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Background: In Japan, biennial mammography screening has been recommended for the early detection of breast cancer (BC) in women aged 40 years or above since 2004 by the Ministry of Health, Labor and Welfare. The purpose of this study is to estimate the economic impact of BC screening on work productivity, using a new measure called the productivity-adjusted life-year (PALY). Methods: We used a dynamic life table modeling approach to estimate the work productivity of female patients aged 40–64 years diagnosed with BC in 2019 over the year of diagnosis and the subsequent 5 years. Changes in life-years, PALYs, and gross domestic product (GDP) were assessed by changing the screening detection rate from the current (34.2%) to an ideal (100%) percentage. Each input for modeling was obtained from the most recent public database available. Results: BC patients were estimated to lose 1903 in life-years, 3596 in PALYs, and US$281 million in GDP at the current screening detection rate compared with the ideal detection rate. On the other hand, the following gains are expected when the current screening detection rate was increased to 40–80%; life-years gain; 168–1325, PALYs gain; 317–2503, GDP gain: US$25–196 million. Conclusion: This study has used modeling to show that detecting BC without screening is associated with a lower work productivity and an economic and life-years loss. Encouraging BC screening may be beneficial to maintaining work productivity after diagnosis. [ABSTRACT FROM AUTHOR]

Background: Eptinezumab's impact on self-reported work productivity in adults with migraine and 2‒4 prior preventive migraine treatment failures is not fully understood. Methodology: Electronic diaries captured monthly migraine days (MMDs) reported by patients enrolled in the randomized, double-blind, placebo-controlled DELIVER trial (NCT04418765). The migraine-specific Work Productivity and Activity Impairment questionnaire, administered at baseline and each monthly visit, was a secondary outcome of DELIVER and used to model changes from baseline in self-reported monthly hours of absenteeism (decreased work attendance) and presenteeism (reduced work efficiency while at work with a migraine) in Canada, as the base case. Path analysis illustrated eptinezumab's impact on work productivity beyond MMDs. Results: As MMDs increased, monthly hours of absenteeism increased linearly while those of presenteeism increased quadratically. Best-fit models were improved after including an eptinezumab treatment effect, showing benefit over placebo after controlling for MMD frequency. Compared to placebo, patients treated with eptinezumab (pooled) had a modeled reduction from baseline of 7.2 h/month (absenteeism) (95% CI: −9.9, −4.5; P < 0.001) and 21.4 h/month (presenteeism) (95% CI: −26.3, −16.5; P < 0.001) over weeks 1‒24. Beyond MMD reductions, improvements in patient-identified most bothersome symptom (PI-MBS) and reductions in percent of severe migraine attacks contributed to eptinezumab's effect. Conclusions: Eptinezumab decreased absenteeism and presenteeism based on patient reports, with data highlighting the importance of considering the PI-MBS. The greater change from baseline than placebo in self-reported absenteeism and presenteeism was only partly explained by changes in MMDs, presenting a potential opportunity to decrease the cost of migraine in the workplace. Trial registration: ClinicalTrials.gov (Identifier: NCT04418765); EudraCT (Identifier: 2019-004497-25) [ABSTRACT FROM AUTHOR]

Introduction: Many patients who have undergone a periacetabular osteotomy (PAO) for developmental dysplasia of the hip (DDH) have had jobs preoperatively. Postoperative return to work and work productivity are important for livelihood security and the social economy. However, there is a lack of evidence on work productivity after PAOs. Therefore, this study investigated the return to work rates and influence of workload, clinical, and radiographic parameters on work productivity after a curved PAO. Materials and methods: In this study, the data of 68 hip joints among 48 participants who underwent curved PAO for symptomatic DDH were analyzed. Correlations between postoperative work productivity and clinical, radiographic, and workload parameters were assessed. Work productivity was evaluated using the Work Productivity and Activity Impairment (WPAI) questionnaire. Clinical factors were assessed using the modified Harris Hip Scores (mHHS) and University of California, Los Angeles Activity scores. Preoperative and postoperative radiographic parameters were compared with postoperative work productivity. The workload was categorized using the Reichsausschuß für Arbeitszeitermittlung (REFA)-classification system. Results: Of the participants, 98% returned to work and 87.5% returned to their original jobs. Work productivity was significantly improved in all workload categories at the 1-year postoperative follow-up. Multivariate analysis demonstrated that preoperative Tönnis and REFA classification grades were significantly associated with the postoperative WPAI. Conclusion: Curved PAOs can improve postoperative work productivity and return to work rates. Preoperative progression of osteoarthritis and heavy workload affect postoperative work productivity. [ABSTRACT FROM AUTHOR]

While preventing renal damage and symptomatic urinary tract infection are of paramount importance to persons with a spinal cord lesion (SCL), patient-reported outcomes (PROs) are receiving much more attention than ever before. We performed a cross-sectional internet survey of 282 adult members of SCL patient advocacy groups and investigated, for the first time, the impact of different types of urinary catheter, including a Japanese reusable silicone catheter and a reusable intermittent balloon catheter, on PROs of persons with SCL. Intermittent self-catheterization (ISC) did not surpass continuous indwelling catheterization in terms of a disease-specific urinary quality of life. Urinary incontinence, regular ISC, and performing ISC away from home confronted these individuals. Work productivity and regular activities correlated fairly well with the disease-specific urinary quality of life. Bowel management problems affected all PROs evaluated. The absence of differences in PROs among the types of catheter used for ISC implies that Japanese reusable catheters have the potential to benefit selected persons with SCL. Further research is warranted to develop measures for maximizing work productivity by overcoming urinary as well as bowel problems. [ABSTRACT FROM AUTHOR]

Loneliness is becoming an increasingly prevalent emotional experience in workplaces. While there is a growing body of research concentrating on the adverse effects of workplace loneliness on both individuals and organizations, strategies for effective intervention remain largely unexplored. Through the lens of Conservation of Resources (COR) theory, this study examines how employees' encounters with workplace loneliness as resource depletion can lead to a decrease in work productivity. It also assesses whether and how workplace mindfulness and job autonomy may buffer this harmful dynamic. A thorough three-wave survey involving 443 IT professionals was conducted to evaluate our theoretical model. The findings reveal that (1) workplace loneliness significantly erodes work productivity and (2) workplace mindfulness and job autonomy act as buffers, and in tandem, they synergistically transform the negative impact of workplace loneliness into a catalyst for enhancing work productivity. This is likely because, in contexts of high workplace mindfulness and autonomy, employees are able to effectively transform the negative emotions associated with involuntary solitude, capitalizing on the benefits of solitude. This research introduces an innovative framework for interventions to address the widespread problem of workplace loneliness and offers valuable practical implications for managing employees' loneliness. [ABSTRACT FROM AUTHOR]

Introduction: To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial. Methods: Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. Results: Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (− 23.8% to − 28.0%) and nonwork daily activity impairment (– 26.6% to − 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1–16.4% were not employed at week 100, and 20.0–25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409. Conclusion: Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. Trial Registration: Clinicaltrials.gov identifier: NCT03158285. [ABSTRACT FROM AUTHOR]

Introduction: Plaque psoriasis is a chronic condition that may impact patients' work productivity. Tildrakizumab, an interleukin-23 p19 inhibitor, is approved for treatment of moderate-to-severe plaque psoriasis in adults. However, the effect of tildrakizumab treatment on work productivity in patients with psoriasis is not well characterized. Methods: In this multicenter, open-label, uncontrolled phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. Patients completed the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) at baseline and every 12 weeks from week 16 through week 64. The following four domains of the WPAI:PSO were examined: absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduction of productivity while at work due to psoriasis), total activity impairment (percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Missing data were not imputed. Results: Of the 55 patients enrolled, 31 patients completed all domains of the WPAI:PSO at week 64. From baseline to week 64, respectively, mean ± standard deviation (SD) scores improved for presenteeism (20.5 ± 21.7 to 2.6 ± 5.8; P < 0.001), total activity impairment (29.5 ± 26.6 to 4.4 ± 9.4; P < 0.001), and total work productivity impairment (20.9 ± 22.2 to 2.6 ± 5.8; P < 0.001). The mean ± SD score for absenteeism decreased from 1.1 ± 5.7 at baseline to 0.0 ± 0.0 at week 64, but this change was not statistically significant. Conclusion: Tildrakizumab treatment mitigated work productivity loss due to psoriasis as measured by the presenteeism, total activity impairment, and total work productivity impairment domains of the WPAI:PSO. Trial Registration: ClinicalTrials.gov identifier, NCT03718299. [ABSTRACT FROM AUTHOR]

Primary hyperoxaluria (PH) is a family of ultra-rare, autosomal recessive, metabolic disorders associated with frequent kidney stones, chronic kidney disease and kidney failure, and serious complications due to systemic oxalosis, resulting in significant morbidity. We investigated the burden of PH among affected patients and caregivers. This cross-sectional, web-based survey was used to quantify the burden of PH, in terms of healthcare resource utilization, health-related quality of life, and work productivity and activity impairment among adults (≥ 18 years) with PH and caregivers of children (≤ 17 years) with PH in the US. Among the 20 respondents, there were 7 adults with PH and 13 caregivers of children with PH. Adherence to hyperhydration was noted as the most, or one of the most, difficult aspects of PH by 56% of respondents. Most patients (95%) had experienced painful kidney stone events, one-third had visited the emergency room, and 29% were hospitalized for complications due to PH. Of the 24% of patients on dialysis, all found the procedure burdensome. Adult patients’ quality of life was negatively affected across several domains. Most respondents (81%) reported that PH had a negative effect on their finances. Employed adult patients and caregivers, and children with PH, had moderate impairment in work productivity, school attendance, and activity. Anxiety about future PH-related sequelae was moderate to high. These findings highlight the need for improvements in PH medical management. A plain language summary is available in the supplementary information. [ABSTRACT FROM AUTHOR]

Background: Eptinezumab demonstrated efficacy in adults with migraine and prior preventive treatment failures in the placebo-controlled phase of the DELIVER clinical trial; its long-term effectiveness in this population has not yet been reported. The objective of this study was to evaluate the long-term effectiveness of eptinezumab in a migraine patient population during the 48-week extension phase of DELIVER. Methods: DELIVER was conducted June 1, 2020 to September 15, 2022. 865 adults with migraine, with documented evidence of 2–4 prior preventive migraine treatment failures and with completion of the 24-week placebo-controlled period of DELIVER received eptinezumab (100 or 300 mg) during the dose-blinded extension, either continuing their randomized dose or, if originally receiving placebo, were randomized 1:1 to an eptinezumab dose (100 or 300 mg). A mixed model for repeated measures was used to evaluate changes from baseline in the number of monthly migraine days (MMDs). Results: Of 865 patients entering the extension (eptinezumab 100 mg, n = 433; 300 mg, n = 432), 782 (90.4%) completed and 11 (1.3%) discontinued due to an adverse event. Eptinezumab was associated with early and sustained reductions in migraine frequency. Mean MMDs at baseline were approximately 14 days across groups. Mean (standard error) change from baseline in MMDs over the final dosing interval (weeks 61–72) was −6.4 (0.50) with placebo/eptinezumab 100 mg, –7.3 (0.49) with placebo/eptinezumab 300 mg, –7.1 (0.39) with eptinezumab 100 mg, and −7.0 (0.39) with eptinezumab 300 mg. During weeks 61–72, 63–70% of patients demonstrated ≥ 50% reduction in MMDs, and 36–45% demonstrated ≥ 75% reduction. Headache severity and acute medication use reductions, and patient-reported improvements in most bothersome symptom, disease status, quality of life, and work productivity, were observed. Adverse events were generally mild, transient, and similar in frequency/type to previous eptinezumab trials. Conclusions: The long-term effectiveness and safety/tolerability of eptinezumab in patients with migraine and 2–4 prior preventive treatment failures was demonstrated by high completion rates and migraine-preventive benefits sustained for up to 18 months, implying that eptinezumab is a viable long-term treatment option for patients still seeking successful migraine treatments. Trial registration: ClinicalTrials.gov (Identifier: NCT04418765; URL: https://www.clinicaltrials.gov/ct2/show/NCT04418765); EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25). [ABSTRACT FROM AUTHOR]

Introduction: Atopic dermatitis (AD) can require long-term therapy. Few real-world studies have evaluated long-term effectiveness from the patients' perspective. The aim of this study was to evaluate patient-reported outcomes (PROs) during long-term dupilumab treatment. Methods: Adults with moderate-to-severe AD who initiated dupilumab through the US manufacturer patient support program and participated in RELIEVE-AD (a prospective patient survey study with a 12-month follow-up) were recontacted 30–36 months post-initiation regardless of current dupilumab use. The online questionnaire consisted of PROs, including the Atopic Dermatitis Control Tool (ADCT), use of concomitant AD therapies, satisfaction with current therapy, global change in itch relative to before dupilumab initiation, non-itch skin symptoms (skin pain/soreness, hot/burning feeling, and sensitivity to touch), flares, Dermatology Life Quality Index, sleep problems, and the AD-specific Work Productivity and Activity Impairment Questionnaire. Results: Of 698 patients who initiated dupilumab (baseline) and were recontacted, 425 completed the 30–36-month survey. Significant reductions from baseline were reported in concomitant AD therapy use (P < 0.05); 54.4% reported not using other AD medications vs. 12.8% at baseline. At 30–36 months, all results (non-itch skin symptoms, flares, sleep problems, health-related quality of life work/activity impairment, disease control, and treatment satisfaction) were similar to or incrementally better than the 12-month timepoint, with significant improvements vs. baseline (P < 0.001). Global change in itch was reported as "very much better" by 75.3% of respondents. Adequate disease control (score < 7 on ADCT) was reported by 80.7% of respondents, and 86.8% were satisfied with the treatment. Conclusions: In clinical practice settings, patient-reported benefits of dupilumab were maintained in survey respondents during long-term treatment up to 36 months while the use of concomitant AD therapies reduced. Plain Language Summary: Atopic dermatitis (also known as eczema) is a chronic skin disease that can have a profoundly negative effect on patients' quality of life. To control disease symptoms, patients often need long-term treatment. Dupilumab is a treatment that has shown benefits in adults with moderate-to-severe atopic dermatitis (AD) when used in long-term (under 4 years) clinical trials; however, few studies have evaluated patients' experiences of long-term dupilumab treatment outside of a clinical trial setting. This study was conducted to do so: 425 adults with moderate-to-severe AD who received dupilumab through a US manufacturer patient support program filled in an online questionnaire 30–36 months after starting treatment. The questionnaire included items on use of additional AD therapies, AD symptoms, quality of life, disease control, and satisfaction with treatment. Patients' responses showed that, at 30–36 months after starting dupilumab treatment, 54% of patients reported not using any other medications for AD vs. 13% of patients when starting dupilumab treatment. In addition, since starting dupilumab, 75% of patients reported one of the most burdensome AD symptoms, itch, as being "very much better" vs. before starting treatment; 81% reported control of AD symptoms; 85% reported a meaningful improvement in quality of life; and 76% were "extremely" or "very" satisfied with the treatment. In summary, this study showed that long-term dupilumab treatment provides continued improvement in symptoms, treatment satisfaction, disease control, and quality of life in adults with moderate-to-severe AD while reducing the need for other AD treatments. 3iG3PGa9W2P2LdjPJWXwbt Video abstract: How do patients with atopic dermatitis perceive long-term dupilumab treatment in the real world? (MP4 31888 kb) [ABSTRACT FROM AUTHOR]

Background: The YOu and Ulcerative colitis: Registry and Social network (YOURS) is a large-scale, multicenter, patient-focused registry investigating the effects of lifestyle, psychological factors, and clinical practice patterns on patient-reported outcomes in patients with ulcerative colitis in Japan. In this initial cross-sectional baseline analysis, we comprehensively explored impacts of symptom severity or proctocolectomy on nine patient-reported outcomes. Methods: Patients receiving tertiary care at medical institutions were consecutively enrolled in the YOURS registry. The patients completed validated questionnaires on lifestyle, psychosocial factors, and disease-related symptoms. Severity of symptoms was classified with self-graded stool frequency and rectal bleeding scores (categories: remission, active disease [mild, moderate, severe]). The effects of symptom severity or proctocolectomy on nine scales for quality of life, fatigue, anxiety/depression, work productivity, and sleep were assessed by comparing standardized mean differences of the patient-reported outcome scores. Results: Of the 1971 survey responses analyzed, 1346 (68.3%) patients were in remission, 583 (29.6%) had active disease, and 42 (2.1%) had undergone proctocolectomy. A linear relationship between increasing symptom severity and worsening quality of life, fatigue, anxiety, depression, and work productivity was observed. Patients with even mild symptoms had worse scores than patients in remission. Patients who had undergone proctocolectomy also had worse scores than patients in remission. Conclusions: Ulcerative colitis was associated with reduced mood, quality of life, fatigue, and work productivity even in patients with mild symptoms, suggesting that management of active ulcerative colitis may improve patient-reported outcomes irrespective of disease severity. (UMIN Clinical Trials Registry: UMIN000031995, https://www.umin.ac.jp/ctr/index-j.htm). [ABSTRACT FROM AUTHOR]

This paper investigates the effects of obesity, socio-economic variables, and individual-specific factors on work productivity across Italian regions. A dynamic panel data with correlated random effects is used to jointly deal with incidental parameters, endogeneity issues, and functional forms of misspecification. Methodologically, a hierarchical semiparametric Bayesian approach is involved in shrinking high dimensional model classes, and then obtaining a subset of potential predictors affecting outcomes. Monte Carlo designs are addressed to construct exact posterior distributions and then perform accurate forecasts. Cross-sectional Heterogeneity is modelled nonparametrically allowing for correlation between heterogeneous parameters and initial conditions as well as individual-specific regressors. Prevention policies and strategies to handle health and labour market prospects are also discussed. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study is to investigate how different cancer-related symptoms influence work outcomes among cancer survivors. Methods: A literature search was performed in PubMed, EMBASE, CINAHL, PsycINFO, and Scopus to identify studies published between 1st January 1999 and 30th October 2020 that investigated the impact of specific cancer-related symptoms on work outcomes among cancer survivors who have completed primary antineoplastic treatment. Study findings were extracted and grouped by symptoms and work outcomes, allowing comparison of associations between these outcomes. Results: Seventy-three articles representing 68 studies were eligible for inclusion. From these studies, 27 cancer-related symptoms, 9 work outcomes, and 68 unique associations between specific symptoms and work outcomes were identified. Work status (return to work and employment rates) was most commonly studied, and symptom burden was mainly measured from the patient's perspective. Higher symptom burden was generally associated with trends of poorer work outcomes. Significant associations were reported in most studies evaluating body image issues and work status, oral dysfunction and work status, fatigue and work ability, and depression and work ability. Conclusion: Several cancer-related symptoms were consistently associated with inferior work outcomes among cancer survivors. Body image issues and oral dysfunction were shown to be associated with poorer employment rates, while fatigue and depression were linked to lower levels of work performance. Implications for Cancer Survivors: Failure to return to work and decreased productivity post-cancer treatment can have negative consequences for cancer survivors and society at large. Findings from this review will guide the development of work rehabilitation programs for cancer survivors. Protocol registration: PROSPERO identifier CRD42020187754 [ABSTRACT FROM AUTHOR]

Introduction: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA).Methods: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.Results: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.Conclusion: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.Trial Registration: ClinicalTrials.gov identifier, NCT03158285. [ABSTRACT FROM AUTHOR]

Introduction: Dysmenorrhea is a physical and mental burden for women, negatively affecting health-related quality of life (HRQL) and work productivity. However, data on HRQL and work productivity of Japanese women are scarce. Methods: In this prospective observational study, 397 Japanese women received low-dose estrogen/progestin (LEP) or non-LEP treatment (non-steroidal anti-inflammatory drugs or Chinese herbal medicines) for primary/secondary dysmenorrhea and completed survey questionnaires online regarding menstrual symptoms, HRQL, and work productivity. Regression analysis was performed to compare the groups and evaluate outcomes over time using the paired t test. Subgroup analysis was performed using stratification by patient background, and correlations between improvement in menstrual symptoms/HRQL and work productivity were investigated using Spearman's rank correlation coefficient. Results: Significant reductions in the modified Menstrual Distress Questionnaire (mMDQ) total score were shown in the LEP group (n = 251) (P < 0.01), but not the non-LEP group (n = 146). Significant improvements in HRQL, measured by the 36-Item Short-Form Health Survey v2.0 (SF-36v2.0), were shown in the LEP group, but not the non-LEP group. Improvements were seen in mental component summary and 7/8 domains (role physical, bodily pain, general health, role emotional, mental health, vitality, and social functioning) in the LEP group, but not the non-LEP group. There were no differences in the physical component summary and role functioning in either group. Improvements in work productivity, measured by the modified Work Productivity and Activity Impairment Questionnaire (mWPAI), were greater in the LEP group vs. non-LEP group. Regression analysis showed differences in improvements between the groups in the mMDQ total score, SF-36v2.0, and mWPAI. A correlation between mMDQ or HRQL and work productivity was seen. Conclusion: In Japanese women, dysmenorrhea is associated with reduced HRQL and work productivity. In real-world clinical practice, improvements in physical and mental menstrual symptoms, HRQL, and work productivity were observed with LEP treatment. Trial Registration: NCT04607382 (ClinicalTrials.gov). [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to characterize employment, work productivity, and biologic disease-modifying anti-rheumatic drug (bDMARD) treatment in a predominantly female population of axial spondyloarthritis (axSpA) patients in a real-world setting. Methods: This was a cross-sectional study of axSpA participants within the ArthritisPower registry. Outcomes were assessed with surveys (Work Productivity and Activity Impairment [WPAI], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], and Patient-Reported Outcomes Measurement Information System instruments) and compared between subgroups (employed vs. not employed; taking vs. not taking a bDMARD). Results: Among the 195 participants, 117 (60.0%) were employed and 78 (40.0%) were not employed entirely or partially due to axSpA. The mean age of the participants was 47.6 years and 86.7% were female. Current bDMARD use was reported by 57.4% of those surveyed (59.8% employed vs. 53.9% not employed; p = 0.408). Compared to not employed participants, employed participants had more favorable disease activity (BASDAI 6.0 vs. 7.6; p < 0.001) and overall health (self-rated health 2.5 vs. 1.8; p < 0.001). Employed participants, compared to not employed participants, were diagnosed at an earlier age (36.0 vs. 42.5 years, respectively) and experienced a shorter time between symptom onset and diagnosis (9.5 vs. 13.6 years, respectively). Employed participants reported missing on average 6.5 days of work and experienced a 52.7% impairment on work productivity due to axSpA over a 3-month period. Absenteeism and presenteeism were statistically similar between participants taking a bDMARD versus those not taking a bDMARD. Conclusions: Although bDMARD treatment rates were similar between employed and not employed participants, disease activity and overall health were better in employed than non-employed participants. Employed participants experienced substantial work productivity impairment due to axSpA. [ABSTRACT FROM AUTHOR]

Introduction: The ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE study in Japan (OVERCOME [Japan]) assessed the impact and burden of migraine in Japan. Methods: OVERCOME (Japan) was a cross-sectional, observational, population-based web survey of Japanese people with migraine conducted between July and September 2020. The burden and impact of migraine were assessed using the Migraine Disability Assessment (MIDAS), Migraine-Specific Quality-of-Life Questionnaire (MSQ), Migraine Interictal Burden Scale (MIBS-4), and Work Productivity and Activity Impairment-Migraine scale. Results were stratified by average number of monthly headache days (0–3, 4–7, 8–14, ≥ 15). Results: In total, 17,071 Japanese people with migraine completed the survey. Of these, 14,033 (82.2%) met International Classification of Headache Disorders, 3rd edition criteria for migraine and 9667 (56.6%) reported a physician diagnosis of migraine. Overall, 20.7% of respondents experienced moderate-to-severe disability (MIDAS). Moderate-to-severe interictal burden (MIBS-4) was experienced by 41.5% of respondents. MSQ scores in all domains were lowest in respondents with the most frequent headaches (≥ 15 monthly headache days) and highest in those with the lowest frequency headaches (≤ 3 monthly headache days), indicating poorer quality of life in those with more frequent headaches. Work time missed due to migraine (absenteeism) increased with increasing headache frequency, from 3.8 to 6.2%; presenteeism affected 29.8–49.9% of work time. Although migraine burden was greatest in people with the most frequent headaches, those with the lowest headache frequency still experienced substantial disability, interictal burden, and impacts on productivity and quality of life. There was also substantial unmet need for migraine care: 36.5% of respondents had ever hesitated to seek medical care for their headaches, and 89.8% had never used preventive medication. Conclusion: In Japan, the burden of migraine and barriers to migraine care are substantial. Improving patient awareness and healthcare provider vigilance may help improve patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Spondyloarthritis (SpA) affects patients in the prime of their economic productivity and can cause loss of work productivity and unemployment. We aim to identify factors associated with poor work outcomes in patients with SpA. Methods: A cross-sectional study was performed in 100 patients with SpA who were employed, retired, or off work because of SpA. Data on sociodemographic and professional characteristics were collected as well as specific indices: BASDAI, ASDAS-CRP, BASFI, and BASMI. Work productivity in employed patients was assessed by the Work Productivity and Activity Impairment scale (WPAI:SpA). Results: Patients were divided into 73 men and 27 women; the mean age was 43.68 ± 10.3 years. Fifty-nine percent of patients were employed and 26% were off work. The average disease duration was 12.24 ± 8.73 years. The mean BASDAI score was 4.4 ± 2.4, the average BASFI score was 4.6 ± 2.7, and the average ASDAS-CRP score was 2.77 ± 1.18. The mean BASMI was 4.4 ± 2.8. Among employed patients, the mean of absenteeism, presenteeism, and work productivity loss was 21.8 ± 33.13%, 42 ± 32%, and 46.5 ± 35.31%, respectively. In multivariable analysis, absenteeism was associated with ASDAS ≥ 2.1 (β = 20.14), peripheral joint involvement (β = 15.6), manual work (β = 14.31), low level of education (β = 7.92), and BASFI ≥ 4 (β = 6.39). Presenteeism and work productivity loss were associated with manual work, BASFI ≥ , body mass index ≥ 25 kg/m2, smoking, the use of symptomatic treatment, and ASDAS-CRP ≥ 2.1. Conclusion: Spondyloarthritis affects work productivity. Screening for predictive factors should be considered by the clinician in the overall management of the disease. Key Points • SpA occurs among young and active patients; it could affect their professional lives and thus lead to loss of work productivity and unemployment. • The management of patients with SpA must be multidisciplinary; this includes assessing contextual factors in order to act on modifiable factors such as smoking and BMI, optimal management of the disease to maintain at least a low disease activity, and to ensure workstation layout and elimination of professional constraints that can affect work outcomes in patients with SpA. [ABSTRACT FROM AUTHOR]

Introduction: Psoriatic arthritis (PsA) has a major impact on health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), important components in the assessment of therapeutic efficacy. We evaluated the impact of upadacitinib on PROs in PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR). Methods: Patients enrolled in the phase 3 SELECT-PsA 2 randomized controlled trial (RCT) received 56 weeks of oral upadacitinib 15 mg QD, upadacitinib 30 mg QD, or placebo switched to either dose of upadacitinib at week 24. PROs included patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), health-related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores), fatigue (FACIT-F), psoriasis symptom severity (SAPS), and work productivity (WPAI). Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values, and maintenance of improvements were assessed. Results: At weeks 12 and 24, patients treated with either upadacitinib dose reported statistically and nominally significant improvements from baseline across all PROs versus placebo (p ≤ 0.05), except the WPAI absenteeism domain, which were maintained or further improved to week 56. A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56. Improvements ≥ MCID were reported as early as week 2 in PtGA, pain, and HAQ-DI. Conclusions: Upadacitinib provides rapid, clinically meaningful, and sustained improvements in PROs reported by bDMARD-IR PsA patients. SELECT-PsA 2 ClinicalTrials.gov number, NCT03104374. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this work is to assess the effect of upadacitinib versus adalimumab and placebo on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with inadequate responses to ≥ 1 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR) in SELECT PsA-1. Methods: In this placebo- and active comparator, phase 3 randomized, controlled trial, patients received daily upadacitinib 15 or 30 mg, placebo, or adalimumab 40 mg every other week through 56 weeks. At week 24, placebo-assigned patients were rerandomized to upadacitinib 15 or 30 mg. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form 36 Health Survey (SF-36), EQ-5D-5L index score, Bath Ankylosing Spondylitis Disease Activity Index, morning stiffness, Self-Assessment of Psoriasis Symptoms, and Work Productivity and Activity Impairment. Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID), scores ≥ normative values, and sustained clinically meaningful responses were compared between treatment groups. Results: At weeks 12 and 24, upadacitinib treatment resulted in improvements from baseline versus placebo across all PROs as well as improvements versus adalimumab in HAQ-DI and SF-36 Physical Component Summary score (nominal p < 0.05). Improvements in PtGA, pain, and HAQ-DI were reported as early as week 2. At week 12, significantly (nominal p < 0.05) more upadacitinib- versus placebo-treated patients reported improvements ≥ MCID across all PROs including seven SF-36 domains. The proportions of upadacitinib-treated patients reporting clinically meaningful improvements at week 12 were similar to or greater than with adalimumab and sustained through week 56. Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab. Conclusions: Upadacitinib treatment provides rapid, sustained, and clinically meaningful improvements in PROs in non-bDMARD-IR patients with PsA. SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400. [ABSTRACT FROM AUTHOR]

Introduction: Migraine is consistently ranked as one of the most disabling neurological conditions in the world, often causing a substantial impairment of daily activities and quality of life. It also carries a high economic burden of direct and indirect healthcare costs. Patients with difficult-to-treat migraine often cycle through different preventive therapies, but real-world prospective evidence describing the burden of migraine in patients with prior preventive treatment failure (PPTF) in Europe is limited. In BECOME, we aimed to characterize and assess the prevalence and burden of migraine in patients with PPTF attending specialist headache centers in Europe and Israel. Furthermore, we assessed this burden in pre-specified subgroups based on the frequency of monthly migraine days (MMD) and number of PPTFs. Methods: BECOME was a prospective, non-interventional study conducted in two concurrent parts across 17 countries in Europe and Israel. In part 1, patients visiting the centers over a 3-month period were screened for frequency of PPTF, MMD, and other characteristics. In part 2, patients from part 1 with ≥ 1 PPTF and ≥ 4 MMD were enrolled, and impact of migraine on patient-reported outcomes, and healthcare resource utilization (HRU) were examined. Results: In part 1 (n = 20,837), 62.2% of patients reported ≥ 1 PPTF. In part 2 (n = 2419), 15.3% of patients reported ≥ 4 PPTF. In part 2, the migraine burden measured by the EuroQoL 5 dimensions 5 level (EQ-5D-5L) questionnaire indicated an impact of at least moderate severity in performing usual activities in 26.5% of patients, pain/discomfort in 51.2%, and 26.1% reported being at least moderately anxious/depressed. Most patients reported a severe impact on daily activities and disability due to migraine. Abnormal Hospital Anxiety and Depression subscale scores of ≥ 11 were observed in 29% (anxiety) and 19.8% (depression) of the population. In part 2, analysis of HRU showed 21.2% patients visited an emergency department and 8.4% were hospitalized for headache/migraine in the past year. Conclusions: This study provides real-world evidence of the high personal, social, and HRU burden of migraine in Europe and Israel. [ABSTRACT FROM AUTHOR]

Introduction: Breast cancer survivors (BCS) who represent approximately 3.5 million survivors in the USA frequently report ongoing cognitive dysfunction that may impact work outcomes. However, little is known about how perceived everyday cognitive function may affect work engagement (a measure of work efficacy and work well-being) in BCS who have completed treatment. Objectives: The purpose of this study was to examine the relationship between perceived everyday cognitive function and work engagement in BCS. Methods: A convenience sample of 68 employed BCS seen at a Midwest NCI-Cancer Center who were at least 1-year post-treatment, completed a cross-sectional questionnaire assessing demographic and medical characteristics, and perceived everyday cognitive function (Everyday Cognition Scale) and work engagement (Utrecht Work Engagement Scale). Descriptive statistics, Pearson's r, and separate regression models controlling for age and education were used to analyze the data. Results: BCS who were on average 52 (SD = 8.6) years old, 5 (SD = 3.8) years post-treatment, and primarily employed full-time (79%) participated. A subset of BCS (12%) identified poorer everyday cognitive function after BC diagnosis and treatment. Everyday cognition, including subscales vigor and dedication, were correlated with work engagement (p˂0.01), controlling for age and education. Conclusions: Findings indicate the important role of perceived everyday cognitive function in work engagement well into survivorship. Reducing cognitive dysfunction may be an important area for future intervention research to support BCS who return to work. Implications to practice: Healthcare providers need to assess and address perceived cognitive dysfunction to promote work-related outcomes in BCS well into survivorship. [ABSTRACT FROM AUTHOR]

Introduction: Familial Mediterranean fever (FMF) is characterized by recurrent attacks of fever, serositis, and arthritis. Some patients suffer from associated inflammatory conditions and damage related to FMF that may potentially impair work productivity which have not been studied to date. Methods: Consecutive FMF patients who were attending a tertiary referral center and age-and sex-matched healthy subjects enrolled into the study. Disease activity was assessed with autoinflammatory disease activity index (AIDAI) and patient global assessment. Damage was evaluated using Autoinflammatory Disease Damage Index (ADDI). Quality of life (QoL) and work productivity were determined with 36-Item Short Form Health Survey (SF-36) and Work Productivity and Activity Impairment Specific Health Problem v2.0 (WPAI:SHP), respectively. Results: There were 111 FMF patients, 60 female (54%), mean age 32.7±8.7 years. There were significant impairments in all domains of the SF-36 QoL in FMF patients. Of the 111 patients enrolled, 65 (58.6%) were employed in a paid work. Mean% ±SD impairment in work productivity both assessed as absenteeism (9.3±23.2% vs. 0.7±2.6, p=0.013) and presenteeism (35.2±32.6% vs. 9.6±14.7, p<0.001) were significantly higher in FMF patients compared to healthy subjects. Impairment in work productivity was correlated with the number of attacks, disease activity, colchicine resistance, and disease-associated damage. Impairment was most significant in colchicine-resistant FMF patients but lower in those on interleukin (IL)-1 antagonist treatments. Conclusions: FMF causes significant work impairment and reduced QoL which is associated with disease activity and damage. The use of IL-1 antagonists may help to improve work productivity and QoL in FMF patients with frequent attacks. Key points •Work productivity is impaired in patients with FMF. • Disease activity was an independent predictor for impaired work productivity. • IL-1 antagonists may improve work productivity and quality of life in FMF patients with frequent attacks. [ABSTRACT FROM AUTHOR]

Background: The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed work ability, quality of life, and cognitive processing speed during natalizumab treatment. Methods: WANT was a 1-year, prospective, multicenter observational study conducted in Italy. Inclusion criteria included relapsing-remitting multiple sclerosis (MS), natalizumab treatment, full-time worker status, and loss of working hours due to MS as measured by the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS). The primary endpoint was change in WPAI:MS domain scores after 1 year on natalizumab. Secondary endpoints included change in annualized relapse rate (ARR), Multiple Sclerosis Impact Scale (MSIS-29) score, and Symbol Digit Modalities Test (SDMT) score. Results: At enrollment, the 91 patients had a mean age of 38.3 (standard deviation [SD], 9.0) years and a mean ARR of 1.5 (SD, 0.8). After 1 year, improvements were observed in all WPAI:MS domains, with significant reductions in Absenteeism (−4.2 [SD, 26.0], p = 0.0190) and Work Productivity Loss (−7.2 [SD, 28.6]; p = 0.0456). These changes were accompanied by a low ARR (0.1), and 87.9% of patients were relapse free. Significant improvement was observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6; p = 0.0295] and 6.3 [SD, 15.6; p = 0.0007], respectively) and SDMT score (increase of 2.4 [SD, 7.9; p = 0.0006]). Adverse events were reported in 32 of 104 patients (30.8%). Conclusions: The reductions in Absenteeism and Work Productivity Loss and the improved physical and psychological functioning reported after 1 year of natalizumab treatment in real-world settings extend our understanding of natalizumab's effects on patient-centric and health economics outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Migraine attacks notably impact people's daily lives, health-related quality of life (HRQoL), and ability to work. Triptans are widely used as acute medication for a migraine attack but are ineffective, poorly tolerated, or contraindicated in some patients. HRQoL and work productivity are therefore likely to pose particular problems for patients whose migraine attacks do not respond sufficiently to triptan acute treatment. This real-world study aimed to determine whether migraine-related HRQoL, disability, and work productivity differed between triptan insufficient responders (TIRs) and sufficient responders (TSRs) receiving this acute treatment for migraine in Japan. Methods: This was a retrospective analysis of 2017 Adelphi Migraine Disease Specific Programme cross-sectional survey data collected from physicians and their consulting patients with migraine in Japan. Patients had to be receiving a triptan as their sole acute prescribed medication for migraine. TIRs were defined as patients who achieved headache pain freedom within 2 h of taking triptan acute treatment in no more than three of five migraine attacks. Differences in outcomes between TIRs and TSRs were examined in adjusted analyses using a multivariable general linear model. Results: Of 200 patients receiving a triptan as their sole prescribed acute treatment for migraine, 88 (44.0%) were classed as TIRs. Migraine-Specific Quality of Life Questionnaire scores were significantly lower—indicating poorer HRQoL—among TIRs than TSRs, as were mean EuroQol 5-dimension utility and visual analog scale scores (p < 0.05 for comparisons). TIRs also reported significantly (p ≤ 0.003) greater impairment than TSRs across all Work Productivity and Activity Impairment domains, with the exception of work time missed. Migraine disability was higher among TIRs than TSRs. Conclusion: Migraine attacks had a negative impact on the HRQoL, disability, and work productivity of people with migraine in Japan reporting insufficient efficacy with acute triptan treatment, highlighting the need for more effective acute treatment options. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated work and activity impairment in patients with multiple sclerosis (MS) treated with ocrelizumab (OCR) versus other disease-modifying therapies (DMTs). Methods: Data were obtained from the Adelphi Real World Disease Specific Programme for Multiple Sclerosis. Patients with relapsing–remitting or secondary progressive MS who completed surveys in 2018 and 2019 and received ≥ 6 months of an eligible therapy, including OCR, injectable therapy, and oral therapy, were included. Outcomes were assessed using the patient-reported Work Productivity and Activity Impairment questionnaire. Doubly robust estimation, which combined propensity score weighting and regression modeling, was used to compare treatments, controlling for baseline clinical and demographic characteristics. Results: This study included 630 patients (OCR, n = 90; injectable DMT, n = 224; oral DMT, n = 316) with a mean (standard deviation) age of 42 (11) years. A greater proportion of OCR-treated patients had an Expanded Disability Status Scale score of ≥ 3 at treatment initiation compared with those receiving oral and injectable DMTs (51 vs. 15% and 15%, respectively), and a smaller proportion of OCR-treated patients received treatment for ≥ 1 year (43 vs. 90% and 92%, respectively). OCR-treated patients had higher odds of employment [odds ratio (95% confidence interval) 3.4 (1.5–7.7) vs. oral DMT, 5.6 (2.6–12.0) vs. injectable DMT], lower overall work productivity loss [difference (95% confidence interval) − 10.0% (− 6.1 to − 15.0%) vs. oral DMT, − 13.0% (− 8.5 to − 17.0%) vs. injectable DMT] and lower activity impairment [difference (95% confidence interval) − 11% (− 7.1 to − 16.0%) vs. oral DMT, − 9.7% (− 5.0 to − 14.0%) vs. injectable DMT]. Conclusion: This real-world evidence suggests that patients with MS treated with OCR experience lower work and activity impairment than patients treated with other DMTs. Plain Language Summary: Multiple sclerosis (MS) is the most common progressive neurological disease in young adults. It typically starts between the ages of 20 and 40 years—arguably some of the most productive years of an individual's life—and it has a large impact on many aspects of everyday life for the rest of a person's life. The reduction in the ability to do routine activities, including working, results in a large economic burden. Disease-modifying treatments (DMTs) available for MS, particularly high-efficacy DMTs, have been shown to improve work productivity. This study looked at work and activity impairment using the Work Productivity and Activity Impairment Questionnaire in patients with MS who were treated with ocrelizumab (OCR) or other DMTs for ≥ 6 months. A total of 630 patients with relapsing–remitting MS (RRMS) or secondary progressive MS (SPMS) from the Adelphi Real World Disease Specific Programme for Multiple Sclerosis were included in the study, including 90, 316 and 224 patients who completed ≥ 6 months of treatment with OCR, oral or injectable therapy. Compared with patients receiving oral or injectable DMTs, those receiving OCR had higher odds of employment [odds ratio (OR) vs. oral DMT 3.4; OR vs. injectable DMT 5.6], lower overall work productivity impairment (difference vs. oral DMT − 10%; difference vs. injectable DMT − 13%) and lower activity impairment (difference vs. oral DMT − 11%; difference vs. injectable DMT − 9.7%). These findings in patients with RRMS or SPMS being treated in the real world suggest that OCR may reduce the impact of MS disease on work productivity more than other DMTs. [ABSTRACT FROM AUTHOR]

Background: Migraine is the leading cause of days lost due to disability in the world among people less than 50 years of age. There is a paucity of evidence on the impact of migraine and other headache disorders and the cost and productivity losses in the workplace. Methods: Employee population survey assessed prevalence, characteristics, and disability of headache disorders at a Japanese information technology company. This study was supported by the World Health Organization Western Pacific Region Office and International Headache Society. Results: 2458 (1963men, 495 women) out of 2494 responded to the survey that utilized ICHD-3 beta criteria. Among these, 13% (205 male/123 female) had migraine (M), 53% (1093 male/207 female) had tension-type headache (TTH) and 4% (61 male/27 female) had migraine and TTH (M/TTH). The number of days when productivity at work was reduced by half or more because of headache was significantly higher in migraine compared to TTH. The norm-based scoring of SF-12v2 was significantly lower in M/TTH and M than TTH. The economic loss due to absenteeism for migraine was calculated to be $ 238.3US$/year/person for day-off and 90.2US$/year/person for half-day off using migraine disability assessment score (MIDAS). The economic loss due to presenteeism for migraine was calculated to be $ 375.4US$/year/person using MIDAS and 2217US$/year/person using work productivity and activity impairment questionnaire (WPAI). Furthermore, estimated cost of productivity loss associated with presenteeism using WPAI was calculated at 21.3 billion US$/year in Japan as a whole. Conclusions: This study revealed a high prevalence and disease burden among employees with migraine that is associated with substantial losses in productivity and employer cost. These results support the development and implementation of workplace programs to improve migraine management in the workplace and reduce the burden and costs associated with lost workplace productivity. [ABSTRACT FROM AUTHOR]

Introduction/objectives: The effect of intravenous (IV) golimumab on health-related quality of life (HRQoL) and productivity in patients with ankylosing spondylitis (AS) was evaluated. Method: Patients were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo (n = 103) at weeks 0, 4, 12, with crossover to golimumab 2 mg/kg at weeks 16, 20, then q8w through week 52. Changes from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL) were assessed. Correlations between these outcomes and disease activity and patient functioning outcomes were evaluated post hoc. Results: At week 16, changes from baseline (mean ± standard deviation) in EQ-5D-5L index (0.17 ± 0.16 vs 0.05 ± 0.14), EQ-VAS (20.3 ± 24.6 vs 4.8 ± 23.5), daily productivity VAS (− 2.9 ± − 2.9 vs − 1.1 ± − 2.5), WLQ productivity loss score (− 3.5 ± − 5.3 vs − 1.9 ± − 4.0), and ASQoL (− 5.4 ± − 5.0 vs − 1.8 ± − 4.5) were greater in the IV golimumab versus placebo group, respectively. At week 28, changes from baseline were similar between the IV golimumab and placebo-crossover groups (EQ-5D-5L index: 0.18 ± 0.17 and 0.16 ± 0.16, EQ-VAS: 20.5 ± 27.9 and 22.5 ± 23.1, daily productivity VAS: − 3.1 ± − 3.0 and − 3.1 ± − 2.8, WLQ productivity loss: − 3.9 ± − 5.5 and − 4.5 ± − 4.5, and ASQoL: − 5.3 ± − 5.2 and − 5.3 ± − 4.8, respectively); improvements were maintained through week 52. HRQoL and productivity outcomes were generally moderately correlated with disease activity and functioning outcomes. Conclusions: In patients with AS, IV golimumab produced sustained improvements in HRQoL and productivity through 1 year, which correlated with improvements in disease activity and functioning. ClinicalTrials.gov registry number is NCT02186873. Key Points • Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess the association between sustained smoking and quitting with work-related outcomes among older workers. Methods: We categorized a sample of older employees into non-smokers, sustained smokers and quitters. Multivariable regression models were used to test longitudinal associations of sustained smoking and smoking cessation with sickness absence, productivity loss and work ability. Results: We included 3612 non-smokers, 673 sustained smokers and 246 quitters. Comparing sustained smokers to non-smokers, we found higher (but not statistically significant) sickness absence for sustained smokers [1.01, 95% confidence interval (CI) − 0.16–2.17]. We did not find differences in productivity loss (OR 0.82, 95% CI 0.60–1.13) and work ability (0.05, 95% CI −0.05–0.15). For employees with a relatively high physical health at baseline, comparing quitters to sustained smokers, we found higher (but not statistically significant) productivity loss for quitters (OR 2.23, 95% CI 0.94–5.31), and no difference in sickness absence (0.10, 95% CI − 2.67–2.87), and work ability (− 0.10, 95% CI − 0.36–0.16). For employees with a relatively low physical health at baseline, comparing quitters to sustained smokers, we found a statistically significant lower work ability (− 0.31, 95% CI − 0.57–0.05), and no difference in sickness absence (2.53, 95% CI − 1.29–6.34) and productivity loss (OR 1.26, 95% CI 0.66–2.39). Conclusions: We found no evidence that sustained smokers have less favorable work-related outcomes than non-smokers or that quitters have more favorable work-related outcomes than sustained smokers. The benefits of smoking cessation for employers might take a longer time to develop. [ABSTRACT FROM AUTHOR]

Introduction: Patients with ankylosing spondylitis (AS) are burdened with symptoms impacting work productivity measured by presenteeism, absenteeism, overall work impairment, and activity impairment. Ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, has been demonstrated to improve disease signs and symptoms in two phase 3 trials of AS. This study investigated for 52 weeks the effect of ixekizumab treatment on work productivity in patients with active AS. Methods: COAST-V (NCT02696785) and COAST-W (NCT02696798) were phase 3, multicenter, randomized, controlled trials investigating the efficacy of ixekizumab 80 mg every 4 weeks (Q4W) and every 2 weeks (Q2W) in patients with AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) or who were inadequate responders or intolerant to tumor necrosis factor inhibitors (TNFi; COAST-W). Work productivity was measured with the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis at weeks 16 and 52. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work. Activity impairment was assessed regardless of work status. Results: At baseline, 66.2% (434/656) of patients reported paid work. At week 16, bDMARD-naïve patients treated with both ixekizumab dose regimens and TNFi-experienced patients treated with ixekizumab Q2W reported significant improvements in activity impairment (p < 0.01 and p < 0.05, respectively). TNFi-experienced patients treated with ixekizumab showed significant improvements versus placebo in presenteeism and overall work impairment (p < 0.05); bDMARD-naïve patients had numeric improvements. After week 16, patients initially on placebo switched to ixekizumab and patients already treated with ixekizumab continued treatment. Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients. Conclusion: Both bDMARD-naïve and TNFi-experienced patients with AS had greater improvements in work productivity and activity impairment when receiving ixekizumab compared to placebo at week 16. Improvements in work productivity and activity impairment achieved at week 16 were sustained through week 52 with ixekizumab treatment. [ABSTRACT FROM AUTHOR]

Introduction: Patients with chronic hepatitis C virus infection (HCV) may incur significant indirect costs due to health-related work loss. However, the impact of curative HCV therapy on work productivity is not well characterized. We estimated the economic value of improved productivity following HCV treatment. Methods: Adults diagnosed with HCV infection (Optum Healthcare Solutions data; Q1 1999 to Q1 2017) were stratified into two cohorts: (1) treated cohort, patients who received HCV therapy and (2) untreated cohort, therapy-naïve patients. For the treated cohort, the index date was set at the end of the post-treatment monitoring period, assumed to be 6 months after the end of treatment for patients with cirrhosis or for those treated with interferon-based therapy, and 3 months after the end of treatment for patients without cirrhosis who received interferon-free therapy. For the untreated cohort, an index date was randomly selected post-HCV diagnosis. Time from the index date to the first work-loss event was assessed using time to event analyses. An economic modeling approach was used to monetize the improved productivity from reduced risk of work-loss event in the 4 years post-index. Results: Patients in the treated cohort had a lower risk of experiencing a work-loss event compared to untreated patients [unadjusted and adjusted hazard ratios and 95% CI 0.72 (0.61–0.86), and 0.68 (0.55–0.85), respectively; p < 0.001 for both]. The mean cumulative added productivity value associated with HCV treatment was US$4511 (CI $2778–$6278) at 1 year post-index and $21,429 (CI $12,733–$30,199) at 4 years post-index. Conclusion: HCV treatment reduces the risk of work loss resulting in productivity gains for employers and employees. The monetary value associated with these productivity gains is substantial, and, after about 4 years, it is comparable to the wholesale acquisition cost of some direct-acting antiviral regimens in the United States. Employers may derive economic benefits from adopting HCV elimination strategies. [ABSTRACT FROM AUTHOR]

Introduction: Psoriatic arthritis (PsA) is a chronic, systemic, inflammatory disease where disease burden and quality of life (QoL) are affected by both joint and skin manifestations. Methods: Patient and physician reported data were collected about 3200 patients in a cross-sectional survey of patients from nine countries. Patient-reported outcomes (PROs) included perceptions of symptom importance, EuroQol questionnaire (EQ-5D), Psoriatic Arthritis Impact of Disease (PsAID12), and Work Productivity and Activity Impairment (WPAI) Index. Outcomes were compared in patients with 'joint-only' and 'joint and skin' disease symptoms. Results: Of the 3200 patients, 2703 had complete information for 'joint-only' or 'joint and skin' involvement and were included in the analysis. Patients had a mean age of 49.2 years, 45.2% were female, and 64.5% had 'joint and skin' involvement. Patients with 'joint and skin' involvement had higher mean tender and swollen joint counts (5.2 and 4.8) than patients who were 'joint-only' (2.0 and 1.5). Significantly more patients with active 'joint and skin' symptoms experienced a flare (currently or within the last 12 months) compared with 'joint-only' patients (34.9 vs. 23.2%, p < 0.001). When asked to prioritize the burden of symptoms, 61.6% of patients prioritized joints, 38.4% prioritized skin. Anxiety/depression was experienced by 41.4% of patients, 62.4% of whom indicated that both joint and skin symptoms were the cause. Patients with 'joint and skin' involvement reported significantly worse QoL, work productivity and activity impairment than 'joint-only' patients (EQ-5D index 0.79 vs. 0.85, p < 0.001; EQ-5D VAS 71.98 vs. 77.68, p < 0.001; PsAID12 2.91 vs. 1.66, p < 0.001; WPAI overall work impairment 25.61 vs. 16.32, p < 0.001). Conclusions: PsA patients who experience 'joint and skin' symptoms had significantly worse clinical outcomes, health-related QoL, and work productivity compared with patients with 'joint-only' symptoms. [ABSTRACT FROM AUTHOR]

Introduction: To evaluate, from the patient's perspective, the burden of pain associated with hip/knee osteoarthritis (OA) in the USA and selected European Union (EU) countries. Methods: Data were drawn from the 2017 global Adelphi OA Disease Specific Programme™ (DSP). Patients with hip/knee OA were stratified based on pain intensity and the presence/absence of current opioid use. Outcomes included Western Ontario and McMaster Universities Osteoarthritis Index scores, functional limitations, unmet treatment needs, Charlson Comorbidity Index, relevant comorbid conditions, the 5-dimension 5-level EuroQol, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem. Bivariate testing compared outcomes using patients with no/mild pain without opioid use as the reference group. Results: The study population comprised 2170 patients (US: n = 623 [28.7%]; EU: n = 1547 [71.3%]) with knee (54.9%), hip (24.6%), or knee/hip (20.5%) OA. Mean (SD) age was 66.4 (11.2) years. Patients had no/mild pain without opioid use (39.6%), no/mild pain with opioid use (10.2%), moderate/severe pain without opioid use (30.6%), and moderate/severe pain with opioid use (19.7%). Compared with the reference group, patients with moderate/severe pain reported significantly (p < 0.05) higher functional limitations, greater use of ≥ 3 treatments and treatment dissatisfaction, reduced quality of life, and impaired work productivity and activity. The burden was highest with moderate/severe pain with opioid use. Results were generally similar in the US and EU cohorts. Conclusions: The results from this multinational cross-sectional study indicate that the impact of OA pain is multidimensional, worsened by increasing pain intensity, and may not be adequately addressed by current treatment strategies. [ABSTRACT FROM AUTHOR]

Background Community pharmacists provide an essential service by promoting, maintaining and improving the health of the community. However, factors affecting community pharmacists' work productivity remain poorly studied. Objective Our study aimed to assess, on a national level, work productivity components and its correlates among Lebanese community pharmacists. Methods: The study was carried out between March and July 2018, using a representative sample of community pharmacies from all districts of Lebanon. Main outcome measure: The work productivity components were assessed using the Work Productivity and Activity Impairment questionnaire. Results The study included 435 community pharmacists, the prevalence of sickness presenteeism and sickness absenteeism reached 91% and 45%, respectively. Presenteeism was positively associated with reporting higher depression score (β = 0.26) and insomnia (β = 0.20) whereas better mental (β = − 0.35) and physical health (β = − 0.38) were negatively associated with presenteeism. Absenteeism was positively associated with male gender (adjusted OR 2.05, 95% CI 1.14–3.70), reporting higher depression score (adjusted OR = 1.07, 95% CI 1.02–1.11) and negatively associated with better mental and physical health (adjusted OR = 0.93, 95% CI 0.90–0.96 and adjusted OR = 0.96, 95% CI 0.93–0.99; respectively). Activity impairment was positively associated with depression (β = 0.16) and insomnia (β = 0.12) and negatively associated with better mental (β = − 0.22) and physical health (β = − 0.015). Conclusion This is the first study assessing work productivity and activity impairment among Lebanese community pharmacists. Further research is needed to predict sickness absenteeism and presenteeism and this information will be useful to ensure quality of care is delivered. [ABSTRACT FROM AUTHOR]

Purpose of review: During the last two decades, the therapeutic decisions and strategies for rheumatoid arthritis (RA) management have improved dramatically. Today, the therapeutic armamentarium is significantly augmented, and by using both old and new drugs, remission or low disease activity is a reasonable goal. The use of conventional synthetic (cs) disease-modifying anti-rheumatic drugs (DMARDs) in combination with biologic (b) or targeted synthetic (ts) DMARDs has revolutionized RA treatment. Methotrexate administration is considered fundamental among other csDMARDs for the treatment of RA. It is recommended as the initial drug (monotherapy), or in combination with other csDMARDs, bDMARDs, and tsDMARDs in a step-up strategy. Furthermore, it can be used with other csDMARDs as initial combination-therapy. On the other hand, despite the fact that bDMARDs and ts DMARDs are highly efficacious and can also be used as monotherapy in certain cases, cost-effectiveness is still questionable when compared with csDMARDs. In this direction, the classic argument of utmost importance has to do with the most appropriate treatment strategy that shall be initially applied: csDMARD combination-therapy versus monotherapy, or step-up combinationtherapy with bDMARDs, especially tumor necrosis factor-α (TNFa) blockers. For this reason, a literature review of the most important csDMARDs combination and bDMARDs combination studies has been deployed. Recent findings: The results showed that the triple csDMARDs therapy approach is more effective and less expensive. In addition, workers' productivity is higher than any other treatment options for RA. Summary: Triple-therapy constitutes a smart, efficacious, and significantly cheaper choice for RA therapeutic management. [ABSTRACT FROM AUTHOR]

Background/objective: Productivity and monetary loss due to migraine in the workplace may be substantial. This study aimed to determine the impact of migraine on productivity and monetary lost among employees in the banking sectors, in a multiethnic middle income country. Methods: A cross-sectional online survey was conducted among employees in two multinational banks in Malaysia between April and July 2019. Screening for migraine was conducted using the self-administered ID-Migraine™ questionnaire. Migraine-related disability (MIDAS) and headache frequency were recorded. Impact of migraine on work productivity and activities were evaluated using the Work Productivity and Activity Impairment (WPAI) questionnaire. Results: Of the 1268 employees who submitted complete responses, 47.2% (n = 598) were screened positive for migraine. Strikingly, the mean percent productivity loss at work (presenteeism) was almost 20-fold higher than the mean percent work time missed due to migraine (absenteeism) (39.1% versus 1.9%). The mean percent productivity loss in regular activity (activity impairment) and overall work productivity loss (work impairment) was 38.4% and 39.9%, respectively. It was also found that the costs related to presenteeism (MYR 5392.6) (US$1296) was 3.5-fold higher than absenteeism (MYR1,548.3) (US$370). Highest monetary loss related to presenteeism was reported in migraineurs with frequency of headache of above 3 days (MYR 25,691.2) (US$6176), whereas highest monetary loss related to absenteeism was reported in migraineurs with MIDAS grade IV (MYR 12,369.1) (US$2973). Only 30% of migraineurs of MIDAS grade IV reported taking prescribed medication. Notably, a vast majority (96%) of migraineurs who had three or lower episodes of migraine per month did not seek treatment. Conclusion: The significant impact of migraine on work productivity and regular activity, appears to lead to substantial monetary loss attributed to not only absenteeism, but more importantly to presenteeism. This study also highlights the unmet needs in migraine management among employees in the banking sector. [ABSTRACT FROM AUTHOR]

Purpose: Patients with sickle cell disease (SCD) may experience sickle cell-related pain crises, also referred to as vaso-occlusive crises (VOCs), which are a substantial cause of morbidity and mortality. The study explored how VOC frequency and severity impacts health-related quality of life (HRQoL) and work productivity.Methods: Three hundred and three adults with SCD who completed an online survey were included in the analysis. Patients answered questions regarding their experience with SCD and VOCs, and completed the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) and the Workplace Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP). Differences in ASCQ-Me and WPAI:SHP domains were assessed according to VOC frequency and severity.Results: Nearly half of the patient sample (47.2%) experienced ≥ 4 VOCs in the past 12 months. The most commonly reported barriers to receiving care for SCD included discrimination by or trouble trusting healthcare professionals (39.6%, 33.3%, respectively), limited access to treatment centers (38.9%), and difficulty affording services (29.4%). Patients with more frequent VOCs reported greater impacts on emotion, social functioning, stiffness, sleep and pain, and greater absenteeism, overall productivity loss, and activity impairment than patients with less frequent VOCs (P < 0.05). Significant impacts on HRQoL and work productivity were also observed when stratifying by VOC severity (P < 0.05 for all ASCQ-Me and WPAI domains, except for presenteeism).Conclusions: Results from the survey indicated that patients with SCD who had more frequent or severe VOCs experienced deficits in multiple domains of HRQoL and work productivity. Future research should examine the longitudinal relationship between these outcomes. [ABSTRACT FROM AUTHOR]

Background: Migraine is a chronic, disabling neurological disease characterized by moderate-to-severe headache pain with other symptoms, including nausea, vomiting, and photophobia. Triptans, while generally effective, are insufficiently efficacious in 30–40% of patients and poorly tolerated by or contraindicated in others. We assessed the impact of insufficient response to triptans on health-related quality of life (HRQoL) and work productivity in patients currently receiving any prescribed triptan formulation as their only acute migraine medication. Methods: Data were from the 2017 Adelphi Migraine Disease Specific Programme, a cross-sectional survey of primary care physicians, neurologists, and headache specialists and their consulting patients with migraine in the USA, France, Germany, Italy, Spain, and UK. Triptan insufficient responders (TIRs) achieved freedom from headache pain within 2 h of acute treatment in ≤3/5 migraine attacks; triptan responders (TRs) achieved pain freedom within 2 h in ≥4/5 attacks. Multivariable general linear model examined differences between TIRs and TRs in HRQoL and work productivity. Logistic regression identified factors associated with insufficient response to triptans. Results: The study included 1413 triptan-treated patients (TIRs: n = 483, 34.2%; TRs: n = 930, 65.8%). TIRs were more likely to be female (76% vs. 70% for TIRs vs TRs, respectively; p = 0.011), older (mean age 42.6 vs. 40.5 years; p = 0.003), and had more headache days/month (7.0 vs. 4.4; p < 0.001). TIRs had significantly more disability, with higher Migraine Disability Scores (MIDAS; 13.2 vs. 7.7; p < 0.001), lower Migraine-specific Quality of Life scores, indicating greater impact (Role Function Restrictive: 62.4 vs. 74.5; Role Function Preventive: 70.0 vs. 82.2; Emotional Function: 67.7 vs. 82.1; all p < 0.001), and lower EQ5D utility scores (0.84 vs. 0.91; p = 0.001). Work productivity and activity were impaired (absenteeism, 8.6% vs. 5.1% for TIRs vs. TRs; presenteeism, 34.3% vs. 21.0%; work impairment, 37.1% vs. 23.3%; overall activity impairment, 39.8% vs. 25.3%; all p < 0.05). Conclusion: HRQoL and work productivity were significantly impacted in TIRs versus TRs in this real-world analysis of patients with migraine acutely treated with triptans, highlighting the need for more effective treatments for patients with an insufficient triptan response. Further research is needed to establish causal relationships between insufficient response and these outcomes. [ABSTRACT FROM AUTHOR]

Background: Gliomas are associated with significant healthcare burden, yet reports of costs are scarce. While many costs are unavoidable there may be treatable symptoms contributing to higher costs. We describe healthcare and societal costs in glioma patients at high risk for depression and their family caregivers, and explore relationships between costs and treatable symptoms. Methods: Data from a multicenter randomized trial on effects of internet-based therapy for depressive symptoms were used (NTR3223). Costs of self-reported healthcare utilization, medication use, and productivity loss were calculated for patients and caregivers separately. We used generalized linear regression models to predict costs with depressive symptoms, fatigue, cognitive complaints, tumor grade (low-/high-grade), disease status (stable or active/progression), and intervention (use/non-use) as predictors. Results: Multiple assessments from baseline through 12 months from 91 glioma patients and 46 caregivers were used. Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers. In patients, higher healthcare utilization costs were associated with more depressive symptoms; higher medication costs were associated with active/progressive disease. In caregivers, higher overall costs were linked with increased caregiver fatigue, cognitive complaints, and lower patient tumor grade. Higher healthcare utilization costs were related to more cognitive complaints and lower tumor grade. More productivity loss costs were associated with increased fatigue (all P < 0.05). Conclusions: There are substantial healthcare and societal costs for glioma patients and caregivers. Associations between costs and treatable psychological symptoms indicate that possibly, adequate support could decrease costs. Trial registration: Netherlands Trial Register NTR3223. [ABSTRACT FROM AUTHOR]

We provide a general overview of spatial distribution and the economic situation of aquaculture enterprises in Czechia (the Czech Republic) in terms of revenues, profitability, work productivity, indebtedness and grants. We analysed data available in the State Veterinary Administration and information system of the State Agricultural Intervention Fund. The most significant fish producers (enterprises) are located in the regions of South Bohemia. Aquaculture sector profitability and enterprises profits have been moderately rising since 2010. The profitability in 2015 is roughly the same as that in 2005. The amount of provided grants showed a higher value than the generated average annual profits. The enterprises were not able to generate sufficient resources to finance investments without grants resources. Enterprises that realised financing for larger investments from bank credits showed relatively high levels of indebtedness (micro-enterprises at 95.5%). On the contrary, work productivity was the highest for micro-enterprises. Micro-enterprises had the largest share of revenues in relation to the number of employees. Each group of enterprises is considerably specific and needs an individual approach for the subsequent evaluation. [ABSTRACT FROM AUTHOR]

Introduction: The Work Productivity and Activity Impairment Specific Health Problem Questionnaire (WPAI:SHP) is used to assess the impact of an intervention on work productivity in patients with psoriatic arthritis (PsA). Unfortunately, studies reporting changes or improvements in domains of WPAI:SHP by patients with PsA have a limited threshold of meaning due to the absence of published minimal clinically important differences (MCIDs). Our objective was to determine the MCIDs for improvement in WPAI:SHP in patients with active PsA. Methods: MCIDs for WPAI:SHP domains (presenteeism, work productivity loss, and activity impairment) were derived for patients with active PsA who were biologic naïve or TNF inhibitor (TNFi) experienced using 24-week results from two phase 3 trials (SPIRIT-P1 and SPIRIT-P2). MCIDs were derived using the anchor-based method supplemented by the distribution-based method. Anchors included achievement of the American College of Rheumatology 20 responder index (ACR20), the minimal disease activity (MDA), and the Health Assessment Questionnaire and Disability Index (HAQ-DI) MCID (improvement ≥ 0.35). Anchor validity was assessed by biserial correlation and analysis of covariance modeling against the domains. MCIDs were triangulated using the receiver operating characteristic (ROC) method supplemented by the distribution-based method. Results: The analyses included 417 biologic-naïve and 363 TNFi-experienced patients. ACR20, MDA, and HAQ-DI were valid anchors. Significant differences in WPAI:SHP domain scores were observed between patients achieving ACR20, MDA, or HAQ-DI compared to patients not achieving these clinical thresholds (all P < 0.001). ROC analyses suggested that a ≥ 20% improvement in presenteeism, a 15% improvement in work productivity loss, and a 20% improvement in activity impairment represented clinically meaningful improvements in both populations. The distribution-based method supported the results. Conclusion: MCIDs for the presenteeism, work productivity loss, and activity impairment domains were estimated to be 20%, 15%, and 20%, respectively, in biologic-naïve or TNFi-experienced PsA populations. These results will help improve the meaningfulness of WPAI:SHP improvements reported by PsA patients. Trial Registration: SPIRIT-P1: NCT01695239, SPIRIT-P2: NCT02349295. Funding: Eli Lilly and Company. [ABSTRACT FROM AUTHOR]

Purpose: Advanced non-small cell lung cancer (aNSCLC) impacts the lives of patients and their caregivers. This analysis examined the association between patient clinical characteristics and patient and caregiver humanistic burden.Methods: Data for patients with aNSCLC and their informal caregivers in France, Germany and Italy, were collected between May 2015 and June 2016 via chart review and patient and caregiver surveys. Patients and caregivers completed validated instruments to evaluate their health state (EuroQol-5-dimensions-3-levels [EQ-5D-3L]), work and activity impairment (Work Productivity Activity Impairment [WPAI]) and health-related quality of life (HRQoL; European Organisation for Research and treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]). Caregivers also completed the Zarit Burden Interview (ZBI). Univariate and regression analyses were stratified by patient Eastern Cooperative Group Performance Status (ECOG-PS 0, 1, 2 or 3/4).Results: In total, 1030 patients and 427 accompanying informal caregivers participated. Regression analyses indicated that patients reported lower EQ-5D-3L utility index, EQ-VAS and EORTC QLQ-C30 global health status and greater work and activity impairment with worsening ECOG-PS (all p < 0.05). Caregivers also reported greater activity impairment and higher ZBI scores with worsening ECOG-PS of the patient they were providing care for (all p < 0.05).Conclusions: As patients' functionality deteriorates as measured by the ECOG-PS, so do their outcomes related to health utility, work productivity, activity impairment and HRQoL. This deterioration is also reflected in increased caregiver burden and activity impairment. There is a need for interventions to maintain patients' physical function to relieve the humanistic burden of both patients and caregivers. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the humanistic burden on caregivers of patients with advanced non-small cell lung cancer (aNSCLC) as the disease progresses.Methods: Data were drawn from a cross-sectional study of patients with aNSCLC and their caregivers conducted in France, Germany, and Italy between 2015 and 2016. Data were collected by medical chart review and patient and caregiver questionnaires. The EuroQol five-dimension three-level (EQ-5D-3L) was used to evaluate patient and caregiver health status. Caregivers also completed the Work Productivity and Activity Impairment (WPAI) questionnaire and Zarit Burden Interview (ZBI).Results: The population for the analysis consisted of 427 caregivers (mean age 53.5 years; 72.6% female; 54.9% spouse; 36.2% in full-time employment) and 427 matched patients (mean age 66.2 years; 68.6% male). Most (69.5%) patients were receiving first-line therapy for advanced disease. Patients' caregivers provided a mean of 29.5 h of support per week. Significant differences in EQ-5D-3L scores were observed between caregivers of patients receiving first and later lines of therapy in France (0.87 vs. 0.78; p = 0.0055). Among employed caregivers, overall work impairment was considerable and ranged from 21.1% in Germany to 30.4% in France and 29.7% in Italy. Caregivers of patients receiving later lines of therapy in France rated their own health status as significantly worse than did those caring for patients receiving first-line therapy (82.7 vs. 72.9; p = 0.0039).Conclusions: Informal caregivers provided the majority of support for patients with advanced NSCLC and their caregiving activities impose a significant humanistic burden. [ABSTRACT FROM AUTHOR]

Background: We examined the association between caregiver burden and work productivity (i.e., absenteeism, presenteeism, and overall work impairment) among working family caregivers of people with dementia and whether job characteristics (i.e., job demands, job control, supervisor and coworker support) moderate this association. Methods: A cross-sectional correlational study design using a web-based questionnaire survey was conducted among 379 Japanese working family caregivers of people with dementia (105 female, age range 20–77) in May 2016, which measured caregiver burden, work productivity, care situation, job characteristics, and demographics. Caregiver burden was designated as an independent variable and each aspect of work productivity as a dependent variable in a hierarchical multiple regression analysis, adjusting for demographics. Interaction terms between caregiver burden and each job characteristic were also included in the model. Results: Caregiver burden was significantly and positively associated with presenteeism (β = 0.219, p < 0.001) and overall work impairment (β = 0.181, p < 0.001), while the association of caregiver burden with absenteeism was not significant (β = − 0.003, p = 0.953). Interaction effects of caregiver burden × coworker support on presenteeism (β = − 0.189, p = 0.023) and overall work impairment (β = − 0.172, p = 0.034) were significant. According to simple slope analyses, caregiver burden was greater at lower levels of coworker support compared to higher levels of coworker support for both presenteeism and overall work impairment. Conclusions: Our study suggests that higher caregiver burden is associated with a decrease in work productivity. Additionally, coworker support appears to buffer the association of caregiver burden with presenteeism and overall work impairment among working family caregivers of people with dementia. [ABSTRACT FROM AUTHOR]

Introduction: This study investigated the effectiveness of adalimumab treatment in improving Work Productivity and Activity Impairment (WPAI) in patients with psoriatic arthritis (PsA) in real-world settings in Japan.Methods: This 24-week, single-arm, postmarketing surveillance study (2014-2017), conducted at 75 centers in Japan, enrolled adalimumab-naïve patients (paid workers, including part-time) meeting ClASsification criteria for Psoriatic ARthritis (CASPAR). The primary endpoint was improvement in overall work impairment (OWI) scores from baseline to week 24. Secondary endpoints included changes in WPAI-PsA (OWI, absenteeism, presenteeism, and activity impairment), Psoriasis Area and Severity Index (PASI), psoriatic arthritis screening and evaluation (PASE) scores, Disease Activity Scores in 28 joints using C-reactive protein (DAS28[CRP]), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, and PASI75/90 and American College of Rheumatology (ACR) 20/50/70 rates.Results: In the effectiveness population (n = 106; 72.6% men; mean ± standard deviation [SD] age, 49.3 ± 10.7 years), OWI scores significantly improved (mean ± SD change, - 25.2 ± 35.3; p < 0.0001) from baseline to week 24. Other WPAI domain scores also improved significantly. Changes in OWI were significantly correlated (p < 0.0001) with PASE (r = 0.6284), DAS28(CRP) (r = 0.6059), BASDAI (r = 0.7281), and HAQ-DI (r = 0.6161) scores and were significantly influenced by previous nonsteroidal anti-inflammatory drug use (p = 0.0142), and baseline PASE (p = 0.0098), DAS28(CRP) (p = 0.0026), HAQ-DI (p = 0.0004), and BASDAI (p < 0.0001) scores. At the last evaluation, rate (95% confidence interval) of PASI 75 and 90 (n = 100) was 58.0% (47.7-67.8) and 39.0% (29.4-49.3), respectively, and that of ACR 20, 50, and 70 (n = 58) was 86.2% (74.6-93.9), 70.7% (57.3-81.9), and 53.4% (39.9-66.7), respectively. No new safety signals were observed in the safety population (n = 148).Conclusion: Adalimumab treatment improved WPAI in patients with PsA. Improvements in OWI and joint symptoms were significantly associated.Trial Registration Number: ClinicalTrials.gov identifier: NCT02414633.Funding: AbbVie GK and Eisai Co., Ltd. [ABSTRACT FROM AUTHOR]

Background: Evidence of humanistic detriments of Clostridium difficile infection (CDI) remains limited.Aims: To assess humanistic burden associated with CDI.Methods: Self-reported National Health and Wellness Survey data between 2013 and 2016 were analyzed for the USA, five European countries, China, and Brazil. Outcome measures included SF-36v2® for health-related quality of life (HRQoL) and Work Productivity and Activity Impairment questionnaire. Respondents (≥ 18 years old) were classified as (1) currently treated doctor-diagnosed CDI (C-CDI), (2) doctor-diagnosed prior CDI (P-CDI), or (3) never experienced CDI (NO-CDI). Regression modeling assessed the association between CDI status and outcomes, adjusting for potential confounders.Results: Of 352,780 respondents, 299, 2111, and 350,370 met the criteria for C-CDI, P-CDI, and NO-CDI, respectively, with 45% of the total from the USA. C-CDI and P-CDI respondents were older, were less often employed and had more comorbidities than those with NO-CDI. After adjustment for covariates, C-CDI and P-CDI had significantly lower HRQoL relative to NO-CDI for mental (MCS 39, 43 vs. 46) and physical (PCS 39, 41 vs. 46) component summary scores, and health utility (SF-6D 0.58, 0.64 vs. 0.71) (all p < 0.05), meeting common thresholds for minimally important differences. Those with C-CDI and P-CDI reported missing more work (21, 16 vs. 8%), greater impairment while working (43, 34 vs. 22%), and more activity impairment (61, 49 vs. 34%) than those with NO-CDI (all p < 0.05), respectively.Conclusions: CDI is associated with meaningfully worse HRQoL and greater impairment to work and activities compared with NO-CDI. The impairment directly attributable to CDI requires further evaluation. [ABSTRACT FROM AUTHOR]

Purpose: This study examined the relationship between perceived cognitive function including perceived cognitive impairment (PCI) and perceived cognitive ability (PCA) and work ability, work performance, work productivity, and intention to leave employment in breast cancer survivors (BCS).Methods: A cross-sectional study design was used in the study. Employed BCS completed questionnaires assessing PCI and PCA (Functional Assessment of Cancer Therapy-Cognitive-3); emotional work demands (Self-Focused Emotional Labor Scale); and work ability index (WAI), work performance, work productivity (Work Limitations Questionnaire (WLQ), and intention to turnover. Separate regression models examined the relationship between PCI and PCA and work-related outcomes.Results: Participants were 68 employed female BCS who were on average 52 (SD = 8.6) years old and 5 (SD = 3.8) years post-treatment with majority working full time. PCI was associated with poorer work ability (B = - 0.658), work performance (time-B = 0.647, physical-B = - 0.414, and mental-B = 0.689), and work productivity (B = 0.731), but not intent to leave work. PCA was related to higher levels of work ability (B = 0.472), work performance (time-B = - 0.462 and mental-B = - 0.453), and work productivity (β = - 0.494), but not physical demands or intent to turnover.Conclusions: Employed BCS with negative perceptions of cognitive function reported poorer work outcomes with the exception of the intent to leave employment. In contrast, positive views of one's cognitive abilities were related to improved ratings of work outcomes again with the exception of intent to leave employment.Implications For Cancer Survivors: Healthcare providers need to assess and address perceived cognitive functioning to promote work-related outcomes in BCS. [ABSTRACT FROM AUTHOR]

Myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET) are myeloproliferative neoplasms (MPNs) associated with high disease burden, reduced quality of life (QOL), and shortened survival. To assess how MPNs affect patients, we conducted a global MPN Landmark survey. This online survey of patients with MPNs and physicians was conducted in Australia, Canada, Germany, Japan, Italy, and the United Kingdom. The survey measured MPN-related symptoms and the impact of MPNs on QOL and the ability to work as well as disease-management strategies. Overall, 219 physicians and 699 patients (MF, n = 174; PV, n = 223; ET, n = 302) completed the survey; 90% of patients experienced MPN-related symptoms. The most frequent and severe symptom was fatigue. Most patients experienced a reduction in QOL, including those with low symptom burden or low-risk scores. A substantial proportion of patients reported impairment at work and in overall activity. Interestingly, physician feedback and blood counts were the most important indicators of treatment success among patients, with improvements in symptoms and QOL being less important. Regarding disease management, our study revealed a lack of alignment between physician and patient perceptions relating to communication and disease management, with patients often having different treatment goals than physicians. Overall, our study suggested that therapies that reduce symptom burden and improve QOL in patients with MPNs are crucial in minimizing disease impact on patient daily lives. Additionally, our findings showed a need for improved patient-physician communication, standardized monitoring of symptoms, and agreement on treatment goals. [ABSTRACT FROM AUTHOR]

Introduction: Dimethyl fumarate (DMF) is a novel oral therapy used for the treatment of relapse-remitting multiple sclerosis (RRMS). In two 2-year pivotal Phase 3 trials in patients with RRMS, DMF significantly reduced disease activity based on both clinical and magnetic resonance imaging (MRI) findings and demonstrated an acceptable safety profile. However, there is currently a lack of comparative data which explore the relationship between work productivity and health-related quality of life (HRQoL) outcomes in RRMS and how these differ among RRMS therapies, including DMF. Methods: We explored this relationship through patient-reported data from the EuroQol Five-Dimensions (EQ-5D) tool, Work Productivity and Activity Impairment Questionnaire (WPAI), and the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) using the Adelphi MS DSP® dataset. Results: Our data demonstrated that patients receiving DMF experienced better outcomes, relative to patients receiving beta (β)interferons or glatiramer acetate, in all WPAI subscales [overall; average treatment effect (ATE) −13.92, 95% confidence interval (CI) −18.87 to −7.08; p < 0.001], EQ-5D (ATE +0.075, 95% Cl 0.014-0.136; p = 0.016) and HAQUAMS [ATE −0.45, 95% Cl −0.61 to −0.29; p < 0.001]. The EQ-5D and HAQUAMS were used with WPAI to determine the relationship between HRQoL outcomes and work productivity. Multiple linear regression analyses were performed, adjusting for age, sex, body mass index, ethnicity and number of comorbid conditions. Conclusions: These data demonstrate that therapy with DMF was associated with increased work productivity and HRQoL for patients with RRMS and that these outcomes were consistently improved compared to outcomes with interferon and glatiramer acetate therapies. [ABSTRACT FROM AUTHOR]

Purpose: Patients with inflammatory bowel disease (IBD) often experience severe impairment in different life domains. Psychological factors, such as illness perceptions and coping, may play a role in the adjustment to IBD as indicated by mental and physical health, activity, and work impairment. The present study aimed at examining the assumption of the Common Sense Model (CSM) that coping mediates the relationship between illness perceptions and adjustment in patients with IBD. Method: In a cross-sectional design, 211 IBD patients (73 % Crohn's disease, 40 % male, mean age 42.9 ± 12.9 years) attending an outpatient clinic completed questionnaires assessing illness perceptions (IPQ-R), coping (CORS), mental and physical health (SF-36), as well as activity and work impairment (WPAI). Multiple mediation analyses were applied that allow estimating the total and direct effects of all illness perception dimensions and the indirect effects through all coping strategies on the illness outcomes simultaneously. Results: The analyses yielded significant direct effects of perceptions regarding the cyclical course, the chronic course, the severity of the consequences, the comprehensibility, and the emotional impact of IBD on study outcomes. Additionally, significant indirect effects were found for the perceptions regarding the severity of the consequences, the possibility of personal control, and the comprehensibility of IBD on mental and physical health as well as activity impairment through the use of one specific coping strategy, i.e., reduction of activity. Conclusion: The results provide evidence for the assumptions of the CSM and suggest the importance of addressing illness perceptions and activity stimulation in quality health care for IBD patients. [ABSTRACT FROM AUTHOR]