12.1 Local implementation

Implementation of national clinical guidelines is the responsibility of each NHS Trust and is an essential part of clinical governance. It is acknowledged that every Trust cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit.

12.2 Key points for audit and recommendations for research

12.2.1 AUDIT

In order to review the previous SIGN dataset for colorectal cancer in the light of this revised guideline, a multidisciplinary working group was convened consisting of representatives of SIGN, the Clinical Standards Board for Scotland (CSBS) and the Scottish Cancer Intelligence Unit (SCIU).

The group met several times throughout the period of development of the guideline and established a common dataset which allows the audit not only of SIGN guideline recommendations but also facilitates the collection of data relevant to clinical standards, core cancer registration data items and key information for calculation of waiting times.

The dataset is available for download from the following website:

http://www.isdscotland.org/isd/files/Colorectal%20Cancer%20Defs%20Jan%202004%20Distribution%20Copy.doc

Further details of the timing of implementation of this data set and associated data definitions are available from the SCIU website.

12.2.2 RESEARCH RECOMMENDATIONS

The guideline development group have highlighted a number of areas which could not be addressed by the systematic review of evidence and have flagged these up as urgent areas for future research activity.

Screening and risk factors

Elucidation of dietary and lifestyle risk factors of colorectal cancer

Development of strategies to change diet and lifestyle in patients at high risk of developing cancer

Improving the sensitivity and specificity of existing screening tests

Improving uptake for screening

Establishing ideal intervals for colonoscopic surveillance in patients with inflammatory bowel disease

Establishing ideal intervals for colonoscopic surveillance in patients with adenomatous polyps

Research into the psychological consequences of screening both general populations and high risk groups

Primary care and diagnosis

Research into ideal referral strategies between primary and secondary care

Research into the use of magnetic resonance imaging to diagnose and stage colorectal cancer.

Research into the role of CT pneumocolon

Surgery

Research into standardising techniques for rectal cancer surgery

Establishing the role of local excision of colorectal cancer

Establishing the role of stenting in the management of malignant colonic obstruction

Clarifying the role of in situ ablation for liver metastases

Chemotherapy and Radiotherapy

Patients in older age groups should be included in future trials given that they are the band of population most commonly affected by colorectal cancer, that they may have a different toxicity profile, or response to therapy and that they may have a higher surgical risk profile.

There is a need for a randomised trial of adjuvant chemotherapy in patients with Dukes’ B tumours who are considered, on the basis of histopathological features, to be at high risk of recurrence. Such patients would include those with perforated tumours or with evidence of peritoneal involvement.

There is no RCT evidence concerning regimens, such as de Gramont FUFA or orally active agents, which have been shown in patients with advanced disease to be more effective and less toxic, than bolus FUFA. Given these uncertainties, entry into appropriate randomised trials, comparing different adjuvant regimens, is recommended for patients with Dukes’ C cancer of the colon and rectum.

Further trials are needed to define whether portal vein infusion or intraperitoneal chemotherapy provides any additional benefit to that achieved using systemic chemotherapy.

Development and implementation of new anti-cancer agents with increased effectiveness and reduced toxicity for advanced disease.

Active specific immunotherapy (ASI) has been evaluated in a single randomised trial, but this was of insufficient quality to allow a conclusion to be drawn and further studies with this mode of treatment are needed.

Clinical trials should be supported which investigate whether shorter and/or more convenient and/or less toxic chemotherapy regimens (e.g. PVI 5-FU as in SAFFA) are better than bolus FUFA. In addition, trials are required investigating combination regimens, which have been shown to be associated with higher response rates in patients with advanced disease.

Communication and teamwork

It is not easy to explain the concept of adjuvant chemotherapy to patients. It is particularly difficult to deal with the balance between the risks and benefits at the individual, as opposed to the population, level. More high quality research is required on how best to communicate prognostic information and how to ensure that the decisions made by individual patients are truly informed.

Research into the role of specialist nursing in colorectal cancer

Follow up

Further information is required on the clinical and cost-effectiveness of the various follow up methodologies.

Having one or more of these risk factors does not guarantee that a person will develop colorectal cancer, however it increases the chances. People may want to talk with a doctor about these risk factors. The doctor may be able to suggest ways to reduce the chance of developing colorectal cancer and can plan an appropriate schedule for check-ups.