{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T04:18:45Z","timestamp":1792642725870,"version":"4.5.0"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2023,8,8]],"date-time":"2023-08-08T00:00:00Z","timestamp":1691452800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,8]],"date-time":"2023-08-08T00:00:00Z","timestamp":1691452800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100011851","name":"Kom op tegen Kanker","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100011851","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Dysphagia"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Prophylactic swallowing exercises (PSE) during head-and-neck cancer (HNC) (chemo)radiotherapy (CRT) have a positive effect on swallowing function and muscle strength. Adherence rates to PSE are, however, moderate to low, undermining these effects. PRESTO already showed that the service-delivery mode (SDM), the way the exercises are offered, can influence adherence. The aim of this study was to investigate the effect of SDM on swallowing function and muscle strength during and post-CRT. In addition, the effect of overall adherence (OA), independent of SDM, was also investigated.\u00a0A total of 148 HNC patients, treated with CRT, were randomly assigned to one of the three SDM\u2019s (paper-supported, app-supported, or therapist-supported PSE) and performed a 4-week PSE program. OA was calculated based on the percentage of completed exercises. Patients were divided into OA levels: the OA75+\u2009and OA75\u2212\u00a0group performed respectively\u2009\u2265\u200975 and\u2009&lt;\u200975% of the exercises. Swallowing function based on Mann Assessment of Swallowing Ability-Cancer (MASA-C), tongue and suprahyoid muscle strength during and up to 3\u00a0months after CRT were compared between the SDM\u2019s and OA levels. Linear Mixed-effects Models with post hoc pairwise testing and Bonferroni\u2013Holm correction was used. No significant differences were found between the three SDMs. Significant time effects were found: MASA-C scores decreased and muscle strength increased significantly during CRT. By the end of CRT, the OA75+\u2009showed significantly better swallowing function compared to OA75\u2212. Muscle strength gain was significantly higher in the OA75+\u2009group. SDM had no impact on swallowing function and muscle strength; however, significant effects were shown for OA level. Performing a high level of exercise repetitions is essential to benefit from PSE.<\/jats:p>\n                  <jats:p>\n                    <jats:italic>Trial registration<\/jats:italic>\n                    ISRCTN, ISRCTN98243550. Registered December 21, 2018\u2014retrospectively registered,\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN98243550?q=gwen%20van%20nuffelen&amp;filters=&amp;sort=&amp;offset=1&amp;totalResults=2&amp;page=1&amp;pageSize=10&amp;searchType=basic-search\">https:\/\/www.isrctn.com\/ISRCTN98243550?q=gwen%20van%20nuffelen&amp;filters=&amp;sort=&amp;offset=1&amp;totalResults=2&amp;page=1&amp;pageSize=10&amp;searchType=basic-search<\/jats:ext-link>\n                  <\/jats:p>","DOI":"10.1007\/s00455-023-10609-7","type":"journal-article","created":{"date-parts":[[2023,8,7]],"date-time":"2023-08-07T22:01:41Z","timestamp":1691445701000},"page":"267-281","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Prophylactic Swallowing Therapy During Head-and-Neck Cancer Radiotherapy: Effect of Service-Delivery Mode and Overall Adherence Level on Swallowing Function and Muscle Strength\u2014the PRESTO Trial"],"prefix":"10.1007","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0431-5854","authenticated-orcid":false,"given":"Margot","family":"Baudelet","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leen","family":"Van den Steen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fr\u00e9deric","family":"Duprez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Goeleven","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Nuyts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daan","family":"Nevens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Vandenbruaene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanne","family":"Massonet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Vergauwen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Vauterin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilde","family":"Verstraete","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristien","family":"Wouters","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Vanderveken","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"De Bodt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwen","family":"Van Nuffelen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"members of the Belgian PRESTO-group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,8,8]]},"reference":[{"issue":"6","key":"10609_CR1","doi-asserted-by":"publisher","first-page":"883","DOI":"10.1097\/01.mlg.0000217278.96901.fc","volume":"116","author":"BD Kulbersh","year":"2006","unstructured":"Kulbersh BD, Rosenthal EL, McGrew BM, et al. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006;116(6):883\u20136.","journal-title":"Laryngoscope"},{"issue":"1","key":"10609_CR2","doi-asserted-by":"publisher","first-page":"210","DOI":"10.1016\/j.ijrobp.2011.06.1954","volume":"83","author":"G Carnaby-Mann","year":"2012","unstructured":"Carnaby-Mann G, Crary MA, Schmalfuss I, Amdur R. \u201cPharyngocise\u201d: randomized controlled trial of preventative exercises to maintain muscle structure and swallowing function during head-and-neck chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2012;83(1):210\u20139.","journal-title":"Int J Radiat Oncol Biol Phys"},{"issue":"2","key":"10609_CR3","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1007\/s00455-010-9288-y","volume":"26","author":"L van der Molen","year":"2011","unstructured":"van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR, Hilgers FJ. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011;26(2):155\u201370.","journal-title":"Dysphagia"},{"issue":"11","key":"10609_CR4","doi-asserted-by":"publisher","first-page":"1127","DOI":"10.1001\/jamaoto.2013.4715","volume":"139","author":"KA Hutcheson","year":"2013","unstructured":"Hutcheson KA, Bhayani MK, Beadle BM, et al. Eat and exercise during radiotherapy or chemoradiotherapy for pharyngeal cancers: use it or lose it. JAMA Otolaryngol Head Neck Surg. 2013;139(11):1127\u201334.","journal-title":"JAMA Otolaryngol Head Neck Surg"},{"issue":"8","key":"10609_CR5","doi-asserted-by":"publisher","first-page":"1907","DOI":"10.1002\/hed.26120","volume":"42","author":"RT Karsten","year":"2020","unstructured":"Karsten RT, van der Molen L, Hamming-Vrieze O, et al. Long-term swallowing, trismus, and speech outcomes after combined chemoradiotherapy and preventive rehabilitation for head and neck cancer; 10-year plus update. Head Neck. 2020;42(8):1907\u201318.","journal-title":"Head Neck"},{"issue":"6","key":"10609_CR6","doi-asserted-by":"publisher","first-page":"878","DOI":"10.1177\/0194599813502310","volume":"149","author":"VM Duarte","year":"2013","unstructured":"Duarte VM, Chhetri DK, Liu YF, Erman AA, Wang MB. Swallow preservation exercises during chemoradiation therapy maintains swallow function. Otolaryngol Head Neck Surg. 2013;149(6):878\u201384.","journal-title":"Otolaryngol Head Neck Surg"},{"issue":"4","key":"10609_CR7","doi-asserted-by":"publisher","first-page":"376","DOI":"10.1001\/archoto.2012.187","volume":"138","author":"T Kotz","year":"2012","unstructured":"Kotz T, Federman AD, Kao J, et al. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012;138(4):376\u201382.","journal-title":"Arch Otolaryngol Head Neck Surg"},{"issue":"4","key":"10609_CR8","doi-asserted-by":"publisher","first-page":"487","DOI":"10.1007\/s00455-017-9790-6","volume":"32","author":"BP Messing","year":"2017","unstructured":"Messing BP, Ward EC, Lazarus CL, et al. Prophylactic swallow therapy for patients with head and neck cancer undergoing chemoradiotherapy: a randomized trial. Dysphagia. 2017;32(4):487\u2013500.","journal-title":"Dysphagia"},{"issue":"2","key":"10609_CR9","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1002\/hed.23570","volume":"37","author":"A Virani","year":"2015","unstructured":"Virani A, Kunduk M, Fink DS, McWhorter AJ. Effects of 2 different swallowing exercise regimens during organ-preservation therapies for head and neck cancers on swallowing function. Head Neck. 2015;37(2):162\u201370.","journal-title":"Head Neck"},{"issue":"3","key":"10609_CR10","doi-asserted-by":"publisher","first-page":"304","DOI":"10.1007\/s00455-015-9600-y","volume":"30","author":"HR Mortensen","year":"2015","unstructured":"Mortensen HR, Jensen K, Aksglaede K, Lambertsen K, Eriksen E, Grau C. Prophylactic swallowing exercises in head and neck cancer radiotherapy. Dysphagia. 2015;30(3):304\u201314.","journal-title":"Dysphagia"},{"issue":"12","key":"10609_CR11","doi-asserted-by":"publisher","first-page":"1707","DOI":"10.1002\/hed.23255","volume":"35","author":"EH Shinn","year":"2013","unstructured":"Shinn EH, Basen-Engquist K, Baum G, et al. Adherence to preventive exercises and self-reported swallowing outcomes in post-radiation head and neck cancer patients. Head Neck. 2013;35(12):1707\u201312.","journal-title":"Head Neck"},{"issue":"2","key":"10609_CR12","doi-asserted-by":"publisher","first-page":"1129","DOI":"10.1007\/s00405-016-4367-9","volume":"274","author":"IC Cnossen","year":"2017","unstructured":"Cnossen IC, van Uden-Kraan CF, Witte BI, et al. Prophylactic exercises among head and neck cancer patients during and after swallowing sparing intensity modulated radiation: adherence and exercise performance levels of a 12-week guided home-based program. Eur Arch Oto-Rhino-Laryngol. 2017;274(2):1129\u201338.","journal-title":"Eur Arch Oto-Rhino-Laryngol"},{"issue":"5","key":"10609_CR13","doi-asserted-by":"publisher","first-page":"863","DOI":"10.1177\/0194599815575508","volume":"152","author":"KA Peng","year":"2015","unstructured":"Peng KA, Kuan EC, Unger L, Lorentz WC, Wang MB, Long JL. A swallow preservation protocol improves function for veterans receiving chemoradiation for head and neck cancer. Otolaryngol Head Neck Surg: Off J Am Acad Otolaryngol Head Neck Surg. 2015;152(5):863\u20137.","journal-title":"Otolaryngol Head Neck Surg: Off J Am Acad Otolaryngol Head Neck Surg"},{"issue":"2","key":"10609_CR14","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1007\/s00455-016-9757-z","volume":"32","author":"LR Wall","year":"2017","unstructured":"Wall LR, Ward EC, Cartmill B, Hill AJ, Porceddu SV. Adherence to a prophylactic swallowing therapy program during (chemo) radiotherapy: impact of service-delivery model and patient factors. Dysphagia. 2017;32(2):279\u201392.","journal-title":"Dysphagia"},{"issue":"5","key":"10609_CR15","doi-asserted-by":"publisher","first-page":"658","DOI":"10.1080\/0284186X.2018.1563715","volume":"58","author":"SF Hajd\u00fa","year":"2019","unstructured":"Hajd\u00fa SF, Christensen MB, Kristensen M\u00d8, Wessel I, Johansen C, Dalton S. Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo) radiotherapy treatment. Acta Oncol. 2019;58(5):658\u201364.","journal-title":"Acta Oncol"},{"issue":"3","key":"10609_CR16","doi-asserted-by":"publisher","first-page":"e74","DOI":"10.2196\/jmir.2990","volume":"16","author":"IC Cnossen","year":"2014","unstructured":"Cnossen IC, van Uden-Kraan CF, Rinkel RN, et al. Multimodal guided self-help exercise program to prevent speech, swallowing, and shoulder problems among head and neck cancer patients: a feasibility study. J Med Internet Res. 2014;16(3):e74.","journal-title":"J Med Internet Res"},{"issue":"8","key":"10609_CR17","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1258\/jtt.2012.gth104","volume":"18","author":"CL Burns","year":"2012","unstructured":"Burns CL, Ward EC, Hill AJ, et al. A pilot trial of a speech pathology telehealth service for head and neck cancer patients. J Telemed Telecare. 2012;18(8):443\u20136.","journal-title":"J Telemed Telecare"},{"key":"10609_CR18","doi-asserted-by":"publisher","first-page":"886","DOI":"10.1007\/s00455-022-10513-6","volume":"38","author":"M Baudelet","year":"2022","unstructured":"Baudelet M, Duprez F, Van den Steen L, et al. Increasing adherence to prophylactic swallowing exercises during head and neck radiotherapy: the multicenter, randomized controlled PRESTO-trial. Dysphagia. 2022;38:886.","journal-title":"Dysphagia"},{"issue":"4","key":"10609_CR19","doi-asserted-by":"publisher","first-page":"392","DOI":"10.1007\/s00455-015-9611-8","volume":"30","author":"SA Kraaijenga","year":"2015","unstructured":"Kraaijenga SA, van der Molen L, Stuiver MM, Teertstra HJ, Hilgers FJ, van den Brekel MW. Effects of strengthening exercises on swallowing musculature and function in senior healthy subjects: a prospective effectiveness and feasibility study. Dysphagia. 2015;30(4):392\u2013403.","journal-title":"Dysphagia"},{"issue":"3","key":"10609_CR20","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1007\/s00455-006-9074-z","volume":"22","author":"LM Burkhead","year":"2007","unstructured":"Burkhead LM, Sapienza CM, Rosenbek JC. Strength-training exercise in dysphagia rehabilitation: principles, procedures, and directions for future research. Dysphagia. 2007;22(3):251\u201365.","journal-title":"Dysphagia"},{"issue":"1","key":"10609_CR21","doi-asserted-by":"publisher","first-page":"237","DOI":"10.1186\/s13063-020-4171-0","volume":"21","author":"M Baudelet","year":"2020","unstructured":"Baudelet M, Van den Steen L, Duprez F, et al. Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial). Trials. 2020;21(1):237.","journal-title":"Trials"},{"issue":"3","key":"10609_CR22","doi-asserted-by":"publisher","first-page":"595","DOI":"10.1007\/s00520-013-2011-4","volume":"22","author":"GD Carnaby","year":"2014","unstructured":"Carnaby GD, Crary MA. Development and validation of a cancer-specific swallowing assessment tool: MASA-C. Support Care Cancer. 2014;22(3):595\u2013602.","journal-title":"Support Care Cancer"},{"issue":"2","key":"10609_CR23","doi-asserted-by":"publisher","first-page":"293","DOI":"10.1007\/s00455-016-9758-y","volume":"32","author":"JA Cichero","year":"2017","unstructured":"Cichero JA, Lam P, Steele CM, et al. Development of international terminology and definitions for texture-modified foods and thickened fluids used in dysphagia management: the IDDSI framework. Dysphagia. 2017;32(2):293\u2013314.","journal-title":"Dysphagia"},{"issue":"10","key":"10609_CR24","doi-asserted-by":"publisher","first-page":"1943","DOI":"10.1002\/hed.24710","volume":"39","author":"SAC Kraaijenga","year":"2017","unstructured":"Kraaijenga SAC, Molen LV, Stuiver MM, et al. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017;39(10):1943\u201361.","journal-title":"Head Neck"},{"issue":"5","key":"10609_CR25","doi-asserted-by":"publisher","first-page":"873","DOI":"10.1002\/hed.26060","volume":"42","author":"LR Wall","year":"2020","unstructured":"Wall LR, Ward EC, Cartmill B, et al. Prophylactic swallowing therapy for patients with head and neck cancer: a three-arm randomized parallel-group trial. Head Neck. 2020;42(5):873\u201385.","journal-title":"Head Neck"},{"issue":"1","key":"10609_CR26","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1097\/MLG.0b013e31815659b0","volume":"118","author":"WR Carroll","year":"2008","unstructured":"Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008;118(1):39\u201343.","journal-title":"Laryngoscope"},{"issue":"1","key":"10609_CR27","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1007\/s00455-013-9486-5","volume":"29","author":"V Adams","year":"2014","unstructured":"Adams V, Mathisen B, Baines S, Lazarus C, Callister R. Reliability of measurements of tongue and hand strength and endurance using the Iowa oral performance instrument with healthy adults. Dysphagia. 2014;29(1):83\u201395.","journal-title":"Dysphagia"},{"issue":"2","key":"10609_CR28","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1111\/eos.12022","volume":"121","author":"M Kothari","year":"2013","unstructured":"Kothari M, Svensson P, Huo X, Ghovanloo M, Baad-Hansen L. Motivational conditions influence tongue motor performance. Eur J Oral Sci. 2013;121(2):111\u20136.","journal-title":"Eur J Oral Sci"},{"issue":"3","key":"10609_CR29","doi-asserted-by":"publisher","first-page":"233","DOI":"10.1113\/expphysiol.1989.sp003268","volume":"74","author":"DA Jones","year":"1989","unstructured":"Jones DA, Rutherford OM, Parker DF. Physiological changes in skeletal muscle as a result of strength training. Quart J Exp Physiol. 1989;74(3):233\u201356.","journal-title":"Quart J Exp Physiol"},{"issue":"3","key":"10609_CR30","doi-asserted-by":"publisher","first-page":"9311","DOI":"10.4081\/ejtm.2020.9311","volume":"30","author":"C Reggiani","year":"2020","unstructured":"Reggiani C, Schiaffino S. Muscle hypertrophy and muscle strength: dependent or independent variables? A provocative review. Eur J Transl Myol. 2020;30(3):9311.","journal-title":"Eur J Transl Myol"},{"issue":"7","key":"10609_CR31","doi-asserted-by":"publisher","first-page":"2197","DOI":"10.1002\/hed.25684","volume":"41","author":"L Van den Steen","year":"2019","unstructured":"Van den Steen L, Van Gestel D, Vanderveken O, et al. Evolution of self-perceived swallowing function, tongue strength and swallow-related quality of life during radiotherapy in head and neck cancer patients. Head Neck. 2019;41(7):2197\u2013207.","journal-title":"Head Neck"},{"key":"10609_CR32","doi-asserted-by":"publisher","first-page":"337","DOI":"10.1007\/s00455-017-9858-3","volume":"33","author":"L Van den Steen","year":"2017","unstructured":"Van den Steen L, Schellen C, Verstraelen K, et al. Tongue-strengthening exercises in healthy older adults: specificity of bulb position and detraining effects. Dysphagia. 2017;33:337.","journal-title":"Dysphagia"},{"issue":"3","key":"10609_CR33","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1007\/s00455-018-9940-5","volume":"34","author":"L Van den Steen","year":"2019","unstructured":"Van den Steen L, Vanderwegen J, Guns C, Elen R, De Bodt M, Van Nuffelen G. Tongue-strengthening exercises in healthy older adults: does exercise load matter? A randomized controlled trial. Dysphagia. 2019;34(3):315\u201324.","journal-title":"Dysphagia"}],"container-title":["Dysphagia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00455-023-10609-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00455-023-10609-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00455-023-10609-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T04:12:06Z","timestamp":1710994326000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00455-023-10609-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,8]]},"references-count":33,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["10609"],"URL":"https:\/\/doi.org\/10.1007\/s00455-023-10609-7","relation":{},"ISSN":["0179-051X","1432-0460"],"issn-type":[{"value":"0179-051X","type":"print"},{"value":"1432-0460","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,8]]},"assertion":[{"value":"7 October 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 July 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 August 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}},{"value":"Central ethical approval has been obtained from the Ethical Committee of the Antwerp University Hospital and the University of Antwerp (Ethisch Comit\u00e9 van het Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen) (B300201835273). Local ethical approval has been obtained from the Ethical Committees of the Ghent University Hospital and Ghent University, Leuven University Hospital and Leuven University and AZ Sint-Jan Hospital Bruges.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"Written informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed Consent"}},{"value":"The study is conducted in accordance with the guidelines of good clinical practice (ICH\/GCP) and the Helsinki Declaration, written to protect those involved in clinical studies.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Publish"}}]}}