FDG-PET/CT in indeterminate thyroid nodules: cost-utility analysis alongside a randomised controlled trial

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Abstract

Purpose

To evaluate cost-effectiveness of an [ ¹⁸F]FDG-PET/CT-driven diagnostic workup as compared to diagnostic surgery, for thyroid nodules with Bethesda III/IV cytology. [ ¹⁸F]FDG-PET/CT avoids 40% of futile diagnostic surgeries for benign Bethesda III/IV nodules.

Methods

Lifelong societal costs and quality-adjusted life years (QALYs) were assessed for 132 patients participating in a randomised controlled multicentre trial comparing [ ¹⁸F]FDG-PET/CT to diagnostic surgery. The observed 1-year trial results were extrapolated using a Markov model. The probability of cost-effectiveness was estimated using cost-effectiveness acceptability curves, taking uncertainty about sampling, imputation, and parameters into account.

Results

The observed 1-year cost difference of [ ¹⁸F]FDG-PET/CT as compared to diagnostic surgery was − €1000 (95% CI: − €2100 to €0) for thyroid nodule–related care (p = 0.06). From the broader societal perspective, the 1-year difference in total societal costs was − €4500 (− €9200 to €150) (p = 0.06). Over the modelled lifelong period, the cost difference was − €9900 (− €23,100 to €3200) (p = 0.14). The difference in QALYs was 0.019 (− 0.045 to 0.083) at 1 year (p = 0.57) and 0.402 (− 0.581 to 1.385) over the lifelong period (p = 0.42). For a willingness to pay of €50,000 per QALY, an [ ¹⁸F]FDG-PET/CT-driven work-up was the cost-effective strategy with 84% certainty.

Conclusion

Following the observed reduction in diagnostic surgery, an [ ¹⁸F]FDG-PET/CT-driven diagnostic workup reduced the 1-year thyroid nodule–related and societal costs while sustaining quality of life. It is very likely cost-effective as compared to diagnostic surgery for Bethesda III/IV nodules.

Trial registration number: This trial is registered with ClinicalTrials.gov: NCT02208544 (5 August 2014), https://clinicaltrials.gov/ct2/show/NCT02208544.

Supplementary Information

The online version contains supplementary material available at 10.1007/s00259-022-05794-w.

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Most cited references 66

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2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

Bryan Haugen, Erik Alexander, Keith Bible … (2016)

Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer.

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Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

M. Herdman, C. Gudex, S Lloyd … (2011)

Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.

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The 2017 Bethesda System for Reporting Thyroid Cytopathology.

Syed Z. Ali, Edmund S Cibas (2017)

The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) established a standardized, category-based reporting system for thyroid fine-needle aspiration (FNA) specimens. The 2017 revision reaffirms that every thyroid FNA report should begin with one of six diagnostic categories, the names of which remain unchanged since they were first introduced: (i) nondiagnostic or unsatisfactory; (ii) benign; (iii) atypia of undetermined significance (AUS) or follicular lesion of undetermined significance (FLUS); (iv) follicular neoplasm or suspicious for a follicular neoplasm; (v) suspicious for malignancy; and (vi) malignant. There is a choice of two different names for some of the categories. A laboratory should choose the one it prefers and use it exclusively for that category. Synonymous terms (e.g., AUS and FLUS) should not be used to denote two distinct interpretations. Each category has an implied cancer risk that ranges from 0% to 3% for the "benign" category to virtually 100% for the "malignant" category, and, in the 2017 revision, the malignancy risks have been updated based on new (post 2010) data. As a function of their risk associations, each category is linked to updated, evidence-based clinical management recommendations. The recent reclassification of some thyroid neoplasms as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) has implications for the risk of malignancy, and this is accounted for with regard to diagnostic criteria and optional notes. Such notes can be useful in helping guide surgical management.

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Author and article information

Contributors

Elizabeth J. de Koster:

ORCID: http://orcid.org/0000-0001-8111-1172

Lisanne.deKoster@radboudumc.nl

Journal

Journal ID (nlm-ta): Eur J Nucl Med Mol Imaging

Journal ID (iso-abbrev): Eur J Nucl Med Mol Imaging

Title: European Journal of Nuclear Medicine and Molecular Imaging

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 1619-7070

ISSN (Electronic): 1619-7089

Publication date (Electronic): 18 April 2022

Publication date PMC-release: 18 April 2022

Publication date (Print): 2022

Volume: 49

Issue: 10

Pages: 3452-3469

Affiliations

[1 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Radiology and Nuclear Medicine, , Radboud University Medical Centre, ; Nijmegen, the Netherlands

[2 ]GRID grid.10419.3d, ISNI 0000000089452978, Department of Radiology, Section of Nuclear Medicine, , Leiden University Medical Center, ; Leiden, the Netherlands

[3 ]GRID grid.413591.b, ISNI 0000 0004 0568 6689, Department of Internal Medicine, , Haga Hospital, ; The Hague, the Netherlands

[4 ]GRID grid.414725.1, ISNI 0000 0004 0368 8146, Department of Internal Medicine, Meander Medical Centre, ; Amersfoort, the Netherlands

[5 ]GRID grid.415930.a, Department of Radiology and Nuclear Medicine, , Rijnstate Hospital, ; Arnhem, the Netherlands

[6 ]GRID grid.452490.e, Department of Biomedical Sciences and Humanitas Clinical and Research Centre, Department of Nuclear Medicine, , Humanitas University, ; Milan, Italy

[7 ]GRID grid.5645.2, ISNI 000000040459992X, Department of Internal Medicine, , Erasmus University Medical Centre, ; Rotterdam, the Netherlands

[8 ]GRID grid.10419.3d, ISNI 0000000089452978, Department of Surgery, , Leiden University Medical Center, ; Leiden, the Netherlands

[9 ]GRID grid.6214.1, ISNI 0000 0004 0399 8953, Biomedical Photonic Imaging Group, , University of Twente, ; Enschede, the Netherlands

[10 ]GRID grid.10419.3d, ISNI 0000000089452978, Department of Biomedical Data Sciences, , Leiden University Medical Center, ; Leiden, the Netherlands

Author information

Elizabeth J. de Koster http://orcid.org/0000-0001-8111-1172

Dennis Vriens http://orcid.org/0000-0001-5762-6766

Maarten O. van Aken http://orcid.org/0000-0002-6686-5459

Lioe-Ting Dijkhorst-Oei http://orcid.org/0000-0001-7673-3743

Wim J. G. Oyen http://orcid.org/0000-0001-8235-7078

Robin P. Peeters http://orcid.org/0000-0001-7732-9371

Abbey Schepers http://orcid.org/0000-0003-0504-3491

Lioe-Fee de Geus-Oei http://orcid.org/0000-0003-1817-2743

Wilbert B. van den Hout http://orcid.org/0000-0002-6425-0135

Article

Publisher ID: 5794

DOI: 10.1007/s00259-022-05794-w

PMC ID: 9308600

PubMed ID: 35435497

SO-VID: a0203d0d-9eb8-4f6f-aa10-52e420da520b

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 12 January 2022

Date accepted : 3 April 2022

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004622, KWF Kankerbestrijding;

Award ID: KUN 2014-6514

Award Recipient : Dennis Vriens

Custom metadata

ScienceOpen disciplines: Radiology & Imaging

Keywords: [18f]fdg-pet/ct,indeterminate thyroid nodule,thyroid carcinoma,thyroid surgery,cost-effectiveness,costs,health-related quality of life,qaly

Data availability:

ScienceOpen disciplines: Radiology & Imaging

Keywords: [18f]fdg-pet/ct, indeterminate thyroid nodule, thyroid carcinoma, thyroid surgery, cost-effectiveness, costs, health-related quality of life, qaly

FDG-PET/CT in indeterminate thyroid nodules: cost-utility analysis alongside a randomised controlled trial

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Probing cerebral hemodynamics with BOLD fMRI

Most cited references 66

2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

The 2017 Bethesda System for Reporting Thyroid Cytopathology.

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