Follow-up Visit Research Articles

Safety and efficacy of the amino acid crosslinked hyaluronic acid in the treatment of temple hollowing.

Loss of volume in the temples is an early sign of aging and often gives the impression of a gaunt and emaciated appearance. The authors conduct a clinical study to investigate the safety and effectiveness of the amino acid crosslinked hyaluronic acid (ACHA) for the treatment of temple hollowing. 75 subjects with Temple Hollowing Scale (THS) from 2 to 4 were enrolled and assigned according to the ratio of 2 (ACHA group, n=50): 1 (no treatment control group, n=25). All subjects were assessed at the 12-month follow-up visit using the THS, Global Aesthetic Improvement Scale (GAIS), ultrasound, and three-dimensional scanning. Subjects were instructed to report any adverse events (AEs) within 14 days after the ACHA treatment. An average volume of 4.72±1.13ml was injected into the temples. We received 18 treatment-related AEs reported by 10 subjects. Compared with the control group, THS, GAIS, and soft tissue thickness were significantly improved in the ACHA group at 1 month, 6, and 12 months after injection. Three-dimensional scanning showed that ACHA could maintain a certain volume in the temple 12 months after ACHA injection. ACHA is an effective and safe hyaluronic acid for patients with minimal to severe temple hollowing.

Health status and quality of life before critical illness: Northern Finland Birth Cohort 1966 study.

Previous findings support the claim intensive care unit (ICU) patients have a higher rate of comorbidities and reduction of health- and functional status compared with the normal population. In this prospective observational study, our aim was to determine those health-related factors at the age of 31 years which were associated with a later critical illness among previously un-hospitalized individuals by exploring data obtained from the Northern Finland Birth Cohort 1966 (NFBC1966). NFBC1966 is a Finnish birth cohort, which includes 12,058 live births with expected dates of delivery during 1966. The study was conducted among cohort participants who had not been hospitalized for any reason before the cohort follow-up visit at the age of 31. The study group included NFBC1966 participants who were admitted to the ICU of the Oulu University Hospital. The control group included participants who were treated for any reason in regular hospital wards. The data considering the participants' health status and behavior at the age of 31 were collected from the NFBC1966 database. The gathering of ICU and hospitalization data was concluded on December 31, 2016. 849 NFBC1966 participants met the inclusion criteria: 69 were treated in the ICU (study group) and 780 on regular hospital wards (controls). In the study group, the rate of neurological diseases (26% vs. 16%, 95% CI: -21.8%, -0.2%), malignancy (3% vs. 0.7%, 95% CI: -9.7%, 0.0%), alcohol abuse (4.5% vs. 1%, 95% CI: -11.5%, -0.3%) and smoking (77% vs. 65%, 95% CI: -21.6%, -0.3%) were higher compared with the control group. The patients in the ICU group were also more prone to violent injuries, (17% vs. 7%, 95% CI: -20.2%, -1.9%), practiced less hard physical activity (65% vs. 78%, 95% CI: 2.1%, 25.3%) and had lower maximal muscle strength according to the hand grip test (30 vs. 34 kg, 95% CI: -8.2, 8.6 kg). In this study examining previously un-hospitalized patients, the main factors associated with future critical illness were neurological comorbidities, malignancy, alcohol misuse, smoking, low maximum muscle strength, and less frequent physical exercise compared with those with hospitalization not requiring ICU admission.

Rationale and Design of the DEFIANCE Study: A Randomized Controlled Trial of Mechanical Thrombectomy Versus Anticoagulation Alone for Iliofemoral Deep Vein Thrombosis

BackgroundDeep vein thrombosis (DVT) is a common medical condition that is associated with clinically significant sequelae, including postthrombotic syndrome (PTS). Anticoagulation alone remains the guideline-recommended treatment for many patients with iliofemoral DVT. Recent technological advances have led to an increase in the use of mechanical thrombectomy for DVT, but mechanical thrombectomy-based procedures have not yet been compared with standard-of-care anticoagulation therapy in randomized studies. MethodsThe DEFIANCE study (ClinicalTrials.gov: NCT05701917) is an international and actively enrolling randomized controlled trial (RCT) in lower extremity DVT assessing an interventional strategy that includes mechanical thrombectomy with the ClotTriever System (Inari Medical, Irvine, CA) versus anticoagulation alone. Approximately 300 patients with unilateral iliofemoral DVT and symptom duration ≤12 weeks will be randomized 1:1. Study conduct includes an independent core laboratory for duplex ultrasound assessment, an independent medical monitor for safety adjudication, and evaluation of PTS severity on the Villalta scale using best clinical practices. The primary endpoint is a composite outcome structured as a hierarchal win ratio of 1) the occurrence of treatment failure or therapy escalation as adjudicated by the medical monitor, with failure defined as amputation or gangrene of the target leg or venous thromboembolism-related mortality, and 2) the assessment of PTS severity at the 6-month follow-up visit. In addition to being a component of the primary endpoint, the severity of PTS at 6 months is also evaluated as a stand-alone secondary endpoint. An additional secondary endpoint is a composite of outcomes at the 10-day visit and is structured as a hierarchal win ratio of 1) vessel compressibility on duplex ultrasound, 2) patient-reported pain, and 3) improvement of edema. The safety endpoints are access site complications requiring endovascular or surgical repair and the occurrence through the 30-day visit of mortality, major bleeding, or new symptomatic pulmonary embolism. ConclusionsDEFIANCE will be the first RCT to evaluate a mechanical thrombectomy-based interventional approach versus anticoagulation therapy alone for DVT. The results will inform the treatment of patients with iliofemoral DVT and the prevention of PTS-associated morbidity. Trial RegistrationDEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (DEFIANCE), ClinicalTrials.gov: NCT05701917, URL: https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1

The Potential of Sound Analysis to Reveal Hemodynamic Conditions of Arteriovenous Fistulae for Hemodialysis.

Arteriovenous fistula (AVF), the preferred vascular access for hemodialysis, is associated with high failure rate. The aim of this study was to investigate the potential of AVF sound auscultation in providing quantitative information on AVF hemodynamic conditions. This single-center prospective study involved six patients with native radio-cephalic AVFs who underwent multiple follow-up visits. Doppler Ultrasound blood flow volume (BFV) assessment and electronic stethoscope-based sound recordings were performed during each visit, whereas MRIs were acquired 3days, 3weeks and 1year after surgery. Computational fluid dynamic (CFD) simulations were performed on patient-specific MRI-derived geometrical models. Higher values of median peak amplitudes ratios (high-low peak ratio-HLPR) were found to be associated with complex blood flow and velocity streamlines recirculation at systolic peak, and corresponding extended regions of high oscillatory shear index (OSI). On the contrary, lower values of HLPR were associated with laminar flow pattern and low values of OSI. Significant differences were observed in HLPR between subgroups with extended or limited areas with OSI > 0.1 (0.67 vs 0.31, respectively). Significant relationships were found between AVF sound intensity and brachial BFV (slope = 0.103, p < 0.01) as well as between longitudinal changes in brachial BFV and HLPR (slope = - 0.001, p < 0.01). Our results show that AVF sound can be exploited to extract fundamental information on AVF hemodynamic conditions, providing indication of the presence of complex hemodynamic and adequate BFV to perform hemodialysis. Sound analysis has therefore the potential to improve clinical AVF surveillanceand to ameliorate outcome.

Profile of Lumbar Spinal Stenosis Patients at Dr. M. Djamil Central Public Hospital from 2018-2022

Background: Lumbar Spinal Stenosis (LSS) is a pathological condition characterized by narrowing of the spinal canal in the lower back. In Indonesia, comprehensive data on LSS is currently unavailable. This study aimed to determine the profile of LSS patients at Dr. M. Djamil Central Public Hospital. Methods: This descriptive cross-sectional study utilized medical record data from 122 LSS patients at Dr. M. Djamil Central Public Hospital between 2018 and 2022, selected via consecutive sampling. Inclusion criteria included age over 18 years and a confirmed LSS diagnosis. Exclusion criteria included incomplete medical records, lack of MRI results, and follow-up visits without treatment. Univariate analysis was performed using SPSS 25.0 to describe patient characteristics, causative factors, symptoms, location of stenosis, and management type. Results: In this study, 122 samples met the inclusion and exclusion criteria. LSS was mainly found in patients aged 60-69 years (33.6%) and in women (59%). Most LSS patients had obesity (BMI category I, 32%). Many LSS patients were housewives (42.62%) and reported light work activity (63.1%). The most common cause of LSS was degenerative factors (59%). The main symptom experienced by LSS patients was lower back pain (94.3%), frequently accompanied by radicular pain (79.5%). The most common location of stenosis was L4-L5 (43.4%). Most LSS patients in this study were managed both conservatively and operatively (70.5%). Conclusion: These findings contribute to a better understanding of LSS prevalence and distribution among patients. Further multicenter studies are needed to establish a comprehensive national LSS profile.

Longitudinal trajectories of the overall and regional body composition between severe acute malnourished and well-nourished children of Rohingya refugee camps.

The present study aimed to observe how body composition differs between severe acute malnutrition (SAM) (treated with ready-to-use therapeutic food, RUTF) and well-nourished children. A longitudinal investigation was conducted among well-nourished and SAM children of 6-59 months in Rohingya refugee camps. These two groups (350 children in each group) of children were observed over 12 weeks and individual data were collected during admission, follow-up visits, and at the time of discharge. Anthropometric information was collected following standard procedures. The thicknesses of the biceps, triceps, subscapular, and supra iliac skinfolds were measured using a Herpenden-type skinfold caliper. Separate linear mixed models were conducted to assess associations of the independent variables (i.e., group and time) with each of the dependent variables (i.e., biceps, triceps, subscapular, supra-iliac skinfold thickness (ST), fat mass (FM), and fat-free mass (FFM)). Both in well-nourished and SAM children, the mean biceps, triceps, subscapular, and supra-iliac ST, FM, and FFM increased over the 12 weeks. The increase in biceps ST was significantly faster in the SAM children compared to the well-nourished children (difference in slope = 0.366 mm every four weeks; p < 0.001). The increment rate in triceps ST was also faster in the SAM children compared to the well-nourished children (difference in slope = 0.430 mm every four weeks; p < 0.001). Moreover, the pace of increase in subscapular (difference in slope = 0.027 mm every four weeks; p < 0.001), and supra-iliac (difference in slope = 0.211 mm every four weeks, p < 0.001) ST was also significantly higher in the SAM group. Similarly, the change in FM (difference in slope = 0.065 kg every four weeks, p < 0.001) and FFM (difference in slope = 0.152 kg every four weeks, p = 0.023) was also significantly faster in SAM children compared to the well-nourished children over the treatment period. Furthermore, the girls gained significantly higher triceps ST, subscapular ST, FM, and FFM compared to the boys. The benefit of RUTF was evident from this longitudinal study in the recovery of FM and FFM contents among the SAM children of Rohingya refugee camps.

Bird beak-related ocular injuries in southern India: Factors and visual implications

PurposeTo evaluate the visual outcomes and identify prognostic factors in patients with ocular bird beak injuries treated at a tertiary eye care center in South India. MethodsWe conducted a comprehensive analysis of patients with bird beak injuries, considering factors such as age, gender, mode of injury, and size of laceration. The affected eyes underwent detailed examinations using slit-lamp biomicroscopy, and B-scan ultrasonography was performed to assess the status of the posterior segment. Postoperatively, the best-corrected visual acuity (BCVA) was measured at the last follow-up visit. ResultsOur findings demonstrated significant improvements in visual outcomes, including BCVA and uncorrected visual acuity (UCVA), over a follow-up period ranging from 1 week to 3 years (p < 0.05). No significant changes were observed in endophthalmitis, intraocular pressure (IOP), lens status, or retinal abnormalities during the study duration. ConclusionThis retrospective study highlight the potential for favorable long-term visual improvement in patients with ocular injuries caused by bird beaks and emphasize the importance of timely intervention. Delayed surgical treatment and the requirement for multiple surgeries within the first week were found to negatively impact visual acuity. Hence, it is crucial to raise public awareness, particularly in rural areas, to prevent these potentially devastating injuries and ensure early intervention for optimal visual recovery.

Hereditary vitreoretinal amyloidosis with transthyretin Gly83Arg variant, a long-term study.

This study evaluated the clinical data on ophthalmic follow-up and treatment efficacy of hereditary vitreoretinal amyloidosis kindred due to transthyretin Gly83Arg variant over a 15-year follow-up period. The clinical data of patients with hereditary ATTRG83R amyloidosis from 2006 to 2021 were analysed retrospectively. Sanger sequencing of the transthyretin gene, detailed medical history, pedigree charting, and systemic and ophthalmic examinations were carried out in all patients. The changes of best-corrected visual acuity (BCVA) after vitrectomy and the associations of amyloidosis recurrence and post-vitrectomy glaucoma were analysed. Fourteen patients with ATTRG83R were included, all experiencing vision loss due to vitreous opacities. The average age of onset was 40.93 ± 6.96 (29 to 52) years. The preoperative BCVA was 2.20 ± 0.69 logMAR, whereas the postoperative BCVA improved to 0.13 ± 0.35 logMAR (P < 0.05). The recurrence time was 58.83 ± 20.85 months after vitrectomy. At 90 months after vitrectomy, the cumulative recurrence rate was 94.7%. Eight eyes developed glaucoma after vitrectomy. None of the 5 eyes without vitrectomy developed glaucoma. Paired chi-square test showed a significant difference in the incidence rate of glaucoma between eyes with or without vitrectomy (P < 0.05). However, retinal amyloid angiopathy and cataract surgery were not associated with glaucoma (P > 0.05). Poor intraocular pressure control in 7 eyes resulted in severe visual impairment. Hereditary ATTRG83R amyloidosis predominantly manifests as vitreous opacity, and vitrectomy can improve the visual acuity in affected patients. However, the recurrence of amyloidosis and related complications significantly impact long-term visual outcomes. Thus, delaying vitrectomy appropriately and maintaining regular follow-up visits is advisable.

Percutaneous repair of achilles tendon ruptures: short-term results of 41 patients

Aims: Despite the current popularity of surgical treatment of Achilles tendon ruptures, there is no clear consensus about which technique should be applied. The aim of this study is to evaluate the short- to mid-term results of acute Achilles tendon ruptures treated with the percutaneous method and to discuss these results in light of the literature. Methods: In this study, 41 patients who were operated on percutaneously with the diagnosis of acute Achilles tendon rupture between 2016 and 2019, whose treatment was completed, and who had a follow-up period of at least 1 year were included. At the patients’ final follow-up visits, the range of motion of the ankle joint, time to return to work and sports, and complications were evaluated. For functional evaluations, the scoring system of the American Orthopaedic Foot &amp; Ankle Society (AOFAS) for the ankle joint was used. Results: The mean age of the patients was 29.3 (18-50) years and the mean follow-up duration was 23 (12-38) months. The mean dorsiflexion angle was 32.27° (20-45°) and the mean plantar flexion angle was 34.58° (20-45°). The time to return to work was 14.2 (8-21) weeks, while time to return to sports was 30.4 (17-49) weeks. The mean AOFAS score of the patients was 91.63 (74-100). The complications included infection in 2 (4.8%) patients, wound necrosis in 1 (2.4%) patient, re-rupture in 1 (2.4%) patient, and sural nerve neuropraxia in 1 (2.4%) patient. Conclusion: The findings of this study suggest that percutaneous repair is an effective method in the treatment of acute Achilles tendon ruptures, like other surgical methods that offer good functional results with low complication rates.

Cervical Myeloradiculopathy With Bilateral Foraminal Stenosis Treated by Unilateral Biportal Endoscopic Decompression with Alternating Hemilaminectomy and Bilateral foraminotomy: A Case Report and Technical Note

Cervical myeloradiculopathy is a debilitating condition characterized by progressive spinal cord dysfunction commonly caused by degenerative changes in the cervical spine. It typically exhibits an insidious onset and progressive functional decline, along with multiple exiting nerve root entrapments bilaterally in some patients. Traditional surgical interventions, such as discectomy and fusion, are associated with some complications and limitations. Unilateral biportal endoscopic (UBE) decompression can have significant advantages over traditional techniques when cervical central and bilateral foraminal decompression is required. In this case report and technical note, we describe our experience with this novel surgical technique for the treatment of cervical myelopathy. A 67-year-old patient presented with progressive neck pain; bilateral upper extremity radiculopathy; loss of power and sensation in the C5, C6, and C7 nerve root distribution; gait imbalance, and spasticity. Magnetic resonance imaging revealed multilevel cervical spondylosis with central canal and bilateral foraminal stenosis. The patient underwent UBE central and bilateral foraminal decompression. At a 9-month follow-up visit, he was able to walk unassisted, his reflexes had returned to normal, no spasticity was observed, and he had good grip strength in both hands. This is a novel technique of UBE decompression with bilateral foraminotomy at the C4–5, C5–6, and C6–7 levels and laminectomy named “the floating tip technique.” The procedure involved bilateral 3-level lamino-foraminotomy and hemilaminotomy on both C5 and C6. A hemilamina was removed on the opposite sides, and flavectomy was performed. Postoperative computed tomography findings showed an intact, complete muscular mass with an intact central spinous process. Therefore, this method was labelled the “floating tip technique.”

Safety and tolerability of tegoprubart in patients with amyotrophic lateral sclerosis: A Phase 2A clinical trial.

The interaction of CD40L and its receptor CD40 on activated T cells and B cells respectively control pro-inflammatory activation in the pathophysiology of autoimmunity and transplant rejection. Previous studies have implicated signaling pathways involving CD40L (interchangeably referred to as CD154), as well as adaptive and innate immune cell activation, in the induction of neuroinflammation in neurodegenerative diseases. This study aimed to assess the safety, tolerability, and impact on pro-inflammatory biomarker profiles of an anti CD40L antibody, tegoprubart, in individuals with amyotrophic lateral sclerosis (ALS). In this multicenter dose-escalating open-label Phase 2A study, 54 participants with a diagnosis of ALS received 6 infusions of tegoprubart administered intravenously every 2 weeks. The study was comprised of 4 dose cohorts: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 8 mg/kg. The primary endpoint of the study was safety and tolerability. Exploratory endpoints assessed the pharmacokinetics of tegoprubart as well as anti-drug antibody (ADA) responses, changes in disease progression utilizing the Revised ALS Functional Rating Scale (ALSFRS-R), CD154 target engagement, changes in pro-inflammatory biomarkers, and neurofilament light chain (NFL). Seventy subjects were screened, and 54 subjects were enrolled in the study. Forty-nine of 54 subjects completed the study (90.7%) receiving all 6 infusions of tegoprubart and completing their final follow-up visit. The most common treatment emergent adverse events (TEAEs) overall (>10%) were fatigue (25.9%), falls (22.2%), headaches (20.4%), and muscle spasms (11.1%). Mean tegoprubart plasma concentrations increased proportionally with increasing dose with a half-life of approximately 24 days. ADA titers were low and circulating levels of tegoprubart were as predicted for all cohorts. Tegoprubart demonstrated dose dependent target engagement associated and a reduction in 18 pro-inflammatory biomarkers in circulation. Tegoprubart appeared to be safe and well tolerated in adults with ALS demonstrating dose-dependent reduction in pro-inflammatory chemokines and cytokines associated with ALS. These results warrant further clinical studies with sufficient power and duration to assess clinical outcomes as a potential treatment for adults with ALS. Clintrials.gov ID:NCT04322149.

Treatment of gingival enlargement caused by orthodontic treatment

The aim of this study was to assess the healing process of gingival enlargement in adolescents with and without fixed orthodontic appliances using conventional scalpel treatments over a 3-month follow-up period. 20 patients with gingival enlargement were divided into two groups. The control group, without fixed orthodontic appliances, received mechanical treatment through conventional scalpel. Test group, comprising patients with fixed orthodontic appliances, was treated using conventional scalpel. Follow-up visits were conducted on days 1 and 90. Clinical periodontal parameters, including plaque index, gingival index, bleeding on probing, probing pocket depth, and gingival overgrowth index, were compared across groups at different time intervals from baseline. All groups exhibited statistically significant reductions in clinical periodontal parameters during the study period (P &lt; 0.05). Test group, treated with conventional scalpel, showed the fastest and most consistent improvements in the healing process compared to baseline. Conventional scalpel therapy proved to be an effective method for treating gingival enlargement, with no reported discomfort or pain during or after the procedure. Given the challenges patients with fixed orthodontic appliances face in maintaining oral hygiene, they should be scheduled for more frequent follow-ups and given thorough home-care instructions.

Pyoderma Gangrenosum: A Retrospective Case Series of 44 Patients

Introduction: Pyoderma gangrenosum (PG) poses a significant dermatological challenge due to its rapidly evolving, painful, necrotic ulcerations. Understanding its multifaceted pathogenesis and diverse clinical presentation is crucial for effective management. Objectives: We aimed to analyze demographic characteristics, clinical manifestations, lesion distributions, systemic disease associations, therapeutic interventions, and patient outcomes in PG cases. Methods: Medical records from 2017 to 2023 of PG patients at IRCCS Sant’Orsola Malpighi Hospital, Bologna, Italy, were retrospectively analyzed. Inclusion criteria encompassed persistent ulcers with clinical and histological evidence of PG, excluding cases with alternative diagnoses or inadequate follow-up. Clinical evaluations, including pain assessment and lesion measurements, were conducted at diagnosis and follow-up visits. Results: A total of 44 patients were evaluated. Pain was a universal symptom, and tissue pathergy was documented in 28.6% of patients. Ulcerative PG was the most common subtype (88.1%). Associations with inflammatory bowel diseases (25%), rheumatoid arthritis (9.1%), and hematological diseases (17.2%) were noted. Lower limbs were frequently affected (63.6%). Treatment approaches included wound management, topical and systemic corticosteroids, and immunosuppressive therapy, with varying response rates. Conclusion: Advanced dressing and steroid therapy were pivotal in mild PG cases, while moderate to severe cases often associated with systemic diseases showed incomplete healing despite treatment, especially in patients with inflammatory bowel diseases and hematological disorders. This study contributes to understanding PG's complexities, highlighting the need for multidisciplinary management and further prospective research.

Efficacy of 1.5% levofloxacin otic solution in treating acute otitis externa: A post hoc analysis of ENT103-3001, a multicenter randomized double-blind parallel-group placebo-controlled phase III study in otitis media with persistent otorrhea

ObjectiveIn this post hoc analysis, we aimed to evaluate the efficacy of 1.5% levofloxacin (LVFX) otic solution for the treatment of acute otitis externa (AOE) in patients with nonintact tympanic membrane (NTM) accompanied by chronic suppurative and acute otitis media. MethodsDigital endoscopic images of the tympanic membrane and cavity were evaluated. In addition, the full analysis set from the original ENT103-3001 study was analyzed to determine the efficacy of the 1.5% LVFX otic solution in treating patients with otitis media with persistent otorrhea. AOE was diagnosed by a study-specific blinded independent review committee (BIRC) in the present study, which reviewed the presence of inflammatory findings, such as edema, erosion, and/or erythema (redness), in the external ear canal on the digital endoscopic images acquired at screening. The improvement in the inflammatory findings in each diseased ear was evaluated by examining the digital endoscopic images acquired at the end of treatment (EOT; including study discontinuation) and follow-up (F/U) visits. Data regarding residual purulent otorrhea at EOT and F/U visits were assessed by the BIRC of the ENT103-3001 study. Similarly, otological symptoms at EOT were recorded in the patients’ diaries, and the bacterial eradication rates were used from the ENT103-3001 study. Improvement was defined as the resolution of the inflammatory findings and purulent otorrhea. ResultsAmong the 201 patients with otitis media, 161 patients had AOE (LVFX group, 82; placebo group, 79). The difference (95% confidence interval) between the groups at EOT was 27.3% (12.7, 40.3), and the proportion of patients showing improvement in all inflammatory findings in the external ear canal in the LVFX group (47.6%, 39/82) was significantly higher than that in the placebo group (20.3%, 16/79; Fisher's exact test, p < 0.001). Similarly, the bacterial eradication rate in the LVFX group (94.3%, 66/70) was also significantly higher than that in the placebo group (10.3%, 7/68; Fisher's exact test, p < 0.001). ConclusionThe use of 1.5% LVFX otic solution resulted in a significantly higher rate of improvement in inflammatory findings in the external ear canal and bacterial eradication rate, indicating its efficacy. Thus, 1.5% LVFX otic solution may be an effective treatment for chronic suppurative otitis media and acute otitis media, as well as AOE with NTM.

Validity and Reliability of the Peds QLᵀᴹ 4.0 Generic Core Scale in Indonesian Version in Children with Chronic Kidney Disease Undergoing Hemodialysis in the Dialysis Unit of Cipto Mangunkusumo Hospital

Background: The Peds QLᵀᴹ 4.0 Generic Core Scales is a modular instrument for measuring health-related quality of life (HR-QoL) in children and adolescents aged 2 to 18 years. The Peds QLᵀᴹ 4.0 GCS consists of 23 items applicable to healthy school and community populations and populations of children with acute and chronic health conditions. The Pediatric Quality of Life Inventory (Peds QLᵀᴹ 4.0 Generic Core Scales) is a modular instrument designed to measure health-related quality of life (HR-QoL) in children and adolescents aged between two and thirteen years. It measures health-related quality of life (HR-QoL) in children and adolescents with progressive chronic kidney disease (CKD), regardless of the underlying etiology, due to the need for regular follow-up visits, strict medication regimens, and dietary intake. Purpose: This study aimed to evaluate the validity and reliability of the Peds QLᵀᴹ 4.0 GCS Indonesian version in children with CKD undergoing hemodialysis (HD) in the Dialysis Unit of Cipto Mangunkusumo Hospital. Methods: This type of research is analytical and observational in nature. The Peds QLᵀᴹ 4.0 GCS were administered to 30 children and 30 parents recruited from a pediatric dialysis unit. This study was conducted at a pediatric dialysis unit at Cipto Mangunkusumo Hospital Jakarta, Indonesia, in Mei-Juni 2024. Validity was tested using Pearson product moment, and reliability was tested using Cronbach's alpha. Results: A total of 30 children and 30 parents undergoing hemodialysis agreed to participate. The average age of the patients was 8–18 years old. Cronbach’s alpha coefficient for the total Peds QLᵀᴹ 4.0 GCS (α child self-report 0.918; α parent proxy report 0.928). Conclusion: The Indonesian versions of The Peds QLᵀᴹ 4.0 GCS were valid and reliable instruments to measure the HR-QoL of children with CKD on hemodialysis. The Peds QLᵀᴹ 4.0 GCS can be applied to provide relevant evidence that helps the function of quality of life among Indonesian patients on hemodialysis in evaluating health programs.

Effectiveness and Safety of GLP-1 Receptor Agonists in Patients with Type 1 Diabetes.

Background: GLP-1 receptor agonists (GLP-1RA) are used in the management of type II diabetes mellitus or obesity, although its role in patients with type I diabetes mellitus (T1DM) has been debated. This study aimed to investigate the efficacy and safety of GLP-1RA in patients with T1DM using real-world data. Methods: This multicenter, retrospective study was conducted at three tertiary medical centers in Riyadh, Saudi Arabia. The study followed up patients (>16 years old) with T1DM treated with insulin followed by GLP-1RA add-on therapy. The efficacy outcomes included changes in HbA1c, body weight, and insulin requirements from baseline to each follow-up visit. The main safety outcomes assessed included hypoglycemic events and gastrointestinal (GI) adverse events. Results: The study included 144 patients with a mean age of 33.0 ± 10.1 years. Semaglutide was the most used GLP-1RA (63.9%) followed by liraglutide (34.0%). From baseline to 3-month follow-up, HbA1c (mean difference (MD) = -0.8%; p = 0.0053), weight (MD = -2.4 kg; p = 0.0253), and daily basal insulin dose (MD = -2.1 units; p = 0.0349) were significantly reduced. Likewise, HbA1c (MD = -0.5%; p = 0.0004), weight (MD = -3.6 kg; p < 0.0001), and daily basal insulin (MD = -2.4 units; p = 0.0282) were significantly reduced at the 4-6-month follow-up. The significant reductions in HbA1c, weight, and daily basal insulin levels were consistent for up to 18-month follow-up. Only one patient had a major hypoglycemic event, whereas 8.3% of the patients had GI adverse events. Conclusions: Overall, significant improvements in glycemic control, weight loss, and insulin requirements were observed with the use of GLP-1RA in patients with T1DM, with a limited number of GI adverse events.

Cost-utility and clinical outcome analysis of surgery or oral corticosteroids treatment in patients with chronic rhinosinusitis with nasal polyps

Background: Surgery and oral corticosteroids are recommended therapies for chronic rhinosinusitis with nasal polyps (CRSwNP) patients who are nonresponsive to intranasal corticosteroid treatment. Objective: This study aimed to compare the effectiveness of these 2 treatments in terms of improving sinus-related symptoms, enhancing quality of life, and economic costs and duration costs. Methods: This prospective study enrolled CRSwNP patients. All participants were instructed to complete the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale, and 36-item short-form (SF-36) questionnaire at baseline and 3 months after treatment. The nasal polyp score (NPS) was assessed via endoscopic examination. Additionally, patients were requested to maintain records of economic direct costs, other indirect costs, and duration costs throughout the 3-month period and to report them during each follow-up visit. Results: A total of 40 patients who underwent surgery or received oral corticosteroids were enrolled in this study. After 3 months of treatment, significant improvements were observed between baseline and 3 months after treatment in the NPS, total SNOT-22 score, and nasal congestion, runny nose, facial pain, olfactory function, and overall symptoms measured. Only headache and sleep order were improved in the surgery group. Both physical functioning and general health, as measured by the SF-36, improved after both treatments, and the role-physical, bodily pain, and social functioning domains of the SF-36 improved only in the surgery group. The changes in the NPS, nasal congestion, runny nose, olfactory function, and sleep disorders in the surgery group were greater than those in the oral corticosteroid group (P values = 0.0003, 0.0092, 0.0258, 0.0284, and 0.0164, respectively). Changes in the total SNOT-22 score and SF-36 subscores were not different between the 2 treatment groups. The direct economic costs and duration costs of surgical treatment were 4.5 times and 17.0 times higher, respectively, than those of oral corticosteroid treatment. Conclusions: Both surgical and oral corticosteroid treatments effectively improved clinical symptoms and quality of life in patients with CRSwNP. Patients who underwent surgery exhibited greater improvements in sinus-related symptoms. Nevertheless, oral corticosteroid treatment presented notable advantages in terms of economic cost and duration cost of disease-related care.

Digital Phenotypes of Mobile Keyboard Backspace Rates and Their Associations With Symptoms of Mood Disorder: Algorithm Development and Validation.

Passive sensing through smartphone keyboard data can be used to identify and monitor symptoms of mood disorders with low participant burden. Behavioral phenotyping based on mobile keystroke data can aid in clinical decision-making and provide insights into the individual symptoms of mood disorders. This study aims to derive digital phenotypes based on smartphone keyboard backspace use among 128 community adults across 2948 observations using a Bayesian mixture model. Eligible study participants completed a virtual screening visit where all eligible participants were instructed to download the custom-built BiAffect smartphone keyboard (University of Illinois). The BiAffect keyboard unobtrusively captures keystroke dynamics. All eligible and consenting participants were instructed to use this keyboard exclusively for up to 4 weeks of the study in real life, and participants' compliance was checked at the 2 follow-up visits at week 2 and week 4. As part of the research protocol, every study participant underwent evaluations by a study psychiatrist during each visit. We found that derived phenotypes were associated with not only the diagnoses and severity of depression and mania but also specific individual symptoms. Using a linear mixed-effects model with random intercepts accounting for the nested data structure from daily data, the backspace rates on the continuous scale did not differ between participants in the healthy control and in the mood disorders groups (P=.11). The 3-class model had mean backspace rates of 0.112, 0.180, and 0.268, respectively, with a SD of 0.048. In total, 3 classes, respectively, were estimated to comprise 37.5% (n=47), 54.4% (n=72), and 8.1% (n=9) of the sample. We grouped individuals into Low, Medium, and High backspace rate groups. Individuals with unipolar mood disorder were predominantly in the Medium group (n=54), with some in the Low group (n=27) and a few in the High group (n=6). The Medium group, compared with the Low group, had significantly higher ratings of depression (b=2.32, P=.008). The High group was not associated with ratings of depression with (P=.88) or without (P=.27) adjustment for medication and diagnoses. The High group, compared with the Low group, was associated with both nonzero ratings (b=1.91, P=.02) and higher ratings of mania (b=1.46, P<.001). The High group, compared with the Low group, showed significantly higher odds of elevated mood (P=.03), motor activity (P=.04), and irritability (P<.05). This study demonstrates the promise of mobile typing kinematics in mood disorder research and practice. Monitoring a single mobile typing kinematic feature, that is, backspace rates, through passive sensing imposes a low burden on the participants. Based on real-life keystroke data, our derived digital phenotypes from this single feature can be useful for researchers and practitioners to distinguish between individuals with and those without mood disorder symptoms.

Familial Mediterranean fever in children from central-southern Italy: a multicentric retrospective cohort study.

Although familial Mediterranean fever (FMF) is a relevant disease in countries surrounding the Mediterranean Sea, there are still few reports from Italy. We retrospectively evaluated patients with FMF diagnosed according to the EuroFever/PRINTO classification criteria in three pediatric rheumatology referral centers in central-southern Italy. Logistic regression analysis assessed the associations between age at disease onset and symptoms. Overall, 48 patients were enrolled (28 females, 20 males), with a median age at onset of 3.3 [3.1] years, and a median follow-up period of 5.1 [10.8] years. The most common MEFV genotype was M694V/- (11 patients, 22.9%), followed by M694V/M694V (6 patients, 12.5%). At onset, recurrent fever was observed in 47 patients (97.9%), with a median time between attacks of 18 [11] days. Overall, recurrent fever was observed in all patients, abdominal pain in 44 (91.7%), and chest pain in 18 (37.5%). At the last follow-up visit, 24 patients were on colchicine (50%), 2 on biologic (4.2%), and 6 on both (12.5%). Canakinumab was the most used biologic drug, in 6 (12.5%) patients. MEFV genotype was associated with disease severity (p = 0.007) and the use of a biological drug (p = 0.01). FMF prevalence in the Abruzzo region was found highly than expected (at least 1:45,000). Differently, we found a relevant gap among FMF patients expected and observed in the Apulia and Sicily regions. FMF is a relevant issue in central-southern Italy. A large epidemiologic study should be performed to better define its prevalence in the country. Key Points • Italian children with familial Mediterranean fever tend to have an early age of onset, primarily manifesting with recurrent fever and characteristic associated symptoms. • Many MEFV gene variants are present in Italian children with familial Mediterranean fever, and these patients are most often heterozygous, exhibiting a mild to moderate phenotype. • The prevalence of familial Mediterranean fever in Italy is still unknown but recently estimated to be around 1:60,000, probably higher in central and southern Italy. • According to our cohort, the prevalence of FMF in the Abruzzo region is at least 1:45,000, higher than expected. Differently, we found lower prevalence rates of the disease in Apulia and Sicily.

Removable dental prostheses for patients with Sjögren's syndrome

Sjögren's syndrome (SS) is a chronic autoimmune condition primarily affecting the salivary and lacrimal glands, leading to pronounced dry mouth (xerostomia) and dry eyes. These symptoms create unique challenges for SS patients requiring removable dental prostheses, as the lack of saliva significantly impacts the retention, comfort, and overall effectiveness of these devices. Without adequate saliva, prosthetic retention diminishes, and patients frequently experience issues such as mucosal irritation and increased susceptibility to infections. To address these issues, tailored material choices are critical in designing effective prosthetic solutions. Soft liners, moisture-retentive acrylics, and antimicrobial coatings are among the innovations improving both retention and comfort for SS patients. The aesthetic and functional outcomes of prosthetic solutions are also essential considerations. Enhanced retention mechanisms, such as implant-supported overdentures, not only improve masticatory performance but also aid in preserving the patient’s facial profile and lip support. Advanced materials offering translucency and color stability contribute to a more natural appearance, which is critical for patient satisfaction. The maintenance of these prostheses requires specific care routines to mitigate microbial buildup and tissue irritation. Specialized cleaning agents and salivary substitutes help maintain hygiene and reduce discomfort, while regular follow-up visits enable timely adjustments to accommodate tissue changes and extend the prosthesis lifespan. Implementing a comprehensive approach that considers material selection, functional and aesthetic outcomes, and maintenance strategies can greatly enhance the quality of life for SS patients. By understanding and addressing the specific needs associated with xerostomic conditions, dental professionals can provide prosthetic solutions that offer both reliability and comfort in this challenging context. Regular patient education and diligent care routines remain essential to ensure the long-term success and durability of removable dental prostheses for individuals with SS.