127 research outputs found
Self-Rated Health as a Predictor of Death after Two Years:The Importance of Physical and Mental Wellbeing Postintensive Care
Introduction. The objective of this study is, among half-year intensive care survivors, to determine whether self-assessment of health can predict two-year mortality. Methods. The study is a prospective cohort study based on the Procalcitonin and Survival Study trial. Half-year survivors from this 1200-patient multicenter intensive care trial were sent the SF-36 questionnaire. We used both a simple one-item question and multiple questions summarized as a Physical Component Summary (PCS) and a Mental Component Summary (MCS) score. The responders were followed for vital status 730 days after inclusion. Answers were dichotomized into a low-risk and a high-risk group and hazard ratios (HR) with 95% confidence interval (CI) were calculated by Cox proportional hazard analyses. Conclusion. We found that self-rated health measured by a single question was a strong independent predictor of two-year all-cause mortality (HR: 1.8; 95% CI: 1.1–3.0). The multi-item component scores of the SF-36 also predicted two-year mortality (PCS: HR: 2.9; 95% CI 1.7–5.0) (MCS: HR: 1.9; 95% CI 1.1–3.4). These results suggest that self-rated health questions could help in identifying patients at excess risk. Randomized controlled trials are needed to test whether our findings represent causality
Response to the FDA Draft Guidance for Industry document: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Docket 2006D-0044)
The Danish Psychosocial Work Environment Questionnaire (DPQ):Development, content, reliability and validity
Comparative effectiveness of certolizumab pegol, abatacept and biosimilar infliximab in patients with rheumatoid arthritis treated in routine care. Observational data from the Danish DANBIO registry emulating a randomized trial
Varying the item format improved the range of measurement in patient-reported outcome measures assessing physical function
BACKGROUND: Physical function (PF) is a core patient-reported outcome domain in clinical trials in rheumatic diseases. Frequently used PF measures have ceiling effects, leading to large sample size requirements and low sensitivity to change. In most of these instruments, the response category that indicates the highest PF level is the statement that one is able to perform a given physical activity without any limitations or difficulty. This study investigates whether using an item format with an extended response scale, allowing respondents to state that the performance of an activity is easy or very easy, increases the range of precise measurement of self-reported PF.
METHODS: Three five-item PF short forms were constructed from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)) wave 1 data. All forms included the same physical activities but varied in item stem and response scale: format A ( Are you able to ... ; without any difficulty / unable to do ); format B ( Does your health now limit you ... ; not at all / cannot do ); format C ( How difficult is it for you to ... ; very easy / impossible ). Each short-form item was answered by 2217-2835 subjects. We evaluated unidimensionality and estimated a graded response model for the 15 short-form items and remaining 119 items of the PROMIS PF bank to compare item and test information for the short forms along the PF continuum. We then used simulated data for five groups with different PF levels to illustrate differences in scoring precision between the short forms using different item formats.
RESULTS: Sufficient unidimensionality of all short-form items and the original PF item bank was supported. Compared to formats A and B, format C increased the range of reliable measurement by about 0.5 standard deviations on the positive side of the PF continuum of the sample, provided more item information, and was more useful in distinguishing known groups with above-average functioning.
CONCLUSIONS: Using an item format with an extended response scale is an efficient option to increase the measurement range of self-reported physical function without changing the content of the measure or affecting the latent construct of the instrument
Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items
The use of global health items permits an efficient way of gathering general perceptions of health. These items provide useful summary information about health and are predictive of health care utilization and subsequent mortality.
Analyses of 10 self-reported global health items obtained from an internet survey as part of the Patient-Reported Outcome Measurement Information System (PROMIS) project. We derived summary scores from the global health items. We estimated the associations of the summary scores with the EQ-5D index score and the PROMIS physical function, pain, fatigue, emotional distress, and social health domain scores.
Exploratory and confirmatory factor analyses supported a two-factor model. Global physical health (GPH; 4 items on overall physical health, physical function, pain, and fatigue) and global mental health (GMH; 4 items on quality of life, mental health, satisfaction with social activities, and emotional problems) scales were created. The scales had internal consistency reliability coefficients of 0.81 and 0.86, respectively. GPH correlated more strongly with the EQ-5D than did GMH (r = 0.76 vs. 0.59). GPH correlated most strongly with pain impact (r = −0.75) whereas GMH correlated most strongly with depressive symptoms (r = −0.71).
Two dimensions representing physical and mental health underlie the global health items in PROMIS. These global health scales can be used to efficiently summarize physical and mental health in patient-reported outcome studies
Effort-reward imbalance at work and risk of type 2 diabetes in a national sample of 50,552 workers in Denmark : A prospective study linking survey and register data
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.Peer reviewe
Long working hours and risk of coronary heart disease and stroke: a systematic review and meta-analysis of published and unpublished data for 603 838 individuals
Background Long working hours might increase the risk of cardiovascular disease, but prospective evidence is scarce,
imprecise, and mostly limited to coronary heart disease. We aimed to assess long working hours as a risk factor for
incident coronary heart disease and stroke.
Methods We identifi ed published studies through a systematic review of PubMed and Embase from inception to
Aug 20, 2014. We obtained unpublished data for 20 cohort studies from the Individual-Participant-Data Meta-analysis
in Working Populations (IPD-Work) Consortium and open-access data archives. We used cumulative random-eff ects
meta-analysis to combine eff ect estimates from published and unpublished data.
Findings We included 25 studies from 24 cohorts in Europe, the USA, and Australia. The meta-analysis of coronary
heart disease comprised data for 603 838 men and women who were free from coronary heart disease at baseline; the
meta-analysis of stroke comprised data for 528 908 men and women who were free from stroke at baseline. Follow-up
for coronary heart disease was 5·1 million person-years (mean 8·5 years), in which 4768 events were recorded, and
for stroke was 3·8 million person-years (mean 7·2 years), in which 1722 events were recorded. In cumulative
meta-analysis adjusted for age, sex, and socioeconomic status, compared with standard hours (35–40 h per week),
working long hours (≥55 h per week) was associated with an increase in risk of incident coronary heart disease
(relative risk [RR] 1·13, 95% CI 1·02–1·26; p=0·02) and incident stroke (1·33, 1·11–1·61; p=0·002). The excess risk of
stroke remained unchanged in analyses that addressed reverse causation, multivariable adjustments for other risk
factors, and diff erent methods of stroke ascertainment (range of RR estimates 1·30–1·42). We recorded a
dose–response association for stroke, with RR estimates of 1·10 (95% CI 0·94–1·28; p=0·24) for 41–48 working
hours, 1·27 (1·03–1·56; p=0·03) for 49–54 working hours, and 1·33 (1·11–1·61; p=0·002) for 55 working hours or
more per week compared with standard working hours (ptrend<0·0001).
Interpretation Employees who work long hours have a higher risk of stroke than those working standard hours; the
association with coronary heart disease is weaker. These findings suggest that more attention should be paid to the
management of vascular risk factors in individuals who work long hours
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