Evidence map›Paper›PMID 30219088›Full record

ArticleTrials2018

Total thyroidectomy (Tx) versus thionamides (antithyroid drugs) in patients with moderate-to-severe Graves' ophthalmopathy - a 1-year follow-up: study protocol for a randomized controlled trial.

Lindsay Brammen, Philipp Riss, Julius Lukas, Alois Gessl, Daniela Dunkler, Shuren Li, Asha Leisser, Sandra Rezar-Dreindl, Katharina Eibenberger, Andreas Selberherr and 2 more

Open access · goldAbstract readClinical Trial ProtocolComparative Study
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. 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

12 authors at 2 institutions in 1 country.

Lindsay BrammenSection of Endocrine Surgery, Department of Surgery, Medical University Vienna, Vienna, Austria.
Philipp RissSection of Endocrine Surgery, Department of Surgery, Medical University Vienna, Vienna, Austria. philipp.riss@meduniwien.ac.at.ORCID http://orcid.org/0000-0003-1472-6606
Julius LukasDepartment of Ophthalmology, Medical University Vienna, Vienna, Austria.
Alois GesslDepartment of Internal Medicine- Section of Endocrinology, Medical University Vienna, Vienna, Austria.
Daniela DunklerSection for Clinical Biometrics, CeMSIIS, Medical University Vienna, Vienna, Austria.
Shuren LiDepartment of Nuclear Medicine, Medical University Vienna, Vienna, Austria.
Asha LeisserDepartment of Nuclear Medicine, Medical University Vienna, Vienna, Austria.
Sandra Rezar-DreindlDepartment of Ophthalmology, Medical University Vienna, Vienna, Austria.
Katharina EibenbergerDepartment of Ophthalmology, Medical University Vienna, Vienna, Austria.
Andreas SelberherrSection of Endocrine Surgery, Department of Surgery, Medical University Vienna, Vienna, Austria.
Christian ScheubaSection of Endocrine Surgery, Department of Surgery, Medical University Vienna, Vienna, Austria.
Andrea PappDepartment of Ophthalmology, Medical University Vienna, Vienna, Austria.
Medical University of Vienna · ATVienna General Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGraves' disease (GD) is characterized by thyrotoxicosis and goiter and arises through circulating autoantibodies that bind to, and stimulate, the thyroid hormone receptor (TSHR). A temporal relation between the onset of hyperthyroidism and the onset of ophthalmopathy, a common extrathyroidal manifestation, has been demonstrated. Graves' ophthalmopathy (GO) is typically characterized by an inflammation and expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered for hyperthyroidism caused by Graves' disease: antithyroid drugs (ATD) (thionamides), radioiodine ablation (RAI) and thyroidectomy (Tx). To date, there is no clear recommendation on the treatment of Graves' disease and GO, mainly due to the individuality of the disease in each patient. The aim of the study is to examine the difference in the outcome of GO in patients with moderate-to-severe GO who receive Tx versus further ATD after suffering their first relapse of GO, or in which GO stays the same following the initial decrease in ATD therapy after 6 months. METHODS/

designThis prospective randomized clinical trial with observer-blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: Clinical Activity Score (CAScore), NOSPECS score, superonasal index measurements via ultrasound, and quality of life score. DISCUSSION: This study should allow for better therapeutic choices in patients with moderate-to-severe GO. In addition, it should demonstrate whether the outcome of GO in patients with moderate-to-severe GO is better in those who receive early Tx versus further ATD. Furthermore, this study will aim to establish a standard glucocorticoid scheme before and after Tx in patients with moderate-to-severe EO.

trial registrationEudra-CT: 2015-003515-38; Medical University of Vienna Protocol Record 1839/2015. Date of Ethics Committee approval: 19 January 2017. Registered on 27 January 2017.

Indexed as

ThyroidectomyAntithyroid AgentsAustriaClinical Trials, Phase III as TopicGraves OphthalmopathyHumansProspective StudiesRandomized Controlled Trials as TopicRecurrenceSeverity of Illness IndexTime FactorsTreatment OutcomeAntithyroid AgentsAntithyroid drugsCAScoreGraves’ diseaseGraves’ ophthalmopathyHyperthyroidismMuscle indexNOSPECSSuperonasal indexThyroidectomy

Identifiers

PMID30219088
PMCPMC6139165
OpenAlexW2890743703

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.