Abstract
Objectives Amblyopia, strabismus and ocular motility
disorders are common conditions with significant impact
on visual function, appearance and quality of life. We
aimed to establish a core set of outcomes for each of the
three conditions for use in clinical trials and routine clinical
practice.
Design A comprehensive databank of outcomes was
developed from a systematic review of the literature and
a series of focus groups with healthcare professionals,
researchers, patients and carers. The databank of
outcomes was scored in a two-round Delphi Survey
completed by two stakeholder groups: healthcare
professionals/researchers and patients/carers. Results
of the online Delphi were discussed at a face-to-face
consensus meeting where the core outcome sets were
finalised.
Setting UK-wide consultation.
Participants Researchers, clinicians, patients and carers.
Outcome measures Core outcome sets.
Results For amblyopia, strabismus and ocular motility,
40/42/33 participants contributed to both rounds of the
Delphi; six/nine/seven members attended consensus
meetings, respectively. Consensus was reached on ten
core outcomes for both amblyopia and ocular motility and
nine for strabismus. All three conditions shared the core
outcomes: adverse events, cost, vision-related quality
of life and ocular alignment. The strabismus and ocular
motility disorder core sets included, in addition, measuring
the deviation, binocular vision, ocular movement, patient
satisfaction and symptoms. The amblyopia set, distinct
from the sets for the other two conditions, included best
corrected distance and near visual acuity, spherical and
cylindrical refraction, compliance and treatment-related
and functionality/long-term impacts.
Conclusions The study used robust consensus methods
to develop a core outcome set for three ophthalmic
conditions. Implementation of these core outcome sets in
clinical trials and routine clinical practice will ensure that
the outcomes being measured and reported are relevant to
all stakeholders. This will enhance the relevance of study
findings and enable comparison of results from different
studies.
disorders are common conditions with significant impact
on visual function, appearance and quality of life. We
aimed to establish a core set of outcomes for each of the
three conditions for use in clinical trials and routine clinical
practice.
Design A comprehensive databank of outcomes was
developed from a systematic review of the literature and
a series of focus groups with healthcare professionals,
researchers, patients and carers. The databank of
outcomes was scored in a two-round Delphi Survey
completed by two stakeholder groups: healthcare
professionals/researchers and patients/carers. Results
of the online Delphi were discussed at a face-to-face
consensus meeting where the core outcome sets were
finalised.
Setting UK-wide consultation.
Participants Researchers, clinicians, patients and carers.
Outcome measures Core outcome sets.
Results For amblyopia, strabismus and ocular motility,
40/42/33 participants contributed to both rounds of the
Delphi; six/nine/seven members attended consensus
meetings, respectively. Consensus was reached on ten
core outcomes for both amblyopia and ocular motility and
nine for strabismus. All three conditions shared the core
outcomes: adverse events, cost, vision-related quality
of life and ocular alignment. The strabismus and ocular
motility disorder core sets included, in addition, measuring
the deviation, binocular vision, ocular movement, patient
satisfaction and symptoms. The amblyopia set, distinct
from the sets for the other two conditions, included best
corrected distance and near visual acuity, spherical and
cylindrical refraction, compliance and treatment-related
and functionality/long-term impacts.
Conclusions The study used robust consensus methods
to develop a core outcome set for three ophthalmic
conditions. Implementation of these core outcome sets in
clinical trials and routine clinical practice will ensure that
the outcomes being measured and reported are relevant to
all stakeholders. This will enhance the relevance of study
findings and enable comparison of results from different
studies.
| Original language | English |
|---|---|
| Number of pages | 9 |
| Journal | BMJ Open |
| Volume | 11 |
| Issue number | e042403 |
| DOIs | |
| Publication status | Published - 11 May 2021 |