1Introduction

1.1. Guideline aims

Clinical guidelines are defined as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances”.(1) This guideline offers advice on the referral of patients with suspected cancer to specialist services. It updates previously published guidelines,(2) following a commitment in the NHS Cancer Plan(3) that these guidelines would be reviewed by NICE. The new guideline takes account of new research evidence and the findings of audits{969] undertaken since the publication of the previous guideline.

1.2. Referral of patients with suspected cancer

A key aim for the NHS is improvement in the care of people with cancer, including a reduction in mortality by 20% in people under 75 by 2010 in comparison with a 1995–97 baseline. Progress is being made towards this objective, and death rates are falling.{970} In England and Wales in 2003, 136,030 people died from cancer(4). The cancers causing most deaths are shown in Table 1.

Table 1. Deaths from cancer males and females, all ages, in England and Wales(4).

Table 1

Deaths from cancer males and females, all ages, in England and Wales(4).

Five-year survival rates for some cancers are increasing. For example, rates for breast cancer rose from 72.8% in the period 1991–5 to 77.5% in the period 1996–9; for colon cancer the improvement was from 42.1% in men and 42.8% in women to 46.9% in men and 47.9% in women over the same period. However, in cancers survival rates have been relatively unchanged, for example certain types of cancers of the bladder, brain, and cervix.(5)

Early referral has a role to play in the improvement of care for people with cancer, and in some cancers early referral may improve survival rates. In addition to its roles in prevention, support and long-term management of people with cancer, primary health care has particular responsibility for the early detection of cancer and the initiation of speedy referral to specialist services. To assist primary healthcare professionals identify people with suspected cancer as early as possible, the Department of Health issued guidelines on the topic in 2000.(2)

A recent report by the National Audit Office(6) on cancer services in England observed that patients in England tended to have more advanced cancer at the time of diagnosis than some other countries, at least for breast and bowel cancer. Older people and those from deprived areas were more likely to be diagnosed with cancer at a more advanced stage.

The national Audit Office accepted that more action was needed to reduce delay in the presentation of patients for treatment. Delay may be explained by the failure of some patients to seek help quickly, and by the difficulties general practitioners can face in identifying people with cancer. An electronic survey was circulated to the several thousand subscribers of a general practitioner information network. The survey attracted 814 responses, just under half of whom had read the Department of Health guidelines published in 2000 and found them useful. Some respondents reported that the guidelines had not added to their existing knowledge. A survey of consultants indicated that respiratory physicians reported that 80% of referrals from general practitioners were appropriate, but colorectal surgeons reported 50% that only were appropriate. The National Audit Office recommended that the updated guidelines should be widely disseminated and acted upon, and that stronger joint working relationships between general practitioners and hospitals should be encouraged through the continued development of standardised referral procedures and feedback to general practitioners on appropriateness of referrals.

1.3. Principles underlying the guideline development

The key principles behind the development of this guideline were that it should:

  • take full account of the perspective of the person with suspected cancer and their family and/or carers
  • consider all the issues that are important in the primary care assessment and referral of people with suspected cancer
  • base the recommendations on the published evidence that supports them, with explicit links to the evidence
  • be useful and usable by all health care professionals dealing with people with suspected cancer
  • indicate areas of uncertainty requiring further research.

1.4. Who should use this guideline

The guideline is intended for use by individual healthcare professionals in primary care, people with suspected cancer and their carers, the wider general public, and health care commissioning organisations and provider organisations.

Separate short form documents for people with suspected cancer and healthcare professionals are available without details of the supporting evidence. The guideline does not consider health promotion or education of the public about cancer.

1.5. Structure of guideline documentation

The guideline is divided into sections which cover in detail specific topics relating to twelve groups of cancers:

  • lung
  • upper gastrointestinal cancers
  • lower gastrointestinal cancers
  • breast cancer
  • gynaecological cancers
  • urological cancers
  • haematological cancers
  • skin cancers
  • head and neck including oral cancers
  • brain/central nervous system cancers
  • bone and sarcoma, and
  • children’s and young people’s cancers.

In each section, the symptoms, signs and risk factors relevant to initial assessment in primary health care are considered. The role of investigations in primary care is then addressed, and the sections conclude with consideration of factors related to delay and difficulties in diagnosis.

Two additional sections are included at the beginning of the guideline. The first deals with the needs of patients with suspected cancer at the time of referral. The second considers the process followed by healthcare professionals in reaching an initial diagnosis, and interventions to help healthcare professionals improve their ability to identify patients who should be suspected of having cancer.

Important general methodological issues are flagged up as appropriate. Where appropriate, full details of the papers reviewed are presented in the evidence tables (see Appendix A and B).

1.6. Guideline limitations

The guideline documentation and recommendations are limited to the detection of people who may have cancer in primary care, and do not address the assessment or investigation of patients after referral. The guideline will be relevant to professionals in general practice, walk-in centres, accident and emergency departments and other open access services that may be consulted by patients with symptoms or signs caused by undiagnosed cancers.

1.7. Scope

Guideline title

Referral guidelines for suspected cancer.

Short title

Referral guidelines for suspected cancer.

Background

The Institute’s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework is to be published. The statements in each NSF reflect the evidence that was available at the time the Framework was prepared.

The National Institute for Clinical Excellence (‘NICE’ or ‘the Institute’) has commissioned the National Collaborating Centre for Primary Care to develop referral guidelines for suspected cancer for use in the NHS in England and Wales. This follows referral of the topic by the Department of Health and Welsh Assembly Government. The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness.

The guideline will be an update of previously published guidelines,(2) following a commitment in the NHS Cancer Plan that these guidelines would be reviewed by NICE. The new guideline will take account of new research evidence and the findings of audits undertaken since the publication of the previous guideline.

Both the Department of Health and the Welsh Assembly Government have introduced policies on the urgent referral of patients with suspected cancer.

Clinical need for the guideline

Cancer was responsible for a quarter of all deaths in England and Wales in 1997, and for over half of all deaths among women between 45 and 55 years of age.(7) The incidence of new cases of cancer increased by 12% in males and 28% in females between 1960 and 1997. For some cancers, mortality rates in the UK compare unfavourably with those in other countries.

Delays of three to six months between the onset of symptoms and diagnosis are associated with worse survival rates in breast cancer.(8) However, evidence about the influence of relatively short delays in other cancers is less clear. The initial symptoms of some cancers can be difficult to distinguish from the symptoms of other more common disorders,(9) and delays can occur between the first presentation and referral for suspected cancer. In a study of the time between presentation and treatment of six common cancers in general practice, the median number of days between presentation of the first symptom or sign and initiation of referral was 0 days for breast, 28 days for large bowel, 31 days for lung, 84 days for oesophageal, 20 days for prostate and 66 days for stomach cancer.(10)

Survival rates for some cancers are lower than elsewhere in Europe, and patients in the UK may have more advanced disease at the time of diagnosis or treatment.(11;12)

The guideline

The guideline development process is described in detail in three booklets that are available from the NICE website (see ‘Further information’).

The Guideline Development Process – Information for Stakeholders describes how organisations can become involved in the development of a guideline. This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. The areas that will be addressed by the guideline are described in the following sections.

Population

Groups and categories that will be covered

Patients in all age groups suspected of having one of the cancers covered by the guideline will be included. The guideline will cover the following cancers:

  • lung
  • upper gastrointestinal cancers
  • lower gastrointestinal cancers
  • breast cancer
  • gynaecological cancers
  • urological/renal cancers
  • haematological malignancies
  • skin cancers
  • head and neck including oral cancers
  • brain/central nervous system malignancies
  • sarcomas
  • children’s and young people’s malignancies.

Groups and categories that will not be covered

The guideline will not cover:

  • the organisation or effectiveness of screening schemes for cancer
  • the tests undertaken after referral, therefore definitive diagnosis will not be covered
  • referral for suspected recurrence or metastases in previously diagnosed cancer, or referral for palliative care.

Healthcare setting

The guideline will cover the care received from primary healthcare professionals who have direct contact with, and make decisions concerning, the referral of people with suspected cancer.

The guideline will address care in primary care prior to referral for specialist assessment, but will not address care after referral in secondary and tertiary centres.

The guideline will also be relevant to healthcare professionals in secondary care who suspect a patient they are managing for another condition also has cancer, and in whom referral to another specialist would be indicated.

The guideline will also be relevant to the work, but will not cover the practice, of those working in:

  • accident and emergency departments
  • walk-in centres
  • NHS Direct
  • voluntary sector
  • occupational health
  • other health professionals who may encounter patients with symptoms of cancer, for example allied health professionals, dentists, clinicians in secondary care and pharmacists.

Clinical management

The guideline will address:

  1. the symptoms, signs and other factors that should prompt consideration of the need for referral, taking into account variation in risk by age and ethnic group
  2. the initial investigations that contribute to the assessment of patients prior to, or in association with, urgent referral for suspected cancer
  3. interventions intended to help healthcare professionals appropriately identify patients needing urgent referral for suspected cancer
  4. the need for urgent referral, and the consequences of delay in referral
  5. the information and support needs of patients who are referred for suspected cancer and their families
  6. the monitoring of patients after referral but before the first specialist assessment will be considered in the guideline

Audit support within guideline

The guideline will include review criteria and advice.