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Objectives To investigate the predictive validity of 32 measures of the Danish Psychosocial Work Environment Questionnaire (DPQ) against two criteria variables: onset of depressive disorders and long-term sickness absence (LTSA). Methods The DPQ was sent to 8958 employed individuals in 14 job groups of which 4340 responded (response rate: 48.4%). Depressive disorders were measured by self-report with a 6-month follow-up. LTSA was measured with a 1-year follow-up in a national register. We analyzed onset of depressive disorders at follow-up using logistic regression models, adjusted for age, sex, and job group, while excluding respondents with depressive disorders at baseline. We analyzed onset of LTSA with Cox regression models, adjusted for age, sex, and job group, while excluding respondents with previous LTSA. Results The general pattern of the results followed our hypotheses as high job demands, poorly organized working conditions, poor relations to colleagues and superiors, and negative reactions to the work situation predicted onset of depressive disorders at follow-up and onset of LTSA during follow-up. Analyzing onset of depressive disorders and onset of LTSA, we found risk estimates that deviated from unity in most of the investigated associations. Overall, we found higher risk estimates when analyzing onset of depressive disorders compared with onset of LTSA. Conclusions The analyses provide support for the predictive validity of most DPQ-measures. Results suggest that the DPQ constitutes a useful tool for identifying risk factors for depression and LTSA in the psychosocial work environment.

Objective: Patient-reported transition ratings are supposed to reflect the change between a previous baseline health state and a present follow-up state, but may reflect the present state to a greater extent. This so-called “present state bias” (PSB) potentially threatens the validity of transition ratings. Several criteria have been proposed to assess PSB. We examined how well these criteria perform and to which extent confirmatory factor analysis (CFA) for categorical data provides an accurate assessment of the degree of PSB. Study Design and Setting: We simulated multiple samples with baseline and follow-up item responses to a hypothetical questionnaire, and transition ratings. The samples varied with respect to various distributional characteristics and the degree of PSB. The performance of criteria proposed in the literature, and a new CFA-based criterion, were evaluated by the proportion of explained variance in PSB. In addition, four real datasets were analyzed. Results: The known criteria explained 36–74% of the variance in PSB. A new CFA-based criterion, namely the ratio of the factor loadings of the transition ratings plus one, explained 81–98% of the variance in PSB across the samples. Conclusion: Present state bias in transition ratings can be estimated accurately using CFA.

PurposeMeaningful thresholds are needed to interpret patient-reported outcome measure (PROM) results. This paper introduces a new method, based on item response theory (IRT), to estimate such thresholds. The performance of the method is examined in simulated datasets and two real datasets, and compared with other methods.MethodsThe IRT method involves fitting an IRT model to the PROM items and an anchor item indicating the criterion state of interest. The difficulty parameter of the anchor item represents the meaningful threshold on the latent trait. The latent threshold is then linked to the corresponding expected PROM score. We simulated 4500 item response datasets to a 10-item PROM, and an anchor item. The datasets varied with respect to the mean and standard deviation of the latent trait, and the reliability of the anchor item. The real datasets consisted of a depression scale with a clinical depression diagnosis as anchor variable and a pain scale with a patient acceptable symptom state (PASS) question as anchor variable.ResultsThe new IRT method recovered the true thresholds accurately across the simulated datasets. The other methods, except one, produced biased threshold estimates if the state prevalence was smaller or greater than 0.5. The adjusted predictive modeling method matched the new IRT method (also in the real datasets) but showed some residual bias if the prevalence was smaller than 0.3 or greater than 0.7.ConclusionsThe new IRT method perfectly recovers meaningful (interpretational) thresholds for multi-item questionnaires, provided that the data satisfy the assumptions for IRT analysis. Purpose: Meaningful thresholds are needed to interpret patient-reported outcome measure (PROM) results. This paper introduces a new method, based on item response theory (IRT), to estimate such thresholds. The performance of the method is examined in simulated datasets and two real datasets, and compared with other methods. Methods: The IRT method involves fitting an IRT model to the PROM items and an anchor item indicating the criterion state of interest. The difficulty parameter of the anchor item represents the meaningful threshold on the latent trait. The latent threshold is then linked to the corresponding expected PROM score. We simulated 4500 item response datasets to a 10-item PROM, and an anchor item. The datasets varied with respect to the mean and standard deviation of the latent trait, and the reliability of the anchor item. The real datasets consisted of a depression scale with a clinical depression diagnosis as anchor variable and a pain scale with a patient acceptable symptom state (PASS) question as anchor variable. Results: The new IRT method recovered the true thresholds accurately across the simulated datasets. The other methods, except one, produced biased threshold estimates if the state prevalence was smaller or greater than 0.5. The adjusted predictive modeling method matched the new IRT method (also in the real datasets) but showed some residual bias if the prevalence was smaller than 0.3 or greater than 0.7. Conclusions: The new IRT method perfectly recovers meaningful (interpretational) thresholds for multi-item questionnaires, provided that the data satisfy the assumptions for IRT analysis.

Objective: This study aimed to gain insight into decision-making strategies individuals used when evaluating pairs of SF-6Dv2 health states in discrete choice experiments (DCEs). Methods: This qualitative, cross-sectional, noninterventional study asked participants to use a think-aloud approach to compare SF-6Dv2 health states in DCEs. Thematic analysis focused on comprehension and cognitive strategies used to compare health states and make decisions. Results: Participants (N = 40) used 3 main strategies when completing DCEs: (1) trading, (2) reinterpretation, and (3) relying on previous experience. Trading was the most common strategy, used by everyone at least once, and involved prioritizing key attributes, such as preferring a health state with significant depression but no bodily pain. Reinterpretation was used by 17 participants and involved reconstructing health states by changing underlying assumptions (eg, rationalizing selecting a health state with significant pain because they could take pain medications). Finally, some (n = 13) relied on previous experience when making decisions on some choice tasks. Participants with experience dealing with pain, for instance, prioritized health states with the least impact in this dimension. Conclusions: Qualitatively evaluating the decision-making strategies used in DCEs allows researchers to evaluate whether the tasks and attributes are interpreted accurately. The findings from this study add to the understanding of the generation of SF-6Dv2 health utility weights and the validity of these weights (e.g., reinterpreting health states could undermine the validity of DCEs and utility weights), and the overall usefulness of the SF-6Dv2. The methodology described in this study can and should be carried forth in valuing other health utility measures, not just the SF-6Dv2.

PurposeThresholds for meaningful within-individual change (MWIC) are useful for interpreting patient-reported outcome measures (PROM). Transition ratings (TR) have been recommended as anchors to establish MWIC. Traditional statistical methods for analyzing MWIC such as mean change analysis, receiver operating characteristic (ROC) analysis, and predictive modeling ignore problems of floor/ceiling effects and measurement error in the PROM scores and the TR item. We present a novel approach to MWIC estimation for multi-item scales using longitudinal item response theory (LIRT).MethodsA Graded Response LIRT model for baseline and follow-up PROM data was expanded to include a TR item measuring latent change. The LIRT threshold parameter for the TR established the MWIC threshold on the latent metric, from which the observed PROM score MWIC threshold was estimated. We compared the LIRT approach and traditional methods using an example data set with baseline and three follow-up assessments differing by magnitude of score improvement, variance of score improvement, and baseline-follow-up score correlation.ResultsThe LIRT model provided good fit to the data. LIRT estimates of observed PROM MWIC varied between 3 and 4 points score improvement. In contrast, results from traditional methods varied from 2 to 10 points—strongly associated with proportion of self-rated improvement. Best agreement between methods was seen when approximately 50% rated their health as improved.ConclusionResults from traditional analyses of anchor-based MWIC are impacted by study conditions. LIRT constitutes a promising and more robust analytic approach to identifying thresholds for MWIC. Purpose: Thresholds for meaningful within-individual change (MWIC) are useful for interpreting patient-reported outcome measures (PROM). Transition ratings (TR) have been recommended as anchors to establish MWIC. Traditional statistical methods for analyzing MWIC such as mean change analysis, receiver operating characteristic (ROC) analysis, and predictive modeling ignore problems of floor/ceiling effects and measurement error in the PROM scores and the TR item. We present a novel approach to MWIC estimation for multi-item scales using longitudinal item response theory (LIRT). Methods: A Graded Response LIRT model for baseline and follow-up PROM data was expanded to include a TR item measuring latent change. The LIRT threshold parameter for the TR established the MWIC threshold on the latent metric, from which the observed PROM score MWIC threshold was estimated. We compared the LIRT approach and traditional methods using an example data set with baseline and three follow-up assessments differing by magnitude of score improvement, variance of score improvement, and baseline-follow-up score correlation. Results: The LIRT model provided good fit to the data. LIRT estimates of observed PROM MWIC varied between 3 and 4 points score improvement. In contrast, results from traditional methods varied from 2 to 10 points—strongly associated with proportion of self-rated improvement. Best agreement between methods was seen when approximately 50% rated their health as improved. Conclusion: Results from traditional analyses of anchor-based MWIC are impacted by study conditions. LIRT constitutes a promising and more robust analytic approach to identifying thresholds for MWIC.

Background There are increasing concerns about the appropriateness of generic preference-based measures to capture health benefits in the area of mental health. Objectives The aim of this study is to estimate preference weights for a new measure, Recovering Quality of Life (ReQoL-10), to better capture the benefits of mental healthcare. Methods Psychometric analyses of a larger sample of mental health service users (n = 4266) using confirmatory factor analyses and item response theory were used to derive a health state classification system and inform the selection of health states for utility assessment. A valuation survey with members of the UK public representative in terms of age, sex, and region was conducted using face-to-face interviewer administered time-trade-off with props. A series of regression models were fitted to the data and the best performing model selected for the scoring algorithm. Results The ReQoL-Utility Index (UI) classification system comprises 6 mental health items and 1 physical health item. Sixty-four health states were valued by 305 participants. The preferred model was a random effects model, with significant and consistent coefficients and best model fit. Estimated utilities modeled for all health states ranged from −0.195 (state worse than dead) to 1 (best possible state). Conclusions The development of the ReQoL-UI is based on a novel application of item response theory methods for generating the classification system and selecting health states for valuation. Conventional time-trade-off was used to elicit utility values that are modeled to enable the generation of QALYs for use in cost-utility analysis of mental health interventions., Highlights • In light of concerns around the use of EQ-5D to assess mental health outcomes, there is a need for a new generic preference-based measure with focus on mental health for use in the economic evaluation of interventions aimed at improving outcomes in this area. • This paper uses item response theory (IRT) to construct a health classification system for the ReQoL-10 and the ReQoL-20. IRT was also used in a novel way to select health states amenable for valuation, ensuring the plausibility of these states. Preference weights were generated to enable utilities to be calculated from ReQoL-10 and ReQoL-20. • The paper highlights a novel method of selecting health states for valuation purposes. An algorithm is presented to generate quality adjusted life years from the ReQoL measures for use in the economic evaluation of health and care interventions in the area of mental health. Future research comparing ReQoL-UI and EQ-5D will determine whether the former presents an improvement in capturing benefits in the area of mental health.

Objectives Tension-type headache (TTH) is the most prevalent primary headache disorder. We assessed the cross-sectional impact of TTH on health related quality of life (HRQoL) in a general population. We also examined the association of HRQoL scores with headache frequency, disability, medication overuse, poor self-rated health, psychiatric comorbidity, and pain sensitivity in individuals with TTH. Methods A sample of 547 subjects completed a headache diagnostic interview, the SF-12 to calculate physical (PCS) and mental (MCS) health component scores, depression (major depression inventory [MDI]) and neuroticism (Eysenck Personality Questionnaire) measures. We defined the following headache diagnosis categories: pure TTH, pure migraine, and coexistent headache (TTH + migraine). Cases were further classified into chronic (≥15) or episodic ( Results Using generalized linear models (GLM) adjusted for age, sex and education, both PCS-12 and MCS-12 scores varied in groups distinguished by migraine and TTH status; scores were lower for individuals with coexistent headache (TTH + migraine; n=83), followed by pure TTH (n=97) and pure migraine (n=43) compared to the no headache group (n=324) (p≤0.001). In analyses considering chronicity, PCS-12 scores were lower in chronic coexistent headache followed by pure chronic TTH (CTTH), episodic migraine +/− episodic TTH (ETTH) and pure ETTH than in the no headache group (p≤0.001). MCS-12 scores were lower in pure CTTH, followed by chronic coexistent headache, episodic migraine +/− ETTH and pure ETTH compared to the no headache group (p≤0.001). Multiple regression models showed that in TTH, lower PCS-12 scores were associated with age (p=0.04), female sex (p=0.02), and poor self-rated health (p≤0.001). Lower MCS-12 scores in TTH were associated with depression (p≤0.001). Conclusions In a population sample, TTH, and to higher degree CTTH, are associated with decreased HRQoL.

Background In 2013, Denmark implemented a reform that tightened the criteria for disability pension, expanded a subsidized job scheme (‘flexi-job’) and introduced a new vocational rehabilitation scheme. The overall aim of the reform was to keep more persons attached to the labour market. This study investigates the impact of the reform among persons with chronic disease and whether this impact differed across groups defined by labour market affiliation and chronic disease type. Methods The study was conducted as a register-based, nationwide cohort study. The study population included 480 809 persons between 40 and 64 years of age, who suffered from at least one of six chronic diseases. Hazard ratios (HR) and 95% confidence intervals (CI) of being awarded disability pension or flexi-job in the 5 years after vs. the 5 years prior to the reform were estimated. Results Overall, the probability of being awarded disability pension was halved after the reform (HR = 0.49, CI: 0.47–0.50). The impact was largest for persons receiving sickness absence benefits (HR = 0.31, CI: 0.24–0.39) and for persons with functional disorders (HR = 0.38, CI: 0.32–0.44). Also, the impact was larger for persons working in manual jobs than for persons working in non-manual jobs. The probability of being awarded a flexi-job was decreased by one-fourth (HR = 0.76, CI: 0.74–0.79) with the largest impact for high-skilled persons working in non-manual jobs. Conclusion Access to disability pension and flexi-job decreased after the reform. This impact varied according to labour market affiliation and chronic disease type.

Background This survey examined the experiences of people living with schizophrenia who have used oral antipsychotics (APs). Methods Adults with self-reported physician-diagnosed schizophrenia (N=200), who were members of an online research participation panel and reported taking one or more oral APs within the last year, completed a cross-sectional online survey that focused on direct report of their experiences regarding APs (eg, symptoms, side effects, adherence). Descriptive analyses were conducted for the total survey sample and for subgroups defined a priori by experience with specific, prevalent side effects. Results The mean age of the sample was 41.9 (SD=11.0) years, 50% of participants were female, and 32% were nonwhite. Overall ratings were positive for medication effectiveness and convenience but negative for side effects. While most participants reported that APs improved schizophrenia symptoms (92%), 27% reported APs as having done "more harm than good." Almost all participants (98%) reported experiencing side effects of APs, with the most common being anxiety (88%), feeling drowsy/tired (86%), and trouble concentrating (85%). Side effects frequently cited as either "extremely" or "very" bothersome were weight gain (56%), sexual dysfunction (55%), and trouble concentrating (54%). Over 80% reported that side effects had negatively impacted their work and social functioning (eg, social activities or family/romantic relationships). Since initiating treatment, 56% of respondents had stopped taking APs at some point (65% of these due to side effects). Side effects commonly reported as having led to stopping AP treatment were "feeling like a 'zombie'" (22%), feeling drowsy/tired (21%), and weight gain (20%). Conclusion Most participants reported improvements in schizophrenia symptoms associated with the use of APs. However, most participants also reported experiencing numerous bothersome side effects that negatively impacted their work, social functioning, and treatment adherence. Results highlight the unmet need for new APs with favorable benefit-risk profiles.

BackgroundAdaptation of a patient-reported outcomes survey into a new language requires careful translation procedures as well as qualitative and quantitative psychometric testing. This study aimed to evaluate the basic psychometric properties of the new Saudi Arabian SF-36v2 and establish norm data for Saudi Arabia.MethodsTranslation and adaptation of the SF-36v2 used standard methodology. Psychometric validation included two stages: 1) A qualitative study (n = 100) explored the components of health and health-related quality of life considered important in Saudi Arabia and evaluated the content validity of the SF-36v2 in Saudi Arabia, and 2) A quantitative study (n = 6166) evaluated the basic psychometric properties of the Saudi SF-36v2 and established norm data for Saudi Arabia. Comparison with US general population data (n = 4040) evaluated differential item function (DIF) and cross-national differences.ResultsThe qualitative study supported the content validity of the Saudi SF-36v2. Cognitive debriefing identified only few and minor problems. Psychometric analyses supported item convergence within scales and differentiation across scales of the SF-36v2. Scale level exploratory factor analyses did not support the typical distinction between physical health and mental health components. Internal consistency reliability was satisfactory for all scales except the social function scale (alpha = 0.67). Cross-national DIF was identified for 9 items. In the Saudi general population, the average vitality score was lower for women (− 2.71 points) compared to men. For men, older age groups scored lower on the physical function scale (− 3.31) and the physical health component (− 3.06). For women, older age groups scored lower on the role physical (− 3.72), bodily pain (− 3.66), and vitality (− 2.32) scales as well as the physical health component (− 3.52). Compared to the 2009 United States general population, and after adjusting for age, gender, and differential item function, persons in Saudi Arabia had lower average scores for the physical function (− 3.10), role physical (− 4.75), social function (− 4.23), role emotional (− 5.67), and mental health (− 4.82) scales, as well as the mental health component (− 4.57).ConclusionThis Saudi normative study of patient reported outcomes supported the validity and reliability of the new Saudi SF-36v2 and found cross-national differences with the USA.

Background Heavy alcohol consumption increases the risk of several chronic diseases. In this multicohort study, we estimated the number of life-years without major chronic diseases according to different characteristics of alcohol use. Methods In primary analysis, we pooled individual-level data from up to 129,942 adults across 12 cohort studies with baseline data collection on alcohol consumption, drinking patterns, and history between 1986 and 2005 (the IPD-Work Consortium). Self-reported alcohol consumption was categorised according to UK guidelines - non-drinking (never or former drinkers); moderate consumption (1-14 units); heavy consumption (>14 units per week). We further subdivided moderate and heavy drinkers by binge drinking pattern (alcohol-induced loss of consciousness). In addition, we assessed problem drinking using linked data on hospitalisations due to alcohol abuse or poisoning. Follow-up for chronic diseases for all participants included incident type 2 diabetes, coronary heart disease, stroke, cancer, and respiratory disease (asthma and chronic obstructive pulmonary disease) as ascertained via linkage to national morbidity and mortality registries, repeated medical examinations, and/or self-report. We estimated years lived without any of these diseases between 40 and 75 years of age according to sex and characteristics of alcohol use. We repeated the main analyses using data from 427,621 participants in the UK Biobank cohort study. Findings During 1.73 million person-years at risk, 22,676 participants in IPD-Work cohorts developed at least one chronic condition. From age 40 to 75 years, never-drinkers [men: 29.3 (95%CI 27.9-30.8) years, women 29.8 (29.2 - 30.4) years)] and moderate drinkers with no binge drinking habit [men 28.7 (28.4-29.0) years, women 29.6 (29.4-29.7) years] had the longest disease-free life span. A much shorter disease-free life span was apparent in participants who experienced alcohol poisoning [men 23.4 (20.9-26.0) years, women 24.0 (21.4-26.5) years] and those with self-reported heavy overall consumption and binge drinking [men: 26.0 (25.3-26.8), women 27.5 (26.4 - 28.5) years]. The pattern of results for alcohol poisoning and self-reported alcohol consumption was similar in UK Biobank. In IPD-Work and UK Biobank, differences in disease-free years between self-reported moderate drinkers and heavy drinkers were 1.5 years or less. Interpretation Individuals with alcohol poisonings or heavy self-reported overall consumption combined with a binge drinking habit have a marked 3- to 6-year loss in healthy longevity. Differences in disease-free life between categories of self-reported weekly alcohol consumption were smaller. CC BY 4.0Corresponding author at: Clinicum, Department of Public Health, Faculty of Medicine, University of Helsinki, Tukholmankatu 8B, FI-00014 Helsingin yliopisto, Helsinki, Finland. E-mail address: solja.nyberg@helsinki.fi (S.T. Nyberg).Funding Medical Research Council, National Institute on Aging, NordForsk, Academy of Finland, Finnish WorkEnvironment Fund.

Introduction : Transition ratings (TRs) are single item measures which ask patients to report on their health change. They allow for a simple assessment of improvement or deterioration and are frequently used as an “anchor” to determine interpretation thresholds on an patient-reported outcome measure (PROM). Despite their widespread use, a routinely applicable method to assess their reliability is lacking. This paper introduces a method to estimate the reliability of TRs based on confirmatory factor analysis (CFA) for categorical data. Method : We modelled longitudinal PROM data as independent factors representing Time 1 and Time 2 in a CFA model. PROM items taken at Time 1 (T1) loaded on the first factor, while the same items taken at Time 2 (T2) loaded on the second. The TR item loaded onto both T1 and T2 factors. Three models with various constraints on the loadings and thresholds were examined. The communality (R2) statistic was used as a measure of the TR reliability. The approach was evaluated using simulated data and exemplified in four empirical datasets. Results : The simplest CFA model without constraints on the item loadings and thresholds performed equivalently to models with constraints on loadings and thresholds over time. Further constraints on the TR item loadings to be equal and opposite over time caused biased TR reliability estimates if the T1 and T2 loadings differed in magnitude. In the four empirical datasets, reliability of TRs ranged from 0.27 to 0.48. In three examples the TR had numerically stronger loading on T2 than on T1. Discussion and conclusions : Results support the use of the proposed method in understanding the reliability of TRs. Empirical study results reflect the typical range of reliability that has previously been reported for single items. Methodological considerations to improve TR reliability are presented, and developments of this method, are posited.

Background: Studies on the association between long working hours and health have captured only a narrow range of outcomes (mainly cardiometabolic diseases and depression) and no outcome-wide studies on this topic are available. To achieve wider scope of potential harm, we examined long working hours as a risk factor for a wide range of disease and mortality endpoints. Methods: The data of this multicohort study were from two population cohorts from Finland (primary analysis, n=59 599) and nine cohorts (replication analysis, n=44 262) from Sweden, Denmark, and the UK, all part of the Individual-participant Meta-analysis in Working Populations (IPD-Work) consortium. Baseline-assessed long working hours (≥55 hours per week) were compared to standard working hours (35-40 h). Outcome measures with follow-up until age 65 years were 46 diseases that required hospital treatment or continuous pharmacotherapy, all-cause, and three cause-specific mortality endpoints, ascertained via linkage to national health and mortality registers. Findings: 2747 (4·6%) participants in the primary cohorts and 3027 (6·8%) in the replication cohorts worked long hours. After adjustment for age, sex, and socioeconomic status, working long hours was associated with increased risk of cardiovascular death (hazard ratio 1·68; 95% confidence interval 1·08-2·61 in primary analysis and 1·52; 0·90-2·58 in replication analysis), infections (1·37; 1·13-1·67 and 1·45; 1·13-1·87), diabetes (1·18; 1·01-1·38 and 1·41; 0·98-2·02), injuries (1·22; 1·00-1·50 and 1·18; 0·98-1·18) and musculoskeletal disorders (1·15; 1·06-1·26 and 1·13; 1·00-1·27). Working long hours was not associated with all-cause mortality. Interpretation: Follow-up of 50 health outcomes in four European countries suggests that working long hours is associated with an elevated risk of early cardiovascular death and hospital-treated infections before age 65. Associations, albeit weak, were also observed with diabetes, musculoskeletal disorders and injuries. In these data working long hours was not related to elevated overall mortality. Funding: NordForsk, the Medical Research Council, the National Institute on Aging, the Wellcome Trust, Academy of Finland, and Finnish Work Environment Fund. CC BY-NC-ND 4.0© 2021 The AuthorsCorresponding author: Jenni ErvastiFunding: NordForsk, the Medical Research Council, the National Institute on Aging, the Wellcome Trust, Academy of Finland, and Finnish Work Environment Fund.

Background The SF-6Dv2 classification system assesses health states in six domains—physical functioning, role function, bodily pain, vitality, social functioning, and mental health. Scores have previously been derived from the SF-36v2® Health Survey. We aimed to develop a six-item stand-alone SF-6Dv2 Health Utility Survey (SF-6Dv2 HUS) and evaluate its comprehensibility. Methods Two forms of a stand-alone SF-6Dv2 HUS were developed for evaluation. Form A had 6 questions with 5–6 response choices, while Form B used 6 headings and 5–6 statements describing the health levels within each domain. The two forms were evaluated by 40 participants, recruited from the general population. Participants were randomized to debrief one form of the stand-alone SF-6Dv2 HUS during a 75-min interview, using think-aloud techniques followed by an interviewer-led detailed review. Participants then reviewed the other form of SF-6Dv2 and determined which they preferred. Any issues or confusion with items was recorded, as was as overall preference. Data were analyzed using Microsoft Excel and NVivo Software (v12). Results Participants were able to easily complete both forms. Participant feedback supported the comprehensibility of the SF-6Dv2 HUS. When comparing forms, 25/40 participants preferred Form A, finding it clearer and easier to answer when presented in question/response format. The numbered questions and underlining of key words in Form A fostered quick and easy comprehension and completion of the survey. However, despite an overall preference for Form A, almost half of participants (n = 19) preferred the physical functioning item in Form B, with more descriptive response choices. Conclusion The results support using Form A, with modifications to the physical functioning item, as the stand-alone SF-6Dv2 HUS. The stand-alone SF-6Dv2 HUS is brief, easy to administer, and comprehensible to the general population.

Background Between 1975 and 1985 a total of 91 Danish patients with moderate and severe hemophilia (PWH) was infected with HIV constituting a major scandal in the Danish health care system. This study describes the burden of HIV infection among Danish PWH by evaluating changes from 1988 to 2012 in well-being, social function, experiencing stigma and openness about disease among Danish HIV+ PWH. Methods Three anonymous surveys were conducted in 1988, 2001 and 2012 targeting all Danish patients with moderate to severe hemophilia. Survey responses were received from 53, 21 and 18 HIV+ PWH respectively. A matched comparison sample of HIV− PWH was identified for each survey-year, using propensity score matching. Differences for each survey-year and trends over time were analyzed using ordinal logistic regression. Results In 1988, HIV+ PWH had more psychosomatic symptoms than HIV− PWH, but in 2001 life satisfaction was higher among HIV+ PWH than among HIV− PWH. Tests of differences in trend over time showed larger improvements in life satisfaction among HIV+ PWH than HIV− PWH, while HIV− PWH showed an increase in educational level compared to HIV+ PWH. Analysis restricted to HIV+ PWH showed an increase in perceived stigmatization. Conclusions Differences between Danish HIV+ and HIV− PWH regarding well-being and psychosomatic symptoms seem to have evened out between 1988 and 2012. However, results suggest that HIV+ PWH still experience stigmatization and lower levels of education.

Purpose Tardive dyskinesia (TD) is a common but serious hyperkinetic movement disorder and side effect of antipsychotic medications used to treat bipolar disorder (BD), major depressive disorder (MDD), and schizophrenia (SZ). The purpose of this study was to evaluate health-related quality of life (HRQoL) in a population with diagnoses for BD, MDD, or SZ by comparing patients with TD (n = 197) with those without TD (n = 219). HRQoL in each group was also compared with HRQoL of the general population. Methods This study employed a cross-sectional web-based survey. HRQoL was assessed by four instruments: the SF-12 Health Survey, Version 2 (SF-12v2), the Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF), the Social Withdrawal subscale of the Internalized Stigma of Mental Illness Scale (SW-ISMI); and two questions on movement disorders. Results Patients with TD had significantly worse HRQoL and social withdrawal than those without. The differences were more pronounced for physical HRQoL domains than for mental health domains. Patients with more-severe TD, assessed through either self-rating or clinician rating, experienced significantly worse HRQoL than did those with less-severe TD. The impact of TD was substantially greater in patients with SZ than in those with BD or MDD. Compared with the general population, patients with BD, MDD, or SZ experienced significantly worse HRQoL regardless of TD status, although this deficit in HRQoL was greater among those with TD. Conclusions The presence of TD is associated with worse HRQoL and social withdrawal. The most severe impact of TD is on physical aspects of patients’ HRQoL.

Objectives The aim of this study was to describe the development and the content of the Danish Psychosocial Work Environment Questionnaire (DPQ) and to test its reliability and validity. Methods We describe the identification of dimensions, the development of items, and the qualitative and quantitative tests of the reliability and validity of the DPQ. Reliability and validity of a 150 item version of the DPQ was evaluated in a stratified sample of 8958 employees in 14 job groups of which 4340 responded. Reliability was investigated using internal consistency and test-retest reliability. The factorial validity was investigated using confirmatory factor analysis (CFA). For each multi-item scale, we undertook CFA within each job group and multi-group CFA to investigate factorial invariance across job groups. Finally, using multi-group multi-factor CFA, we investigated whether scales were empirically distinct. Results Internal consistency reliabilities and test-retest reliabilities were satisfactory. Factorial validity of the multi-item scales was satisfactory within each of the 14 job groups. Factorial invariance was demonstrated for 10 of the 28 multi-item scales. The hypothesis that the scales of the DPQ were empirically distinct was supported. The final DPQ version consisted of 119 items covering 38 different psychosocial work environment dimensions. Conclusions Overall, the DPQ is a reliable and valid instrument for assessing psychosocial working conditions in a variety of job groups. The results indicate, however, that questions about psychosocial working conditions may be understood differently across job groups, which may have implications for the comparability of questionnaire-based measures of psychosocial working conditions across job groups.

IntroductionThe effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.Research design and methodsWe performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, ‘U-TURN’), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).ResultsWe included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI −0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI −4.6 to −0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).ConclusionIn persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.Trial registration numberNCT02417012.

Background Patients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health. Methods A qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance). Results Thirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation. Conclusion Pain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

Background The 12-item Medical Outcomes Study Sleep Scale (MOS Sleep Scale) has been used to capture patient-reported sleep problems in hundreds of studies. A revised version of the MOS Sleep Scale (MOS Sleep-R) was developed that uses simplified response sets, provides interpretable norm-based scoring, and has two recall versions (one-week or four-week). The objective of this study was to evaluate the psychometric properties (reliability and construct validity) of the MOS Sleep-R using data from a representative sample of U.S. adults. Methods Standardization of raw scores into norm-based T-scores (mean = 50, standard deviation = 10) was based on data from a 2009 U.S. internet-based general population survey. The internal consistency reliability of multi-item subscales and global sleep problems indices for both one-week and four-week recall forms of the MOS Sleep-R were examined using Cronbach’s alphas and inter-item correlations. Construct validity was tested by comparing item-scale correlations between items within subscales with item-scale correlations across subscales. Scale-level convergent validity was tested using correlations with measures including generic health-related quality of life (i.e., SF-36v2) and other relevant outcomes (e.g., job performance, number of days in bed due to illness or injury, happiness/satisfaction with life, frequency of stress/pressure in daily life, the impact of stress/pressure on health, and overall health). Results The one-week and four-week recall forms of the MOS Sleep-R were completed by 2045 and 2033 respondents, respectively. The psychometric properties of the one-week and four-week forms were similar. All multi-item subscales and global index scores showed adequate internal consistency reliability (all Cronbach’s alpha > 0.75). Patterns of inter-item and item-scale correlations support the scaling assumptions of the MOS Sleep-R. Patterns of correlations between MOS Sleep-R scores with criterion measures of health-related quality of life and other outcomes indicated adequate construct validity. Conclusions The MOS Sleep-R introduces a number of revisions to the original survey, including simplified response sets, the introduction of a one-week recall form, and norm-based scoring that enhances interpretability of scores. Both the one-week and four-week recall period forms of the MOS Sleep-R demonstrated good internal consistency reliability and construct validity in a U.S. general population sample.

Objective ThyPRO is the standard thyroid patient-reported outcome (PRO). The change in scores that patients perceive as important remains to be ascertained. The purpose of this study was to determine values for minimal important change (MIC) for ThyPRO. Methods A total of 435 patients treated for benign thyroid diseases completed ThyPRO at baseline and 6 weeks following treatment initiation. At 6 weeks follow-up, patients also completed Global Rating of Change items. For each 0–100 scale, two MIC values were identified: An MIC for groups, using the receiver operating characteristic (ROC) curve method and an MIC for individual patients, using the Reliable Change Index. Results ROC analyses provided group-MIC estimates of 6.3–14.3 (score range 0–100). Evaluation of area under the curve (AUC) supported the robustness for 9 of 14 scales (AUC > 0.7). Reliable Change Index estimates of individual-MIC were 8.0–21.1. For all scales but two, the individual-MIC values were larger than the group-MIC values. Conclusions Interpretability of ThyPRO was improved by the establishment of MIC values, which was 6.3–14.3 for groups and 8.0–21.1 for individuals. Thus, estimates of which changes are clinically relevant, are now available for future studies. We recommend using MIC values found by ROC analyses to evaluate changes in groups of patients, whereas MIC values identified by a dual criterion, including the reliability of changes, should be used for individual patients, for example, to identify individual responders in clinical studies or practice.

OBJECTIVES: This study aimed to (i) estimate working life expectancies (WLE) and the number of working years lost (WYL) among individuals with type 1 and type 2 diabetes over a 30-year period and (ii) identify educational differences in WLE and WYL. METHODS: Individuals aged 18–65 years diagnosed with type 1 (N=33 188) or type 2 diabetes (N=81 930) in 2000–2016 and age- and gender-matched controls without diabetes (N=663 656) were identified in Danish national registers. WLE in years were estimated as time in employment from age 35–65 years. We used a life-table approach with multi-state (eg, disability pension, sickness absence, unemployment) Cox proportional hazard modeling. Analyses were performed separately for sex, cohabitation status, educational duration, and type of diabetes. Inverse probability weights accounted for differences between populations. RESULTS: People with diabetes had significantly shorter WLE and greater WYL compared to people without diabetes over the 30-year span. At age 35, cohabitant women with lower education and diabetes lost up to 8.0 years [95% confidence interval (CI) 5.0–11.0] and men 7.0 years (95% CI 4.0–8.7). WYL among women with higher education was 4.4 (95% CI 6.6–2.3) and 3.7 years among men (95% CI 1.5–4.5). Compared to people with type 2 diabetes, those with type 1 spend significantly more years in disability pension, but there were no significant differences in the other WYL estimates. CONCLUSIONS: The WYL among people with diabetes is substantial and characterized by social disparities. The WYL help identify intervention targets at different ages, types of diabetes, sex, educational and cohabitant status.

Background Although diabetes is among the most common causes of lifelong disability, no studies have yet outlined work disability from a life course perspective. This study estimated the number of years people with type 1 and type 2 diabetes lost in a work life span compared to people without diabetes Methods Individuals aged 18-65 years, diagnosed with type 1 (n = 33,188) or type 2 diabetes (n = 81,930) were identified from national registers from the entire Danish population and age and gender matched with controls without diabetes (n = 663,656), for period 2000-2017. WLE in years were estimated as time in employment from age 35 to 65. We used a life table approach with multi-state Cox proportional hazard modelling (95% Confidence Intervals: CI). Age was the underlying time-axis. Inverse probability weights accounted for differences between populations. Analyses were performed separately for sex, educational status, and types of diabetes in 5-year age intervals. Results Individuals with type 1 diabetes and type 2 diabetes had significantly shorter WLE compared to people without diabetes in the 30-year span. Type 1 diabetes: WLE ranged from 8 years shorter among women with short education [-8.0; CI:-11/-5.0] to 4 years shorter [-4.4; CI:-6.6/-2.3] with high education; WLE in men ranged from -6.4 [CI:-8.7/-4.0] with short education to -3.0 [CI:-4.5/-1.5] with high education. Type 2 diabetes: WLE ranged from -6.5 [CI: -8.9/-4.0] in women with short education to -2.9 [CI: -4.5/-1.3] with high education. WLE in men ranged from -7.0 [CI: -9.4/-4.5] with short education to -3.7 [CI: -5.4/-2.0] with high education. Conclusions The substantial number of years lost in a work life span for individuals with type 1 or type 2 diabetes, highlight need for new strategies that prevent work disability, particularly for individuals with short education. Key messages Individuals with type 1 diabetes and type 2 diabetes had between 9 and 3 years shorter work life expectancies compared to people without diabetes in a 30-year span. The work life spans are substantial shorter for individuals with type 1 or type 2 diabetes with short educations.

Objectives This study determined the prospective relation between physical workload and long-term sickness absence (LTSA) and examined if work-unit social capital may buffer the effect of high physical workload on LTSA. Methods We included 28 925 participants from the Danish Well-being in HospitAL Employees (WHALE) cohort, and followed them for two years. Physical workload and social capital were self-reported and categorized into low, medium, and high. Physical workload was analyzed on the individual level, whereas social capital was analyzed on the work-unit level. LTSA data were obtained from the employers' payroll system. We performed two-level logistic regression analyses: joint-effect and stratified analyses adjusted for baseline covariates. Results High versus low physical workload was associated with a higher risk of LTSA [odds ratio (OR) 1.55, 95% confidence interval (CI) 1.40-1.72]. There was a multiplicative interaction (P=0.007) and a tendency of sub-additive interaction [relative excess risk due to interaction (RERI) -0.49, 95% CI -1.03-0.06] between physical workload and social capital. Doubly exposed employees had the highest risk of LTSA (OR 2.45; 95% CI 2.02-2.98), but this effect was smaller than expected from the sum of their main effects. Conclusions We found a prospective relation between physical workload and LTSA but no evidence of high social capital buffering the effect of high physical workload. High physical workload was a risk factor for LTSA at all levels of social capital and employees exposed to both exposures had the highest risk of LTSA. Interventions should aim at both improving social capital and reducing physical workload in order to efficiently prevent LTSA.

Background: The SF-12v2 health survey (SF-12) is widely used as a generic measure of health-related quality of life. However, interpretation of score differences can be difficult. Aim: To estimate benchmarks for interpretation of score differences on the SF-12 for readmission and all-cause mortality in cardiac patients. Methods: Data from the DenHeart study, a national cross-sectional survey including one year follow-up register data, were used. Patients with ischaemic heart disease, arrhythmia, heart failure and heart valve disease answered the survey at hospital discharge. Cox proportional hazards models were used to regress readmission and all-cause mortality. Results: A total of 10,813 cardiac patients completed the SF-12. For patients with ischaemic heart disease and arrhythmia, a one point lower physical component summary score was associated with a 2% increase in risk in readmission (hazard ratio (HR) 1.022 (95% confidence interval 1.017;1.027) and HR 1.024 (1.018; 1.029), respectively) and a 3% increase in risk for patients with heart failure (HR 1.027 (1.015; 1.038)). A one point lower mental component summary score was associated with a 2% increase in the risk of readmission (HR 1.017 (1.013; 1.022)) across diagnoses. For both the physical and mental component summary score, a one point lower score meant a 5% increase in the risk of all-cause mortality (HR 1.046 (1.031; 1.060) and HR 1.046 (1.029; 1.065), respectively) across diagnoses. Conclusion: In a large group of cardiac patients, a one point lower physical or mental component summary score was associated with an up to 3% increased risk of readmission and a 5% increased risk of mortality in the first year after discharge.

ObjectivesWe aimed to examine whether a participatory organisational workplace intervention focusing on core tasks at work resulted in lower primary healthcare utilisation of employees.MethodsThe cluster randomised controlled trial included 78 preschools, 44 allocated to the intervention group (1745 employees) and 34 allocated to the control group (1267 employees). The intervention aimed to involve employees in improving the psychosocial work environment while focusing on core tasks at work. Using Poisson regression, we tested the rate ratios (RRs) of consultations in the intervention compared with the control group in terms of all consultations in primary healthcare and general practitioner (GP) consultations, respectively, per person-year during 31 months of follow-up. The fully adjusted model included adjustment for sex, age, job group, workplace type and size, and previous primary healthcare utilisation.ResultsDuring the follow-up, intervention group employees had 11.0 consultations/person-year, while control group employees had 11.6 consultations/person-year (RR 0.97, 95% CI 0.92 to 1.01). Employees in the intervention group had 7.5 GP consultations/person-year, while control group employees had 8.2 GP consultations/person-year (RR 0.95, 95% CI 0.90 to 0.99). Post hoc analyses indicated that the effect of the intervention was particularly strong in employees in preschools with a moderate or high level of implementation.ConclusionsThe participatory organisational workplace intervention focusing on core tasks at work among preschool employees had a small, statistically non-significant effect on overall primary healthcare utilisation and a small, statistically significant effect on GP consultations. These results suggest a beneficial effect of the participatory organisational intervention on employees’ health.Trial registration numberISRCTN16271504

Purpose The objective of this study was to estimate the association between SF-12v2® Health Survey (SF-12v2) scores and subsequent health care resource utilization (HCRU) among patients with cancer. Methods We analyzed 18+ year participants in the Medical Expenditure Panel Survey, diagnosed with active cancer or malignancy (n = 647). HCRU was measured by total medical expenditures (MEs) and number of medical events (EVs) in the 6 months following the SF-12v2 assessment. The effect of SF-12v2 scores (physical (PCS) and mental (MCS) component summary scores and the SF-6D health-utility score) on HCRU was estimated using generalized linear models. Estimates were obtained for the entire sample and for the four cancer groups present in the sample: breast, prostate, skin, and lung. Results For PCS and MCS, a one-point better score was associated with 2% lower MEs (P

Purpose Patient-reported outcome (PRO) measures originally developed for paper administration are increasingly being administered electronically in clinical trials and other health research studies. Three published meta-analyses of measurement equivalence among paper and electronic modes aggregated findings across hundreds of PROs, but there has not been a similar meta-analysis that addresses a single PRO, partly because there are not enough published measurement equivalence studies using the same PRO. Because the SF-36(R) Health Survey (SF-36) is a widely used PRO, the aim of this study was to conduct a meta-analysis of measurement equivalence studies of this survey. Methods A literature search of several medical databases used search terms for variations of “SF-36” or “SF-12” and “equivalence” in the title or abstract of English language publications. The eight scale scores and two summary measures of the SF-36 and SF-12 were transformed to norm-based scores (NBS) using developer guidelines. A threshold of within ± 2 NBS points was set as the margin of equivalence. Comprehensive meta-analysis software was used. Results Twenty-five studies were included in the meta-analysis. Results indicated that mean differences across domains and summary scores ranged from 0.01 to 0.39 while estimates of agreement ranged from 0.76 to 0.91, all well within the equivalence threshold. Moderator analyses showed that time between administration, survey language, and type of electronic device did not influence equivalence. Conclusions The results of the meta-analysis support equivalence of paper-based and electronic versions of the SF-36 and SF-12 across a variety of disease populations, countries, and electronic modes.

ObjectiveAn open-label extension study (NCT02873208) evaluated the long-term tolerability, safety, and efficacy of combination olanzapine/samidorphan (OLZ/SAM) treatment in patients with schizophrenia. This qualitative sub study explored perceptions of benefit, burden, and satisfaction with previous medications and OLZ/SAM.MethodsSemi-structured interviews (60 minutes; audio-recorded) were conducted. Interviewer sensitivity training, senior interviewer oversight, and a list of common medications to aid recall supported data collection. Interview transcripts were content coded and analyzed (NVivo v11.0).ResultsAll 41 patients reported a lifetime burden with schizophrenia adversely impacting employment, relationships, emotional health, social activities, and daily tasks. Hospitalization for schizophrenia management was another reported aspect of disease burden. Although most (n=32) patients reported previous medication benefits, side effects affecting physical, emotional/behavioral, and cognitive functioning were reported by all (n=41). Following OLZ/SAM treatment, 39/41 patients (95%) reported improvements in symptoms including hallucinations, paranoia, depression, sleep, and concentration. Furthermore, patients described improvements in self-esteem, social activities, relationships, and daily activities. Twenty-three patients (56%) reported side effects attributed to OLZ/SAM; lack of energy (n=12 [29%]) and dry mouth (n= 5 [12%]) were most common. Twenty-four (59%) patients were “very satisfied” with OLZ/SAM; most (n=35 [85%]) preferred to continue OLZ/SAM vs switching to another medication. As most substudy patients (n=40; 98%) completed the extension study, satisfied patients may be overrepresented in this analysis.ConclusionThis qualitative interview approach provided valuable insight into patients’ experiences with previous medications and OLZ/SAM. Overall, most patients reported treatment satisfaction and improvements in symptoms, function, and health-related quality of life with OLZ/SAM.FundingAlkermes, Inc.

Purpose: The purpose of this study is to develop and validate a prediction model for identifying employees at increased risk of long-term sickness absence (LTSA), by using variables commonly measured in occupational health surveys. Materials and methods: Based on the literature, 15 predictor variables were retrieved from the DAnish National working Environment Survey (DANES) and included in a model predicting incident LTSA (≥4 consecutive weeks) during 1-year follow-up in a sample of 4000 DANES participants. The 15-predictor model was reduced by backward stepwise statistical techniques and then validated in a sample of 2524 DANES participants, not included in the development sample. Identification of employees at increased LTSA risk was investigated by receiver operating characteristic (ROC) analysis; the area-under-the-ROC-curve (AUC) reflected discrimination between employees with and without LTSA during follow-up. Results: The 15-predictor model was reduced to a 9-predictor model including age, gender, education, self-rated health, mental health, prior LTSA, work ability, emotional job demands, and recognition by the management. Discrimination by the 9-predictor model was significant (AUC = 0.68; 95% CI 0.61–0.76), but not practically useful. Conclusions: A prediction model based on occupational health survey variables identified employees with an increased LTSA risk, but should be further developed into a practically useful tool to predict the risk of LTSA in the general working population. Implications for rehabilitation Long-term sickness absence risk predictions would enable healthcare providers to refer high-risk employees to rehabilitation programs aimed at preventing or reducing work disability. A prediction model based on health survey variables discriminates between employees at high and low risk of long-term sickness absence, but discrimination was not practically useful. Health survey variables provide insufficient information to determine long-term sickness absence risk profiles. There is a need for new variables, based on the knowledge and experience of rehabilitation professionals, to improve long-term sickness absence risk profiles.

Objective Generic preference-based measures such as the EuroQol five-dimensional questionnaire (EQ-5D) are used in economic evaluation, but may not be appropriate for all conditions. When this happens, a possible solution is adding bolt-ons to expand their descriptive systems. Using review-based methods, studies published to date claimed the relevance of bolt-ons in the presence of poor psychometric results. This approach does not identify the specific dimensions missing from the Generic preference-based measure core descriptive system, and is inappropriate for identifying dimensions that might improve the measure generically. This study explores the use of principal-component analysis (PCA) and confirmatory factor analysis (CFA) for bolt-on identification in the EQ-5D. Methods Data were drawn from the international Multi-Instrument Comparison study, which is an online survey on health and well-being measures in five countries. Analysis was based on a pool of 92 items from nine instruments. Initial content analysis provided a theoretical framework for PCA results interpretation and CFA model development. PCA was used to investigate the underlining dimensional structure and whether EQ-5D items were represented in the identified constructs. CFA was used to confirm the structure. CFA was cross-validated in random halves of the sample. Results PCA suggested a nine-component solution, which was confirmed by CFA. This included psychological symptoms, physical functioning, and pain, which were covered by the EQ-5D, and satisfaction, speech/cognition,relationships, hearing, vision, and energy/sleep which were not. These latter factors may represent relevant candidate bolt-ons. Conclusions PCA and CFA appear useful methods for identifying potential bolt-ons dimensions for an instrument such as the EQ-5D.

Aims: Most previous prospective studies have examined workplace social capital as a resource of the individual. However, literature suggests that social capital is a collective good. In the present study we examined whether a high level of workplace aggregated social capital (WASC) predicts a decreased risk of individual-level long-term sickness absence (LTSA) in Danish private sector employees. Methods: A sample of 2043 employees (aged 18–64 years, 38.5% women) from 260 Danish private-sector companies filled in a questionnaire on workplace social capital and covariates. WASC was calculated by assigning the company-averaged social capital score to all employees of each company. We derived LTSA, defined as sickness absence of more than three weeks, from a national register. We examined if WASC predicted employee LTSA using multilevel survival analyses, while excluding participants with LTSA in the three months preceding baseline. Results: We found no statistically significant association in any of the analyses. The hazard ratio for LTSA in the fully adjusted model was 0.93 (95% CI 0.77–1.13) per one standard deviation increase in WASC. When using WASC as a categorical exposure we found a statistically non-significant tendency towards a decreased risk of LTSA in employees with medium WASC (fully adjusted model: HR 0.78 (95% CI 0.48–1.27)). Post hoc analyses with workplace social capital as a resource of the individual showed similar results. Conclusions: WASC did not predict LTSA in this sample of Danish private-sector employees.

Objectives The aim was to study work ability in patients with RA compared with the general population by investigating the rates and risks of long-term sickness absence, unemployment and disability pension, and the chance of returning to work and the changes in these risks over time (1994-2011). Methods This was a cohort study with up to 17 years of follow-up (mean 6.95 years/person) including 6677 RA patients of working age (identified in the nationwide DANBIO registry) and 56 955 matched controls from the general population. A multi-state model was used to analyse all shifts between the work-related states (long-term sickness absence, unemployment and disability pension, as well as the chance of returning to work) and calculate hazard rates (HRs). Analyses were stratified by disease duration and controlled for socio-demographic factors, physical job exposure and somatic and psychiatric co-morbidities. Results RA patients had increased risk of long-term sickness absence (e.g. early RA: HR = 4.00, 95% CI: 3.64, 4.30) and disability pension (e.g. established RA: HR = 2.75, 95% CI: 2.54, 2.98) relative to controls. From 1994-99 to 2006-11, a decrease in the effect of established RA was observed [long-term sickness absence: from HR = 2.25 (95% CI: 1.99, 2.54) to 1.63 (95% CI: 1.51, 1.75); and disability pension: from HR = 3.49 (95% CI: 2.83, 4.32) to 2.40 (95% CI: 2.15, 2.69)]. RA patients had a lower chance of returning to work from long-term sickness absence or unemployment (HR = 0.60, HR=0.80), and this did not change over time. Conclusion RA patients remain at high risk for long-term sickness absence and disability pension, despite a positive development between 1996-99 and 2006-11. Returning to work after sick leave or unemployment remains a challenge for RA patients.

Contains fulltext : 216607.pdf (Publisher’s version ) (Open Access) Aims: This study explored differences in determinants (i.e. health-related, work-related and social factors) of voluntary early retirement between older workers with and without chronic diseases in Denmark. Methods: Workers aged 56–64 years who were members of a voluntary early retirement scheme were selected from the Danish National Working Environment Survey (2008–2009) and were followed in a public register for four years. Cox regression analyses were performed separately for older workers with and without chronic disease to identify the associations between determinants and voluntary early retirement. To explore the differences between groups, an interaction term between the determinant and having a chronic disease was included in the analyses for the total population. Results: Among 1861 eligible older workers, determinants associated with a higher risk of voluntary early retirement included poorer self-rated health, more depressive symptoms, a higher physical workload, lower job satisfaction and lower influence at work. For older workers with a chronic disease (n=1185), the presence of work–family conflict was also associated with a higher risk of voluntary early retirement, whereas for those with no chronic disease (n=676), a poorer relationship with colleagues was an additional determinant. Higher emotional demands, a higher work pace and higher quantitative demands were not significantly associated with voluntary early retirement for either group. None of the interaction terms was found to be statistically significant (p>0.05). Conclusions: Determinants associated with voluntary early retirement did not significantly differ between older workers with or without a chronic disease in Denmark. We conclude that several health-related, work-related and social factors are important for prolonged labour force participation of older workers (with and without a chronic disease). 10 p.

Objective/background Associations between exposure to effort-reward imbalance at work (eg, high time pressure/low appreciation) and risk of sleep disturbances have been reported, but the direction of the effect is unclear. The present study investigated changes in effort-reward imbalance and risk of concomitant and subsequent onset of sleep disturbances. Methods Participants with sleep disturbances at baseline were excluded. We included participants from a population-based cohort in Denmark (n = 8,464, 53.6% women, mean age = 46.6 years), with three repeated measurements (2012 (T0); 2014 (T1); 2016 (T2)). Changes in effort-reward imbalance (T0-T1) were categorized into ‘increase’, ‘decrease’ and ‘no change’. Self-reported sleep disturbances (difficulties initiating or maintaining sleep, non-restorative sleep, daytime tiredness) were dichotomized (presence versus absence). We regressed concomitant (T1) and subsequent (T2) sleep disturbances on changes in effort-reward imbalance (T0-T1) and calculated odds ratios (OR) and 95% confidence intervals, adjusted for sex, age, education and cohabitation. Results At follow-up, 8.4% (T1) and 12.5% (T2) reported onset of sleep disturbances. Increased effort-reward imbalance was associated with concomitant sleep disturbances (T1) (OR = 3.16, 2.56–3.81), whereas decreased effort-reward imbalance was not (OR = 1.22, 0.91–1.63). There was no association between increased effort-reward imbalance and subsequent sleep disturbances (T2) (OR = 1.00, 0.74–1.37). Results were similar for men and women. Conclusions Increased effort-reward imbalance was associated with a three-fold higher risk of concomitant onset of sleep disturbances at two-year follow-up, but not subsequent onset of sleep disturbances at four-year follow-up, indicating that changes in effort-reward imbalance have immediate rather than delayed effects on sleep impairment. It is possible that the results from the two-year follow-up were to some extent affected by reverse causality., Highlights • Psychosocial work stressors are discussed as risk factors for sleep disturbances. • Working conditions in which efforts exceeds rewards may elicit stress. • We studied the effect of changes in stressors on sleep in a large nationwide cohort. • Effort-reward imbalance was associated with 3-fold higher risk of sleep disturbances. • Changes in stressors had immediate rather than delayed effects on sleep impairment.

Objective: \ud The objective of this study was to develop the classification system for version of the SF-6D (SF-6Dv2) from the SF-36v2. SF-6Dv2 is an improved version of SF-6D, one of the most widely used generic measures of health for the calculation of quality-adjusted life years.\ud \ud Study Design and Setting: \ud A 3-step process was undertaken to generate a new classification system: (1) factor analysis to establish dimensionality; (2) Rasch analysis to understand item performance; and (3) tests of differential item function. To evaluate robustness, Rasch analyses were performed in multiple subsets of 2 large cross-sectional datasets from recently discharged hospital patients and online patient samples.\ud \ud Results: \ud On the basis of factor analysis, other psychometric evidence, cross-cultural considerations, and amenability to valuation, the 6-dimension classification used in SF-6D was maintained. SF-6Dv2 resulted in the following modifications to SF-6D: a simpler classification of physical function with clearer separation between levels; a more detailed 5-level description of role limitations; using negative wording to describe vitality; and using pain severity rather than pain interference.\ud \ud Conclusions: \ud The SF-6Dv2 classification system describes more distinct levels of health than SF-6D, changes the descriptions used for a number of dimensions and provides clearer wording for health state valuation. The second stage of the study has developed a utility value set using discrete choice methods so that the measure can be used in health technology assessment. Further work should investigate the psychometric characteristics of the new instrument.

This cohort study examines disease-free life-years in participants with varying combinations of lifestyle risk factors. Question Are different combinations of lifestyle factors associated with years lived without chronic diseases? Findings In a multicohort study of 116 & x202f;043 participants, a statistically significant association between overall healthy lifestyle score and an increased number of disease-free life-years was noted. Of 16 different lifestyle profiles studied, the 4 that were associated with the greatest disease-free life years included body mass index lower than 25 and at least 2 of 3 factors: never smoking, physical activity, and moderate alcohol consumption. Meaning Various healthy lifestyle profiles appear to be associated with extended gains in life lived without type 2 diabetes, cardiovascular and respiratory diseases, and cancer. Importance It is well established that selected lifestyle factors are individually associated with lower risk of chronic diseases, but how combinations of these factors are associated with disease-free life-years is unknown. Objective To estimate the association between healthy lifestyle and the number of disease-free life-years. Design, Setting, and Participants A prospective multicohort study, including 12 European studies as part of the Individual-Participant-Data Meta-analysis in Working Populations Consortium, was performed. Participants included 116 & x202f;043 people free of major noncommunicable disease at baseline from August 7, 1991, to May 31, 2006. Data analysis was conducted from May 22, 2018, to January 21, 2020. Exposures Four baseline lifestyle factors (smoking, body mass index, physical activity, and alcohol consumption) were each allocated a score based on risk status: optimal (2 points), intermediate (1 point), or poor (0 points) resulting in an aggregated lifestyle score ranging from 0 (worst) to 8 (best). Sixteen lifestyle profiles were constructed from combinations of these risk factors. Main Outcomes and Measures The number of years between ages 40 and 75 years without chronic disease, including type 2 diabetes, coronary heart disease, stroke, cancer, asthma, and chronic obstructive pulmonary disease. Results Of the 116 & x202f;043 people included in the analysis, the mean (SD) age was 43.7 (10.1) years and 70 & x202f;911 were women (61.1%). During 1.45 million person-years at risk (mean follow-up, 12.5 years; range, 4.9-18.6 years), 17 & x202f;383 participants developed at least 1 chronic disease. There was a linear association between overall healthy lifestyle score and the number of disease-free years, such that a 1-point improvement in the score was associated with an increase of 0.96 (95% CI, 0.83-1.08) disease-free years in men and 0.89 (95% CI, 0.75-1.02) years in women. Comparing the best lifestyle score with the worst lifestyle score was associated with 9.9 (95% CI 6.7-13.1) additional years without chronic diseases in men and 9.4 (95% CI 5.4-13.3) additional years in women (P

Background Job strain is implicated in many atherosclerotic diseases, but its role in peripheral artery disease ( PAD ) is unclear. We investigated the association of job strain with hospital records of PAD , using individual‐level data from 11 prospective cohort studies from Finland, Sweden, Denmark, and the United Kingdom. Methods and Results Job strain (high demands and low control at work) was self‐reported at baseline (1985–2008). PAD records were ascertained from national hospitalization data. We used Cox regression to examine the associations of job strain with PAD in each study, and combined the study‐specific estimates in random effects meta‐analyses. We used τ 2 , I 2 , and subgroup analyses to examine heterogeneity. Of the 139 132 participants with no previous hospitalization with PAD , 32 489 (23.4%) reported job strain at baseline. During 1 718 132 person‐years at risk (mean follow‐up 12.8 years), 667 individuals had a hospital record of PAD (3.88 per 10 000 person‐years). Job strain was associated with a 1.41‐fold (95% CI, 1.11–1.80) increased average risk of hospitalization with PAD . The study‐specific estimates were moderately heterogeneous (τ 2 =0.0427, I 2 : 26.9%). Despite variation in their magnitude, the estimates were consistent in both sexes, across the socioeconomic hierarchy and by baseline smoking status. Additional adjustment for baseline diabetes mellitus did not change the direction or magnitude of the observed associations. Conclusions Job strain was associated with small but consistent increase in the risk of hospitalization with PAD , with the relative risks on par with those for coronary heart disease and ischemic stroke.

Objective To examine the prospective relation between effort-reward imbalance at work and risk of type 2 diabetes. Methods We included 50,552 individuals from a national survey of the working population in Denmark, aged 30–64 years and diabetes-free at baseline. Effort-reward imbalance was defined, in accordance with the literature, as a mismatch between high efforts at work (e.g. high work pace, time pressure), and low rewards received in return (e.g. low recognition, job insecurity) and assessed as a continuous and a categorical variable. Incident type 2 diabetes was identified in national health registers. Using Cox regression we calculated hazard ratios (HR) and 95% confidence intervals (95% CI) for estimating the association between effort-reward imbalance at baseline and risk of onset of type 2 diabetes during follow-up, adjusted for sex, age, socioeconomic status, cohabitation, children at home, migration background, survey year and sample method. Results During 136,239 person-years of follow-up (mean = 2.7 years) we identified 347 type 2 diabetes cases (25.5 cases per 10,000 person-years). For each one standard deviation increase of the effort-reward imbalance score at baseline, the fully adjusted risk of type 2 diabetes during follow-up increased by 9% (HR: 1.09, 95% CI: 0.98–1.21). When we used effort-reward imbalance as a dichotomous variable, exposure to effort-reward imbalance was associated with an increased risk of type 2 diabetes with a HR of 1.27 (95% CI: 1.02–1.58). Conclusion The results of this nationwide study of the Danish workforce suggest that effort-reward imbalance at work may be a risk factor for type 2 diabetes.

Objective: Nationwide Danish guidelines regarding rheumatoid arthritis (RA) patients initiating biologic treatment (i.e., biologic disease-modifying antirheumatic drugs [DMARDs]) are issued on an approximately annual basis. For biologics-naive patients treated with concomitant methotrexate, mandatory medications included certolizumab pegol (CZP; year 2013–2014, recommended compliance 80%), abatacept (ABA; 2014–2015, 80%), and biosimilar infliximab (CT-P13; 2015–2016, 50%). We hypothesized that these guidelines could be perceived as a surrogate randomization tool in which calendar period rather than patient-specific factors defined the choice of the biologic DMARD. We undertook this study to assess compliance with guidelines (supporting the assumption of surrogate randomization) and to compare the effectiveness of CZP, ABA, and CT-P13 in patients treated according to guidelines. Methods: This was an observational cohort study emulating a randomized trial (using intent-to-treat analyses). RA patients compliant with the treatment guidelines were identified in DANBIO, and information on prior comorbidities was obtained by linking to national registries. Outcome measures included remission rates according to the Disease Activity Score in 28 joints (DAS28) (at 6 and 12 months) and treatment retention at 1 year, compared across treatment regimens. Comorbidity/confounder-adjusted multivariable logistic and Cox regression analyses were used. Results: Seven hundred seventy-six patients were included in the study (336 receiving CZP, 215 receiving ABA, 225 receiving CT-P13). Compliance with treatment guidelines was high: 70%, 65%, and 59%, respectively. Six-month DAS28 remission rates were 35%, 33%, and 42%, and 12-month rates were 35%, 31%, and 35%, respectively. Compared to CZP, adjusted odds ratios for 6- and 12-month DAS28 remission rates were 0.96 (95% confidence interval [95% CI] 0.63–1.47) and 0.74 (95% CI 0.47–1.15) for ABA and 1.38 (95% CI 0.91–2.09) and 0.96 (95% CI 0.62–1.49) for CT-P13, respectively. Adjusted hazard ratios for withdrawal (during days 0–90 and days 91–365) were 0.70 (95% CI 0.39–1.27) and 1.16 (95% CI 0.84–1.60) for ABA and 0.58 (95% CI 0.33–1.10) and 0.83 (95% CI 0.59–1.17) for CT-P13, respectively, compared to CZP. Conclusion: The surrogate randomization procedure enabled head-to-head comparisons of CZP, ABA, and CT-P13. Although some differences in estimated effectiveness were observed across drugs, confidence intervals were wide and statistical significance was not reached.

Objective To investigate the relation between effort‐reward imbalance (ERI) at work and subsequent weight changes. Methods We included participants from a population‐based cohort of workers in Denmark (mean age = 47 years, 54% women) with two (n = 9005) or three repeated measurements (n = 5710). We investigated the association between (a) ERI (ie, the mismatch between high efforts spent and low rewards received at work) at baseline and weight changes after a 2‐year follow‐up (defined as ≥5% increase or decrease in body mass index (BMI) vs stable), and (b) onset and remission of ERI and subsequent changes in BMI. Using multinomial logistic regression we calculated risk ratios (RR) and 95% confidence intervals (CI), adjusted for sex, age, education, cohabitation, migration background, and follow‐up time. Results After 2 years, 15% had an increase and 13% a decrease in BMI. Exposure to ERI at baseline yielded RRs of 1.09 (95% CI: 0.95‐1.25) and 1.04 (95% CI: 0.90‐1.20) for the increase and decrease in BMI, respectively. There were no differences between sex and baseline BMI in stratified analyses. The onset of ERI yielded RRs of 1.04 (95% CI: 0.82‐1.31) and 1.15 (95% CI: 0.84‐1.57) for subsequent increase and decrease in BMI. The RRs for the remission of ERI and subsequent increase and decrease in BMI were 0.92 (95% CI: 0.71‐1.20) and 0.78 (95% CI: 0.53‐1.13), respectively. Of the ERI components, high rewards were associated with a lower risk of BMI increase. Conclusion ERI was not a risk factor for weight changes. Future studies may investigate whether this result is generalizable to other occupational cohorts and settings.

Background and Aim: Diabetes has been associated with considerable work disability, but different risks of disability have not been assessed systematically among people with type 1 (T1D) and type 2 diabetes mellitus (T2D). This study evaluated risks of long-term sickness absence (LTSA), unemployment, return to work and disability pension in individuals with T1D or T2D. Method: We observed individuals with T1D (n=431), T2D (n=4,047) and without diabetes (n=101,295) in Danish national registers of health, work and social benefits from 1994 -2011. In a multi-state model, Cox proportional analyses estimated hazard ratios (95% Confidence Intervals) of each transition between work, LTSA, unemployment and disability pension. Analyses were performed separately for men and women. Results: Compared to people without diabetes, women and men with T1D and T2D had significantly higher hazard ratios of LTSA and disability pension (Table 1). Except for women with T1D we observed significantly higher risks of unemployment. Women with T2D had significantly lower chances of returning to work from LTSA or unemployment. Conclusions: People with T1D and T2D have elevated risks of temporary and permanent work disability. Future studies should include all work-related outcomes to avoid underestimating the burden of living with T1D and T2D. Disclosure M.A. Nexo: None. J. Pedersen: None. B. Cleal: None. J.B. Bjorner: Employee; Self; Optum Patient Insights.

BackgroundAdverse psychosocial working environments characterized by job strain (the combination of high demands and low control at work) are associated with an increased risk of depressive symptoms among employees, but evidence on clinically diagnosed depression is scarce. We examined job strain as a risk factor for clinical depression.MethodWe identified published cohort studies from a systematic literature search in PubMed and PsycNET and obtained 14 cohort studies with unpublished individual-level data from the Individual-Participant-Data Meta-analysis in Working Populations (IPD-Work) Consortium. Summary estimates of the association were obtained using random-effects models. Individual-level data analyses were based on a pre-published study protocol.ResultsWe included six published studies with a total of 27 461 individuals and 914 incident cases of clinical depression. From unpublished datasets we included 120 221 individuals and 982 first episodes of hospital-treated clinical depression. Job strain was associated with an increased risk of clinical depression in both published [relative risk (RR) = 1.77, 95% confidence interval (CI) 1.47–2.13] and unpublished datasets (RR = 1.27, 95% CI 1.04–1.55). Further individual participant analyses showed a similar association across sociodemographic subgroups and after excluding individuals with baseline somatic disease. The association was unchanged when excluding individuals with baseline depressive symptoms (RR = 1.25, 95% CI 0.94–1.65), but attenuated on adjustment for a continuous depressive symptoms score (RR = 1.03, 95% CI 0.81–1.32).ConclusionsJob strain may precipitate clinical depression among employees. Future intervention studies should test whether job strain is a modifiable risk factor for depression.

Objective To evaluate the health-related quality of life (HRQOL) of patients with diabetes and persons at high risk of developing diabetes and the association between HRQOL scores and subsequent medical expenditures in these persons. Methods Data came from the Medical Expenditure Panel Survey. Body mass index (BMI) and hypertension were used to identify risk of diabetes. Burden was assessed by comparing SF-12 physical (PCS) and mental (MCS) summary scores in patients with diabetes and those at risk of having diabetes to the age- and gender-adjusted PCS and MCS of those with normal BMI and no hypertension. Associations between PCS and MCS and medical expenditures were modeled using a two-part model that controlled for clinical and demographic factors. Percent increase in expenditure associated with PCS and MCS differences was evaluated as the ratio of estimated expenditure, holding other factors fixed. Results Diabetes risk factors were associated with up to 9-point lower PCS and 3-point lower MCS score. Overall, 1-, 2-, 5-, and 10-point lower PCS scores were associated with 2.9%, 5.8%, 15.0%, and 31.8% higher expenditures, and lower MCS scores were associated with 1.3%, 2.6%, 6.5%, and 13.5% higher expenditures, respectively. Conclusions The reported associations can help clinicians and researchers interpret the magnitude of HRQOL score differences.