Dataset Information

Core outcome set for three ophthalmic conditions: a healthcare professional and patient consensus on core outcome sets for amblyopia, ocular motility and strabismus (COSAMS Study).

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.

SUBMITTER: Al-Jabri S

PROVIDER: S-EPMC8118006 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCore Outcome Sets (COS) are defined as the minimum sets of outcomes that should be measured and reported in all randomised controlled trials to facilitate combination and comparability of research. The aim of this review is to produce an item bank of previously reported outcome measures from published studies in amblyopia, strabismus and ocular motility disorders to initiate the development of COS.MethodsA review was conducted to identify articles reporting outcome measures for amblyopia, strabismus and ocular motility disorders. Using systematic methods according to the COMET handbook we searched key electronic bibliographic databases from 1st January 2011 to 27th September 2016 using MESH terms and alternatives indicating the different subtypes of amblyopia, strabismus and ocular motility disorders in relation to treatment outcomes and all synonyms. We included Cochrane reviews, other systematic reviews, controlled trials, non-systematic reviews and retrospective studies. Data was extracted to tabulate demographics of included studies, primary and secondary outcomes, methods of measurement and their time points.ResultsA total of 142 studies were included; 42 in amblyopia, 33 in strabismus, and 68 in ocular motility disorders (one study overlap between amblyopia and strabismus). We identified ten main outcome measure domains for amblyopia, 14 for strabismus, and ten common "visual or motility" outcome measure domains for ocular motility disorders. Within the domains, we found variable nomenclature being used and diversity in methods and timings of measurements.ConclusionThis review highlights discrepancies in outcome measure reporting within published literature for amblyopia, strabismus and ocular motility and it generated an item bank of the most commonly used and reported outcome measures for each of the three conditions from recent literature to start the process of COS development. Consensus among all stakeholders including patients and professionals is recommended to establish a useful COS.

Project description:ObjectivesVisual impairment following stroke is common with a reported incidence of visual impairment in 60% of stroke survivors. Screening for visual impairment is neither routine nor standardised. This results in a health inequality where some stroke survivors receive comprehensive vision assessment to identify any existent visual problems while others receive no vision assessment leaving them with unmet needs from undiagnosed visual problems. The aim of this study was to define two core outcome sets (COS), one for vision screening and one for full visual assessment of stroke survivors.DesignA list of potentially relevant visual assessments was created from a review of the literature. The consensus process consisted of an online 3-round Delphi survey followed by a consensus meeting of the key stakeholders.ParticipantsStakeholders included orthoptists, occupational therapists, ophthalmologists, stroke survivors and COS users such as researchers, journal editors and guideline developers.SettingUniversity.Outcome measuresCOS.ResultsFollowing the consensus process we recommend the following nine assessments for vision screening: case history, clinical observations of visual signs, visual acuity, eye alignment position, eye movement assessment, visual field assessment, visual neglect assessment, functional vision assessment and reading assessment. We recommend the following 11 assessments for full vision assessment: case history, observations, visual acuity, eye alignment position, eye movement assessment, binocular vision assessment, eye position measurement, visual field assessment, visual neglect assessment, functional vision assessment, reading assessment and quality of life questionnaires.ConclusionsCOS are defined for vision screening and full vision assessment for stroke survivors. There is potential for their use in reducing heterogeneity in routine clinical practice and for improving standardisation and accuracy of vision assessment. Future research is required to evaluate the use of these COS and for further exploration of core outcome measures.

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