Article Text

Outcomes in randomised controlled trials of multifocal lenses in cataract surgery: the case for development of a core outcome set
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  1. Jennifer R Evans1,
  2. Samantha R de Silva2,
  3. Mohammed Ziaei3,
  4. Varo Kirthi4,
  5. Martin D Leyland5
  1. 1 International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK
  2. 2 Oxford Eye Hospital, Oxford, UK
  3. 3 Department of Ophthalmology, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand
  4. 4 Department of Ophthalmology, King’s College Hospital, London, UK
  5. 5 Department of Ophthalmology, The Royal Berkshire NHS Foundation Trust, Reading, UK
  1. Correspondence to Dr Jennifer R Evans, International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; jennifer.evans{at}lshtm.ac.uk

Abstract

Background/aims To describe and summarise the outcomes reported in randomised controlled trials of multifocal versus monofocal intraocular lenses in cataract surgery.

Methods We identified all randomised controlled trials of multifocal versus monofocal lenses in a Cochrane review (last search date June 2016). We extracted and summarised data on all outcomes reported using the framework of domain, measurement, metric and method of aggregation.

Results All studies collected data on distance and near visual acuity but there was considerable variation in the measures used and whether these outcomes were unaided or best corrected. Most studies reported final value measurements, rather than change from baseline. Approximately half of the studies reported data as a continuous measure only, one-third reported both continuous and categorical measures and a minority reported categorical measures only. There was little consensus as to cut-points. Although a majority of studies included one or more patient-reported outcome measures, none of the studies reported patient involvement in the choice of outcomes.

Conclusion The collection and analysis of data on outcome measures in studies of multifocal intraocular lenses in cataract surgery are complicated. As a result, there is considerable heterogeneity in collection and reporting in the medical literature. This makes it difficult to synthesise such data to provide robust estimates of effect and is a potential source of research waste. Investigators in this field must produce a core outcome set that is informed by patients’ views and we propose an initial set of outcomes on which these could be based.

  • treatment surgery
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Footnotes

  • Contributors JRE conceived the idea for this paper in discussion with all coauthors, coordinated the data collection and analysis and wrote the first draft of the paper. SdeS, MZ and KV collected the data. All authors revised the manuscript critically for important intellectual content and gave final approval of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

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