2-year Study Research Articles

Community-based epilepsy care in an onchocerciasis-endemic area: A 3-year cohort study in Mahenge, Tanzania.

In onchocerciasis-endemic areas, limited access to antiseizure medications (ASMs) contributes to a high epilepsy burden. This study evaluated the impact of a community-based epilepsy care program in Mahenge, Tanzania, an onchocerciasis-endemic area with high epilepsy prevalence. A baseline survey (2017-2018) identified persons with epilepsy (PWE) in four rural villages. Subsequently, PWE were invited to enroll in the epilepsy treatment program (2019-2022), where trained community health workers (CHWs) screened for epilepsy, promoted ivermectin intake to treat onchocerciasis, distributed ASMs, and monitored seizure frequency and ASM adherence monthly under supervision from the project clinician trained in epilepsy diagnosis and treatment. A concluding survey (2022) collected sociodemographic data and participants' status as alive, deceased, or lost to follow-up. Mixed-effects negative binomial regression analyzed risk factors for weekly seizure incidence rate. Of 206 participants, 77.7% reported bilateral tonic-clonic seizures, and 32.0% reported focal seizures. More than one third (38.5%) were suspected of having nodding syndrome. Weekly seizure frequency decreased significantly from a mean of 1.9 seizures (interquartile range [IQR] = 0-2) at enrollment to .4 seizures (IQR = 0-0) at the last follow-up (Wilcoxon test p < .0001), with significantly improved ASM adherence (57.5%-94.7%, McNemar test p < .0001). Factors associated with lower weekly seizure incidence included longer program participation, ASM adherence, carbamazepine use compared to phenobarbital, and ivermectin intake in 2022. ASM adverse events were associated with increased seizure frequency. The mortality rate was 32.7 deaths per 1000 person-years, with most deceased not fully adhering to ASM (88%) and having epilepsy-related causes of death (60%). The community-based program using CHWs was associated with a significant reduction in seizure frequency and improved ASM adherence. In onchocerciasis-endemic areas, it should be investigated whether carbamazepine should be a preferred ASM in PWE. Ivermectin's impact on seizure frequency merits further investigation in onchocerciasis-endemic areas. Community-based epilepsy care is a promising strategy for scaling up epilepsy care in rural areas in Africa.

Five-Year Outcomes of Lenadogene Nolparvovec Gene Therapy in Leber Hereditary Optic Neuropathy.

Limited studies have assessed the long-term benefit/risk of gene therapy for Leber hereditary optic neuropathy (LHON). To determine the safety and efficacy of lenadogene nolparvovec in patients with LHON due to the MT-ND4 gene variant for up to 5 years after administration. The RESCUE and REVERSE Long-Term Follow-up Study (RESTORE), conducted from 2018 to 2022, is the 5-year follow-up study of the 2 phase 3 clinical studies RESCUE (Efficacy Study of Lenadogene Nolparvovec for the Treatment of Vision Loss Up to 6 Months From Onset in LHON Due to the MT-ND4 Mutation) and REVERSE (Efficacy Study of Lenadogene Nolparvovec for the Treatment of Vision Loss From 7 Months to 1 Year From Onset in LHON Due to the MT-ND4 Mutation). At the end of each study, ie, 2 years after gene therapy administration, patients were offered enrollment in the RESTORE trial, a multinational, multicenter, prospective study, for an additional 3 years of follow-up. Patients with LHON due to the MT-ND4 gene variant received lenadogene nolparvovec in 1 eye and a sham injection in the other eye. Lenadogene nolparvovec was administered as a single intravitreal injection in the RESCUE/REVERSE studies. Measures included best-corrected visual acuity (BCVA), quality of life using the National Eye Institute visual functioning questionnaire 25 (NEI VFQ-25), and adverse events. Among the 76 patients who received gene therapy in the RESCUE (n = 39) and REVERSE (n = 37) studies, 72 (94.7%) completed these studies; 62 patients (81.6%) participated in the RESTORE trial, and 55 patients (72.4%) completed the 5-year follow-up. Participants were mostly male (49 [79.0%]) with a mean (SD) age of 35.9 (15.3) years at treatment. At baseline, the mean (SD) BCVA was 1.5 (0.5) logMAR (20/600 Snellen) in eyes to be treated with lenadogene nolparvovec and 1.4 (0.5) logMAR (20/500) in sham eyes. At the end of the RESCUE/REVERSE trials, ie, 2 years after treatment, eyes treated with lenadogene nolparvovec and eyes treated with sham reached a mean BCVA value of 1.4 (0.6) logMAR (20/500). The mean (SD) change from baseline to year 2 was -0.05 (0.6) logMAR (+1 line) and 0.01 (0.6) logMAR (-0 line) in gene therapy-treated and sham eyes, respectively (difference, -0.03; 95% CI, -0.16 to 0.09; P = .60). Five years after treatment, the bilateral improvement from nadir was similar to that observed at 2 years, with a mean (SD) change in BCVA of -0.4 (0.5) logMAR (more than +4 lines) for eyes treated with lenadogene nolparvovec and -0.4 (0.4) logMAR (+4 lines) for eyes treated with sham (difference, -0.05; 95% CI, -0.15 to 0.04; P = .27). An improvement of at least -0.3 logMAR (+3 lines) from the nadir in at least 1 eye was observed in 66.1% of participants (41 of 62). Between 2 and 5 years, intraocular inflammation was noted in 4 participants with 8 events in eyes treated with lenadogene nolparvovec and 1 event in an eye treated with sham. In this analysis of the RESTORE trial, follow-up of patients with LHON due to the MT-ND4 gene variant unilaterally treated with lenadogene nolparvovec demonstrated a sustained bilateral improvement in BCVA and a good safety profile up to 5 years after treatment. This evidence of persistent benefit over time is promising for the use of gene therapy in these patients. ClinicalTrials.gov Identifier: NCT03406104.

Identifying multidrug-resistant organisms in diabetic foot ulcers: a study of risk factors and antimicrobial resistance genes.

This study aims to evaluate the antibiotic susceptibility profiles of bacterial isolates from DFU patients, identify the prevalence of MDROs, and identify specific risk factors contributing to these infections to inform effective antibiotic treatment strategies. This prospective cohort study included 187 DFU patients from March 2023 to February 2024 at King Khalid Hospital, Saudi Arabia. The exclusion criteria were nondiabetic ulcers, specific infections, tumours, or recent antibiotic use. Data on demographics, diabetes duration, DFU characteristics, and antibiotic history were collected. Ethical approval and informed consent were obtained. During the 1-year study, 187 DFU patients were included, with 72.7% males and 27.3% females. The mean age of the study participants was 54.9 ± 11.8 years. The average duration of diabetes was 6.3 ± 3.7 years, and themean HbA1c was 8.0 ± 1.0%. Over half (54.5%) of the patients had Wagner ulcer grade III, and neuropathy (67%) and retinopathy (73%) were the most common complications. Polymicrobial infections were identified in 54% of the cases, with 61.5% of the isolates producing biofilms. The key risk factors for MDR infections included amputation (OR: 5.92), polymicrobial infections (OR: 7.49), biofilm production (OR: 5.00), recent antibiotic use (OR: 3.97), and an ulcer duration > 30 days (OR: 2.23). Sex, age, and weight were not significantly associated with MDR infections. Among the 27 MRSA isolates, 81.5% carried the mecA gene, and 98.8% of the ESBL-producing organisms harboured at least one ESBL gene, with blaCTX-M being the most common (27.2%). Carbapenem resistance was confirmed in 25.6% of the isolates, with blaNDM being the predominant carbapenemase gene (69.3%). Coresistance with ESBL genes was detected in 66.7% of the blaNDM-producing isolates. This study demonstrates a high prevalence of MDROs in DFUs, primarily driven by biofilm-producing polymicrobial infections and resistance genes like blaNDM and blaCTX-M. The findings accentuate the clinical importance of integrating molecular diagnostics for early detection of resistance determinants, enabling precise, targeted therapy. Tailored antibiotic stewardship and enhanced infection control measures are critical to optimizing treatment outcomes, reducing complications, and mitigating the burden of chronic DFUs in healthcare settings.

Circulating Levels of Low-Density Granulocytes and Cell-Free DNA as Predictors of Cardiovascular Disease and Bone Deterioration in SLE Patients.

The present work evaluates the predictive value of low-density granulocytes (LDGs) for the development of cardiovascular disease (CVD) and/or bone deterioration (BD) in a 6-year prospective study in systemic lupus erythematosus (SLE). Considering the high SLE-LDG capacity to form neutrophil extracellular traps (NETs), circulating levels of total cell-free DNA (cirDNA) and relative amounts of mitochondrial and nuclear DNA (mtDNA and nDNA, respectively) were tested as LDG-associated biomarkers to identify SLE patients at risk of CVD and BD. The frequency of total blood LDGs, as well as the CD16negCD14neg (nLDG) and CD16posCD14low (pLDG) subsets, was quantified by flow cytometry in 33 controls and 144 SLE patients. Total cirDNA and relative amounts of mitochondrial (mtDNA) and nuclear (nDNA) cell-free DNA were measured by fluorometry or qPCR in plasma from a subgroup of 117 patients and 23 controls at enrolment. Our findings showed increased blood levels of SLE-nLDGs at enrolment associated with prospective CVD development (pCVD) and the presence of BD, thus revealing LDG expansion as a predictor of both comorbidities in SLE progression. The amounts of the different types of circulating DNA analyzed were increased in patients, especially those presenting with traditional CV risk factors or subclinical atheromatosis. Similar to nLDGs, the nDNA concentration could predict the development of pCVD in SLE, supporting the quantification of cirDNA levels as a surrogate marker of LDGs in clinical practice.

Improvements in quality of life of patients with multiple sclerosis receiving alemtuzumab in clinical practice: the LEMVIDA study

BackgroundAlemtuzumab is a humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). Its efficacy and safety have been widely demonstrated in clinical trials, but experience from real-world cohorts is also needed to support its clinical use. Quality of life (QoL) outcomes are an important complement to the clinical benefits of treatment, offering a patient-centered perspective on how the drug contributes to general well-being. In this line we aimed to evaluate the QoL of patients treated with alemtuzumab in clinical practice.MethodsThis prospective 3-year multicenter study was carried out in adult patients diagnosed with RRMS who had started alemtuzumab according to clinical practice within 8 weeks before inclusion. The primary endpoint was the change in QoL over three years of treatment with alemtuzumab using the 29-item Multiple Sclerosis Impact Scale (MSIS-29). Secondary endpoints included changes from baseline in the 21-item Modified Fatigue Impact Scale (MFIS-21), Beck Depression Inventory (BDI-II), Symbol Digit Modalities Test (SDMT, oral version) and Work Productivity. Disability worsening was also assessed based on the Expanded Disability Status Scale (EDSS), along with the annualized relapse rate (ARR) and radiological activity.ResultsA cohort of 165 patients was analyzed (mean age 38.6 years, mean disease duration 8.5 years, mean EDSS score 3.3). MSIS-29 physical domain scores decreased significantly from baseline by a mean of 7.2 ± 1.8 points at year 1, 6.4 ± 2.2 at year 2 and 5.6 ± 2.3 at year 3 (p < 0.05 in all cases). Similarly, MSIS-29 psychological domain scores decreased significantly by a mean of 7.9 ± 2.4 points at year 1, 12.8 ± 2.9 at year 2 and 13.2 ± 3.0 at year 3 (p < 0.05 in all cases). Significant reductions from baseline were also evidenced in MFIS-21 and BDI-II scores, while SDMT scores remained unchanged. During the 3 years on alemtuzumab, the ARR was 0.15, representing an 83% reduction from the 2 years before initiation. At 3 years, 81.5% of patients were free from radiological activity and 87% were free from disability worsening.ConclusionsThese results indicate early and substantial improvements in patients’ perception of their QoL and functioning with alemtuzumab that were sustained over three years.

Severe Outcomes of Pneumocystis Pneumonia: A 10-year Retrospective Cohort Study.

A considerable knowledge gap exists in predicting severe Pneumocystis pneumonia (PCP) outcomes following PCP diagnosis. In this retrospective cohort, we studied immunocompromised patients with PCP admitted to 5 University Health Network centers in Canada (2011-2022). The study outcome included severe PCP, a composite of 21-day ICU admission or 28-day all-cause mortality. Adjusted odds ratios (aOR) estimated the association between severe PCP and comorbidities as well as clinical and laboratory variables at diagnosis. A total of 44 out of 182 (24.2%) immunocompromised patients (19 [10.4%] HIV-infected, 55 [30.2%] hematologic malignancies, 32 [17.6%] hematopoietic stem cell transplants, 32 [17.6% solid tumors, 26 solid organ transplants [14.3%], 12 (6.6%) autoimmune diseases, and 6 (3.3%) other immunosuppressive conditions) developed composite outcomes (40 ICU admissions [21.9%], 18 deaths [9.9%]). Patients with composite outcomes more often had acute-onset PCP (< 7 days) (18/34 [52.9%] vs. 38/126 [30.1%], p = 0.013), shortness of breath (39/44 [88.6%] vs. 96/136 [70.6%], p = 0.002), chronic liver disease (15/44 [34.1%] vs. 9/138 [6.5%], p < 0.001), hypoalbuminemia (median [IQR] albumin (g/L): 27 [25-31] vs. 32 [29-35], p < 0.001), elevated lactate dehydrogenase (median [IQR] LDH (U/L): 537 [324-809] vs. 340 [237-475], p < 0.001), lymphopenia (median [IQR] absolute lymphocyte count [(10*9/L),]: 0.4 [0.2-0.6] vs. 0.7 [0.3-1.2], p < 0.001), or required supplemental oxygen (39/44 [88.6%] vs. 60/136 [44.1%], p < 0.001) than those without composite outcomes. In multivariable analysis, chronic liver disease (aOR: 11.6, 95% CI: 2.2-61.3) and requiring supplemental oxygen on admission (aOR: 19.7, 95% CI: 3.0-128.5) were significantly associated with severe PCP. Alongside hypoxemia upon admission, chronic liver disease appears to significantly predict severe PCP in immunocompromised patients. This biologically plausible finding warrants further investigation.

Can We Predict Poor Outcomes for Arthroscopic Partial Meniscectomy?: Commentary on an article by Michael R. Moore, BA, et al.: "Levels of Synovial Fluid Inflammatory Biomarkers on Day of Arthroscopic Partial Meniscectomy Predict Long-Term Outcomes and Conversion to TKA. A 10-Year Mean Follow-up Study".

Can We Predict Poor Outcomes for Arthroscopic Partial Meniscectomy?: Commentary on an article by Michael R. Moore, BA, et al.: "Levels of Synovial Fluid Inflammatory Biomarkers on Day of Arthroscopic Partial Meniscectomy Predict Long-Term Outcomes and Conversion to TKA. A 10-Year Mean Follow-up Study".

Changes in the Volume and Diameter of Benign Thyroid Nodules: A 10-Year Follow-Up Study.

Background: The incidence of asymptomatic thyroid nodules has risen enormously, with > 90% being benign. Despite limited long-term data, significant nodule growth (SNG) is common. Guidelines recommend cytology reevaluation if SNG occurs. Our study aimed to identify the rate and factors associated with SNG, compare diameter and volume-based assessments, and examine the association between SNG and malignancy risk over the long term (10 years). Methods: The retrospective cohort study, conducted at Ankara University, School of Medicine, Department of Endocrinology and Metabolism, included 732 nodules from 376 euthyroid patients, all monitored over a 10-year period by the same experienced sonographer, with evaluations at baseline, 5th and 10th years. The nodules were cytologically benign and/or sonographically in the low-to-intermediate risk category. Size changes at the 5th and 10th years were considered significant if there was a 20% or 2 mm increment in two diameters according to diameter-based criterion (DBC) or 50% increment in volume-based criterion (VBC) designed by the ellipsoid formula. Generalized linear mixed-effects models were used to account for the clustered data structure and analyze factors affecting nodule growth. Nodule growth was the dependent variable, while sex, age at diagnosis, initial TSH level, total nodule count, nodule volume, echogenicity, and localization were independent variables. Results: At the 5th and 10th years, SNG frequencies were higher when calculated using VBC [27.7% (n = 203) and 44% (n = 321), respectively] compared with DBC [19.1% (n = 140) and 35% (n = 256), respectively], with the differences being statistically significant (McNemar test, p < 0.01). Factors associated with SNG included being younger than 45 years of age (VBC OR = 1.704, CI = 1.227-2.366, p = 0.002; DBC OR = 1.913, CI = 1.379-2.656, p < 0.001), having higher number of nodules (VBC: OR = 1.171, CI = 1.061-1.291, p = 0.002; DBC: OR = 1.147, CI = 1.040-1.265, p = 0.006), and having smaller nodule volume (VBC: OR = 0.870, CI = 0.806-0.940, p < 0.001; DBC: OR = 0.912, CI = 0.850-0.978, p = 0.010). Thyroid cancer was diagnosed in four original nodules (0.5%), whereas the malignancy rate in biopsies performed was 1.4% (n = 4). Conclusions: In long-term follow-ups of sonographically and/or cytologically benign thyroid nodules, SNG is not rare. Growth is more likely in younger patients, those with higher number of nodules and smaller nodules. In the follow-up of nodule size, VBCs yield augmented results compared with DBCs. However, malignancy is quite rare in growing nodules. Therefore, adopting flexible long-term follow-up protocols appears to be practical for benign nodular thyroid disease.

Efficacy of mycophenolate mofetil combined with topical 0.05% tacrolimus in high-risk keratoplasty: 1-year cohort study.

To investigate the efficacy of systemic mycophenolate mofetil (MMF) as an adjunct in combination with topical tacrolimus (FK506) and corticosteroid eyedrops for preventing corneal graft rejection after high-risk keratoplasty (HRK). In this cohort study, 55 consecutive patients (55 eyes) from an eye center who met the criteria of HRK were included. The definition for HRK includes large grafts of no less than 9 mm diameter, vascularized cornea of two or more quadrants, regrafting, or eccentric grafts. After penetrating keratoplasty, 25 patients treated with systemic MMF in combination with 0.05% FK506 and tapering corticosteroid eyedrops were enrolled in Group 1 from October 2019. Thirty patients receiving postoperative treatment with 0.05% FK506 and tapering corticosteroid eyedrops alone were enrolled in Group 2 from January 2018 to September 2019. All participants were closely monitored after surgery, and episodes of graft rejection and relevant clinical data were collected and assessed over a one-year follow-up period. After a follow-up of 9.6±3.2mo, graft rejection episodes occurred in 4 cases (16%) in Group 1 and 18 cases (60%) in Group 2. One reversible and 3 irreversible graft rejections occurred in Group 1, while 3 reversible and 15 irreversible rejections occurred in Group 2. Kaplan-Meier analysis revealed that 82.5% of grafts in Group 1 and 37.1% in Group 2 did not experience corneal graft rejection (P<0.01, log-rank test). The clear graft survival rate was 83.6% in Group 1 and 36.7% in Group 2 (P<0.01, log-rank test) within one year of follow-up. No severe systemic side effects were observed in either group during the follow-up period. The triple treatment regimen consisting of MMF, topical FK506, and corticosteroid eyedrops represents a promising strategy for effectively preventing graft rejection and improving graft survival in patients with HRK.

Incidence and clinical course of post-infectious irritable bowel syndrome in patients admitted to university hospitals: 1-year prospective follow-up study.

Post-infectious irritable bowel syndrome (PI-IBS) is characterized by chronic gastrointestinal symptoms that arise following an episode of infectious enteritis. The incidence rates vary, ranging from 5% to 32% and the risk factors are not well known. We aim to investigate the incidence and risk factors of PI-IBS in enteritis patients admitted to university hospitals in Korea. This multi-center prospective study was conducted in patients hospitalized for infectious enteritis. Each patient underwent 1 outpatient visit and 3 telephone surveys during the first year after discharge to determine if PI-IBS occurred within the follow-up period. In the 3-month survey, 7 out of 354 patients (2%) were diagnosed with PI-IBS, and after 1 year, only 1 patient met the criteria for IBS. No statistically significant difference was found between the PI-IBS group and the non-PI-IBS group in terms of age, sex, underlying diseases, medication history, gastrointestinal symptoms, enteritis location, causative strain, hospitalization and treatment periods, and laboratory findings. Female sex (P = 0.003), enteropathogenic Escherichia coli (EPEC) infection (P = 0.044), and a longer total treatment period (P = 0.018) were independent risk factors for diarrhea lasting ≥ 3 months after enteritis. The incidence of PI-IBS in Korea was relatively low, and most cases improved over time. No risk factors associated with the development of PI-IBS were found. However, persistent diarrhea after enteritis was associated with female sex, EPEC infection, and severe or long-lasting enteritis. IBS symptoms may persist after severe enteritis but usually improve with time.

Modification of bone architecture following sleeve gastrectomy: a 5-year follow-up.

Bariatric surgery induces a decrease in areal bone mineral density (aBMD), but the long-term effect on trabecular and cortical volumetric bone mineral density (vBMD) has not been well assessed. The main aim of this 5-year longitudinal study was to investigate the changes following sleeve gastrectomy (SG) in aBMD, bone turnover markers and trabecular and cortical vBMD. Forty-five patients with obesity were assessed before and 1, 2 and 5years after SG. Trabecular and cortical vBMD, cortical thickness and structural parameters were assessed by 3D-Shaper® software at hip. Values of bone turnover markers peaked after 1year and decreased after 2 and 5years, but without returning to baseline values. aBMD decreased mostly at femoral neck(-9.7%) and total hip(-10.7%) over the 5years, with the greatest loss occurring at 1year(-5.9% and -6.3%, respectively). A similar profile of decrease was observed for integral hip vBMD with significant decreases of 6.6%, 7.7% and 10.7% after 1, 2 and 5years, mainly due to a reduction in the trabecular (10.5%, 12.0% and 17.2%, respectively) rather than cortical (1.4%, 1.9% and 2.9%, respectively) component. A modest decrease in mean cortical thickness (2.5%, 2.8% and 3.9%, respectively) and an alteration in the structural parameters were concomitantly observed. Older age and greater body weight loss were the factors most associated with an increased loss of aBMD and vBMD. In conclusion, the study demonstrates that SG induces not only an alteration in bone turnover and aBMD, but also a reduction in vBMD at hip, predominantly due to trabecular component deterioration as determined by 3D-Shaper® software. The maintenance of bone deterioration for at least 5years - that is, after 4years of relative body weight stabilization or minimal weight regain - suggests the need for a therapeutic approach to preserve bone health in patients who undergo SG.

Therapy with clopidogrel or rivaroxaban has equivalent impacts on recurrence of thromboembolism and survival in cats following cardiogenic thromboembolism: the SUPERCAT study.

To assess the impact of clopidogrel or rivaroxaban administration on recurrence of arterial thromboembolism (ATE) in cats that have recovered from cardiogenic ATE. This multicenter prospective double-masked protocol enrolled 45 cats that had recovered from cardiogenic ATE and were randomized to receive either clopidogrel (18.75 mg/cat, PO; n = 19) or rivaroxaban (2.5 mg/cat, PO; 26) as sole anticoagulant therapy for up to 2 years after the initial ATE. Primary outcome measures included recurrent ATE or death from any cause. In addition to bimonthly internet-based surveys of animal quality of life, echocardiograms were performed by veterinary cardiologists at 2, 6, 12, and 18 months after initial ATE. 17 cats experienced ATE recurrence: 7 of 19 (37%) in the clopidogrel group and 10 of 26 (39%) in the rivaroxaban group. Three cats in each group survived for the entire 2-year study without recurrence. In the clopidogrel group, median (95% CI) time to ATE recurrence was 663 days (150 to not calculable) and in the rivaroxaban group, 513 days (242 to not calculable). Median time from enrollment to death from cardiac or noncardiac causes was also not different between treatment groups. Single-agent antithrombotic therapy with rivaroxaban in cats recovered from cardiogenic embolism delayed recurrence of ATE for a similar time period as single-agent therapy with clopidogrel. In cats that have recovered from cardiogenic ATE, either rivaroxaban or clopidogrel may be used for single-agent thromboprophylaxis to delay ATE recurrence.

Obstetric outcomes in women with vulvodynia and vaginismus: a systematic review.

Vulvodynia and vaginismus are pain disorders associated with adverse pregnancy outcomes. The few published studies addressing this topic were limited in terms of the different outcomes studied; hence, the purpose of our study was to perform the first systematic review examining maternal, neonatal and obstetric outcomes in patients with vulvodynia and/or vaginismus (VV). We conducted a systematic review searching PubMed, EMBASE, Cochrane Library and SCOPUS until November 2023 for observational studies reporting maternal and/or neonatal outcomes of VV in pregnancy. Data on maternal characteristics and obstetric outcomes were independently extracted from the included studies by two reviewers and then summarized between those with and without VV. The search strategy yielded 1118 citations, of which 10 were included. A total of 2209 patients with a diagnosis of VV prior to pregnancy were identified over a 27-year study period. Compared with women without VV, women with VV were more likely to deliver by cesarean sect. (40.3 vs 29.8%, p < 0.001). Cesarean sections were more likely elective (41.0 vs 35.7%) and performed in response to maternal request (26.0 vs 9.5%) for women with VV. Of those who delivered vaginally, instrumental deliveries were more common among women with VV (16.7 vs 6.2%, p < 0.001), with more perineal injuries as well (43.0 vs 32.7% p < 0.001). Vaginismus/vulvodynia are high-risk conditions during pregnancy with increased rates of cesarean sections performed for elective reasons and upon maternal request. Offering support, education, and treatment for these conditions prior to pregnancy is important to reduce the rate of avoidable cesarean sections.

Surgical Trauma Comparison of Inframammary Fold versus Endoscopic Transaxillary Approaches in Breast Augmentation: A 7-Year Cohort Study.

This retrospective cohort study aimed to assess differences in surgical trauma between the inframammary fold approach and endoscopic transaxillary approach in breast augmentation surgery. One hundred and ninety-four patients who underwent breast augmentation using either an inframammary fold or endoscopic transaxillary approach were enrolled. All procedures were primary and bilateral cases. Patients' demographics and indicators, such as operation duration, postoperative volume of drainage, drainage duration, length of hospital stay, and postoperative pain scores, were observed and analyzed. One hundred and five patients underwent inframammary fold incisions, while the remaining 89 received transaxillary incisions. The operation duration was significantly shorter in the inframammary fold group than in the transaxillary group, while the VAS scores were significantly lower (p < 0.001). Similarly, differences in the age and fertility status between the two groups were statistically significant (p < 0.05). However, no statistically significant differences were noted in the scores of the remaining indicators (p < 0.05). This research demonstrated that while patients in the endoscopic transaxillary group were typically younger, which is commonly hypothesized to result in superior results, the inframammary fold approach may offer a surgical option with reduced trauma and pain and concomitantly greater convenience and efficiency, yielding high satisfaction levels among Chinese women. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Serological Evidence of Cryptic Rift Valley Fever Virus Transmission Among Humans and Livestock in Central Highlands of Kenya

Although the highlands of East Africa lack the geo-ecological landmarks of Rift Valley fever (RVF) disease hotspots to participate in cyclic RVF epidemics, they have recently reported growing numbers of small RVF clusters. Here, we investigated whether RVF cycling occurred among livestock and humans in the central highlands of Kenya during inter-epidemic periods. A 2-year prospective hospital-based study among febrile patients (March 2022–February 2024) in Murang’a County of Kenya was followed by a cross-sectional human–animal survey. A total of 1468 febrile patients were enrolled at two clinics and sera tested for RVF virus RNA and antiviral antibodies. In the cross-sectional study, humans (n = 282) and livestock (n = 706) from randomly selected households were tested and questionnaire data were used to investigate sociodemographic and environmental risk factors by multivariate logistic regression. No human (n = 1750) or livestock (n = 706) sera tested positive for RVFV RNA. However, 4.4% livestock and 2.0% humans tested positive for anti-RVFV IgG, including 0.27% febrile patients who showed four-fold IgG increase and 2.4% young livestock (&lt;12 months old), indicating recent virus exposure. Among humans, the odds of RVF exposure increased significantly (p &lt; 0.05, 95% CI) in males (aOR: 4.77, 2.08–12.4), those consuming raw milk (aOR: 5.24, 1.13–17.9), milkers (aOR: 2.69, 1.23–6.36), and participants residing near quarries (aOR: 2.4, 1.08–5.72). In livestock, sheep and goats were less likely to be seropositive (aOR: 0.27, 0.12–0.60) than cattle. The increase in RVF disease activities in the highlands represents a widening geographic dispersal of the virus, and a greater risk of more widespread RVF epidemics in the future.

Risk Factors and Postoperative Outcomes in Pouchitis Following Restorative Proctocolectomy: An 18-Year Single-Center Study

Background/Objectives: Restorative proctocolectomy with ileo-anal pouch anastomosis (IPAA) remains the preferred surgical treatment for ulcerative colitis (UC). However, complications like pouchitis can occur. This study aimed to describe patients who underwent IPAA for inflammatory bowel disease (IBD) at Padua Hospital from 2005 to 2023 and identify risk factors for pouchitis. Secondary objectives included evaluating the effectiveness of biological therapy in chronic antibiotic-refractory pouchitis (CARP), Crohn’s disease of the pouch (CDP), and Crohn’s-like inflammation of the pouch (CDLPI), and assessing risk factors for pouch failure. Methods: This retrospective, observational study included 109 patients whose data were collected from medical records. Univariate logistic regression was used to analyze associations between preoperative and postoperative factors and outcomes such as acute pouchitis and pouch failure. The effectiveness of biological therapy was assessed by measuring changes in the Pouchitis Disease Activity Index (PDAI) and the Modified Pouchitis Disease Activity Index (mPDAI) over a 12-month treatment period. Results: Univariate logistic regression revealed significant associations between preoperative extraintestinal manifestations (OR 3.569, 95% CI 1.240–10.720), previous diagnosis of Crohn’s disease (OR 10.675, 95% CI 1.265–90.089), and transmural inflammation at cross-sectional imaging before surgery (OR 3.453, 95% CI 1.193–9.991) with an acute pouchitis risk. Pouch failure was significantly associated with a previous diagnosis of Crohn’s disease (OR 9.500, 95% CI 1.821–49.571) and post-surgical fistulas (OR 41.597, 95% CI 4.022–430.172). Biological therapy led to a significant reduction in the PDAI score in patients with CARP, decreasing from a median of 10 to 4 (p = 0.006). Similarly, in patients with CDP or CDLPI, the mPDAI score was significantly reduced from a median of 9 to 1 (p = 0.034), with remission achieved in 5/6 (83.3%) of these patients. Conclusions: This study provides valuable insights into the management of IPAA patients and highlights the importance of early identification and treatment of risk factors for pouchitis and failure. Biological therapy demonstrated significant effectiveness in reducing disease activity in patients with CARP, CDP, and CDLPI, suggesting its role as a crucial component in managing these complications.

Unveiling the Malignancy Risk of Surgically Treated Bethesda III Thyroid Nodules: A 10-Year Retrospective Study Comparing Fine-Needle Aspiration Cytology (FNAC) and Histopathology

Unveiling the Malignancy Risk of Surgically Treated Bethesda III Thyroid Nodules: A 10-Year Retrospective Study Comparing Fine-Needle Aspiration Cytology (FNAC) and Histopathology

Congenital hyperinsulinism in the Ukraine: a 10-year national study

IntroductionCongenital Hyperinsulinism (CHI) has not been previously studied in Ukraine. We therefore aimed to elucidate the genetics, clinical phenotype, histological subtype, treatment and long-term outcomes of Ukrainian patients with CHI.MethodsForty-one patients with CHI were recruited to the Ukrainian national registry between the years 2014-2023. Genetic testing (n=40), 18F-fluorodihydroxyphenylalanin and 68Ga-DOTANOC PET/CT imaging followed by surgical treatment and subsequent histological analysis (n=19) was performed through international collaboration.ResultsPathogenic variants were identified in 19/22 (86.3%) individuals with persistent CHI (p-CHI) and 8/18 (44.4%) with early remission CHI (er-CHI). Pathogenic variants in the K-ATP channel genes were the only identified genetic cause of p-CHI (ABCC8 (n=17) and KCNJ11 (n=2)) with greater genetic heterogeneity observed in those with er-CHI (ABCC8 (n=3), KMT2D (Kabuki Syndrome, n=1), Beckwith-Wiedemann syndrome (n=2) and INSR (Donohue syndrome (n=2)). Histological analysis performed on 19 children with persistent CHI confirmed focal disease in 14 (73.7%), diffuse disease in two (10.5%) and atypical histology in three (15.8%). After surgery, complete recovery was observed in all 14 with focal disease, while relapse occurred in three patients with diffuse or atypical histology.ConclusionA genetic diagnosis was achieved for 67.5% (27/40) of the cohort with a higher pick-up rate observed in those with p-CHI. The genetics and imaging studies enabled subtype-targeted treatment with surgical cure achieved in all individuals with focal disease.

Evaluate the Risk of Multilevel Non-Contiguous Spinal Fractures in Patients with Traumatic Cervical Spine Injury: A 12-Year Retrospective Study

Objective: To understand the risk factors and incidence of multilevel non-contiguous spinal fractures is crucial for improving diagnosis, management, and outcomes. Materials and Methods: The 12-year retrospective observational study included 588 patients with traumatic cervical spine fractures admitted at Maharaj Nakorn Chiang Mai Hospital between January 2011 and December 2022. Patients were categorized into two groups, those with multilevel non-contiguous spine fractures and those without multilevel non-contiguous spine fractures. Outcomes were analyzed using multivariable analysis. Results were presented as adjusted odd ratio (AOR) and 95% confidence interval (CI). Results: Among 588 patients, the incidence of multilevel non-contiguous spine fractures was 17.01% (100 out of 588 patients). Independent factors associated with multilevel non-contiguous spine fractures were motor weakness (AOR 1.89, 95% CI 1.19 to 3.01, p=0.007), intracranial injuries (AOR 2.61, 95% CI 1.61 to 4.23, p=0.000), intrathoracic injuries (AOR 2.88, 95% CI 1.77 to 4.69, p=0.040), and intraabdominal injuries (AOR 1.91, 95% CI 1.03 to 3.55, p=0.000). Conclusion: The present study identified critical risk factors for multilevel non-contiguous spine fractures in patients with traumatic cervical spine fracture. Those risk factors were motor weakness, intracranial injuries, intrathoracic injuries, and intraabdominal injuries. These findings can help guide clinical decision-making and improve patient outcomes. Keywords: Risk factor; Multilevel non-contiguous spinal fractures; Cervical spine injury

Specialty-specific hand hygiene compliance: 5-year study from a large public sector teaching hospital, South India

: Hand hygiene (HH) is essential for preventing healthcare-associated infections (HAIs), especially in ICUs and cancer care centers. These settings often involve immunocompromised patients and invasive devices, making HH critical for patient safety. Despite its recognized importance, consistent adherence to HH practices by healthcare workers (HCWs) remains a significant challenge. This study aimed to evaluate HH compliance in a tertiary care hospital in South India using a customized Android application aligned with WHO guidelines. : This observational study was conducted across high-risk areas of a tertiary care hospital from June 2019 to May 2024. The hospital's high-risk units, under medical, surgical, and pediatric alliances, were included. An Android application based on the Ibhar platform and WHO hand hygiene audit guidelines was used for data collection. The study recorded HH opportunities, Complete HH Adherence (HHCAR), Partial HH Adherence (HHPAR), and Total HH Adherence (HHTAR). The data were analyzed for location-specific, profession-specific, and moment-specific compliance rates. : A total of 196,252 HH opportunities were recorded, with the surgical alliance accounting for the highest number. Pediatric units had the highest compliance, with an HHTAR of 89% and an HHCAR of 66%. Nurses demonstrated the highest compliance among professions, with an HHTAR of 82.8%. Compliance was higher after patient care moments compared to before. Statistically significant differences were noted across different specialties and moments. : This large-scale study highlights the variation in HH compliance across different specialties and the need for targeted training sessions. Given the resource constraints in many tertiary care centers, focusing audits on high-risk areas is practical. The use of software-based applications like Ibhar enhances data collection and analysis, making the audit process more efficient. Regular HH audits and behavioral changes are essential to improve and sustain high standards of HH compliance, ultimately contributing to better infection control practices.