Development of a core outcome set for amblyopia, strabismus and ocular motility disorders: a review to identify outcome measures

Abstract

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.Electronic supplementary materialThe online version of this article (10.1186/s12886-019-1055-8) contains supplementary material, which is available to authorized users.

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)

“…They also identified the importance of 'stereopsis' and 'the range of single vision' for inclusion of success definition in some Open access strabismus types, which interestingly could be mapped to 'binocular vision' in our strabismus COS. The study also found that there was no consensus on the length of time after surgery for determination of success, magnitude of deviation consistent with success and whether manifest or latent deviation should be considered to define success, which the review of our study 27 has also found and which we are advocating to define, by future work. Differences from our study are that their survey did not involve scoring of outcomes, there was no systematic search of literature of reported outcomes prior to survey construction and patients or service users were not consulted in the process.…”

“…To assist this process, the systematic review for generating the databank of outcomes also recorded the measurement instruments and timings associated with each outcome. 27 Moreover, for some outcomes, the metric (eg, change from baseline or interocular difference (IOD) of BCVA) and method of aggregation (eg, mean or median) 22 would need to be determined. Defining success criteria (eg, 8 or 10 dioptres from orthophoria for alignment, for distance and/or near) is another aspect of outcome refining and definition to be done by further work.…”

“…The detailed search strategy, methods and results for the systematic review have been published elsewhere. 27 Outcomes from the systematic review and suggested outcomes from the recorded focus group meetings were extracted verbatim and grouped into suitable domains to facilitate easy classification. The final list was checked by experts in all three clinical conditions (SA-J and FJR), who also had the opportunity to use their clinical expertise to add additional outcomes to the list.…”

Short-Listing the Program Choice for Perimetry in Neurological Conditions (PoPiN) Using Consensus Methods

“…However. this study opted not to use the Delphi technique because of the low completion rates with this technique seen in eye research (Al Jabri et al 2019;). Instead we favoured using results from a systematic review to populate a shorter survey to maximise the return rate.…”

Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment

“…19,20 Core outcome set methodology is designed to ensure that the views of all key stakeholders are elicited for consideration during COS development to ensure that the final COS includes outcomes that matter to patients, clinicians, and policy-makers/commissioners. 20 To date, COSs have been developed for a number of areas in ophthalmology, including dry eyes, 21 cataract, 22 macular degeneration, 23 glaucoma, 24 thyroid eye disease, 25 and strabismus and ocular motility disorders, 26 with ongoing work in cerebral visual impairment 27 and Behcet's syndrome. 28 The development of a COS for NIU-PS has the potential to profoundly enhance the value of trials in this condition by avoiding inappropriate outcome measures and providing the standardization needed to enable comparison and metaanalysis of outcomes across trials (even where they may have selected different primary outcomes).…”