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  • 1
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    Characterization and outcomes of 414 patients with primary SS who developed haematological malignancies
    Oxford University Press (OUP) ; 2022
    In:  Rheumatology Vol. 62, No. 1 ( 2022-12-23), p. 243-255
    Details
    In: Rheumatology, Oxford University Press (OUP), Vol. 62, No. 1 ( 2022-12-23), p. 243-255
    Abstract: To characterize 414 patients with primary SS who developed haematological malignancies and to analyse how the main SS- and lymphoma-related features can modify the presentation patterns and outcomes. Methods By January 2021, the Big Data Sjögren Project Consortium database included 11 966 patients fulfilling the 2002/2016 classification criteria. Haematological malignancies diagnosed according to the World Health Organization (WHO) classification were retrospectively identified. Results There were 414 patients (355 women, mean age 57 years) with haematological malignancies (in 43, malignancy preceded at least one year the SS diagnosis). A total of 376 (91%) patients had mature B-cell malignancy, nearly half had extranodal marginal zone lymphoma (MZL) of mucosa-associated lymphoid tissue (MALT lymphoma) (n = 197), followed by diffuse large B-cell lymphoma (DLBCL) (n = 67), nodal MZL lymphoma (n = 29), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (n = 19) and follicular lymphoma (FL) (n = 17). Rates of complete response, relapses and death were 80%, 34% and 13%, respectively, with a 5-year survival rate of 86.5% after a mean follow-up of 8 years. There were significant differences in age at diagnosis (younger in MALT, older in CLL/SLL), predominant clinical presentation (glandular enlargement in MALT lymphoma, peripheral lymphadenopathy in nodal MZL and FL, constitutional symptoms in DLBCL, incidental diagnosis in CLL/SLL), therapeutic response (higher in MALT lymphoma, lower in DLBCL) and survival (better in MALT, nodal MZL and FL, worse in DLBCL). Conclusion In the largest reported study of haematological malignancies complicating primary SS, we confirm the overwhelming predominance of B-cell lymphomas, especially MALT, with the salivary glands being the primary site of involvement. This highly-specific histopathological scenario is linked with the overall good prognosis with a 5-year survival rate of nearly 90%.
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    URL: Article
    DOI: 10.1093/rheumatology/keac205
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 1474143-X
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  • 2
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    The observational clinical registry (cohort design) of the European Reference Network on Rare Adult Solid Cancers: The protocol for the rare head and neck cancers
    Public Library of Science (PLoS) ; 2023
    In:  PLOS ONE Vol. 18, No. 3 ( 2023-3-16), p. e0283071-
    Details
    In: PLOS ONE, Public Library of Science (PLoS), Vol. 18, No. 3 ( 2023-3-16), p. e0283071-
    Abstract: Care for head and neck cancers is complex in particular for the rare ones. Knowledge is limited and histological heterogeneity adds complexity to the rarity. There is a wide consensus that to support clinical research on rare cancer, clinical registries should be developed within networks specializing in rare cancers. In the EU, a unique opportunity is provided by the European Reference Networks (ERN). The ERN EURACAN is dedicated to rare adults solid cancers, here we present the protocol of the EURACAN registry on rare head and neck cancers (ClinicalTrials.gov Identifier: NCT05483374). Study design Registry-based cohort study including only people with rare head and neck cancers. Objectives to help describe the natural history of rare head and neck cancers; to evaluate factors that influence prognosis; to assess treatment effectiveness; to measure indicators of quality of care. Methods Settings and participants It is an hospital based registry established in hospitals with expertise in head and neck cancers. Only adult patients with epithelial tumours of nasopharynx; nasal cavity and paranasal sinuses; salivary gland cancer in large and small salivary glands; and middle ear will be included in the registry. This registry won’t select a sample of patients. Each patient in the facility who meets the above mentioned inclusion criteria will be followed prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. It is a secondary use of data which will be collected from the clinical records. The data collected for the registry will not entail further examinations or admissions to the facility and/or additional appointments to those normally provided for the patient follow-up. Variables Data will be collected on patient characteristics (eg. patient demographics, lifestyle, medical history, health status); exposure data (eg. disease, procedures, treatments of interest) and outcomes (e.g. survival, progression, progression-free survival, etc.). In addition, data on potential confounders (e.g. comorbidity; functional status etc.) will be also collected. Statistical methods The data analyses will include descriptive statistics showing patterns of patients’ and cancers’ variables and indicators describing the quality of care. Multivariable Cox’s proportional hazards model and Hazard ratios (HR) for all-cause or cause specific mortality will be used to determine independent predictors of overall survival, recurrence etc. Variables to include in the multivariable regression model will be selected based on the results of univariable analysis. The role of confounding or effect modifiers will be evaluated using stratified analysis or sensitivity analysis. To assess treatment effectiveness, multivariable models with propensity score adjustment and progression-free survival will be performed. Adequate statistical (eg. marginal structural model) methods will be used if time-varying treatments/confounders and confounding by indication (selective prescribing) will be present. Results The registry initiated recruiting in May 2022. The estimated completion date is December 2030 upon agreement on the achievement of all the registry objectives. As of October 2022, the registry is recruiting. There will be a risk of limited representativeness due to the hospital-based nature of the registry and to the fact that hospital contributing to the registry are expert centres for these rare cancers. Clinical Follow-up could also be an issue but active search of the life status of the patients will be guaranteed.
    Type of Medium: Online Resource
    ISSN: 1932-6203
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1371/journal.pone.0283071
    DOI: 10.1371/journal.pone.0283071.g001
    DOI: 10.1371/journal.pone.0283071.t001
    Language: English
    Publisher: Public Library of Science (PLoS)
    Publication Date: 2023
    detail.hit.zdb_id: 2267670-3
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  • 3
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    Structured Reporting of Head and Neck Sonography Achieves Substantial Interrater Reliability
    Georg Thieme Verlag KG ; 2023
    In:  Ultrasound International Open Vol. 09, No. 01 ( 2023-01), p. E26-E32
    Details
    In: Ultrasound International Open, Georg Thieme Verlag KG, Vol. 09, No. 01 ( 2023-01), p. E26-E32
    Abstract: Purpose Ultrasound examinations are often criticized for having higher examiner dependency compared to other imaging techniques. Compared to free-text reporting, structured reporting (SR) of head and neck sonography (HNS) achieves superior time efficiency as well as report quality. However, there are no findings concerning the influence of SR on the interrater reliability (IRR) of HNS. Materials and Methods Typical pathologies (n=4) in HNS were documented by video/images by two certified head and neck ultrasound instructors. Consequently, structured reports of these videos/images were created by n=9 senior physicians at departments of otolaryngology or maxillofacial surgery with DEGUM instructors on staff. Reports (n=36) were evaluated regarding overall completeness and IRR. Additionally, user satisfaction was assessed by a visual analog scale (VAS). Results SR yielded very high report completeness (91.8%) in all four cases with a substantial IRR (Fleiss‘ κ 0.73). Interrater agreement was high at 87.2% with very good user satisfaction (VAS 8.6). Conclusion SR has the potential to ensure high-quality examination reports with substantial comparability and very high user satisfaction. Furthermore, big data collection and analysis are facilitated by SR. Therefore, process quality, workflow, and scientific output are potentially enhanced by SR.
    Type of Medium: Online Resource
    ISSN: 2509-596X , 2199-7152
    URL: Article
    DOI: 10.1055/a-2173-3966
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
    detail.hit.zdb_id: 2838384-9
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  • 4
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    Alternating vocal cord paresis and sleep apnea syndrome
    Springer Science and Business Media LLC ; 2023
    In:  HNO Vol. 71, No. 3 ( 2023-03), p. 183-185
    Details
    In: HNO, Springer Science and Business Media LLC, Vol. 71, No. 3 ( 2023-03), p. 183-185
    Type of Medium: Online Resource
    ISSN: 0017-6192 , 1433-0458
    URL: Article
    DOI: 10.1007/s00106-022-01245-y
    RVK:
    XA 45800
    Language: German
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 1459183-2
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  • 5
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    Selective upper airway stimulation for obstructive sleep apnea: a single center clinical experience
    Springer Science and Business Media LLC ; 2017
    In:  European Archives of Oto-Rhino-Laryngology Vol. 274, No. 3 ( 2017-3), p. 1727-1734
    Details
    In: European Archives of Oto-Rhino-Laryngology, Springer Science and Business Media LLC, Vol. 274, No. 3 ( 2017-3), p. 1727-1734
    Type of Medium: Online Resource
    ISSN: 0937-4477 , 1434-4726
    URL: Article
    DOI: 10.1007/s00405-016-4297-6
    RVK:
    XA 26650
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2017
    detail.hit.zdb_id: 1459042-6
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  • 6
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    In reference to Inclusion of the first cervical nerve does not influence outcomes in upper airway stimulation for treatment of obstructive sleep apnea
    Wiley ; 2020
    In:  The Laryngoscope Vol. 130, No. 7 ( 2020-07)
    Details
    In: The Laryngoscope, Wiley, Vol. 130, No. 7 ( 2020-07)
    Type of Medium: Online Resource
    ISSN: 0023-852X , 1531-4995
    URL: Issue
    URL: Article
    DOI: 10.1002/lary.v130.7
    DOI: 10.1002/lary.28496
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2026089-1
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  • 7
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    Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post‐market study
    Wiley ; 2018
    In:  The Laryngoscope Vol. 128, No. 2 ( 2018-02), p. 509-515
    Details
    In: The Laryngoscope, Wiley, Vol. 128, No. 2 ( 2018-02), p. 509-515
    Abstract: Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate‐to‐severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient‐reported outcome after 12 months of implantation. Study Design Multicenter prospective single‐arm study. Methods Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index  〉  35 kg/m 2 , apnea–hypopnea index (AHI)  〈  15 or  〉  65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6‐ and 12‐month visit include home sleep test and patient‐reported outcome measures. Results Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient‐reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. Conclusion This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. Level of Evidence 4. Laryngoscope , 128:509–515, 2018
    Type of Medium: Online Resource
    ISSN: 0023-852X , 1531-4995
    URL: Issue
    URL: Article
    DOI: 10.1002/lary.v128.2
    DOI: 10.1002/lary.26688
    Language: English
    Publisher: Wiley
    Publication Date: 2018
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  • 8
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    Sonographic differentiation between lymphatic and metastatic diseases in cervical lymphadenopathy
    Wiley ; 2018
    In:  The Laryngoscope Vol. 128, No. 4 ( 2018-04), p. 859-863
    Details
    In: The Laryngoscope, Wiley, Vol. 128, No. 4 ( 2018-04), p. 859-863
    Abstract: The spectrum of differential diagnosis in cervical lymphadenopathy is extremely broad. In lymphoma and inflammatory diseases, surgical approaches are restricted to diagnostic lymph extirpation, whereas metastatic outgrowth into regional lymph nodes usually requires neck dissection. Lymph node surgery has to manage the balancing act between sufficient radicality and preservation of functional structures. The current study, therefore, aimed to identify parameters to differentiate between lymph nodes of lymphatic and metastatic origin. Study Design Single‐center, retrospective cohort study. Methods Clinical and sonographic parameters from all patients who underwent diagnostic cervical lymphadenectomy from 2010 to 2015 (N = 262) were included in this retrospective analysis. Parameters with significant differences between the two subgroups were utilized to create a clinical algorithm to distinguish between cervical lymphadenopathy of lymphatic and metastatic genesis. Results Statistically significant differences between the two subgroups could be shown for clinical (gender, age, nicotine/alcohol abuse, B symptoms, history of cutaneous melanoma, or lymphoma) and ultrasonographic parameters (string‐of‐beads confirmation, bilaterality, homogenous echostructure, localization in level I, long‐to‐short axis ratio, and hilar vascularity). The proposed algorithm yielded a sensitivity of 92.4% for metastatic disease. Conclusions The implemented algorithm based on ultrasonographic and clinical criteria contributes to one‐step surgical approaches that guarantee a sufficient radicality with a minimum of functional loss. Level of Evidence 4. Laryngoscope , 128:859–863, 2018
    Type of Medium: Online Resource
    ISSN: 0023-852X , 1531-4995
    URL: Issue
    URL: Article
    DOI: 10.1002/lary.v128.4
    DOI: 10.1002/lary.26837
    Language: English
    Publisher: Wiley
    Publication Date: 2018
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  • 9
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    Tongue motion variability with changes of upper airway stimulation electrode configuration and effects on treatment outcomes
    Wiley ; 2018
    In:  The Laryngoscope Vol. 128, No. 8 ( 2018-08), p. 1970-1976
    Details
    In: The Laryngoscope, Wiley, Vol. 128, No. 8 ( 2018-08), p. 1970-1976
    Abstract: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA). Previous data have demonstrated a correlation between the phenotype of tongue motion and therapy response. Closed loop hypoglossal nerve stimulation implant offers five different electrode configuration settings which may result in different tongue motion. Study Design Two‐center, prospective consecutive trial in a university hospital setting. Methods Clinical outcomes of 35 patients were analyzed after at least 12 months of device use. Tongue motion was assessed at various electrode configuration settings. Correlation between the tongue motion and treatment response was evaluated. Results OSA severity was significantly reduced with the use of UAS therapy ( P   〈  .001). Changes in tongue motion patterns were frequently observed (58.8%) with different electrode configuration settings. Most of the patients alternated between right and bilateral protrusion (73.5%), which are considered to be the optimal phenotypes for selective UAS responses. Different voltage settings were required to achieve functional stimulation levels when changing between the electrode settings. Conclusions UAS is highly effective for OSA treatment in selected patients with an apnea‐hypopnea index between 15 and 65 events per hour and higher body mass index. Attention should be given to patients with shifting tongue movement in response to change of electrode configuration. The intraoperative cuff placement should be reassessed when tongue movement shifting is observed. Level of Evidence 4 Laryngoscope , 1970–1976, 2018
    Type of Medium: Online Resource
    ISSN: 0023-852X , 1531-4995
    URL: Issue
    URL: Article
    DOI: 10.1002/lary.v128.8
    DOI: 10.1002/lary.27064
    Language: English
    Publisher: Wiley
    Publication Date: 2018
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  • 10
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    Bronchogenic cancer: It still exists
    Wiley ; 2016
    In:  The Laryngoscope Vol. 126, No. 3 ( 2016-03), p. 638-642
    Details
    In: The Laryngoscope, Wiley, Vol. 126, No. 3 ( 2016-03), p. 638-642
    Abstract: Branchial cleft cysts rank among the most common differential diagnoses of cystic cervical masses. Rarely, classic cystic structures exhibit a squamous cell carcinoma differentiation that represents a bronchogenic carcinoma. The existence of bronchogenic carcinoma is controversial due to the lack of systematic immunohistologic workup. The present study aimed to identify the clinical and immunohistologic features of bronchogenic carcinoma to clearly distinguish this entity from other cystic cervical masses. Methods Immunohistologic (epidermal growth factor receptor; cytokeratin 5, 6, 7, 13; and p16) and epidemiologic assessments were performed for branchial cleft cysts (n = 63), bronchogenic carcinomas (n = 5), cystic metastasized oropharyngeal carcinomas (n = 97), and carcinomas of unknown primary (n = 51). The study was conducted as a retrospective case series study with comparison. Results The patients with bronchogenic carcinomas differed significantly in age and in the number of involved lymph nodes compared with the cystic metastasized oropharyngeal carcinoma (and carcinoma of unknown primary) patients. Regular histologic wall structures were only observed in the bronchogenic carcinomas and branchial cleft cysts. Solitary cytokeratin‐7 staining was only observed in the bronchogenic carcinomas, and all of the bronchogenic carcinomas were p16 negative. Conclusions The existence of bronchogenic carcinoma seems to be plausible based on clinical findings. Cytokeratin‐7 and p16 staining might be helpful in the diagnostic workflow. Level of Evidence 4 Laryngoscope , 126:638–642, 2016
    Type of Medium: Online Resource
    ISSN: 0023-852X , 1531-4995
    URL: Issue
    URL: Article
    DOI: 10.1002/lary.v126.3
    DOI: 10.1002/lary.25660
    Language: English
    Publisher: Wiley
    Publication Date: 2016
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