Secondary Outcome Measures Research Articles

Applying the Kessler Foundation modified Story Memory Technique (KF-mSMT ®) to Improve New Learning in Aging Populations

Introduction: The current study examines the efficacy of the 10-session Kessler Foundation modified Story Memory Technique (KF-mSMT®) to improve new learning in older adults. Methods. This double-blind, placebo-controlled randomized clinical trial included twenty-eight individuals over age 65 randomized to the treatment group (n=17) or placebo control group (n=13). Participants completed a baseline neuropsychological assessment, including questionnaires assessing everyday memory, and a repeat assessment immediately post-treatment. The primary outcome measure was the total learning score from the California Verbal Learning Test II (CVLT II) and the secondary outcome measure was total score from the Memory Functioning Questionnaire. Results: A significant effect of the KF-mSMT® was noted on the CVLT-II total learning score in the treatment group, demonstrating a large effect size. Post-hoc analysis examining benefit from the KF-mSMT in the healthy aging group as compared with the MCI group showed a trend toward significance (p=.069), with a large effect size. With benefit defined as a 10% or greater improvement on the CVLT total learning, 65% of patients in the treatment group showed improvement from baseline to immediate follow-up, compared with 31% of the control group (p=.06). Significant treatment effects were also noted on a self-report measure of memory in daily life, the Memory Functioning Questionnaire. Post-treatment changes in depression or anxiety from before to after treatment were not significant between the groups. Conclusion: The current study presents preliminary evidence in support of the KF-mSMT® for improving learning and memory abilities in older populations of those aging normally and those meeting criteria for MCI.

Bacteriophage therapy in women with chronic recurrent cystitis caused by multidrug-resistant bacteria: A prospective, observational, comparative study

Abstract Objectives The aim of this study was to evaluate the effects of the combination of bacteriophage therapy with antibiotics and bacteriophage treatment alone on relieving clinical symptoms of chronic recurrent cystitis caused by multidrug-resistant bacteria. Materials and methods This clinical trial compared the treatment methods of 217 female patients with chronic recurrent cystitis caused by multidrug-resistant bacteria, who were investigated from June 2020 to May 2023. Patients were allocated into 4 groups: group I: received bacteriophage (Sextaphage) therapy alone; group II: received a combination of bacteriophages (Sextaphage) and furazidin; group III: received a combination of bacteriophage (Sextaphage) and furazidin with cefixime; and group IV: received furazidin and cefixime (without bacteriophage). The primary outcome included changes in the acute cystitis symptom scale and the pain visual analog scale, which were completed on days 7 and 14 following treatment. Secondary outcome measures included bladder diary records of urinary symptoms, median voided volumes, level of bacteriuria, and degree of leukocyturia. Results Initially, 217 female patients were presented during baseline visits. Those who did not meet the criteria inclusions were excluded, and 178 female patients were included in the final analysis. Statistically significant improvements from baseline in acute cystitis symptom scale scores for differential, typical symptoms, and quality of life domains were observed after 14 days of treatment in groups II, III, and IV. The pain level measured on the 14th day with the visual analog scale significantly decreased in groups II, III, and IV compared with group I. The patients of group I had a reduction of mean level bacteriuria of Escherichia coli from 106 to 102 CFU/mL at 14 days of therapy. Significant improvement of voided volume from baseline was observed in groups II, III, and IV. Episodes of urinary frequency, both daytime and night-time, reduced significantly from baseline in all 4 groups only at 14 days of treatment. Conclusions Bacteriophage cocktail alone or with antibiotics may improve clinical symptoms in women with chronic recurrent cystitis caused by multidrug-resistant bacterial pathogens. In addition to improving clinical symptoms, the therapy with a phage cocktail may restore antibiotic sensitivity and increase the efficacy of antimicrobial agents.

Association Between Surgeon Volume and Patient Outcomes After Elective Patellofemoral Arthroplasty: A Population-Based Cohort Study Using Data from the National Joint Registry and Hospital Episode Statistics for England.

The objective of this study was to determine the relationship between surgical volume and patient outcome after arthroplasty of the patellofemoral joint, to improve patient outcomes and inform future resource planning. All patellofemoral arthroplasty (PFA) records in the National Joint Registry from January 2003 to December 2021 were linked to the Hospital Episode Statistics database for England. The main outcome measure was revision surgery. Secondary outcome measures were serious adverse effects, patient selection characteristics, and implant designs used. Associations of early and late revision with surgical volume were examined based on surgical volume, and reasons for revision were explored. Of the knee arthroplasty surgeons in the database, 858 (26%) performed ≥1 PFA during the study period; 14,615 PFA cases were available for analysis. The modal caseload was 2 per year. High-volume surgeons were defined as surgeons performing >5 PFAs per year. The hazard ratio (HR) for a high-volume surgeon was 0.98 per additional PFA per year, and the patients treated by these surgeons had a lower risk of revision than than those treated by low-volume surgeons irrespective of the patient's age. High-volume surgeons were more likely to identify and treat patients with patellar disorders than low-volume surgeons (odds ratio [OR], 1.34; 95% confidence interval [CI], 1.09 to 1.77; p < 0.05), and their patients were less likely to have serious adverse effects as these surgeons' experience increased (OR per additional PFA per year, 0.97; 95% CI, 0.95 to 0.99; p = 0.02). Inlay implants had a higher risk of revision than onlay implants irrespective of surgical experience: for low-volume surgeons, inlays had an HR of 1.68 (95% CI, 1.23 to 2.30; p = 0.01), and for high-volume surgeons, inlays had an HR of 2.38 (95% CI, 1.83 to 3.11; p = 0.01). The most common reason for revision was progressive osteoarthritis. High-volume surgeons' patients were less likely than low-volume surgeons' patients to have an early revision (<2 years postoperatively) (OR, 0.72; 95% CI, 0.55 to 0.93; p < 0.05). An association was found between surgeons performing >5 PFAs per year and a lower revision rate. This study should inform surgical planning services to improve the outcomes of PFA. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Continuous overnight monitoring of body temperature during embryo transfer cycles as a proxy for establishing progesterone fluctuations by comparison with P4 blood progesterone results: a prospective, observational study

BackgroundA prospective, observational study to identify relationships between body temperature and levels of peripheral P4 blood progesterone, and examine if these differ according to body temperature cycle pattern.Methods62 data points from 18 patients undergoing hormone assisted embryo transfer cycles at IVIRMA IVF clinics in Madrid, Mallorca and Malaga, Spain volunteered to use OvuSense, an intra-vaginal body temperature monitor. Primary outcome measures were OvuSense Raw and Smooth Temperature (ST) (°C), P4 (ng/ml). Secondary outcome measures: Ongoing Pregnancy, Miscarriage or biochemical pregnancy. Graphical time based comparison analyses and multilevel regression analyses using MLwiN 3.10 [Charlton C, Rasbash J, Browne WJ, Healy M, Cameron B. MlwiN Version 3.10. Centre for Multilevel Modelling. University of Bristol; 2024.] software were conducted.ResultsA graphical analysis showed an apparent relationship between P4 levels and Temperature taken on P4 blood draw day. A multilevel regression analysis using MLwiN 3.10 Centre for Multilevel Modelling. University of Bristol software investigated this relationship, allowing between-patient variation to be accounted for and estimated. This established a strong linear relationship between LnP4 and ST, and cross correlation was carried out which identified the optimum predictor of levels of LnP4 was ST measured on the day prior to blood sampling. Further graphical analyses showed an apparent lower luteal level of P4 for cycles flagged as atypical by OvuSense, and for negative outcomes, except on embryo transfer day.ConclusionsThe results provide extremely strong evidence of a linear relationship between LnP4 and Smooth Temperature (ST) measured the day before blood sampling (Z = 15.6, p < 0.0001, 2 sided). This suggests that ST could provide a less invasive, continuous, and more practical method of assessing P4 response. Secondary outcomes may be related to ST pattern established during an embryo transfer cycle. Further investigation is required to establish the value of the ST pattern for improving outcomes.

Trends in clinical encounters and management for infertility among women attending Australian general practice: a national longitudinal study using MedicineInsight, 2011 to 2021

ObjectiveTo examine longitudinal trends in infertility management in women attending general practice.DesignCohort study using the national general practice dataset, MedicineInsight.SettingAustralian general practice.Intervention(s)Not applicable.ParticipantsThe cohort included 2 552 339 women aged...

Cerebrospinal fluid biomarkers as predictors of multiple sclerosis severity.

Prognostic biomarkers at multiple sclerosis (MS) onset to predict disease severity may help guide initial therapy selection for people with MS. Over 20 disease-modifying treatments (DMTs) of varying levels of risk and efficacy now exist. The ability to predict MS severity would help to identify those patients at higher risk where a highly effective, but potentially risky, therapy would be optimal. The goal of this project was to determine if cerebrospinal fluid (CSF) soluble markers obtained near time of diagnosis can predict disease severity in people with relapsing remitting MS (RRMS). We identified 42 RRMS subjects with 4 or more years of clinical follow-up at our center, 8 subjects with other inflammatory neurological diseases (OIND), and 4 subjects with non-inflammatory neurological diseases (NIND) who had donated CSF samples collected for disease diagnosis. This study evaluated soluble CSF biomarkers chosen to reflect neuroinflammation (chemokine ligand 13 - CXCL13), microglia activity (soluble triggering receptor expressed on myeloid cells 2 - sTREM2), demyelination (myelin basic protein -MBP), axon injury and loss (neurofilament light, heavy, and intermediate chains - NFL, NFH, internexin-alpha - INT-α) and neuronal loss (parvalbumin - PVALB) to determine whether any of these CSF factors might predict future MS disease severity. The main outcome measure was MS Severity Score (MSSS), which takes into account disability accumulation (expanded disability status scale - EDSS) and duration of disease. EDSS at last clinical visit was a secondary outcome measure. Univariate and multivariable regression models were used for analysis. Spearman correlations were performed to evaluate correlation between laboratory and clinical variables. Forty-two RRMS patients with mean 9.4 years follow-up since lumbar puncture (LP) contributed data. Higher NFH, NFL, and sTREM2 each predicted worse MSSS using both univariate and multivariable regression models. Older age at the time of LP predicted worse MSSS both in the univariate and multivariable models. NFL correlated with NFH, and both were positively correlated with sTREM2 and CXCL13. In the combined OIND and NIND comparator group, NFH correlated with both NFL and CXCL13. These data support that CSF sTREM2, NFH, and NFL are predictors of MSSS, a measure of MS disease aggressiveness. This study adds to a growing literature implicating microglial activity and axonal injury in MS progression, starting from early stages of the disease.

Decreasing Unnecessary Resource Utilization for New-onset, Unprovoked, Afebrile Seizure in the Emergency Department.

Pediatric seizures account for approximately 1% of emergency department (ED) presentations. Laboratory evaluation and emergent electroencephalogram (EEG) are not indicated in patients with a new-onset, unprovoked, afebrile seizure with a normal physical examination. This study aimed to reduce unnecessary ED resource utilization. Through plan-do-study-act cycles from March 2021 to July 2023, a multidisciplinary team implemented change concepts, including creating a clinical pathway and supporting order sets, scheduling outpatient EEGs from the ED, and automating messages to the neurology team to ensure patient follow-up. The primary outcome measure was the percentage of qualified patients who received an EEG in the ED. Secondary outcome measures were the percentage of patients who had ED complete blood counts or neurology consults, the room-to-discharge time in minutes, and healthcare cost per patient. The balancing measure was the 30-day ED bounce-back rate. Thirty-four and 99 patients met the inclusion criteria for the baseline and implementation phases, respectively. ED EEGs decreased from 59% to 1%. Complete blood counts and neurology consults decreased from 50% to 16% and 90% to 31%, respectively. Room-to-disposition time decreased from 308 to 203.5 minutes. Preliminary healthcare cost per patient decreased by $630. The 30-day bounce-back rate increased from 0% to 8%. Implementing a new-onset seizure pathway decreased ED resource utilization, shortened room-to-discharge time, and lowered healthcare costs.

Evaluating the effect of a non-linguistic cognitive intervention on functional communication in global aphasia: A case series study.

Global aphasia is a severe communication disorder affecting all language modalities, commonly caused by stroke. Evidence as to whether the functional communication of people with global aphasia (PwGA) can improve after speech and language therapy (SLT) is limited and conflicting. This is partly because cognition, which is relevant to participation in therapy and implicated in successful functional communication, can be severely impaired in global aphasia. Cognitive treatments that aim to improve functional communication for people with aphasia do exist, but few have been trialled with PwGA and no studies have robustly demonstrated gains. This study aimed to explore the effect of a novel non-linguistic cognitive intervention on the functional communication skills of PwGA. A non-linguistic intervention, developed to target cognitive skills underpinning functional communication, was delivered to six participants three times weekly for up to 6 weeks (depending on the rate of progression through the intervention programme). All participants met the criteria for global aphasia following screening with the Western Aphasia Battery Bedside Record Form. A multiple baseline case series design was employed to investigate changes in functional communication using the American Speech and Hearing Association Functional Assessment of Communication (ASHA-FACS). Secondary outcome measures were auditory comprehension and informal tests of non-verbal cognition. Statistical analyses of change after intervention were performed using the Wilcoxon signed-ranks test and weighted statistics. Participants completed the intervention programme in an average of nine sessions. Four out of six participants made statistically significant gains in functional communication as measured by communication independence (amount of assistance or prompting required) on the ASHA-FACS. Five of six participants made statistically significant gains in non-verbal semantics, two in non-verbal reasoning and two in auditory comprehension. The findings provide preliminary evidence that a non-linguistic cognitive intervention delivered with a dose replicable in clinical practice can improve functional communication and non-verbal cognition in some PwGA. This finding contrasts with much existing evidence suggesting that improvements in global aphasia can be achieved only after intensive or prolonged input over many years. What is already known on the subject People with global aphasia (PwGA) have the potential to make impairment level gains after intensive or prolonged speech and language therapy (SLT). However, evidence of functional communication gains is limited. Cognition plays an important role in functional communication, particularly the ability to switch to alternative means of communication and switch modalities. What this study adds Contrary to many previous studies, the findings indicate that PwGA can benefit from SLT and make functional communication gains with a relatively low dose of intervention. The findings highlight cognitive skills that appear relevant to basic functional communication abilities in PwGA. These are: attention, visual perception, semantics and non-verbal problem solving. What are the clinical implications of this work? This work suggests that clinicians should offer cognitive, non-linguistic interventions to PwGA and consider delivering intervention using little to no verbal language.

Aneuploidy rates and clinical pregnancy outcomes after preimplantation genetic testing for aneuploidy using the progestin-primed ovarian stimulation protocol or the gonadotropin-releasing hormone antagonist protocol.

To investigate the chromosome abnormality rates and clinical pregnancy outcomes after preimplantation genetic testing for aneuploidy (PGT-A) using either the progestin-primed ovarian stimulation (PPOS) protocol or the gonadotropin-releasing hormone (GnRH) antagonist protocol. The study included 431 PGT-A cycles in which controlled ovarian stimulation was performed using the PPOS protocol (n = 320 cycles) or GnRH antagonist protocol (n = 111 cycles) between January 2018 and December 2021. Frozen embryo transplantation was subsequently performed in 309 cycles with transplantable blastocysts. The number of retrieved oocytes, embryo development, next-generation sequencing results, and clinical pregnancy outcomes were compared between the two protocols. The primary outcome measure was the aneuploidy rate. Secondary outcome measures were clinical pregnancy per first frozen-thawed embryo transfer cycle and cumulative live birth rates per PGT-A cycle. There were no statistically significant between-group differences in the number of retrieved oocytes, available blastocysts, and high-quality blastocyst rate. The aneuploidy rates were similar between the two groups. There was no significant difference in clinical pregnancy outcomes, including the clinical pregnancy, implantation, miscarriage, live birth, or cumulative live birth rates, after frozen-thawed embryo transfer cycles (P>0.05). The study found no significant difference in the aneuploidy rate, clinical pregnancy rate and cumulative live birth rate after PGT-A cycles between those using the PPOS protocol and those using the GnRH antagonist protocol.

Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI): a randomised, controlled, parallel-group, non-inferiority, single-blinded, screening accuracy study.

Emerging evidence suggests that artificial intelligence (AI) can increase cancer detection in mammography screening while reducing screen-reading workload, but further understanding of the clinical impact is needed. In this randomised, controlled, parallel-group, non-inferiority, single-blinded, screening-accuracy study, done within the Swedish national screening programme, women recruited at four screening sites in southwest Sweden (Malmö, Lund, Landskrona, and Trelleborg) who were eligible for mammography screening were randomly allocated (1:1) to AI-supported screening or standard double reading. The AI system (Transpara version 1.7.0 ScreenPoint Medical, Nijmegen, Netherlands) was used to triage screening examinations to single or double reading and as detection support highlighting suspicious findings. This is a protocol-defined analysis of the secondary outcome measures of recall, cancer detection, false-positive rates, positive predictive value of recall, type and stage of cancer detected, and screen-reading workload. This trial is registered at ClinicalTrials.gov, NCT04838756 and is closed to accrual. Between April 12, 2021, and Dec 7, 2022, 105 934 women were randomly assigned to the intervention or control group. 19 women were excluded from the analysis. The median age was 53·7 years (IQR 46·5-63·2). AI-supported screening among 53 043 participants resulted in 338 detected cancers and 1110 recalls. Standard screening among 52 872 participants resulted in 262 detected cancers and 1027 recalls. Cancer-detection rates were 6·4 per 1000 (95% CI 5·7-7·1) screened participants in the intervention group and 5·0 per 1000 (4·4-5·6) in the control group, a ratio of 1·29 (95% CI 1·09-1·51; p=0·0021). AI-supported screening resulted in an increased detection of invasive cancers (270 vs 217, a proportion ratio of 1·24 [95% CI 1·04-1·48]), wich were mainly small lymph-node negative cancers (58 more T1, 46 more lymph-node negative, and 21 more non-luminal A). AI-supported screening also resulted in an increased detection of in situ cancers (68 vs 45, a proportion ratio of 1·51 [1·03-2·19]), with about half of the increased detection being high-grade in situ cancer (12 more nuclear grade III, and no increase in nuclear grade I). The recall and false-positive rate were not significantly higher in the intervention group (a ratio of 1·08 [95% CI 0·99-1·17; p=0·084] and 1·01 [0·91-1·11; p=0·92], respectively). The positive predictive value of recall was significantly higher in the intervention group compared with the control group, with a ratio of 1·19 (95% CI 1·04-1·37; p=0·012). There were 61 248 screen readings in the intervention group and 109 692 in the control group, resulting in a 44·2% reduction in the screen-reading workload. The findings suggest that AI contributes to the early detection of clinically relevant breast cancer and reduces screen-reading workload without increasing false positives. Swedish Cancer Society, Confederation of Regional Cancer Centres, and Swedish governmental funding for clinical research.

Behavioural, cognitive, and neurophysiological effects of a synbiotic supplementation enriched with pigmented corn extract or cornstarch in drug-naïve children with attention-deficit hyperactivity disorder: A randomised, double-blind, comparison-controlled clinical trial.

Considerable interest has been recently given to the potential role of the gut-brain axis (GBA) -a two-way communication network between the gut microbiota and the central nervous system- in the pathogenesis of attention-deficit hyperactivity disorder (ADHD), suggesting the potential usefulness of probiotic and synbiotic supplementations. In light of the limited available evidence, synbiotic efficacy in ADHD children not taking medications should be clarified. This study aimed to investigate the efficacy of a synbiotic dietary supplementation on fatty acids levels as well as on microbiota composition, behaviour, cognition, and brain function in children with ADHD. A total of 41 drug-naïve school-aged children diagnosed with ADHD were enrolled in a 3-month randomised, double-blind, comparison-controlled clinical trial, receiving either a synbiotic mix (COMP group) or the same synbiotic mix enriched with an additional extract from pigmented corn (EXP group). Changes in levels of some specific short-chain and branched-chain fatty acids were considered as primary outcomes. Secondary outcome measures included gut microbiota profiling, Child Behaviour Checklist, Conners Parent Rating Scale-revised, computerised cognitive tasks, and haemodynamic response to a Go-NoGo task measured by fNIRS. No superiority of the EXP synbiotic mix was observed. Analysis of fatty acids did not reveal any significant difference between groups. Children in the COMP group reported a slightly greater improvement than those in the EXP group in focused attention and in the haemodynamic response to a cognitive task. This study shows that pigmented corn extract does not enhance the effects of the synbiotic supplementation in ADHD children in terms of fatty acid production, microbiota composition, clinical, cognitive and neurophysiological measures. However, a synbiotic mix of probiotics plus prebiotic acacia fibre and cornstarch could have some promising effects on ADHD symptoms, which warrants further research. Future studies should also continue to explore the potential of fNIRS for monitoring the effects of interventions that target the GBA. ClinicalTrials.gov: NCT06005506.

From research to practice: bridging the implementation gap on the use of tranexamic acid in total knee arthroplasty

BackgroundThe use of intravenous tranexamic acid (TXA), an antifibrinolytic agent, has been shown to effectively reduce total blood loss and transfusion rates in total knee arthroplasty (TKA). The aim of this paper is to evaluate the implementation lag and clinical uptake of the use of TXA for primary TKA after publication of two landmark studies. Additionally, it assessed the efficacy of TXA use in TKA in reducing post-operative blood transfusions and hospital length of stay (LOS).MethodsA total of 763 patients aged over 18 years of age underwent primary TKA at a level 4 metropolitan hospital in Australia between January 2011 and December 2017. Primary outcome measure was use of TXA at operative induction. Secondary outcome measures were post-operative blood transfusion, haemoglobin levels and in-hospital length of stay.ResultsThe rate of TXA uptake was ≥ 50% by April–June 2013, 1.5 years following landmark paper publication. TXA use was ≥ 90% by April–June 2015, equating to 3.5 years after landmark publication. For each additional year since publication, the odds that TXA was used in a TKA surgery increased by 254.3%, 95% CI (confidence interval) [195.2%, 334.1%]. There was a negative association between TXA use and blood transfusion rate (p < 0.001), while controlling for other variables. TXA use reduced the odds of blood transfusions occurring by 73.5%, 95% CI [35.8% and 89.8%]. Analysis showed that reduced LOS was seen even after controlling for post-operative blood transfusion (p < 0.05).ConclusionThe implementation lag from research to clinical practice, using ≥ 90% TXA use in TKA as a proxy, was 3.5 years. The use of TXA reduced LOS and blood transfusion rate in TKA patients.

Exercise-based cardiac rehabilitation for patients with atrial fibrillation receiving catheter ablation: protocol for a feasibility randomised controlled trial (RCT) with embedded process evaluation

IntroductionAtrial fibrillation (AF) affects approximately 2.5% of the UK population, with a risk of 1 in 3–5 individuals after the age of 45 years. The global prevalence has risen sharply...

The effects of integrated traditional Chinese and western medicine rehabilitation programs on post-acute ankle sprain: A randomized controlled trial study protocol.

Ankle sprain is a common clinical disease, which has the highest incidence rate among joint and ligament injuries. And acute ankle sprains can easily develop into chronic ankle instability, thereby increasing the difficulty of treatment. The current clinical guidelines for post-acute ankle sprains are still controversial. Pain and functional impairment are the most significant symptoms after ankle sprain. The main purpose of this study is to explore the safety and effectiveness of the intervention of integrated traditional Chinese and Western medicine rehabilitation programs on post-acute ankle sprains. This study is a single center, prospective, intervention randomized controlled trial with a control group. 174 patients of 18-35 years old with post-acute ankle sprain will be included. A randomized controlled study is conducted and divided into a control group and an experimental group. The control group receive routine treatment, while the experimental group receive integrated traditional Chinese and western medicine rehabilitation programs. The intervention lasted for a total of 2 weeks. The main outcome measures are Visual Analog Scale and Short Form McGill Pain Questionnaire; the secondary outcome measures are the Foot Ankle Ability Assessment Scale, AOFAS Ankle Posterior Foot Scale, torque and gait. This study protocol aims to evaluate the safety and effectiveness of integrated traditional Chinese and western medicine rehabilitation programs by comparing the results of two groups before and after treatment. This protocol will follow the SPIRIT guidance. At present, there is a lack of rehabilitation management for post-acute ankle sprains. Therefore, this study has the potential to improve the healthcare for post-acute ankle sprains patients and might be used for future standardized evidence-based rehabilitation concepts. The trial was registered at Chinese Clinical Trial Registry https://www.chictr.org.cn/showproj.html?proj=234465 (Registration No.: ChiCTR2400087456). Date: 2024-07-29.

Efficacy and Tolerance of the Tampsec Vaginal Tampon for Treating Stress Urinary Incontinence. A Randomized Controlled Trial.

Stress urinary incontinence (SUI) is a highly prevalent condition in women. We hypothesized that the Tampsec™ vaginal tampon will be efficacious and well tolerated in its treatment. This was a multicenter open-label parallel-group randomized control trial. All participants were recommended to make lifestyle modifications and perform pelvic floor muscle training for SUI treatment. Additionally, women in the tampon group were instructed to use a Tampsec™ throughout the day. The primary outcome measure was a ≥50% reduction in pad weight by the end of treatment. Secondary outcome measures were women's perception of improvement evaluated using the Patient Global Impression of Improvement (PGI-I) questionnaire, decrease in the mean number of SUI episodes/day, and improvement in the impact of urinary incontinence (UI) on everyday life. Tampon tolerance and usability were also evaluated. Forty-six women with a positive urinary stress test were randomized 1:1 to tampon or control treatments. Regarding the primary outcome, a ≥50% reduction was achieved in 69.9% of patients in the tampon group and 26.1% in controls (RR 2.7; 95%CI 1.3-5.4). On the basis of PGI-I responses, the treatment was successful in 60.9% of women in the tampon group and 17.4% of controls (p = 0.003). The tampon group also reported greater decreases in SUI episodes/day (mean 2.0±2.2 vs 0.5±1.1; p = 0.007) and more improvement in the impact of UI on everyday life. Tolerance and usability were good in most women. The Tampsec™ tampon is efficacious and well tolerated in women with SUI. This treatment decreases the number of SUI episodes/day and improves UI-related quality of life.

Efficacy and safety of combination of semaglutide and basal insulin in patients with of type 2 diabetes mellitus: A systematic review and meta-analysis.

Semaglutide has demonstrated efficacy in both glycemic control and weight loss. This systematic review and meta-analysis aimed to assess the efficacy and safety of the combined use of semaglutide and basal insulin in individuals diagnosed with type 2 diabetes mellitus (T2DM). PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal Database (VIP) were searched to identify relevant publications. The primary outcome measure was the change in HbA1c levels. Secondary outcome measures encompassed change in body weight, fluctuations in FPG levels, occurrence of adverse events, serious adverse events, hypoglycemic episodes, and gastrointestinal reactions including nausea, vomiting, and diarrhea. Mean differences (MDs) and relative risk (RR) with confidence intervals (CI) of 95% were used to analyze the deference. 7 RCTs with 2354 patients were incorporated into the study. Compared to placebo or other active treatment, the addition of semaglutide to basal insulin demonstrated significant reductions in hemoglobin A1c (HbA1c) [mean differences (MD): -1.17%, P<0.00001], body weight [MD -5.99 kg, P<0.00001], and fasting blood glucose (FPG) [MD -1.08%, P<0.00001]. No evidence indicated a higher risk of adverse events [RR 1.46, P=0.13]. However, it did result in increased rates of gastrointestinal adverse events, including nausea, vomiting and diarrhea. The combination treatment of semaglutide and basal insulin demonstrates significant improvements in glycemic control and reduction in body weight, without an increased risk of hypoglycemia. Our findings provided support for the utilization of a combination therapy involving semaglutide and basal insulin in T2DM.

Prevalence and Clinical Associations of Peripapillary Hyperreflective Ovoid Mass-like Structures in Craniosynostosis.

Patients with craniosynostosis are at high risk of developing elevated intracranial pressure (ICP) causing papilledema and secondary optic atrophy. Diagnosing and monitoring optic neuropathy is challenging because of multiple causes of vision loss including exposure keratopathy, amblyopia, and cognitive delays that limit examination. Peripapillary hyperreflective ovoid mass-like structures (PHOMS) are an optical coherence tomography (OCT) finding reported in association with papilledema and optic neuropathy. We investigated the prevalence of PHOMS in patients with syndromic craniosynostosis and the relationship with known risk factors of optic neuropathy. This was a cross-sectional retrospective study was performed at Boston Children's Hospital and included 118 eyes (60 patients) with syndromic craniosynostosis that had at least one good quality optic nerve OCT volumetry scan between January 2010 and December 2023. Testing was reviewed by 2 neuro-ophthalmologists to determine the presence of PHOMS. Information collected included demographics, and clinical course including possible Chiari malformation, obstructive sleep apnea (OSA), history of elevated ICP, best-corrected visual acuity (VA), spherical equivalent (SE), retinal nerve fiber layer thickness, macular ganglion cell layer volume, and funduscopic examination. Our primary outcome measure was presence of PHOMS, and secondary outcome measure was the relationship between clinical characteristics and the presence of PHOMS. Mean age at imaged OCT was 9.8 ± 5.2 years and 41/60 (68.3%) patients were female. The prevalence of PHOMS was 17/60 patients (28.3%) or 26/118 eyes (22.0%), higher than previously reported in children without craniosynostosis (P < 0.001). PHOMS were significantly associated with a history of elevated ICP (odds ratio [OR] 14.4, 95% CI: 1.9-111.0, P < 0.001) and with concurrent papilledema (OR 40.4, 95% CI: 6.6-248.0, P < 0.001). OSA, Chiari malformation, best-corrected VA, craniosynostosis variant, and SE were not independently associated with PHOMS. Eyes in children with craniosynostosis had a higher prevalence of PHOMS than reported in children without craniosynostosis. PHOMS were significantly more common with a history of elevated ICP and with concurrent papilledema. PHOMS may serve as a clinically useful indicator of optic neuropathy, and of recurrence of papilledema in patients with craniosynostosis and in other populations characterized by multiple sources of vision loss and cognitive changes that limit evaluation.

Intermediate-Term Outcomes and Complications of Ahmed Glaucoma Valve in Type 1 Keratoprostheses.

To evaluate intermediate-term outcomes and complications associated with Ahmed glaucoma valve (AGV) implantation in eyes with type 1 keratoprosthesis (KPro). We retrospectively reviewed records of 43 eyes of 43 Indian patients with type 1 KPro and AGV from 2009 to 2021 with a minimum of 6-months of follow-up. Five eyes that had AGV before KPro were excluded, leaving 38 eyes for analysis. Primary outcome measure was postoperative complications. Secondary outcome measure was stability of glaucoma, assessed by Humphrey visual fields, intraocular pressure, and best-corrected visual acuity (BCVA). Sight-threatening complications, implant removal, or repeat glaucoma surgery was considered failure. Median age (interquartile range) at AGV implantation was 36.5 (23-49) years, with median post-AGV follow-up of 30.5 (6.5-53) months. Preoperative logarithm of minimal angle of resolution median BCVA was 0.6 (0.4-1). Post-AGV, median intraocular pressure as measured by scleral Schiotz reduced significantly from 30.4 (20.6-30.4) to 13.5(12.2-14.8) mm Hg (P < 0.0001), and the mean number of antiglaucoma medications significantly decreased from 3.4 to 1.7 (P < 0.0001). Mean BCVA (P = 0.24) remained stable. Humphrey visual fields mean deviation progressed from -13.5 dB (-25, -9) to -26 dB (-30, -13) at final follow-up (P = 0.05) and progression occurred in 10 eyes. Seven eyes (18.4%) had postoperative complications needing surgical intervention, including tube block [5 eyes (13.1%)] and tube exposure [2 eyes (5%)]. One failed AGV needed additional glaucoma surgery after 8 years. None had implant extrusion/explanation or endophthalmitis. Ahmed glaucoma valve implantation offered promising results in managing glaucoma in eyes with type 1 KPro, particularly in relatively young Indian population. However, close monitoring for tube-related complications and glaucoma progression is warranted.

T2-low severe asthma clinical spectrum and impact: The Greek PHOLLOW cross-sectional study.

Data on type 2 (T2)-low severe asthma (SA) frequency is scarce, resulting in an undefined unmet therapeutic need in this patient population. Our objective was to assess the frequency and characterize the profile and burden of T2-low SA in Greece. PHOLLOW was a cross-sectional study of adult SA patients. Based on a novel proposed classification system, patients were classified as T2-low if blood eosinophil count (BEC; cells/μL) was <150, fractional exhaled nitric oxide (FeNO)<25 ppb and any allergy status or BEC < 150/FeNO < 50 ppb/no allergy or BEC < 300/FeNO < 25 ppb/no allergy. For patients receiving biologics and/or oral corticosteroids, only those with BEC < 150/FeNO < 25 ppb/no allergy/no response to therapy were classified as T2-low. Secondary outcome measures were: Asthma Control Test (ACTTM), Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), hospital anxiety and depression scale (HADS), and Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire. From 22-Mar-2022 to 15-Mar-2023, 602 eligible SA patients were enrolled. The frequency of T2-low asthma was 20.1%. Of those, 71.1% had experienced ≥1 clinically significant exacerbations in the past year, 62.8% had ACT score <20 (uncontrolled asthma), and 22.3% were biologic-treated. Mini-AQLQ score was <6 (impairment) in 79.5% of patients, HADS-total score was ≥15 (clinically significant emotional distress) in 43.8%, while median percent activity impairment and work productivity loss were 30.0 for both domains. Clinical and patient-reported outcomes were worse among patients with ACT-defined uncontrolled asthma. One-fifth of SA patients present with a T2-low endotype. These patients frequently have uncontrolled disease and experience impairments in their quality of life, emotions and work ability.

P-2254. Incidence, Clinical Characteristics and Outcomes of Heart Transplant Patients with Mucormycosis Infection: A Systematic Review and Meta-Analysis

Abstract Background Mucormycosis confers high morbidity and mortality in the immunocompromised population due to its rapid angio-invasive nature. Of note, this group of people includes those who have undergone solid organ or stem cell transplants, many of whom are placed on chronic immunosuppressive regimens. Mucormycosis incidence and clinical outcomes have been studied in bone marrow, lung, liver and kidney transplant recipients but not in heart transplant patients. Thus, our aim with this systematic review and meta-analysis is to characterize the incidence as well as clinical outcomes of Mucor infections in heart transplant recipients.Figure 1.PRISMA Flowchart Methods This study was registered with PROSPERO. Electronic databases Google Scholar, PubMed, Embase, Scopus and CINAHL were searched from inception up to 1 February 2024 for peer-reviewed articles of heart transplant patients who contracted mucormycosis. The primary and secondary outcome measures were incidence of mucormycosis infection and times to onset of infection and mortality, respectively. For statistical analysis, overall meta-analytic incidence was estimated using the user-written metaprop_one[FD1] [m2] command in Stata 15.1.Table 1.Species Identified in Infection Results Our search identified 296 studies, 88 of which underwent full-text review and 47 met inclusion criteria with 3916 total cases (Figure 1). Rhizopus was the most common pathogen identified causing mucormycosis infection (Figure 2). Pooled incidence of mucormycosis infection in heart transplant patients is 0.6% (95% CI 0 - 2%) across 12 studies (Figure 3). The majority of patients were male, 39/41 (95%) (Figure 4). Mucormycosis infection most commonly occurred during first 30 days post-transplant and decreased with time. Logistic regression analysis did not show significant association between time of infection post-transplant and mortality: Odds Ratio = 0.89 (95% CI 0.55-1.42, p = 0.616).Figure 2.Results of Meta-Analysis for Incidence of Mucormycosis Infection in Heart Transplant Recipients Conclusion Overall incidence of mucormycosis in heart transplant patients is 0.6%. Patients were more likely to contract the infection early (within 30 days) in the post-transplant period but there was no significant difference in mortality over time. The majority of affected patients were male and further studies are needed to determine if males are at higher risk of infection.Table 2.Demographics and Time of Infection Onset Disclosures All Authors: No reported disclosures