6-month Visit Research Articles

A randomized controlled trial of the dissemination of an mHealth intervention for improving health outcomes: the WiseApp for Spanish-speakers living with HIV study protocol

BackgroundWhile there is no cure for HIV, adherence to antiretroviral therapy can extend the lifespan and improve the quality of life of people with HIV. Despite the global reduction of HIV infection rates in recent years, New York City and La Romana, Dominican Republic, continue to report high infection rates among Latino populations. Many people with HIV remain virally unsuppressed in these geographic hotspots, suggesting a need for additional interventions to overcome medication adherence barriers. Tailored and culturally appropriate mobile health (mHealth) technology can be an engaging way to improve adherence. The primary objective of this trial is to test the effectiveness of an mHealth tool to improve HIV medication adherence among Spanish-speaking people living in New York City and the Dominican Republic.MethodsThe WiseApp study is a two-arm randomized controlled trial among 248 people with HIV across the New York and Dominican Republic sites over the course of 12 months. Participants are randomly assigned to either receive a CleverCap pill bottle that is linked to the WiseApp (intervention) or standard of care (control). All participants complete surveys at baseline, 3-month, 6-month, and 12-month follow-up visits and the study team obtains HIV-1 viral load and CD4 count results through blood draw at each study timepoint.DiscussionThe use of mHealth technologies to improve medication adherence among people with HIV has been implemented in recent years. Although some studies have found improvement in adherence to antiretroviral therapy in the short term, there is limited information about how these interventions improve adherence among Spanish-speaking populations. Disproportionate rates of HIV infection among Latinos in New York City suggest an existing inequitable approach in reaching and treating this population. Due to a lack of mHealth studies with Latino populations, and apps tailored to Spanish-speakers, the WiseApp study will not only demonstrate the effectiveness of this particular mHealth app but will also contribute to the mHealth research community as a whole.Trial registrationThis trial was registered with Clinicaltrials.gov (NCT05398185) on 5/31/2022.

A Mobile Health Application Integrated in the Electronic Health Record for Rheumatoid Arthritis Patient-Reported Outcomes: A Controlled Interrupted Time-Series Analysis of Impact on Visit Efficiency.

Patient-reported outcome (PRO) collection between visits for rheumatoid arthritis (RA) could improve visit efficiency, reducing in-person visits for patients with stable symptoms while facilitating access for those with symptoms. We examined whether a mobile health PRO application integrated in the electronic health record (EHR) could reduce visit volume for those with RA. We developed an application for RA that prompted patients every other day to complete brief PRO questionnaires. Results of the application were integrated into the EHR. We tested the application in a controlled interrupted time-series analysis between 2020 and 2023. Rheumatologists received EHR-based messages based on PRO results recommending the patient receive a visit earlier or later than scheduled. The primary outcome was monthly visit volume during the year before versus the year after initiation. A total of 150 patients with RA consented and used the application. The median age was 62 years, 83% were female, 7% had fewer than 2 years of disease, and 50% were seropositive; 150 controls were well matched. Among those in the application cohort, the estimated monthly median visit volume in the year before use of the application was 31.2 (95% confidence interval [95% CI] 28.0-34.3); in controls, this was 30.4 (95% CI 27.3-33.6). In the year using the application, the estimated monthly visit volume was 36.8 (95% CI 33.4-40.3) compared to 38.7 (95% CI 35.2-42.3) in controls. The difference in the differences between the cohorts was not statistically significant (-2.7 visits, 95% CI -9.3 to 4.0). No differences were noted in flare rates or visit delays. In this initial trial of a PRO application intervention to improve visit efficiency, we found no association with reduced visit volume.

Exploring the impact of mild-to-moderate foraminal stenosis at L5−S1 on clinical outcomes following L4−5 posterior lumbar interbody fusion

BACKGROUND CONTEXTPatients scheduled for L4−5 PLIF often have FS at L5-S1. However, data on the clinical and radiographic outcomes of cases with mild-to-moderate L5−S1 FS are lacking, which may affect clinical outcomes or require additional surgery after L4−5 fusion. PURPOSETo evaluate the clinical and radiographic outcomes of L4−5 PLIF in patients with and without mild-to-moderate L5−S1 FS, with a primary focus on the association between L5−S1 FS and postoperative clinical outcomes including back pain, leg pain, and scores on the oswestry disability index (ODI) and EuroQol 5-dimension (EQ-5D). STUDY DESIGNRetrospective comparative study. PATIENT SAMPLEA retrospective review of patients who underwent L4−5 PLIF from 2014 to 2018. The patients were divided according to the presence of mild-to-moderate FS at L5−S1. OUTCOME MEASURESClinical assessment included the pain visual analog scale (VAS), ODI, and EQ-5D score. Radiographic assessments included spinopelvic parameters and grades for central and foraminal stenosis. METHODSClinical outcomes were assessed using validated outcome measures at preoperative, 6-month, 12-month, and 36-month follow-up visits. Radiographic evaluations were performed using preoperative and postoperative radiographs. Foraminal stenosis was assessed qualitatively using MRI with a grading system from none to severe and quantitatively by measuring changes in the foraminal area on CT. RESULTSAmong 186 patients, 55 were categorized as the FS group and 131 as the non-FS group. The FS group was older (p=0.039) and had more severe central stenosis at L5−S1 (p=0.007) as well as more severe FS at both L4−5 and L5−S1 (both p<0.001). Preoperative disc height (p<0.001), C7-S1 sagittal vertical axis (p=0.003), lumbar lordosis (p=0.005), and pelvic incidence–lumbar lordosis mismatch (p=0.026) were more aggravated in the FS group. The FS group showed inferior clinical outcomes at the final follow-up in terms of back pain (p=.010) and ODI score (p=.003). CONCLUSIONThe presence of mild-to-moderate FS at L5–S1 was associated with more aggravated sagittal balance in terms of smaller preoperative disc height, larger sagittal vertical axis, smaller lumbar lordosis, and larger pelvic incidence–lumbar lordosis mismatch. Patients with L5−S1 FS also had poorer clinical outcomes including back pain and ODI score after L4−5 PLIF. Patients with L5−S1 FS need to be carefully examined before L4−5 fusion considering their adverse outcomes due to underlying degenerative changes.

Unilateral Syphilitic Optic Neuritis without Uveitis

This report describes a case of case of unilateral syphilitic optic neuritis without uveitis. A 56-year-old man presented with complaints of four days history of decreasing vision in his left eye. At the initial visit, the patient’s best corrected visual acuity was 1.2 and 0.03 in the right and left eye, respectively. A relative afferent pupillary defect was observed in the left eye. Slit-lamp examination revealed no cells, flare or keratic precipitates in the anterior segment either eye. Fundoscopy revealed diffuse optic disc swelling with peripapillary hemorrhage in the left eye. Goldmann visual field testing identified central absolute scotoma and an enlarged blind spot in the left eye. On serological evaluation for syphilis, serum rapid plasma reagin (RPR) and treponema pallidum hemagglutination assay (TPHA) were positive (RPR 52.5, TPHA 740.0). In addition, IgM fluorescent Treponemal antibody absorbance (FTA-ABS) was positive. In contrast, cerebrospinal fluid showed negative RPR and positive TPHA (TPHA 11.8). Cerebrospinal fluid (CSF) analysis showed lymphocytic pleocytosis and increased protein content and glucose. Magnetic resonance imaging showed a swollen enhanced lesion in the left optic nerve. The patient was diagnosed with syphilitic optic neuritis and received the currently recommended treatment with intravenous penicillin G (PCG). Twenty-four million units per day of PCG were administered for 2 weeks. After 2 weeks of therapy, his left visual acuity improved to 0.3 in 2 months. However, the optic disc looked diffusely pale in the left eye. At 6-month visit, the patient was clinically stable. RPR turned out negative and there was a reduction in serological TPHA reactivity. We consider that it is essential to perform serological tests for syphilis in every patient with optic neuritis, which makes it possible to initially treat syphilitic optic neuritis with PCG.

Mediation analysis of chronic kidney disease risk factors using kidney biomarkers in women living with HIV.

Novel urinary biomarkers reflecting kidney tubule health are associated with chronic kidney disease (CKD) risk in persons living with HIV. However, it is unknown whether these biomarkers provide mechanistic insight into the associations between clinical risk factors for CKD and subsequent CKD risk. Among 636 women living with HIV in the Women's Interagency HIV Study with estimated glomerular filtration rate (eGFR) >60 ml/min/1.73 m 2 , we used a counterfactual approach to causal mediation analysis to evaluate the extent to which systolic blood pressure (SBP), diastolic blood pressure (DBP), hemoglobin a1c (Hba1c) and serum albumin associations with incident CKD were mediated by eight urine proteins. These biomarkers reflect proximal tubular reabsorptive dysfunction (α1-microglobulin [a1m], β2-microglobulin, trefoil factor 3); tubular injury (interleukin 18 [IL-18], kidney injury molecule 1 [KIM-1]); kidney repair (epidermal growth factor); tubular reserve (uromodulin); and glomerular injury (urinary albumin). Incident CKD was defined as eGFR <60 ml/min/1.73 m 2 measured at two consecutive 6-month visits with an average annual eGFR decline ≥3% per year. During a median follow-up of 7 years, 11% developed CKD. Urinary albumin and KIM-1 mediated 32% (95% CI: 13.4%, 76.6%) and 23% (6.9%, 60.7%) of the association between SBP and incident CKD, respectively; and 19% (5.1%, 42.3%) and 22% (8.1%, 45.7%) of the association between DBP and incident CKD, respectively. Urinary albumin, α1m, and IL-18 were significant mediators of the association between Hba1c and incident CKD. None of the eight biomarkers mediated the association between serum albumin and incident CKD. Among women living with HIV, several urinary biomarkers reflecting distinct dimensions of kidney health may partially explain the associations between SBP, DBP, and Hba1c and subsequent CKD risk.

Insights into the pattern of choroidal vascularity index changes in idiopathic macular hole

This retrospective study aimed to investigate the changes in choroidal vascularity index (CVI) before and after surgery for idiopathic macular hole (MH). Enhanced depth imaging optical coherence tomography (EDI-OCT) images were analyzed at baseline and at 1-week, 1-month, and 3-month postoperative visits. A total of 97 patients (97 eyes) were included in the study. At baseline, overall CVI and macular CVI showed negative correlation with axial length (AL) and positive correlation with central corneal thickness (CCT). There were no significant differences in macular CVI or overall CVI between affected and healthy eyes, as well as in subgroup analysis of different stages of macular CVI. Following surgery, there was a significant decrease in CVI at 1 week postoperatively, followed by a gradual recovery to baseline levels over time. The observed changes in CVI may be attributed to factors such as air tamponade, pressure changes, and photoreceptor metabolism. This study provides insights into the pattern of CVI changes associated with MH surgery. The findings suggest that stage 4 MH is associated with decreased macular CVI in affected eyes. These results contribute to a better understanding of the effects of surgery on choroidal blood flow in MH patients.

Prediction model for elevated intraocular pressure risk after silicone oil filling based on clinical features.

To evaluate risk factors and further develop prediction models for intraocular pressure elevation (IOP) after vitreoretinal surgery with silicone oil tamponade to support clinical management. A retrospective study analyzed 1,061 eyes of 1,061 consecutive patients that presented to the Jiangsu Province Hospital between December 2015 and December 2020, the IOP was measured from the preoperative visit and at the 1-week, 1-month, 3-month, and 6-month visits, and the final postoperative visit before silicone oil removal. Four machine learning methods were used to carried out the prediction of IOP elevation: Decision Tree, Logistic Regression, Random Forest, and Gradient-Boosted Decision Trees (GBDT) based on features including demographic and clinical characteristics, preoperative factors and surgical factors. Predictors were selected based on the p-value of the univariate analysis. Elevated intraocular pressure developed in 26.01% of the eyes postoperatively. Elevated intraocular pressure primarily occurred within 1-2 weeks after surgery. Additionally, the majority of IOP values were distributed around 25-40 mmHg. GBDT utilizing features with p-values less than 0.5 from the hypothesis testing demonstrated the best predictive performance for 0.7944 in accuracy. The analysis revealed that age, sex, hypertension, diabetes, myopia, retinal detachment, lens status and biological parameters have predictive value. Age, sex, hypertension, diabetes, myopia, retinal detachment, lens status and biological parameters have influence on postoperative intraocular pressure elevation for patients with silicone oil tamponade after pars plana vitrectomy. The prediction model showed promising accuracy for the occurrence of IOP elevation. This may have some reference significance for reducing the incidence of high intraocular pressure after pars plana vitrectomy combined with silicone oil filling.

Short-Term Metabolic Changes and Their Physiological Mediators in the Roux-en-Y Gastric Bypass Bariatric Surgery

BackgroundThe Roux-en-Y gastric bypass (RYGB) is a common bariatric surgery to treat obesity. Its metabolic consequences are favourable and long-term clinical corollaries beneficial. However, detailed assessments of various affected metabolic pathways and their mediating physiological factors are scarce.MethodsWe performed a clinical study with 30 RYGB patients in preoperative and 6-month postoperative visits. NMR metabolomics was applied to profiling of systemic metabolism via 80 molecular traits, representing core cardiometabolic pathways. Glucose, glycated haemoglobin (HbA1c), insulin, and apolipoprotein B-48 were measured with standard assays. Logistic regression models of the surgery effect were used for each metabolic measure and assessed individually for multiple mediating physiological factors.ResultsChanges in insulin concentrations reflected those of BMI with robust decreases due to the surgery. Six months after the surgery, triglycerides, remnant cholesterol, and apolipoprotein B-100 were decreased −24%, −18%, and −14%, respectively. Lactate and glycoprotein acetyls, a systemic inflammation biomarker, decreased −16% and −9%, respectively. The concentrations of branched-chain (BCAA; leucine, isoleucine, and valine) and aromatic (phenylalanine and tyrosine) amino acids decreased after the surgery between −17% for tyrosine and −23% for leucine. Except for the most prominent metabolic changes observed for the BCAAs, all changes were almost completely mediated by weight change and insulin. Glucose and type 2 diabetes had clearly weaker effects on the metabolic changes.ConclusionsThe comprehensive metabolic analyses indicate that weight loss and improved insulin sensitivity during the 6 months after the RYGB surgery are the key physiological outcomes mediating the short-term advantageous metabolic effects of RYGB.The clinical study was registered at ClinicalTrials.gov as NCT01330251.Graphical

European Unmet Needs in the Management of Neovascular Age-Related Macular Degeneration in Daily Practice: Data from the Fight Retinal Blindness! Registry

PurposeTo evaluate the proportion, predictors and outcomes of neovascular age-related macular degeneration (nAMD) patients treated with a high burden of vascular endothelial growth factor (VEGF) inhibitor injections (IVT) after two years in routine clinical practice. DesignRetrospective analysis of data from a prospectively designed observational outcomes registry, Fight Retinal Blindness! project, of patients treated in European centers. ParticipantsTreatment-naïve eyes (one eye per patient) starting VEGF inhibitors for nAMD from January 2017 to March 2020 with 24 months of follow-up. We analyzed three treatment burden groups defined by the mean interval of the three closest injections to the 24-month visit: (1) those with a high treatment burden had injection intervals ≤ 42 days, (2) those with a low treatment burden had injection intervals between 43 and 83 days and those with tolerable treatment burden had injection intervals between 84 and 365 days. MethodsMultinomial regression was used to evaluate baseline risk predictors of patients requiring a high treatment burden. Main Outcome MeasuresThe proportion of patients that experienced a high treatment burden at 2 years and its predictors. ResultsWe identified 2,038 eligible patients completing 2 years of treatment (2038/3943 patients [60%]) with a median (Q1, Q3) of 13 (10, 17) injections. The proportion of patients with a high treatment burden was 25% (516 patients) at 2 years. Younger patients (Odds ratio (OR), 0.97; 95%CI, 0.96-0.99; P<0.01) were more likely to have high treatment burden, while eyes with type 3 CNV at baseline were significantly less likely (OR, 0.26; 95%CI, 0.13-0.52; P<0.01). Regarding type of fluid, patients with subretinal fluid only at baseline (OR, 3.85; 95%CI, 1.34-11.01; P=0.01) and persistent active intraretinal (OR, 1.56; 95%CI, 1.18-2.06; P<0.01) or subretinal fluid only (OR, 2.21; 95%CI, 1.52-3.21; P<0.01) after the loading phase had a higher risk of high treatment burden at 2 years. ConclusionsHigh treatment burden is common issue in routine clinical practice in Europe, with a quarter of patients requiring injections of conventional VEGF inhibitors every 6 weeks at 2 years and 40 percent discontinuing treatment within 2 years.

Implementation and Outcomes of a Pilot Collaborative Surgical Hydrocele Training in Côte d'Ivoire.

Lymphatic filariasis (LF) is a neglected tropical disease that can cause hydrocele and its associated stigma, loss of economic productivity, and depression. Hydrocele surgery is an essential part of LF morbidity management but can be difficult for national programs to implement. To improve access to hydrocele surgeries in Côte d'Ivoire, we provided a WHO-certified surgical training for six surgical teams from five health districts in Côte d'Ivoire. We then evaluated the surgical outcomes and assessed the impact of hydrocele surgery on quality of life of hydrocelectomy patients. Preoperative and operative records were reviewed to describe baseline hydrocele characteristics and operative details. Postoperative interviews were conducted 4 to 6 months after surgical correction using a standardized questionnaire. Seventeen men underwent surgery during the training and were available for an interview at the 6-month visit. At the time of 6-month follow-up, 11/17 (64.7%) reported improvement in activities of daily living and reduction in difficulties with work, 8/17 (47.1%) reported an improved economic situation, 15/17 (88.2%) reported improved social interactions, and 15/16 (93.8%) reported improved sex life after surgical correction. Three patients (17.6%) had minor postoperative complications, but none required hospitalization. All 17 patients who were available for an interview were satisfied with their surgery. Surgical hydrocelectomy training in Côte d'Ivoire was well received and provided life-altering health improvements for participating patients across multiple domains of life. Support to scale up surgical capacity for this neglected problem is needed.

Pelvic floor function after third and fourth degree perineal lacerations: a case-control study on quality of life

BackgroundThe primary aim of this study was to compare the quality of life between women with obstetric anal sphincter injury (OASI) and women with intact perineum or minor vaginal tears following their first vaginal birth through a validated urogynaecological questionnaire. As a secondary aim, we wanted to identify the specific symptoms for pelvic floor dysfunction after a vaginal birth.MethodsOne hundred thirty-three cases (III- and IV-degree vaginal tears) and 133 controls (intact perineum or I- and II-degree vaginal tear) were asked to fill the PFDI-20 condition-specific and quality of life survey at three and 12 months after vaginal delivery. The survey evaluates pelvic floor dysfunction symptoms through three subsections: the Pelvic Organ Prolapse Distress Inventory (POPDI), the Colorectal-Anal Distress Inventory (CRADI), and Urinary Distress Inventory, (UDI). The scoring system ranges from 0 (no distress) to 100 (maximum distress) for each subsection, subsequently summed up to obtain the summary score (0 to 300). The patients recruited were asked to complete the survey at 3- and 12-months follow-up visit. Accordingly, data collection started. Categorical variables were subjected to Chi-square test or Fisher’s Exact test. Quantitative variables were compared through Student’s t-test or Mann-Whitney test.ResultsAll surveys have shown statistically significant differences when comparing the cases to the control group. Consequently, PFDI-20 has shown a strong correlation between III- and IV-grade lacerations and pelvic floor dysfunction persistence at 12 months after delivery. Intestinal symptoms were the most reported disturbances among women with previous OASI.ConclusionsMajor vaginal tears have demonstrated to have a strong impact on women’s quality of life up to a follow-up of 12 months. The use of PFDI-20 questionnaire is a useful and valid tool in the diagnosis and follow-up of genital prolapse, fecal and urinary incontinence in primiparous women with a history of OASI. Thus, its application in clinical practice can help offering the most adequate rehabilitative treatment.

Clinical and pathological characteristics and prognosis analysis of gray zone lymphoma

To explore the clinical and pathological characteristics as well as therapies and prognosis of gray zone lymphoma (GZL). The clinical data of 10 GZL patients admitted to the First Affiliated Hospital of Soochow University from December 2016 to December 2022 were retrospectively collected. The clinical and pathological characteristics, therapies and prognosis were analyzed. The cut-off time for follow-up visits was December 31, 2022, and the median time for follow-up visits [M(Q1, Q3)] was 40.0 (28.3, 59.8) months. Treatment efficacy was divided into complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD). There were 6 males and 4 females, with a median age [M(Q1, Q3)] of 33.5 (27.3-39.5) years. Among them, 8 patients had mediastinal (thymus) involvement and 7 patients were accompanied with extranodal involvement. According to Ann Arbor staging, 1 case was in the limited stage and 9 cases were in the progressive stage. The immunophenotypes of 4 patients were strong expression of CD20, expression of CD30, and no expression of CD15. The immunophenotypes of 6 patients were unequal expression of CD20 and strong expression of CD30 and CD15. One patient received classical hodgkin lymphoma(cHL)-like immunochemotherapy and only achieved PR, and then received enhanced diffuse large b-cell lymphoma (DLBCL)-like immunochemotherapy to achieve CR. Five patients received enhanced DLBCL-like immunochemotherapy for induction therapy and achieved CR. All 4 patients who did not achieve CR achieved CR after receiving second-line or third-line salvage therapy. All patients were given autologous stem cell transplantation (ASCT) for consolidation therapy. One patient relapsed and died during the follow-up visit in the 33rd month, and the remaining patients currently maintained a state of sustained remission. It is found that GZL mostly occurs in young patients, mediastinal involvement is common, and diagnosis relies on pathological morphology and immunophenotype. GZL may be more sensitive to DLBCL-like intensive immune regimens. Sequential ASCT for consolidation can reduce the risk of relapse.

Racial Disparities in Telemedicine Uptake during the COVID-19 Pandemic among Patients with Hematologic Malignancies in the United States

Background: The COVID-19 pandemic impacted healthcare visit trends, transitioning care to utilize telemedicine. We aimed to investigate if the uptake in telemedicine during pandemic was equitable across racial groups for patients with hematologic malignancies. Methods: Using the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database we analyzed patients with diagnosis of acute myelogenous leukemia (AML), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) or multiple myeloma (MM). Patients were categorized into treatment types within lines of therapy: outpatient (oral therapy and outpatient infusions combined with oral therapy) vs. inpatient treatments (chemotherapy, cellular therapy). Monthly visit rates were calculated as the number of visits (telemedicine or in-person [in-clinic treatment administration, vitals, and/or labs]) per active patient per 30-day standardized month. We used time-series forecasting methods on pre-pandemic monthly visit rate data (March 2016 - February 2020) to estimate projected counterfactual monthly visit rates between March 2020 - February 2021.Telemedicine uptake was descriptively analyzed over time (t). Results: We included 18,924 active patients (2,394 Black and 16,530 White) and 884,504 visits (117,673 Black and 766,831 White). 4,053 AML, 3,468 diffuse large B cell lymphoma, 1,943 follicular lymphoma, 2,151 mantle cell lymphoma, 5,926 chronic lymphocytic leukemia and 7,752 myeloma patients. Black patients had no significant reductions in in-person visit rates throughout the pandemic period compared to the projected rates. Conversely, White patients experienced an 18% (95% PI 9.9% - 25%) lower rate of in-person visits for outpatient therapy during the early pandemic (March - May 2020) (actual monthly visit rate 1.61; projected visit rate 2.0 [95% CI 1.8-2.2]). Telemedicine uptake was significantly higher for White patients compared with Black patients for all diseases and treatment categories between March 2020-February 2021 (t = 9.5, p &lt; 0.01), AML inpatient (t = 2.4, p = 0.04), MM outpatient (Figure 3C) (t = 6.0, p &lt; 0.01) and MM inpatient treatment categories (Figure 3D) (t = 2.3, p = 0.04). Conclusions: White patients had significantly higher telemedicine uptake compared with Black patients for all treatment categories. These findings challenge healthcare systems to direct efforts toward reducing the gap in healthcare access.

Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study).

We investigated the effects of testosterone replacement therapy (TRT) on the Fibrosis-4 (FIB-4) index among hypogonadal patients who were extracted from a randomized controlled study in Japan (the EARTH study). Data of 186 patients (88 in the TRT group; 98 in the control group) were collected. The patients in the TRT group received intramuscular administration of testosterone enanthate (250 mg) every 4 weeks for 12 months. The patients' background information such as current medical history and lifestyle habits were collected. Waist circumference, body mass index, and body fat volume were measured at baseline and 12-month visit. Fasting blood sugar (FBS), hemoglobin A1c, total cholesterol, triglyceride (TG), and high-density lipoprotein cholesterol levels were collected at baseline and 12-month visit. The FIB-4 index was calculated according to age, aspartate aminotransferase, alanine transaminase, and platelet count. Except for serum FBS values, most of baseline characteristics were comparable between the TRT and control groups. When comparing the changes of each variable from baseline at 12-month visit in both groups, significant differences were found in waist circumference (p=0.00248), fat volume (p=0.00812), and platelet counts (p=0.0478), whereas a FIB-4 index did not change. On the contrary, in a subanalysis including only patients with a FIB-4 index ≥1.30 at baseline, a significant difference in a FIB-4 index (-0.10±0.39 vs. 0.04±0.44; p=0.0311) was observed with significant decreases in waist circumference, body fat volume, and TG levels, and an increase in platelet counts. The FIB-4 index was significantly decreased by TRT from 1.98±0.52 to 1.87±0.60 (p=0.0277). TRT for 12 months improved the FIB-4 index among hypogonadal men with a higher baseline FIB-4 index.

Corneal densitometry changes after femtosecond laser-assisted intracorneal ring segments implantation in keratoconus.

Intrastromal corneal ring segments are commonly implanted in the corneas of eyes with mild-to-moderate keratoconus; however, changes in corneal densitometry (CD) after implantation are a matter of debate in the current literature. We evaluated the changes in CD 1 and 3 months after femtosecond laser-assisted Keraring implantation. This retrospective, non-comparative, multicenter, case series study included patients with keratoconus who underwent femtosecond laser-assisted implantation of double segments with 90° and 160° arc lengths or two 160° arc length Keraring segments. Demographic and baseline clinical ophthalmic data were recorded. Corneal topography and tomography data acquired using a Pentacam HR Scheimpflug tomography system (Pentacam High Resolution; Oculus, Wetzlar, Germany) with a best-fit sphere were used as a reference surface. Using the Pentacam HR, CD measurements were acquired over a corneal area of 12 mm in total and at four concentric zones (0-2, 2-6, 6-10, and 10-12 mm) of three corneal stromal depths: 120 μm of the anterior corneal stromal layer, 60 μm of the posterior corneal stromal layer, and the central layer of stroma lying between these two layers. We included 40 eyes of 40 patients, including 8 (20%) male and 32 (80%) female individuals, with a mean (standard deviation) age of 21.0 (6.4) years. We observed a significant improvement in the topographic values of steep keratometry (K), flat K, maximum K, and corneal astigmatism (all P < 0.05), but not in the mean K, thinnest corneal pachymetry, corneal thickness at the apex, back elevation, or front elevation (all P > 0.05). The mean total anterior, central, and posterior CD differed significantly among the time points, with a significant increase from the preoperative to the 1-month and 3-month postoperative visits (all P < 0.05) and no difference between those of the 1-month and 3-month postoperative visits (all P > 0.05). The mean CD for the anterior layer in the central, paracentral, and mid-peripheral zones, and the central layer in all four zones, differed significantly among time points, with a significant increase from the preoperative to the 1-month and 3-month postoperative visits (all P < 0.05), which remained unchanged from the 1-month to the 3-month postoperative visit (all P < 0.05), except for the central 2-6-mm zone, which decreased significantly from the 1-month to the 3-month postoperative visit (P < 0.001). The CD of the central 10-12-mm zone did not differ significantly in each pairwise comparison (all P > 0.05). In contrast, CD for the posterior layer in the paracentral zone decreased significantly from the preoperative to the 1-month and 3-month postoperative visits but increased, to a lesser extent, from the 1-month to the 3-month postoperative visit (all P < 0.05). Femtosecond laser-assisted Keraring implantation significantly changes CD, with improvement in most topography parameters. Further longitudinal studies with larger sample sizes are required to verify these preliminary findings.

Anterior segment parameters after trabeculectomy in pseudoexfoliation glaucoma versus primary open-angle glaucoma.

The effects of trabeculectomy on anterior segment parameters have been widely investigated. However, the stabilization time for various glaucoma types after trabeculectomy remains debatable. We investigated the effect of mitomycin C-augmented trabeculectomy on ocular anterior segment parameters in primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PXG) during short-term follow-up using the Pentacam HR. In this retrospective observational study, consecutive patients diagnosed with medically uncontrolled POAG or PXG who underwent MMC-augmented trabeculectomy were recruited. All individuals underwent detailed ocular examinations. All trabeculectomies were performed by a single surgeon using the same technique. Anterior segment parameters, including anterior chamber depth (ACD), anterior chamber volume (ACV), anterior chamber angle (ACA), and central corneal thickness (CCT) were measured using the Pentacam HR, along with intraocular pressure (IOP) using a Goldmann applanation tonometer, pre-operatively and at 1-week, 1-month, and 3-month post-operative visits. We included 80 patients with a median (range) age of 58.0 (41.0-86.0) years having a nearly similar sex ratio. The study groups were matched according to sex and age (both P > 0.05). The group-by-time interaction was significant for CCT and ACV (both P < 0.05) but not for IOP, ACD, and ACA (all P > 0.05). The mean (standard deviation [SD]) IOP, ACD, and ACA were comparable between groups (all P > 0.05) during the 3-month period; however, they changed significantly over time in both groups (all P < 0.001). The mean CCT and ACV were comparable between groups at each time point (all P > 0.05), except at the 1-month post-operative visit, at which the mean (SD) ACV was significantly lower in the PXG group (P < 0.05). We found a comparable mean (SD) CCT between paired visits in each group (all P > 0.05), except for the mean (SD) CCT at 3 months, which was significantly lower than that at the 1-month post-operative visit in the PXG group (P < 0.05). We found a comparable mean (SD) ACV between paired visits in each group (all P > 0.05); however, it was significantly lower at the 1-month post-operative versus the baseline visit in both groups and resumed a significantly higher value at the 1-month versus the 1-week visit and at the 3-month versus the 1-month visit in the PXG group (all P < 0.05). We observed significant changes in IOP, ACD, and ACA over 3 months after post-augmented trabeculectomy in eyes with POAG and PXG; however, the majority of anterior segment parameters were comparable between the two groups. Further large-scale studies with longer follow-up periods should be conducted to verify the post-operative fluctuations in these parameters in POAG and PXG.

Quality of life for androgen receptor targeted agents in patients with metastatic castration resistant prostate cancer.

Few studies have evaluated health-related quality of life (HRQoL) with abiraterone acetate plus prednisone (abiraterone) compared to enzalutamide in metastatic castration resistant prostate cancer (mCRPC). So, this study aimed to assess impact of abiraterone and enzalutamide on patients´ functioning in mCRPC real-world setting. In this 12-month, prospective, observational study, 36 mCRPC patients from Slovakia were included. Patients were treated with abiraterone or enzalutamide according to routine practice. HRQoL was assessed at baseline and 3-/6-/9-/12-month visits using the Functional Assessment of Cancer Therapy-Prostate (FACT‑P) and European Quality of Life 5 Dimensions (EQ-5D) questionnaires. Changes from baseline and occurrence of deteriorations/improvements were compared using two-sample t-test/Mann-Whitney test and Pearson's chi-square/Fisher's exact test, respectively. Mixed-effects model for repeated measures was used to evaluate the difference between the two arms in mean changes of quality of life after 12 months. Frequency of clinically meaningful deterioration of quality of life assessed by FACT-P was similar for abiraterone and enzalutamide: 0%, 14.3%, 23.1%, 16.7% vs. 10%, 26.3%, 22.2%, 40% at 3-, 6-, 9- and 12 months of therapy (p=0.496, 0.670, 1.000 and 0.236, respectively). After 12 months of treatment, no statistically significant difference between the treatment arms was observed in estimated mean changes in FACT-P total scores (p=0.620) and its components, EQ-5D index (p=0.108), and EQ-5D visual analogue scale (p=0.324). According to the results of this study, abiraterone and enzalutamide had acomparable impact on quality of life in chemo-naive mCRPC in routine practice (Tab. 4, Fig. 4, Ref. 23). Text in PDF www.elis.sk Keywords: quality of life, abiraterone, enzalutamide, castration resistant prostate cancer.

Effectiveness and safety of telitacicept for refractory generalized myasthenia gravis: a retrospective study.

Refractory generalized myasthenia gravis (GMG) remains a substantial therapeutic challenge. Telitacicept, a recombinant human B-lymphocyte stimulator receptor-antibody fusion protein, holds promise for interrupting the immunopathology of this condition. This study retrospectively assessed the effectiveness and safety of telitacicept in patients with refractory GMG. A single-center retrospective study. Patients with refractory GMG receiving telitacicept (160 mg/week or biweekly) from January to September in 2023 were included. We assessed effectiveness using Myasthenia Gravis Foundation of America post-intervention status (MGFA-PIS), myasthenia gravis treatment status and intensity (MGSTI), quantitative myasthenia gravis (QMG), and MG-activity of daily living (ADL) scores, alongside reductions in prednisone dosage at 3- and 6-month intervals. Safety profiles were also evaluated. Sixteen patients with MGFA class II-V refractory GMG were included, with eight females and eight males. All patients were followed up for at least 3 months, and 11 patients reached 6 months follow-up. At the 3-month evaluation, 75% (12/16) demonstrated clinical improvement with MGFA-PIS. One patient achieved pharmacological remission, two attained minimal manifestation status, and nine showed functional improvement; three remained unchanged, and one deteriorated. By the 6-month visit, 90.1% (10/11) sustained significant symptomatic improvement. MGSTI scores and prednisone dosages significantly reduced at both follow-ups (p < 0.05). MG-ADL and QMG scores showed marked improvement at 6 months (p < 0.05). The treatment was well tolerated, with no severe adverse events such as allergy or infection reported. Our exploratory investigation suggests that telitacicept is a feasible and well-tolerated add-on therapy for refractory GMG, offering valuable clinical evidence for this novel treatment option.

Insights into Visual Outcomes and Determinants in Pituitary Adenoma Surgery: A 5-Year Retrospective Cohort Study.

To investigate the long-term visual outcome and their determinants after an operation in Thai pituitary adenoma (PA). A retrospective cohort study was conducted on PA patients who underwent surgery at Rajavithi Hospital. Baseline characteristics and visual parameters, including visual acuity (VA) and visual field (VF), were analyzed in relation to the visual prognosis outcome. The outcome was defined as VA improvement at 1-year postoperatively. Visual parameters were measured at each follow-up visit and compared. Factors for improved visual prognosis were evaluated using logistic regression analysis. A total cohort of 87 patients (64.37% female), 62.07% showed improvement in visual outcome. Most improvement occurred immediately after surgery, evident at the 1-month visit. The mean follow-up time was 47.45 months (±28.49 SD), mean difference in VA improvement at 1-year was -0.56 logMAR (95% CI -0.73, -0.47). In multivariable logistic regression model, prolonged onset duration was associated with a reduced odds of improved visual outcome, with an odds ratio (OR) of 0.946 (95% CI 0.899-0.996, p = 0.034). Baseline characteristics, tumor volume, Hardy and Knops classification, and surgical approaches were not identified as significant predictors. Both TSS and transcranial approaches are effective for pituitary adenoma. A prompt operation is recommended for patients with prolonged onset duration, with thorough discussion on poor postoperative visual outcomes.

Factors Predicting Slow Visual Recovery Following Hyperopic LASIK.

To identify factors predicting slow visual recovery following hyperopic laser in situ keratomileusis (LASIK). The study included consecutive patients who underwent hyperopic LASIK between January 2005 and December 2019 at a single medical center. Patients were divided into two groups according to whether they experienced normal recovery of visual acuity (1-week visit) or slow visual recovery (1-month visit). Visual recovery was defined as achieving an efficacy index of 0.9 or greater. Efficacy index was calculated as postoperative uncorrected distance visual acuity / preoperative corrected distance visual acuity. A comparison of baseline and intraoperative parameters was performed. Binary logistic regression was performed to identify potential predictors of slow visual recovery. Overall, 861 eyes of 861 patients were included. Mean age was 48.0 ± 9.5 years and 55.9% were women. Two hundred forty-nine patients (28.9%) experienced slow visual recovery. Younger age (P = .01), a larger preoperative spherical equivalence (P = .002), and greater maximum ablation depth (P = .002) were predictors of slow visual recovery. In binary logistic regression, female gender (P = .036) and greater spherical equivalence (P = .007) remained significant predictors of slow visual recovery. Female gender and greater preoperative spherical equivalence were associated with slow visual recovery. Patients may be advised accordingly. [J Refract Surg. 2024;40(1):e42-e47.].