Predicting non-response to intraglandular botulinum neurotoxin A injections for drooling in children with neurodevelopmental disabilities.

AIM: To develop robust multivariable prediction models for non-response to (1) submandibular botulinum neurotoxin A (BoNT-A) injections and (2) concurrent submandibular and parotid (four-gland) injections, to guide treatment decisions for drooling in children with neurodevelopmental disabilities, including cerebral palsy. METHOD: This was a retrospective cohort study including 262 children (155 males/107 females, median age 7 years 11 months [IQR 5 years 1 month], range 4 years 0 months - 17 years 11 months) receiving submandibular injections and 74 children (52 males/22 females, median age 7 years 7 months [IQR 4 years 3 months], range 4 years 9 months - 18 years 8 months) receiving four-gland injections. Multivariable logistic regression analyses were used to estimate associations between candidate predictors and non-response 8 weeks after injection. RESULTS: Ninety-six children (37%) were non-responders to submandibular injections, for which developmental age was the strongest predictor (adjusted odds ratio [aOR] 2.13; 95% confidence interval [CI] 1.02-4.45 for developmental age <4 years or 4-6 years with IQ <70). Other characteristics that showed a trend towards an increased risk of non-response were diagnosis, sex, and head position. Thirty-four children (46%) were non-responders to four-gland injections, for which tongue protrusion (aOR 3.10; 95% CI 1.14-8.43) seemed most predictive, whereas multiple preceding submandibular injections (aOR 0.34; 95% CI 0.10-1.16) showed a trend towards being protective. Predictors were, however, unstable across different definitions of non-response and both models (i.e. submandibular and four-gland) had insufficient discriminative ability. INTERPRETATION: Potential predictors of non-response to BoNT-A injections were identified. Nevertheless, the developed prediction models seemed inadequate for guidance of treatment decisions. WHAT THIS PAPER ADDS: Developmental age seemed most predictive of non-response to submandibular botulinum neurotoxin A injections. Non-response to concurrent submandibular and parotid injections was best predicted by tongue protrusion and number of previous injections. Multivariable prediction models including these clinical characteristics were unable to discriminate well. Predictors differed when non-response was defined using alternative outcome measures.

Comparing the evidence for botulinum neurotoxin injections in paediatric anterior drooling: a scoping review.

Paediatric anterior drooling has a major impact on the daily lives of children and caregivers. Intraglandular botulinum neurotoxin type-A (BoNT-A) injections are considered an effective treatment to diminish drooling. However, there is no international consensus on which major salivary glands should be injected to obtain optimal treatment effect while minimizing the risk of side effects. This scoping review aimed to explore the evidence for submandibular BoNT-A injections and concurrent submandibular and parotid (i.e. four-gland) injections, respectively, and assess whether outcomes could be compared across studies to improve decision making regarding the optimal initial BoNT-A treatment approach for paediatric anterior drooling. PubMed, Embase, and Web of Science were searched to identify relevant studies (until October 1, 2023) on submandibular or four-gland BoNT-A injections for the treatment of anterior drooling in children with neurodevelopmental disabilities. Similarities and differences in treatment, patient, outcome, and follow-up characteristics were assessed. Twenty-eight papers were identified; 7 reporting on submandibular injections and 21 on four-gland injections. No major differences in treatment procedures or timing of follow-up were found. However, patient characteristics were poorly reported, there was great variety in outcome measurement, and the assessment of side effects was not clearly described.   Conclusion: This review highlights heterogeneity in outcome measures and patient population descriptors among studies on paediatric BoNT-A injections, limiting the ability to compare treatment effectiveness between submandibular and four-gland injections. These findings emphasize the need for more extensive and uniform reporting of patient characteristics and the implementation of a core outcome measurement set to allow for comparison of results between studies and facilitate the optimization of clinical practice guidelines. What is Known: • There is no international consensus on which salivary glands to initially inject with BoNT-A to treat paediatric drooling. What is New: • Concluding on the optimal initial BoNT-A treatment based on literature is currently infeasible. There is considerable heterogeneity in outcome measures used to quantify anterior drooling.and clinical characteristics of children treated with intraglandular BoNT-A are generally insufficiently reported. • Consensus-based sets of outcome measures and patient characteristics should be developed and implemented.

Interdisciplinary assessment and treatment of paediatric drooling: two decades of experience by the Nijmegen saliva control team reflected in a stepwise algorithm.

Anterior and posterior drooling are prevalent comorbidities in children with neurodevelopmental disabilities. Considering the heterogeneity of the patient population and the multifactorial aetiology of drooling, an interdisciplinary and individualised treatment approach is indispensable. However, no tool for stepwise decision-making in the treatment of paediatric drooling has been developed previously. Within the Radboudumc Amalia Children's Hospital, care for children with anterior and/or posterior drooling secondary to neurodevelopmental disabilities is coordinated by a saliva control team with healthcare professionals from six disciplines. In alignment with international literature, published guidelines, and evidence gained from two decades of experience and research by our team, this paper proposes an algorithm reflecting the assessment and treatment approach applied in our clinic. First, directions are provided to decide on the necessity of saliva control treatment, taking type of drooling, the child's age, and the severity and impact of drooling into account. Second, the algorithm offers guidance on the choice between available treatment options, highlighting the importance of accounting for child characteristics and child and caregiver preferences in clinical (shared) decision-making. CONCLUSIONS: With this algorithm, we aim to emphasise the importance of repeated stepwise decision-making in the assessment and treatment of drooling in children during their childhood, encouraging healthcare professionals to apply a holistic approach. WHAT IS KNOWN: • Children with anterior or posterior drooling secondary to neurodevelopmental disabilities comprise a heterogeneous group, necessitating an individualised treatment approach. • No stepwise decision-making tool is available for the treatment of paediatric drooling. WHAT IS NEW: • Deciding on the necessity of saliva control treatment should be a conscious process, based on type of drooling, age, and drooling severity and impact. • Type of drooling, age, cognition, oral motor skills, self-awareness, posture, diagnosis, and child/caregiver preferences need to be considered to decide on the optimal treatment.

Outpatient parotidectomy with or without the use of a post-operative drain: A retrospective bi-institutional study.

OBJECTIVE: Parotid surgery is historically performed as an inpatient procedure and suctions drains are predominantly used during surgery. Recent literature provides evidence that outpatient parotid surgery is safe and effective. Our study aims to describe the results of drainless outpatient parotidectomy and outpatient parotidectomy with drain placement and compare their outcomes. DESIGN: Retrospective cohort study. SETTING: Bi-institutional retrospective cohort study. PARTICIPANTS: Patients that underwent outpatient drain-less parotidectomy and patients that underwent outpatient parotidectomy with post-operative drain placement. MAIN OUTCOME MEASURES: Complication rates, unplanned post-operative visits, unplanned prolonged stay. RESULTS: Three hundred eighty patients underwent outpatient parotidectomy with drain placement and 31 patients underwent outpatient drainless parotidectomy in two different hospitals. The incidence of haematoma (drain: 3.1% vs. drainless: 0%, p = 1), infection (drain: 14.3% vs. drainless: 13.8%, p = 1) and salivary fistula (drain: 5.6% vs. drainless: 3.4, p = 1) were comparable between both groups. Seroma or sialocele was more frequently seen in the drain-less group (27.6% vs. 6.2%, p < .001), but were all managed conservatively. Within 10 days after surgery, unplanned visits seemed more frequent in the drain group, although the difference was not statistically significant (14.9% vs. 3.4%, p = .16). CONCLUSIONS: Outpatient parotid surgery with or without the use of a post-operative drain is safe, practical and feasible. Same-day discharge with and without drain placement yield comparable outcomes. However, the results need to be interpreted cautiously as this study was limited by a small cohort of parotidectomies without drain placement. Future studies should further compare both approaches.

Surgery versus botulinum neurotoxin A to reduce drooling and improve daily life for children with neurodevelopmental disabilities: a randomized controlled trial.

AIM: To compare the effect of bilateral submandibular duct ligation and botulinum neurotoxin A (BoNT-A) on drooling severity and its impact on daily life and care in children and adolescents with moderate-to-severe drooling. METHOD: This was a randomized, interventional, controlled trial in which 53 children and adolescents (31 males, 22 females, mean age 11y, range 8-22y, SD 2y 10mo) with cerebral palsy (58.5%) or other non-progressive developmental disorders (41.5%) were randomized to BoNT-A (n=26) or bilateral submandibular duct ligation (n=27). A parent questionnaire on the severity of drooling in specific positions and daily activities and the impact of drooling on daily life and care was filled out at baseline and 8 and 32 weeks posttreatment. RESULTS: Both BoNT-A and bilateral submandibular duct ligation had a positive effect on daily care, damage to electronic equipment and/or furniture, social interactions, and self-esteem. However, bilateral submandibular duct ligation had a significant greater and longer-lasting short- (8wks) and medium-term (32wks) effect on daily care, reducing damage to electronic devices, and improving social interactions and satisfaction with life in general. INTERPRETATION: This randomized controlled trial confirms reduced drooling by both BoNT-A and bilateral submandibular duct ligation, but provides new evidence on improved well-being through a reduction in drooling. Even though there is a greater risk of complications and morbidity after bilateral submandibular duct ligation, compared to BoNT-A there was a significantly greater and longer-lasting positive effect on most outcomes. What this paper adds Bilateral botulinum neurotoxin A (BoNT-A) and submandibular duct ligation had a positive effect on the well-being of individuals with moderate-to-severe drooling. Bilateral submandibular duct ligation had a greater effect on the impact of drooling during daily care than BoNT-A. Bilateral submandibular duct ligation reduced damage to electronic devices and improved social interactions and satisfaction with life.

Impact of optimizing diagnostic workup and reducing the time to treatment in head and neck cancer.

BACKGROUND: Timely and efficient diagnostic workup of patients with head and neck cancer (HNC) is challenging. This observational study describes the implementation of an optimized multidisciplinary oncological diagnostic workup for patients with HNC and its impact on diagnostic and treatment intervals, survival, costs, and patient satisfaction. METHODS: All patients with newly diagnosed HNC who underwent staging and treatment at the Radboud University Medical Center were included. Conventional workup (CW) in 2009 was compared with the fast-track, multidisciplinary, integrated care program, that is, optimized workup (OW), as implemented in 2014. RESULTS: The study included 486 patients with HNC (218 with CW and 268 with OW). The time-to-treatment interval was significantly lower in the OW cohort than the CW cohort (21 vs 34 days; P < .0001). The 3-year overall survival rate was 12% higher after OW (72% in the CW cohort vs 84% in the OW cohort; P = .002). After correction for confounders, the 3-year risk of death remained significantly lower in the OW cohort (hazard ratio, 1.73; 95% confidence interval, 1.14-2.63; P = .010). Total diagnostic costs were comparable in the 2 cohorts. The general satisfaction score, as measured with the Consumer Quality Index for Oncological Care, was significantly better in a matched OW group than the CW group (9.1 vs 8.5; P = .007). CONCLUSIONS: After the implementation of a fast-track, multidisciplinary, integrated care program, the time-to-treatment interval was significantly reduced. Overall survival and patient satisfaction increased significantly, whereas costs did not change. This demonstrates the impact and improved quality of care achieved by efficiently organizing the diagnostic phase of HNC management.

Submandibular duct ligation after botulinum neurotoxin A treatment of drooling in children with cerebral palsy.

AIM: To assess: (1) the effect on drooling of bilateral submandibular duct ligation as surgical therapy after the administration of submandibular botulinum neurotoxin A (BoNT-A) for excessive drooling and (2) the predictive value of treatment success with BoNT-A on treatment success after bilateral submandibular duct ligation. METHOD: This was a within-participant retrospective observational study in which 29 children with severe drooling (15 males, 14 females) received BoNT-A treatment at a mean age of 9 years 6 months (SD 2y 5mo), followed by bilateral submandibular duct ligation at a mean age of 10 years 11 months (SD 2y 4mo). Fifteen children were diagnosed with cerebral palsy (CP), with 12 children classified in Gross Motor Function Classification System levels IV and V. The 14 children without CP had non-progressive developmental disorders. The primary drooling severity outcomes were the Visual Analogue Scale (VAS; subjective assessment) and drooling quotient (objective assessment). Measurements were taken before each intervention and again at 8 and 32 weeks. RESULTS: The VAS was significantly lower after bilateral submandibular duct ligation at follow-up compared to BoNT-A treatment (mean difference -33, p≤0.001; 95% confidence interval [CI]=-43.3 to -22.9). The mean drooling quotient did not significantly differ between BoNT-A treatment and bilateral submandibular duct ligation at follow-up (3.3, p=0.457; 95% CI=-4.35 to 9.62) or between 8 and 32 weeks (4.7, p=0.188; 95% CI=-2.31 to 11.65). INTERPRETATION: BoNT-A treatment and bilateral submandibular duct ligation are both effective treatment modalities for drooling. At 32-week follow-up, subjective drooling severity after bilateral submandibular duct ligation was significantly lower compared to previous BoNT-A injections in participants. However, treatment success with BoNT-A is no precursor to achieving success with bilateral submandibular duct ligation. WHAT THIS PAPER ADDS: Bilateral submandibular duct ligation is an effective therapy for drooling after treatment with botulinum neurotoxin A (BoNT-A). Treatment success with BoNT-A is not a predictor of successful therapy with bilateral submandibular duct ligation.

Submandibular gland botulinum neurotoxin A injection for predicting the outcome of submandibular duct relocation in drooling: a retrospective cohort study.

AIM: This study evaluated whether the effect of submandibular gland botulinum neurotoxin A (BoNT-A) injection can predict the outcome of submandibular duct relocation with sublingual gland excision (SMDR) in children with drooling. Furthermore, we compared the effectiveness of both procedures. METHOD: A retrospective cohort study was performed in 42 children and adolescents (25 males, 17 females; mean [SD] age at BoNT-A injection 11y [4], range 4-20y; mean [SD] age at SMDR 15y [4], range 7-23y) with cerebral palsy or another non-progressive developmental disability who had undergone both BoNT-A injection and SMDR for drooling. Main outcomes were the drooling quotient and the visual analogue scale (VAS) on drooling severity at 8 weeks and 32 weeks follow-up. RESULTS: Failure or success of previous BoNT-A injections had no influence on success of consecutive SMDR. Relative change in main outcomes showed no significant relation between BoNT-A injection and SMDR for any follow-up measurement. After 8 weeks, SMDR was more successful than BoNT-A injection in diminishing VAS (VAS 80.0% vs 54.3%; drooling quotient 56.2% vs 51.0%). After 32 weeks, both drooling quotient (64.3% vs 29.5%) and VAS (75.7% vs 37.1%) showed significantly higher proportions of success for SMDR. INTERPRETATION: The effect of submandibular BoNT-A injection does not predict subsequent SMDR success in drooling. Furthermore, SMDR has a larger and longer-lasting positive effect on drooling than BoNT-A injections. WHAT THIS PAPER ADDS: Submandibular botulinum neurotoxin A (BoNT-A) injection effect does not predict submandibular duct relocation with sublingual gland excision outcome. Submandibular duct relocation is more effective and more permanent than BoNT-A injection.

INYECCIÓN DE NEUROTOXINA BOTULÍNICA A EN LA GLÁNDULA SUBMANDIBULAR PARA PREDECIR EL RESULTADO DE LA REUBICACIÓN DEL CONDUCTO SUBMANDIBULAR EN BABEO: UN ESTUDIO DE COHORTE RETROSPECTIVO: OBJETIVO: Este estudio evaluó si el efecto de la inyección de neurotoxina A botulínica submandibular (BoNT-A) puede predecir el resultado de la reubicación del conducto submandibular con escisión de la glándula sublingual (SMDR) en niños con babeo. Además, comparamos la efectividad de ambos procedimientos. MÉTODO: Se realizó un estudio de cohorte retrospectivo en 42 niños y adolescentes (25 varones, 17 mujeres; edad media [DE] en la inyección de BoNT-A 11 años [4], rango 4-20 años; edad media [SD] a SMDR 15 años [4] rango 7-23 años) con parálisis cerebral u otra discapacidad del desarrollo no progresiva que se haya sometido a una inyección de BoNT-A y SMDR para babear. Los resultados principales fueron el cociente de babeo y la escala analógica visual (VAS) en la severidad del babeo a las 8 semanas y 32 semanas de seguimiento. RESULTADOS: El fracaso o el éxito de las inyecciones anteriores de BoNT-A no tuvo influencia en el éxito de la SMDR consecutiva. El cambio relativo en los resultados principales no mostró una relación significativa entre la inyección de BoNT-A y SMDR para cualquier medición de seguimiento. Después de 8 semanas, SMDR fue más exitoso que la inyección de BoNT-A en la VAS disminuida (VAS 80,0% vs 54,3%; cociente de babeo 56,2% vs 51,0%). Después de 32 semanas, tanto el cociente de babeo (64,3% vs 29,5%) como el VAS (75,7% vs 37,1%) mostraron proporciones significativamente más altas de éxito para SMDR. INTERPRETACIÓN: El efecto de la inyección submandibular de BoNT-A no predice el éxito posterior de SMDR en el babeo. Además, el SMDR tiene un efecto positivo mayor y más duradero en el babeo que las inyecciones de BoNT-A.

INJEÇÃO DE NEUROTOXINA BOTULÍNICA NA GLÂNDULA SUBMANDIBULAR PARA PREDIÇÃO DO RESULTADO DA RELOCACÃO DO DUCTO SUBMANDIBULAR NA SIALORRÉIA: UM ESTUDO DE COORTE RETROSPECTIVO: OBJETIVO: Este estudo avaliou se o efeito da neurotoxina botulínica A (NTBo-A) na glândula submandibular pode predizer o resultado da relocação do ducto submandibular com excisão sublingual da glândula (RDSM) em crianças com sialorréia. Ainda, comparamos a efetividade de ambos os procedimentos. MÉTODO: Um estudo de coorte retrospectivo foi realizado em 42 crianças e adolescentes (25 do sexo masculino, 17 do sexo feminino; idade média [DP] no momento da injeção de NTBo-A 11a[4], variação de 4-20a; idade média [DP] no momento da RDSM 15a [4], variação de 7-23a) com paralisia cerebral ou outra desordem não-progressiva do desenvolvimento que passaram por injeção de NTBo-A e RDSM para sialorréia. Os principais desfechos foram o quociente de sialorréia e a escala visual análoga (EVA) sobre a severidade da sialorréia no acompanhamento de 8 e 32 semanas. RESULTADOS: A falha ou sucesso da NTBo-A prévia não teve influência no sucesso da RDSM consecutiva. A mudança relativa nos principais desfechos não mostrou nenhuma relação significativa entre a injeção de NTBo-A e a RDSM para nenhuma das medidas no acompanhamento. Após 8 semanas, a RDSM foi mais bem sucedida do que a NTBo-A na redução da EVA (EVA 80,0% vs 54,3%; quociente de sialorréia 56,2% vs 51,0%). Após 32 semanas, tanto o quociente de sialorréia (64,3% vs 29,5%) quanto a EVA (75,7% vs 37,1%) mostram proporções significativamente mais altas de sucesso para a RDSM. INTERPRETAÇÃO: O efeito da injeção submandibular de NTBo-A não prediz o sucesso da RDSM subsequente na sialorréia. Ainda, a RDSM tem efeito maior e mais duradouro na sialorréia do que injeções de NTBo-A.

Cost analysis of office-based transnasal esophagoscopy.

PURPOSE: Although office-based transnasal esophagoscopy has been investigated extensively, a cost analysis is still lacking. We performed a cost analysis combined with feasibility study for two diagnostic processes: patients with globus pharyngeus and/or dysphagia, and hypopharyngeal carcinoma. METHODS: Prospective cohort study. RESULTS: Forty-one procedures were performed, of which 35 were fully completed. The procedure was well tolerated with mild complaints such as nasal or pharyngeal pain and burping. Four complications occurred: two minor epistaxis and two vasovagal reactions. In patients with globus pharyngeus and/or dysphagia, transnasal esophagoscopy resulted in a cost saving of €94.43 (p 0.026) per procedure, compared to our regular diagnostic process. In patients with suspicion of hypopharyngeal carcinoma, cost savings were €831.41 (p 0.000) per case. CONCLUSIONS: Cost analysis showed that office-based transnasal esophagoscopy can provide significant cost savings for the current standard of care. Furthermore, this procedure resulted in good patient acceptability and few complications.

Office-based vs. operating room-performed laryngopharyngeal surgery: a review of cost differences.

PURPOSE: Office-based transnasal flexible endoscopic surgery under topical anesthesia has recently been developed as an alternative for transoral laryngopharyngeal surgery under general anesthesia. The aim of this study was to evaluate differences in health care costs between the two surgical settings. METHODS: PubMed, EMBASE and Cochrane Library were searched for studies reporting on costs of laryngopharyngeal procedures that could either be performed in the office or operating room (i.e., laser surgery, biopsies, vocal fold injection, or hypopharyngeal or esophageal dilation). Quality assessment of the included references was performed. RESULTS: Of 2953 identified studies, 13 were included. Quality assessment revealed that methodology differed significantly among the included studies. All studies reported lower costs for procedures performed in the office compared to those performed in the operating room. The variation within reported hospital and physician charges was substantial. CONCLUSION: Office-based laryngopharyngeal procedures under topical anesthesia result in lower costs compared to similar procedures performed under general anesthesia.

Effectiveness of submandibular duct relocation in 91 children with excessive drooling: A prospective cohort study.

OBJECTIVE: To evaluate the effectiveness of submandibular duct relocation (SMDR) in drooling children with neurological disorders. DESIGN: Prospective cohort study. SETTING: Academic Outpatient Saliva Control Clinic. PARTICIPANTS: Ninety-one children suffering from moderate to severe drooling. MAIN OUTCOME MEASURES: Direct observational drooling quotient (DQ; 0-100) and caretaker Visual Analogue Scale (VAS; 0-100). Secondary outcome measures were drooling severity (DS) and frequency rating scales. RESULTS: The DQ at baseline, 8 and 32 weeks postoperatively was 26.4, 12.3 and 10.8, respectively. VAS score decreased from 80.1 at baseline to 28.3 and 37.0 at 8 and 32 weeks after surgery. Median DS at baseline, 8 and 32 weeks was 5, 3 and 4, whereas the drooling frequency median scores were 4, 2 and 2, respectively. Five children required prolonged intubation due to transient floor of the mouth swelling, two of whom developed a ventilator-associated pneumonia. Another child developed atelectasis with postoperative pneumonia. Two more children needed tube feeding because of postoperative eating difficulties for 3 days or suprapubic catheterisation for urinary retention. Children aged 12 years or older (OR = 3.41; P = 0.03) and those with adequate stability and position of the head (OR = 2.84; P = 0.09) appeared to benefit most from treatment. CONCLUSIONS: Submandibular duct relocation combined with excision of the sublingual glands appears to be relatively safe and effective in diminishing visible drooling in children with neurological disorders, particularly in children aged 12 years and older and those without a forward head posture.

Safety of flexible endoscopic biopsy of the pharynx and larynx under topical anesthesia.

Recent advancements in transnasal endoscopy enable a shift in diagnostic workup of lesions in the pharynx and larynx, from an examination with biopsy under general anesthesia to an office-based examination with flexible endoscopic biopsy under topical anesthesia. Procedural complications were evaluated to assess the safety of office-based flexible endoscopic biopsy in patients with benign and malignant laryngopharyngeal lesions. Patients who underwent flexible endoscopic biopsy from 2012 to 2016 were evaluated retrospectively. Complications were classified using the Clavien-Dindo classification of surgical complications. A total of 201 flexible endoscopic biopsies were performed in 187 patients. Two Clavien-Dindo grade I (laryngospasm and anterior epistaxis), one grade II (laryngeal bleeding), and one grade IIIb (laryngeal edema) complication were observed. The first complication was self-limiting and the other three required an intervention. All patients fully recovered without sequelae. Flexible endoscopic biopsy appears to be a safe office-based procedure for the diagnosis of benign and malignant laryngopharyngeal lesions.

The when, why, and how of using glycopyrronium to diminish drooling in children with neurodevelopmental disabilities: Implications for clinical practice.

BACKGROUND: Despite the established efficacy of glycopyrronium bromide in reducing drooling among children with neurodevelopmental disabilities, evidence on its impact on the daily lives of children and parents and effectiveness in a real-world setting are scarce, especially among long-term users. This study explored timing and duration of glycopyrronium treatment, effect and impact on daily life, and occurrence of side effects to inform clinical practice. METHODS: This was a retrospective cohort study at a national referral centre for drooling, including 61 children with nonprogressive neurodevelopmental disabilities, treated with glycopyrronium for anterior and/or posterior drooling between 2011 and 2021. Data were obtained from medical records and supplemented by structured telephone interviews with parents. RESULTS: Anterior drooling severity decreased in 82% of the included children. Changes in the impact of drooling on burden of care, social interaction, and self-esteem were reported in 55%, 31%, and 36%, respectively. Side effects were noted for 71% of cases, yet only 36% of parents deemed these as outweighing the positive impact of treatment. A substantial majority (77%) of the included children were long-term users (≥6 months). Among these, 38% of parents reported decreasing effectiveness and 27% noticed more prominent side effects over time. CONCLUSIONS: Glycopyrronium demonstrated potential in mitigating the impact of drooling on daily life, although variations were observed in the specific aspects and extent of improvement. The real-world context of our study provides important insights for refining clinical practices, emphasizing the need for balanced consideration of treatment benefits and potential side effects to facilitate shared decision-making.

Pathology-based validation of FDG PET segmentation tools for volume assessment of lymph node metastases from head and neck cancer.

PURPOSE: FDG PET is increasingly incorporated into radiation treatment planning of head and neck cancer. However, there are only limited data on the accuracy of radiotherapy target volume delineation by FDG PET. The purpose of this study was to validate FDG PET segmentation tools for volume assessment of lymph node metastases from head and neck cancer against the pathological method as the standard. METHODS: Twelve patients with head and neck cancer and 28 metastatic lymph nodes eligible for therapeutic neck dissection underwent preoperative FDG PET/CT. The metastatic lymph nodes were delineated on CT (NodeCT) and ten PET segmentation tools were used to assess FDG PET-based nodal volumes: interpreting FDG PET visually (PETVIS), applying an isocontour at a standardized uptake value (SUV) of 2.5 (PETSUV), two segmentation tools with a fixed threshold of 40% and 50%, and two adaptive threshold based methods. The latter four tools were applied with the primary tumour as reference and also with the lymph node itself as reference. Nodal volumes were compared with the true volume as determined by pathological examination. RESULTS: Both NodeCT and PETVIS showed good correlations with the pathological volume. PET segmentation tools using the metastatic node as reference all performed well but not better than PETVIS. The tools using the primary tumour as reference correlated poorly with pathology. PETSUV was unsatisfactory in 35% of the patients due to merging of the contours of adjacent nodes. CONCLUSION: FDG PET accurately estimates metastatic lymph node volume, but beyond the detection of lymph node metastases (staging), it has no added value over CT alone for the delineation of routine radiotherapy target volumes. If FDG PET is used in radiotherapy planning, treatment adaptation or response assessment, we recommend an automated segmentation method for purposes of reproducibility and interinstitutional comparison.

Postoperative Airway Management after Submandibular Duct Relocation in 96 Drooling Children and Adolescents.

The aim of this study was to evaluate our institutions airway management and complications after submandibular duct relocation (SMDR). We analysed a historic cohort of children and adolescents who were examined at the Multidisciplinary Saliva Control Centre between March 2005 and April 2016. Ninety-six patients underwent SMDR for excessive drooling. We studied details of the surgical procedure, postoperative swelling and other complications. Ninety-six patients, 62 males and 34 females, were treated consecutively by SMDR. Mean age at time of surgery was 14 years and 11 months. The ASA physical status was 2 in most patients. The majority of children were diagnosed with cerebral palsy (67.7%). Postoperative swelling of the floor of the mouth or tongue was reported in 31 patients (32.3%). The swelling was mild and transient in 22 patients (22.9%) but profound swelling was seen in nine patients (9.4%). In 4.2% of the patients the airway was compromised. In general, SMDR is a well-tolerated procedure, but we should be aware of swelling of the tongue and floor of the mouth. This may lead to a prolonged period of endotracheal intubation or a need for reintubation which can be challenging. After extensive intra-oral surgery such as SMDR we strongly recommend a extended perioperative intubation and extubation after the airway is checked and secure.

Prioritizing parotid gland surgery: A call for the implementation of the MSRSGC classification.

BACKGROUND: The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) is developed to aid diagnosis and management of salivary gland tumors. This study evaluates the time-to-treatment initiation (TTI) for parotid gland tumors in the Netherlands and relates these to the MSRSGC classification. Subsequently, the use of the MSRSGC in the Netherlands is evaluated. METHODS: Data regarding fine-needle aspiration cytology (FNAC) and histopathological resections of the parotid were gathered from the Dutch nationwide pathology data bank (PALGA). The TTI was calculated for each MSRSGC category and type of treating center. FNACs performed from 2018 to 2021 were gathered from PALGA to estimate how frequently the MSRSGC classification was applied. RESULTS: Median TTI in days were 86 for nondiagnostic (MSRSGC I), 75 for nonneoplastic (MSRSGC II), 65 for atypia of unknown significance (AUS) (MSRSGC III), 89 for benign (MSRSGC IVa), 52 for salivary gland neoplasm of unknown malignant potential (SUMP) (MSRSGC IVb), 31 for suspected malignant (MSRSGC V), and 30 for malignant (MSRSGC VI) categories. Significant variation in the TTI between the types of treating centers was found for the nondiagnostic, nonneoplastic, AUS, SUMP, and suspected malignant categories. In the first 3 years after the introduction of the MSRSGC, the pathologist stated the MSRSGC classification in 6.4% of all reports. CONCLUSIONS: The median TTI for most categories is long, and there is significant interhospital variation in TTI. Preoperative risk stratification and treatment prioritization in parotid gland surgery in the Netherlands should be improved. The MSRSGC could contribute to this. Until 2021, the MSRSGS classification was implemented on a limited scale in the Netherlands.

Long-term effects of submandibular gland excision on drooling in children with neurodevelopmental disorders: A cross-sectional study.

AIM: Submandibular gland excision (SMGE) is suitable for the management of drooling in patients with non-progressive neurodisabilities. We aimed to investigate the long-term effects of SMGE. METHOD: Patients who had SMGE between 2007 and 2018 were included. Main outcomes were a Visual Analogue Scale (VAS), Drooling Severity (DS), and Drooling Frequency (DF) collected at baseline, 8 weeks, 32 weeks and with a median of 313 weeks after SMGE (long-term). Secondary outcomes were satisfaction with the procedure, Drooling Quotient (DQ) and adverse events (AEs). RESULTS: We included thirty-five patients in the long-term analysis with a mean age of 14.5 years. A baseline VAS score of 80.4 was found, which improved on the long-term (mean difference -21.8, t(26) = 4.636, p < 0.0005)). DS and DF decreased significantly at the long-term compared to baseline (Z = -4.361, p < 0.0001 for DS, Z = -3.065, p = 0.002 for DF). Twenty-three out of 35 (66%) patients would recommend the procedure to peers. INTERPRETATION: This study indicates a long-term stable effect on drooling after SMGE in patients with anterior drooling. Recurrence of drooling occurs due to unknown reasons, nevertheless most caregivers and/or patients are still satisfied and would recommend the procedure to others.

Virtues in Competency-Based Assessment Frameworks: A Text Analysis.

Introduction: Official documentation of specialty training provides comprehensive and elaborate criteria to assess residents. These criteria are commonly described in terms of competency roles and entrustable professional activities (EPA's), but they may also implicitly encompass virtues. Virtues are desirable personal qualities that enable a person, in this case, a medical specialist, to make and act on the right decisions. We articulate these virtues and explore the resulting implied ideal of a medical professional. Method: We applied a two-staged virtue ethical content analysis to analyze documents, specific to the Dutch training program of the Ear, Nose, and Throat (ENT) specialty. First, we identified explicit references to virtues. Next, we articulated implicit virtues through interpretation. The results were categorized into cardinal, intellectual, moral, and professional virtues. Results: Thirty virtues were identified in the ENT- training program. Amongst them, practical wisdom, temperance, and commitment. Furthermore, integrity, curiosity, flexibility, attentiveness, trustworthiness and calmness are often implicitly assumed. Notable findings are the emphasis on efficiency and effectiveness. Together, these virtues depict an ideal of a future medical specialist. Conclusion: Our findings suggest that competency-frameworks and EPA's implicitly appeal to virtues and articulate a specific ideal surgeon. Explicit attention for virtue development and discussion of the role and relevance of implied ideal professionals in terms of virtues could further improve specialty training.

Validation of the Milan System for Reporting Salivary Gland Cytopathology and the diagnostic accuracy of FNA cytology for submandibular gland lesions.

BACKGROUND: The Milan System for Salivary Gland Cytopathology (MSRSGC) is a categorical system for salivary gland fine-needle aspiration cytopathology (FNAC) developed to aid clinicians in the management of salivary gland lesions. This classification is widely studied and validated, especially in cohorts that consist of mostly parotid gland lesions. However, only sparse literature describes the use of this classification for submandibular gland lesions in particular. METHODS: All patients in the Netherlands that underwent a submandibular gland resection between January 1, 2006, and January 1, 2017, with a FNAC before resection were identified with the use of the Dutch Pathology Registry database (PALGA). All FNAC results were retrospectively classified according to the MSRSGC. The risk of malignancy was calculated for all the MSRSGC categories. The sensitivity and specificity of the MSRSGC classification were calculated for submandibular gland FNAC. RESULTS: A total of 837 patients who underwent 975 FNAC aspirates from the submandibular glands were included in the analysis. Risks of malignancy for each of the MSRSGC categories were 14.4% in nondiagnostic, 4.4% in nonneoplastic, 37.0% in atypia of unknown significance, 3.9% in benign neoplasms, 40.7% in salivary gland neoplasms of unknown malignant potential, 76.2% in suspected malignant, and 91.3% in malignant cytology results. The sensitivity for diagnosing malignant submandibular gland tumors was 71.6% and specificity was 98.4%. CONCLUSIONS: The results of the present study validate the use of this classification for submandibular gland lesions. Risks of malignancy vary according to the anatomical subsites of the salivary gland lesions. LAY SUMMARY: The risks of malignancy of the various Milan System for Salivary Gland Cytopathology (MSRSGC) categories vary according to the anatomical subsite of the salivary gland lesion. The proposed management techniques of the MSRSGC are valid for use with submandibular gland lesions.

Flexible Endoscopic Biopsy: Identifying Factors to Increase Accuracy in Diagnosing Benign and Malignant Laryngopharyngeal Pathology.

OBJECTIVES: To assess the influence that several factors, such as the amount of obtained biopsies, difficult procedures, biopsy site and the experience of the attending physician, have on accuracy of flexible endoscopic biopsy (FEB). MATERIALS AND METHODS: 203 FEB procedures for benign or malignant laryngopharyngeal lesions were prospectively included. During the procedure, three representative biopsies (macroscopically containing vital tumor tissue and not only necrosis or healthy tissue) were obtained. The accuracy of each biopsy was separately analyzed. Difficulties during the procedures leading to failure of acquiring three representative biopsies were recorded and classified into tumor, patient and procedural factors. Histological results of FEB were defined correct when consistent with clinical context, additional biopsies or Positron emission tomography-computed tomography (PET-CT) revealed equivalent pathology, or the lesion was stable or resolved in >6 months follow-up. RESULTS: The first representative biopsy yielded a correct diagnosis in 65% of the cases. After the second representative biopsy, 78% was correctly diagnosed. The contribution of the third and fourth representative biopsies to accuracy was 3%. The overall accuracy of FEB was 85%. Difficult procedures were more likely to result in misdiagnosis, whereas biopsy site or experience of the attending physician did not influence results. CONCLUSIONS: FEB was accurate in diagnosing laryngopharyngeal lesions when at least two representative biopsies were obtained. Accuracy of FEB could be further improved by limiting possible constraints during the procedures, for example by selecting, informing, and anesthetizing patients carefully.