scholarly journals Serum Amyloid A Is a Biomarker of Disease Activity and Health-Related Quality-of-Life in Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Taejun Yoon ◽  
Sung Soo Ahn ◽  
Juyoung Yoo ◽  
Jason Jungsik Song ◽  
Yong-Beom Park ◽  
...  
Keyword(s):  
Disease Activity ◽  
Serum Amyloid A ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Amyloid A ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Serum amyloid A (SAA) is one of the acute phase proteins synthesized in hepatocytes and secreted by various inflammation or infectious stimuli. We investigated the clinical implication of measuring SAA in patients with antineutrophil cytoplasmic antibody- (ANCA-) associated vasculitis (AAV). Seventy-five patients who had been classified as AAV and enrolled in our prospective observational cohort for AAV patients were included. Clinical and laboratory data were obtained on the day of blood sampling, and SAA was measured by ELISA kits. Birmingham Vasculitis Activity Score (BVAS) and Short-Form 36-Item Health Survey (SF-36) were assessed for disease activity and health-related quality-of-life (HRQoL) measures. We stratified patients into having high BVAS when the BVAS was over the median values, and those with either low SF-36 PCS or low SF-36 MCS were defined as having poor HRQoL. Multivariate logistic regression analysis was conducted to estimate independent predictors of high BVAS. The relative risk (RR) was analyzed using the contingency tables and the chi-squared test. SAA was positively correlated with BVAS ( r = 0.642 ) and FFS ( r = 0.367 ) and was inversely correlated with both the SF-36 physical component summary ( r = − 0.456 ) and mental component summary scores ( r = − 0.394 ). Furthermore, SAA was significantly correlated with acute phase reactants ESR ( r = 0.611 ) and CRP ( r = 0.629 ). Patients with high BVAS exhibited significantly higher SAA than those with low BVAS (1317.1 ng/mL vs. 423.1 ng/mL). In multivariable logistic regression analysis, serum albumin (odds ratio (OR) 0.132) and SAA > 1173.6   ng / mL (OR 15.132) were independently associated with high BVAS. The risk of having high BVAS and poor HRQoL in patients with SAA > 1173.6   ng / mL was higher than in those with SAA ≤ 1173.6   ng / mL (RR 3.419 and 1.493). Our results suggest that SAA might be a useful biomarker in assessing disease activity and HRQoL in AAV.

scholarly journals Neutral theory: applicability and neutrality of using generic health-related quality of life tools in diseases or conditions where specific tools are available

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ravi Jandhyala
Keyword(s):  
Rare Disease ◽  
Neutral Theory ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Disease Condition ◽  
Related Quality ◽  
Health Related ◽  
Sensitivity Specificity

Abstract Background Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers. Neutral Theory describes the ideal construct that includes all relevant indicators and, therefore, complete accuracy, or neutrality. Neutral Theory can thereby provide the framework to develop or test constructs. To assess the application of Neutral Theory, the neutrality of generic tools (SF-36 and EQ-5D) at measuring HRQoL was compared to disease/condition-specific tools, with the latter considered surrogates for the Neutral construct. Methods Full descriptions of all disease/condition-specific HRQoL tools published on PubMed (to 01-Jul-19) were sourced. For each tool, the number of items with and without a direct match within the SF-36 and EQ-5D was recorded and the sensitivity/specificity calculated. Results The SF-36 and EQ-5D did not achieve a sensitivity/specificity both > 50% against any of the 163 disease/condition-specific tools identified. At 20% prevalence of poor HRQoL, the false positive rate (FPR) was > 75% for all but two tools against the SF-36 and six tools against the EQ-5D. Increasing poor HRQoL to 80%, 47 tools for the SF-36 and 48 tools for the EQ-5D had a FPR < 50%. For rare disease tools (< 1/2000 population; n = 17), sensitivity/specificity ranged from 0 to 40%/5–31% for the SF-36 and 0–22%/29–100% for the EQ-5D. For non-rare (n = 75) and symptom-specific tools (n = 71) sensitivity/specificity was: 0–100%/0–100% (SF-36) and 0–50%/0–100% (EQ-5D); and 0–60%/0–19% (SF-36) and 0–25%/0–100% (EQ-5D), respectively. No concordance was recorded for 18% (2/11) of results from studies of rare disease tools versus the SF-36 (no data vs EQ-5D). For non-rare, disease-specific tools, results were discordant for 30% (25/84) and 35% (23/65) of studies against the SF-36 and EQ-5D, respectively. For symptom-specific tools, corresponding results were 36% (24/66) and 16% (5/31). Conclusions Generic HRQoL tools appear poorly correlated with disease/condition-specific tools, which indicates that adoption of Neutral Theory in the development and assessment of HRQoL tools could improve their relevance, accuracy, and utility in economic evaluations of health interventions.

scholarly journals Impact of malnutrition on health-related quality of life in persons receiving dialysis: a prospective study

2021 ◽  
pp. 1-24
Author(s):  
Daniela Viramontes-Hörner ◽  
Zoe Pittman ◽  
Nicholas M Selby ◽  
Maarten W Taal
Keyword(s):  
Quality Of Life ◽  
Prospective Study ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
The Impact ◽  
Over Time

Abstract Health-related quality of life (HRQoL) is severely impaired in persons receiving dialysis. Malnutrition has been associated with some measures of poor HRQoL in cross-sectional analyses in dialysis populations, but no studies have assessed the impact of malnutrition and dietary intake on change in multiple measures of HRQoL over time. We investigated the most important determinants of poor HRQoL and the predictors of change in HRQoL over time using several measures of HRQoL. We enrolled 119 haemodialysis and 31 peritoneal dialysis patients in this prospective study. Nutritional assessments (Subjective Global Assessment [SGA], anthropometry and 24-hour dietary recalls) and HRQoL questionnaires (Short Form-36 [SF-36] mental [MCS] and physical component scores [PCS] and European QoL-5 Dimensions [EQ5D] health state [HSS] and visual analogue scores [VAS]) were performed at baseline, 6 and 12 months. Mean age was 64(14) years. Malnutrition was present in 37% of the population. At baseline, malnutrition assessed by SGA was the only factor independently (and negatively) associated with all four measures of HRQoL. No single factor was independently associated with decrease in all measures of HRQoL over 1 year. However, prevalence/development of malnutrition over one year was an independent predictor of 1-year decrease in EQ5D HSS and 1-year decrease in fat intake independently predicted the 1-year decline in SF-36 MCS and PCS, and EQ5D VAS. These findings strengthen the importance of monitoring for malnutrition and providing nutritional advice to all persons on dialysis. Future studies are needed to evaluate the impact of nutritional interventions on HRQoL and other long-term outcomes.

scholarly journals The Impact of Cytokines on the Health-Related Quality of Life in Patients with Systemic Lupus Erythematosus

2019 ◽  
Vol 8 (6) ◽  
pp. 857 ◽  
Author(s):  
Warren David Raymond ◽  
Gro Østli Eilertsen ◽  
Sharanyaa Shanmugakumar ◽  
Johannes Cornelis Nossent
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Health Related Quality ◽  
Sf 36 ◽  
Cytokine Levels ◽  
Related Quality ◽  
Health Related ◽  
Ifn Γ ◽  
Tgf Β1

Introduction: Systemic lupus erythematosus (SLE) reduces the health-related quality of life (HRQoL), even during periods of disease quiescence. We investigated whether subclinical inflammation as reflected by cytokine levels is linked with reduced HRQoL. Methods: A cross-sectional study of SLE patients (n = 52, mean age 47.3, 86.5% female) who completed a Short Form Health Survey-36 (SF-36) questionnaire. The clinical and demographic data, scores for the disease activity (SLEDAI-2K), organ damage (SDI), and laboratory data were collected simultaneously. The autoantibody and cytokine levels (IFN-γ, IL-1β, IL-4, IL-6, IL-10, IL-12, IL-17, BAFF, TNF-α, TGF-β1, MIP-1α, MIP-1β and MCP-1 (levels in pg/mL) were quantified by sandwich ELISA. The comparisons and associations were assessed non-parametrically, and a multiple regression determined the effect sizes (ES) of the variables on the SF-36 domain and summary scores. Results: The SF-36 summary and domain scores for SLE patients were significantly (20–40%) lower than in a comparable control group, with the exception of the Mental Health scores (p = 0.06). SLE patients had a normal body mass index (BMI) (median, 24.2 kg/m2), a high rate of smoking (69.2%), and usage of social security benefits (90.4%). TGF-β1 (ES 0.06), IL-12 (ES −0.11), IFN-γ (ES 0.07) and MCP-1 (ES 0.06) influenced the SF-36 domain scores; and MCP-1 (ES 0.04) influenced the Mental Health Summary Score (MCS). Obvious manifestations, including patient visual analogue scale (VAS) (ES −2.84 to −6.29), alopecia (ES −14.89), malar rash (ES −14.26), and analgesic requirement (ES −19.38), independently influenced the SF-36 items; however, the SF-36 scores were not reflected by the physician VAS or disease activity (SLEDAI-2K). Conclusions: Cytokines had a minimal impact on HRQoL in SLE patients, especially compared to visible skin manifestations, central nervous system (CNS) damage, and pain. Better tools are needed to capture HRQoL in measures of disease activity.

scholarly journals FRI0592 IMPACT OF INDIVIDUAL SYMPTOMS OF PSORIATIC ARTHRITIS ON PHYSICAL COMPONENT SCORE AND MENTAL COMPONENT SCORE OF SF-36 AS A MEASURE OF HEALTH RELATED QUALITY OF LIFE (QOL): AN OBSERVATIONAL COHORT STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 901.1-902
Author(s):  
M. Skougaard ◽  
T. Schjødt Jørgensen ◽  
M. J. Jensen ◽  
C. Ballegaard ◽  
J. Guldberg-Møller ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Advisory Board ◽  
Health Related Quality ◽  
Research Support ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Background:Patients with Psoriatic Arthritis (PsA) experience diverse symptoms including skin and nail psoriasis, swollen and tender joints, enthesitis, and fatigue that have shown to impair health related quality of life (QoL). We hypothesized that different elements of disease influence SF-36 physical (PCS) and mental (MCS) component summary scores differently.Objectives:The objective of the study was to assess the interaction between change in disease activity (DAS28CRP), PsA symptoms (psoriasis [PsO], nail PsO, enthesitis, fatigue, pain, and physical function) with changes in PCS and MCS scores in a PsA patient cohort exploring effect of treatment on clinical manifestations and patient-reported outcome (PRO).Methods:Data were obtained from the PIPA cohort (1) at baseline and after 4 months of treatment. Patients’ characteristics were described as medians with interquartile ranges (IQRs) and numbers with percentages. Data were presented as changes between baseline and follow-up with delta (Δ) values on xyz-plots. Associations between PCS and MCS scores, DAS28CRP, and PsA symptoms were described with fitted linear regression plane models. PCS and MCS were derived from 8 domains of SF-36 and ranged from 0-100 with lower values reflecting more impaired QoL.Results:71 PsA patients were included in the study. 40 (56%) patients were female with a mean age of 50 (IQR 41-60) years and disease duration of 2.15 (IQR 0.2-9) years. Figure 1 shows associations between PsA symptoms, DAS28CRP, and PCS (green regression plane) and MCS (blue regression plane). For all PROs; pain, fatigue and physical function, improvements in both ΔPCS and Δ MCS scores were associated with improvements in either Δpain, ΔPsAID fatigue, and/or ΔHAQ, and to a larger extent than improvements in ΔDAS28CRP. Improvements in Δnail PsO (regression coefficient (RC): -0.22) and ΔPASI (RC: -0.31) positively impacts ΔMCS, without a clear association in PCS scores (RC: 0.13 and 0.38 for Δnail PsO and ΔPASI, respectively). Improvement in inflammatory features SPARCC enthesitis and DAS28CRP showed improvement in both ΔPCS and ΔMCS.Figure 1.Association between disease activity, individual symptoms and PCS/MCS PCS; physical component summary (green regression plane), MCS; mental component summary (blue regression plane). Arrows indicate the positive improvement vector. SF-36: short form-36, CI: Confidence Interval, DAS28CRP: disease activity score with 28 joints and c-reactive protein, PASI: Psoriasis Area Severity Index, SPARCC: Spondyloarthritis Research Consortium of Canada enthesitis index, VAS: visual analogue scale, PsAID: Psoriatic Arthritis Impact of Disease, HAQ: Health Assessment QuestionnaireConclusion:Pain and fatigue are well-known factors to impair QoL in PsA patient. Here we show that diminishing these factors, pain and fatigue, improved both PCS and MCS scores more than changes in DAS28CRP. Improvements in skin and nail manifestations impacted MCS scores and are as important as changes in joint manifestations which affect PCS and MCS scores equally.References:[1] Hojgaard P et al. Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis (…) BMJ Open. 20Disclosure of Interests:Marie Skougaard: None declared, Tanja Schjødt Jørgensen Speakers bureau: Abbvie, Pfizer, Roche, Novartis, UCB, Biogen, and Eli Lilly, Mia Joranger Jensen: None declared, Christine Ballegaard: None declared, Jørgen Guldberg-Møller Speakers bureau: Novartis, Ely Lilly, AbbVie, BK Ultrasound, Alexander Egeberg Grant/research support from: Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation and the Kgl Hofbundtmager Aage Bang Foundation, Consultant of: UCB Pharma (Advisory Board), Speakers bureau: AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co. Ltd., Pfizer, Eli Lilly, Novartis, Galderma, Dermavant, UCB Pharma, Mylan, Bristol-Myers Squibb and Janssen Pharmaceuticals, Robin Christensen: None declared, Joseph F. Merola Consultant of: Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB Pharma, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and LEO Pharma, Laura C Coates: None declared, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Lars Erik Kristensen Consultant of: UCB Pharma (Advisory Board), Sannofi (Advisory Board), Abbvie (Advisory Board), Biogen (Advisory Board), Speakers bureau: AbbVie, Amgen, Biogen, Bristol-Myers Squibb,Celgene, Eli Lilly, Gilead, Forward Pharma, Janssen Pharmaceuticals, MSD, Novartis, Pfizer, and UCB Pharma

scholarly journals Impact of fatigue on health-related quality of life and illness perception in a monocentric cohort of patients with systemic lupus erythematosus

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001133 ◽  
Author(s):  
Elena Elefante ◽  
Chiara Tani ◽  
Chiara Stagnaro ◽  
Francesco Ferro ◽  
Alice Parma ◽  
...  
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Disease Duration ◽  
Illness Perception ◽  
Health Related Quality ◽  
Systemic Lupus ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

BackgroundFatigue is a very common and debilitating symptom in patients with systemic lupus erythematosus (SLE), even among those with a mild or inactive disease. The objective of this study is to define fatigue determinants and describe the impact of fatigue on health-related quality of life (HRQoL) and illness perception in a monocentric cohort of patients with SLE.MethodsThis is a cross-sectional study. Adult patients with SLE were included. For each patient, demographics, medications, comorbidities, organ damage (Systemic Lupus International Collaborating Clinics Damage Index), active disease manifestations and Systemic Lupus Disease Activity Index scores were collected. It was evaluated if each patient met the definitions of remission and low disease activity. At enrolment, each patient completed the Short Form-36 (SF-36), Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F), Lupus Impact Tracker (LIT), Systemic Lupus Activity Questionnaire (SLAQ) and Brief Index of Lupus Damage (BILD). The FACIT-F questionnaire was also administered to a group of healthy controls.Results223 patients were included (mean age 44.9±13.2 years, median disease duration 13 years). 18.2% had an active disease, 43.5% met the definition of remission on treatment, and 11.8% had a concomitant fibromyalgia. The median FACIT-F score of our cohort was significantly lower compared with that of healthy controls (40 vs 47; p<0.001). FACIT-F scores were irrespective of age, disease duration, disease activity and damage. FACIT-F score was significantly lower in patients with fibromyalgia (p<0.01). FACIT-F scores demonstrated a significant correlation with all other patient-reported outcomes: SF-36 (r=0.53–0.77), LIT (r=−0.78), SLAQ (r=−0.72) and BILD (r=−0.28).ConclusionsFatigue in patients with SLE has a strong negative impact on HRQoL and patient perception of the disease burden. Fatigue seems irrespective of disease activity but significantly influenced by the presence of fibromyalgia.

scholarly journals Neutral Theory: Applicability and Neutrality of Using Generic Health-related Quality of Life Tools in Diseases or Conditions Where Specific Tools Are Available

2020 ◽  
Author(s):  
Ravi Jandhyala
Keyword(s):  
Rare Disease ◽  
Neutral Theory ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Disease Condition ◽  
Related Quality ◽  
Health Related ◽  
Sensitivity Specificity

Abstract Background:Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers. Neutral Theory describes the ideal construct that includes all relevant indicators and, therefore, complete accuracy, or Neutrality. Neutral Theory can thereby provide the framework to develop or test constructs. To assess the application of Neutral Theory, the Neutrality of generic tools (SF-36 and EQ-5D) at measuring HRQoL was compared to disease/condition-specific tools, with the latter considered surrogates for the Neutral construct. Methods:Full descriptions of all disease/condition-specific HRQoL tools published on PubMed (to 01-Jul-19) were sourced. For each tool, the number of items with and without a direct match within the SF-36 and EQ-5D was recorded and the sensitivity/specificity calculated. Results:The SF-36 and EQ-5D did not achieve a sensitivity/specificity both >50% against any of the 163 disease/condition-specific tools identified. At 20% prevalence of poor HRQoL, the false positive rate (FPR) was >75% for all but two tools against the SF-36 and six tools against the EQ-5D. Increasing poor HRQoL to 80%, 47 tools for the SF-36 and 48 tools for the EQ-5D had a FPR <50%. For rare disease tools (<1/2,000 population; n=17), sensitivity/specificity ranged from 0-40%/5-31% for the SF-36 and 0-22%/29-100% for the EQ-5D. For non-rare (n=75) and symptom-specific tools (n=71) sensitivity/specificity was: 0-100%/0-100% (SF-36) and 0-50%/0-100% (EQ-5D); and 0-60%/0-19% (SF-36) and 0-25%/0-100% (EQ-5D), respectively. No concordance was recorded for 18% (2/11) of results from studies of rare disease tools versus the SF-36 (no data vs EQ-5D). For non-rare, disease-specific tools, results were discordant for 30% (25/84) and 35% (23/65) of studies against the SF-36 and EQ-5D, respectively. For symptom-specific tools, corresponding results were 36% (24/66) and 16% (5/31).Conclusions:Generic HRQoL tools appear poorly correlated with disease/condition-specific tools, which indicates that adoption of Neutral Theory in the development and assessment of HRQoL tools could improve their relevance, accuracy, and utility in economic evaluations of health interventions.

The Effect of Golimumab Therapy on Disease Activity and Health-related Quality of Life in Patients with Ankylosing Spondylitis: 2-year Results of the GO-RAISE Trial

2014 ◽  
Vol 41 (6) ◽  
pp. 1095-1103 ◽  
Author(s):  
Désirée van der Heijde ◽  
Atul Deodhar ◽  
Jürgen Braun ◽  
Michael Mack ◽  
Benjamin Hsu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Inactive Disease ◽  
Health Related Quality ◽  
Major Improvement ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Objective.To evaluate the effects of golimumab therapy on achieving inactive disease or major improvement, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS), and improvements in health-related quality of life (HRQOL) and productivity through 2 years in patients with AS.Methods.In the phase III GO-RAISE trial, 356 patients were randomized to placebo with crossover to golimumab 50 mg at Week 24 (n = 78), golimumab 50 mg (n = 138), or golimumab 100 mg (n = 140) at baseline and every 4 weeks. The proportions of patients with ASDAS major improvement (improvement ≥ 2.0) or inactive disease (score < 1.3) were determined. HRQOL was assessed using the 36-item Medical Outcomes Study Short Form-36 physical/mental component summary (SF-36 PCS/MCS) scores (normal score ≥ 50). The effect of disease on productivity was assessed by visual analog scale (0–10). Regression analyses on the association of disease activity and HRQOL were performed. The final assessment was at Week 104.Results.Significantly greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease at weeks 14 and 24 versus placebo. Through Week 104, patients who achieved ASDAS inactive disease or major improvement had significantly greater improvements in SF-36 PCS and MCS scores and productivity than did patients not meeting these targets. Among all patients, achieving ASDAS inactive disease at weeks 52 and 104 was associated with normalized SF-36 PCS/MCS scores and significant improvements in work productivity.Conclusion.Greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease and improved HRQOL versus placebo. Achieving an inactive disease state by ASDAS criteria (< 1.3) was associated with normalized HRQOL through 2 years.

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