Coll PP, Abourizk NN. Successful withdrawal of thyroid hormone therapy in nursing home patients. Journal of the American Board of Family Practice / American Board of Family Practice 2000;13:403-07
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/11117336
Full text article: https://www.jabfm.org/content/jabfp/13/6/403.full.pdf
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants 22 enrolled, 22 completed
Age: 78 years (range 50 to 90 years) Sex: 20 female, 2 male Included people with dementia: No Inclusion criteria: · Resident at a participating aged care facility · Taking thyroid hormone therapy at the time the study started Exclusion criteria: · Thyroid-stimulating hormone level of more than 10 mU/L was noted anywhere in their records · Taking lithium or amiodarone at the time the study started · History of thyroid hormone therapy because of a thyroid nodule or goiter · Thyroid-stimulating hormone level of more than 7 mU/L were excluded from the study, and their primary care physicians were informed that they had an elevated thyroid-stimulating hormone level · Palpable thyroid nodule during a neck examination performed by one of the two authors Country: United States of America Setting: Residential aged care facilities – four |
| Interventions | Medicine: Levothyroxine
Withdrawal schedule: · Thyroid hormone therapy dose reduced by as close to one-half as was practically possible If they were taking: o 125 mcg daily, their dose was reduced to 75 mcg daily o 75 mcg daily, their dose was reduced to 50 mcg daily · Follow-up thyroid-stimulating hormone level was measured approximately 1 month later. If a patient’s level was: o < 7 mU/L: patient was excluded from the study and resumed his or her original dose of thyroid hormone therapy o > 7 mU/L: thyroid hormone therapy discontinued |
| Outcomes | Successful deprescribing
Adverse effects |
| Dates | Dates: Not described
Follow-up duration: Three months |
| Funding sources | American Academy of Family Physicians Foundation (grant #G9519) |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | One group – not randomized. |
| Allocation concealment (selection bias) | High risk | As above. |
| Blinding of participants and personnel (performance bias) | High risk | Open single-arm study. |
| Blinding of outcome assessment (detection bias) | High risk | As above. |
| Incomplete outcome data (attrition bias) | Low risk | No missing outcome data. |
| Selective reporting (reporting bias) | Low risk | Research Ethics Committee approval granted, so protocol probably in place before recruitment. Intended outcomes not available. The stated outcomes in the paper were reported. |
| Confounding (non-randomized) | Unclear risk | There was not a concurrent control group. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Truly representative of the average residential aged care resident on thyroid replacement hormone who have borderline Thyroid-Stimulating Hormone levels. |
| Selection of the non-exposed cohort | Ascertainment of exposure was through secure records. | |
| Ascertainment of exposure | There was no concurrent control group. | |
| Demonstration that outcome of interest was not present at start of study | They demonstrated that the outcome of interest was not present at the start of the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The studycontrols for thyroid replacement therapy withdrawal. |
| Outcome bias
Selection bias |
Assessment of outcome | Outcome assessment through record linkage. |
| Was follow-up long enough for outcomes to occur
|
Follow-up of three months was sufficient to have the thyroid-stimulating hormone levelsnormalize,though it would have been interesting to see if this was maintained longer term.
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| Adequacy of follow-up of cohorts | Complete follow-up with all subjects accounted for. | |
| Representativeness of the exposed cohort | ||
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