Methodology for the development of National Multidisciplinary Management Recommendations using a multi-stage meta-consensus initiative.

BACKGROUND: Methods for developing national recommendations vary widely. The successful adoption of new guidance into routine practice is dependent on buy-in from the clinicians delivering day-to-day patient care and must be considerate of existing resource constraints, as well as being aspirational in its scope. This initiative aimed to produce guidelines for the management of head and neck squamous cell carcinoma of unknown primary (HNSCCUP) using a novel methodology to maximise the likelihood of national adoption. METHODS: A voluntary steering committee oversaw 3 phases of development: 1) clarification of topic areas, data collection and assimilation, including systematic reviews and a National Audit of Practice; 2) a National Consensus Day, presenting data from the above to generate candidate consensus statements for indicative voting by attendees; and 3) a National Delphi Exercise seeking agreement on the candidate consensus statements, including representatives from all 58 UK Head and Neck Multidisciplinary Teams (MDT). Methodology was published online in advance of the Consensus Day and Delphi exercise. RESULTS: Four topic areas were identified to frame guideline development. The National Consensus Day was attended by 227 participants (54 in-person and 173 virtual). Results from 7 new systematic reviews were presented, alongside 7 expert stakeholder presentations and interim data from the National Audit and from relevant ongoing Clinical Trials. This resulted in the generation of 35 statements for indicative voting by attendees which, following steering committee ratification, led to 30 statements entering the National Delphi exercise. After 3 rounds (with a further statement added after round 1), 27 statements had reached 'strong agreement' (n = 25, 2, 0 for each round, respectively), a single statement achieved 'agreement' only (round 3), and 'no agreement' could be reached for 3 statements (response rate 98% for each round). Subsequently, 28 statements were adopted into the National MDT Guidelines for HNSCCUP. CONCLUSIONS: The described methodology demonstrated an effective multi-phase strategy for the development of national practice recommendations. It may serve as a cost-effective model for future guideline development for controversial or rare conditions where there is a paucity of available evidence or where there is significant variability in management practices across a healthcare service.

Civilian penetrating neck trauma at a level I trauma centre: A five-year retrospective case note review.

OBJECTIVES: To report the experience of civilian penetrating neck trauma (PNT) at a UK level I trauma centre, propose an initial management algorithm and assess the degree of correlation between clinical signs of injury, operative findings and radiological reports. DESIGN: Retrospective case note review. SETTING: UK level I trauma centre April 2012-November 2017. PARTICIPANTS: Three hundred ten cases of PNT were drawn from electronic patient records. Data were extracted on hard and soft signs of vascular or aerodigestive tract injury, clinical management, radiological imaging and patient outcomes. MAIN OUTCOME MEASURES: Patient demographics, mechanism of injury, morbidity and mortality. The correlation between clinical signs, and radiological reports to internal injury on surgical exploration. RESULTS: Two hundred seventy-one (87.4%) male and 39 (13.6%) female patients with a mean age of 36 years (16-87) were identified. The most common causes of injury were assault 171 (55.2%) and deliberate self-harm 118 (38%). A knife was the most common instrument 240 (77.4%). Past psychiatric history was noted in 119 (38.4%), and 60 (19.4%) were intoxicated. 50% were definitively managed in theatre with a negative exploration rate of 38%, and 50% were managed in ED. Pre-operative radiological reports correlated with operative reports in 62% of cases with venous injury the most common positive and negative finding. Multivariate correlation was r = 0.89, p = 0.045, between hard signs plus positive radiology findings and internal injury on neck exploration. CONCLUSIONS: Management of PNT by clinical and radiological signs is safe and effective, and can be streamlined by a decision-making algorithm as proposed here.

Prognostic indicators in clinically node-negative malignant primary salivary tumours of the parotid: A multicentre experience.

OBJECTIVES: Nodal metastasis is an important prognosticator in primary parotid cancers. The management of the clinically node-negative neck is an area lacking consensus. This study investigates the occult nodal metastasis rate, and prognostic indicators in primary parotid cancers. MATERIALS AND METHODS: We performed a multicentre retrospective case note review of patients diagnosed and treated surgically with curative intent between 1997 and 2020. Demographic, clinic-pathological and follow-up data was recorded. RESULTS: After exclusions, 334 patients were included for analysis, with a median follow-up of 48 months. The overall rate of occult lymph node metastasis amongst patients undergoing elective neck dissection was 22.4%, with older age, high-grade and more advanced primary tumours being associated with higher rates. On multivariable analysis, age ≥ 60 years (HR = 2.69, p = 0.004), high-grade tumours (HR = 2.70, p = 0.005) and advanced primary tumours (pT3-4, HR = 2.06, p = 0.038) were associated with worse overall survival. Occult nodal metastasis on final pathology was associated with a close-to-significant reduction in regional recurrence free survival (HR = 3.18, p = 0.076). CONCLUSION: This large series confirms the significant occult lymph node metastasis rate in primary parotid cancer, and demonstrates the importance of primary histology, tumour grade and stage in predicting survival outcome. This data supports the use of elective neck dissection in patients with high-risk tumours.

Pretreatment High MCV as Adverse Prognostic Marker in Nonanemic Patients with Head and Neck Cancer.

OBJECTIVE: Mean corpuscular volume (MCV) has been shown in to be a reliable prognostic marker in other cancers; however, no evidence exists on its use in head and neck squamous cell carcinoma (HNSCC). This study aimed to investigate the association between MCV, hemoglobin, platelet count and albumin concentration, and survival in stage III/IVA-B HNSCC treated with concurrent chemoradiotherapy. STUDY DESIGN: Retrospective cohort study. METHODS: In this multicenter retrospective study, we analyzed MCV, platelet count, hemoglobin concentration, and albumin concentration in peripheral blood samples from 260 patients with HNSCC undergoing organ preservation treatment with curative intent at the time of diagnosis. We then analyzed survival outcomes after accounting for confounders using multivariate analysis. RESULTS: After adjustment for potential confounders, patients with low hemoglobin had a 3.3-fold higher risk of death (95% confidence interval [CI]: 2.26-4.81) than those with normal hemoglobin. Patients with an elevated MCV had a 1.54-fold higher risk of death (95% CI: 1.06-2.24), independent of site, stage, and human papillomavirus status. Interestingly, the effect of MCV on overall and progression-free survival was limited to those with a normal pretreatment hemoglobin. We identified no associations between pretreatment platelet count or albumin concentration and survival. CONCLUSION: These findings suggest that pretreatment anemia and macrocytosis are independent predictors of lower overall and progression-free survival in HNSCC patients undergoing organ preservation treatment. LEVEL OF EVIDENCE: III Laryngoscope, 131:E836-E843, 2021.

The impact of nodal status in major salivary gland carcinoma: A multicenter experience and proposal of a novel N-classification.

OBJECTIVES: Despite differences in oncological behavior, the 8th edition of AJCC TNM staging currently proposes the same N-classification for major salivary glands (MSG) carcinoma and squamous cell carcinoma of the upper aerodigestive tract. The present study aims to investigate a more reliable definition of N-categories for MSG carcinoma. MATERIALS AND METHODS: A retrospective multicenter study was performed, including 307 patients treated for primary MSG carcinoma from 1995 to 2019. Outcome measures included overall survival (OS), disease specific survival, and local, regional, and distant recurrence. Survival analysis was performed using log-rank test and Cox proportional-hazards model. Overall number (ON) and largest diameter (LD) of nodal metastases, including intra-parotid metastases, were considered to develop three novel proposals of N-classification; their performance were compared with the current TNM staging using Akaike information criterion (AIC), Bayesian information criterion (BIC), and Nagelkerke pseudo-R2. RESULTS: Intra-parotid nodes, ON and LD of nodal metastases emerged as major prognosticators for OS, while extra-nodal extension did not impact on any survival. The current N-classification did not show a satisfactory OS stratification. Three novel N-classifications were developed according to number of metastatic nodes (0 vs 1-3 vs ≥ 4) and/or their maximum diameter (<20 mm vs ≥ 20 mm). They all showed better accuracy in OS stratification, and achieved better AIC, BIC and Nagelkerke pseudo-R2 indices when compared to current N-classification. CONCLUSION: All the proposed N-classifications improved OS stratification and could help in defining a specific N-classification for MSG carcinoma. Their validation and assessment in an external cohort is needed.

Rapid implementation of an evidence-based remote triaging system for assessment of suspected referrals and patients with head and neck cancer on follow-up after treatment during the COVID-19 pandemic: Model for international collaboration.

BACKGROUND: Outpatient telemedicine consultations are being adopted to triage patients for head and neck cancer. However, there is currently no established structure to frame this consultation. METHODS: For suspected referrals with cancer, we adapted the Head and Neck Cancer Risk Calculator (HaNC-RC)-V.2, generated from 10 244 referrals with the following diagnostic efficacy metrics: 85% sensitivity, 98.6% negative predictive value, and area under the curve of 0.89. For follow-up patients, a symptom inventory generated from 5123 follow-up consultations was used. A customized Excel Data Tool was created, trialed across professional groups and made freely available for download at www.entintegrate.co.uk/entuk2wwtt, alongside a user guide, protocol, and registration link for the project. Stakeholder support was obtained from national bodies. RESULTS: No remote consultations were refused by patients. Preliminary data from 511 triaging episodes at 13 centers show that 77.1% of patients were discharged directly or have had their appointments deferred. DISCUSSION: Significant reduction in footfall can be achieved using a structured triaging system. Further refinement of HaNC-RC-V.2 is feasible and the authors welcome international collaboration.

Patient advocacy in head and neck cancer: Realities, challenges and the role of the multi-disciplinary team.

This paper explores the concept of advocacy in head and neck cancer. We define inherent challenges in the development and success of advocacy within this context and offer ways to embed it within clinical practice. We outline what advocacy is, ways in which it may benefit people with head and neck cancer and the engagement required from healthcare professionals to facilitate advocacy to improve outcomes.

The diagnostic value of cytology in parotid Warthin's tumors: international multicenter series.

INTRODUCTION: Warthin's tumor (WT) is a common benign salivary gland neoplasm with a negligible risk of malignant transformation. However, there is a risk of malignant tumors being misdiagnosed as WT on cytology and inappropriately managed conservatively. METHODS: Patients from nine centers in Italy and the United Kingdom undergoing parotid surgery for cytologically diagnosed WT were included in this multicenter retrospective series. Definitive histology was compared with preoperative cytological diagnoses. Surgical complications were recorded. RESULTS: A total of 496 tumors were identified. In 88.9%, the final histological diagnosis was WT. In 21 cases (4.2%) a malignant neoplasm was diagnosed, which had been incorrectly labeled as WT on cytology. CONCLUSIONS: The risk of undiagnosed malignancy should be balanced against surgical risks when considering the management of WT. Although nonsurgical management remains an appropriate option, there may be a rationale for serial clinical or radiological evaluation if surgical excision is not performed.

Penetrating neck trauma: radiological predictors of vascular injury.

PURPOSE: Vascular injury in penetrating neck trauma predicts a poorer outcome and usually requires surgical neck exploration. Multi-detector computed tomography (MDCT) angiography is a readily available non-invasive diagnostic tool that can identify direct and indirect signs of vascular injury in stable patients. This study aims to investigate the diagnostic accuracy of radiological signs of vascular injury on MDCT, and their implications on patient management in the setting of penetrating neck trauma. METHODS: A retrospective cohort study of penetrating neck injuries (PNI) between 2012 and 2018 in a UK major trauma centre was performed. Clinical data and operative findings were compared with radiological findings on MDCT performed at the time of admission. RESULTS: 157 patients were identified with PNI in the study period, with 67 meeting inclusion criteria. The predictive value of indirect radiological signs of vascular injury alone was low, with only 12.1% of these patients having significant vascular injury found at neck exploration. However, the combined use of direct radiological signs with clinical signs resulted in a specificity of 97.7% for vascular injury. CONCLUSIONS: The use of direct and indirect radiological signs of vascular injury can increase the accuracy of diagnosis when used in conjunction with clinical signs. Combining clinical assessment and radiological investigation, specifically contrast-enhanced MDCT, improves the specificity in pre-operative assessment of potential vascular injury in PNI. MDCT is recommended in stable patients with clinical signs of vascular injury to reduce the rate of negative neck exploration.

Refining the head and neck cancer referral guidelines: a two centre analysis of 4715 referrals.

Our aim was to identify the set of referral criteria that will offer optimal diagnostic efficacy in patients suspected to have head and neck cancer (HNC) in the primary care setting. We analysed the referral criteria and outcomes from two tertiary care cancer centres in the United Kingdom. Between 2007 and 2010, 4715 patients were referred via the fast track system with a suspected HNC. The main outcome measures were the parameters of diagnostic efficacy, a multivariate regression model to calculate estimated probability of HNC and the area under the receiver operating characteristic curve (AUROC). We found that the majority of referring symptoms had a positive predictive value higher than the 3% cut-off point stated to be significant for HNC detection in the 2015 NICE recommendations. Nevertheless, our multivariate analysis identified 9 symptoms to be linked with HNC. Of these, only 4 are included in the latest NICE guidelines. The best fit predictive model for this dataset included the following symptoms: hoarseness>3 weeks, dysphagia>3 weeks, odynophagia, unexplained neck mass, oral swelling >3 weeks, oral ulcer >3weeks, prolonged otalgia with normal otoscopy, presence of blood in mouth with concurrent sensation of lump in throat, and presence of otalgia with concurrent lump in throat sensation. Intermittent hoarseness and sensation of lump in throat were negatively associated with HNC. The AUROC demonstrated that our model had a higher predictive value (0.77) compared to those generated using the NICE 2005 (0.69) and 2015 (0.68) referral criteria (p<0.0001). An online risk calculator based on this study is available at http://www.orlhealth.com/risk-calculator.html. This paper presents a significantly refined version of referral guidelines which demonstrate greater diagnostic efficacy than the current NICE guidelines. We recommend that further iterative refinements of referral criteria be considered when referring patients with suspected HNC.

Jejunal free flap for reconstruction of pharyngeal defects in patients with head and neck cancer-the Birmingham experience.

We retrospectively audited operative complications, success of flaps, and speech and swallowing outcomes in patients with head and neck cancer who had reconstruction with jejunal free tissue transfer to the pharynx. A total of 104 patients had jejunal free flaps between 1987 and 2009 at University Hospital, Birmingham. Management was by a multidisciplinary team, and the same vascular surgeon did all the anastomoses. We investigated the relations between patients, operative factors, and postoperative complications, and noted the ischaemic time of the flaps and coexisting conditions of the patients. Outcomes measured included initial and final survival rates of flaps, donor and recipient site complications, and speech and swallowing outcomes on discharge and up to 2 years postoperatively. Of the 104 patients, 14 (13%) had initial flap complications but overall flap survival was 97%. A total of 11 (11%) patients developed a fistula at a mean of 15 days postoperatively and 11 (11%) had minor donor site complications. A total of 95 (91%) were able to resume oral diet on discharge. Of the 44 who were followed up on discharge, 32 (73%) were able to maintain oral intake at 2 years and 31 (70%) could use their voice in everyday situations. The jejunal free flap enables the tumour to be removed, and reconstruction and restoration of function to be done in a single operation using tissue that is versatile. The operation is associated with low morbidity at the donor and recipient sites, and results in good speech and swallowing outcomes. The flap can also be used to reconstruct pharyngolaryngeal defects.

Hypopharyngeal perforation during endoscopic ultrasound treated by primary repair.

BACKGROUND: An endoscopic ultrasound scan is a common procedure used to diagnose conditions of the upper gastrointestinal tract. We present a case of hypopharyngeal perforation complicating endoscopic ultrasound scan treated with primary surgical repair. METHODS AND RESULTS: A 62-year-old woman underwent an endoscopic ultrasound scan for investigation of a pancreatic lesion. A high esophageal perforation occurred during the procedure. She underwent emergency repair of this perforation via an external approach. Unfortunately her recovery was complicated by a pleural effusion which required a chest drain. She made a complete recovery, which was confirmed with a barium swallow. DISCUSSION: Upper esophageal perforation is a rare complication of an endoscopic ultrasound scan and, to our knowledge, there have been no reported cases of hypopharyngeal perforation. The risk factors, incidence, and management of perforations are reviewed. Early recognition of hypopharyngeal perforation is important and, in selected cases, immediate repair of the defect can lead to a good result.