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UK National Eye Health Survey'Quality data on vision and eye health for adults in the four nations'

Project Plan/Funding Proposal

Date: 5 December 2016 Activity Sponsor: Mercy Jeyasingham, CEO, Vision 2020 UK

Chief Investigator: Prof Rupert Bourne, Vision & Eye Research Unit, Anglia Ruskin University, Cambridge. Contact: Heather Pearman, [email protected]

UK NEHS Project Plan 5 December 20161

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Table of Contents

Section Page1 Title 32 Rationale 33 Background 34 Objectives 45 Outputs 46 Outcomes 57 Scope of Work 58 Key Personnel and Governance 79 Overview of Methodology 8

9.1 National Coordination Centre 89.2 Ethics 89.3 Sample population 89.4 Sampling Frame and Sample Size Calculation 99.5 Recruitment and Clinical Examination 9

10 Timeline 10

11 Budget 11

12 Appendix: Biographies of Vision 2020 UK and Key Personnel 12


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1. Title

UK National Eye Health Survey (NEHS) -'Quality data on vision and eye health for adults in the four nations'

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 deployedEquity - certain groups in society do not have parity of access to eye careAwareness - decision makers still do not understand the importance of eye health and the relationship with general healthDemand 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 better guide eye health strategies in the UK.

3. Background

The NEHS has been developed by a group of UK ophthalmic epidemiologists with 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.


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4. Objectives

The objectives of the NEHS are to:

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

Performance Indicator Description

Target Target Completion Date

Accountability

Ethics Approval Submission of ethics application to a NIHR Research Ethics Committee (REC) and approval from the UK Health Research Authority. Approval will also be sought from all other ethics committees to allow for recruitment at all identified sampling areas.

Ethics submission to the REC will take place on the 1st May 2017 and other approvals will be requested during the course of the developmental and training stages of the Project.

Chief Investigator

Mapping of recruitment areas

Stratified random sampling by country, ethnicity (England only) and area deprivation will be undertaken to obtain a representative sample of adults across the UK.

30 April, 2017 Database Consultant and Chief Investigator

NEHS Manual A comprehensive manual on all stages of screening, recruitment, testing protocol and data management will be developed.

1 May 2017 Project Manager

Tablet-based Easy to use, secured 1 May 2017 Database Consultant


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database and up to date software to be used by all recruiters for screening, recruitment and a proportion of the clinical examinations (domiciliary visits). Online database for clinical examination entry. Ongoing electronic data entry.

Project Manager

Staff training Training of staff on all aspects of recruitment and testing using validated methodologies

Ongoing process that commences on the 1 June 2017

Project Manager

Master Database A clean dataset of all enrolled and examined participants

1 February 2020 Database Consultant and Project Manager

6. Outcomes

The NEHS will help to improve the evidence base, in accordance with the UK Vision Strategy. The UK Vision Strategy is 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.


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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

Part of the Activity (Inside Scope) Responsibility

Sampling map for recruitment of participants from randomly selected clusters. Sampling map for recruitment of participants from randomly selected care homes.

Project Manager and Database Consultant

Inclusion criteria: age and residency Recruiters and Examiners

Training operational staff to use the new system

Activity Manager

Objective clinical measurements of major eye diseases and conditions

Project Manager, Recruiters and Examiners

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.


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8. Key Personnel & Governance

Professor Rupert Bourne is a Consultant Ophthalmologist and Professor 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 Optometrists4. Jugnoo Rahi, Consultant Ophthalmologist, Institute of Child Health, London.5. Tasanee Braithwaite, Ophthalmologist (Moorfields Eye Hospital) & Lead

Investigator National Eye Survey of Trinidad & Tobago, 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.

Supporter / Stakeholder

Advisory Governance Operational

UK NEHS group

UK NEHS Steering Group

International Scientific Advisory Group:

Executive Board Project Management Group

UK NEHS group members

Chair: CEO VISION 2020 UKVice-Chair: TBC

Members:Independent StatisticianIndependent EpidemiologistFinance professionalHost organisation (ARU) representativeProject Partners PPI / Lay (x2 min)Stakeholder reps (X6) - sector and industry / funder-TBC

Chair: TBCEpidemiologist(s)Ophthalmologist(s)Optometrist(s)

Chair:Prof. Sir Michael RawlinsVice-chair:CEO VISION 2020 UKMembers:UK Govt. Rep. - DHGovt. Rep. WALESGovt. Rep. SCOTLANDGovt. Rep. NORTHERN IRELANDLay person / PPI (x2 min)

Chief Investigator:Rupert BourneCo-Investigators:Richard Wormald,Tasnaee Braithwaite,Jugnoo Rahi,Mo DiraniProject office team:Project ManagerSenior Project CoordinatorProject Administrators (x3?)Finance manager (0.2 FTE?)Project Field Team:Screeners; Ophthalmologists/Optometrists


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Sponsor / Host organisation rep.

UK NEHS Group ToR / Purpose

Stakeholder / funder / supporter forum.Receive and feedback on progress reports.Facilitate access to sector networks.Provide support and facilitation to project team.Identify and enable in-kind support and feed in to fundraising activities.

Advice on technical scientific features of the project.Provide independent review of protocol, protocol related issues / changes, data analysis plan and delivery of analysis.

Provide independent oversight.Review and advise on the development of the project.

Manage the project.Collect data.Manage data.Analyse data.Produce interim and final reports.Produce papers.

UK NEHS group

UK NEHS Lay Advisory Group

Expert Working Groups:1. Data centre / IT2. Imaging3. E-Health4. Equity group5. Child Health6. Care homes7. Prisoners

UK NEHS group members

Suggest this is a remote / electronic group that uses the applicants from the original call.

UK NEHS Group ToR / Purpose

Provide PPI perspective on protocol and patient / public facing project materials.

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


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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 sampling with 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 ExaminationFeature Model 1 Model 2 Model 3

Enumeration (1st physical contact that may follow

postal/telephone/e contact)*

Doorstep consent and tablet-measured visual acuity +

contrast sensitivity (VA, 60 seconds)





Follow-up clinical examination for those passing a VA cut-off

Local centre chosen by survey team (eg. health ctr, optom practice, municipal

space)

Local optometrist from the UK NEHS Optometric

Network (pre-determined standardization of eqpt and

testing protocol)Non-attendees offered

assessment in mobile NEHS unit / domiciliary visit

Doorstep/living room using portable e-technology

Follow-up clinical examination for those

failing a VA cut-off

Local centre chosen by survey

team (eg. health ctr, optom practice, municipal space)

Local Hospital Trust supplying eyecare services from the UK NEHS Trainee

Research Network (pre-determined standardization of eqpt and testing protocol)

Doorstep/living room using portable e-technology


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Non-attendees offered assessment in mobile NEHS

unit / domiciliary visitAdvantages Using local eyecare

specialists (ophthalmologists and optometrists) to assess

patients who understand local referral pathways

Opportunity to perform a clinical examination at first contact with the participant

(thereby less of a risk in terms of response rate)

Disadvantages May be more difficult to coordinate although this can

be tested.

Retinal images are not currently of suitable quality

for this approach (end 2016), although this may be

different end 2017. Unlikely to be able to capture the

depth of information that a separate visit by the

participant would offer

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 AssistantJunior 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


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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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12. Appendix: Biographies of Vision 2020 UK and Key Personnel

VISION 2020 UK is the umbrella organisation which leads the collaboration of interested organisations in order to improve the eye health of the UK, prevent avoidable sight loss, and ensure inclusion and participation of people who have impaired vision in society.

Working with over 50 member organisations across eye health and sight loss VISION 2020 UK seek to provide a unified response on key issues affecting blind and partially sighted people. We facilitate engagement to create standards, improve quality and influence change.

As the unified voice for the sector VISION 2020 UK are well placed to support The UK Eye Survey, a large research project to find out about the eye health of people living in the UK. At the moment there is no comprehensive, up-to-date and reliable source of information about eye health in the UK. The wide aim for the UK Eye Survey is to use it to assist in the shaping of eye health policy and delivery of services, including informing eye research.

Key personnel

Mercy JeyasinghamMercy is CEO of VISION 2020 UK, the membership organisation leading collaboration in eye health and sight loss. She brings to the project board over 25 years of health and social care experience in both the voluntary and statutory sectors.She was a non-executive Director of NICE for 12 years, overseeing the expansion of NICE from appraisals and clinical guidance to public health and social care. She was a lay Chair of the Fitness to Practice Committee of the General Optical Council for 10 years and a consultant with the King’s Fund for 14 years. Mercy has held posts as Director of Registration for the GSCC, Head of Accreditation for the RCN, and Programme Manager for the King’s Fund.Mike BowenMichael is the Director of Research at the College of Optometrists, where he is responsible for the strategic development of the College's Research activities. Michael has led various research projects within the sector, including PrOVIDe - which gathered data on the prevalence of visual impairment among people living with dementia in England. Prior to joining the College in 2008, Michael worked at the professional and regulatory body for Psychotherapy in the UK, running their research, education and standards, and fitness to practice functions. Michael's academic background is in psychology, biology and medical ethics.


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Rupert BourneRupert Bourne is Professor of Ophthalmology at Anglia Ruskin University, Cambridge, directs the Huntingdon Glaucoma Diagnostic and Research Centre at Hinchingbrooke Hospital, Huntingdon, and is also Honorary Consultant Ophthalmic Surgeon to Addenbrooke’s Hospital, Cambridge. He trained at Moorfields Eye Hospital and undertook two Glaucoma fellowships, one there and another at the Shiley Eye Centre/Hamilton Glaucoma Center in San Diego, California. He has a strong research interest, particularly in advanced techniques of Glaucoma diagnosis and progression and the management of Glaucoma in the community, along with overseas ophthalmology which has involved design and analysis of several large population-based surveys of eye disease, several national in scope, eg. Pakistan, Bangladesh and Trinidad. He is the Chair of the National Institute for Health Research Ophthalmology Specialty Group, responsible for NHS research delivery. In his role as Coordinator of the Vision Loss Expert Group of the Global Burden of Disease Study, he has overseen the long-term research into the world-wide prevalence rates of blindness and visual impairment, in partnership with the World Health Organization.Tasanee BraithwaiteTasanee Braithwaite is a London-based ophthalmologist with a background in general medicine, public health and health economics. She obtained her MPH from Johns Hopkins University and led the 2013-2014 National Eye Survey ofTrinidad and Tobago. She is a contact editor for Cochrane Eyes and Vision. She brings experience in study design, logistics and statistical analysis to the UK NEHS.

Mohamed DiraniDr Dirani is currently the Head of Health Services at the Centre for Eye Research Australia (CERA), National Health and Medical Research Council (NHMRC) Research Fellow and is the principal investigator on the National Eye Health Survey (NEHS) – the first national study to determine the prevalence and causes of vision loss in Australia. Mo is a graduate of the Australian Institute of Company Directors (AICD) and an MBA graduate from the Australian Institute of Business (AIB).


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Richard WormaldConsultant ophthalmologist at Moorfields Eye Hosptial and honorary senior lecturer at The Institute of Ophthalmology, UCL and London School of Hygiene and Tropical Medicine. Co-coordinating editor of Cochrane Eyes and Vision, experienced Ophthalmic epidemiologist with hands on involvement of three surveys in London, one in Hertfordshire, one in Manchester, one In the republic of Ireland and most recently a Rapid Assessment of Avoidable Blindness in Moldova. Trustee of VISION 2020 UK Fred Hollows Foundation (UK). Member of the Royal College Scientific committee, VISION 2020 UK Ophthalmic Public Health Committee and Co-chair of the Eye Research Committee.


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