First Phase Development of a Patient-reported Outcome Measure for Midface Oncology.

Background: Facial cancer surgery involving the midface (comprising the lower eyelids, nose, cheeks, and upper lip) can have debilitating life-changing functional, social, and psychological impacts on the patient. Midface symptoms are inadequately captured by existing patient-reported outcome measures (PROMs). PROMs are increasingly used for individual patient care, quality improvement, and standardized reporting of treatment outcomes. This study aimed to present our findings from the first phase of the development of a midface, specifically periocular and nasal, PROM. Methods: After international guidance for PROM development, the first phase comprised identification of salient issues and item generation. Fifteen patients who had midface surgery and 10 clinicians from various specialties with more than 5 years' experience treating these patients were recruited. Semi-structured interviews explored aesthetic, functional, social, and psychological outcomes, with specific attention to deficiencies in current PROMs. Thematic analysis was used to develop an item pool, and group interviews with clinicians were carried out to create and refine PROM scales. Results: Qualitative data from patient interviews were grouped into aesthetic, functional, and psychosocial domains for the eyelids and nose. Ninety-nine draft items were generated across these domains. Following focus group discussions, the final version of the midface-specific PROM contained 31 items (13 eye-specific, 10-nose-specific, eight general midface items). Conclusions: This midface-specific PROM is valuable in assessing and comparing patient-reported outcomes in those who have undergone complex resection and reconstruction of the midface. This PROM is currently undergoing field testing.

Improving accuracy in nodal staging of oral cancer: Proposal of a new system.

BACKGROUND: Despite introduction of extranodal extension (ENE) into the AJCC 8th edition of oral cancer staging, previous criticisms persist, such as limited discrimination between sub-stages and doubtful prognostic value of contralateral nodal disease. The purpose of this study was to compare our novel nodal staging system, based on the number of positive nodes and ENE, to the AJCC staging system in surgically treated patients. METHODS: Retrospective analysis of 4710 patients with oral squamous cell carcinoma (OSCC) treated with surgery±adjuvant therapy in 8 institutions in Australia, North America and Asia. With overall survival (OS) and disease specific survival (DSS) as endpoint, the prognostic performance of AJCC 8th and 7th editions were compared using hazard consistency, hazard discrimination, likelihood difference and balance. RESULTS: Our new nodal staging system (PN) a progressive and linear increase in hazard ratio (HR) from pN0 to pN3, with good separation of Kaplan Meier curves. Using the predetermined criteria for evaluation of a staging system, our proposed staging model outperformed AJCC 8th and 7th editions in prediction of OS and DSS. CONCLUSION: PN was the lymph node staging system that provided the most accurate prediction of OS and DSS for patients in our cohort of OSCC. Additionally, it can be easily adopted, addresses the shortcomings of the existing systems and should be considered for future editions of the TNM staging system.

Prognostic and predictive biomarkers in head and neck cancer: something old, something new, something borrowed, something blue and a sixpence in your shoe.

A biomarker is a measurable indicator of biological or pathological processes or the response to an exposure or intervention and is used to guide management decisions. In head and neck pathology, biomarkers are assessed by histological criteria and immunohistochemical and molecular studies. Surgical resection remains the mainstay of management of many head and neck malignancies. Adjuvant radiotherapy and/or systemic therapy may be administered depending on the presence of adverse prognostic factors identified on histopathological or immunohistochemical examination. In this review, we outline the clinically relevant prognostic and predictive factors in head and neck malignancies including conventionally recognised factors such as tumour size, depth of invasion, lymphovascular and perineural invasion and margin status as well as novel evolving factors such as recurrent genetic rearrangements and assessment of immune checkpoints. Practical issues are discussed to assist with recognising and reporting of these factors. A summary of useful tools such as structured pathology report formats is also included to assist with comprehensive reporting of all clinically relevant parameters, minimise risk and improve workflow efficiencies.

When should patients with T1N0 oral squamous cell carcinoma be considered for elective neck dissection?

AIMS: To identify adverse pathological features (APF) predicting nodal failure in clinically node negative T1 oral squamous cell carcinoma (OSCC). METHODOLOGY: This study evaluated patients with T1N0 (≤5 mm depth of invasion (DOI) and ≤2 cm diameter) oral cancers from a prospectively maintained database between 1988 and 2020. All patients underwent surgical excision of the primary lesion without neck dissection. Patients underwent three monthly clinical surveillance and salvage neck dissection was performed if nodal relapse was diagnosed. RESULTS: Overall, 141 patients were included. Nodal relapse was reported in 16/141 (11.3%) patients. Factors impacting regional recurrence-free survival were DOI ≥3 mm (HR: 2.4, P < 0.001), maximum tumour diameter ≥12 mm (HR: 1.1, P = 0.009), perineural invasion (PNI) (HR 7.5, P = 0.002) and poor differentiation (HR 5.3, P = 0.01). Rates of nodal relapse increased from 2% amongst patients with no APFs to 100% for those with four APFs. Patients with two or more APFs had significantly poorer 5-year regional recurrence-free survival (94.8% vs. 56.3%, P < 0.001). CONCLUSION: Patients with T1N0 OSCC with two or more APFs (DOI ≥3 mm, diameter ≥12 mm, PNI or poor differentiations) should be considered for elective neck dissection.

Development and validation of a novel TNM staging N-classification of oral cavity squamous cell carcinoma.

BACKGROUND: For oral cavity squamous cell carcinoma (OSCC), extent of extranodal extension (ENE) (minor, ≤2 mm; major, >2 mm) is differentially prognostic, whereas limitations exist with the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N-classification (TNM-8-N). METHODS: Resected OSCC patients at four centers were included and extent of ENE was recorded. Thresholds for optimal overall survival (OS) discrimination of lymph node (LN) features were established. After dividing into training and validation sets, two new N-classifications were created using 1) recursive partitioning analysis (RPA), and 2) adjusted hazard ratios (aHRs) and were ranked against TNM-8-N and two published proposals. RESULTS: A total of 1460 patients were included (pN0: 696; pN+: 764). Of the pN+ cases, 135 (18%) had bilateral/contralateral LNs; 126 (17%) and 244 (32%) had minor and major ENE, and two (0.3%) had LN(s) >6 cm without ENE (N3a). LN number (1 and >1 vs. 0: aHRs, 1.92 [95% confidence interval (CI), 1.44-2.55] and 3.21 [95% CI, 2.44-4.22]), size (>3 vs. ≤3 cm: aHR, 1.88 [95% CI, 1.44-2.45]), and ENE extent (major vs. minor: aHR, 1.40 [95% CI, 1.05-1.87]) were associated with OS, whereas presence of contralateral LNs was not (aHR, 1.05 [95% CI, 0.81-1.36]). The aHR proposal provided optimal performance with these changes to TNM-8-N: 1) stratification of ENE extent, 2) elimination of N2c and 6-cm threshold, and 3) stratification of N2b by 3 cm threshold. CONCLUSION: A new N-classification improved staging performance compared to TNM-8-N, by stratifying by ENE extent, eliminating the old N2c category and the 6 cm threshold, and by stratifying multiple nodes by size.

Surgical and health related quality of life outcomes following treatment with zygomatic implant perforated (ZIP) flaps.

BACKGROUND: The zygomatic implant perforated (ZIP) flap is a novel approach to the challenge of reconstructing the maxilla. We report on our experience using the ZIP flap technique for patients undergoing infrastructure maxillectomy at Chris O'Brien Lifehouse, Sydney, Australia. METHODS: Thirteen patients who underwent a ZIP flap reconstruction between August 2019 and August 2021 were identified. Demographic, surgical, and histopathological information was collected. Health Related Quality of Life (HRQOL) was assessed using the FACE-Q Head and Neck Cancer module, the M.D. Anderson Dysphagia Inventory, and the Speech Handicap Index. RESULTS: A total of 44 zygomatic implants were placed, of which 42 (95%) survived. The median time from surgery to dental rehabilitation was 35 days. HRQOL data was available for nine patients over 24 months, demonstrating improved speech and swallowing outcomes over the follow up period. CONCLUSIONS: The ZIP flap is a reproducible surgical technique that facilitates rapid dental rehabilitation post infrastructure maxillectomy.

Improving the oral function of patients with upper and lower lip tensor fascia lata slings for patients with flaccid facial nerve palsy.

BACKGROUND: Facial nerve paralysis (FNP) often causes decreased quality of life and may lead to significant facial dysfunction. Oral competence is frequently raised as a concern by patients as it impacts nutrition, hydration, social participation, and mental health. This can result in social isolation and reduced capacity to return to vocational roles. Despite its prevalence, it is incompletely understood and rarely described. This study prospectively evaluated the impact that facial nerve static and dynamic reanimation has on oral competence, with a specific focus on speech intelligibility and the oral phase of the swallow. MATERIALS AND METHODS: Patients who had a static or dynamic facial reanimation at Chris O'Brien Lifehouse due to facial nerve paralysis were recruited consecutively between September 2020 and October 2022. Their speech and swallow were analysed using patient reported outcome measures including the speech handicap index and the oral competence questionnaire, and speech intelligibility rated by the patient and their speech pathologist at baseline (up to 2-weeks prior to surgery), then at 6- and 12- months post-surgery. Outcomes were evaluated firstly by a paired analysis (pre- compared to post-operative oral competence outcomes), and secondly by a cohort analysis of static, compared to dynamic reanimation. RESULTS: 19 participants underwent a facial nerve reconstruction (10 static, 9 dynamic and static) due to pre-operative facial nerve paralysis. At 12-months improvements in both the oral competence questionnaire (OCQ) and the speech handicap index (SHI) (score reduced at a rate of 0.3 points per week and the 0.2 points respectively) and that this change met statistical significance (OCQ; p = p < 0.003, SHI; p < 0.001). Patient rated intelligibility increased 0.3 and clinician rated intelligibility increased 0.2 points per week which also significantly improved (p = 0.001 and p < 0.001 respectively). CONCLUSIONS: Both static and dynamic facial reanimation procedures significantly improved both speech and swallowing measures for oral competence at 6- and 12- months post-procedure. There was not a significant difference found between static and dynamic procedures.

The impact of multifocal perineural invasion in predicting survival in patients with oral squamous cell carcinoma: A multicenter investigation.

BACKGROUND: Perineural invasion (PNI) in oral squamous cell carcinoma (OSCC) does not contribute to the current American Joint Committee on Cancer 8th edition (AJCC8) staging manual. This study seeks to validate the effect of multifocal PNI in a large cohort of patients. METHODS: Patients undergoing primary surgical treatment of OSCC with curative intent between 1995 and 2022 was retrieved from two Australian head and neck databases. PNI was categorized as a single focus or multiple foci. Study end points included disease-specific survival (DSS) and overall survival (OS). RESULTS: Complete data for survival analysis was available in 993 patients. Multifocal PNI was associated with a 61% increased risk of death due to OSCC (HR 1.61, 95% CI 1.11-2.33, p = 0.014) and a 32% increased risk of death from any cause (HR 1.32, 95% CI 1.01-1.73, p = 0.045). CONCLUSIONS: Multifocal PNI is a significant predictor of survival in OSCC.

Persisting facial nerve palsy or trigeminal neuralgia - red flags for perineural spread of head and neck cutaneous squamous cell carcinoma (HNcSCC).

BACKGROUND: Perineural spread (PNS) of head and neck cutaneous squamous cell carcinoma (HNcSCC) is a unique diagnostic challenge, presenting with insidious trigeminal (CN V) or facial nerve (CN VII) neuropathies without clinically discernible primary masses. These patients are often sub-optimally investigated and misdiagnosed as Bell's palsy or trigeminal neuralgia. This case series highlights the red flags in history and pitfalls that lead to delays to diagnosis and treatment. METHODS: A retrospective case series of 19 consecutive patients with complete clinical histories with HNcSCC PNS without an obvious cutaneous primary lesion at time of presentation to a quaternary head and neck centre in Australia were identified and included for analysis. RESULTS: Fifteen had CN VII PNS, 17 had CN V PNS, and 13 had both. The overall median symptom-to-diagnosis time was 12-months (IQR-15 months). Eight patients had CN VII PNS and described progressive segmental facial nerve palsy with a median symptom-to-diagnosis time of 9-months (IQR-11.75 months). Eleven patients had primary CN V PNS and described well localized parathesia, formication or neuralgia with a median symptom-to-diagnosis time of 19-months (IQR 27.5 months). CONCLUSION: PNS is often mistaken for benign cranial nerve dysfunction with delays in diagnosis worsening prognosis. Red flags such as progressive CN VII palsy or persistent CN V paraesthesia, numbness, formication or pain, particularly in the presence of immuno-compromise and/or a history of facial actinopathy should raise suspicion for PNS. Gadolinium-enhanced MR Neurography should be obtained expediently in patients with persistent/progressive CN V/CN VII palsies in patients with red flags, with low threshold for referral to a Head and Neck Surgeon.

Prediction nomogram development and validation for postoperative radiotherapy in the management of oral squamous cell carcinoma.

BACKGROUND: Predictive nomograms are useful tools to guide clinicians in estimating disease course. Oral squamous cell carcinoma (OSCC) patients would benefit from an interactive prediction calculator that defines their levels of survival-risk specific to their tumors to guide the use of postoperative radiotherapy (PORT). METHODS: Patients with OSCC surgically treated with curative intent at four Head and Neck Cancer Centres were recruited retrospectively for development and validation of nomograms. Predictor variables include PORT, age, T and N classification, surgical margins, perineural invasion, and lymphovascular invasion. Outcomes were disease-free, disease-specific, and overall survivals over 5 years. RESULTS: 1296 patients with OSCC were in training cohort for nomogram analysis. Algorithms were developed to show relative benefit of PORT in survivals for higher-risk patients. External validation on 1212 patients found the nomogram to be robust with favorable discrimination and calibration. CONCLUSION: The proposed calculator can assist clinicians and patients in the decision-making process for PORT.

Outcomes of immediate dental implants in vascularised bone flaps for mandibular reconstruction.

BACKGROUND: The aim of this study is to assess the outcomes of immediate implant placement for dental rehabilitation following mandibular reconstruction with vascularised bone flaps in a single Australian tertiary cancer centre. METHODS: A retrospective analysis of patients who underwent immediate dental implant or delayed placement in vascularised bone flaps was performed. Primary outcome measures assessed included the number of implants placed, operative time, complication rates, time to radiotherapy initiation, dental rehabilitation rates and time to dental rehabilitation. RESULTS: In total, 187 dental implants were placed in 52 patients, of which 34 patients underwent immediate implant placement and 18 had delayed implant placement. There were no significant differences in the postoperative complication rate (32% immediate vs. 33% delayed, P = 0.89) or time to postoperative radiotherapy (median 42 days immediate vs. 47 days delayed, P = 0.24). Dental rehabilitation was achieved in 62% of the immediate cohort versus 78% of the delayed cohort. The time to be fitted with a dental prosthesis was significantly shorter in the immediate cohort (median 150 days immediate vs. 843 days delayed, P = 0.002). CONCLUSIONS: The placement of immediate dental implants at the time of primary reconstruction of the mandible is a safe procedure and facilitates timely dental rehabilitation.

Development of an implantable bionic for dynamic eye closure in facial nerve paralysis: Evolution of the design.

Facial nerve paralysis (FNP) presents with a constellation of clinical problems but its most concerning consequence is corneal exposure from lack of blinking. Bionic lid implant for natural closure (BLINC) is an implantable solution for dynamic eye closure in FNP. It uses an electromagnetic actuator to mobilise the dysfunctional eyelid by means of an eyelid sling. This study highlights issues relating to device biocompatibility and describes its evolution to overcome some of these issues. The essential components of the device are the actuator, the electronics including energy storage, and an induction link for wireless power transfer. Effective arrangement of these components within the anatomical confines and their integration is achieved through a series of prototypes. The response of each prototype is tested in a synthetic or cadaveric model for eye closure with the final prototype designed for acute and chronic animal trials.

Comparing Genomic Landscapes of Oral and Cutaneous Squamous Cell Carcinoma of the Head and Neck: Quest for Novel Diagnostic Markers.

Squamous cell carcinoma is the most common head and neck malignancy arising from the oral mucosa and the skin. The histologic and immunohistochemical features of oral squamous cell carcinoma (OSCC) and head and neck cutaneous squamous cell carcinoma (HNcSCC) are similar, making it difficult to identify the primary site in cases of metastases. With the advent of immunotherapy, reliable distinction of OSCC and HNcSCC at metastatic sites has important treatment and prognostic implications. Here, we investigate and compare the genomic landscape of OSCC and HNcSCC to identify diagnostically useful biomarkers. Whole-genome sequencing data from 57 OSCC and 41 HNcSCC patients were obtained for tumor and matched normal samples. Tumor mutation burden (TMB), Catalogue of Somatic Mutations in Cancer (COSMIC) mutational signatures, frequent chromosomal alterations, somatic single nucleotide, and copy number variations were analyzed. The median TMB of 3.75 in primary OSCC was significantly lower (P < .001) than that of 147.51 mutations/Mb in primary HNcSCC. The COSMIC mutation signatures were significantly different (P < .001) between OSCC and HNcSCC. OSCC showed COSMIC single-base substitution (SBS) mutation signature 1 and AID/APOBEC activity-associated signature 2 and/or 13. All except 1 HNcSCC from hair-bearing scalp showed UV damage-associated COSMIC SBS mutation signature 7. Both OSCC and HNcSCC demonstrated a predominance of tumor suppressor gene mutations, predominantly TP53. The most frequently mutated oncogenes were PIK3CA and MUC4 in OSCC and HNcSCC, respectively. The metastases of OSCC and HNcSCC demonstrated TMB and COSMIC SBS mutation signatures similar to their primary counterparts. The combination of high TMB and UV signature in a metastatic keratinizing squamous cell carcinoma suggests HNcSCC as the primary site and may also facilitate decisions regarding immunotherapy. HNcSCC and OSCC show distinct genomic profiles despite histologic and immunohistochemical similarities. Their genomic characteristics may underlie differences in behavior and guide treatment decisions in recurrent and metastatic settings.

MYB RNA detection by in situ hybridisation has high sensitivity and specificity for the diagnosis of adenoid cystic carcinoma.

Adenoid cystic carcinoma (ACC) is one of the most common primary salivary gland cancers. ACC has several benign and malignant mimics amongst salivary gland neoplasms. An accurate diagnosis of ACC is essential for optimal management of the patients and their follow-up. Upregulation of MYB has been described in 85-90% of ACC, but not in other salivary gland neoplasms. In ACC, MYB upregulation can occur as a result of a genetic rearrangement t(6;9) (q22-23;p23-24), MYB copy number variation (CNV), or enhancer hijacking of MYB. All mechanisms of MYB upregulation result in increased RNA transcription that can be detected using RNA in situ hybridisation (ISH) methods. In this study, utilising 138 primary salivary gland neoplasms including 78 ACC, we evaluate the diagnostic utility of MYB RNA ISH for distinguishing ACC from other primary salivary gland neoplasms with a prominent cribriform architecture including pleomorphic adenoma, basal cell adenoma, basal cell adenocarcinoma, epithelial myoepithelial carcinoma, and polymorphous adenocarcinoma. Fluorescent in situ hybridisation and next generation sequencing were also performed to evaluate the sensitivity and specificity of RNA ISH for detecting increased MYB RNA when MYB gene alterations were present. Detection of MYB RNA has 92.3% sensitivity and 98.2% specificity for a diagnosis of ACC amongst salivary gland neoplasms. The sensitivity of MYB RNA detection by ISH (92.3%) is significantly higher than that of the FISH MYB break-apart probe (42%) for ACC. Next generation sequencing did not demonstrate MYB alterations in cases that lacked MYB RNA overexpression indicating high sensitivity of MYB RNA ISH for detecting MYB gene alterations. The possibility that the sensitivity may be higher in clinical practice with contemporary samples as compared with older retrospective tissue samples with RNA degradation is not entirely excluded. In addition to the high sensitivity and specificity, MYB RNA testing can be performed using standard IHC platforms and protocols and evaluated using brightfield microscopy making it a time and cost-efficient diagnostic tool in routine clinical practice.

Outcomes of immediate facial nerve reanimation with nerve transfer for facial nerve neoplasm-induced paralysis: a retrospective review.

BACKGROUND: The purpose of this study was to evaluate the outcomes of our polyneural, zone-based reanimation approach for patients with neoplasm-induced facial paralysis. METHODS: A retrospective review of consecutive patients who underwent facial reanimation surgery using multiple donor nerve transfers was undertaken. In each case, the selection of donor nerves was based on the availability of donor nerve and the viability of the motor endplate on the affected side. Sources of the neural inputs utilized included the remnant facial nerve stump, masseteric nerve, partial hypoglossal nerve, and branches of the contralateral facial nerve. Clinical outcomes were scored by expert raters. Ratings were undertaken using the modified House-Brackmann, eFACE and MEEI FACEgram scoring systems. RESULTS: Between 2017 and 2020, 12 patients were included in the study (mean age 60 years; range 26-81 years). Eight patients (67%) achieved a grade III outcome on the modified House-Brackmann grading scale. Mean eFACE static and dynamic scores were 76 and 57 respectively, reflecting a high degree of symmetry at rest and moderate restoration of dynamic movement. Mean time to movement was 5.4 months (SD 1.9). Objective FACE-gram measurements confirmed restoration of midface movement with an average improvement in smile excursion and mouth angle excursion of 3.19 mm (SD 3.18) and 4.81° (SD 2.90) respectively. CONCLUSION: Facial reanimation using multiple nerve transfers is effective in achieving improvements in facial function and symmetry.

Comparative analysis of pre-operative ultrasound and histopathology in small papillary thyroid carcinoma in the era of active surveillance.

BACKGROUND: Contemporary management of small papillary thyroid carcinomas (PTC) includes active surveillance (AS) as a number of these tumours are indolent. Overseas studies have reported AS in tumours up to 15 mm. This study aims to look at an Australian cohort of patients who have had surgery for non-incidental PTCs and analyse their pre-operative ultrasound and histopathology data to investigate potential issues that might arise in the era of AS. METHODS: Retrospective review of 82 patients who had surgical removal of PTCs ≤15 mm in diameter. Pre-operative ultrasound imaging was reviewed by an experienced sonologist and histopathology data was obtained from medical records. The AS risk stratification framework by Brito et al. was used to determine those who were feasible for AS based on ultrasound findings. RESULTS: Review of pre-operative ultrasounds demonstrated there were 68 (82.9%) patients who were shown to be either appropriate or ideal for AS. On review of histopathology, 49 (69%) patients had at least one adverse pathological risk factor. This is more than half of the patients that were originally identified as candidates for AS. CONCLUSION: Our study has revealed a large proportion were suitable for AS but when compared with histopathological guidelines there was a high incidence of adverse pathological features found. This discrepancy indicates that although the guidelines are important, there are unknown pathological variables that need to be considered in patients selected for AS.

Anterolateral thigh, radial forearm and superficial circumflex iliac perforator flaps in oral reconstruction: a comparative analysis.

BACKGROUND: Anterolateral thigh (ALT) and Radial forearm free flaps (RFFF) are historically the most common methods of oral reconstruction. The Superficial circumflex iliac artery perforator flap (SCIP) is an alternative providing a donor site that can be readily closed primarily with improved cosmesis in younger patients, due to its concealability. METHODS: We reviewed 135 patients who received ALT, RFFF or SCIP flaps for oral reconstruction in our institution. Our aim was to compare operative and perioperative outcomes between each cohort. ANOVA and χ2 test were used for statistical analysis. RESULTS: There were 37 ALT, 64 RFFF and 35 SCIP reconstructions. Patients reconstructed with SCIP flaps had smaller resection volumes (P < 0.001) and earlier T and N classifications (P = 0.001, P = 0.008), and consequently reduced tracheostomy rates (P < 0.001), reduced need for enteral feeding at discharge (P < 0.001) and shorter length of stay and perioperative times (P < 0.001). SCIP flaps were more common in younger patients (P < 0.01). ALT flaps were used for more advanced disease (P = 0.001) and had larger resection volumes (P < 0.001) and increased need for assisted enteral feeding (P < 0.001). There were no significant differences in flap or donor site outcomes. There were two flap failures, both RFFF. CONCLUSION: Each flap plays an important role in the reconstruction of oral defects, with larger defects preferentially reconstructed with ALT flaps. SCIP appears to be a reliable alternative in small defects with excellent perioperative and postoperative outcomes.

Utility of an oral competence questionnaire for patients with facial nerve paralysis.

OBJECTIVE: To investigate the utility of a patient-reported outcome measure that evaluates oral competence; speech and swallowing functions after facial nerve paralysis (FNP). METHODS: The Oral Competence Questionnaire (OCQ) covers 16 questions from known, validated patient-reported outcome measures. The OCQ was completed by 40 patients with facial nerve paralysis (FNP) and 40 healthy controls. The sensitivity of the questionnaire was tested against other validated questionnaires for oral function, speech/swallowing functions, and facial nerve-related disability. Normative data were obtained by administering the OCQ to a group of healthy volunteers. RESULTS: A total of 80 participants completed the OCQ (40 FNP and 40 healthy controls). Strong linear relationships (Spearman correlation coefficients >0.8) were observed between speech intelligibility ratings, objective speech outcomes, and the OCQ. Linear correlations were also noted between OCQ and FDI (Spearman correlation coefficient >0.4). The mean OCQ score for participants with FNP was 28.8 and 0.0 for healthy controls. CONCLUSIONS: This succinct, 16-item questionnaire demonstrated good sensitivity for testing oral competence and oral function for patients with FNP, and the ability to discriminate between patients with FNP from patients with normal facial nerve function.