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Aims: To describe the health-related quality of life (HRQoL) of melanoma brain metastasis (MBM) patients throughout the first 18 weeks of ipilimumab–nivolumab or nivolumab treatment. Materials & methods: HRQoL data (European Organisation for Research and Treatment of Cancer's Core Quality of Life Questionnaire, additional Brain Neoplasm Module, and EuroQol 5-Dimension 5-Level Questionnaire) were collected as a secondary outcome of the Anti-PD1 Brain Collaboration phase II trial. Mixed linear modeling assessed changes over time, whereas the Kaplan–Meier method was used to determine median time to first deterioration. Results: Asymptomatic MBM patients treated with ipilimumab–nivolumab (n = 33) or nivolumab (n = 24) maintained baseline HRQoL. MBM patients with symptoms or leptomeningeal/progressive disease treated with nivolumab (n = 14) reported a statistically significant trend toward improvement. Conclusion: MBM patients treated with either ipilimumab–nivolumab or nivolumab did not report a significant deterioration in HRQoL within 18 weeks of treatment initiation. Clinical trial registration: NCT02374242 ( ClinicalTrials.gov )

Our aims in this study were to examine the construct/concurrent validity and internal/test-re-test reliabilities of both the self-report and parent-report questionnaires of a Turkish version of the KIDSCREEN-27 for adolescents with cerebral palsy (CP). We used a convenience sample of 135 children and adolescents with CP aged 8–18 years (65 males, 70 females; M age = 12.39, SD = 3.57) and their parents/caregivers (123 mothers, seven fathers, and five grandmothers). We explored structural construct validity via confirmatory factor analysis (CFA). Concurrent validity was examined via Spearman’s correlations between the KIDSCREEN-27 questionnaires and the self-report and primary caregiver report forms of the Cerebral Palsy Quality of Life for Children (CP QOL-Child) and adolescents (CP QOL-Teen). We explored test-retest and internal consistency reliabilities utilizing intraclass correlation coefficients (ICC) and Cronbach’s alpha (α), respectively. CFA goodness-of fit indices verified that the predefined model of the KIDSCREEN-27 was a good fit for data from the CP population (X2/df0.90, AGFI >0.90, RMSEA0.70). Both versions of the KIDSCREEN-27 have satisfactory psychometric properties for use in evaluating health-related quality of life (HRQOL) outcomes in children and adolescents with CP.

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials. Methods Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks (SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery. Results At baseline, patients had poor disease-specific HRQoL and general health status and identified "Decreased sense of smell/taste" and "Nasal blockage" as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p < .0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p < .05 except patients without surgery at Week 24). Conclusions Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.

BACKGROUND: Health-related quality of life (HRQoL) in patients with pulmonary TB may be predictive of disease outcome; however, HRQoL instruments are often complicated and unsuitable for use in low-resource settings. A single-item self-rated health (SRH) score may represent a simpler alternative which could be used in clinical decision-making.AIMS: To evaluate internal and external validity of SRH and its correlation with TBscore/TBscoreII in a low-resource setting.METHODS: We used data from our ongoing prospective TB cohort study in Guinea-Bissau. Cohen´s d was used to assess internal validity, and receiver-operating characteristics and mortality statistics to assess external validity. Correlation between SRH and TBscore/TBscoreII was estimated using linear regression.RESULTS: SRH showed satisfactory internal validity and ability to discriminate between fatal cases at high and low scores, although not at middling scores. SRH and TBscore/TBscoreII correlated well at each examination but changes in scores did not, which may be due to ceiling/floor effects and a lag between disease severity and HRQoL.CONCLUSION: SRH shows potential as a quick and simple method to identify patients in need of intensified follow-up during treatment provision. More research is needed to assess its generalisability beyond our setting and to develop models for clinical use of SRH.

Background For a better understanding of the factors underlying the Post-Acute COVID Syndrome, we studied the relationship between symptoms and functional alterations in COVID-19 patients 10 months after hospitalization. Methods One-hundred-one patients hospitalized between March 1st and June 30th 2020 participated in a follow-up visit for an assessment of clinical history, comorbidities, lung function, physical capacity and symptoms, including the SGRQ for health-related quality of life, PHQ-9-D for depression, and SOMS-2 J for somatoform disorders. Data were analyzed by univariate comparisons and multiple logistic regression analyses. Results Median age was 60 years, 42% were female, 76% had at least one comorbidity, the median length of the hospital stay was 8 days, 19% had been on the ICU. The most prevalent symptoms included shortness of breath (49%), fatigue (49%) and cognitive impairment (39%). Signs of major depression (PHQ-9-D ≥ 10) occurred in 28%/2% (p

Adjusting to a new culture and context in a new environment can be challenging, especially for unaccompanied refugee minors (Makarova et al., 2021). Despite being exposed to adversities, many URMs show resilience and strength (Keles et al., 2018). This positive functioning can be related to subjective well-being (Birman et al., 2014). There is, however, a lack of knowledge about URMs’ well-being and quality of life. Quality of life is considered a complex concept, and it can often be understood as happiness or lack thereof (World Health Organization, 2012). Health-related quality of life (HRQoL) is a measure of a person’s perception of their physical and mental health, which gives an understanding of their quality of life (World Health Organization, 2012). It is considered a concept of well-being where health is a state, instead of well-being as an absence of disease. It is increasingly used in population health research because it can identify health disparities in different subgroups of the population (Brand et al., 2017). This article aims to gain more knowledge about the HRQoL reported by a group of URMs, and how this relates to their reported depressive symptoms, and post-traumatic symptoms, and examine the association between health-related quality of life, and known protective characteristics such as gender and contact with family in the home country.

Introduction Chimeric antigen receptor T-cell (CAR T) therapy offers a potentially curative option for patients with relapsed and refractory hematologic malignancies, including diffuse large B-cell lymphoma (DLBCL). Patient-reported experiences with CAR T therapy are limited and have not been well characterized. The purpose of this qualitative study was to explore patient descriptions of key domains of health-related quality of life (HRQoL) in DLBCL patients treated with CAR T therapy. Methods A targeted literature review was initially conducted to inform the development of the interview guide comprising predetermined open-ended questions. Two focus groups were conducted with a total of 18 patients with DLBCL identified from patient advisory boards. Focus group sessions were recorded and transcribed verbatim. MAXQDA 18.2.0 qualitative data analysis software was utilized to facilitate a constant-comparative coding process to identify key concepts. Results Eight domain impairments (social functioning, emotional functioning, fatigue, physical functioning, cognitive functioning, role functioning, sleep, and pain/discomfort) were identified from the qualitative analysis and endorsed by DLBCL patients treated with CAR T. Compared with before CAR T therapy, patients reported increased impairment in every domain during or immediately after CAR T therapy. This impairment improved for each domain 6 months after CAR T therapy except for pain/discomfort. Compared with before CAR T therapy, improvement in impairment for each domain was observed 6 months after CAR T therapy except for fatigue, sleep, and pain/discomfort. Conclusion This study provides meaningful information regarding the impact of CAR T therapy on HRQoL in patients with DLBCL throughout their treatment journey. Health care professionals and investigators can utilize these data in examining existing patient-reported outcome (PRO) measures that are used in DLBCL clinical trials and to better understand the needs of DLBCL survivors.

STUDY OBJECTIVES: Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the United States and European Union for excessive daytime sleepiness in adults with narcolepsy (75–150 mg/day) or obstructive sleep apnea (OSA; 37.5–150 mg/day). In 12-week studies, solriamfetol was associated with improvements in quality of life in participants with narcolepsy or OSA. These analyses evaluated the long-term effects of solriamfetol on quality of life. METHODS: Participants with narcolepsy or OSA who completed previous solriamfetol studies were eligible. A 2-week titration was followed by a maintenance phase ≤ 50 weeks (stable doses: 75, 150, or 300 mg/day). Quality of life assessments included Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, and 36-Item Short Form Health Survey version 2. Mean (standard deviation) changes from baseline to end of study were evaluated. Data were summarized descriptively. Adverse events were assessed. RESULTS: Safety population comprised 643 participants (417 OSA, 226 narcolepsy). Solriamfetol improved Functional Outcomes of Sleep Questionnaire short version Total scores (mean change [standard deviation], 3.7 [3.0]) and 36-Item Short Form Health Survey version 2 Physical and Mental Component Summary scores (3.1 [6.9] and 4.3 [8.4], respectively); improvements were sustained throughout treatment. On Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, solriamfetol reduced (improved) % presenteeism, % overall work impairment, and % activity impairment by a minimum of 25%. Common adverse events (≥ 5%): headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection. CONCLUSIONS: Long-term solriamfetol treatment was associated with clinically meaningful, sustained improvements in functional status, work productivity, and quality of life for up to 52 weeks. Adverse events were similar between narcolepsy and OSA. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or OSA; Identifier: NCT02348632; URL: https://clinicaltrials.gov/ct2/show/NCT02348632 CITATION: Weaver TE, Pepin J-L, Schwab R, et al. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021;17(10):1995–2007.

Background: The Mediterranean diet (MD) is an anti-inflammatory diet linked to improved health-related quality of life (HRQoL). Germline (g)BRCA1/2 mutation carriers have an increased risk of developing breast cancer and are often exposed to severe cancer treatments, thus the improvement of HRQoL is important. Little is known about the associations between dietary intake and HRQoL in this population. Methods: We included 312 gBRCA1/2 mutation carriers from an ongoing prospective randomized controlled lifestyle intervention trial. Baseline data from the EPIC food frequency questionnaire was used to calculate the dietary inflammatory index (DII), and adherence to MD was captured by the 14-item PREDIMED questionnaire. HRQoL was measured by the EORTC QLQ-C30 and LOT-R questionnaires. The presence of metabolic syndrome (MetS) was determined using anthropometric measurements, blood samples and vital parameters. Linear and logistic regression models were performed to assess the possible impact of diet and metabolic syndrome on HRQoL. Results: Women with a prior history of cancer (59.6%) reported lower DIIs than women without it (p = 0.011). A greater adherence to MD was associated with lower DII scores (p < 0.001) and reduced odds for metabolic syndrome (MetS) (p = 0.024). Women with a more optimistic outlook on life reported greater adherence to MD (p < 0.001), whereas a more pessimistic outlook on life increased the odds for MetS (OR = 1.15; p = 0.023). Conclusions: This is the first study in gBRCA1/2 mutation carriers that has linked MD, DII, and MetS to HRQoL. The long-term clinical implications of these findings are yet to be determined.

Hearing loss is a growing public health concern associated with decreased health-related quality of life (HRQoL) and a negative impact on work life. Knowledge about the long-term benefits for patients receiving cochlear implants may provide knowledge imperative for policymakers to promote better HRQoL and working life outcomes for individuals with hearing loss. The purpose of this study was to explore how HRQoL, hearing disabilities, and work satisfaction outcomes changed in working-aged adults with severe to profound hearing loss from pre- to post-receiving a cochlear implant (CI) between the baseline, year one, and year two. This longitudinal study used Cochlear’s Implant Recipient Observational Study (IROS) registry data to assess HRQoL, hearing disabilities, and work satisfaction in 18–65-year-old CI recipients. Data were collected pre- and post-implantation at baseline, year one, and year two follow-up. One hundred and twenty-seven CI recipients participated in the study. Significant improvements were observed for HRQoL outcomes for hearing, speech, emotion, and health utility post-implant. Overall hearing disability decreased post-CI, and work satisfaction improved. With the increasing prevalence of hearing disabilities, this is pertinent knowledge that supports the use of CIs for hearing rehabilitation which may promote better HRQoL and work satisfaction. CC BY 4.0© 2022 by the authors.Correspondence: aalewis@cochlear.comThis research received no external funding but was supported by Cochlear Limited.

Background: Few studies have investigated the health-related quality of life (HRQOL) in patients with melanoma in-transit metastases (ITM). The aim was to investigate the association between tumor burden and HRQOL, including disparities pertaining to sex and age, in treatment-naïve patients with ITM. Methods: Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire was used to assess HRQOL Pairwise comparisons using t-tests between clinical cutoffs are presented and multiple linear regression analysis showing the unique associations of gender, age, number of tumors, tumor size, presence of lymph node metastases, and tumor localization. Results: A total of 95 patients, 47% females and 53% males (median age 72 years) were included between 2012 and 2021. Women scored significantly lower on emotional well-being (p = 0.038) and lower on FACT-M (p = 0.058). Patients who had ≥10 tumors scored significantly lower on FACT-M (p = 0.015), emotional- and functional well-being (p = 0.04, p = 0.004, respectively), melanoma scale (p = 0.005), and FACT-G (p = 0.027). There was no significant difference in HRQOL depending on age, size of tumors, localization, or presence of lymph node metastases. Conclusion: For patients with melanoma ITMs, the female sex and higher tumor burden (i.e., number of tumors) were significantly correlated with lower HRQOL. However, these findings do not fully explain HRQOL for this patient population, and future research should consider the possibility that there are specific questions for patients with ITM where current instruments might fail to measure their discomfort to the full extent.

A retrospective, observational cohort study was conducted to generate real-world evidence in adult patients diagnosed with sarcoidosis-associated pulmonary hypertension (SAPH) at a referral center in England between 2012 and 2019. Data from the referral center electronic medical record database were linked to the National Health Service Hospital Episode Statistics database to collect and analyze patient demographics, clinical characteristics, comorbidities, treatment patterns, health-related quality of life (HRQoL; assessed using the EmPHasis-10 questionnaire), healthcare resource utilization (HCRU), costs, and survival. Sixty-two patients with SAPH were identified. At diagnosis, 84% were in WHO functional class III and presented with significant pulmonary hemodynamic impairment. Cardiovascular and respiratory comorbidities were commonly reported prediagnosis. Median EmPHasis-10 score at diagnosis was 34, indicative of poor HRQoL. In the 1st year after diagnosis, median (Q1, Q3) per-patient HCRU was 1 (0, 2) all-cause inpatient hospitalizations; 3 (2, 4) same-day hospitalizations; and 9 (6, 11) outpatient consultations. In 24 patients who were hospitalized longer than 1 day in the 1st year after diagnosis, the median duration of hospitalization was 4 days. With a median follow-up of 1.8 years, the median overall survival was 2.9 years. In this cohort of patients with SAPH, poor HRQoL and high HCRU were observed following diagnosis. To our knowledge, this is the first study to report on HRQoL and HCRU in patients with SAPH. More research is needed on treatment options for this population with high unmet needs.

Background Although nocturnal leg cramps are common, little research is available about their impact on quality of life. This mixed-methods study explored the impact of nocturnal leg cramps on health-related quality of life (HRQoL). Methods The study included primary care patients (>50 years) who reported suffering from nocturnal leg cramps (2016–2017). In the quantitative phase, patients completed a questionnaire about their HRQoL (SF-36) and the frequency of their cramps, and we computed the SF-36 scores. Then, we conducted a qualitative study using semi-structured interviews with patients with various levels of HRQol to explore their perception of the impact of cramps on their lives. Results A total of 114 patients (49%) agreed to participate in the quantitative study (mean age: 71, women: 62%) and 15 patients were included in the qualitative study (mean age: 69, women: 67%). The number of cramps in the previous week was low (mean: 1.6 (SD 1.5)). The SF-36 mean physical and mental summary scores were 43 and 50, respectively, and the domain scores were similar to a comparative general population. Whilst some patients reported little interference with their daily lives, others reported a major decrease in their HRQoL. SF-36 scores were not sufficient to describe the cramp-related impairment, as patients from all levels of SF-36 scores reported major impacts of NLC in the interviews. Conclusions Some patients describe a specific impact of cramps on their lives, regardless of their HRQoL. These patients should be the target of future intervention trials.

Purpose: An important outcome measure of patient care is the impact on the patient's health-related quality of life (HRQoL). Current ear-specific HRQoL instruments are designed for one diagnosis and emphasize different subdivisions such as symptoms, hearing problems, psychosocial impact, and the need for care. The optimal length of the recall period has not been studied. For these reasons, a new survey is needed that would cover most chronic ear diseases. Methods: A preliminary 24-item survey (EOS-24) was created. Untreated adult patients (included n = 186) with one of seven different chronic otologic conditions from all university hospitals in Finland were recruited to respond to EOS-24 and the 15D general HRQoL instrument. The recruiting otologists evaluated the severity of the disease and the disability caused by it. A control group was recruited. Based on the patients' responses in different diagnosis groups, the items were reduced according to pre-defined criteria. The resulting survey was validated using a thorough statistical analysis. Results: The relevance and necessity of the original 24 items were thoroughly investigated, leading to the exclusion of 8 items and the modification of 1. The remaining 16 items were well-balanced between subdivisions and were useful in all seven diagnosis groups, thus constituting the final instrument, EOS-16. The most suitable recall period was three months. Conclusions: EOS-16 has been created according to the HRQoL survey guidelines with a versatile nationwide patient population. The survey has been validated and can be used for a wide range of chronic ear diseases as a HRQoL instrument. (C) 2021 PLA General Hospital Department of Otolaryngology Head and Neck Surgery. Production and hosting by Elsevier (Singapore) Pte Ltd.

Chronic venous insufficiency (CVI) is a condition with high prevalence and incidence in general population. The clinical expression is wide, ranging from asymptomatic or with reticulating veins to recurrent venous ulcers. The analysis of the psychometric properties of health-related quality of life questionnaires in patients with CVI is necessary in order to assist as a good tool in clinical practice and in the scope of research. Searches will be made at MEDLINE, CINAHL, Science Web, LILACS and Scopus databases, using the terms “Venous insufficiency”, “Quality of Life “Chronic venous disease”, “HRQOL”, “Chronic venous disease”, and “Varicose veins”.

Objective: to identify the items that impact the HRQoL of patients with Chagas disease. Data Sources: Searches will be made at LILACS, MEDLINE, EMBASE, PsycINFO e Web of Science databases, using terms related to “Chagas disease”, “Quality of Life” and “Qualitative studies”. Eligibility criteria: qualitative studies that assessed the perception of patients with Chagas disease about which items impact their HRQoL.

Disease-specific health-related quality of life questionnaire after deep vein thrombosis

First responders, including law enforcement, firefighters, and emergency medical personnel may experience potentially morally injurious events (PMIEs) due to the nature of their occupation. PMIEs, which are events that violate the moral fiber of a person, have never been investigated in a first responder population. In other populations, including among combat veterans, PMIEs are related to posttraumatic stress disorder (PTSD) and health-related quality of life (HRQoL). Furthermore, gratitude has been shown to buffer the effect of traumatic events on PTSD symptoms, but has not been examined as a buffer of the effect of PMIEs on PTSD symptoms or HRQoL. The current study seeks to address gaps in the literature by 1) establishing that PMIEs exist in a first responder population, 2) examining the association of PMIEs with PTSD symptoms and HRQoL in a first responder population, and 3) investigating gratitude as a moderator of PMIEs’ association with PTSD symptoms and HRQoL. The 299 participants were recruited from multiple agencies/departments nationwide via online and in-person data collection. Participants completed the Moral Injury Events Scale, the Posttraumatic Stress Checklist for Civilians, the Gratitude, Resentment, and Appreciation Short Form, and a modified version of the SF-12 v.2. We will use SPSS and SPSS PROCESS Macro to test specific hypotheses via descriptive statistics and multiple regression analyses. The findings may support gratitude as a potential target for intervention in first responder populations who experience PMIEs.

The aim of this study is to identify all of the available preference-based instruments to measure the HRQoL of patients with cardiovascular diseases and to evaluate and compare the available data on the underlying conceptual model, development process, and psychometric properties (reliability, validity, interpretability, and responsiveness) for the questionnaires identified.

Background: Following discharge from intensive care units (ICUs), it is common for patients to develop new mental health impairments including depression, post-traumatic stress disorder (PTSD), and anxiety, among others. Mental health consequences affect more than 50 percent of ICU survivors, little is understood surrounding associated risk factors. Although the healthcare community is aware of such effects, there are little strategies in place to alleviate these consequences, and limited research to suggest new possibilities for management. Objective: Are there sex-related differences in the incidence, severity and duration of mental health sequelae in adults after ICU discharge? Eligibility Criteria: English papers published within the last 20 years, with a focus on mental health sequelae from ICU discharge and sex differences

Inflammatory Bowel Disease (IBD) is a chronic relapsing and remitting autoimmune disorder which causes an inflammation of the intestinal tract. It can be divided into two main groups, ulcerative colitis (CU) and Crohn's disease (CD). The exact reasons for the occurrence of IBD are still unknown (Moser, 2007). A sharp rise in the incidence of IBD has been observed in many western countries since 1950. The prevalence of Crohn's disease in Germany is estimated at 0.32 % and for ulcerative colitis is approximately 0.41 % (Ng et al., 2017). IBD progresses in episodes. During a disease flare-up, embarrassing and painful symptoms occur such as highly frequented bloody diarrhea, abdominal pain, weight loss, anemia, and arthralgia. Treatment can involve medications such as corticosteroids and biologics. In addition, surgery is often needed (Knowles et al., 2018). These symptoms can lead to negative emotions and worries about many aspects of life such as bowel control, fatigue or social isolation. Therefore, IBD is associated with significant psychosocial burden and higher rates of anxiety and depression (Graff et al., 2009). There are robust findings that general quality of life is significantly poorer for individuals with IBD, when compared with healthy individuals (Knowles et al., 2018). IBD can greatly inhibit the personal, social, employment and leisure functioning of individuals with IBD, thus deeply impacting their health-related quality of life (HRQoL) (Grano et al., 2016). Factors affecting the HRQoL of IBD patients seem to be the disease course, prescribed therapy and non-disease-related factors such as coping strategies (Sajadinejad et al., 2012). Maladaptive coping behaviors like self-blame or avoidance strategies are negatively correlated with patients’ HRQoL and emotional well-being (Grano et al., 2016). The more detailed identification of coping behaviors may improve HRQoL, and even improve the prognosis, for IBD patients (Luo et al., 2018). Coping represents cognitive and behavioral efforts to handle the burden of a stressor, such as a chronic illness. For this reason and because of the given unique challenges faced by IBD patients, e.g. bathroom dependency, it is important to examine IBD specific coping strategies, which are about thoughts and dealing with the disease e.g. blaming oneself for making the disease worse (McCombie et al., 2016). There is a growing body of literature from Positive Psychology that demonstrates the importance of psychological well-being resp. flourishing in life circumstances, including physical health (Howell, Kern, & Lyubomirsky, 2007). Keyes and colleagues (2010) stated that adults with less flourishing mental health report more physical ailments and chronic disease, miss more days of work, use more health care and are more likely to develop mental illness. Flourishing includes both hedonic and eudaimonic dimensions and is considered to be a richer way of assessing people’s well-being (Mesurado et al., 2021). Seligman (2011) refers to an arrangement of positive emotion, engagement, meaning, positive relationships and accomplishment. A high expression of flourishing stands for generalized well-being that spans broad areas of life and describes the optimal state of mental health. Tompetter and colleagues (2019) could demonstrate that people with chronic pain are generally able to flourish. The findings suggest that IBD patients are also capable of flourishing. However, no research has yet been conducted in this regard (Bullock et al., 2020). Flourishing can usefully help broaden the focus from one primarily focused on deficits and impairments compared to a baseline or normative functioning to the more positive aspects of HRQOL (Park, 2015). More research is needed to find specific and modifiable antecedents of flourishing that could then be addressed in new interventions (Schotanus-Dijkstra et al., 2016). Recent studies in positive psychology also found that Coping is associated with flourishing in life, which is defined as optimal functioning, consisting of growth, generativity, purpose and engagement (Diener et al., 2010). Faulk, Gloria and Steinhardt (2013) were able to determine that individuals using adaptive coping methods were more likely to be flourishing, whereas individuals using maladaptive coping were more likely to be languishing. This leads to the possibility that coping mechanisms may also play an important role in patients with IBD in relation to flourishing Illness identity is defined as the degree to which a chronic illness becomes integrated into one’s identity. It generally comprises four different states which are engulfment, rejection, acceptance and enrichment (Oris et al., 2018). Illness Identity gives rise to a feeling of continuity and sameness and has been demonstrated to contribute to psychological well-being (Campbell, Assanand, & Paula, 2003). In terms of IBD it was found that patients’ adaptive attitudes towards the disease and its treatment make them more resilient and able to manage disease-related stressors (Hall et al, 2005). Therefore, the relationship between Illness Identity and HRQoL and Flourishing and Well-Being in patients with IBD will be further investigated in this study. As an extension of the construct of Illness Identity, ingroup identification is considered (inclusion of others in the self). This has already been related to HRQoL and Well-being in the context of other chronic diseases such as diabetes or celiac disease (Helgeson, 2018; Shani et al, 2020). The rising incidence of IBD highlights the need for innovation in health-care systems to manage IBD as a complex disease (Ng et al., 2017). A better understanding of people with IBD and flourishing can be a beneficial approach to improve interventions (Trompetter et al., 2019). Due to the high multidimensional burden for IBD patients, it is particularly important to shed light on predictors and thus levers for a higher HRQoL as well as for the possibility to flourish. The current research aims to fill the gap in the literature by evaluating the potential contribution of Illness Identity and IBD-related coping mechanisms to HRQoL as well as the contribution of HRQoL to flourishing in life and well-being. Thus, it should be able to improve and define chronic pain models and interventions in patients with IBD more precisely.

Background The clinical signs and symptoms of hypophosphatasia (HPP) can manifest during any stage of life. The age at which a patient’s symptoms are reported can impact access to targeted treatment with enzyme replacement therapy (asfotase alfa), as this treatment is indicated for patients with pediatric-onset HPP in most countries. As such, many patients reported to have adult-onset HPP typically do not receive treatment. Comparison of the disease in treated and untreated adult patients is confounded by the approved indication. To avoid this confounding factor, a comparison between baseline disease manifestations prominent among treated versus untreated adult patients was limited to those with pediatric-onset HPP using data collected from the Global HPP Registry. The hypothesis was that treated adults will have a greater disease burden at baseline than untreated adults. The analysis of disease manifestations in adults with adult-onset HPP was conducted separately. Results A total of 398 adults with HPP were included; 213 with pediatric-onset (114 treated, 99 untreated) and 141 with adult-onset HPP (2 treated and 139 untreated). The treated, pediatric-onset patients were more likely to have a history of pain (prevalence ratio [PR]: 1.3, 95% confidence interval [CI] 1.1, 1.4), skeletal (PR: 1.3, 95% CI 1.1, 1.6), constitutional/metabolic (PR: 1.7, 95% CI 1.3, 2.0), muscular (PR: 1.8, 95% CI 1.4, 2.1) and neurological (PR: 1.7, 95% CI 1.1, 2.3) manifestations of HPP, and also had poorer measures for health-related quality of life, pain, and disability compared with untreated pediatric-onset patients. In patients with adult-onset HPP, the most frequent signs and symptoms were chronic bone pain (52.5%), dental manifestations (42.6%), fatigue (23.4%), recurrent fractures or pseudofractures (22.0%), and generalized body pain (22.0%). Conclusions Along with the more classical skeletal signs and symptoms, pain, muscular, and constitutional/metabolic manifestations are common in adults with HPP, regardless of age of disease onset, highlighting a full spectrum of HPP manifestations.

The COVID-19 pandemic and related restrictions have affected the wellbeing of schoolchildren worldwide, but the extent and duration of specific problems are still not completely understood. We aimed to describe students’ psychosocial and behavioral parameters and associated factors during the COVID-19 pandemic in Berlin, Germany. Our longitudinal study included 384 students from 24 randomly selected Berlin primary and secondary schools, assessing psychosocial wellbeing at four time points between June 2020 and March 2021. We analyzed temporal changes in the proportions of anxiety, fear of infection, reduced health-related quality of life (HRQoL), physical activity and social contacts, as well as sociodemographic and economic factors associated with anxiety, fear of infection and HRQoL. During the observation period, the presence of anxiety symptoms increased from 26.2% (96/367) to 34.6% (62/179), and fear of infection from 28.6% (108/377) to 40.6% (73/180). The proportion of children with limited social contacts (

This study aimed to investigate psychological distress among patients hospitalized with a COVID-19 diagnosis in Denmark during the first 12 months of the pandemic and to assess changes in psychological distress in the three months following discharge. A single-center prospective observational survey study among patients hospitalized with a COVID-19 diagnosis between May 2020 and May 2021 was conducted. Participants completed a survey at three time points: at admission, and 1 and 3 months after discharge. Psychological distress was assessed by validated scales measuring symptoms related to depression, anxiety, stress, insomnia, post-traumatic stress disorder (PTSD), and health-related quality of life (HRQoL). In total, 95 patients were included. At admission, the proportion of patients with symptoms of depression was 43%, symptoms of anxiety 32%, moderate/high level of stress 39%, insomnia 52%, and probable/positive PTSD 19%. The burden of symptoms related to depression and anxiety decreased significantly over time, while there was no significant change over time in stress, insomnia, or PTSD. Suboptimal levels of physical and mental HRQoL were detected at admission but improved over time. Patients hospitalized due to COVID-19 during the first year of the pandemic experienced considerable levels of psychological distress at admission, with some improvements within 3 months after discharge.

In this study, we evaluated the presence of residual disease in patients with axial spondyloarthritis (axSpA) in remission/low disease activity (LDA) status. This cross-sectional post-hoc analysis of the QUASAR study involving 23 rheumatology centres across Italy included adults with axSpA classified according to the Assessment of SpondyloArthritis International Society criteria. Patients with inactive disease (score < 1.3) or at least LDA status (score < 2.1) at baseline visit according to Ankylosing Spondylitis Disease Activity Score were investigated to evaluate how residual disease activity impacts patients’ quality of life. They were assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) and EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaires. This study included 480 patients with axSpA (mean age, 47.5 ± 12.9 years, 64% male). In total, 123 patients (25.6%) had inactive disease and 262 (54.6%) had at least LDA. Using the ASQoL, ranges of 10–25% and 20–40% of patients with inactive disease and with LDA status, respectively, experienced tiredness/fatigue. Despite being classified with inactive disease, 48.8% of patients reported light pain/discomfort according to the EQ-5D-5L, with 4.1% reporting moderate pain/discomfort, whereas 55.7% of patients with LDA reported light pain/discomfort and 13% had moderate pain/discomfort. Using the ASQoL questionnaire, in patients with at least LDA, a higher proportion of women compared with males and a higher proportion of patients > 48 years of age (vs. patients ≤ 48 years) experienced tiredness. In this post-hoc analysis, ≥25% of axSpA patients in remission/LDA status were still burdened by residual disease, mainly characterised by pain and fatigue.

Purpose Long-term effects on patient health-related quality of life (HRQoL) after direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) are unknown. We assessed the impact of DAA-mediated HCV clearance on HRQoL from DAA initiation to 1 year after confirmed sustained virological response at 24 weeks post-treatment (SVR24). Methods HRQoL was evaluated using the eight-item Short Form Health Survey (SF-8). Chronic HCV-infected patients were treated for 12 weeks with sofosbuvir-based DAAs. SF-8 was administered at baseline, treatment cessation, SVR24, and 1-year post-SVR24. Results A total of 109 chronic HCV-infected patients were enrolled. The average SF-8 scores were higher than the Japanese national standard values for bodily pain (BP) and mental health at baseline and for general health at 1-year post-SVR24. None of the SF-8 scores differed significantly between baseline and 1-year post-SVR24. Regarding age, sex, liver status, and treatment regimen, the SF-8 scores at 1-year post-SVR24 were affected by only age; individuals aged Conclusion Upon long-term assessment, although more factors trended higher than national standard values at 1-year post-SVR24 than at baseline, there were no significant changes within factors. As PCS tended to be associated with age, patients aged ≥ 65 years should be carefully monitored for PCS.

The goals of the research are to determine the latent morbidity and financial losses of the Russian Ministry of Defense due to the dismissal of service members with HIV infection at symptomatic stages; to establish the supposed clinical and pharmacoeconomic effectiveness of the early detection and treatment of service members.The materials compile 379 case histories of patients of the only specialized department for HIV-positive military personnel in the Armed Forces for 2017–2019, as well as various reporting forms. The study uses the following methods for the analysis: Markov chains are employed to calculate QALYs (Quality Adjusted Life Years), “cost-effectiveness”, and “willingness to pay”. The research compares two competitive models: “Current Situation” - without the introduction of algorithms for early detection and treatment of HIV infection, and “Prognosis” - with the introduction of these algorithms.The following results are obtained: implementing a mandatory triennial screening for HIV-antibodies among military personnel allows to raise the detection of HIV-positive military personnel in the early stages of the disease by 55%. At the same time, early administered antiretroviral therapy prevents the progression of HIV infection, while the number of military personnel who have reached symptomatic stages of HIV infection and the number of deaths decreases by 35,6% and 80,2% (six-fold), respectively. The economic effectiveness of these measures includes a reduced cost of treatment and an increased length of military service. The sensitivity analysis of the method shows that the proposed measures remain pharmacoeconomically highly effective with a wide variability of the initial data.Conclusion. The results of the study demonstrate that a significant improvement of the epidemiological situation in the field of HIV infection in the Armed Forces is achievable at very low economic costs. With the full implementation of the proposed measures, the cohort of military personnel of the Armed Forces is able to achieve the World Health Organization’s “90-90-90”criteria of in 3–5 years.

Study Design: Systematic review. Objectives: Adult spinal deformity (ASD) can be a debilitating condition with a profound impact on patients’ health-related quality of life (HRQoL). Many reports have suggested that the frailty status of a patient can have a significant impact on the outcome of the surgery. The present review aims to identify all pre-operative patient-specific frailty markers that are associated with postoperative outcomes following corrective surgery for ASD of the lumbar and thoracic spine. Methods: A systematic review of the literature was performed to identify findings regarding pre-operative markers of frailty and their association with postoperative outcomes in patients undergoing ASD surgery of the lumbar and thoracic spine. The search was performed in the following databases: PubMed, Embase, Cochrane and CINAHL. Results: An association between poorer performance on frailty scales and worse postoperative outcomes. Comorbidity indices were even more frequently employed with similar patterns of association between increased comorbidity burden and postoperative outcomes. Regarding the assessment of HRQoL, worse pre-operative ODI, SF-36, SRS-22 and NRS were shown to be predictors of post-operative complications, while ODI, SF-36 and SRS-22 were found to improve post-operatively. Conclusions: The findings of this review highlight the true breadth of the concept of “frailty” in ASD surgical correction. These parameters, which include frailty scales and various comorbidity and HRQoL indices, highlight the importance of identifying these factors preoperatively to ensure appropriate patient selection while helping to limit poor postoperative outcomes.

(1) Background: There is a lack of literature that examines the impact of early vs. late sport specialization on quality of life after retirement from tennis. Thus, the purpose of this study was to examine the relationship between early specialization in the sport of tennis and health outcomes after retirement from collegiate/professional sport; (2) Methods: Participants were recruited through social media posts, newsletters, and contacts with tennis organizations. Basic demographic and injury information was collected from 157 former tennis players, along with the age of tennis specialization and two questionnaires: the Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC), and the CDC HRQOL-14 “Healthy Days Measure” Questionnaire (HRQOL); (3) Results: Significant differences (F1,117 = 5.160, p < 0.025) in the specialization age between the low (11.9 ± 4.5 y) and high (9.8 ± 4.1 y) OSTRC groups were found after covarying for the current age. No difference (F1,72 = 0.676, p < 0.414) was shown among the high (10.9 ± 4.4 y) and low (11.28 ± 4.6 y) HRQOL groups for the specialization age after covarying for the current age. A weak negative correlation was identified between the OSTRC score and specialization age (r = −0.233, p = 0.008), while no significant changes were shown between the specialization age and HRQOL score (r = −0.021, p = 0.857), or between the OSTRC and HRQOL scores (r = 0.146, p = 0.208); (4) Conclusions: Retired tennis players with low injury/illness severity scores specialized in tennis later than those with high injury/illness severity scores, while no differences in the specialization age were noted when the sample was separated into HRQOL groups.

Purpose Assessing cochlear implant (CI)-associated patient outcomes is a focus of implant research. Most studies have analyzed outcomes retrospectively with low patient numbers and few measurement time points. In addition, standardized CI-specific health-related quality of life (HRQoL) instruments have not been used. To address this, we prospectively assessed HRQoL in patients before and after implantation. Methods We assessed HRQoL using the Nijmegen Cochlear Implant Questionnaire (NCIQ), Abbreviated Profile of Hearing Aid Benefit (APHAB), Hearing Participation Scale (HPS), and the Visual Analogue Scale (VAS) in 100 deaf or severely hearing-impaired patients (57 unilaterally deaf and 43 bilaterally deaf) before and 3, 6, and 12 months after cochlear implantation. We compared the results of unilaterally and bilaterally hearing-impaired patients and patients with or without a hearing aid. Principal component (PCA) and exploratory factor analyses (EFA) were also conducted. Results The NCIQ measured improvements in all 6 domains after CI and correlated well with other QoL instruments. The PCA revealed that the NCIQ can be better explained by physical, physical advanced, and socio-psychological components. The APHAB score ameliorated over time, except for the background noise domain. The overall HPS score improved over time, but the hearing handicap subscore significantly decreased. Sociodemographic influences on the questionnaire scores were relatively weak. Conclusion Assessing HRQoL is essential for quantifying the patient outcome after CI. NCIQ scores in our patient cohort showed improved HRQoL in all domains and we recommend that the NCIQ be used as a first-line questionnaire for assessing QoL in hearing-impaired patients after CI.

Objective To explore the health-related quality of life (HRQoL) of children and adolescents with simple congenital heart defects before and after the transcatheter intervention. Methods The Pediatric Quality of Life Inventory 4.0 scale was used to assess the quality of life of 78 children and adolescents before and after the transcatheter intervention and to evaluate the parents' perception of their children's quality of life. Results In all, 76 patients were completed the study. The results showed that the scores of the four dimensions and the total score for the quality of life of the patients significantly improved 1 month after the intervention. At 6 months after treatment, the scores in all dimensions continued to improve. From the parents' perspective, the scores of the patients in all dimensions improved significantly at 1 month and 6 months after treatment. In terms of the quality of life assessment, the self-assessment results of the patients were more positive than those of their parents. Conclusions The results showed that the quality of life of children and adolescents with simple congenital heart defects can be positively affected by the transcatheter intervention. Moreover, this improvement is not transient and seems to increase over time.

Background Previous studies have shown that physical activity (PA) correlates positively with health-related quality of life (HRQoL) in the general population. Few studies have investigated associations between device-measured PA and HRQoL among premenopausal women at risk for type 2 diabetes (T2D). In addition to physical well-being, general well-being improved by PA has been suggested to strengthen PA’s benefits in reducing metabolic diseases. The aim of this study was to examine the associations between PA and HRQoL (general and dimensions) among high-risk women in the early post-pregnancy years when T2D risk is highest and to estimate whether current obesity or prior gestational diabetes (GDM) modified these associations. Methods This cross-sectional study of high-risk women [body mass index (BMI) ≥ 30 kg/m2 and/or prior GDM)]4–6 years after delivery measured sleep, sedentary time, daily steps, and light (LPA), moderate-to-vigorous (MVPA), and vigorous PA (VPA) with the SenseWear ArmbandTM accelerometer for seven days and HRQoL with the 15D instrument. Results The analyses included 204 women with a median (IQR) age of 39 (6.0) years and a median BMI of 31.1 kg/m2 (10.9). 54% were currently obese (BMI ≥ 30 kg/m2), and 70% had prior gestational diabetes (GDM+). Women with obesity had lower PA levels than women with normal weight or overweight (p p s = 0.262 p = 0.001) and the 15D score. After grouping according to BMI (2), the associations remained significant only in women without obesity. Among them, sleep, total steps, MVPA, and VPA were positively associated with 15D. Conclusions Higher PA levels are associated with better HRQoL among high-risk women with normal weight and overweight but no differences were found among women affected by obesity in the early years after pregnancy. Trial registration Ethics committees of Helsinki University Hospital (Dnro 300/e9/06) and South Karelian Central Hospital (Dnro 06/08).

Background and Objectives: As advances in medicine are proceeding, so are treatment goals shifting from sheer mortality rates to improving HRQoL and social reintegration after burn injury. Following this trend, we aimed to assess HRQoL, employment and life satisfaction after burn injury to gain insight on confounding factors. Materials and Methods: This single-center follow-up study was conducted using the SF-36 V1.0 in German and further questions evaluating employment and life satisfaction. It reached 128 adult in-patients (recall 33.0%) with former burn injuries, treated between 2012 and 2019 at the Division of Plastic, Aesthetic and Reconstructive Surgery at the University Hospital of Graz. The questionnaire outcomes were set into relation with clinical data obtained from the medical records. Statistical analysis was performed with SPSS 27.0 for Windows. Results: Of the 128 participants, 72.7% were male and 27.3% female. The mean age at the time of injury was 40.0 ± 15.7 years and mean %TBSA among the study population was 9.2 ± 11.0%. The male patients had sustained more extensive injuries (p = 0.005). However, the female patients scored significantly (p < 0.05) and consistently lower in all the domains of the SF-36, except for “bodily pain” (p = 0.061). Moreover, the female patients scored lower in all the domains of life satisfaction, although significant differences were only found in the domains of fulfillment (p = 0.050) and mental wellbeing (p = 0.015). Furthermore, employment status differed significantly between the male and female patients before as well as after the burn injury. Proportionally less women were employed at both time points. Overall, unemployment had declined. Conclusions: Life satisfaction after burn injury in this study cohort seems to be good. Return to work has shown a promising trend. Strikingly, HRQoL and life satisfaction were lower in women after burn injury. Further research on the reasons for this gender discrepancy might improve HRQoL and life satisfaction after burns.

Mitaw Girma,1 Shambel Wodajo,2 Sewunet Ademe,3 Afework Edmealem,3 Mulugeta W/silasie,4 Gebremeskel Mesafint5 1Department of Adult Health Nursing, Wollo University, Dessie, Amhara, Ethiopia; 2Department of Public Health, Wollo University, Dessie, Amhara, Ethiopia; 3Department of Nursing, Wollo University, Dessie, Amhara, Ethiopia; 4Department of Pediatric Nursing, Wollo University, Dessie, Amhara, Ethiopia; 5Department of Nursing, Mizan Tepi University, Mizan Tepi, South Ethiopia, EthiopiaCorrespondence: Sewunet AdemeDepartment of Nursing, Wollo University, Dessie, Amhara, EthiopiaTel +251 918126233Email sewunet.ademe@gmail.comBackground: Diabetes mellitus is a disorder of carbohydrate metabolism and it is highly related with diminished HRQOL in Ethiopia; diabetic related complications especially bring major negative impacts on HRQOL.Objective: To assess HRQOL and associated factors among type two diabetic patients in Dessie Comprehensive Specialized Hospital, north east Ethiopia, 2020.Methods: Institutional-based cross-sectional study design was conducted on 417 patients through systematic random sampling technique from February 08 to April 08, 2020. WHO HRQOL 26 items were used to measure outcome variable. Face-to-face interview, document review and measurement were implemented to collect data. The data were analyzed by IBM SPSS Statistics version 25 and summarized by using tables. Simple linear regression analysis was done and forwarded to multivariable linear regression analysis at p-value < 0.25. Next multivariable linear regression analysis was done and variables whose p-value less than 0.05 with unstandardized B-coefficient were declared significant predictor variables.Results: The mean scores of physical domain, psychological domain, environmental domain and social domain were 48± 6.7 (47– 49), 52± 4.2 (50– 52.3), 48.9± 3.4 (48– 50.4) and 49± 4 (48– 50), respectively. As age increased by one year, patients’ physical HRQOL decreased by 0.031 factor, keeping effect of other variables constant [− 0.031, 95% CI (− 0.050 to-0.013)]. As duration of diabetes increased by one year, patients’ physical HRQOL increased by 0.034 factor, keeping effect of other variables constant [0.034, 95% CI (0.004 to 0.065)]. In general, age, depression, perceived social stigma, self-employed, having two complications, widowed, insulin and oral anti-diabetic medication affected HRQOL negatively and duration of diabetes in physical domain and university level of education in environmental domain affected HRQOL positively.Conclusion and Recommendation: The mean score of health-relatedquality of life in physical health domain, psychological health domain, social health domain and environmental health domain was recorded nearly half score point out of ahundred. Health professionals should follow a holistic approach to management to address negatively associated predictor variables with HRQOL.Keywords: HRQOL, type II diabetes

Objectives Anticholinergic burden defined by the Anticholinergic Risk Scale (ARS) has been associated with cognitive and functional decline. Associations with health-related quality of life (HRQoL) have been scarcely studied. The aim of this study was to examine the association between anticholinergic burden and HRQoL among older people living in long-term care. Further, we investigated whether there is an interaction between ARS score and HRQoL in certain underlying conditions. Design and participants Cross-sectional study in 2017. Participants were older people residing in long-term care facilities (N=2474) in Helsinki. Measurements Data on anticholinergic burden was assessed by ARS score, nutritional status by Mini Nutritional Assessment, and HRQoL by the 15D instrument. Results Of the participants, 54% regularly used ARS-defined drugs, and 22% had ARS scores ≥2. Higher ARS scores were associated with better cognition, functioning, nutritional status and higher HRQoL. When viewing participants separately according to a diagnosis of dementia, nutritional status or level of dependency, HRQoL was lower among those having dementia, worse nutritional status, or being dependent on another person’s help (adjusted for age, sex, comorbidities). Significant differences within the groups according to ARS score were no longer observed. However, interactions between ARS score and dementia and dependency emerged. Conclusion In primary analysis there was an association between ARS score and HRQoL. However, this relationship disappeared after stratification by dementia, nutritional status and dependency. The reasons behind the interaction concerning dementia or dependency remain unclear and warrant further studies.

Background: Chronic diseases are the leading cause of death worldwide with increasing prevalence in the population aged 65 years and above. This study aimed to evaluate the relationship between physical activity level and health-related quality of life in elderly individuals. Material and methods: The participants aged 65 years and older (46 males and 35 females) were divided into 3 groups according to their physical activity levels: low physical activity (300 minutes/week). Health-related quality of life (HRQoL) was calculated using EQ-5D scale. Spearman's correlation coefficient was used to determine the relationship between physical activity level and HRQoL scores in elderly individuals. Results: A significant relationship and differences were found between high, moderate and low physical activity levels and HQQoL dimensions (P

Background: Several studies have assessed safety and efficacy outcomes for lumacaftor/ivacaftor therapy. We report on lumacaftor/ivacaftor's impact on lung function, physical performance, and health-related quality of life (HRQOL) in a subpopulation of Danish people with Cystic Fibrosis (CF; PWCF) with advanced pulmonary disease who would not fulfill inclusion criteria for these studies. Methods: This follow-up study examined lumacaftor/ivacaftor's effect in a highly selected CF population. Inclusion criteria included low percent predicted forced expiratory volume in one second (ppFEV1), fast deteriorating ppFEV1, low body mass index (BMI), and difficult-to-treat infections. Primary endpoints included change in ppFEV1 slope, cardiopulmonary exercise testing (CPET), and all domains of the Cystic Fibrosis Questionnaire-Revised (CFQ-R). Secondary outcomes included change in ppFEV1, BMI Z-score, and sweat chloride concentration. Results: A total of 21 patients homozygous for the F508del mutation and a median ppFEV1 of 38.7 were included. We found significant improvements in ppFEV1 (+4.2 p 1 after 3, 6, 9, and 12 months of treatment compared to baseline), ppFEV1 slope (+6.84 ppFEV1/year between the year before and the year after treatment initiation; p =.02), and saturation at CPET initiation (+1.4%, p

Background Limited evidence exists regarding the cost and health-related quality of life (HRQoL) effects of non–muscle-invasive bladder cancer (NMIBC) recurrence and progression to muscle-invasive bladder cancer (MIBC). We examined these effects using evidence from a recent randomized control trial. Material and Methods The costs and HRQoL associated with bladder cancer were assessed using data from the BOXIT trial (bladder COX-2 inhibition trial; n = 472). The cost and HRQoL effects from clinical events were estimated using generalized estimating equations. The costs were derived from the recorded resource usage and UK unit costs. HRQoL was assessed using the EQ-5D-3L and reported UK preference tariffs. The events were categorized using the TMN classification. Results Cases of grade 3 recurrence and progression were associated with statistically significant HRQoL decrements (−0.08; 95% confidence interval [CI], −0.13 to −0.03; and −0.10; 95% CI, −0.17 to −0.03, respectively). The 3-year average cost per NMIBC patient was estimated at £8735 (95% CI, 8325-9145). Cases of grade 1, 2, and 3 recurrence were associated with annual cost effects of £1218 (95% CI, 403-2033), £1677 (95% CI, 920-2433), and £3957 (95% CI, 2332-5583), respectively. Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152). Conclusion Evidence from the BOXIT trial suggests that patients with NMIBC will both experience decrements in HRQoL and incur significant costs, especially in the event of a grade 3 recurrence or a progression to MIBC., Micro-Abstract Limited evidence exists regarding the costs and health-related quality of life (HRQoL) effects of bladder cancer. Our study derived both the mean and marginal UK HRQoL and cost effects across multiple grades and stages of bladder cancer using data from the BOXIT (bladder COX-2 inhibition trial; n = 472). We found that patients with bladder cancer will experience decrements in HRQoL, which impose significant costs in the event of disease recurrence or progression that increase with the abnormality and invasiveness of the lesion. The results of the present study will help to lay the foundation for future burden of disease studies and cost-effectiveness analyses.

Purpose The quality of life (QoL) of patients with type 2 diabetes mellitus (T2DM) is a measure of the successful outcomes of therapy. The program of management of chronic diseases “Program Pengelolaan Penyakit Kronis” (Prolanis) among patients with hypertension and T2DM is a new strategy of the Badan Penyelenggara Jaminan Sosial (BPJS), which is the Indonesian national health insurance system. Here, we analyzed the impact of pharmacist counseling interventions on health-related QoL (HRQoL) in Prolanis T2DM patients. Methods This cluster randomized controlled trial was designed to include two groups [control (n = 111) and intervention (n = 109) groups], and pre- and post-test procedures. The participants were Prolanis T2DM patients who attended four primary health-care centers (Puskesmas) in Makassar City, South Sulawesi, Indonesia from August 2017 to August 2018. The intervention group received systematic counseling for 6 months. The data were collected using the Bahasa Indonesia version of the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5 L) questionnaire and were analyzed using EQ-5D preference weight for each health state with the Indonesian EQ-5D-5 L value Set. Furthermore, the EQ-5D index and the EQ-5D VAS score were calculated and HbA1c levels were assessed. Results The change in the EQ-5D-5 L index score (post-pre) was 0.01 in the control group and 0.04 in the intervention group (P = 0.041). The change in the VAS score was −0.07in the control group (post-pre) and 2.66 in the intervention group (P = 0.000). Conclusion Pharmacist counseling may help improve the HRQoL of Prolanis T2DM patients.

Background Cardiovascular disease (CVD) and thyroid dysfunction are common in older people, but little is known about how they affect health-related quality of life (HRQoL). Methods We assessed HRQoL with the 15D instrument in 329 home-dwelling patients aged ≥ 75 years with stable CVD and compared the results to those of an age- and gender-matched general population (n = 103). We also studied the impact of age, BMI, number of medications, thyroid-stimulating hormone (TSH) concentration, levothyroxine (L-T4) substitution and Mini-Mental State Examination (MMSE) on HRQoL. Results Overall HRQoL was impaired in older people with stable CVD (mean 15D score 0.777 vs 0.801, p = 0.001), and also on single dimensions of breathing, sleeping, discomfort and symptoms, distress, vitality (all p p = 0.016) compared to the age- and gender-matched general population. Furthermore, in the patients, L-T4 substitution associated with impaired sleeping (p = 0.018) and sexual activity (p = 0.030). Moreover, MMSE points, number of medications used, age (all p p = 0.009) predicted impaired HRQoL. Conclusions Older people with stable CVD are characterized by impaired HRQoL compared to age- and gender-matched controls. We demonstrate that this is the consequence of impaired breathing, sleeping, discomfort and symptoms, distress, vitality, and depression. L-T4 substitution has a negative impact on HRQoL in old patients with stable CVD. MMSE score, number of medications, age and BMI predict worse HRQoL.

Background Total knee arthroplasty (TKA) remains the surgical gold standard treatment for patients suffering from end‐stage osteoarthritis (OA) of the knee. However, due to the high demand and scarce medical resources, the waiting time for surgery is astoundingly lengthy. Controversies are shown in numerous studies, on whether physical functionality and mental status decline or remain stable over the waiting period. This study aims to evaluate the progression in patients suffering from end‐stage OA while on the waiting list for TKA. Methods One hundred and twenty‐seven patients suffering from end‐stage OA who were on the TKA waiting list were prospectively recruited from our orthopaedics specialist clinic. They were assessed once a year for 2 years or until surgery. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC), SF‐36 self‐rated questionnaire and 15D health‐related quality of life (HRQoL) questionnaire were used as outcome measurements for functionality and disability assessment. Results Patients on the waiting list for TKA showed a progressive increase in pain and disability level within the first year (P = .035). Those patients waiting for more than 2 years showed worsening HRQoL (P

BACKGROUND: Localized prostate cancer (PCa) treatments provide high survival rates, with patients often surviving a decade or longer after treatment. Therefore, treatment options are progressively based on quality of life. The objective of this research was to investigate magnitude of response shift (RS) in health-related quality of life (HRQOL) responses in men with clinically localized PCa using a generic questionnaire and a disease-specific questionnaire in an observational longitudinal patient registry study. PATIENTS AND METHODS: A cohort study was conducted using the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database. Patients were annually surveyed using the Medical Outcomes Study Questionnaire Short Form 36 (SF-36) and the UCLA Prostate Cancer Index (PCI) HRQOL measures. A total of 3161 active patients were eligible for a one-off supplemental study asking retrospective HRQOL scores (then-test). We calculated RS, observed change, and RS adjusted change. Statistical difference was determined by t test. RESULTS: Patients consistently reported higher recalled pretreatment HRQOL compared to baseline scores for SF-36 and PCI, confirming the existence of a RS (P < .05). On average, PCI demonstrated larger RS by a factor of 2 than SF-36. More specific, RS was greater especially in SF-36 physical domains compared to mental health items. PCI measured PCa-specific physical adverse effects only. Patients whose cancer had recurred reported slightly lower SF-36 RS than those whose cancer had not recurred. CONCLUSION: RS occurrence was measured in both the disease-specific questionnaire and the generic HRQOL questionnaire, demonstrating continued low health and symptom scores after RS adjustment. Therefore, health professionals should adjust for this phenomenon when assessing patient's HRQOL treatment responses, and clinicians should address their continued sexual and urinary functional loss.

is missing (Short Communication)

Objective: To evaluate the effect of Non-alcoholic fatty liver disease (NAFLD) status in the impact of lifestyle over Health-related quality of life (HRQoL) in patients with metabolic syndrome (MetS). Methods: Baseline and 1 year follow up data from the PREDIMED-plus cohort (men and women, 55-75 years old with overweight/obesity and MetS) were studied. Adherence to an energy-restricted Mediterranean Diet (er-MeDiet) and Physical Activity (PA) were assessed with a validated screeners. Hepatic steatosis index (HSI) was implemented to evaluate NAFLD while the SF-36 questionnaire provided HRQoL evaluation. Statistical analyses were performed to evaluate the influence of baseline NAFLD on HRQoL as affected by lifestyle during 1 year of follow up. Results: Data from 5205 patients with mean age of 65 years and a 48% of female participants. Adjusted linear multivariate mixed regression models showed that patients with lower probability of NAFLD (HSI < 36 points) were more responsive to er-MeDiet (b 0.64 vs b 0.05 per er-MeDiet adherence point, p< 0.01) and PA (b 0.05 vs b 0.01 per MET-h/week, p = 0.001) than those with high probability for NAFLD in terms Physical SF- 36 summary in the 1 year follow up. 10 points of er-MeDiet adherence and 50 MET-h/ week were thresholds for a beneficial effect of lifestyle on HRQoL physical domain in patients with lower probability of NAFLD. Conclusion: The evaluation of NAFLD by the HSI index in patients with MetS might identify subjects with different prospective sensitivity to lifestyle changes in terms of physical HRQoL (http://www.isrctn.com/ISRCTN89898870)., CIBER Fisiopatologia de la Obesidad y Nutricion (CIBEROBN), Instituto de Salud Carlos III (ISCIII) through the Fondo de Investigacion para la Salud (FIS), European Commission PI13/00673 PI13/00492 PI13/00272 PI13/01123 PI13/00462 PI13/00233 PI13/02184 PI13/00728 PI13/01090 PI13/01056 PI14/01722 PI14/00636 PI14/00618 PI14/00696 PI14/01206 PI14/01919 PI14/00853 PI14/01374 PI14/00972 PI14/00728 PI14/01471 PI16/00473 PI16/00662 PI16/01873 PI16/01094 PI16/00501 PI16/00533 PI16/00381 PI16/00366 PI16/01522 PI16/01120 PI17/00764 PI17/01183 PI17/00855 PI17/01347 PI17/00525 PI17/01827 PI17/00532 PI17/00215 PI17/01441 PI17/00508 PI17/01732 PI17/00926 PI19/00957 PI19/00386 PI19/00309 PI19/01032 PI19/00576 PI19/00017 PI19/01226 PI19/00781 PI19/01560 PI19/01332 PI20/01802 PI20/00138 PI20/01532 PI20/00456 PI20/00339 PI20/00557 PI20/00886 PI20/01158, Special Action Project "Implementacion y evaluacion de una intervencion intensiva sobre la actividad fisica Cohorte PREDIMED-Plus", La Caixa Foundation 2013ACUP00194, Junta de Andalucia PI0458/2013 PS0358/2016 PI0137/2018, SEMERGEN grant, Department of Health of the Government of Navarra 61/201, Fundacio La Marato de TV 201630.10, European Research Council (ERC) European Commission 340918, Ministerio de Ciencia e Investigacion RTI2018-095569-B-I00 PCI2018-093009 35/2011

Background Selection of appropriate trial endpoints and outcome measures is particularly important in rare disease and rapidly progressing disease such as amyotrophic lateral sclerosis (ALS) where the challenges to conducting clinical trials, are substantial: patient and disease heterogeneity, limited understanding of exact disease pathophysiology, and lack of robust and available biomarkers. To address these challenges in ALS, the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised version (ALSFRS-R) was developed and has become a key primary endpoint in ALS clinical trials to assess functional disability and disease progression, often replacing survival as a primary outcome. However, increased understanding of the ALS disease journey and improvements in assistive technology for ALS patients have exposed issues with the ALSFRS-R, including non-linearity, multidimensionality and floor and ceiling effects that could challenge its continued utility as a primary outcome measure in ALS clinical trials. Recently, other qualitative scale measures of functioning disability have been developed to help address these issues. With this in mind, we conducted a literature search aimed at identifying both established and promising new measures for potential use in clinical trials. Methods We searched PubMed, Google, Google Scholar, and the reference sections of key studies to identify papers that discussed qualitative measures of functional status for potential use in ALS studies. We also searched clinicaltrials.gov to identify functional status and health-related quality of life (HRQoL) measures that have been used in ALS interventional studies. Results In addition to the ALSFRS-R, we identified several newer qualitative scales including ALSFRS-EX, ALS-MITOS, CNS-BFS, DALS-15, MND-DS, and ROADS. Strengths and limitations of each measure were identified and discussed, along with their potential to act as a primary or secondary outcome to assess patient functional status in ALS clinical trials. Conclusion This paper serves as a reference guide for researchers deciding which qualitative measures to use as endpoints in their ALS clinical trials to assess functional status. This paper also discusses the importance of including ALS HRQoL and ALS cognitive screens in future clinical trials to assess the value of a new ALS therapy more comprehensively.

In the last decade, through Clinical Outcome Assessment, and especially measurement of patient-reported outcome measures (PROM)s, we, among others, have initiated a shift in focus from meningioma tumors to meningioma patients. In various studies we describe an improvement in surgical approaches for skull base meningioma. Nevertheless, patient functioning remains impaired in the long-term. We describe that on average nine years after treatment or diagnosis patients still suffer from participation restrictions in social situations with their friends, family, and at work. Often, at the outpatient clinic, we do not pay enough attention to these problems, especially as patient visits become less frequent in the long-term. Importantly, functioning of patients and their informal caregivers (i.e., close relatives/friends) is strongly interdependent. Moreover, patients and healthcare providers find different outcomes and care processes relevant. This underlines the importance of implementation of PROMs in clinical practice. The studies in this thesis suggest that meningioma care trajectories could benefit from the use of 1) case managers guiding patients and their informal caregivers, 2) implementation of PROMs, and 3) prediction models assisting in the identification of individual patients at high risk of long-term lowered functioning. Ideally, these trajectories should follow the value-based healthcare (VBHC) principles.

Purpose: Fatigue in patients with acquired brain injury (ABI) is common. However, to better target fatigue, clear ways to categorize/interpret fatigue-severity in individual patients are lacking. This study aims to determine/categorize fatigue severity among children, adolescents, and young adults with ABI. Methods: This cross-sectional study included young patients admitted to outpatient rehabilitation and their parents. To determine fatigue, the PedsQL (TM) Multidimensional-Fatigue-Scale was used (MFS, scores 0-100, lower scores = higher fatigue, patient-/parent-reported). Based on scores from a reference population, four categories were formed: "1 = no/little fatigued" to "4 = severely-more fatigued." Results: All scores were lower than those from the reference population, with comparisons in the adolescent and young adult groups reaching statistical significance (p < .05). The proportions of patients in category 4 were: 9%/50%/58% among children/adolescents/young adults, showing that many patients were "severely-more fatigued"-than the reference population. Conclusions: Measuring fatigue and categorizing fatigue severity looks promising for clinical practice and could help to better target fatigue.

Psychological factors are strong predictors of recovery in other cardiac populations but have seldom been studied in CA survivorship. No study of post-CA recovery has examined the role of positive psychological factors or behavioral mechanisms of recovery.