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People with type 2 diabetes mellitus (T2DM) show a high prevalence of steatotic liver disease (SLD), and especially metabolic dysfunction-associated steatotic liver disease (MASLD), with liver fibrosis. Their health-related quality of life (HRQL) is affected by multiple in part overlapping factors and aggravated by metabolic and liver-related comorbidities, including liver fibrosis stage. The aim of this study was to investigate the effect size of advanced fibrosis (AF) on the HRQL in people with T2DM. A total of 149 individuals with T2DM treated at a primary care provider within the German disease management program (DMP) were included in the final analysis. Vibration-controlled transient elastography (VCTE) was used to non-invasively detect steatosis and AF. The EQ-5D-3L questionnaire was used to assess the HRQL. Uni- and multivariable linear regression models were used to identify independent predictors of impaired HRQL. The majority was male (63.1%), and the median age was 67 years (IQR 59; 71). In the entire cohort, the prevalence of MASLD and AF was 70.7% and 19.5%, respectively. People with T2DM and AF had an overall lower HRQL in comparison to those without AF (p < 0.001). Obesity (β: − 0.247; 95% CI − 0.419, − 0.077) and AF (β: − 0.222; 95% CI − 0.383, − 0.051) remained independent predictors of a poor HRQL. In turn, T2DM-related comorbidities were not predictive of an impaired HRQL. Obesity and AF negatively affect the HRQL in patients with SLD and T2DM in primary care. Awareness of liver health and specific interventions may improve patient-reported and liver-related outcomes in people with T2DM. [ABSTRACT FROM AUTHOR]

Abstract People with type 2 diabetes mellitus (T2DM) show a high prevalence of steatotic liver disease (SLD), and especially metabolic dysfunction-associated steatotic liver disease (MASLD), with liver fibrosis. Their health-related quality of life (HRQL) is affected by multiple in part overlapping factors and aggravated by metabolic and liver-related comorbidities, including liver fibrosis stage. The aim of this study was to investigate the effect size of advanced fibrosis (AF) on the HRQL in people with T2DM. A total of 149 individuals with T2DM treated at a primary care provider within the German disease management program (DMP) were included in the final analysis. Vibration-controlled transient elastography (VCTE) was used to non-invasively detect steatosis and AF. The EQ-5D-3L questionnaire was used to assess the HRQL. Uni- and multivariable linear regression models were used to identify independent predictors of impaired HRQL. The majority was male (63.1%), and the median age was 67 years (IQR 59; 71). In the entire cohort, the prevalence of MASLD and AF was 70.7% and 19.5%, respectively. People with T2DM and AF had an overall lower HRQL in comparison to those without AF (p

Purpose: Frailty in HIV is extensively explored in epidemiological and clinical studies; it is infrequently assessed as an outcome in routine care. The focus on health-related quality of life (HRQL) measures in HIV presents a unique opportunity to understand frailty at a larger scale. The objective was to identify the extent to which generic and HIV-related HRQL measures capture information relevant to frailty. Methods: A systematic mapping review using directed and summative content analyses was conducted. An online search in PubMed/Medline identified publications on frailty indices and generic and HIV-related HRQL measures. Directed content analysis involved identifying contributors, components, and consequences of frailty from the frailty indices based on the International Classification of Functioning, Disability, and Health framework. Summative content analysis summarized the results numerically. Results: Electronic and hand search identified 447 review publications for frailty indices; nine reviews that included a total of 135 unique frailty indices. The search for generic and HIV-related HRQL measures identified 2008 records; five reviews that identified 35 HRQL measures (HIV-specific: 17; generic: 18). Of the 135 frailty indices, 88 cover more than one frailty dimension and 47 cover only physical frailty. Contributors to frailty, like sensory symptoms and nutrition, are extensively covered. Components of frailty such as physical capacity, cognitive ability, and mood are also extensively covered. Consequences of frailty namely self-rated health, falls, hospitalization, and health services utilization are incomprehensively covered. HRQL measures are informative for contributing factors, components of frailty, and a consequence of frailty. Conclusion: HRQL items and measures show a strong potential to operationalize multidimensional frailty and physical frailty. The study suggests that these measures, connected to evidence-based interventions, could be pivotal in directing resources toward vulnerable populations to mitigate the onset of frailty. [ABSTRACT FROM AUTHOR]

Tuberculosis (TB) is associated with psychological distress, poor coping, deterioration in health-related quality of life (HRQL), and stigma. However, these issues have never received sufficient attention as a part of routine care. The healthcare workers and physicians of primary contact are not sensitized to use discrete screening questionnaires to identify and address these issues. A longitudinal study was hence conducted in the Department of Pulmonary Medicine in collaboration with the Department of Psychiatry. 75 microbiologically confirmed ‘new’ pulmonary TB patients were enrolled. Socio-demographic and clinical details were noted. The patients were then evaluated for psychological distress using the General Health Questionnaire-12-Hindi version (GHQ-12) and Patient Distress Thermometer (PDT); coping strategies using the Coping Strategy Check List-Hindi Version (CSCL); HRQL using the World Health Organization Quality of Life-Brief-Hindi version (WHOQOL-Bref), and stigma using the Explanatory Model Interview Catalogue-affected persons Stigma Scale (EMIC-SS), at the start of treatment. Those having a GHQ-12 score ≥3 were labeled as ‘screen positive’ for psychological distress and referred to a consultant psychiatrist for detailed psychological assessment. Treatment was given by the psychiatrist if diagnosed with a psychiatric illness. All those without the diagnosis of a psychiatric illness were counseled by a pulmonologist. All patients were called for a follow-up visit and repeat assessments on the 15th day at the end of the intensive phase, using the same instruments employed at baseline. The patients already on treatment by the psychiatrist were again evaluated for their psychiatric illness. 32 (42.7%) patients had psychological distress (GHQ-12≥3) at baseline. 20 of them (26.7%) were diagnosed with a psychiatric illness. However, only 2 (2.7%) patients had psychological distress and psychiatric illness at follow-up (p

Study Design. Retrospective review of an adult deformity database. Objective. To identify pelvic incidence (PI) and age-appropriate physical function alignment targets using a component angle of T1- pelvic angle within the fusion to define correction and their relationship to proximal junctional kyphosis (PJK) and clinical outcomes. Summary of background data. In preoperative planning, a patient's PI is often utilized to determine the alignment target. In a trend toward more patient-specific planning, age-specific alignment has been shown to reduce the risk of mechanical failures. PI and age have not been analyzed with respect to defining a functional alignment. Methods. A database of patients with operative adult spinal deformity was analyzed. Patients fused to the pelvis and upperinstrumented vertebrae above T11 were included. Alignment within the fusion correlated with clinical outcomes and PI. Short form 36-Physical Component Score (SF36-PCS) normative data and PI were used to compute functional alignment for each patient. Overcorrected, under-corrected, and functionally corrected groups were determined using T10-pelvic angle (T10PA). Results. In all, 1052 patients met the inclusion criteria. T10PA correlated with SF36-PCS and PI (R= 0.601). At six weeks, 40.7% were functionally corrected, 39.4% were overcorrected, and 20.9% were under-corrected. The PJK incidence rate was 13.6%. Overcorrected patients had the highest PJK rate (18.1%) compared with functionally (11.3%) and under-corrected (9.5%) patients (P<0.05). Overcorrected patients had a trend toward more PJK revisions. All groups improved in HRQL; however, undercorrected patients had the worst 1-year SF36-PCS offset relative to normative patients of equivalent age (-8.1) versus functional (-6.1) and overcorrected (-4.5), P<0.05. Conclusions. T10PA was used to determine functional alignment, an alignment based on PI and age-appropriate physical function. Correcting patients to functional alignment produced improvements in clinical outcomes, with the lowest rates of PJK. This patient-specific approach to spinal alignment provides adult spinal deformity correction targets that can be used intraoperatively. [ABSTRACT FROM AUTHOR]

Abstract The impact of cancer interventions has been conducted in several research due to the significant burden of this non-communicable disease. The interventions that played an important role in the improvement of the patient’s quality of life (QoL) and health-related quality of life (HRQL) can be classified into two main groups: pharmaceutical and non-pharmacological methods. However, studies so far often analyze a specific group of interventions for specific types of cancer. Thus, in this systematic review and meta-analysis, we synthesized the overall impact of cancer interventions on patients’ quality of life in several cancers. In this research, we followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) to search the longitudinal original research on the Web of Science (WOS) database. After that, the Newcastle-Ottawa Scale (NOS) and Jadad Scale were used to assess the quality of non-randomized control trials and randomized control trials, respectively. Then, the characteristics of the included studies were described in the six main fields table and the random effect model with robust estimation was applied to analyze the impact of interventions on the health utility of patients. From the database, 122 longitudinal original research were included in the meta-regression, with most of them having high or fair quality. The European Organization for the research and treatment of cancer scale for quality of life (EORTC-QLQ) was the most used health utility measurement at 65.15%. In the adjusted effect models, the Visual Analogue Scale (VAS) had significant statistics in all models when we compared it with the EQ-5D Scale (p

Background: Karnataka ranks third with regards the number of mines in India and Kolar, at one time, had the world’s deepest and most productive gold mines. Miners are exposed to hazardous agents like silica, coal and asbestos which adversely impact health. Objectives: To assess the health-related quality of life (HRQL) of ex-mine workers at Kolar Gold Fields (KGF), Kolar, Karnataka. Methodology: An analytical cross-sectional study was conducted among 240 (estimated 196 with 50% prevalence) male ex-mine workers of KGF. An interview scheduled, consisting of socio-demographic factors, COPD Assessment Test (CAT) and Kings Brief Interstitial Lung Disease (KBILD) was administered. Lower CAT score and higher KBILD score indicate better HRQOL. Results: The mean age of the participants was 69.71±8.56 years. Participants were previously involved in drilling (113-47%) and blasting (127-53%) activities in the mines, with a mean of 14.68±6.46 years of work exposure. The mean scores for CAT and KBILD were 15.80±7.42 and 52.83±8.77 respectively. Based on CAT scores, half (51%) of participants reported medium impact of COPD on their health. Participants with longer duration of work experience had significantly higher CAT scores [OR-36.64 (12.14-110.6)]. KBILD score was significantly higher among those who worked in blasting (M=113. SD=52.14) than those involved in drilling (M=127, SD=53.43). Lower duration of work was significantly associated with higher KBILD scores (p

The impact of cancer interventions has been conducted in several research due to the significant burden of this non-communicable disease. The interventions that played an important role in the improvement of the patient's quality of life (QoL) and health-related quality of life (HRQL) can be classified into two main groups: pharmaceutical and non-pharmacological methods. However, studies so far often analyze a specific group of interventions for specific types of cancer. Thus, in this systematic review and meta-analysis, we synthesized the overall impact of cancer interventions on patients' quality of life in several cancers. In this research, we followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) to search the longitudinal original research on the Web of Science (WOS) database. After that, the Newcastle-Ottawa Scale (NOS) and Jadad Scale were used to assess the quality of non-randomized control trials and randomized control trials, respectively. Then, the characteristics of the included studies were described in the six main fields table and the random effect model with robust estimation was applied to analyze the impact of interventions on the health utility of patients. From the database, 122 longitudinal original research were included in the meta-regression, with most of them having high or fair quality. The European Organization for the research and treatment of cancer scale for quality of life (EORTC-QLQ) was the most used health utility measurement at 65.15%. In the adjusted effect models, the Visual Analogue Scale (VAS) had significant statistics in all models when we compared it with the EQ-5D Scale (p < 0.05) and several types of cancer such as breast, lung, and prostate cancer had significant statistics when comparing with hematological cancer in the model types of cancer (p < 0.01). Moreover, radiotherapy, screening, and a combination of chemotherapy and best supportive care also had significant statistics (p < 0.01) in the model of interventions when compared with radiotherapy applied only. Our research can suggest a vital combination of both pharmaceutical and non-pharmacological interventions to improve the quality of life of some common types of cancer patients. [ABSTRACT FROM AUTHOR]

Upper gastrointestinal (GI) conditions vastly affect each individual's physical, social, and emotional status. The decision-making process by the medical personnel about these patients is currently based on a patient's life quality evaluation scale, HRQL scales. By utilizing HRQL scales, a better understanding of the various surgical and non-surgical treatment options, as well as their long-term consequences, can be achieved. In our study, an organ-based approach is used in an attempt to examine and characterized the effect of upper GI surgery on HRQL. Therefore, HRQL scales' function as a prognostic tool is useful, and the need for future research, the creation of valid training programs, and modern guidelines is highlighted. [ABSTRACT FROM AUTHOR]

(1) Background: Lower Limb deformities include many conditions where pain and physical limitations negatively impact the health-related quality of life (HRQL) of children. The ideal way to assess this impact is by using a Patient Reported Outcome Measure (PROM). Such a condition-specific PROM is under development, called LIMB-Q Kids. This study aimed to perform a translation and cultural adaption (TCA) of the LIMB-Q Kids for use in Danish-speaking children. (2) Methods: TCA guidelines established by the World Health Organization (WHO) and the Professional Society for Health Economics and Outcomes Research (ISPOR) were followed. This process consisted of two independent forward translations, a reconciliation meeting, a backward translation with an assessment, an expert meeting, cognitive interviews with patients, editing based on the interviews, and proofreading. (3) Results: The TCA process contributed to the Danish version of LIMB-Q Kids. The reconciliation meeting resulted in a reconciled Danish version. The revision of the backward translation led to 16 corrections, and after the expert panel meeting, 26 changes were made. Twelve cognitive interviews led to nine changes, which were validated by two further interviews. Proofreading led to no further comments. (4) Conclusions: The TCA process led to a linguistically validated and culturally adapted Danish version of LIMB-Q Kids. This version is being used in the international field test study. [ABSTRACT FROM AUTHOR]

Background: We conducted a cross-sectional study to characterize health-related quality of life and symptom burden in individuals living with light chain (AL) amyloidosis. Methods: Members of the Amyloidosis Support Groups, Inc. with AL amyloidosis who consented to this IRB-approved survey provided information on their amyloidosis diagnosis, treatment, symptoms, and functioning. HRQL was measured using PROMIS and PRO-CTCAE questionnaires. Results: Among 297 participants who responded, the median age at diagnosis was 60 years (23–82) with 52% female and 90% white race. There were 69% AL (lambda) and 39% reported 3 or more organs involved with amyloidosis (58% cardiac, 58% renal, 30% neurological AL). Time from diagnosis was less than 2 years in 64 (22%), 2–5 years in 105 (36%), > 5 years in 126 (43%), and unknown in 2 (< 1%) individuals. Therapy included prior chemotherapy in 88% and stem cell transplant in 52%. Fifty percent of the cohort was on active treatment. Multiple domains were impaired in AL amyloidosis compared to the general population, including physical function, fatigue, and social roles. While highest among those within 2 years of diagnosis, high symptom burden was also seen in long-term survivors. A trend to decreased severity and number of impaired symptoms was seen with longer treatment-free interval but many symptoms remained persistent. Conclusions: Significant and persistent symptom burden is seen in AL amyloidosis. Patient-reported outcomes should be routinely measured and used to provide best supportive care to all AL amyloidosis patients, including long-term survivors and those not on active therapy. [ABSTRACT FROM AUTHOR]

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 recommends a comprehensive multidimensional assessment for patients with chronic obstructive pulmonary disease (COPD) and stresses the need for evaluation of their health status and quality of life (QOL). COPD assessment test (CAT), clinical COPD questionnaire (CCQ) and St. George Respiratory questionnaire (SGRQ) are recommended by GOLD for such assessments. However, their correlation with spirometry in the Indian population is not known. Other similar questionnaires like COPD and sleep impact scale (CASIS), functional performance inventory-short form (FPI-SF) and COPD and asthma fatigue scale (CAFS) though used internationally as a research tool, are still in the offspring stage and have never been used in India. A cross-sectional study was hence conducted in the Department of Pulmonary Medicine, Government Medical College, Patiala, Punjab, India on 100 COPD patients. Patients were assessed for health status and QOL by CAT, CCQ, SGRQ, CASIS, FPI-SF and CAFS. The relationship between these questionnaires and airflow limitation was investigated. The majority of the patients were males (n=97) and >50 years of age (n=83), illiterate (n=72), had moderate/severe COPD and belonged to group B (n=66). The mean value of forced expiratory volume in one second (%FeV1) decreased with a deterioration in CAT and CCQ score grouping (p

Abstract Background Minimally invasive aortic surgery is growing in popularity among surgeons. Although many clinical reports have proven both the safety and efficacy from a surgical point of view, there are few data regarding its impact on patients’ quality of life and whether there is a difference between ministernotomy and minithoracotomy from the patient perspective. Methods This prospective, questionnaire-based, nonrandomized study included 189 patients who underwent aortic valve replacement via a minimally invasive incision between May 2014 and December 2020 and completed at least 1 year of follow-up. The study uses the RAND SF 36-Item Health Survey 1.0 to assess and compare health-related quality of life between ministernotomy and minithoracotomy. Results There was a statistically significant improvement in the minithoracotomy group with regard to physical functioning, role limitation due to a physical problem, and social functioning (79.69 ± 20.72, 75.28 ± 26.52, 87.91 ± 16.98) compared to the ministernotomy group (70.31 ± 22.88, 58.59 ± 31.17, 66.15 ± 27.32) with p values (0.0036, 0.0001,

Purpose: Liver-related comorbidities can impair the health-related quality of life (HRQL) in people living with human immunodeficiency virus (HIV) (PLWH). However, the role of hepatic steatosis and significant fibrosis in PLWH remains incompletely characterized. Therefore, the aim of this study was to explore the association of hepatic steatosis and significant fibrosis on the HRQL using the medical outcomes study HIV health survey (MOS-HIV) in PLWH. Methods: A total of 222 PLWH were included in the final analysis of this cohort study. Metabolic comorbidities, socioeconomic factors, and HIV-related parameters were assessed. Hepatic steatosis and fibrosis were measured using vibration-controlled transient elastography (VCTE). The MOS-HIV survey, containing two summary scores (physical health summary (PHS) and mental health summary (MHS)) and ten domains, was used to assess the HRQL. Clinical predictors were identified using multivariable linear regression models. Results: The majority of this cohort was male, and the median age was 52 years, with a high prevalence of hepatic steatosis (n = 81, 36.5%). Significant fibrosis was present in 7.7% (n = 17). The mean PHS and MHS scores were 52.7 ± 9.5 and 51.4 ± 10.5, respectively. The lowest scores were in the general health perception (GHP) and energy/fatigue (EF) domains. A high BMI and waist circumference were associated with a poor PHS score. Lower education, unemployment, arterial hypertension, and significant fibrosis remained independent predictors of an impaired HRQL. Conclusion: Metabolic comorbidities, significant fibrosis, and a lower socioeconomic status may negatively affect the HRQL in PLWH. Considering the negative impact of significant fibrosis on the outcome, counseling and preventive measures according to current guidelines are recommended in this subgroup of PLWH. [ABSTRACT FROM AUTHOR]

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Upper gastrointestinal (GI) conditions vastly affect each individual’s physical, social, and emotional status. The decision-making process by the medical personnel about these patients is currently based on a patient’s life quality evaluation scale, HRQL scales. By utilizing HRQL scales, a better understanding of the various surgical and non-surgical treatment options, as well as their long-term consequences, can be achieved. In our study, an organ-based approach is used in an attempt to examine and characterized the effect of upper GI surgery on HRQL. Therefore, HRQL scales’ function as a prognostic tool is useful, and the need for future research, the creation of valid training programs, and modern guidelines is highlighted.

OBJECTIVE:Extracorporeal membrane oxygenation (ECMO) is increasingly used as a bridge to lung transplantation. The impact of preoperative ECMO on health-related quality of life (HRQL) and depressive symptoms after lung transplantation remains unknown, however. METHODS:In a single-center prospective cohort study, we assessed HRQL and depressive symptoms before and at 3, 6, and 12 months after lung transplantation using the Short Form 12 Physical and Mental Component Scores (SF12-PCS and SF12-MCS), Airway Questionnaire 20-Revised (AQ20R), EuroQol 5D (EQ5D), and Geriatric Depression Scale (GDS). Changes in HRQL were quantified by segmented linear mixed-effects models controlling for age, sex, diagnosis, preoperative forced expiratory volume in 1 second, 6-minute walk distance, and Lung Allocation Score. We compared changes in HRQL among subjects bridged with ECMO, subjects hospitalized but not on ECMO, and subjects called in for transplantation as outpatients. RESULTS:Out of 189 subjects, 17 were bridged to transplantation with ECMO. In all groups, improvements in HRQL following lung transplantation exceeded the minimally clinically important difference using the SF12-PCS, AQ20R, EQ5D, and GDS. HRQL defined by SF12-MCS did not change after transplantation. Improvements were generally similar among the groups, except for EQ5D, which showed a trend toward less benefit in the outpatients, possibly due to their better HRQL before lung transplantation. CONCLUSIONS:Subjects ill enough to require ECMO as a bridge to lung transplantation appear to achieve similar improvements in HRQL and depressive symptoms as those who do not. It is reassuring to both providers and patients that lung transplantation provides substantial improvements in HRQL, even for those patients who are critically ill in the run up to transplantation.

Study Design: Retrospective single-center, consecutively enrolled database of adult spinal deformity (ASD) patients.Objective: The aim of this study was to assess the performance of the mASD-FI in predicting clinical and patient-reported outcomes after ASD-corrective surgery.Summary Of Background Data: The recently described modified Adult Spinal Deformity frailty index (mASD-FI) quantifies frailty of ASD patients, but the utility of this clinical prediction tool as a means of prognosticating postoperative outcomes has not been investigated.Methods: ASD patients with available mASD-FI scores and HRQL data at presentation and 2-years postop were included.Patients were stratified by mASD-FI score using published cutoffs: not frail (NF <7), frail (F, 7-12), severely frail (SF, >12). Analysis of vaiance assessed differences in patient factors across frailty groups. Linear regression assessed the relationship of mASD-FI with length of stay (LOS) and HRQLs. Multivariable logistic regression revealed how frailty category predicted odds of complications, infections and reoperation.Results: A total of 509 patients included (59 years, 79%F, 27.7 kg/m 2 ). The cohort presented with moderate baseline deformity: sagittal vertical axis (83.7 mm ± 71), PT (12.7° ± 10.8°), PI-LL (43.1° ± 21.1°). Mean preoperative mASD-FI score was 7.2, frailty category: NF (50.3%), F (34.0%), SF (15.7%).Age, BMI, and Charlson Comorbidity Index increased with frailty categories (all P < 0.001); however, fusion length ( P = 0.247) and osteotomy rate ( P = 0.731) did not. At baseline, increasing frailty was associated with inferior Oswestry Disability Index (ODI), EuroQol 5-Dimension Questionnaire (EQ-5D), SRS-22r, Pain Catastrophizing Scale, and NRS Back and Leg (all P < 0.001). Greater frailty was associated with increased LOS and reduced postoperative HRQL. Controlling for complication incidence, baseline mASD-FI predicted 2 year postop scores for year ODI (b = 0.7, 0.58-0.8, P < 0.001) SRS (b = -0.023, -0.03 to -0.02, P < 0.001), EQ-5D (b = -0.003, -0.004 to -0.002, P < 0.001). F and SF were associated with greater odds of unplanned revision surgery and complications.Conclusion: Higher preoperative mASD-FI score was associated with significantly greater complications, higher rate of unplanned reoperations and lower postoperative HRQL in this investigation. The mASD-FI provides similar prognostic utility while reducing burden for surgeons and patients. [ABSTRACT FROM AUTHOR]

Introduction: Food allergy is a chronic disease that requires a great deal of effort. It can result not only in a reduced quality of life, but also increased feelings of anxiety and stress. This study examines the association between health-related quality of life (HRQL) and trait anxiety levels in adults with food allergy. Methods: The research sample consisted of 167 adults with food allergy aged 19-69 years, arithmetic average (M) age 37. The STAI X2 questionnaire was used to measure trait anxiety. The food allergy quality of life questionnaire for adult population (FAQLQ-AF) was used to measure the health-related quality of life -- and this achieved high reliability values. Results: A moderate, positive relationship was demonstrated between anxiety and the FAQLQ-AF. Simple linear regression analysis demonstrated that trait anxiety level is a predictor of HRQL level, and an increase in anxiety level decreases HRQL. Factors such as tetanus syndrome, comorbidities, prescribed medications and recommended over-the-counter medications are associated with trait anxiety levels. Related illnesses and symptom clusters are related to HRQL levels. Conclusions: Adults with food allergy who are more anxious are more likely to experience a poorer quality of life. Early intervention, prevention and optimization of treatment management should be a necessary part of the psychological care of patients with food allergy. [ABSTRACT FROM AUTHOR]

Abstract Background The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer. Methods We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians’ input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated. Results Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and − 13 to − 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and − 10 to − 5 for deterioration. Conclusions Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

(1) Background: Lower Limb deformities include many conditions where pain and physical limitations negatively impact the health-related quality of life (HRQL) of children. The ideal way to assess this impact is by using a Patient Reported Outcome Measure (PROM). Such a condition-specific PROM is under development, called LIMB-Q Kids. This study aimed to perform a translation and cultural adaption (TCA) of the LIMB-Q Kids for use in Danish-speaking children. (2) Methods: TCA guidelines established by the World Health Organization (WHO) and the Professional Society for Health Economics and Outcomes Research (ISPOR) were followed. This process consisted of two independent forward translations, a reconciliation meeting, a backward translation with an assessment, an expert meeting, cognitive interviews with patients, editing based on the interviews, and proofreading. (3) Results: The TCA process contributed to the Danish version of LIMB-Q Kids. The reconciliation meeting resulted in a reconciled Danish version. The revision of the backward translation led to 16 corrections, and after the expert panel meeting, 26 changes were made. Twelve cognitive interviews led to nine changes, which were validated by two further interviews. Proofreading led to no further comments. (4) Conclusions: The TCA process led to a linguistically validated and culturally adapted Danish version of LIMB-Q Kids. This version is being used in the international field test study.

Background: Minimally invasive aortic surgery is growing in popularity among surgeons. Although many clinical reports have proven both the safety and efficacy from a surgical point of view, there are few data regarding its impact on patients' quality of life and whether there is a difference between ministernotomy and minithoracotomy from the patient perspective.Methods: This prospective, questionnaire-based, nonrandomized study included 189 patients who underwent aortic valve replacement via a minimally invasive incision between May 2014 and December 2020 and completed at least 1 year of follow-up. The study uses the RAND SF 36-Item Health Survey 1.0 to assess and compare health-related quality of life between ministernotomy and minithoracotomy.Results: There was a statistically significant improvement in the minithoracotomy group with regard to physical functioning, role limitation due to a physical problem, and social functioning (79.69 ± 20.72, 75.28 ± 26.52, 87.91 ± 16.98) compared to the ministernotomy group (70.31 ± 22.88, 58.59 ± 31.17, 66.15 ± 27.32) with p values (0.0036, 0.0001, < 0.0001), respectively.Conclusions: Both minimally invasive aortic valve incisions positively impacted patient quality of life. The minithoracotomy incision showed significant improvements in physical capacity and successful patient re-engagement in daily physical and social activities. This, in turn, positively improved their general health status compared to the 1-year preoperative status.Trial Registration: This study was approved by the Research Ethics Committee (REC) at the Faculty of Medicine, Ain Shams University, under the number code (FWA 000017585, FAMSU R 91 /2021). [ABSTRACT FROM AUTHOR]

Background: The objective was to investigate the longitudinal relationship between physical activity and health-related quality of life (HRQL) in adults with type 2 diabetes. Methods: Data were from a prospective cohort of adults with type 2 diabetes. Weekly moderate-to-vigorous physical activity (MVPA) was reported using the Godin Leisure-Time Physical Activity Questionnaire, and HRQL was reported using the SF-12 and 5-level EQ-5D. Participants were categorized based on current weekly MVPA recommendations. Multivariable linear regression was used to explore associations between MVPA and HRQL, and multinomial logistic regression was used to assess the direction of change in HRQL after 1 year. Results: Mean age of participants (N = 1948) was 64.5 ± 10.8 years and 45% were female. Participants reported a mean of 84.1 ± 172.4 min of MVPA/week, and 21% (n = 416) met weekly MVPA recommendations. MVPA was associated with differences in the physical functioning (b = 5.42; P < .001), general health (b = 2.45; P = .037), and vitality (b = 2.83; P = .016) SF-12 dimensions. Participants who met recommendations were less likely to report a decline (vs. no change) in EQ-5D index score (OR = 0.75; 95% CI [0.57, 0.99]), and SF-12 physical component summary (OR = 0.67; 95% CI [0.50, 0.90]), compared with participants not meeting recommendations. Conclusions: Participants who met weekly MVPA recommendations reported better physical functioning and were more likely to maintain their physical and overall HRQL over time. [ABSTRACT FROM AUTHOR]

Purpose: To determine the validity and responsiveness of PROMIS metrics versus the SRS-22r questionnaire in adult spinal deformity (ASD). Methods: Surgical ASD patients undergoing ≥ 4 levels fused with complete baseline PROMIS and SRS-22r data were included. Internal consistency (Cronbach's alpha) and test–retest reliability [intraclass correlation coefficient (ICC)] were compared. Cronbach's alpha and ICC values ≥ 0.70 were predefined as satisfactory. Convergent validity was evaluated via Spearman's correlations. Responsiveness was assessed via paired samples t tests with Cohen's d to assess measure of effect (baseline to 3 months). Results: One hundred and ten pts are included. Mean baseline SRS-22r score was 2.62 ± 0.67 (domains = Function: 2.6, Pain: 2.5, Self-image: 2.2, Mental Health: 3.0). Mean PROMIS domains = Physical Function (PF): 12.4, Pain Intensity (PI): 91.7, Pain Interference (Int): 55.9. Cronbach's alpha, and ICC were not satisfactory for any SRS-22 and PROMIS domains. PROMIS-Int reliability was low for all SRS-22 domains (0.037–0.225). Convergent validity demonstrated strong correlation via Spearman's rho between PROMIS-PI and overall SRS-22r (− 0.61), SRS-22 Function (− 0.781), and SRS-22 Pain (− 0.735). PROMIS-PF had strong correlation with SRS-22 Function (0.643), while PROMIS-Int had moderate correlation with SRS-22 Pain (− 0.507). Effect size via Cohen's d showed that PROMIS had superior responsiveness across all domains except for self-image. Conclusions: PROMIS is a valid measure compared to SRS-22r in terms of convergent validity, and has greater measure of effect in terms of responsiveness, but failed in reliability and internal consistency. Surgeons should consider the lack of reliability and internal consistency (despite validity and responsiveness) of the PROMIS to SRS-22r before replacing the traditional questionnaire with the computer-adaptive testing. [ABSTRACT FROM AUTHOR]

• Drawbacks of current metrics compel use of novel patient-reported outcome indices. • This study developed MCID values for PROMIS, a novel patient-reported outcome metric. • Greater deformity severity by TS-CL was associated with lower MCID thresholds. Patient Reported Outcome Measurement Information System (PROMIS) instruments have been shown to correlate with established patient outcome metrics. The aim of this retrospective study was to determine the MCID for the PROMIS physical domains of Physical Function (PF), Pain Intensity (PI), and Pain Interference (Int) in a population of surgical cervical deformity (CD) patients. Surgical CD patients ≥ 18 years old with baseline (BL) and 3-month (3 M) HRQL data were isolated. Changes in HRQLs: ΔBL-3M. An anchor-based methodology was used. The cohort was divided into four groups: 'worse' (ΔEQ5D ≤ −0.12), 'unchanged' (≥0.12, but < −0.12), 'slightly improve' (>0.12, but ≤ 0.24), and 'markedly improved' (>0.24) [0.24 is the MCID for EQ5D]. PROMIS-PF, PI and Int at 3M was compared between 'slightly improved' and 'unchanged'. ROC computed discrete MCID values using the change in PROMIS that yielded the smallest difference between sensitivity ('slightly improved') and specificity ('unchanged'). We repeated anchor-based methods for the Ames-ISSG classification of severe deformity. 140 patients were included. EQ5D groups: 9 patients 'worse', 53 'unchanged', 20 'slightly improved', and 57 'markedly improved'. Patients classified as 'unchanged' exhibited a PROMIS-PF improvement of 2.9 ± 17.0 and those 'slightly improved' had an average gain of 13.3 ± 17.8. ROC analysis for the PROMIS-PF demonstrated an MCID of +2.26, for PROMIS-PI of −5.5, and PROMIS-Int of −5.4. In the Ames-ISSG TS-CL severe CD modifier, ROC analysis found MCIDs of PROMIS physical domains: PF of +0.5, PI of −5.2, and Int of −5.4. MCID for PROMIS physical domains were established for a cervical deformity population. MCID in PROMIS Physical Function was significantly lower for patients with severe cervical deformity. [ABSTRACT FROM AUTHOR]

Achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) leads to patient reported outcome (PRO) improvement. We aimed to assess the long-term post-SVR PRO trends in HCV patients with cirrhosis. Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAAs) who achieved SVR-12 were prospectively enrolled in a long-term registry (clinicaltrials.gov #NCT02292706). PROs were collected every 24 weeks using the Short Form-36v2 (SF-36), CLDQ-HCV, and WPAI-HCV. Pre-treatment baseline data were available for 854 cirrhotic patients who achieved SVR after DAAs. Of these, 730 had compensated (CC) and 124 had decompensated cirrhosis (DCC) before treatment- patients with DCC reported severe impairment in their PROs in comparison to CC patients (by mean -5% to -16% of a PRO range size; p <.05 for 16 out of 20 studied PROs]. After achieving SVR and registry enrollment, significant PRO improvements were noted from pre-treatment levels in 11/20 domains for those with DCC (+4% to +21%) and 19/20 PRO domains in patients with CC (+3% to +17%). Patients with baseline DCC had higher rates of hepatocellular carcinoma and mortality (P <.05). In patients with CC, the PRO gains persisted up to 168 weeks (3.5 years) of registry follow-up. In patients with DCC, the improvements lasted for at least 96 weeks but a declining trend after year 2. Patients with HCV cirrhosis experience severe PRO impairment at baseline with sustainable improvement after SVR. Though those with DCC experience improvement, there is a decline after 2 years. [ABSTRACT FROM AUTHOR]

Purpose: Esophagectomy for cancer is an extensive procedure often followed by severe complications. This study investigated whether patients with severe symptoms of reflux are more likely to have sleep disturbances and reduced health-related quality of life (HRQL) after esophagectomy. Methods: This Swedish nationwide prospective cohort study encompassed all patients who had undergone esophagectomy for cancer between 2013 and 2018. One year after surgery, the patients responded to three questionnaires on reflux (EORTC QLQOG25), sleep disturbances (KSQ), and HRQL (EORTC QLQ-C30). Multivariable logistic regression provided odds ratios (OR) with 95% confidence intervals (CI) for sleep disturbance/reduced HRQL between patients with and without reflux, adjusted for potential confounders. Results: Among 241 esophagectomy patients, 66 (27%) reported severe reflux. Patients with reflux had an increased risk of sleep disturbances (OR 2.3, 95% CI: 1.3–4.3) compared to patients without reflux. More specifically, these patients were more likely to suffer from poor sleep quality (OR 4.9, 95% CI: 1.9–12.4). Patients with reflux and sleep disturbances reported reductions in global quality of life, role function, emotional function, social function, and more symptoms in all scales, except for dyspnea. Conclusions: This study suggests that patients with severe symptoms of reflux after esophagectomy have an increased risk of sleep disturbances and poor sleep quality, which in turn are associated with reduced HRQL. Implications for Cancer Survivors: Alleviating reflux after oesophageal cancer surgery is important, since this common symptom might reduce HRQL and well-being. [ABSTRACT FROM AUTHOR]

Abstract Background The growing move towards personalised health and social care systems means that every effort needs to be made to generate patient-reported outcome data. However, the deteriorating nature of dementia can make it difficult for people with dementia to complete self-reported questionnaires and it is often necessary to rely on a family member (proxy) to report on their behalf. There is little evidence to guide how the difference between self- and proxy-reports of health reported quality of life (HRQL) in dementia can be interpreted. Methods We recruited people with dementia and their family carers from 78 memory Assessment Services in the UK. We used Rasch measurement methods to investigate whether a HRQL questionnaire known as DEMQOL (self-reported by the person with dementia) and DEMQOL-Proxy (proxy-reported by a family carer) can be placed on the same continuum and whether a revised scoring algorithm, based on this equated model, can be developed that takes account of the relationship between self- and proxy-reports. Results In a sample of 1434 patients and 1030 carers, our findings supported equating DEMQOL/DEMQOL-Proxy (overall fit to the model; no mis-fitting items) after addressing specific issues (eight disordered items requiring re-scoring, four pairs locally dependent items, and five items showing DIF). Cross walk tables have been produced. Conclusions We have established for the first time that DEMQOL and DEMQOL-Proxy can be placed on the same continuum and that patients and carer proxies are reporting on the same construct when they complete these questionnaires. Where possible both DEMQOL and DEMQOL-Proxy should still be administered together, using the improved scoring algorithm reported here. Where only DEMQOL-Proxy is available, the cross walk tables provide an estimate of DEMQOL for a particular person from their DEMQOL-Proxy score.

Background: The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer.Methods: We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians' input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated.Results: Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and - 13 to - 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and - 10 to - 5 for deterioration.Conclusions: Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer. [ABSTRACT FROM AUTHOR]

Background: Autoimmune hepatitis (AIH) is a rare chronic liver disease. Impaired health-related quality of life (HRQL) contributes to the overall disease burden. At current, only limited data related to the impact of treatment response on HRQL are available. Objective: The aim of the study was to determine the impact of biochemical remission on HRQL. Methods: Patients with AIH were prospectively enrolled between July 2018 and June 2019. A liver disease-specific tool, the chronic liver disease questionnaire (CLDQ) and the generic EQ-5D-5L were used to quantify HRQL. Treatment response was assessed biochemically by measurement of immunoglobulin G, ALT and AST. The cohort was divided into two groups according to their biochemical remission status in either complete vs. incomplete remission. Clinical as well as laboratory parameters and comorbidities were analysed using univariable and multivariable analysis to identify predictors of poor HRQL. Results: A total of 116 AIH patients were included (median age: 55; 77.6% female), of which 9.5% had liver cirrhosis. In this cohort, 38 (38.4%) showed a complete and 61 (61.6%) an incomplete biochemical remission at study entry. The HRQL was significantly higher in patients with a complete as compared to an incomplete biochemical remission (CLDQ overall score: 5.66 ± 1.15 vs. 5.10 ± 1.35; p = 0.03). In contrast, the generic EQ-5D-5L UI-value was not different between the groups. Multivariable analysis identified AST (p = 0.02) and an incomplete biochemical remission (p = 0.04) as independent predictors of reduced HRQL (CLDQ total value). Conclusion: Patients with a complete biochemical remission had a significantly higher HRQL. Liver-related quality of life in patients living with AIH is dependent on the response to immunosuppressive treatment. [ABSTRACT FROM AUTHOR]

Purpose: Congenital 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. Methods: This 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. Results: This 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. Conclusion: Educating 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. [ABSTRACT FROM AUTHOR]

The purpose was to investigate whether social distancing during the COVID-19 pandemic reduced health-related quality of life (HRQL) in esophageal cancer patients and if so, to identify factors related to the HRQL changes. A prospective Swedish nationwide study of patients who undergone surgery for esophageal cancer between 2013 and 2019. Telephone interviews were conducted 5 weeks and 13 weeks after the introduction of social distancing recommendations. The participants responded to a few scales and items from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Regression models adjusted for potential confounders were used to examine mean score differences (MSD) with 95% confidence intervals (CI) between compliance with the recommendations and HRQL. In total, 134 individuals participated in the study. At 5 weeks, a reduction in role function was seen for individuals who fully (MSD −8, 95% CI: −16 to 0) and to a large extent (MSD −19, 95% CI: −26 to −12) complied with the recommendations. Less fatigue (MSD 9, 95% CI: 3–15) was also detected for this group. Being female, elderly, having comorbidities, living in a region with higher COVID-19 incidence, living in a villa, and being considered as an at-risk person were related to changes in role function. At 13 weeks, reductions in role function continued for those who fully complied with the recommendations (MSD −10, 95% CI: −19 to −1), but the risk variables were of less importance. Improvements in fatigue were no longer detected. Global quality of life, emotional function, or insomnia remained stable over time. This study indicates that individuals who undergone surgery for esophageal cancer and fully or to a large extent complied with the recommendations experienced reductions in role function, but not in global quality of life or emotional function, during the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Abstract Objective To examine the association between individual-level deprivation and health-related quality of life (HRQL) in the general population. Methods Data from a population-based survey in the Canadian province of Alberta were used. Individual-level deprivation was assessed using the Canadian Deprivation Index (CDI) and the Ontario Deprivation Index (ODI). HRQL was assessed using the EQ-5D-5 L. Differences in problems in the EQ-5D-5 L dimensions, index and visual analogue scale (VAS) scores across levels of deprivation were examined. Multivariate logistic and linear regression models adjusted for socio-demographic and other characteristics were used to examine the independent association between deprivation and HRQL. Results Of the 6314 respondents, 39% were aged between 18 and 44 years and 38% between 45 and 64 years; 60% were female. Mean EQ-5D-5 L index and VAS scores were 0.85 (standard deviation [SD] 0.14) and 79.6 (SD 17.7), respectively. Almost one-third (30.6%) of respondents reported no problems on all EQ-5D-5 L dimensions. Few participants reported some problems with mobility (23.8%), self-care (6.2%) and usual activities (25.2%), while 59.3 and 35.5% reported some levels of pain/discomfort and anxiety/depression, respectively. Differences between the most and least deprived in reporting problems in EQ-5D-5 L dimensions, index and VAS scores were statistically significant and clinically important. In adjusted regression models for both deprivation indices, the least well-off, compared to the most well-off, had higher likelihood of reporting problems in all EQ-5D-5 L dimensions. Compared to the most well-off, the least well-off had an EQ-5D-5 L index score decrement of 0.18 (p

Abstract Background The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) was developed to meet Food and Drug Administration (FDA) recommendations for patient-reported outcome (PRO) endpoints in gastroparesis studies, including therapeutic trials. The current version of the ANMS GCSI-DD contains five items pertaining to nausea, early satiety, post-prandial fullness, upper abdominal pain, and vomiting. The specific aims of this study were to determine if the appropriate symptoms are included in the ANMS GCSI-DD and to assess the content validity in patients with idiopathic (IG) and diabetic gastroparesis (DG). Methods Patients diagnosed with IG or DG were recruited by five clinical sites in the United States for a cross-sectional, qualitative study involving one-on-one in-person concept elicitation and cognitive debriefing interviews. Concept elicitation included open-ended questions to elicit patients’ symptoms and impacts of gastroparesis, while cognitive debriefing was designed to assess the comprehensiveness of the ANMS GCSI-DD and clarity of the instructions, items, and response scales. The interviews were audio-recorded and transcribed. Transcripts were analyzed using a content analysis approach with ATLAS.ti. Results Of 25 patients interviewed, 15 (60%) had IG and 10 (40%) DG. Mean age of the sample was 42.3 years (range: 20–70 years), and most patients were female (n = 19, 76%) and white (n = 19, 76%). During concept elicitation, patients endorsed the following signs and symptoms as relevant and important to their condition: early satiety (n = 25, 100%), post-prandial fullness (n = 25, 100%), nausea (n = 22, 88%), upper abdominal pain (n = 18, 72%), vomiting (n = 15, 60%), and bloating (n = 11, 44%). Many patients (n = 20, 80%) experienced day-to-day symptom change. During cognitive debriefing, patients confirmed the ANMS GCSI-DD content was comprehensive and reflective of their gastroparesis experience. Patients could easily select a response option and describe how they arrived at their answers. Overall, patients found the instrument’s instructions, recall period, items, and response options clear and understandable. Conclusions The ANMS GCSI-DD was easily understood, found to contain the most important symptoms for patients with IG and DG, and no changes were recommended. Results support the content validity of the ANMS GCSI-DD for clinical trials and clinical care among IG or DG patients.

Purpose: Dizziness may affect quality of life in a negative way and contribute to falls. The aim of this study was to investigate and compare 75 years old with dizziness caused by benign paroxysmal positional vertigo (BPPV) to those with general dizziness/impaired balance (non-BPPV related) and to those reporting no dizziness, regarding health-related quality of life (HRQL), falls, tiredness, and walking speed in a population-based setting. Method: A cross-sectional population-based sample, including 671 75 years old (398 women, 273 men), was investigated for BPPV, dizziness symptoms, falls, and walking speed. HRQL was assessed using the 36-item Short Form-36 Health Survey (SF-36). Result: A total of 67 persons (10%) had symptoms of BPPV with 11 (1.6%) having nystagmus when tested for BPPV. Having BPPV as well as general dizziness/impaired balance was associated with reduced HRQL, more tiredness, enhanced number of falls, and lower walking speed. Furthermore, the risk of having BPPV increased fourfold if symptoms of dizziness when turning in bed was reported. Conclusion: Having problems with dizziness is common among senior citizens where BPPV can be an unrecognized cause of dizziness that may impact HRQL and overall well-being. As BPPV is common among older adults, and is potentially curable through reposition maneuvers, it is important to liberally test for, and treat the condition. Information about dizziness when turning in bed can help to pinpoint persons with enhanced risk for BPPV also on a population-based level. [ABSTRACT FROM AUTHOR]

Health-Related Quality of Life (HRQL) can be used to measure the impact of Sickle Cell Disease (SCD) on the child and their family and is generally reduced. No research has yet measured HRQL in Portuguese pediatric SCD patients. Objectives: (1) Describe and compare HRQL of children with SCD reported by them and their parents; (2) Compare with a pediatric population with no SCD; (3) Find predictive factors of HRQL in SCD children. Methods: Descriptive, case-control study that included sixty-eight children and adolescents with SCD (aged 3 to 18 years) and their parents. Control group—children with no SCD, matched by age, gender and ethnic background. HRQL was assessed using the multidimensional self-report PedsQL® 4.0 Generic Scales. Summary scores for overall HRQL and subscale scores for physical, emotional, social and school functioning were compared within groups (children-parents) and with the control group. Clinical and socio-demographic variables were analyzed to find predictive factors of HRQL in pediatric SCD patients. Results: Children with SCD and their parents had significantly lower overall and all subdomains of HRQL, compared with the control group. Children with SCD also rated lower when compared with their parents (only significant for social functioning), with low to moderate correlations. Children and parent reports declined with increasing age. Higher pain frequency was associated with worse total and psychosocial domains of HRQL. The number of hospitalizations was a predictor of worse school score, and female gender was a predictor of worse emotional score. Conclusions: SCD significantly affects children’s HRQL. Parents can provide a good proxy report, although both evaluations are beneficial. Disease status, like number of hospitalizations and frequency of pain, influences HRQL. Interventions in SCD should consider improvements in HRQL as an important outcome.

Abstract Background Patient reports of health related quality of life can provide important information about the long-term impact of prostate cancer. Because patient symptoms and function can differ by age of the survivor, the aim of our study was to examine patient-reported quality of life and prostate symptoms by age at diagnosis among a registry of Dutch prostate cancer survivors. Methods A population of 617 individuals from the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) database was surveyed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and prostate symptom (EORTC QLQ-PR25) scales. Age at diagnosis was the main independent variable, with three age categories: 60 years and younger, 61–70 years, and 71 years and older. Dependent variables were the EORTC-QLQ-C30 and EORTC QLQ-PR25 scales, divided into positive and negative outcomes. Positive measures of health-related quality of life included global health, physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. Negative outcomes included fatigue, nausea, pain, dyspnea, insomnia, appetite, constipation, and diarrhea. We also assessed sexual activity, and urinary, bowel and hormonal symptoms. Descriptive analyses included frequencies with chi-square tests and medians with Kruskal-Wallis tests. Multivariable adjusted analyses were conducted by median regression modeling. Results Among the numerous scales showing some unadjusted association with age group, only two scales demonstrated significant differences between prostate cancer patients age 71+ compared to the youngest group (age

Abstract Background The Brief Pain Inventory-short form (BPI-sf) is widely used in self-reported pain assessment, incorporates pain numeric rating scales (NRS) and is commonly utilized in electronic format in clinical trials, however, there is no published information about its usability as an electronic patient-reported outcome (ePRO) measure. The objective of this qualitative study was threefold: 1) to better understand pain experiences among patients with pleural or peritoneal mesothelioma; 2) to assess the interpretability of the instructions, item stem, recall period, and response option of the “worst pain” item of the BPI-sf; and 3) to examine the usability of the TrialMax Touch™ (CRF Health, Inc., Plymouth Meeting, PA) screen-based handheld device and the electronic format of the BPI-sf in a sub-sample of pleural mesothelioma patients. Methods A cross-sectional qualitative study was conducted among participants with pleural and peritoneal mesothelioma recruited from 4 clinical sites in the US. Semi-structured telephone or in-person interviews were conducted consisting of concept elicitation, cognitive interviewing of the 11-item BPI-sf, and in-person interview evaluation of ePRO assessment usability in pleural mesothelioma patients. Results Twenty-one participants recruited from 4 clinical sites in the US were interviewed in-person (n = 9) and by telephone (n = 12); 71% male; mean age 68.7 ± 13.6 years. Pleural and peritoneal patients described pain as ranging from discomfort to intense pain and reported being able to distinguish tumor pain from treatment pain. The BPI-sf “worst pain” item was relevant to, and easily understood by, study participants with pleural and peritoneal mesothelioma. The ePRO version was found to be easy to use, but readability of small font may be an issue. Participants reported minimal differences between their responses on the paper and ePRO version for all of the pain severity and pain interference items. Conclusions Results support the relevance and ease of understanding of the “worst pain” item and provide support for its content validity in patients with pleural and peritoneal mesothelioma. Usability of the ePRO format of the BPI-sf was confirmed for use in clinical trials among patients with pleural mesothelioma.

The existing research aims to explore the relationships between working conditions, job satisfaction and health‐related quality of life (HRQL) of Chinese rural‐to‐urban migrants. Both probability and nonprobability sampling methods were done in four randomly chosen jurisdictions of Nanjing (N = 712). Results reveal that the working environment has the strongest and positive correlation with job satisfaction. In addition, job satisfaction is negatively correlated with the number of working days per week, and affects the physical and psychological health status of Chinese rural‐to‐urban migrants. This study highlights the importance to improve working conditions for migrants and their HRQL and recommends government policies to provide services to Chinese migrants and protect their human rights, as well as promote awareness of their working conditions and HRQL. [ABSTRACT FROM AUTHOR]

Purpose: This study investigated the psychometric yield of extension of the EQ-5D-5L with a cognitive domain (EQ-5D+C) in a mixed cohort of trauma patients with repeated data. Methods: A stratified sample of patients that presented at the emergency department filled out a follow-up survey 6 and 12 months after trauma. The surveys included the EQ-5D-5L+C, EQ-VAS, and the impact of events scale-revised (IES-R), a validated post-traumatic stress disorder (PTSD) self-assessment scale. Generally, results of the EQ-5D and EQ-5D+C were compared. Psychometrics included the following: distributional features (ceiling/floor effects), discriminatory performance, convergent validity with the EQ-VAS as reference, and responsiveness to change. Psychometric properties were compared between predefined subgroups based on conditions with cognitive impact (Traumatic Brain Injury (TBI)/PTSD). Results: In total, 1799 trauma patients responded 6 and 12 months after trauma, including 107 respondents with PTSD, and 273 with TBI. Six months post-trauma, ceiling of the EQ-5D (26.3%) was reduced with 2.2% with the additional cognitive domain. Using EQ-VAS as reference, convergent validity increased slightly with the addition of the cognitive domain: correlation increasing from 0.651 to 0.664. Cognitive level was found to slightly improve over time in TBI (delta: 0.04) and PTSD patients (delta: 0.05), while (almost) no change was found in patients without TBI and PTSD. Conclusion: Adding a cognitive domain to the EQ-5D-5L slightly improved measurement properties and better captured change in health status for trauma patients with TBI and PTSD. Inclusion of the cognitive domain in the EQ-5D-5L when measuring in populations with cognitive problems should be considered. [ABSTRACT FROM AUTHOR]

Background: Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients' health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional Assessment of Cancer Therapy EGFRI 18 (FACT-EGFRI 18) using 7-items from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to assess EGFRI-induced skin-related toxicities and their impact on functional status. Methods: Patients with a diagnosis of colorectal or lung cancer to receive EGFRI therapies for at least 6 weeks were enrolled. Patient self-assessments using the FACT-EGFRI 18 were completed prior to undergoing CTCAE assessment by trained clinicians at baseline, weekly × 6, and then monthly × 3. The psychometric properties of the FACT-EGFRI 14 (skin toxicity items only) and 18 (plus 2 nail and 2 hair items) were established based on criterion validity, known groups validity, internal consistency reliability, and responsiveness to change. Results: Of the 146 registered patients, 124 were evaluable. High Cronbach's alpha (> 0.70) for both FACT-EGFRI 14 and FACT-EGFRI 18 scores across assessment times were observed. Although agreement (i.e. criterion validity) between individual and summary scales of the FACT-EGFRI 18 for assessing skin toxicity was good, agreement with the clinician-reported CTCAE was only fair. The minimal important difference was determined to be 3 points. The results also demonstrated responsiveness to symptom change. Discussion: Based on the results of this multi-center validation study, the FACT-EGFRI 18 patient-reported outcome instrument provided data from the patient's perspective yielding unique information as well as complementing clinician-rated CTCAE grades, especially for the symptoms of pain, pruritus, and paronychia. Conclusions: Good to excellent psychometric properties for the FACT-EGFRI 18 were demonstrated, supporting further use of this patient-reported outcomes measure. Additional validation with a more diverse group of patients should be conducted. [ABSTRACT FROM AUTHOR]

Background: The growing move towards personalised health and social care systems means that every effort needs to be made to generate patient-reported outcome data. However, the deteriorating nature of dementia can make it difficult for people with dementia to complete self-reported questionnaires and it is often necessary to rely on a family member (proxy) to report on their behalf. There is little evidence to guide how the difference between self- and proxy-reports of health reported quality of life (HRQL) in dementia can be interpreted.Methods: We recruited people with dementia and their family carers from 78 memory Assessment Services in the UK. We used Rasch measurement methods to investigate whether a HRQL questionnaire known as DEMQOL (self-reported by the person with dementia) and DEMQOL-Proxy (proxy-reported by a family carer) can be placed on the same continuum and whether a revised scoring algorithm, based on this equated model, can be developed that takes account of the relationship between self- and proxy-reports.Results: In a sample of 1434 patients and 1030 carers, our findings supported equating DEMQOL/DEMQOL-Proxy (overall fit to the model; no mis-fitting items) after addressing specific issues (eight disordered items requiring re-scoring, four pairs locally dependent items, and five items showing DIF). Cross walk tables have been produced.Conclusions: We have established for the first time that DEMQOL and DEMQOL-Proxy can be placed on the same continuum and that patients and carer proxies are reporting on the same construct when they complete these questionnaires. Where possible both DEMQOL and DEMQOL-Proxy should still be administered together, using the improved scoring algorithm reported here. Where only DEMQOL-Proxy is available, the cross walk tables provide an estimate of DEMQOL for a particular person from their DEMQOL-Proxy score. [ABSTRACT FROM AUTHOR]

Background: We aimed to describe school‐entry age neurocognitive, functional, and HRQL outcomes and their predictors after liver transplant done at age <6 years. Methods: A prospective cohort of all (n = 69) children surviving liver transplant from 1999 to 2014 were assessed at age 55.4 (SD 7.2) months and 38.6 (12.4) months after transplant. Assessment included: the Wechsler Preschool and Primary Scales of Intelligence, Beery‐Buktenica Developmental Test of VMI, Adaptive Behavior Assessment System caregiver‐completed questionnaire, and PedsQL 4.0 Generic Core Scales. Univariate and multiple linear regression determined predictors of outcomes at P <.05. Results: Neurocognitive and functional outcomes were on average within 1 SD of population norms, although shifted to the left (P ≤.03), with more patients than expected having scores >2 (3.7‐5.9 times more, P ≤.007) SD below population norms. Total and Summary HRQL scores were statistically significantly lower than the healthy normative population (P ≤.02) and a congenital heart disease group (P ≤.02), but similar to children with other chronic health conditions; differences often exceeded the MCID and were lowest in the School functioning domain. There were few predictors on multiple linear regressions, and we could not confirm previous studies that suggested various inconsistent predictors of outcomes. Neurocognitive and functional outcomes scores were highly correlated with HRQL scores except for the School functioning domain, but did not fully explain them. Conclusions: Long‐term follow‐up of this vulnerable population is important in order to facilitate support for the patient and family, and early intervention for any difficulties identified. [ABSTRACT FROM AUTHOR]

Abstract Background Hypertension is a common and frequently occurring chronic disease of the cardiovascular system. Besides the pathological factors, the occurrence and exacerbation of hypertension are also associated with many factors of lifestyle and behaviors. Thus hypertensive patients’ Health-related quality of life (HRQL) is not only influenced by the disease itself but also by many subjective factors such as health literacy and self-management efficacy, especially in the deeper part of southwestern China and thus is less developed compared to the other places. The purpose of this study was to examine the association between the HRQL of hypertensive patients and health literacy and self-management efficacy as well as how they affect the HRQL, so as to provide a theoretical reference for improving the HRQL of patients with hypertension in less developed areas. Methods This was a cross-sectional study of baseline data from a clustered randomized controlled trial. The study design had passed a cross-national peer review and accepted grants by the China Medical Board. It was also registered in the Chinese Clinical Trial Registry (ChiCTR-OOR-14005563). A standardized questionnaire adapted from a previous validated WHO questionnaire was used for the survey which included detailed questions about patient’s socio-demographic characteristics and self-reported information. Patients’ HRQL was measured by the Mandarin version of the 36-item Short Form. We used the validated Mandarin version of the Self-Efficacy for Managing Chronic Disease 6-Item Scale to assess patients’ self-management efficacy. The validated three-item Brief Health Literacy Screening (BHLS) was used to measure the patients’ health literacy. A structural equation model was constructed, and p ≤ 0.05 was taken as significant. Results Demographic characteristics, health literacy and self-management efficacy have all significant effects on HRQL. Age, education level, self-management efficacy and health literacy were significantly related to the HRQL. The constructed model had a good fit for the data according to the model fit indices. Based on the model, health literacy (r = 0.604, p = 0.029) and Self-management efficacy (r = 0.714, p = 0.018) have a significant impact on HRQL. Demographic characteristics were inversely related to HRQL (r = −0.419, p = 0.007), but have a significant impact on health literacy (r = 0.675, p = 0.029) and self-management efficacy (r = 0.379, p = 0.029). At the same time, self-management efficacy was positively correlated to health literacy (r = 0.413, p