Evidence map›Paper›PMID 28158982›Full record

Trial reportBMC endocrine disorders2017

Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).

David J Stott, Jacobijn Gussekloo, Patricia M Kearney, Nicolas Rodondi, Rudi G J Westendorp, Simon Mooijaart, Sharon Kean, Terence J Quinn, Naveed Sattar, Kirsty Hendry and 15 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC endocrine disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.9field-weighted citation impact, top 6% of its field
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.

NCT01660126 phase4completednot on this map

Multi-modal Effects of Thyroid Hormone Replacement for Untreated Older Adults With Subclinical Hypothyroidism; a Randomised Placebo-controlled Trial

TypeinterventionalSponsorNHS Greater Glasgow and ClydeRan2014 to 2016Enrolled737ConditionsSubclinical HypothyroidismArmsLevothyroxine, Placebo
NCT04354896 phase4completednot on this map

The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism - a Substudy of TRUST and IEMO Trials

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2014 to 2018Enrolled322ConditionsSubclinical Hypothyroidism, SarcopeniaArmsLevothyroxin, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 45 citations in OpenAlex.

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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

25 authors at 9 institutions in 6 countries.

David J StottGeriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK. David.J.Stott@glasgow.ac.uk.
Jacobijn GusseklooDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
Patricia M KearneyDepartment of Epidemiology and Public Health, University College Cork, Cork, Ireland.
Nicolas RodondiInstitute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
Rudi G J WestendorpLeyden Academy on Vitality and Ageing, Leiden, Netherlands.
Simon MooijaartDepartment of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.
Sharon KeanRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Terence J QuinnGeriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Naveed SattarInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Kirsty HendryGeriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Robert Du PuyDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
Wendy P J Den ElzenDepartment of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands.
Rosalinde K E PoortvlietDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
Jan W A SmitRadboud University Medical Center, Nijmegen, The Netherlands.
J Wouter JukemaDepartment of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
Olaf M DekkersDepartment of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.
Manuel BlumDepartment of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Tinh-Hai ColletService of Endocrinology Diabetes and Metabolism, University Hospital of Laussanne, Lausanne, Switzerland.
Vera McCarthySchool of Nursing and Midwifery, University College Cork, Cork, Ireland.
Caroline HurleyDepartment of Epidemiology and Public Health and Clinical Research Facility, University College Cork, Cork, Ireland.
Stephen ByrneSchool of Pharmacy, University College Cork, Cork, Ireland.
John BrowneDepartment of Epidemiology and Public Health, University College Cork, Cork, Ireland.
Torquil WattDepartment of Internal Medicine, Copenhagen University Hospital Herlev, Gentofte, Denmark.
Douglas BauerDepartment of Medicine, University of California, San Francisco, USA.
Ian FordRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Leiden University Medical Center · NLUniversity College Cork · IEUniversity of Glasgow · GBUniversity Hospital of Bern · CHGentofte Hospital · DKGlasgow Royal Infirmary · GBLeyden Academy on Vitality and Ageing · NLRadboud University Nijmegen · NLUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH.

methodsParticipants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. DISCUSSION: This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition.

trial registrationClinicaltrials.gov NCT01660126 ; registered 8th June 2012.

Indexed as

Hormone Replacement TherapyAgedBlood BanksClinical ProtocolsDouble-Blind MethodHumansHypothyroidismPatient SafetyThyroxineThyroxineElderlyLevothyroxineQuality of lifeRandomised controlled trialSubclinical hypothyroidismThyroid disease

Identifiers

PMID28158982
PMCPMC5291970
OpenAlexW2583713299

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.