Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol

Identifying existing knowledge

To identify all outcomes reported by randomized controlled studies on prevention and
treatment of caries lesions in primary and permanent teeth, two search strategies
will be developed; one for screening trials on prevention of caries lesion development,
the other for management of caries lesions. Inclusion criteria will be systematic
reviews of RCTs, or RCTs, on preventing or managing caries lesions. The reviews and
trials will either:

compare an intervention for preventing or managing the lesions to:

another prevention or management intervention or

no treatment; or

compare interventions to support patients undergoing dental procedures related to
caries

No restrictions with regards to setting or location and type of the prevented or treated
lesion will be made.

Four electronic databases (Cochrane Central Register of Controlled Trials, Cochrane
Database of Systematic Reviews, Medline via PubMed, Embase) will be searched using
defined strategies, and de-duplicated to provide a single set of titles/abstracts.
Titles and abstracts will be screened by two calibrated reviewers for eligibility,
and consensus obtained by discussion or consulting a third reviewer. Data from eligible
studies will be independently extracted by two reviewers using electronic spreadsheets
until both parties agree that saturation has been reached and no new outcomes are
being found. A list of outcomes will be compiled, and outcomes with different verbatim
terms but similar meaning combined in a single term.

Consensus process

The COS will be developed by a consensus process involving key stakeholders: namely,
patients and members of the public, dentists, clinical researchers, health economists,
statisticians, policy-makers and industry representatives. Panelists will give their
informed consent prior to taking part in the consensus process. To increase uptake
of the resulting COS, we will engage with the Cochrane Oral Health Group, clinical
guideline developers, research funders, journal editors, regulators such as research
ethics committees, and trial registries. We will attempt to ensure adequate representation
from each of the stakeholder groups to improve the acceptance and implementation of
the COS. No ethical approval will be required for this study according to the East
of Scotland Research Ethics Service (reference 15/GA/0033).

We will attempt to gain consensus via a three-stage Delphi process using an online
platform to support a specially designed e-Delphi portal. This has been chosen as
the most inclusive and pragmatic method to include key stakeholders from different
settings, backgrounds and geographical locations. If consensus cannot be reached on
a full outcome set we will propose a smaller core set based on those outcomes that
have agreement.

For the first stage of the Delphi process, there will be two panels created, a patient
panel and a separate group consisting of researchers, clinicians, teachers, industry
affiliated researchers, policy-makers, and other interested parties that are identified.
The first round of the Delphi process will be held separately for each of the two
panels and they will be combined in the later Delphi stages. Recruitment of patient
panelists and members of the public will be performed within dental clinics (patients
will be recruited from an existing pool in different clinics) in different countries.
An inclusive approach will be taken aiming to involve patients from various socio-economic
and geographic backgrounds. An invitation (plain language version sent where appropriate)
with the background of the COS development process will be sent or given to potential
panelists, providing them with additional information regarding the practicalities
of the consensus process. Participants will be asked to reply to the invitation using
the e-Delphi portal, and, to minimize attrition, only those accepting the invitation
and confirming active participation will be included in the process. Panelists will
be asked to review the list of outcomes and add any that they consider relevant but
missing from the list. Panelists will be informed that a minimum of two participants
will have to propose an outcome for it to be included in the next stage of the process.
The resulting list will again be harmonized using this rule and with single terms
being used for items mentioned with multiple names. For this complete list, panelists
will then be asked to score each outcome using the scale proposed by the GRADE group
(http://www.gradeworkinggroup.org), in which 1 to 3 signifies an outcome of limited importance, 4 to 6 important but
not critical, and 7 to 9 critical.

The results from the two panels will be summarized and fed back to individuals for
the second round. In the second round, the panels will be combined to give a single
panel and members will be reminded of their first choice, and will be allowed to change
their score in light of the panel’s overall opinion. If there is a risk in the second
round of the patient voice not coming through we will consider possible management
options such as weighting. As people who do not agree with the group may be less inclined
to continue the process, reminders will be sent to participants who do not respond.
This should help to minimize overestimation of the extent of the consensus.

Consensus that an outcome should be included in the COS, will be defined as 70 % or
more of the respondents scoring it 7 to 9 and fewer than 15 % scoring it as 1 to 3
(e.g. outcome will be retained). Consensus that an outcome should not be included
in the COS will be defined as 70 % or more scoring it as 1 to 3 and fewer than 15
% scoring it as 7 to 9 (outcome will be discarded). If we reach consensus on more
than two and up to five items, we will stop the consensus process and these items
will form the COS. If this is not achieved, the Delphi process will be re-run.

Dissemination

To help increase the uptake of COS we will engage with relevant groups such as the
Cochrane Oral Health Group, ORCA (the European Organization for Caries Research),
the International Association for Dental Research Cariology Group, guideline development
groups including National Institute for Clinical Excellence, the Scottish Intercollegiate
Guideline Network and the Scottish Dental Clinical Effectiveness Program, journal
editors, trial registries and major funding bodies such as the UK National Institute
for Health Research (NIHR) Health Technology Assessment or the German Research Foundation.
An overview of the trial can be found in Fig. 1.

Fig. 1. Study flow