Evidence map›Paper›PMID 27766119›Full record

ArticleThyroid research2016

Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) - results from the feasibility randomised controlled trial.

Salman Razvi, Lorna Ingoe, Vicky Ryan, Simon H S Pearce, Scott Wilkes

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Thyroid research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01647750 (Study of Optimal Replacement of Thyroxine in the Elderly), which is not on this 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
2.7field-weighted citation impact, top 9% 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.

NCT01647750 phase4completednot on this map

Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) SORTED 1 - a Randomised Controlled Trial (Pilot Study), SORTED 2 - Qualitative Interviews, SORTED 3 - Retrospective Cohort

TypeinterventionalSponsorNewcastle-upon-Tyne Hospitals NHS TrustRan2012 to 2014Enrolled48ConditionsHypothyroidismArmsLevothyroxine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Review
  7. Article
  8. Older patients' experience of primary hypothyroidism: A qualitative study.Health expectations : an international journal of public participation in health care and health policy · 2018
    Article
  9. Article
  10. Thyroid Disease in Aging.Missouri medicine
    Article
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

5 authors at 4 institutions in 1 country.

Salman RazviInstitute of Genetic Medicine and Queen Elizabeth Hospital, International Centre for Life, Newcastle University, Central Parkway, Newcastle upon Tyne, NE1 3BZ UK ; Department of Endocrinology, Queen Elizabeth Hospital, Gateshead, NE9 6SX UK.ORCID 0000-0002-9047-1556
Lorna IngoeDepartment of Endocrinology, Queen Elizabeth Hospital, Gateshead, NE9 6SX UK.
Vicky RyanInstitute of Health & Society, Newcastle University, Baddiley Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX UK.
Simon H S PearceInstitute of Genetic Medicine and Queen Elizabeth Hospital, International Centre for Life, Newcastle University, Central Parkway, Newcastle upon Tyne, NE1 3BZ UK.
Scott WilkesDepartment of Pharmacy, Health and Wellbeing, Faculty of Applied Sciences, University of Sunderland, Sunderland, SR1 3SD UK.
Centre for Life · GBNewcastle University · GBQueen Elizabeth Hospital · GBUniversity of Sunderland · GB

Funding

Department of Health CDF-2012-05-231Department of Health PB-PG-0610-22139Medical Research Council G0500783
6 · The paper itself

Abstract

backgroundHypothyroidism is a common condition, particularly in the older population. Thyroid hormone requirements change with age and serum TSH levels also alter, especially in older patients. However, in practice laboratory reference ranges for thyroid function are not age-specific and treatment in older patients aims to achieve a similar target thyroid function level as younger age groups.

methodsA dual centre, single blind, randomised controlled trial was conducted to determine the feasibility of a future definitive RCT in hypothyroid individuals aged 80 years or older who were treated with levothyroxine. Potential participants were identified from 17 research-active GP practices (

resultsFifteen percent (57/390) of potentially eligible hypothyroid individuals consented to participate in this trial and 48 were randomised to trial medication for 24 weeks, giving a recruitment rate of 12 %. Recruitment averaged 5.5 participants per month over approximately 9 months. Eight participants withdrew (3/24 and 5/24 in the usual and higher TSH arms, respectively) with the commonest reason cited (5 patients) being tiredness. Interestingly, 3/5 participants withdrew from the site that required a visit to a Research Facility whereas only 5/43 participants withdrew from the site that offered home visits. In the higher TSH arm, of those participants who completed the study, approximately half of participants (10/19) reached target TSH.

conclusionsIt is feasible to perform a randomised controlled trial of thyroid hormones in hypothyroid patients aged 80 or older. A definitive trial would require collaboration with a large number of General Practices and the provision of home visits to achieve recruitment to time and target. Power calculations should take into account that approximately 12 % of those approached will be randomised and 1 in 6 participants are likely to withdraw from the study. Finally, several dose adjustments may be required to achieve target serum TSH levels in this age group.

trial registrationISRCTN Number: 16043724 Registered 22 June 2012 Clinicaltrial.gov Number: NCT01647750 EudraCT Number: 2011-004425-27.

Indexed as

FeasibilityHypothyroidismOlder age

Identifiers

PMID27766119
PMCPMC5057427
OpenAlexW2531737957

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.