Mean Symptom Scores Research Articles

Mindfulness, work-family conflict, family-work conflict and depressive symptoms among nurses: A cross-sectional design.

Work and family role conflict is a common source of stressors that affect nurses, leading to negative outcomes on their mental health, such as depressive symptoms, which affect nurses' job performance and patients' health outcomes. Mindfulness positively affected mental health, but its role in the relationship between role conflict and depressive symptoms was not previously examined. To examine the mediating role of mindfulness in the relationship between work-family conflict and family-work conflict with depressive symptoms among nurses. A descriptive cross-sectional design was used to collect data from a sample of 188 nurses from two large referral hospitals in northern and central Jordan. Data analysis was performed using Pearson correlation and macro PROCESS. The mean score of depressive symptoms in our sample indicated that our sample is at risk for clinical depression. The bivariate correlation showed that depressive symptoms were significantly and negatively associated with work-family and family-work conflicts and significantly and positively associated with mindfulness. Both regression models explained 52% of the variance in depressive symptoms (F [6, 181] = 35.38, p< .001). The models also showed that mindfulness had a significant negative effect on depressive symptoms (t= -8.98, p< .001). The results of macro PROCESS indicated that mindfulness mediated the relationship between work-family conflict and family-work conflict with depressive symptoms. Nurses are exposed to a number of stressors in their work environment, including long work hours and frequent exposure to traumatic events. The current study showed that mindfulness might play a role in mediating the relationship between family-work conflict and family-work conflict with depressive symptoms. Nurses, nurse managers and policymakers can work with healthcare organizations to promote nurses' work quality by controlling risk factors, such as depressive symptoms, and implementing strategies to mitigate these risks.

The physiological determinants of symptom burden in cirrhosis with ascites.

Paracentesis is commonly used to manage patient discomfort due to ascites. The relationship between ascites pressure, ascites volume, and patient discomfort has not been elucidated. We prospectively enrolled adult patients with non-malignant ascites undergoing outpatient therapeutic paracenteses from 2021 to 2024 at a tertiary care hospital. Patients completed a validated symptom questionnaire (ASI-7, maximum score 35) before, immediately after, and 1week after paracentesis. An open-ended manometer was used to measure ascites pressure at the beginning and end of paracentesis. Mixed effect linear regression was performed to evaluate the relationships between patient characteristics, pressure, volume, and symptoms. One hundred and fifty paracentesis procedures among 48 unique patients with an average Model for End Stage Liver Disease-Sodium 3.0 of 16.7 were included. An average of 6.5L was drained, which reduced abdominal pressure from a mean of 13.7 to 6.0cm H2O (10.1 to 4.4mmHg, p<0.001) and mean symptom score from 22.6 to 6.5 (p<0.001). Regression models identified that symptoms and abdominal pressure linearly correlated above a pressure of 6cm H2O or ASI-7 score of 16 (p<0.01). Taller patients required about 670ml additional drainage per inch above the cohort mean height (5'8″) to achieve the same symptom relief. Pressure measured at the bedside can be used to explore changes in abdominal pressure during paracentesis. Pressure, volume, and patient level factors such as height contribute to patient symptoms but cannot fully explain discomfort associated with ascites and relief after paracentesis.

Non-invasive positive pressure ventilation for acute asthma in children.

Asthma is one of the most common reasons for hospital admission among children, with significant economic burden and impact on quality of life. Non-invasive positive pressure ventilation (NPPV) is increasingly used in the care of children with acute asthma, although the evidence supporting it is weak, and clinical guidelines do not offer any recommendations on its routine use. However, NPPV might be an effective way to improve outcomes for some children with asthma. A previous review did not demonstrate a clear benefit, but was limited by few studies with small sample sizes. This is an update of the previous review. To assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children (< 18 years) with acute asthma. We searched the Cochrane Airways Group Specialised Register, CENTRAL, MEDLINE, and Embase. We also conducted a search of ClinicalTrials.gov and the WHO ICTRP. We searched all databases from their inception to March 2023, with no restrictions on language of publication. We included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children hospitalised for acute asthma exacerbations. We used standard Cochrane methods. We included three RCTs randomising 60 children with acute asthma to NPPV and 60 children to control. All included trials assessed the effects of bilevel positive airway pressure (BiPAP) for acute asthma in a paediatric intensive care unit (PICU) setting. None of the trials used continuous positive airway pressure (CPAP). The controls received standard care. The median age of children ranged from three to six years, and asthma severity ranged from moderate to severe. Our primary outcome measures were all-cause mortality, serious adverse events, and asthma symptom score. Secondary outcomes were non-serious adverse events, health-related quality of life, arterial blood gases and pH, pneumonia, cost, and PICU length of stay. None of the trials reported any deaths or serious adverse events (except one trial that reported intubation rate). Two trials reported asthma symptom score, each demonstrating reductions in asthma symptoms in the BiPAP group. In one trial, the asthma symptom score was (mean difference (MD) -2.50, 95% confidence interval (CI) -4.70 to -0.30, P = 0.03; 19 children) lower in the BiPAP group. In the other trial, a cross-over trial, BiPAP was associated with a lower mean asthma symptom score (MD -3.7; 16 children; very low certainty evidence) before cross-over, but investigators did not report a standard deviation, and it could not be estimated from the first phase of the trial before cross-over. The reduction in both trials was above our predefined minimal important difference. Overall, NPPV with standard care may reduce asthma symptom score compared to standard care alone, but the evidence is very uncertain. The only reported serious adverse event was intubation rate in one trial. The trial had an intubation rate of 40% and showed that BiPAP may result in a large reduction in intubation rate (risk ratio 0.47, 95% CI 0.23 to 0.95; 78 children), but the evidence is very uncertain. Post hoc analysis showed that BiPAP may result in a slight decrease in length of PICU stay (MD -0.87 day, 95% CI -1.52 to -0.22; 100 children), but the evidence is very uncertain. Meta-analysis or Trial Sequential Analysis was not possible because of insufficient reporting and different scoring systems. All three trials had high risk of bias with serious imprecision of results, leading to very low certainty of evidence. The currently available evidence for NNPV is uncertain. NPPV may lead to an improvement in asthma symptom score, decreased intubation rate, and slightly shorter PICU stay; however, the evidence is of very low certainty. Larger RCTs with low risk of bias are warranted.

Effect of transdermal testosterone therapy on mood and cognitive symptoms in peri- and postmenopausal women: a pilot study.

The purpose of this study was to assess the impact of testosterone therapy on mood and cognitive symptoms in perimenopausal and postmenopausal women. A retrospective cohort study undertaken in a UK specialist menopause clinic. 510 women using hormone replacement therapy (HRT) with persistent low libido, cognitive and negative mood symptoms were treated with testosterone cream or gel for 4 months. A modified version of the Greene Climacteric Scale was used to measure self-reported symptom frequency and severity at baseline and 4 months after initiating treatment. All nine cognitive and mood symptoms significantly improved across the study period. Mood improved more than cognition (47% of women reported an improvement in mood vs. 39% reported an improvement in cognition; 34% vs. 22% decrease in mean symptom scores, respectively). Regarding libido, 52% of women reported an improvement; mean symptom score decreased by 33%. Transdermal testosterone therapy for 4 months was associated with significant improvements in mood and cognition. Further research including randomised clinical trials are needed to establish the long-term efficacy and safety of testosterone for the treatment of menopausal cognitive and psychological symptoms.

635. FLEXIBLE ENDOSCOPIC SEPTUM DIVISION FOR ZENKER’S DIVERTICULUM: A SINGLE CENTRE EXPERIENCE

Abstract Background Zenker diverticulum (ZD) is a pseudodiverticulum of the Killian’s triangle and usually affects males in the 6th-9th decade of life. Symptoms include dysphagia, regurgitation, chronic cough, aspiration, halitosis, and weight loss. The treatment of symptomatic ZD is operative and can surgical or endoscopic. Flexible endoscopic septum division is becoming a prominent treatment option for Zenker's diverticulum (ZD). We report our experience with Flexible endoscopic septum division. Methods Data on all consecutive patients that underwent flexible endoscopic treatment for symptomatic Zenker’s diverticulum from February 2021 to December 2023 were retrieved. All patients were diagnosed trough both barium esophagogram and EGDS. All procedures were performed in our centre by the same endoscopist. Dysphagia, regurgitation, and respiratory symptoms severity before the procedure were graded with the Kothari-Haber Scoring System (KH SS). Complications, LOS, symptoms scores and recurrences were recorded. Follow up was performed trough clinical and radiological evaluation. Results 19 patients were included, 16 (84%) men, mean age 77.2 years (53-79). Pre-operative mean symptoms score was 6.1 (4-9). The pre-operative mean pouch size was 4,16 cm (range 2,3-6). Median length of stay was 3 days (2-18). One patient had an oesophageal leak that was managed endoscopically with clip positioning, nasogastric tube, fasting, and antibiotics, with satisfactory long term clinical outcome. No other complications were reported. All patients reported significant symptom improvement, median post-operative symptoms score was 0,3 (0-3). Mild relapsing symptoms were present in two patients (10,5%), at 12 and 35 months. Both patients refused further treatments for recurrence. Conclusions Treatment of ZD with flexible endoscopic septum division is a feasible, safe and effective option with satisfactory long-term results.

The burden of allergic rhinitis is undermanaged in a large proportion of Chinese young adults from Singapore

BackgroundAllergic rhinitis (AR) is a nasal disorder characterized by the simultaneous manifestation of at least 2 out of 4 possible symptoms: rhinorrhea, nasal itching, nasal pruritus, and sneezing. Presently, among Chinese young adults from Singapore, we characterised AR phenotypes, established Total Nasal Symptom Score (TNSS) baselines, and examined the management of AR. MethodsParticipants completed an investigator-administered International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire and underwent a skin prick test (SPT). Individuals exhibiting sensitization during the SPT while having at least 2 rhinitis symptoms were identified as AR cases, then categorized into Allergic Rhinitis in Asthma (ARIA) classifications. ResultsThere were 9323 subjects analyzed. AR prevalence was estimated at 35.4%. Rhinorrhea was perceived as the most severe (mean Nasal Symptom Score (mNSS) ± SD: 1.42 ± 0.74), while nasal pruritus was the least severe (mNSS ± SD: 1.24 ± 0.68). Among moderate-severe AR (68.1%), most were affected by either troublesome symptoms (27.7%) or sleep disturbances (18.4%). By ARIA classes, 26.6% were mild intermittent, 5.4% were mild persistent, 50.3% were moderate-severe intermittent, and 17.6% were moderate-severe persistent. The mean TNSS (mTNSS) of AR cases was 4.43 (SD = 2.49) and between AR classifications, the mTNSS was significantly different. Notably, a large proportion of AR cases remained undiagnosed (85.2%), untreated (72.5%), or both (65.4%); 19.8% self-medicated for AR. ConclusionsThere was a significant difference in TNSS of the AR phenotypes, and among phenotypes with a higher mTNSS, a large proportion remained untreated, undiagnosed, or both. The evidence indicates an existing burden of AR among Chinese young adults in Singapore which is notably undermanaged.

The Impact of the Dietary Intake of Vitamin B12, Folic Acid, and Vitamin D3 on Homocysteine Levels and the Health-Related Quality of Life of Levodopa-Treated Patients with Parkinson's Disease-A Pilot Study in Romania.

Previous studies have shown that the levodopa treatment of Parkinson's disease (PD) elevates circulating homocysteine levels, which are associated with an increased risk of cardiovascular and neurological disorders, or thrombosis. The present trial aimed to examine whether the intake of vitamin B12, folic acid, and vitamin D3 supplements improved homocysteine level and quality of life (QoL). An interventional prospective trial was conducted in multiple centers across Romania. Participants with clinically established PD taking at least 300 mg/day of levodopa for more than 1 year received a daily tablet of a supplement containing 800 UI of vitamin D3, 1000 µg of folic acid, and 15 µg of vitamin B12. They were followed for 6 months and their serum homocysteine, vitamin B12, vitamin D, and QoL scores were measured at baseline and at 6 months of treatment. QoL was measured using a 15D questionnaire, which assesses mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Twenty-four PD patients with a mean age of 71 ± 5.04 years (54.2% male and 45.8% female) finished the study. After the intervention, the mean score of speech, mental function, discomfort and symptoms, depression, and QoL significantly increased (p < 0.05 for all). Also, the serum homocysteine and vitamin D were significantly enhanced (p < 0.0001 and p = 0.025, respectively). Changes in vitamin B12 were not statistically significant at 6 months of treatment (p = 0.996). No gender differences were found among the changes that we have demonstrated for homocysteine, vitamin B12, vitamin D, and QoL levels (p < 0.05 for all). The findings of this study showed that the dietary intake of vitamin B12, folic acid, and vitamin D3 remarkably decreased the dimensions of homocysteine and finally increased the total score of QoL in PD patients. We have successfully captured the potential benefits of the supplementation regimen over time and provided insights into the broader implications for managing PD with a focus on nutritional support.

The Burden of symptoms and Quality of life of Filipino patients with Myeloproliferative neoplasm: A Multicenter Cross-sectional survey.

Myeloproliferative neoplasms (MPN) are hematologic malignancies characterized by cellular proliferation of one or more hematopoietic cell lines. Management has been focused on blood count control but addressing relief from symptoms and providing a better quality of life (QOL) are equally important in the care of these patients. The MPN Symptom Assessment Form-Total Symptom Score (MPN-SAF TSS) is used to determine symptoms at baseline and during treatment. Understanding the symptom burden is important in developing a holistic management plan for MPN. Hence, this study aimed to determine the symptom burden and QOL of Filipino patients with MPN. Using a validated Filipino version of the MPN-SAF-TSS questionnaire and the University of the Philippines-Department of Health QOL (UP-DOH QOL) questionnaire, a cross-sectional survey of consecutive patients with MPN from two public and two private tertiary hospitals was conducted. We purposively sampled adults, newly diagnosed or previously diagnosed with polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF). The mean scores were compared with the type of MPN using analysis of variance. Linear regression was done to determine the association of patients' characteristics to the mean symptom burden and QOL scores, while logistic regression was used to determine the association of patient and disease characteristics with the level of symptom severity and QOL. A total of 167 (63 PV, 66 ET, and 38 MF) patients were surveyed from four centers. The mean overall symptom burden score was 24.41 (standard deviation [SD]=18.91) with MF having the highest score at 28.53, followed by PV at 23.75 and ET at 22.67. The majority (80.24%) had a high QOL with a mean global QoL score of 84.92 (SD=16.75). Comparison of individual scores showed bone pain and weight loss were significantly higher in patients with MF compared to PV (p=0.0002) and ET (p=0.032); while pruritus was significantly higher in PV compared to ET and MF (p=0.043). Logistic regression analysis showed female sex and being newly diagnosed (adjusted odds ratio [aOR] 11.22, 95% confidence interval [CI] 2.32-54.25) were associated with high symptom burden while having a controlled blood count (aOR 0.26, 95% CI 0.10-0.71) was associated with low symptom burden and high QOL. The majority of the participants were symptomatic with moderate to severe symptom burden. While no statistically significant difference was seen among the three types of MPN in terms of overall mean symptom score, patients with MF were more likely to have a severe symptom burden while patients with ET had the least symptoms. Despite having symptoms, QOL was regarded as high. QoL was significantly higher among those with PV or ET than those with MF. Our study highlighted the utility of a validated symptom scoring system in determining the symptom burden and who would benefit from pharmacologic/non-pharmacologic symptom management. Results emphasized incorporating symptom scoring in clinical practice and going beyond blood counts in caring for our patients with MPN.

Differential Prevalence of Depression Symptoms in Obese Versus Non-obese Women with Polycystic Ovary Syndrome

Background: Polycystic ovarian syndrome (PCOS) is a prevalent chronic endocrine disorder that effects on women ovaries. It is characterized by mental health issues including depression and obesity. Hence the purpose of this particular study was to determine whether depressive symptoms were more common in obese PCOS women or in non-obese women. Methodology: The current study involved a cross-sectional design where the participants were 200 women with PCOS, and they were further divided into the obese and non-obese groups on the bases of their BMI. The depressive symptoms were assessed with the Beck Depression Inventory – II (BDI-II). Raw data were interpreted bio- statistically by applying chi-squared test and logistic regression to determine the association between symptoms of obesity and depression by using a software known as SPSS. Results: The women of obese group with polycystic ovarian syndrome had a mean score of moderate (35.12± 0.01) and severe depressed symptoms than the non-obese PCOS women (22.11± 0.03). The applications of the logistic regression model revealed that the obesity could be considered to have a statistically significant (P≤0.05) impact on the depression symptoms. Conclusion: Through the research that the study carried out it was discovered that obesity could be causatively related to depression in women with PCOS. These results point to the importance of the proposed features of PCOS as a complex disorder that requires a holistically oriented treatment approach that involves not only physical but also psychological factors.

Comparison of Treatment Outcome of Ganciclovir Ophthalmic Gel and Moxifloxacin Eye Drop in Acute Adenoviral Keratoconjunctivitis

Adenoviral ophthalmic infection is a self-limiting, highly contagious, very frequent infectious process. It can present in three acute clinical forms: nonspecific acute follicular conjunctivitis, pharyngo-conjunctival fever and epidemic keratoconjunctivitis. This study aims to assess and compare the efficacy of 0.15% ganciclovir gel with Moxifloxacin eye drop in the treatment of acute adenoviral keratoconjunctivitis.This longitudinal prospective study was conducted among 40 patients of acute adenoviral keratoconjuctivitis attending in the cornea clinic of National Institute of Ophthalmology &amp; Hospital (NIOH), Dhaka, Bangladesh. They were randomly divided into two groups: group-I (study group) with 20 patients who used 0.15% ganciclovir gel and group-ii (control group) with 20 patients who used artificial tear and 0.5% moxifloxacin eye drop. Diagnosis was confirmed by expert cornea specialist by methodical ophthalmic examination. They were followed-up on 1,2,4 and 6 weekly. Mean score of symptoms and signs were calculated in every follow-up and compared between two groups. Unpaired t test and chi square test were done in applicable cases with statistical significance p&lt;0.05. This study showed that in study group mean age of the respondents were 36.4±9.59 years and in control group 37±11.02 years. Most of them were male (82.5%). In study group, mean score of symptoms at the beginning of the study was 1.4. It was 1.14, 0.64, 0.20 and 0.04 after1,2,4,6 weeks respectively after starting treatment and in control group mean score of symptoms at the beginning of the study was 1.48. It was 1.46, 1.125,0.59 and 0.23 after1,2,4,6weeks respectively after starting treatment. A trend towards better response was observed in the treatment group and the difference was statically significant. The mean score of signs after starting treatment in group-iwas 1.8.It was 1.35, 0.775, 0.30 and 0.175 after ,2,4,6weeks respectively and in group-ii, mean score of signs at the beginning of the study was 1.675. It was 1.725,1.35,0.725 and 0.300 after 1,2,4,6 weeks respectively after starting treatment. A trend towards improved sings were observed in the study group and the difference was statistically significant at 1 week (p=0.0283), 2 week (p= 0.0003), 4 week (p=0.0016) except 6 week (p=0.1524). At 6th week of treatment improvement of signs occur but not statistically significant because of persistence of some corneal lesion. The significant symptomatic relief and clinical improvement was found in the study group treated with Ganciclovir ophthalmic gel suggesting an effective method for treatment of acute adenoviral keratoconjunctivitis. Mugda Med Coll J. 2024; 7(1): 9-13

Primary outcomes of the enhanced, EHR-facilitated cancer symptom control (E2C2) cluster-randomized, stepped wedge, pragmatic trial.

LBA12006 Background: Symptom burden and functional decline are prevalent, inconsistently treated, and associated with adverse health outcomes in patients with cancer. Symptom monitoring with electronic patient-reported outcome measures (ePROMs) has yielded mixed results due, in part, to care teams’ variable bandwidth and resourcing for symptom management. The collaborative care model (CCM) offers a validated means to address these issues and potentially improve clinical and health services outcomes. Capturing ePROMS through the electronic health record (EHR) for use in CCM delivery provides a potentially scalable approach to manage symptoms at the population level. Methods: E2C2 is a cluster-randomized, population-level, stepped wedge pragmatic trial that compares a bundled, EHR-facilitated, CCM-based intervention to improve control of SPPADE symptoms (Sleep interference, Pain, impaired Physical function, Anxiety, Depression, and Energy deficit/fatigue) with usual care. All patients, regardless of cancer type or stage, treated in the medical oncology clinics of a multi-state health system, were assigned to one of fifteen clusters. Control and intervention conditions monitored SPPADE symptoms with Epic EHR administered 11-point numerical rating scales (NRSs). Moderate and severe symptoms were defined as 4-6/10 and &gt;7/10, respectively. The intervention added EHR clinician decision support; automated delivery of symptom self-management information; and options to address severe symptoms with a dedicated symptom care manager. The primary outcome was post-baseline SPPADE scores assessed using multivariate regression of six cluster-period mean SPPADE symptom scores against E2C2 exposure, fixed cluster and secular time effects. Results: From March 2019 to January 2023, 50,559 patients were assigned to E2C2 clusters and 40,295 completed at least one ePROM. At first assessment, participants’ mean age was 63.3 years; 58% were female; 26% were rural, and the prevalences of moderate or worse symptoms were fatigue 42%, impaired function 34%, sleep disturbance 34%, anxiety 27%, pain 26%, and depression 23%. The intervention significantly reduced mean composite SPPADE symptom scores, p &lt;0.001, among all patients, as well as those with &gt;1 moderate or worse symptom. All mean symptom scores were lower in the intervention group, with the largest effects detected among patients with fatigue -0.2 (-0.4, -0.07), anxiety -0.14 (-0.2, -0.03), and depression -0.1 (-0.2, -0.002). Conclusions: In this large cluster-randomized trial, an EHR-facilitated, bundled intervention that scaled CCM-based surveillance and management of SPPADE symptoms significantly reduced population-level symptom burden, particularly for fatigue, anxiety, and depression. This study provides real world evidence and the foundation for future national efforts aimed at controlling symptoms in patients with cancer. Clinical trial information: NCT03892967 .

Frailty and depressive symptoms in older kidney transplant recipients: opportunities for collaboration between transplant nephrologists and geriatricians

BackgroundFrailty is one of the key syndromes in geriatric medicine and an important factor for post-transplant outcomes. We aimed to describe the prevalence of frailty and examine the correlates of frailty and depressive symptoms in older kidney transplant recipients (KTRs).MethodsThis cross-sectional study involved 112 kidney transplant recipients (KTRs) aged 70 and above. Frailty syndrome was assessed using the Fried frailty criteria, and patients were categorized as frail, pre-frail, or non-frail based on five frailty components: muscle weakness, slow walking speed, low physical activity, self-reported exhaustion, and unintentional weight loss. Depressive symptoms were measured using the 15-item Geriatric Depression Scale (GDS). The relationship between frailty and depressive symptoms was evaluated using multinomial logistic regression, with the three frailty categories as the dependent variable and the severity of depressive symptoms as the independent variable, while controlling for age, gender, renal graft function, and time since transplant surgery.ResultsThe participants had a mean age of 73.3 ± 3.3 years, and 49% were female. The prevalence of frailty syndrome was 25% (n = 28), pre-frailty was 46% (n = 52), and 29% (n = 32) of the KTRs were non-frail. The mean score for depressive symptoms was 3.1 ± 2.4 points, with 18% scoring above the clinical depression cutoff. Depressive symptoms were positively correlated with frailty (r = .46, p < .001). Among the frailty components, self-reported exhaustion (r = .43, p < .001), slow walking speed (r = .26, p < .01), and low physical activity (r = .44, p < .001) were significantly positively correlated with depressive symptoms, while muscle strength (p = .068) and unintentional weight loss (p = .050) were not. A multinomial logistic regression adjusted for covariates indicated that, compared to being non-frail, each additional point on the GDS increased the odds of being pre-frail by 39% (odds ratio [OR] = 1.39, 95% confidence interval [CI] 1.01–1.96) and roughly doubled the odds of being frail (OR = 2.01, 95% CI 1.39–2.89).ConclusionThere is a strong association between frailty and depression in KTRs aged 70 years and older. Targeted detection has opened up a new avenue for collaboration between geriatricians and transplant nephrologists.

Quality of Life in Patients Undergoing Emergency Surgery for Complex Colorectal Cancer: Protocol and Piloting of the Surgical Utilization and Recovery Patterns for Advanced Stage Colorectal Cancer Study.

Introduction: Globally, cancer is the leading cause of mortality, with colorectal neoplasia ranking third in terms of incidence and mortality worldwide. Patients face disease- and treatment-specific impacts, which can significantly influence their quality of life (QoL). Aim: This study aimed to propose a protocol to measure in-hospital and long-term QoL in patients with complicated colorectal cancer (CRC). Material and Methods: multicenter prospective observational cohort study. Results: QoL is a multidimensional concept that includes criteria for physical, mental, emotional, and social functionality as perceived by the patient. Periodically evaluating QoL offers measurable and objective tools to intervene at the appropriate time to decrease the Years of Life Lost and Years Lived with Disabilities for CRC patients. However, a structured and functional system requires dedicated and common institutional effort. A pilot study using this protocol included 69 patients, 65.12+-10.92 years, M:F ratio = 56.5:43.5%. Surgical procedure was right hemicolectomy, left colectomy, transverse colectomy, sigmoidectomy, total colectomy, rectal resection, and colorectal resection with stoma (ileostomy or colostomy) in 21.7%, 11.6%, 2.9%, 11.6%, 1.4%, 23.2%, and 27.5% of the cases, respectively. The mean Global Health Status Score, Symptom Score, and Functional Score was 82.36+-18.60, 11.89+-10.27, and 86.27, 74.50-94.11, respectively. Conclusions: CRC diagnosis has major effects on patients physical and psychological status, and concentrated efforts should be made by the involved medical team and healthcare systems to improve QoL throughout the treatment pathway.

Reducing Recurrent Urinary Tract Infections in Women with MV140 Impacts Personal Burden of Disease: Secondary Analyses of a Randomized Placebo-controlled Efficacy Study

BackgroundRecurrent urinary tract infection (rUTI) remains a major health burden for women. A randomized, double-blind, placebo-controlled trial (RCT; NCT02543827) reported that female patients with rUTI receiving a sublingual vaccine, MV140, had a reduction in rUTI and increase in UTI-free rate compared with placebo. ObjectiveTo determine the impact of MV140 on the personal burden of disease in women with rUTI using secondary endpoint data from the pivotal RCT evaluating MV140. Design, setting, and participantsIn the primary RCT, female patients with rUTI enrolled in Spain and UK (from October 2015 to April 2019) were randomized to placebo (6 mo) or MV140 (3 or 6 mo), and followed for 12 mo. Individuals analyzed in this secondary analysis included those in the placebo and 3-mo (recommended dose) groups. InterventionA polybacterial sublingual vaccine, MV140 (four inactivated whole-cell bacteria—Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis), or placebo. Outcome measurements and statistical analysisSymptom severity scoring, antibiotic use, safety, and multiple aspects of quality of life (QoL; Short-Form Questionnaire [SF-36]) were assessed. Results and limitationsCompared with the placebo group (n = 76), the 3-mo vaccinated group (n = 74) experienced fewer overall UTI symptoms (mean symptom score 102.2 ± 222.9 vs 194.2 ± 178.8; p = 0.0002), fewer days on antibiotics (12.4 ± 17.7 vs 28.7 ± 25.2; p = 0.0001), and improved total, general, and physical SF-36 QoL improvement (differences in means for total SF-36 score 15.7; 95% confidence interval [CI] 8.80, 22.64; p < 0.0001), with only social function QoL showing no impact (4.07; 95% CI –4.93, 13.08; p = 0.3744). ConclusionsThree months of MV140 is associated with a reduction of the personal burden of UTI by reducing overall UTI symptoms and antibiotic use, improving QoL in women with rUTI. Patient summaryThree months of MV140 vaccine, which has previously been shown to reduce the risk of urinary tract infection safely, is associated with a reduction in the personal burden of disease.

Secular trends in mental health problems among young people in Norway: a review and meta-analysis.

There is a growing concern that the mental health of recent generations of youth is deteriorating, yet the etiology of these secular changes is not fully understood. We aimed to review the evidence on trends in mental health problems among young people in Norway. Seven large-scale repeated cross-sectional studies were included in this study, comprising 35 cross-sectional data collections between 1992 and 2019, with a total sample of 776,606 young people. Our study found a clear increase in mental health problems among young females in Norway over the past few decades, while the trends were less marked for males. The proportion of individuals scoring above the problematic symptom score threshold increased on average by 11.2% (range 2.2% to 21.9%) for females and 5.2% (range - 0.9% to 11.1%) for males, based on data from the individual studies. The results from a meta-regression analysis showed that across all surveys, mean symptom scores increased by 17% (95% CI 12 to 21%) among females and 5% (95% CI 1 to 9%) among males from 1992 to 2019. Overall, mental health problems have increased continually since the early 1990s among young people, especially among young females. The cause of these secular changes remains unknown but likely reflect the interplay of several factors at the individual and societal level.Protocol registration: Open science framework, November 8, 2021 ( https://osf.io/g7w3v ).

A271 EFFECT OF ANTI-TNF AGENTS ON DNA METHYLATION IN PERIPHERAL BLOOD OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Abstract Background Despite the success and ongoing use of tumor necrosis factor inhibitors (TNFi) in the treatment of inflammatory bowel disease (IBD), there are no predictors of response to therapy. While much research has gone into understanding genetic risks for IBD, less work has been done exploring epigenetic associations with treatment. Hence, we wondered whether epigenetic changes were associated with failure of TNFi in IBD. Aims Describe the association of TNFi response with DNA methylation in patients with IBD. Methods Participants ≥18 years with IBD (N=169) were selected from the Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects (IMAGINE) Strategy for Patient Oriented Research (SPOR) Network. At enrollment participants completed a questionnaire that included their disease diagnosis, therapy, smoking history, and disease activity using the validated IBD Symptom Inventory (IBDSI). Patients provided whole blood samples that were processed for and run on Illumina DNA methylation arrays. Results The 169 patients were in three treatment groups: TNFi naïve (N=98, never exposed to an anti-TNF agent), TNFi responder (N=32, inactive disease on anti-TNF agent), and TNFi nonresponder (N=39, active disease not on any biologic at time of enrollment). The mean symptom score (SIBDSI) was different across the three groups (pampersand:003C0.001): TNFi nonresponders having a higher SIBDSI (24 ± 6.1) than the TNFi naïve (9.1 ± 5.5) or responder (8.3 ± 4.3) treatment groups. Relative proportions of leukocyte populations were estimated using DNA methylation. CD4 and CD8 T cell and B cell counts were higher (pampersand:003C0.05) in the nonresponders and responders versus TNFi naïve group. Neutrophil counts were lower (pampersand:003C0.05) in the TNFi nonresponders and responders compared to the TNFi naïve group (Figure 1). There was a trend towards increased epigenetic estimates of age acceleration (pampersand:003E0.05) in nonresponders versus responders and TNFi naïve patients, likely driven by disease activity (data not shown). Epigenome-wide analysis of the three groups revealed 16 CpGs for responder versus naïve (e.g. CDK5 regulatory subunit-associated protein 1-like 1 (CDKAL1), and two CpGs for nonresponders versus responders (Table 1). This includes a CpG for guanine nucleotide-binding protein subunit gamma-2 (GNG2) that was shared between the two comparisons. Conclusions Exposure to TNFi is associated with changes in peripheral leukocyte populations independent of response to treatment, indicating a TNFi effect. This implies that anti-TNF treatment is having some effect on patients even if there is clinical nonresponse. Differentially expressed CpGs implicates possible markers of response to treatment, particularly CDKAL1, a gene that has been associated with TNFi response in psoriasis. Funding Agencies Guts and Roses Charity

Novel Antireflux “RELIEF” Stent to Prevent Vesicoureteral Reflux

ObjectiveTo assess efficacy, comfort, & symptoms of a novel ureteral stent (RELIEF) substituting the distal semirigid coil of a traditional double-J (DJ) for a floating, monofilament tether allowing coaptation of the ureteral orifice. Ureteral instrumentation notoriously cause discomfort, urgency, frequency, dysuria & hematuria; prolonged morbidity is likely related to stent-associated vesicoureteral reflux (VUR). We hypothesized this design would eliminate VUR, be safe & provide comfort following intervention. Methods28 patients within a single institution were enrolled. Passive cystography was performed pre- & post-stent placement assessing VUR. Patients completed Ureteric Stent Symptoms Questionnaires (USSQ) before placement (baseline), post-op day 1, & day of removal. Results20 RELIEF stents were placed (11 female and 9 male). 95% demonstrated no VUR following placement. No unexpected adverse complications occurred; 1 patient opted for early stent removal for significant discomfort. Average total USSQ scores demonstrated statistically significant improvement between first and third surveys (p<0.001). Statistically significant improvement in body pain, general health & work performance scores were noted as well (p<0.05). ConclusionsThe RELIEF stent eliminates VUR with similar stent-related morbidity and overall well-tolerance. RELIEF associated USSQ scores were below published mean symptom scores for standard DJ stents and appear safe in this preliminary clinical trial.

P625 Electronic patient-reported outcomes in Inflammatory Bowel Diseases on vedolizumab therapy: Interim analysis of the non-interventional German LISTEN II study

Abstract Background Integrating systematic monitoring of patient-reported outcomes (PROs) with clinical information may enhance disease management and improve patient outcomes. Vedolizumab (VDZ) is approved for treating patients with ulcerative colitis (UC) and Crohn’s disease (CD). The German, multicentre, prospective, non-interventional LISTEN II study evaluates patient characteristics and effectiveness of VDZ treatment in real-world clinical practice, focusing on PROs. Methods Adult UC or CD patients, who either initiate VDZ intravenously (IV) or switch from IV maintenance to subcutaneous (SC) formulation, are enrolled. Data on patient characteristics, modalities of VDZ use and disease activity are recorded quarterly over one year. PROs are recorded via weekly questionnaires in app (ePRO). Sustained ePRO use was defined as proportion of patients reporting at least one PRO for ≥80% of available questionnaires. Interim data up to 9 months follow-up are presented. Results Data of 299 UC and 174 CD patients (51% and 59% female, respectively) with a mean age of 40 years were analysed. VDZ treatment was newly initiated IV (start) in 259 UC and 151 CD patients and switched from IV to SC application (switch) by 40 UC and 23 CD patients at baseline. Total mean pMayo score decreased in UC start-patients from 5.0 to 1.7 and from 1.1 to 0.8 in switch-patients. In CD start-patients HBI score decreased from 5.5 to 2.5 and from 3.1 to 2.3 in switch-patients. The ePRO was initially utilized by 226 UC and 124 CD patients (51% and 61% female, 57% and 52% sustained ePRO users, respectively) with a mean age of 39 years; 86% were start- and 14% switch-patients. Disease activity at baseline was comparable to the overall population, showing a total mean pMayo score of 4.5 for UC and a HBI of 5.3 for CD patients. Most UC (82%) and CD patients (88%) used a patient support program for the first time. ePRO use declined to approx. 40% usage within the second quarter and to 30% during further follow-up. Overall, mean symptom scores reported via the ePRO declined during the 9-month follow-up period. The most notable improvements (baseline to month 9) were reported for the symptom impact on work productivity (from 3.9 to 1.7 points) in UC patients and for sick leave (from 1.3 to 0.4 points) in CD patients (Table). For most PROs reduction in symptom scores was apparent within the first week of ePRO-use (Figure). Conclusion LISTEN II real-world data confirm VDZ effectiveness in UC and CD patients, with reduction in disease activity in IV starters and maintained effectiveness in IV-to-SC switchers. Both UC and CD patients reported sustained symptom improvement under VDZ treatment, with scores indicating improvement within the first week of ePRO-use.

Concussion Symptoms and Neurocognitive Performance of Children and Adolescents on Antidepressants.

There is a well-established association between preexisting depression/anxiety and greater postconcussion symptom burden, but the potential impact of antidepressant medications has not been fully explored. The primary objective of this study was to compare preinjury/baseline and postinjury concussion symptom scores and neurocognitive performance of athletes on antidepressant medications, both with healthy controls and with those with depression/anxiety not on antidepressants. This is a cross-sectional study using data collected from 49,270 junior and high school athletes from computerized neurocognitive assessments (Immediate Post-Concussion Assessment and Cognitive Test [ImPACT]) administered between 2009 and 2018 held by the Massachusetts Concussion Management Coalition. The main outcome measures were symptom scores and neurocognitive performance measures, all of which were assessed both at baseline and postinjury. Statistical analysis included analysis of variance and Tukey pairwise comparisons for continuous variables and Fisher's exact test for categorical variables. Multivariate regression models were used to adjust for potential confounding variables. Both at baseline and postinjury, athletes with depression/anxiety had mean total symptom scores that were more than double that of healthy controls regardless of antidepressant use. Although there were no significant differences in neurocognitive performance at baseline, depression/anxiety was associated with small but significant decreases in postinjury visual memory and visual motor scores. Both at baseline and after sustaining a concussion, young athletes with depression/anxiety experience significantly greater symptom burden compared with healthy controls regardless of antidepressant use.

Impact of postinflammatory hyperpigmentation on quality of life in patients with skin of color

Background: Dyschromias are the second most commonly diagnosed dermatological entity in patients with skin of color (SOC). People with SOC develop postinflammatory hyperpigmentation (PIH) with a higher frequency and greater severity attributed to the presence of reactive melanocytes. This can have severe repercussions on self-esteem and social/emotional functioning. While there are studies on the impact of post-acne PIH on quality of life (QOL), the assessment of impact of PIH on QOL as a heterogenous group of dermatoses has not been studied previously. Objectives: The aim of this study was to assess the impact of PIH on QOL in patients with SOC using Skindex-16. Materials and Methods: This was a cross-sectional study conducted from October 2019 to September 2021, involving 60 patients with SOC having biopsy-proven PIH. All patients underwent thorough clinical workup, followed by the administration of the Skindex-16 questionnaire. Data were tabulated and analyzed. Results: The mean age was 32.53±11.73 years: 35 (58%) patients were male, and 25 (42%) were females. Most patients presented with PIH secondary to papulosquamous disorders (n=23; 38.34%), followed by acne/acneiform eruptions (n=11; 18.33%). The mean scores for symptoms, emotions, functioning, and total scores were 0.37±0.51, 2.30±1.13, 2.26±1.40, and 1.64±0.85, respectively. PIH lesions with simultaneous evolution were associated with higher symptoms subscale scores. A previous tendency of PIH, involvement of exposed sites, higher intensity of PIH, epidermal PIH, and lesions accentuating on Wood’s lamp had higher, statistically significant impact on emotions, functioning, and total scores. Conclusion: PIH had significant impact on Quality of Life in patients of Skin-of-Color. Our study was limited by the sample size, and larger, multicentric, population-based studies are recommended.