61 Burnout in Core Surgical Trainees and Potential Use of Mindfulness

Aim Surgical trainees deal with long hours and stressful work content. We aimed to assess the burnout levels in London trainees, and trial a mindfulness intervention. Method London core surgical trainees (CST1) were asked to complete an online survey including validated burnout scoring system (Oldenburg Inventory). 54 of a possible 78 trainees responded (69%). We then asked them to take part in a 2-week mindfulness intervention (approximately 5 minutes a day using the app Headspace). We later resurveyed. Results 60% of trainees who answered the survey feel ‘somewhat’ or ‘completely’ burnt out. Oldenburg burnout inventory calculates 85% of trainees to be ‘disengaged’ and 93% ‘exhausted’. 13/54 trainees completed the mindfulness training. 10 out of 13 trainees found this to be ‘somewhat’ or ‘massively’ helpful for burnout. Conclusions A high percentage of year one surgical trainees can be categorised as burnt out. The low uptake of mindfulness may speak to lack of capacity trainees have to invest in resources that will self-resolve this. We cannot say with significance whether mindfulness helped burnout (and length of trial could be too short) but the majority who did trial report positive experience with mindfulness.

Writing up your clinical trial report for a scientific journal: The REPORT trial guide for effective and transparent research reporting without spin

The REPORT guide is a “How to” guide to help you achieve effective and transparent clinical trial reporting. It is intended to supplement “first choice” reporting tools, such as CONSORT, by adding tacit knowledge about reporting topics we have struggled with as authors or see others struggle with as journal reviewers or editors. Focus is the randomised controlled trial, but the guide is useful for other study designs as well. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing, and much more. We hope you find it useful.Preprint (open access): https://doi.org/xxxxxxxxxxxxxxx

Racial diversity and reporting in FDA registration trials for genitourinary (GU) cancers from 2006-20.

22 Background: GU cancers account for 1 in 5 of new cancer diagnoses in the USA. Significant racial disparities exist in terms of incidence, treatment and outcomes. Current FDA clinical trial guidance advises race reporting as a minimum of 5 categories (White/Caucasian, Black, Asian, American Indian or Alaskan Native [AIAN] and Native Hawaiian or Pacific Islander [NHPI]). Guidelines from the International Committee of Medical Journal Editors (ICMJE) recommend that authors should as a minimum, provide descriptive data for variables such as race and ethnicity. We analysed racial diversity in GU registration trials and compliance with FDA/ICMJE guidance in reporting. Methods: A retrospective review of new market authorisations in GU cancers from Jan 2006 to Oct 2020 was conducted utilizing the FDA website. Clinical trials cited on the licensing label for market authorization were recorded and corresponding registration trial publication identified. If race was unreported or partially reported (defined ≤3 groups), then the trial report on clinicaltrials.gov or FDA website was analysed. Total proportion of racial group participation and the proportion of registration trials with adequate reporting was determined. Results: We identified 42 new licensing indications, involving 33 unique drugs. Overall 30,316 patients participated in GU cancer registration trials; 21,068 (69.5%) White or Caucasian, 2516 (8.3%) Asian, 621(2%) Black or African American, 92 (0.3%) AIAN, 17 (0.1%) NHPI, 558 (1.8%) other or multiple races and 5463 (18%) unknown. Table shows breakdown by tumour group. Race reporting occurred in 23 (55%) registration trial publications, of which 5 provided only limited information (e.g. Caucasian only). For studies where no race information was reported, a further 10 (24%) had information within the trial report. In the 5 years prior to the introduction of FDA guidance in 2016 only 30% of registration studies met FDA/ICJME requirements. Since 2016 this has improved significantly to 60%. Conclusions: Despite the higher incidence of GU cancers in non-white populations, this study has revealed the relative over-representation of white participants in GU registration trials. The inclusion of black trial participants is in particular disproportionately low when compared to the burden of disease in this population group. Recruitment of black and other minority participants should be a research priority. [Table: see text]

Are Most of the Published Clinical Trial Results in Restorative Dentistry Invalid? An Empirical Investigation

Background: To establish the number of invalid clinical trial reports in restorative dentistry, due to lack of effective randomisation and/or inadequate sample size and whether this number changed, during the 1990-2019 period. Methods: Databases were searched up to 14 July 2019 without limitations regarding publication language. A Journal hand search and reference check were conducted for trial reports. Selection criteria were: reporting on a prospective, controlled clinical trial; relevance to placing direct tooth restorations in human vital teeth; direct comparison between restorative materials concerning tooth restoration longevity; trial report published from 1990. Randomisation reported (Yes/No) and treatment group sample size ≥ 200 were applied as criteria, using the deductive falsification approach for trial report appraisal. Results: 683 trial reports were appraised. 660 lacked effective randomisation. Of the remaining 23 reports, only 2 included a sample size of more than 200 restored teeth (mean number per treatment group 87; Standard deviation = 108.51). 92.5% of all treatment groups had a sample size of < 200. Randomisation reporting increased and sample size remained essentially unchanged between 1990 and 2019. Conclusion: Most of the published clinical trial results in restorative dentistry were judged invalid, due to lack of effective randomisation and adequate sample size. These results are in line with previous findings. Evidence-based recommendations on how to improve trial methodology are available in the dental/medical literature.