Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Clinical Guideline From the American College of Physicians.

DESCRIPTION: The American College of Physicians (ACP) developed this clinical guideline to update recommendations on newer pharmacologic treatments of type 2 diabetes. This clinical guideline is based on the best available evidence for effectiveness, comparative benefits and harms, consideration of patients' values and preferences, and costs. METHODS: This clinical guideline is based on a systematic review of the effectiveness and harms of newer pharmacologic treatments of type 2 diabetes, including glucagon-like peptide-1 (GLP-1) agonists, a GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, and long-acting insulins, used either as monotherapy or in combination with other medications. The Clinical Guidelines Committee prioritized the following outcomes, which were evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach: all-cause mortality, major adverse cardiovascular events, myocardial infarction, stroke, hospitalization for congestive heart failure, progression of chronic kidney disease, serious adverse events, and severe hypoglycemia. Weight loss, as measured by percentage of participants who achieved at least 10% total body weight loss, was a prioritized outcome, but data were insufficient for network meta-analysis and were not rated with GRADE. AUDIENCE AND PATIENT POPULATION: The audience for this clinical guideline is physicians and other clinicians. The population is nonpregnant adults with type 2 diabetes. RECOMMENDATION 1: ACP recommends adding a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control (strong recommendation; high-certainty evidence). • Use an SGLT-2 inhibitor to reduce the risk for all-cause mortality, major adverse cardiovascular events, progression of chronic kidney disease, and hospitalization due to congestive heart failure. • Use a GLP-1 agonist to reduce the risk for all-cause mortality, major adverse cardiovascular events, and stroke. RECOMMENDATION 2: ACP recommends against adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control to reduce morbidity and all-cause mortality (strong recommendation; high-certainty evidence).

Implementation of a One-Day Living Kidney Donor Assessment Clinic to Improve the Efficiency of the Living Kidney Donor Evaluation: Program Report.

Purpose of program: A key barrier to becoming a living kidney donor is an inefficient evaluation process, requiring more than 30 tests (eg, laboratory and diagnostic tests), questionnaires, and specialist consultations. Donor candidates make several trips to hospitals and clinics, and often spend months waiting for appointments and test results. The median evaluation time for a donor candidate in Ontario, Canada, is nearly 1 year. Longer wait times are associated with poorer outcomes for the kidney transplant recipient and higher health care costs. A shorter, more efficient donor evaluation process may help more patients with kidney failure receive a transplant, including a pre-emptive kidney transplant (ie, avoiding the need for dialysis). In this report, we describe the development of a quality improvement intervention to improve the efficiency, effectiveness, and patient-centeredness of the donor candidate evaluation process. We developed a One-Day Living Kidney Donor Assessment Clinic, a condensed clinic where interested donor candidates complete all testing and consultations within 1 day. Sources of information: The One-Day Living Kidney Donor Assessment Clinic was developed after performing a comprehensive review of the literature, receiving feedback from patients who have successfully donated, and meetings with transplant program leadership from St. Joseph's Healthcare Hamilton. A multistakeholder team was formed that included health care staff from nephrology, transplant surgery, radiology, cardiology, social work, nuclear medicine, and patients with the prior lived experience of kidney donation. In the planning stages, the team met regularly to determine the objectives of the clinic, criteria for participation, clinic schedule, patient flow, and clinic metrics. Methods: Donor candidates entered the One-Day Clinic if they completed initial laboratory testing and agreed to an expedited process. If additional testing was required, it was completed on a different day. Donor candidates were reviewed by the nephrologist, transplant surgeon, and donor coordinator approximately 2 weeks after the clinic for final approval. The team continues to meet regularly to review donor feedback, discuss challenges, and brainstorm solutions. Key findings: The One-Day Clinic was implemented in March 2019, and has now been running for 4 years, making iterative improvements through continuous patient and provider feedback. To date, we have evaluated more than 150 donor candidates in this clinic. Feedback from donors has been uniformly positive (98% of donors stated they were very satisfied with the clinic), with most noting that the clinic was efficient and minimally impacted work and family obligations. Hospital leadership, including the health care professionals from each participating department, continue to show support and collaborate to create a seamless experience for donor candidates attending the One-Day Clinic. Limitations: Clinic spots are limited, meaning some interested donor candidates may not be able to enter a One-Day Clinic the same month they come forward. Implications: This patient-centered quality improvement intervention is designed to improve the efficiency and experience of the living kidney donor evaluation, result in better outcomes for kidney transplant recipients, and potentially increase living donation. Our next step is to conduct a formal evaluation of the clinic, measuring qualitative feedback from health care professionals working in the clinic and donor candidates attending the clinic, and measuring key process and outcome measures in donor candidates who completed the one-day assessment compared with those who underwent the usual care assessment. This program evaluation will provide reliable, regionally relevant evidence that will inform transplant centers across the country as they consider incorporating a similar one-day assessment model.

Objectifs du programme: Devenir donneur de rein vivant est difficile, le principal obstacle étant le processus d'évaluation inefficace auquel les candidats doivent se soumettre. Ce processus comporte plus de 30 examens (p. ex. tests de laboratoire et tests diagnostiques), questionnaires et consultations avec des spécialistes. Les candidats donneurs font plusieurs visites dans les hôpitaux et cliniques, et passent souvent plusieurs mois à attendre des rendez-vous et des résultats de tests. En Ontario (Canada), le délai médian pour l'évaluation d'un candidat au don est de près d'un an. Les temps d'attente plus longs sont associés à de moins bons résultats pour les receveurs d'une greffe rénale, ainsi qu'à des coûts de soins de santé plus élevés. Un processus d'évaluation plus court et plus efficace des donneurs potentiels permettrait à un plus grand nombre de patients atteints d'insuffisance rénale de recevoir une greffe, y compris une greffe préventive (c.-à-d. permettant d'éviter la dialyse). Cet article décrit une intervention d'amélioration de la qualité visant à augmenter l'efficience, l'efficacité et la personnalisation du processus d'évaluation des candidats au don. Nous avons développé une clinique d'un jour pour l'évaluation des donneurs de reins vivants (One-Day Living Kidney Donor Assessment Clinic), soit une clinique condensée où les candidats passent tous les tests et consultent un spécialiste dans la même journée. Sources de l'information: La clinique d'un jour pour l'évaluation des donneurs de reins vivants a été développée à la suite d'un examen approfondi de la littérature, de la consultation des commentaires de patients ayant donné avec succès et de rencontres avec les dirigeants du programme de transplantation du St Joseph's Healthcare d'Hamilton. Une équipe multipartite a été formée; celle-ci réunit du personnel soignant en néphrologie, chirurgie de transplantation, radiologie, cardiologie, travail social et médecine nucléaire, ainsi que des patients ayant une expérience vécue du don de rein. L'équipe s'est réunie régulièrement pendant les étapes de planification pour déterminer les objectifs, les paramètres et le calendrier de la clinique, ainsi que les critères de participation et le flux de patients. Méthodologie: Les donneurs potentiels qui avaient complété les tests de laboratoire initiaux et qui acceptaient de se soumettre à un processus accéléré ont été évalués à la clinique d'un jour. Si des tests supplémentaires étaient nécessaires, ceux-ci étaient effectués un autre jour. Les candidats ont été rencontrés par le néphrologue, le chirurgien de transplantation et le coordonnateur des dons environ deux semaines après leur visite à la clinique pour l'approbation finale. L'équipe multipartite continue de se réunir régulièrement pour examiner les commentaires des donneurs, discuter des défis et trouver des solutions. Principaux résultats: La clinique d'un jour, mise sur pied en mars 2019, est en activité depuis quatre ans et permet des améliorations itératives grâce à la rétroaction continue des patients et des soignants. À ce jour, plus de 150 candidats au don ont été évalués à la clinique. Les commentaires des donneurs sont quasi unanimement positifs (98 % des candidats ont déclaré être très satisfaits de la clinique), la plupart soulignant l'efficacité de la clinique et les conséquences minimes du processus sur les obligations professionnelles et familiales. La direction de l'hôpital, tout comme les professionnels de la santé des services participants, continue d'appuyer la clinique d'un jour et de collaborer à la création d'une expérience fluide pour les donneurs potentiels qui la fréquentent. Limites: Les places à la clinique sont limitées; ainsi, certains candidats au don d'un rein vivant pourraient ne pas pouvoir être admis dans le mois où ils se présentent à la clinique. Conclusion: Cette intervention d'amélioration de la qualité axée sur les patients est conçue pour augmenter l'efficacité du processus d'évaluation et bonifier l'expérience des donneurs de rein vivants. Elle vise également à améliorer les résultats des receveurs d'une greffe rénale et, potentiellement, augmenter le don vivant. La prochaine étape sera une évaluation formelle de la clinique, c'est-à-dire la mesure de la rétroaction qualitative des professionnels de la santé qui y travaillent et des candidats au don qui la fréquentent, et l'analyse des processus clés et des résultats des candidats évalués à la clinique d'un jour par rapport à ceux qui suivent le processus d'évaluation habituel. Cette évaluation du programme fournira des données probantes fiables et propres à la région qui pourront informer les centres de transplantation de tout le pays qui envisagent d'intégrer un processus d'évaluation similaire.

Head and neck cancer survivorship consensus statement from the American Head and Neck Society.

OBJECTIVES: To provide a consensus statement describing best practices and evidence regarding head and neck cancer survivorship. METHODS: Key topics regarding head and neck cancer survivorship were identified by the multidisciplinary membership of the American Head and Neck Society Survivorship, Supportive Care & Rehabilitation Service. Guidelines were generated by combining expert opinion and a review of the literature and categorized by level of evidence. RESULTS: Several areas regarding survivorship including dysphonia, dysphagia, fatigue, chronic pain, intimacy, the ability to return to work, financial toxicity, lymphedema, psycho-oncology, physical activity, and substance abuse were identified and discussed. Additionally, the group identified and described the role of key clinicians in survivorship including surgical, medical and radiation oncologists; dentists; primary care physicians; psychotherapists; as well as physical, occupational, speech, and respiratory therapists. CONCLUSION: Head and neck cancer survivorship is complex and requires a multidisciplinary approach centered around patients and their caregivers. As survival related to head and neck cancer treatment improves, addressing post-treatment concerns appropriately is critically important to our patient's quality of life. There continues to be a need to define effective and efficient programs that can coordinate this multidisciplinary effort toward survivorship.

Appropriate Use of Short-Course Antibiotics in Common Infections: Best Practice Advice From the American College of Physicians.

DESCRIPTION: Antimicrobial overuse is a major health care issue that contributes to antibiotic resistance. Such overuse includes unnecessarily long durations of antibiotic therapy in patients with common bacterial infections, such as acute bronchitis with chronic obstructive pulmonary disease (COPD) exacerbation, community-acquired pneumonia (CAP), urinary tract infections (UTIs), and cellulitis. This article describes best practices for prescribing appropriate and short-duration antibiotic therapy for patients presenting with these infections. METHODS: The authors conducted a narrative literature review of published clinical guidelines, systematic reviews, and individual studies that addressed bronchitis with COPD exacerbations, CAP, UTIs, and cellulitis. This article is based on the best available evidence but was not a formal systematic review. Guidance was prioritized to the highest available level of synthesized evidence. BEST PRACTICE ADVICE 1: Clinicians should limit antibiotic treatment duration to 5 days when managing patients with COPD exacerbations and acute uncomplicated bronchitis who have clinical signs of a bacterial infection (presence of increased sputum purulence in addition to increased dyspnea, and/or increased sputum volume). BEST PRACTICE ADVICE 2: Clinicians should prescribe antibiotics for community-acquired pneumonia for a minimum of 5 days. Extension of therapy after 5 days of antibiotics should be guided by validated measures of clinical stability, which include resolution of vital sign abnormalities, ability to eat, and normal mentation. BEST PRACTICE ADVICE 3: In women with uncomplicated bacterial cystitis, clinicians should prescribe short-course antibiotics with either nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole (TMP-SMZ) for 3 days, or fosfomycin as a single dose. In men and women with uncomplicated pyelonephritis, clinicians should prescribe short-course therapy either with fluoroquinolones (5 to 7 days) or TMP-SMZ (14 days) based on antibiotic susceptibility. BEST PRACTICE ADVICE 4: In patients with nonpurulent cellulitis, clinicians should use a 5- to 6-day course of antibiotics active against streptococci, particularly for patients able to self-monitor and who have close follow-up with primary care.

Nonabsorbable intrasellar stent placement for recurrent Rathke cleft cyst: illustrative case.

BACKGROUND: Rathke cleft cyst (RCC) has a recurrence rate of 10% to 22%, and preventing recurrence is challenging. For patients who experience persistent recurrence of RCC, placement of steroid-eluting bioabsorbable intrasellar stents has been rarely described. However, recurrences are often delayed, suggesting that dissolvable stents may not be successful long-term. The release of steroids in close proximity to the pituitary gland may also unintentionally influence the hypothalamic-adrenal-pituitary axis. OBSERVATIONS: The authors present a case of a 66-year-old woman with a persistently recurrent RCC who underwent drainage of her cyst with placement of a nonabsorbable intrasellar stent in the form of a tympanostomy tube. After repeat transsphenoidal drainage of her cyst, a tympanostomy T-tube was placed to stent open the dural aperture. Postoperatively, the patient's condition showed improvement clinically and radiographically. LESSONS: Placement of an intrasellar stent for recurrent RCC has rarely been described. Steroid-eluting bioabsorbable stents may dissolve before RCC recurrence and may have an unintentional effect on the hypothalamic-pituitary-adrenal axis. The authors present the first case of nonabsorbable stent placement in the form of a tympanostomy tube for recurrence of RCC. Additional studies and longer follow-up are necessary to evaluate the long-term efficacy of both absorbable and nonabsorbable stent placement.

Survivorship support in head and neck cancer: American Head and Neck Society survey.

BACKGROUND: The value of supporting cancer survivors beyond formal treatment has become increasingly recognized among clinicians who care for patients with head and neck cancer. METHODS: A survey was developed by the American Head and Neck Society (AHNS) Survivorship Committee and distributed to members of the AHNS electronically. RESULTS: The survey was distributed to 1403 AHNS members, with 202 responses (14.4%). Among survivorship topics, respondents were most likely to address detection of recurrence/second primary malignancies (97.5%), dysphagia (93.1%), and thyroid function (90.1%) with their patients; they were least likely to address sleep disturbance/apnea (27.7%) and body and self-image issues (29.7%.) Less than half provide patients with a written treatment summary (43.1%) or follow-up care plan (36.9%). CONCLUSIONS: These results highlight the need for improved survivorship care planning and offer an opportunity for the development of educational and survivorship research in head and neck cancer care.

Prevalence of High-Risk Human Papillomavirus in Tonsil Tissue in Healthy Adults and Colocalization in Biofilm of Tonsillar Crypts.

IMPORTANCE: The pathogenesis of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma is currently an important topic of elucidation. The presence of latent HPV infection in tonsil tissue of healthy adults may provide an explanation for a component of this process and contribute to the understanding of HPV-associated squamous cell carcinoma oncogenesis of the oropharynx. OBJECTIVE: To determine the prevalence of oropharyngeal HPV and to determine the spatial relationship between the virus and crypt biofilm in tonsil tissue. DESIGN, SETTING, AND PARTICIPANTS: A retrospective, cross-sectional study was carried out using samples obtained from tonsils that were archived at a university hospital following elective nononcologic tonsillectomy from 2012 to 2015. Samples consisted of formalin-fixed paraffin embedded samples of tumor-free tonsil tissue from 102 adults between the ages of 20 and 39 years. EXPOSURES: Human papillomavirus status was assessed by polymerase chain reaction, and high-risk subtypes 16 and 18 were assessed with quantitative polymerase chain reaction assay. Samples that demonstrated presence of HPV were then analyzed by in situ hybridization to localize the viral capsid protein. These samples were then stained with concanavalin A to establish biofilm presence and morphology. These samples were also stained with diamidino-phenylindole (DAPI) to visualize location of the virus in relation to cell nuclei. These data were then assembled for aggregate analysis to colocalize HPV in the biofilm of the tonsillar crypts. MAIN OUTCOMES AND MEASURES: Outcome measurements were determined prior to data collection and include prevalence of high-risk HPV types 16 and 18 in tonsil tissue of otherwise healthy adults, as well as demonstration with immunohistochemistry of HPV in tonsillar crypt biofilm. RESULTS: In 102 otherwise healthy adults (55 [53.9%] female; age range, 20-39 years), the overall prevalence of HPV in tonsils was 4.9% (n = 5); and high-risk type 16 or 18, 3.9% (n = 4). In this sample population, in situ hybridization colocalized HPV virus to the biofilm of the tonsillar crypts. CONCLUSIONS AND RELEVANCE: Biofilm is present in the tonsillar crypts in a considerable proportion of tonsil tissues and may be reproducibly identified. Human papillomavirus is demonstrated to colocalize to the crypt biofilm. This has important implications with respect to the determination of HPV prevalence rates in the oropharynx. It may also play a role in the pathogenesis of HPV-related oropharyngeal carcinoma.

AHNS Series: Do you know your guidelines? Principles of surgery for head and neck cancer: A review of the National Comprehensive Cancer Network guidelines.

This article continues a series developed by the American Head and Neck Society's Education Committee entitled "Do you know your guidelines?" It is hoped that these features will increase awareness of and adherence to current best practices in head and neck cancer care. In this installment, the National Comprehensive Cancer Network (NCCN) guidelines for surgical therapy are reviewed. © 2016 Wiley Periodicals, Inc. Head Neck 39: 791-796, 2017.

Geographic variation in cost of care for pituitary tumor surgery.

PURPOSE: Geography is known to affect cost of care in surgical procedures. Understanding the relationship between geography and hospital costs is pertinent in the effort to reduce healthcare costs. We studied the geographic variation in cost for transsphenoidal pituitary surgery in hospitals across New York State. METHODS: Using the Healthcare Cost and Utilization Project State Inpatient Database for New York from 2008 to 2011, we analyzed records of patients who underwent elective transsphenoidal pituitary tumor surgery and were discharged to home or self-care. N.Y. State was divided into five geographic regions: Buffalo, Rochester, Syracuse, Albany, and Downstate. These five regions were compared according to median charge and cost per day. RESULTS: From 2008 to 2011, 1803 transsphenoidal pituitary tumor surgeries were performed in New York State. Mean patient age was 50.7 years (54 % were female). Adjusting prices for length of stay, there was substantial variation in prices. Median charges per day ranged from $8485 to $13,321 and median costs per day ranged from $2962 to $6837 between the highest and lowest regions from 2008 to 2011. CONCLUSION: Within New York State, significant geographic variation exists in the cost for transsphenoidal pituitary surgery. The significance of and contributors to such variation is an important question for patients, providers, and policy makers. Transparency of hospital charges, costs, and average length of stay for procedures to the public provides useful information for informed decision-making, especially for a highly portable disease entity like pituitary tumors.

Survivorship in Head and Neck Cancer: A Primer.

Survivors of cancer and cancer-directed therapies may encounter substantial medical, psychosocial, interpersonal, financial, and functional consequences. The collective experience of being a cancer survivor has been dubbed survivorship. As a unique discipline, cancer survivorship has garnered much attention in recent years. However, its constructs have yet to be formally introduced or applied to head and neck oncology. Recognizing this, the American Head and Neck Society (AHNS) has convened a committee on survivorship. The concept of survivorship is reviewed and placed into historical perspective to identify current gaps in head and neck survivor care and to provide a roadmap for future initiatives in survivorship care and research.

Tongue base exposure during TORS without the use of a mouth prop.

This study describes a novel exposure technique for base of tongue trans-oral robotic surgery (BOT TORS) and early experience with it. The technique discussed involves placement of a suture through the mobile tongue with distraction and suspension of the tongue to the operating table. TORS is then performed per previously described techniques. In our series, 13 patients with either benign or malignant mass lesions involving the tongue base were treated with TORS at a tertiary academic medical center. We reviewed the rates of adequate exposure, console time, adequacy of resection (in malignant cases), complication rates, and costs associated with this technique. In our series, adequate exposure was achieved in 92.3 % of patients. Mean console time was 36 min. Negative surgical margins were achieved in all cancer resections. Five minor complications (tongue lacerations) were observed. Per-case cost attributable to this technique is $3.81. We conclude that BOT TORS is feasible without the use of a mouth prop. Operative times are consistent with those reported by centers that routinely use mouth props for BOT TORS. This technique does not appear to compromise margin adequacy during oncologic resections. Its use may result in a significant cost savings when compared to the FK and other similar retractors.

Robotics in otolaryngology and head and neck surgery: Recommendations for training and credentialing: A report of the 2015 AHNS education committee, AAO-HNS robotic task force and AAO-HNS sleep disorders committee.

Training and credentialing for robotic surgery in otolaryngology - head and neck surgery is currently not standardized, but rather relies heavily on industry guidance. This manuscript represents a comprehensive review of this increasingly important topic and outlines clear recommendations to better standardize the practice. The recommendations provided can be used as a reference by individuals and institutions alike, and are expected to evolve over time. © 2016 Wiley Periodicals, Inc. Head Neck 38: E151-E158.

Do you know your guidelines? An initiative of the American Head and Neck Society's Education Committee.

Clinical practice guidelines abound in medicine. Head and neck oncology is no exception. Well-crafted guidelines can promote evidence-based diagnosis, treatment, and followup for patients with head and neck cancers. Recognizing this, the Education Committee of the American Head and Neck Society has developed a series of articles to review clinical practice guidelines germane to our field, the evidence behind them, and opportunities for improvement and better adherence to them. This paper serves to introduce the concepts relevant to guideline development and clinical application. It serves as a framework for the topical guideline papers that will follow.

Disease-Specific Survival with Spindle Cell Carcinoma of the Head and Neck.

OBJECTIVES: (1) Determine factors influencing survival in patients diagnosed with spindle cell carcinoma (SpCC), a rare variant of head and neck squamous cell carcinoma (SCC). (2) Compare survival of patients with SpCC to those with conventional SCC. STUDY DESIGN: Retrospective cohort study. SETTING: Surveillance, Epidemiology, and End Results 18 database (years 2004-2009). SUBJECTS AND METHODS: Among patients receiving treatment for a single primary in the oral cavity, oropharynx, hypopharynx, or larynx, 118 subjects with SpCC and 18,298 subjects with SCC were identified with complete data for the variables of age, sex, grade, tumor size, stage group, and TNM stage. Disease-specific survival curves were compared. Univariate and multivariate analyses were used to examine the effects of each factor on survival over all sites and within each of 3 sites. RESULTS: Univariate analysis of the combination of the 3 anatomic subsites showed survival with SpCC was worse than with conventional SCC (P < .001). Three-year disease-specific survival with SpCC was 49.5%, and 5-year disease-specific survival was 40.2%. Compared with conventional SCC, survival was worse for SpCC of the oral cavity (P < .001) and oropharynx (P < .001) but no different for the larynx and hypopharynx site (P = .15). Multivariate analysis identified age (P = .02), tumor size (P = .006), and M stage (P < .001) as the only variables significantly affecting survival with SpCC. All variables significantly affected survival with conventional SCC. CONCLUSIONS: Spindle cell carcinoma carries a worse prognosis than SCC. Larger tumor size, older age, and metastatic disease portend worse survival with SpCC of the head and neck.