Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial
Background Many older persons use the thyroid hormone levothyroxine which is often continued for life. Scientifically, there is much uncertainty whether simple continuation is the optimal approach. First, the physical need for levothyroxine can decrease with age thereby posing a higher risk of overt...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e070741.full |
| _version_ | 1797839009446100992 |
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| author | Simon P Mooijaart Rosalinde K E Poortvliet Jacobijn Gussekloo Robert S Du Puy Olaf M Dekkers A Janneke Ravensberg |
| author_facet | Simon P Mooijaart Rosalinde K E Poortvliet Jacobijn Gussekloo Robert S Du Puy Olaf M Dekkers A Janneke Ravensberg |
| author_sort | Simon P Mooijaart |
| collection | DOAJ |
| description | Background Many older persons use the thyroid hormone levothyroxine which is often continued for life. Scientifically, there is much uncertainty whether simple continuation is the optimal approach. First, the physical need for levothyroxine can decrease with age thereby posing a higher risk of overtreatment and adverse effects. Second, large trials in subclinical hypothyroidism have shown no benefit for the use of levothyroxine. Interestingly, guidelines do not address re-evaluation of the indication. This self-controlled trial aims to determine the effects of discontinuation of levothyroxine treatment in older adults.Methods and analysis Participants are community-dwelling subjects aged ≥60 years using levothyroxine continuously at a stable dosage of ≤150 µg and a level of thyroid-stimulating hormone (TSH) <10 mU/L. After a control period of 12 weeks, levothyroxine treatment is discontinued gradually using a stepwise approach with regular monitoring of thyroid function guided by their GP. The primary outcome is the proportion of participants withdrawn from levothyroxine while maintaining a free T4 level within the reference range and a TSH level <10 mU/L, 52 weeks after the start of discontinuation. Secondary outcomes are compared with the control period (self-controlled) and include among others, the effects on thyroid-specific and general health-related quality of life. Furthermore, patients’ attitudes towards deprescribing and regret regarding discontinuing levothyroxine treatment will be recorded. A total of 513 participants will be recruited to estimate the expected proportion of 50% with a 95% CI ranging from 45% to 55%.Ethics and dissemination Approval was obtained from the institutional Medical Ethics Committee. The Older People Advisory Board Health and Well-being has reviewed the research proposal and their comments were used for improvement. In line with the funding policies of the grant organisation funding this study, the study results will be proactively disseminated to the general public and key public health stakeholders.Trial registration number NL7978; NCT05821881. |
| first_indexed | 2024-04-09T15:51:16Z |
| format | Article |
| id | doaj.art-df078c57b9d445728bbd628abf29608a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T15:51:16Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-df078c57b9d445728bbd628abf29608a2023-04-26T09:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-070741Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trialSimon P Mooijaart0Rosalinde K E Poortvliet1Jacobijn Gussekloo2Robert S Du Puy3Olaf M Dekkers4A Janneke Ravensberg5Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, Zuid-Holland, NetherlandsDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, The NetherlandsLeiden University Medical Center, Department of Public Health and Primary Care (V0-P), PO Box 9600, 2300 RC Leiden, Netherlands6 Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The NetherlandsprofessorDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, NetherlandsBackground Many older persons use the thyroid hormone levothyroxine which is often continued for life. Scientifically, there is much uncertainty whether simple continuation is the optimal approach. First, the physical need for levothyroxine can decrease with age thereby posing a higher risk of overtreatment and adverse effects. Second, large trials in subclinical hypothyroidism have shown no benefit for the use of levothyroxine. Interestingly, guidelines do not address re-evaluation of the indication. This self-controlled trial aims to determine the effects of discontinuation of levothyroxine treatment in older adults.Methods and analysis Participants are community-dwelling subjects aged ≥60 years using levothyroxine continuously at a stable dosage of ≤150 µg and a level of thyroid-stimulating hormone (TSH) <10 mU/L. After a control period of 12 weeks, levothyroxine treatment is discontinued gradually using a stepwise approach with regular monitoring of thyroid function guided by their GP. The primary outcome is the proportion of participants withdrawn from levothyroxine while maintaining a free T4 level within the reference range and a TSH level <10 mU/L, 52 weeks after the start of discontinuation. Secondary outcomes are compared with the control period (self-controlled) and include among others, the effects on thyroid-specific and general health-related quality of life. Furthermore, patients’ attitudes towards deprescribing and regret regarding discontinuing levothyroxine treatment will be recorded. A total of 513 participants will be recruited to estimate the expected proportion of 50% with a 95% CI ranging from 45% to 55%.Ethics and dissemination Approval was obtained from the institutional Medical Ethics Committee. The Older People Advisory Board Health and Well-being has reviewed the research proposal and their comments were used for improvement. In line with the funding policies of the grant organisation funding this study, the study results will be proactively disseminated to the general public and key public health stakeholders.Trial registration number NL7978; NCT05821881.https://bmjopen.bmj.com/content/13/4/e070741.full |
| spellingShingle | Simon P Mooijaart Rosalinde K E Poortvliet Jacobijn Gussekloo Robert S Du Puy Olaf M Dekkers A Janneke Ravensberg Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial BMJ Open |
| title | Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial |
| title_full | Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial |
| title_fullStr | Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial |
| title_full_unstemmed | Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial |
| title_short | Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial |
| title_sort | effects of discontinuation of levothyroxine treatment in older adults protocol for a self controlled trial |
| url | https://bmjopen.bmj.com/content/13/4/e070741.full |
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