Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor.

Background: Lymphedema after treatment for head and neck cancer negatively impacts the quality of life and can produce neck tissue stiffness, dysphagia, pain, and swelling. One form of treatment for lymphedema is machine-delivered sequential lymphedema massage, which is home based and self administered. This study was undertaken to determine economic and system access to home-based lymphedema therapy and to measure patient-reported outcomes among those able to access therapy. Methods: This study is a retrospective cohort study of 84 head and neck cancer patients who met the criteria for referral for home-based lymphedema treatment. Patients who were able to access lymphedema therapy were surveyed prior to initiation of therapy and again after therapy. Results: Thirty-five out of 84 patients were approved for home-based therapy and received the equipment. Medicare denial of coverage (21/84) was the most common cause of the inability to access therapy. Of the 35 patients who accessed therapy, presenting complaints included: stiffness (31), pain (29), dysphagia (20), and swelling (19). The average time from completion of cancer treatment to initiation of lymphedema therapy was 9 months. Thirty-four (97%) reported compliance with prescribed therapy, 33 (94%) reported reduced fibrosis, and 30 (89%) reported improvement in activities of daily living. All reported symptoms improved with therapy in 30 (86%) patients. Thirty-two (91%) reported overall satisfaction with home-based lymphedema treatment. Conclusions: Stiffness and pain were the most common complaints of our patients with head and neck lymphedema. Forty-two percent of patients who were recommended home lymphedema machine use were able to obtain this with cost coverage by their insurance company or by donation from the company. We found a high compliance rate and a highly reported improvement in symptoms with the machine. The only identifiable factor for the patients with less improvement in symptoms was a greater time gap between treatment and initiation of use of home lymphedema machine. Level of evidence: 2 Retrospective cohort analysis.

Oropharynx cancer after sleep apnea surgery.

Surgery can treat sleep apnea. An elderly male underwent lingual/palatine tonsillectomy for OSA. He was then found to have T3N2 p16+ squamous cell carcinoma. He is receiving chemoradiation. Recognition of occult malignancy in tonsillectomy specimens may facilitate early diagnosis and treatment for patients following sleep apnea surgery.

Quality of life in obese patients after thyroidectomy for goiter.

BACKGROUND: Compressive symptoms are common in thyroid disease. Many studies have focused on the size of the gland and its effects on patients. However, few have taken into account the body mass of the patient. The aim of our study was to examine whether or not a patient's body mass index (BMI) influences symptomatic outcomes following thyroid surgery for benign disease. METHODS: We conducted a prospective analysis evaluating 60 patients that underwent thyroidectomy for benign goiter (single or multinodular) disease. Patients were classified as obese, overweight, or normal based on BMI. Pre- and post-operative surveys were administered including the MRC breathlessness scale, M.D. Anderson Dysphagia Inventory (MDADI), and the ThyPRO quality of life questionnaire to evaluate dysphagia, dyspnea, and quality of life respectively. RESULTS: Patients classified as obese (n=37) scored significantly worse pre-operatively on MRC, MDADI, and ThyPRO surveys when compared to overweight (n=13) or normal weight (n=10) counterparts. Subjects in the obese group, but not the other groups, showed post-surgical improvement on both the MRC and MDADI surveys (P<0.0001). Similarly, obese subjects showed significant improvement on all 11 domains of the ThyPRO survey following surgery (P<0.0001), and overall degree of improvement was highly correlated with BMI among all subjects (r=0.60; P=0.0005). CONCLUSIONS: Obesity, as determined by BMI, is a critical factor to consider in the alleviation of compressive symptoms before and after thyroidectomy for goiter. Our analysis of survey data indicates obese subjects have increased benefit of surgery compared to their lighter counterparts.

Unusual cause of acute sinusitis and orbital abscess in COVID-19 positive patient: Case report.

BACKGROUND: Peptoniphilus indolicus is not usually seen in the eye or paranasal sinuses but is a commensal of the human vagina and gut. However, with COVID-19, eye infections and other unusual complications are possible with such unsuspected bacteria. CASE PRESENTATION: The patient is a 76-year-old white male from a nursing home tested positive for COVID-19 and was sent from a nursing facility for left eye drainage and psychiatric evaluation. Upon presentation, the patient was not fully oriented and could not provide a history of the eye drainage. CT scan showed sinusitis with left orbital and periorbital abscess formation, cellulitis, and extensive osteomyelitis. He underwent endoscopic transnasal drainage and orbiotomy. Cultures returned positive for methicillin-resistant Stapholococcus aureus (MRSA), Streptococcus constellatus, and Peptoniphilus indolicus. He was maintained on several days of IV antibiotics and returned to the nursing home. He then presented 2 months later and required enucleation of his globe, due to the presence of multiple scleral perforations in the setting of orbital abscess, as well as removal of necrotic orbital bone. CONCLUSIONS: Given the concomitant infection with COVID-19 and unusual presentation, the patient's sinus cultures support the notion that COVID-19 can affect the presence of bacteria within certain anatomical regions. Specifically, Peptoniphilus indolicus is not normally found outside of the vagina or gut biome. Avascular, pale mucosa and bone of the nasal cavity was noted during surgery of this COVID-19 infected patient, which is in contrast to the friable and edematous tissue typically found in acutely infected sinuses. Our patient's orbital abscess began to drain spontaneously through the skin, which is rare for orbital abscesses. Also uncommon with orbital abscesses is the need for enucleation, which in this case was deemed necessary given that the abscess had perforated the sclera in multiple locations.

Thyroid surgery YouTube videos: estimating quality by surgeon characteristics and view rate.

BACKGROUND: With readily available material online we aimed: (I) to estimate the volume of thyroid surgery-related video content readily available to the surgical trainee; (II) to stratify the sources of thyroid surgery-related video content by source (patient, institution, surgeon, or other) and (III) to estimate the quality of the surgeon source by related scholarly output. METHODS: A search of YouTube, a widely used source of open-access video content, was undertaken using "thyroidectomy" as the search term. The first 100 "hits" were analyzed for source. When the video was surgeon-sourced, the surgeon's name was used in a PubMed author query for "thyroidectomy" and publications noted. RESULTS: Approximately 7,260 videos were returned using "thyroidectomy" as the search term. The first 100 "hits" were stratified by source, assuming the typical surgical trainee would not delve further into the list. The sources were primarily surgeons, followed by patient testimonials, and institutions. The surgeons were stratified by related publications listed in PubMed. The majority of surgeons were not published in thyroid surgery-related topics. CONCLUSIONS: Internet video content is an increasingly utilized source of surgical education. Since video content can be posted without peer review or confirmation of veracity, this study measures the variety of sources of thyroid surgery information. Individuals without thyroid surgery publication history posted the majority of surgeon-sourced video content, although this history serves only as a surrogate for an academic career. Trainees and educators alike should critically analyze the quality of video content.

Anomalous Right Subclavian Artery-Esophageal Fistulae.

An aberrant right subclavian artery (ARSA) is the most common aortic arch anomaly, but only 19 previous cases of ARSA-esophageal fistula have been reported. Six patients have survived their bleeding episode. We describe the case of a 44-year-old woman who developed massive hemoptysis. Laryngoscopy, bronchoscopy, head and neck angiogram, and median sternotomy did not reveal what was presumed initially to be a tracheoinnominate fistula. Contrasted CT showed an anomalous subclavian artery posterior to the esophagus. Given the technical challenge of approaches for this pathology, the patient was unfit for open surgical repair. Therefore, endovascular covered stent grafts were deployed spanning the segment of the subclavian artery in continuity with the esophagus, via a right brachial artery approach. Unfortunately, the patient died after successful placement of the grafts.

Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance.

Medical countermeasures (MCMs) are medical products used during public health emergencies. This study, conducted within the Mini-Sentinel Initiative, sought to develop the patient identification and matching processes necessary to assess safety outcomes for MCMs. A handheld device was used to collect identifying information (e.g., name, birthdate, and sex) from the driver's licenses of 421 individuals presenting for routine care at their primary care medical office. Overall, 374 individuals (88.8%) could be linked to their electronic health data using driver's license information. The device was also pilot-tested at a seasonal influenza immunization clinic: detailed vaccine information (e.g., lot number and manufacturer) was captured with a high degree of accuracy. This investigation demonstrated that a handheld device is a feasible means of collecting patient identity and medical product receipt data. This capacity should be useful for safety surveillance of MCMs, particularly when dispensed in settings outside the traditional health-care delivery system.

Regulatory underpinnings of Global Health security: FDA's roles in preventing, detecting, and responding to global health threats.

In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.

Legal preparedness: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

BACKGROUND: Significant legal challenges arise when health-care resources become scarce and population-based approaches to care are implemented during severe disasters and pandemics. Recent emergencies highlight the serious legal, economic, and health impacts that can be associated with responding in austere conditions and the critical importance of comprehensive, collaborative health response system planning. This article discusses legal suggestions developed by the American College of Chest Physicians (CHEST) Task Force for Mass Critical Care to support planning and response efforts for mass casualty incidents involving critically ill or injured patients. The suggestions in this chapter are important for all of those involved in a pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. METHODS: Following the CHEST Guidelines Oversight Committee's methodology, the Legal Panel developed 35 key questions for which specific literature searches were then conducted. The literature in this field is not suitable to provide support for evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process resulting in seven final suggestions. RESULTS: Acceptance is widespread for the health-care community's duty to appropriately plan for and respond to severe disasters and pandemics. Hospitals, public health entities, and clinicians have an obligation to develop comprehensive, vetted plans for mass casualty incidents involving critically ill or injured patients. Such plans should address processes for evacuation and limited appeals and reviews of care decisions. To legitimize responses, deter independent actions, and trigger liability protections, mass critical care (MCC) plans should be formally activated when facilities and practitioners shift to providing MCC. Adherence to official MCC plans should contribute to protecting hospitals and practitioners who act in good faith from liability. Finally, to address anticipated staffing shortages during severe and prolonged disasters and pandemics, governments should develop approaches to formally expand the availability of qualified health-care workers, such as through using official foreign medical teams. CONCLUSIONS: As a fundamental element of health-care and public health emergency planning and preparedness, the law underlies critical aspects of disaster and pandemic responses. Effective responses require comprehensive advance planning efforts that include assessments of complex legal issues and authorities. Recent disasters have shown that although law is a critical response tool, it can also be used to hold health-care stakeholders who fail to appropriately plan for or respond to disasters and pandemics accountable for resulting patient or staff harm. Claims of liability from harms allegedly suffered during disasters and pandemics cannot be avoided altogether. However, appropriate planning and legal protections can help facilitate sound, consistent decision-making and support response participation among health-care entities and practitioners.

Ethical considerations: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

BACKGROUND: Mass critical care entails time-sensitive decisions and changes in the standard of care that it is possible to deliver. These circumstances increase provider uncertainty as well as patients' vulnerability and may, therefore, jeopardize disciplined, ethical decision-making. Planning for pandemics and disasters should incorporate ethics guidance to support providers who may otherwise make ad hoc patient care decisions that overstep ethical boundaries. This article provides consensus-developed suggestions about ethical challenges in caring for the critically ill or injured during pandemics or disasters. The suggestions in this article are important for all of those involved in any pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. METHODS: We adapted the American College of Chest Physicians (CHEST) Guidelines Oversight Committee's methodology to develop suggestions. Twenty-four key questions were developed, and literature searches were conducted to identify evidence for suggestions. The detailed literature reviews produced 144 articles. Based on their expertise within this domain, panel members also supplemented the literature search with governmental publications, interdisciplinary workgroup consensus documents, and other information not retrieved through PubMed. The literature in this field is not suitable to support evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process. RESULTS: We report the suggestions that focus on five essential domains: triage and allocation, ethical concerns of patients and families, ethical responsibilities to providers, conduct of research, and international concerns. CONCLUSIONS: Ethics issues permeate virtually all aspects of pandemic and disaster response. We have addressed some of the most pressing issues, focusing on five essential domains: triage and allocation, ethical concerns of patients and families, ethical responsibilities to providers, conduct of research, and international concerns. Our suggestions reflect the consensus of the Task Force. We recognize, however, that some suggestions, including those related to end-of-life care, may be controversial. We highlight the need for additional research and dialogue in articulating values to guide health-care decisions during disasters.

Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Preparing for and responding to public health emergencies involving medical countermeasures (MCMs) raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.S. Department of Health and Human Services' (HHS) Office of the General Counsel (OGC), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Specifically, the authors describe the Public Readiness and Emergency Preparedness (PREP) Act and Emergency Use Authorization (EUA) authority, outlining the conditions under which these tools can be utilized and providing examples of how they have supported both pre-event (e.g., doxycycline mass dispensing preparedness for anthrax) and intra-event (e.g., 2009 H1N1 influenza pandemic response) activities.

Development and reliability of the Mealtime Social Interaction Measure for Long-Term Care (MSILTC).

Mealtimes are important social events in retirement (RH) and long term care homes (LTC). This manuscript describes the development, refining and scaling of the MSILTC as well as inter-observer reliability. Two facilities provided access to their RH (n~100) and LTC (n~30-45) dining rooms. This observation-based tool captures both frequency and nature of interactions. Mealtime observations were carried out by trained researchers for development (n=13 tables), refinement (n=12 tables) scaling (n=17 tables) and reliability (n= 30 tables). Tablemate and staff level sub scores are calculated considering number of residents at the table and duration of the meal. Statistical analysis using Cohen's kappa demonstrated that the tool possesses adequate reliability for capturing frequency of interaction among residents and staff [kappa 0.712 and 0.790 respectively]; reliability for nature of interaction was lower [kappa 0.590 and 0.441 respectively]. Construct validity testing is planned to complete the development of the MSILTC.

Meeting the challenges of medical countermeasure development.

Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three-pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures - and the systems to deliver them - and the requisite support of all stakeholders, including national leadership.

Legal considerations during pediatric emergency mass critical care events.

INTRODUCTION: Recent public health emergencies, such as the 2009 Influenza A/H1N1 Pandemic and Hurricane Katrina, underscore the importance of developing healthcare response plans and protocols for disasters impacting large populations. Significant research and scholarship, including the 2009 Institute of Medicine report on crisis standards of care and the 2008 Task Force for Mass Critical Care recommendations, provide guidance for healthcare responses to catastrophic emergencies. Most of these efforts recognize but do not focus on the unique needs of pediatric populations. In 2008, the Centers for Disease Control and Prevention supported the formation of a task force to address pediatric emergency mass critical care response issues, including legal issues. Liability is a significant concern for healthcare practitioners and facilities during pediatric emergency mass critical care that necessitates a shift to crisis standards of care. This article describes the legal considerations inherent in planning for and responding to catastrophic health emergencies and makes recommendations for pediatric emergency mass critical care legal preparedness. METHODS: The Pediatric Emergency Mass Critical Care Task Force, composed of 36 experts from diverse public health, medical, and disaster response fields, convened in Atlanta, GA, on March 29-30, 2010, to review the pediatric emergency mass critical care recommendations developed by a 17-member steering committee. During the meeting, experts determined that the recommendations would be strengthened by a manuscript addressing legal issues. Authors drafted the manuscript through consensus-based study of peer-reviewed research, literature reviews, and expert opinion. The manuscript was reviewed by Pediatric Emergency Mass Critical Care Steering Committee members and additional legal counsel and revised. TASK FORCE RECOMMENDATIONS: While the legal issues associated with providing pediatric emergency mass critical care are not unique within the overall context of disaster healthcare, the scope of the parens patriae power of states, informed consent principles, and security should be considered in pediatric emergency mass critical care planning and response efforts because parents and legal guardians may be unavailable to participate in healthcare decision making during disasters. In addition, practitioners who follow properly vetted and accepted pediatric emergency mass critical care disaster protocols in good faith should be protected from civil liability, and healthcare facilities that provide pediatric care should incorporate informed consent and security protocols into their disaster plans.