Self-reported workplace bullying and subsequent risk of diagnosed mental disorders and psychotropic drug prescriptions: A register-based prospective cohort study of 75,252 participants.

BACKGROUND: Evidence concerning workplace bullying as a risk factor for mental disorders is currently limited to depressive disorders and mainly based on non-clinical assessments. This study aims to examine the prospective association of self-reported workplace bullying with different types of register-based hospital-diagnosed mental disorders and redeemed psychotropic drug prescriptions. METHODS: Using a cohort study design, we examined a pooled dataset of 75,252 participants from 14 questionnaire-based surveys conducted between 2004 and 2014. In the questionnaires, workplace bullying was measured by a single item. The questionnaires were linked to Danish registers on hospital-diagnosed mental disorders and redeemed psychotropic drug prescriptions up to 2016. Data were analysed by multivariate Cox proportional hazard models, including only participants without a history of mental disorders or prescriptions since 1995. RESULTS: After adjustment for sex, age, marital and socio-economic status, workplace bullying was associated with an excess risk of any mental disorder (HR 1.37; 95 % CI: 1.17-1.59) as well as mood disorders and neurotic, stress-related, and somatoform disorders. In stratified analyses, this association were statistically significant only among women. Workplace bullying was also associated with any psychotropic drug prescription (fully-adjusted HR 1.43; 95 % CI: 1.35-1.53). This association was observed in both sexes and for all prescriptions, including anxiolytics, hypnotics and sedatives, antidepressants, and nootropics. LIMITATIONS: Firm conclusions about sex-related differences cannot be drawn. Residual confounding by unmeasured factors such as personality cannot be ruled out. CONCLUSIONS: Workplace bullying was associated with higher risks of diagnosed mental disorders among women and psychotropic drug prescriptions in both sexes.

Selenium supplementation and placebo are equally effective in improving quality of life in patients with hypothyroidism.

PURPOSE: We investigated whether selenium supplementation improves quality-of-life (QoL) in patients with autoimmune thyroiditis (ID:NCT02013479). METHODS: We included 412 patients ≥18 years with serum thyroid peroxidase antibody (TPOAb) level ≥100 IU/mL in a multicentre double-blinded randomised clinical trial. The patients were allocated 1:1 to daily supplementation with either 200 µg selenium as selenium-enriched yeast or matching placebo tablets for 12 months, as add-on to levothyroxine (LT4) treatment. QoL, assessed by the Thyroid-related Patient-Reported-Outcome questionnaire (ThyPRO-39), was measured at baseline, after six weeks, three, six, 12, and 18 months. RESULTS: In total, 332 patients (81%) completed the intervention period, of whom 82% were women. Although QoL improved during the trial, no difference in any of the ThyPRO-39 scales was found between the selenium group and the placebo group after 12 months of intervention. In addition, employing linear mixed model regression no difference between the two groups was observed in the ThyPRO-39 composite score (28.8 [95%CI:24.5-33.6] and 28.0 [24.5-33.1], respectively; P=0.602). Stratifying the patients according to duration of the disease at inclusion, ThyPRO-39 composite score, TPOAb level, or selenium status at baseline did not significantly change the results. TPOAb levels after 12 months of intervention were lower in the selenium group than in the placebo group (1995 [95%CI:1512-2512] vs. 2344 kIU/L [1862-2951]; P=0.016) but did not influence LT4 dosage or free triiodothyronine/free thyroxin ratio. CONCLUSION: In hypothyroid patients on LT4 therapy due to autoimmune thyroiditis, daily supplementation with 200 µg selenium or placebo for 12 months improved QoL to the same extent.

Meaningful score changes for SF-36v2, FACIT-fatigue, and RASIQ in rheumatoid arthritis.

BACKGROUND: Interpretation thresholds for patient-reported outcome (PRO) scores are of crucial importance, particularly when interpreting treatment benefit. This study was designed to determine the within-patient meaningful improvement (WPMI) thresholds for the Short-Form 36 Health Survey version 2 (SF-36v2), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and the novel Rheumatoid Arthritis Symptoms and Impact Questionnaire (RASIQ) among patients with rheumatoid arthritis (RA). METHODS: In this post-hoc analysis, anchor-based and supportive distribution-based methods were used to derive WPMI based on blinded data from all treatment arms in two Phase 2 RA trials with otilimab. Patient's Global Assessment of Disease Activity (PtGA) was the general anchor for all SF-36v2 scales. SF-36 Patient's Global Impression of Status (PGIS), PtGA, and VT03 (an SF-36v2 item) were used as anchors for FACIT-Fatigue. SF-36 PGIS, PtGA, and Patient's Assessment of Arthritis Pain (PAIN) were anchors for RASIQ. Mean change was calculated for the anchor category associated with minimal meaningful improvement from baseline to Week 24 for SF-36v2 and FACIT-Fatigue, and to Week 12 for RASIQ. Sensitivity and specificity were used to evaluate the accuracy of estimated WPMI values. RESULTS: For the SF-36v2 physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health domains, anchor-based estimates of WPMI based on 0-100 scores were 24.5, 24.5, 25.4, 13.6, 21.5, 20.5, 16.9, and 14.3, respectively. Anchor-based WPMI estimates were 9.7 for the Physical Component Summary score and 7.6 for the Mental Component Summary score (using norm-based T-score metric). For FACIT-Fatigue (range 0-52), WPMI estimates ranged from 9.7 to 11.3 points. For RASIQ (range 0-100), anchor-based WPMI was determined as a change between -32.7 and -21.7 points for the Joint Pain scale, -26.7 to -23.7 for the Joint Stiffness scale, and -21.1 to -17.4 for the Impact scale. CONCLUSIONS: This study derived WPMI thresholds for SF-36v2, FACIT-Fatigue, and RASIQ among patients with RA, using multiple anchors. Derivation of WPMI thresholds for these PRO instruments will enable their broader use in evaluating and interpreting treatment benefit in future RA studies.

When assessing medical treatments in clinical trials, it is important to understand whether the treatment improves symptoms or impacts of a disease to an extent which is meaningful for patients. Patients are often asked to complete questionnaires about their symptoms throughout clinical trials to measure if and how symptoms change. Questionnaire responses are used to calculate a score that is compared before and after treatment. This study was designed to investigate how much scores in three questionnaires (SF-36v2, FACIT-Fatigue, and RASIQ) changed for patients with rheumatoid arthritis who reported experiencing meaningful symptom improvement based on data from two clinical trials. As the RASIQ is a new questionnaire that was designed specifically for rheumatoid arthritis, this research is particularly important for interpretation of RASIQ results.

Severity of hypothyroidism is inversely associated with impaired quality of life in patients referred to an endocrine clinic.

PURPOSE: We investigated the association between health-related quality of life (HRQL) and the severity of hypothyroidism at diagnosis in patients referred to a secondary hospital clinic. METHODS: Sixty-seven adult patients referred from primary care were enrolled. All patients had newly diagnosed hypothyroidism due to autoimmune thyroiditis and were treated with levothyroxine (LT4). The dose was adjusted according to thyroid function tests aiming at a normal plasma thyrotropin. Patients were stratified according to the severity of hypothyroidism in two different ways: the conventional approach (subclinical or overt hypothyroidism) and a novel approach according to the change (decrease or increase) in plasma level of free triiodothyronine index (FT3I) following LT4 treatment. The ThyPRO-39 questionnaire was used for measurement of HRQL at referral to the Endocrine Outpatient Clinic (higher score corresponds to worse HRQL). RESULTS: Free thyroxine index (FT4I) at diagnosis correlated positively with the scores on the Hypothyroid Symptoms and Tiredness scales (p = 0.018 for both). In accordance, patients with subclinical hypothyroidism (n = 36) scored higher on Hypothyroid Symptoms (p = 0.029) than patients with overt hypothyroidism (n = 31). The difference in HRQL was more pronounced if patients were stratified according to the dynamics in FT3I following LT4 treatment. Thus, patients who showed a decrease in FT3I following treatment (n = 24) scored significantly worse for Anxiety (p = 0.032) and Emotional Susceptibility (p = 0.035) than patients with an increase in FT3I (n = 43). CONCLUSION: Patients referred to an endocrine clinic with mild hypothyroidism had an impaired HRQL, compared to patients with more severe hypothyroidism. The most likely explanation of this finding is a lower threshold for seeking medical consultation and secondary care referral if HRQL is deteriorated. The dynamics in plasma FT3I following treatment may be more sensitive for such a discrimination in HRQL than a stratification according to the thyroid function tests at diagnosis.

The improved health utility of once-weekly subcutaneous semaglutide 2.4 mg compared with placebo in the STEP 1-4 obesity trials.

AIM: To assess health utility values in the Semaglutide Treatment Effect in People with obesity (STEP) 1-4 trials. MATERIALS AND METHODS: The STEP 1-4 phase 3a, 68-week, double-blind randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with a body mass index (BMI) of 30 kg/m2 or higher or a BMI of 27 kg/m2 or higher and at least one comorbidity (STEP 1, 3 and 4), or a BMI of 27 kg/m2 or higher and type 2 diabetes (STEP 2). Patients received lifestyle intervention plus intensive behavioural therapy in STEP 3. Health-related quality of life was assessed using the Short Form 36-item Health Survey version 2 (SF-36v2) at baseline and week 68. Scores were converted into Short Form Six-Dimension version 2 (SF-6Dv2) utility scores or mapped onto the European Quality of Life Five-Dimension Three-Level (EQ-5D-3L) utility index using UK health utility weights. RESULTS: At week 68, semaglutide 2.4 mg was associated with minor health utility score improvements from baseline (all trials), while scores for placebo typically decreased. SF-6Dv2 treatment differences by week 68 for semaglutide 2.4 mg versus placebo were significant in STEP 1 and 4 (P ≤ .001), but not STEP 2 or 3. EQ-5D-3L treatment differences by week 68 for semaglutide 2.4 mg versus placebo were significant in STEP 1, 2 and 4 (P < .001 for all), but not STEP 3. CONCLUSIONS: Semaglutide 2.4 mg was associated with improvement in health utility scores compared with placebo, reaching statistical significance in STEP 1, 2 and 4.

Quality of life in thyroid cancer.

To explore the impact of differentiated thyroid cancer (DTC) on quality of life (QoL) a clinical analytical framework was developed. Based on the clinical analytical framework, a systematic literature search was performed to identify studies applying patient-reported outcomes (PRO) instruments among patients with DTC. Subsequently, the scope was narrowed down to studies comparing scores on the Medical Outcomes Study (MOS) Short form 36 (SF-36) to a reference population (clinical interpretability criterion). Further, the currently available thyroid cancer (TC) specific QoL PROs were review in accordance with the standards of the International Society of Quality of Life Research. In the initial search, 213 studies were included. The additional 'clinical interpretability'-criteria, limited the final study sample to 16 studies, 13 cross-sectional and 3 longitudinal. QoL was impacted across all SF-36 scales. The impact was generally modest and the impact was impeded by time since diagnosis and treatment. Four TC specific instruments were identified. Generally, the documentation of their measurement properties, particularly content validity and clinical validity, including substantial quantitative validation, was scarce. As was the cross-cultural applicability of the currently available instruments. This restricted, focused, clinically founded review showed an impact on a broad range of QoL issues. There is a need for large-scale measurement of QoL outcome longitudinally, using well-validated PRO instruments in order to identify with certainty the impact on subgroups.

Health and quality of life of patients with haemophilia: A national study of 124 Danish men.

PURPOSE: In the past decades, haemophilia treatment has greatly improved the health of persons with haemophilia (PWH). This study compares PWH to the general population on social conditions and health. METHODS: In December 2021, all Danes with moderate or severe haemophilia A or B, or von Willebrands disease type 3 were invited to participate in an online self-report survey concerning sociodemographic factors, self-rated health, teeth status, chronic health conditions, symptoms and loneliness. This study compares responses from the 124 adult male PWH with responses from a male general population sample (N = 4849). Analyses used logistic regression, controlling for age and highest completed education. RESULTS: Fewer PWH were in the oldest age group (65-84 years). Controlling for age, no significant differences were found regarding cohabitation status or education. Fewer PWH were employed (OR = .48, [.33-.71])-particularly in the 45-64 age group. PWH were less likely to report good health (OR = .49, [.31-.77]). The odds of joint disease was much higher (OR = 13.00, [8.37-20.28]). Also, hypertension (OR = 2.25, [1.13-5.65]) and previous stroke (OR = 2.51, [1.44-3.50]) were more frequent. PWH were more likely to report pain in the arms/hands/legs/hips (OR = 2.94, [1.92-4.52]), but less likely to report pain in the head/neck/shoulder (OR = .66, [.45-.96]). CONCLUSION: The disease burden of haemophilia has improved so PWH resembles the general population in areas such as marriage and education. However, even for young PWH, the disease still imposes a significant burden from hemophilia arthropathy and pain in extremities and joints. Middle-aged PWH also have poorer levels of employment than same-aged peers.

Establishing thresholds for meaningful within-individual change using longitudinal item response theory.

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.

Implementation of thyroid-related patient-reported outcomes in routine clinical practice.

Patient-reported outcomes (PROs) are increasingly used in clinical practice to improve clinical care. Multiple studies show that systematic use of PROs can enhance communication with patients and improve patient satisfaction, symptom management and quality of life. Further, such data can be aggregated to examine health levels for patient groups, improve quality of care, and compare patient outcomes at the institutional, regional or national level. However, there are barriers and challenges that should be handled appropriately to achieve successful implementation of PROs in routine clinical practice. This paper briefly overviews thyroid-related PROs, describes unsolved quality of life issues in benign thyroid diseases, provides examples of routine collection of PROs, and summarizes key points facilitating successful implementation of thyroid-related PROs in routine clinical practice. Finally, the paper touches upon future directions of PRO research.

Physical work demands and expected labor market affiliation (ELMA): Prospective cohort with register-follow-up among 46 169 employees.

OBJECTIVE: This study aimed to estimate the impact of high physical work demands on expected labor market affiliation (ELMA) among men and women of different ages in the general working population. METHODS: After participating in the Danish Work Environment and Health study (2012, 2014, and/or 2016), 46 169 employees were followed for two years in national registers. Using multi-state modeling, taking all day-to-day transition probabilities of labor market affiliation into account (work, unemployment, sickness absence, temporary out, and permanently out), and performing multilevel adjustment, we estimated the prospective association between physical work demands (ergonomic index including 7 factors) and ELMA. RESULTS: During 104 896 person-years of follow-up, we identified of 439 045 transitions. Using low physical work demands as reference, higher physical work demands were associated with fewer days of active work (2-35 days) during 730 days of follow-up, and more days of sickness absence (4-26 days) and unemployment (ranging 1-9 days) among men and women of aged 40-49 and 50-64 years. Among men and women aged 18-39 years, high physical work demands only had minor and inconsistent impact on ELMA. CONCLUSIONS: Analyzing multiple and highly detailed patterns of transition probabilities concerning labor market affiliation we showed that reducing physical work demands is likely to increase the active working time and prevent high societal cost of sickness absence and unemployment, especially among middle-aged and older workers.

Workplace bullying and risk of suicide and suicide attempts: A register-based prospective cohort study of 98 330 participants in Denmark.

OBJECTIVES: The aim of this study was to analyze whether individuals reporting exposure to workplace bullying had a higher risk of suicidal behavior, including both suicide attempt and death by suicide, than those not reporting such exposure. METHODS: Using a prospective cohort study design, we linked data from nine Danish questionnaire-based surveys (2004-2014) to national registers up to 31 December 2016. Exposure to workplace bullying was measured by a single item. Suicide attempts were identified in hospital registers and death by suicide in the Cause of Death Register. Among participants with no previous suicide attempts, we estimated hazard ratios (HR) and 95% confidence intervals (CI), adjusting for sex, age, marital status, socioeconomic status, and history of psychiatric morbidity. RESULTS: The sample consisted of 98 330 participants (713 798 person-years), 63.6% were women, and the mean age was 44.5 years. Of these participants, 10 259 (10.4%) reported workplace bullying. During a mean follow-up of 7.3 years, we observed 184 cases of suicidal behavior, including 145 suicide attempts, 35 deaths by suicide and 4 cases that died by suicide after surviving a suicide attempt. The fully-adjusted HR for the association between workplace bullying and suicidal behavior was 1.65 (95% CI 1.06-2.58). The HR for suicide attempts and death by suicide were 1.65 (1.09-2.50) and 2.08 (0.82-5.27), respectively. Analyses stratified by sex showed a statistically significant association between workplace bullying and suicidal behavior among men but not women. CONCLUSIONS: The results suggest that exposure to workplace bullying is associated with an elevated risk of suicidal behavior among men.

A confirmatory factor analysis approach was found to accurately estimate the reliability of transition ratings.

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 a 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, although 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.

Mediating role of multimorbidity in inequality in mortality: a register study on the Danish population.

BACKGROUND: The social inequality in mortality is due to differential incidence of several disorders and injury types, as well as differential survival. The resulting clustering and possible interaction in disadvantaged groups of several disorders make multimorbidity a potentially important component in the health divide. This study decomposes the effect of education on mortality into a direct effect, a pure indirect effect mediated by multimorbidity and a mediated interaction between education and multimorbidity. METHODS: The study uses the Danish population registers on the total Danish population aged 45-69 years. A multimorbidity index based on all somatic and psychiatric hospital contacts as well as prescribed medicines includes 22 diagnostic groups weighted together by their 5 years mortality risk as weight. The Aalen additive hazard model is used to estimate and decompose the 5 years risk difference in absolute numbers of deaths according to educational status. RESULTS: Most (69%-79%) of the effect is direct not involving multimorbidity, and the mediated effect is for low educated women 155 per 100 000 of which 87 is an effect of mediated interaction. For low educated men, the mediated effect is 250 per 100 000 of which 93 is mediated interaction. CONCLUSION: Multimorbidity plays an important role in the social inequality in mortality among middle aged in Denmark and mediated interaction represents 5%-17%. As multimorbidity is a growing challenge in specialised health systems, the mediated interaction might be a relevant indicator of inequities in care of multimorbid patients.

Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis.

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.

Solving the Tower of Babel Problem for Patient-Reported Outcome Measures : Comments on: Linking Scores with Patient-Reported Health Outcome Instruments: A Validation Study and Comparison of Three Linking Methods.

The PROsetta Stone Project, summarized in this issue by Schalet et al. (Psychometrika 86, 2021), is a major step forward in enabling comparability between different patient-reported outcomes measures. Schalet et al. clearly describe the psychometric methods used in the PROsetta Stone project and other projects from the Patient-Reported Outcomes Measurement Information System (PROMIS): linking based on unidimensional item response theory (IRT), equipercentile linking, and calibrated projection based on multidimensional IRT. Analyses in a validation data set and simulation studies provide strong support that the linking methods are robust when basic assumptions are fulfilled. The links already established will be of great value to the field, and the methodology described by Schalet et al. will hopefully inspire the next series of linking studies. Among potential improvements that should be considered by new studies are: (1) a thorough evaluation of the content of the measures to be linked to better guide the evaluation of measurement assumptions, (2) improvements in the design of linking studies such as selection of the optimal sample to provide data in the score ranges where linking precision is most critical and using counterbalanced designs to control for order effects. Finally, it may be useful to consider how the linking algorithms are used in subsequent data analyses. Analytic strategies based on plausible values or latent regression IRT models may be preferable to the simple transformation of scores from one patient at the time.

Estimating a Preference-Based Index for Mental Health From the Recovering Quality of Life Measure: Valuation of Recovering Quality of Life Utility Index.

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.

Determining minimal important change for the thyroid-related quality of life questionnaire ThyPRO.

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.

Disability pension among persons with chronic disease: Differential impact of a Danish policy reform.

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.

Associations between physical and psychosocial work environment factors and sickness absence incidence depend on the lengths of the sickness absence episodes: a prospective study of 27 678 Danish employees.

OBJECTIVES: This study examined if the association between work environment factors and sickness absence (SA) depended on the inclusion or exclusion of short-term SA episodes. METHODS: We linked the 'Work Environment and Health in Denmark' survey with the 'Danish Register of Work Absences' (n=27 678). Using covariate adjusted Cox regression, we examined the associations between work environment factors and SA by changing the cut-off points for the length of the SA episodes, for example, episodes ≥1 day, ≥6 days and ≥21 days. We examined three physical work environment factors: 'Back bend or twisted', 'Lifting or carrying', 'Wet hands' and three psychosocial work environment factors: 'Poor influence', 'Role conflicts' and 'Bullying'. RESULTS: 'Back bend or twisted' and 'Lifting or carrying' had small significant HRs for SA episodes ≥1 day and large and highly significant HRs for SA episodes ≥6 days and ≥21 days. 'Wet hands' had small significant HRs for SA episodes ≥1 day for both sexes and large and highly significant HR for ≥6 days for women. HRs of all three psychosocial factors were highly significant for SA episodes ≥1 day and ≥6 days for both sexes, and 'Poor influence' and 'Role conflicts' were significant for SA episodes ≥21 days for women. CONCLUSIONS: The physical work factors had higher associations with SA when SA episodes of 1-5 days were excluded and focus was on SA episodes ≥6 days. The psychosocial work factors were strongly associated with SA both with and without SA episodes of 1-5 days included in the analyses.

An item response theory analysis of an item pool for the recovering quality of life (ReQoL) measure.

PURPOSE: ReQoL-10 and ReQoL-20 have been developed for use as outcome measures with individuals aged 16 and over, experiencing mental health difficulties. This paper reports modelling results from the item response theory (IRT) analyses that were used for item reduction. METHODS: From several stages of preparatory work including focus groups and a previous psychometric survey, a pool of items was developed. After confirming that the ReQoL item pool was sufficiently unidimensional for scoring, IRT model parameters were estimated using Samejima's Graded Response Model (GRM). All 39 mental health items were evaluated with respect to item fit and differential item function regarding age, gender, ethnicity, and diagnosis. Scales were evaluated regarding overall measurement precision and known-groups validity (by care setting type and self-rating of overall mental health). RESULTS: The study recruited 4266 participants with a wide range of mental health diagnoses from multiple settings. The IRT parameters demonstrated excellent coverage of the latent construct with the centres of item information functions ranging from - 0.98 to 0.21 and with discrimination slope parameters from 1.4 to 3.6. We identified only two poorly fitting items and no evidence of differential item functioning of concern. Scales showed excellent measurement precision and known-groups validity. CONCLUSION: The results from the IRT analyses confirm the robust structure properties and internal construct validity of the ReQoL instruments. The strong psychometric evidence generated guided item selection for the final versions of the ReQoL measures.