Retrospective Data Collection Research Articles

Can the radiation dose be safely reduced in the treatment of nk/T cell lymphoma?

The aim of this study is to investigate the feasibility and safety of dose reduction in the radiotherapy of NK/T-cell lymphoma. A retrospective collection of clinical and treatment data was conducted on 41 patients. The analysis aimed to assess whether the reduction in radiation therapy dosage affected patients’ local control and survival. Among the 41 patients, all achieved complete remission after the initial treatment. With a median follow-up of 28.4 months, all except one patient demonstrated good control within the irradiated area. In the entire cohort, a total of 6 patients died and none of the deaths were caused by local tumor failure. The 3-year overall survival rate and progression-free survival rate was 83.8%, 94.4%, respectively. The incidence of long-term toxicity was low. It seems safe to reduce the prophylactic radiation dose to 45 Gy and the preliminary treatment results are satisfactory, with further reduction in side effects.

Impact of migraine and fibromyalgia on temporomandibular disorder: A retrospective study on pain, psychological factors and quality of life.

This study assessed the impact of migraine and fibromyalgia (FM) in TMD patients, focusing on pain, anxiety, depression, and quality of life (QoL). Additionally, we investigated how these variables relate to the total number of comorbidities to gain insights into their interactions. A retrospective data collection was conducted during January 2016 to December 2022, involving 409 adult TMD patients. TMD patients were categorised into four groups: those without comorbidity (TMD-only) and those with comorbid migraine and/or fibromyalgia (TMD + MG, TMD + FM and TMD + MG + FM). Quantitative variables were compared among them. Linear regression was used to analyse the associations between these variables. Most of study population were women (79%) with a mean age of 44.43 years. TMD + MG patients reported longer pain duration, higher pain scores and greater pain interference compared with TMD-only patients. Similarly, TMD + FM patients had higher pain intensity than patients with TMD only. Both the TMD + MG and TMD + FM groups had higher levels of anxiety, depression, and health impairment compared with patients with TMD only. Patients with all three pain conditions (TMD + MG + FM) experienced the longest pain duration, highest pain intensity, psychological distress, and impaired QoL. The result showed positive associations between pain outcomes, psychological measures, pain's impact on QoL, and the number of comorbidities and a negative association between overall health states and the number of comorbidities. These findings underscore the importance of considering the presence of comorbidities and addressing physical and psychological aspects in the management of TMD patients.

O-085 Oocyte cryopreservation: a comprehensive analysis of live birth rate by age and indication of treatment provides reassurance for young cancer patients

Abstract Study question Does the outcome of oocyte cryopreservation vary across different age groups and treatment indications, i.e. cancer diagnosis, other medical conditions or non medical fertility preservation? Summary answer Live birth rate (LBR) is significantly influenced by a woman's age, although not by indication of treatment. What is known already OC is increasingly applied in assisted reproduction, although little is about the outcomes, including livebirth according to indication. Study design, size, duration Retrospective cohort study analyzing all OC and subsequent warmed oocyte cycles in two fertility centers - Melbourne IVF and the Royal Women’s Hospital, Melbourne, Australia, between the years 2014 to 2022. Participants/materials, setting, methods Women undergoing autologous IVF treatment using vitrified and warmed oocytes. Outcome of stimulation cycles and warmed oocyte cycles were assessed according to women’s age at OCP (≤ 35 years, 35-40 years and ≥ 40 years) and treatment indication- cancer diagnosis, other medical conditions and non medical. Main results and the role of chance 2689 women underwent a total of 3801 cycles of OC, comprising 702 cycles for cancer diagnosis (18.6%), 1146 cycles for other medical (30.5%), and 1953 cycles for non-medical (50.9%). Regardless of indication, younger age groups exhibited a higher median number of mature oocytes: <35 (11, 8-17), 35-40 (9, 6-11), and >40 (6, 3-9) (H(2)=15.1, p < 0.05). Among 582 warmed oocytes cycles, the >40 group demonstrated lower rate cycles with at least one good-quality blastocyst (76.7%) compared to 35-40 (87.1%) and <35 (87.2%), p < 0.05. Cumulative live birth rates (cLBR) were also lower in the >40 age group (14.9%) compared to 35-40 (34.9%) and <35 (46.5%), p < 0.01. When analyzing cycles by indication, patients with cancer had lower oocyte survival rate (80.8% vs 84.8% in other medical and 82.1% in non medical, p < 0.01). Nonetheless, no differences in rate of cycles with at least one good quality embryo rates (cancer diagnosis 87.2%, other medical 82.1% and non medical 89.3%, p = 0.06). Patients with cancer diagnosis had higher clinical miscarriage rate (25%) compared with other medical (7%) and non medical (10.5%), p < 0.01. However, cLBR did not differ between the indication groups (29.7% in cancer diagnosis, 35% in other medical and 38.1% in non medical, p = 0.5. Limitations, reasons for caution Retrospective data collection. Wider implications of the findings Our study offers comprehensive data that may assist patients desiring OC, and provides reassurance that even with a cancer diagnosis, outcomes are as favorable as those having non-medical OC. Given the substantial impact of age, health care providers should, when possible, advise to complete this procedure at a young age. Trial registration number Not applicable

Visual scale to document acute dizziness in the hospital

BACKGROUND: Managing acute vertigo/dizziness for inpatients requires valid communication between the various healthcare professionals that triage such life-threatening presentations, yet there are no current scaling methods for managing such acute vertigo symptoms for inpatients. OBJECTIVE: To describe the development and validation of the Krems Acute Vertigo/Dizziness Scale (KAVEDIS), a new instrument for tracking subjective symptoms (vertigo, dizziness) and gait impairment across four unique vestibular diagnoses (Menière’s disease, benign paroxysmal positional vertigo, peripheral vestibular hypofunction, and vestibular migraine) over a one-year period after inpatient hospital admission. METHODS: Retrospective data collection study from KAVEDIS scale and chart documentation. RESULTS: The KAVEDIS scale can significantly distinguish scores from admission to discharge in three of four vestibular diagnoses. The documented course of subjective vestibular symptoms and gait disturbances were correlated in all four groups. CONCLUSION: We suggest that KAVEDIS documentation among inpatients admitted with acute vertigo/dizziness may improve communication between the various intervening clinicians and help to raise concern in cases of symptomprogression.

Neuronal Ceroid Lipofuscinoses Type 7 (CLN7)- A Case Series Reporting Cross Sectional and Retrospective Clinical Data to Evaluate Validity of Standardized Tools to Assess Disease Progression, Quality of Life, and Adaptive Skills.

Background This study evaluated the clinical characteristics of neuronal ceroid lipofuscinosis type 7 or CLN7 disease spectrum to characterize the clinical, electrophysiologic and neuroimaging phenotypes. Methods We performed a single-center cross sectional data collection along with retrospective medical chart review in patients with a genetic diagnosis of CLN7. This study received ethical approval by the University of Texas Southwestern Medical Center Institutional Review Board. A total of 8 patients were included between the ages of 4 to 6 years. All patients had a genetic diagnosis of CLN7 with homozygous or compound heterozygous mutations in the MFSD8 gene. The information collected includes patient demographics, developmental history, neurological events including seizures and neurodevelopmental regression along with further evaluation of brain magnetic resonance imaging and electrophysiological findings. The clinical phenotype is described through cross sectional and retrospective data collection and standardized tools assessing quality of life and functional skills. Conclusions Our findings in this cohort of CLN7 patients indicated that development is initially normal with onset of clinical symptoms as early as two years of age. Language problems were noted prior to or at the onset of seizures in all cases. Gait problems were noted prior to seizure onset in 3 of 8 patients, and at or within 6 months after the onset of seizures in 5 of 8 patients. All patients followed a progressive course of language, motor, and neurocognitive deterioration. Congruent with the medical history, our patients had significantly low scores on adaptive abilities. Natural history data such as this can be used to support future clinical trial designs.

Impact of Safety Device Features Upon Motor Vehicle Collision Facial Fracture Traumas: A Five-Year Retrospective Study in the Appalachian Tri-State Area.

Motor vehicle collisions (MVCs) represent a significant public health concern, contributing to substantial morbidity and mortality globally. Despite advancements in vehicle safety technology, the impact of safety measures on facial fractures in MVCs remains poorly understood, especially in regions with diverse road conditions like the Appalachian tri-state area. This retrospective study analyzed data from two regional level II trauma centers in Appalachia, focusing on MVC-related facial fractures and safety device usage from January 2017 to December 2021. Descriptive statistics and logistic regression models were employed to assess associations between safety devices and injury outcomes. The study comprised 85 participants, categorized into groups based on safety device usage. Results indicated no significant differences in demographic characteristics, injury severity, surgical intervention rates, or specific facial fractures among groups. These findings challenge some previous research suggesting the protective effects of safety devices on facial fractures in MVCs, underscoring the complex nature of injury prevention in this context. While limitations such as retrospective data collection and sample size constrain generalizability, this study contributes valuable insights for informing injury prevention strategies and trauma care practices in Appalachia and beyond.

Results of neoadjuvant therapy for patients with triple negative breast cancer in a public hospital in Brazil (Federal District).

e12660 Background: Breast cancer is the neoplasm with the highest number of deaths among women in Brazil. Triple negative breast cancer contributes to the worsening of this condition, considering that it is more aggressive, accounting for 15% of deaths. Furthermore, more aggressive treatments and new medications have recently been added to neoadjuvant protocols, improving the complete pathological response, but with more side effects. In this way, it is predictive to understand the profile and treatment of choice for patients diagnosed with triple negative breast cancer, contributing to a better understanding of the treatment outcome, survival and quality of life in patients with this health condition. Methods: observational and cross-sectional study with retrospective data collection, in the electronic medical record of the TrakCare system. Patients diagnosed with triple-negative breast cancer between January 2020 and December 2021 and who underwent neoadjuvant treatment were included. Information was collected regarding the date of treatment, age, color/race, comorbidity, staging, type of chemotherapy used, postoperative response rate, and patient evolution during follow-up. Results: 78 patients with triple-negative breast cancer were included. The average age of patients was 56.3 years (26 – 83 years) and approximately 38.5% of patients were under 50 years of age. Around 42.3% of patients had hypertension and 33.3% were obese. Only 28.2% of patients did not have associated comorbidities. Approximately 59% of patients were staged T4 and 35.9% staged T3. Pathological complete response (cPR) was achieved in 56.4%, but progression was recorded in 13% of cases. In 88.5% of patients, the AC-T protocol was used (doxorubicin and cyclophosphamide followed by weekly paclitaxel) and 52% obtained CPR. On the other hand, only 11.5% (9 patients) used the AC-TC protocol (doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin) with a CPR of 89% (p=0.016), with no record of progression or death. Conclusions: Triple negative patients were young and tended to have at least one comorbidity in addition to a highest rate of locally advanced tumor. The more aggressive protocol (AC-TC) was used less often, but has a higher rate of cRP and should be used more frequently in this scenario despite the greater complexity of these patients.

Comparative efficacy of six programmed cell death protein-1 inhibitors in first-line treatment for advanced non-small cell lung cancer: A retrospective cohort study.

e14702 Background: All six programmed cell death-1 (PD-1) inhibitors (nivolumab, pembrolizumab, sintilimab, tislelizumab, toripalimab, and camrelizumab) have been used as first-line therapy in Chinese patients with advanced non-small cell lung cancer (NSCLC), but the comparative efficacy of these different drugs remains unclear. Methods: Retrospective collection of patient data from the First, Third, and Fifth Medical Centers of the Chinese PLA General Hospital who received PD-1 inhibitors (monotherapy or combination therapy) from June 2015 to April 2023. Analysis of patient clinical characteristics, treatment response, and survival outcomes was conducted, with the primary endpoints being overall survival (OS) and progression-free survival (PFS). Secondary endpoints include objective response rate (ORR) and disease control rate (DCR). Results: 913 patients were included and divided into 6 groups: nivolumab (123, 13.5%), pembrolizumab (421, 46.1%), sintilimab (239, 26.1%), tislelizumab (64, 7.0%), toripalimab (39, 4.3%), and camrelizumab (27, 3.0%). Median PFS was 16.0, 16.1, 18.4, 16.9, 23.7, and 12.8 months, and median OS was 33.7, 36.1, 32.5, not reached, 30.9, and 46.0 months for the nivolumab, sintilimab, pembrolizumab, tislelizumab, toripalimab, and camrelizumab groups, respectively. PFS and OS did not differ among the different PD-1 inhibitor groups (all P>0.05). There were differences in ORR among the different PD-1 inhibitors (P<0.05), but no differences in DCR (P>0.05). Conclusions: Nivolumab, pembrolizumab, sintilimab, tislelizumab, toripalimab, and camrelizumab exhibit similar efficacy in first-line treatment for patients with advanced NSCLC.

Real-world outcomes in patients with chronic spontaneous urticaria receiving omalizumab: insights from a clinical practice survey

Objective Chronic spontaneous urticaria (CSU) is a debilitating inflammatory skin condition, often impacting quality of life. International guidelines recommend omalizumab, an anti-immunoglobulin E antibody, for second-line treatment. Our objective was to understand patient characteristics associated with prescription of omalizumab, and assess real-world outcomes in patients with CSU treated with omalizumab. Methods We analyzed data from the Adelphi Real World CSU Disease Specific Programme, a cross-sectional survey with retrospective data collection (December 2020–October 2021) from physicians and patients with CSU in the United States. Results Data from allergists (n = 45), dermatologists (n = 51), and primary care physicians (PCPs; n = 20) were included. At the time of data collection, one-third of patients were receiving omalizumab (n = 220) and 67% were eligible for but not receiving omalizumab (n = 455). Using logistic regression, the odds of receiving omalizumab were higher in patients whose entire bodies were affected by hives [odds ratio (OR) = 2.551; 95% confidence interval (CI) 1.502–4.333; p < 0.001] or with deteriorating/unstable prognoses at treatment initiation [OR = 2.219; 95% CI 1.031–4.777; p = 0.042], and lower in patients managed by PCPs [OR = 0.276; 95% CI 0.130–0.584; p < 0.001]. Estimates from an inverse probability weighted regression adjustment model indicated that patients receiving omalizumab had higher treatment satisfaction, improvements in itching, hives, angioedema, insomnia, and anxiety, and lower impact on work productivity, compared with patients not receiving omalizumab. Conclusion Around two-thirds of patients with CSU considered eligible for omalizumab were not receiving the guideline-recommended therapy. Patients receiving omalizumab had better real-world outcomes compared with patients not receiving omalizumab. Ensuring patients receive the most appropriate treatment could benefit patients with CSU.

Insulin Requirements According to Sex and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery.

The prediction of the individual insulin needs may facilitate the initiation of insulin therapy. Our aim was to explore the relationships between body weight, sex, and daily amounts of insulin delivered by a hybrid closed-loop system. We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Europe with the Diabeloop Generation 1 (DBLG1) hybrid closed-loop insulin delivery device between March 1, 2021 and February 28, 2023. A total of 9036 users (59% females, age 45.6 ± 14.3 years) were included, reaching a mean follow-up of 320 ± 143 days, an overall 2 887 188 days of data. We observed a mean insulin-weight ratio of 0.617 ± 0.207 U/kg (0.665 ± 0.217 for males and 0.584 ± 0.193 for females, P < .001). Exploratory analysis of a subset of 4066 patients reaching >70% Time in Range (70-180 mg/dL) showed a mean insulin-weight ratio of 0.55 ± 0.17 U/kg (P < .001) (0.59 ± 0.18 for the 1438 males and 0.53 ± 0.16 for the 2628 females). This large real-world analysis provides a quantitative estimation of the daily insulin requirements in adult patients with type 1 diabetes and shows significant differences between sex. These findings have relevant implications in the practical management of insulin therapy.

Comparing the risk of death, major adverse cardiac events, and relapse in bullous pemphigoid patients treated with systemic or topical corticosteroids.

According to current guidelines, systemic or topical corticosteroids are recommended as first-line treatments for bullous pemphigoid (BP). There is evidence suggesting that topical application may be associated with a lower risk of mortality. However, there is a lack of comprehensive large-scale data comparing mortality rates, as well as the risk of major adverse cardiac events (MACE), infections, and relapse, between systemic and topical corticosteroid treatments. To evaluate the risk of death, MACE, infections, and relapse in BP patients treated with systemic or topical corticosteroids. A population-based retrospective cohort study was performed in the TriNetX US Collaborative Network. As a measure against bias, propensity-score matching for age, sex, ten diseases and six medications, and three sensitivity analyses were conducted. All-time risk of death was increased in US BP patients exposed to any dose of systemic corticosteroids (n=2,917) compared to topical clobetasol propionate treated patients (n=2,932, hazard ratio [HR], 1.43, 95% confidence interval [CI] 1.28-1.58, p<0.0001). This was consistent in time-stratified analysis (1- and 3-year mortality rates), and in analysis contrasting prednisone (equivalent) does of 1-10 mg (low) or 30-100 mg (medium-high) systemic corticosteroid to topical treatment. The increased risk of death in US BP patients exposed to any dose of systemic corticosteroids compared to topical treatment was accompanied by increased risks for MACE (HR 1.33, CI 1.08-1.64, p=0.0075) and infections (HR 1.33, CI 1.15-1.54, p=0.0001). The risk of continued disease or relapse was decreased in patients treated with systemic as opposed to topical corticosteroid (HR 0.85, CI 0.77-0.94, p=0.0016). Results regarding mortality and continued disease or relapse persisted in three of three sensitivity analyses. Potential limitations are the retrospective data collection, bias for treatment selection and miscoding. Pending validation in prospective studies, where feasible, and despite the heightened risk of relapse, topical corticosteroid treatment may be advantageous compared to systemic corticosteroid treatment due to its significantly lower risk of death.

Impact of untreated preoperative asymptomatic bacteriuria in patients undergoing holmium laser enucleation of prostate.

Treatment of preoperative asymptomatic bacteriuria (ASB) before endoscopic surgery is recommended by European Association of Urology (EAU) guidelines. United Kingdom (UK) practice varies, however, owing to the historical nature of the evidence behind the guidelines, risk of increased antimicrobial resistance, the paradoxical view that treatment of ASB leads to increased infection and inefficiencies in rescheduling. We do not routinely treat ASB in our practice before holmium enucleation of the prostate (HoLEP). To determine the safety of this, we examined our experience focusing on the infective complications. Retrospective data collection was performed on consecutive patients undergoing HoLEP between 2015 and 2020. Indication, preoperative urine cultures and infective complications were recorded. No patients were pretreated with oral antibiotics. All patients received intravenous antibiotics on induction and routine postoperative oral antibiotics at the surgeon's discretion. Some 443 patients were studied. No urosepsis occurred in the 125 patients with ASB compared with 2 of 318 patients (0.6%) with no growth on preoperative urine culture. Twenty-nine (7%) patients were treated with oral antibiotics for symptomatic postoperative complications (urinary tract infection without fever, epididymitis and haematuria). ASB did not predict for infective complications (urosepsis odds ratio [OR]: 0.50 p=0.66; oral antibiotics OR: 0.97 p=0.93). Not treating ASB before a HoLEP procedure is safe. This supports the judicious use of antimicrobials preoperatively. Other modalities of endoscopic surgery should be similarly assessed.

#1011 Clinical characteristics and outcomes of C3 glomerulopathy and immune complex MPGN from the UK National Registry of Rare Kidney Diseases (RaDaR)

Abstract Background and Aims Primary membranoproliferative glomerulonephritis (MPGN), is a rare kidney disorder which can be further divided into immune-complex MPGN (IC-MPGN) and C3 glomerulopathy (C3G) based on relative complement and immunoglobulin staining on biopsy specimens. There is limited literature on the natural history and long-term outcomes of this disorder. The aims of this study were to: Method Adult and paediatric patients with diagnostic biopsy reports that could be classified or reclassified as C3G or IC-MPGN within RaDaR were included. RaDaR contains data on MPGN patients from kidney units across the UK, with automated collection of retrospective and prospective laboratory data. Follow-up time was from diagnosis, defined by biopsy date, until KF, death or last available test result. Kidney failure was defined as initiation of dialysis, kidney transplantation or sustained eGFR ≤15 mL/min/1.73 m2 for ≥4 weeks. Annualized rate of eGFR loss (eGFR slope) was calculated for the first 24 months and over full duration of follow-up. A linear mixed model was used to estimate each patient's intercept and slope of eGFR using a minimum of four observations. Analyses of time to KF were conducted using Kaplan–Meier estimates with log-rank tests for comparisons and Cox regression. The latter was used to investigate the association of early (within 24 months of diagnosis) changes in urine protein:creatinine ratio (UPCR), eGFR and eGFR slope with KF events over maximum of 20 years. Results Our cohort included 135 patients with C3G and 152 patients with IC-MPGN diagnosed between 1987 and 2020. At the time of diagnosis 153/287 (53%) of the cohort were paediatric (&amp;lt;18 years old). Both groups had significant proteinuria at baseline (Table 1). Median eGFR was 70 mL/min/1.73 m2 (IQR 30-92) and 58 mL/min/1.73 m2 (IQR 40-110) for C3G and IC-MPGN respectively. Median time to KF was 9.3 years for C3G and 12 years for IC-MPGN but the difference was not statistically significant (p = 0.31). KF was significantly associated with changes in UPCR between 0-12 months and 6-12 months (HRs adjusted for eGFR) (Fig. 1). Similarly, a 50 mg/mmol reduction in time-averaged UPCR between 0-12 months and 6-12 months was also strongly associated with a lower risk of KF (HR adjusted for eGFR [95% Confidence Interval] 0.66 [0.53-0.83] and 0.71 [0.59-0.85] respectively). Both annualized 24 month eGFR slope, and percentage change in eGFR at 24 months were also significantly associated with KF events (Fig. 1). Conclusion We present one of largest studies describing the demographics, clinical characteristics, and long-term outcomes of 287 UK patients with IC-MPGN and C3G. Consistent with other studies we found no statistically significant difference in time to KF for C3G and IC-MPGN patients. We also demonstrate the value of short-term changes in proteinuria and eGFR (within 24 months of biopsy diagnosis), for predicting long-term risk of kidney failure.

#1214 Post-kidney transplant cancer: incidence, risk factors and future perspectives. Real-world analysis of a single Italian center

Abstract Background Our retrospective observational study aims to describe the epidemiology of cancer after KTx and to investigate its risk factors and the impact on therapeutic management and survival, in a big monocentric cohort of kidney transplant patients (KT-ps). The association between a specific modification of immunosuppressive therapy after cancer diagnosis and survival outcomes will be analyzed. Methods Retrospective collection of data in KTx-ps transplanted between January 2004 and December 2021, subjected to outpatient follow-up with a median follow-up of 7 [1-19] years. Results We included 930 KTx-ps with mean age at KTx of 49 years. 91% had received pre-TR dialysis, for an average of 52 months. The majority had received KTx from a deceased donor (84%). 74% had undergone induction therapy with Basiliximab and 26% ATG. Maintenance therapy included in most cases the use of steroids (87%), calcineurin inhibitors (tacrolimus 92%, ciclosporin 8%), and mycophenolate (94.6%). Patients with at least one cancer (CAN+) were 177 (19%). The mean time from TR to oncological diagnosis was 83 months. Non-melanoma skin cancers (NMSC) were the most common tumors (55%), while solid tumors were observed in 38.6% of cases. Deceased donor was more represented in CAN+. CAN+ were older and with higher BMI. They had greater presence of vasculitis as basic nephropathy. In the period between 2016 and 2021, induction therapy with ATG was significantly associated with CAN+. In multivariable analysis, ATG emerged as an independent risk factor for CAN+ (p=0.014) and, in survival analyses, ATG was strongly and significantly related to the earlier development of CAN+ (p=0.010). During follow up, cancer-related causes were the second cause of mortality (23%); the average time from cancer diagnosis to death was 23 months. The median survival from TR was 148 (CAN+) and 82 months (CAN−). After oncological diagnosis, significant evidence on tumor survival was derived from the shift to mTOR inhibitors compared to the group with definitive drug suspension (p=0.004). Conclusion The data reported by our study confirm the relevance of cancer as a complication in KTx. ATG represent an independent risk factor for cancer; in this context, a personalized choice of immunosuppressive therapy to be proposed at the time of TR represents a crucial point in the prevention of neoplastic risk. In the KTx-ps, therapeutic strategies with antineoplastic agents and management of immunosuppression therapy after malignancy remain important research perspectives in the near future.

#2632 Quality of life and fatigue burden in individuals living with Complement 3 Glomerulopathy – a real-world study

Abstract Background and Aims C3 glomerulopathy (C3G) has an estimated incidence of 1 to 2 per million per year and is associated with a high risk of disease progression, with approximately 50% of patients reaching kidney failure within ten years of diagnosis; despite this, there are currently limited treatment options available. The impact of C3G on patient fatigue and quality of life (QoL) is well understood but not well described in large scale real-world settings; this study aims to address this. Method Data were drawn from the Adelphi C3G Disease Specific Programme™, a cross-sectional survey with retrospective data collection of C3G-treating nephrologists in France, Germany, Italy, Spain, the United Kingdom (EU5), China, Japan, and the United States (US) from August 2022 – April 2023. Nephrologists completed surveys for 1–9 consecutively consulted C3G patients, reporting patient demographics, treatment history, symptoms and QoL. Patients for whom nephrologists completed a form were then invited to complete a voluntary follow-up questionnaire to capture impact of C3G across QoL metrics including the 5-level EQ-5D version [EQ-5D-5L] (which captures QoL at the time of survey) and the Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue (which captures typical impact of fatigue across the 7 days prior to survey completion). Analyses were descriptive. Results Overall, 111 nephrologists reported on 385 patients (EU5 n=189, China n=60, Japan n=36, US n=100). At the time of the survey, median (interquartile range; IQR) patient age was 42.0 (30.0, 55.0) years and 59% of patients were male. Median (IQR) proteinuria was 1.4 g/24 hr (0.8 g/24 hr-3.0 g/24 hr) and eGFR was 50.0 mL/min/1.73m2 (32.00 mL/min/1.73m2 -70.00 mL/min/1.73m2). Of the 385 patients with physician reported data, 118 patients completed their own matched questionnaire, the majority of which were based in China (EU5 n=33, China n=60, Japan n=6, US n=19). Among these patients who completed the EQ-5D 74% experienced anxiety and/or depression, 65% felt pain and/or discomfort and 63% experienced problems doing their usual activities. QoL was also impacted across the further 2 domains: 42% experienced mobility problems and 30% experienced self-care problems (washing or dressing themself). Fatigue as measured by the FACIT fatigue was commonly reported across all patients; 93% of patients felt tired, 91% felt fatigued, 84% felt listless and 82% felt weak all over. The majority (77%) also reported that they needed to sleep during the day. Fatigue impacted all aspects of the patients’ lives; 47% reported feeling too tired to eat, 62% required some help to conduct their usual activities, 71% struggled to start things because they are tired, 74% struggled to finish things because they are tired and 78% reported limiting their social activities due to their fatigue. Most patients (69%) also reported feeling some level of frustration due to tiredness preventing them from doing what they want to do, and 3% felt they could not do their usual activities at all. All the above results on anxiety and depression, pain and discomfort and fatigue were relatively similar across all regions, with EU5 generally reporting a slightly lower frequency. Conclusion Chronic kidney disease (CKD) such as C3G places a substantial burden on patients’ QoL. Living with C3G has a clear impact on all aspects of the patients’ lives, encompassing both an emotional impact (e.g., anxiety/depression and frustration), as well as a physical impact (e.g., pain/discomfort, mobility and fatigue). More efficacious treatment options are needed to treat the cause of C3G to improve patients’ daily lives, increase their QoL, and to reduce the impact of living with C3G.

Predicting the PSQA results of volumetric modulated arc therapy based on dosiomics features: a multi-center study

Backgroud and objectivesThe implementation of patient-specific quality assurance (PSQA) has become a crucial aspect of the radiation therapy process. Machine learning models have demonstrated their potential as virtual QA tools, accurately predicting the gamma passing rate (GPR) of volumetric modulated arc therapy (VMAT)plans, thereby ensuring safe and efficient treatment for patients. However, there is limited multi-center research dedicated to predicting the GPR. In this study, a dosiomics-based machine learning approach was employed to construct a prediction model for classifying GPR in multiple radiotherapy institutions. Additionally, the model’s performance was compared by evaluating the impact of two distinct feature selection methods.MethodsA retrospective data collection was conducted on 572 VMAT patients across three radiotherapy institutions. Utilizing a three-dimensional dose verification technique grounded in real-time measurements, γ analysis was conducted according to the criteria of 3%/2 mm and 2%/2 mm, employing a dose threshold of 10% along with absolute dose and global normalization mode. Dosiomics features were extracted from the dose files, and distinct subsets of features were selected as inputs for the model using the random forest (RF) and RF combined with SHapley Additive exPlanations (SHAP) methods. The data underwent training using the extreme gradient boosting (XGBoost) algorithm, and the model’s classification performance was assessed through F1-score and area under the curve (AUC) values.ResultsThe model exhibited optimal performance under the 3%/2 mm criteria, utilizing a subset of 20 features and attaining an AUC value of 0.88 and an F1-score of 0.89. Similarly, under the 2%/2 mm criteria, the model demonstrated superior performance with a subset of 10 features, resulting in an AUC value of 0.91 and an F1-score of 0.89. The feature selection methods of RF and RF + SHAP have achieved good model performance by selecting as few features as possible.ConclusionBased on the multi-center PSQA results, it is possible to utilize dosiomics features extracted from dose files to construct a machine learning predictive model. This model demonstrates excellent discriminative abilities, thus promoting the progress of gamma passing rate prognostic models in clinical application and implementation. Furthermore, it holds potential in providing patients with secure and efficient personalized QA management, while also reducing the workload of medical physicists.

Increased risk of fetal left-right asymmetry disorders associated with maternal SARS-CoV-2 infection during the first trimester.

Our center has observed a substantial increase in the detection rate of fetal left-right(LR) asymmetry disorders between March and May 2023. This finding has raised concerns because these pregnant women experienced the peak outbreak of SARS-CoV-2 in China during their first trimester. To explore the relationship between maternal SARS-CoV-2 infection and fetal LR asymmetry disorders. A retrospective collection of clinical and ultrasound data diagnosed as fetal LR asymmetry disorders was conducted from January 2018 to December 2023. The case-control study involved fetuses with LR asymmetry disorders and normal fetuses in a 1:1 ratio. We evaluated and compared the clinical and fetal ultrasound findings in pregnant women with SARS-CoV-2 infection and pregnant women without infection. The Student t-test was utilized to compare continuous variables, while the chi-squared test was employed for univariable analyses. The incidence rate of LR asymmetry disorders from 2018 to 2023 was as follows: 0.17‰, 0.63‰, 0.61‰, 0.57‰, 0.59‰, and 3.24‰, respectively. A total of 30 fetuses with LR asymmetry disorders and 30 normal fetuses were included. This case-control study found that SARS-CoV-2 infection (96.67% vs 3.33%, P = .026) and infection during the first trimester (96.55% vs 3.45%, P = .008) were identified as risk factors. The odds ratio values were 10.545 (95% CI 1.227, 90.662) and 13.067 (95% CI 1.467, 116.419) respectively. In cases of SARS-CoV-2 infection in the first trimester, the majority of infections (88.1%, 37/42) occurred between 5 and 6weeks of gestation. We found that 43.7% (66/151) of fetuses with LR asymmetry disorder had associated malformations, 90.9% (60/66) exhibited cardiac malformations. SARS-CoV-2 infection during the first trimester significantly increases the risk of fetal LR asymmetry disorders, particularly when the infection occurs between 5 and 6 gestation weeks. The most common associated malformation is heart malformation.

Result of the left bundle branch area pacing data collection registry, an international multicenter study of conduction system pacing with a Tendril STS 2088 stylet-driven lead.

Left bundle branch area (LBBA) pacing (LBBAP) has been proposed as an alternative therapy option in patients indicated for cardiac pacing to treat bradycardia or heart failure. The aim of the study was to evaluate the safety and effectiveness of LBBAP in patients implanted with a Tendril 2088 stylet-driven lead. The international retrospective data collection registry included 11 sites from 5 countries globally. Patients with attempted implants of the Tendril lead in the LBBA were followed for at least 6 months post the implant attempt. The primary safety and efficacy endpoints were freedom from LBBAP lead-related serious adverse events and the composite of LBBA capture threshold of ≤2.0 V and R-wave amplitudes ≥5 mV (or ≥value at implant), respectively. Of 221 patients with attempted implants of the Tendril 2088 lead in the LBBA, 91.4% (202/221) had successful implants for LBBAP. Regardless of the LBBAP implant success, all patients were followed for at least 6 months (8.7 ± 7.3 months). Baseline characteristics: 44% female, 84% ≥65 years old, 34% coronary artery disease, and 86% of primary indications for pacemaker implant. Both primary safety and effectiveness endpoints were met (freedom from LBBAP lead-related serious adverse device effects of 99.5% and electrical performance composite success rate of 93%). The capture thresholds in LBBAP at implant and 6 months were 0.8 ± 0.3 V@0.4 ± 0.1 ms and 0.8 ± 0.3 V@0.4 ± 0.1 ms. The rate of patients with capture threshold rise ≥1 V was 1.5% through 6 months. The R-wave amplitudes in LBBAP at implant and 6 months were 9.3 ± 3.2 mV and 10.6 ± 3.0 mV. This large multicenter study demonstrates that the stylet-driven Tendril™STS 2088 lead is safe and effective for LBBAP with high success and low complication rates.

Patient Burden of Nonsegmental Vitiligo: A US Real-World Survey of Dermatologists and Their Patients.

Vitiligo is a chronic autoimmune disease characterized by destruction of melanocytes, leading to skin depigmentation. Vitiligo can have a high quality-of-life burden and profound impact on psychosocial well-being. The objectives of this study were to describe the self-reported patient burden among patients with nonsegmental vitiligo with≤10% affected body surface area, summarize the physician-reported psychosocial and psychological impact of vitiligo on patient lives, and describe disease characteristics and treatment history, goals, and satisfaction. Data were drawn from the Adelphi Vitiligo Disease Specific Programme™, a real-world, cross-sectional survey with retrospective data collection of physicians and patients with vitiligo, collected in the United States between October 2021 and April 2022. Separate surveys for dermatologists and patients contained questions on clinical and demographic characteristics of patients with vitiligo and burden of vitiligo. Treatment history, goals, and satisfaction were assessed together with the impact of vitiligo on quality of life. Sixty-one dermatologists provided data for 326 patients with≤10% affected body surface area (adults, n=221; adolescents, n=105); 90 of those patientsalso responded to the survey. The most common treatments were topical corticosteroids, topical calcineurin inhibitors, and narrow-band ultraviolet-B phototherapy, with the main treatment goal being repigmentation. Physician-reported treatment satisfaction was 56%; 25% of patients reported frustration with treatment options. Physicians reported impact of vitiligo on everyday life in 46% of patients. Patients reported 12.7% overall work impairment; mean scores for Hospital Anxiety and Depression Scale anxiety and depression domains were 3.5 and 2.2, respectively, and mean Vitiligo-specific Quality of Life index score was 26.9. Patients with facial involvement experienced higher burden than those without. A high patient burden was reported by dermatologists and their patients with vitiligo who had≤10% affected body surface area, including psychosocial and psychological consequences. Thesefindings highlight an unmet need in the treatment of vitiligo.

Does intravesical Bacillus Calmette-Guérin for bladder cancer protect from COVID-19?

The study aimed to correlate the history of intravesical BCG as well as infantile BCG immunization with the incidence and severity of COVID-19 infection. Retrospective data collection of patients with high-risk non muscle invasive bladder cancer (NMIBC) from two Canadian centers. Data collection included a history of BCG instillation, infantile immunization, and the development of COVID-19 infection. Admission and/ or mortality because of COVID-19 was reported. We could include data from 348 patients: including 188 and 160 patients from Ontario and British Columbia respectively. COVID-19 affected 15% of these patients. Intravesical BCG was used in 44% of these patients. Intravesical BCG and/or infantile BCG immunization did not correlate with the incidence of COVID-19 infection. Previous intravesical BCG and/ or a history of infantile BCG vaccination were not more/ less frequent in patients who had COVID-19 infection.