Dysphagia and QoL 3 Years After Treatment of Oropharyngeal Cancer With TORS or Radiotherapy.

OBJECTIVE(S): To investigate dysphagia and quality of life (QoL) outcomes 3 years after treatment of oropharyngeal cancer with either primary trans oral robotic surgery (TORS) or radiotherapy (RT). METHODS: A prospective cohort study conducted at the Copenhagen University Hospital. Endpoints were objective swallowing function, examined using fiberoptic endoscopic evaluation of swallowing (FEES) and video fluoroscopy (VF). QoL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30), Head & Neck Module (EORTC QLQ-HN35), and MD Anderson Dysphagia Inventory (MDADI). A comparison was made between 1-, and 3-year results. RESULTS: Forty-four patients were included prior to treatment, 31 treated with TORS and 13 with RT. One-year results for this cohort have previously been published (https://doi.org/10.1080/00016489.2020.1836395). Significant improvement on FEES in retention at the piriform sinus was noted in both groups. Patients treated with TORS had improved safety scores as well as dynamic imaging grade of swallowing toxicity (DIGEST) and efficiency scores, whereas patients treated with RT only had improvements in the latter two. Improvement in QoL scores was only noted for patients treated with TORS in composite MDADI scores. CONCLUSION: We found significant improvements in objective swallowing function from one to 3 years after treatment, particularly in patients treated with TORS. However, these improvements were not reflected as clinically meaningful improvements in QoL. LEVEL OF EVIDENCE: 3, cohort follow-up study Laryngoscope, 133:1893-1898, 2023.

Days alive and out of hospital following primary surgery for oral cavity squamous cell carcinoma.

BACKGROUND: Days Alive and Out of Hospital (DAOH) is a recently introduced, readily obtainable postoperative outcome measure method that expresses procedure and disease-associated morbidity and mortality. In this study, we evaluated DAOH with 30- and 365-days follow-up periods after primary surgery (DAOH30 and DAOH365, respectively) for patients with oral cavity squamous cell carcinoma (OSCC). The aim of this study is to identify patient-, procedure- and disease-associated risk factors for patients treated with primary surgery for primary OSCC. MATERIAL AND METHODS: This retrospective cohort study from a prospective collected database represents patients from Eastern Denmark surgically treated for primary OSCC in the period 2000-2014. DAOH30 and DAOH365 were calculated and associations with patient characteristics including comorbidity, tumor characteristics, clinical outcomes such as length of stay, readmission, and mortality were evaluated. Tests for difference and significance between groups were assessed with Mann-Whitney U test and quantile linear regression. RESULTS: We included 867 patients (63% males, median age: 63 years (IQR 56-70 years)). Median DAOH30 and DAOH365 after OSCC surgery were 25 days (IQR 21-27 days) and 356 days (IQR 336-360 days), respectively. Alcohol consumption had a significant association with a lower DAOH365, p < 0.01, but not with DAOH30. Advanced T-stage, adjuvant radiotherapy (RT) and increased Charlson Comorbidity Index (CCI) score was significantly associated with a lower DAOH30 and DAOH365. CONCLUSION: In this population-based study in OSCC patients treated with primary surgery, we found that DAOH after 30 days was 25 days (83%), while DAOH after 365 days was 356 days (98%). Advanced T-stage acts as a predictor for significant DAOH30 and DAOH365 reduction while excessive alcohol consumption predicts a significant DAOH365 reduction. Readmission within 30 days following surgery was associated with further readmission within one year.

[Transoral robotic surgery for the head and neck].

Transoral robotic surgery (TORS) has been utilized in the head and neck field for more than a decade. It is a minimally invasive technique which ensures flexible instrumentation and 3D visualization of the oropharynx. This has led to a paradigm shift in the treatment of early-stage oropharyngeal cancer and in the diagnostic management of unknown primary of the head and neck. Over time, the indications for TORS have broadened. This review discusses the development, current indications, and future perspectives of TORS within head and neck surgery.

Days alive and out of hospital following transoral robotic surgery: Cohort study of 262 patients with head and neck cancer.

BACKGROUND: Days alive and out of hospital (DAOH) is a validated outcome in clinical trials, since it reflects procedure-associated morbidity and mortality. Transoral robotic surgery (TORS) has become a widely adopted procedure with increasing demand for knowledge and data on morbidity. METHODS: Retrospective single-center assessment of a prospective TORS database comprising patients treated for malignancy between 2013 and 2018 using DAOH to describe procedure- and disease-related morbidity the first 12-postoperative months. RESULTS: For 262 patients, median DAOH365 was 357 days (IQR 351-360). Indications for TORS were (i) primary curative resection (61%), (ii) salvage resection (15%), and (iii) diagnostic work-up of cancer of unknown primary in the head and neck (24%). Median DAOH365 was 359 days (IQR 351-361 days), 348 days (IQR 233-355), and 357 days (351-361), respectively. Pneumonia had the highest impact in DAOH365 reduction. CONCLUSION: Total median DAOH365 after TORS was 357 days. The main cause leading to DAOH365 reduction was pneumonia.

Danish translation of the Neck Dissection Impairment Index.

BACKGROUND: Shoulder pain and impairment are known complications to neck dissections (NDs) as part of the surgical management of head and neck cancer (HNC). The Neck Dissection Impairment Index (NDII) is a validated shoulder function-related quality-of-life instrument and an important patient reported outcome measure after head-neck surgery. The correct translation of questionnaires into other languages is important for both individual assessment of patients and future research. AIMS: Translation of the NDII into Danish. METHODS: The NDII was translated from English into Danish using forward and backward translational procedures. Pilot-testing was performed on the pre-final version of the translated questionnaire. RESULTS: Pilot-testing found the translation easily comprehensible, but a few changes were made to improve language flow. CONCLUSIONS: NDII was successfully translated into Danish using forward and backward translations. Further validation on a larger scale is warranted. SIGNIFICANCE: NDII is an important aid to identifying patients with impairments and optimize the aftercare following ND for HNC. Translation of validated questionnaires into other languages is important for future research and international comparison of surgery outcome.

Days alive and out of hospital a validated patient-centred outcome to be used for patients undergoing transoral robotic surgery: protocol and perspectives.

BACKGROUND: Days Alive and Out of Hospital (DAOH) has been validated as a suitable clinical trial outcome. It can be used as a proxy for surgical quality and reflects both procedure specific morbidity and mortality. AIMS/OBJECTIVES: We propose DAOH as a supplement to established patient-related and objective outcomes, since it adds information on health care burden. Two upcoming studies incorporating DAOH are planned and will report DAOH for patients undergoing transoral robotic surgery. METHODS: Firstly, a multicentre national prospective cohort study investigating DAOH with a 1-year follow-up after TORS is planned. Secondly a retrospective study of DAOH with a 1-year follow-up period will be performed using our institute's, the largest TORS center in Scandinavia, transoral robotic surgery (TORS) database. The database consists of more than 250 patients with more than 300 procedures performed between 2013 and 2018. CONCLUSION AND SIGNIFICANCE: The planned studies of DAOH may, when applied to TORS, contribute to a better interpretation of post-treatment morbidity and provide a basis for further interventional studies to enhance recovery, perioperative optimization, and serve as a comparison tool between treatment modalities.

Long-term quality of life & functional outcomes after treatment of oropharyngeal cancer.

Functional and QoL outcomes were compared longitudinally in a cohort of patients treated for oropharyngeal squamous cell carcinoma (OPSCC) with primary transoral robotic surgery (TORS) or radiotherapy (RT). Forty-four patients undergoing primary TORS (n = 31) or RT (n = 13) for any stage OPSCC were included. Only low-stage disease was treated with TORS. Functional outcomes were: salivary flow rate, image-based swallowing function, and a self-reported 10-point scale comparing current swallowing function to baseline (CvB scale). QoL was assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30), Head & Neck Module (EORTC QLQ-HN35), and MD Anderson Dysphagia Inventory (MDADI). Shoulder impairment was assessed with Neck Dissection Impairment Index (NDII) and Oxford Shoulder Score (OSS). In the RT group, salivary flow rates had significantly declined at 12-month follow-up, with the biggest declines in QoL subscale scores recorded in the RT group for dry mouth and sticky saliva. Swallowing function on imaging studies was overall good, with no severe dysphagia within 1 year although, both treatment groups showed significant deterioration relative to baseline at the 12-month follow-up with increased DIGEST scores and pharyngeal retention. Shoulder impairment was rare at 1 year in both groups. A comprehensive examination of this cohort treated for OPSCC showed overall good functional and QoL outcomes 1 year after treatment. However, persistent impairment was seen in both groups with regards to swallowing function. In the TORS group, at 12-months follow-up, the QoL questionnaires showed worse scores in only one subscale (sticky saliva).

Days alive and out of hospital after treatment for oropharyngeal squamous cell carcinoma with primary transoral robotic surgery or radiotherapy - a prospective cohort study.

BACKGROUND: With the rising incidence of oropharyngeal squamous cell cancer, there is a need to assess the burden of treatment. AIMS/OBJECTIVES: This study assessed 'days alive and out of hospital' (DAOH) in a cohort of patients with oropharyngeal squamous cell carcinoma (OPSCC) treated with either transoral robotic surgery (TORS) or radiotherapy (RT). MATERIAL AND METHODS: A prospective cohort study conducted between May 2017-June 2019. Primary outcome was DAOH in the first 30 days after treatment (DAOH30). The secondary outcome was DAOH180. RESULTS: Forty-four patients were included, 31 treated with TORS and 13 with RT. Patients treated with TORS had a median DAOH30 of 25 (IQR 22.8-26) including a required four-day postoperative stay- and a median DAOH180 of 168 (IQR 163-171.3). In contrast, patients treated with RT had a median DAOH30 of 30 (IQR 26-30) and a DAOH180 of 143 days (IQR 135.5-149). CONCLUSIONS AND SIGNIFICANCE: DAOH has not been examined in oropharyngeal cancer before. We found, patients overall spent 92.5% of the first 180 days alive and out of hospital. Patients treated with TORS had high DAOH30, which remained high in DAOH180, while patients treated with RT with reduced DAOH30, had reduced DAOH180 calling for further large-scale studies.

Design and validation of a cross-specialty simulation-based training course in basic robotic surgical skills.

BACKGROUND: The aim of this study was to design and validate a cross-specialty basic robotic surgical skills training program on the RobotiX Mentor virtual reality simulator. METHODS: A Delphi panel reached consensus on six modules to include in the training program. Validity evidence was collected according to Messick's framework with three performances in each simulator module by 11 experienced robotic surgeons and 11 residents without robotic surgical experience. RESULTS: For five of the six modules, a compound metrics-based score could significantly discriminate between the performances of novices and experienced robotic surgeons. Pass/fail levels were established, resulting in very few novices passing in their first attempt. CONCLUSIONS: This validated course can be used for structured simulation-based basic robotic surgical skills training within a mastery learning framework where the individual trainee can practice each module until they achieve proficiency and can continue training on other modalities and more specific to their specialty.

[Transoral robotic surgery for head and neck cancer].

Oropharyngeal squamous cell carcinoma (OPSCC) induced by human papillomavirus (HPV) is highly prevalent in the western part of the world. Patients with HPV-induced OPSCC are often younger and have a much better prognosis than patients with HPV-negative OPSCC. The newly introduced transoral robotic surgery offers the ability to perform en bloc tumour resection with good margin control. It may be an alternative to the traditional radiation therapy for early-stage OPSCC. A Danish randomised clinical trial is now aiming at comparing these two treatments with a focus on long-term functional outcomes.

Time course of subacute pain after transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma versus traditional bilateral tonsillectomy in adults - a case-control study.

OBJECTIVE: To examine pain after Transoral Robotic Surgery (TORS) for oropharyngeal squamous cell carcinoma (OPSCC) versus traditional bilateral tonsillectomy in adults. METHODS: Pain evolvement was assessed in a prospective case-control design of 16 consecutive patients treated with TORS for early stage OPSCC versus 12 patients, who underwent bilateral tonsillectomy on suspicion of malignant disease. The TORS group received an optimized analgesia regime of preoperative oral celecoxib and gabapentin, intra- and postoperative high-dose intravenous dexamethasone, and regular postoperative oral contalgin, gabapentin, celecoxib, paracetamol and rescue morphine. The tonsillectomy group received the departmental standard analgesia regime with low-dose preoperative oral dexamethasone, celecoxib and paracetamol. Postoperative regular analgesia consisted of oral NSAID and paracetamol with weak opioids prescribed as required. Pain intensity was recorded at rest and during swallowing twice a day. RESULTS: The median pain intensity on postoperative day (POD) 1-4 was 2 in the TORS group versus 4.5 in the tonsillectomy group. From POD 5-10 median pain intensity was 3.5 and 4, respectively. The median length of stay was 5 days in the TORS group and less than 24 hours in the tonsillectomy group. CONCLUSION: With an optimized analgesia regime TORS for OPSCC can be performed with postoperative pain levels comparable to bilateral tonsillectomy in adults.

Dipeptidyl Peptidase-4 Inhibitor Induced Angioedema - An Overlooked Adverse Drug Reaction?

INTRODUCTION: Angioedema is a potentially fatal adverse drug reaction of some medications, as swellings of the upper airways can cause death by asphyxiation. Angiotensin converting enzymeinhibitors are widely known to cause angioedema but less is known about the association between dipeptidyl peptidase-4 inhibitors (gliptins) and angioedema. Dipeptidyl peptidase-4 inhibitors are antidiabetic drugs used to improve glycaemic control. They, as a class effect, inadvertently affect the degradation of the vasoactive kinins bradykinin and substance P, both of which can cause angioedema due to vasodilatation and increase in vascular permeability in the capillaries. OBJECTIVE: To assess the risk and pathomechanism of angioedema due to inhibition of dipeptidyl peptidase- 4 inhibitors when used as monotherapy and in combination with angiotensin converting enzymeinhibitors. METHOD: PubMed, Embase, the Cochrane Library, PubMed Central, Web of Science, Google Scholar and clinicaltrials.gov were searched using different combinations of keywords "angioedema", "dipeptidyl peptidase 4", "dipeptidyl peptidase 4 inhibitors", "gliptins", "bradykinin", "substance P" and "angiotensin converting enzyme-inhibitors". Original research papers were preferably used as references and their bibliographies were used to further the search for original research results. RESULTS: Both angiotensin converting enzyme and dipeptidyl peptidase-4 are major enzymes in the degradation pathway of bradykinin and substance P, and when inhibited pharmacologically - especially at the same time - the theoretical risk of angioedema is increased due to accumulation of vasoactive kinins. CONCLUSION: Treatment with dipeptidyl peptidase-4 inhibitors must be carefully considered and monitored especially during concurrent treatment with angiotensin converting enzyme-inhibitors or when treating patients with a known predisposition to angioedema.

Consonant and sign phoneme acquisition in signing children following cochlear implantation.

Deaf children from signing programs provide new opportunities to investigate changes in sign and speech acquisition following cochlear implantation. We describe the acquisition of sign phonemes (location, movement, and handshapes) and speech phonemes (consonants) in 22 implanted children with diverse demographic backgrounds. New consonants and new sign phonemes emerged in developmentally expected sequences and with statistically significant correlation coefficients between cumulative number of new consonants and new sign phonemes over time. Regression slopes from plotted z scores revealed a burst in consonant and sign growth in early months post-implant, with continuous but plateauing growth over time. These results and documentation of developmental levels of sign and speech phoneme trajectories should be helpful to other researchers and to clinicians working with signing children who have cochlear implants.

Neighbourhood fruit and vegetable availability and consumption: the role of small food stores in an urban environment.

OBJECTIVE: Previous studies on the relationship of dietary intake to the neighbourhood food environment have focused on access to supermarkets, quantified by geographic distance or store concentration measures. However, in-store food availability may also be an important determinant, particularly for urban neighbourhoods with a greater concentration of small food stores. This study synthesises both types of information - store access and in-store availability - to determine their potential relationship to fruit and vegetable consumption. DESIGN: Residents in four census tracts were surveyed in 2001 about their fruit and vegetable intake. Household distances to food stores in these and surrounding tracts were obtained using geographical information system mapping techniques. In-store fruit and vegetable availability was measured by linear shelf space. Multivariate linear regression models were used to measure the association of these neighbourhood availability measures with consumption. SETTING: Four contiguous census tracts in central-city New Orleans. SUBJECTS: A random sample of 102 households. RESULTS: Greater fresh vegetable availability within 100 m of a residence was a positive predictor of vegetable intake; each additional metre of shelf space was associated with 0.35 servings per day of increased intake. Fresh fruit availability was not associated with intake, although having a small food store within this same distance was a marginal predictor of fruit consumption. CONCLUSIONS: The findings suggest the possible importance of small neighbourhood food stores and their fresh produce availability in affecting fruit and vegetable intake.

Prevalence of indoor allergen exposures among New Orleans children with asthma.

Studies of inner-city asthmatic children have shown significant regional variation in dust allergen exposures. The home environment of asthmatic children in the Gulf South region of the USA has not been characterized. This study describes indoor dust allergen levels in the homes of 86 asthmatic children in New Orleans and explores regional variability in dust allergen exposure. Data were used from baseline home visits of children in the New Orleans Healthy Homes Initiative. Interview, visual observation, and environmental dust sampling data of 86 children between 4 and 17 years of age were analyzed. Seventy-seven percent of households had moderate (>2.0-9.9 microg/g) or high (> or =10.0 microg/g) levels of either Der p 1 or Der f 1 dust mite allergen and 56.6% had moderate (>2.0-8.0 U/g) or high (>8.0 U/g) levels of cockroach allergen (Bla g 1). The prevalence of high (>10 microg/g) levels of dog (Can f 1) allergen was 26.5%, and few households (6.0%) had high cat allergen (Fel d 1) levels (>8.0 microg/g). Households with average humidity levels >50% were three times more likely to have elevated dust mite levels (odds ratio = 3.2; 95% confidence interval = 1.1, 9.3; p = 0.03). Home ownership and education level were inversely associated with cockroach and dust mite allergen levels, respectively. Our findings reinforce the evidence of regional variability in dust allergen exposure levels. Asthmatic children living in the Gulf South are exposed to multiple indoor allergen exposures and live in a highly allergenic environment.

Comorbidity among the morbidly obese: a comparative study of 2002 U.S. hospital patient discharges.

BACKGROUND: Increased morbidity is associated with increasing severity of obesity. However, among morbidly obese patients, comorbid prevalence has been reported primarily in the bariatric surgical literature. This study compares demographic characteristics and selected comorbid conditions of morbidly obese patients discharged after surgical obesity procedures and morbidly obese patients discharged after all other hospital procedures. METHODS: The 2002 National Hospital Discharge Survey (a nationally representative sample of hospital discharge records) and the International Classification of Diseases, 9th Revision, Clinical Modification were used to identify and describe all morbidly obese patient discharges (n = 3,473) and to quantify the prevalence of selected obesity-related comorbid conditions. RESULTS: Compared with all other morbidly obese patients, the obesity surgery patients (n = 833) were younger (median, 42 vs 48 years; range, 17 to 67) and more female (82.3% vs. 63.7%), with higher rates of sleep apnea (24.0% vs. 11.8%), osteoarthritis (22.9% vs. 11.8%), and gastroesophageal reflux disease (27.7% vs. 11.7%) (all P < .001). The prevalence of type 2 diabetes mellitus was lower in the obesity surgery patients (16.1% vs. 24.3%; P = .003), whereas the rates of hypertension (45.9% vs. 41.0%; P = .13) and asthma (9.6% vs. 12.0%; P = .26) were similar in the two groups. CONCLUSIONS: Demographic characteristics and comorbid prevalence of morbidly obese patients discharged after obesity surgery are consistent with reports in the bariatric surgical literature. Obesity surgery patients had a higher prevalence of some comorbid conditions. Possible explanations for this include preferential diagnosis, differential diagnostic coding, or increased severity of morbid obesity. Advancing surgical and insurance guidelines for bariatric surgery will require clinical data that accurately describe and quantify the demographic distribution of obesity and the associated burden of disease.