Developing the intervention & outcome components of a proposed RCT of screening for open angle glaucoma

Lead Research Organisation: University of Aberdeen
Department Name: Unlisted

Abstract

Open angle glaucoma (OAG) is a common cause of blindness. Many people do not know they are developing OAG and miss out on the potential benefit of early treatment. This study develops the design for a randomised controlled trial (RCT) studying screening for OAG.

Screening may be a good way to find and treat more people who have OAG. Screening involves inviting everybody who has a particular characteristic, for example of a certain age, for testing. However, we need to know that screening will reduce the number of people losing vision and that it is value for money compared with the current system of people choosing to attend for a sight test. To answer these questions we need a large, high quality research study, i.e. a randomised controlled trial (RCT).

Before we can conduct a screening RCT we have to determine which screening tests should be evaluated, where testing should take place and who to include. Also we need to know how best to measure benefits and any harms of screening.

We will seek the views of people who do and do not have glaucoma, as well as views of health care professionals involved in providing eye care services.

Technical Summary

Open angle glaucoma (OAG) is a primary, progressive optic neuropathy; the onset is asymptomatic, progression occurs silently until the disease is moderately advanced when vision is affected. Blindness due to OAG is irreversible. It is suggested that OAG may be a condition that fulfils the criteria for population screening. Two recent studies, based on economic modelling evaluations and reviews of the literature, suggest that screening in higher-risk groups might be worthwhile. Both these studies highlighted the considerable uncertainties in the available primary data and that further research is required to inform decisions on whether a screening programme should be initiated. A RCT is the optimal design to determine whether screening is effective, and no such RCT has been undertaken. Prior to initiating a RCT further research is required to inform the trial design, specifically the optimal screening approach and how outcome should be determined. This is what this proposed study aims to do.
A mixed method, multidisciplinary approach will be used to address the following research questions:
1. What screening strategy (i.e., test; site; target population; provider) will give the optimal combination of feasibility and acceptability to providers?
2. How feasible are the proposed identification strategies for each at-risk group and, given the results, what is the most appropriate unit of clustering?
3. What are the most likely effective interventions for maximising screening attendance by the targeted individuals?
4. What are the most appropriate methods for obtaining primary clinical and patient reported outcomes for use in the trial?

This research will deliver an acceptable screening strategy; feasible strategies to invite each of the target groups; informed trial design (unit of clustering); a decision as to whether a behavioural intervention might increase uptake of screening; an updated economic model to inform the RCT; defined trial outcomes. This research will thus enable a precise and evidence-based trial protocol to be developed that has the best opportunity to demonstrate the success or not of a glaucoma screening programme.

The study will be led from the Health Services Research Unit and the Health Economics Research Unit, University of Aberdeen and involves collaborators across the UK and Europe. The lead centre has long term infrastructure funding, making the ideal environment for undertaking this study and any definitive screening trial with long term follow up.

Publications

10 25 50

publication icon
Che Hamzah J (2011) Choosing appropriate patient-reported outcomes instrument for glaucoma research: a systematic review of vision instruments. in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

publication icon
Glaucoma Screening Platform Study Group (2011) Developing the clinical components of a complex intervention for a glaucoma screening trial: a mixed methods study. in BMC medical research methodology

publication icon
Prior M (2013) Why do people present late with advanced glaucoma? A qualitative interview study. in The British journal of ophthalmology

publication icon
Prior ME (2011) Pre-validation methods for developing a patient reported outcome instrument. in BMC medical research methodology

 
Description Project grant
Amount £357,236 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 02/2009 
End 07/2010
 
Description Visiting Fellowship
Amount £30,000 (GBP)
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 04/2010 
End 08/2010
 
Title Aberdeen Glaucoma Questionnaire 
Description A 71 A Pilot glaucoma specific patient reported outcome measure has been developed 
Type Of Material Physiological assessment or outcome measure 
Provided To Others? No  
Impact The pilot instrument is in the process of validation. The final instrument will be an important measure for clinical practice and research. 
 
Description Applied Clinical Trials Centre Investigating Vision and Eyes 
Organisation Moorfields Eye Hospital NHS Foundation Trust
Department NIHR Moorfields Biomedical Research Centre
Country United Kingdom 
Sector Academic/University 
PI Contribution I am executive chair of the collaborative partnership between University of St Andrews and Moorfields BRC. I have brought expertise in the design , conduct and reporting of clinical trials. ACTIVE has a formal collaboration agreement with the UCL-Comprhensive Clinical Trails Unit
Collaborator Contribution The group is a collaborative ophthalmology resource for the design, conduct, analysis and reporting of randomised controlled clinical trials of important questions for eye health and vision brining together context ( ophthalmology) and intellectual expertise in systematic reviews, statistics, economics and triallists.
Impact Funded NIHR portfolio studies. The team is multidisciplinary
Start Year 2011
 
Description Applied Clinical Trials Centre Investigating Vision and Eyes 
Organisation University College London
Department Comprehensive Clinical Trials Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution I am executive chair of the collaborative partnership between University of St Andrews and Moorfields BRC. I have brought expertise in the design , conduct and reporting of clinical trials. ACTIVE has a formal collaboration agreement with the UCL-Comprhensive Clinical Trails Unit
Collaborator Contribution The group is a collaborative ophthalmology resource for the design, conduct, analysis and reporting of randomised controlled clinical trials of important questions for eye health and vision brining together context ( ophthalmology) and intellectual expertise in systematic reviews, statistics, economics and triallists.
Impact Funded NIHR portfolio studies. The team is multidisciplinary
Start Year 2011
 
Description Australia 
Organisation Glaucoma Australia
Country Australia 
Sector Charity/Non Profit 
PI Contribution The preliminary outputs of the research have been presented at international meetings; this has stimulated collaborators and patient organisations to contact us regarding future collaboration.
Collaborator Contribution Insight into how the outputs from our research in the UK context may be applied in an Australian context,
Impact The committee on glaucoma detection reporting to the board of Glaucoma Australia (a patient organisation) have sought a collaboration with the Dr Burr and the outputs of the glaucoma screening platform study. Glaucoma Austraila are funding Dr Burr to visit Sydney in 2011 to discuss the details of future potential collaborations. This will be a multidisciplinary collaboration involving clinicans (optometrists, nurses and ophthalmologists), patients and clinical scientists,
Start Year 2010
 
Description EPIC study (Professor Paul Foster) 
Organisation Moorfields Eye Hospital NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution The European Prospective Investigation of Cancer (EPIC) study is a large multi-centre cohort study looking at the connection between diet and cancer.The EPIC-Norfolk cohort, consists of 30,446 men & women, was established in 1993. Since 2004, detailed eye examination data on 6,277 subjects aged 49 years and older have been gathered, and examination on 8,000 subjects is complete The data includes among others, parameters for glaucoma assessment, such as visual acuity, intraocular pressure, retinal nerve fibre layer imaging with scanning laser polarimetry, optic nerve head tomography with Heidelberg HRT2, as well as disc & macular digital photographs. I am a collaborator and advisor to a MRC /Fight for sight funded fellowsip. The fellow is exploring the Ophthalmology data nested in the EPIC-Norfolk cohort. togther we are exploring how these data can be used to address the policy question of the value of glaucoma screening.
Collaborator Contribution The partnership provides additional information to inform the policy question of glaucoma screening or enhanced case detection
Impact MRC ?Fight for Sight pre-doctoral fellowship
Start Year 2011
 
Description Finland 
Organisation Government of Finland
Country Finland 
Sector Public 
PI Contribution The preliminary outputs of the research have been presented at international meetings; this has stimulated collaborators and patient organisations to contact us regarding future collaboration.
Collaborator Contribution Insight into how the outputs from this research in the UK context may be applied in a Finnish context.
Impact The Finnsh government have funded a pilot study in Finland to explore how our findings may be applied in a Finnish context. The PI and one co-investigator on the glaucoma platform study are on the advisory panel. The Finnish project will start in 2011.
Start Year 2010
 
Title Public health intervention 
Description The mixed methods study has developed the clinical components of the clinical testing strategy following the MRC framework for the development of complex interventions; additionally the components of a behavioural intervention to maximise attendance for glaucoma screening have been developed. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Initial development
Year Development Stage Completed 2010
Development Status Under active development/distribution
Impact The developed interventions will be evaluated in a future randomised controlled trial evaluating glaucoma screening or ehanced glaucoma case detection. 
 
Description Patient group meeting (IGA) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact About 50 people with glaucoma attended this patient day . I was talking about screening for glaucoma and the potential benefits and pitfalls of any glaucoma screening programme.
JB is speaking at the IGA Scotland National Glaucoma Patient Meeting 25th October 2013. Future glaucoma care (What the evidence suggests)

Information for the public on the International Glaucoma Association website, about how screening may not be the way forward to improve glaucoma detection but interventions to maximise uptake by those who do not seek are and improved detection by health care professionals is indicated.
Year(s) Of Engagement Activity 2012,2013
URL http://www.glaucoma-association.com/uploads/Newsletters/Spring%20News%202013%20Web%204MB.pdf
 
Description Public health and community eye care 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Around 30 people, including users with sight loss, community optometrists, ophthalmologists and public health physicians and representatives from RNIB Scotland attended this workshop. The aim was to discuss initiatives to reduce sight loss from blinding eye disease in Scotland and to explore implementation.

I am in discussions with RNIB and the International Glaucoma Association on funding for future implementation research on enhanced glaucoma case detection.
Year(s) Of Engagement Activity 2011
 
Description UK Glaucoma Alliance 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Two researchers presented the outline of the whole study and described the interviews undertaken with health care providers to develop the Glaucoma screening intervention for the future trial.

The presentation was on the 20th November 2009. The anticipated impact will be dissemination of information about the future research agenda to evaluate screening for glaucoma.
Year(s) Of Engagement Activity 2009