Bowel Screening Wales First Round

• Public Health WalesBoard

Contents

Bowel Screening Wales First Round

Interim Report

Executive Summary

1Introduction

2Programme aim and scope

3Eligible population

3.1Identification

3.2Invitations

3.3Public Information

4Screening pathway

5Organisational Structure

5.1The Welsh Bowel Screening Centre

5.1.1Management Arrangements

5.2Local Assessment Centres

6Screening test

6.1Uptake

6.2Performance

6.3Positivity rate

Figure 3: Positivity Rate from Beginning of Programme

7Specialist screening practitioners

7.1Role and responsibilities

7.2Training

7.3Activity

8Screening Colonoscopy

8.1Assessment of colonoscopists

8.2Quality assurance

8.3Training

8.4Activity

9Pathology

9.1Quality assurance

9.2Training

10Radiology

10.1Quality assurance

10.2Training

10.3Activity

11Surgery

11.1Quality assurance

12Information systems

13Outcome data

14Adverse event

15Programme impact

15.1Impact on Local Assessment Centres

15.2Impact on the symptomatic service

16Challenges

17Future developments

18Conclusion

19Appendices

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.

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.

1Introduction

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 homefaecal 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 laboratoryin 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 reportbased 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.

2Programme 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

3Eligible 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 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.

3.1Identification

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 eightweeks 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 Walesdata amendments.

3.2Invitations

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

3.3Public 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
• 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.

4Screening 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.

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

5Organisational 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.

5.1The Welsh Bowel Screening Centre

Based in Pontyclun, Llantrisant the Welsh Bowel Screening Centrehouses 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 biomedical scientist staff will be available and have already been trained to validate Bowel Screening Wales results.

5.1.1Management Arrangements

5.2Local Assessment Centres

Bowel Screening Walescommissions colonoscopy, histopathology and radiology services from the health boards. Long Term Agreements (LTAs) specify that each heath boardservice complies with the relevant elements of the Bowel Screening Walespolicy, 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 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.

6Screening 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 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 testis 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.

6.1Uptake

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 2illustrates 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 centwithin threeweeks). The 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 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

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.

6.2Performance

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 centpositive rate for FIT kits and 55 per cent with associated negative colonoscopy. This is compared with findings from the current Scottish programme which has a 21 per cent positivity for FIT kit and 35per cent associated negative colonoscopy. These findings are interesting and need further investigation.