Evidence map›Paper›PMID 28778170›Full record

ArticleTrials2017

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study.

Aliki Tsichlaki, Kevin O'Brien, Ama Johal, Zoe Marshman, Philip Benson, Fiorella B Colonio Salazar, Padhraig S Fleming

Erratum issuedOpen access · goldAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
9.7field-weighted citation impact, top 2% 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

6 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Aliki TsichlakiDepartment of Orthodontics, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 1BB, UK. a.tsichlaki@qmul.ac.uk.ORCID 0000-0002-9130-4506
Kevin O'BrienDivision of Dentistry, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, M13 9PL, UK.
Ama JohalDepartment of Orthodontics, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 1BB, UK.
Zoe MarshmanSchool of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK.
Philip BensonSchool of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK.
Fiorella B Colonio SalazarDepartment of Orthodontics, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 1BB, UK.
Padhraig S FlemingDepartment of Orthodontics, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 1BB, UK.
Queen Mary University of London · GBUniversity of Sheffield · GBUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOrthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. METHODS/

designThis is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. DISCUSSION: This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved.

trial registrationThe project has been registered on the Core Outcome Measures in Effectiveness Trials ( COMET ) website, January 2016.

Indexed as

Controlled Clinical Trials as TopicDelphi TechniqueEndpoint DeterminationMalocclusionOrthodonticsResearch DesignAdolescentAdolescent BehaviorChildChild BehaviorClinical ProtocolsConsensusFemaleFocus GroupsHumansInterviews as TopicCore outcome setDelphiMixed-methodsOrthodontics

Identifiers

PMID28778170
PMCPMC5545003
OpenAlexW2742852557

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.