scholarly journals Effects on health-related quality of life in the randomized, controlled crossover trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258716
Author(s):  
Anna Turesson Wadell ◽  
Linnea Bärebring ◽  
Erik Hulander ◽  
Inger Gjertsson ◽  
Lars Hagberg ◽  
...  

Background Patients with Rheumatoid Arthritis (RA) often report impaired health-related quality of life (HrQoL) such as difficulties in daily life, pain, fatigue and an affected social life. Even when lowering disease activity, pharmacological treatment does not always resolve these factors. Objective To investigate if a proposed anti-inflammatory diet improves HrQoL in patients with RA. Design In this controlled crossover trial, 50 patients were randomized to start with either an intervention diet (anti-inflammatory) or a control diet (usual Swedish intake) for ten weeks followed by a wash out period before switching to the other diet. Participants received food equivalent to ~1100 kcal/day, five days/week, and instructions to consume similarly for the remaining meals. HrQoL was evaluated using Health Assessment Questionnaire (HAQ), 36-item Short Form Survey (SF-36), Visual Analogue Scales (VAS) for pain, fatigue and morning stiffness, and a time scale for morning stiffness. Results Forty-seven participants completed ≥1 diet period and were included in the main analyses. No significant difference between intervention and control diet at end of diet periods was observed for any outcome. However, significant improvements were obtained for SF-36 Physical Functioning (mean:5.79, SE: 2.12, 95% CI: 1.58, 10.01) during the intervention diet period. When excluding participants with anti-rheumatic medication changes, the differences between diet periods increased for most outcomes, favoring the intervention diet period, and the difference for SF-36 Physical Functioning became significant (n = 25, mean:7.90, 95% CI:0.56, 15.24, p = 0.036). Conclusions In main analyses, the proposed anti-inflammatory diet did not significantly improve HrQoL for patients with RA compared to control diet. In sub-analyses, significant improvements in physical functioning were detected. Larger studies with consistent medication use and in populations more affected by the disease may be needed to obtain conclusive evidence.

Medicina ◽  
2009 ◽  
Vol 45 (5) ◽  
pp. 405 ◽  
Author(s):  
Vilma Raškelienė ◽  
Marija Babarskienė ◽  
Jūratė Macijauskienė ◽  
Arvydas Šeškevičius

Arterial hypertension (AH) is one of the most important risk factors for development of ischemic heart disease; thus, control of AH and effective treatment are of great importance. Since arterial hypertension is commonly referred as asymptomatic condition, the question whether hypertensive condition is associated with the change of well-being and health-related quality of life is still debatable. The aim of the study. To evaluate the impact of duration and treatment of AH on health-related quality of life. Material and methods. The contingent of the study consisted of patients who arrived for a cardiologist’s consultation at the Clinic of Cardiology, Hospital of Kaunas University of Medicine. The patients were randomly selected for the study. The inclusion criteria were as follows: diagnosed arterial hypertension, diabetes mellitus, and the metabolic syndrome. Diagnosed ischemic heart disease (chronic and acute coronary syndromes and their complications) and severe concomitant diseases were exclusion criteria. A total of 101 patients (19 males and 82 females) met the inclusion criteria and consented to participate in the study. Their mean age was 58.03±5.63 years. The patients’ quality of life was evaluated using the Medical Outcomes Study short form 36-item questionnaire (SF-36 questionnaire), which comprises 36 questions grouped into eight domains. The questionnaire was filled in by the subjects independently. Other methods applied to the study were inquiry (for the evaluation of risk factors, lifestyle, and medical history), analysis of medical documents (cholesterol levels and glycemia in blood), and objective examination (height, weight, waist circumference, and arterial blood pressure). Results. The subjects with AH showed lower values compared to normotensive patients in the following domains: physical functioning (P=0.014), role limitations due to physical health (P=0.012), energy/vitality (P=0.016), and general health evaluation (P=0.023). We have not determined the differences in quality of life of the patients whose AH was regulated if compared to those patients without AH. The patients whose treatment of AH was not effective reported lower quality of life in the following SF-36 domains: physical functioning (P=0.003), role limitations due to physical health (P=0.003), general evaluation of health (P=0.017), energy/vitality (P=0.008), and emotional status (P=0.015), if compared to the patients without AH. Conclusions. Patients with AH reported lower quality of life in the following domains: physical functioning, role limitations due to physical health, energy/vitality, and general evaluation of health. Compared to patients without AH, the quality of life of the patients who had the effective treatment did not differ, whereas patients with ineffective treatment had the lower quality of life. Functioning is more statistically significantly limited due to physical health in patients with AH.


F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 282
Author(s):  
Alessia Saverino ◽  
Eva Zsirai ◽  
Raphael Sonabend ◽  
Lorenza Gaggero ◽  
Isabella Cevasco ◽  
...  

Background: Health-related quality of life (HRQL) is important for evaluating the impact of a disease in the longer term across the physical and psychological domains of human functioning. The aim of this study is to evaluate HRQL in COVID-19 survivors in Italy using the short form 36-items questionnaire (SF-36). Methods: This is an observational study involving adults discharged home following a coronavirus disease 2019 (COVID-19)-related hospital admission. Baseline demographic and clinical data including the Cumulative Illness Rating Scale (CIRS) and the Hospital Anxiety and Depression Scale (HADS) were collected. The validated Italian version of SF-36 was administered cross-sectionally. The SF-36 contains eight scales measuring limitations in physical and social functioning, the impact on roles and activities, fatigue, emotional well-being, pain and general health perception. Results: A total of 35 patients, with a mean age of 60 years, completed the SF-36. The results showed difficulties across the physical and psychological domains, particularly affecting the return to previous roles and activities. A higher burden of co-morbidities as well as a more severe muscle weakness was associated to a lower physical functioning. Younger age, rather than older, correlated to a perceived greater limitation in physical functioning and vitality. Conclusions: COVID-19 survivors particularly the ones of working age may need support for resuming their premorbid level of functioning and returning to work.


2009 ◽  
Vol 44 (6) ◽  
pp. 603-610 ◽  
Author(s):  
Tamara C. Valovich McLeod ◽  
R. Curtis Bay ◽  
John T. Parsons ◽  
Eric L. Sauers ◽  
Alison R. Snyder

Abstract Context: Health-related quality of life (HRQOL) is a global concept that takes into account the physical, psychological, and social domains of health. Determining the extent to which injury affects HRQOL is an important aspect of rehabilitation practice, enabling comparisons of clinical outcomes across different conditions in diverse patient groups. Objective: To examine the extent to which a self-reported recent injury affected HRQOL in adolescent athletes using 2 generic patient self-report scales. Design: Cross-sectional study. Setting: High school classrooms and athletic training facilities. Patients or Other Participants: A convenience sample of uninjured (n  =  160) and injured (n  =  45) adolescent athletes. Intervention(s): The independent variable was injury status: uninjured versus injured. All participants completed a self-administered brief health status questionnaire and the Short Form–36 Health Survey Questionnaire (SF-36) and Pediatric Outcomes Data Collection Instrument (PODCI) in a counterbalanced manner. Main Outcome Measure(s): Dependent variables included 8 subscale and 2 composite scores of the SF-36 and 5 subscale scores and 1 global score of the PODCI. Group differences were assessed with the Mann-Whitney U test (P ≤ .05) and reported as median and interquartile range. Results: On the SF-36, the injured group demonstrated lower scores (P < .008) for physical functioning, limitations due to physical health problems, bodily pain, social functioning, and the physical composite. On the PODCI, the injured group reported lower scores (P < .01) on the pain and comfort subscale and the global score. Conclusions: Adolescent athletes with self-reported injuries demonstrated lower HRQOL than their uninjured peers. As expected, recent injury affected physical functioning and pain. Social functioning (on the SF-36) and global HRQOL (on the PODCI) also decreased, suggesting that injuries affected areas beyond the expected physical component of health. Clinicians need to recognize the full spectrum of negative influences that injuries may have on HRQOL in adolescent athletes.


2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Susan H. Boklage ◽  
Toshio Kimura ◽  
Florence Joly ◽  
Anita Boyapati ◽  
...  

Abstract Background Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA. Methods Baseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6–7.1 pg/mL), medium (7.2–39.5 pg/mL), and high (39.6–692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID). Results At baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar. Conclusions Patients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade. Trial registration NCT02332590. Registered on 5 January 2015


Life ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. 76 ◽  
Author(s):  
Hiroki Nishikawa ◽  
Kazunori Yoh ◽  
Hirayuki Enomoto ◽  
Yoshinori Iwata ◽  
Yoshiyuki Sakai ◽  
...  

We sought to examine the relationship between frailty and health-related quality of life as evaluated using the 36-item Short-Form Health Survey (SF-36) questionnaire in Japanese chronic liver disease (CLD) patients (n = 341, 122 liver cirrhosis cases, median age = 66 years). Frailty was defined as a clinical syndrome in which three or more of the following criteria were met (frailty score 3, 4, or 5): unintentional body weight loss, self-reported exhaustion, muscle weakness (grip strength: <26 kg in men and <18 kg in women), slow walking speed (<1.0 m/s), and low physical activity. Robust (frailty score 0), prefrail (frailty score 1 or 2), and frailty were found in 108 (31.7%), 187 (54.8%), and 46 (13.5%) patients, respectively. In all eight scales of the SF-36 (physical functioning, role physical, bodily pain, general health perception, vitality, social functioning, role emotion, and mental health), and the physical component summary score and mental component summary score, each score was well stratified according to the frailty status (all p < 0.0001). In the multivariate analysis, age (p = 0.0126), physical functioning (p = 0.0005), and vitality (p = 0.0246) were independent predictors linked to the presence of frailty. In conclusion, Japanese CLD patients with frailty displayed poorer conditions, both physically and mentally.


2021 ◽  
Vol 8 ◽  
Author(s):  
Alvaro Gomez ◽  
Victor Qiu ◽  
Arvid Cederlund ◽  
Alexander Borg ◽  
Julius Lindblom ◽  
...  

Objective: To determine the prevalence of adverse health-related quality of life (HRQoL) outcomes in patients with SLE who achieved an adequate clinical response after a 52-week long standard therapy plus belimumab or placebo, and identify contributing factors.Methods: We included patients who met the primary endpoint of the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials, i.e., SLE Responder Index 4 (total population: N = 760/1,684; placebo: N = 217/562; belimumab 1 mg/kg: N = 258/559; belimumab 10 mg/kg: N = 285/563). Adverse HRQoL outcomes were defined as SF-36 scale scores ≤ the 5th percentile derived from age- and sex-matched population-based norms, and FACIT-Fatigue scores &lt;30. We investigated factors associated with adverse HRQoL outcomes using logistic regression analysis.Results: We found clinically important diminutions of HRQoL in SLE patients compared with matched norms and high frequencies of adverse HRQoL outcomes, the highest in SF-36 general health (29.1%), followed by FACIT-Fatigue (25.8%) and SF-36 physical functioning (25.4%). Overall, frequencies were higher with increasing age. Black/African American and White/Caucasian patients reported higher frequencies than Asians and Indigenous Americans, while Hispanics experienced adverse HRQoL outcome less frequently than non-Hispanics. Established organ damage was associated with adverse physical but not mental HRQoL outcomes; particularly, damage in the cardiovascular (OR: 2.12; 95% CI: 1.07–4.21; P = 0.032) and musculoskeletal (OR: 1.41; 95% CI: 1.01–1.96; P = 0.041) domains was associated with adverse SF-36 physical component summary. Disease activity showed no impact on HRQoL outcomes. In multivariable logistic regression analysis, addition of belimumab to standard therapy was associated with lower frequencies of adverse SF-36 physical functioning (OR: 0.59; 95% CI: 0.39–0.91; P = 0.016) and FACIT-F (OR: 0.53; 95% CI: 0.34–0.81; P = 0.004).Conclusions: Despite adequate clinical response to standard therapy plus belimumab or placebo, a substantial proportion of SLE patients still reported adverse HRQoL outcomes. While no impact was documented for disease activity, established organ damage contributed to adverse outcome within physical HRQoL aspects and add-on belimumab was shown to be protective against adverse physical functioning and severe fatigue.


2010 ◽  
Vol 2 (1) ◽  
pp. 20-24 ◽  
Author(s):  
Dominik Michalski ◽  
Stefanie Liebig ◽  
Eva Thomae ◽  
Susanne Singer ◽  
Andreas Hinz ◽  
...  

Anxiety, depression and impaired health-related quality of life (HRQoL) are commonly reported in patients with multiple sclerosis (MS) and are of great interest for therapeutic approaches. Based on regional differences a quantitative assessment of these factors in comparison to the general population, and the consideration of demographic cofactors, would be useful when designing specific interventions. We adopted such an approach in a German cohort of MS patients. Anxiety, depression (HADS) and HRQoL (SF-36) were measured in 49 consecutive outpatients with MS and compared to age- and gender-adjusted control groups (n=1330 for HADS; n=5087 for SF-36) extracted from German National Health Surveys. Patients with MS showed significantly increased levels of anxiety and depression as well as decreased HRQoL with the exception of mental health; the effect sizes ranged from 0.39 (depression) to 1.06 (physical functioning). As could be expected, MS patients with relapsing-remitting clinical course had better physical functioning than patients with secondary progressive MS. There were strong relations between anxiety and depression (r=0.54; P<0.01), and between neurological impairment (EDSS) and physical functioning (r=-0.80; P<0.001) as well as depression (r=0.48; P<0.05). This investigation of MS patients confirms the prevalence and impact of anxiety, depression and most of the HRQoL dimensions in MS patients and provides evidence for the usefulness of a quantitative comparison to a region-specific general population as a starting point for therapeutic approaches.


2018 ◽  
Vol 1 (5) ◽  
Author(s):  
Hanxiao Zhu

Objective With aging, the health and self-care ability of the elderly generally decrease, falling into frailty ultimately. In this process, the loss of muscle mass is very obvious, which will result sluggishness, especially in walking speed. This study aimed to assess whether gait speed could be used as a predictor for health-related quality of life in older adults. Methods 368 subjects were recruited from community-dwelling older adults. Gait speed measurements included usual gait speed (UGS) and fast gait speed (FGS), at a distance of 50 meters. Health-related quality of life (HRQoL) was assessed through SF-36 questionnaire. The correlation of gait speed and quality of life was analyzed. Results Gait speed (both UGS and FGS) possessed a closed correlation with the total score of SF-36 questionnaire (r >0.6, P <0.05). Most subcomponent of HRQoL (Physical functioning, role limitations because of physical health problems, social functioning, vitality, and general health perceptions) are related to UGS and FGS, where the correlation coefficient is higher on FGS in Physical functioning, vitality, and general health perception than UGS. Conclusions Gait speed is correlate to health-related quality of life in elderly people. Therefore, in health services for the elderly, we should strengthen the monitoring of gait speed, and take brisk walking as an effective way of exercise.  


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ravi Jandhyala

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.


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