Evidence map›Paper›PMID 30231866›Full record

Trial reportBMC endocrine disorders2018

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, I 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 and 11 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC endocrine disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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.

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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. 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

21 authors at 10 institutions in 5 countries.

R S Du PuyDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.
I PostmusDepartment of Gerontology and Geriatrics (C7-Q), Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
D J StottGeriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
M R BlumDepartment of General Internal Medicine, Bern University Hospital, University of Bern, Bern, Switzerland.
R K E PoortvlietDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.
W P J Den ElzenDepartment of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, the Netherlands.
R P PeetersDepartment of Internal Medicine, Erasmus University Medical Centre, Rotterdam, the Netherlands.
B C van MunsterDepartment of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands.
B H R WolffenbuttelDepartment of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
R G J WestendorpDepartment of Public Health, University of Copenhagen, Copenhagen, Denmark.
P M KearneyDepartment of Epidemiology and Public Health, University College Cork, Cork, Ireland.
I FordRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
S KeanRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
C M MessowRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
T WattDepartment of Internal Medicine, Copenhagen University Hospital Herlev, Gentofte, Denmark.
J W JukemaDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
O M DekkersDepartment of Endocrinology and metabolic disorders, Leiden University Medical Center, Leiden, the Netherlands.
J W A SmitRadboud University Medical Center, Nijmegen, the Netherlands.
N RodondiDepartment of General Internal Medicine, Bern University Hospital, University of Bern, Bern, Switzerland.
J GusseklooDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.
S P MooijaartDepartment of Gerontology and Geriatrics (C7-Q), Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. S.P.Mooijaart@lumc.nl.ORCID http://orcid.org/0000-0003-3106-3568
Leiden University Medical Center · NLUniversity of Glasgow · GBUniversity of Bern · CHAmsterdam UMC Location University of Amsterdam · NLErasmus University Rotterdam · NLGentofte Hospital · DKRadboud University Nijmegen · NLUniversity College Cork · IEUniversity Medical Center Groningen · NLUniversity of Copenhagen · DK

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 320030-150025 & 320030-172676ZonMw 627001001
6 · The paper itself

Abstract

backgroundSubclinical 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.

methodsThe 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 ≤ 19.9 mU/L and fT4 within laboratory reference ranges). Participants are randomised to levothyroxine 25 or 50 micrograms daily or matching placebo with dose titrations according to TSH levels, for a minimum follow-up of one and a maximum of three years. Primary study endpoints: hypothyroid physical symptoms and tiredness on the thyroid-related quality of life patient-reported outcome (ThyPRO) at one year. Secondary endpoints: generic quality of life, executive cognitive function, handgrip strength, functional ability, blood pressure, weight, body mass index, and mortality. Adverse events will be recorded with specific interest on cardiovascular endpoints such as atrial fibrillation and heart failure. 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.

trial registrationNederlands (Dutch) Trial Register: NTR3851 (12-02-2013), EudraCT: 2012-004160-22 (17-02-2013), ABR-41259.058.13 (12-02-2013).

Indexed as

Aged, 80 and overAge FactorsDouble-Blind MethodFemaleFollow-Up StudiesHumansHypothyroidismMaleNetherlandsThyroxineTreatment OutcomeThyroxine80-plusLevothyroxineQuality of lifeRandomised controlled trialSubclinical hypothyroidism

Identifiers

PMID30231866
PMCPMC6146605
OpenAlexW2891668205

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.