versus 15 (11%) in the delayed intervention group. There were no statistically significant differences between the early and the delayed arms in regard to time to union, quality of final reduction, and return to baseline function. The findings of this study support that the timing of surgical intervention of femoral shaft fractures in the pediatric population is not correlated to time to union and final function. Clinically, prompt treatment of pediatric femoral shaft fractures should not supersede medical methods of resuscitation and likely has no bearing on the final outcome. Level III.

A Silver Fluoride Intervention to Improve Oral Health Trajectories of Young Indigenous Australians: Protocol for a Cluster Randomized Controlled Trial

Background Indigenous Australian children and adolescents experience profound levels of preventable dental disease. The application of silver fluoride (AgF) to active dental caries is a noninvasive alternative to traditional dental treatment approaches. There is particular utility among Indigenous children and young people with dental fear, who may not have access to timely or culturally safe dental service provisions. Objective The aims of this study are to: (1) assess levels of active dental caries among Indigenous children and young people in 6 Australian states and territories; (2) determine if an AgF intervention reduces levels of active disease over 12-24 months; (3) measure the impact of improved oral health on social and emotional well-being (SEWB) and oral health-related quality of life; and (4) calculate the cost-effectiveness of implementing such an initiative. Methods The study will use a 2-arm, parallel cluster randomized controlled trial design. Approximately 1140 Indigenous children and youth aged between 2 and 18 years will be recruited. Each state or territory will have 2 clusters. The intervention group will receive the AgF intervention at the start of the study, with the delayed intervention group receiving the AgF intervention 12 months after study commencement. The primary outcome will be the arrest of active carious lesions, with arrested caries defined as nonpenetration by a dental probe. Secondary outcomes will include SEWB, oral health-related quality of life, and dental anxiety, with covariates including dental behaviors (brushing and dental visits). Effectiveness measures for the economic evaluation will include the number of children and young people managed in primary oral health care without the need for specialist referral, changes in SEWB, the numbers and types of treatments provided, and caries increments. Results Participant recruitment will commence in May 2023. The first results are expected to be submitted for publication 1 year after a 24-month follow-up. Conclusions Our findings have the potential to change the way in which active dental disease among Indigenous children and young people can be managed through the inclusion of specifically tailored AgF applications to improve dental health and SEWB delivered by Indigenous health care workers. Desired impacts include cost savings on expensive dental treatments; improved SEWB, nutrition, social, and learning outcomes; and improved quality of life for both children and young people and their caregivers and the broader Indigenous community. The AgF application could be easily implemented into the training program of Indigenous health workers and yield critical information in the management armamentarium of health and well-being recommendations for Australia’s First Peoples. International Registered Report Identifier (IRRID) PRR1-10.2196/48558

Early versus delayed antihypertensive treatment in patients with acute ischaemic stroke: multicentre, open label, randomised, controlled trial

ObjectivesTo compared the effect of early antihypertensive treatment started within 24-48 h of stroke onset versus delaying treatment until day eight on reducing dependency or death.DesignMulticentre, randomised, open label trial.Setting106...

Effectiveness of Stuttering Modification Treatment in School-Age Children Who Stutter: A Randomized Clinical Trial.

This study investigated the effectiveness of the stuttering modification intervention Kinder Dürfen Stottern (KIDS) in school-age children who stutter. Seventy-three children who stutter were included in this multicenter, two-group parallel, randomized, wait-list controlled trial with a follow-up of 12 months. Children aged 7-11 years were recruited from 34 centers for speech therapy and randomized to either the immediate-treatment group or the 3 months delayed-treatment group. KIDS was provided by 26 clinicians who followed a treatment manual. Although the primary outcome measure was the impact of stuttering (Overall Assessment of the Speaker's Experience of Stuttering-School-Age [OASES-S]), the secondary outcomes included objective and subjective data on stuttering severity. At 3 months postrandomization, the mean score changes of the OASES-S differed significantly between the experimental (n = 33) and control group (n = 29; p = .026). Furthermore, treatment outcomes up to 12 months were analyzed (n = 59), indicating large effects of time on the OASES-S score (p < .001, partial η2 = .324). This was paralleled by significant improvements in parental ratings and objective ratings (stuttering severity, frequency, and physical concomitants). The significant short-term treatment effects in the OASES-S are in line with the (initial) focus of KIDS on cognitive and affective aspects of stuttering. Over 12 months, these changes were maintained and accompanied by behavioral improvements. The results suggest that individual treatment with KIDS is an adequate treatment option for this age group. https://doi.org/10.23641/asha.24207864.

Alcohol-Related Problems As Moderators of PTSD Symptom Change During Use of a Web-Based Intervention for Hazardous Drinking and PTSD.

Alcohol-related problems (e.g., physical, interpersonal, intrapersonal, impulse control, social responsibility) can have an impact on posttraumatic stress disorder (PTSD) symptoms during treatment. Evidence-based online self-help tools exist to target alcohol use and related problems and co-occurring PTSD symptoms. It is unknown to what degree individuals with varying alcohol-related problems respond differently to web-based interventions for hazardous alcohol use and PTSD. The current study evaluated specific alcohol-related problems as potential moderators of PTSD symptom changes during the VetChange online intervention while controlling for average daily alcohol use, gender, race, and age. We conducted a secondary analysis of a randomized controlled trial that included 600 post-9/11 veterans (518 men and 82 women). Mixed-effects regression models of alcohol-related problems on PTSD severity scores over time were performed separately in an initial intervention group (IIG; n = 404) and a delayed intervention group (DIG; n = 196) that was used as a comparison condition. Interpersonal problems emerged as a moderator of PTSD symptom changes in IIG such that veterans endorsing greater interpersonal problems demonstrated larger reductions in PTSD symptoms throughout VetChange. There were no significant moderation effects in DIG. Non-White veterans reported significantly higher PTSD symptoms during VetChange. Post hoc analyses indicated that veterans with higher interpersonal problems were more likely to engage in online intervention content focused on identifying high-risk drinking situations and coping with symptoms. Findings imply that veterans reporting alcohol-related interpersonal problems may benefit the most from, and be more motivated to use, online interventions for hazardous alcohol use and PTSD symptoms.

Peer-to-peer support: digital networking in aphasia to improve quality of life (PeerPAL)

BackgroundPeople with aphasia (PWA) often suffer from reduced participation and quality of life. Nevertheless, there are currently only a few specific interventions that respond to this problem. Participation and quality of life could be increased by interacting with peers who have similar experiences. Digital social networks could stimulate an autonomous interaction. However, digital social networks need to be adapted to the specific needs of PWA. Therefore, a participatory, agile process involving the target group should be chosen to develop such a solution, i.e., an app. The research project consists of a total of three phases. In the first phase—app development—the app was developed and programmed including the target group. In the second phase—app testing—the usability and user-friendliness of the app were evaluated with four PWA. In the third phase—feasibility and preliminary efficacy—that will be described in the article, the impact of the app on PWA will be evaluated.AimsThe overarching aim of our study is to provide preliminary efficacy of the intervention. Digital social interaction with other PWA can lead to increased social integration. In addition to digital interaction, personal encounters between PWA should be encouraged. As a result, we expect an improvement in quality of life of PWA. Additionally, we focus on identification of the most appropriate measurements to discover changes associated with the intervention.MethodsThe evaluation, which is described in this paper, takes place in a pre-test - post-test design with a total of n = 48 PWA. Participants will be recruited in regional clusters to facilitate face-to-face meetings. Half of the participants will be assigned to the delayed intervention group and the other half to the immediate intervention group. Participants in the delayed intervention group will go through a 3-month waiting period before using the app, while the participants of the immediate intervention group will start using the app for 3 months right away. Inclusion criteria are the presence of chronic aphasia (at least 6 months) and possession of a smartphone with internet access. Questionnaires on quality of life (SAQOL-39, GHQ-12), depression (GDS, DISCs), communicative participation (CPIB), and social support (F-SozU) will be conducted at inclusion (t0), after 3 months of app use (t1), and after another 3 months for follow-up (t2). Participants in the delayed intervention group will be assessed twice before the intervention, before the 3-month waiting period (t0a) and after the waiting period (t0b). In addition to the quantitative measures, interviews will take place with 6 to 8 selected participants after 3 months of app use. Responses will be analysed using Thematic Analysis.DiscussionThe app will be the first social network tool that is systematically developed with PWA. Initial indications from the first phases are that the app can be used by PWA, so that the evaluation of this app version can take place in the third phase. Results of this study can provide an initial indication of whether social network support is a suitable intervention. Findings will help provide information on the feasibility of digital connectivity for PWA. Preliminary findings on its impact on the participation and quality of life of PWA could be made available.

Intra-articular delivery of micronized dehydrated human amnion/chorion membrane reduces degenerative changes after onset of post-traumatic osteoarthritis.

Background: Micronized dehydrated human amnion/chorion membrane (mdHACM) has reduced short term post-traumatic osteoarthritis (PTOA) progression in rats when delivered 24h after medial meniscal transection (MMT) and is being investigated for clinical use as a disease modifying therapy. Much remains to be assessed, including its potential for longer-term therapeutic benefit and treatment effects after onset of joint degeneration. Objectives: Characterize longer-term effects of acute treatment with mdHACM and determine whether treatment administered to joints with established PTOA could slow or reverse degeneration. Hypotheses: Acute treatment effects will be sustained for 6weeks, and delivery of mdHACM after onset of joint degeneration will attenuate structural osteoarthritic changes. Methods: Rats underwent MMT or sham surgery (left leg). mdHACM was delivered intra-articularly 24h or 3weeks post-surgery (n = 5-7 per group). Six weeks post-surgery, animals were euthanized and left tibiae scanned using equilibrium partitioning of an ionic contrast agent microcomputed tomography (EPIC-µCT) to structurally quantify joint degeneration. Histology was performed to examine tibial plateau cartilage. Results: Quantitative 3D µCT showed that cartilage structural metrics (thickness, X-ray attenuation, surface roughness, exposed bone area) for delayed mdHACM treatment limbs were significantly improved over saline treatment and not significantly different from shams. Subchondral bone mineral density and thickness for the delayed treatment group were significantly improved over acute treated, and subchondral bone thickness was not significantly different from sham. Marginal osteophyte degenerative changes were decreased with delayed mdHACM treatment compared to saline. Acute treatment (24h post-surgery) did not reduce longer-term joint tissue degeneration compared to saline. Histology supported µCT findings and further revealed that while delayed treatment reduced cartilage damage, chondrocytes displayed qualitatively different morphologies and density compared to sham. Conclusion: This study provides insight into effects of intra-articular delivery timing relative to PTOA progression and the duration of therapeutic benefit of mdHACM. Results suggest that mdHACM injection into already osteoarthritic joints can improve joint health, but a single, acute mdHACM injection post-injury does not prevent long term osteoarthritis associated with meniscal instability. Further work is needed to fully characterize the durability of therapeutic benefit in stable osteoarthritic joints and the effects of repeated injections.

Abstract 139: Hypertension Control In The Afro-dpp Program, A Virtual Cardiometabolic Health Intervention Among African Immigrants

Background: Black people and immigrants in the US are disproportionately affected by poor cardiometabolic health. Aim: To test the effectiveness of a virtual, culturally tailored lifestyle intervention with remote blood pressure (BP) monitoring on BP control among African immigrants. Methods: In this pilot cluster-randomized trial (NCT05144737), two churches were randomly assigned to first intervention or delayed intervention groups. African immigrants aged 25-75 years with a smartphone and &amp;ge; 2 of the following were enrolled: body-mass index (BMI) &amp;ge; 25 kg/m 2 , HbA1c 5.7-6.5%, systolic BP (SBP) &amp;ge; 140 mmHg or diastolic BP (DBP) &amp;ge; 90 mmHg. Intervention involved lifestyle coaching using the diabetes prevention program curriculum, adapted to African immigrants, Bluetooth-enabled BP monitor synced to a mobile app (Sphygmo TM ), allowing for remote BP readings. The primary outcome was 6-month change in BP. Results: A total of 60 participants, 30 per site, were recruited; mean age 50.6(±11.9). At baseline, mean SBP was 144.5 mmHg in the first intervention group and 148.3 mmHg in the delayed intervention group. At 6 months, there was 11.32 mmHg SBP, 9.73 mmHg DBP reduction in the first intervention group and 9.31 mmHg SBP, 5.34 mmHg DBP reduction in the delayed intervention group ( Figure ); mean SBP reduction was 4.35 mm Hg greater in the first intervention group (95% CI, -13.56, 4.87). Additional BP control (&amp;lt; 130/80 mmHg) was achieved in 22% of participants in the first intervention group, and 10% in the delayed intervention group. Conclusions: Among African immigrants at risk for cardiovascular disease, a culturally tailored, lifestyle intervention led to BP reduction.

Long-term treatment outcomes of temozolomide-based chemoradiation in patients with adult-type diffuse IDH-mutant grade 2 astrocytoma

PurposeTo report the long-term outcomes in adult patients with grade 2 IDH-mutant astrocytoma treated with temozolomide (TMZ)-based chemoradiation. Methods: One hundred and three patients with histologically proven grade 2 astrocytoma received radiation therapy (RT), 50.4–54 Gy in 1.8 Gy fractions, and adjuvant TMZ up to 12 cycles. Fifty-two patients received RT at the time of tumor progression and 51 in the early postoperative period for the presence of at least one high-risk feature (age > 40 years, preoperative tumor size > 5 cm, large postoperative residual tumor, tumor crossing the midline, or presence of neurological symptoms). Overall survival (OS) and progression-free survival (PFS) were calculated from the time of diagnosis.ResultsWith a median follow-up time of 9.0 years (range, 1.3–15 years), median PFS and OS times were 9 years (95%CI, 6.6–10.3) and 11.8 years (95%CI, 9.3–13.4), respectively. Median PFS was 10.6 years in the early treatment group and 6 years in delayed treatment group (hazard ratio (HR) 0.30; 95%CI 0.16–0.59; p = 0.0005); however, OS was not significantly different between groups (12.8 vs. 10.4 years; HR 0.64; 95%CI 0.33–1.25; p = 0.23). Extent of resection, KPS, and small residual disease were associated with OS, with postoperative tumor ≤ 1 cc that emerged as the strongest independent predictor (HR: 0.27; 95%CI 0.08–0.87; p = 0.01).ConclusionsTMZ-based chemoradiation is associated with survival benefit in patients with grade 2 IDH-mutant astrocytoma. For this group of patients, chemoradiation can be deferred until time of progression in younger patients receiving extensive resection, while early treatment should be recommended in high-risk patients.

Timing of adjuvant chemoradiation for pancreatic cancer with positive surgical margins

Aims: Impact of adjuvant chemoradiation timing on the outcome of pancreatic cancer patients with positive surgical margins is unknown. The aim of this study was to evaluate the effect of adjuvant chemoradiation timing for margin positive pancreatic cancer patients. Methods: A total of 36 pancreatic adenocarcinoma patients with positive surgical margins and received adjuvant chemoradiation were included in the study. The median radiation dose was 50.4 Gy in 28 fractions. The primary study variable was the timing of chemoradiation, grouped as immediate (after ? 1 cycle of chemotherapy) and delayed (after two or more cycles of chemotherapy) chemoradiation. Gemcitabine (n = 16) and capecitabine (n = 20) were chemotherapy regimens administered with radiation. Results: Median follow-up time was 23.7 months. Thirteen patients (36%) received immediate and 23 (64%) received delayed chemoradiation. For immediate and delayed treatment groups, median overall survival was 13.5 and 42.5 months, and disease-free survival was 6.4 and 18.8 months, respectively. Disease-free survival and overall survival were better with delayed chemoradiation (p = 0.02). However, the two groups did not significantly differ in locoregional control (p = 0.96). Conclusion: Delaying chemoradiation until completion of systemic therapy improves disease-free survival and overall survival without any difference in locoregional failure compared to early chemoradiation in pancreatic cancer patients with positive surgical margins.

Delayed Versus Immediate Start of Chemotherapy in Asymptomatic Patients With Advanced Cancer: A Meta-Analysis.

Due to increased use of imaging, advanced stages of cancer are increasingly being diagnosed in an early, asymptomatic phase. Traditionally, chemotherapy is started immediately in these patients. However, a strategy wherein chemotherapy is withheld until symptoms occur may be beneficial for patients in terms of quality of life (QOL). A systematic review regarding optimal timing of chemotherapy including survival and QOL is lacking. We systematically searched PubMed, EMBASE, and Cochrane for studies investigating the timing of start of chemotherapy in asymptomatic patients with advanced cancer. Overall survival (OS) was abstracted as primary, QOL, and toxicity as secondary outcomes. A meta-analysis was performed on OS. QOL was described using the global health status derived from the EORTC-QLQ-C30 questionnaire and toxicity as grade 3-4 adverse events. Overall, 919 patients from 4 randomized controlled trials and 1 retrospective study were included. The included studies investigated colorectal cancer (n = 3), ovarian cancer (n = 1), and gastric cancer (n = 1). Pooled analysis demonstrated no significant differences in OS between delayed and immediate start of chemotherapy (pooled HR: 1.05, 95% CI, 0.90-1.22, P = .52). QOL, evaluated in 3 studies, suggested a better QOL in the delayed treatment group. Toxicity, evaluated in 2 studies, did not differ significantly between groups. This meta-analysis confirms the need for prospective studies on timing of start of chemotherapy in asymptomatic patients with advanced cancer. The limited evidence available suggests that delayed start of chemotherapy, once symptoms occur, as compared to immediate start in asymptomatic patients does not worsen OS while it may preserve QOL.

Reasons for Delayed Anti-VEGF Treatment During COVID-19 Lockdown and Clinical Impact in Neovascular Age-Related Macular Degeneration.

Timely anti-vascular endothelial growth factor (VEGF) treatment is crucial for visual function in neovascular age-related macular degeneration (nAMD). The aim of this study was to assess the reasons for anti-VEGF treatment delay during the COVID-19 lockdown and its clinical impact in patients with nAMD. A retrospective, observational, multicentre study in patients with nAMD treated with anti-VEGF therapy was performed in 16 centres nationwide. Data were retrieved from the FRB Spain registry, patient medical records and administrative databases. Patients were divided into two groups based on whether they received or missed intravitreal injections during the COVID-19 lockdown. A total of 302 eyes from 245 patients were included (timely treated group [TTG] 126 eyes; delayed treatment group [DTG] 176 eyes). Visual acuity (VA; ETDRS letters) decreased from baseline to post-lockdown visit in the DTG (mean [standard deviation] 59.1 (20.8) vs. 57.1 (19.7); p = 0.020) and was maintained in the TTG (64.2 [16.5] vs. 63.6 [17.5]; p = 0.806). VA worsened by an average of -2.0 letters in the DTG and by -0.6 in the TTG (p = 0.016). A higher proportion of visits were cancelled due to hospital overload in the TTG (76.5%) than in the DTG (47%), and a higher proportion of patients missed visits in the DTG (53%) than in the TTG (23.5%, p = 0.021), with fear of COVID-19 infection being the main reason for missed visits (60%/50%). Treatment delays were caused by both hospital saturation and patients' decision; the latter being mainly driven by fear of COVID-19 infection. These delays had a detrimental effect on the visual outcomes in nAMD patients.

Effect of surgical timing in outcomes in Hispanic patients after arthroscopic capsular release in diabetic and idiopathic adhesive capsulitis

Adhesive capsulitis of the shoulder is a painful and debilitating condition. While the majority of patients improve with conservative treatment, those who do not improve require surgery such as arthroscopic capsular release (ACR) for symptom relief. However, there is limited literature regarding the optimal timeframe to proceed with surgery. This retrospective cohort evaluated 134 Hispanic patients who underwent ACR for the treatment of adhesive capsulitis. Patients were divided into an early and a delayed treatment group that included all patients. Patients were then divided into diabetic and idiopathic subgroups. Early vs. delayed treatment outcomes (forward flexion, external rotation, Visual Analog Scale pain scores, and recurrence requiring reoperation) were assessed in all patients and in each subgroup. No statistically significant differences were found between the early and delayed release groups in postoperative forward flexion, external rotation, pain intensity scores, and recurrence requiring reoperation at 1 month, 3 months, and 6 months of follow-up in the all-patient group. In the idiopathic frozen shoulder subgroup, no significant differences were observed in postoperative forward flexion, external rotation, pain intensity scores, and recurrence requiring reoperation at 1 month, 3 months, and 6 months of follow-up. In the diabetic frozen shoulder subgroup, no significant differences were observed in postoperative forward flexion, external rotation, pain intensity scores, and recurrence requiring reoperation at 1 month and 6 months of follow-up visits. There was no difference in outcomes following ACR for adhesive capsulitis between patients who underwent early release vs. delayed release. There were no significant differences in outcomes between early and delayed arthroscopic release in patients with a history of diabetes mellitus.

Early Versus Delayed Oral Anticoagulation in Patients With Acute Ischemic Stroke Due to Atrial Fibrillation: A Meta-Analysis.

The aim of this study was to compare the safety and efficacy of early oral anticoagulation with delayed anticoagulant therapy in patients who have had a recent stroke and have atrial fibrillation (AF). This meta-analysis was conducted following the Preferred Reporting Items for Systemic Reviews and Meta-analyses (PRISMA) statement. The literature search was independently performed by two authors. We searched PubMed and Scopus using search strings that included the following terms: "stroke," "atrial fibrillation," "oral anticoagulants," "recurrent stroke," and "intracerebral hemorrhage." Our search spanned from the inception of databases to May 25, 2023. The primary outcome assessed in this study was the composite efficacy outcome (as defined by individual studies). Recurrent ischemic stroke (IS), intracranial hemorrhage (ICH), and death from any cause were assessed as secondary outcomes. For safety analysis, bleeding events were compared between the two study groups. We included five articles in this meta-analysis, comprising a total of 7958 patients (including 3793 in the early treatment group and 4165 in the delayed treatment group). Pooled analysis showed that the risk of composite efficacy outcome (RR: 0.69, 95% CI: 0.51-0.93, p-value: 0.01) and recurrent ischemic stroke (RR: 0.71, 95% CI: 0.53-0.94, p-value: 0.02) were lower in the early treatment group. However, no significant differences were observed between the two groups in terms of all-cause mortality, intracranial hemorrhage, or bleeding events. In light of the findings, healthcare professionals should carefully evaluate the risks and benefits of early versus delayed DOAC treatment in individual patients, considering factors such as stroke severity, bleeding risk, and patient preferences.

Semantic Feature Analysis (SFA) treatment in L1 and L2 in bilingual aphasia: Effects of cognitive and language factors

ABSTRACT Background Semantic Feature Analysis (SFA) treatment has been proven to be effective in alleviating word finding difficulties in individuals with aphasia. However, there is no consensus on the impact of SFA on naming abilities and general language skills in bilingual persons with aphasia (BiPWAs), nor on factors that determine the success of the SFA treatment. Aims This study aimed to investigate the efficacy of SFA treatment in a group of L1-Russian – L2-Hebrew chronic stage BiPWAs and to evaluate the contribution of background factors, language and cognitive measures on the treatment success. Methods & Procedures The current study included two groups of BiPWAs. In the experimental group (n=10), six individuals received SFA therapy in both languages and four individuals in L2. The delayed-treatment group (n=10) did not receive therapy and served as a control group. All BiPWAs completed the Bilingual Aphasia Test (BAT) in both languages, as well as a battery of 10 cognitive tests and linguistic background questionnaires. Outcome & Results The results indicated a direct effect of SFA treatment on naming as well as within-language generalization and cross-language transfer. Importantly, we found significant improvements of general language skills in the treated and untreated languages in BiPWAs who received SFA treatment, while no such improvement was observed in the control group. Non-verbal inhibition and verbal working memory in L1-Russian predicted success of SFA treatment in BiPWAs. Conclusions SFA therapy has positive effects on naming ability of BiPWAs. In addition, SFA therapy affects general language skills in BiPWAs. Yet, within-language generalization, cross-linguistic transfer, and maintenance of the treatment results vary across individuals. The success of SFA treatment in BiPWAs is predicted by cognitive functions rather than background factors of bilingualism.

Evaluation of the New England Office Based Addiction Treatment ECHO: A Tool for Strengthening the Addiction Workforce.

Reducing substance-related morbidity requires an educated and well-supported workforce. The New England Office Based Addiction Treatment Extension for Community Healthcare Outcomes (NE OBAT ECHO) began in 2019 to support community-based addiction care teams through virtual mentoring and case-based learning. We sought to characterize the program's impact on the knowledge and attitudes of NE OBAT ECHO participants. We conducted an 18-month prospective evaluation of the NE OBAT ECHO. Participants registered for 1 of 2 successive ECHO clinics. Each 5-month clinic included ten 1.5-hour sessions involving brief didactic lectures and de-identified patient case presentations. Participants completed surveys at Month-0, -6, -12, and -18 to assess attitudes about working with patients who use drugs and evidence based practices (EBPs), stigma toward people who use drugs, and addiction treatment knowledge. We compared outcomes using 2 approaches: (i) between-groups, which involved comparing the first intervention group to the delayed intervention (comparison) group, and (ii) within-groups, which involved comparing outcomes at different time points for all participants. In the within-group approach, each participant acted as their own control. Seventy-six health professionals participated in the NE OBAT ECHO, representing various roles in addiction care teams. Approximately half (47% [36/76]) practiced primary care, internal, or family medicine. The first intervention group reported improved job satisfaction and openness toward EBPs compared to the delayed intervention group. Within-group analyses revealed that ECHO participation was associated with increased positive perceptions of role adequacy, support, legitimacy, and satisfaction 6 months following program completion. No changes were identified in willingness to adopt EBPs or treatment knowledge. Stigma toward people who use drugs was persistent in both groups across time points. NE OBAT ECHO may have improved participants' confidence and satisfaction providing addiction care. ECHO is likely an effective educational tool for expanding the capacity of the addiction workforce.

The Effect of Immediate Microsurgical Resection of Vestibular Schwannoma on Hearing Preservation.

Evaluate for differences in postoperative hearing in patients who undergo immediate versus delayed hearing preservation microsurgical resection of vestibular schwannomas (VS). Retrospective single-institution cohort study spanning November 2017 to November 2021. Single-institution tertiary care hospital. Sporadic VS in patients with American Academy of Otolaryngology-Head and Neck Surgery hearing classification A or B, with tumor size less than or equal to 2 cm and undergoing hearing preservation microsurgical resection. Delayed surgical intervention defined by time from first diagnostic MRI to date of surgery being greater than 3 months. Preoperative and postoperative audiometric performance. In total, 193 patients met inclusion criteria. Within the cohort, 70 (36%) proceeded with surgery within 3 months of diagnostic MRI with a mean observation time of 62 days, whereas 123 (63%) underwent surgery after 3 months with a mean observation time of 301 days. There was no difference in preoperative hearing between the two groups with word recognition score 99% in early intervention group and 100% in delayed intervention group (p = 0.6). However, 64% of those who proceeded with immediate surgery had successful hearing preservation, compared to a 42% of those who had delayed intervention (p < 0.01). In a multivariable logistic regression accounting for preoperative word recognition score, tumor size, and age at diagnosis, the odds of hearing preservation were lower in those who delayed surgery compared to immediate surgery (odds ratio, 0.31; 95% confidence interval, 0.15-0.61). Patients who underwent microsurgical resection within 3 months of diagnosis demonstrated a hearing preservation advantage compared to those who did not. Findings of this study highlight the counseling challenges associated with the timing of surgical treatment of VS in patients presenting with good preoperative hearing and small tumors.

Early versus delayed treatment of lateral condylar fracture of the humerus with > 2 mm displacement in children: a retrospective study

BackgroundThe purpose of this study was to investigate the clinical and functional outcomes of early versus delayed treatment of pediatric lateral condylar fractures of the humerus with a displacement greater than 2 mm.MethodsSixty-seven children treated surgically at our hospital from March 2016 to September 2021 for lateral condylar fracture of the humerus with displacement > 2 mm were retrospectively analyzed. The children were divided into two groups where early surgery consisted of patients being operated on within 24-h post-injury (n = 36) and delayed surgery consisted of children operated after 24-h post-injury (n = 31). Clinical and functional results were compared between the two groups.ResultsThere were no significant differences between the two groups in terms of operation time, blood loss and incidences of perioperative complications. However, mean length of incision was significantly greater (P < 0.0001) in the delayed treatment group (5.68 ± 1.08 cm) compared to the early treatment group (3.89 ± 0.82 cm). No differences were found in functional outcomes, consisting of the Baumann angle of the affected limb, the carrying angle, Mayo Elbow Performance Score, and Flynn’s criteria at final follow-up.ConclusionsDelay in surgery for more than 24 h after injury does not influence the clinical and functional results for lateral condylar fracture of the humerus with displacement > 2 mm in children. However, delayed open reduction and pinning may increase the incision length possibly due to increased edema.

The impact of gingivitis reduction on lung function: a randomized trial under intensified oral hygiene

BackgroundPeriodontal disease and lung function impairment were found to be associated with low-grade systemic or local inflammation, and it might be that gingival/periodontal inflammation triggers lung function due to systemic inflammation or the transfer of oral bacteria or its components to the lung. A recent observational study in non-smoking subjects showed that lung volumes and flow rates were significantly reduced by 71–185 ml for severe gingivitis regardless of the adjustment for potential confounders. The result did not show any confounding by smoking, and the association between gingivitis and lower lung function was not modified by systemic inflammation. The designed interventional trial primarily aims to test the hypothesis that gingivitis reduction by optimized daily oral hygiene, professional tooth cleaning and antibacterial chlorhexidine (CHX)-containing mouth rinse improves lung function in terms of forced vital capacity (FVC) by at least 2%. The secondary objective will test the hypothesis that gingivitis reduction improves forced expiratory volume in 1 s (FEV1) and forced expiratory flow at 25–75% of the pulmonary volume (FEF25-75) by at least 2%. Furthermore, the influence of the oral microbiome will be taken into account.MethodsThe study has to include 120 non-smoking subjects aged between 18 and 30 years with biofilm-induced gingivitis. The chosen “waiting control group design” will compare the immediate intervention group with the delayed intervention group, which serves as a control group. Dental and gingival status, lung function and oral microbiome will be recorded. The intensified preventive intervention—professional tooth cleaning, one-stage full-mouth disinfection with CHX and safeguarding an optimal daily oral hygiene by each subject—cannot be blinded, but the outcome measurement in terms of lung function tests is blind.DiscussionThis proposed multidisciplinary study has several strengths. Only one previous intervention study with patients with severe periodontitis (mostly smokers) has been performed. It is novel to include non-smoking subjects with mild and potentially reversible oral inflammation. Furthermore, this research is innovative, because it includes evidence-based interventions for gingivitis reduction, standardized measures of the outcome on lung function and oral microbiome and combines expertise from dentistry, lung physiology, oral microbiology and epidemiology/statistical modelling.Trial registrationGerman Clinical Trial Register DRKS00028176. Registered on February 2022.