UK National Eye Health Survey

Item 8

UK National Eye Health Survey

Project Plan/Funding Proposal

Date: 5 December 2016

Activity Sponsor: Mercy Jeyasingham, CEO, Vision 2020 UK

Chief Investigator: ProfRupert Bourne, Vision & Eye Research Unit, Anglia Ruskin University, Cambridge.

Contact: Heather Pearman,

Table of Contents

1.Title

UK NationalEyeHealthSurvey (NEHS)

2. Rationale

The United Kingdom currently has no nation-wide population based data on the prevalence and causes of vision impairment.

This is of great concern, given that health interventions and future programs have no evidence base other than a few small local population-based studies performed 20-30 years ago.

Why is such a survey needed now? There are several public health and economic reasons that justify the conduct of a NEHS in the UK, these include:

Resources –we do not know if resources are best deployed

Equity - certain groups in society do not have parity of access to eye care

Awareness - decision makers still do not understand the importance of eye health and the relationship with general health

Demand for eyecare currently outstrips capacity and we do not know the full extent of demand

These factors need to be considered in the context of:

i.a marked increase in our ageing population, where it is estimated that almost 85% of all vision impairment will be among those aged 50 years or more.

ii.a rise in the prevalence of diabetes and related risk factors, eg obesity, with consequences such as diabetic eye disease.

iii.great advances in the delivery of eyecare such as improved precision of eye testing technologies, more collaborative working across primary and secondary care among eyecare professionals, and opportunities to integrate research into clinical care which have the potential to lead to better outcomes, yet barriers to the coordination of eyecare and detection of eye disease still exist and are poorly understood

For these reasons, as a contributing country in reducing the global prevalence of avoidable vision impairment, we wish to fulfil the important indicator of determining the nation-wide prevalence, causes and coverage of major eye disease and associated conditions in the UK. The NEHS will betterguideeyehealthstrategies in the UK.

3. Background

The NEHS has been developed by a group of UK ophthalmic epidemiologistswith the support of Anglia Ruskin University (ARU) in conjunction with Vision 2020 UK to improve the evidence base and to determine the prevalence and causes of vision impairment and blindness in UK adults.

The stakeholders for the NEHS met throughout 2016 culminating with a Fundraising Directors meeting attended by the principal eyecare charities on 9 November 2016.

4. Objectives

TheobjectivesoftheNEHSareto:

1. To determine the prevalence and causes of vision impairment and blindness in the UK population aged 50 years and older, by gender, age, geographical area, and socioeconomic stratum [prevalence]
2. To measure the detection and treatment coverage rate of major eye diseases and conditions, including cataract, diabetic retinopathy, glaucoma, age-related macular degeneration and refractive error, and barriers to uptake of eyecare in UK adults. All participants will be provided with verbal feedback on their eye results at the completion of the clinical examination, and any participant with undiagnosed eye disease that can be detected through the survey’s testing protocol will receive a letter of recommendations for referral to an eye care professional. [utilisation]

5. Outputs

The following activities have been identified as the major outputs for the NEHS.

Table A: Activity Performance Indicators

6. Outcomes

The NEHS will help to improve the evidence base, in accordance with the UK Vision Strategy. The UK Vision Strategyis a blueprint for coordinated action by governments, health professionals, non-government organisations and industry to work in partnership to focus activity on the prevention and avoidance of vision loss and disease.

The NEHS will define the principles and methods to assess the extent of eye disease and conditions, provide useful information for policy, planning, service delivery and better direction in the allocation of funds.

Data from the NEHS will be used to report against the indicators in the WHO’s Global Action Plan (Universal Eye health: A Global Action Plan 2014-19).

7. Scope of Work

1. National recruitment maps computed using advanced sampling methodologies; stratified random sampling by country, ethnicity, area deprivation to obtain a representative sample of UK adults. A separate sampling frame involving care homes across the UK.

2. A detailed account of the statistical rationale used to define this sampling strategy.

3. A comprehensive manual of the testing protocol for the Project.

4. Ethics approvals to allow recruitment at all selected testing sites nationwide.

5. Improved data entry, storage and management systems using tablet-based databases.

6. Master database of all participants enrolled in the Project. Participant confidentiality will be maintained, with each participant having a unique identification code.

7. Progress report on the NEHS at the completion of the data collection phase

8. An up to date and nationwide report on major eye prevalence in the UK, that will allow for more guided economic analysis, resource allocation, eye health care service delivery and policy development.

Table B: Scope of Work

Included

 Geography: within the scope of the recruitment areas defined using our sampling methodology

 Participants – UK adults aged 50 years or older living in households and in care homes 50 years who reside at the point of recruitment will be invited to participate in the NEHS.

 Stated Objectives: The project will only meet the objectives outlined in the Project description (see section 4).

 Stated Budget: Completion of the stages of the Project will be subject to allocated funds

 Stated Time: Data collection will only be conducted in the allocated time period defined in our timeline. Time for screening, recruitment and examinations will be consistent between all recruitment sites to ensure consistency and internal validity of our study methodology.

Excluded

The data collected in the current Project will not extend beyond the defined testing sites within the UK derived from our sampling methodologies. Therefore, participants beyond our recruitment areas will not be invited into the study and the total sample size will not exceed the initial sample size estimations. This project will not include UK adults aged less than 50 years.

8.Key Personnel & Governance

Professor Rupert Bourneis a Consultant Ophthalmologist andProfessor of Ophthalmology at Anglia Ruskin University with extensive experience of national population-based surveys of eye disease and the lead for the Vision Loss Expert Group of the Global Burden of Disease Study, responsible for coordinating global estimates for blindness and vision impairment with the World Health Organization. He will be the chief investigator of the National Eye Health Survey (NEHS), supported from a number of world experts in the areas of epidemiology, translational research in ophthalmology and public health. Key support will be provided from the following:

1. Richard Wormald, Coordinating Editor of Cochrane Eyes and Vision Group and Consultant Ophthalmic Surgeon, Moorfields Eye Hospital.
2. Mercy Jeyasingham, CEO, Vision 2020 UK.
3. Michael Bowen, Director of Research, College of Optometrists
4. JugnooRahi, Consultant Ophthalmologist, Institute of Child Health, London.
5. Tasanee Braithwaite, Ophthalmology Resident, Moorfields Eye Hospital
6. Dr Mo Dirani [Chief Investigator, Australian National Eye Health Survey].

An international advisory board includes Professor Hugh Taylor, Professor Jost Jonas, and others to be confirmed.

Additional support and partnerships with other medical research institutes will be sought during the course of the survey and non-governmental organisations that reflect the broad membership of Vision 2020 Australia.

The governance structure is illustrated in Table C.

Table C: Governance Structure.

9.Overview of Methodology

9.1National Coordination Centre

A national coordination centre (NCC) will be established to plan, monitor the recruitment and examinations, manage the data and take responsibility of the analysis and reporting of the results. This will be based at the Host Institution, Anglia Ruskin University, in Cambridge.

9.2 Ethics

The NEHS management team will seek ethics approval for the NEHS via the Health Research Authorities for England and the devolved nations. Each participant will be required to sign a consent form that outlines the aims, significance and methodology of the NEHS. The NEHS will adhere to the tenets of the Declaration of Helsinki and all privacy requirements will be met.

9.3 Sample population

The NEHS will involve a representative sample of people from all regions of the United Kingdom. Each participant enrolled in the NEHS will undergo a simple eye examination and complete a standardised general questionnaire. Interviews and examinations will be conducted at each testing site. All examinations will be conducted by trained eye NEHS and local staff.

9.4 Sampling Frame and Sample Size Calculation[national survey]

The national survey will adopt a multi-stage stratified probability sampling design, common to the Health Survey England series. The sampling frame will be the small user Postcode Address File (PAF). The very small proportion of households living at addresses not on PAF (less than 1%) will not be covered.

Total Sample size = 24,294 adults aged 50 years and older to give precision in % blind in UK, assuming:

Blindness prevalence of 0.4%

Precision in MSVI in each of the 4 countries, assuming 3.5%(prevalence assumption based on GBD model*)

Design effect of 1.5

487 clusters of 50 people selected by stratified (1.country 2.ethnicity in England then 3. Index of Multiple Deprivation). 349 in England, 46 in each of the other countries (oversampling to achieve precision in MSVI %).

Random samplingwith PPS methods using UK postcode sampling frame.

A random sample of care homes will be selected for the Survey of care homes in the UK.

* this prevalence is based on estimates for the UK from the Global Vision Database- see Bourne RRA, Jonas JB, Flaxman SR, Keeffe J, Leasher J, Naidoo K, Parodi M, Pesudovs K, Price H, White RA, Wong TY, Resnikoff S, Taylor HR, on behalf of the Vision Loss Expert Group of the Global Burden of Disease Study. Prevalence and causes of vision loss in high-income countries and in Eastern and Central Europe: 1990-2010. Br J Ophthalmol 2014; 98:629-638.

9.5Recruitment and Clinical Examination

Three models have been considered (Table D). Models 1 or 2 are favoured and will be tested during an internal pilot.

Table D: Models for Recruitment and Clinical Examination

10. Timeline

Set-up phase / “Kickstart”

This phase will include the initiation, planning and development phases shown in the timeline, and data collection from 10 clusters of randomly selected sites (approx.. 500 people examined).

Appointments of key personnel of the Project Management Team will include:

Chief Investigator (0.5 wte)

Project Manager (postdoc)

PhD student (ophthalmologist/optometrist)

Senior Research Assistant

Junior Research Assistants x 5 (part-time)

Consultancy (data analysis + statistician)

Project Tolerances

A time tolerance 10% of the expected course of time of any particular stage of the Project, including the developmental, training, ethics, data collection, statistical analysis and reporting will be allocated. A variance beyond this tolerance will require formal reporting to the Project Steering Committee.

A cost tolerance of 5% of the total proposed Project budget will be assigned, and if this variance is exceeded, the Project Steering Committee must be consulted.

11. Budget

The budget for the UK NEHS is estimated to be £10.7 million.

The set-up phase for the UK NEHS will cost £250,000 (2.3% of the total budget)

NB. The Australian NEHS cost £500 per participant. At such costs, the UK NEHS would cost approximately £12.5 million.

Table E. Summary of Budget

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UK NEHS Project Plan 5 December 2016