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Assessment of glaucoma : using patient-reported outcome measures in randomised controlled trials

Background: Glaucoma is a chronic, progressive eye disease and the second cause of blindness in the world. To measure the patients’ perspective in randomised controlled trials (RCTs), patient-reported outcome measures (PROMs) are increasingly being used. However, the use of PROMs in glaucoma trials is low suggesting there may be a reluctance to use PROMs. Objectives: To explore three methodological challenges of using PROMs in RCTs in glaucoma: 1) PROM selection; 2) characterising glaucoma severity; and 3) interpreting PROM scores in terms of minimal important difference (MID). Methods: Vision PROMs used in glaucoma studies were identified and content validated using a systematic review approach and categorised by a new PROM taxonomy. Existing visual field staging systems (VFSSs) based on standard automated perimetry were systematically identified and quality assessed with a new tool developed for this review using a consensus method. The performance of four high quality visual field staging systems were evaluated and referenced against an experienced ophthalmologist in a diagnostic test accuracy study. A pilot study using the social comparison approach was undertaken to test the feasibility of an anchor-based approach in determining the MID of a vision PROM in a glaucoma population. Results: Thirty-three vision PROMs were identified and categorised, according to content into impairment, disability, status and satisfaction measures. Twenty-three VFSSs were identified but evaluation of quality assessment, particularly performance, was affected by poor VFSS reporting. The diagnostic accuracy study demonstrated suboptimal performance of the four highest quality staging systems. The pilot study to determine the MID for a vision PROM found the social comparison method to be a feasible approach in a glaucoma population. Conclusion: This thesis demonstrated how to select a PROM and identified difficulties with characterising glaucoma severity. Future research needs include development of robust methods for characterising glaucoma severity and full scale evaluation of MIDs in PROMs in glaucoma.

Identiferoai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:558603
Date January 2011
CreatorsChe Hamzah, Jemaima
PublisherUniversity of Aberdeen
Source SetsEthos UK
Detected LanguageEnglish
TypeElectronic Thesis or Dissertation
Sourcehttp://digitool.abdn.ac.uk:80/webclient/DeliveryManager?pid=186205

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