- Background
Colorectal cancer is the second commonest cause
of cancer death in the
UK, with over 3000 new cases and
1700 deaths each year in Scotland.
Three population based randomised trials
1,2,3 have shown conclusively that
screening using faecal occult blood testing (
FOBt) can reduce death rates
from colorectal cancer by about 20%. However, such
trials are tightly controlled studies carried out
by highly motivated individuals and there was some
doubt as to whether similar results could be
obtained in a routine setting within the
NHS.
- Developing the Pilot
The National Screening Committee (
NSC) held two workshops in 1997
and 1998 to canvas a wide range of expert opinion
and critically review the available evidence. It
was recommended that the feasibility of a national
screening programme should be tested before
committing the
UK Health Departments to such a
programme. To do this, a demonstration project (
DP) based on two populations of
about one million each, in different parts of the
country was proposed. An outline specification for
the project was agreed - including the target age
range (all 50-69 year olds) and the technique to be
used (biennial
FOB testing with colonoscopy as
the follow up investigation for those testing
positive).
When this national specification had been
approved, all
UK Health Authorities were
invited to submit expressions of interest in
hosting a pilot site. 5 proposals were shortlisted
for further consideration by an assessment panel
appointed by
NSC. Members of this panel
visited these sites and, in early 1999, the final
selection was made after presentations and
interviews.
The sites chosen for the pilot were North East
Scotland (Grampian, Tayside and Fife) and Coventry
and Warwick in England. An Executive group was set
up to oversee the operational development and
running of the pilot, comprising the National
Screening Coordinators for Scotland and England,
their central project managers, the two clinical
directors and the two pilot managers. A
UK steering group was also set
up to formulate general policy.
Working groups were set up to develop the
specification for the computer system, to select
the
FOB test, to develop data sets,
protocols, quality assurance systems and
information materials.
The first round of screening began in March
2000.
FOBt kits were sent by post to
the target population, with instructions to
complete the test and to send it back to the
screening centres in Dundee and Coventry for
analysis.
- Evaluation Model and Methods
3.1 External evaluation
Independent evaluation was an essential part of
the project and a single evaluation covering both
the Scottish and English arms of the pilot was
agreed. This was put out to tender by the R&D
Directorate of the Department of Health in London.
On the basis of competitive bids, the evaluation
was awarded to a group from the Universities of
Edinburgh, Warwick and Essex.
The evaluation covered many aspects of the
pilot: performance against benchmarks, the impact
on primary and secondary care services, uptake and
the reasons for non - participation, physical and
psychological morbidity associated with screening,
and an economic evaluation.
The evaluation was complex and required a
multi-disciplinary approach, including
epidemiology, health services management,
psychology, health economics, primary and secondary
care. The evaluation team were located at three
sites, and needed to interact with the two pilots
and with individuals in the Scottish Executive and
the Department of Health.
Developing a carefully managed relationship with
the pilot sites was essential. The evaluation had
to be independent and unbiased, yet good
communication with the pilot sites was essential -
e.g. to ensure agreement on definitions and on
quality standards, and to coordinate the evaluation
surveys with the screening programme. For these
reasons, the evaluators developed a 'Terms of
Engagement' document which aimed to make explicit
the competing imperatives of independence and
integration. This was found useful by all
concerned.
In February 2003, the Evaluation Group produced
an independent report for the Department of Health
R&D Directorate on the outcomes of the pilot,
with the aim of informing a decision on a national
programme.
3.2 Internal monitoring/evaluation
Initially, insufficient priority and resources
were given to developing the internal monitoring
capacity. There was an implicit assumption that the
external evaluation would address all the issues.
When this was identified as a priority, there were
some problems with timely access to the data and
ensuring the
IT system could provide the
necessary information.
- Results of the Evaluation
A decision on whether to continue the pilot for
a second round was needed during 2002, well before
the results of the evaluation were available. A
second round of screening began in Scotland in
December 2002.
The final report of the evaluation group was
submitted to the Department of Health in February
2003. It showed that the
UK pilot had demonstrated that
key parameters of test and programme performance
observed in randomised studies of
FOBT screening can be repeated
in population based pilot studies. The cost
effectiveness also compared well with other forms
of cancer screening.
The independent external evaluation has not been
continued to cover the second round of screening.
The internal monitoring capacity has been enhanced
to address this.
In July 2003, the Scottish Executive gave a
commitment in principle to roll out a national
colorectal screening programme, while recognising
that planning for its introduction could take up to
5 years.
- Key Issues