6-month Visit Research Articles

Prolonged dual antiplatelet therapy in an extended Phase 3 Cardiac Rehabilitation Program following myocardial infarction

Abstract Background Prolonged dual antiplatelet therapy (P-DAPT) is recommended in selected patients beyond 12 months after myocardial infarction (MI). Several risk scores have been developed to estimate the ischemic and bleeding risk and individualize the decision-making process. Purpose We aim to analyse the factors, including ischemic and bleeding scores, associated with P-DAPT prescription in MI patients submitted to a Cardiac Rehabilitation Program (CRP). Methods Patients with ST-segment elevation MI (STEMI) or occlusion MI (OMI) who were submitted to our CRP underwent Phase 2 CRP and were prospectively included. Patients were followed in an extended Phase 3 CRP, and a follow-up visit was scheduled 12 months after hospital discharge. Baseline and follow-up clinical characteristics and treatment after the 12-months visit were registered, specifically P-DAPT. Ischemic (DAPT score) and bleeding (PRECISE-DAPT and CRUSADE scores) risk scores were retrospectively computed. Predictors of P-DAPT were studied by univariate analysis and multivariable binary logistic regression. The model was tested by area under the curve (AUC) analysis in receiver operating characteristic curves. A p<0.05 was considered statistically significant. Results The cohort comprised 78 patients (mean age 61±11 years, 84.6% male). Anterior and inferior STEMI were the most common presentations (43.6% and 47.4%, respectively). The most prevalent cardiovascular risks factors were hypercholesterolemia (85.9%), hypertension (53.8%), smoking habit (46.2%) and diabetes mellitus (23.1%). P-DAPT was prescribed in 39 (50%) patients beyond 12 months after MI, primarily combining aspirin 100mg o.d. and ticagrelor 60mg b.i.d. (n=33, 84.6%). On multivariate analysis, variables associated with P-DAPT prescription were hypertension (HR 4.92 [1.37-17.68], p=0.02), diabetes mellitus (HR 5.13 [1.09-24.09], p=0.04), multivessel disease (HR 5.54 [1.55-19.79], p=0.008), and stent diameter <3mm (HR 5.46 [1.25-23.78], p=0.02). The predictive power of the model was excellent (AUC 0.88 [0.8-0.96], p<0.001). Ischemic (DAPT score) and bleeding (PRECISE-DAPT and CRUSADE) risk scores were not associated with P-DAPT neither in continuous form nor by using their standard cutoffs (≥2, <25 and >40 points, respectively). Conclusions In a real-life cohort of MI patients undergoing extended Phase 3 Cardiac Rehabilitation, P-DAPT was prescribed in half of the population. Clinical (hypertension and diabetes mellitus) and angiographic (multivessel disease and stent diameter <3mm) variables straightforwardly predict the likelihood of receiving P-DAPT, unlike ischemic and bleeding risk scores. The clinical consequences of this management should be further explored.Prolonged DAPT in Cardiac Rehabilitation

Masked hypotension in patients with heart failure

Abstract Background Hypotension limits the up-titration of guideline-directed medical therapies (GDMTs) and correlates with poor prognosis in patients with heart failure. The value of ambulatory blood pressure monitoring (ABPM) in heart failure patients and its association with GDMTs optimization and clinical outcomes were undetermined. Methods REM-HF (Risk Evaluation and Management in Heart Failure) is a multicenter, prospective observational cohort. Our study screened patients from REM-HF who were hospitalized for incident HF and newly initiated GDMTs between April 2018 and December 2022. Eligible participants conducted a 24-hour ABPM before discharge and were followed-up as the cohort routine. GDMTs target dose achievement and dose trajectories were assessed at 3-month visit. The primary outcome was a composite of all-cause mortality and heart failure readmission. Results On adjusted restricted cubic spline analysis, office SBP demonstrated a U-shape relationship with the primary outcome (P for nonlinearity=0.003), while 24-hour SBP was linear (P for nonlinearity=0.338). The risk-related threshold of ambulatory and office systolic hypotension was defined as corresponding SBP < 120 mmHg accordingly. Combining these two measurements together, we described three blood pressure status as sustained hypotension (s-hypo, both SBP < 120 mmHg), masked hypotension (m-hypo, 24h SBP < 120 mmHg while office SBP ≥ 120mmHg), and non-hypotension (n-hypo). Among the 491 patients included, 124 (25.3%), 151 (30.8%) and 216 (44.0%) had s-hypo, m-hypo, and n-hypo, respectively. The m-hypo group showed similar clinical features as the s-hypo subjects, including more serious left ventricle remodeling and worse cardiac function. After the GDMTs dose titration, either patients with s-hypo or m-hypo were as unlikely to achieve target dose as the non-hypotensives (OR for s-hypo 0.42, 95%CI 0.19-0.95, P=0.038; OR for m-hypo 0.39, 95%CI 0.19-0.80, P=0.011). During a median follow-up of 693 days, the adjusted risk of primary outcome was higher in the s-hypo group and m-hypo group compared with the non-hypo group (HR for s-hypo 2.47, 95%CI 1.54-3.96, P<0.001; HR for m-hypo 1.68, 95%CI 1.06-2.65, P=0.027). No significant differences were found in target dose achievement and clinical outcomes between the s-hypo and m-hypo groups. Conclusion Masked systolic hypotension can occur in nearly one-third of new-onset HF patients. Patients with m-hypo and s-hypo exhibit similar clinical characteristics, both associated with GDMTs intolerance and adverse outcomes, suggesting m-hypo deserves recognition as a discrete entity. ABPM provides a more comprehensive view of patients’ blood pressure status by identifying this population.

Mechanical dyssynchrony and response to cardiac resynchronization therapy in heart failure patients with right ventricular pacing: a pre-specified subgroup analysis of the BUDAPEST CRT Upgrade trial

Abstract Introduction The BUDAPEST CRT Upgrade trial has established the strong clinical benefit of upgrading heart failure patients with a reduced left ventricular (LV) ejection fraction (HFrEF) and a high right ventricular pacing (RVP) burden to cardiac resynchronization therapy with defibrillator (CRT-D). Importantly, however, the CRT upgrade response is not homogeneous regarding LV reverse remodeling and associated clinical outcomes. The presence of mechanical dyssynchrony (MD) assessed by echocardiography has been linked to more CRT benefits; still, its change in response to CRT and added prognostic value in HFrEF patients with high RVP are scarcely investigated. Purpose Accordingly, we aimed to assess the prevalence, clinical characteristics, CRT response rate, and prognostic value of RVP-induced MD in the BUDAPEST CRT Upgrade cohort. Methods The multicentre, randomized, controlled trial enrolled 360 HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD) and significant RVP (≥ 20%) who were randomly assigned to receive CRT-D upgrade or ICD in a 3:2 ratio. Protocol echocardiography was performed at baseline and at 12-month follow-up visits and was evaluated at a central core lab. Beyond LV end-diastolic (EDV) and end-systolic volumes (ESV), longitudinal strain-derived septal deformation patterns by speckle tracking were assessed to determine the presence of RVP-induced MD. The endpoints were volumetric non-response (defined by a relative decrease in LV ESV <15%) and the composite of volumetric non-response or HF hospitalization. Results The echocardiographic assessment was feasible in 325 patients at baseline; 133 (41%) patients presented with MD. Females were more likely to present with MD (female vs. male, 65% vs. 38%, p=0.003). MD patients had higher LV EDV (MD vs. no-MD, 248±78 vs. 219±78 mL, p=0.001) and LV ESV (190±67 vs. 165±64 mL, p<0.001) at baseline. In the CRT-D group, 126 (75%) patients were volumetric responders, and 41 (25%) were non-responders at 12 months. CRT patients with baseline MD were less likely to experience volumetric non-response (OR 0.35 [95% CI 0.15-0.82], p=0.015) or the composite endpoint (OR 0.37 [95% CI 0.17-0.77], p=0.008). Out of 57 CRT patients with baseline MD who had follow-up assessment available, 52 (91%) patients had a favorable change: the MD pattern disappeared. Patients with MD resolution at 12 months were less likely to experience volumetric non-response or the composite endpoint (OR 0.39 [95% CI 0.17-0.93], p=0.034; OR 0.38 [95% CI 0.16-0.86], p=0.021, respectively). CRT patients with resolved MD were less likely of ischemic etiology and had 100% posterior or lateral LV lead location. Conclusions The presence of RVP-induced MD and its resolution is associated with better clinical response in HFrEF patients undergoing CRT-D upgrade. MD assessment can refine patient selection algorithms of CRT.Figure 1

Clinical Evaluation of Violet Light Filtration and High-Resolution Lathing on a Diffractive Extended Depth of Focus IOL.

This study is a prospective, randomized, subject/evaluator-masked clinical trial in a single-center clinical setting. The purpose of the study is to compare the clinical performance of Tecnis Symfony Optiblue IOL (models ZXR00V and ZXW150) with violet light filter (VLF) and manufacturing improvements versus Tecnis Symfony IOL (models ZXR00 and ZXT150) with ultraviolet light filter (UVF) in patients undergoing cataract surgery. Patients with cataracts aged ≥ 22years were randomly assigned 1:1 to bilateral implantation with ZXR00V/ZXW150 (VLF group) or ZXR00/ZXT150 (UVF group). Key endpoints at 6months postoperative included patient reported nighttime dysphotopsia symptoms, 25% low contrast visual acuity with glare, and patient satisfaction. Sixty patients were implanted with ZXR00V/ZXW150 (30) or ZXR00/ZXT150 (30). At 6months, the VLF group did not show a statistically significant differences in mean monocular photopic uncorrected distance visual acuity (UCDVA), best-corrected distance visual acuity (BCDVA), uncorrected near visual acuity (UCNVA) (40cm), or distance-corrected near visual acuity (DCNVA) (40cm) compared to the UVF group. At 1month, patients in the VLF group reported significantly less difficulty due to halo (p = 0.016) and starburst (p = 0.028) symptoms. By the 6months, dysphotopsia complaints were no longer significantly different between the groups. Although the VLF group trended toward better low contrast visual acuity and patient satisfaction, statistical significance was not reached. Managing the patients' expectations is key to achieving success. At the 1-month visit the patients who reported dysphotopsia complaints in the VLF group had significantly less difficulty with starbursts and halos as compared to the UVF group. By the 6-month visit, there was no significant difference between the two groups in the difficulty with starbursts and halos. ClinicalTrials.gov identifier, NCT06567834.

15 Predictive validity of two developmental screening tools at the 18-month visit and neurodevelopmental consultation at an average age of 8 years

Abstract Background The Canadian Paediatric Society (CPS) recommends an enhanced 18-month well-baby visit incorporating a developmental screening tool to stimulate discussion with parents, and notes that a widely used tool is the Nipissing District Developmental Screen (NDDS). For early detection of autism spectrum disorder, the CPS notes that a commonly used screening tool is the Infant Toddler Checklist (ITC). Objectives To examine the predictive validity of the ITC and NDDS at the 18-month visit using later neurodevelopmental consultation as the criterion measure; and examine whether positive developmental screening was associated with health care utilization (HCU). Design/Methods Using a prospective design, parents completed the ITC and the NDDS at the 18-month visit in primary care practices. Seven types of HCU were collected from health administrative databases, via linkage using the child’s health insurance number, including: neurodevelopmental consultation, special paediatric consultation, scheduled primary care visit billings, unscheduled primary care or minor visit billings, other non-primary care visit billings, hospitalizations, and emergency department visits. Covariates included child and family characteristics. We calculated screening test properties (using neurodevelopmental consultation as the criterion) and used multivariable negative binomial regression to estimate rate ratios (RR) for each of the 7 types of HCU. Results For both the ITC (n=1460) and NDDS (n=802) cohorts, mean age at screening was 18 months and mean age at follow up was 8 years. Of the ITC cohort, 11% were screen positive, 2.6% had a neurodevelopmental consultation. A positive ITC had 40% sensitivity (95% CI 24%-57%), 90% specificity (95% CI 88%-91%), 10% false positive rate (95% CI 9%-12%). A positive ITC was associated with 6 of 7 types of HCU, including neurodevelopmental consultation (RR=2.78, 95% CI 1.37-5.67). Of the NDDS cohort, 36% were screen positive, 2.5% had a neurodevelopmental consultation. A positive NDDS had a sensitivity of 50% (95% CI 27%-73%), specificity of 65% (95% CI 61%-68%), false positive rate of 35% (95% CI 31%-40%). A positive NDDS was associated with only 1 of 7 types of HCU: unscheduled primary care or minor visit billings 1.24 (95% CI 1.01, 1.53, p=0.04). Conclusion The predictive validity of the ITC was stronger than the NDDS due to high specificity and low false positive rates. The low sensitivity of the ITC is similar to other screening tools used at 18 months, highlighting the importance of ongoing developmental surveillance. The false positive rate of the NDDS is unacceptably high for a screening tool.

Challenging Case: Family Navigation for Autism Spectrum Disorder.

Leo is a 28-month-old boy from a monolingual Spanish-speaking family who was referred to a developmental-behavioral pediatrics (DBP) clinic for concerns regarding autism. His parents migrated to the United States 8 years ago and currently live and work on a farm. He was born in a US hospital after an uncomplicated pregnancy and has been generally healthy. His parents first became concerned about his development when he was 16 months old. He stopped saying mama/dada in Spanish and started lining up random objects. He had frequent temper tantrums and was difficult to console during unexpected changes in his routine. He screened positive on the Modified Checklist for Autism in Toddlers,Revised with Follow-Up (M-CHAT-R/F) at his 18-month well-child visit, and his pediatrician referred him to the local early intervention program. Calls from the early intervention program to his parents were unanswered. At his 24-month well-child visit, he again screened positive on the M-CHAT-R/F, and his pediatrician placed a referral for a DBP consultation. During the DBP visit at 28 months of age, developmental testing indicated his receptive and expressive language skills to be in the extremely low range, with significant scatter in his cognitive and adaptive skills. Behavioral observations were consistent with parental history and showed differences in social communication and interaction, the presence of repetitive behaviors, and extreme distress with transitions. He was diagnosed with autism spectrum disorder. Recommendations, including referral to early intervention, applied behavior analysis therapy, speech and language therapy, audiology evaluation, and genetic testing, were discussed with his parents through an interpreter. An autism packet, written in Spanish, with detailed information about autism and community resources was given to the family. By the time of a follow-up DBP visit 6 months later, Leo had not started on any early intervention or therapeutic services. Where do you go from here?

Sensor-Acquired Reachable Workspace (RWS) Correlates with Activities of Daily Living (ADL) Function in Stroke as Measured by Functional Independence Measure (FIM) Self-Care

Optimal upper extremity motor control and range of motion are necessary to achieve even the basic activities of daily living (ADL) function. Stroke, with resulting hemiparesis, can significantly and negatively impact an individual’s ADL function. Functional Independence Measure (FIM) self-care score can provide an assessment of what aspects and to what degree ADL functions are impaired. FIM self-care assessment can also track changes in ADL function during stroke recovery and rehabilitation. Recently, the sensor-acquired 3D motion analysis of stroke patients’ upper extremity has shown promise as a potential alternative to assess ADL function. This observational study evaluates whether the sensor-acquired upper extremity reachable workspace (RWS) measure correlates with clinician-evaluated FIM self-care score in stroke patients. Seventeen patients with stroke were enrolled in the study. FIM self-care, NeuroQoL upper extremity, and reachable workspace outcome measures (relative surface area, RSA) were collected upon rehabilitation hospital admission, at discharge, and at the 3-month visit. Pearson and Spearman’s rank correlation coefficients as well as multiple linear regression analyses were used to determine the relationships between FIM self-care, NeuroQoL, and reachable workspace RSAs. Moderately strong correlation between total reachable workspace RSA and total FIM self-care score at discharge and at 3 months were noted (r = 0.619, r = 0.661, p < 0.05), and similarly strong correlation was also noted with the upper extremity NeuroQoL total score (r = 0.690, r = 0.815, p < 0.05). Multiple linear regression analyses revealed a change in average bilateral total RSA of 0.1 unit from admission to the 3-month follow-up correlated with a respective change in the FIM self-care score of 2.011 points (95%CI: 0.663–3.360). Longitudinal improvement in ADL function during stroke rehabilitation and recovery process is correlated with improvement in reachable workspace.

Ahmed's sub-flap mattress suture deep sclerectomy assessment with Ultrasound Biomicroscopy.

To assess the efficacy of adding Ahmed's sub-flap mattress suture to deep sclerectomy (DS). Forty eyes with open angle glaucoma were assigned randomly into two groups: Group A: underwent DS with Ahmed's sub-flap mattress suture. Group B: underwent conventional DS. Patients were followed up closely for 6 months with serial IOP measurements and ultrasound biomicroscopy (UBM) was used to assess the surgical site functionally and anatomically at the first and sixth month. Adding Ahmed's sub-flap mattress suture improved the IOP lowering effect of DS significantly from 43% in group B to 53% in group A at 6-month (p = 0.027). IOP in group A was at 1 week, 1 month and 6-month visits (7.9 ± 1.3, 11.7 ± 2.2 and 13.3 ± 1.9 mmHg respectively) compared to group B (10.1 ± 4.6, 14.1 ± 5.2 and 16.8 ± 4.1 mmHg respectively) (p = 0.025, 0.041 and 0.001 respectively). UBM parameters were significantly larger in group A at 1 and 6 months. Strong statistically significant negative correlations were established between IOP and all the UBM parameters apart from intrascleral lake height at the first and sixth month (p < 0.01 in all of them). Finally, significant correlations were found between IOP at 6 months and whole bleb anteroposterior length and height at 1 month (p = 0.001). Adding Ahmed's sub-flap mattress suture to routine DS is an effective economical addition that will enhance the IOP lowering effect of DS. Also, assessment of the bleb by UBM is useful in predicting the success of deep sclerectomy surgery.

Deprescribing antipsychotics in patients with schizophrenia: findings from a specialized clinic.

While antipsychotic medication reduces the risk of relapse for patients with schizophrenia, high prevalence of adverse effects results in low adherence. Lower doses of antipsychotics have been associated with increased level of function but also with increased risk of relapse. This study presents findings from a specialized deprescribing clinic. In addition, we aim to identify clinical predictors for relapse. Patients diagnosed with schizophrenia were referred to the clinic, which offers a six-month guided tapering program. Antipsychotic dose was reduced by 10% every four weeks. Patients were monitored closely for symptom progression or decrease in level of function, with defined cut-offs prompting a pause in or cessation of dose reduction. After 12 months, the antipsychotic dose was reduced from 404 (±320 mg) to 255 (±236 mg) chlorpromazine equivalent. Of the 88 patients included, 22 (27%) experienced relapse during the six-month tapering period, while 29 (37%) experienced relapse at the 12-month follow-up visit and nine patients were antipsychotic free. Patients who remained stable experienced a slightly increased level of functioning and markedly fewer side effects (p < 0.001). Following relapse, patients were clinically stabilized and showed an improved attitude toward antipsychotic medication. The predictive models were weak. We show that most patients undergoing guided antipsychotic tapering remained stable after one year and improved in level of function, while most patients who relapsed were quickly stabilized. Our inability to create strong predictive models could be due to limitations in the study design, warranting future studies exploring tapering of antipsychotics in patients with schizophrenia.

Visual and patient reported outcomes provided by a refractive multifocal intraocular lens based on continuous transitional focus

PurposeTo analyze the quality of vision of patients implanted bilaterally with the multifocal Precizon Presbyopic intraocular lens (IOL), as well as to evaluate the visual performance provided by the lens.SettingVissum Miranza Alicante.DesignProspective multicenter study.Methods56 patients (mean age 65.0 ± 8.7 years old) underwent bilateral implantation with multifocal Precizon Presbyopic IOL. The quality of vision was assessed by a quality of vision questionnaire at 6 months after the implantation procedure, a complete eye examination was also performed including visual and refractive measurements, defocus curve and contrast sensitivity assessment. Visual and refractive variables were compared in preoperative, 3-month postoperative and 6-month postoperative visits by Wilcoxon test.ResultsThe quality of vision analysis showed the absence of severe glare and severe haloes in all evaluated patients. Likewise, non-symptoms of glare, haloes and starbursts were seen in 75%, 68%, and 55% of subjects, respectively. Efficacy and safety index was 1.26 and 1.42, respectively. The 6-month postoperative binocular uncorrected distance visual acuity and near uncorrected visual acuity were 0.00 ± 0.09 and 0.20 ± 0.13 logMAR, respectively. Mean spherical equivalent was 0.29 ± 0.45 D.ConclusionsThe Precizon Presbyopic NVA IOL (OPHTEC BV) provides a suitable quality of vision with a low rate of disturbance photic phenomena induction, as well as an excellent visual performance at main distances of sight accomplishing the visual demands of the majority of patients.

A Directed Content Analysis of Discussions Between Mothers and Pediatricians Around Feeding and Growth Topics During Infant Well-Child Visits.

This study identified specific feeding and growth topics discussed during 2-, 4-, and 6-month well-child visits. Conversations between mothers (N = 20) and pediatricians (N = 5) during visits were audio-recorded. Conversation segments were classified as pediatrician-initiated guidance, mother-initiated questions/concerns, or updates using directed content analysis. Pediatricians and mothers completed surveys on perceptions of guidance delivered. Feeding clusters included introducing solids/drinks, breast milk/formula amount and timing, feeding in specific situations; and breast milk/formula preparation. Growth clusters included appropriate growth and growth tracking. There was considerable variability in specific topics discussed between and within families across visits. Mothers desired additional guidance around introducing solids (42.1%) and allergen foods (31.6%). Pediatricians (80%) felt the amount of guidance to deliver in a standard visit was too much, and additional guidance outside of visits would benefit caregivers. Future research should investigate strategies to further support families by offering additional guidance during or outside of well-child visits.

Palatal root endodontic microsurgery in maxillary molars using the palatal approach: a case study

BackgroundIn clinical practice, the buccal approach is typically the primary choice for endodontic microsurgery. Owing to the thickness of the buccal bone plate, the distance between the buccal bone plate and palatal lesion location, and soft tissue traction, the palatal approach may be more suitable for microsurgery for apical periodontitis of the palatal roots of the maxillary molars. However, the length of the palatal root, location of the greater palatine artery (GPA) and foramen (GPF), and surgical field of observation make palatal surgery challenging.Case presentationWith the aid of Cone-beam computed tomography imaging, the palatal approach was successfully applied in nine cases of endodontic microsurgery of the palatal root of a maxillary molar with a periapical lesion in Hangzhou Stomatology Hospital from January to December 2022.ConclusionsComplete healing was assessed based on clinical symptoms and radiographic images at the 3- and 24-month follow-up visits in all nine cases. Several tips have been proposed including surgical positioning, incision design, palate flap modification, bone removal, and root-end resection.

Bedside 3D ultrasound fistula maturation assessment by non-expert sonographers provides equivalent accuracy to formal duplex sonography: A prospective clinical trial.

EchoSure is an automated point-of-care 3D ultrasound (3DUS) designed to be used by dialysis technicians without advanced ultrasound training. The EchoMark/EchoSure System is a two-part system comprised of a bioresorbable implant, EchoMark, and a diagnostic ultrasound imaging platform, EchoSure. EchoSure was designed to enable any healthcare personnel in a dialysis clinic setting to obtain non-invasive, direct measurements of flow and vessel parameters that are critical quantifications used in the assessment of AVF maturation and readiness for hemodialysis cannulation. In this pilot feasibility study, we sought to explore whether use of an automated 3DUS could enable fistula assessment by non-experts and obtain measurement accuracy comparable to expert sonographer Duplex. This was a 20 subject prospective multicenter trial conducted at four sites in the United States. All subjects had an EchoMark implanted under their AVF during the fistula creation procedure. Subjects were evaluated at 2-weeks post-op with EchoSure and Duplex, followed by monthly assessments until either the 4-month visit or until radiographic maturation was achieved, whichever was longer. Beyond monthly ultrasound assessments, clinical follow-up continued every 6 months between months 6 and 24. Technical success of EchoMark implantation was demonstrated in 100% of subjects. Technical success of EchoSure was 99% across all scans. The mean percent difference in flow rate measurements between EchoSure and Duplex was -9.2% with a standard deviation of 38.1% compared to a mean percent difference of -15.7% with a standard deviation of 35.5% between Duplex measurements taken at the cannulation zone and brachial artery. Pearson correlation between EchoSure and Duplex was 0.708 versus 0.716 for the two Duplex measurements. Radiographic maturation was achieved in 70% of study subjects by 30 days and continued to rise to 90% through 90 days and 95% through 180 days after baseline. This study demonstrates the feasibility and accuracy of an automated 3D ultrasound system for assessment of maturation at the dialysis bedside by non sonographers.

Effects of orthokeratology and spectacle lenses with highly aspherical lenslets on unilateral myopic anisometropia control.

To evaluate the 1-year effects of orthokeratology (OK) lenses and spectacle lenses with highly aspherical lenslets (HALs) on axial length (AL) elongation in children with unilateral myopic anisometropia. This ambispective cohort study recruited 81 children aged 8-14 years with unilateral myopic anisometropia. Of these, 42 participants (mean age 11.07 ± 1.54 years; 23 males) were treated with monocular OK lenses (OK group), and 39 (mean age 10.64 ± 1.72 years; 22 males) with binocular HALs (HAL group). Changes in AL and spherical equivalent refraction (SER) from baseline at 3, 6 and 12 months were compared between eyes and groups. Kaplan-Meier estimation and Cox proportional hazard regression were performed to analyse the risk of myopia onset in the initially non-myopic eyes. Mean axial elongation in the myopic and non-myopic eyes at the 12-month follow-up visit were 0.17 ± 0.20 and 0.41 ± 0.26 mm in the OK group (p < 0.001) and 0.10 ± 0.15 and 0.12 ± 0.12 mm in the HAL group (p = 0.32), respectively. Compared with the OK group, the non-myopic eyes in the HAL group had less axial elongation, lower cumulative myopia incidence and percentage of participants with rapid myopic shift at the 6- and 12 month follow-up (all p < 0.05). Cox regression analysis showed that a higher initial SER decreased the risk of myopia onset significantly in the initially non-myopic eyes (B = -2.06; 95% CI, 0.03-0.49; p = 0.003). Monocular OK lenses suppressed axial elongation in the myopic eye and minimised anisometropia; however, the non-treated contralateral eye may experience faster myopia onset and myopic shift. Binocular HALs can effectively reduce axial elongation in both eyes of children with unilateral myopic anisometropia.

Marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser melted cobalt chromium bar: a randomized clinical trial

BackgroundTo assess marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser-melted cobalt chromium (Co-Cr) bars.MethodThis research was set to be a parallel, triple-blinded, randomised controlled trial. Twenty completely edentulous patients received new conventional complete dentures according to conventional techniques. Two implants were placed at mandibular canine areas bilaterally, and patients were randomly allocated into two equal groups: the milled Co-Cr bar group and the selective laser melted (SLM) Co-Cr bar group. Marginal bone loss (MBL), modified plaque index (mPI), modified gingival index (mGI), and probing depth (PD) were evaluated at 0-month (baseline), 6-month, and 12-month follow-up visits. Repeated measures ANOVA test and Bonferroni’s post-hoc test were used for parametric data as PD, while for non-parametric data as MBL, mGI, and mPI, Mann-Whitney U test and Friedman’s test were used. A P-value ≤ 0.05 was set as the statistical level of significance. The study protocol was approved by the Faculty Research Ethics Committee at Minia University (636 4/10/2022). Registration for the clinical trial was made retrospectively on clinicaltrials.gov with ID NCT06401200 at 04/30/2024.ResultsThe follow-up period (one year) was completed without a dropout. Regarding MBL, no statistically significant difference was found between the two groups throughout the study. However, the milled group showed significantly increased MBL from 0- to 6-month follow up period. In both groups, mPI increased significantly from 0- to 6-months post-loading. On the other hand, no statistically significant difference between the two groups was found regarding mPI and mGI throughout the study follow-up periods. The PD was significantly lower in the milled compared to the SLM group at the 6- and 12-month follow up period.ConclusionTwo-implant mandibular overdenture retained with milled or SLM Co-Cr bar can provide an acceptable treatment option for completely edentulous patients regarding marginal bone loss and soft tissue outcomes.

Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence

PurposeThe region of growth (ROG) of geographic atrophy (GA) throughout the macular area has an impact on visual outcomes. Here, we developed multiple deep learning (DL) models to predict the 1-year ROG of GA lesions using fundus autofluorescence (FAF) images. DesignIn this retrospective analysis, 3 types of models were developed using FAF images collected 6 months after baseline to predict the GA lesion area (segmented lesion mask) at 1.5 years, FAF images collected at baseline and 6 months to predict the GA lesion at 1.5 years, and FAF images collected 6 months after baseline to predict the GA lesion at 1 and 1.5 years. The 1-year ROG from the 6-month visit was derived by taking the difference between the GA lesion area (segmented lesion mask) at the 1.5-year and 6-month visits. ParticipantsPatients enrolled in the following lampalizumab clinical trials and prospective observational studies: NCT02247479, NCT02247531, NCT02479386, and NCT02399072. MethodsDatasets of study eyes from 597 patients were split into model training (310), validation (78), and test sets (209), stratified by baseline or initial lesion area, lesion growth rate, foveal involvement, and focality. DL experiments were performed using the 2-dimensional U-Net, whole-lesion and multiclass models were developed. Main Outcome MeasuresThe performance of the models was evaluated by calculating the Dice score, coefficient of determination (R2), and the squared Pearson correlation coefficient (r2) between the true and derived GA lesion 1-year ROG. ResultsThe model using baseline and 6-month FAF images to predict GA lesion enlargement at 1.5 years had the best performance for the derived 1-year ROG. Mean Dice scores were 0.73, 0.68, and 0.70, respectively, in the training, validation, and test sets. The R2 (0.77, 0.53, and 0.79) and r2 (0.83, 0.61, and 0.79) showed similar trends across the 3 sets. ConclusionsThese findings show the potential of using baseline and/or 6-month visit FAF images to predict 1-year GA ROG using a DL approach. This work could potentially help support decision making in clinical trials and more informed treatment decisions in clinical practice.

Curcumin extract improves beta cell functions in obese patients with type 2 diabetes: a randomized controlled trial

BackgroundType 2 diabetes mellitus (T2DM) is a chronic condition characterized by insulin resistance and impaired insulin production, leading to elevated blood glucose levels. Curcumin, a polyphenolic compound from Curcuma longa, has shown potential in improving insulin sensitivity and reducing blood glucose levels, which may help mitigate type 2 diabetes progression.ObjectiveTo assess the efficacy of improving type 2 diabetes (T2DM).Study designThis randomized, double-blind, placebo-controlled trial included subjects (n = 272) with criteria for type 2 diabetes.MethodsAll subjects were randomly assigned to receive curcumin (1500 mg/day) or placebo with blind labels for 12 months. To assess the improvement of T2DM after curcumin treatments body weight and body mass index, fasting plasma glucose, glycosylated hemoglobin A1c, β-cell function (homeostasis model assessment [HOMA-β]), insulin resistance (HOMA-IR), insulin, adiponectin, and leptin were monitored at the baseline and at 3-, 6-, 9-, and 12-month visits during the course of intervention.ResultsAfter 12 months of treatment, the curcumin-treated group showed a significant decrease in fasting blood glucose (115.49 vs.130.71; P < 0.05), HbA1c (6.12 vs. 6.47; P < 0.05). In addition, the curcumin-treated group showed a better overall function of β-cells, with higher HOMA-β (136.20 vs. 105.19; P < 0.01) The curcumin-treated group showed a lower level of HOMA-IR (4.86 vs. 6.04; P < 0.001) and higher adiponectin (14.51 vs. 10.36; P < 0.001) when compared to the placebo group. The curcumin-treated group also showed a lower level of leptin (9.42 vs. 20.66; P < 0.001). Additionally, body mass index was lowered (25.9 4 vs.29.34), with a P value of 0.001.ConclusionsA 12-month curcumin intervention in type 2 diabetes patients shows a significant glucose-lowering effect. Curcumin treatment appeared to improve the overall function of β-cells and reduce both insulin resistance and body weight, with very minor adverse effects. Curcumin intervention in obese patients with type 2 diabetes may be beneficial.Trial registrationThai clinical trials regentrify no.20140303003.

Association between ethnicity and emergency department visits in the last three months of life in England: a retrospective population-based study using electronic health records

IntroductionEmergency department (ED) visits are distressing yet common in the last months of life and many could be avoided. The association between ethnicity and ED visits in the last months...

Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial.

Peer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa. The Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025). Ten TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence. We screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred. Peer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.

Utility of pan-immune-inflammation value as a predictor of the prognosis of childhood lupus.

Systemic lupus erythematosus (SLE) is a chronic inflammatory multisystemic disease. Monitoring disease activity thoughtout the disease course is important for effective management and assessment of disease outcome. To assess whether the pan-immune inflammation value (PIIV) at diagnosis could predict organ involvement and disease activity in childhood SLE (cSLE) patients after 12months of disease onst. This is an observational retrospective multicenter study that comprised cSLE patients seen and followed at the participating centers between January 2010 and December 2022. All patients met the EULAR/ACR-19 criteria, were immunosuppressive drug-naïve at the time of SLE diagnosis and had a minimal follow-up period of 12months. The data included clinical and laboratory findings and disease activity using the SLEDAI-2K. Receiver operating characteristic (ROC) curves were employed to determine the optimal cut-off value of PIIV and assess its predictive potential for disease activity, and organ involvement. A total of 125 patients (104 female) with a median age of 16.0 (IQR 5.6) years, a median age at disease onset of 10.9 (IQR 3.0) years, and a median disease duration of 4.8 (IQR 5.3) years were included. The most frequent involved organs at diagnosis were hematological (89.6%), musculoskeletal (68.8%), mucocutaneous (63.2%), and renal (58.4%). However, at a 12-month follow-up visit, the most frequent involved organs were renal (40.0%), hematological (39.2%), musculoskeletal (15.2%), and mucocutaneous (10.4%). The median PIIV at diagnosis was 139 (IQR 229.6), while the median SLEDAI was 12 (IQR 6.5) and 3.5 (IQR 7.0) at diagnosis and 12months, respectively. An optimal PIIV cut-off of 250 was found to be a predicative for disease activity, with a sensitivity of 45% and a specificity of 86%. The study revealed that the PIIV successfully predicted four systems in our cohort of patients. Our work suggests the PIIV might be a reasonable predictor for organ involvement and disease activity in newly diagnosed cSLE, though further research, particularly larger studies, is required to validate these findings, especially regarding organ involvement.