6-month Time Point Research Articles

Mid-Term Migration Pattern of a Cemented Collared Anatomical Stem-A Retrospective Study Using EBRA-FCA.

Background: Aseptic loosening is one of the leading causes of stem revision. Einzel Bild Röntgen Analyse-Femoral Component Analysis allows for the detection of distal stem migration, which is used as a predictive factor for implant longevity. This study aims to demonstrate the migration behavior of a cemented collared anatomical stem. Methods: This study retrospectively examined all patients who received a cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) between 2003 and 2019. We used the EBRA-FCA software (University of Innsbruck, Austria) to determine the migration patterns and thoroughly examined the patients' medical histories. In addition, the potential influence of femoral configuration and BMI on the migration behavior was assessed. Results: This study included 61 patients (48 females and 13 males) with a total of 61 stems that met our inclusion criteria. The mean age at surgery was 76 years (ranging from 30 to 93 years). According to EBRA-FCA migration analysis, a median subsidence of 0.7 mm was observed at 24 months and at the final follow-up (median 78 months). Distal stem migration was significantly higher at the 6-month time point in patients with Dorr type A femurs compared to Dorr type B femurs (p = 0.016). Body mass index (BMI) had no significant effect on stem migration. Conclusions: The measured subsidence of the Lubinus SP 2 stem using EBRA-FCA was below established thresholds, indicating excellent long-term outcomes. Although there was significantly increased subsidence in Dorr type A femurs during the initial 6 months, thereafter, no statistically significant difference was observed compared to Dorr type B femurs.

Oncologic surveillance after surgical treatment for clinically localized kidney cancer: UroCCR study n. 129.

In 2021, the EAU Guidelines implemented a novel, expert opinion-based follow-up scheme, with a three-risk-category system for clear cell (cc) and non-cc renal cell carcinoma (non-ccRCC) after surgery with curative intent. We aimed to validate the novel follow-up scheme and provide data-driven recurrence estimates according to risk groups, to confirm or implement the oncologic surveillance strategy. We identified 5,320 patients from a prospectively maintained database involving 28 French referral centers. The risk of recurrence, as either loco-regional or distant, was evaluated with the Kaplan-Meier method for each group (low- intermediate- or high-risk) according to ccRCC or non-ccRCC histology. The noncumulative distribution of recurrences was graphically investigated through the LOWESS smoother. Two thousand two hundred ninety-three (58%), 926 (23%), and 738 (19%) had low-, intermediate, and high-risk ccRCC, and 683 (50%), 297 (22%), and 383 (28%) had low-, intermediate, and high-risk non-ccRCC, respectively. Median follow-up for survivors was 46 months. Overall, 661 patients experienced recurrence. Over time, the noncumulative risk of recurrence was approximately 10% for low-risk cc-RCC, non-ccRCC, and intermediate-risk non-ccRCC, with non-significant difference among the three recurrence functions (P=0.9). At 5-year, time point after which imaging should be de-intensified to biennial, the noncumulative risks of recurrence were: for intermediate risk ccRCC and non-ccRCC: 15% and 11%, respectively; for high-risk ccRCC and non-ccRCC: 24% and 8%, respectively. Among high-risk non-ccRCC patients there were 9 recurrences at 3-month. There was no significant difference between the recurrence function of high-risk non-ccRCC patients with negative imaging at 3-month and the one of intermediate-risk ccRCC (P=0.3). Given the relatively low recurrence risk of patients with intermediate-risk non-ccRCC, those individuals could be followed up with a similar strategy to the low-risk category. Similarly, patients with high-risk non-ccRCC with negative imaging at 3-month, could be followed up similarly to intermediate-risk ccRCC after the 3-month time point.

454. QUALITY OF LIFE AFTER ESOPHAGECTOMY WITH INTRATHORACIC VS CERVICAL ANASTOMOSIS: A NATIONWIDE COHORT STUDY

Abstract Background Transthoracic esophagectomy with either intrathoracic or cervical anastomosis is considered standard of care in patients with mid to distal esophageal or gastroesophageal junction (GEJ) cancer. Patients after esophagectomy will experience a deterioration in health-related quality of life (HR-QoL) after esophageal cancer surgery. Whilst some reports describe long-lasting deterioration, other reports show recovery of HR-QoL comparable with the general population after 2 years. The aim of this study was to investigate the difference in HR-QoL in patients after a transthoracic esophagectomy with either intrathoracic- or cervical anastomosis in a nationwide database. Methods A nationwide cohort study was performed combining data from two registries: Netherlands Cancer Registry (NCR) and Prospective Observational Cohort Study of Esophageal-Gastric Cancer Patients (POCOP). All patients after esophagectomy for mid/distal esophageal or GEJ cancer between 2015 and 2022 were included. HR-QoL was measured at baseline, 3, 6, 9, 12, 18, and 24 months postoperatively using EORTC QLQ-C30 and OG-25 questionnaires. Linear mixed models were used to assess the mean score difference between patients with intrathoracic and cervical anastomosis. A difference of 10 points or more was considered clinically relevant. Adjustments were made for potential confounders (age, gender, ASA classification). Results Of the 4269 registered patients in the NCR, in 1274 patients at least one questionnaire was available. Of these patients 346 underwent an esophagectomy with cervical - and 928 with intrathoracic anastomosis. Patients after esophagectomy with cervical anastomosis reported statistically significant more problems in the following categories: dysphagia, couching, trouble eating with others and swallowing saliva during the first 3 months, choked when swallowing and trouble talking during the first 12 months postoperatively. In all other categories no significant difference was found. Only trouble talking at the 3-month time point was considered as a clinically relevant difference. Conclusion Although the intrathoracic anastomosis is associated with significantly better HR-QoL in several categories, only trouble talking at 3 months postoperatively was considered clinically relevant. Overall HR-QoL was comparable for esophageal cancer patients after an esophagectomy with either a cervical or intrathoracic anastomosis.

Comparison of Outcomes After Cochlear Implantation in a Veteran Versus Nonveteran Population.

To evaluate for equivalence in postoperative changes of speech recognition scores in a veteran patient population undergoing cochlear implantation (CI) compared to matched nonveteran patients. Retrospective chart review. Tertiary referral center. A total of 83 veteran patients who underwent CI at a single Veterans Affairs Medical Center (VA cohort) were matched to 83 nonveteran patients from the Health Insurance Portability and Accountability Act-secure, Encrypted, Research, Management and Evaluation Solution database (HERMES cohort) based on age, sex, and baseline Consonant-Nucleus-Consonant (CNC) scores. Patients underwent CI. Comparison of postoperative CNC and Arizona Biomedical Institute recognition scores. The mean difference and lower confidence interval of CNC scores between matched Veterans Affairs and HERMES cohorts were within a -ΔNI boundary of -15% at the 3-month (mean = 6.15, lower confidence interval = -2.38), 6-month (mean = 7.36, lower confidence interval = -2.21), and 12-month (mean = 4.03, lower confidence interval = -4.88) postoperative time points. The mean difference and lower confidence interval of Arizona Biomedical Institute scores between cohorts were within the -ΔNI boundary of -30% at 3 months (mean = 1, lower confidence interval = -8.71), 6 months (mean = 0.31, lower confidence interval = -12.30), and 12 months (mean = 0.72, lower confidence interval = -10.48). Our veteran population demonstrated improvements in speech recognition scores after CI comparable to a matched nonveteran population. Although veterans face unique factors that affect their hearing, access to medical care, and baseline general health, these findings affirm appropriate veteran candidates should be offered CI.

Müller Muscle Conjunctival Resection: A Prospective Multicenter Comparison of Eyelid Height at the Immediate, 1-Week, and 3-Month Postoperative Time Points.

The primary objective was to document change in postoperative marginal reflex distance-1 (MRD1) after Müller muscle conjunctival resection surgery. The secondary objective was to identify predictors of change in postoperative MRD1. A multicenter prospective cohort study was performed on patients consecutively recruited for Müller muscle conjunctival resection. MRD1 was measured immediately after Müller muscle conjunctival resection, at the 1-week postoperative visit, and the ≥3-month postoperative visit. MRD1 at the immediate and 1-week time points were compared with MRD1 ≥3 months using descriptive statistics. Predictors of change in MRD1 were analyzed using multivariate regression analysis. A total of 150 patients (226 eyelids) were included. Regarding the immediate to ≥3-month interval, 53.8% of eyelids remained clinically similar (rise or fall ≤0.5 mm), 19.8% rose ≥1 mm, and 26.4% fell ≥1 mm. Regarding the 1-week to ≥3-month interval, 76.5% remained clinically similar, 17.3% rose ≥1 mm, and 6.2% fell ≥1 mm. No variable predicted change in MRD1 over either interval with both clinical and statistical significance. Immediate postoperative MRD1 is likely to reflect the late result in only 54% of cases. However, 1-week postoperative MRD1 is similar to the late result in 77% of cases and is highly unlikely (6%) to fall by the final visit. No variable significantly impacts change in postoperative MRD1.

Delayed peak antibody titers after the second dose of SARS-CoV-2 vaccine in solid organ transplant recipients: Prospective cohort study

Poor post-vaccination production of antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a concern among solid organ transplant (SOT) recipients. Furthermore, the timing and kinetics of antibody titers after the second vaccine dose are unknown. We conducted a multicenter prospective observational study that included 614 SOT recipients: 460 kidney, 53 heart, 50 liver, 20 lung, and 31 simultaneous pancreas–kidney (SPK). The participants received two doses of the mRNA vaccine (Pfizer BNT162b2 or Moderna mRNA-1273), as indicated. Serum samples were collected before the first and second vaccinations and at 1, 3, and 6 months after the second vaccine dose, which were then assessed for SARS-CoV-2 antibodies. The overall seropositivity rate was 43% at 1 month after administration of the second vaccine dose; it gradually increased to 68% at 3 months after second dose administration and to 70% at 6 months. In addition, recipient of kidney, lung or SPK transplants had lower antibody titers at the 3- and 6-month time points than did the other recipients. SOT recipients acquired SARS-CoV-2 S-IgG antibodies slowly, and the peak titer differed significantly from that of the general population.

The Impact of Chemotherapy on Arterial Stiffness and Ventricular-Arterial Coupling in Women with Breast Cancer.

The cardiac toxicity of chemotherapy for breast cancer is not uncommon and has been associated with elevated morbidity and mortality. In the present study, we assessed the impact of chemotherapy on cardiovascular function by assessing the cardio-ankle vascular index (CAVI), global longitudinal strain (GLS) and ventricular-arterial coupling (VAC: CAVI/GLS ratio) in chemotherapy-treated women. This prospective study enrolled 78 women with breast cancer who were receiving anthracycline-based chemotherapy +/- anti-HER2 therapy (trastuzumab +/- pertuzumab). Forty-one age-matched healthy women served as controls. We comparatively evaluated left ventricular ejection fraction (LVEF), CAVI, GLS and VAC, between the chemotherapy and control groups. We also assessed their changes over time (baseline, 3-month and 6-month time point) and their independent association with the incidence of cancer therapy-related cardiovascular dysfunction (CTRCD) in the chemotherapy group. In comparison to healthy controls, women receiving chemotherapy presented with significantly higher GLS (from -21.02 ± 2.09% to -19.01 ± 2.81%, p < 0.001) and VAC (-0.36 ± 0.06 to -0.41 ± 0.11, p < 0.001). The presence of CTRCD was associated with a further increase in GLS and CAVI and a significant decline in LVEF and VAC compared to CTRCD-free women (p < 0.001). Baseline, CAVI, GLS and VAC were independently associated with CTRCD development during follow-up. Women with breast cancer undergoing chemotherapy displayed abnormal levels of CAVI, VAC and GLS, compared to healthy individuals. Those effects on VAC and CAVI were more exaggerated among women with CTRCD, implicating their potential use to refine screening and therapeutic strategies for this specific population.

Relationship Between Treatment Hours of Selected Disciplines And Change in Pain Impact During the Year Following Referral to an Interdisciplinary Pain Management Center: A Latent Class Analysis.

Introduction: Pain management clinics differ in treatments offered, and little evidence exists regarding which combinations of therapies result in best outcomes. This study analyzed clinical encounters and pain outcomes data for associations between treatment composition and outcomes. Methods: Retrospective observational study of 2,142 predominantly active-duty US service members referred to an interdisciplinary pain management center between 2014 and 2021. Latent class analysis was used to identify treatment groups with distinct outcome patterns during the year following initial assessment. The primary outcome measure was the National Institutes of Health Task Force on Research Standards for Chronic Low-Back Pain impact score. Results: Four distinct treatment groups were identified: 1 group engaged in conventional medical therapies alone (n = 726, median 3.5 treatment hours), and 3 groups used a combination of conventional, psychological, rehabilitative, and complementary therapies, with different levels of treatment hours: low (n = 814, median 15.7 h), medium (n = 177, median 40.1 h), and high (n = 425, median 72.5 h). All groups showed significant improvement in pain impact score from baseline up to 9 months but not at 12 months following initial assessment. At the 6-month time point, the group with high multimodal treatment hours had the most improvement in pain impact (-3.1 [95% CI -3.8, -2.4]) compared with the group using only conventional therapies (-1.0 points [95% CI -1.8, -0.1]) or with low multimodal treatment hours (-1.3 points [95% CI -1.9, -0.7]). There were no between-group differences at the 9- or 12-month time points. Conclusion: These results suggest that a combination of pain therapy approaches results in greater reduction in pain impact than the use of conventional medical treatment alone for up to 6 months after initiating therapy and that there may be a threshold of treatment hours that must be exceeded to achieve this benefit. Clinical trial registration: As this study is not a clinical trial, no registration was required.

Outcomes of Active Middle Ear Implants: Speech Perception and Quality of Life.

To evaluate audiological outcomes, quality of life, and complications in patients implanted with Active middle ear implants (AMEI). The secondary objective is to investigate the required duration after implantation to reach satisfactory outcomes. This retrospective study included 31 patients implanted with Active middle ear implants (AMEI) with different methods of floating mass transducer attachment. Patients with incomplete medical records and those who did not respond to postoperative follow-up were excluded. Patients were assessed preoperatively, and at one, three, and six months postoperatively. The assessment included Pure Tone Average (PTA4), speech reception threshold (SRT), and speech discrimination score (SDS). The Speech Spatial and Qualities of Hearing scale (SSQ12) was also used to evaluate levels of satisfaction. There are no significant differences found in PTA and SRT between the 3-, 6-, and 12-month visits. The speech reception threshold (SRT) showed a statistically significant improvement at 3, 6, and 12 months post-operative measures compared to pre-operative. Additionally, the SDS exhibited a significant increase only after 12 months, compared to the 3-month time point. However, satisfaction levels did not significantly differ between the 6-month and 12-month measurements following surgery. The Vibrant Soundbridge improves subjective satisfaction scores and audiological test scores in patients with different types of hearing loss. AMEI has a low risk of medical or surgical complications, the ease of using a hearing implant, and the social benefits of good hearing and communication.

Evaluation of an eating disorder screening and care pathway implementation in a general mental health private inpatient setting

BackgroundGeneral mental health inpatient units hold a valuable place in the stepped system of care, and for identification and treatment of people with eating disorders (EDs) or disordered eating behaviours (DEBs). This study aimed to pragmatically evaluate an evidence-informed screening and care pathway, alongside a staff education program, implemented to improve identification and treatment access for consumers with EDs and DEBs, with co-occurring psychiatric conditions, on a general mental health ward.MethodsA mixed methodology design was mapped to the RE-AIM implementation framework. It encompassed medical record audits across two 3-month time points pre and post implementation of the pathway, and key informant consumer and health professional interviews.ResultsProcess and implementation data were compared for three-month periods pre (2019, n = 348) and post-implementation (2021, n = 284). Post-implementation, intake SCOFF screening occurred in 94.7% of admissions. People with ED/DEBs diagnoses were 35 times more likely to have a SCOFF score ≥ 2 (OR = 35.2, p < .001) with the odds of identifying previously undiagnosed DEBs 3.3 times greater (p = .002). Post-implementation, for those with an ED/DEB, dietitian referrals (p < .001) and micronutrient supplementation (p = .013) were more likely. For those with weight and height data, both absolute (-1.1 kg ± 2.2 vs. 1.3 kg ± 2.3; p < .001) and percentage weight change were significantly higher post-implementation with similarities across BMI categories. Universally, consumers and health professionals expressed that the service had “changed care for the better” encouraging therapeutic relationships, mediated by trust, that resulted in better consumer outcomes. 50 health professionals undertook tailored ED and meal support therapy education. They noted that their knowledge and confidence improved allowing value to be seen in understanding EDs and the role for care within general mental health.ConclusionsThis study demonstrated that an articulated screening and care pathway could be feasibly implemented in general mental health. The evaluation demonstrated advances in ED detection and management with noted improvements in management access, care planning, physical monitoring and weight gain outcomes. Understanding stakeholders’ experiences of new care practices enabled the identification of enablers and barriers for implementation, and avenues to optimise care for consumers with EDs in the general mental health setting.

Clinical features and prognostic factors of cryptococcal infections in HIV-infected patients: a 10-year study from an infectious disease specialist hospital.

Cryptococcosis is an invasive infection that commonly affects immunosuppressed individuals, especially patients with HIV infection. Cryptococcal infection in HIV-infected patients should be considered a major health concern because it is associated with high morbidity and mortality rates. In this study, we aimed to evaluate the clinical characteristics and prognostic factors of cryptococcal infections in human immunodeficiency virus (HIV)-infected patients to facilitate effective clinical management and improve patient outcomes. We reviewed and analyzed the clinical data and relevant laboratory test results of HIV-infected patients with positive cryptococcal cultures and reserved strains between 2013 and 2023 from Beijing Youan Hospital affiliated to Capital Medical University. The clinical characteristics and laboratory test results of the patients were compared, and the correlation between parameters and the prognoses of the patients at different observation timepoints (3, 6, 9, and 12 months) was analyzed. A total of 76 patients (70 males and six females; median age, 37 years) were included in this study. The results indicated that the later the initiation of antiretroviral therapy (ART) after the diagnosis of HIV infection (> 6 months), the higher the probability of death. Analysis of the correlation between the time of ART initiation and the timing of treatment for cryptococcal infections showed that the time of ART initiation was strongly related to survival at different timepoints. Initiation of ART time within 0-4 weeks, 4-6 weeks and more than 6weeks of starting treatment for Cryptococcus infection was associated with a lower mortality rate at 12-month, the 3-month, 6- and 9-month follow-up timepoint separately. Although cryptococcal infection in HIV-infected patients continues to be a challenging and intricate issue, ART is a key factor that affects its prognosis. The later ART is started, the worse the prognosis of the infection. The time of ART initiation and the timing of treatment for cryptococcal infections should be further refined and balanced based on different clinical courses. Thus, clinicians should pay closer attention to cryptococcal infections in patients with HIV infection and initiate ART based on the patient's clinical condition.

Buprenorphine treatment and clinical outcomes under the opioid use disorder cascade of care

BackgroundChallenges to engagement and retention on buprenorphine undermine treatment of individuals with opioid use disorder (OUD). Under the OUD Cascade of Care framework, we sought to identify patient characteristics and treatment response associated with superior clinical outcomes. MethodsA retrospective cohort study of specialty buprenorphine treatment patients entering treatment (n=19,487) based on EHR records from a large multi-state buprenorphine treatment network (2011–2019). Person-level care episodes were evaluated across treatment intake, engagement (i.e. 2+ visits in the month following intake), and retention at 6, 12, and 24 months. Time to achieving 90 days of continuous opioid abstinence was assessed using Cox proportional hazards regressions models and also assessed as a predictor of long-term retention. ResultsMost patients engaged (82.4 %), but retention steadily declined over 6-month (38.7 %), 12-month (26.2 %), and 24-month (17.1 %) timepoints. Opioid-positive baseline tests were associated with lower hazards of achieving continuous abstinence for both buprenorphine-positive (aHR=0.33, p<.001) and buprenorphine-negative (aHR=0.49,p<.001) intakes. Opioid abstinence was associated with buprenorphine-positive baseline testing (aHR=1.59,p<.001), especially for those testing opioid-negative (aHR=1.82,p<.001). Patients who achieved and sustained abstinence at 6 months in care were 4.1 and 5.5 times as likely to achieve 12-month and 24-month retention, respectively, compared to patients with intermittent opioid use. ConclusionTreatment discontinuation was concentrated early in care and buprenorphine and opioid status at intake were prognostic of achieving and sustaining abstinence. Early abstinence was associated with higher likelihood of subsequent stage progression. Implementing interventions to support early clinical stability for high-risk patients is critical to improve clinical outcomes.

Effectiveness of Injection Strategies on Patients With Patellar Tendonitis (Jumpers' Knee): A Network Meta-analysis of Randomized Controlled Trials.

Patellar tendonitis (PT) is a common degenerative disease of the patellar tendon that seriously affects the sports careers of elite athletes and activities of daily living of sports enthusiasts. Injection therapy is a prevalent invasive treatment for PT. This work comprehensively analyzes various injection treatments for PT that consider agent type and characteristics, frequency, and assessment timepoints by meta-analysis. PubMed, Embase, and the Cochrane Library were sources of data. Randomized controlled trials (RCTs) analyzing the effect of various injection strategies on the treatment of patients with PT were considered. Systematic review and meta-analysis. Level 2. First author, year of publication, research location, registration information, patient type, sample size, age, sex, intervention, control treatment, and follow-up period in each study were extracted. Nineteen RCTs were included in the analysis. In the network meta-analysis of Victorian Institute of Sports Assessment-Patellar (VISA-P) outcomes, polidocanol (standardized mean difference (SMD), 6.52; 95% CI 4.75, 8.30; P < 0.01), tenocyte-like cells (SMD, 4.08; 95% CI 2.92, 5.25; P < 0.01), and leukocyte-poor platelet-rich plasma (LP-PRP) plus high-volume image-guided injection (HVIGI) (SMD, 1.56; 95% CI 0.62, 2.50; P < 0.01) were significantly superior to noninjection conservative treatment, mainly at the 6-month follow-up timepoint. For visual analog scale results, multiple dry needling (DN) (SMD, -1.78; 95% CI -2.56, -1.00; P < 0.01), LP-PRP (SMD, -0.71; 95% CI -1.31, -0.12; P = 0.02), and LP-PRP plus HVIGI (SMD, -1.31; 95% CI -2.22, -0.39; P < 0.01) were significantly superior to blank, which was also mainly at the 6-month timepoint. Injection-related treatments: polidocanol, tenocyte-like cells, LP-PRP, and multiple DN showed potential short (1-3 months) or medium (6 months)-term treatment benefits. There is still no evidence for injection interventions with long-term therapeutic benefit.

Predictors of patient satisfaction in the surgical treatment of cervical spondylotic myelopathy.

Patients with cervical spondylotic myelopathy (CSM) experience progressive neurological impairment. Surgical intervention is often pursued to halt neurological symptom progression and allow for recovery of function. In this paper, the authors explore predictors of patient satisfaction following surgical intervention for CSM. This is a retrospective review of prospectively collected data from the multicenter Quality Outcomes Database. Patients who underwent surgical intervention for CSM with a minimum follow-up of 2 years were included. Patient-reported satisfaction was defined as a North American Spine Society (NASS) satisfaction score of 1 or 2. Patient demographics, surgical parameters, and outcomes were assessed as related to patient satisfaction. Patient quality of life scores were measured at baseline and 24-month time points. Univariate regression analyses were performed using the chi-square test or Student t-test to assess patient satisfaction measures. Multivariate logistic regression analysis was conducted to assess for factors predictive of postoperative satisfaction at 24 months. A total of 1140 patients at 14 institutions with CSM who underwent surgical intervention were included, and 944 completed a patient satisfaction survey at 24 months postoperatively. The baseline modified Japanese Orthopaedic Association (mJOA) score was 12.0 ± 2.8. A total of 793 (84.0%) patients reported satisfaction (NASS score 1 or 2) after 2 years. Male and female patients reported similar satisfaction rates (female sex: 47.0% not satisfied vs 48.5% satisfied, p = 0.73). Black race was associated with less satisfaction (26.5% not satisfied vs 13.2% satisfied, p < 0.01). Baseline psychiatric comorbidities, obesity, and length of stay did not correlate with 24-month satisfaction. Crossing the cervicothoracic junction did not affect satisfactory scores (p = 0.19), and minimally invasive approaches were not associated with increased patient satisfaction (p = 0.14). Lower baseline numeric rating scale neck pain scores (5.03 vs 5.61, p = 0.04) and higher baseline mJOA scores (12.28 vs 11.66, p = 0.01) were associated with higher satisfaction rates. Surgical treatment of CSM results in a high rate of patient satisfaction (84.0%) at the 2-year follow-up. Patients with milder myelopathy report higher satisfaction rates, suggesting that intervention earlier in the disease process may result in greater long-term satisfaction.

Health outcomes of telemonitoring of patients with type-2 diabetes mellitus: One-year results from a randomized controlled trial (Optimizing care of Patients via Telemedicine In Monitoring and aUgmenting their control of diabetes Mellitus).

Telehealth increases care accessibility to patients with type-2 diabetes mellitus but the duration of its implementation to sustain optimal glycaemic control remains unclear. This study aimed to assess the health outcomes of these patients using the Optimizing care of Patients via Telemedicine In Monitoring and aUgmenting their control of diabetes Mellitus (OPTIMUM) home tele-monitoring (HTM) system 6 months post-intervention, compared to standard care. An open-labelled randomized controlled trial involving 330 participants with type-2 diabetes mellitus, aged 26-65 years, and suboptimal glycaemic control (HbA1c = 7.5%-10%) was conducted. Intervention group received OPTIMUM HTM for 6 months followed by usual care for another 6 months, while control group received usual care for 12 months. OPTIMUM HTM includes in-app video-based tele-education, tele-monitoring of the blood pressure, capillary glucose and weight via Bluetooth devices and mobile applications, followed by algorithm-based tele-management by the OPTIMUM HTM team. Assessments using self-care inventory scale and medication adherence were administered for both groups at baseline, 6-month, and 12-month timepoints. Complete data from 156 (intervention) and 159 (control) participants, with comparable demographic profiles, were analysed. Both groups showed a significant reduction in HbA1c from baseline (p < 0.001). From 6-month to 12-month time-points, the intervention group was twice as likely to maintain their HbA1c ≤ 8% (adjusted odds ratio = 2.02, 95%CI = 1.18-3.49; p < 0.011). The intervention group demonstrated higher scores for self-care behaviours (adjusted odds ratio = 3.83 [95%CI = 1.68-5.97], p = 0.001) and not skipping medications (adjusted odds ratio = 2.32 [95%CI = 1.09-4.97], p = 0.030) at 12 months. The OPTIMUM HTM system enabled patients to maintain their glycaemic control beyond the intervention period. The favourable outcomes could be the effect of telehealth in sustaining self-care behaviour and medication adherence.

Antibody persistence and safety of a live-attenuated chikungunya virus vaccine up to 2 years after single-dose administration in adults in the USA: a single-arm, multicentre, phase 3b study

Chikungunya virus infection can lead to long-term debilitating symptoms. A precursor phase 3 clinical study showed high seroprotection (defined as a 50% plaque reduction of chikungunya virus-specific neutralising antibodies on a micro plaque reduction neutralisation test [μPRNT] titre of ≥150 in baseline seronegative participants) up to 6 months after a single vaccination of the chikungunya virus vaccine VLA1553 (Valneva Austria, Vienna, Austria) and a good safety profile. Here we report antibody persistence and safety up to 2 years. In this single-arm, multicentre, phase 3b study, we recruited participants from the precursor phase 3 trial from professional vaccine trial sites in the USA. Participants (aged ≥18 years) were eligible if they had completed the previous study and received VLA1553. Chikungunya virus-specific neutralising antibodies were evaluated at 28 days, 6 months, and 1 year and 2 years after vaccination. The primary outcome was the proportion of seroprotected participants (ie, μPRNT50 titre of ≥150) at 1 and 2 years, assessed in all eligible participants who had at least one post-vaccination immunogenicity sample available, overall and by age group at the time of vaccination (18-64 years and ≥65 years). Adverse events of special interest at the time of transition from the previous study to the current study (ie, at 6 months) and serious adverse events during the current study were recorded (ie, between 6 months and 2 years). All analyses were descriptive. This study is registered with ClinicalTrials.gov, NCT04838444, and immunogenicity follow-up is ongoing. In the precursor study, participants were screened between Sept 17, 2020, and April 10, 2021; data cutoff for this analysis was March 31, 2023. Of 2724 participants in the precursor study who received one dose of VLA1553, 363 participants were analysed in this study (310 [85%] aged 18-64 years and 53 [15%] aged ≥65 years at enrolment in the precursor study; mean age 47·7 years [SD 14·2], 207 [57%] of 363 participants were female, 156 [43%] were male, 280 [77%] were White, and 314 [87%] were not Hispanic or Latino). Strong seroprotection was observed at 1 year (98·9% [356 of 360 assessable participants; 97·2-99·7]) and 2 years (96·8% [306 of 316; 94·3-98·5]) after vaccination, and was very similar between those aged 18-64 years (at 1 year: 98·7% [303 of 307; 96·7-99·6]; at 2 years: 96·6% [256 of 265; 93·7-98·4]) and those aged 65 years and older (at 1 year: 100% [53 of 53; 93·3-100]; at 2 years: 98·0% [50 of 51; 89·6-100]) at each timepoint. No adverse events of special interest were ongoing at the time of transition. Ten serious adverse events occurred in nine (2%) participants between the 6-month and 2-year timepoints, including one death (due to drug overdose) that was determined to not be related to VLA1553. After a single VLA1553 vaccination, chikungunya virus-neutralising antibodies above the threshold considered to be protective persisted up to 2 years and there were no long-term serious adverse events related to vaccination. VLA1553 is an efficient and safe intervention that offers high seroprotection against chikungunya virus infection, a virus likely to spread globally with an urgent demand for long-lasting prophylaxis. Valneva Austria, Coalition for Epidemic Preparedness Innovation, and EU Horizon 2020.

Stereotactic radiosurgery versus combined stereotactic radiosurgery and bevacizumab for recurrent glioblastoma; a systematic review and meta-analysis of survival.

Recurrent glioblastoma (rGBM) is a brain tumor that is resistant to standard treatments. Although stereotactic radiosurgery (SRS) is a non-invasive radiation technique, it cannot fully prevent tumor recurrence and progression. Bevacizumab blocks tumor blood supply and has been approved for rGBM. However, the best way to combine SRS and bevacizumab is still unclear. We did a systematic review and meta-analysis of studies comparing SRS alone and SRS plus bevacizumab for rGBM. We searched three databases for articles published until June 2023. All statistical analysis was performed by STATA v.17. Our meta-analysis included 20 studies with 926 patients. We found that the combination therapy had a significantly lower rate of overall survival (OS) than SRS alone at 6-month 0.77[95%CI:0.74-0.85] for SRS alone and (100%) for SRS plus bevacizumab. At 1-year OS, 0.39 [95%CI: 0.32-0.47] for SRS alone and 0.61 [95%CI:0.44-0.77] for SRS plus bevacizumab (P-value:0.02). However, this advantage was not seen in the long term (18 months and two years). Additionally, the combination therapy had lower chances of progression-free survival (PFS) than SRS alone at the 6-month and 1-year time points, but the differences were insignificant. Our study indicates that incorporating bevacizumab with SRS may lead to a short-term increase in OS for rGBM patients but not long-term. Additionally, the PFS rate did not show significant improvement in the group receiving combination therapy. Further clinical trials are necessary to validate the enhanced overall survival with combination therapy for rGBM.

Memantine to Reduce Cognitive Impairment After Radiation in Children: A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients after Radiation Therapy for Central Nervous System Tumors

Memantine is standard in certain adults receiving brain radiation therapy (RT) to decrease cognitive impacts, but it is unknown whether pediatric patients can take, tolerate, and/or benefit from memantine. In this prospective single-arm feasibility study, we hypothesized that pediatric patients receiving central nervous system (CNS) RT would tolerate memantine with good adherence. Patients aged 4 to 18 years with a primary CNS malignancy (excluding World Health Organization grade 4 astrocytoma, glioblastoma) receiving intracranial RT were eligible. A 6-month memantine course was given during and after RT, with dose titration in 5 mg increments over 4 weeks targeting a weight-based maximum (0.4 mg/kg to the closest 5 mg), not to exceed 10 mg twice a day. The primary endpoint was to achieve 80% drug adherence rate in 80% of patients measured 1 month after RT. Secondary objectives included memantine feasibility at 3 and 6 months. Eighteen patients enrolled from 2020 to 2022 and were prescribed memantine with RT. The study closed early to avoid competing with the phase 3 randomized Children's Oncology Group study ACCL2031. No predefined stopping rules were met. One patient withdrew for cognition-altering substance use, leaving 17 patients available for analysis. One patient discontinued memantine after one dose due to nausea. For the remaining 16 patients, there was a median of 100% pill completion rate (range, 74%-100%; n = 9/17 with 100% adherence) at 1 month after RT, with 15/16 (94%) with adherence rates >80%. At the 3- and 6-month post-RT time points for secondary endpoints, the median adherence rates were 100% (range, 55%-100%) and 96% (range, 33%-100%), respectively. Grade 1 to 2 fatigue, headache, and nausea were the most common toxicity events, at least possibly related to the study drug (n = 27), without attributable grade 3+ events. Memantine is a feasible, safe, and well-tolerated addition to multimodality treatment for pediatric CNS malignancies. Results of ACCL2031 are awaited to define the value of memantine in this population.

Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial

BackgroundRecently we reported results of phase 1 pilot clinical trial of 2 consecutive intracavernous (IC) injection of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (DM-ED). In phase 2 of this study our aim is to evaluate long term safety and efficacy of IC injections of BM-MSC on additional eight patients with DM-ED.ResultsEach patient received 2 consecutive IC injections of BM-MSC and evaluated at 1, 3, 6, 12, and 24-month time points. Primary outcome was the tolerability and safety of stem cells therapy (SCT), while the secondary outcome was improvement of erectile function (EF) as assessed using the International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS) questionnaires, and Color Duplex Doppler Ultrasound (CDDU). IC injections of BM-MSCs was safe and well-tolerated. Minor local and short-term adverse events related to the bone marrow aspiration and IC injections were observed and treated conservatively. There were significant improvement in mean IIEF-5, EHS, all over the follow-up time points in comparison to the baseline. At 24-month follow up there were significant decline in the mean IIEF-5, and EHS compared to the baseline. The mean basal and 20-min peak systolic velocity was significantly higher at 3-month after the IC injections compared to baseline.ConclusionsThis phase 2 clinical trial confirmed that IC injections of BM-MSC are safe and improve EF. The decline in EF over time suggests a need for assessing repeated injections.Clinical trial registrationNCT02945462

Poster 306: Establishing the Minimum Clinically Important Difference Two Years Following Medial Patellofemoral Ligament Reconstruction

Objectives: Medial patellofemoral ligament (MPFL) reconstruction is used to address cases of recurrent patellar instability. Minimal clinically important difference (MCID) is an important marker that relays the smallest clinical improvement in which patients feel a significant change after surgery. MCID has been previously established for MPFL reconstruction after 6 months and 1 year. To date, no study has established MCID for patient reported outcomes 2 years after MPFL reconstruction. The purpose of this study is to define the MCID for the Kujala, International Knee Documentation Committee (IKDC), and Knee Injury and Osteoarthritis Outcome Score for Joint Reconstruction (KOOS JR) at minimum two-year follow-ups after isolated MPFL reconstruction. Methods: All patients undergoing isolated MPFL reconstruction for recurrent patellar instability at a single institution between December 2015-June 2021 were included. Patients with concomitant osseous procedures beyond chondroplasty and any ligamentous procedure were excluded. A distribution-based approach was used to calculate the MCID. This was performed by determining the standard deviation (SD) of the delta two-year patient reported outcome scores (PROS) and then multiplying the SD by 0.5. The number of patients achieving MCID were then presented as a percentage. Results: Eighty-six of 117 patients who underwent isolated MPFL reconstruction completed preoperative and a two-year follow-up PRO survey (59 female, 27 male; age 21.1 ± 8.7 years). For Kujala, the preoperative mean was 59.3 ± 17.1, two-year follow-up mean was 87.6 ± 13.6, and MCID was 9.2 with 88% of the cohort achieving MCID. For IKDC, preoperative mean was 50.2 ± 17.2, two-year mean was 80.5 ± 18.6, and MCID was 12.4 with 80% of patients achieving MCID. KOOS JR had a preoperative man of 66.0 ± 14.6, two-year follow-up mean of 88.8 ± 11.9, and MCID of 8.5 with 72% of patients meeting this MCID (Figure 1). Conclusions: At two years following MPFL reconstruction, the MCID’s for clinically relevant subjective PROS were 9.2 (Kujala), 12.5 (IKDC), and 8.5 (KOOS JR). MCID’s for MPFL reconstruction are already established for 6-month and 1-year time points, and this was the first presentation of two-year MCID values. Establishing the 2-year MCID for MPFL reconstruction gives surgeons another tool to use in the diagnoses of patellar instability patients who may be struggling post-operatively.