Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

R. S. Du Puy; P.E. Postmus; D. J. Stott; M. R. Blum; R. K. E. Poortvliet; W. P. J. Den Elzen; R. P. Peeters; B. C. van Munster; B. H. R. Wolffenbuttel; R. G. J. Westendorp; P. M. Kearney; I. Ford; S. Kean; C. M. Messow; T. Watt; J. W. Jukemal; O. M. Dekkers; J. W. A. Smit; N. Rodondi; J. Gussekloo; S. P. Mooijaart

doi:10.1186/s12902-018-0285-8

Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

R. S. Du Puy, P.E. Postmus, D. J. Stott, M. R. Blum, R. K. E. Poortvliet, W. P. J. Den Elzen, R. P. Peeters, B. C. van Munster, B. H. R. Wolffenbuttel, R. G. J. Westendorp, P. M. Kearney, I. Ford, S. Kean, C. M. Messow, T. Watt, J. W. Jukemal, O. M. Dekkers, J. W. A. Smit, N. Rodondi, J. GusseklooS. P. Mooijaart^*

^*Corresponding author for this work

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Abstract

Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base.

Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH >= 4.6 and

Discussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date.

Original language	English
Article number	67
Number of pages	14
Journal	Bmc endocrine disorders
Volume	18
DOIs	https://doi.org/10.1186/s12902-018-0285-8
Publication status	Published - 19-Sept-2018

Keywords

Subclinical hypothyroidism
80-plus
Randomised controlled trial
Quality of life
Levothyroxine
QUESTIONNAIRE
DISEASE
VERSION
VALIDITY
ADULTS
THYPRO

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Du Puy, R. S., Postmus, P. E., Stott, D. J., Blum, M. R., Poortvliet, R. K. E., Den Elzen, W. P. J., Peeters, R. P., van Munster, B. C., Wolffenbuttel, B. H. R., Westendorp, R. G. J., Kearney, P. M., Ford, I., Kean, S., Messow, C. M., Watt, T., Jukemal, J. W., Dekkers, O. M., Smit, J. W. A., Rodondi, N., ... Mooijaart, S. P. (2018). Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over. Bmc endocrine disorders, 18, Article 67. https://doi.org/10.1186/s12902-018-0285-8

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title = "Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over",

abstract = "Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base.Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH >= 4.6 andDiscussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date.",

keywords = "Subclinical hypothyroidism, 80-plus, Randomised controlled trial, Quality of life, Levothyroxine, QUESTIONNAIRE, DISEASE, VERSION, VALIDITY, ADULTS, THYPRO",

author = "{Du Puy}, {R. S.} and P.E. Postmus and Stott, {D. J.} and Blum, {M. R.} and Poortvliet, {R. K. E.} and {Den Elzen}, {W. P. J.} and Peeters, {R. P.} and {van Munster}, {B. C.} and Wolffenbuttel, {B. H. R.} and Westendorp, {R. G. J.} and Kearney, {P. M.} and I. Ford and S. Kean and Messow, {C. M.} and T. Watt and Jukemal, {J. W.} and Dekkers, {O. M.} and Smit, {J. W. A.} and N. Rodondi and J. Gussekloo and Mooijaart, {S. P.}",

year = "2018",

month = sep,

day = "19",

doi = "10.1186/s12902-018-0285-8",

language = "English",

volume = "18",

journal = "Bmc endocrine disorders",

issn = "1472-6823",

publisher = "BMC",

}

Du Puy, RS, Postmus, PE, Stott, DJ, Blum, MR, Poortvliet, RKE, Den Elzen, WPJ, Peeters, RP, van Munster, BC , Wolffenbuttel, BHR, Westendorp, RGJ, Kearney, PM, Ford, I, Kean, S, Messow, CM, Watt, T, Jukemal, JW, Dekkers, OM, Smit, JWA, Rodondi, N, Gussekloo, J & Mooijaart, SP 2018, 'Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over', Bmc endocrine disorders, vol. 18, 67. https://doi.org/10.1186/s12902-018-0285-8

TY - JOUR

T1 - Study protocol

T2 - a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

AU - Du Puy, R. S.

AU - Postmus, P.E.

AU - Stott, D. J.

AU - Blum, M. R.

AU - Poortvliet, R. K. E.

AU - Den Elzen, W. P. J.

AU - Peeters, R. P.

AU - van Munster, B. C.

AU - Wolffenbuttel, B. H. R.

AU - Westendorp, R. G. J.

AU - Kearney, P. M.

AU - Ford, I.

AU - Kean, S.

AU - Messow, C. M.

AU - Watt, T.

AU - Jukemal, J. W.

AU - Dekkers, O. M.

AU - Smit, J. W. A.

AU - Rodondi, N.

AU - Gussekloo, J.

AU - Mooijaart, S. P.

PY - 2018/9/19

Y1 - 2018/9/19

N2 - Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base.Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH >= 4.6 andDiscussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date.

AB - Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base.Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH >= 4.6 andDiscussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date.

KW - Subclinical hypothyroidism

KW - 80-plus

KW - Randomised controlled trial

KW - Quality of life

KW - Levothyroxine

KW - QUESTIONNAIRE

KW - DISEASE

KW - VERSION

KW - VALIDITY

KW - ADULTS

KW - THYPRO

U2 - 10.1186/s12902-018-0285-8

DO - 10.1186/s12902-018-0285-8

M3 - Article

SN - 1472-6823

VL - 18

JO - Bmc endocrine disorders

JF - Bmc endocrine disorders

M1 - 67

ER -

Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

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