Improving colorectal cancer screening outcomes: Proceedings of the second meeting of the International Colorectal Cancer Screening Network,a global quality initiative

Abstract

The International Colorectal Cancer Screening Network (ICRCSN) is a global consortium of initiatives delivering organized colorectal cancer (CRC) screening to their populations. The aim of the Network is to promote improvements in quality assurance (QA) and programme evaluation to maximize the benefit and to minimize the risk associated with CRC screening. ICRCSN currently includes 41 member initiatives from 27 countries. The ICRCSN held its second international meeting in Oxford in September 2008 with representatives from 24 countries. This report summarizes the presentations and discussions, the feedback from participants on their current and future needs and the potential role of the ICRCSN in supporting those needs.

The International Colorectal Cancer Screening Network (ICRCSN) is a global consortium of initiatives delivering organized colorectal cancer (CRC) screening to their populations. The ICRCSN is sponsored by the Centers for Disease Control and Prevention (CDC) and the American Cancer Society (ACS) (Atlanta, GA, USA). The aim of ICRCSN is to promote improvements in quality assurance (QA) and programme evaluation to maximize the benefit and to minimize the risk associated with CRC screening.

Currently the ICRCSN includes 41 member initiatives from 27 countries worldwide that fulfil most of the criteria for an organized programme as defined by the International Agency for Research on Cancer (IARC). ¹ Characteristics of an organized screening programme include an explicit policy with specified eligibility categories, method and interval for screening; a defined target population; a management team responsible for implementation; a healthcare team for decisions and care; a QA structure; and a method for identifying cancer occurrence in the target population.

The ICRCSN held its second meeting in Oxford in September 2008, with participants representing 24 countries attending. This report summarizes the presentations and discussions that took place at this meeting, the feedback from participants on their current and future needs, and the potential role of the ICRCSN in supporting those needs.

The first of the four sessions focused on achievements of the first phase project of the ICRCSN to ascertain all organized screening initiatives worldwide. The second session focused on the phase 2 project to standardize terminology and derive a minimum set of indicators and their component measures (or variables), and to facilitate collection and comparison of data on the quality of CRC screening. The third session was devoted to the proposed phase 3 project to develop an international guideline on best practice in the delivery of CRC screening. The final session provided an opportunity for debate about the future direction of ICRCSN and its relationship with other international organizations.

SESSION 1: BACKGROUND AND ACHIEVEMENTS OF THE ICRCSN

Opportunistic screening for CRC occurs in many parts of the world and is the predominant method in the USA, but increasingly countries that have established breast and cervical cancer screening programmes are beginning to introduce organized CRC screening. The European Union (EU) has passed a resolution on CRC screening that includes 27 countries. ² In the USA, ACS and CDC and other organizations have for many years promoted the effective and efficient delivery of cancer screening. During 1996 and 1997, following the publication of new CRC screening guidelines, ³ ACS and CDC collaborated to establish the National Colorectal Cancer Round Table (NCCRT) dedicated to increasing CRC screening among the USA public. ⁴

In June 2002, the ACS and International Union Against Cancer sponsored an international meeting in Oslo on ‘Facilitating Screening for Colorectal Cancer’.^5,6 This meeting brought together experts from North America, Europe, Asia and Australia and was organized into five workgroups focusing on criteria for screening; the screening process; QA and programme evaluation; and public and professional education. A key aim of the workshop was to emphasize the importance of the entire process of screening as a system of interrelated and interdependent elements, rather than just the technological elements of the individual screening methods. Development of consensus strategies for measuring and monitoring quality was identified as a priority.

It became apparent from the workshop that there was a great deal of CRC screening activity worldwide and that it would be useful to describe it and build a Network that could share learning, materials, experience and best practice. To address this need, CDC and ACS supported a collaborative effort with Cancer Research UK to develop the ICRCSN.

The first aim of the ICRCSN was to identify and document the status of organized screening initiatives. In phase 1 (2003-2005), screening programmes, pilot programmes or research projects that had been in operation prior to May 2004 were identified and surveyed. Thirty-five independent initiatives were identified in 17 countries and considerable variability was noted in setting and structure, with a lack of commonly agreed measures for reporting screening outcomes and QA. ⁷

The second phase of the Network focused on deriving a set of common measures for use in all healthcare contexts and relevant to all the currently available CRC screening modalities. During this phase, the ICRCSN membership was limited to organized screening programmes and pilots; research projects were no longer included.

SESSION 2: DEFINING A MINIMUM SET OF QUALITY INDICATORS

Screening initiatives typically are tailored to their target population, the healthcare system and the levels of funding. Thus, there are variable approaches to the delivery of cancer screening both between and within countries. Nonetheless, it is beneficial to collect and share implementation and performance data between initiatives. Information on the effectiveness of technologies and methodologies can benefit existing initiatives by providing comparative data, and also can provide data on testing approaches not implemented but under consideration. Comparative performance data also can provide insights and guidance to regions that have not yet implemented screening, but are in the planning stages. To facilitate the sharing of such information and comparisons, it is important to have a common nomenclature and for the initiatives to be collecting the appropriate data. Because CRC screening is in its infancy in most countries, a common language to describe the screening process and measures by which quality can be examined for all tests and types of initiatives had not yet been established.

In phase 2 (2006-2008), the ICRCSN developed, piloted and tested a minimum set of quality indicators and their component measures designed to capture the short-term performance of a screening initiative (see Appendix A). Key indicators included the participation rate, positivity rate, the predictive value of a positive test, detection rates of cancers, adenomas and polyps, and 30-day overall and colonoscopy-specific deaths. To permit comparison of rates, we sought to provide a clear, unambiguous definition of the measures used in the numerator and denominator of each indicator. The development of the indicators and the descriptions of the performance measures was an iterative process taking several months. Initially, a set of indicators was drafted based on those developed for breast cancer screening by such agencies as IARC, ¹ the International Breast Screening Network (http://appliedresearch.cancer.gov/icsn/) and the NHS Breast Screening Programme (http://www.cancerscreening.nhs.uk/breastscreen/). An Expert Working Group, consisting primarily of public health researchers and those responsible for developing and running screening activities (see Appendix B), reviewed the indicators and definitions at a meeting in London in 2007. A pilot survey of these quality measures was performed in seven screening initiatives representing a broad spectrum of different modalities and different health systems.

The pilot generated a number of questions concerning definitions and inclusion criteria. Particularly problematic were definitions of the target population, the periods for which data were required and the uptake rate. The Expert Working Group reached a consensus by email and by teleconference, and in April 2008 the revised survey was sent to 54 identified initiatives. Of the 41 initiatives that responded, 33 were eligible to participate in the survey: 24 were programmes and nine were pilots, with the majority of the initiatives being located in Europe and North America. The most commonly used screening modality was faecal occult blood testing (FOBt), followed by colonoscopy; flexible sigmoidoscopy was the least frequently used test. The remaining eight initiatives had not been running for long enough to have sufficient data. The results of the survey will be published elsewhere, and up-to-date definitions will be made available on the ICRCSN website in due course (http://icrcsn.ceu.ox.ac.uk/).

SESSION 3: QA GUIDELINES AND STANDARDS FOR CRC SCREENING PROGRAMMES

The next phase of activity of ICRCSN, phase 3, will focus on QA and programme evaluation and, based on the experience of members of ICRCSN, will develop an international guideline.

Screening programmes involve a trade-off between resources, benefits, limitations and risks. QA efforts and programme evaluation are intended to ensure that these competing elements are kept in balance. In the case of screening for CRC, this means maximizing the potential morbidity and mortality reduction from early detection of precursor lesions and cancers while minimizing the undesirable side-effects of screening, such as false-negative results, and the potential morbidity associated with endoscopy. In order to achieve this potential, the elements of a QA programme must be monitored over both the short and long term, and linked with programme outcomes.

Existing national and international guidelines

There are several national quality initiatives but currently only one international QA guideline for delivery of CRC screening. This is a comprehensive work that is sponsored by the EU and comprises a detailed, evidence-based set of guidelines on all aspects of CRC screening following the model of the previous guidelines for breast and cervical cancer.^8,9 Ten chapters have been developed by teams of experts in specific areas of CRC screening, all of which follow a common format and are supported by an extensive literature review. Finally evidence-based recommendations are given, each of which is graded by the strength of the recommendation and the level of evidence, as decided by the working group for each chapter. The EU guideline on CRC screening is due for publication in 2010. It is expected that member states will adhere to recommendations in the guideline in developing their CRC screening programmes as has happened with preceding breast and cervical cancer guidelines.

Several countries are implementing national quality initiatives, and examples were presented. Cancer Care Ontario (CCO) is a provincial agency that has initiated the first organized cancer screening programme in Canada. The programme sets FOBt and colonoscopy standards, and undertakes QA, audit and feedback,^10,11 requiring that participating hospitals report monthly on quality, and initiating remedial action as necessary.

In the UK, efforts have been directed towards improving the quality of colonoscopy.^12,13 In addition to maximizing detection rates, key guiding principles which underpin the quality initiative in endoscopy are that (i) patients have as good an experience as possible such that they recommend screening to their friends, family and colleagues; (ii) the QA required for screening should have an enhancing effect on the quality of endoscopy performed for symptomatic patients; and (iii) the introduction of screening endoscopy should not have a deleterious effect on symptomatic endoscopy services. An endoscopy global rating scale (GRS) has been introduced in endoscopy units in the UK. ¹² The GRS takes into account the quality of the patient experience (timeliness, choice, privacy and dignity, aftercare and ability to provide feedback) as well as clinical quality (such as appropriateness, information/consent, safety, comfort and timely results). Since the introduction of the GRS, substantial improvements in clinical quality have been achieved in a short space of time. ¹² All major endoscopy units in the UK that provide services to the English Bowel Cancer Screening Programme have been through an accreditation process. ¹⁴

In the USA, delivery of CRC screening is more complex due to the absence of a national healthcare system. Several efforts to improve the quality of screening were discussed. The NCCRT has initiated a call to action to discourage the use of a single digital rectal examination to obtain a stool sample for FOB testing - a practice which persists despite evidence of its lack of efficacy.^15,16 To improve the quality of colonoscopy, the Multi-Society Task Force on Colorectal Cancer proposed quality indicators for all aspects of colonoscopy ¹⁷ and the QA Task Group of the NCCRT has developed a comprehensive colonoscopy reporting and data system (CO-RADS). ¹⁸ The QA Task Group is currently developing guidance for primary care providers on recognizing quality in a colonoscopist and is addressing the management of small polyps and the important role of high quality stool testing in CRC screening. Future plans include exploration of the potential for accreditation programmes for endoscopy and computed tomographic colonography.

Recruitment is an important indicator of quality

Recruitment and uptake are important indicators of quality for all screening programmes. Indeed adequate uptake in the wider population is required to bring about the disease-specific mortality reductions observed in trials. Various interventions have been shown to be effective in improving uptake rates including personalizing the invitation process; mailing the FOBt kit with invitation letters; using reminders, information sheets (leaflets) and removing financial barriers. To improve recruitment, approaches can be taken to adapt the recruitment materials by acknowledging the difficulties and barriers to screening. No ‘one-size fits all’ approach can be used to increase participation; the specific approach taken varies by healthcare system, design of programme, type of test and target group. ¹⁹

In contrast to the early days of cancer screening, it is now accepted that individuals being invited for screening should be provided with information about the limitations of the process as well as the benefits. Only then could they be considered to have made an informed choice about whether to participate or not. ^{20 22} For CRC screening this is particularly important because the colonoscopy examination that is always a part of screening, whether as the initial screening test or as the diagnostic test, carries some risks.

Proposed ICRCSN quality guideline

The quality guideline proposed by the ICRCSN will be based on the EU guideline, the first international collaborative effort to define best practice in CRC screening. Using the EU guideline as a template will avoid duplication of effort and make best use of the extensive work already performed. However, as it will apply globally, it will of necessity be more general and will include only the essential principles. In developing the guideline, the ICRCSN will work in partnership with other international organizations, each providing a different focus, to ensure inclusion of a diverse range of perspectives with respect to delivery of CRC screening. Establishing basic principles for QA through the ICRCSN will provide countries with a template to develop more detailed country-specific guidelines.

It was suggested by meeting attendees that the guideline should include a minimum set of quality indicators of the screening process. It was also recognized that QA is a continuous process and frequent revision of QA standards is needed to sustain improvement in outcomes. Thus the longterm commitment of ICRCSN members to the quality initiative is vital.

A discussion followed on the need to regulate QA and the disadvantages of employing a voluntary reporting scheme. The general consensus was voluntary schemes do not deliver. For example, in the UK, QA is not an integral part of the cervical screening programme and coercion is still required to obtain adequate feedback. Conversely, with breast cancer screening QA was built into the programme from the start and is viewed as an acceptable part of the screening programme. ²³ It is therefore important to build in QA from the beginning.

A further contentious issue is the requirement for accreditation of laboratories and endoscopy units to participate in the programme. This has been a requirement in some countries but has not been widely implemented.^24,25

SESSION 4: FUTURE OF THE ICRCSN

In the future, collaboration with other international groups, including the International Cancer Screening Network ²⁶ and IARC, will be strengthened to facilitate extension of the Network to areas of the world currently under-represented, such as South America and South-East Asia and to ensure that the ICRCSN is well placed to continue its work. In phase 3, in addition to development of internationally accepted QA guidelines, there will be a strong practical and educational focus to facilitate implementation of quality indicators and QA worldwide.

Several meeting participants indicated that they intend to incorporate changes into their programme based on the indicator questionnaire from phase 2. It is planned to send a follow-up questionnaire to determine the extent to which data collection in programmes has improved as a result of participation in the phase 2 ICRCSN survey.

In summary, the ICRCSN is committed to deriving common guidelines for the delivery of CRC screening and basic principles for QA, and to identifying minimum standards of practice that are applicable worldwide. As the Network broadens, a rich dataset will afford the unique opportunity of achieving a truly international consensus on the quality of CRC screening.