Health-related Quality Of Life Impact Research Articles

The severity of facial burns, dental caries, periodontal disease, and oral hygiene impact oral health-related quality of life of burns victims in Pakistan: a cross-sectional study

BackgroundA burn to the face and neck area leaves a visible scar that impacts the victims physically and psychologically. This report was aimed to examine the factors associated with oral health-related quality of life (OHRQoL) in patients with a facial burn injury.MethodsPatients with facial burn who attended the Burn Care Centre in Islamabad, Pakistan were systematically and randomly invited to participate in this cross-sectional study. They underwent extra- and intra-oral examinations and, completed self-administered instruments in the Urdu language. The severity of disfigurement, dental caries experience (DMFT), periodontal disease (CPI) and oral hygiene (OHI-S) statuses were assessed. The validated instruments collected information relating to sociodemographic background, oral health behaviours, OHRQoL and satisfaction with appearance (SWAP). Information relating to the time of the incident, cause and severity (type, TBSA) of the burn were obtained from medical records. The OHRQoL prevalence of impact and severity measures were derived and analysed using simple and multiple, logistic and linear regression.ResultsA total of 271 patients had participated in the study. The OHIP-14 prevalence of impact was 94% with mean severity score = 37 unit (sd = 8.5). The most impacted domains were physical pain (87%), psychological disability (87%), social disability (85%) and physical discomfort (83%). The main determinants of oral health-related quality of life were poor clinical oral conditions - particularly caries, and severity deformity. Other risk factors included poor oral health behaviours, psychological distress and longer time elapsed since the incident, and sex (p < 0.05).ConclusionDental caries, the severity of the facial deformity, oral health behaviour and time are associated with oral health-related quality of life of patients with facial burns. Oral health behaviour improvement can lower the risk of developing dental problems and oral health-related quality of life impact.

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-Related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Final Data from the Phase 2 ELOQUENT-3 Trial

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-Related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Final Data from the Phase 2 ELOQUENT-3 Trial

The EQ-5D-5L Predicts Treatment Outcomes and Provides Added Value to the R-IPSS in Patients with MDS, CMML or AML Treated within the Austrian Azacitidine Registry - a Prospective Cohort Study By the AGMT Study Group

The EQ-5D-5L Predicts Treatment Outcomes and Provides Added Value to the R-IPSS in Patients with MDS, CMML or AML Treated within the Austrian Azacitidine Registry - a Prospective Cohort Study By the AGMT Study Group

Gender Differences in Health-Related Quality of Life (HRQL) of Overweight and Obese Adults in a Representative Sample of Greek Urban Population.

Background:The main objective was to investigate the relationship between Health-Related Quality of Life (HRQL) and Body Mass Index (BMI) status according to gender in a representative sample of Greek urban population.Methods:In this cross-sectional study, data were collected from 1060 participants (mean age 47.10 yr, 95%CI 46.09–48.07, 52.7% females) in a stratified sample of representative urban population during 1–20 Apr 2016 in Athens, Greece. Socio-demographic characteristics and medical history were involved. BMI (kg/m2) was calculated, based on reported height and weight. HRQL was assessed by using the Greek version of SF36. Parametric tests and multiple logistic regression analysis were applied to identify whether socio-demographic characteristics differed across BMI groups. Mann–Whitney test was used to detect significant differences in SF36 scales between men and women across different BMI and age groups. Multivariate stepwise linear regression analyses were performed to investigate the influence of sociodemographic variables on HRQL.Results:The effect of being overweight or obese differs by age and gender and that this negative impact in HRQL was greater in women than in men. More vulnerable were overweight young and obese middle-aged woman both in terms of physical and mental health. On the other hand, HRQL of normal weight men and women did not differ in almost all age groups.Conclusion:Gender differences on HRQL observed in the general population were mediated by the different way that the two genders affected by increases in body weight.

Qol-O-06 - Development of EORTC/CLTF questionnaire to assess HRQOL in primary cutaneous T-cell and B-cell lymphomas: phase I

<h3>Background:</h3> Health-related quality of life (HRQoL) in patients with cutaneous lymphoma (CL) is negatively impacted by a large burden of disease symptoms including intractable itch, pain, discomfort and socially stigmatising cosmetic disfigurement which may adversely affect patient self-esteem and interpersonal relationships. There is currently no cure for CL and as such, accurate determination of patient HRQoL is of paramount importance. To date, the impact of both skin disease and of a cancer diagnosis on patient HRQoL in CL is assessed using separate, non-CL-specific questionnaires. A composite HRQoL questionnaire addressing all aspects of the disease is lacking. <h3>Methods:</h3> The EORTC Quality of Life Group questionnaire development guidelines were followed. For phase I, semi-structured interviews were conducted in 15 patients with early-stage mycosis fungoides (IA–IIA), 30 patients with late-stage mycosis fungoides/Sézary syndrome (IIB–IVB) (15 patients <3 years and >3 years from diagnosis) and 15 patients with cutaneous B cell lymphoma. Collaborators communicated during the patient recruitment to ensure balanced patient selection with respect to age, gender, stage, duration of the disease, and number of (previous) treatments. <h3>Results:</h3> Patients were recruited in 5 countries (6 centres) across Europe. So far, 62 patients participated (target 60) from each of the following representative patient groups: early MF (stage IA–IIA), late MF (stage IIB–IVB) and cutaneous B cell lymphoma. Data from patient interviews and questionnaires is being analyzed using basic quantitative analyses, including generation of descriptive statistics (e.g., %missing data, means and standard deviations, floor and ceiling effects, etc.), prevalence (number of patients who experienced each complaint i.e. who scored 2, 3 or 4, divided by the total number of patients who completed that item, multiplied by 100), priority ratings (number of patients and professionals who have given priority ratings to each item) and range of responses for each item. The data from the debriefing questions will be reported both quantitatively and qualitatively (in narrative form). <h3>Conclusion:</h3> Once completed, phase I issues will be operationalised into items and any new items created in a style and format compatible with the EORTC quality of life group translation guidelines (phase II). The preliminary module will be pre-tested in phase III followed by large-scale international field-testing in phase IV. A comprehensive HRQoL questionnaire (module) for patients with CL is being developed to more accurately measure assessment of the impact of HRQoL in patients with skin lymphomas.

Identifying the content for an item bank and computerized adaptive testing system to measure the impact of age-related macular degeneration on health-related quality of life.

We are developing an age-related macular degeneration (AMD) health-related quality of life (HRQoL) item bank, applicable to Western and Asian populations. We report primarily on content generation and refinement, but also compare the HRQoL issues reported in our study with Western studies and current AMD-HRQoL questionnaires. In this cross-sectional, qualitative study of AMD patients attending the Singapore National Eye Centre (May-December 2019), items/domains were generated from: (1) AMD-specific questionnaires; (2) published articles; (3) focus groups/semi-structured interviews with AMD patients (n = 27); and (4) written feedback from retinal experts. Following thematic analysis, items were systematically refined to a minimally representative set and pre-tested using cognitive interviews with 16 AMD patients. Of the 27 patients (mean ± standard deviation age 67.9 ± 7.0; 59.2% male), 18 (66.7%), two (7.4%), and seven (25.9%) had no, early-intermediate, and late/advanced AMD (better eye), respectively. Whilst some HRQoL issues, e.g. activity limitation, mobility, lighting, and concerns were similarly reported by Western patients and covered by other questionnaires, others like anxiety about intravitreal injections, work tasks, and financial dependency were novel. Overall, 462 items within seven independent HRQoL domains were identified: Activity limitation, Lighting, Mobility, Emotional, Concerns, AMD management, and Work. Following item refinement, items were reduced to 219, with 31 items undergoing amendment. Our 7-domain, 219-item AMD-specific HRQoL instrument will undergo psychometric testing and calibration for computerized adaptive testing. The future instrument will enable users to precisely, rapidly, and comprehensively quantify the HRQoL impact of AMD and associated treatments, with item coverage relevant across several populations.

Health-related quality of life in osteoarthritis patients: a systematic review and meta-analysis

ABSTRACT The aim of this meta-analysis was to compare health-related quality of life (HRQoL) of Osteoarthritis (OA) patients and controls. A systematic literature search was performed on PubMed, Web of Science and EMBASE from database inception to 7 January 2020. Random effect model was performed to summarize the scores of each domain and the forest plot was used to compare the scores of OA patients with healthy controls. Subgroup analyses were conducted to explore the source of heterogeneity. Statistical analyses were executed using Review Manager (version 5.1). In total, six studies were included in this study, including 7094 patients with OA and 12 100 healthy controls, which were all reliable to summarize the scores of the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Meta-analyses found that pooled mean HRQoL score for the SF-36 each domain (physical function, physical role function, body pain, general health, vitality, social function, emotional role function, mental health) was lower in patients with OA than in healthy controls, especially the score in the dimension of physical role function. OA have a substantial impact HRQoL. HRQoL is a significant component of measuring overall health, which contributes to formulate successful self-disease management plan, patient-centered care, and develop effective interventions target confidence.

A Systematic Literature Review of the Epidemiology, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy.

Introduction: This systematic literature review analyzed published evidence on IgA nephropathy (IgAN), focusing on US epidemiology, health-related quality of life (HRQoL), and economic burden of illness.Methods: Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Embase®, MEDLINE®, Cochrane, and Econlit (January 2010 to June 2020) were searched, along with relevant congresses (2017-2020).Results: Of 123 epidemiologic studies selected for data extraction, 24 reported IgAN diagnosis rates ranging from 6.3% to 29.7% among adult and pediatric patients undergoing renal biopsy, with all reported US rates <15%. No US studies reported IgAN prevalence. A meta-analysis of US studies calculated an annual incidence of 1.29/100 000 people, translating to an annual US incidence of 4236 adults and children. Relative to Europe, the United States had more patients diagnosed with IgAN in later chronic kidney disease stages. US rates of transition to end-stage renal disease (ESRD) ranged from 12.5% to 23% during 3-3.9 years of observation, rising to 53% during 19 years of observation. Across 8 studies reporting HRQoL, pain and fatigue were the most reported symptoms, and patients consistently ranked kidney function and mortality as the most important treatment outcomes. Patients with glomerulopathy reported worse mental health than healthy controls or hemodialysis patients; proteinuria was significantly associated with poorer HRQoL and depression.Conclusion: While economic evidence in IgAN remains sparse, management of ESRD is a major cost driver. IgAN is a rare disease where disease progression causes increasing patient burden, underscoring the need for therapies that prevent kidney function decline and HRQoL deterioration while reducing mortality.

Surveillance of indeterminate pulmonary nodules detected with CT in a Swedish population-based study (SCAPIS): psychosocial consequences and impact on health-related quality of life—a multicentre prospective cross-sectional study

ObjectivesTo investigate whether surveillance of pulmonary nodules detected with low-dose CT (LDCT) impacted health-related quality of life and psychosocial consequences in the Swedish population-based study, Swedish CArdioPulmonary bioImage Study (SCAPIS).DesignA...

A Systematic Literature Review of the Epidemiology, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy

Introduction: This systematic literature review analyzed published evidence on IgA nephropathy (IgAN), focusing on US epidemiology, health-related quality of life (HRQoL), and economic burden of illness. Methods: Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Embase®, MEDLINE®, Cochrane, and Econlit (January 2010 to June 2020) were searched, along with relevant congresses (2017-2020). Results: Of 123 epidemiologic studies selected for data extraction, 24 reported IgAN diagnosis rates ranging from 6.3% to 29.7% among adult and pediatric patients undergoing renal biopsy, with all reported US rates &lt;15%. No US studies reported IgAN prevalence. A meta-analysis of US studies calculated an annual incidence of 1.29/100 000 people, translating to an annual US incidence of 4236 adults and children. Relative to Europe, the United States had more patients diagnosed with IgAN in later chronic kidney disease stages. US rates of transition to end-stage renal disease (ESRD) ranged from 12.5% to 23% during 3-3.9 years of observation, rising to 53% during 19 years of observation. Across 8 studies reporting HRQoL, pain and fatigue were the most reported symptoms, and patients consistently ranked kidney function and mortality as the most important treatment outcomes. Patients with glomerulopathy reported worse mental health than healthy controls or hemodialysis patients; proteinuria was significantly associated with poorer HRQoL and depression. Conclusion: While economic evidence in IgAN remains sparse, management of ESRD is a major cost driver. IgAN is a rare disease where disease progression causes increasing patient burden, underscoring the need for therapies that prevent kidney function decline and HRQoL deterioration while reducing mortality.

CML-417: ASCEMBL Phase 3 Health-Related Quality of Life (HRQL) Comparison of Asciminib and Bosutinib for Patients with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated with 2 or More Tyrosine Kinase Inhibitors (TKI)

<h3>Context:</h3> Asciminib is a first-in-class potent and specific BCR-ABL1 inhibitor that specifically targets the ABL1 Myristoyl Pocket (STAMP). ASCEMBL, the first controlled study comparing treatments for resistant/intolerant CML-CP, demonstrated that asciminib has a superior efficacy and an improved safety and tolerability profile compared with bosutinib. <h3>Objective:</h3> To evaluate the HRQL impact of asciminib compared with bosutinib at 24 weeks of treatment. <h3>Design:</h3> A phase 3, multi-center, open-label, randomized clinical trial. <h3>Patients:</h3> A total of 157 patients, randomized to asciminib 40 mg twice daily, and 76 patients randomized to bosutinib 500 mg once daily. <h3>Main Outcome Measures:</h3> HRQL was assessed in the intent to treat population with the MD Anderson Symptom Inventory – chronic myeloid leukemia (MDASI-CML), an exploratory endpoint. Additional HRQL measures were included in ASCEMBL and are reported elsewhere. Analyses included mixed model repeated measures (MMRM). <h3>Results:</h3> MMRM analyses on MDASI-CML demonstrated that asciminib patients maintained or improved from baseline on all items (demonstrating improvement on 20 out of 26 items), symptom total score, and symptom distress score. Notable item improvements from baseline included fatigue, mood, and feeling of being upset. HRQL was similar to baseline in the bosutinib arm on symptom total score, symptom distress score, and all items, except for nausea and diarrhea, with treatment differences favoring asciminib. Questionnaire compliance rates at week 24 were high and similar between treatment arms (83.1% <i>vs</i> 82.0%, respectively, for asciminib and bosutinib). <h3>Conclusions:</h3> Asciminib patients showed improvement in treatment-related symptoms and HRQL compared with baseline and relative to bosutinib, within the first 24 weeks of treatment, confirming earlier findings.

Prognostic value of patient-reported quality of life for survival in oesophagogastric cancer: analysis from the population-based POCOP study

BackgroundAccumulating evidence of trials demonstrates that patient-reported health-related quality of life (HRQoL) at diagnosis is prognostic for overall survival (OS) in oesophagogastric cancer. However, real-world data are lacking. Moreover, differences in disease stages and tumour-specific symptoms are usually not taken into consideration. The aim of this population-based study was to assess the prognostic value of HRQoL, including tumour-specific scales, on OS in patients with potentially curable and advanced oesophagogastric cancer.MethodsData were derived from the Netherlands Cancer Registry and the patient reported outcome registry (POCOP). Patients included in POCOP between 2016 and 2018 were stratified for potentially curable (cT1-4aNallM0) or advanced (cT4b or cM1) disease. HRQoL was measured with the EORTC QLQ-C30 and the tumour-specific OG25 module. Cox proportional hazards models assessed the impact of HRQoL, sociodemographic and clinical factors (including treatment) on OS.ResultsIn total, 924 patients were included. Median OS was 38.9 months in potentially curable patients (n = 795) and 10.6 months in patients with advanced disease (n = 129). Global Health Status was independently associated with OS in potentially curable patients (HR 0.89, 99%CI 0.82–0.97), together with several other HRQoL items: appetite loss, dysphagia, eating restrictions, odynophagia, and body image. In advanced disease, the Summary Score was the strongest independent prognostic factor (HR 0.75, 99%CI 0.59–0.94), followed by fatigue, pain, insomnia and role functioning.ConclusionIn a real-world setting, HRQoL was prognostic for OS in patients with potentially curable and advanced oesophagogastric cancer. Several HRQoL domains, including the Summary Score and several OG25 items, could be used to develop or update prognostic models.

Health-related quality of life impact of scabies in the Solomon Islands.

BackgroundScabies causes intense itching and skin lesions. A small number of studies have shown that scabies impacts health-related quality of life (HRQoL), but no studies have been conducted in the Pacific region. We assessed the impact of scabies on HRQoL in a high-prevalence setting using the Children's Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI). We also assessed the validity of these tools in a Pacific Island population.MethodsThe study was conducted in the Solomon Islands. Participants with and without skin disease were randomly selected. HRQoL indices were scored on a scale of 0–30.ResultsWe surveyed 1051 adults (91 with scabies) and 604 children (103 with scabies). Scabies had a small impact on HRQoL, with a median DLQI score of 2 (interquartile range [IQR] 0–6) and a CDLQI score of 2 (IQR 0–4). Scores increased linearly with severity. The greatest impact on QoL was due to itch, sleep disturbance and impacts on education and employment.ConclusionsScabies has a small but measurable impact on HRQoL. The DLQI and CDLQI scores were discriminated between the skin-related QoL of patients with scabies and the control group, indicating that these tools are appropriate to measure skin-related QoL in the Solomon Islands.

Re-Presentation to Medical Care Due to Adverse Effects of Intravenous Immunoglobulin Therapy in Pediatric Immune Thrombocytopenia Patients

Background : Immune Thrombocytopenia (ITP) is one of the most common acquired bleeding disorders affecting children, with an incidence rate of approximately 5-10 per 100,000 children per year. Intravenous immunoglobulin (IVIG) is an effective and widely employed frontline therapy for ITP; but is associated with substantial adverse effects, most commonly including headaches (~40%) and nausea/vomiting (5-26%). These may occur immediately following infusion or up to 72 hours later, often resulting in re-presentation to medical care. Additional diagnostic testing is often performed, including computed tomography (CT) imaging of the head, given concern for intracranial hemorrhage in these severely thrombocytopenic patients who have not yet responded to IVIG.Objective : To identify rates of re-presentation to medical care due to IVIG-associated adverse effects within a cohort of treated pediatric ITP patients, and to identify the impact of this re-presentation to care on patient safety, health-related quality of life (HRQoL), and healthcare-related costs.Methods : We completed a retrospective chart review, inclusive of all pediatric ITP patients receiving IVIG therapy at a large pediatric referral center within a 6-year timeframe from 2010 - 2016. Included patients were between the ages of 0 and 18 years, receiving IVIG for the primary indication of ITP at a dose of 1 g/kg/dose, and receiving the commercial IVIG product Gamunex-C® 10% (Grifols). All patients not meeting these criteria were excluded in order to maximize homogeneity of evaluated patients. Pre-medication with acetaminophen and diphenhydramine is the standard of practice for IVIG administration within the institution.Results : Among the 473 ITP patients who received Gamunex-C® at Texas Children's Hospital from 2010 - 2016, 133 (28%) experienced documented headache, nausea/vomiting, or both following IVIG infusion, consistent with published incidences. Among these patients, 101 (76%) sought medical care due to these symptoms. Of the 81 patients who had already been discharged, 54 (67%) re-presented for Urgent or Emergency Care services; while 27 (33%) called for medical advice or to obtain supportive prescriptions. Of the 20 patients remaining hospitalized, 100% presented as calls to the on-call physician, resulting in additional medical evaluation, often including laboratory or imaging evaluation. Among all patients re-presenting to medical care, 60 (59%) underwent additional laboratory testing, and 36 (36%) underwent CT imaging to evaluate for life-threatening intracranial bleeding. No CT evaluations revealed evidence of intracranial bleeding, and for all 101 patients re-presenting to medical care, symptoms fully resolved with supportive management.Conclusions : Nearly 1/3 of treated patients in our cohort experienced headache and/or nausea/vomiting, consistent with published incidences for Gamunex-C®. Of these, 76% sought further medical care. Subsequent medical management ranged from supportive care only (41%) to full evaluation with repeat laboratory studies (59%) + CT imaging in many cases (36%). These findings implicate substantially increased healthcare-related costs in the form of laboratory, CT imaging, and emergency service expenses; as well as increased risk to these patients' health and safety, in the form of additional radiation exposure, infection risk, and potential exposure to unnecessary therapies. Formal evaluation of downstream HRQoL and costs is ongoing. Additionally, we believe that a standardized prophylactic post-medication strategy could prevent or significantly reduce re-presentation to medical care due to IVIG-associated headache and/or nausea/vomiting, thereby improving HRQoL and cost impact in this patient population; and a formal prospective trial of this strategy is planned. [Display omitted] DisclosuresLambert:AstraZeneca: Research Funding; Educational Concepts in Medicine: Honoraria; Novartis: Honoraria. Despotovic:Sanofi: Consultancy; Schell Cooley LLP: Other: Expert witness.

Clusters of comorbidities in idiopathic pulmonary fibrosis

IntroductionComorbidities are common in patients with idiopathic pulmonary fibrosis (IPF) and negatively impact health-related quality of life, health-care costs and mortality. Retrospective studies have focused on individual comorbidities, but clusters of multiple comorbidities have rarely been analysed. This study aimed to comprehensively and prospectively assess comorbidities in a multicentre, real-world cohort of patients with IPF, including prespecified conditions of special interest and to analyse clusters of comorbidities and examine characteristics, disease course and mortality of the clusters. MethodsSeveral measurements, questionnaires, medications and medical history were combined to assess comorbidities. Using self-organizing maps, clusters of comorbidities were identified and phenotypes characterized. Disease course was assessed using mixed effects models and mortality using Cox regression. ResultsOne-hundred and fifty IPF patients were included prospectively. All except one patient suffered from at least one comorbidity and multimorbidity was common. Arterial hypertension, gastro-oesophageal reflux disease, hypercholesterolemia, emphysema and obstructive sleep apnea were most prevalent. Four comorbidity clusters were identified. Each cluster had distinct comorbidity profiles, patient characteristics, symptom burden and disease severity. Patients with fewer comorbidities had better exercise capacity and less dyspnea at baseline, but a trend towards faster deterioration was observed. Mortality analyses showed no significant differences between clusters. ConclusionsMultimorbidity is prevalent in patients with IPF. Four specific clusters of comorbidities may represent phenotypes in IPF. A trend towards faster decline in exercise capacity and dyspnea was observed in patients with fewer comorbidities. Increased knowledge of comorbidities facilitates prevention and treatment of comorbidities in patients with IPF.

The Impact of Health Behaviors on Health-Related Quality of Life in College Students

Abstract Objectives The objective was to explore the influence of health behaviors on health-related quality of life (HRQOL) among college undergraduate students. Methods A convenience sample of college students completed an online survey consisting of the Center for Disease Control's HRQOL modules, perceived stress scale, sleep questionnaire, and the National Cancer Institute Fruit and Vegetable (FV) Screener. Body mass index (BMI) was calculated using self-reported height and weight. Independent t-test were used to compare HRQOL between students who consumed above/below average fruit and vegetable intake. Two multiple regression analyses were used to determine health factors that predicted better HRQOL. Results Participants (N = 655) were 19.8 ± 1.5 years old, female (63%), and white (84%). The average FV intake was 2.2 servings per day. Students who consumed more than the average intake of FV, reported more days/month (d/m) feeling healthy and full of energy (11.9 ± 8.6 vs. 8.9 ± 7.9, P &amp;lt; 0.001), and reported less d/m of poor mental health (8.5 ± 8.1 vs. 11.1 ± 9.8, P &amp;lt; 0.001) compared to those who consumed less than the average. Two predictors explained 38.5% of variance in d/m when mental health was not good (r2 = 0.38, F (2,639) = 200.11, P &amp;lt; 0.001): perceived stress (β = 0.61, P &amp;lt; 0.001) and FV intake (β = −0.08, P &amp;lt; 0.05). Four predictors explained 30.0% of the variance in d/m feeling happy and full of energy (r2 = 0.29, F (4,549) = 58.6, P &amp;lt; 0.001): perceived stress (β = −0.46, P &amp;lt; 0.001), BMI (β = −0.11, P &amp;lt; 0.01), FV intake (β = 0.16, P &amp;lt; 0.001), and hours of sleep (β = 0.08, P &amp;lt; 0.05). Conclusions This data shows that students who consumed above average FV intake reported more days of feeling happy and full of energy and less days of poor mental health, and that modifiable behaviors (FV intake, stress, sleep) impact HRQOL of young adults. This research provides justification for college aimed wellness interventions to include both nutrition education and mental health resources to improve overall HRQOL. Funding Sources This project was supported by the USDA National Institute of Food and Agriculture, Hatch project number #ME0022104 through the Maine Agricultural &amp; Forest Experiment Station. NJ Agriculture Experiment Station.

Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept

BackgroundImpact of recurrent pericarditis (RP) on patient health-related quality of life (HRQoL) was evaluated through qualitative patient interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy and safety of rilonacept (IL-1α/IL-1β cytokine trap) to treat RP.MethodsQualitative interviews were conducted with ten adults with RP to understand symptoms and HRQoL impacts, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) v1.2 was evaluated to determine questionnaire coverage of patient experience. The Phase 2 trial enrolled participants with active symptomatic RP (A-RP, n = 16) and corticosteroid-dependent participants with no active recurrence at baseline (CSD-RP, n = 9). All participants received rilonacept weekly during a 6-week base treatment period (TP) plus an optional 18-week extension period (EP). Tapering of concomitant medications, including corticosteroids (CS), was permitted during EP. HRQoL was assessed using the PROMIS GH, and patient-reported pain and blood levels of c-reactive protein (CRP) were collected at Baseline and follow-up periods. A secondary, descriptive analysis of the Phase 2 trial efficacy results was completed using HRQoL measures to characterize both the impact of RP and the treatment effect of rilonacept.ResultsInformation from qualitative interviews demonstrated that PROMIS GH concepts are relevant to adults with RP. From the Phase 2 trial, both participant groups showed impacted HRQoL at Baseline (mean PROMIS Global Physical Health [GPH] and Global Mental Health [GMH], were lower than population norm average). In A-RP, GPH/MPH improved by end of base TP and were sustained through EP (similar trends were observed for pain and CRP). Similarly, in CSD-RP, GPH/MPH improved by end of TP and further improved during EP, during CS tapering or discontinuation, without disease recurrence (low pain scores and CRP levels continued during the TP and EP).ConclusionThis is the first study demonstrating impaired HRQoL in RP. Rilonacept treatment was associated with HRQoL improvements using PROMIS GH scores. Maintained/improved HRQoL during tapering/withdrawal of CS without recurrence suggests that rilonacept may provide an alternative to CS.Trial registration: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522.

Episodic and Chronic Cluster Headache: Evaluation of Health-Related Quality of Life Impact and Estimation of Health-state Utilities (1267)

Episodic and Chronic Cluster Headache: Evaluation of Health-Related Quality of Life Impact and Estimation of Health-state Utilities (1267)

Impact of the 2019 Coronavirus Disease Pandemic on Health-Related Quality of Life and Psychological Status: The Role of Physical Activity.

This study investigated the impact of the 2019 coronavirus disease (COVID-19) pandemic on health-related quality of life (HRQoL) and psychological status among Saudi adults, and whether physical activity modifies this association. The participants were 518 adults aged ≥18 years (67.4% men). Using an online survey, data regarding demographic information, the impact of COVID-19 (assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5), HRQoL (Short Form-8), psychological distress (Depression, Anxiety and Stress Scale), and physical activity behavior (International Physical Activity Questionnaire-Short Form) were collected. The results demonstrate that adults reporting moderate or high levels of impact of COVID-19 had a lower HRQoL and higher psychological distress than adults reporting a low impact. HRQoL was higher for adults reporting any level impact (low, moderate, or high) of COVID-19 when they participated in recommended levels of physical activity (≥600 metabolic equivalent (MET)-min/week of total physical activity). Psychological distress was lower for adults reporting a high level of impact when they participated in recommended physical activity. Moderate or high levels of impact of COVID-19 were associated with a significantly lower HRQoL and higher psychological distress than the low impact of COVID-19. However, these associations were moderated by the recommended levels of physical activity.

The patient journey to diagnosis and treatment of congenital sucrase-isomaltase deficiency

PurposeCongenital sucrase-isomaltase deficiency (CSID) is a rare genetic disorder characterized by a deficiency of the sucrase-isomaltase (SI) enzyme complex within the brush border membrane of the small intestine. Mutations in the SI gene result in abnormal synthesis and/or incorrect transport of the SI enzyme. Patients with CSID generally have reduced sucrase activity, but levels of isomaltase activity range from absent to almost normal. This study sought to better understand the experience of patients with CSID prior to, during, and after their diagnosis and its subsequent treatment with sacrosidase.MethodsThis was a cross-sectional interview study conducted in conjunction with a longitudinal, observational study of US patients prescribed and taking sacrosidase for at least three consecutive months as treatment for CSID. The observational study included both children and adults.ResultsThis qualitative interview study explored the experiences of 43 adult and pediatric patients (n = 8 adults and n = 35 children/adolescents) with CSID pre-, during, and post-diagnosis. Findings suggest that a CSID diagnosis is particularly problematic given the disparate range of more commonly understood gastrointestinal (GI) disorders. After diagnosis and treatment with sacrosidase, participants reported considerable improvement in symptoms and health-related quality of life (HRQL), yet symptoms persist that continue to affect daily life, indicating areas of potential unmet need.ConclusionEducating clinicians about CSID may help improve the overall diagnosis experience. As this research is the first of its kind in CSID, additional research, qualitative and quantitative, will be important to furthering the understanding of HRQL impact and unmet need experienced by this population and identifying ways to best meet those needs.