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| Name | Class |
|---|---|
| SINTEF Health Research | OTHER |
| Helseapps | UNKNOWN |
| Norinnova | UNKNOWN |
| Helse Nord |
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Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Current clinical practise. Levothyroxine dose is calculated based on weight and adjusted according to TSH-level at 6-8 week intervals until biochemical target is reached | |
| DST 1 | Experimental | Levothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples. |
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| DST 2 | Experimental | Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples. |
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| DST 3 | Experimental | Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision support tool | Other | Patients in the intervention groups are given the option to use the decision support tool when adjusting the levothyroxine dose after total thyroidectomy. Levothyroxine therapy is not a part of the intervention, as all patients receive this therapy regardless of study participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients at biochemical target | Number of patients at biochemical target. Biochemical target is TSH (thyroid stimulating hormone) 0,5-2,0 mIE/L for patients on substitution therapy and 0,1-0,5 mIE/L for patients on suppression therapy | Outcome is measured at 8 weeks, 6 months and 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to biochemical target | Time to biochemical target is reached measured in days. Day 0 is day of surgery | Measured at 18 months after surgery |
| Distance from biochemical target | Distance measured in TSH units. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vegard Brun, PhD | Contact | 0047 77669260 | vegard.heimly.brun@unn.no | |
| Solveig Brun, cand.med | Contact | 004745253006 | solveig.konst@unn.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33980057 | Background | Brun VH, Eriksen AH, Selseth R, Johansson K, Vik R, Davidsen B, Kaut M, Hellemo L. Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy. Thyroid. 2021 Sep;31(9):1297-1304. doi: 10.1089/thy.2021.0125. Epub 2021 Jun 22. | |
| 41857858 | Derived |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D013964 | Thyroid Neoplasms |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Measured at 8 weeks post surgery |
| Patient reported outcome - ThyPRO39 questionnaire | Patient reported outcomes measured by the validated questionnaire ThyPRO39. The ThyPRO39 questionnaire consist of 12 scales that covers physical symptoms (goiter, eye symptoms, hypo- and hyperthyroid symptoms), cosmetic appearance, physical, mental and social well-being and function. Each item is rated on a 0-4 scale from 0 = no symptoms/problems to 4 = Severe symptoms/problems. The average score of items in a scale is divided by four and multiplied by 100 to yield thirteen 0-100 scales, with higher scores indicating worse health status. The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups. | Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery |
| Patient reported outcome - RAND-36 questionnaire | Rand-36 is the Norwegian translation of the SF-36 version 1.2. The questionnaire consists of 36 items, grouped into eight multi-item scales that measure physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The scores can also be summarized into two summary scores for overall physical and mental health. Items scores will be transformed to 0-100 point scales (0=worst, 100=best) using the SF-36 scoring algorithm The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups. | Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery |
| Abscence from work | Days with sick-leave from work the first year after surgery. Data collected from the Norwegian national sick-leave registry | Measured at18 months after surgery |
| Oslo University Hospital | Recruiting | Oslo | Norway |
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| University Hospital of North Norway | Recruiting | Tromsø | 9010 | Norway |
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| Konst SR, Hellemo L, Garcia BH, Brun VH. 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. BMJ Open. 2026 Mar 18;16(3):e103512. doi: 10.1136/bmjopen-2025-103512. |
| D006258 |
| Head and Neck Neoplasms |