Evidence map›Paper›PMID 27798756›Full record

ArticleClinical drug investigation2017

The Economic Impact of Levothyroxine Dose Adjustments: the CONTROL HE Study.

Frank R Ernst, Peri Barr, Riad Elmor, Walter Sandulli, Lionel Thevathasan, Arnold B Sterman, Jessica Goldenberg, Kevin Vora

Abstract read
In one paragraph

Article in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Approach to the Patient Considering Thyroid Hormone Deprescribing.The Journal of clinical endocrinology and metabolism · 2026
    Review
  6. Article
  7. Article
  8. Appropriateness of Levothyroxine Prescription: A Multicenter Retrospective Study.The Journal of clinical endocrinology and metabolism · 2024
    Article
  9. Review
  10. Observational
  11. Article
  12. Article
  13. Article
  14. Article
  15. L-T4 Therapy in Enteric Malabsorptive Disorders.Frontiers in endocrinology · 2021
    Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Levothyroxine Therapy in Thyrodectomized Patients.Frontiers in endocrinology · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Frank R ErnstHealth Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA. frankrernstrx@gmail.com.
Peri BarrHealth Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA.
Riad ElmorHealth Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA.
Walter SandulliAkrimax Pharmaceuticals, LLC, Cranford, NJ, USA.
Lionel ThevathasanLT Associates Ltd, Paris, France.
Arnold B StermanArnold Sterman, MD, LLC, Morristown, NJ, USA.
Jessica GoldenbergAkrimax Pharmaceuticals, LLC, Cranford, NJ, USA.
Kevin VoraAkrimax Pharmaceuticals, LLC, Cranford, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn general, hypothyroidism can be adequately treated with a consistent daily dose of levothyroxine. However, the need for levothyroxine dose adjustments is frequent in clinical practice. The extent to which levothyroxine dose adjustments increase the utilization of healthcare resources has not previously been described in the clinical literature.

objectiveThe primary objective of our study was to measure the effect of levothyroxine dose adjustments in terms of their utilization of healthcare resources including direct and indirect costs. A secondary goal was to identify any differences in patient characteristics that may be responsible for levothyroxine dose adjustments.

methodsA retrospective medical chart review was conducted among patients of selected healthcare providers in the USA. Patients who were recently started on levothyroxine therapy (<6 months) were excluded to avoid situations that were more likely attributable to treatment initiation than inadequate therapeutic effect. Trained nurses extracted data from patient charts and electronic medical record systems for review. We analyzed the cost of resources consumed by the frequency of levothyroxine dose changes over 24 months: 0 dose changes (no dose adjustment group); one dose change, two dose changes, three or more dose changes (≥1 dose adjustment group).

resultsThe study included 454 patients. Overall estimated resource utilization was higher per patient in the ≥1 dose adjustment group (US$5824) vs. the no dose adjustment group (US$3166) during the 24-month study period. When direct and indirect costs were combined, overall costs of care were greatest in patients requiring three or more dose adjustments (US$8220/patient). Patients in this cohort incurred 2.5-fold greater total costs compared with patients requiring no dose adjustments (US$8220 vs. US$3166). Among the 58 patients in the group requiring three or more dose adjustments, mean direct medical costs were significantly higher than in the patients requiring no dose adjustments (US$6387 vs. US$2182). Patients with at least one dose adjustment experienced a 40.3% increase in lost productivity vs. patients who had no dose adjustments (US$1381 vs. US$984). Loss of productivity was highest among patients with three or more levothyroxine dose adjustments. Among this cohort, there was an 86.4% increase in lost productivity vs. patients who had no levothyroxine dose adjustments (US$1833 vs. US$984).

conclusionsPatients experiencing multiple levothyroxine dose adjustments were shown to consume more healthcare resources, resulting in higher costs than those who required no dose adjustments. Each care episode contributed to lost time and wages with total estimated lost productivity escalating with increasing levothyroxine dose adjustments over a 24-month period.

Indexed as

Drug CostsAdolescentAdultAgedAged, 80 and overFemaleHealth Care CostsHealth ResourcesHumansMaleMiddle AgedRetrospective StudiesThyrotropinThyroxineThyrotropinThyroxine

Identifiers

PMID27798756
PMCPMC5209418

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.