Health-related Quality Of Life Research Articles

LeAf Trauma- an intersectoral prospective multicenter study assessing quality of life and return to work after majortrauma-study protocol.

With increasing survival rates, the functional outcome and quality of life of trauma patients are gaining more importance. Survivors suffer from chronic pain, psychosomatic disorders, and unemployment as well as increased post-traumatic morbidity, which can lead to an impaired quality of life. So far, the TraumaRegister DGU® records patient data during in-hospital treatment. In this study severely injured patients after major trauma are assessed when discharged from hospital, as well as 6, 12 and 18 months after trauma. The aim is to document cross-sector patient pathways and to identify and quantify the factors influencing the health-related quality of life (hrQoL) and the return to work (RTW), using patient-reported experience measures (PREM) and patient reported outcome measures (PROM). Patients are recruited in certified trauma centers of the German Society for Trauma Surgery (DGU). This study protocol describes the methodology of the prospective multicentre study of LeAf Trauma. Translation of the results will be implemented by using the network structures of the German Society for Trauma Surgery (DGU) for the treatment of patients with major trauma.

A06 - OGC LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): Multicentre validation cohort study

Abstract Background Patients are living longer with the long-term morbidity of oncological and surgical therapies as oesophageal cancer outcomes improve. Existing symptomatology and quality of life tools are cumbersome and moreover not designed for the post-treatment survivorship setting. The LASER study identified six key symptoms thought to predict poor health-related quality of life. The current study aimed to validate this six-symptom LAsting Symptoms after Oesophageal Resection (LASOR) clinical tool, and assess its clinical utility. Method Between 2015 and 2019, patients from UK centres who underwent curative-intent oesophageal cancer treatment, and were disease-free at least one year postoperatively, were asked to complete LASOR, EORTC QLQ-C30 and QLQ-OG25 questionnaires. LASOR symptoms (low mood, reduced energy, thoracotomy pain, heartburn, diarrhoea, and bloating after eating) were correlated with EORTC HRQOL scores. Multivariable regression analysis identified symptoms associated with poor HRQoL. Receiver operating characteristic curve analysis was used to validate the LASOR tool. Results 263 patients, spanning a combination of surgical approaches (two-stage, three-stage, left thoracoabdominal, transhiatal), techniques (open, minimally invasive, hybrid), and disease stage, completed the questionnaires. Four of the six LASOR symptoms were associated with poor HRQoL: reduced energy (OR 2.13; 95% CI 1.20-2.87), low mood (OR 1.86; 95% CI 1.4503.12), diarrhoea (OR 1.48; 95% CI 1.06-2.05), and bloating after eating (OR 1.35; 95% CI 1.03-1.77). The LASOR tool produced an area under the curve of 0.85. Conclusion The six-symptom LASOR tool generated a reliable model for identification of patients with a poor HRQOL, with an overall diagnostic accuracy of over 80%. This is the first clinical symptom and quality of life tool to be validated in esophageal cancer patients post-curative treatment. The LASOR tool is straightforward to administer and acceptable to patients. Clinical utility lies both in identifying patients at risk of poor HRQoL and in planning survivorship services.

A time trade-off study in the UK, Canada and the US to estimate utilities associated with the treatment of haemophilia.

Haemophilia is a rare bleeding disorder caused by a deficient or absent clotting factor, leading to frequent bleeding. Multiple intravenous (IV) infusions have been the standard prophylactic treatment; however, newer treatment options involve less frequent subcutaneous (SC) injections. To inform future health economic evaluations, this study applied the time trade-off (TTO) method for estimation of utilities associated with haemophilia treatment for both people with the disease and potential caregivers. Using the TTO method, utilities were estimated through two online surveys distributed in the UK, Canada and the US. In survey 1 (S1), adults from the general population aged 18years and above evaluated health states as if they were living with haemophilia themselves and were receiving treatment for the condition. In survey 2 (S2), adults from the general population with a child under the age of 15years evaluated health states as if they were treating their child for haemophilia. The surveys assessed the following treatment aspects: frequency of treatment, treatment device and injection site reactions. In total, 812, 739 and 703 respondents completed S1 and 712, 594 and 527 completed S2 in the UK, Canada and the US, respectively. In both surveys, the treatment device was associated with the largest impact on utilities for both people with haemophilia and caregivers. Monthly SC injections with a prefilled pen-device were associated with a significant utility gain compared with SC injections with a syringe and IV infusions. In S1, a lower treatment frequency was preferred in all three countries, while in S2, a lower treatment frequency was preferred only in the UK. Avoiding injection site reactions was associated with a significant utility gain in both surveys, but only in the UK and Canada. The study suggests that the administration of haemophilia treatment in particular has an impact on utilities for both people and caregivers living with the disease. Thus, less complex and time-consuming treatment devices are expected to improve health-related quality of life. This can be further modified additively by less frequent administration. These results can inform future health economic analyses of haemophilia and haemophilia treatment.

Participants' perspectives on a multimodal stress management and comprehensive lifestyle modification program for patients with Crohn's disease-A qualitative interview study.

Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) that is prevalent worldwide and associated with reduced quality of life for patients. Multimodal therapy approaches, which emphasize lifestyle modifications such as mindfulness and stress reduction, can be promising in enhancing health-related quality of life for IBD patients. However, research on multimodal therapy approaches for CD remains insufficient. This qualitative interview study is part of a mixed-methods approach that is embedded in a randomized controlled trial. It investigates the impact of a comprehensive 10-week day clinic lifestyle modification program on the health condition and quality of life of CD patients. Telephone interviews (n = 19) were conducted three months after the program to examine individuals' viewpoints on the intervention, including perceived changes and transfer of elements into daily life. Reflexive thematic analysis was performed using MAXQDA software. The results indicate that CD can have very individual and comprehensive impacts (psychological, physical, social), leading to reduced perceived quality of life and well-being. By participating in the program, patients wanted to find self-help options to complement conventional pharmacotherapy and actively manage their disease. Patients expressed high satisfaction with the program, feeling it provided valuable support for daily disease management. They were able to integrate adequate therapy elements into their routines to complement their care. Patients recognized significant improvements in various domains, mainly in the psychological domain, e.g., improved self-efficacy, symptom management, and, also partly physical/symptomatic and social improvements. A multimodal stress reduction and lifestyle modification day clinic appears to be beneficial as a complementary therapy for CD patients. It offers additional options and helps patients to address individual symptoms and needs, improve their understanding of the disease and their quality of life. Although promising, further research is needed to assess its long-term effects. ClinicalTrials.gov, identifier: NCT05182645.

The economic burden of nosocomial infections for hospitals: evidence from Germany.

Nosocomial infections (NI) significantly worsen patient outcomes, resulting in higher mortality rates and reduced health-related quality of life. Furthermore, they pose substantial economic strain on healthcare systems and hospitals. For instance, patients with nosocomial infections (NIs) experience prolonged hospital stays compared to those without NIs. These extended stays result in occupied bed-days, leading to opportunity costs for hospitals. This study aimed to estimate the opportunity costs for a German hospital based on hospital stays, daily revenue, and occupancy rates (OCR). We analysed cost data obtained from routine records maintained by the accounting department of a German hospital's surgical and orthopedic units from 2018 to 2019 for the "HygArzt" research project. To ensure balance, we employed genetic matching. We estimated the differences in length of stay (LOS) and daily revenue between patients with and without nosocomial infections (NI) using linear regression. Finally, we calculated the opportunity cost borne by the hospital by treating NI patients instead of non-NI patients. All costs are reported in 2018 Euros. The final sample included 81 patients with NI matched with 207 patients without NI. The majority of the NI patients (77.0%) had surgical site infection (SSI). Compared to non-NI patients, we observed that NI patients had a longer LOS (10 days, p < 0.001) and lower daily revenue (€400, p < 0.001). We also found that comorbidities and the frequency of operations had significant impact on the LOS. Using a baseline 30 to 50% preventable NIs, successful prevention of a single NI could potentially reduce the length of hospital stay by 3 to 5 days and increase hospital revenue by approximately €120 to €200 per day per prevented NI. Consequently, the hospital saves 3 to 5 more bed-days to backfill and generate more revenue, and/or make more efficient resource allocation by changing bed-capacity and staffing. The resulting opportunity costs can potentially exceed €1,000 per preventable case. NIs pose a substantial economic burden for hospitals. From a health economics' perspective, there are strong economic incentives for hospitals to implement infection control interventions, such as the involvement of a prevention link physician/nurse.

BN O03 - Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis

Abstract Background The most common gastrointestinal disorder globally is gastroesophageal reflux disease (GERD). Standard-of-care treatments for GERD are medical therapy, via proton pump inhibitors (PPIs), and traditional antireflux surgery (i.e., Nissen fundoplication). Unfortunately, PPI therapy is associated with medication irresponsiveness in up to 40% of cases and Nissen fundoplication results in significant rates of postoperative adverse events (AEs), such as postoperative dysphagia. Notably, patients with large hiatal hernia (&amp;gt;3 cm) are exceedingly difficult to treat with antireflux surgery. This report presents the clinical results of patients treated with an emerging technology, the RefluxStop device, in Germany at our two centers. Method Between July of 2021 and November of 2023, 158 patients were operated on with RefluxStop surgery. This procedure entails correction of a defunct antireflux barrier through cruroplasty (with hiatal hernia reduction, if necessary), limited (90-120°) esophagogastroplication to recreate the acute angle of His and gastroesophageal flap valve, and regional stabilization of newly constructed anatomy with implantation of the RefluxStop device in a fully invaginated fundic pouch. Clinical outcomes included GERD Health-Related Quality of Life (GERD-HRQL) score, PPI use, and perioperative AEs. Results Patients of mean age 49±13.3 years and male (51.3%) had hiatal hernia &amp;gt;3 cm (22.2%). At 20±7-month follow-up, the median (IQR) GERD-HRQL score improved by 90.9% to 2 (0-2) from a baseline of 22 (19-31.5) (p&amp;lt;.001). PPI use decreased by 96.3%. Preoperative dysphagia (n=18) resolved in all patients with five cases (3.2%) of new-onset dysphagia occurring, but none requiring postoperative dilation. Hiatal hernia recurred in two patients (1.3%) and was treated with device repositioning. Device migration presented in two patients (1.3%) from excessively tight suturing of the fundic pouch. One of these patients was converted to Toupet fundoplication. Conclusion This study shows that RefluxStop provides excellent effectiveness and safety outcomes. Quality-of-life improvements were particularly appreciated with a 90.9% reduction in GERD-HRQL score. With the added context of 22.2% of this pooled cohort composed of difficult-to-treat patients (i.e., hiatal hernia &amp;gt;3 cm), RefluxStop surgery provides favorable efficacy in real-world settings with such patients. As with any novel surgical procedure, training is paramount to optimizing surgical outcomes and minimizing unwanted AEs. Further study is required to bolster the evidence supporting this emerging technology.

Abstract 4128187: Does Health-related Quality of Life Differ by Race over time in Older Patients with Heart Failure from Before to After Heart Transplantation or Long-term Mechanical Circulatory Support?

Background: Minority patients are disproportionately affected by heart failure. Therefore, we aimed to determine the impact of race on health-related quality of life in three groups of older patients (60-80 years) with heart failure who underwent advanced surgical therapies (within race and by surgery group): (1) heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS]), (2) HT without pre-transplant MCS (HT Non-MCS), or (3) long-term MCS, if ineligible for HT. Methods: Secondary analyses were conducted using data from the Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support study. From 10/1/15 to 12/31/18, 396 patients with heart failure were recruited at 13 U.S. medical centers, of which 305 patients underwent HT (n=161 [68 HT MCS and 93 HT Non-MCS]) or long-term MCS (n=144) and had data through 1 year follow-up. Analysis included non-inferiority testing (Long-term MCS vs HT MCS; Long-term MCS vs HT Non-MCS). To demonstrate non-inferiority, the surgical strategies by race needed to show a difference of at least 5 percentage points, with a 95% lower confidence boundary and a two-tailed p-value&lt;0.05 in health-related quality of life, using the Kansas City Cardiomyopathy-12 Questionnaire Overall Summary Score at baseline and 3-, 6-, and 12 months. Results: The entire cohort was on average 66.2±4.7 years, 78% male, and 84% White. All three surgical groups experienced improved health-related quality of life from before to 1 year follow-up; with the largest gain through 3-months. Using non-inferiority testing, the long-term MCS minority group did not demonstrate non-inferiority when compared to both the HT MCS minority group and HT Non-MCS minority group confidence limits above the non-inferiority margin of -5 (Figure). Also, the White long-term MCS group did not demonstrate non-inferiority when compared to the White HT MCS and White HT Non-MCS groups. Conclusion: Differences in health-related quality of life among groups based on race were not statistically significant. Per non-inferiority testing, HT is superior to long-term MCS for health-related quality of life, regardless of race.

Abstract 4129729: Relationship Between Inflammatory Biomarkers and Quality of Life in Black Adults Living with Heart Failure: A Pilot Study

Introduction: Heart failure (HF) impacts quality of life considerably, with inflammatory biomarkers potentially playing a significant role in this relationship. The purpose of this study is to examine the relationship between NYHA Class, inflammatory biomarkers, and quality of life in Black adults living with HF. Methods: Black adults living with HF (N=41) were enrolled in this study. NYHA Class was extracted from the medical record. Health-related quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item questionnaire that quantifies physical function, symptoms, social function, and health-related quality of life in HF. Scores are transformed to a range of 0-100, with higher scores reflecting better health status. One-way ANOVA and correlation analyses were used to assess associations between NYHA class, inflammatory biomarkers (XO activity, IL-1β, IL-15, and CCL-19), and KCCQ scores. Results: Participants were 57±11 years of age and 66% female, with mean LVEF 33±14%. NYHA Class ranged from I (20%) to IV (12%), with the majority of participants in Class II (34%) and III (22%). Mean KCCQ Clinical Summary Score was 85± 21. NYHA Class I had significantly lower scores on the KCCQ Clinical Summary Score compared to Class III and IV (p &lt; .001, η 2 = 0.54), KCCQ Physical Limitation compared to Class II, III, and IV (p &lt; .001, η 2 = 0.53), and KCCQ Symptom Frequency compared to Class IV (p = .001, η 2 = 0.39). The KCCQ Clinical Summary Score was negatively associated with XO activity (r = -0.440, p = .046), IL-1β (r = -0.407, p = .043), IL-15 (r = -0.427, p = .033), and CCL-19 (r = -0.559, p = .004). Similar negative associations were observed for the KCCQ subscales. Conclusion: The negative association between XO activity and health-related quality of life (KCCQ) in individuals with HF highlights the potential impact of oxidative stress on these patients' subjective well-being and functional status. Understanding this relationship could underscore the importance of mitigating oxidative stress pathways to improve the overall quality of life and symptom burden experienced by individuals with HF. The KCCQ and subscales were also negatively associated with markers of inflammation, highlighting the potential impact of systemic inflammatory processes on subjective well-being and functional status in persons with HF. Targeting inflammatory pathways may improve quality of life and mitigate the burden of symptoms in HF.

Abstract 4147647: Effects on Cognition, Sleep, Quality of life and Exercise Capacity of a 12-week Tele-yoga Intervention in Persons with Heart Failure - Results from 3 and 6 Months Follow-up

Background and Objectives: Yoga may be a promising form of mind-body rehabilitation for patients with long term illness. Digitally delivered yoga increases access to participation but has not previously been evaluated in the heart failure population. The aim of this study was to examine the effects of tele-yoga on cognition, sleep, health-related quality of life and exercise capacity in persons with heart failure. Methods: The Tele-yoga study (ClinicalTrials.gov, ID: NCT 03703609) was a parallel two-arm randomised controlled trial (RCT) with 1:1 distribution to an intervention and control group. Study participants were randomised to tele-yoga including live-streamed group-yoga for 60 minutes twice weekly during 12 weeks and yoga individually for 10 minutes/day using an app, or to a control group receiving individual exercise advice. Cognition (Montreal Cognitive Assessment: MoCA), sleep (minimal insomnia symptom scale; MISS), health-related quality of life (EQ-5D VAS) and sub-maximal exercise capacity (6 minute walk test; 6MWT) were assessed at baseline, after 3 and 6 months. Linear mixed model with random intercept for patients as the random effect and group-time interaction along with age was taken as the fixed effects to analyse outcomes. Results: A total of 311 participants were included (tele-yoga n=156 and active controls n=155), mean age 66 years, 70% men. Adherence to the group yoga was very good. The linear mixed models showed a significant change in cognition, health-related quality of life and exercise capacity favouring the tele-yoga group. No significant differences between the groups were seen regarding sleep. When analysing the fixed effects of all outcomes, age, group assignment and time-points interaction had significant effects on EQ-5D VAS score, 6MWT distance and MoCA scores. For EQ-5D VAS the tele-yoga group performed significantly better than the control group at 3 months, but not at 6 months. For the 6MWT distance, the tele-yoga group performed better than the control group at 3 months, but not at 6 months. The tele-yoga group had significantly higher MoCA scores than the control group at both 3 and 6 months. Conclusion: This adequately powered RCT showed that digitally delivered mind-body training in the format of group and individual yoga during 12 weeks lead to an improvement in cognition, quality of life and exercise capacity at the end of the intervention. The effect was sustained for cognition also after 6 months.

Abstract 4127664: Influences of Age on Improvement of Health-Related Quality of Life in Patients with Atrial Fibrillation following Initial Treatment

Background: The prevalence of Atrial Fibrillation (AF), the most cardiac common arrhythmia, increases with age. Various treatment strategies are available to improve health-related quality of life (HRQoL) in patients with AF; however, the impact of age on HRQoL treatment benefits is unknown. Aims: To investigate the association of age with HRQoL benefit across different treatment strategies. Methods: Using data from a multicenter registry for outpatients with early recognized AF, HRQoL at enrollment and 1 year later was measured with the Atrial Fibrillation Effect on Quality-of-life quesTionnaire (AFEQT). The association between age and the 1-year changes in AFEQT-overall summary (OS) and subdomain scores with either rate or rhythm control strategies were assessed using generalized additive models (GAM) to address non-linear relationships. To support clinical interpretation, multivariable linear regression models were performed with categories of age ranges. Results: Among 2786 patients (31.7% women, 54.7% rhythm control); 946 were &lt;65 of age, 1019 were ≥65–75, and 821 were ≥75 years old. Rhythm (vs. rate) control was pursued in 76.6%, 58.0%, and 33.6% and mean AFEQT-OS changes were 11.1 (SD 16.6), 8.0 (17.0), and 4.7 (18.2) in those aged &lt;65, 65–74, and ≥75, respectively. The GAM showed improvements in AFEQT-OS attenuated with advancing age with both treatment strategies ( Figure ). Linear regression analyses showed lesser improvements in AFEQT-OS as higher age categories (≥65–75 vs. &lt;65, β -1.12 [95% CI, -2.33 – 0.09]; ≥75 vs. &lt;65, β -3.86 [-5.29 – -2.42]), which were mainly driven by lesser improvement in AFEQT-daily activities scores, without differences in AFEQT scores for symptom or treatment concerns ( Table ). Conclusions: In AF patients, HRQoL benefits after treatment were attenuated by advancing age, primarily driven by less improvement in functional limitations, underscoring the need for further research to identify optimal treatment strategies for older adults.

Abstract 4122307: Longitudinal Changes in Parent-reported Quality of Life in Children with Single Ventricle

Introduction: Increased knowledge of quality of life (QOL) and the potential impact of the Fontan on QOL is essential to improving outcomes in patients with single ventricle. The primary aim of the Pediatric Heart Network Single Ventricle Reconstruction (SVR) trial II was to investigate outcomes in subjects with SV at age 6 yrs while SVR III characterized outcomes in this cohort at age 10-12 yrs. Aims: The purpose of this study was to evaluate changes in health-related QOL from SVR II to SVR III and to identify factors associated with changes in QOL over time. Methods: Parents completed proxy-reports for their child using the Pediatric Quality of Life Inventory (PedsQL) generic and cardiac scales at SVR II and SVR III. Within-subject differences in PedsQL scores and proportions scoring in the ‘at-risk’ range for significantly impaired QOL between time points were examined using one-sample t-test and McNemar’s tests, respectively. Factors associated with changes in QOL were evaluated using standard univariate tests. Results: A total of 163 patients were included (63% male, 89% Caucasian, 16% Hispanic). PedsQL scores reported by parents decreased across all domains: total score -6.1 ± 17.1, p &lt;.0001; physical -4.0 ± 22.3, p=0.02; psychosocial -7.2 ± 17.4, p&lt;.0001; emotional -6.5 ± 20.7, p=.0001; social -6.6 ± 22.6, p= 0.0003; and school -8.6 ± 22.5, p&lt;.0001, functioning. No significant change in parent-reported heart problems/cardiac symptoms was detected across timepoints (-1.0 ± 20.4, p=0.52). Proportions with impaired QOL increased over time: total 28 to 39%, p=.01, physical 27 to 39%, p=.01, psychosocial 25 to 40%, p=.002, emotional 20 to 34%, p=.001, social 22 to 31%, p=.06, and school 21 to 38%, p=.0001. Only treatment for a psychological or behavioral disorder (n=26) was significantly associated with decline in psychosocial (mean -14.0 vs. -5.9; p=.03) and emotional (mean -17.1 vs. -4.5; p=.004) functioning scores. There was no significant association between socioeconomic status, Vineland adaptive scores at SVR II, or interval complications or procedures and changes in QOL. Conclusion: As perceived by their parents, health-related QOL in children with SV decreases over time unrelated to cardiac symptoms and complications. The greatest decline was in school functioning with 1 in 3 children having significantly impaired school QOL at SVR III. Greater attention to assessment of learning and psychosocial needs is essential to improve QOL in patients with SV.

Abstract 4117856: Effects of a Nurse-led Common-sense Model of Self-regulation-Based Heart Failure Self-care Program on Patient Outcomes: A Randomized Controlled Trial

Introduction: Guidelines have recognized the critical role of self-care in heart failure (HF), but people with HF do not adequately practice self-care. The Common-Sense Model (CSM) of Self-Regulation is a widely used theoretical framework for promoting behavior change and improving disease prognosis among patients. However, studies on the effects of the application of this model among people with HF are limited and present mixed results. Aims: To examine the effects of a nurse-led CSM of Self-Regulation-based self-care intervention on illness perceptions, self-care behaviors, self-care self-efficacy, self-care behaviors, health-related quality of life, depression, anxiety, symptom burden, sleep quality, healthcare service utilization, and mortality among people with HF. Methods: A randomized controlled trial was conducted. Participants were recruited from a university-affiliated hospital and randomized at a 1:1 ratio into the intervention or the control groups. Participants in the intervention group received a 6-week nurse-led CSM of Self-Regulation-based self-care program and usual care. Control group participants only received the usual care. Outcomes of interest were measured at baseline, 6 weeks (T1), and 3 months (T2) after enrollment. The generalized estimating equations model and Mann-Whitney U test were used to examine the intervention effects on the study outcomes. Results: 138 subjects were enrolled in the study between March and May 2023. Participants in the intervention showed statistically greater improvements in illness perceptions, self-care self-efficacy, self-care behaviors, health-related quality of life, depression, symptom burden, and sleep quality compared with the controls at T1 and T2. We also observed a statistically significant reduction in the number of HF-related unscheduled outpatient department visits in the intervention group compared to the control group at T2. However, no significant differences were found in anxiety, number of HF-related hospital readmissions, length of HF-related hospital stays, number of HF-related emergency department visits, or HF-related mortality between the study groups at T1 and T2. Conclusion: Our program generates favorable effects on promoting behavior change and improving health outcomes among people with HF. It also fills the knowledge gaps around the application of CSM of Self-Regulation in people with HF and provides more empirical evidence supporting the effectiveness of nurse-led interventions.

Preliminary results from a multicenter, randomized trial using fecal microbial transplantation to induce remission in patients with mild to moderate Crohn's disease.

Fecal microbial transplantation (FMT) has shown promise at inducing remission in ulcerative colitis. This study is the first of its kind to evaluate the efficacy and safety of FMT at inducing remission in Crohn's disease (CD). This double-blind, placebo-controlled trial was conducted in three Canadian academic centers; randomized patients with mild to moderate CD received FMT or placebo. The first treatment was administered by colonoscopy followed by weekly fecal capsules for 7 weeks. Primary endpoint was clinical and endoscopic remission at week 8. Secondary outcomes included clinical and endoscopic response, adverse events, and health-related quality of life using generic and disease-specific instruments. From July 2017 to June 2021, 21 and 13 patients were randomized to FMT and placebo groups, respectively. The trial terminated early due to futility. At week 8, 0% (0/15) of patients in the FMT group versus 8.3% (1/11) in the placebo group reached the primary endpoint of combined clinical and endoscopic remission as per protocol analysis. There were no differences between the groups in clinical or endoscopic responses. One participant in each group had worsening of CD. Although both groups experienced statistically significant improvements in health-related quality of life, only the FMT group had a significant decrease in activity impairment. Although there were no significant changes in microbial diversity or composition, participants who achieved clinical response became more similar to their donors in stool microbial composition. FMT was not effective at inducing clinical and endoscopic remission in CD using the FMT regimen in this study. Future studies may use other strategies to enhance treatment response, including longer intervention, antibiotic pretreatment, optimized donor-recipient pairing, and concomitant anti-inflammatory diet, biologic or small molecule therapies.

Psychosocial, emotional and behavioral problems, quality of life, and mental health care seeking behaviors among children and adolescents in Jordan: a national school-based survey

ObjectivesThis study aimed to estimate the prevalence of psychosocial, emotional, and behavioral problems and their symptoms among children and adolescents in Jordan, assess their quality of life, and examine mental health help-seeking behavior.MethodsA large-scale school-based national survey was conducted in Jordan among children and adolescents aged 8 to 18 years (grades 3 to 12) from the host and refugee populations, utilizing a multi-stage stratified cluster sampling technique to select a nationally representative sample. Two versions of structured questionnaires were used: proxy parent version for students in grades 3 to 6 (8–11 years) and self-report version for students in grades 7 to 12 (12–18 years). The study questionnaires employed internationally recognized and validated tools in English, which were translated into Arabic.ResultsA total of 8,000 (3,433 (42.9%) boys, 4,567 (57.1%) girls) and (3,593 (44.9%) children, 4,407 (55.1%) adolescents) were included. About 24.5% of children had anxiety symptoms (18.0% of Jordanians, 34.5% of Syrian camp refugees, 33.7% of Syrian urban refugees, and 24.7% of Palestinian camp refugees) and 16.6% of children had major depressive disorder symptoms (11.0% of Jordanians, 25.4% of Syrian camp refugees, 25.0% of Syrian urban refugees, and 14.0% of Palestinian camp refugees). Almost 13.9% of children and 19.7% of adolescents had abnormal levels of total emotional and behavioral difficulties. Nearly 16.5% of children and 35.0% of adolescents had poor overall health-related quality of life. When experiencing a personal or emotional problem, only 28.1% of children’s parents would seek help for their children and 19.7% of adolescents would seek help for themselves.ConclusionThe study revealed a high prevalence of various mental health issues’ symptoms, particularly among refugees and female adolescents. Intention to seek help is relatively low, suggesting that children and adolescents’ mental health needs are not being widely met. It is crucial to implement integrated and coordinated plans and programs that effectively target multiple factors that impact children and adolescents’ mental health, while also respecting the prevailing cultural context. A key aspect of promoting the mental well-being of children and adolescents in Jordan is the inclusive involvement of refugees and individuals from other nationalities.

Nutritional education on health beliefs, metabolic profiles, and quality of life among high-risk pregnant women for gestational diabetes mellitus: a randomized controlled trial.

In recent years, nutrition has become increasingly important in treating and managing gestational diabetes mellitus. The Health Belief Model (HBM) is a conceptual framework in health behavior research used in some medical research. The present study aimed to evaluate the effect of glycemic index training based on the HBM on metabolic indicators and pregnant women's health-related quality of life. In this open-label, parallel-controlled randomized trial, 90 pregnant women from primary health centers in Iran were recruited and randomly assigned to either the intervention group or the control group, using a block randomization method with a block size of six. The intervention group underwent 12 weeks of nutritional education on the glycemic index and load of foodstuff. The control group only received routine health care. Valid and reliable questionnaires included demographic and prenatal information, physical activity, three days of food records, quality of life (SF-12), and HBM constructs. Fasting blood samples were taken at baseline and end of the study, to assess fasting blood glucose (FBS), fasting insulin, hs-CRP, and lipids. Eighty-four pregnant women with an age mean of 30.12 ± 4.35 completed 12 weeks of intervention. At baseline, there were no significant differences between groups in the HBM subscales (P > 0.05). However, within the intervention group, there was an increase in perceived susceptibilities (mean change 1.45 ± 4.21; P = 0.03) and cue to action (mean change: 1.22 ± 3.38; P = 0.02). In the adjusted model, the General Health subscale of Quality of Life showed a significant increase in the comparison between groups (mean change 13.69 ± 29.83 vs. 0.00 ± 29.58; P = 0.04). Additionally, the adjusted model revealed a notable difference between the groups in serum hs-CRP level, (mean change -0.877 ± 3.47 vs. -0.067 ± 3.40; P = 0.01) and triglyceride level (mean change - 55.24 ± 111.21 vs. 40.92 ± 142.01; P = 0.001). However, in the adjusted model, the total cholesterol levels increased between groups (mean change 22.75 ± 66.17 vs. 30.12 ± 61.33; P = 0.01) at the end of the study. There was no significant difference in glycemic indices (P > 0.05). Participation in a nutrition education program might positively impact nutritional beliefs, behaviors, and some biochemical indicators among pregnant women. Future studies with larger sample sizes and longer follow-ups are warranted.Trial registration number: IRCTID: IRCT20190227042858N1. Registration date: 2019-07-18.

QOL-14. HEALTH-RELATED QUALITY OF LIFE AND COGNITIVE FUNCTIONING IN SURVIVORS OF OLIGODENDROGLIOMA: AN INTERNATIONAL CROSS-SECTIONAL INVESTIGATION

Abstract BACKGROUND Patients with oligodendroglioma have a relatively favourable prognosis. Treatment modalities used vary, and the long-term impacts of the tumour itself and its treatment on health-related quality of life (HRQOL) and cognition remain largely unclear. We investigated associations between treatment and functioning of oligodendroglioma patients. METHODS In this international cross-sectional observational study, patients with oligodendroglioma (IDH-mutant and 1p/19q-codeleted) diagnosed ≥5 years ago, were recruited through the European Organisation for Research and Treatment of Cancer (EORTC) networks. Diagnosis and treatment data were collected from medical records; patients completed outcomes for HRQOL (EORTC QLQ-C30; BN20), self-reported cognitive functioning (MOS Cognitive Complaints Scale) and cognitive tests (HVLT-R, TMT, COWAT). Associations between HRQOL and cognition outcomes, and clinical variables (time since diagnosis; progression; tumour location; treatments delivered; current medication; Karnofsky Performance Status (KPS)) were explored with regression analyses. RESULTS 242 oligodendroglioma patients on average 9.9 years post-diagnosis (sd=4.3, range=5.0-26.3) took part from 33 sites across 9 countries. Patients were M=52 years old (sd=12, range=23-78), the majority were men (N=145; 60%). Higher KPS, no radiotherapy (ever), no current medication (anxiolytics/sedatives; antidepressants; dexamethasone) were associated with better generic HRQOL outcomes (QLQ-C30 functioning scale models; R2 range 0.068-0.371, all p&amp;lt;.001). Higher KPS, fewer recurrences, no radiotherapy treatment (ever), and no current antidepressant use were linked to better disease-specific HRQOL (BN20 multi-item scale models; R2 range 0.067-0.246, p&amp;lt;0.001). Fewer subjective cognitive complaints were associated with higher KPS and no current antipsychotic medication (R2=0.153, p&amp;lt;0.001). Better KPS, right hemispheric tumours, longer time since diagnosis, no chemotherapy (ever), no radiotherapy (ever), and no current medications (dexamethasone; antipsychotics) were predictive of better cognitive functioning (R2 range 0.056-0.248, p&amp;lt;0.001). CONCLUSION In oligodendroglioma survivors, better HRQOL and cognitive outcomes appeared consistently linked with higher KPS, no current medication use, and never having received radiotherapy. Additionally, better cognitive outcomes were associated with no chemotherapy treatment.

Health-Related Quality of Life Among Discharged Patients With Hemophagocytic Lymphohistiocytosis: A Follow-Up Study.

Evaluating the post-discharge health-related quality of life (HRQoL) in hemophagocytic lymphohistiocytosis (HLH) and exploring its influencing factors. The study was conducted at a regional pediatric medical center and involved pediatric patients diagnosed with HLH between July 2017 and July 2022. Healthy children of the same age and sex were included as the control group. The HRQoL and its associated factors in pediatric patients were assessed using the PedsQL 4.0 Parent Proxy Report and a general information survey. In the first year following diagnosis, psychological health and overall score in HLH patients were worse than those of the control group. However, scores for emotional functioning, school functioning, physical health, psychosocial health, and overall scores in the HLH group increased over the years since diagnosis. By the 5-year post diagnosis, there were no significant differences between the HLH group and the control group in social functioning, school functioning, physical health, psychosocial health, and overall scores (p>0.05). Generalized linear model analysis revealed that HLH patients who underwent transplantation have worse social functioning, physical health, overall score, while HLH patients with HLH recurrence have worse social functioning, psychosocial health, overall score (p<0.05). The HRQoL of HLH patients is compromised after discharge; however, it progressively returns to levels comparable to those of healthy cohorts over time since diagnosis. Transplantation, and HLH recurrence are identified as factors affecting the HRQoL in HLH patients.

Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial.

In ovarian cancer frequently reported side effects are muscle wasting and malnutrition, leading to frailty, decreased health-related quality of life (HRQoL), and cancer-related fatigue (CRF). Both often begin during first-line chemotherapy and develop progressively into a refractory state, if left untreated. Primary objective is to evaluate effectiveness of a newly developed app-based exercise and nutrition program under non-standardized conditions of clinical routine. We hypothize that patients who receive an individually tailored exercise and nutrition program for six months will have improved physical performance compared to patients who receive usual care. This is a multicenter randomized controlled open-label trial comparing an intervention group receiving a six-month exercise and nutrition intervention and a control group receiving usual care. Primary endpoint is the change in 6-Minute Walk Test (6MWT) from baseline to T2 (26 weeks after baseline) as a measure of physical functioning. Secondary endpoints include patients' utilization and adherence to the nutrition program (MEDAS), their malnutrition risk (NRS2002), as well as patients' HRQoL (see Table1). Using the two-sample t-test with a two-sided type I error of 5% and 80% power, a medium effect size of Cohen's d = 0.50 can be demonstrated with a minimum of 128 participants (64 per group). With a conservatively estimated dropout rate of 30%, 182 patients will be recruited. Patients who are included must be over 18 years of age, be diagnosed with ovarian cancer, cancer of fallopian tubes, or peritoneal cancer, FIGO stages II-IV, receive surgery and chemotherapy (adjuvant or neoadjuvant). Exclusion criteria are an ECOG status greater than 2, inadequate proficiency in German, or physical or mental impairments hindering the implementation of the program or execution of study procedures. In case of success, the project contributes in the long term to (i) improving medical care (diagnosis, psychoeducation, patient orientation, and empowerment), (ii) reducing the burden of disease and promoting physical autonomy for patients, and (iii) being incorporated into relevant guidelines. The study was registered at ClinicalTrials.gov (NCT06250686).

CTNI-83. PROPOSAL FOR A PILOT PHASE 1B CLINICAL TRIAL WITH ADDITION OF NATURAL MARINE PRODUCT FUCOIDAN TO ANTI-NEOPLASTIC THERAPY FOR PATIENTS WITH RECURRENT GLIOBLASTOMA (RGBM) TO IMPROVE FATIGUE AND OTHER HEALTH-RELATED QUALITY OF LIFE (HRQOL) SYMPTOMS

Abstract BACKGROUND Recurrent Glioblastoma (rGBM) has poor outcome with limited treatment options. rGBM causes significant fatigue and other health-related quality of life (HRQOL) symptoms secondary to tumor progression and anti-neoplastic therapies. More than 80% of brain tumor patients were found to experience fatigue during anti-neoplastic therapy and the incidence of cancer related fatigue may reach 89-94% among patients with rGBM. Therefore, improvement of fatigue and HRQOL in rGBM patients are crucial. Marine natural product, fucoidan, available as health supplement in the US, was found to play important roles in oncological management as supportive therapy against cancer and chemoradiation-related adverse effects and as a potential anti-neoplastic therapy. Fucoidan is a seaweed-derived sulfated polysaccharide. Data resulted from randomized clinical trials for colon, head and neck, and lung cancer patients suggest that fucoidan can improve cancer and chemotherapy or chemoradiation therapy related negative symptoms. In addition, Tachikawa et al. reported &amp;gt;50% tumor regression and increased natural killer (NK) cell activity in sarcoma-transplanted mice treated with Fucoidan. In Vitro anticancer investigation found that Fucoidan fractions clearly suppressed the growth of GBM U-251MG cancer cells. Multiple studies have also shown that fucoidan is tolerable with a good safety profile. METHOD 18 rGBM patients will be enrolled. Fucoidan based product will be administered orally at established dose for cancer patients daily with anti-neoplastic therapy over 6 months. Patients will be evaluated monthly for AEs and HRQOL score; laboratory and brain MRI monitoring will be performed per SOC guidelines. NK cell activity will be measured. POTENTIAL OUTCOME Fucoidan is safe and has good tolerability in combination with anti-neoplastic therapy for rGBM and improves fatigue and other HRQOL symptoms by ameliorating tumor progression and treatment related negative impact. Fucoidan may also improve survival in rGBM patients by improving the tolerability of anti-tumor therapy, augmenting cytotoxic effects, and inhibiting angiogenesis.

Illuminating Hypomania in Early Adolescence: Associations Between Dark-Side and Bright-Side Hypomania, Insomnia, and Health-Related Quality of Life

Background: Adolescence is a period of significant psychological, physical, and social changes. During this time, adolescents face increasing responsibilities, such as making educational and career decisions, managing peer relationships, and becoming more independent from their families. These changes are often accompanied by mood fluctuations and altered sleep patterns. This study aimed to explore the relationships between bright- and dark-side hypomania, insomnia, and various dimensions of health-related quality of life (HRQOL), such as self-esteem, family and peer relationships, social acceptance, and autonomy. Methods: A total of 1475 participants in mid-adolescence (mean age: 13.4 years; range: 11–16 years; 48.8% males) completed a series of self-reported questionnaires covering sociodemographic information, hypomania, including dark and bright-side hypomania, insomnia, and HRQOL. Results: Compared to participants with no or dark-side hypomania, participants with bright-side hypomania reported better HRQOL. Bright-side hypomania was significantly associated with favorable relationships with parents and home, peer relationships, and the school environment and with less insomnia. In contrast, dark-side hypomania showed significant associations with lower scores for self-esteem, moods and emotional states, peer relationships, social acceptance, the school environment, and more insomnia. Conclusions: Among a larger sample of adolescents, bright- and dark-side hypomania were associated with a broad, though specific variety of aspects of HRQOL and insomnia. Given that standardized programs are available to improve insomnia and resilience as a proxy of psychological well-being, such interventions may have the potential to improve adolescents’ psychological well-being and sleep quality concomitantly.