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Approximately 70% of head and neck cancer (HNC) patients present with locoregionally advanced disease. The curative rate for early disease is 80-95%; for advanced tumors, locoregional recurrence rate remains at about 50-60% despite advances in treatment, and 20-30% will have distant metastases. Further, patients will develop a second primary malignancy (SPM) with a rate of 2-4% per year. Follow-up (FU) is important to detect recurrence (REC) and SPM at an early stage, to enable effective salvagetherapy, manage treatment-related sequelae, and provide functional rehabilitation and psychosocial support. In the absence of high-level evidence, there is no clear international consensus in FU regimens. There are only retrospective studies addressing this topic, mostly showing no difference in overall survival between patients with REC detected during routine FU and symptom-driven self-referral visits. The value of imaging is also subject of debate. Moreover, many of the hitherto published studies did not include the logistical, psychological and financial consequences and the relevant cost evaluations in today's healthcare systems facing increasing financial pressure. We propose a large multicenter, randomized prospective trial in HNC patients with complete remission 6 months after curative treatment to compare two FU schemes differing in frequency of scheduled clinical examinations and imaging. We hypothesize that implementing an individualized de-intensified FU with active patient involvement does not differ from a conventional regular FU in terms of death from any cause up to 5 years (=primary endpoint). We also hypothesize that symptom-driven self-referral FU visits have a higher diagnostic yield in detection of REC/SPM than regular scheduled clinical and radiological examinations. Consequently, we assume that fewer scheduled exams in well-instructed patients will not lead to worse outcome. The secondary objectives are the comparison of death from HNC and any cancer, detection of first REC/SPM, health-related quality of life, fear of recurrence, compliance with FU assessments, number of visits and HNC-specific health-care utilization. The objective of the herein presented Pilot 1 study was to assess the feasibility of patients' recruitment, motivation for trial participation and compliance in completing a monthly, paper-based symptoms' monitoring (patient-reported outcome [PRO], symptom tracker). This Pilot is supported by Swiss Cancer Research. The study design is shown in Figure 1 (RMST: restricted mean survival time). [Display omitted] The main study is a randomized-controlled combined non-inferiority and superiority trial with explicit Pilot 1 and 2. After curative treatment, participants are randomized to an individualized de-intensified FU with monthly symptoms' monitoring (Figure 2) (experimental arm) or to standard FU. [Display omitted] Alerting symptoms possibly indicating REC/SPM or non-completion of the PROs will result in an urgent clinical FU appointment in the experimental arm. Minimal FU within Pilot 1 is 12 months (as opposed to 60 months in the main trial). Recruitment was done in three Swiss tertiary referral centers, which committed to enroll at least 20 patients during one year. The primary aim of Pilot 1, evaluating the feasibility of patient recruitment, has been confirmed faster than expected (20 committed patients randomized after 7 and 29 patients randomized after 11 months accrual time, respectively). Six unscheduled visits were triggered by our paper-based PRO. Within Pilot 1, a prescreening survey was conducted to better understand the specific motivation of patients to participate in the trial or not. We surveyed 41 potential participants of which 27 (66%) agreed to participate. The potential reduction in imaging was the main reason for the patients to participate in the trial (52%). Additionally, we collected feedback on the design of the paper-based PRO questionnaire at the 6-month FU visit when participants had already gained some experience. Participants expressed that the PRO questionnaire was easy to understand and comprehensive, thus facilitating them to communicate with their corresponding study center. The completion time for the PRO was between 5-10 minutes in 63% of the participants. In addition, 63% of the patients were in favor of transitioning the paper-based PRO to an electronic version (ePRO), the other 37% felt unsure about using an ePRO. Interim compliance data will be presented. The recruitment and symptoms' monitoring for HNC patients have been proofed as feasible. Pilot 2 is in planning to allow for a smooth continuation of Pilot 1 with following specific goals: 1) to expand the trial to 12 Swiss and 4 European sites; 2) to recruit up to 200 participants; 3) to implement a web-based version of the symptom tracker (ePRO); 4) to develop an enhanced training strategy for HNC patients; 5) to evaluate the usability of the ePRO; and 6) to assess the safety of omitting systematic lung imaging. [ABSTRACT FROM AUTHOR]

Excessive daytime sleepiness (EDS) and insomnia (IN) complaints represent the most common sleep/wake disorders. Currently, the specific needs of these patients and their relatives, as well as the overall socio-economic burden of IN and EDS remains widely unexplored. This pilot study to be carried out in Switzerland is a retro- and prospective, national, one-center cohort observational study for the systematic evaluation of the burden of EDS and IN and its evolution 12 months after the first assessment. Patient recruitment will be organized through 7-8 primary care providers (primary/general care practitioners and pharmacies). Primary outcomes are the prevalence of EDS/IN in the primary care setting and the association between EDS/IN with health-related quality of life (QOL) as assessed with the established instruments. Secondary outcomes are the association between EDS/IN with the presence of comorbidities, number of injuries/accidents, and number of sick/leave days for the subgroup of working subjects. Calculation of direct per-patient costs will be undertaken to analyze the economic implications of sleep/wake disorders, providing valuable insights into the financial burden experienced by affected individuals within the healthcare system. This research will provide information on the feasibility of such a study and inform on aspects of the QOL most associated with EDS/IN. Based on this pilot project, a European multicenter study on the burden of sleep/wake disorders will be conducted by the European Academy of Neurology.

Introduction: The Swiss Eosinophilic Esophagitis Cohort Study (SEECS) is a national cohort that was established in 2015 with the aim of improving quality of care of affected adults with eosinophilic esophagitis (EoE). Between 2020 and 2022, paper questionnaires were gradually replaced by fully electronic data capture using Research Electronic Data Capture (REDCap ® ) software. We aim to provide an update of the SEECS 8 years after its launch., Methods: The SEECS prospectively includes adults (≥18 years of age) with EoE as well as patients with gastroesophageal reflux disease (GERD) and healthy control subjects (HC). Upon inclusion and follow-up (typically once every 12-18 months), patients and physicians complete REDCap ® questionnaires, which are available in German, French, and English. Patient-reported outcomes (PROs) and biologic findings are assessed on the same day using validated instruments (EEsAI PRO for symptoms; EoE-QoL-A for QoL; EREFS for endoscopic activity; modified EoE-HSS for histologic activity). The SEECS biobank includes biosamples from patients with EoE, GERD, and HC., Results: As of July 2023, the SEECS included 778 patients (716 [92%] with EoE, 29 [3.8%] with GERD, and 33 [4.2%] HC; 559/778 [71.9%] were male). Mean age ± SD (years) at enrollment according to diagnosis was as follows: EoE 41.9 ± 12.9, GERD 53.6 ± 16.4, HC 51.7 ± 17.2. Concomitant GERD was found in 200 patients (27.9%) of the EoE cohort. Concomitant allergic disorders (asthma, rhinoconjunctivitis, eczema) were present in 500 EoE patients (74.4%). At inclusion, 686 (95.8%) of EoE patients were on ongoing treatment (orodispersible budesonide tablet [Jorveza ® ] in 281 patients [41%]; budesonide or fluticasone syrup or swallowed powder in 290 patients [42.3%]; proton-pump inhibitors in 162 patients [23.6%]; elimination diets in 103 patients [15%]; and esophageal dilation at last visit in 166 patients [24.2%]). A total of 8,698 biosamples were collected, of which 1,395 (16%) were used in the framework of translational research projects., Conclusion: SEECS continuously grows and is operational using fully electronic data capture. SEECS offers up-to-date epidemiologic and real-world clinical efficacy data on EoE and promotes clinical and translational research., Competing Interests: Jeanine Wakim has no relevant financial, professional, or personal relationships to disclose. Ekaterina Safroneeva reports (i) consulting fees from Avir Pharma, Inc., Aptalis Pharma, Inc., Celgene Corp., Novartis, AG, and Regeneron Pharmaceuticals Inc.; (ii) being an employee of Tillotts Pharma AG. Catherine Saner has no relevant financial, professional, or personal relationships to disclose. Jean-Benoit Rossel has no relevant financial, professional, or personal relationships to disclose. Sven Trelle has no relevant financial, professional, or personal relationships to disclose. Marcel Zwahlen has no relevant financial, professional, or personal relationships to disclose. Luc Biedermann received consulting fees and/or speaker fees and/or research grants from Adare/Ellodi Pharmaceuticals, Inc., AstraZeneca, AG, Switzerland, Receptos-Celgene-BMS, Dr. Falk Pharma, GmbH, Germany, Glaxo Smith Kline, AG, Nestlé S. A., Switzerland, Novartis, AG, Switzerland, and Regeneron-Sanofi Pharmaceuticals. Andrea Kreienbuehl has no relevant financial, professional, or personal relationships to disclose. Thomas Greuter received consulting fees and/or speaker fees and/or research grants from Adare/Ellodi Pharmaceuticals, Inc., AstraZeneca, AG, Switzerland, Receptos-Celgene-BMS, Dr. Falk Pharma, GmbH, Germany, Glaxo Smith Kline, AG, Nestlé S. A., Switzerland, Novartis, AG, Switzerland, and Regeneron-Sanofi Pharmaceuticals. Philipp Schreiner received consulting fees and/or speaker fees from Dr. Falk Pharma, GmbH, Takeda, Regerenon-Sanofi Pharmaceuticals, AbbVie, Janssen-Cilag, Receptos-Celgene-BMS. Peter Netzer has no relevant financial, professional, or personal relationships to disclose. Annett Franke has no relevant financial, professional, or personal relationships to disclose. Stephan Brand has no relevant financial, professional, or personal relationships to disclose. Chantal Hasler has no relevant financial, professional, or personal relationships to disclose. Patrick Aepli has no relevant financial, professional, or personal relationships to disclose. Emanuel Burri has no relevant financial, professional, or personal relationships to disclose. Achim Weber has no relevant financial, professional, or personal relationships to disclose. Christine Sempoux has no relevant financial, professional, or personal relationships to disclose. Ruggero Biral has no relevant financial, professional, or personal relationships to disclose. Wolfram Jochum has no relevant financial, professional, or personal relationships to disclose. Joachim Diebold has no relevant financial, professional, or personal relationships to disclose. Niels Willi has no relevant financial, professional, or personal relationships to disclose. Alex Straumann received consulting fees and/or speaker fees and/or research grants from Adare/Ellodi Pharmaceuticals, Inc., AstraZeneca, AG, Switzerland, Receptos-Celgene-BMS, Dr. Falk Pharma, GmbH, Germany, Glaxo Smith Kline, AG, Nestlé S. A., Switzerland, Novartis, AG, Switzerland, and Regeneron-Sanofi Pharmaceuticals. Alain Schoepfer received consulting fees and/or speaker fees and/or research grants from Adare/Ellodi Pharmaceuticals, Inc., AstraZeneca, AG, Switzerland, Receptos-Celgene-BMS, Dr. Falk Pharma, GmbH, Germany, Glaxo Smith Kline, AG, Nestlé S. A., Switzerland, Novartis, AG, Switzerland, and Regeneron-Sanofi Pharmaceuticals., (© 2024 The Author(s). Published by S. Karger AG, Basel.)