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    2020-08-18


    Methods
    Procedures
    This retrospective medical record review was approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board (IF1718786). As part of their routine initial surgical consult visit, new HNC patients are asked to complete the “Patient First” Questionnaire, which includes a pre-operative medical assessment, and questions about the patient’s medical history, QOL, and dysphagia. Completed questionnaires were scanned into the electronic health record (EHR) as part of a larger quality improvement data collection project.
    For this MK 2206 study, patient eligibility criteria included: (1) being newly diagnosed with squamous cell carcinoma (SCC) of the head and neck or a salivary gland tumor, (2) having a surgical consult in the Department of Otolaryngology-Head and Neck Surgery between January 2012 and December 2014, (3) completing the “Patient First” questionnaire, and,
    (4) undergoing surgery at Mount Sinai Hospital for HNC. There were no exclusion criteria. Research staff abstracted data from the Patient First questionnaire into a secure database along with clinical and demo-graphic data from the EHR for eligible patients. This data was then linked to health resource use data obtained from the Mount Sinai Data Warehouse (MSDW), which has clinical and operational data derived from patient care at the Mount Sinai Hospital and Mount Sinai Faculty Practice Associates.
    Data collection
    Outcome variables
    Data abstracted from the MSDW included LOS (defined as number of days from surgery to hospital discharge, and categorized as low = ≤4 days, medium = 5–9 days, or high = > 9 days, based on national averages for LOS after HNC surgery) [10,11], presence/ab-sence of a 30-day unplanned readmission (30dUR) to Mount Sinai Hospital for a postoperative occurrence likely related to the principal surgical procedure [42,43], and presence/absence of an ED visit within 30 days of initial hospital discharge.
    Predictor variables
    Sociodemographics. Age, gender, marital status, and ethnicity (Hispanic vs non-Hispanic) were abstracted. Race is not routinely en-tered into the medical record at Mount Sinai, so this data was not available.
    Disease characteristics. Tumor site (i.e., oral cavity, oropharynx, hypopharynx, and larynx) and clinical stage at diagnosis.
    Medical history and comorbidities. History of prior cancer (yes/no), psychiatric illness (yes/no), smoking (never, former, or current smoker), alcohol use (never, former, active-social drinker, active-abuse), and illicit drug use (yes/no) were abstracted from the EHR, in addition to completion of neo-adjuvant/adjuvant treatment (e.g., che-motherapy, chemoradiation), and HPV status (P16 positive, P16 nega-tive, or not tested). Food intake changes in the past month were cate-gorized as either unchanged/eating more than usual or eating less than usual. Presence or absence of the following relevant comorbidities was also assessed: chronic pulmonary disease (i.e., chronic obstructive pulmonary disease, pulmonary fibrosis, and severe asthma with at least 1 previous hospital admission because of an asthma exacerbation), chronic artery disease (CAD; i.e., prior myocardial infarction or having a coronary stent/bypass graft), hypertension (i.e., carrying a diagnosis of hypertension and being on antihypertensive medication), hepatic disease (i.e., known chronic hepatitis, elevated liver enzymes on at least
    2 occasions over the year before surgery, or known cirrhosis), vascular disease (i.e., known peripheral vascular disease or a history of a cere-brovascular accident), hypothyroidism (i.e., known diagnosis of hy-pothyroidism and being on thyroid hormone supplementation or an elevated preoperative thyroid-stimulating hormone), diabetes, GI pro-blems, renal disease, and neurological disorders.
    Peri- and post-operative variables. Operative procedures were classi-fied as either lower (e.g., laryngoscopy, tracheostomy, skin grafts or local flaps, parotidectomy, and neck dissection with or without partial glossectomy) or higher risk (e.g., laryngopharyngectomies, any major skull base surgery, or operations needing a free-flap). MK 2206 Perioperative variables included type of surgery (i.e., open or transoral robotic sur-gery; TORS), management of airway via tracheostomy (yes/no), and PEG placement during surgery (yes/no). Post-operative variables in-cluded medical complications related to the index procedure occurring during the index hospital admission [15,27], or surgical complications occurring either during the index admission or within 30 days of hos-pital discharge. Medical complications included cardiovascular (e.g., myocardial ischemia), pulmonary, neurologic, infectious (e.g., sepsis), and miscellaneous complications (e.g., deep venous thrombosis, renal insufficiency). Surgical complications included wound infection, fistula formation, flap donor and recipient site complications, hematomas, dehydration, anemia, tracheostomy complications, and bleeding at the surgical site, and performance of additional or unexpected surgical procedures.