Reference intervals in the diagnosis of thyroid dysfunction: treating patients not numbers

Jonklaas, Jacqueline; Razvi, Salman

doi:10.1016/s2213-8587(18)30371-1

Cited by 100Thyroid Disorders and TreatmentsClinical Laboratory Practices and Quality ControlThyroid Cancer Diagnosis and Treatment

Reference intervals in the diagnosis of thyroid dysfunction: treating patients not numbers

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Jonklaas, Jacqueline, Razvi, Salman·2019·The Lancet Diabetes & Endocrinology

DOI 10.1016/s2213-8587(18)30371-1

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Abstract

Although assigning a diagnosis of thyroid dysfunction appears quite simple, this is often not the case. Issues that make it unclear whether thyroid function is normal include transient changes in thyroid parameters, inter-individual and intra-individual differences in thyroid parameters, age-related differences, and ethnic variations. In addition, a statistically calculated distribution of thyroid analytes does not necessarily coincide with intervals or cutoffs that have predictive value for beneficial or adverse health outcomes. Based on current clincial trial data, it is unclear which individuals with mild thyroid-stimulating hormone elevations will benefit from levothyroxine treatment. For example, only a small number of patients with thyroid-stimulating hormone values of more than 10 mIU/L have been studied in a randomised manner. Even if therapy is initiated for abnormal thyroid function, not all treated individuals are maintained at the desired treatment target, and therefore might still be at risk. The consequence of this is that each patient's thyroid function needs to be assessed on an individual basis with the entire clinical picture in mind. Monitoring also needs to be vigilant, and the targets for treatment reassessed continually.

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Most cases of primary hypothyroidism are initially mild or subclinical and there is no consensus on when to start treatment.
“This issue is further complicated by the evidence that most cases of primary hypothyroidism are initially mild or subclinical and there is no consensus on when to start treatment (3, 9).”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [3]
Serum TSH concentrations may be altered by patient demographic characteristics, comorbidities, concomitant drug use, and assay interference.
“It is worth noting that serum TSH concentrations may be altered by the patient’s demographic characteristics and comorbidities, concomitant drug use, assay interference and so on (3, 4).”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [3]
Diagnostic reference ranges are, by definition, a one-size-fits-all solution to the challenge of interpreting biomarker results.
“Diagnostic reference ranges are, by definition, a one-size-fits-all solution to the challenge of interpreting biomarker results [37].”
From Challenges in Interpreting Thyroid Stimulating Hormone Results in the Diagnosis of Thyroid Dysfunction (2019) · cites this paper as [37]

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Karmisholt, J., Andersen, S., & Laurberg, P. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2010-1521 · Cited by 103 · see citing works
Age‐specific <scp>TSH</scp> reference ranges have minimal impact on the diagnosis of thyroid dysfunction
Kahapola‐Arachchige, K. M., Hadlow, N., Wardrop, R., Lim, E. M., & Walsh, J. P. (2012) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2012.04463.x · Cited by 95 · see citing works
Systemic Thyroid Hormone Status During Levothyroxine Therapy In Hypothyroidism: A Systematic Review and Meta-Analysis
McAninch, E. A., Rajan, K. B., Miller, C. H., & Bianco, A. C. (2018) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2018-01361 · Cited by 94 · see citing works
Thyroxine alone or thyroxine plus triiodothyronine replacement therapy for hypothyroidism
Chao, M., Jiawei, X., Xia, H., Guoming, W., Yangang, W., Xufu, W., & Shuyao, Z. (2009) · Nuclear Medicine Communications · doi:10.1097/mnm.0b013e32832c79e0 · Cited by 93 · see citing works
Reference limits of serum TSH and free T4 are significantly influenced by race and age in an urban outpatient medical practice
Bissell, M. G. (2010) · Yearbook of Pathology and Laboratory Medicine · doi:10.1016/s1077-9108(09)79368-5 · Cited by 92 · see citing works
Thyroid Function Within the Reference Range and the Risk of Stroke: An Individual Participant Data Analysis
Chaker, L., Baumgartner, C., den Elzen, W. P. J., Collet, T.-H., Ikram, M. A., Blum, M. R., Dehghan, A., Drechsler, C., Luben, R. N., Portegies, M. L. P., et al. (2016) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2016-2255 · Cited by 92 · see citing works
Self-citation
Serum Thyroid Function, Mortality and Disability in Advanced Old Age: The Newcastle 85+ Study
Pearce, S. H. S., Razvi, S., Yadegarfar, M. E., Martin-Ruiz, C., Kingston, A., Collerton, J., Visser, T. J., Kirkwood, T. B., & Jagger, C. (2016) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2016-1935 · Cited by 91 · see citing works
Self-citation
Significant inverse relationship between serum free T4 concentration and body mass index in euthyroid subjects: differences between smokers and nonsmokers
Makepeace, A., Bremner, A., O'Leary, P. C., Leedman, P. J., Feddema, P., Michelangeli, V. P., & Walsh, J. P. (2008) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2008.03239.x · Cited by 90 · see citing works
Serum TSH Levels in Smokers and Non-Smokers. The 5th Tromsø Study
Jorde, R., & Sundsfjord, J. (2006) · Experimental and Clinical Endocrinology & Diabetes · doi:10.1055/s-2006-924264 · Cited by 86 · see citing works
Homeostatic equilibria between free thyroid hormones and pituitary thyrotropin are modulated by various influences including age, body mass index and treatment
Hoermann, R., Midgley, J. E. M., Giacobino, A., Eckl, W. A., Wahl, H. G., Dietrich, J. W., & Larisch, R. (2014) · Clinical Endocrinology · doi:10.1111/cen.12527 · Cited by 82 · see citing works
Age- and gender-specific reference intervals of TSH and free T4 in an iodine-replete area: Data from Korean National Health and Nutrition Examination Survey IV (2013–2015)
Park, S. Y., Kim, H. I., Oh, H.-K., Kim, T. H., Jang, H. W., Chung, J. H., Shin, M.-H., & Kim, S. W. (2018) · PLOS ONE · doi:10.1371/journal.pone.0190738 · Cited by 79 · see citing works
A Progress Report of the IFCC Committee for Standardization of Thyroid Function Tests
Thienpont, L. M., Van Uytfanghe, K., Van Houcke, S., Das, B., Faix, J. D., MacKenzie, F., Quinn, F. A., Rottmann, M., & Van den Bruel, A. (2014) · European Thyroid Journal · doi:10.1159/000358270 · Cited by 72 · see citing works
Thyrotropin Levels Within the Lower Normal Range Are Associated With an Increased Risk of Hip Fractures in Euthyroid Women, But Not Men, Over the Age of 65 Years
Leader, A., Ayzenfeld, R. H., Lishner, M., Cohen, E., Segev, D., & Hermoni, D. (2014) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2013-2474 · Cited by 61 · see citing works
Low-Normal or High-Normal Thyrotropin Target Levels During Treatment of Hypothyroidism: A Prospective, Comparative Study
Boeving, A., Paz-Filho, G., Radominski, R. B., Graf, H., & de Carvalho, G. A. (2011) · Thyroid · doi:10.1089/thy.2010.0315 · Cited by 58 · see citing works
Serum TSH within the Reference Range as a Predictor of Future Hypothyroidism and Hyperthyroidism: 11-Year Follow-Up of the HUNT Study in Norway
Åsvold, B. O., VATTEN, L. J., Midthjell, K., & Bjøro, T. (2011) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2011-1724 · Cited by 58 · see citing works
Treatment of clinical hypothyroidism with thyroxine and triiodothyronine: a literature review and metaanalysis
Joffe, R. T., Brimacombe, M., Levitt, A. J., & Stagnaro-Green, A. (2007) · Psychosomatics · doi:10.1176/appi.psy.48.5.379 · Cited by 57 · see citing works
Consenso brasileiro para a abordagem clínica e tratamento do hipotireoidismo subclínico em adultos: recomendações do Departamento de Tireoide da Sociedade Brasileira de Endocrinologia e Metabologia
Sgarbi, J. A., Teixeira, P. D. F. D. S., Maciel, L. M. Z., Mazeto, G. M. F. D. S., Vaisman, M., Montenegro, R. M., & Ward, L. S. (2013) · Arquivos Brasileiros de Endocrinologia & Metabologia · doi:10.1590/s0004-27302013000300003 · Cited by 56 · see citing works
Subclinical thyrotoxicosis in an outpatient population - predictors of outcome: Subclinical thyrotoxicosis - predictors of outcome
Schouten, B. J., Brownlie, B. E. W., Frampton, C. M., & Turner, J. G. (2011) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2010.03908.x · Cited by 55 · see citing works
Development and Pilot Testing of an Encounter Tool for Shared Decision Making About the Treatment of Graves' Disease
Brito, J. P., Castañeda-Guarderas, A., Gionfriddo, M. R., Ospina, N. S., Maraka, S., Dean, D. S., Castro, M. R., Fatourechi, V., Gharib, H., Stan, M. N., et al. (2015) · Thyroid · doi:10.1089/thy.2015.0277 · Cited by 55 · see citing works
Comparison of method-related reference intervals for thyroid hormones: studies from a prospective reference population and a literature review
Barth, J. H., Luvai, A., Jassam, N., Mbagaya, W., Kilpatrick, E. S., Narayanan, D., & Spoors, S. (2018) · Annals of Clinical Biochemistry: International Journal of Laboratory Medicine · doi:10.1177/0004563217691549 · Cited by 53 · see citing works
Roux-en-Y gastric bypass and calorie restriction induce comparable time-dependent effects on thyroid hormone function tests in obese female subjects
Lips, M. A., Pijl, H., van Klinken, J. B., de Groot, G. H., Janssen, I. M. C., van Ramshorst, B., van Wagensveld, B. A., Swank, D. J., Dielen, F. V., & Smit, J. W. A. (2013) · European Journal of Endocrinology · doi:10.1530/eje-13-0339 · Cited by 51 · see citing works
A novel minimal mathematical model of the hypothalamus-pituitary-thyroid axis validated for individualized clinical applications
Goede, S. L., Leow, M. K.-S., Smit, J. W. A., & Dietrich, J. W. (2014) · Mathematical Biosciences · doi:10.1016/j.mbs.2014.01.001 · Cited by 50 · see citing works
Relationship Between Circulating Thyroid‐Stimulating Hormone, Free Thyroxine, and Free Triiodothyronine Concentrations and 9‐Year Mortality in Euthyroid Elderly Adults
Ceresini, G., Marina, M., Lauretani, F., Maggio, M. G., Bandinelli, S., Ceda, G. P., & Ferrucci, L. (2016) · Journal of the American Geriatrics Society · doi:10.1111/jgs.14029 · Cited by 48 · see citing works
Age and the thyrotropin response to hypothyroxinemia
Over, R., Mannan, S., Nsouli-Maktabi, H., Burman, K. D., & Jonklaas, J. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2010-0281 · Cited by 45 · see citing works
Self-citation
Trends, Determinants, and Associations of Treated Hypothyroidism in the United Kingdom, 2005–2014
Razvi, S., Korevaar, T. I. M., & Taylor, P. (2019) · Thyroid · doi:10.1089/thy.2018.0251 · Cited by 45 · see citing works
Self-citation
Higher FT4 or TSH below the normal range are associated with increased risk of dementia: a meta-analysis of 11 studies
Wu, Y., Pei, Y., Wang, F., Xu, D., & Cui, W. (2016) · Scientific Reports · doi:10.1038/srep31975 · Cited by 38 · see citing works
Derivation of a multivariate reference range for pituitary thyrotropin and thyroid hormones: diagnostic efficiency compared with conventional single-reference method
Hoermann, R., Larisch, R., Dietrich, J. W., & Midgley, J. E. M. (2016) · European Journal of Endocrinology · doi:10.1530/eje-16-0031 · Cited by 37 · see citing works
Thyroid Function Variation in the Normal Range, Energy Expenditure, and Body Composition in L-T4–Treated Subjects
Samuels, M. H., Kolobova, I., Antosik, M., Niederhausen, M., Purnell, J. Q., & Schuff, K. G. (2017) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2017-00224 · Cited by 36 · see citing works
Favorable clinical heart and bone effects of anti-thyroid drug therapy in endogenous subclinical hyperthyroidism
Buscemi, S., Verga, S., Cottone, S., Andronico, G., D’Orio, L., Mannino, V., Panzavecchia, D., Vitale, F., & Cerasola, G. (2007) · Journal of Endocrinological Investigation · doi:10.1007/bf03347430 · Cited by 35 · see citing works
Effects of altering levothyroxine dose on energy expenditure and body composition in subjects treated with LT4
Samuels, M. H., Kolobova, I., Niederhausen, M., Purnell, J. Q., & Schuff, K. G. (2018) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2018-01203 · Cited by 35 · see citing works
Prevalence of treated hypothyroidism in the community: Analysis from general practices in North‐East England with implications for the United Kingdom
Ingoe, L. E., Phipps, N., Armstrong, G., Rajagopal, A., Kamali, F., & Razvi, S. (2017) · Clinical Endocrinology · doi:10.1111/cen.13440 · Cited by 34 · see citing works
Self-citation
Defining optimal health range for thyroid function based on the risk of cardiovascular disease
Chaker, L., Korevaar, T. I. M., Rizopoulos, D., Collet, T.-H., Völzke, H., Hofman, A., Rodondi, N., Cappola, A. R., Peeters, R. P., & Franco, O. H. (2017) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2017-00410 · Cited by 33 · see citing works
Rationalizing Thyroid Function Testing: Which TSH Cutoffs Are Optimal for Testing Free T4?
Henze, M., Brown, S. J., Hadlow, N. C., & Walsh, J. P. (2017) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2017-01322 · Cited by 31 · see citing works
Treatment of hypothyroidism with levothyroxine or a combination of levothyroxine plus L-triiodothyronine
Escobar-Morreale, H. F., Botella-Carretero, J. I., & Morreale de Escobar, G. (2015) · Best Practice & Research Clinical Endocrinology & Metabolism · doi:10.1016/j.beem.2014.10.004 · Cited by 30 · see citing works
Mortality and Coronary Heart Disease in Euthyroid Patients
Pereg, D., Tirosh, A., Elis, A., Neuman, Y., Mosseri, M., Segev, D., Lishner, M., & Hermoni, D. (2012) · The American Journal of Medicine · doi:10.1016/j.amjmed.2011.11.023 · Cited by 29 · see citing works
Sex-Specific Associations Between Thyrotropin and Serum Lipid Profiles
Meisinger, C., Ittermann, T., Tiller, D., Agger, C., Nauck, M. A., Schipf, S., Wallaschofski, H., Jørgensen, T., Linneberg, A. R., Thiery, J., et al. (2013) · Thyroid · doi:10.1089/thy.2013.0259 · Cited by 28 · see citing works
Is Antithyroid Treatment Really Relevant for Young Patients with Subclinical Hyperthyroidism?
Yönem, Ö., Dökmetaş, H. S., Aslan, S. M., & Erselcan, T. (2002) · Endocrine Journal · doi:10.1507/endocrj.49.307 · Cited by 27 · see citing works
Risks and safety of combination therapy for hypothyroidism
Jonklaas, J. (2016) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2016.1182019 · Cited by 27 · see citing works
Self-citation
Effect of Thyroid Function Variations Within the Laboratory Reference Range on Health Status, Mood, and Cognition in Levothyroxine-Treated Subjects
Samuels, M. H., Kolobova, I., Smeraglio, A., Niederhausen, M., Janowsky, J. S., & Schuff, K. G. (2016) · Thyroid® · doi:10.1089/thy.2016.0141 · Cited by 26 · see citing works
Normal limits for serum thyrotropin vary greatly depending on method
Strich, D., Karavani, G., Levin, S., Edri, S., & Gillis, D. (2015) · Clinical Endocrinology · doi:10.1111/cen.12970 · Cited by 23 · see citing works
Associations of Thyroid-Stimulating Hormone and Free Thyroxine Concentrations with Health and Life Satisfaction in Elderly Adults
Eskelinen, S. I., Vahlberg, T. J., Isoaho, R. E., Löppönen, M. K., Kivelä, S., & Irjala, K. M. A. (2007) · Endocrine Practice · doi:10.4158/ep.13.5.451 · Cited by 15 · see citing works

Flagged first, then by citations

Sorted by citations

Hypothyroidism
Chaker, L., Razvi, S., Bensenor, I. M., Azizi, F., Pearce, E. N., & Peeters, R. P. (2022) · Nature Reviews Disease Primers · doi:10.1038/s41572-022-00357-7 · Cited by 330 · see citing works
Self-citation
Hypothyroidism in the older population
Leng, O., & Razvi, S. (2019) · Thyroid Research · doi:10.1186/s13044-019-0063-3 · Cited by 112 · see citing works
Challenges in Interpreting Thyroid Stimulating Hormone Results in the Diagnosis of Thyroid Dysfunction
Razvi, S., Bhana, S., & Mrabeti, S. (2019) · Journal of Thyroid Research · doi:10.1155/2019/4106816 · Cited by 90 · see citing works
“Diagnostic reference ranges are, by definition, a one-size-fits-all solution to the challenge of interpreting biomarker results [37].”
BackgroundSelf-citation
Optimal thyroid hormone replacement
Jonklaas, J. (2022) · Endocrine Reviews · doi:10.1210/endrev/bnab031 · Cited by 89 · see citing works
Self-citation
Prevalence and Risk Factors of Thyroid Dysfunction in Older Adults in the Community
Diab, N., Daya, N. R., Juraschek, S. P., Martin, S. S., McEvoy, J. W., Schultheiß, U. T., Köttgen, A., & Selvin, E. (2019) · Scientific Reports · doi:10.1038/s41598-019-49540-z · Cited by 86 · see citing works
Subclinical hypothyroidism in older individuals
Biondi, B., & Cappola, A. R. (2021) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(21)00285-0 · Cited by 80 · see citing works
To Treat or Not to Treat Subclinical Hypothyroidism, What Is the Evidence?
Calissendorff, J., & Falhammar, H. (2020) · Medicina · doi:10.3390/medicina56010040 · Cited by 69 · see citing works
“This is invariably difficult, as hypothyroid symptoms are unspecific by nature, and the decision to treat or not has to be individualized [9].”
Background
Diagnosis and treatment of hypothyroidism in the elderly
Duntas, L. H., & Yen, P. M. (2019) · Endocrine · doi:10.1007/s12020-019-02067-9 · Cited by 65 · see citing works
The ageing thyroid: implications for longevity and patient care
van Heemst, D. (2024) · Nature Reviews Endocrinology · doi:10.1038/s41574-023-00911-7 · Cited by 43 · see citing works
“In addition to genetics, age, ethnicity and sex, environmental factors (including iodine status, smoking, circadian rhythmicity, season and temperature) contribute to variation in thyroid status 40,41 .”
Background
Factors influencing the reference interval of thyroid‐stimulating hormone in healthy adults: A systematic review and meta‐analysis
Xing, D., Liu, D., Li, R., Zhou, Q., & Xu, J. (2021) · Clinical Endocrinology · doi:10.1111/cen.14454 · Cited by 36 · see citing works
Divergent prognostic effects of pre-existing and treatment-emergent thyroid dysfunction in patients treated with immune checkpoint inhibitors
von Itzstein, M. S., Gonugunta, A. S., Wang, Y., Sheffield, T. Y., Lü, R., Ali, S., Fattah, F. J., Xie, D., Cai, J. X., Xie, Y., et al. (2022) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-022-03151-2 · Cited by 36 · see citing works
“As done in earlier studies [18, 22, 23], we defined ICI-induced clinical thyroid dysfunction as any of the following: (1) initiation or any change in dose of levothyroxine treatment after ICI initiation; (2) a single substantial laboratory deviation from reference range indicating overt thyroid dysfunction (FT4 > 1.”
Result
Reinterpreting patterns of variation in human thyroid function
Keestra, S., Tabor, V., & Alvergne, A. (2020) · Evolution Medicine and Public Health · doi:10.1093/emph/eoaa043 · Cited by 38 · see citing works
“These biomarkers are compared with reference intervals for large populations without thyroid disease, using a 95% interval for T4 and T3 and the 2.5th and 97.5th percentiles to determine the normal TSH reference range [31].”
Influential
ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism
Centanni, M., Duntas, L., Feldt-Rasmussen, U., Koehrle, J., Peeters, R. P., Razvi, S., Trimboli, P., & Virili, C. (2025) · European Thyroid Journal · doi:10.1530/etj-25-0123 · Cited by 38 · see citing works
“This issue is further complicated by the evidence that most cases of primary hypothyroidism are initially mild or subclinical and there is no consensus on when to start treatment (3, 9).”
Self-citation
Sex-Dependent Environmental Health Risk Analysis of Flupyradifurone
Xu, L., Xu, X., Wu, X., Kuang, H., & Xu, C. (2022) · Environmental Science & Technology · doi:10.1021/acs.est.1c07726 · Cited by 32 · see citing works
A U‐shaped association between serum albumin with total triiodothyronine in adults
Zhang, Y., Xie, R., & Ou, J. (2022) · Journal of Clinical Laboratory Analysis · doi:10.1002/jcla.24473 · Cited by 31 · see citing works
Prevalence, predictors and outcomes of thyroid dysfunction in patients with acute myocardial infarction: the ThyrAMI-1 study
Jabbar, A., Ingoe, L. E., Thomas, H. E., Carey, P. E., Junejo, S., Addison, C., Vernazza, J., Austin, D., Greenwood, J. P., Zaman, A., et al. (2020) · Journal of Endocrinological Investigation · doi:10.1007/s40618-020-01408-0 · Cited by 30 · see citing works
“This understanding may help to prevent inappropriate diagnoses being made and unnecessary treatments being initiated [11].”
BackgroundSelf-citation
Thyroid Function Reference Intervals by Age, Sex, and Race
Li, Q., Tang, Y., Yu, X., Qin, G., Tian, L., Cheng, L., Lü, Y., Zhao, Z., Liu, L., Zhang, K., et al. (2025) · Annals of Internal Medicine · doi:10.7326/annals-24-01559 · Cited by 29 · see citing works
Free thyroxine measurement in clinical practice: how to optimize indications, analytical procedures, and interpretation criteria while waiting for global standardization
D’Aurizio, F., Kratzsch, J., Gruson, D., Ovčariček, P. P., & Giovanella, L. (2022) · Critical Reviews in Clinical Laboratory Sciences · doi:10.1080/10408363.2022.2121960 · Cited by 31 · see citing works
Toward a science-based testing strategy to identify maternal thyroid hormone imbalance and neurodevelopmental effects in the progeny – part I: which parameters from human studies are most relevant for toxicological assessments?
Sauer, U. G., Asiimwe, A., Botham, P. A., Charlton, A., Hallmark, N., Jacobi, S., Marty, S., Melching‐Kollmuss, S., Palha, J. A., Strauss, V., et al. (2020) · Critical Reviews in Toxicology · doi:10.1080/10408444.2020.1839380 · Cited by 25 · see citing works
“…are assay- and laboratory-dependent (Oken et al. 2009; Korevaar et al. 2013, 2017; Medici et al. 2015; Spencer et al. 2015; Lain et al. 2017; Maraka et al. 2017; Derakhshan et al. 2018a, 2018b; Jonklaas and Razvi 2019; Midgley et al. 2019; Razvi and Hostalek 2019; Su et al. 2019; Yang et al. 2019).”
BackgroundInfluential
The Swinging Pendulum in Treatment for Hypothyroidism: From (and Toward?) Combination Therapy
McAninch, E. A., & Bianco, A. C. (2019) · Frontiers in Endocrinology · doi:10.3389/fendo.2019.00446 · Cited by 24 · see citing works
The GLP‐1 receptor agonist exenatide reduces serum TSH by its effect on body weight in people with type 2 diabetes
Tee, S. A., Tsatlidis, V., & Razvi, S. (2023) · Clinical Endocrinology · doi:10.1111/cen.14901 · Cited by 21 · see citing works
“Obesity is a major determinant of serum TSH levels.(3) It has been hypothesized that a higher TSH in the context of normal or unchanged TH levels reflects a state of central resistance to TH.”
BackgroundSelf-citation
Patient Context and Thyrotropin Levels Are Important When Considering Treatment of Subclinical Hypothyroidism
Sawka, A. M., Cappola, A. R., Peeters, R. P., Kopp, P. A., Bianco, A. C., & Jonklaas, J. (2019) · Thyroid · doi:10.1089/thy.2019.0494 · Cited by 19 · see citing works
Self-citation
Managing symptoms in hypothyroid patients on adequate levothyroxine: a narrative review
Razvi, S., Mrabeti, S., & Luster, M. (2020) · Endocrine Connections · doi:10.1530/ec-20-0205 · Cited by 15 · see citing works
Self-citation
Triiodothyronine secretion in early thyroid failure: The adaptive response of central feedforward control
Hoermann, R., Pekker, M. J., Midgley, J. E. M., Larisch, R., & Dietrich, J. W. (2020) · European Journal of Clinical Investigation · doi:10.1111/eci.13192 · Cited by 14 · see citing works
Frequency, determinants and costs of thyroid function testing in a laboratory serving a large population
Javaid, U., Kennedy, D., Addison, C., Tsatlidis, V., & Razvi, S. (2022) · European Journal of Endocrinology · doi:10.1530/eje-21-1172 · Cited by 14 · see citing works
Self-citation
Impact of Variation between Assays and Reference Intervals in the Diagnosis of Endocrine Disorders
Lorde, N., Elgharably, A., & Kalaria, T. (2023) · Diagnostics · doi:10.3390/diagnostics13223453 · Cited by 14 · see citing works
Association between High Normal TSH Levels and Obesity in Women with Anti-Thyroid Autoantibodies (ATAs)
Velluzzi, F., Pisanu, S., Galletta, M., Fosci, M., Secci, G., Deledda, A., Boi, F., Rodia, R., Fanciulli, G., Delitala, A., et al. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11175125 · Cited by 14 · see citing works
“The positive association between TSH and BMI in subjects with thyroid autoimmunity is partially supported by the observations derived from population studies, in which the inclusion of ATAs-positive subjects shifted the Gaussian distribution of mean TSH values to the right [81,82].”
Result
Study of reference intervals for free triiodothyronine, free thyroxine, and thyroid-stimulating hormone in an elderly Chinese Han population
Xiong, J., Liu, S., Hu, K., Xiong, Y., Wang, P., & Xiong, L. (2020) · PLoS ONE · doi:10.1371/journal.pone.0239579 · Cited by 12 · see citing works
“An inhibitory effect on the hypothalamic-pituitary axis, destructive thyroiditis, or immune-reactivating mechanisms can affect thyroid function [6].”
Background
Age-Related Serum Thyroid-Stimulating Hormone Reference Range in Older Patients Treated with Levothyroxine: A Randomized Controlled Feasibility Trial (SORTED 1)
Razvi, S., Ryan, V., Ingoe, L. E., Pearce, S. H. S., & Wilkes, S. (2019) · European Thyroid Journal · doi:10.1159/000504047 · Cited by 11 · see citing works
Self-citation
The Clinical Relevance of Hypothyroidism in Patients with Solid Non-Thyroid Cancer: A Tantalizing Conundrum
Deligiorgi, M. V., & Trafalis, D. T. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11123417 · Cited by 12 · see citing works
“to harmonize the different TSH reference intervals across laboratories and countries is hampered by: (i) interindividual and intraindividual differences in thyroid parameters; (ii) age-related and ethnic variations; iii) variability in the sensitivity of different assays and in the statistical methods used to establis…”
BackgroundMethod
Variation in the reference range limits of thyroid function tests and association with the prevalence of levothyroxine treatment
Razvi, S., Jabbar, A., Addison, C., Vernazza, J., Syed, A. A., Soran, H., & Leng, O. (2023) · European Journal of Endocrinology · doi:10.1093/ejendo/lvad016 · Cited by 10 · see citing works
Self-citation
Thyroid stimulating hormone values of clinical decisions of hypothyroidism measurement by three different automated immunoassays
Mirjanić-Azarić, B., Jerin, A., & Savic, Z. R. (2019) · Scandinavian Journal of Clinical and Laboratory Investigation · doi:10.1080/00365513.2019.1703215 · Cited by 9 · see citing works
“Not only does it disrupt the natural metabolic pathways, but inappropriate and unnecessary treatment might also increase disease and economic burdens [30].”
BackgroundInfluential
Does Clinical and Biochemical Thyroid Dysfunction Impact on Endometrial Cancer Survival Outcomes? A Prospective Database Study
Barr, C. E., Njoku, K., Hotchkies, L., Ryan, N. A. J., Wan, Y.-L. L., Davies, D. A., Razvi, S., & Crosbie, E. J. (2021) · Cancers · doi:10.3390/cancers13215444 · Cited by 9 · see citing works
“Most were biochemically euthyroid, but 30% had elevated serum TSH levels, suggesting suboptimal thyroid replacement therapy or inappropriate reference ranges [46,47].”
BackgroundSelf-citation
Daily requirement of softgel thyroxine is independent from gastric juice pH
Virili, C., Capriello, S., Stramazzo, I., Brusca, N., Santaguida, M. G., Gargano, L., Bagaglini, M. F., Bruno, G., Severi, C., & Centanni, M. (2022) · Frontiers in Endocrinology · doi:10.3389/fendo.2022.1002583 · Cited by 8 · see citing works
Thyroid Hormone Reference Intervals among Healthy Individuals In Lanzhou, China
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“Rather than absolute numbers, the RI values should be evaluated individually, taking into account all possible factors that could interfere with the results (29).”
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Mass Spectrometry-Based Determination of Thyroid Hormones and Their Metabolites in Endocrine Diagnostics and Biomedical Research – Implications for Human Serum Diagnostics
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Defining Trimester-Specific Reference Intervals for Thyroid Hormones: Insights from a Bulgarian Monocenter Study
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InfluentialSelf-citation
Turner Syndrome and the Thyroid Function—A Systematic and Critical Review
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“Therefore, open questions on this topic are: (1) whether other biomarkers of thyroid homeostasis are available in addition to TSH [ 18 , 19 ]; and (2) consequently, how to improve replacement therapy in patients with hT [ 9 , 11 , 13, 20 ].”
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BackgroundInfluential
Higher cadmium exposure was associated with sex-specific thyroid dysfunction: Consistent evidence from two independent cross-sectional studies based on urinary and blood cadmium measurementsPreprint
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Genetics of Thyroid Function: Relevance for Biology and Disease Management
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“There is some recent evidence that a TSH at goal is being achieved in 80% of treated patients [4], compared with closer to 60% in prior studies (reviewed in [5]).”
ResultSelf-citation
One sip of water with LT-4 supplementation—a key to euthyroidism in Hashimoto’s thyroiditis
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The Controversy Continues Regarding the Management of Subclinical Hypothyroidism
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“…recent thoughtful review regarding the testing and treating of thyroid dysfunction, Jonklaas and Razvi proposed that mild thyroid dysfunction based on a statistical approach to defining serum thyroid function reference ranges may not match the definition of clinically important thyroid disease (6).”
WITHDRAWN: Radiation induced hypothyroidism – Why is early intervention necessary?
Aggarwal, K., Thakur, S., Shetty, S. S., & Rao, V. U. S. (2019) · Oral Oncology · doi:10.1016/j.oraloncology.2019.104442
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Multivariate Conditional Transformation Models. Application to Thyroid-Related Hormones
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Personalized Reference Intervals for Thyroid Function Tests: A Paradigm Shift in the Diagnosis of Thyroid Disease
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Establishment of Reference Intervals for Plasma TSH Across the Lifespan in an Algerian Mediterranean Population
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“International differences in TSH reference intervals arise from genetic, environmental, and demographic factors, particularly iodine status and age distribution, as well as methodological variability [24].”
Comparison of thyroid hormones reference intervals based on thyroid antibody levels: A multicenter study
Beyter, H., Acar, O., Portakal, O., Gülbahar, Ö., Türkeş, G. F., Saral, N. Y., Serdar, M. A., & Özpınar, A. (2026) · PLoS ONE · doi:10.1371/journal.pone.0344197
The effectiveness of levothyroxine starting doses after thyroidectomy is compromised by early body variations occurring after surgery
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Ottimizzazione del trattamento con levotiroxina: indice ragionato della linea guida della European Thyroid Association 2025
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“In questa evenienza, non ancora codiﬁcata, è necessario tenere in conto altri parame-tri come l’età del paziente, il suo stato metabolico, la pa-togenesi dell’ipotiroidismo e la presenza di segni e sintomi riconducibili all’ipotiroidismo [6].”
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Limitaciones en la interpretación de los análisis de función tiroidea
Galofré, J. C. (2026) · Medicina Clínica · doi:10.1016/j.medcli.2026.107492
A Robust Control Group Identification Approach for Reference Intervals of Thyroid Biomarkers: The Case of Jordan
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Food intolerance/malabsorption in Hashimoto’s thyroiditis
Schnedl, W. J., Michaelis, S., Schenk, M., Enko, D., & Holasek, S. J. (2026) · Clinics · doi:10.1016/j.clinsp.2026.101168
“27 In particular, the prevalence of LIT in the global population is high at approximately 70%, and LIT prevalence was found to be 75% in patients diagnosed with Hashimoto's disease.”
Limitations in the interpretation of thyroid function tests
Galofré, J. C. (2026) · Medicina Clínica (English Edition) · doi:10.1016/j.medcle.2026.107492

Thyroid-function reference ranges in the diagnosis of thyroid dysfunction in adults
Razvi, S. (2024) · Nature Reviews Endocrinology · doi:10.1038/s41574-024-00972-2 · Cited by 6 · see citing works
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Challenges in Interpreting Thyroid Stimulating Hormone Results in the Diagnosis of Thyroid Dysfunction
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Variation in the reference range limits of thyroid function tests and association with the prevalence of levothyroxine treatment
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Authors
D, J. S. M. (2011)
Evaluating the Link Between Thyroid Function Test Results and Levothyroxine Dose in the Management of Hypothyroidism: Can We Improve Dosing Regimes?
Heald, A. H., Premawardhana, L. D. K. E., Taylor, P. N., Bahl, S., Okosieme, O. E., Fryer, A. A., Bianco, A. C., Dayan, C. M., & Stedman, M. (2025) · Clinical Endocrinology · doi:10.1111/cen.70074 · Cited by 4 · see citing works

Authors: Jonklaas, J., & Razvi, S.
Affiliations: Georgetown University (US)
Newcastle University (GB)
Corresponding author: Jonklaas, Jacqueline
ORCID: Jonklaas, Jacqueline
Razvi, Salman
Venue: The Lancet Diabetes & Endocrinology
Publisher: Elsevier BV
Published: 2019-06
Volume: 7
Issue: 6
Pages: 473-483
ISSN: 2213-8587 (ISSN-L)
DOI: 10.1016/s2213-8587(18)30371-1
OpenAlex: W2904558892
Semantic Scholar: e9c99c1b095715a4a8aaa2a8e0c8ce69341a9971
Cited by: 100
References: 113
Citations by year: 2026: 13 · 2025: 15 · 2024: 16 · 2023: 10 · 2022: 13 · 2021: 9 · 2020: 10 · 2019: 14
FWCI: 1.77
Type: journal article
Language: en
Open access: green
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Diabetes & Endocrinology (publishedVersion)
PubMed (publishedVersion)
Newcastle University ePrints (Newcastle Univesity) (cc-by-nc-nd)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Cancer Diagnosis and Treatment
Keywords: thyroid dysfunction, reference values, thyroid-stimulating hormone, levothyroxine, overtreatment, treatment goals, individualized assessment, thyroid function monitoring, age differences, ethnic differences, interindividual variability
MeSH terms: Humans, Reference Values, Thyroid Diseases, Thyroid Function Tests, Thyroid Hormones, Thyrotropin, Prevalence

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Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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Reference intervals in the diagnosis of thyroid dysfunction: treating patients not numbers

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