Surgical rescue for persistent head and neck cancer after first-line treatment.

PURPOSE: Surgical rescue is a treatment option for persistent disease after first-line treatment treatment of head and neck cancer (HNC). METHODS: Patients with persistent HNC treated with rescue surgery between 2008 and 2016 were included. Patients who received a rescue neck dissection (ND only) and who received primary site surgery ± ND were analysed separately (primary site surgery ± ND). RESULTS: During the observation period, 35 patients received ND only and 17 primary site surgery ± ND. No perioperative mortality was observed. In nine patients with ND only and 12 patients with primary site surgery ± ND at least one complication was encountered. 41/52 (79%) patients had a complete response. Median overall survival of patients receiving rescue surgery was 56 months (95% CI 44-69 months). Median overall survival was best for patients with initial laryngeal and oropharyngeal cancer and worst for patients with hypopharyngeal cancer (p = 0.02). Functional deficits following rescue surgery were mainly observed in the domains speech, nutrition, and shoulder/arm mobility. The risk of functional impairment was higher for patients with rescue surgery at the primary tumor site (OR 2.5 ± 2; p = 0.07). CONCLUSION: Rescue surgery offers patients with resectable, persistent disease a realistic chance to achieve long-term survival. Especially patients with laryngeal and oropharyngeal cancer profited from rescue surgery. Rescue neck dissection is an effective and safe procedure. Patients with rescue surgery at the primary tumor site ± ND should expect complications and permanent functional impairment.

The SNOT-22 factorial structure in European patients with chronic rhinosinusitis: new clinical insights.

PURPOSE: The sino-nasal outcomes test-22 (SNOT-22) represents the reference questionnaire to assess patients with chronic rhinosinusitis (CRS). As weak correlations between objective CRS parameters and SNOT-22 total score have been observed, factor analyses have aimed to identify underlying factorial structures. However, ambiguous factor loadings and problematic item-domain assignments have resulted. Moreover, such factor analyses have mainly been performed in non-European CRS patients, while European data remain sparse. This study thus sought to address these issues. METHODS: Principal component analysis and confirmatory factor analysis were performed from SNOT-22 questionnaires completed by European CRS patients. Goodness of fit, internal consistencies, and factor loadings were calculated. Item-domain assignment was based on statistical grounds and clinical meaningfulness. Additionally, this study investigated correlations between SNOT-22 domains and external reference criteria, including Lund-Mackay score, Lund-Naclerio score and the brief symptom inventory 18 (BSI-18). RESULTS: One hundred and thirty-four European CRS patients were included. Principal component analysis proposed four SNOT-22 domains ("nasal symptoms", "otologic symptoms", "sleep symptoms", "emotional symptoms"), which explained 63.6% of variance. Observed item-domain-assignment differed from previously proposed item-domain assignments. All factor loadings were > 0.5, except "cough" (0.42) and "facial pain or pressure" (0.49). For confirmatory factor analysis, satisfactory goodness of fit (RMSEA = 0.66; CFI = 0.92; TLI = 0.90) and internal consistencies (Cronbach-α: total score = 0.93; domains = 0.75-0.91) were observed. Significant positive correlations were found between the "nasal symptoms" domain and both the Lund-Mackay score (r = 0.48; p < 0.001) and the Lund-Naclerio score (r = 0.27, p < 0.01). Significant positive correlations were also identified between "emotional symptoms" and BSI-18 total score (r = 0.64, p < 0.001). CONCLUSIONS: Principal component analysis performed for SNOT-22 questionnaires completed by European CRS patients indicated a different item-domain-assignment than previously reported. Confirmatory factor analysis suggested acceptable and clinically plausible psychometric properties for the resulting factorial structure. Significant correlations between the "nasal symptoms" and the "emotional symptoms" domains were observed with objective CRS parameters. The resulting factorial structure with different item-domain assignments may thus be more suitable for European CRS patients.

Tavipec in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial.

BACKGROUND: This randomized clinical trial was designed to evaluate the efficacy and safety of Tavipec® (Spicae aetheroleum), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients suffering from acute viral rhinosinusitis. METHODOLOGY: Patients with acute viral rhinosinusitis were randomly assigned to treatment with 2 capsules Tavipec® 150 mg or placebo thrice daily over a period of 7 days in a double-blind, parallel-group design. No additional treatment was admitted. The efficacy endpoints comprised the improvement of the main rhinosinusitis symptoms as per Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) as well as of quality of life (QoL) by global assessment scale, evaluated at baseline, day 5 and day 8, respectively. RESULTS: 288 patients were enrolled and randomized to treatment. At day 8 the patients in the Tavipec® group had a significantly lower MSS compared to placebo and the impact of rhinosinusitis symptoms on QoL was significantly reduced. A significantly higher proportion of Tavipec® treated patients experienced a change in SNOT-22 score greater than or equal to 10 points at day 5 or day 8. No new safety signals were identified. CONCLUSIONS: The treatment with Tavipec® effectively reduced the symptoms of acute rhinosinusitis in adult patients.

EAACI Position paper on the standardization of nasal allergen challenges.

Nasal allergen challenge (NAC) is an important tool to diagnose allergic rhinitis. In daily clinical routine, experimentally, or when measuring therapeutic success clinically, nasal allergen challenge is fundamental. It is further one of the key diagnostic tools when initiating specific allergen immunotherapy. So far, national recommendations offered guidance on its execution; however, international divergence left many questions unanswered. These differences in the literature caused EAACI to initiate a task force to answer unmet needs and find a consensus in executing nasal allergen challenge. On the basis of a systematic review containing nasal allergen challenges of the past years, task force members reviewed evidence, discussed open issues, and studied variations of several subjective and objective assessment parameters to propose a standardized way of a nasal allergen challenge procedure in clinical practice. Besides an update on indications, contraindications, and preparations for the test procedure, main recommendations are a bilaterally challenge with standardized allergens, with a spray device offering 0.1 mL per nostril. A systematic catalogue for positivity criteria is given for the variety of established subjective and objective assessment methods as well as a schedule for the challenge procedure. The task force recommends a unified protocol for NAC for daily clinical practice, aiming at eliminating the previous difficulty of comparing NAC results due to unmet needs.

Intratympanic steroid use for idiopathic sudden sensorineural hearing loss: current otolaryngology practice in Germany and Austria.

AIMS: The frequency of the use of intratympanic steroids (ITS) as a treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) in Europe is still unknown and remains a contentious issue amongst otolaryngologists. We undertook a survey of otolaryngologists in Germany and Austria to establish if there is any professional consensus with which to form a protocol for its use. METHODS: A survey of 21 questions was distributed electronically to otolaryngologists in Germany and Austria and data on demographics, indications for intratympanic treatment, procedure, follow-up, and outcomes were analysed. RESULTS: We received 908 responses. 49.1% of otolaryngologists used ITS for ISSNHL. Of those otolaryngologists who use ITS, 73.7% do not use it as primary treatment. 20.6% use ITS in conjunction with oral steroids for primary treatment and only 5.8% use ITS as monotherapy for primary treatment. 90.5% use ITS as salvage therapy. 81.1% do not consider the use of ITS after 2 weeks from the onset of symptoms. 8.3% used a tympanostomy tube and while the most commonly used steroid was dexamethasone at a concentration of 4 mg/ml (61%), a wide variety or other steroids and concentrations were used. CONCLUSIONS: This survey illustrates wide variation of current practice of intratympanic corticosteroid injection for ISSHL in Germany and Austria. In the absence of high-level evidence, knowing what current practice is allows clinicians to assess what they do against what their colleagues are doing, and if they do something very different, make them question their practice. Moreover, the obtained data will help to direct future clinical trials with the aim to compare the outcomes of more commonly used protocols.

mySinusitisCoach: patient empowerment in chronic rhinosinusitis using mobile technology.

Mobile health technology is emerging to take a prominent position in the management of chronic diseases. These technologies aim at enhancing patient empowerment via education and self-management. To date, of all the different apps available for patients with sinus disease, none were developed by medical experts dealing with chronic rhinosinusitis (CRS). The European Forum for Research and Education in Allergy and Airway diseases (EUFOREA) has undertaken a multi-stakeholder approach for designing, developing and implementing a tool to support CRS patients in monitoring their symptoms and to provide patients with a digital support platform containing reliable medical information about their disease and treatment options. mySinusitisCoach has been developed by medical experts dealing with CRS in close collaboration with patients, primary care physicians and community pharmacists, meeting the needs of both patients and health care providers. From a research perspective, the generation of real life data will help to validate clinical studies, patient stratification and improve understanding of the socio-economic impact of CRS, thereby paving the way for better treatment strategies.

A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients.

BACKGROUND: The safety and tolerability of a mite allergoid subcutaneous allergen immunotherapy (SCIT) product was previously established. The aim of this study (EudraCT number: 2011-000393-61) was to find the optimally safe and effective allergoid dose by evaluating several dosages in patients with house dust mite (HDM)-induced allergic rhinoconjunctivitis (ARC) using a titrated nasal provocation test (TNPT). METHODS: In total, 290 adult ARC patients (148 females; 142 males) with established HDM allergy and with a positive TNPT were randomized to receive placebo or mite allergoid SCIT 6667, 20 000, 50 000 or 100 000 AUeq/ml for 12 months. Patients were updosed weekly, followed by monthly maintenance dosing. The primary study endpoint comprised the clinical response to TNPT after 12 months of treatment. Secondary endpoints included response to TNPT after 6 months, PNIF measurements, symptom and medication scores during the last 8 weeks of treatment, serum immunoglobulins and safety assessments. RESULTS: After 12 months, a dose-response was observed showing statistically significant improvements in the TNPT with SCIT concentrations of ≥20 000 AUeq/ml, while no significantly different outcomes were reached after 6 months. Specific serum IgG and IgG4 levels were dose dependently increased. In the highest dose group, more treatment-emergent adverse events were observed compared with the lower dose groups. CONCLUSION: In this mite allergoid SCIT dose finding study in HDM-induced ARC, concentrations of ≥20 000 AUeq/ml showed both immunological effects and clinical efficacy in the TNPT compared with placebo. The risk-benefit ratio favours 20 000 AUeq/ml and 50 000 AUeq/ml strengths for further clinical development.

Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common health problem. If medical treatment fails, endonasal sinus surgery is a valuable treatment option. A thorough postsurgical treatment is needed including, among others, nasal saline irrigations (NSI). In this prospective, controlled, single blinded, randomized trial, we aimed to evaluate efficacy of nasal saline irrigations following endonasal sinus surgery in CRS-patients with nasal polyps. METHODOLOGY: We examined patient's nasal symptoms, general quality of life and postoperative condition of the mucosa. We also investigated whether or not NSI reduced the number of missed workdays after surgery (MWD). Patients were randomized into an irrigation and non-irrigation arm. RESULTS: Following treatment, mean nasal sum-score in the irrigation arm was 4.4 and in the non-irrigation arm it was 6.3. Accordingly, mean general sum-score in the irrigation arm was 2.5 and in the non-irrigation arm 4.8. Thus, nasal irrigation led to a more pronounced improvement of nasal and general symptoms than in the non-irrigation arm. No differences were observed in postoperative condition of mucosa or number of MWD. CONCLUSIONS: Nasal irrigation improves symptoms score after ESS in patients with CRSwNP.

[Presbycusis - Age Related Hearing Loss]. / Presbyakusis - Altersschwerhörigkeit.

Presbycusis or age related hearing loss can be defined as a progressive, bilateral and symmetrical sensorineural hearing loss due to age related degeneration of inner ear structures. It can be considered a multifactorial complex disorder with environmental and genetic factors. The molecular, electrophysiological and histological damage at different levels of the inner ear cause a progressive hearing loss, which usually affects the high frequencies of hearing. The resulting poor speech recognition has a negative impact on cognitive, emotional and social function in older adults. Recent investigations revealed an association between hearing impairment and social isolation, anxiety, depression and cognitive decline in elderly. These findings emphasize the importance of diagnosis and treating hearing loss in the elderly population. Hearing aids are the most commonly used devices for treating presbycusis. The technical progress of implantable hearing devices allows an effective hearing rehabilitation even in elderly with severe hearing loss. However, most people with hearing impairments are not treated adequately.

[Actinic Keratosis]. / Aktinische Keratose.

Actinic keratosis is a cutaneous lesion characterized by proliferation of atypical epidermal keratinocytes due to prolonged exposure to exogenous factors such as ultraviolet radiation. AKs are in-situ-squamous cell carcinomas (PEC) of the skin. AK typically presents as erythematous, scaly patch or papule (classic AK), occasionally as thick, adherent scale on an erythematous base. Mostly fair-skinned adults are affected. AKs typically occur in areas of frequent sun exposure (balding scalp, face, "H-region", lateral neck, décolleté, dorsum of the hand and lower extremities). Actinic Cheilitis is the term used for AKs appearing on the lips. The diagnosis of AK is based on clinical examination including inspection and palpation. The typical palpable rough surface of AK often precedes a visible lesion. Dermoscopy may provide additional information. If diagnosis is uncertain and invasion suspected, biopsy and histopathologic evaluation should be performed. The potential for progression to invasive PECs mandates therapeutic intervention. Treatment options include topical and systemic therapies. Topical therapies are classified into physical, medical and combined physical-chemical approaches and a sequential combination of treatment modalities is possible. Topical-physical cryotherapy is the treatment of choice for isolated, non-hypertrophic AK. Topical-medical treatment, e. g. 5-fluoruracil (5FU) cream or Imiquomod or Ingenolmebutat application is used for multiple, non-hypertrophic AKs. For hypertrophic AKs, a dehorning pretreatment with salicinated vaseline is recommended. Isolated hypertrophic AKs often need cryotherapy with prolonged freezing time or several consecutive applications. Sequentially combined approaches are recommended for multiple, hypertrophic AKs. Photodynamic therapy (PDT) as example for a combined physical-chemical approach is an established treatment for multiple, non-hypertrophic and hypertrophic AKs. Prevention includes avoidance of sun and application of sunscreen with high sun protection factor. Regular clinical checkups aid in early recognition of AKs.

Rac1 as a potential therapeutic target for chemo-radioresistant head and neck squamous cell carcinomas (HNSCC).

BACKGROUND: In order to improve therapy for HNSCC patients, novel methods to predict and combat local and/or distant tumour relapses are urgently needed. This study has been dedicated to the hypothesis that Rac1, a Rho GTPase, is implicated in HNSCC insensitivity to chemo-radiotherapy resulting in tumour recurrence development. METHODS: Parental and radiation-resistant (IRR) HNSCC cells were used to support this hypothesis. All cells were investigated for their sensitivity to ionising radiation and cisplatin, Rac1 activity, its intracellular expression and subcellular localisation. Additionally, tumour tissues obtained from 60 HNSCC patients showing different therapy response were evaluated for intratumoral Rac1 expression. RESULTS: Radiation-resistant IRR cells also revealed resistance to cisplatin accompanied by increased expression, activity and trend towards nuclear translocation of Rac1 protein. Chemical inhibition of Rac1 expression and activity resulted in significant improvement of HNSCC sensitivity to ionising radiation and cisplatin. Preclinical results were confirmed in clinical samples. Although Rac1 was poorly presented in normal mucosa, tumour tissues revealed increased Rac1 expression. The most pronounced Rac1 presence was observed in HNSCC patients with poor early or late responses to chemo-radiotherapy. Tissues taken at recurrence were characterised not only by enhanced Rac1 expression but also increased nuclear Rac1 content. CONCLUSIONS: Increased expression, activity and subcellular localisation of Rac1 could be associated with lower early response rate and higher risk of tumour recurrences in HNSCC patients and warrants further validation in larger independent studies. Inhibition of Rac1 activity can be useful in overcoming treatment resistance and could be proposed for HNSCC patients with primary or secondary chemo-radioresistance.

[Chronic Rhinosinusitis - EPOS 2012 Part I]. / Chronische Rhinosinusitis - EPOS 2012 Teil I.

An expert group of the European Academy of Allergy and Clinical Immunology (EAACI) and the European Rhinologic Society (ERS) has recently published the revised position paper for acute and chronic rhinosinusitis (EPOS 2012). In the following article, the most important aspects of the EPOS 2012 paper concerning chronic rhinosinusitis (CRS) are referenced. Every 10th European is suffering from a chronic inflammation of the nose and paranasal sinuses.2 EPOS key messages according CRS are: 1. CRS is an inflammatory disease, not an infection. 2. CRS comes in 2 different subtypes, namely CRS without polyps (CRSsNP) and CRS with polyps (CRSwNP). CRSwNP is diagnosed, when nasal polyps are visible at an appropriate nasal endoscopic examination. Otherwise CRSsNP is classified. In the EPOS 2012 paper the current pathogenetic knowledge of these 2 different CRS subtypes are discussed. Current research focuses on epithelial/immune cell interactions, the biofilm hypothesis and the superantigen hypothesis. Both CRS subtypes may be associated with different frequencies with other diseases, especially allergies, asthma and aspirin exacerbated respiratory disease (AERD). These comorbidities should be recorded and treated. The standard diagnostic procedures include medical history, nasal endoscopy, CT-scans of the paranasal sinus, and allergy test of common inhalant allergens. The classification of disease severity in mild, moderate and severe was complemented with a concept of symptom control in controlled, partly controlled and uncontrolled. Also, a 'difficult-to-treat-CRS' was defined. The choice of therapy depends upon symptom intensity. In patients with moderate and severe symptoms, usually several weeks of conservative treatment including topical steroids are administered. In non-responders, surgical treatment (functional endonasal sinus surgery) is indicated. The EPOS Group offers evidence-based treatment algorithms for general practitioners and ENT-specialists.

[Acute rhinosinusitis in adults--EPOS 2012 Part II]. / Akute Rhinosinusitis bei Erwachsenen--EPOS 2012 Teil II.

Rhinosinusitis (RS) is an inflammatory disorder of the mucous membranes of the nose and paranasal sinuses, which are almost always affected concurrently. The EPOS2012 position paper initiated by the European Rhinologic Society and the European Academy of Allergy and Clinical Immunology is a recent comprehensive source on this common disease affecting approximately 20% of the population worldwide. Inflammation, not infection, is considered the cornerstone of RS, which is considered a temporal and pathophysiologic disease continuum with various subtypes. Acute rhinosinusitis is diagnosed, if typical symptoms last less than 12 weeks. It affects approximately 10% of the European population. Acute RS is further subdivided into acute viral, acute postviral and acute bacterial RS. Acute viral RS lasts less than 10 days with decreasing symptom intensity, while acute postviral RS is characterized by longer duration or a sudden increase of symptom severity around the 5th day ('double sickening'). Acute bacterial RS is assumed if 3 of the following 5 criteria are additionally met: Discoloured discharge (with unilateral predominance), severe local pain (with unilateral predominance), fever (>38ºC), elevated ESR/CRP, and 'double-sickening'. For the treatment of acute viral RS, nasal saline irrigations and OTC cold remedies are advised. In acute postviral RS, additional topical steroids are suggested. Advantages and disadvantages of antibiotic treatment in acute bacterial RS are detailed. Overall, the new EPOS position paper infers a reorientation in this area of high medical, pharmaceutical and economic relevance.

Optical and electromagnetic tracking for navigated surgery of the sinuses and frontal skull base.

BACKGROUND: New hardware and software algorithms in electromagnetic tracking for computer assisted surgery (CAS) have been developed. We aimed to compare electromagnetic tracking for navigated procedures in frontal skull base surgery to optical tracking. METHODS: Target registration error (TRE) was determined in 6 anatomic specimens in an experimental wet-lab. As targets, 6 titanium screws were evenly distributed over the surgical areas of interest from the frontal sinus to the clivus. Optical tracking and electromagnetic tracking was evaluated in identical software environment using a last generation commercially available navigation system. RESULTS: Submillimetric application accuracy could be achieved with both tracking modalities. Optical was more accurate than electromagnetic tracking and its reliability was better. Target position did not influence TRE, however TRE varied significantly from skull to skull. CONCLUSIONS: Although less accurate than optical tracking, electromagnetic tracking still offers excellent accuracy and reliability for anterior skull base surgery. Electromagnetic tracking is not dependent on direct line of sight between its hardware components and therefore easily integrated even in cluttered operating theatres.

[Hypopharyngeal carcinoma and red ear drum]. / Hypopharynxkarzinom und gerötetes Trommelfell.

A 46-year-old male patient with an unresectable hypopharyngeal carcinoma was treated with primary radio-chemotherapy. At follow-up, the patient presented with a red ear drum and combined hearing loss. Because of radiotherapy-induced tubal dysfunction, paracentesis was performed. Biopsy of the polypoid middle ear mucosa revealed petrous bone infiltration of hypopharyngeal carcinoma. MRI studies revealed paracarotideal tumor infiltration to the petrous bone and the middle ear arising from a cervical retropharyngeal lymph node metastasis.

[Fungal sinusitis]. / Pilzsinusitis.

The incidence of fungal sinusitis is subjected to significant geographical variation. Basically, invasive and non-invasive fungal sinusitis is distinguished. Invasive fungal sinusitis is observed mainly in immunocompromised hosts. The diagnopsis is based on positive fungus detection combined with characteristic clinical features. The treatment of invasive fungal sinusitis is based on surgical debridement and systemic antifungal therapy. Non-invasive fungal sinusitis is either treated with surgery alone or surgery combined with systemic steroid therapy. The majority of studies showed no benefit of postoperative antimycotic medical treatment in patients with non-invasive fungal sinusitis.

[The learning curve of registration in navigated skull base surgery]. / Lernkurve bei der Registrierung navigierter Eingriffe an der Schädelbasis.

BACKGROUND: Computer aided surgery (CAS) is advantageous in challenging procedures in head and neck surgery. It is not clear, if the application of CAS has to be trained to achieve reliable results. The learning curve of the registration of the patient's coordinates to prior acquired radiologic imagery was investigated. MATERIAL AND METHODS: 4 residents performed pair-point registrations on 5 anatomic specimens in an experimental wet lab. The residents were in the same year of education and had no experience in CAS procedures. After each registration the application error was evaluated by determining the target registration error (TRE). Pair point matching by skin glued external fiducials was compared with pair point matching by internal anatomical landmarks. RESULTS: The application accuracy was improved by increasing numbers of performed registrations (p<0.001, trendtest of Page). An inverse trend of the learning curve could be observed, the median TRE values improved from 3.3 mm in the first registration to 1.6 mm after the fifth registration. In comparison e. g. an experienced CAS-user can achieve submillimetric TRE values under wet lab conditions. Pair point matching by anatomical landmarks resulted in worse application accuracy initially and the learning curve was steeper than with external fiducial markers. CONCLUSION: There is a training effect in CAS interventions. Pair point matching results in sufficient application accuracy after training only.

Pre-surgery planning tool for estimation of resection volume to improve nasal breathing based on lattice Boltzmann fluid flow simulations.

PURPOSE: State-of-the-art medical examination techniques (e.g., rhinomanometry and endoscopy) do not always lead to satisfactory postoperative outcome. A fully automatized optimization tool based on patient computer tomography (CT) data to calculate local pressure gradient regions to reshape pathological nasal cavity geometry is proposed. METHODS: Five anonymous pre- and postoperative CT datasets with nasal septum deviations were used to simulate the airflow through the nasal cavity with lattice Boltzmann (LB) simulations. Pressure gradient regions were detected by a streamline analysis. After shape optimization, the volumetric difference between the two shapes of the nasal cavity yields the estimated resection volume. RESULTS: At LB rhinomanometry boundary conditions (bilateral flow rate of 600 ml/s), the preliminary study shows a critical pressure gradient of -1.1 Pa/mm as optimization criterion. The maximum coronal airflow ΔA  := cross-section ratio [Formula: see text] found close to the nostrils is 1.15. For the patients a pressure drop ratio ΔΠ  := (pre-surgery - virtual surgery)/(pre-surgery - post-surgery) between nostril and nasopharynx of 1.25, 1.72, -1.85, 0.79 and 1.02 is calculated. CONCLUSIONS: LB fluid mechanics optimization of the nasal cavity can yield results similar to surgery for air-flow cross section and pressure drop between nostril and nasopharynx. The optimization is numerically stable in all five cases of the presented study. A limitation of this study is that anatomical constraints (e.g. mucosa) have not been considered.

Assessment of health-related quality-of-life in patients with chronic Rhinosinusitis - Validation of the German Sino-Nasal Outcome Test-22 (German-SNOT-22).

PURPOSE: The Sino-Nasal-Outcome-Test-22 (SNOT-22) represents the reference questionnaire to assess symptoms, health-related quality-of-life (HRQOL) and treatment-response in patients with chronic rhinosinusitis (CRS). The SNOT-22 has been validated for various languages, yet no validation is available for the German version. Thus, we provide a validation of the SNOT-22 for German. METHODS: In this prospective observational study 139 CRS-patients and 36 control-participants were included. CRS-patients completed the German-SNOT-22 before treatment (T0) and four (T1), twelve (T2) and 48 weeks after inclusion (T3). At T0, Mackay-Naclerio-, Lund-Mackay- and Brief-Symptom-Inventory-18 (BSI-18) scores were collected as external reference for the German-SNOT-22 and its subscales. At T1, T2, and T3 health-transition-items (HTIs) were raised to explore responsivity. Control-participants completed the German-SNOT-22 at T0. Reliability (internal consistency, item-total correlation), validity (concurrent validity, discriminatory validity) and responsiveness (distribution- and anchor-based) were explored for the German-SNOT-22. RESULTS: At T0, the mean German-SNOT-22 total-score for CRS patients was 38.0 (± 20.9) and responded to treatment (T1 = 26.3 ± 19.1; T2 = 25.8 ± 20.6; T3 = 20.5 ± 16.3). For control-participants, the mean total-score at T0 was 15.1 (±10.9). The German-SNOT-22 was reliable (excellent internal consistency α = 0.93; good overall item-total correlations r = 0.39-0.85), valid (significant correlations between Mackay-Naclerio-, Lund-Mackay- and BSI-18 scores, all r > 0.39, p < 0.01) and responsive (significant correlations between HTIs and mean change in German-SNOT-22 total-score F = 9.57, p < 0.001). CONCLUSION: The German-SNOT-22 validated here matches the original SNOT-22. It is a reliable, valid and responsive questionnaire to assess symptoms, HRQOL and treatment-response in CRS-patients. Good psychometric properties were observed.