11.7
Bowel Screening
Wales First Round
Interim Report
Author: Hayley Heard, Head of Programme
Helen Beer, Senior Information Manager and Research Specialist
Date: 1 April 2011
Version: 2
Publication/ Distribution:

Public Health Wales Board
Review Date: 1 July 2011
Purpose and Summary of Document:
This interim report describes the first round of bowel screening in Wales
including data on uptake, positivity rate and outcome.
Ongoing challenges are described and anticipated future developments
explained.
Further details will be published in a full report in September 2011.
Work Plan reference: BSW / Reports
Public Health Wales
Interim first round report
Contents
BOWEL SCREENING WALES FIRST ROUND .................................... 1
INTERIM REPORT .......................................................................... 1
EXECUTIVE SUMMARY ................................................................... 4
1
INTRODUCTION ...................................................................... 6
2
PROGRAMME AIM AND SCOPE ................................................ 7
3
ELIGIBLE POPULATION........................................................... 7
3.1 Identification ........................................................................ 8
3.2 Invitations ........................................................................... 9
3.3 Public Information................................................................. 9
4
SCREENING PATHWAY .......................................................... 10
5
ORGANISATIONAL STRUCTURE ............................................ 12
5.1 The Welsh Bowel Screening Centre ........................................ 12
5.1.1
Management Arrangements ............................................ 13
5.2 Local Assessment Centres ..................................................... 13
6
SCREENING TEST .................................................................. 14
6.1 Uptake ............................................................................... 15
6.2 Performance ....................................................................... 17
6.3 Positivity rate ...................................................................... 18
Figure 3: Positivity Rate from Beginning of Programme ..................... 20
7
SPECIALIST SCREENING PRACTITIONERS ............................ 21
7.1 Role and responsibilities ....................................................... 21
7.2 Training .............................................................................. 22
7.3 Activity ............................................................................... 22
8
SCREENING COLONOSCOPY .................................................. 26
8.1 Assessment of colonoscopists ................................................ 26
8.2 Quality assurance ................................................................ 27
8.3 Training .............................................................................. 27
8.4 Activity ............................................................................... 28
9
PATHOLOGY .......................................................................... 29
9.1 Quality assurance ................................................................ 30
9.2 Training .............................................................................. 31
10 RADIOLOGY .......................................................................... 31
10.1 Quality assurance ................................................................ 31
10.2 Training .............................................................................. 32
10.3 Activity ............................................................................... 32
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11 SURGERY .............................................................................. 32
11.1 Quality assurance ................................................................ 33
12 INFORMATION SYSTEMS ...................................................... 33
13 OUTCOME DATA .................................................................... 34
14 ADVERSE EVENT ................................................................... 35
15 PROGRAMME IMPACT ........................................................... 35
15.1 Impact on Local Assessment Centres...................................... 35
15.2 Impact on the symptomatic service ........................................ 36
16 CHALLENGES......................................................................... 37
17 FUTURE DEVELOPMENTS....................................................... 38
18 CONCLUSION ........................................................................ 39
19 APPENDICES ......................................................................... 40
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Interim first round report
Executive Summary
This interim report describes the first round of bowel screening in Wales.
Between October 2008 and November 2010 412,025 men and women
aged between 60 and 69 years of age were invited for screening. Further
details will be published in September 2011 as not enough time has
elapsed for a true measure of uptake and colonoscopy outcome.
The aim of the bowel screening programme is to reduce mortality from
bowel cancer by 15 per cent in the population invited for screening by
2020. To achieve this aim uptake needs to be good and pathology
detected and removed. During the first round of screening 55% uptake
was achieved and pathology yield at colonoscopy was nearly 70% which
was greater than anticipated.
Some findings were unexpected such as the high faecal occult blood test
positivity rate and the number of adenomas compared to cancers.
Increased demand for screening colonoscopy has been met and additional
capacity in Local Assessment Centres developed. The programme is now
well placed to begin planning age expansion up to 74 years with local
assessment centre teams.
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Acknowledgements The Bowel Screening Wales team would like to thank
local assessment centre screening teams for their commitment and hard
work in establishing the programme and addressing challenges caused by
the high positivity rate.
Thanks must also go to screening teams in England and Scotland for their
ongoing help and support.
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1
Interim first round report
Introduction
The first round of bowel screening in Wales took place between 22 October
2008 and 24 November 2010. During this period 412,025 men and women
who were resident in Wales and aged between 60 and 69 years were
invited to complete the home faecal occult blood test (FOBt) kit.
The screening programme works by sending FOBt kits by post for
completion at home and return to the central screening laboratory in
Llantrisant. The FOBt kit looks for hidden blood within the bowel motion
which may suggest a higher chance of bowel cancer.
If the result is positive participants are invited for telephone assessment
with a Specialist Screening Practitioner (SSP). Specialist Screening
Practitioners are specially trained nurses who are based in Local
Assessment Centres in hospitals across Wales. Following assessment with
the SSP participants are usually offered screening colonoscopy.
Colonoscopy is a way of looking at the lining of the bowel to see whether
there is any disease present. It allows the opportunity to remove or biopsy
cancers or polyps which may go on to become malignant.
The programme has now been extended to invite people aged between 60
and 71 years of age and will be increasing the eligible age range further
over the next 2 years to include people up to the age of 74 years old as
capacity in Local Assessment Centres allows.
The last participant of the first screening round was invited at the end of
November 2010 and it is therefore not possible to calculate exact outcome
measures as not enough time has elapsed. This is an interim report based
on information available on the 31 March 2011 to inform members of the
Public Health Wales Trust Board. Final analysis of the complete data set
for the first round of screening will be available in the summer and
published by September 2011.
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2
Interim first round report
Programme aim and scope
The aim of the programme is to reduce mortality from bowel cancer by 15
per cent in the population invited for screening by 2020. Bowel Screening
Wales is responsible for the service up to the point of diagnosis of cancer,
that is for:

Identifying eligible people to be invited for screening

Inviting and recalling eligible people to be screened

Providing testing kits and supporting information

Analysing faecal occult blood test kits

Providing results

Referring to a Specialist Screening Practitioner

Diagnosis by colonoscopy or radiological investigations

Histopathological reporting of samples taken at colonoscopy

Referring to multidisciplinary treatment services

Providing a surveillance programme for people with intermediate
and high risk adenomas
Bowel Screening Wales is also responsible for:

Providing quality standards and protocols

Raising public and professional awareness of the programme

Evaluating the programme

Ensuring staff working within the programme are appropriately
trained
3
Eligible population
In order to reduce the impact on Local Assessment Centres it was agreed
by the Bowel Screening Project Steering Board that the programme should
be phased in across Wales based on age at first invitation. Bowel
Screening Wales has invited all 60 – 69 year olds in Wales over the last
two years and recently increased to 71 years of age. The planned next
phase of the implementation is to roll out the programme to invite the
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older age group so that all people aged 70-74 would be invited by
December 2012, in addition to the 60-69 year olds already being invited.
The rate at which the programme can be extended is critically dependent
on capacity in Local Assessment Centres. Bowel Screening Wales is
currently planning the roll-out in detail and will be discussing plans to
increase the age range with local teams in April and May 2011.
3.1
Identification
The Bowel Screening Information Management System (BSIMS) obtains
demographic information including date of birth and GP practice, directly
from the Welsh Demographic Service (WDS). This is used to determine
the cohort to be invited for bowel screening. During the first round the
roll-out was undertaken using the day of birth ranges starting with
participants born on 1 January. The date of birth range parameters were
increased each week until all participants aged 60-69 years with a date of
birth range between 1 January and 31 December were invited. During this
110 week round, there were eight weeks where the invitation call runs did
not take place. These planned breaks coincided with specific times of year,
when staffing in the laboratory was known to be reduced such as during
Christmas, Easter and summer holidays.
The quality of the demographic data on the WDS was lower than expected
particularly for men. Many invitations issued were returned undelivered, or
participants contacted the helpline to update their address details. This
caused a significant amount of unexpected additional administrative work
to investigate data discrepancy and the demographic information on WDS
was updated as a result. The WDS data source is used throughout NHS
Wales and will benefit from Bowel Screening Wales data amendments.
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3.2
Interim first round report
Invitations
Initial invitation letters are sent with a folder containing information about
bowel cancer and the screening programme, the test kit and instructions
for use. A free phone telephone helpline number is included on all
correspondence and helpline staff trained to deal with queries from
members of the public. Nursing staff are available in the bowel screening
centre to deal with medical enquiries.
If there is no response to the initial invitation a reminder letter is sent at
six weeks and again at twelve weeks.
A total of 847,773 invitation letters were issued to the 412,025
participants as illustrated in table 1 during the first round of screening.
Table 1: Invitation letters issued
Type of Invitation
First invitations
Number of Invitations
Issued
412,025
First non responder
letter
Second non responder
letter
246,307 (59.8% of
total)
189,441 (46.0% of
total)
3.3
Public Information
A suite of public information leaflets is available and sent to participants at
relevant times during their screening pathway. Leaflets include:

Bowel Screening Explained

Instructions for use of test kit

Repeat Test kit

Further Investigations
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
Colonoscopy

How we use information about you

General promotional leaflet

Post colonoscopy information
This layered approach to information appears to be well received and BSW
is planning formal evaluation of literature in the near future. Information
is available in 12 different languages, on the website, on audio CD and in
Braille on request.
4
Screening pathway
When FOBt kits are returned to the screening laboratory results are issued
within seven days. People with negative results will be re-invited in two
years time.
If results are equivocal (weak positive reaction on the initial screening
test) a second more sensitive test called a faecal immunochemical test
(FIT) kit is sent. If this is negative people are routinely recalled in two
years. If either test is positive a letter is sent inviting people to contact the
helpline to arrange an appointment with the SSP as illustrated in figure 1.
Initial contact with the SSP will be by telephone within two weeks of
receiving a positive result. Most people are assessed over the telephone
using a standardised proforma. Face to face appointments are arranged if
requested or
deemed necessary.
The
SSP will assess fitness for
colonoscopy and refer to the Screening Colonoscopist if necessary.
If considered fit, colonoscopy is offered at the assessment appointment
and, if accepted, an appointment arranged within two weeks. Waiting
times for colonoscopy in most units have been longer due to the increased
positivity rate and good uptake, but this is being addressed and significant
improvements have been made.
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Depending on the findings at colonoscopy participants are either returned
to routine recall, referred to the multi disciplinary team with a diagnosis of
cancer or a complex polyp or put onto a surveillance programme according
to the number and size of polyps removed.
Figure 1: Pathway
Invitation
Test kit
returned
and tested
Negative
Recall 2
Years
Positive
Equivocal
SSP
Assessment
FIT Test
sent
Unfit for
colonoscopy
Consider CT
Fit for
colonoscopy
Refer to clinician
Colonoscopy
Complete
Recall for
FOBt in 2
years
Negative
Polyps
Consider repeat
or CT
Cancer
Surveillance programme
Refer to
MDT
Or recall FOBt in 2 years
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5
Interim first round report
Organisational Structure
Bowel Screening Wales (BSW) is part of the Screening Division of Public
Health Wales.
It is a single organisation providing the bowel screening
programme throughout Wales.
BSW monitors the quality of the service
provided for each element of the programme, including those elements
provided by other health boards.
The BSW All Wales Management Group comprises senior managers from
within the Screening Division and five Quality Assurance (QA) Advisors
for:

Screening Colonoscopy

Pathology

Biochemistry

Radiology

Surgery
This group provides advice and support to the Director of Screening on
policy and strategic management.
5.1
The Welsh Bowel Screening Centre
Based in Pontyclun, Llantrisant the Welsh Bowel Screening Centre houses
the central administration team and screening laboratory. The centre is
managed by the All Wales Bowel Screening Manager, assisted by the
Centre Coordinator who manages administration staff. The laboratory
manager has a deputy who is responsible for line management of the four
laboratory screeners. At the beginning of the programme the laboratory
was isolated, but collaborated with the English and Scottish screening
programmes. Cervical Screening Wales has relocated to the Bowel
Screening Wales site and some laboratory functions will be merged in the
near future. This will strengthen the laboratory structure as additional
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biomedical scientist staff will be available and have already been trained
to validate Bowel Screening Wales results.
5.1.1
5.2
Management Arrangements
Local Assessment Centres
Bowel Screening Wales commissions colonoscopy, histopathology and
radiology services from the health boards.
Long Term Agreements (LTAs)
specify that each heath board service complies with the relevant elements
of the Bowel Screening Wales policy, standards and protocols outlined in
the Quality Manual.
Each health board has at least one of the 12 Local Assessment Centres in
Wales and there is one in Hereford, catering for border participants
(appendix 1). Local Assessment Centres must satisfy Bowel Screening
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Wales criteria for screening (appendix 2) and are monitored to ensure
ongoing compliance.
Annual risk assessment of decontamination equipment and processes is
undertaken by a team comprising Bowel Screening Wales staff and Welsh
Health
Estates.
Significant
improvements
have
been
made
to
decontamination equipment in Wales as a result of Bowel Screening Wales
investment.
Each Local Assessment Centre was given pump prime money in order to
develop units to ensure compliance with criteria for screening in advance
of implementation of the programme. The published report in September
2011 will include details of improvements made as a result of Bowel
Screening Wales funding. Although significant improvements have been
made some units need further development and longer term action plans
have been agreed.
Local
Assessment
Centres
are
managed
by
a
Lead
Screening
Colonoscopist who is paid an allowance to ensure local management of the
programme. Prior to roll out of the programme each Local Assessment
Centres
appointed
a
multidisciplinary
team
to
prepare
for
local
implementation of the programme. Health boards have been encouraged
to
maintain
these
local
teams.
Chaired
by
the
Lead
Screening
Colonoscopist local teams should meet regularly to address issues
identified and oversee management of the programme locally. Members of
local teams are invited to regional coordinating groups.
6
Screening test
A guaiac test kit is used initially and contains six wells for testing the three
samples, which are collected on separate days. Testing involves applying
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hydrogen peroxide to the test kit which will change colour if there is
haemoglobin present. If five or six wells show a positive reaction on the
initial screening test kit a positive result is issued. If between one and four
wells are positive the result is equivocal and an immunochemical test kit is
sent to the participant.
This strategy is also used by the Scottish screening programme, but not in
England where only the guaiac test is used. The two stage process was
intended to reduce the number of colonoscopies offered as the FIT kit
should filter out false positive results because it is specific to human
globins.
6.1
Uptake
Definitions are currently being reviewed to ensure effective comparison
with other UK programmes. Figures presented in this report may change
when re-run at a later date.
The current definition of eligible people is that they must be registered on
the
Bowel
Screening
Information
Management
System
(BSIMS)
(dependent on age and date of birth parameters). They must have been
invited for bowel screening in the specified time period, but participants
that have had returned undelivered mail are excluded.
Participants are deemed to have responded if they have returned a used
test kit within the same screening episode, which had a negative or
positive result code. Participants with spoilt test kits and equivocal results
are excluded.
Figure 2 illustrates the time taken from date of postage of invitation for
participants to return test kits, by gender. The majority of kits are
returned within the first few weeks (57 per cent within three weeks). The
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proportion returning kits each week then decreases steadily until around
week 7-8, when the first non responder letter has been received by
participants. The trends are similar for men and women, with slightly more
women returning their bowel screening test kits sooner.
Figure 2: Time taken to return test kits, by gender
Analysis has been restricted to count only those participants who returned
test kits during their first round of screening. If a second round invitation
has been issued and participant responded by sending in an older kit, this
has been assumed to be as a result of the second round invitation and
does not count as first round uptake.
Not all participants who were invited in the first round have had enough
time to respond to their invitation (last invitation 24 Nov 2010). The
uptake figure quoted in this interim report will be missing some
participants who have not yet had time to respond. Data is presented in
table 2 showing uptake by quarter of initial invitation and gender. The
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later quarters appear to have worse uptake as they have had the least
time to respond.
Table 2: Uptake of Bowel Screening by gender and quarter
Female
Quarter
Male
Total
Eligible
Tested
Uptake
Eligible
Tested
Uptake
Eligible
Tested
Uptake
Q1 Oct-Dec 2008
10937
7340
67.1
10718
6452
60.2
21655
13792
63.7
Q2 Jan-Mar 2009
22107
14202
64.2
21610
12175
56.3
43717
26377
60.3
Q3 Apr-Jun 2009
30292
18383
60.7
30260
15820
52.3
60552
34203
56.5
Q4 Jul-Sep 2009
23564
13849
58.8
23265
12254
52.7
46829
26103
55.7
Q5 Oct-Dec 2009
25370
14659
57.8
25375
12987
51.2
50745
27646
54.5
Q6 Jan-Mar 2010
22564
13130
58.2
22272
11243
50.5
44836
24373
54.4
Q7 Apr-Jun 2010
19931
11613
58.3
19458
10056
51.7
39389
21669
55.0
Q8 Jul-Sep 2010
30010
17246
57.5
29105
14714
50.6
59115
31960
54.1
Q9 Oct-Nov 2010
20475
11644
56.9
20096
10043
50.0
40571
21687
53.5
205250
122066
59.5
202159
105744
52.3
407409
227810
55.9
TOTAL
Women have a higher uptake (59.5 per cent) compared to men (52.3 per
cent). Uptake has decreased from over 60 per cent seen in Q1 Oct-Dec
2008 and Q2 Jan-Mar 2009 in the first year of the bowel screening
programme, to between 54 and 55 per cent
for the second year (Oct
2009 to Sep 2010). This trend is reflected in the figures for both genders.
6.2
Performance
Prior to implementation of the programme literature was reviewed and a
Scottish study particularly influenced the choice of testing strategy. The
study found that FIT positivity was around 20 per cent and of those with a
positive FIT result, only 13 per cent had negative findings at colonoscopy.
In practice Bowel Screening Wales has observed a 31 per cent positive
rate for FIT kits and 55 per cent with associated negative colonoscopy.
This is compared with findings from the current Scottish programme which
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has a 21 per cent positivity for FIT kit and 35 per cent associated negative
colonoscopy. These findings are interesting and need further investigation.
6.3
Positivity rate
Positivity rates have been calculated using the number of participants that
returned a FIT or FOB bowel screening test kit which gave a positive result
(excluding equivocal results), as a proportion of all participants who
returned a bowel screening test kit which gave either a negative or
positive result (also excluding spoilt and equivocal results).
Of the 412,025 participants invited in the first round of screening, to date
229,201 participants have returned 264,624 test kits. This does not
exclude ineligible people, as in the uptake calculation above. Table 3
shows all test kits validated on participants invited in the first round of
bowel screening. Note that some participants invited in the first round
may return a test kit at a later date.
Table 3: Number of test kits validated, by quarter tested and
result
Kit
Type
Result
Q2
JanMar
2009
1336
Q3
AprJun
2009
2203
Q4
JulSep
2009
2193
Q5
OctDec
2009
2570
Q6
JanMar
2010
2323
Q7
AprJun
2010
1450
Q8
JulSep
2010
3038
Q9
OctDec
2010
2795
Q10
JanMar
2011
1942
Total
Equivocal
Q1
OctDec
2008
52
F
F
Negative
910
24444
29697
22687
27984
25177
15764
27641
26565
18986
219855
F
Positive
2
66
97
89
147
93
72
140
116
73
895
F
Spoilt
71
476
699
469
537
454
305
422
528
380
4341
I
Negative
23
661
1434
1462
1719
1598
1017
2072
2053
1437
13476
I
Positive
14
534
681
637
742
778
462
695
802
618
5963
I
Spoilt
1
7
15
24
28
23
22
30
25
17
192
1073
27524
34826
27561
33727
30446
19092
34038
32884
23453
264624
Key:
F = Guaiac FOB
I = FIT kit
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Interim first round report
Positive rates started as expected from the pilot studies at around 0.2 to
0.3 per cent for FOB kits, but rose unexpectedly during the first year to
0.5 per cent and remained at this level for the remainder of the first
round, as shown in table 4 and 5 and in figure 3.
The overall positive rates for both types of test kit combined are shown in
table 6.
From the pilots a rate of around 2.1 per cent was expected.
However in early 2009 we saw rates of 2.3% and 2.4 per cent, but these
rose to 3 per cent during 2009 and the remainder of round 1.
Table 4: Positive rates
Kit
Type
F
I
Q1
OctDec
2008
0.2
Q2
JanMar
2009
Q3
AprJun
2009
0.3
Q4
JulSep
2009
0.3
0.4
Q5
OctDec
2009
Q6
JanMar
2010
0.5
Q7
AprJun
2010
0.4
Q8
JulSep
2010
0.5
0.5
Q9
OctDec
2010
0.4
Q10
JanMar
2011
0.4
Total
0.4
37.8 44.7 32.2 30.3 30.2 32.7 31.2 25.1 28.1 30.1 30.7
Table 5: Overall positive rates for FOB and FIT kits combined
Q1
OctDec
2008
1.7
Q2
JanMar
2009
2.3
Q3
AprJun
2009
2.4
Date: 4 April 2011
Q4 JulSep
2009
2.9
Q5
OctDec
2009
2.9
Q6
JanMar
2010
3.2
Q7
AprJun
2010
3.1
Version: 2
Q8 JulSep
2010
2.7
Q9
OctDec
2010
3.1
Q10
JanMar
2011
3.3
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Total
2.9
11.7
Figure 3: Positivity Rate from Beginning of Programme
11.7
The increased positivity rate has been investigated and there appear to be
various contributing factors. These include the apparent high adenoma
rate in the Welsh population. It is also possible that testing processes used
in some UK laboratories may have contributed to the increased positivity
rate. A review of these processes suggests that, in some cases,
manufacturer’s
equivocal
recommendations
results,
referral
for
were
not
followed.
colonoscopy
only
However,
occurs
after
for
an
independent FIT check test and therefore referrals have been appropriate.
Practices have been reviewed in Wales and positive rates are currently
being monitored weekly.
Some test kits are spoilt and cannot be tested. This may occur because
the sample has been inappropriately applied or, for a variety of other
reasons, but every effort is made to test the kit as participants have taken
time to complete the kit. Spoilt kit rates for each kit type and for each
time period are shown in table 6. Around 1 per cent of immunochemical
FIT kits are spoilt, compared to 1.8 per cent of FOB test kits.
Table 6: Spoilt rates (percentage of total kits validated)
Kit
Type
Q2
JanMar
2009
1.8
Q3
AprJun
2009
2.1
Q4
JulSep
2009
1.8
Q5
OctDec
2009
1.7
Q6
JanMar
2010
1.6
Q7
AprJun
2010
1.7
Q8
JulSep
2010
1.4
Q9
OctDec
2010
1.8
Q10
JanMar
2011
1.8
Total
F
Q1
OctDec
2008
6.9
I
2.6
0.6
0.7
1.1
1.1
1.0
1.5
1.1
0.9
0.8
1.0
7
7.1
1.8
Specialist screening practitioners
Role and responsibilities
The Specialist Screening Practitioner supports a participant from the time
they receive a positive FOBt result until they are either returned to routine
recall or referred to the MDT following a diagnosis of cancer. They are
Public Health Wales
Interim first round report
responsible for assessing fitness for colonoscopy, arranging colonoscopy
appointments, attending colonoscopy, for giving results and attending
Multi Disciplinary Team meetings. This is a new role in Wales and the
programme began with 16 SSPs based in Local Assessment Centres. There
are now 19 SSPs in post and more will be recruited as the age range
expands.
SSPs manage a caseload, ensuring that participants are on the correct
pathway and that BSW is kept informed at each stage. Supported by
regional nurses SSPs are pivotal to the smooth running of the local
screening programme.
7.2
Training
Prior to implementation of the programme all SSPs underwent a four week
induction programme. This was followed up by a local orientation
programme
which
included
demonstration of
agreed competencies.
Regional nurses and Lead Screening Colonoscopists provide mentorship
for SSPs. New recruits undergo a tailored induction programme depending
on their needs.
As all SSPs have degrees, Bowel Screening Wales has collaborated with
Cardiff University to develop a MSc module for SSPs and five
have
recently completed the module with more due to take part next year.
Network meetings have been held quarterly since the beginning of the
programme. They have recently been reduced to twice yearly, but
continue to offer peer support and have an educational element.
7.3
Activity
In the first round of bowel screening, 6,846 participants had 6,858
positive test results which was more than had been expected. Each
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participant with a positive result was offered a referral to an SSP for
assessment.
Participants were sent their positive test results and asked to contact the
helpline to make an SSP appointment. Not all participants contacted the
helpline immediately: 1,066 were sent a reminder letter two weeks later,
another 459 were sent a second reminder letter three weeks later.
137 participants contacted the helpline to decline their SSP assessment,
some following receipt of their reminder letters. This was before any SSP
appointments had been booked on BSIMS.
In total, 6,374 participants with a positive bowel screening test result in
round one, contacted the helpline and made an SSP assessment
appointment. Some required multiple appointments to be booked. A total
of 7,293 SSP appointments were booked, as shown in table 7.
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Table 7: SSP assessment appointments booked by outcome
Phone
Face to
Face
Total
5959
6
5965
Participant declined SSP appointment
31
0
31
Appointment time changed by service
45
0
45
4
0
4
Appointment date changed by service
401
0
401
Appointment date changed by participant
112
0
112
Appointment cancelled - participant died
1
0
1
Appointment cancelled - booked in error
39
0
39
Appointment cancelled by service
329
1
330
Appointment cancelled by participant
138
0
138
1
0
1
47
0
47
179
0
179
7286
7
7293
SSP Appointment Outcome
Attended
Appointment time changed by participant
Service error
participant
-
contact
not
made
with
Participant could not be contacted (Did Not
Attend)
Unknown
Total
In total 5,965 (81.8 per cent) SSP appointments were attended, i.e.
participant was contacted by phone or turned up for face to face visit.
There have only been six attended face to face visits during round one.
Some appointments were declined (n = 31, 0.4 per cent) after having
been booked. Other appointments were changed / cancelled by participant
(n = 254, 3.5 per cent) or service (n = 776, 10.6 per cent), another 47
(0.6 per cent) were not attended by participant or they could not be
contacted
by
phone
Date: 4 April 2011
on
the
date
and
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time
arranged.
Forty
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appointments (0.6 per cent) were not needed or booked in error and 179
appointments (2.5 per cent) have no outcome recorded, it is presumed
that they were not attended.
Waiting times for SSP appointments have been captured by SSPs since
April 2010. Figure 4 in section 8.4 shows that participants wait on average
around two weeks for their SSP appointment, from the date they phone to
make an appointment. There has been a variation in waiting times
between health boards, ranging from nil weeks in Cardiff and Vale and
Abertawe Bro Morgannwg to five weeks in Betsi Cadwaladr and Aneurin
Bevan Health Boards.
Bowel Screening Wales waiting time standard for
SSP appointment is two weeks.
For those 5,965 who attended SSP assessment appointments, table 8
shows that just over 90 per cent of participants assessed were fit for
colonoscopy. Of the remaining 10 per cent that were not fit for
colonoscopy, most would have been offered other tests such as a CT scan
or a barium enema.
Table 8: Participants assessed and fitness for colonoscopy
procedure
Fitness for colonoscopy
Number
%
78
1.3
5389
90.3
Permanently unfit
121
2.0
Temporarily unfit
166
2.8
Unsure
211
3.5
Unknown
Fit
Total
Date: 4 April 2011
5965 100.0
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8
Interim first round report
Screening Colonoscopy
Colonoscopy is an invasive procedure associated with a risk of around one
in 10,000 of dying from the procedure and about one in 1,000 of a bowel
perforation. Other complications include bleeding and adverse drug
reactions. Screening colonoscopists must undergo an assessment process
to ensure they meet national standards of best practice.
Screening colonoscopy is undertaken on dedicated, separately funded
screening lists with only four colonoscopies per list. There is generally
more pathology found on screening lists and additional time and enhanced
therapeutic skills are required.
Funding is based on £738 per colonoscopy and additional funds are
allocated for pathology, SSP and administration time.
8.1
Assessment of colonoscopists
Potential screening colonoscopists apply to BSW and submit six months of
anonymised colonoscopy reports for scrutiny prior to acceptance and
starting the assessment process. Quality criteria have been agreed which
potential screening colonoscopists need to satisfy. Examples include a life
time number of colonoscopies in excess of 750, completion rate of 90 per
cent and low sedation rates.
If candidates satisfy these criteria they are invited to attend a training list
where they are informally assessed by a Bowel Screening Wales assessor.
Training is offered if necessary and when the assessor and candidate are
happy to proceed to assessment the formal process comprises of multiple
choice questions and directly observed procedures.
Only when candidates have passed the assessment process are they
approved to undertake screening procedures. The programme began with
16 approved screening colonoscopists. There are now 25 with two more
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currently in the assessment process and others who have expressed an
interest and been sent application forms.
It is recognised that screening colonoscopists should undertake a
minimum number of screening colonoscopies per annum to maintain
competence. The Welsh standard requires screening colonoscopists to
undertake a minimum of 50 screening procedures per year to maintain
approval from Bowel Screening Wales. This is considered when reviewing
applications for additional screening colonoscopists.
8.2
Quality assurance
Data capture for audit and quality assurance is currently incomplete. The
first round of screening relied on paper proformas to capture data on
colonoscopy. Exported data from health board endoscopy reporting
systems will be available in the near future enabling robust quality
assurance.
The QA advisor for screening colonoscopy analysed data for the first year
of the programme and, in general, screening colonoscopists performed to
very high standards, largely meeting the auditable outcomes outlined in
the British Society of Gastroenterologists guideline documents. Further
details will be available for the September report.
8.3
Training
Polypectomy competency is not specifically addressed in the majority of
assessments and it is clear that practice varies. To address this a training
day was facilitated at Welsh Institute for Minimal Access Therapy (WIMAT)
in Cardiff, taking advantage of the pig intestine therapeutic model.
The All Wales Management Group will consider the introduction of an
assessment process for polypectomy at future assessments of potential
screening colonoscopists. Bowel Screening Wales plans to support further
training in advanced polypectomy for screening colonoscopists.
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8.4
Interim first round report
Activity
Planning figures predicted that 3,654 colonoscopy procedures would take
place during the first two years of the programme. In reality 5,389 SSP
assessment appointments were attended and participants found fit for
colonoscopy. This relates to 5,168 participants as multiple assessment
appointments have taken place.
All of the 5,168 participants who were found fit would have been offered a
colonoscopy procedure. At least 4,470 of the booked colonoscopies were
attended (82.9 per cent). One hundred and thirty eight participants (2.6
per cent) appear to have declined a colonoscopy procedure and 11 (0.2
per cent) did not attend their procedure. Other participants may still be
waiting for their colonoscopy procedure at the time this interim report was
written.
As the positivity rate has been higher than anticipated and colonoscopy
activity significantly greater than expected waiting times for colonoscopy
have been high in some areas. It appears that some participants have
declined screening colonoscopy with Bowel Screening Wales and elected to
have a more timely private procedure. This situation is expected to
improve as waiting times reduce.
Waiting times for colonoscopy appointments have been captured by SSPs
since April 2010. Figure 4 shows that participants were waiting on average
around ten weeks for their colonoscopy appointment, from the date they
were assessed and found fit for colonoscopy. This has reduced in August
2010 and remains at an average of six weeks wait for colonoscopy
currently. There has been a large variation in waiting times between
health boards, ranging from 0.5 weeks in Cardiff and Vale to nearly 22
weeks in Betsi Cadwaladr.
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Waiting times in round 2 have improved and most health boards are
expected to be within standard by the end of April 2011.
Figure 4: Waiting Times for SSP Assessment and Colonoscopy, by
month
9
Pathology
Significant pathology is being detected on screening colonoscopy lists.
Correlating colonoscopic findings with histopathology is essential and
pathologists have been asked to report using a proforma to ensure the
minimum dataset is collected. This will be simplified with the introduction
of CHIRP which includes colorectal histopathology proformas. CHIRP has
recently been implemented in one health board and will begin a national
roll out shortly. Further details will be available for the September report.
There
are
currently
30
Bowel
Screening
pathologists in Wales. They have
Wales
named
reporting
all undergone training prior to
implementation of the programme and new recruits have had individual
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training from the QA advisor. Training was undertaken by the same people
and using the same programme as in England.
9.1
Quality assurance
All Bowel Screening Wales reporting pathologists participate in the UK
External Quality Assurance scheme. This is a newly established scheme
and pathologists have participated in two rounds with the first reported
round planned for Spring 2011. Bowel Screening Wales QA advisor will be
notified of outliers in performance.
The Bowel Screening Wales funded
improved monitors for reporting pathologists to improve data quality for
EQA.
During the Bowel Screening Wales QA visit in 2009/10 the QA advisor
audited five slides from each laboratory. Findings were positive and
reassuring. The QA advisor will undertake ad hoc audits in addition to the
scheduled QA activity as considered necessary.
The first round of screening detected more adenomas and fewer cancers
than expected. In response to these findings the QA advisor is auditing
twenty slides containing advanced adenomas from each laboratory to
ensure correct reporting. Further details will be available in September.
There is little evidence to support guidance for reporting and treatment of
early cancers. The English screening programme is planning to undertake
an audit or evaluation of pathological reporting of early cancers detected
in the screening programme. Details of its proposal are not yet clear, but
Bowel Screening Wales has expressed an interest in being involved
subject to a detailed proposal being approved by the
All Wales
Management Group (AWMG). In the meantime a proposal is being
developed to present to AWMG in June to develop a process which will
allow collection of Welsh data and audit of T1 lesions. This will inform
practice in Wales in the future, but will also ensure effective participation
in the UK process if appropriate.
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9.2
Interim first round report
Training
Following initial training, all pathologists are expected to attend annual
BSW training. This will either be in the form of a conference with
professional breakout sessions or specific pathology training sessions.
The QA advisor attends UK screening meetings and is actively involved in
developments. Training is in line with practice elsewhere in the UK and
tailored to the Welsh population.
10
Radiology
There are named reporting radiologists in each health board. Although
radiology activity accounts for a small proportion of Bowel Screening
Wales work, radiologists are asked to complete a checklist when reporting
to ensure the minimum data set is captured.
CT is the investigation of choice for participants who are not fit for
colonoscopy or who have had an incomplete colonoscopy. The standard of
CT across Wales is variable with 30 per cent of units not currently offering
low dose procedures. This will improve during 2011 as new scanners have
been ordered.
Ongoing work is needed in terms of data capture and Bowel Screening
Wales is considering options at present.
10.1
Quality assurance
Bowel Screening Wales QA process will involve the QA advisor reviewing
images. This process is to be further developed for future rounds of QA.
The QA advisor has collected baseline information and is satisfied that
there are no major issues relating to radiology for the bowel screening
programme in Wales.
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10.2
Interim first round report
Training
Radiologists reporting CT scans for Bowel Screening Wales must be
appropriately training. Information has been gathered on training courses
accessed by reporting radiologists and further work is needed. Most Bowel
Screening Wales reporting radiologists have undertaken a recognised CT
course. In house training is currently begin considered in addition to
encouraging more radiologists to access external recognised courses.
10.3
Activity
During round one 554 participants were found not to be fit for a
colonoscopy procedure. One hundred and twenty nine participants were
offered CT scans (23.3 Per cent). This equates to radiological activity for
1.9 per cent of people with positive results. At least 101 participants
attended 111 appointments and some had multiple CT scans. A further
five participants were offered a barium enema (0.9 per cent) of which at
least five participants attended six BE tests.
11
Surgery
Bowel Screening Wales is responsible up to the point of diagnosis and
therefore health boards manage surgical activity, but Bowel Screening
Wales needs to be assured that participants are able to access timely, safe
and appropriate surgery if required. Data collection is being explored and,
although information on cancer treatment is relatively robust, there is
little data currently available on surgery for benign disease.
Anecdotal evidence suggests that surgical activity for benign disease is
very variable across Wales. Some units offer more complex endoscopic
polypectomy procedures than others, some units refer to neighbouring
units where colonoscopists are more experienced in dealing with complex
lesions, while others refer for surgery. The English programme has had
mortality following surgery for benign disease. Although evidence is
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limited to support endoscopic procedures in preference to surgery, BSW
would like to develop an equitable service where participants have the
choice of undergoing a complex polypectomy procedure endoscopically at
a national referral centre or local surgery after consideration of associated
risks and the possibility of a permanent colostomy.
Information on stage at diagnosis is available and is currently being
analysed. This information will be available for the full report in
September.
11.1
Quality assurance
The QA surgeon liaises with local surgeons and is developing a quality
assurance programme aimed at ensuring safe and appropriate surgery.
This will be dependent on effective data collection and further information
will be available in September 2011.
12
Information systems
The Bowel Screening Information Management System (BSIMS) is being
developed in phases. Call, recall, testing and results issuing modules were
developed in time to implement the programme and the development has
been ongoing ever since. The system is successful in managing participant
pathways and collecting some data, but is not yet able to collect quality
assurance data in an efficient manner. Statistical data can be derived from
BSIMS.
Data will be exported from health board endoscopy systems and pathology
will come directly from CHIRP. Radiology and surgery data sets need
review and collection strategies need to be agreed.
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13
Interim first round report
Outcome data
Table 9 shows final outcome of the 4,470 colonoscopy procedures
attended.
Table 9: Colonoscopy outcomes
NUMBERS
Colonoscopy Outcome
Unknown
FOB
PERCENTAGES
FIT Total
FOB
FIT
%
37
207
244
6.9
5.3
5.5
Routine recall
194
2131
2325
36.3
54.1
52.0
Surveillance - intermediate
risk
108
781
889
20.2
19.8
19.9
Surveillance - high risk
64
397
461
12.0
10.1
10.3
Diagnosed with IBD
17
78
95
3.2
2.0
2.1
106
253
359
19.9
6.4
8.0
Ceased (other reasons)
2
7
9
0.4
0.2
0.2
Repeat Procedure needed
6
82
88
1.1
2.1
2.0
Diagnosed with cancer
TOTAL
534 3936 4470 100.0 100.0 100.0
The majority of cases are returned to routine recall (52.0 per cent), but
594 (13.3 per cent of total) had a biopsy taken or polyps removed. Around
30 per cent enter the surveillance programmes, 2.1 per cent have IBD
diagnosed and are ceased from recall. The cancer detection rate is
currently 8.0 per cent, lower than expected in this prevalent round.
A difference can be seen between the two test kits, with 19.9 per cent of
positive guaiac FOBt showing cancer detection compared to only 6.4 per
cent of FIT kits.
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The polyp detection rate was 62.3 per cent with 2,785 attended
colonoscopies having polyps removed (66.1 per cent of guaiac FOB kits
and 61.8 per centof FIT kits). Another 2 per cent of procedures require a
further repeat procedure to be undertaken.
14
Adverse event
Most adverse events are notified by SSPs, but it is likely that incidents
were under-reported during the first round of screening. BSW is keen to
develop a culture of reporting incidents and events that others can learn
from. A first alert process has recently been developed and is improving
reporting rates.
Further details on complication rates and other adverse events will be
available for the September report, but to date there have been no
screening related deaths and four bowel perforations, all of which were
following polypectomy.
15
Programme impact
15.1
Impact on Local Assessment Centres
The demand placed on health boards as a result of the introduction of the
service has far exceeded expectations, for the following reasons:

The positivity rate of FOBt has been consistently higher than
envisaged,

Higher than predicted rates of polyp detection have resulted in
increased requirements for surveillance colonoscopy and recall
procedures to clear colons of polyps.
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As a result, demand on SSP and colonoscopy appointments has been
much higher than anticipated when planning the programme. Bowel
Screening Wales and health boards have worked hard in partnership to
develop the capacity required to meet this demand.
Limiting factors have been:

The small pool of potential screening colonoscopists to draw from in
Wales,

The inability of English border Trusts to establish capacity to take
referrals from Bowel Screening Wales, resulting in increased demand
on Welsh services.
However capacity has been identified in Wales and waiting times are
improving as a result. Screening colonoscopists are being actively
recruited and it seems entirely possible that the original plan to increase
up to 74 years of age by the end of 2012 will be achieved despite a
pressurised first round of screening.
15.2
Impact on the symptomatic service
Implementation of the bowel screening programme has brought benefits
to the symptomatic service. Units have used pump priming money to
make improvements in preparation for screening.
Colonoscopists have undergone training and assessment. Evaluation of the
assessment process was positive and colonoscopists stated that their
technique has improved as a result which will in turn benefit symptomatic
patients.
Screening lists are separately funded and staffed and were therefore not
expected to have an impact on the symptomatic service. As demand for
screening colonoscopy has been so high and waiting times longer than
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they should have been it seems some participants with positive screening
FOBts have turned to their general practitioners for referral to the
symptomatic
service
for
more
timely
colonoscopy.
While
this
is
unfortunate it has involved small numbers of people and is not envisaged
to be an ongoing problem. As waiting times for screening colonoscopy
reduce this issue will be resolved.
It is probably too early to see a reduction in emergency admission rates as
a result of the screening programme, but baseline information will be
obtained for the full report in September.
16
Challenges
The first round of screening has been successful, but many challenges
remain. These include:

Increasing and maintaining capacity for colonoscopy

Improving uptake

Recruiting
screening
colonoscopists
while
ensuring
existing
Screening Colonoscopists maintain screening 50 cases per annum

Obtaining electronic QA data in a timely manner

Maintaining ongoing development of BSIMS to ensure complete
development

Developing a flexible programme which is able to adapt to new
developments and testing strategies

Collaborating with other screening programmes to develop efficient
working strategies to reduce costs while maintaining standards
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17
Interim first round report
Future developments
As the programme matures and expands exciting new developments are
on the horizon. The English screening programme is preparing to
implement a flexible sigmoidoscopy screening programme and are
currently running three pathfinder sites. It is likely that the National
Screening Committee will recommend this approach and the Welsh
Assembly Government will need to take a view for future development in
Wales. Further details may be available for the September report.
The All Wales Management Group will be asked to comment on a proposal
to develop a screening network multi disciplinary team (MDT) and national
referral centre for complex polypectomy in June. If approved, this will be
subject to a business case and application for funding but, if successful,
will be the first in the UK and should be documented and published to
inform UK colleagues.
Bowel Screening Wales is about to start a pilot of screening prisoners.
When the complete cohort have been invited and ongoing strategy agreed
other hard to reach groups such as homeless people will be invited.
Training is being addressed for all groups of staff and will be developed to
include e-Learning materials this year. Professional training will continue
to be tailored to need and provided at least annually. Support from
sponsors will be sought to ensure cost effective training and professional
development is ongoing.
As a new screening programme there are many research opportunities
and a research group has been established. Interesting proposals are
being developed and more information should be available in September.
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18
Interim first round report
Conclusion
The first round of screening has demonstrated a pathology yield at
screening colonoscopy of nearly 70 per cent which is good news in terms
of public health.
The first round of screening has been successful and while there are still
ongoing challenges there are also interesting new developments for the
maturing programme. Some findings were unexpected such as the high
positivity rate and the number of adenomas compared to cancers.
These factors increased demand on the programme in terms of finding
capacity for screening colonoscopy, SSP time, managerial time and
laboratory and administrative workload. Despite these challenges good
relationships have been forged with local teams. Capacity has been
developed and goodwill maintained. The programme is now well placed to
begin planning age expansion with local assessment centre teams.
While this interim report lacks confirmation of figures the full first round
report will be published by September 20011. This will update figures
confirming the number of non responders, the uptake and colonoscopy
outcomes. A more in depth analysis of all figures by gender, age group
and area of residence will be undertaken.
Second round behaviour will be analysed in terms of uptake and previous
engagement. Further information will be given on interval cancer rates,
stage at diagnosis, adverse events and possible impact on emergency
admission rates.
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19
Interim first round report
Appendices
Appendix 1: Local Assessment Centres
Heath Board
Betsi Cadwaladr
Local Assessment Centre
Wrexham Maelor Hospital
Ysbyty Glan Clwyd
Ysbyty Gwynedd
Hywel Dda
West Wales General Hospital
Bronglais Hospital
Withybush Hospital
Abertawe Bromorganwg University Princess of Wales Hospital
health Board
Singleton Hospital
Cardiff and Vale
Llandough Hospital
Aneurin Bevan
Caerphilly Miners Hospital
Cwm Taf
Prince Charles Hospital
Powys
Brecon (established March 2011)
Borders
Hereford General Hospital
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Appendix 2: Local Assessment Centre Criteria
Essential
Desirable
Service requirements
 Departmental multi disciplinary
meetings as recommended by
CSCG
 Complies with BSW assessment
model for screening colonoscopists
 Adequate number of staff – (BSG
guidelines i.e. 2 trained members of
staff per room, one of whom is a
qualified nurse)
 Appropriate grades of staff
 Relevant competencies achieved by
nursing and HCA staff
 Dedicated reception and clerical
staff
 Funding, IT support and routine
replacement for local IT
infrastructure including endoscopy
system, network, hardware (PCs,
printers, scanners, etc), and locally
provided software (e.g. PAS, office
software)
 Service and individual activity audit
 Able to provide specific audit data
e.g. unplanned admissions,
mortality and bleeding incidents
 Supportive radiology and pathology
service
 Key performance indicators as
prescribed by BSW
 Image capture
 System for monitoring and
reviewing unpredicted incidents and
near misses
Environmental
 Based in an acute hospital with
cardiac arrest team on site
 Complies with BSG Standard for
decontamination of equipment and
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

Separate waiting
and recovery areas
More than 1
colonoscopy room
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





Interim first round report
participates in all Wales audit
Separate preparation area
Sufficient room for increase in
capacity
Good decorative order
Access to acute surgical opinion
Adequate storage space
Private rooms for discussion /
admission/ SSP phone calls
Equipment
 Number of scopes recommended by
the BSG guidelines
 Modern video endoscopes <8 years
old
 Image capture facilities
 Suitable networked IT infrastructure
providing access to wide-area
network (for links to Bowel
Screening Information System,
pathology system, etc), access to
endoscopy system for direct data
entry after examinations, with
sufficient PCs, printers, scanners,
etc, provided by and replaced by
the local site
 Appropriate computerised
endoscopy record system with
interface and/or data exports for
screening information (to be
defined by Bowel Screening Wales)
and funded software maintenance
 Dedicated resuscitation trolley and
appropriately trained staff
 Piped oxygen to colonoscopy rooms
and recovery rooms
 Equipment of monitoring blood
pressure, ECG, pulse oximetry and
ECG monitoring for high risk
patients
 Equipment for cessation of bleeding
and tattooing of polyps
 Capital asset replacement plan
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
Facilities for trolley
and seated recovery
areas

Video facilities
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Training
 Offer access to and agree to attend
BSW training programme
 Multidisciplinary training
programme
 All staff assessed as competent are
able to practice
 Agree to attend a screening course
relating to screening
 Identify medical and nursing leads
and nominate facilitators/ mentors
 Willingness to release staff for
meetings and training sessions
 Provision and updating of basic IT
training (e.g. Windows, IT security,
office software, etc), and endoscopy
system use and data entry


Sustainable delivery
plan for training
programme
Work force
development plans
e.g. nurse
colonoscopists
Further considerations:
 Geography
 Convenience for participants e.g. access, parking
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