(A) Contributions

Dear Colleague,

Survey results are in an we thank you all for your outstanding response! The Core Outcome Set team will now analyze the data and meet to make the decisions to complete this project.

A core outcome set is a set of outcomes that should be measured and reported as a minimum in clinical studies for a specific condition.  By identifying the minimum outcomes that should be reported, it makes it easier for the results of each clinical study to be compared, contrasted or combined as appropriate.

The project is sponsored by the International Association of Dental Traumatology. If you have any questions, please feel free to contact me.

Kind regards,

Peter

Dr. Peter Day (p.f.day@leeds.ac.uk)
Associate Professor and Consultant in Paediatric Dentistry,
Chair of the Research Committee, IADT
School of Dentistry, University of Leeds, UK

(B) EXPERT WORKING GROUP

Current Expert Working Group for developing the Core Outcome Set for traumatic dental injuries: 

The Expert Working Group is supported by a research team who will manage the day to day running of the project. 
They are Kate Counihan, Owaise Sharif and Peter Day.

(C) PROTOCOL

Title
Development of a Core Outcome Set (COS) for traumatic dental injuries in children and adults

Evidence-based comparisons of treatments and interventions can be challenging because of the diversity of outcomes reported in clinical studies.  Outcomes need to be relevant to patients, clinicians and policy makers if the findings of research are to influence practice and future research.  Furthermore, there is evidence to show that clinical researchers may favour reporting of outcomes that enhance results – this is known as outcome reporting bias.

These issues could be addressed through the development and use of an agreed standardised collection of outcomes, known as a core outcome set (COS). The reporting of core outcomes in published studies allows researchers to compare outcomes from different studies and where appropriate, using meta-analysis techniques, to combine the results from studies in a particular area. Adoption of a core outcome set does not imply that a particular study or review should be restricted only to those outcomes.  The expectation is that, as a minimum, the core outcomes will always be collected and reported [Williamson et al., 2012].

The most notable work relating to outcome standardisation has been conducted by the OMERACT (Outcome Measures for Rheumatology Clinical Trials) collaboration.  More than 50 other groups have been working on COS in specific areas of health care, including dentistry. An example of core outcome set in dentistry is for primary molar pulpotomy [Smail-Faugeron et al., 2013].

Aims
To develop a core outcome set for traumatic dental injuries in children and adults.

Objectives
To define what outcomes should be collected, how they should be measured and at what time points.

Methodology
The Chair of the Scientific committee will invite nine clinicians/researchers to join an Expert Working Group to develop COS for traumatic dental injuries.A further three Expert Working Group members will be recruited through an advertisement placed on the IADT website.
To ascertain the views of clinicians, all members of the IADT will be invited to participate in a two or three-round, web-based survey. 

It is envisaged that a core outcome set will be developed for each of:

• Uncomplicated hard tissue injuries
• Complicated hard tissue injuries
• Uncomplicated PDL injuries
• Complicated PDL injuries (including extra-alveolar details for avulsed teeth)
• Immature non-vital teeth

The outcomes proposed through the web-based survey will be assimilated and similar outcomes amalgamated.  The Expert Working Group will then decide which outcomes should form the COS.  They will use a Delphi technique, which has been used to develop other core outcome sets (Sinha et al., 2011). This is a structured and transparent method for reaching consensus, in which participants’ complete sequential rounds of questionnaires, with the results of each questionnaire informing the composition of the next.

The project will undertake the following stages:

1.  Initial meeting of Expert Working Group via email

a. Introductions and further background on Core Outcome Set development
b. Presentation of first questionnaire for IADT members and modification as required
c. Decision on scoring system for outcomes
d. Decision on what constitutes consensus
e. How many and how we elect IADT members who have placed their name forward to join the Expert Working Group.
f. Identify timeline and potential dates for web-based meetings where these are felt to be necessary.

2.  IADT members will be invited to participate by identifying what minimum trauma outcomes they feel should be reported for different types of traumatic     dental injuries
    [Web-based] [September 2014 – four weeks]

a. Announcement at IADT Conference
b. Email notification to all members
c. Replies to be directed through the IADT website
d. One month to respond, weekly email reminders to IADT members

3.  Collation of replies and suggested core outcomes (by KC, OS and PD).  Questionnaire for Round 2 to be devised.  This questionnaire will include     questions on how outcomes are to be measured and at what time points they should be measured.
    [Face to face] [October 2014]

4.  Expert Working Group
    [Web-based] [November 2014]

a. Presentation of results from Round 1
b. Review list of outcomes and reach consensus on which to be included for next round
    i. List to be published on IADT website
c. Review of questionnaire for Round 2 and modifications as required

5.  IADT Members
    [Web-based] [December 2014 / January 2015 – four weeks]

a. Members to be notified of outcome list on IADT website
b. Round 2 questionnaire to be sent to all members
c. Replies to be directed through IADT website
d. One month to respond, weekly email reminders to IADT members

6.  Collation of responses (by KC, OS and PD). 
    [Face to face] [February 2014]

 a. Outcomes, measurement and timing

7.  Expert Working Group
  [Web-based] [March 2015]

a. Presentation of results
b. Finalised core outcome set for dental traumatology to be agreed
c. Discussion and decision on measurement of outcomes and timing of these measurements.

8.  Expert Working Group
    [Web-based] [April 2015]

a. Modifications if required, based on membership comments
b. Preparation for publication

References
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P.  developing core outcome sets for clinical trials: issues to consider.  Trials 2012, 13:132

Sinha IP, Smyth RL, Williamson PR.  Using the Delphi technique to determine which outcomes to measure in clinical trials; recommendations for the future based on a systematic review of existing studies.  PLoS Med 2011, 8(1):e 1000393

Smail-Faugeron V, Fron Chabouis H, Durieux P et al.,  Development of a core set of outcomes for randomised controlled trials with multiple outcomes – example of pulp treatment of primary teeth for extensive decay in children.  PLoS One 2013, 8: e51908