Return to work and activity after rib-fixation for acute chest trauma: first application of a validated patient-reported outcomes assessment tool.

OBJECTIVES: Rib fractures present a heavy pain and functional burden in trauma. Our primary aim was to determine return to work in patients with acute rib fractures requiring surgical stabilization of rib fractures. Our secondary outcomes were pain and quality of life. We also document the first application of the Work Productivity and Activity Impairment Instrument, a validated injury-specific patient-reported outcome measure, for chest wall injury in the literature. METHODS: A retrospective review was conducted on patients with rib fractures requiring surgical fixation in a single centre between 2008 and 2020. After applying inclusion and exclusion criteria to ensure relevance, all eligible patients were asked to complete patient-reported outcome measure questionnaires. RESULTS: Of 1841 trauma patients with rib fractures, 66 underwent surgical fixation. Thirty-nine patients were eligible and 31 completed the questionnaires. Pre-injury and post-injury answers were compared. The number of patients in employment decreased postoperatively from 22 to 16 (P = 0.006). For those who returned to work, there was no difference in hours missed but reduced weekly hours and productivity scores. There were significantly more patients with pain and on pain relief. There was a lower quality of life score postoperatively. CONCLUSIONS: Approximately 1 in 5 patients who require surgical fixation for rib fractures will not return to work. This is the first chest wall trauma study that uses the Work Productivity and Activity Impairment Instrument, a validated tool for work productivity outcomes. We recommend this instrument as a reliable tool for investigating return-to-work outcomes in trauma patients.

The Burden of Work Productivity and Activity Impairment in Patients with Psoriasis, Psoriatic Arthritis, Ulcerative Colitis, and Crohn's Disease.

BACKGROUND: Comparisons among autoimmune diseases enable understanding of the burden and factors associated with work productivity loss and impairment. AIMS: The objective was to compare work productivity and activity and associated factors among patients with inflammatory bowel diseases and other autoimmune conditions. METHODS: This cross-sectional study included employed, adult patients (age 20-64 years) in the CorEvitas Inflammatory Bowel Disease, Psoriasis, and Psoriatic Arthritis/Spondyloarthritis Registries between 5/2017 and 6/2020. Any patient-reported impairment on four domains of the Work Productivity and Activity Index (WPAI) was collected across registries. Prevalence for each autoimmune disease was reported and stratified by disease activity using direct age-sex-standardization. Factors associated with the presence of any WPAI were identified in logistic regression models. RESULTS: A total of 7,169 patients with psoriasis (n = 4,768, 67%), psoriatic arthritis (n = 1,208, 17%), Crohn's disease (CD, n = 621, 9%), and ulcerative colitis (UC, n = 572, 8%) met inclusion criteria. Among patients not in remission across all disease cohorts, the age-sex-standardized prevalence of any presenteeism, work productivity loss, and activity impairment ranged from 54 to 97%. Patients with CD in remission had higher standardized prevalence of presenteeism (53% [48-57%]) and work productivity loss (54% [49-59%]), compared to those from other cohorts (presenteeism [range: 33-39%] and work productivity loss [range: 37-41%]). For all WPAI domains, the strongest adjusted associations were for moderate to severe disease activity and psychosocial symptoms. CONCLUSIONS: Patients with moderate to severe disease activity reported the highest WPAI burden. However, patients in remission or mild disease activity also report some WPAI burden, emphasizing a multidisciplinary treatment approach to improve work productivity loss and impairment.

Patient acceptable symptom state and treatment failure threshold values for work productivity and activity Impairment and EQ-5D-5L in osteoarthritis.

OBJECTIVE: To estimate patient acceptable symptom state (PASS) and treatment failure (TF) threshold values for Work Productivity and Activity Impairment (WPAI) measure and EQ-5D-5L among people with hip or knee osteoarthritis (OA) 3 and 12 months following participation in a digital self-management intervention (Joint Academy®). METHODS: Among the participants, we computed work and activity impairments scores (both 0-100, with a higher value reflecting higher impairment) and the Swedish hypothetical- (range: - 0.314 to 1) and experience-based (range: 0.243-0.976) EQ-5D-5L index scores (a higher score indicates better health status) at 3- (n = 14,607) and 12-month (n = 2707) follow-ups. Threshold values for PASS and TF were calculated using anchor-based adjusted predictive modeling. We also explored the baseline dependency of threshold values according to pain severity at baseline. RESULTS: Around 42.0% and 48.3% of the participants rated their current state as acceptable, while 4.2% and 2.8% considered the treatment had failed at 3 and 12 months, respectively. The 3-month PASS/TF thresholds were 16/29 (work impairment), 26/50 (activity impairment), 0.92/0.77 (hypothetical EQ-5D-5L), and 0.87/0.77 (the experience-based EQ-5D-5L). The thresholds at 12 months were generally comparable to those estimated at 3 months. There were baseline dependencies in PASS/TF thresholds with participants with more severe baseline pain considering poorer (more severe) level of WPAI/EQ-5D-5L as satisfactory. CONCLUSION: PASS and TF threshold values for WPAI and EQ-5D-5L might be useful for meaningful interpretation of these measures among people with OA. The observed baseline dependency of estimated thresholds limits their generalizability and values should be applied with great caution in other settings/populations.

Factors affecting work productivity and activity impairment among chronic obstructive pulmonary disease patients.

Chronic obstructive pulmonary disease (COPD) can negatively affect patients' employment and work-life activities with a significant indirect economic impact. The current study aimed to measure unemployment, work productivity, activity impairment, and their associated factors among COPD patients. A cross-sectional study was conducted in the Chest outpatient clinic, Mansoura University Hospital, Egypt. COPD patients completed an interviewer-administered questionnaire including sociodemographic, occupational data, clinical history, medical research council (mMRC) dyspnea scale, the COPD assessment test (CAT), and work productivity and activity impairment Questionnaire (WPAI-COPD). A total 140 patients were included in the study and 22.1% of them gave up their jobs because of their COPD. Due to COPD, the mean percentage of daily activity impairment was 39.8 among all patients. The mean percentages of absenteeism, presenteeism, and overall work impairment among the 84 working patients were 0.07, 24.4, and 24.5. The CAT score was the significant predictor of all components of WPAI. In conclusion, COPD causes early retirement, high work productivity loss, and impaired daily activities. Higher CAT scores and increased disease severity significantly increase absenteeism, presenteeism, overall work, and activity impairment. Thus, timely diagnosis of COPD with appropriate management can help improve outcomes and lower the disease burden and economic impact.

Patient-reported outcomes in patients with primary immunodeficiency diseases in Japan: baseline results from a prospective observational study.

Introduction: Primary immunodeficiency diseases (PIDs) are rare inherited diseases resulting in impaired immunity. People with PID experience lower health-related quality of life (HR-QOL) and disease-related burdens in daily activities. This ongoing, prospective observational study aims to evaluate disease activity, treatment status, treatment-related burden, daily activities, and HR-QOL in patients with PID in Japan over a 1-year period. In this interim report (database lock: July 29, 2022), we present baseline results. Methods: Participants were enrolled between November 2021 and May 2022; data were collected four times/year per participant until May 2023 using an online electronic patient-reported outcomes system. Patients with PID and healthy volunteers aged ≥12 years, residing in Japan, and with access to a smartphone were eligible. HR-QOL (primary endpoint) was assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Work productivity was assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Other aspects of PID and burden were assessed with a new questionnaire developed in-house. The study is registered at the University hospital Medical Information Network clinical trials registry (UMIN000045622). Results: The full interim analysis set comprised 71 patients with PID and 47 healthy volunteers. The most common International Union of Immunological Societies PID category was primary antibody deficiency (56.3% of patients). Complications were common, especially recurrent respiratory tract infections (63.4%). Most patients with PID were treated with immunoglobulin replacement therapy (73.2%); 22.4% of these patients had serum immunoglobulin levels <700 mg/dL. Among patients who did not undergo hematopoietic cell transplantation, EQ-5D-5L (n=67) and SF-36 (n=59) Physical and Mental Component Summary scores were significantly lower than in healthy volunteers (p < 0.001). WPAI absenteeism, work productivity loss, and activity impairment scores were significantly lower in 42 working patients with PID than in 37 working healthy volunteers (p < 0.05). Other results indicated that patients with PID experience substantial burdens related to medical visits, expenses, work, and daily activities. Discussion: This interim analysis confirms that patients with PID in Japan have lower HR-QOL and work productivity compared with healthy individuals and experience substantial limitations and burdens in their daily lives.

Exploring work productivity loss in patients with inflammatory bowel disease.

Aim: We aimed in this study to evaluate the impact of inflammatory bowel disease (IBD) on patients' professional life and to determine predictors of severe work productivity loss (WPL). Materials & methods: A cross sectional study including patients with a confirmed diagnosis of IBD. Work productivity was evaluated with the work productivity and activity impairment score. Results: Severe absenteeism and WPL were found in respectively 7 (5.1%) and 54 (39.1%) patients. In multivariate analysis, the following features were found to be independently associated with severe WPL: penetrating Crohn's disease (p: 0.001, OR: 6), anemia (p: 0.031, OR: 3.23), diarrhea (p < 0.001, OR: 11.23) and a secondary level of education (p: 0.003, OR: 1.95). Conclusion: Our results show that IBD have a substantial effect on patients' professional life.

Inflammatory bowel diseases (IBD) are chronic conditions that cause inflammation in the digestive system. We wanted to know how IBD affects people's ability to work and what factors contribute to work difficulties. We asked adults with IBD about their education, work conditions and medical history. We found that a significant number of patients experience severe work productivity loss and absenteeism. Factors such as certain types of IBD, anemia, diarrhea and lower education level were linked to more severe work problems. These findings emphasize the impact of IBD on work life and highlight the importance of addressing these challenges in patient care.

Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine.

BACKGROUND: No available studies demonstrate validity and meaningful change thresholds of Work Productivity and Activity Impairment (WPAI) questionnaire in patients with migraine. In this post-hoc analysis, we assessed reliability, validity, responsiveness, and meaningful within-patient change from baseline to Month 3 for Work Productivity and Activity Impairment (WPAI) domain scores in patients with episodic migraine (EM) or chronic migraine (CM). METHOD: The Phase 3, multicenter, randomized, double-blind, placebo-controlled CONQUER study (NCT03559257, N = 462) enrolled patients with EM or CM who failed two to four categories of prior preventive medication in past ten years. The analyses were performed for WPAI domain scores (absenteeism, presenteeism, overall work productivity, and non-work-related activity impairment). Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) domain scores (Role Function-Restrictive [RFR] and Role Function-Preventive [RFP]), and monthly migraine headache days were used as anchors. Responder criteria were changes from baseline to Month 3 for each of these anchors and were defined as: increase in MSQ-RFR by ≥ 25.71 points and MSQ-RFP by ≥ 20.00 points and a 50% reduction in monthly migraine headache days. Assessments were performed for overall population, and patients with EM or CM. The meaningful change threshold was determined based on Youden index, Phi coefficient and sensitivity. RESULTS: Of 462 randomized patients, 444 who completed WPAI questionnaire were included in post-hoc analysis. Test-retest reliability over 3 months in a stable subgroup revealed moderate correlations for non-work-related Activity Impairment (ICC = 0.446) presenteeism (ICC = 0.438) and a fair correlation for overall work productivity loss (ICC = 0.360). At baseline, all correlations between WPAI domain scores and continuous anchor variables exceeded recommended threshold of ≥ 0.30, except for WPAI domain scores with number of monthly migraine headache days. Patients achieving pre-specified responsiveness thresholds for monthly migraine headache days, and MSQ-RFP, MSQ-RFR from baseline to Month 3 (responders) showed significant improvements in WPAI domain scores compared with non-responders (P < 0.001). The meaningful change thresholds of -20 (% unit) were identified for WPAI domain scores. CONCLUSION: In conclusion, WPAI has sufficient validity, reliability, responsiveness, and appropriate interpretation standards to assess the impact of EM or CM on presenteeism and overall work productivity loss and non-work-related activity impairment. TRIAL REGISTRATION: NCT number of CONQUER study, NCT03559257.

The psychosocial burden of hidradenitis suppurativa in Singapore.

Background: Hidradenitis suppurativa (HS) is a chronic debilitating inflammatory skin disorder known to result in significant psychological symptoms and impaired quality of life. However, most of these studies are limited to western countries, with limited data from other sociocultural regions. Objective: To understand the psychosocial burden of HS in the Asian context, by exploring the correlation between objective disease measures with psychosocial health and work productivity. Methods: A prospective single-center questionnaire study was conducted. A total of 45 patients with HS completed a questionnaire and examination by a dermatologist. Results: Higher objective disease severity scores (Hurley, physician global assessment, International Hidradenitis Suppurative Severity, and modified Sartorius) correlated with poorer quality of life (Dermatology Life Quality Index and Patient Global Assessment), increased anxiety and depression (hospital anxiety and depression scale) and at-work productivity loss. There was no significant correlation between objective disease severity and other domains Work productivity and activity impairment score or self-esteem (Rosenburg Self-Esteem Scale). Limitations: The main limitation of our study is the small sample size, assessment at a single time point, and lack of control cohort. Conclusion: Our findings demonstrate the impact of HS on a patient's psychosocial well-being and emphasize the importance of treating patients from a holistic standpoint.

Association between patient-reported outcomes and impairments in work and activity in patients with rheumatoid arthritis in clinical remission: A retrospective analysis using the IORRA database.

OBJECTIVES: To explore the patient-reported outcomes (PROs) associated with work productivity and activity impairment (WPAI) in patients with rheumatoid arthritis (RA) in clinical remission. METHODS: We enrolled patients with RA ≥18 years and with a simplified disease activity index ≤3.3 from the Institute of Rheumatology, Rheumatoid Arthritis data set collected in October 2017. The pain-visual analogue scale, patients' global assessment visual analogue scale (VAS), Japanese version of the Healthcare Assessment Questionnaire (J-HAQ) Disability Index, and duration of morning joint stiffness were selected as the PROs. To evaluate work productivity and activity, the WPAI for RA instrument (WPAI-RA) was used. To assess the contribution of each PRO to the WPAI-RA score, an analysis of variance model was constructed. RESULTS: The mean age of the 2614 patients was 62.4 years; 85.1% were female. Median values of the WPAI-RA score were 1.1% for absenteeism, 6.5% for presenteeism, 7.4% for work impairment, and 10.2% for activity impairment. Morning joint stiffness contributed the most to absenteeism (18.0%), while pain-VAS contributed the most to presenteeism (57.4%), work productivity loss (51.1%), and daily activity impairment (53.7%). J-HAQ was the second most contributing factor to presenteeism (17.4%), work productivity loss (16.3%), and daily activity impairment (26.0%). CONCLUSIONS: The pain-VAS and J-HAQ highly contributed to WPAI in patients with RA in clinical remission.

The disease burden and quality of life of chronic cough patients in South Korea and Taiwan.

Background: Chronic cough (CC) is a common condition, but the burden of CC in general populations remains largely unknown. This study aims to investigate the disease prevalence and burden among community-based CC patients in South Korea and Taiwan, using structured tools. Methods: A population-based cross-sectional study uses data from the 2020 South Korea and Taiwan National Health and Wellness Survey (NHWS) as well as a CC survey conducted between January-February 2020 and March-April 2020, respectively. Health outcome measures included health-related quality of life (HRQoL), health state utilities, work productivity and activity impairment (WPAI), and measurement of depression, anxiety, and insomnia among CC patients. Results: The weighted lifetime and 12-month prevalence of CC was 6.20% and 4.34% in South Korea, and 8.27% and 5.55% in Taiwan. Compared to matched non-CC controls, CC patients reported poorer HRQoL (SF-12v2) in terms of physical component summary (PCS) score (South Korea: 47.69 ± 7.68 vs. 50.08 ± 7.29; Taiwan: 48.58 ± 7.15 vs. 50.50 ± 7.30) and mental component summary (MCS) score (44.15 ± 8.85 vs. 46.28 ± 8.50; 42.44 ± 7.78 vs. 44.60 ± 8.08), health state utilities EQ-5D index (0.73 ± 0.23 vs. 0.82 ± 0.16; 0.82 ± 0.13 vs. 0.86 ± 0.14), and more visits to healthcare professionals (7.80 vs. 4.61; 6.09 vs. 4.20) (p < 0.05). In terms of WPAI, CC patients reported higher impairments in presenteeism (32.8% vs. 21.0%; 25.9% vs. 19.4%), total work productivity (36.2% vs. 22.3%; 27.7% vs. 20.6%), and total activity (34.2% vs. 23.2%; 27.7% vs. 20.3%) than non-CC controls (p < 0.001). CC patients in South Korea and Taiwan experienced anxiety, depression, and insomnia more than non-CC controls. Poorer health outcomes were associated with the severity of CC. Patients with severe CC (visual analogue scale [VAS]>4) in both nations reported lower PCS score (45.80 vs. 49.48; 47.41 vs. 49.22) and higher absenteeism (8.5% vs. 3.6%; 5.5% vs. 1.8%) than patients with mild CC (VAS≤4) (p < 0.05). Conclusions: The findings revealed that the disease burden of CC in general populations of South Korea and Taiwan is considerable with a negative impact on the overall quality of life, social and work life, and psychological comorbidities and is significantly associated with increased severity of the CC. There is an unmet need for further treatment interventions for CC patients to relieve the burden of CC in both nations.

The burden of non-alcoholic steatohepatitis: A systematic review of health-related quality of life and patient-reported outcomes.

Background & Aims: Non-alcoholic steatohepatitis (NASH) is associated with increased mortality and a high clinical burden. NASH adversely impacts patients' health-related quality of life (HRQoL), but published data on the humanistic burden of disease are limited. This review aimed to summarise and critically evaluate studies reporting HRQoL or patient-reported outcomes (PROs) in populations with NASH and identify key gaps for further research. Methods: Medline, EMBASE, the Cochrane Library and PsycINFO were searched for English-language publications published from 2010 to 2021 that reported HRQoL/PRO outcomes of a population or subpopulation with NASH. Results: Twenty-five publications covering 23 unique studies were identified. Overall, the data showed a substantial impact of NASH on HRQoL, particularly in terms of physical functioning and fatigue, with deterioration of physical and mental health as NASH progresses. Prevalent symptoms, including fatigue, abdominal pain, anxiety/depression, cognition problems, and poor sleep quality, adversely impact patients' ability to work and perform activities of daily living and the quality of relationships. However, some patients fail to attribute symptoms to their disease because of a lack of patient awareness and education. NASH is associated with high rates of comorbidities such as obesity and type 2 diabetes, which contribute to reduced HRQoL. Studies were heterogeneous in terms of diagnostic methods, population, outcomes, follow-up time, and measures of HRQoL/utility. Most studies were rated 'moderate' at quality assessment, and all evaluable studies had inadequate control of confounders. Conclusions: NASH is associated with a significant HRQoL burden that begins early in the disease course and increases with disease progression. More robust studies are needed to better understand the humanistic burden of NASH, with adequate adjustment for confounders that could influence outcomes. Lay summary: Non-alcoholic steatohepatitis (NASH) has a significant impact on quality of life, with individuals experiencing worse physical and mental health compared with the general population. NASH and its symptoms, which include tiredness, stomach pain, anxiety, depression, poor focus and memory, and impaired sleep, affect individuals' relationships and ability to work and perform day-to-day tasks. However, not all patients are aware that their symptoms may be related to NASH. Patients would benefit from more education on their disease, and the importance of good social networks for patient health and well-being should be reinforced. More studies are needed to better understand the patient burden of NASH.

Burden of schizophrenia among Japanese patients: a cross-sectional National Health and Wellness Survey.

BACKGROUND: Schizophrenia places a great humanistic and financial burden to patients, families, and societies, and the burden is substantially impacted by comorbid conditions. This study aimed to estimate the lifetime prevalence of schizophrenia and to assess the health-related quality of life (HRQoL), work productivity, and indirect cost among schizophrenia patients with and without comorbidities (depressive symptoms, sleep disturbances, and anxiety problems). METHODS: This is a secondary analysis of existing data collected in 2019 from the Japan National Health and Wellness Survey. The schizophrenia patients were categorized based on their Patient Health Questionnaire-9 score, self-reported experience of sleep disturbances, and anxiety problems. The lifetime prevalence was estimated using the total number of diagnosed schizophrenia patients as the numerator and the total number of respondents as the denominator. The HRQoL was evaluated through the Short Form 12-Item (version 2) Health Survey and EuroQoL 5-dimensions scale. Work productivity and annual indirect costs were evaluated through the Work Productivity and Activity Impairment instrument and monthly wage rates. Multivariate analyses included the comparison of outcomes using generalized linear models. RESULTS: The study was conducted with 178 schizophrenia patients with an average age of 42.7 years old and an estimated lifetime prevalence of 0.59% (95% CI: 0.51%, 0.68%). Patients who experienced sleep disturbances, more severe depressive symptoms, and anxiety problems had lower HRQoL, higher levels of absenteeism, presenteeism, total work productivity and activity impairment, and almost twice more indirect costs, compared to those without these conditions. CONCLUSION: Comorbid conditions among patients with schizophrenia impact significantly on their quality of life, work productivity as well as indirect costs.

Work-Related Productivity Loss and Associated Indirect Costs in Patients With Crohn's Disease or Ulcerative Colitis in the United States.

Background: Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), affects an estimated 1.6 million US adults, and results in humanistic and economic burden even among mild patients, which grows with increasing disease activity. Methods: Gastroenterologists and their IBD patients provided real-world data via US IBD Disease Specific Programmes 2014-2018. Patients with physician- and patient-reported data completing a Work Productivity and Activity Impairment questionnaire were categorized by disease activity, defined using Crohn's Disease Activity Index (CD) and partial Mayo scores (UC), respectively. Associations of disease activity with patient-reported productivity loss and indirect costs were assessed. Results: The analyses included 281 patients with CD and 282 patients with UC. Mean ages were 40.0 and 40.5 years, and mean disease durations 7.1 and 5.4 years, for CD and UC, respectively. In CD, absenteeism (0.95%-14.6%), presenteeism (11.7%-44.9%), and overall work impairment (12.4%-51.0%) increased with increasing disease activity (all P < .0001). In UC, absenteeism (0.6%-11.9%), presenteeism (7.1%-37.1%), and overall work impairment (7.5%-41.9%) increased with increasing disease activity (all P < .0001). Annual indirect costs due to total work impairment increased with increasing disease activity (all P < .0001), from $7169/patient/year (remission) to $29 524/patient/year (moderately-to-severely active disease) in CD and $4348/patient/year (remission) to $24 283/patient/year (moderately-to-severely active disease) in UC. Conclusions: CD and UC patients experienced increased absenteeism, presenteeism, and overall work impairment with increasing disease activity, resulting in higher indirect costs. Treatments significantly reducing IBD disease activity could provide meaningful improvements in work productivity and associated costs.

The burden of caring for adults with depression and suicidal ideation in five large European countries: analysis from the 2020 National Health and Wellness Survey.

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.

Impact of Endometriosis in Women of Arab Ancestry on: Health-Related Quality of Life, Work Productivity, and Diagnostic Delay.

Introduction: Endometriosis has a negative effect on health-related quality of life (HRQoL), wellbeing and daily functioning. Endometriosis is an under-researched condition within non-western populations. Cultural representations are needed to understand the relative roles of societal norms, traditional factors, and religious sensitivities on the impact of endometriosis on HRQoL in various populations. In particular, there is a lack of emphasis placed in understanding the association of HRQoL on endometriosis in Arab women. Method: In this prospective case-control study, 2,610 Arab ancestry women in the United Arab Emirates were recruited to investigate the impact of endometriosis on HRQoL, diagnostic delay, psychological co-morbidities, work productivity, and physical activity. Participants completed the following standardized, validated questionnaires: Short Form-36 version 2 questionnaire, the World Endometriosis Research Foundation EPHect minimum clinical questionnaire version, and Work Productivity and Activity Impairment questionnaire. Translations to the Arabic language, validated using the forward-backward translation method, of the questionnaires were utilized. Results: HRQoL scores were significantly impaired in women with endometriosis, as demonstrated in the Physical Composite Scores and Mental Composite Scores in the symptomatic control group (p = 0.001; p = 0.003, respectively) and the asymptomatic control group (p < 0.001; p < 0.001, respectively). Susceptibility and severity of multiple pain syndromes and infertility in women with endometriosis was the main indicator of lower HRQoL. Anxiety (p = 0.007) and depression (p = 0.005) were significantly associated with endometriosis, in comparison to symptomatic controls. The average diagnostic delay was 11.61 years, however single women experience 15.81 years of diagnosis delay, with approximately 18% (n = 15) of the single women experiencing more than a 20-year delay in diagnosis. The intensity of physical activity was not associated with endometriosis, when compared to symptomatic (p = 0.405) or asymptomatic controls (p = 0.144). Conclusion: For the first time, we provide evidence from a combined hospital, clinic, and population-based study that Arab women with endometriosis experience significant impacts on HRQoL, substantial diagnostic delay after the onset of symptoms, significant association to psychological disorders (anxiety and depression), and a negative impact on work productivity. Future research must focus on understanding the personal and culturally centered beliefs of Arab women to ensure a positive HRQoL trajectory by improving diagnosis and management strategies.

Valuation of Lost Productivity in Caregivers: A Validation Study.

OBJECTIVE: This study aimed to: (a) adapt the previously validated Valuation of Lost Productivity (VOLP) questionnaire for people with health problems, to a caregiver version to measure productivity losses associated with caregiving responsibilities, and (b) evaluate measurement feasibility and validity of an online version of the caregiver VOLP questionnaire. METHODS: A mixed methods design was utilized. Qualitative methods, such as reviewing existing questionnaires that measured caregiver work productivity losses and performing one-on-one interviews with caregivers, were used for VOLP adaptation and online conversion. Quantitative methods were used to evaluate feasibility and validity of the online VOLP. The Work Productivity and Activity Impairment (WPAI) questionnaire for caregivers was included to compare its absenteeism and presenteeism outcomes and their correlations with VOLP outcomes. RESULTS: When adapting the VOLP for caregivers, our qualitative analysis showed the importance of adding three major components: caregiving time, work productivity loss related to volunteer activities and caregivers' lost job opportunities. A total of 383 caregivers who completed online survey were included in our final quantitative analysis. We found small Spearman rank correlations between VOLP and WPAI, observing a larger correlation between their absenteeism [r = 0.49 (95% confidence interval: 0.37-0.60)] than their presenteeism [r = 0.36 (0.24-0.47)]. Correlations between VOLP outcomes and total caregiving hours were larger for absenteeism [r = 0.38 (0.27-0.47)] than presenteeism [r = 0.22 (0.10-0.34)]. Correlations between WPAI outcomes and total caregiving hours were smaller for absenteeism [r = 0.27 (0.15-0.38)] than presenteeism [r = 0.35 (0.23-0.46)]. CONCLUSION: The study provides evidence of the feasibility and preliminary validity evidence of the adapted VOLP caregiver questionnaire in measuring productivity losses due to caregiving responsibilities, when compared with the results for WPAI and the results from the previous patient-VOLP validation study.

Impact of bipolar disorder on health-related quality of life and work productivity: Estimates from the national health and wellness survey in Japan.

BACKGROUND: Previous studies have shown that bipolar disorder (BD) patients frequently present with difficulties in interpersonal relationships, education or employment and suffer poorer quality of life. This study aimed to estimate the impact of BD on health-related quality of life (HRQOL), work productivity loss and indirect costs. METHODS: Data was from the online, self-administered 2019 National Health and Wellness Survey. Outcomes were compared for those who self-reported a physician diagnosis of BD (N=179), major depressive disorder (MDD, N=1,549) and controls who have never experienced BD, MDD and schizophrenia (N=27,485). RESULTS: The lifetime prevalence was estimated to be 0.60% for BD and 5.16% for MDD. Significantly lower Mental Component Summary (MCS), Role Component Summary (RCS) scores and EuroQol 5-dimension scale (EQ-5D-5L) summary index and significantly higher presenteeism, total work productivity impairment and activity impairment assessed by Work Productivity and Activity Impairment questionnaire and indirect costs for BD versus controls and BD PHQ-9≥10 versus PHQ-9<10 were observed. Compared to MDD patients, BD patients had significantly lower RCS score and greater work productivity loss and activity impairment. The national morbidity cost of BD in Japan was estimated to be Japanese yen 1,236 billion using a human-capital approach. LIMITATIONS: The data used were self-reported and is cross-sectional in nature, thus causal relationship cannot be assumed. CONCLUSION: BD patients and those with severe depressive symptoms experience significantly poorer HRQOL and greater work productivity loss and indirect costs. These findings highlight the importance of proper screening, diagnosis and treatment of BD and bipolar depression.

Impact of Atopic Dermatitis on Work and Activity Impairment in Taiwan.

Atopic dermatitis has a substantial impact on work and activity impairment according to studies from Western communities. Prospective studies of work productivity and activity impairment in Asian patients with atopic dermatitis are lacking. The aims of this study were to investigate the impacts of atopic dermatitis on work productivity and activity impairment among Taiwanese patients, and to stratify the analyses by disease severity. One-third of employed participants reported missing work (absenteeism) in the preceding week due to atopic dermatitis, while 88.5% of the remaining two-thirds reported impaired work effectiveness (presenteeism). In addition, 92.5% of all participants reported impaired daily activities. Overall work impairment (aggregate productivity loss from absenteeism and presenteeism) was 1.8- and 2.6-fold greater in subjects with moderate and severe atopic dermatitis, respectively, compared with those with mild atopic dermatitis. Presenteeism, but not absenteeism, contributes to the majority of total work impairment in this cohort. Daily activity impairment was 1.5-fold greater in moderate atopic dermatitis, and 2.0-fold greater in severe atopic dermatitis, compared with mild atopic dermatitis. Both work and activity impairment showed significant positive correlations with atopic dermatitis severity scores (SCORing Atopic Dermatitis; SCORAD). In conclusion, work productivity and activity impairment is significantly correlated with disease severity in this Taiwanese atopic dermatitis cohort. In order to obtain a full picture of disease burden to patients and caregivers, patients with atopic dermatitis should be monitored for disease activity as well as corresponding impacts on quality of life.

Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis.

BACKGROUND: Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequate response to prior disease-modifying antirheumatic drugs (DMARDs). METHODS: Patients from two randomized, placebo-controlled, double-blind, phase 3 trials (RAJ3 and RAJ4) received once-daily peficitinib 100 mg, peficitinib 150 mg, or placebo, alone or in combination with DMARDs (RAJ3), or in combination with methotrexate (RAJ4). Mean changes in Work Productivity and Activity Impairment (WPAI) questionnaire domain scores from baseline, and percentages of patients achieving minimal clinically important differences (MCIDs) for patient- and physician-reported outcomes (WPAI, Health Assessment Questionnaire - Disability Index [HAQ-DI], and Subject's Global Assessment of Pain [SGAP]), and Physician's Global Assessment of disease activity (PGA) were evaluated at weeks 4, 8, 12, and 12/early termination (ET). RESULTS: Data from 1025 patients were analyzed. At week 12/ET in both studies, patients who received peficitinib 100 mg or 150 mg reported significantly improved WPAI domain scores from baseline (except for absenteeism in RAJ4) compared with placebo (both doses, p<0.05). A higher proportion of peficitinib- versus placebo-treated patients achieved MCID in WPAI, HAQ-DI, SGAP, and PGA in studies RAJ3 and RAJ4. Significant differences with peficitinib versus placebo were evident in both studies as early as week 4 in HAQ-DI (peficitinib 150 mg only), SGAP, and PGA, and week 8 in WPAI loss of work productivity and daily activity impairment. At week 12/ET, significantly higher proportions of patients receiving peficitinib versus placebo achieved MCID in HAQ-DI, SGAP, PGA, and WPAI domains of presenteeism (RAJ3 only), loss of work productivity (RAJ3 only), and daily activity impairment (p<0.05 for all comparisons). CONCLUSIONS: Peficitinib 100 mg or 150 mg administered daily over 12 weeks resulted in clinically meaningful improvements in outcomes that are important to RA patients, including pain, physical function, and work productivity and activity. These observations were reinforced through similar improvements in physicians' rating of disease activity. TRIAL REGISTRATION: RAJ3: ClinicalTrials.gov, NCT02308163 , registered 4 December 2014. RAJ4: ClinicalTrials.gov, NCT02305849 , registered 3 December 2014.

Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine-preventive medications in the phase 3b FOCUS study.

BACKGROUND: Migraine is associated with depression as well as negative impact on quality of life and work productivity. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa), selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine. OBJECTIVE: In this open-label extension (OLE) of the phase 3b FOCUS study, we assessed patient-reported outcomes (PROs) over time. METHODS: Patients with episodic migraine (EM) and chronic migraine (CM) completing the 12-week, double-blind (DB) period of the FOCUS trial entered the 12-week OLE and received three monthly doses of fremanezumab (225 mg). PROs included the Migraine-Specific Quality of Life (MSQoL) questionnaire (role function-restrictive [RFR], role function-preventive [RFP], and emotional function [EF] domains), EuroQol-5-Dimension-5-Level (EQ-5D-5L) questionnaire, Patient Global Impression of Change (PGIC) assessment, Work Productivity and Activity Impairment (WPAI) questionnaire, and 9-Item Patient Health Questionnaire (PHQ-9). RESULTS: A total of 838 patients were randomized in the DB period, 807 entered the OLE at 3 months, and 772 were still enrolled at 6 months. At 6 months, patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups, respectively, reported improvements in RFR (mean [standard deviation] change from baseline: 24.6 [21.9]; 22.9 [21.3]; 20.8 [26.5]), RFP (19.6 [20.0]; 18.3 [19.7]; 16.0 [19.9]), and EF (22.5 [24.2]; 19.1 [23.6]; 17.2 [24.7]) domains of the MSQoL questionnaire, the EQ-5D-5L questionnaire (8.0 [19.6]; 7.3 [21.1]; 6.6 [21.0]), all four domains of the WPAI questionnaire, and the PHQ-9 (-2.4 [5.3]; -1.6 [5.5]; -2.0 [4.9]); 77.1% (209/271), 75.4% (205/272), and 68.8% (181/263) of patients were identified as PGIC responders. CONCLUSION: Among patients with EM or CM and prior inadequate response to multiple migraine-preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6 months of fremanezumab treatment.