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2022 ◽  
Vol 24 (1) ◽  
Author(s):  
Clifton O. Bingham ◽  
David Walker ◽  
Peter Nash ◽  
Susan J. Lee ◽  
Lei Ye ◽  
...  

Abstract Background The effects of filgotinib on patient-reported outcomes (PROs) from 3 trials in patients with active rheumatoid arthritis were investigated. Methods Methotrexate (MTX)-naïve patients received filgotinib 200 or 100 mg plus MTX (FIL200+MTX, FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX monotherapy through 52 weeks (NCT02886728). Patients with inadequate response (IR) to MTX (MTX-IR) received FIL200+MTX, FIL100+MTX, adalimumab 40 mg +MTX (ADA+MTX), or placebo (PBO)+MTX (rerandomized to FIL200+MTX or FIL100+MTX at week 24) through 52 weeks (NCT02889796). Patients with IR to biologic disease-modifying antirheumatic drugs (bDMARD-IR) received FIL200 or FIL100 or PBO with background stable conventional synthetic (cs) DMARDs for up to 24 weeks (NCT02873936). PROs included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) physical/mental component summary (PCS/MCS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and Patient Global Assessment of Disease Activity (PtGA). Data are reported as least-squares mean changes from baseline with standard error to the timepoint representing each study’s primary endpoint. All statistical comparisons are of filgotinib groups vs their respective control groups. Results At week 24, among MTX-naïve patients, change from baseline (standard deviation) in HAQ-DI was − 1.00 (0.03; P < 0.001) with FIL200+MTX, − 0.94 (0.04; P < 0.01) with FIL100+MTX, and − 0.91 (0.04; P < 0.05) with FIL200 alone compared with − 0.81 (0.03) with MTX alone. At week 12, among MTX-IR patients, change from baseline in HAQ-DI was − 0.69 (0.04; P < 0.001 vs PBO+MTX, P < 0.05 vs ADA) with FIL200+MTX, − 0.57 (0.04; P < 0.001 vs placebo) with FIL100+MTX, and − 0.60 (0.04) with ADA vs − 0.40 (0.04) with PBO+MTX. At week 12, among bDMARD-IR patients, change from baseline in HAQ-DI was − 0.50 (0.06; P < 0.001) with FIL200+csDMARD and − 0.46 (0.05; P < 0.001) with FIL100+csDMARD vs − 0.19 (0.06) with placebo+csDMARD. Changes in SF-36 PCS and MCS, FACIT-Fatigue, WPAI, and PtGA tended to favor filgotinib over PBO, MTX, and ADA. Greater proportions of patients experienced clinically meaningful differences with either dosage of FIL in combination with csDMARDs (including MTX) and with FIL200 monotherapy vs comparators. Conclusions Filgotinib provided improvements in PROs across patient populations. These findings suggest filgotinib can be an effective treatment option for patients with insufficient response to MTX or bDMARDs and patients who are MTX-naïve. Trial registration ClinicalTrials.gov, FINCH 1, NCT02889796, first posted September 7, 2016; FINCH 2, NCT02873936, first posted August 22, 2016, retrospectively registered; FINCH 3, NCT02886728, first posted September 1, 2016, retrospectively registered.


Author(s):  
Catalina Gómez ◽  
Judit Barrena ◽  
Vanesa García-Paz ◽  
Ana M. Plaza ◽  
Paula Crespo ◽  
...  

AbstractEvidence regarding asthma’s impact on children’s daily lives is limited. This prospective and cross-sectional, observational, multicenter study assessed school/work and activity impairment in children and adolescents with allergic asthma and their caregivers and allergen immunotherapy (AIT) effects. Included patients were schooled children and adolescents (5 to 17 years) with allergic asthma due to house dust mites (HDM). Impairment of school/work (i.e., absenteeism and presenteeism) and activity was measured in patients and their caregivers using the Work Productivity Impairment Questionnaire plus Classroom Impairment Questions: Allergy Specific (WPAI + CIQ:AS). HDM allergic patients with school impairment received subcutaneous AIT with a MicroCrystalline Tyrosine-associated allergoid. WPAI + CIQ:AS and effectiveness variables were compared between baseline and 1-year post-AIT. Of the 113 patients included, 59 (52.2%) and 51 (45.1%) showed school and activity impairment, respectively, missing a mean (SD) of 37.6 (24.4) % and 42.6 (25.6) % of school and activity time, respectively. Twenty-six (23%) caregivers reported activity impairment and, of the 79 (69.9%) employed, 30 (38%) reported work impairment. Of the 65 patients with school/activities impairment, 41 (63.1%) received AIT, of which 21 (51.2%) completed 1 year of treatment. Effectiveness variables and WPAI + CIQ:AS significantly improved: Mean (SD) school impairment decreased from 39.7 (26.7) to 2.1 (7.1) % (p < 0.001) and activity impairment from 46.2 (34.6) to 1.4 (3.6) % (p < 0.001).Conclusion: Allergic asthma due to HDMs results in school/work and activity impairment in children and adolescents and their caregivers. One year of AIT provided clinical benefits and reduced school and activity impairment. What is Known:• Allergic asthma impairs children’s school performance and daily activities.• Allergen immunotherapy modifies allergic disease course and ameliorates its symptoms. What is New:• Asthma symptoms due to allergy to house dust mites impair children’s school attendance and productivity and daily activity and their caregivers’ work performance and daily lives.• Allergen immunotherapy with a house dust mite MicroCrystalline Tyrosine (MCT)-associated allergoid seems to provide clinical benefits, associated with decreased school and activity impairment, supporting it as an effective treatment option.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 1044-1045
Author(s):  
Megan Thomas Hebdon ◽  
Jiayun Xu ◽  
Djin Tay ◽  
Maija Reblin ◽  
Kristin Cloyes ◽  
...  

Abstract Hospice caregivers experience burden that impacts their physical, emotional, and social well-being. Little is known about how caregiver burden impacts occupational well-being through employment and work productivity. Thus, our purpose was to explore the relationships between caregiver burden and dimensions of work productivity/impairment (absenteeism, presenteeism, activity impairment, and overall impairment) among working hospice cancer caregivers. This is a secondary data analysis of baseline data from a larger study of caregiver communication and bereavement. Study data including demographics, preparedness for caregiving, caregiver burden, and work productivity/impairment were analyzed using descriptive statistics, correlation analysis, and stepwise multiple linear regression. Dimensions of work productivity/impairment were dependent variables, and age and preparedness for caregiving were covariates. Working caregivers (N=54) had an average age of 52 (SD: 12.65), and were primarily White (83%), female (70%), married (69%), employed full-time (70%) and had a household income of $50,000 or more (65%). Greater caregiver burden was significantly associated with lower preparedness for caregiving (r=-.41, p&lt;.01), and greater activity impairment (r=.50, p&lt;.01), presenteeism (r=.44, p&lt;.01), and overall impairment (r=.36, p&lt;.05), but not absenteeism. Caregiver burden predicted activity impairment (b=1.72 [.72, 2.71], p&lt;.01), presenteeism (b=1.44 [.33, 2.55], p&lt;.01), and overall impairment (b=1.42 [.09, 2.74], p&lt;.05), even after controlling for age and preparation for caregiving. More burdened caregivers may be having more challenges with work productivity. Additional research is needed to examine these relationships in a larger, more diverse sample. Future research should also investigate how supportive work environments and leave policies reduce caregiver burden and promote work productivity.


2021 ◽  
pp. flgastro-2021-102027
Author(s):  
Emma Paulides ◽  
Demi Cornelissen ◽  
Annemarie C de Vries ◽  
C Janneke van der Woude

BackgroundInflammatory bowel disease (IBD) has a major impact on different aspects of life of patients with IBD, but functioning in the home environment is under-reported in literature. The aim of this study was to assess the impact of IBD on household and/or family life.MethodAdult patients with IBD from the outpatient clinic of the Erasmus MC (Rotterdam, the Netherlands) were invited to participate in this cross-sectional study between September and December 2020. A questionnaire was composed to measure the impact of IBD on functioning in the household and family life. In addition, the IBD Disability Index and Work Productivity and Activity Impairment Questionnaire were used. Data were analysed using descriptive statistics and multiple logistic regression modelling.ResultsOf 308 invited patients, 229 patients were included (response rate 74%). Sixty-eight per cent of patients were diagnosed with Crohn’s disease, 69% were female and median age was 38.0 years. Many patients reported difficulties with domestic activities (55.0%), leisure (53.9%), parenting (50.6%), sexual activities (48.4%) and interpersonal relationships (39.1%). Fatigue was associated with the experience of more severe difficulties in domestic activities (OR 16.160, 95% CI 6.053 to 43.141). Furthermore, 32.7% of patients felt that IBD influenced their desire to have children.ConclusionIBD has a markedly negative impact on household and/or family life in many patients. To optimise patient care, household and family related difficulties need to be considered in a holistic treatment approach.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anees ur Rehman ◽  
Sohail Ayaz Muhammad ◽  
Zermina Tasleem ◽  
Alyaa Alsaedi ◽  
Mamoona Dar ◽  
...  

AbstractChronic obstructive pulmonary disease (COPD) is associated with substantial humanistic and socioeconomic burden on patients and their caregivers. COPD is expected to be 7th leading cause of disease burden till 2030. The objective of the current study was to assess the humanistic and socioeconomic burden of COPD patients and their caregivers in Malaysia. The burden includes the cost of management of COPD, QOL of COPD patients and their caregivers, work productivity and activity impairment of COPD patients and their caregivers due to COPD. One hundred and fifty COPD patients and their caregivers from the chest clinic of Penang Hospital were included in the study from August 2018 to August 2019. Caregiving cost was estimated using the replacement cost approach, while humanistic and social burden was assessed with the help of health status questionnaires. Overall, 64.66% and 7.1% of COPD patients reported to depend on informal caregivers and professional caregivers respectively. COPD patients reported dyspnoea score as 2.31 (1.31), EQ-5D-5L utility index 0.57 (0.23), CCI 2.3 (1.4), SGRQ-C 49.23 (18.61), productivity loss 31.87% and activity impairment 17.42%. Caregivers reported dyspnoea score as 0.72 (0.14), EQ-5D-5L utility index 0.57 (0.23), productivity loss 7.19% and social activity limitation as 21.63% due to taking care of COPD patients. In addition to the huge direct cost of management, COPD is also associated with substantial burden on society in terms of compromised quality of life, reduced efficiency at the workplace, activity impairment and caregiver burden.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
D. H. Jaffe ◽  
B. L. Balkaran ◽  
L. Yue ◽  
S. Mulhern-Haughey ◽  
J. Anjo

Abstract Background Suicidal ideation (SI) affects approximately 30–40% of those with major depressive disorder (MDD). To date, studies have examined the substantial humanistic and economic burden to caregivers of persons with MDD, however little is known of the impact of caring for persons with MDD when SI is present. This study examined the additional burden imposed on caregivers for persons with unipolar depression and SI in five major European countries. Methods A retrospective, cross-sectional analysis was conducted in five European countries using 2020 Europe National Health Wellness Survey (France, Germany, Italy, Spain and the United Kingdom) to compare differences in health and economic outcomes between caregivers of adults with unipolar depression and SI (CAUD-SI) and caregivers of adults with unipolar depression without SI (CAUD-nSI). The outcomes assessed included health-related quality of life (HRQoL; Medical Outcomes Study Short Form [SF-12v2]), health status (Short-Form 6 Dimension [SF-6D], EuroQol 5-Dimension 5-Level [EQ-5D-5L]), Work productivity and activity impairment (WPAI) and healthcare resource utilization (HRU). Linear mixed models and generalized linear mixed models adjusted for covariates were used to compare the two groups on outcomes of interest. Results Of 62,319 respondents, 0.89% (n = 554) were CAUD-SI and 1.34% (n = 837) were CAUD-nSI. In adjusted models, CAUD-SI reported greater humanistic burden than CAUD-nSI, with lower HRQoL (PCS: 42.7 vs. 45.0, p < 0.001 and MCS: 37.5 vs. 38.9, p = 0.007) and health status (SF-6D: 0.57 vs 0.60, p < 0.001 and EQ-5D-5L: 0.58 vs 0.66, p < 001). CAUD-SI respondents reported significantly higher economic burden than CAUD-nSI respondents for WPAI (percent activity impairment: 64.9% vs. 52.5%, p = 0.026) and HRU (provider visits: 10.0 vs. 7.9, p < 0.001, emergency room visits: 1.49 vs. 0.73, p < 0.001 and hospitalizations: 1.03 vs. 0.52, p < 0.001). Conclusion In five European countries, caregivers of adults with depression and SI experience additional humanistic and economic burden than caregivers of adults with depression and no SI. Distinguishing caregiver groupings and their unique burden provide important insights for providing targeted support and interventions for both the patient and caregiver.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4069-4069
Author(s):  
Megan M. Ullman ◽  
Marilyn J Manco-Johnson ◽  
Jonathan C. Roberts ◽  
Nicole Crook ◽  
Rahul Khairnar ◽  
...  

Abstract Introduction: Persons with hemophilia suffer from recurrent bleeds, especially hemarthrosis, which results in joint damage. Hemophilia inhibitor status impacts bleeding, which is associated with acute and chronic pain. To better characterize the impact of inhibitor status, we compared patient-reported outcomes (bleed rate, pain, and joint health), work productivity and activity impairment (WPAI), and health-related quality of life (HRQoL) by inhibitor status, and investigated the correlation of patient-reported outcomes with WPAI and HRQoL. Methods: The U.S. Hematology Utilization Group Studies Part VIII prospectively collected data to examine the cost and burden of hemophilia in persons with hemophilia A (PwHA) aged ≥2 years obtaining care at four federally-supported hemophilia treatment centers. From April 2019 to May 2021 we enrolled PwHA with and without inhibitors at a 1:2 ratio. Parents/adult participants completed a survey at enrollment to collect sociodemographic and clinical characteristics, self-reported bleeds in the last month, pain, and joint stiffness (5-item scale). We also measured WPAI and HRQoL using EQ-5D-3L. Clinical chart review documented hemophilic severity, inhibitor level and treatment regimen. Participants were classified into three groups: 1) active inhibitor (inhibitor titer ≥1.0 Bethesda Units (BU) six months prior to enrollment), 2) tolerized inhibitor (history of inhibitor titer ≥1.0 BU, immune tolerance induction (ITI) and/or currently using factor VIII for prophylaxis), and 3) no inhibitor. Patient-reported data were compared across these groups using Chi-square tests for categorical variables and generalized linear models for continuous variables. Association of bleeds, pain, and joint stiffness with HRQoL and WPAI were assessed using Pearson correlation. Results: Among 80 PwHA enrolled, 9 (11%) had active inhibitors, 22 (27.5%) had tolerized inhibitors, and 49 (61.3%) had no inhibitors. Mean age was 24.9±14.3 (standard deviation) years, 66.3% were adults, 87.5% had severe hemophilia, and 87.5% used prophylaxis. Mean age of the non-inhibitor group (29.3±13.5) was older than the tolerized inhibitor group (16.3±9.5 years, p&lt;0.05) or the active inhibitor group (21.9±19.1, p&gt;0.05). The non-inhibitor group had a lower rate of severe hemophilia (81.6%) or prophylactic treatment (81.6%) than those in the active (100%) or tolerized groups (95.5%, p=0.13). Larger proportions of participants with active inhibitors (66.7%) and no inhibitors (57.1%) reported having bleeds in the last month compared to those with tolerized inhibitors (22.7%, p=0.01). Participants without inhibitors had a greater mean number of bleeding episodes (1.09±standard error (SE) 0.26 vs. 0.23±0.38, p=0.03), specifically joint bleeds (0.58±0.16 vs. 0.08±0.24, p=0.03,) than the tolerized group. Those with active inhibitors reported significantly higher mean joint stiffness scores (35.1±2.6 vs. 27.5±1.9, p=0.006) or more joint pain (77.8% vs. 54.5%, p=0.23) than the tolerized group. Mean EQ-5D index score was significantly lower in the active inhibitor group (0.79±SE (0.07) than in the tolerized group (0.96±0.05, p=0.03). Joint bleeding, chronic pain, and joint stiffness were negatively correlated with the EQ-5D visual analogue scale, and index scores (all correlation coefficients |r|&gt;0.43, all p&lt;0.001). Number of bleeds and the joint stiffness score in children were positively correlated with their parents' level of impairment while working (r=0.41, p=0.04; r=0.62, p=0.001) and overall work impairment (r=0.41, p=0.046; r=0.60, p=0.002). Joint bleeding, chronic pain, and joint stiffness in adults were positively correlated with proportion of work time missed (r=0.31, p=0.03; r=0.39, p=0.006; r=0.48, p=0.0004), overall work impairment (r=0.37, p=0.007; r=0.41, p=0.003; r=0.42, p=0.002), and activity impairment (r=0.33, p=0.02; r=0.63, p&lt;0.0001; r=0.59, p&lt;0.0001), respectively. Conclusions: This study is limited to a small sample skewed toward a younger age in the tolerized inhibitor group. PwHA in the active and no inhibitor groups experienced greater clinical burden as measured by bleeds compared to the tolerized group. Those with active inhibitor displayed lower HRQoL scores than the tolerized inhibitor group. Bleeds, chronic pain and joint stiffness were inversely correlated with HRQoL, resulting in lower work productivity and activity. Figure 1 Figure 1. Disclosures Roberts: Takeda; Speakers Bureau: Novo Nordisk, Octapharma, Sanofi, Takeda.: Research Funding; Genentech, Novo Nordisk, Octapharma, Pfizer, Sanofi, Takeda, uniQure: Consultancy. Khairnar: University of Maryland, Baltimore: Ended employment in the past 24 months; Roche: Current equity holder in publicly-traded company; Genentech Inc - A Member of The Roche Group: Current Employment. Decker-Palmer: Genentech Inc. --A member of the Roche Group.: Current Employment, Current equity holder in publicly-traded company. Curtis: Pfizer, Bayer, and Novo Nordisk: Consultancy; University of Southern California: Consultancy. Wu: Baxalta US Inc., Bannockburn, IL (a Takeda Company), CSL Behring L.L.C., Octapharma USA, Inc., Genentech Inc.: Research Funding. Nichol: Pfizer, Genentech Inc., Baxalta US Inc., Bannockburn, IL (a Takeda Company), Octapharma, CSL Behring, Global Blood Therapeutics, and Novo Nordisk: Research Funding.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S119-S120
Author(s):  
Jeffrey Thompson ◽  
Alen Marijam ◽  
Fanny S Mitrani-Gold ◽  
Jonathon Wright ◽  
Ashish V Joshi

Abstract Background Uncomplicated urinary tract infections (uUTI) are among the most common infections in women; however, there are few data on the impact of uUTIs on daily activity and health-related quality of life (HRQoL). Methods This was a prospective, cross-sectional survey of US females aged ≥ 18 years with a self-reported uUTI in the 60 days prior to participation. Participants were included if they received oral antibiotic treatment and participated in surveys fielded by Dynata, Lucid/Federated, or Kantar Profiles. See Table 1 for inclusion/exclusion criteria. Study objectives were to describe activity impairment (using the Activity Impairment Assessment [AIA]) and HRQoL (assessed with Short Form 36 version 2, Physical Component Score [PCS], Mental Component Score [MCS], and health utility index [SF-6D]) associated with uUTI. After screening, participants completed an online questionnaire on their most recent uUTI. Outcomes were reported with descriptive statistics, chi-squared tests, and t-tests. Analysis of HRQoL used 1:1 propensity score matching to compare to a matched US population from the 2020 National Health and Wellness Survey. Table 1. Inclusion and exclusion criteria Results In total, 375 participants completed the questionnaire. Common impaired activities were: sexual intercourse (66.9%), sleep (60.8%), exercise (52.3%), housework (51.5%), and social activities (46.9%; Table 2). Overall mean AIA score was 11.1/20 (higher score = more impairment). Most participants (58.7%) had a PCS that was the same or better than the matched population, while for MCS, most participants (52.8%) had scores well below the matched population average. Overall PCS, MCS, and SF-6D composite scores were 46.5, 40.0, and 0.63, respectively; these outcomes were significantly worse compared to the matched population, most notably MCS (Table 3). Stratification by number of antibiotics used revealed statistically significant differences in the effect of uUTI on exercise, PCS, SF-6D (based on use of 1 or ≥ 3 therapies), and on sleep (based on use of 2 or ≥ 3 therapies; Table 4). Table 2. Activities impacted by uUTI Table 3. Matched analysis of SF-36v2-measured HRQoL outcomes Table 4. Outcomes stratified by number of oral antibiotics used to treat last uUTI Conclusion uUTIs are significantly associated with adverse patient outcomes for daily activities and HRQoL, compounded by suboptimal treatment evident by the use of multiple antibiotics. MCS was notably affected, which is important as this is not often studied in uUTI. Disclosures Jeffrey Thompson, PhD, Kantar Health (Employee, Employee of Kantar Health, which received funding from GlaxoSmithKline plc. to conduct this study) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Jonathon Wright, BSc, Kantar Health (Employee, Employee of Kantar Health, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S495-S495
Author(s):  
Nate Way ◽  
Ashley Martin ◽  
Chris Wallick ◽  
Edward Neuberger ◽  
Mitra Corral

Abstract Background Influenza is a highly prevalent seasonal disease that has a wide range of impact on patients, including experiencing symptoms, social isolation, missing work, and worrying about transmitting to others. The aim of this study was to better understand patients’ experience with influenza, areas of life that were most impacted and what matters most to patients. Methods Data for this study were obtained from two online quantitative surveys of influenza patients: A pool of respondents who previously completed the National Health and Wellness Survey (NHWS) (N=74,977) OR from Lightspeed M3 Global’s online “General Panel” (N=500,000+) in the US between January 2020 through May 2020. A total sample of 1,005 patients &gt;18 years of age and having a self-reported diagnosis of influenza by a healthcare professional within the last 90 days were included. Outcomes related to patient demographics, health-related characteristics, perspectives on the influenza episode and productivity impairment (measured by the Work Productivity and Activity Impairment questionnaire) were collected. Results Influenza patients reported greatest impact on physical activity, running errands and chores outside the home, and overall lifestyle. 64% were employed at the time they experienced influenza. They missed a mean 23 hours of work due to problems associated with their influenza and actually worked for 15 hours during the 7 days after first experiencing symptoms. Mean absenteeism (work time missed), presenteeism (impairment at work), overall work impairment, and activity impairment was 59%, 73%, 87% and 75%, respectively. For employed respondents, 60% missed work because of transmission worry; about 40% of patients had somebody else get flu shortly after them and about 68% of those people felt responsible for transmitting. Conclusion Influenza greatly reduced respondents’ ability to be productive at work and in their daily activities outside of work. Worry about transmitting an influenza infection to others was a highly influential motivator for missed work or other responsibilities. Disclosures Nate Way, PhD, Genentech, Inc. (Grant/Research Support)Kantar Health (Employee) Ashley Martin, PhD, Genentech, Inc. (Grant/Research Support)Kantar Health (Employee) Chris Wallick, PharmD, MS, Genentech, Inc. (Employee, Shareholder) Edward Neuberger, PharmD, MBA, MS, Genentech, Inc. (Employee, Shareholder) Mitra Corral, MS, MPH, Genentech, Inc. (Employee, Shareholder)


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