Current medical research and opinion
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Objective: To compare the effectiveness and safety of the fluocinolone acetonide (FAc) intravitreal implant between the observational Iluvien Clinical Evidence study in the United Kingdom (ICE-UK) and the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) randomized controlled trials (RCTs) in people with diabetic macular edema (DME). Clinical Trials Registration: NCT00344968. Methods: This study selected patients randomized to receive 0.2 µg/day FAc insert (FAc treated eyes) or sham injection (control eyes) from the FAME RCTs, and patients' first FAc treated eye and non-FAc treated fellow (control) eye from the ICE-UK study. ⋯ Conclusions: Statistically significant improvements in VA 12 months after FAc implantation were observed in both the real-world study and in the RCTs. The improvement in VA and CFT in the RCTs was marginally greater than in the real-world study; however, recruits in the real-world study had more severe visual morbidity at baseline. Whilst there were many changes in the care of people with DME over this time, these data all support the value of treatment with FAc intravitreal implant.
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Objective: To examine how medical journal editors perceive changes in transparency and credibility of industry-sponsored clinical trial publications over a 5 year period (2010 to 2015). Methods: From July to September 2015, a survey link was emailed to journal editors identified from the Thomson Reuters registry. Editors ranked their perception of: a) change in transparency and credibility of industry-sponsored clinical trial publications; b) 8 "Publication Best Practices" and the impact of each on transparency; and c) the importance and adoption of the previously published "10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research". ⋯ Conclusions: The 293 editors who responded perceived an improvement in the transparency and credibility of industry-sponsored publications from 2010 to 2015. Confirmation of the importance of 9/10 recommendations by the respondents was encouraging. Yet, low adoption rates suggest that additional work is required by all stakeholders to improve best practices, transparency and credibility.
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Objective: Acute myocardial infarction (AMI) is associated with significant risk for long-term morbidity and healthcare expenditure. We investigated healthcare utilization and direct costs throughout 10 years following AMI. Methods: A retrospective study included AMI patients hospitalized in a tertiary medical center throughout 2002-2012. ⋯ Analysis of the relative costs showed that ambulatory services make up most of the expenditure. Conclusions: Healthcare utilization and economic expenditure peak throughout the first year and decline afterwards. For several services it remains higher for up to 10 years compared with the year preceding the AMI.
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Objective: Early initiation of antipsychotic treatment in schizophrenia is associated with improved outcomes. This study aimed to determine if initiation of long-acting injectable (LAI) antipsychotic treatment early in a new schizophrenia episode is associated with lower hospitalization rates and healthcare costs in a real-world setting. Methods: This retrospective (January 1, 2007-June 30, 2016) cohort analysis used claims from Truven Health Analytics MarketScan Commercial, Medicaid, and Medicare Supplemental databases. ⋯ Of early initiators, 14.1% (95% CI = 12.3-16.1%) had a psychiatric hospitalization vs 19.2% (95% CI = 17.7-20.8%) of late initiators (p < .001). Adjusted psychiatric healthcare costs were significantly lower in early initiators compared with late initiators [mean (95% CI) = $21,545 (20,355-22,734) vs $24,132 (23,330-24,933)] (p < .001). Conclusions: LAI initiation within 1 year of a new schizophrenia episode led to lower hospitalization rates and healthcare costs compared with LAI initiation more than 1 year after a new episode.
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Objective: Human papilloma virus (HPV) is the world's most common causative agent in sexually transmitted viral infections; thus requiring clinical guidance, before and after treatment, to promote better quality of life in women diagnosed with HPV. The HPV Impact Profile (HIP) is a comprehensive instrument used to assess the psychosocial impact of HPV and related interventions in a wide range of domains. The main purpose of this study was to validate the HIP in Portuguese women, so that it can be used in this population, both in research and in clinical settings. ⋯ As in the original HIP questionnaire, the exception was sexual impact, with a lower, but acceptable, Cronbach's alpha. Convergent and discriminant validities of the instrument were also assessed. Conclusions: The Portuguese version of the HIP presents good psychometric properties, allowing its use in clinical trials as well as in clinical practice in order to evaluate quality of life in women with HPV.