Download Data held by - Moorfields Eye Hospital

Diabetic retinopathy screening
NSF-based training
Principles of Screening
Tunde Peto
Head of Reading Centre
The eye in relation to other diseases
Key issues for discussion
• Review past experiences related to eye diseases
• Review common diseases that have an impact on eye health
• Review blindness statistics and discuss the impact of blindness on
the community
• Review principles and protocols of NSC
Learning outcome
• Understand the complexity of dealing with eye diseases
• Understand the need for structured approach to eye health and
diseases
• Understand the need for appropriate classification of diseases
• Understand the principle for screening and able to interpret NSC
requirements
Quality assurance
Key issues for discussion
• Review the need for quality control
• Discuss the implication of quality control
on the Screening Programme
Learning outcome
• Understand the need for quality control
• Able to implement quality control in the
Diabetic Retinopathy Screening Programme
The Tragedy of Avoidable Blindness
• World Health Organization: an estimated 180 million
people worldwide are visually disabled and 40-45
million of them are blind.
• About 90 percent of the world's blind live in developing
countries. 80% of the world's blindness is avoidable,
preventable or treatable with available interventions.
Cataract is responsible for nearly 50% of world
blindness.
• Dr. Gro Bruntlandt, Director-General of WHO, notes
that if current population growth and aging trends
continue, the number of blind people in the world
could double by 2020.
Major causes of world blindness
•
•
•
•
•
Cataract
Trachoma
Glaucoma
Xerophthalmia – Vitamin A!
Onchocerciasis - Onchocerciasis is a systemic infestation by a
nematode worm that causes severe ocular inflammation.
Onchocerciasis is widely endemic in tropical Africa and in pockets
of Latin America. It affects more than 20 million people and, in
some communities, is responsible for blindness rates of up to 50
percent of the population.
• Leprosy - Leprosy is a generalized communicable disease that often
affects the eye with corneal and intraocular inflammation.
Major causes of UK blindness
•
•
•
•
•
•
•
Age-related macular degeneration
Glaucoma
Inherited diseases
Diabetes
Cataract
Optic nerve diseases
Br J Ophthalmol. 2003 Oct;87(10):1201-4.
What is the cost of blindness? Meads C, Hyde C.
What is screening?
• WHO definition: Screening is a public health service in
which members of a defined population, who do not
necessarily perceive they are at risk of, or are already
affected by a disease or its complications, are asked a
question or offered a test, to identify those individuals
who are more likely to be helped than harmed by
further tests or treatment to reduce the risk of a disease
or its complications.
• (National Screening Committee : www.nsc.nhs.uk)
Limitations of screening
• Examines apparently healthy people
• People might have unrealistic expectations
• Has the potential to save lives or improve quality of life
through early diagnosis of serious conditions, but the
condition needs to be manageable/treatable
• Can reduce the risk of developing a condition or its
complications but it cannot offer a guarantee of
protection.
• There is an irreducible minimum of false positive results
(wrongly reported as having the condition) and false
negative results (wrongly reported as not having the
When should we set up a screening
programme for a disease?
• If you have a well defined population with a
genuine health problem
• You must be able to define who is at risk and
who is not
• You must have treatment available and it must
be effective
• Screening also must be cost-effective
• It is unethical to screen if you cannot treat!
Aims of DR Screening
• Primary aim is to diagnose, then refer and consequently
treat sight threatening DR retinopathy
• Help the patient and health professionals to identify
further care issues based on level of DR
• It also provides opportunistic diagnosis of cataract,
glaucoma, AMD and other eye diseases photographed,
but it is not a definite aim of the screening.
• Patients with diabetes already have a disease, but this
does not mean they do not find screening stressful
(patients attending pap-smears, breast cancer screening
believe they are healthy – major difference)
Why do we screen for diabetic
retinopathy?
• Defined population who is at risk of blindness
• We have laser treatment available that is
effective and cheap
• Diabetic retinopathy is “silent” for a long time,
vision might remain good despite sight
threatening disease
• Treatment is more effective if administered early
in the disease, as it aims to stabilise vision
Will screening pick up all patients
needing referral?
• Short answer: NO, it will not. Every screening
has patients who have the disease and were
deemed normal (false negatives) and who do not
have the disease and were told they have it (false
positive).
• The way to make sure that the least number of
patients fall into these categories are continuous
training and internal and external quality
control. This can also reduce the risk of patients
finding the screening too stressful.
Exeter standards
• These are for 80% for specificity and 95% for sensitivity
• How are they calculated?
• Sensitivity refers to how good a test is at picking up disease
•
•
True positives
•
-----------------------------x 100
•
True positives + False negatives
• Specificity refers to the accuracy of the detection of images requiring referral
or how good a test is at saying normal is normal
•
•
•
True negatives
----------------------------------- x 100
True negatives + False positives
Do you need patient’s consent?
• Yes, you do. You have to provide enough
information that enables patient to make an
informed choice. You must tell them honestly
about process of screening, what will happen to
the photographs, who might be contacting them
if they need referral.
• Document reasons for non-consent and opt-out
carefully. If possible, examine patient’s
reasoning and answer concerns. Always
consider if they might be having a hypo,
especially if they are irrational!
Consequences of not enough information
• Screening usually occurs in close-knit communities,
one bad patient experience might have serious
repercussions
• Too stressful and the patient does not return
• These in turn will have cost and target implications
• If screening/grading is not right, it might result in overor underreferral, unnecessary cost to the health system;
other patients missing out
• Patients who do not have the right information might
become non-compliant, although life events, work,
fear, denial can also play part in this
How to monitor for these?
• By using internal and external quality assurance
• Internal QA monitors everyday activities and
compares them to local policies and protocols
• External QA compares a programme to others
and to national standards; provides feedback to
individual programmes, helps them to improve.
All programmes help the national standards to be
set and then identifies where they might be re-set.
Components of DR Screening
• Target population is identified and database created
to enable admin staff to produce a reliable call-recall
system, helping them to meet targets, monitor
DNAs, refusals, and performance indicators via DR
software
• Screening Test must be digital now, and every
component of the test must have a standardised
protocol that all screeners/graders follow (imaging,
grading, referral, and monitor treatment targets)
• Administrative and IT support is essential
Who should be screened in England?
• All people with diabetes aged 12 years or older
• Special consideration should be given to
housebound, nursing home and prison population
• Patients under special consideration should be on
the database, and managed according to their
abilities and local pathways
1: To reduce new blindness due to
diabetic retinopathy
• Criteria: Annual blind registration, compared to
1990/1 rate of 9.5 per million per yr.
• Minimal standard: 10% reduction within 5 yr.
Achievable standard: 40% reduction within 5 yr.
• Data held by: National database, but baseline data
will need to established locally as well
• Relevance: will influence quality of life, reduce cost
of treatment by providing early treatment
2: To identify and invite all eligible persons
with known diabetes to attend for the DR
screening test
•
•
•
•
•
•
•
Criteria: Completeness of database
Minimal standard: Proportion of GPs/people on register: 90%
Achievable standard: Proportion of GPs/people: 98%
Percentage of patients invited: 100%
Systematic call recall from single centre on a collated list
All newly dg-d patients screened within 3 months
Data held by: Various agencies, so collaboration is key; single
collated list must be created
• Relevance: Less chance of patients not being screened or being lost
in the system
3: To ensure database is accurate
• Criteria: Accuracy of database of persons
age 12 or more, as determined by Post
Office returns
• Minimal standard: 95%
• Achievable standard: 98%
• Data held by: Screening database
• Relevance: Number of patients screened
remains high; good internal QA needed to
keep the database up to date
4: To maximise the number of
invited persons accepting the test
• Criteria: Percentage of eligible persons
accepting the test
1. Initial screen: Min: 70%; Achievable: 90%
2. Repeat screen: Min: 80%; Achievable: 95%
• Data held by: Screening database
• Relevance: GPs need to be notified of nonconsenting patients, so they can follow it up;
patient education might be given;
5: To ensure photographs are of
adequate quality
• Criteria: Percentage ungradeable (Level U)
• Minimal standard (M): cataract: 10%; no cat:
5%
• Achievable standard (A): 5% and 3%
• Data held by: Needs to be on the grading form as
a separate option
• Relevance: Influenced by population statistics,
availability of ophthalmic services prior to DR
Screening; Re-training of photographer if needed;
ungradeable pathway must be used appropriately
6: To ensure grading is accurate
• Criteria
Inter-grader agreement: M: 75-90% A: 85-95%
Uncertain grading:
M: 90% A: 95%
Provision of external and internal QA activity
• Data held by: Screening database for grader’s
identity; Certified graders only
• Relevance: Reduce errors in referrals;
Supervising body to have a program ready for
retraining
7: Ensure optimum workload, maintain
expertise, avoid errors
•
•
•
•
Criteria:
Graders: 1000–5000 pts read/yr
Optometrists/ophthalmologist: 500 pts read/yr
Fatigue: we found that after 4 (max 6 hours
occasionally) error rate increases
• Data held-by: Quality control grading,
monitoring grading hours
• Relevance: Reduce errors; provide internal and
external quality control
8: To ensure timely consultation
of abnormal screening
• Criteria: Time between screen and grading for fast-track
referrals (R3)
• Minimal standard: 95% referred within 1 week, 100%
within 2 weeks
• Achievable standard: 98% referred within a week
• Data held by: Date of referral is held by the DR
screening softare, Date of Clinic is held by hospital
• Relevance: Clinic dates are to be tracked through the
ophthalmic care provider, so timely treatment can be
provided to those most in need
9: Ensure both GP and patients are
informed of all test results
• Criteria: Time before posting notification letters
to GP and patient
• Minimum: 70% in less than 3 weeks
• Achievable: 100% in less than 6 weeks
• Data held by: Database
• Relevance: All parties concerned know about
the outcome of the screening and can act on it
appropriately while avoiding double referrals
10: Ensure timely consultation for all
screen positive patients
• Criteria: Time between notification of positive test
and consultation
• Maculopathy (M1) M: 70% A: 95% <13 weeks
• Preproliferative (R2) M: 70% A: 95%< 13 weeks
• Proliferative (R3) M: 70% A: 95% <2 weeks
• All grades: 100% less than 18 weeks
• Data held by: Clinic notes and hospital database
• Follow-up: Timely treatment reduces risk of further
visual loss
11: To ensure timely treatment of
those listed by ophthalmologist
• Criteria: Time between listing and laser
1. Proliferative DR: M: 90% A: 95% <2wks
2. Maculopathy: M:70%; A: 95% <10wks
• Data held by: Date of Clinic and the date of
laser are held by the ophthalmic care provider
• Relevance: Laser treatment is to stabilise vision
and preserve sight, so timely treatment is more
likely to help patient preserve the sight they have
12: To minimise overall delay
between screening and first laser
• Criteria: Time between screening and treatment
(if listed) does not exceed
• R3: M: 70% A: 95% <4 wks; 100% within 6 wks
• M1: M: 70% A: 95% <15; 100% <26 weeks
• Data held by: Hospital database/notes
• Relevance: Good communication between
screening and clinics needs to be maintained;
laser designed to preserve sight, not to give sight
13: To follow up screen-positive
patients
• Criteria: DNA rate for ophthalmologist for
PDR within 1 month: M: 10% A: 5%
Maculopathy/R2 within 6 months: M: 10% A: 5%
• Data held by: Hospital notes
• Relevance: The F/U for these patients is
standard hospital procedure, but information
needs to go back to the Screening Programme to
make sure that patients screened/or not on time
14: To minimise the anxiety
associated with screening
• Criteria: Monitor false positive rate of DR test:
M: 25%; A: 20%
• Data held by: These data are to be generated
from the Quality Control grading and clinic notes
• Relevance: To have a procedure on retraining for
staff and re-notifying these patients; ensure best
use of resources
15: To ensure timely rescreening
• Criteria: Time to rescreening compared to
suggested screening interval
• M: 70% within 12 months
• A: 95% within 15 months
• Data held by: Screening database
• Relevance: Ensures no patient is lost in the
system and have the maximum possibility
to have their sight threatening disease
identified
16: To ensure the public and health care
professionals are informed at regular
intervals
• Criteria: Production of annual report
• Data held by: Screening database, Participating
PCT and GPs and ophthalmic care providers
• Relevance: Identify the performance of every
component of the screening and formulate plans
to improve where needed
17: To ensure the service participates
in quality assurance
• Criteria: External quality assurance
• Minimum requirements:
– Evidence of participation of all graders in external image test set
scheme
– Participation in peer-review visit programme
– Annual submission of national minimum data set by 31st
October
• Data held by: Screening and clinical databases
• Relevance: Identify areas of weaknesses and address
these by appropriate re-training
18: To optimise programme efficiency
and ensure ability to assure quality of
service
• Criteria: Minimum programme size
• Minimum standard: Population including
12000 people diagnosed with diabetes on
current patient list
• Achievable standard: 15000 people on list
• Data held by: Screening database
• Relevance: All graders have enough experience
in all disease state; good use of resources
19: To ensure that screening and grading
of retinal images are provided by a
trained and competent workforce
• Criteria: Accreditation of screening and
grading staff in accordance with national
standards
• All staff should be accredited within 2 years of
appt; current staff by April 2008
• Data held by: Screening services
• Relevance: Patient protection; good quality
service overall
Progression to high risk
proliferative diabetic retinopathy
Mild
1 yr 1%
Moderate Severe
3%
15%
V severe
45%
5 yrs 15%
27%
71%
56%
External quality assurance – what
to expect and how to prepare for
it
Dr Tunde Peto
Head of Reading Centre, MEH
Based on NSC Draft Guidelines for external QA,
courtesy of Fionna O’Leary
External QA
• Organised nationally, led by the national QA
director and supported by the regional QA
managers
• Will work closely with SHA
• Regional QA will disseminate standards, share
good practice and raise issues of professional
concern
• QA Manager will identify and act on areas that
are felt to be operating at risk
• Accountable to National Programme Manager
and National QA Director
Purpose of the QA visit
• Assure the quality of the DR screening by:
– Assessing compliance with the national
standards, for all program parts and their
interrelations
– Reviewing quality of data
– Identify and encourage good practice
– Identify areas for improvement and make
recommendations how to achieve this
Structure of the visit
• Prior to the visit the Regional QA Manager
will ask to see the evidence for:
– PCT commissioning
– Processes and protocols in place for
administration, provision of patient information,
photography administration of eyedrops, grading,
referral and treatment
– Annual report for the programme
– Completion of the pre-visit questionnaire sent by
the QA office
•
•
•
•
•
•
Visit components
PCT commissioning
Call/recall administration
Photography
Grading
Ophthalmoscopy
Process of co-ordination of each components
of the programme
There might be more than one visits to complete
all elements of the QA visit.
Who will attend the visit?
• Regional QA Manager will invite the screening
lead from the SHA Public Health Dept to
attend
• Any or each of the following:
– QA Director, National Programme Director,
screening commissioner, local DPH,
administration manager, grading manager, data
analyst, technical specialist, other members of the
national team, GP, optometrist, patient
representative, observers, trainee QA team
members
Cycle of visits
• QA visits aim to provide learning environment
• Visits will occur approx every 18 months
• Tour of the grading room, the administration
centre
• Visit of the screening appointment and
ophthalmology
• Review of working environment, facilities and
equipment
• Meet the staff working in screening
Notification and duration of visits
• Normally at least 4 months notice will be given
• Length of the visit will depend on the
complexity of the programme
• Visits may take one day, but may be spread
over a longer period (up to 2 weeks) to see
satellite clinics
• Programme Manager needs to take
responsibility for organising the visit locally
Key staff to include
•
•
•
•
•
Clinical lead/programme director
Lead ophthalmologist from the acute Trust
Grading room manager
Administration manager
Person responsible for maintaining equipment
and software issue log
Date for the visit will only need to be changed in
exceptional circumstances
Programme manager’s duties
• Assist with practical arrangements for the
day
• Trust need to provide suitable venue,
including small room for team visit and
one-to-one discussions
• Provide maps to all venues and organise car
parking
Pre-visit questionnaires
• National format and include a list of supporting
documents for the QA team to see before the visit
• People who are in post and responsible for certain
elements of the screening need to fill in the
questionnaires
• They will be sent at least 2 months in advance and
need to be sent back at least 4 weeks before the visit
• Relevant members of the visiting team will have
copies of the completed questionnaire
Conduct of a QA visit
• May vary according the the QA team
• If small team, probably 1-2 hours per segment of
screening is sufficient
• Assessment of the role of the programme manager
and the clinical lead
• Then a patient journey is followed
• Review of photography and grading
• QA Team will assess if feedback on the day is likely
or not; if yes, the Programme manager needs to book
a room big enough to hold the team and the CEO-s,
DH, commissioners, etc….
At the end of the visit,
• The QA team will reconvene in private
with the QA director to consider
recommendations and feedback
Programme elements to be reviewed
• One: Programme commissioning and public
health
– Pre-visit questionnaire to be completed
– Appointment of clinical leadership, identification of
job description and identified session time
– This should clarify what has been commissioned and
what is believed to have been commissioned and
identify gaps and help with future planning
– Highly desirable for the Director of Commissioning
and DPH to be present
Programme elements to be reviewed
• Two: Call/recall and administration
– Annual report and pre-visit questionnaire provides the basics
– But all supporting information needed, such as patient
information leaflets, letters of invitation, opt out and results
letters, office manual and ANY other policies and protocols
– Links to GP practices and support from GP practices will be
discussed and reviewed in order to encourage uptake in ethnic
minorities
– Working practices such as database settings, searches,
completeness of the database, methods and frequence of
updating the database, management of exclusion, appts system,
PO returns, referrals follow-up
– Programme Manager and admin team should attend
Programme elements to be reviewed
• Three: Screening and grading
– Annual report, pre-visit questionnaire, information shown to
patients at screening appts, policies and protocols, equipment,
working environment, workload, workflow, training and
qualification will be reviewed
– Feedback from arbitration and from clinical lead discussed
– External Test Set (ETS) results are given: anonomysed, but
clinical lead will distribute it to individuals
– Review a set of grading outcomes with the clinical lead
– Usually takes about 2 hours
Programme elements to be reviewed
• Four: Ophthalmology
– Annual report, ETS, pre-visit questionnaire,
commissioning, processes to ensure that national standards
are met, processes and protocols how feedback is given,
assessment of ungradables and its QA, treatment of all
people with diabetes, patient pathway referrals
– Electronic access will be assessed
– Leadership, content and attandence of multi-disciplinary
team meeting and dissemination of information provision
and reporting is discussed
– Links to diabetology department will be discussed
Feedback
• If possible, verbal feedback will be given at the end of the
visit
• Everyone taking part is invited
• Visiting team will answer questions
• Good practice will be identified and celebrated
• Recommendations for service improvement will be given
• Areas of particular concern will be identified so urgent
action can be taken
• Personal criticism or warning will not be given in the
group feedback, but will be raised with the CEO
•
•
•
•
•
•
Report
Written report is to be provided to the programme within
4 weeks for validation, any errors should be highlighted
within 2 weeks. No response will mean no error!
Each programme part will be commented on
Main focus is compliance with standards
Named individuals will not feature in the report, but will
be sent to CEO
Clear recommendation for action and risks for service
If additional funding is required the commissioners will
be jointly responsible for acting on the report
Sharing the report
• Copies will be sent to:
–
–
–
–
–
Trust(s) involved
National Programme Director
DPH of the relevant SHA
Lead commissioner in PCT
Other relevant PCT leads
• Trust/PCT are expected to develop and action
plan and provide a response in 4/12
• The report and any response will be published
on the NSC website!
• QA documents are to be kept for 8 years
How to avoid ruining your own
screening programme?
• You should know
– the disease and its complications
– the Screening or Study protocol: where you are based
– the photography and grading protocol
– the aims of screening: clinical pathway directions
– your collaborators: from GPs to consultants
– where to get help: phone numbers and clinic time
– the deadlines