Evidence map›Paper›PMID 30086771›Full record

ArticleTrials2018

Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set.

Nicola L Harman, John Wilding, Dave Curry, James Harris, Jennifer Logue, R John Pemberton, Leigh Perreault, Gareth Thompson, Sean Tunis, Paula R Williamson and 1 more

Abstract read
PubMed Full text at PMC Publisher
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 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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

11 authors.

Nicola L HarmanDepartment of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK. n.harman@liv.ac.uk.ORCID http://orcid.org/0000-0001-6958-6466
John WildingObesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UK.
Dave CurryDepartment of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.
James HarrisDepartment of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.
Jennifer LogueInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
R John PembertonDepartment of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.
Leigh PerreaultInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Gareth ThompsonDepartment of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.
Sean TunisCenter for Medical Technology Policy (CMTP), World Trade Center Baltimore, Baltimore, MD, USA.
Paula R WilliamsonDepartment of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.
SCORE-IT study team

Funding

Horizon 2020 654248
6 · The paper itself

Abstract

backgroundType 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes. METHODS/

designThis study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups. DISCUSSION: The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly.

trial registrationThe COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956 . Registered January 2017.

Indexed as

Endpoint DeterminationResearch DesignBiomarkersBlood GlucoseConsensusConsensus Statements as TopicDelphi TechniqueDiabetes Mellitus, Type 2HumansRandomized Controlled Trials as TopicSystematic Reviews as TopicTreatment OutcomeBiomarkersBlood GlucoseCore outcome setSystematic reviewType 2 diabetes

Identifiers

PMID30086771
PMCPMC6081933

What OpenQuestion holds

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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.