Opportunities to integrate new approaches in genetic toxicology: An ILSI-HESI workshop report

Genetic toxicity tests currently used to identify and characterize potential human mutagens and carcinogens rely on measurements of primary DNA damage, gene mutation, and chromosome damage in vitro and in rodents. The International Life Sciences Institute Health and Environmental Sciences Institute (ILSI-HESI) Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity Testing held an April 2012 Workshop in Washington, DC, to consider the impact of new understanding of biology and new technologies on the identification and characterization of genotoxic substances, and to identify new approaches to inform more accurate human risk assessment for genetic and carcinogenic effects. Workshop organizers and speakers were from industry, academe, and government. The Workshop focused on biological effects and technologies that would potentially yield the most useful information for evaluating human risk of genetic damage. Also addressed was the impact that improved understanding of biology and availability of new techniques might have on genetic toxicology practices. Workshop topics included (1) alternative experimental models to improve genetic toxicity testing, (2) Biomarkers of epigenetic changes and their applicability to genetic toxicology, and (3) new technologies and approaches. The ability of these new tests and technologies to be developed into tests to identify and characterize genotoxic agents; to serve as a bridge between in vitro and in vivo rodent, or preferably human, data; or to be used to provide dose response information for quantitative risk assessment was also addressed. A summary of the workshop and links to the scientific presentations are provided.International Life Sciences Institute/Health and Environmental Sciences Institute Committe

Quality of life after intratympanic steroid injection for Meniere's disease

ObjectiveResultsLevel of evidence This study explores how treatment with intratympanic steroid injection affects quality of life, as well as several subjective complaints in patients with Meniere's disease. Methods Patients filled in the Meniere's Disease Outcome Questionnaire (MDOQ) and answered questions about subjective complaints. Scores before and after treatment were compared using pairedttests. Forty-nine patients treated with intratympanic steroid injection were included. Quality of life was improved in 36 (73%) patients, the same in 9 (18%) patients, and lower in 4 (8%) patients. Overall, the mean change in MDOQ was +20.6 points (95% confidence interval +14.5 to +26.7 points, p < 0.001). The improvement was seen in the emotional, physical, and mental domain. Most patients experienced less vertigo and instability but did not notice change in subjective hearing, tinnitus, or aural fullness after treatment. Conclusion Treatment with intratympanic steroid injection leads to an improvement in quality of life in most patients. Moreover, the procedure is only minimally invasive. Based on the findings in this study, treatment with ITS should be discussed with every patient suffering from vertigo attacks due to active Meniere's disease. Level 4OtorhinolaryngologyDisorders of the head and nec

Attitude and behaviour of Dutch Otorhinolaryngologists to Evidence Based Medicine.

OBJECTIVE:The objective of this study was to assess the attitude and behaviour of Dutch ENT surgeons and ENT residents towards Evidence Based Medicine. INTRODUCTION:Evidence Based Medicine is the cornerstone of modern clinical care. It is considered of crucial importance for optimal patient care and health care quality. Practicing it requires positive attitude and behaviour. Little is known about the attitude and behaviour towards Evidence Based Medicine in otorhinolaryngology. METHODS:We performed a web-based questionnaire among 607 Dutch Ear- Nose & Throat surgeons of whom 106 residents (cross-sectional study). The questionnaire consisted of 3 parts; (1) personal characteristics, (2) questions regarding Evidence Based Medicine attitude (McColl questionnaire, scale 0-100%) and (3) questions regarding Evidence Based Medicine behaviour (barriers and information seeking behaviour). Data were collected between March 26th 2018 and June 1st 2018. RESULTS:The median score on the overall McColl questionnaire was 50 (IQR 35). The main barriers respondents experienced were time related. Limited time in the outpatient clinic was considered a more important barrier for residents to practice EBM compared to ENT surgeons. Respondents' gut feeling and their own preference were identified as the main contributing factors in clinical decision making. CONCLUSION:In conclusion Dutch ENT surgeons have a moderate attitude on the McColl questionnaire. The main barriers to practice Evidence Based Medicine they experience are time related

Impact of surgical intervention trials on healthcare: A systematic review of assessment methods, healthcare outcomes, and determinants.

BACKGROUND:Frameworks used in research impact evaluation studies vary widely and it remains unclear which methods are most appropriate for evaluating research impact in the field of surgical research. Therefore, we aimed to identify and review the methods used to assess the impact of surgical intervention trials on healthcare and to identify determinants for surgical impact. METHODS:We searched journal databases up to March 10, 2020 for papers assessing the impact of surgical effectiveness trials on healthcare. Two researchers independently screened the papers for eligibility and performed a Risk of Bias assessment. Characteristics of both impact papers and trial papers were summarized. Univariate analyses were performed to identify determinants for finding research impact, which was defined as a change in healthcare practice. RESULTS:Sixty-one impact assessments were performed in 37 included impact papers. Some surgical trial papers were evaluated in more than one impact paper, which provides a total of 38 evaluated trial papers. Most impact papers were published after 2010 (n = 29). Medical records (n = 10), administrative databases (n = 22), and physician's opinion through surveys (n = 5) were used for data collection. Those data were analyzed purely descriptively (n = 3), comparing data before and after publication (n = 29), or through time series analyses (n = 5). Significant healthcare impact was observed 49 times and more often in more recent publications. Having impact was positively associated with using medical records or administrative databases (ref.: surveys), a longer timeframe for impact evaluation and more months between the publication of the trial paper and the impact paper, data collection in North America (ref.: Europe), no economic evaluation of the intervention, finding no significant difference in surgical outcomes, and suggesting de-implementation in the original trial paper. CONCLUSIONS AND IMPLICATIONS:Research impact evaluation receives growing interest, but still a small number of impact papers per year was identified. The analysis showed that characteristics of both surgical trial papers and impact papers were associated with finding research impact. We advise to collect data from either medical records or administrative databases, with an evaluation time frame of at least 4 years since trial publication