Delayed Treatment Group Research Articles

Impact of time from diagnosis to endoscopic submucosal dissection on curability in superficial esophageal squamous cell carcinoma.

To investigate the time delay effect from initial diagnosis to endoscopic submucosal dissection on superficial esophageal squamous cell carcinoma curability, considering the preoperative invasion depth. This study included superficial esophageal squamous cell carcinoma diagnosed as T1a-epithelial/lamina propria mucosa cancer (cEP/LPM; cancer invading up to the lamina propria mucosa) or cT1a-muscularis mucosa (MM)/T1b-submucosal cancer (cMM/SM1; cancer invading up to 200 µm into the submucosa) and treated using endoscopic submucosal dissection from January 2017 to December 2021. We compared curability in lesions treated within three months (early treatment group) versus those treated ≥7 months post-diagnosis (delayed treatment group). Curative resection criteria included lesions confined within the muscularis mucosae, with negative vertical margins, and with absence of lymphovascular invasion. Non-curative resection included all other cases. Among the 231 and 75 lesions in the early and delayed treatment groups, respectively, no significant difference was observed in non-curative resections for all lesions and cEP/LPM lesions (early: 194, delayed: 70). Conversely, the proportions were significantly higher in the delayed treatment group than in the early treatment group for cMM/SM1 lesions (early: 37, delayed: 5; p = 0.018). This study suggests that delayed endoscopic submucosal dissection does not significantly affect cEP/LPM lesions curability but is associated with reduced cMM/SM1 lesions curability. Prompt treatment is important for cMM/SM1, whereas delayed treatment may be acceptable for cEP/LPM.

Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour

Summary What is this article about? A study (ClinicalTrials.gov identifier: NCT03583359) that tested whether an injectable filler treatment called calcium hydroxylapatite with lidocaine, or CaHA (+), could improve the shape of the jawline.How was the study in this summary conducted? Loss of jawline shape is a change to jawline appearance, like sagging or deflating, that occurs as people get older. A total of 123 participants received CaHA (+) injections on day 1 of the study (immediate treatment). Fifty-seven participants did not receive CaHA (+) until week 12 (delayed treatment). Jawline shape at week 12 was rated on a five-point scale (0 = no loss of shape or volume; 4 = extreme loss). Researchers also looked at participants’ satisfaction and self-reported improvement, ratings of how old participants thought they looked, and side effects.What were the results of the study? In the immediate treatment group, 76% of participants had improvement in jawline shape at week 12 (compared with 9% of participants in the delayed treatment group), which typically lasted approximately 8 months, and 94% self-reported improvement in jawline appearance. The participants were more satisfied with their jawlines and reported looking approximately 3 years younger at week 12 compared with before treatment. Regardless of sex or skin tone, side effects were categorized as mostly mild or moderate reactions, like lumps or bruising, at the site where CaHA (+) was injected.What do the results of this study mean? The results showed that CaHA (+) injections improved jawline shape in most participants and caused only mild or moderate side effects regardless of sex or skin tone, suggesting that CaHA (+) is safe and works well for diverse groups of patients.Who should read this article? This summary is for patients and others interested in learning about how CaHA (+) works, its safety, and its ability to improve jawline shape.Who sponsored this study? The study was sponsored by Merz North America, Inc.

Digital health intervention for children with ADHD to improve mental health intervention, patient experiences, and outcomes: a study protocol

BackgroundAttention Deficit Hyperactivity Disorder (ADHD) is the most prevalent childhood psychiatric condition with profound public health, personal, and family consequences. ADHD requires comprehensive treatment; however, lack of communication and integration across multiple points of care is a substantial barrier to progress. Given the chronic and pervasive challenges associated with ADHD, innovative approaches are crucial. We developed the digital health intervention (DHI)—CoolTaCo [Cool Technology Assisting Co-regulation] to address these critical barriers. CoolTaCo uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient data, support efficient healthcare delivery, enhance patient engagement, and facilitate shared decision-making, thereby improving access to timely and targeted mental health intervention for children at significant risk for poor outcomes. The present paper will describe our planned protocol to evaluate the efficacy of CoolTaCo via randomized control trial (RCT).Methods/designWe will recruit 60 children (ages 8–12) with ADHD who will be randomized to either immediate (n = 30) or delayed (n = 30) treatment (i.e., a waitlist control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application), the other half to an active control treatment as usual (TAU). Unlike the DHI group, the TAU group will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, they will be randomly assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention, and 30 will complete the active control, with half of the total sample completing a waitlist period.DiscussionIndividuals with ADHD have complex needs. Despite improvement in outcomes following cognitive behavioral therapies (CBT) and pharmaceutical treatment, long-term maintenance is a challenge often not addressed by traditional medical approaches, and, as we described, ineffective approaches to information sharing across points of care create further barriers to progress. Our research will fill a significant gap in translating early treatment investments and gains into long-term, sustainable outcomes.This study was registered as a clinic trial at ClinicalTrials.gov (Digital Health Intervention for Children With ADHD, ID# NCT06456372) on 06/13/2024.

A self-guided virtual reality solution for social anxiety: Results from a randomized controlled study

ObjectiveThe study examines the efficacy of a mobile application, oVRcome, which offers self-managed virtual reality exposure therapy combined with cognitive-behavioural techniques to treat social anxiety disorder. MethodsA randomized controlled trial (RCT) was conducted over six weeks with a waitlist delayed treatment group and follow-ups at 12 and 18 weeks. Participants were adults living in New Zealand with moderate to severe social anxiety disorder, as measured by the Liebowitz Social Anxiety Scale (LSAS). The primary focus was on the change in LSAS scores from baseline to the sixth week. All analyses utilized the intention-to-treat data. ResultsOut of 126 randomized participants, 81 completed the six-week follow-up. The retention rate at week 6 was 67.5%. The reduction in LSAS scores was significantly greater in the active group compared to the waitlist delayed treatment group (active group mean = −35.7 [SD = 24.0]; waitlist group: mean = − 2.2 [SD = 13.5]; p < 0.001), for an effect size of 1.8. ConclusionsThe study demonstrates that oVRcome can effectively reduce social anxiety symptoms, offering a viable self-guided treatment option. Trial registryClinicalTrials.gov ID NCT05576259.

Early screening and diagnosis of gestational diabetes mellitus (GDM) and its impact on perinatal outcomes

AimsTo compare the maternal and neonatal outcomes following early diagnosis compared with routine diagnosis of gestational diabetes (GDM). MethodsIn this observational study, 3494 women were categorised by weeks of gestation at GDM diagnosis: early GDM (≤20 weeks) and routine GDM (>20 weeks). The early GDM group was further divided by treatment commencement as immediate (<12 weeks) and delayed (12–20 weeks) and by diagnostic fasting blood glucose as higher- FBG (5.3–6.0 mmol/L) and lower-FBG group (FBG 5.1–5.2 mmol/L). Primary outcomes were large for gestational age (LGA) and small for gestational age (SGA). Generalized linear models used to calculate risk ratios and adjusted for confounding. ResultsRisk ratios (RR) for LGA and SGA were similar for early versus routine diagnosis, and immediate versus delayed treatment. The higher-FBG immediate treatment group had a lower risk of newborn respiratory distress (RR 0.52, 95 %CI 0.34, 0.81) and emergency caesarean (RR 0.55, 95 %CI 0.34, 0.88) compared to the higher-FBG delayed treatment group. Among the lower-FBG group, no such benefits were seen. ConclusionsFasting glucose levels modified the effects of early treatment of GDM where a higher-FBG with immediate treatment appears to reduce perinatal complications, but treating women with lower-FBG early has no benefits.

Efficacy of an internet-based guided trauma-focused intervention in reducing ICD-11 posttraumatic stress disorder symptoms: study protocol of a randomized controlled trial

BackgroundPosttraumatic stress disorder (PTSD) is a common mental disorder. However, many cases of PTSD remain untreated because of limited healthcare resources and other treatment-seeking barriers. Effective internet-based interventions could help to improve access to PTSD treatments. Therefore, the main objective of the planned randomized controlled trial is to evaluate the efficacy of the Lithuanian version of the guided internet-based self-help programme (Spring) in reducing ICD-11 PTSD symptoms.MethodsThe planned sample size is 50 participants exposed to different traumatic experiences. Participants eligible for the study will be randomized into two study groups: the immediate treatment group and the delayed treatment control group. Both groups will receive guided trauma-focused ICBT intervention, but the delayed treatment group will receive access to the programme five months after randomization. The International Trauma Interview (ITI) will be used for the assessment of ICD-11 PTSD symptoms at pre-treatment, post-treatment, and at a 3-month follow-up. Changes in disturbances in self-organization, depression and anxiety levels, as well as posttraumatic cognitions and trauma-related shame, will also be evaluated. In addition, associations between changes in symptoms of PTSD and readiness for treatment, treatment expectations and working alliance will be explored. Changes in treatment outcomes will be evaluated using multiple Latent Change Models.DiscussionThis study is expected to contribute to valuable knowledge on the efficacy of internet-based interventions for posttraumatic stress disorder.Trial registrationClinicalTrials.gov NCT06475716. Registered on 25 June 2024.

Impact of Early Invasive Strategy on Left Ventricular Function Recovery in Acute Myocardial Infarction Patients in Pakistan.

Background Acute myocardial infarction (AMI) is a leading cause of morbidity and mortality worldwide, particularly in low- and middle-income countries like Pakistan, where healthcare resources are limited. Early Invasive Strategy (EIS), typically involving percutaneous coronary intervention (PCI), has been shown to improve outcomes in AMI patients. However, the effectiveness of EIS in resource-limited settings, such as Pakistan, remains under-explored. Objective This prospective observational cohort study aimed to assess the impact of an Early Invasive Strategy (EIS) on left ventricular (LV) function recovery in acute myocardial infarction (AMI) patients in Pakistan. The primary objective was to measure the change in left ventricular ejection fraction (LVEF) over six months. Secondary objectives included evaluating mortality, rehospitalization rates, and incidences of major adverse cardiovascular events (MACE). Multivariate regression analysis was employed to adjust for potential confounders. Methods The study was conducted from January to December 2023 at the National Institute of Cardiovascular Diseases (NICVD) satellite centers in Sukkur, Nawab Shah, and Khairpur. A total of 300 AMI patients presenting within 24 hours of symptom onset were included. Participants were divided into two groups: the EIS group (n = 150) received percutaneous coronary intervention (PCI) within 24 hours of admission, while the delayed treatment group (n = 150) received standard therapy, with invasive procedures performed after 24 hours if clinically indicated. Data were collected at baseline, during hospitalization, and at three- and six-months post-AMI. Results The EIS group demonstrated a significantly greater improvement in LVEF compared to the delayed treatment group (13.1% [95% CI, 10.8%-15.4%] vs. 7.5% [95% CI, 5.8%-9.2%], p < 0.001). Mortality was lower in the EIS group (3% [n = 4] vs. 9% [n = 13], p = 0.01), as were rehospitalizations for heart failure (7% [n = 10] vs. 14% [n = 21], p = 0.02) and incidences of MACE (8% [n = 12] vs. 16% [n = 24], p = 0.01). Multivariate regression analysis confirmed that EIS was independently associated with better LVEF improvement (coefficient = 5.78 [95% CI, 4.21-7.35], p < 0.001). Conclusion Early invasive treatments significantly enhance left ventricular function recovery and reduce mortality and rehospitalization rates in AMI patients in Pakistan. These findings advocate for the implementation of timely PCI interventions in resource-limited settings to improve clinical outcomes, particularly emphasizing cost-effectiveness and the availability of PCI.

Examining timing of periorbital interventions in patients with upper division facial paralysis.

Facial paralysis is a life-altering condition that may arise from various etiologies, ranging from trauma to malignancy. Permanent facial paralysis may occur secondary to facial nerve sacrifice or irreversible damage to the nerve. In these particularly devastating cases, protection and maintaining function of the eye is paramount. There are many effective lagophthalmos corrective surgical procedures available for these patients. While placement of eyelid weights and lid tightening surgeries are the cornerstone of eyelid rehabilitation, limited information exists on whether the timing of eyelid interventions in the setting of permanent facial paralysis impact outcomes, including need for revision surgery. A single-center retrospective chart review was performed for patients with irreversible facial paralysis treated with an upper eyelid weight between 2013 to 2022. Electronic health records were acquired to obtain facial paralysis etiology, associated clinical characteristics, the type of intervention, and the timing of intervention. Patients were classified as immediate if the eyelid weight operation occurred within 29 days of the initial facial paralysis and delayed if the surgery occurred 30 days or more after initial presentation. Outcomes were assessed in terms of revision procedures and surgical complications. There were 70 patients in total, with 35 patients in the immediate category and 35 patients in the delayed category. The most common etiology related to parotid gland pathology, and 58.6% of patients had facial paralysis from cancer-related surgeries. There were no significant differences in revision rates (p < 0.208) or in the types of procedures (p = 0.077) between the two groups. The complication rates also did not differ significantly between groups; however, there were only complications in the delayed intervention group. These findings suggest there is no difference in postoperative complications between groups, including the need for revision surgeries when comparing groups with immediate or delayed intervention. Thus, treatment plans should be customized based on patient and provider preferences.

Stroke Risk Reduction in Atrial Fibrillation Through Pharmacist Prescribing

Major gaps in the delivery of appropriate oral anticoagulation therapy (OAC) exist, leaving a large proportion of persons with atrial fibrillation (AF) unnecessarily at risk for stroke and its sequalae. To investigate whether pharmacist-led OAC prescription can increase the delivery of stroke risk reduction therapy in individuals with AF. This prospective, open-label, patient-level randomized clinical trial of early vs delayed pharmacist intervention from January 1, 2019, to December 31, 2022, was performed in 27 community pharmacies in Alberta, Canada. Pharmacists identified patients 65 years or older with 1 additional stroke risk factor and known, untreated AF (OAC nonprescription or OAC suboptimal dosing) or performed screening using a 30-second single-lead electrocardiogram to detect previously unrecognized AF. Patients with undertreated or newly diagnosed AF eligible for OAC therapy were considered to have actionable AF. Data were analyzed from April 3 to November 30, 2023. In the early intervention group, pharmacists prescribed OAC using guideline-based algorithms with follow-up visits at 1 and 3 months. In the delayed intervention group, which served as the usual care control, the primary care physician (PCP) was sent a notification of actionable AF along with a medication list (both enhancement over usual care). After 3 months, patients without OAC optimization in the control group underwent delayed pharmacist intervention. The primary outcome was the difference in the rate of guideline-concordant OAC use in the 2 groups at 3-month follow-up ascertained by a research pharmacist blinded to treatment allocation. Eighty patients were enrolled with actionable AF (9 [11.3%] newly diagnosed in 235 individuals screened). The mean (SD) age was 79.7 (7.4) years, and 45 patients (56.3%) were female. The median CHADS2 (congestive heart failure, hypertension, age, diabetes, and stroke or transient ischemic attack) score was 2 (IQR, 2-3). Seventy patients completed follow-up. Guideline-concordant OAC use at 3 months occurred in 36 of 39 patients (92.3%) in the early intervention group vs 23 of 41 (56.1%) in the control group (P < .001), with an absolute increase of 34% and number needed to treat of 3. Of the 23 patients who received appropriate OAC prescription in the control group, the PCP called the pharmacist for prescribing advice in 6 patients. This randomized clinical trial found that pharmacist OAC prescription is a potentially high-yield opportunity to effectively close gaps in the delivery of stroke risk reduction therapy for AF. Scalability and sustainability of pharmacist OAC prescription will require larger trials demonstrating effectiveness and safety. ClinicalTrials.gov Identifier: NCT03126214.

Early coronary angiography in NSTEMI: a regional Victorian perspective.

Current guidelines highlight a paucity of evidence guiding optimal timing for non-ST-elevation myocardial infarction (NSTEMI) in high-risk and non-high-risk cases. We assessed long-term major adverse cardiovascular events (MACEs) in NSTEMI patients undergoing early (<24 h) versus delayed (>24 h) coronary angiography at 6 years. Secondary end-points included all-cause mortality and cumulative MACE outcomes. Baseline characteristics and clinical outcomes were assessed among 355 patients presenting to a tertiary regional hospital between 2017 and 2018. Cox proportional hazard models were generated for MACE and all-cause mortality outcomes, adjusting for the Global Registry of Acute Coronary Events (GRACE) score, patient demographics, biomarkers and comorbidities. Two hundred and seventy patients were included; 147 (54.4%) and 123 (45.6%) underwent early and delayed coronary angiography respectively. Median time to coronary angiography was 13.3 and 45.4 h respectively. At 6 years, 103 patients (38.1%) experienced MACE; 41 in the early group and 62 in the delayed group (hazard ratio (HR) = 2.23; 95% confidence interval (CI) = 1.50-3.31). After multivariable adjustment, the delayed group had higher rates of MACE (HR = 1.79; 95% CI = 1.19-2.70), all-cause mortality (HR = 2.76; 95% CI = 1.36-5.63) and cumulative MACE (incidence rate ratio = 1.54; 95% CI = 1.12-2.11). Subgroup analysis of MACE outcomes in rural and weekend NSTEMI presentations was not significant between early and delayed coronary angiography (HR = 1.49; 95% CI = 0.83-2.62). Higher MACE rates in the delayed intervention group suggest further investigation is needed. Randomised control trials would be well suited to assess the role of early invasive intervention across all NSTEMI risk groups.

Does delay to theatre influence morbidity or mortality in femoral periprosthetic fractures?

Femoral periprosthetic fractures are rising in incidence. Their management is complex and carries a high associated mortality. Unlike native hip fractures, there are no guidelines advising on time to theatre in this group. We aim to determine whether delaying surgical intervention influences morbidity or mortality in femoral periprosthetic fractures. We identified all periprosthetic fractures around a hip or knee arthroplasty from our prospectively collated database between 2012 and 2021. Patients were categorized into early or delayed intervention based on time from admission to surgery (early = ≤ 36 hours, delayed > 36 hours). Patient demographics, existing implants, Unified Classification System fracture subtype, acute medical issues on admission, preoperative haemoglobin, blood transfusion requirement, and length of hospital stay were identified for all patients. Complication and mortality rates were compared between groups. A total of 365 patients were identified: 140 in the early and 225 in the delayed intervention group. Mortality rate was 4.1% at 30 days and 19.2% at one year. There was some indication that those who had surgery within 36 hours had a higher mortality rate, but this did not reach statistical significance at 30 days (p = 0.078) or one year (p = 0.051). Univariate analysis demonstrated that age, preoperative haemoglobin, acute medical issue on admission, and the presence of postoperative complications influenced 30-day and one-year mortality. Using a multivariate model, age and preoperative haemoglobin were independently predictive factors for one-year mortality (odds ratio (OR) 1.071; p < 0.001 and OR 0.980; p = 0.020). There was no association between timing of surgery and postoperative complications. Postoperative complications were more likely with increasing age (OR 1.032; p = 0.001) and revision arthroplasty compared to internal fixation (OR 0.481; p = 0.001). While early intervention may be preferable to reduce prolonged immobilization, there is no evidence that delaying surgery beyond 36 hours increases mortality or complications in patients with a femoral periprosthetic fracture.

Reducing stigma and promoting HIV wellness/mental health of sexual and gender minorities: RCT results from a group-based programme in Nigeria.

High levels of HIV stigma as well as stigma directed towards sexual and/or gender minorities (SGMs) are well documented in the African setting. These intersecting stigmas impede psychosocial wellbeing and HIV prevention and care. Yet, there are few if any evidence-based interventions that focus on reducing internalized stigma and promoting mental health and HIV wellness for SGMs in Africa. We developed and evaluated a group-based intervention drawing on cognitive behavioural therapy (CBT) strategies for men who have sex with men (MSM) and transgender women (TGW) at risk for or living with HIV in Lagos, Nigeria. The intervention comprised four weekly in-person group sessions facilitated by community health workers. We conducted a delayed intervention group randomized controlled trial (April-September 2022), with pre-post surveys plus 3-month follow-up (immediate group only), as well as qualitative research with participants and programme staff. Outcomes included internalized stigma related to SGM and HIV status, depression, resiliency/coping and pre-exposure prophylaxis (PrEP)/HIV treatment use. Mean age of the 240 participants was 26 years (range 18-42). Seventy-seven percent self-identified as MSM and 23% TGW; 27% were people with HIV. Most (88%) participants attended all four sessions, and 98% expressed high intervention satisfaction. There was significant pre-post improvement in each psychosocial outcome, in both the immediate and delayed arms. There were further positive changes for the immediate intervention group by 3-month follow-up (e.g. in intersectional internalized stigma, depression). While baseline levels of ever-PrEP use were the same, 75% of immediate-group participants reported currently using PrEP at 3 months post-intervention versus 53% of delayed-group participants right after the intervention (p<0.01). Participants post-intervention described (in qualitative interviews) less self-blame, and enhanced social support and resilience when facing stigma, as well as motivation to use PrEP, and indicated that positive pre-intervention changes in psychosocial factors found in the delayed group mainly reflected perceived support from the study interviewers. This study demonstrated the feasibility and acceptability of a group-based CBT model for MSM and TGW in Nigeria. There were also some indications of positive shifts related to stigma, mental health and PrEP, despite issues with maintaining the randomized design in this challenging environment.

Optimal timing of of cardiac implantable electronic device reoperation

Abstract Background Early re-intervention may increase the risk of infection of cardiac implantable electronic devices (CIED). Some operators therefore delay lead repositioning in case of dislocation by weeks, however there is no evidence to support this practice. The aim of our study was to evaluate the impact of the timing of re-operation on infection risk. Methods Data from consecutive patients (n=249) receiving lead/generator repositioning in one Hungarian and one German tertiary centre between January 1995 and August 2022 were retrospectively analysed. Relative risk of CIED infection in the first year was compared among patients undergoing early (≤1 week) vs. delayed (from 1 week to 1 year) re-operation. Results Out of 249 patients (mean age 70 ± 13 years, 54% male) requiring CIED re-intervention (30% single-chamber, 48% dual-chamber, and 22% CRT devices), 55 patients underwent right atrial (22%), 145 patients underwent right ventricular (59%), 20 patients underwent coronary sinus (8%), and 28 patients underwent multiple lead (11%) repositioning. Eighty-five patients (34%) went through an early (median 2, interquartile range (IQ): 1-4.5) and 164 (66%) patients had a delayed lead/pocket revision (median 53, IQ 36-209 days). A total of 9 (3,6%) wound/device infections were identified during the first year of follow-up, 1 (1,2%) vs. 8 (4,9%) in the in the early vs delayed groups. The risk of infection was numerically lower in the early vs. the delayed intervention groups yielding no statistically significant difference (OR=0.232; 95% CI 0.029-1.888; p=0.172). After adjustment for typical risk factors for CIED infection (i.e., number of implanted leads, diabetes, heart failure, fever prior to implant, therapy with corticosteroids, anticoagulation or antiplatelet therapy, temporary pacemaker) this difference remained non-significant (adjusted OR=0.266, 95% CI 0.032-2.246, p=0.224). System explantation/extraction was necessary in 7 cases (2,8 %), all being revised in the delayed group (OR early vs. delayed 0.128, 95% CI 0.01-2.273, p=0.161). Conclusion In this bicentric study, delayed re-intervention did not reduce the risk of CIED infection compared to patients undergoing an early (&amp;lt;1 week) re-operation.

Long-term clinical outcomes in patients with CIS treated with interferon beta-1b: results from the 15-year follow up of the BENEFIT trial

Multiple sclerosis (MS) treatment intervention with immunomodulating therapy at early disease stage improves short term clinical outcomes. The objective of this study is to describe the long-term outcomes and healthcare utilization of patients with clinically isolated syndrome (CIS) included in the Betaferon®/Betaseron® in Newly Emerging MS for Initial Treatment (BENEFIT) randomized, parallel group trial. In BENEFIT patients were assigned to “early” IFNB-1b treatment or placebo (“delayed” treatment). After 2 years or conversion to clinically definite multiple sclerosis (CDMS), all patients were offered IFNB-1b and were reassessed 15 years later. Of 468 patients, 261 (55.8%) were enrolled into BENEFIT 15 (161 [55.1%] from the early, 100 [56.8%] from the delayed treatment arm). In the full BENEFIT analysis set, risk of conversion to CDMS remained lower in the early treatment group ( – 30.5%; hazard ratio 0.695 [95% CI, 0.547–0.883]; p = 0.0029) with a 15.7% lower risk of relapse than in the delayed treatment group (p = 0.1008). Overall, 25 patients (9.6%; 9.9% early, 9.0% delayed) converted to secondary progressive multiple sclerosis. Disability remained low and stable with no significant difference between groups in Expanded Disability Status Scale score or MRI metrics. Paced Auditory Serial Addition Task-3 scores were better in the early treatment group (p = 0.0036 for treatment effect over 15 years). 66.3% of patients were still employed at Year 15 versus 74.7% at baseline. In conclusion, results 15 years from initial randomization support long-term benefits of early treatment with IFNB-1b.

Immersive virtual reality for prospective memory and eye fixation recovery following traumatic brain injury: A pilot study

Rehabilitation is crucial for the recoveriy from traumatic brain injuries (TBI); yet, only 77 &amp;ndash; 88% of TBI patients are receipients of rehabilitation. Particularly, individuals lacking insurance coverage or facing transportation hurdles, notably within the Hispanic community, are less likely to undergo rehabilitation. Virtual reality (VR), known for its mobility and affordability, is recommended as a rehabilitation alternative. This community-based participatory research project aimed to evaluate the acceptability, feasibility, and potential of VR scenarios in addressing common rehabilitative needs. Focus groups involving TBI patients (N = 12) were conducted to identify rehabilitative needs and design VR scenarios. Two novel scenarios were created to enhance prospective memory and eye tracking. The impact of the prospective memory VR scenario was assessed among individuals with brain injuries 1 year post-TBI (N = 11), who were divided into intervention and delayed-intervention groups. In addition, six participants underwent the eye-tracking VR scenario to evaluate its effectiveness. Data from memory tests and screen recordings were gathered. In the objective memory test, participants in the VR intervention group (66%) exhibited greater improvement than those in the memory card delayed intervention group (0%) after 12 sessions. However, there was no statistically significant difference in mean scores on a Prospective and Retrospective Memory Questionnaire memory scale between the intervention and delayed-intervention groups after 6 weeks. Nonetheless, all participants demonstrated enhanced eye tracking skills after completing the eye tracking VR scenario between the 6th and 12th sessions. In conclusion, the VR scenarios exhibited promise, acceptability, and feasibility in improving prospective memory and eye tracking for individuals with TBI 1 year post-injury.

Analysis of the effect and safety of lumen reshaping after endovascular repair of Stanford B type aortic dissection at different intervention times

Objective: To Compare the effects and safety of lumen reshaping after thoracic endovascular aortic repair (TEVAR) for Stanford B type aortic dissection (AD) at different intervention times. Methods: A retrospective analysis was conducted on the clinical data of 189 patients with Stanford type B aortic dissection treated with TEVAR at the Affiliated Hospital of Chengde Medical College from January 2016 to December 2020.Based on the time from onset to surgery, patients were divided into an early intervention group (≤14 days, n=127) and a delayed intervention group (>14 days, n=62).The diameters of the total aorta, true lumen and false lumen at different times and planes (S1 plane: at the bifurcation of the pulmonary artery; S2 plane: at the lower edge of the left atrium; S3 plane: at the upper edge of the celiac trunk) post-surgery were compared between the two groups, and the rate of change in diameters of true and false lumens across these planes was calculated. The patients were followed until December 1st, 2023, and the median follow-up time was 45(40, 49) months. The postoperative complications and survival of the two groups were compared. Results: The early intervention group comprised 86 men and 41 women, with an average age of (58.3±10.7) years. The delayed intervention group included 41 men and 21 women, with an average age of (58.5±9.2) years. Both groups had an operation success rate of 100%. Six months post-surgery, the early intervention group had an expansion rate of the true lumen diameter at planes S2 and S3 of 40.1%(25.5%, 56.1%) and 5.3%(-2.5%, 15.8%), respectively, which was superior to the delayed intervention group's 18.5%(10.6%, 39.8%) and 1.0%(-8.2%, 9.6%) (both P<0.05).The early intervention group had a reduction rate of the false lumen diameter at planes S1, S2, and S3 of -56.2%(-61.3%, -48.8%), -70.4%(-81.8%, -56.6%), and -5.4%(-17.4%, 0.1%), respectively, better than the delayed intervention group's -44.2%(-53.7%, -38.3%), -49.0%(-57.6%, -35.8%), and -3.1%(-6.7%, 1.8%) (all P<0.05).At plane S1, the true lumen diameter of patients in both groups showed an increasing trend over 36 months post-surgery, while the false lumen diameter showed a decreasing trend (both P<0.05).At plane S2, the true lumen diameter of patients in the early intervention group exhibited an increasing trend over 36 months post-surgery, and the false lumen diameter exhibited a decreasing trend (both P<0.05).At plane S3, the total aortic diameter of patients in the delayed intervention group showed a slight increasing trend over 36 months post-surgery (P<0.05).The overall survival time were 45.0 months (95%CI: 42.9-47.1) for patients in the early intervention group and 46.0 months (95%CI: 43.5-48.5) for those in the delayed intervention group, with no statistically significant difference observed (P>0.05).The incidence rates of complications such as aortic rupture, retrograde Type A dissection, new distal endograft dissection, endoleak, paraplegia, and others showed no statistically significant difference between the two groups (all P>0.05), with no cases of stent migration or deformation observed. Conclusion: Early intervention for Stanford type B aortic dissection provides a better aortic remodeling outcome than delayed intervention, with similar safety.

Visual field progression patterns in the ocular hypertension treatment study correspond to vulnerability regions of the disc.

To determine the locations on the 24-2 visual field (VF) testing grid that are most likely to progress in patients with ocular hypertension (OHTN). Based on a structural model of superior and inferior areas of relative vulnerability at the optic disc, we hypothesized that the nasal and paracentral regions are more prone to show a reduction in sensitivity. Posthoc analysis of data collected in phases 1 and 2 of the Ocular Hypertension Treatment Study (OHTS). A pointwise analysis was applied to determine the progression patterns in the early and delayed treatment groups. Each group's progression rate and frequency were calculated for each of the 52 locations corresponding to the 24-2 VF strategy, using trend- and event-based analyses, respectively. For the event-based analysis, the events were most commonly found in the nasal and paracentral regions. The same regions, with some modest variation, were found to have the fastest rates of progression (ROP) measured with trend analysis. A similar pattern of progression was observed in both the early and delayed treatment groups. The difference in event rates and ROP between the early and delayed treatment groups was also greatest in the nasal and paracentral regions. Development of VF loss in ocular hypertensive eyes appears to be consistent with the vulnerability zones previously described in glaucomatous eyes with established VF loss. Ocular hypotensive treatment likely helps to slow the rate of progression in these regions. This suggests that careful monitoring of these locations may be useful.

Time to surgical management of distal radius fractures: effects on health care utilization and functional outcomes.

Distal radius fractures are common injuries. Open reduction and internal fixation with volar locking plates is the most common approach for surgical fixation. This study investigated the association between time to surgery and health care utilization, income, and functional outcomes among patients undergoing open reduction and internal fixation for distal radius fracture. We conducted a retrospective review of patients who underwent open reduction and internal fixation for isolated acute distal radius fracture between 2009 and 2019. Time to surgery was grouped as early (≤ 14 d) and delayed (> 14 d). We performed χ2 (or Fisher exact) and Wilcoxon rank sum (or Kruskal-Wallis) tests to provide statistical comparison of time to surgery by health care utilization and functional outcomes. Univariable and multivariable logistic regression analyses were performed to identify factors significantly associated with time to surgery. We included all significant univariables in the multivariable logistic regression model, which identified factors based on significant adjusted odds ratios (95% confidence intervals excluding the null) after we adjusted for confounding variables. We included 106 patients, with 36 (34.0%) in the group receiving early treatment and 70 (66.0%) in the group receiving delayed treatment. Patients in the delayed-treatment group attended significantly more clinic visits and postoperative hand therapy sessions. The group with delayed treatment demonstrated significantly lower degrees of wrist flexion at the first follow-up, but this difference did not persist. Patients with higher estimated income (> $39 405 per annum) had lower odds of delayed surgery than those with lower estimated income (≤ $39 405). Delayed time to surgery was associated with greater health care utilization and lower degrees of early wrist flexion. Access to care for lower-income patients warrants further evaluation.

Timing of male urethral injury treatment in patients with polytrauma: A retrospective study

IntroductionMale urethral injuries are uncommon, and the ideal timing of the definitive treatment remains controversial. This study aimed to compare the outcomes of early and delayed interventions (1 month or more after the injury) for male urethral injuries. Patient and methodsWe conducted a retrospective review of the medical records of 67 male patients with urethral injuries treated at our institution between 2011 and 2020. We examined patient age, injury severity score (ISS), abbreviated injury scale, mechanism, location and severity of injury, presence of pelvic fractures, surgical interventions, timing of treatment, and complications. We analysed factors associated with urinary complications based on the location of urethral injury. Additionally, we performed a subset analysis of patients with severe injuries (ISS≥16) to assess the impact of delayed surgery. ResultsOverall, 47 %, 37 %, and 27 % of patients in the delayed treatment group (N = 30) had urethral stricture (US), erectile dysfunction (ED), and/or urinary incontinence (UI). These rates were greater than the 22 % US, 3 % ED, and 11 % UI rates in the early treatment group (N = 37). The subgroup analysis revealed that patients with anterior urethral injury (AUI) who underwent delayed treatment (N = 18) tended to be more severely injured (ISS, 19 vs 9, p = 0.003) and exhibited higher rates of US (44% vs 21 %, p = 0.193) and ED (39% vs 0 %, p = 0.002) than those who received early treatment (N = 24). In the case of posterior urethral injury (PUI), the delayed treatment group (N = 13) had higher rates of US (50% vs 23 %, p = 0.326), ED (33% vs 8 %, p = 0.272), and UI (42% vs 0 %, p = 0.030) than the early treatment group. Regarding study limitations, more than 45 % of the enrolled patients were severely injured (ISS≥16), which may have potentially influenced the timing of urethral injury repair. ConclusionsThe treatment of male urethral injuries may be delayed due to concurrent polytrauma and other associated injuries. However, delayed treatment is associated with higher rates of urinary complications. Early treatment of urethral injuries may be beneficial to male patients with urethral trauma, even in cases of severe injury.

Efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters: the study protocol for a randomized clinical trial

BackgroundVitreous floaters are a common ocular condition that affects individuals of all ages. Although vitreous floaters are typically benign, they can significantly impair visual acuity and quality of life. Laser vitreolysis, which uses an Nd: YAG laser to vaporize collagenous vitreous opacities, is increasingly being used as a treatment option. However, there is currently a lack of evidence regarding its efficacy and the appropriate timing of its application. This study aims to evaluate the efficacy and safety of early intervention with YAG laser vitreolysis in treating symptomatic vitreous floaters.MethodsThe present study is a randomized, controlled, double-blind clinical trial. A total of 70 participants with symptomatic floaters for 1 month were prospectively recruited. These participants will be randomly assigned to two groups, with 35 individuals in each group: the early treatment group and the delayed treatment group. Participants assigned to the early treatment group will undergo YAG laser vitreolysis immediately, followed by a sham laser treatment 3 months later. On the other hand, participants assigned to the delayed treatment group will receive a sham laser treatment and then undergo YAG laser vitreolysis 3 months later. The follow-up time points will be 1, 3, 6, and 12 months from randomization. Primary outcomes will be participants’ self-reported improvement in visual disturbance on a scale of 1 to 10 and their scores on the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary outcomes will be an objective evaluation of the effectiveness of the treatment in reducing vitreous floaters through OCT and fundus photography and tracking any adverse events related to the eyes or overall health.DiscussionThis clinical trial aims to evaluate the effectiveness of YAG laser vitreolysis in treating symptomatic vitreous floaters and assess the safety of performing early intervention with YAG laser vitreolysis.Trial registrationClinicalTrials.gov NCT05800353. Registered on 10 March 2023.