Higher Proportion Of Patients Research Articles

A79 PATIENT AND PHYSICIAN PERSPECTIVES ON IMPLEMENTION OF BEDSIDE INTESTINAL ULTRASOUND FOR THE ASSESSMENT OF INFLAMMATORY BOWEL DISEASE

Abstract Background New tools for evaluating Inflammatory Bowel Disease (IBD) activity and complications are needed to deliver timely disease management and improve patient outcomes. Point of care (POC) intestinal ultrasound (IUS) is safe, inexpensive, and less invasive compared to standard endoscopy and imaging. Aims To evaluate the implementation of POC IUS within an ambulatory IBD clinic at the QEII Health Sciences Center. Methods This was a retrospective evaluation of a cohort of patients who had undergone IUS within the Nova Scotia Collaborative Inflammatory Bowel Diseases Clinic (NSCIBD) between January 18, 2023 and August 13, 2023. Medical records were reviewed retrospectively. Patient demographics, disease-related characteristics, perceived impact of IUS on need for endoscopy, perceived impact of IUS on IBD management, and clinical utility of IUS were collected. Surveys were administered prospectively to referring care providers and patients following IUS. Patient surveys assessed IUS satisfaction, acceptance of other methods to assess IBD activity, whether IUS improved knowledge of illness, and impact on quality of life (QoL). Results One physician completed 107 IUS exams on 92 patients at the NSCIBD clinic over a nine-month period. Of 92 patients, 47 (51%) were male and 78 (85%) had Crohn’s disease. 53 patients provided an email and consented to survey participation. 34 responses were submitted (64%). There were 97 responses (91%) from 12 referring gastroenterology specialist clinicians. Ninety-three percent of responses show IUS reports were very helpful (60%) or somewhat helpful (33%). More than a third (37%) of IUS exams were reported to delay or prevent the need for endoscopic evaluation, and 34% were reported to prompt a therapeutic change. Of available tools, IUS had the highest proportion of patients who felt it was completely acceptable (77%), compared to colonoscopy (41%), stool sampling (50%), blood tests (71%), and computed tomography/magnetic resonance imaging (47%). Most (89%) indicated IUS caused either no discomfort (68%) or little discomfort (21%), with no patient reporting a lot of discomfort. Some patients (41%) reported that IUS improved their understanding of their illness, and 38% believe it improved their QoL. Conclusions POC IUS offers an accurate, less invasive option for monitoring IBD activity compared to traditional investigations. There is limited data on implementation of, and patient and clinician perspectives regarding use of IUS and its clinical implications. Even early in implementation, POC IUS has clear benefits. This study suggests that IUS is highly acceptable to patients for investigating/monitoring their illness. Treating clinicians find significant value in IUS and report that it can prevent the need for endoscopic evaluation and prompt changes in therapeutic management. Funding Agencies None

The influence of sleep factors and dietary habits on the disease pattern of ulcerative colitis patients with long and short disease courses – a multicentre cross-sectional analysis

Background Ulcerative colitis (UC) is a disease characterized by chronic relapsing-remitting inflammatory disorders and is associated with environmental changes. Aim To explore the disease patterns of Chinese UC patients and to determine controllable related environmental factors. Methods This multicentre cross-sectional study was performed using a questionnaire survey. Data on clinical characteristics and environmental factors were collected. Patients with a disease course ≥5 years were defined as the long course group, and those with a disease course < 5 years were defined as the short course group. Results A total of 588 effective questionnaires were collected. The proportion of the chronic continuous pattern was the highest among patients with a long disease course (46.8%), and in patients with a short disease course, the proportion of the active to remission pattern was the highest (53.3%). In patients with a long disease course, a higher proportion of patients with adequate sleep was found in the active to remission pattern than in the chronic intermittent (72.1% vs. 43.3%, p = 0.008) and chronic continuous (72.1% vs. 52.4%, p = 0.016) patterns. In patients with a short disease course, the frequency of shellfish and shrimp was higher in the chronic continuous pattern group than in the active to remission pattern group (P = 0.001 and 0.017 respectively). Conclusions For early diagnosis patients, dietary guidance should be actively carried out. With the prolongation of the disease course, attention should be given to the sleep quality of patients.

The Influence of Sidedness in Unilateral Cleft Lip and Palate on Mid Facial Growth at Five Years of Age.

To determine whether facial growth at five years is different for children with a left versus right sided cleft lip and palate. Retrospective cohort study. Seven UK regional cleft centres. Patients born between 2000-2014 with a complete unilateral cleft lip and palate (UCLP). 5-Year-Old's Index scores. 378 children were included. 256 (68%) had a left sided UCLP and 122 (32%) had a right sided UCLP. 5-Year-Old's index scores ranged from 1 (good) to 5 (poor). There was a higher proportion of patients getting good scores (1 and 2) in left UCLP (43%) compared to right UCLP (37%) but there was weak evidence for a difference (Adjusted summary odds ratio 1.27, 95% CI 0.87 to 1.87; P = .22). Whilst maxillary growth may be different for left versus right sided UCLP, definitive analysis requires older growth indices and arch forms.

The UK Divide: Does Having a Pembrolizumab–Chemotherapy Option in Head and Neck Cancer Matter? Real-world Experience of First-line Palliative Pembrolizumab Monotherapy and Pembrolizumab–Chemotherapy Combination in Scotland

AimsThe Scottish Medical Consortium recently approved first-line pembrolizumab monotherapy or in combination with chemotherapy for head and neck squamous cell carcinoma in the palliative setting, contrasting with the decision made by the National Institute for Health and Care Excellence, who approved monotherapy alone in England and Wales. The aim of this study was to provide real-world performance data for first-line pembrolizumab-containing treatments for head and neck squamous cell carcinoma in the palliative setting in Scotland. Materials and methodsWe analysed the electronic records of patients who started pembrolizumab-containing treatment between 1 March 2020 and 30 September 2021. Outcomes included overall survival, progression-free survival (PFS), the duration of response and the disease control rate. Data were compared with the KEYNOTE-048 study and clinical factors were evaluated for association with survival. ResultsOur cohort included 91 patients (median follow-up 10.8 months). Patient characteristics were similar to those in the KEYNOTE-048 study, although our cohort had a higher proportion of patients with newly diagnosed, non-metastatic disease. For patients receiving monotherapy (n = 76), 12- and 24-month overall survival were 45% and 27%, respectively. For patients receiving pembrolizumab–chemotherapy (n = 15), 12-month overall survival was 60% (24-month overall survival had not yet been reached). Experiencing one or more immune-related adverse event (irAE; versus no irAEs), of any grade, was associated with favourable overall survival and PFS for patients receiving monotherapy in both univariable Log-rank analysis (median overall survival 17.4 months versus 8.6 months, respectively, P = 0.0033; median PFS 10.9 months versus 3.0 months, respectively, P < 0.0001) and multivariable analysis (Cox proportional hazards regression: overall survival hazard ratio 0.31, P = 0.0009; PFS hazard ratio 0.17, P < 0.0001). ConclusionOur real-world data support the KEYNOTE-048 study findings and the value of combination treatment options. Additionally, our data show that irAEs of any grade, as reported in routine clinical records, are associated with better outcomes in this patient group, adding to the growing body of evidence showing that irAEs are generally a positive marker of programmed death-ligand 1 (PD-L1) inhibitor response.

Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study

Purpose: The aim of this study was to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, in the treatment of Demodex blepharitis. Methods: This observational, extension study included patients with Demodex blepharitis (N = 239) who completed the Saturn-1 study and presented for the day 180 visit. All participants were assessed at days 180 and 365 after the initiation of 6-week treatment with the study drug or its vehicle. Results: The proportion of patients with 0 to 2 collarettes (grade 0) was significantly higher in the study group (N = 128 patients) than in the control group (N = 111 patients) (39.8% vs. 2.7% at day 180 and 23.5% vs. 2.9% at day 365; P &lt; 0.0001). Similarly, the proportion of patients with ≤10 collarettes (collarette grade 0–1) in the study group was significantly higher than in the control group (70.3% vs. 18.0% at day 180 and 62.6% vs. 21.9% at day 365; P &lt; 0.0001). In the study group, erythema continued to improve even after completion of the 6-week lotilaner treatment. No serious ocular adverse events were observed in the study group, and there was 1 treatment-related ocular adverse event in the study group, which was considered mild. Conclusions: After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy.

Efficacy and safety of oral sulfate tablet vs. polyethylene glycol and ascorbate for bowel preparation in children.

Bowel preparation for pediatric colonoscopy presents several challenges. However, no bowel preparation regimen is universally preferred for children. We aimed to investigate the efficacy and safety of oral sulfate tablet (OST) in pediatric bowel preparation. This study retrospectively analyzed data from children who received 2l of polyethylene glycol and ascorbate (PEG/Asc) or OST for bowel preparation between 2021 and 2023. A comparative analysis was conducted between the two groups. A total of 146 patients were included (2l PEG/Asc: 115, 73.0% vs. OST: 31). No significant difference was observed in the total BBPS score (median 8.0 vs. 8.0, P = 0.152) and the total OBPS score (median 5.0 vs. 3.0, P = 0.152) between the two groups. No significant difference was noted in the ratio of a bubble score of 0 (73.0% vs. 93.5%, P = 0.132). The incidence of abdominal pain was significantly lower in the OST group (32.2% vs. 3.2%, P = 0.002). The VAS score for overall satisfaction was significantly higher in the OST group (4.0 vs. 7.0, P < 0.001). For the next colonoscopy bowel preparation, a higher proportion of patients in the OST group showed a willingness to use the same preparation regimen (33.9% vs. 83.9%, P < 0.001). OST was as efficacious and safe as 2 L of PEG/Asc for pediatric bowel preparation. The satisfaction level was higher with OST than with 2 L of PEG/Asc. OST may be considered a good alternative for children with poor compliance during bowel preparation.

Analysis of clinical characteristics, treatment patterns, and outcome of patients with bilateral testicular germ cell tumors

IntroductionBilateral testicular germ cell tumor (BGCT) is a rare disease, occasionally considered to be more aggressive than unilateral germ cell tumors (GCT) in some reports. Among BGCT, a synchronous disease might be diagnosed at a higher stage than a metachronous disease, resulting in lower cancer-specific survival. Hence, our study aimed to perform a comparative analysis between unilateral testicular GCT, bilateral synchronous GCT, and bilateral metachronous GCT, aiming to verify the possibility that BGCT is diagnosed with a higher stage and may require more aggressive management.Material and methodsIn our multicenter retrospective study we reviewed medical records of 40 patients with BGCT (24 metachronous and 16 synchronous). Clinical characteristics, pathological features of the primary and secondary tumors, adjuvant treatments (chemotherapy and radiotherapy)and sperm quality were evaluated as well as cancer-specific survival and overall survival. A cohort of one-to-one matched patients with unilateral GCT were used to determine risk factors for developing BGCT.ResultsPatients with BGCT were slightly younger compared to those with unilateral GCT and had more advanced disease. Despite similar T-stage distribution between the two groups, nodal involvement was nearly twofold more frequent in patients with BGCT disease (42% vs 22%, p = 0.056). Additionally, although similar histological subtypes distribution at presentation among the two groups, the synchronous disease was diagnosed with a higher local T-stage (OR = 3.4), higher proportions of patients with elevated serum BHCG levels, and more frequent nodal involvement (OR = 2.2). This was later translated into an 18% higher disease-specific mortality rate. The median time to develop a contralateral tumor was 92 months. Pathological local T-stage (T2–T3) of the primary tumor predicted a shorter time interval to a diagnosis of a second contralateral tumor (HR 0.92, P < 0.05).ConclusionBGCT presents at a younger age and potentially with more advanced disease. Synchronous BGCT is diagnosed at a later stage compared to metachronous BGCT and has higher disease-specific mortality. Metachronous tumors might have a long time interval for the development of a contralateral neoplasm. The main predictor of developing an early metachronous disease is a high primary T stage.

Exploring 5-year changes in general and skin health-related quality of life in psoriatic arthritis patients.

Psoriatic arthritis (PsA) carries a severe disease burden, often leading to deterioration of health-related quality of life (HRQoL). Different comorbidities that are relatively prevalent in PsA are also responsible for compromised HRQoL. To assess real-world data of a 5-year follow-up cohort of PsA patients, focusing on changes in general HRQoL, skin HRQoL, and comorbidities. In this prospective observational study, 114 outpatients diagnosed with PsA were examined at baseline and after 5years. Data collection included demographics, clinical disease activity measures, and patient-reported outcome measures (PROMs). General HRQoL was assessed with a 15D instrument, and skin HRQoL was assessed with the Dermatology Life Quality Index (DLQI). During the 5-year follow-up, no significant deterioration in HRQoL assessed by 15D (23.53 vs. 23.08, p = 0.85) and DLQI (3.48 vs. 2.68, p = 0.07) was observed. There was no observed decline in other PROMs. The mean total number of comorbidities increased (1.13 vs. 1.39, p < 0.01). A significant improvement in disease activity measures, including 66/68 swollen/tender joint count, Disease Activity Index for Psoriatic Arthritis (all p < 0.01), and Psoriatic Arthritis Severity Index (p = 0.04) was seen. A higher proportion of patients at 5years were treated with b/tsDMARDs (37.7% vs. 46.5%, p = 0.03). Despite an increased number of comorbidities over 5years, our PsA cohort showed no decline in HRQoL. This can be attributed to the widespread adoption of modern treatments, leading to improved disease control and the preservation of baseline HRQoL.

Hip arthroscopy is an effective treatment for high-level female athletes

ObjectivesThis study aimed to assess the outcomes of hip arthroscopic surgery in high-level female athletes diagnosed with femoroacetabular impingement (FAI) compared to those with lower levels of sports activity. Additionally, we investigated the effectiveness of patient-reported outcomes (PROs) and the potential ceiling effect as a lack of sensitivity in detecting clinically statistically significant changes in high-level female athletes due to high baseline scores. MethodsWe conducted a retrospective analysis of prospectively collected data from female patients who underwent hip arthroscopy for FAI between January 2016 and August 2022 with a minimum 1-year follow-up. Patients were categorised into two groups: high-level athletes (group A) and low sports activity level (group B). Various PROs, visual analogue scales for pain, and patient satisfaction were assessed preoperatively and postoperatively. Return to sports (RTS) rates were determined based on the patient's reported ability to return to their previous level of sports activity. The minimally clinically important differences (MCIDs) and the Patient-Acceptable Symptomatic State (PASS) analyses were used to evaluate the clinical impact of the Hip Outcome Score-Sport Subscale (HOS-SSS). ResultsA total of 11 high-level female athletes were included in group A, and 22 were included in the low sports activity level group B. Both groups showed significant improvements in PROs, with no significant differences between them. RTS rates were lower in high-level athletes (63.6%) than in low sports activity patients (85.7%). Visual analogue scales for pain improved significantly in both groups. Patient satisfaction was high in both groups, with a median score of 9. The HOS-SSS showed no ceiling effect, and the MCID and PASS analyses indicated that a high proportion of patients in both groups achieved clinically relevant improvement in HOS-SSS. ConclusionHip arthroscopic surgery is effective for FAI treatment in high-level female athletes, with outcomes similar to those in patients with lower sports activity levels. The absence of a ceiling effect in sports-related outcomes suggests that PROs can detect clinically significant changes in high-level female athletes. Although RTS rates were lower in high-level athletes, this difference was not significant. These findings underscore the value of using PROs to evaluate outcomes in female athletes with different sports-activity levels. Level of evidenceIV.

Acute Diabetes-Related Complications in Patients Receiving Chemoradiotherapy for Head and Neck Cancer.

Consecutive patients with head and neck squamous cell or nasopharyngeal cancer who underwent definitive or adjuvant CCRT between 2010 and 2019 at two large cancer centers in Australia were included. Clinicopathological characteristics, treatment complications and outcomes were collected from medical records. Of 282 patients who received CCRT, 29 (10.3%) had pre-existing type 2 diabetes. None had type 1 diabetes. The majority (74.5%) required enteral feeding. A higher proportion of patients with diabetes required admission to a high-dependency or intensive care unit (17.2 versus 4.0%, p = 0.003). This difference was driven by the group who required insulin at baseline (n = 5), of which four (80.0%) were admitted to a high-dependency unit with diabetes-related complications, and three (60.0%) required omission of at least one cycle of chemotherapy. Patients with diabetes requiring insulin have a high risk of acute life-threatening diabetes-related complications while receiving CCRT. We recommend multidisciplinary management involving a diabetes specialist, educator, dietitian, and pharmacist, in collaboration with the cancer care team, to better avoid these complications.

Real-world survival of men with metastatic castration-sensitive prostate cancer (mCSPC) initiated on apalutamide (APA) or enzalutamide (ENZ) in an oncology database: ROME Study.

57 Background: Androgen receptor signaling inhibitors (ARSIs), including APA and ENZ, have demonstrated progression-free and overall survival benefits for men with mCSPC in the clinical trial setting, but data evaluating real-world treatment effectiveness remains limited. The aim of this study was to describe real-world survival among men with mCSPC who initiated APA or ENZ in the United States (US). Methods: In this retrospective longitudinal cohort study, clinical data from the Flatiron Metastatic Prostate Cancer (PC) Core Registry Electronic DataMart (1/1/2013–05/31/2023) were used. Patients with chart-confirmed metastasis and without castration resistance were classified into two treatment cohorts based on earliest initiation of APA or ENZ on/after 12/16/2019 (index date). Patients had ≥12 months of clinical data pre-index and were followed from the index date until the earliest of 24 months post-index, end of clinical activity, or end of data availability. Patients’ date of death was obtained from electronic medical records, Social Security Death Index, or other confirmed sources. Using an intention-to-treat approach, Kaplan-Meier analysis was used to describe the proportion of patients surviving by 24 months post-index. An unadjusted Cox proportional hazards model was used to describe crude differences in survival rates between patients initiating APA and ENZ. Results: There were 234 APA (mean age: 73.2 years; 59.8% White, 13.7% Black) and 527 ENZ (mean age: 73.9 years; 55.2% White, 13.1% Black) patients included in this study (Table). APA median time on-treatment was 10.9 months over a median observation period of 13.3 months, while ENZ median time on-treatment was 11.1 months over a median 14.8 months observation period. By 24 months, a higher proportion of patients in the APA cohort survived than in the ENZ cohort (85.4% vs 73.9%; unadjusted hazard ratio=0.59, 95% confidence interval: 0.39, 0.95; p=0.030; Table). Conclusions: In this real-world analysis of patients with mCSPC, more patients treated with APA survived by 24 months following treatment initiation as compared to treatment with ENZ. While the current study reports unadjusted analyses, future studies adjusting for potential confounding variables should be conducted to confirm these findings in order to inform clinicians on treatment selection for patients with mCSPC. [Table: see text]

Neuroendocrine neoplasms of the ovary: a review of 63 cases

ObjectiveTo describe the clinicopathological characteristics and survival outcomes of ovarian neuroendocrine neoplasms from a curated registry.MethodsThis is a retrospective cross-sectional study of patients in our registry with confirmed ovarian neuroendocrine...

P1172 Epidemiology and initial presentation of newly diagnosed inflammatory bowel diseases in a Danish population-based inception cohort – results from the IBD Prognosis Study

Abstract Background It is unclear whether the incidence of inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), continues to increase. In this study, we aimed to investigate the occurrence and initial disease presentation of IBD in a population-based setting. In addition, we aimed to identify predictors of an early severe disease presentation. Methods The study was conducted as part of IBD Prognosis Study, an ongoing Danish prospective population-based inception cohort study that includes incident patients with IBD according to the Copenhagen Diagnostic Criteria since May 2021, covering the catchment areas of approximately 20% of the Danish population (1.1 million). In this analysis, cutoff for data analysis was in May 2023. Crude incidence rates and European Standard Population (ESP)-adjusted rates were calculated. A multivariable logistical regression model was constructed to identify predictors of a severe disease presentation, defined as the composite need for systemic steroids, immunomodulators, biologics, or IBD-related surgery within three months of disease. Results In total, 554 patients (UC: 344, CD: 210) fulfilled the inclusion criteria, resulting in the following crude incidence rates per 100,000 person-years: IBD 23.4 (95% CI 21.5-25.4), UC 14.0 (12.6-15.6), and CD 8.6 (7.4-9.8). ESP-adjusted rates were: IBD 20.4 (18.2-22.9), UC 11.8 (10.2-13.0), and CD 7.9 (6.5-9.9) (Figure 1). Among patients with UC, 81 (26.3%) and 95 (30.8%) had left-sided or extensive colitis at disease onset, respectively, while 61 (30.3%) and 62 (30.8%) patients with CD had ileal or ileocolonic disease. Stricturing or penetrating CD behaviour was observed in 24 (11.9%) and 11 (5.5%) patients, respectively. A high proportion of patients needed hospitalization (CD: 68 (33.8%), UC: 60 (19.5%), p=0.001) and IBD-related surgery (CD: 21 (10.4%), UC: 10 (3.2%), p=0.004) at the time of diagnosis. In multivariable analysis, a severe disease presentation of UC at the time of diagnosis was associated with left-sided or extensive disease distribution, thrombocytosis, and increased levels of C-reactive protein (CRP) (Table 1). In patients with CD, stricturing, or perianal disease, as well as anemia, levels of albumin, CRP, and calprotectin were predictive of this endpoint (Table 1). Conclusion The incidence of UC and CD in Denmark appears stable compared to historical data from the previous decades.1 The study identified clinical predictors of a severe disease presentation from the time of diagnosis, emphasizing the critical need for early risk stratification and intervention strategies. Reference: 1 Dorn-Rasmussen M et al., J Crohns Colitis. doi: 10.1093/ecco-jcc/jjac138.

P339 Dermatological evaluation of candidates with IBD for biological therapy - should it become part of the scheme during qualification?

Abstract Background Oncological anxiety associated with biological therapy is a common challenge in inflammatory bowel disease (IBD) and it have raised questions about the need for dermatological assessment of the skin before starting a biological therapy to exclude cutaneous malignancies. Methods The aim of the study was to assess the frequency of skin cancers in IBD patients before starting biological therapy. We conducted a retrospective, single-centre evaluation on the frequency of skin cancers. Results A group of patients with IBD who were referred for qualification for biological treatment consisted of n = 805 patients, out of which 348 (43.2%) were female and 457 (56.8%) were male. Average age of patients was 36.84 ± 12.49 years. During qualification for biological treatment dermatological skin assessment was performed and dermal lesions were found in 15.5% (125) patients, of which 9 (1.1%) were cutaneous malignancies. Only steroid dependance and resistance differentiated in a significant way between patients with and without dermal lesions. Dermal lesions group included lower proportion of patients with steroid dependence (84.6% vs 92.9% in group without dermal lesions) and higher proportion of patients with steroid resistance (13.6% vs 7.1% in groups of patients with no dermal lesions) (V = 0.09, CI95 [0.01;0.17], p = 0.022). Surprisingly, there was no effect of thiopurines on development of dermal lesions between group with and without dermal lesions 90.4% vs. 84.6%, MD = 0.06, CI95 [0.01;0.12], p = 0.118. In a multivariate logistic regression model only higher BMI (OR = 1.08, CI95 [1.02;1.14], p = 0.007) was identify as a risk factor for development a dermal lesions. Additionally, as many as 9 patients were diagnosed with cutaneous malignancies, including 4 basal cell carcinomas (BCC), 4 squamous cell carcinomas (SCC) and one MSC. Only 11.4% patients complied with our strict policy of skin surveillance every 6-8 months. Conclusion In this study, we observed dermal lesions in 15.5% of patients, of which 1% were cutaneous malignancies. The only risk factor for dermal lesions was higher BMI. The lack of effect of thiopurines on oncological risk may indicate the need to monitor the skin condition in every patient with IBD. It is also crucial to disseminate knowledge about the need for regular skin assessments among IBD patients.

P585 Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure

Abstract Background Studies on elective switching to the subcutaneous (SC) formulation of infliximab revealed comparable efficacy and safety and higher infliximab level than those exhibited by intravenous (IV) infliximab. However, no studies have reported on the effectiveness of SC switching in ulcerative colitis (UC) patients who experienced IV infliximab failure during maintenance treatment. Methods This retrospective study included UC patients who had been switched to SC infliximab because of IV infliximab failure, between January 2021 and January 2023. Group A was defined as having clinically and biochemically active UC (secondary loss of response), and group B consisted of patients with stable symptoms but biochemically active UC. Results Twenty-three patients met the inclusion criteria: 15 in group A and 8 in group B. The serum infliximab levels significantly increased after SC switching in both groups. Electively switched group also exhibited increased infliximab levels after SC switching. Group A showed improved partial Mayo score with a significant decrease in faecal calprotectin (FC) and C-reactive protein after switching. In group B, the FC level significantly decreased without clinical relapse after switching. A high proportion of patients (≥ 80%) in both groups achieved clinical and/or biochemical response at last follow-up. During the follow-up period, only two patients in group A discontinued SC infliximab, and only one complained of severe injection site reaction. Conclusion In UC patients who experience IV infliximab failure during maintenance treatment, switching to SC infliximab may be a promising option because of its efficacy and safety.

Real world treatment patterns, healthcare resource use and costs in patients with advanced or metastatic non-small cell lung cancer by EGFR mutation type

Aims This study described treatment patterns, healthcare resource utilization (HRU) and costs among advanced or metastatic non-small cell lung cancer (a/mNSCLC) patients with different epidermal growth factor receptor (EGFR) mutation types. Materials and methods This retrospective study leveraged NeoGenomics NeoNucleus linked with IQVIA PharMetrics Plus between 01 January 2016 to 30 April 2021 (study period). Patients with evidence of a/mNSCLC between 01 July 2016 to 31 March 2021 (selection window) with EGFR test results indicating exon 19 deletion (exon19del), exon 21 L858R (L858R), or exon 20 insertion (exon20i) mutations were included; date of first observed evidence of a/mNSCLC was the index date. Treatment patterns, all-cause HRU and costs during ≥1 month follow-up were reported for each cohort (exon19del, L858R, and exon20i). Results A total of 106 exon19del, 75 L858R, and 13 exon20i patients met the study criteria. The prevalence of hospitalization was highest in the exon20i cohort (76.9%), followed by L858R (62.7%) and exon19del (55.7%) cohorts. A higher proportion of patients had evidence of hospice/end-of-life care in the exon20i (30.8%) and L858R (29.3%) cohorts relative to the exon19del cohort (22.6%). The exon20i cohort had higher median total healthcare costs per patient per month ($27,069) relative to exon19del ($17,482) and L858R ($17,763). EGFR tyrosine kinase inhibitors (TKI) were the most frequently observed treatment type for exon19del and L858R cohorts, while chemotherapy was the most observed treatment in exon20i cohort. Limitations The sample size for the study cohorts was small, thus no statistical comparisons were conducted. Conclusions This is one of the first real-world studies to describe HRU and costs among a/mNSCLC patients by specific EGFR mutation type. HRU and costs varied between EGFR mutation types and were highest among exon20i cohort, potentially reflecting higher disease burden and unmet need among patients with this mutation.

P521 Impact of pouch leaks on quality of life and symptoms in patients after ileal pouch-anal anastomosis surgery

Abstract Background Ileal pouch-anal anastomosis(IPAA)is the procedure of choice in patients requiring total proctocolectomy.The reported leak rates after IPAA surgery range from 1-12% with well described significant impact on postoperative morbidity and recovery.However, the long-term impact of salvaged pouch leaks on the broader quality of life outcome and pouch function remains poorly understood.The aim of this study was to compare between patients with and without postoperative leaks after IPAA surgery, hypothesizing that patients with salvaged pouch leaks would have worse long-term quality of life and pouch function compared to matched patients without leaks. Methods This retrospective cohort study included patients who underwent IPAA(n=4058) between 1995-2022.Leak was defined as abscess or fistula requiring intervention, who had definitive resolution of their pouch leaks, whether with conservative treatment or after salvage surgery or pouch excision with end ileostomy creation. The Leak group consisted of 194 patients with treated leaks.The No Leak group included 963 patients without leaks,matched 1:5 on sex, age(± 3 years),and surgery date.Questionnaire data were available for 85 of 194 patients with leaks and 614 of 963 without leaks. Quality of life(QoL) was assessed using SF-36, health status using EORTC QLQ-C30(QoH),and life enjoyment(QoE) using a standardized scale.Bowel movements,seepage,and pad usage were recorded.Outcomes were compared using Mann-Whitney U,t-tests, and chi-square tests. Results A total of 699 patients with IPAA were included, with 85(12%)in the leak group. The median age was 42 (IQR, 31-53) years, and 54% were male. Median time from surgery to the last QoL assessment was 6.58(IQR: 3.5-11.3) years in the Leak group and 6.05 (IQR: 2.5-11.2) days in the No Leak group. Patients with Leaks reported significantly lower QoL (median 7(IQR:5-9)vs8 (IQR:7-9);p&amp;lt;0.001), lower health status on the QoH scale (median 7(IQR: 5-8) vs 8 (IQR :7-9); p&amp;lt;0.001), and lower life enjoyment on the QoE scale (median 7(IQR: 5-8)vs7(IQR :6-9);p=0.003) compared to the No Leak group. A higher proportion of patients in the Leak group reported daytime (49%vs.20%,p&amp;lt;0.001) and nocturnal seepage (66%vs.38%, p=0.001), along with greater daytime(40%vs.22%,p=0.01) and nighttime pad usage (53%vs.30%,p=0.001). There were no significant differences in the number of bowel movements per 24h (p=0.54), daytime bowel movements(p=0.7), or nighttime bowel movements (p=0.695) between the groups. Conclusion In matched cohorts,salvaged pouch leaks were associated with reduced quality of life,health status,and life enjoyment compared with matched patients without leaks.Patients with leaks also had increased rates of seepage and pad usage,indicating worse pouch function.

Correlation between type of surgery and incidence of postoperative venous thromboembolism (VTE)

Venous thromboembolism (VTE) is a significant complication in patients after undergoing major surgery. The type of surgery is believed correlated with the incidence of VTE. This study aimed to evaluate the correlation between type of surgery and incidence of VTE among patients who underwent major surgery. It was a retrospective study conducted in Dr. Sardjito General Hospital, Yogyakarta using medical record data of patients who underwent major surgery and were diagnosed with VTE between 2016 and 2020. Patients were grouped by surgery type, and length of stay (LoS). All caused deaths were also analyzed. Among 29,120 patients who underwent major surgery, 76 (0.26%) experienced VTE with females patients accounting for 75%. The mean age of the patients was 55 yr. All VTE cases had the mean LoS of 25 d. The highest proportion of patients who experienced VTE were patients who underwent tumor removal (67.0%) followed by trauma patients (18.4%). A significant difference in the incidence of mortality between the surgical groups was reported (p = 0.02). Post-cardiology had the highest risk of mortality (OR=7.46; 95% CI: 0.322 - 172.61) while age had the lowest risk of mortality (OR=1.01; 95% CI: 0.953 - 1.071). In conclusion, surgery type is correlated with the incidence of VTE. Surgery due to cancer and trauma has a higher risk of VTE compared to the others.

1899 Early intervention by physiotherapy and occupational therapy in older inpatient population

Abstract Background Currently, on inpatient medical wards at University Hospitals of Leicester NHS Trust, first contact by physiotherapy and occupational therapy is made when patients become medically optimised for discharge. This is due to a number of reasons such as staffing and resource shortages. Aim Analyse the effects of early intervention by therapy on patients on a geriatric medicine inpatient ward. It is hypothesised that earlier intervention can improve patient and service outcomes. Method A data sheet was created to capture baseline information including mobility/care needs prior to admission, date of initial contact by therapy, mobility/care on discharge, length of stay and discharge destination. Data was collected over two phases; initial therapy contact at point of patient being medically optimised, and then with the planned intervention of proactive therapy input early in a patient’s admission. Results The data shows an improvement in all measured patient outcomes in the intervention group. The average time from admission to therapy first contact reduced from 7 days to 2 days. The average length of stay reduced from 14.5 days to 7 days in the intervention group. 70% of patients left the hospital with a reduction in their mobility status in the control group, whereas only 32% of patients left with worse mobility in the intervention group. 41% of patients in the control group left with new or increased care provision compared to 36% in the intervention group. The data also showed that a higher proportion of patients were mobilised by ward staff and less patients were discharged to 24-hour care settings in the intervention group. Conclusion Therapy (with the help of the multi-disciplinary team) should proactively identify patients in need of therapy input as soon as safely possible. This research shows that adopting this approach leads to improvements for our patients and our service.

Single-Center Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients with Bicuspid Anatomy: Procedural and 30-Day Follow-Up.

Aims: To report our single-center data regarding the initial 52 consecutive patients with a bicuspid aortic valve who underwent a Transcatheter Aortic Valve Implantation (TAVI) procedure using the new balloon-expandable MYVAL system. The focus is on reporting procedural details and outcomes over the 30-day postoperative period. Methods: From December 2019 to July 2023, 52 consecutive patients underwent a TAVI procedure with bicuspid anatomy. All patients had moderate to-high surgical risk or were unsuitable for surgical aortic valve replacement based on the Heart Team's decision. Outcomes were analyzed according to the VARC-2 criteria. The results of bicuspid patients were compared to patients with tricuspid anatomy in the overall study group, and further analysis involved a comparison between 52 pairs after propensity score matching. The device performance was evaluated using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results: The mean age was 71 ± 7.1 years, and 65.4% were male. The mean Euroscore II and STS score were 3.3 ± 3.2 and 5.2 ± 3.3, respectively. Baseline characteristics and echocardiographic parameters were well balanced even in the unmatched comparison. Procedures were significantly longer in the bicuspid group and resulted in a significantly higher ARI index. All relevant anatomic dimensions based on the CT scans were significantly higher in bicuspid anatomy, including a higher implantation angulation, a higher rate of horizontal aorta and a higher proportion of patients with aortopathy. In the unmatched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 1.4% (p = 0.394), device success 100% vs. 99.1% (p = 0.487), TIA 1.9% vs. 0% (p = 0.041), stroke 1.9% vs. 0.9% (p = 0.537), major vascular complication 3.8% vs. 2.3% (p = 0.530), permanent pacemaker implantation 34% vs. 30.4% (p = 0.429), and cardiac tamponade 0% vs. 0.5% (p = 0.624). In the propensity-matched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 0%, device success 100% vs. 100%, TIA 1.9% vs. 0% (p = 0.315), stroke 1.9% vs. 0.9% (p = 0.315), major vascular complication 3.8% vs. 0% (p = 0.475), permanent pacemaker implantation 34% vs. 24% (p = 0.274), and cardiac tamponade 0% vs. 0%. There was no annular rupture nor need for second valve or severe aortic regurgitation in both the unmatched and matched comparison. The peak and mean aortic gradients did not differ at discharge and at 30-day follow-up between the two groups regardless of whether the comparison was unmatched or matched. There were no paravalvular leakages (moderate or above) in the bicuspid patients. Intermediate and extra sizes of the Myval THV system used a significantly higher proportion in bicuspid anatomy with a significantly higher oversize percentage in tricuspid anatomy. Conclusions: The TAVI procedure using the Myval THV system in patients with significant aortic stenosis and bicuspid aortic valve anatomy is safe and effective. Hemodynamic parameters do not differ between tricuspid and bicuspid patients. However, the permanent pacemaker implantation rate is higher than expected; its relevance on long-term survival is controversial.