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Background Surrogate outcomes are a significant challenge in drug evaluation for health technology assessment (HTA) agencies. The research objectives were to: identify factors associated with surrogate use and acceptability in Canada's Common Drug Review (CDR) recommendations, and compare the CDR with other HTA or regulatory agencies regarding surrogate concerns. Methods Final recommendations were identified from CDR inception (September 2003) to December 31, 2010. Recommendations were classified by type of outcome (surrogate, final, other) and acceptability of surrogates (determined by the presence/absence of statements of concern regarding surrogates). Descriptive and statistical analyses examined factors related to surrogate use and acceptability. For thirteen surrogate-based submissions, recommendations from international HTA and regulatory agencies were reviewed for statements about surrogate acceptability. Results Of 156 final recommendations, 68 (44%) involved surrogates. The overall 'do not list' (DNL) rate was 48%; the DNL rate for surrogates was 41% (p = 0.175). The DNL rate was 64% for non-accepted surrogates (n = 28) versus 25% for accepted surrogates (odds ratio 5.4, p = 0.002). Clinical uncertainty, use of economic evidence over price alone, and a premium price were significantly associated with non-accepted surrogates. Surrogates were used most commonly for HIV, diabetes, rare diseases, cardiovascular disease and cancer. For the subset of drugs studied, other HTA agencies did not express concerns for most recommendations, while regulatory agencies frequently stated surrogate acceptance. Conclusions The majority of surrogates were accepted at the CDR. Non-accepted surrogates were significantly associated with clinical uncertainty and a DNL recommendation. There was inconsistency of surrogate acceptability across several international agencies. Stakeholders should consider collaboratively establishing guidelines on the use, validation, and acceptability of surrogates. [ABSTRACT FROM AUTHOR]

Background Although on the decline, smoking-related fires remain a leading cause of fire death in the United States and United Kingdom and account for over 10% of fire-related deaths worldwide. This has prompted lawmakers to enact legislation requiring manufacturers to implement reduced ignition propensity (RIP) safety standards for cigarettes. The current research evaluates how implementation of RIP safety standards in different countries influenced smokers' perceptions of cigarette self-extinguishment, frequency of extinguishment, and the impact on consumer smoking behaviors, including cigarettes smoked per day and planning to quit. Methods Participants for this research come from Waves 3 through 8 of the International Tobacco Control (ITC) Four Country Survey conducted longitudinally from 2004 through 2011 in the United States, United Kingdom, Australia, and Canada. Results Perceptions of cigarette self-extinguishment and frequency of extinguishment increased concurrently with an increase in the prevalence of RIP safety standards for cigarettes. Presence of RIP safety standards was also associated with a greater intention to quit smoking, but was not associated with the number of cigarettes smoked per day. Intention to quit was higher among those who were more likely to report that their cigarettes self-extinguish sometimes and often, but we found no evidence of an interaction between frequency of extinguishment and RIP safety standards on quit intentions. Conclusions Overall, because these standards largely do not influence consumer smoking behavior, RIP implementation may significantly reduce the number of cigarette-related fires and the associated death and damages. Further research should assess how implementation of RIP safety standards has influenced smoking-related fire incidence, deaths, and other costs associated with smoking-related fires. [ABSTRACT FROM AUTHOR]

Objective This paper examines how negative experiences with the health-care system create a lack of confidence in receiving medical care in seven countries: Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom, and the United States. Methods The empirical analysis is based on data from the Commonwealth Fund International Health Policy Survey 2007, with nationally representative samples of adults aged 18 and over. For the analysis of the experience of cost barriers and confidence in receiving medical care, we conducted pairwise comparisons of group percentages as well as country-wise multivariate logistic regression models. Results Individuals who have experienced cost barriers show a significantly lower level of confidence in receiving safe and quality medical care than those who have not. This effect is most pronounced in the United States, where people who have foregone necessary treatment because of costs are four times as likely to lack confidence as individuals without the experience of cost barriers (adjusted odds ratio 4.00). In New Zealand, Germany, and Canada, individuals with the experience of cost barriers are twice as likely to report low confidence compared with those without this experience (adjusted odds ratios of 1.95, 2.19 and 2.24, respectively). In the Netherlands and UK, cost barriers are only a marginal phenomenon. Conclusions The fact that the experience of financial barriers considerably lowers confidence indicates that financial incentives, such as private co-payments, have a negative effect on overall public support and therefore on the legitimacy of health-care systems. [ABSTRACT FROM AUTHOR]

Background: In high-income countries, those with low-to-middle incomes have been observing stagnating median wages and marginal improvements in their living standards. Smokers in financial difficulties appear to be less likely to quit smoking. Understanding the reasons for this is essential to intervening to improve cessation outcomes in this population, and reduce smoking-related health inequalities. Methods: We used longitudinal data from Waves 4 to 7 of the ITC Four Country Survey (ITC-4), and included those with data from at least two consecutive waves. Associations between financial difficulties and making a quit attempt, and quit success were analysed using generalised estimating equations, with adjustment for confounders. Mediation analysis was conducted to identify potential mediators of the observed effects of financial difficulties on cessation outcomes. Results: Having financial difficulties had little impact on making quit attempts (adjusted OR 0.84, 95% CI 0.70-1.01). Smokers with financial difficulties were substantially less likely to succeed at quitting (adjusted OR 0.55, 95% CI 0.39-0.76); an effect which was consistent over the survey years. Among the potential mediators examined, those relating to cognition of health-related and quality of life-related consequences of smoking were the most important mediators, though the proportion of the effect mediated by the largest mediator was small (6.8%). Conclusion: Having financial difficulties remains an important barrier to smokers achieving quit success. This effect does not appear to be due to anticipated factors such as reduced use of cessation services or treatment. Further research is required to determine strong mediators of the financial difficulties effect on quit success and to tailor more effective cessation programmes. [ABSTRACT FROM AUTHOR]