EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.

BACKGROUND: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses. OBJECTIVES: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain. METHODS: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously. RESULTS: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9). CONCLUSION: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

The cost-effectiveness of antidepressants for smoking cessation in chronic obstructive pulmonary disease (COPD) patients.

OBJECTIVES: In healthy smokers, antidepressants can double the odds of cessation. Because of its four times lower costs and comparable efficacy in healthy smokers, nortriptyline appears to be favourable compared to bupropion. We assessed which of both drugs was most effective and cost-effective in stopping smoking after 1 year compared with placebo among smokers at risk or with existing chronic obstructive pulmonary disease (COPD). METHODS: A total of 255 participants, aged 30-70 years, received smoking cessation counselling and were assigned bupropion, nortriptyline or placebo randomly for 12 weeks. Prolonged abstinence from smoking was defined as a participant's report of no cigarettes from week 4 to week 52, validated by urinary cotinine. Costs were calculated using a societal perspective and uncertainty was assessed using the bootstrap method. RESULTS: The prolonged abstinence rate was 20.9% with bupropion, 20.0% with nortriptyline and 13.5% with placebo. The differences between bupropion and placebo [relative risk (RR) = 1.6; 95% confidence interval (CI) 0.8-3.0] and between nortriptyline and placebo (RR = 1.5; 95% CI 0.8-2.9) were not significant. Severity of airway obstruction did not influence abstinence significantly. Societal costs were 1368 euros (2.5th-97.5th percentile 193-5260) with bupropion, 1906 euros (2.5th-97.5th 120-17 761) with nortriptyline and 1212 euros (2.5th-97.5th 96-6602) with placebo. Were society willing to pay more than 2000 euros for a quitter, bupropion was most likely to be cost-effective. CONCLUSIONS: Bupropion and nortriptyline seem to be equally effective, but bupropion appears to be more cost-effective when compared to placebo and nortriptyline. This impression holds using only health care costs. As the cost-effectiveness analyses concern some uncertainties, the results should be interpreted with care and future studies are needed to replicate the findings.

A tale of two cities: hospitalization costs in 1897 and 1997.

OBJECTIVES: To compare the hospitalization day price, and the hospitalization costs 100 years ago with the present situation. METHODS: Municipal and hospital archives of two cities, Maastricht in The Netherlands and Tongeren in Belgium, were studied systematically for reports of costs. These were compared with the present accounts. RESULTS: Starting from the second part of the nineteenth century, an official day price was calculated each year by averaging the total hospital expenditures by the total number of hospitalization days. Of all expenditures, nutrition accounted for nearly 50% of expenses. Differences with the current situation are striking. Nowadays, the day price is a negotiated tariff. Management and salaries make up more than 70% of the present expenditures. CONCLUSIONS: Hospitalization day prices have been used for approximately 150 years to determine hospitalization costs. Since then, the total hospital expenditures and the relative cost components have changed considerably. Compared with the spending power of people, the cost of one day in the hospital increased substantially.