{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T02:33:48Z","timestamp":1773887628645,"version":"3.50.1"},"reference-count":27,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T00:00:00Z","timestamp":1773619200000},"content-version":"unspecified","delay-in-days":15,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007137","name":"Northern Norway Regional Health Authority","doi-asserted-by":"crossref","award":["HNI0021-20"],"award-info":[{"award-number":["HNI0021-20"]}],"id":[{"id":"10.13039\/501100007137","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,23]]},"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The hormone replacement drug levothyroxine is the most common therapy for people with reduced function of the thyroid gland. The optimal dosage varies considerably between individuals, and reaching the correct dosage is often a time-consuming task. To reduce the time needed for dose adjustments, we have developed a model for calculating each patient\u2019s optimal dosage and an associated decision support tool (DST). We present the study protocol for a randomised controlled trial using the DST in initiation and adjustment of levothyroxine therapy for thyroidectomised patients. The aim of the study is to assess the tool\u2019s efficacy on therapeutic target achievement and to investigate whether faster dose adjustments lead to better patient-reported outcomes on symptoms and health-related quality of life (HRQoL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We will conduct a randomised, controlled, multicentre, non-blinded, parallel arm trial with three intervention groups and one control group. We will include 240 patients undergoing total or completion thyroidectomy in three Norwegian hospitals. Patients allocated to the three intervention groups will have the option to use the DST in dose adjustments after the operation. Each intervention group will test a different version of the DST. The control group will follow standard care practice. The randomisation ratio will be 1:1:1:1. Our primary outcome is proportion of patients within biochemical target at 8 weeks postoperatively. Secondary outcomes are distance from biochemical target at 8 weeks, mean time to achieve biochemical target, change in HRQoL, adverse events and number of days absence from work.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study has been approved by the Norwegian Medical Products Agency (CIV-23-02-042436), The Norwegian Ethics Committee for Clinical Trials on Medicinal Products and Medical Devices (547311), and the patient protection officer at the University Hospital of North Norway. All participants will give written informed consent prior to inclusion. Results will be published open access in international peer-reviewed journals and communicated to the public through appropriate channels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06455371\">NCT06455371<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-103512","type":"journal-article","created":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T21:55:25Z","timestamp":1773870925000},"page":"e103512","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Impact of a patient-centred levothyroxine decision support tool on rapid achievement of target dosage and improved patient outcomes: protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06455371","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-0798-9848","authenticated-orcid":false,"given":"Solveig Robertsen","family":"Konst","sequence":"first","affiliation":[{"name":"Department of Clinical Medicine, UiT The Arctic University of Norway, Troms\u00f8, Norway"},{"name":"Department of Breast and Endorcrine surgery, University Hospital of North Norway, Troms\u00f8, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"Hellemo","sequence":"additional","affiliation":[{"name":"SINTEF Industry, Trondheim, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beate Hennie","family":"Garcia","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, UiT The Arctic University of Norway, Tromso, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vegard Heimly","family":"Brun","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, UiT The Arctic University of Norway, Troms\u00f8, Norway"},{"name":"Department of Breast and Endorcrine surgery, University Hospital of North Norway, Troms\u00f8, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,3,18]]},"reference":[{"key":"2026031814551022000_16.3.e103512.1","unstructured":"Norwegian Institute of Public Health . Norwegian prescription database. Available: https:\/\/www.reseptregisteret.no [Accessed 3 Nov 2023]."},{"key":"2026031814551022000_16.3.e103512.2","doi-asserted-by":"crossref","DOI":"10.3389\/fendo.2020.626268","article-title":"Levothyroxine Therapy in Thyrodectomized Patients","volume":"11","author":"Miccoli","year":"2020","journal-title":"Front Endocrinol (Lausanne)"},{"key":"2026031814551022000_16.3.e103512.3","doi-asserted-by":"publisher","DOI":"10.1089\/thy.2014.0028"},{"key":"2026031814551022000_16.3.e103512.4","doi-asserted-by":"crossref","first-page":"166","DOI":"10.1016\/j.jss.2019.03.049","article-title":"Identifying Predictors of Prolonged Levothyroxine Dose Adjustment After Thyroidectomy","volume":"242","author":"Atruktsang","year":"2019","journal-title":"J Surg Res"},{"key":"2026031814551022000_16.3.e103512.5","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1016\/j.surg.2018.04.097","article-title":"The optimal dosing scheme for levothyroxine after thyroidectomy: A comprehensive comparison and evaluation","volume":"165","author":"Zaborek","year":"2019","journal-title":"Surgery"},{"key":"2026031814551022000_16.3.e103512.6","doi-asserted-by":"crossref","first-page":"31969","DOI":"10.3402\/fnr.v60.31969","article-title":"Iodine status in the Nordic countries - past and present","volume":"60","author":"Nystr\u00f6m","year":"2016","journal-title":"Food Nutr Res"},{"key":"2026031814551022000_16.3.e103512.7","doi-asserted-by":"crossref","first-page":"841","DOI":"10.1177\/10507256251363120","article-title":"2025 American Thyroid Association Management Guidelines for Adult Patients with Differentiated Thyroid Cancer","volume":"35","author":"Ringel","year":"2025","journal-title":"Thyroid"},{"key":"2026031814551022000_16.3.e103512.8","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1002\/bjs.5157","article-title":"Optimization of thyroxine replacement therapy after total or near-total thyroidectomy for benign thyroid disease","volume":"93","author":"Olubowale","year":"2006","journal-title":"Br J Surg"},{"key":"2026031814551022000_16.3.e103512.9","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.2010.03940.x"},{"key":"2026031814551022000_16.3.e103512.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jamcollsurg.2012.12.002"},{"key":"2026031814551022000_16.3.e103512.11","doi-asserted-by":"crossref","DOI":"10.3390\/ijerph17124295","article-title":"The Impact of Thyroid Diseases on the Working Life of Patients: A Systematic Review","volume":"17","author":"Leso","year":"2020","journal-title":"Int J Environ Res Public Health"},{"key":"2026031814551022000_16.3.e103512.12","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-4468"},{"key":"2026031814551022000_16.3.e103512.13","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1007\/s40618-022-01903-6","article-title":"Changes in quality of life after thyroidectomy in subjects with thyroid cancer in relation to the dose of levothyroxine","volume":"46","author":"Monzani","year":"2023","journal-title":"J Endocrinol Invest"},{"key":"2026031814551022000_16.3.e103512.14","doi-asserted-by":"publisher","DOI":"10.1089\/thy.2014.0111"},{"key":"2026031814551022000_16.3.e103512.15","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/j.jamcollsurg.2015.10.005","article-title":"Prospective Intervention of a Novel Levothyroxine Dosing Protocol Based on Body Mass Index after Thyroidectomy","volume":"222","author":"Elfenbein","year":"2016","journal-title":"J Am Coll Surg"},{"key":"2026031814551022000_16.3.e103512.16","doi-asserted-by":"crossref","first-page":"2559","DOI":"10.1007\/s00405-019-05523-4","article-title":"Optimal levothyroxine dose in post-total thyroidectomy patients: a prediction model for initial dose titration","volume":"276","author":"Al-Dhahri","year":"2019","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"2026031814551022000_16.3.e103512.17","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1089\/thy.2023.0033","article-title":"Computer-Assisted Levothyroxine Dose Selection for the Treatment of Postoperative Hypothyroidism","volume":"33","author":"Barrio","year":"2023","journal-title":"Thyroid"},{"key":"2026031814551022000_16.3.e103512.18","doi-asserted-by":"crossref","first-page":"1297","DOI":"10.1089\/thy.2021.0125","article-title":"Patient-Tailored Levothyroxine Dosage with Pharmacokinetic\/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy","volume":"31","author":"Brun","year":"2021","journal-title":"Thyroid"},{"key":"2026031814551022000_16.3.e103512.19","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-025-03668-w"},{"key":"2026031814551022000_16.3.e103512.20","doi-asserted-by":"crossref","unstructured":"Hellemo L , Brun VH . 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Available: https:\/\/www.helsedirektoratet.no\/retningslinjer\/thyroideakreft-skjoldbruskkjertelkreft-handlingsprogram [Accessed 21 Jan 2026]."},{"key":"2026031814551022000_16.3.e103512.22","doi-asserted-by":"crossref","first-page":"1069","DOI":"10.1089\/thy.2015.0209","article-title":"Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO","volume":"25","author":"Watt","year":"2015","journal-title":"Thyroid"},{"key":"2026031814551022000_16.3.e103512.23","doi-asserted-by":"publisher","DOI":"10.3109\/07853890109002089"},{"key":"2026031814551022000_16.3.e103512.24","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2024-081123","article-title":"CONSORT 2025 statement: updated guideline for reporting randomised trials","volume":"389","author":"Hopewell","year":"2025","journal-title":"BMJ"},{"key":"2026031814551022000_16.3.e103512.25","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1001\/jama.2024.21972","article-title":"World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants","volume":"333","year":"2025","journal-title":"JAMA"},{"key":"2026031814551022000_16.3.e103512.26","unstructured":"Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC (Text with EEA relevance). 2017."},{"key":"2026031814551022000_16.3.e103512.27","unstructured":"International Organization for Standardization . 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