Perioperative hair removal in the 21st century: utilizing an innovative vacuum-assisted technology to safely expedite hair removal before surgery.

Background: Perioperative hair removal using clippers requires lengthy cleanup to remove loose hairs contaminating the operative field. We compared the amount of hair debris and associated microbiologic contamination produced during clipping of surgical sites using standard surgical clippers (SSC) or clippers fitted with a vacuum-assisted hair collection device (SCVAD). Methods: Trained nurses conducted bilateral hair clipping of the chest and groin of 18 male subjects using SSC or SCVAD. Before and during clipping, measurements of particulate matter and bacterial contamination were evaluated on settling plates placed next to each subject’s chest and groin. Skin condition after clipping and total clipping/cleanup times were compared between SSC and SCVAD. Results: The microbial burden recovered from residual hair during cleanup in the SSC group was 3.9 log10 CFU and 4.6 log10 CFU from respective, chest, and groin areas. Use of the SCVAD resulted in a significant (P < .001) reduction in both residual hair and microbial contamination within the operative field compared with SSC. Conclusions: Use of SCVAD resulted in significant (P< .001) reduction in total time required to clip and clean up residual hair contaminating the operative field compared with standard practice (ie, SSC), eliminating the need to physically remove dispersed hairs, which can harbor a significant microbial burden, from within the operative field

A systematic review of grandparents’ influence on grandchildren’s cancer risk factors

Many lifestyle patterns are established when children are young. Research has focused on the potential role of parents as a risk factor for non communicable disease in children, but there is limited investigation of the role of other caregivers, such as grandparents. The aim of this review was to identify and synthesise evidence for any influence grandparents&rsquo; care practices may have on their grandchildren&rsquo;s long term cancer risk factors. A systematic review was carried out with searches across four databases (MEDLINE, Embase, Web of Science, PsycINFO) as well as searches of reference lists and citing articles, and Google Scholar. Search terms were based on six areas of risk that family care could potentially influence&ndash;weight, diet, physical activity, tobacco, alcohol and sun exposure. All study designs were included, as were studies that provided an indication of the interaction of grandparents with their grandchildren. Studies were excluded if grandparents were primary caregivers and if children had serious health conditions. Study quality was assessed using National Institute for Health and Care Excellence checklists. Grandparent impact was categorised as beneficial, adverse, mixed or as having no impact. Due to study heterogeneity a meta-analysis was not possible. Qualitative studies underwent a thematic synthesis of their results. Results from all included studies indicated that there was a sufficient evidence base for weight, diet, physical activity and tobacco studies to draw conclusions about grandparents&rsquo; influence. One study examined alcohol and no studies examined sun exposure. Evidence indicated that, overall, grandparents had an adverse impact on their grandchildren&rsquo;s cancer risk factors. The theoretical work in the included studies was limited. Theoretically underpinned interventions designed to reduce these risk factors must consider grandparents&rsquo; role, as well as parents&rsquo;, and be evaluated robustly to inform the evidence base further

International Consensus Statement on Rhinology and Allergy: Rhinosinusitis

Background: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR‐RS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICAR‐RS‐2021 as well as updates to the original 140 topics. This executive summary consolidates the evidence‐based findings of the document. Methods: ICAR‐RS presents over 180 topics in the forms of evidence‐based reviews with recommendations (EBRRs), evidence‐based reviews, and literature reviews. The highest grade structured recommendations of the EBRR sections are summarized in this executive summary. Results: ICAR‐RS‐2021 covers 22 topics regarding the medical management of RS, which are grade A/B and are presented in the executive summary. Additionally, 4 topics regarding the surgical management of RS are grade A/B and are presented in the executive summary. Finally, a comprehensive evidence‐based management algorithm is provided. Conclusion: This ICAR‐RS‐2021 executive summary provides a compilation of the evidence‐based recommendations for medical and surgical treatment of the most common forms of RS

A checklist for clinical trials in rare disease: obstacles and anticipatory actions-lessons learned from the FOR-DMD trial.

BACKGROUND Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH) for 5 years (July 2010 to June 2015), anticipating that all sites (40 across the USA, Canada, the UK, Germany and Italy) would be open to recruitment from July 2011. However, study start-up was significantly delayed and recruitment did not start until January 2013. METHOD The FOR-DMD study is used as an example to identify systematic problems in the set-up of international, multi-centre clinical trials. The full timeline of the FOR-DMD study, from funding approval to site activation, was collated and reviewed. Systematic issues were identified and grouped into (1) study set-up, e.g. drug procurement; (2) country set-up, e.g. competent authority applications; and (3) site set-up, e.g. contracts, to identify the main causes of delay and suggest areas where anticipatory action could overcome these obstacles in future studies. RESULTS Time from the first contact to site activation across countries ranged from 6 to 24 months. Reasons of delay were universal (sponsor agreement, drug procurement, budgetary constraints), country specific (complexity and diversity of regulatory processes, indemnity requirements) and site specific (contracting and approvals). The main identified obstacles included (1) issues related to drug supply, (2) NIH requirements regarding contracting with non-US sites, (3) differing regulatory requirements in the five participating countries, (4) lack of national harmonisation with contracting and the requirement to negotiate terms and contract individually with each site and (5) diversity of languages needed for study materials. Additionally, as with many academic-led studies, the FOR-DMD study did not have access to the infrastructure and expertise that a contracted research organisation could provide, organisations often employed in pharmaceutical-sponsored studies. This delay impacted recruitment, challenged the clinical relevance of the study outcomes and potentially delayed the delivery of the best treatment to patients. CONCLUSION Based on the FOR-DMD experience, and as an interim solution, we have devised a checklist of steps to not only anticipate and minimise delays in academic international trial initiation but also identify obstacles that will require a concerted effort on the part of many stakeholders to mitigate