Neck Dissection Impairment Index Research Articles

Canadian French Translation and Validation of the Neck Dissection Impairment Index: A Quality of Life Measure for the Surgical Oncology Population.

Neck dissections (ND) are a routine procedure in head and neck oncology. Given the postoperative functional impact that some patients experience, it is imperative to identify and track quality of life (QoL) symptomatology to tailor each patient's therapeutic needs. To date, there is no validated French-Canadian questionnaire for this patient-population. We therefore sought to translate and validate the Neck Dissection Impairment Index (NDII) in Canadian French. A 3-phased approach was used. Phase 1: The NDII was translated from English to Canadian French using a "forward and backward" translational technique following international guidelines. Phase 2: A cognitive debriefing session was held with 10 Canadian French-speaking otolaryngology patients to evaluate understandability and acceptability. Phase 3: The final version was administered prospectively to 30 patients with prior history of ND and 30 control patients. These patients were asked to complete the questionnaire 2 weeks after their first response. Test-retest reliability was calculated with Spearman's correlation. Internal consistency was elicited using Cronbach's alpha. NDII was successfully translated and validated to Canadian French. Cronbach's alpha revealed high internal consistency (0.92, lower 95% confidence limit 0.89). The correlation for test-retest validity were strong or very strong (0.61-0.91). NDII is an internationally recognized QoL tool for the identification of ND-related impairments. This validated Canadian French version will allow clinicians to adequately assess the surgery-related QoL effect of neck surgery in the French-speaking population, while allowing French institutions to conduct and/or participate in multisite clinical trials requiring the NDII as an outcome measure.

Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial.

High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).

Long-term Patient-Reported Outcomes in a Population-Based Cohort Following Radiotherapy vs Surgery for Oropharyngeal Cancer

Oncologic outcomes are similar for patients with oropharyngeal squamous cell carcinoma (OPSCC) treated with primary surgery or radiotherapy. However, comparative differences in long-term patient-reported outcomes (PROs) between modalities are less well established. To determine the association between primary surgery or radiotherapy and long-term PROs. This cross-sectional study used the Texas Cancer Registry to identify survivors of OPSCC treated definitively with primary radiotherapy or surgery between January 1, 2006, and December 31, 2016. Patients were surveyed in October 2020 and April 2021. Primary radiotherapy and surgery for OPSCC. Patients completed a questionnaire that included demographic and treatment information, the MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) module, the Neck Dissection Impairment Index (NDII), and the Effectiveness of Auditory Rehabilitation (EAR) scale. Multivariable linear regression models were performed to evaluate the association of treatment (surgery vs radiotherapy) with PROs while controlling for additional variables. Questionnaires were mailed to 1600 survivors of OPSCC identified from the Texas Cancer Registry, with 400 responding (25% response rate), of whom 183 (46.2%) were 8 to 15 years from their initial diagnosis. The final analysis included 396 patients (aged ≤57 years, 190 [48.0%]; aged >57 years, 206 [52.0%]; female, 72 [18.2%]; male, 324 [81.8%]). After multivariable adjustment, no significant differences were found between surgery and radiotherapy outcomes as measured by the MDASI-HN (β, -0.1; 95% CI, -0.7 to 0.6), NDII (β, -1.7; 95% CI, -6.7 to 3.4), and EAR (β, -0.9; 95% CI -7.7 to 5.8). In contrast, less education, lower household income, and feeding tube use were associated with significantly worse MDASI-HN, NDII, and EAR scores, while concurrent chemotherapy with radiotherapy was associated with worse MDASI-HN and EAR scores. This population-based cohort study found no associations between long-term PROs and primary radiotherapy or surgery for OPSCC. Lower socioeconomic status, feeding tube use, and concurrent chemotherapy were associated with worse long-term PROs. Further efforts should focus on the mechanism, prevention, and rehabilitation of these long-term treatment toxicities. The long-term outcomes of concurrent chemotherapy should be validated and may inform treatment decision making.

A prospective evaluation of neck and shoulder function following treatments of early-stage human papillomavirus-associated oropharynx cancer.

To compare post-treatment neck and shoulder function between human papillomavirus-associated oropharynx squamous cell carcinoma (HPV + OPSCC) treatments. Prospective, repeated-measures study. Tertiary care center. Treatment-naïve patients with American Joint Committee on Cancer eighth edition stage T0-3/N0-2 HPV+OPSCC. Patients completed the Neck Dissection Impairment Index (NDII) pre-treatment and 3-months and 1-year post-treatment. The NDII assesses 10 neck and shoulder functions scored 0-5 (total score 0-100), with higher scores suggesting better function. A total of 106 patients underwent: surgery alone (SA, n = 46, 43%), surgery with adjuvant radiation ± chemotherapy (S + a[C]XRT, n = 18, 17%), or definitive radiation ± chemotherapy (d[C]XRT, n = 42, 40%). cTN classification and pre-treatment NDII scores did not differ between groups. SA patients reported worsened 3-month post-treatment versus pre-treatment self-care (4.6 vs. 5.0), lifting light (4.6 vs. 5.0) and heavy (4.2 vs. 4.8) objects, overhead reach (4.5 vs. 4.9), activity (4.5 vs. 4.9), socialization (4.7 vs. 4.9), recreation (4.6 vs. 4.9), and overall score (86.8 vs. 95.3) (all p < 0.05). One-year post-treatment scores (n = 34) were no different than pre-treatment in all domains. S + a[C]XRT patients reported worsened 3-month versus pre-treatment stiffness (4.0 vs. 4.8), lifting heavy objects (3.8 vs. 4.9), overhead reach (4.2 vs. 4.9), socialization (4.6 vs. 5.0), recreation (4.4 vs. 4.9) and overall score (82.4 vs. 96.0) (all p < 0.05). One-year post-treatment scores (n = 13) were no different than pre-treatment in all domains. d[C]XRT patients reported worsened 3-month versus pre-treatment difficulty lifting heavy objects (4.3 vs. 4.7) and recreation (4.3 vs. 4.7). One-year posttreatment scores (n = 21) were no different than pre-treatment in all domains. HPV + OPSCC patients may experience mild shoulder/neck dysfunction 3 months after treatment that usually resolves by 1 year, independent of treatment modality.

Prospective quality of life outcomes for human papillomavirus associated oropharynx cancer patients after surgery alone

PurposeTo evaluate changes in patient-reported quality of life (QOL) to inform treatment decisions for human papillomavirus-associated oropharynx squamous cell carcinoma (HPV + OPSCC). Materials and methodsPatients with American Joint Committee on Cancer (AJCC) 8th edition cT0-T3 and cN0-N3 HPV + OPSCC treated with transoral robotic surgery to the primary site with neck dissection completed questionnaires prior to surgery and at three-months and one-year post-operatively. Questionnaires included four validated instruments: the University of Washington Quality of Life Questionnaire (UW-QOL), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Head and Neck Module (HN35), and the Neck Dissection Impairment Index (NDII). ResultsForty-eight patients filled out pretreatment and three-month questionnaires. 37 patients filled out one-year questionnaires. With the UW-QOL, at three-months, patients reported a statistically significant and clinically meaningful decreased mean score for appearance that resolved at one-year (presurgery: 92.4, 3-month: 81.0, p < 0.001; one year: 86.5). At three months and one-year, significant and clinically meaningful decreased mean taste scores persisted (presurgery: 98.0; three-months: 76.3, one-year: 80.3; all p < 0.001). With the EORTC QLQ-C30 and HN35, at one-year, only mean scores for sense of taste or smell (one-year: 13.1; p < 0.001) did not return to baseline. With the NDII, patients returned to functions comparable to baseline in all domains. ConclusionPost-treatment quality of life is high for HPV+ OPSCC patients treated with surgery alone. Mild taste and possibly smell dysfunction may continue in some patients. With careful selection, surgery alone for HPV + OPSCC offers favorable QOL outcomes. Lay summaryPatients with HPV+ associated oropharynx cancer treated with surgery alone completed quality of life questionnaires before and after surgery. Quality of life remained high for most patients, with a subset of patients experiencing mild taste dysfunction one-year after surgery.

Quantifying Neck Fibrosis: Establishing the Domain Structure of the Neck Fibrosis Scale.

We recently described the development of the Neck Fibrosis Scale (NFS). In this submission, we confirm domain structure and validate a scoring system for the NFS. Prospective cross-sectional study. Between January 2020 and December 2021, 127 head and neck cancer patients with varying degrees of cutaneous neck fibrosis completed the original 15 item NFS. Exploratory factor analysis was used to identify optimal groupings with similar underlying factors. The association between the domains of the NFS and various measures of neck morbidity (i.e., construct validity) were assessed using gamma regression. Exploratory factor analysis confirmed 13 of the 15 items from the NFS mapped onto two factors, which were labelled 'physical' and 'emotional' domains. Of the remaining two items, 'energy' did not load uniquely onto one factor and was removed. 'Neck-swelling' did not load on either factor (loadings <0.3) but was retained within the physical domain based on clinical importance. This resulted in a revised 14-item questionnaire. Internal consistency for these two domains was high (>0.8, p < 0.01). Both the physical and emotional domains of the revised NFS show strong correlation with the neck dissection impairment index and neck range of motion. The physical domain strongly correlated with neck elasticity (0.902 [95%CI 0.839-0.972], p < 0.01). Patients receiving multimodal therapy had physical domain scores that were 31.6% [95% 13.9-51.8] higher (worse) than unimodal therapy patients. A domain structure and scoring strategy have been developed for the NFS. Future efforts should be directed toward an evaluation of responsiveness. NA Laryngoscope, 133:2198-2202, 2023.

Patient-Reported Financial Toxicity in a Population-Based Cohort of Oropharynx Cancer Survivors

Patients with oropharyngeal squamous cell carcinoma (OPSCC) are at high risk for financial toxicity (FT), but the nature, extent, and predictors of FT experienced after primary radiation therapy (RT) or surgery are poorly understood. We used a population-based sample of patients from the Texas Cancer Registry with stage I to III OPSCC diagnosed from 2006 to 2016 and treated with primary RT or surgery. Of 1,668 eligible patients, 1,600 were sampled, 400 responded, and 396 confirmed OPSCC. Measures included the MD Anderson Symptom Inventory Head and Neck, Neck Dissection Impairment Index, and a financial toxicity instrument adapted from the Individualized Cancer Care (iCanCare) study. Multivariable logistic regression evaluated associations of exposures with outcomes. Of 396 analyzable respondents, 269 (68%) received primary RT and 127 (32%) surgery. The median time from diagnosis to survey was 7 years. Due to OPSCC, 54% of patients experienced material sacrifice (including 28% who reduced food spending and 6% who lost their housing), 45% worried about financial problems, and 29% experienced long-term FT. Independent factors associated with more long-term FT included female sex (odds ratio [OR], 1.72; 95% confidence interval [CI], 1.23-2.40), Black non-Hispanic race (OR, 2.98; 95% CI, 1.26-7.09), unmarried status (OR, 1.50; 95% CI, 1.11-2.03), feeding tube use (OR, 3.98; 95% CI, 2.29-6.90), and worst versus best quartile on the MD Anderson Symptom Inventory Head and Neck (OR, 1.89; 95% CI, 1.23-2.90) and Neck Dissection Impairment Index (OR, 5.62; 95% CI, 3.79-8.34). Factors associated with less long-term FT included age >57 years (OR, 0.54; 95% CI, 0.41-0.71; P < .001) and household income ≥$80,000 (OR, 0.60; 95% CI, 0.44-0.82; P=.001). Primary RT versus surgery was not associated with long-term FT (OR, 0.92; 95% CI, 0.68-1.24). Oropharynx cancer survivors experience high rates of material sacrifice and long-term FT, and we identified important risk factors. Chronic symptom burden was associated with significantly worse long-term financial status, supporting the hypothesis that toxicity mitigation strategies may reduce long-term FT.

Patient-Reported Financial Toxicity in a Population-Based Cohort of Oropharynx Cancer Survivors after Primary Radiotherapy or Surgery

<h3>Purpose/Objective(s)</h3> Patients with oropharynx cancer are at risk for financial toxicity due to the intensive treatment and impact on critical normal functions such as eating and speaking. The nature, extent, and predictors of financial toxicity experienced after primary radiotherapy (RT) or surgery are not well-described in this population. Since the treatment strategy for oropharynx cancer is likely sensitive to patient preferences, the effects on financial toxicity may inform decision-making and facilitate interventions. <h3>Materials/Methods</h3> We identified a population-based sample of oropharynx cancer patients from the Texas Cancer Registry aged ≥18, diagnosed 2006-2016, stage I-III, and treated with primary RT or primary surgery +/- post-operative RT (PORT). Out of 1,668 eligible patients, 1,600 were mailed an invitation, survey, and $10 gift card in 2020-21. The survey included demographic and treatment questions, the MD Anderson Symptom Inventory Head and Neck (MDASI-HN), Neck Dissection Impairment Index (NDII), Effectiveness of Auditory Rehabilitation (EAR) scale, and an 8-question financial toxicity instrument adapted from the iCanCare study. Multivariable (MVA) logistic regression identified predictors of self-reported long-term financial decline attributable to cancer and treatment with p<0.05 considered significant. <h3>Results</h3> In total, 400 patients responded (25% response rate), of whom 271 (68%) received primary RT and 129 (32%) primary surgery. Of primary surgery patients, 105 (83%) received PORT while 22 (17%) did not. Median time from diagnosis to survey was 7 years. Overall, due to oropharynx cancer, 45% used personal savings, 19% could not make bill payments, 28% cut down on food spending, 2% had utilities turned off, 6% could no longer afford their housing, and 54% experienced some form of financial toxicity. Patients who received primary surgery without PORT used less personal savings (p=0.04) with less short-term financial toxicity overall (p=0.04). At the time of survey, 45% of patients worried about financial problems because of their cancer and treatment. On MVA, factors associated with worse long-term financial status included younger age (≤57 years), primary RT (only in >57 years), female sex, Black non-Hispanic race, unmarried status, lower income, tonsil subsite, more recent diagnosis, and worse scores on the MDASI-HN, NDII, and EAR. <h3>Conclusion</h3> In this population-based cohort, oropharynx cancer survivors reported high rates of short- and long-term financial toxicity, with nearly half worrying about financial problems due to their cancer at a median 7 years after diagnosis. Higher chronic symptom burden was associated with worse long-term financial status while the effect of primary RT vs surgery was significantly modified by age. The subset of primary surgery without PORT reported less short-term financial toxicity. Identifying patients with risk factors for financial toxicity presented here may allow for appropriate intervention and counseling.

Anatomy and clinical application of suprascapular nerve to accessory nerve transfer.

BACKGROUNDLoss of motor function in the trapezius muscle is one complication of radical neck dissection after cutting the accessory nerve (AN) during surgery. Nerve repair is an effective method to restore trapezius muscle function, and includes neurolysis, direct suture, and nerve grafting. The suprascapular nerve (SCN) and AN are next to each other in position. The function of the AN and SCN in shoulder elevation and abduction movement is synergistic. SCN might be considered by surgeons for AN reanimation.AIMTo obtain anatomical and clinical data for partial suprascapular nerve-to-AN transfer.METHODSTen sides of cadavers perfused with formalin were obtained from the Department of Human Anatomy, Histology and Embryology, Peking University Health Science Center. The SCN (n = 10) and AN (n = 10) were carefully dissected in the posterior triangle of the neck, and the trapezius muscle was dissected to fully display the accessory nerve. The length of the SCN from the origin of the brachial plexus (a point) to the scapular notch (b point) and the distance of the SCN from the origin point (a point) to the point (c point) where the AN entered the border of the trapezius muscle were measured. The length and branches of the AN in the trapezius muscle were measured. A female patient aged 55 years underwent surgery for partial SCN to AN transfer at Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology. The patient suffered from recurrent upper gingival cancer. Radical neck dissection was performed on the right side, and the right AN was removed at the intersection between the nerve and the posterior border of the SCM muscle. One-third of the diameter of the SCN was cut off, and combined epineurial and perineurial sutures were applied between the distal end of the cut-off fascicles of the SCN and the proximal end of the AN without tension. Both subjective and objective evaluations were performed before, three months after, and nine months after surgery. For the subjective evaluation, the questionnaire included the Neck Dissection Impairment Index (NDII) and the Constant Shoulder Scale. Electromyography was used for the objective examination. Data were analyzed using t tests with SPSS 19.0 software to determine the relationship between the length of the SCN and the linear distance. A P value of < 0.05 was considered as statistically significant.RESULTSThe whole length of the AN in the trapezius muscle was 16.89 cm. The average numbers of branches distributed in the descending, horizontal and ascending portions were 3.8, 2.6 and 2.2, respectively. The diameter of the AN was 1.94 mm at the anterior border of the trapezius. The length of the suprascapular nerve from the origin of the brachial plexus to the scapular notch was longer than the distance of the suprascapular nerve from the origin point to the point where the accessory nerve entered the upper edge of the trapezius muscle. The amplitude of trapezius muscle electromyography indicated that both the horizontal and ascending portions of the trapezius muscle on the right side had better function than the left side nine months after surgery. The results showed that the right-sided supraspinatus and infraspinatus muscles did not lose more function than the left side.CONCLUSIONBased on anatomical data and clinical application, partial suprascapular nerve-to-AN transfer could be achieved and may improve innervation of the affected trapezius muscle after radical neck dissection.

Italian validation of the Neck Dissection Impairment Index questionnaire.

SUMMARYObjectiveThe Neck Dissection Impairment Index (NDII) questionnaire is a useful and validated Quality of Life (QoL) evaluation instrument in patients undergoing major head-neck surgery. Its English version has been used in several studies in the last years. The aim of this work is to validate the NDII in Italian for both patient assessment and future studies.Materials and methodsCross-cultural adaptation of the NDII was performed using standard techniques. Items of the original NDII were translated into Italian by a professional translator and two bilingual investigators. A final consensus version was obtained and given to two professional translators to produce a literal translation into English. The two translators and an expert committee synthesised the results of the translations in an English back-translated version that was compared with the original to check that they had the same semantic value.ResultsFinally, a total of 42 patients completed both copies of the translated questionnaires. Internal consistency proved to be excellent, with Cronbach’s alpha = 0.95.ConclusionsThe NDII was successfully translated into Italian and its use was easy for patients. The translation of the NDII can represent a useful tool for individual patient assessment and future research.

Validation of the Korean Version of the Neck Dissection Impairment Index in Patients Who Underwent Neck Dissection

Background/Objectives: Shoulder function is an important aspect of health related quality of life (QOL). Neck dissection impairment index (NDII) is a simple shoulder-specific questionnaire. This study aimed to evaluate the association between QOL and NDII in patients who underwent neck dissection to validate the Korean version of NDII.Materials &amp; Methods: This study enrolled 74 patients with head and neck cancer who underwent neck dissection from December 2013 to April 2014. Patients completed questionnaires on QOL including the European Organization of Research and Treatment of Cancer 30-item Core QOL questionnaire (EORTC QLQ-C30) and NDII which was translated into Korean. Validity was evaluated by calculating the Pearson correlation coefficient between NDII and EORTC QLQ-C30.Results: We compared preoperative, postoperative within a week, 1st and 3rd months NDII scores. The total NDII scores were 14.7, 47.4, 33.7 and 34.3 each. Clinical variables including gender, site of primary tumor, performing revision neck dissection, radiotherapy and flap reconstruction were not significantly associated with NDII. However NDII mean score of patients who underwent unilateral neck dissection over 3 levels is most increased after operation. During all periods NDII scores were significantly associated with functioning score. Although other scores are lower correlation than function scores, global health status scores and symptom scores are also correlation with NDII.Conclusion: NDII was valid instrument and can be used not only in the clinical practice to assess shoulder dysfunction but also in the simple instrument to evaluate global QOL in Korea patients with having neck dissection.

Motor and Functional Recovery Post Radical Thyroidectomy: A Comparative Study of Two Types of Physical Exercises

Bakeground:Thyroidectomy is one of the standard surgical procedures worldwide. Although mortality and morbidity of thyroidectomy are low, some long-term complications continue to represent significant health and social problem. Early physical exercises for these patients are effective in enhancing the neck and shoulder motor function and improving quality of life. Aim: Assess the efficacy of early exercise programs (self rang of motion and active rang of motion exercises) on radical thyroidectomy patients' motor and functional abilities. Design: the researchers used a a comparative design. setting:The researcher conducted the study at the Head and Neck Surgery Unit in Alexandria Main University Hospital, Egypt. Sample:50 radical thyroidectomy patients were included, and each patient was randomly selected to be allocated to one of the two groups, 25 patients each. Tools: Four tools were used: Socio-demographic and clinical data structured interview schedule, The disabilities of the arm, shoulder and outcome questionnaire, shoulder recovery outcome and neck recovery outcome. Methods: researchers used four tools for data collection. exercise programs were applied one week before the operation and continued for two months postoperative. researchers developed verbal and written instruction and gave it preoperatively, and patients were re-assessed by utilizing tools II, III, and IV after applying the program for each group. Results: 88% of self exercises patients were holding against maximal resistance of muscles strength after two months postoperatively compared to 48% of active exercises patients were holding against gravity elimination. Arm circumference measurements were not statistically significant differences between the two groups, neither preoperatively nor postoperatively. In contrast, range of motion of shoulders, shoulder pain, Disailities of Arm,Shoulder and Hand score, ability to lift objects, ability to do work, and overall activity were significantly improved among self-exercise patients than active exercise patients. Conclusion: Significant improvement of the self exercises group concerning functional and motor activity of the shoulder, arm, and neck. Modification of the disabilities of the arm, shoulder, and hand score of self exercises patients. Statistically significant differences between self and active exercise group regarding Neck Dissection Impairment Index after two months postoperative. Recommendations: Patients and their families must be involved in early rehabilitation to prevent complications and improve their daily living activity.

Shoulder-Specific Patient-Reported Outcome Measures for Use in Patients With Head and Neck Cancer: An Assessment of Reliability, Construct Validity, and Overall Appropriateness of Test Score Interpretation Using Rasch Analysis.

The purpose of this study was to investigate the construct validity and overall appropriateness of test score interpretation of 4 shoulder-related patient-reported outcome (PRO) measures for use in a population of patients with head and neck cancer using Rasch analysis. One hundred eighty-two individuals who had received a neck dissection procedure within the past 2weeks to 18months were recruited for this cross-sectional psychometric study. Rasch methodologies were used to investigate scale dimensionality, scale hierarchy, response scale structure, and reliability of Disabilities of the Arm, Shoulder and Hand (DASH), QuickDASH, Shoulder Pain and Disability Index (SPADI), and Neck Dissection Impairment Index (NDII). DASH did not meet criteria for unidimensionality and was deemed inappropriate for use in this sample. The QuickDASH, SPADI, and NDII were all determined to be unidimensional. All scales had varying issues with person and item misfit, differential item functioning, coverage of ability levels, and optimal rating scale requirements. The NDII met most requirements. All measures were found to meet thresholds for person and item separation as well as reliability statistics. Rasch analysis indicates the NDII is the most appropriate measure studied for this population. The QuickDASH and SPADI are recommended with reservation, whereas the DASH is not recommended. This study demonstrates the use of objective methodologies, using Rasch analysis, to validate PRO recommendations provided by clinical experts in forums such as the Evaluation Database to Guide Effectiveness (EDGE) TaskForce, which are based upon a comprehensive literature review, consideration of published psychometric properties, and expert consensus. Use of Rasch methodologies demonstrates weaknesses in this model and provides opportunities to strengthen recommendations for clinicians.

NRG Oncology HN006: Randomized phase II/III trial of sentinel lymph node biopsy versus elective neck dissection for early-stage oral cavity cancer.

TPS6093 Background: Since patients with early-stage oral cavity cancer (OCC; T1-2N0M0; AJCC 8th ed) have a 20-30% rate of occult nodal metastases despite clinical and radiographic assessment, standard of care treatment includes elective neck dissection (END). Many patients have comprehensive surgical management of the regional cervical nodal basin even though the majority of those necks (70-80%) will not contain disease. Assessment of draining first echelon lymph nodes by sentinel lymph node (SLN) biopsy (Bx), a less invasive surgical procedure, may provide an alternative to END, while potentially reducing morbidity and cost. A decisive clinical trial comparing SLN Bx versus END can focus the HNC clinical and research community and resources on establishing the standard of care for management of the neck in early-stage OCC. Methods: In order to address the efficacy of SLN Bx in this population, we recently activated an international multi-institutional phase II/III prospective trial randomizing patients to two surgical arms: SLN Bx and END. PET/CT is an integral imaging biomarker in this trial. A node-negative PET/CT study with central read is required before randomization. Patients with a positive PET/CT central result will remain in a registry to compare imaging findings with final neck pathology. Given the current evidence available regarding morbidity for SLN Bx versus END, the phase II will determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the Neck Dissection Impairment Index (NDII) shows a signal of superiority of SLN Bx compared to END. A total of 228 randomized patients with negative PET/CT for potential evaluation of shoulder-related morbidity with difference in 6-month NDII scores (minimum important difference ³7.5; one-sided a = 0.10; 90% power) will serve as the “Go/No-Go” decision to move forward into phase III. The phase III portion is a non-inferiority (NI) trial with disease-free survival (DFS) as the primary endpoint (NI margin hazard ratio 1.34 based on a 5% absolute difference in 2-year DFS; one-sided alpha 0.05; 80% power, and an interim look for efficacy at 67% of the events based on an O’Brien-Fleming boundary). The NDII at 6 months after surgery is a hierarchical co-primary endpoint for the phase III. Target accrual of phase III is 618 PET/CT negative patients, including those randomized in phase II (297 DFS events required for the final analysis). In addition to radiotherapy and imaging credentialing, quality assurance will include central pathology review of all negative SLN Bx cases and surgeon credentialing through an education course and SLN Bx and END case review by the surgical co-chairs. A surgical quality assurance working group will review all trial SLN Bx and END outcomes. As of 02/15/21, 7 patients have been screened and 6 of the planned 228 randomized patients in phase II have been enrolled. Clinical trial information: NCT04333537.

Impact of Completion Lymphadenectomy on Quality of Life for Head and Neck Cutaneous Melanoma.

Recent randomized data suggest that completion lymph node dissection after a positive sentinel lymph node biopsy (SLNB) improves locoregional control but does not improve survival for melanoma patients. Locoregional recurrences of head and neck cutaneous melanoma (HNCM) may result in significant morbidity. A better understanding of morbidity is thus important to inform decisions about whether to pursue completion neck dissection (ND). Cross-sectional study. Academic tertiary care hospital. Clinical data were collected for patients with HNCM seen between 2016 and 2019 who were at least 1-year disease free. Each patient completed the Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS), Neck Dissection Impairment Index, and SF-36 (Short Form-36). Scores were compared by surgical treatment: wide local excision (WLE) only, SLNB, and ND. Univariate and multivariable regression was performed. Of 474 patients, 140 returned questionnaires (29.5% response rate; WLE, n = 49; SLNB, n = 76; ND, n = 15). No significant differences in SLANSS or Neck Dissection Impairment Index scores were found between the WLE and SLNB groups. SLANSS scores differed by 2 SD (P = .001) in the ND cohort, which had a 36% rate of neuropathy. Neck impairment was worse by 1 SD (P = .01) in the ND cohort. No differences were found in SF-36 domains. Neuropathy and neck impairment are components of morbidity after ND. These risks must be balanced with potential morbidity of locoregional recurrence in HNCM.

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.

Long-term neck and shoulder function among survivors of oropharyngeal squamous cell carcinoma treated with chemoradiation as assessed with the neck dissection impairment index.

Of interest is the long-term neck and shoulder impairment of patients treated with primary chemoradiotherapy (CRT). This is important for counseling patients regarding treatment decisions when discussing primary CRT. A cross-sectional study to identify factors that contribute to neck and shoulder dysfunction in patients treated with primary CRT. We utilized the neck dissection impairment index (NDII). Eighty-seven patients treated between 2003 and 2010, who were free of disease, responded; 24 of these 87 underwent post-CRT neck dissection. Mean interval since completion of CRT was over 5 years (62.7 months). Mean age, 63.5 years, male:female 75:12. Mean NDII score was 87.4 (SD 22.1, range 5-100). Multiple linear regression revealed worse NDII scores for patients with larger pre-CRT gross tumor nodal volume (GTVnodal), controlled for age, sex, body mass index (BMI), and the presence of neck dissection (p = 0.02). There were significant associations with increasing GTVnodal and "low" scores for components of the NDII that assessed neck pain (p = 0.02), neck stiffness (p = 0.01), lifting heavy objects (p = 0.02), reaching overhead (p = 0.02), and ability to do work (p = 0.02). Physical therapy (PT) was evaluated as an "anchor" but it was prescribed "as needed." Regression revealed participation in PT was associated with higher GTVnodal, lower BMI, presence of neck dissection, and female sex (p = 0.00007). GTVnodal was an independent predictor of neck and shoulder impairment. High GTVnodal was associated with increased pain and stiffness, and increased difficulty lifting heavy objects, reaching overhead, overall ability to perform work-related tasks and was associated with participation in post-treatment PT.

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).

Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index

Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index

2b or not 2b? Shoulder function after level 2b neck dissection: A double-blind randomized controlled clinical trial.

Selective neck dissection (SND) is a mainstay of head and neck cancer treatment. A common sequela is shoulder syndrome from spinal accessory nerve (SAN) trauma. Extensive dissection in neck levels 2 and 5 leads to SAN dysfunction. However, it is not known whether limited level 2 dissection reduces SAN injury. The purpose of this double-blind randomized controlled trial was to determine whether omitting level 2b dissection would improve shoulder-related quality of life and function. Patients with head and neck cancers undergoing surgery were randomized 1:1 to SND without level 2b dissection (group 1) or with it (group 2) on their dominant-hand side. Patients, caregivers, and assessors were blinded. The primary outcome was the change in the Neck Dissection Impairment Index (NDII) score after 6months. An a priori calculation of the minimally important clinical difference in the NDII score was determined to establish a sample size of 15 patients per group (power=0.8). Secondary outcomes included shoulder strength and range of motion (ROM) and SAN nerve conduction. The trial was registered at ClinicalTrials.gov (NCT00765791). Forty patients were enrolled, and 30 were included (15 per group). Six months after the surgery, group 2 demonstrated a significant median decrease in the NDII from the baseline (30 points) and in comparison with group 1, whose NDII dropped 17.5 points (P=.02). Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P≤.05). No adverse events occurred. Level 2b should be omitted in SND when this is oncologically safe and feasible. This allows for an optimal balance between function and cancer cure.