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Infectious Diseases Society of America Guidelines on Infection Prevention for Healthcare Personnel Caring for Patients with Suspected or Known COVID-19

Author/s: 
Lynch, J. B., Davitkov, P., Anderson, D. J., Bhimraj, A., Cheng, V. C. C., Guzman-Cottrill, J., Dhindsa, J., Duggal, A., Jain, M. K., Lee, G. M., Liang, S. Y., McGeer, A., Varghese, J., Lavergne, V., Murad, M. H., Mustafa, R. A., Sultan, S., Falck-Ytter, Y., Morgan, R. L.

Background: Since its emergence in late 2019, SARS-CoV-2 continues to pose a risk to healthcare personnel (HCP) and patients in healthcare settings. Although all clinical interactions likely carry some risk of transmission, human actions like coughing and care activities like aerosol-generating procedures likely have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 continues to create significant challenges in healthcare facilities, particularly with shortages of personal protective equipment (PPE) used by HCP. Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care continue to be needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators.

Objective: Develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known COVID-19.

Methods: IDSA formed a multidisciplinary guideline panel including frontline clinicians, infectious disease specialists, experts in infection control, and guideline methodologists with representation from the disciplines of public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations.

Results: The IDSA guideline panel agreed on eight recommendations, including two updated recommendations and one new recommendation added since the first version of the guideline. Narrative summaries of other interventions undergoing evaluations are also included.

Conclusions: Using a combination of direct and indirect evidence, the panel was able to provide recommendations for eight specific questions on the use of PPE for HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 and PPE recommendations may need to be modified in response to new evidence. These recommendations should serve as a minimum for PPE use in healthcare facilities and do not preclude decisions based on local risk assessments or requirements of local health jurisdictions or other regulatory bodies.

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

Author/s: 
Frykberg, RG, Franks, PJ, Edmonds, M, Brantley, JN, Téot, L, Wild, T, Garoufalis, MG, Lee, AM, Thompson, JA, Reach, G, Dove, CR, Lachgar, K, Grotemeyer, D, Renton, SC, TWO2 Study Group

OBJECTIVE:

Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.

RESEARCH DESIGN AND METHODS:

Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.

RESULTS:

At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P = 0.013).

CONCLUSIONS:

This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.

Keywords 
wound therapy diabetes diabetic foot ulcer topical wound oxygen therapy two2

Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers

Author/s: 
American Diabetes Association

The American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes is updated and published annually in a supplement to the January issue of Diabetes Care. The ADA’s Professional Practice Committee, which includes physicians, diabetes educators, registered dietitians (RDs), and public health experts, develops the Standards. The Standards include the most current evidence-based recommendations for diagnosing and treating adults and children with all forms of diabetes. ADA’s grading system uses A, B, C, or E to show the evidence level that supports each recommendation.

  • A—Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered

  • B—Supportive evidence from well-conducted cohort studies

  • C—Supportive evidence from poorly controlled or uncontrolled studies

  • E—Expert consensus or clinical experience

This is an abridged version of the 2019 Standards containing the evidence-based recommendations most pertinent to primary care. The tables and figures have been renumbered from the original document to match this version. The complete 2019 Standards of Care document, including all supporting references, is available at professional.diabetes.org/standards.

Keywords 
standard of care guidelines diabetes diabetes, type 2 A1C

Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People

Introduction to the guidelines The Center of Excellence for Transgender Health (CoE) at the University of California – San Francisco is proud to present these Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People. Transgender people have a gender identity that differs from the sex which they were assigned at birth, and are estimated to represent 0.5% of the U.S. population.[1] Numerous needs assessments have demonstrated that transgender people encounter a range of barriers to accessing primary health care. A 2006 survey of more than 600 transgender people in California found that 30% postponed seeking medical care due to prior disrespect or discrimination, and that 10% were primary care outright.[2] The 2011 National Transgender Discrimination Survey of more than 6000 transgender people in all 50 U.S. states found several noteworthy disparities, including 28% who delayed care due to past discrimination and 19% who were denied care outright. Most alarmingly, 50% of respondents reported having to teach their providers about their own healthcare.[3] These guidelines aim to address these disparities by equipping primary care providers and health systems with the tools and knowledge to meet the health care needs of their transgender and gender nonconforming patients. These guidelines expand on the original UCSF Primary Care Protocol for Transgender Care, which since its launch in 2011 has served thousands of providers and policymakers across the U.S. and around the world; the page on hormone administration alone received more than 5000 visitors in the month of November, 2015. These Guidelines complement the existing World Professional Association for Transgender Health Standards of Care and the Endocrine Society Guidelines in that they are specifically designed for implementation in every day evidence-based primary care, including settings with limited resources.[4,5] The overall structure and list of topics for inclusion were developed in consultation with the CoE’s Medical Advisory Board (MAB), a diverse group of expert clinicians from a variety of academic and community based settings. Also contributing to the overall design and structure was a review of the range of consultation requests received by the CoE since the 2011 launch of the original Protocol. The guidelines were then written using an authorship – peer review approach. Primary authors from both within and outside the MAB were invited for individual topics, after which a peer review and modified consensus process was used to arrive at the final guidelines presented here. The diverse authorship allows the development of a broadly applicable document, rather than one that solely reflects the practice at a single academic medical center, such as UCSF. These guidelines would not be possible without the contributions of our Medical Advisory Board and other authors and reviewers, as well as the support of my CoE colleagues JoAnne Keatley, MSW and E. Michael Reyes, MD, MPH, as well as Lissa Moran who assisted immensely with literature reviews, bibliography management, version control, copy editing, formatting, and compiling peer reviewer comments. Ben Zovod also assisted with literature reviews, bibliography management, and compiling peer reviewer comments. Their dedication and hours of hard work has resulted in a final product that is relevant, broadly applicable, evidence based, and scientifically sound. I hope you find these guidelines useful and welcome any feedback or questions, which are June 17, 2016 2 Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People helpful in framing future revisions. Thank you for caring about the health of transgender and gender nonconforming people. Madeline B. Deutsch, MD, MPH Editor Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People Director of Clinical Services Center of Excellence for Transgender Health Associate Professor of Clinical Family and Community Medicine Department of Family and Community Medicine University of California, San Francisco Madeline.Deutsch@ucsf.edu

Keywords 
transgender guidelines standard of care gender identity
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