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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: Throughout many countries, professional bodies rely on yearly self-assessment of competence for ongoing registration; therefore, nursing competence is pivotal to safe clinical practice. Our aim was to describe and compare perioperative nurses’ perceptions of competence in four countries, while examining the effect of specialist education and years of experience in the operating room. Methods: We conducted a secondary analysis of cross-sectional surveys from four countries including; Australia, Canada, Scotland, and Sweden. The 40-item Perceived Perioperative Competence Scale-Revised (PPCS-R), was used with a total sample of 768 respondents. We used a factorial design to examine the influence of country, years of experience in the operating room and specialist education on nurses’ reported perceived perioperative competence. Results: Regardless of country origin, nurses with specialist qualifications reported higher perceived perioperative competence when compared to nurses without specialist education. However, cross-country differences were dependent on nurses’ number of years of experience in the operating room. Nurses from Sweden with 6–10 years of experience in the operating room reported lower perceived perioperative competence when compared to Australian nurses. In comparing nurses with > 10 years of experience, Swedish nurses reported significantly lower perceived perioperative competence when compared to nurses from Australia, Canada and Scotland. Conclusion: Researchers need to consider educational level and years of experience in the perioperative context when examining constructs such as competence. [ABSTRACT FROM AUTHOR]