EVIDENCE TABLES Table 1: Recommendations from United Kingdom (UK) and international referral guidelines for patients with suspected lung cancer

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1 EVIDENCE TABLES Table 1: Recommendations from United Kingdom (UK) and international referral guidelines for patients with suspected lung cancer Title authors, date and country Lung cancer: the diagnosis and treatment of lung cancer - NICE clinical guideline UK Referral and indications for chest radiography: 1. Urgent referral for a chest X-ray should be offered when a patient presents with: [2005] haemoptysis, or any of the following unexplained or persistent (that is, lasting more than 3 weeks) symptoms or signs: - cough - chest/shoulder pain - dyspnoea - weight loss - chest signs - hoarseness - finger clubbing - features suggestive of metastasis from a lung cancer (for example, in brain, bone, liver or skin) - cervical/supraclavicular lymphadenopathy. Quality: 7 Recommend: Yes [2005]: means that the evidence has not been updated and reviewed since

2 authors, date and country 2. If a chest X-ray or chest computed tomography (CT) scan suggests lung cancer (including pleural effusion and slowly resolving consolidation), patients should be offered an urgent referral to a member of the lung cancer multidisciplinary team (MDT), usually a chest physician. [2005] 3. If the chest X-ray is normal but there is a high suspicion of lung cancer, patients should be offered urgent referral to a member of the lung cancer MDT, usually the chest physician. [2005] 4. Patients should be offered an urgent referral to a member of the lung cancer MDT, usually the chest physician, while awaiting the result of a chest X-ray, if any of the following are present: persistent haemoptysis in smokers/ex-smokers older than 40 years signs of superior vena cava obstruction (swelling of the face/neck with fixed elevation of jugular venous pressure) stridor. [2005] 5. Where a chest X-ray has been requested in primary or secondary care and is incidentally suggestive of lung cancer, a second copy of the radiologist s report should be sent to a designated member of the lung cancer MDT, usually the chest physician. The MDT should have a mechanism in place to follow up these reports to enable the patient s GP to have a management plan in place. [2005] 2

3 authors, date and country Suspected cancer in primary care: guidelines for investigations, referral and reducing ethnic disparities - New Zealand Guidelines Group New Zealand Urgent referral (within 2 weeks): 1. A person should be referred urgently to a specialist if they have: Grade C persistent haemoptysis and are smokers or ex-smokers aged 40 years or older a chest x-ray suggestive of lung cancer (including pleural effusion and slowly resolving consolidation) 2. A person should be referred urgently for a chest x-ray if they have: Grade C or unexplained haemoptysis any of the following unexplained, persistent (lasting more than 3 weeks or less than 3 weeks in people with known risk factors ) symptoms and signs: - chest and/or shoulder pain - shortness of breath - weight loss/loss of appetite - abnormal chest signs - hoarseness - finger clubbing - cervical and/or supraclavicular lymphadenopathy - cough - features suggestive of metastasis from a lung cancer (for example in brain, bone, liver or skin). Quality: 7 Recommend: Yes, with modifications Grades of recommendation: All grades indicate the strength of the supporting evidence, rather than the importance of the recommendations. Grade C refers to recommendations supported by international expert opinion. Good practice points are developed, where no evidence is available, based on the opinion of the Guideline Development Team, or feedback from consultation within New Zealand. Current or ex-smokers, smoking-related chronic obstructive 3

4 authors, date and country pulmonary disease, previous exposure to asbestos, history of cancer (especially head and neck cancer) 3. A person should be referred urgently to a specialist if they have a normal chest x-ray, but there is a high suspicion of lung cancer. Grade C This guideline further addressed a number of areas that were not covered in the NICE recommendations. This resulted in the development of four good practice points (based on clinical expert opinion). Good practice points :cancer: referral/investigation The smoking status of all patients should be recorded and regularly updated in the practice notes. After urgent referral for chest x-ray, the chest x-ray should be completed and reported within one week. A person with risk factors* for lung cancer who has consolidation on an initial chest x-ray should have a repeat chest x-ray within 6 weeks to confirm resolution. Sputum cytology is not recommended for the investigation of lung cancer. *Current or ex-smokers, smoking-related chronic obstructive pulmonary disease, previous exposure to asbestos, history of cancer (especially head and neck cancer) 4

5 authors, date and country Management of patients with lung cancer - SIGN clinical guideline UK Symptoms and signs: 1. Patients should be referred urgently for a chest X-ray if they have experienced unexplained or persistent haemoptysis. Grade D 2. Patients should be referred for a chest X-ray if any of the following symptoms persist for more than 3 weeks without an obvious cause: Grade D cough chest/shoulder pain dyspnoea weight loss chest signs hoarseness finger clubbing features suggestive of metastases from lung cancer (for example brain, bone, liver or skin) persistent cervical/supraclavicular lymphadenopathy. Referral to a respiratory physician: 3. Patients should be referred urgently to a chest physician if they have any of the following: Grade D persistent haemoptysis in smokers or ex-smokers over 40 years of age a chest X-ray suggestive or suspicious of lung cancer (including pleural effusion and slowly resolving or recurrent consolidation) Quality: 7 Recommend: Yes Grades of recommendation: Grades indicate the strength of the supporting evidence, rather than the clinical importance of the recommendations. Grade D refers to refers to recommendations supported by evidence from level 3 or 4; or extrapolated evidence from studies rated as 2 +. Good practice points are recommended best practice based on the clinical experience of the guideline development group. Levels of evidence: 2 + : Well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 3: Non-analytic studies, such as case reports, case series 4: Expert opinion. 5

6 authors, date and country signs of superior vena caval obstruction (swelling of the face and or neck with fixed elevation of jugular venous pressure) stridor (emergency referral). 4. Even with a normal chest X-ray, patients who have experienced unexplained, non-specific symptoms, such as fatigue potentially attributable to lung cancer, for more than 6 weeks should be referred urgently to a respiratory physician. Grade D Good practice statement Patients referred to a respiratory physician should be seen promptly, ideally within 2 weeks. 6

7 authors, date and country Referral guidelines for suspected cancer - NICE clinical guideline UK General recommendations: 1. A patient who presents with symptoms suggestive of lung cancer should be referred to a team specialising in the management of lung cancer, depending on local arrangements. Grade D Specific recommendations: 2. An urgent referral for a chest X-ray should be made when a patient presents with: Grade D haemoptysis, or any of the following unexplained persistent (that is, lasting more than 3 weeks) symptoms and signs: - chest and/or shoulder pain - dyspnoea - weight loss - chest signs - hoarseness - finger clubbing - cervical and/or supraclavicular lymphadenopathy - cough with or without any of the above - features suggestive of metastasis from a lung cancer (for example, in brain, bone, liver or skin). A report should be made back to the referring primary healthcare professional within 5 days of referral. Quality: 7 Recommend: Yes The referral timelines used in the guideline are as follows: immediate: an acute admission or referral occurring within a few hours, or even more quickly if necessary urgent: the patient is seen within the national target for urgent referrals (currently 2 weeks) non-urgent: all other referrals. Other definitions: Unexplained refers to a symptom(s) and/or sign(s) that has not led to a diagnosis being made by the primary care professional after initial assessment of the history, examination and primary care investigations (if any). Persistent refers to the continuation of specified symptoms and/or signs beyond a period that would normally be associated with self-limiting problems. The precise period will vary depending on the severity of symptoms and 7

8 authors, date and country 3. An urgent referral should be made for either of the following: Grade D persistent haemoptysis in smokers or ex-smokers who are aged 40 years and older a chest X-ray suggestive of lung cancer (including pleural effusion and slowly resolving consolidation). 4. Immediate referral should be considered for the following: Grade D signs of superior vena caval obstruction (swelling of the face and/or neck with fixed elevation of jugular venous pressure) stridor. Investigations: 5. Unexplained changes in existing symptoms in patients with underlying chronic respiratory problems should prompt an urgent referral for chest X-ray. Grade D 6. If the chest X-ray is normal, but there is a high suspicion of lung cancer, patients should be offered an urgent referral. Grade D 7. In individuals with a history of asbestos exposure and recent onset of chest pain, shortness of breath or unexplained systemic symptoms, lung cancer should be considered and a chest X-ray arranged. If this indicates a pleural effusion, pleural mass or any suspicious lung pathology, an urgent referral should be made. Grade C associated features, as assessed by the healthcare professional. In many cases, the upper limit the professional will permit symptoms and/or signs to persist before initiating referral will be 4 6 weeks. Grades of recommendation: Grade C is directly based on: category III evidence, or extrapolated recommendation from category I or II evidence Grade D is directly based on: category IV evidence, or extrapolated recommendation from category I, II, or III evidence. Levels of evidence: Ia: Evidence from systematic review or meta-analysis of randomised controlled trials Ib: Evidence from at least one randomised controlled trial IIa: Evidence from at least one welldesigned controlled study without randomisation IIb: Evidence from at least one welldesigned quasi-experimental study, 8

9 authors, date and country such as a cohort study III: Evidence from well-designed nonexperimental descriptive studies, casecontrol studies, or case series IV: Evidence from expert committee reports, opinions and/or clinical experience of respected authorities. Clinical Practice Guidelines for the Prevention, Diagnosis and Management of Lung Cancer - National Health and Medical Research Council Australia Lung cancer. Practice organization - Alberts WM, Bepler G, Hazelton T, Ruckdeschel JC, Williams JH Jr US All individuals with suspected lung cancer should be referred to a specialist with expertise in the management of lung disease for an opinion. Level IV evidence Referral pattern 1. All patients with known or suspected lung cancer should be referred to a multidisciplinary team of physicians or a physician with experience in the management of lung cancer. (Quality of evidence: poor; net benefit: substantial; strength of recommendation: C) 2. For patients in whom tissue diagnosis or staging remains incomplete, referral should be to a specialist with expertise in Quality: 7 Recommend: Yes, with modifications Levels of evidence: Level IV refers to evidence obtained from case series, either post-test or pretest and post-test. Quality: 7 Recommend: Yes, with modifications Grades of recommendation: Grade C recommendation indicates that there was consensus among the panel to recommend [the service] but that the evidence that [the service] is effective is 9

10 authors, date and country these areas. When completed, the choice of referral may vary with the interventions(s) proposed. (Quality of evidence: poor; net benefit: moderate; strength of recommendation: C) lacking, of poor quality, or conflicting, or the balance of benefits and harm cannot be reliably determined from available evidence. Definition of net benefit types: The levels of net benefit are based on clinical assessment. Estimated net benefit may be downgraded based on uncertainty in estimates of benefits and harms. Substantial benefit: Benefit greatly outweighs harm. Moderate benefit: Benefit outweighs harm. Small/weak benefit: Benefit outweighs harm to a minimally clinically important degree. None/negative benefit: Harms equal or outweigh benefit, less than clinically important. 10

11 authors, date and country Referral Guidelines for Suspected Cancer - UK Department of Health UK Guidelines for urgent referral Note: In most cases where lung cancer is suspected it is appropriate to arrange an urgent chest x-ray before urgent referral to a chest physician. 1. Urgent referral for a chest x-ray haemoptysis unexplained or persistent (more than 3 weeks) - cough - chest/shoulder pain - dyspnoea - weight loss - chest signs - hoarseness - finger clubbing - features suggestive of metastasis from a lung cancer (for example brain, bone, liver or skin) - persistent cervical/supraclavicular lymphadenopathy. 2. Urgent referral to a chest physician Any of the following: chest x-ray suggestive/suspicious of lung cancer (including pleural effusion and slowly resolving consolidation). persistent haemoptysis in smokers/ex-smokers over 40 years of age. signs of superior vena caval obstruction (swelling of face/neck Quality: 7 Recommend: Yes 11

12 authors, date and country with fixed elevation of jugular venous pressure). stridor (consider emergency referral). 12

13 Table 2: Recommendations from UK and international referral guidelines for patients with suspected breast cancer Title Healthcare guideline: diagnosis of breast disease - Institute for Clinical Systems Improvement USA Suspected cancer in primary care: guidelines for investigations, referral and reducing ethnic disparities - New Zealand Guidelines Group New Zealand Clinical highlights: 1. Patients with a bloody or clear discharge should be referred to a radiologist and/or surgeon for further evaluation. 2. A persistent mass with negative imaging does not rule out malignancy and requires a referral to a surgeon. Recommendations for urgent referral (within 2 weeks): 1. A woman with a palpable hard, fixed or tethered breast lump should be referred urgently to a specialist.* Grade C 2. A person presenting with unilateral eczematous skin or nipple change that does not respond to topical treatment, or with nipple distortion of recent onset, should be referred urgently to a specialist.* Grade C 3. A person presenting with spontaneous unilateral bloody nipple discharge should be referred urgently to a specialist.* Grade C Recommendations for referral/investigation: 1. A palpable breast lump in a woman should be investigated. Grade C 2. A woman with an abscess or mastitis which does not Quality: 6 Recommend: Yes, with modifications Annotations: The work group utilised information from current and optimal practices to develop or revise clinical patient pathways and algorithms, and to draft annotations. Quality: 7 Recommend: Yes, with modifications Grades of recommendation: Grades indicate the strength of the supporting evidence, rather than the importance of the recommendations. Grade C refers to recommendations supported by international expert opinions Good practice points are developed, where no evidence is available, based on the opinion of the Guideline Development Team, or feedback from consultation within New Zealand. *Recommendation consistent with: Referral guidelines for suspected cancer. NICE clinical guideline

14 settle after one course of antibiotics should be referred to a specialist. Grade C 3. A woman over 40 years of age with a breast abscess that has settled should be referred for mammography. Grade C 4. Persistent, unilateral, unexplained breast pain in a postmenopausal woman should be investigated. Grade C 5. For a person presenting solely with breast pain, with no palpable abnormality, referral to a specialist may be considered in the event of failure of initial treatment and/or unexplained persistent symptoms. Initial mammography is not recommended.* Grade C Good practice points for referral/investigation 1. An adult man with a unilateral, firm subareolar mass should be referred to a specialist.* 2. For a person presenting with symptoms and/or signs suggestive of breast cancer, investigation may be instigated by the practitioner, but should not delay referral to a specialist. Recommendation consistent with: Scottish Intercollegiate Guidelines Network. Management of breast cancer in women. National clinical guideline No. 84. Edinburgh: SIGN; A woman under 30 years of age presenting with generalised lumpiness in the breast tissue, where a focal area of concern, unchanged following a menstrual period, is identified, should be referred to a specialist. If a woman has a family history of premature breast cancer 14

15 Familial breast cancer: The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care - NICE clinical guideline UK an earlier referral for investigation should be considered. When a woman presents with breast symptoms or has concerns about relatives with breast cancer, a first- and second-degree family history should be taken in primary care to assess risk, because this allows appropriate classification and care. Referral from primary care: 1. Women who meet the following criteria should be offered referral to secondary care: one first-degree female relative diagnosed with breast cancer at younger than age 40 years, or one first-degree male relative diagnosed with breast cancer at any age, or one first-degree relative with bilateral breast cancer where the first primary was diagnosed at younger than age 50 years or two first-degree relatives, or one first-degree and one second-degree relative, diagnosed with breast cancer at any age, or one first-degree or second-degree relative diagnosed with breast cancer at any age and one first-degree or second-degree relative diagnosed with ovarian cancer at any age (one of these should be a first-degree relative) or three first-degree or second-degree relatives diagnosed Quality: 7 Recommend: Yes 15

16 with breast cancer at any age. Referral guidelines for suspected cancer - NICE clinical guideline UK 2. Direct referral to a specialist genetics service should take place where a high-risk predisposing gene mutation has been identified (for example, BRCA1, BRCA2 or TP53). General recommendations: 1. A patient who presents with symptoms suggestive of breast cancer should be referred to a team specialising in the management of breast cancer. Grade D 2. In most cases, the definitive diagnosis will not be known at the time of referral, and many patients who are referred will be found not to have cancer. However, primary healthcare professionals should convey optimism about the effectiveness of treatment and survival because a patient being referred with a breast lump will be naturally concerned. Grade C 3. People of all ages who suspect they have breast cancer may have particular information and support needs. The primary healthcare professional should discuss these needs with the patient and respond sensitively to them. Grade D 4. Primary healthcare professionals should encourage all patients, including women over 50 years old, to be breast aware in order to minimise delay in the presentation of symptoms. Grade D Quality: 7 Recommend: Yes Grades of recommendation: Grade C is directly based on: category III evidence, or extrapolated recommendation from category I or II evidence Delete space for consistency with others Grade D is directly based on: category IV evidence, or extrapolated recommendation from category I, II, or III evidence Delete space Grade B (DS) is directly based on category II evidence (evidence from level 2 studies, or systematic reviews of level 2 studies) DS refers to diagnostic studies. Levels of evidence: Ia: Evidence from systematic review or meta-analysis of randomised controlled 16

17 Specific recommendations: 1. A woman s first suspicion that she may have breast cancer is often when she finds a lump in her breast. The primary healthcare professional should examine the lump with the patient s consent. The features of a lump that should make the primary healthcare professional strongly suspect cancer are a discrete, hard lump with fixation, with or without skin tethering. In patients presenting in this way an urgent referral should be made, irrespective of age. Grade C 2. In a woman aged 30 years and older with a discrete lump that persists after her next period, or presents after menopause, an urgent referral should be made. Grade C 3. Breast cancer in women aged younger than 30 years is rare, but does occur. Benign lumps (for example, fibroadenoma) are common, however, and a policy of referring these women urgently would not be appropriate; instead, non-urgent referral should be considered. However, an urgent referral should be made in women aged younger than 30 years: with a lump that enlarges, Grade C or with a lump that has other features associated with cancer (fixed and hard), Grade C or in whom there are other reasons for concern such as family history. Grade D trials Ib: Evidence from at least one randomised controlled trial IIa: Evidence from at least one welldesigned controlled study without randomisation IIb: Evidence from at least one welldesigned quasi-experimental study, such as a cohort study III: Evidence from well-designed nonexperimental descriptive studies, casecontrol studies, or case series IV: Evidence from expert committee reports, opinions and/or clinical experience of respected authorities. Level-2 studies are studies that have only one of the following: narrow population (the sample does not reflect the population to whom the test would apply) use a poor reference standard (defined as that where a test is included in the reference, or where the testing affects the reference ) the comparison between the test and reference standard is not blind are case-control studies. 17

18 4. The patient s history should always be taken into account. For example, it may be appropriate, in discussion with a specialist, to agree referral within a few days in patients reporting a lump or other symptom that has been present for several months. Grade D 5. In a patient who has previously had histologically confirmed breast cancer, who presents with a further lump or suspicious symptoms, an urgent referral should be made, irrespective of age. Grade C 6. In patients presenting with unilateral eczematous skin or nipple change that does not respond to topical treatment, or with nipple distortion of recent onset, an urgent referral should be made. Grade C 7. In patients presenting with spontaneous unilateral bloody nipple discharge, an urgent referral should be made. Grade C 8. Breast cancer in men is rare and is particularly rare in men under 50 years of age. However, in a man aged 50 years and older with a unilateral, firm subareolar mass with or without nipple distortion or associated skin changes, an urgent referral should be made. Grade C Investigations: 9. In patients presenting with symptoms and/or signs suggestive of breast cancer, investigation prior to referral is not recommended. Grade D 18

19 10. In patients presenting solely with breast pain, with no palpable abnormality, there is no evidence to support the use of mammography as a discriminatory investigation for breast cancer. Therefore, its use in this group of patients is not recommended. Non-urgent referral may be considered in the event of failure of initial treatment and/or unexplained persistent symptoms. Grade B (DS) 19

20 Management of breast cancer in women - SIGN clinical guideline UK Clinical practice guidelines for the management and support of younger women with breast cancer - National Health and Medical research Council Australia Triggers for prompt referral to a breast clinic: Referral from primary to specialist care should be made in accordance with the Scottish Cancer Group referral guideline (see Appendix 1). Younger age has been associated with physician delay in referral for investigation of breast symptoms. For this reason, young women presenting with breast symptoms should be evaluated by means of the triple test approach to exclude or establish a diagnosis of cancer. Level III-2 Quality: 7 Recommend: Yes Good practice points are recommended best practice based on the clinical experience of the guideline development group. Quality: 6 Recommend: Yes, with modifications Level III-2 refers to evidence which is obtained from comparative studies with concurrent controls and allocation not randomised (cohort studies). Clinical practice guidelines for the management of early breast cancer: Second edition - National Health and Medical research Council Australia Key point (not recommendation): When organising referral for women with breast cancer, GPs should consider both the preferences of the patient and the fact that patient outcomes are better if treated by clinicians who are part of a multidisciplinary team. Quality: 7 Recommend: Yes, with modifications 20

21 Guidance on cancer service: improving outcomes in breast cancer - NICE UK Conditions that require urgent referral (within 2 weeks): 1. Patients aged 30 or over (the precise age criterion to be agreed by each network) with a discrete lump in the breast. 2. Patients with breast signs or symptoms which are highly suggestive of cancer. These include: ulceration skin nodule skin distortion nipple eczema recent nipple retraction or distortion (< 3 months) unilateral nipple discharge which stains clothes. Conditions that require referral, not necessarily urgent: 1. Breast lumps in the following patients, or of the following types: discrete lump in a younger woman (age < 30 years) asymmetrical nodularity that persists at review after menstruation abscess persistently refilling or recurrent cyst. 2. Intractable pain which does not respond to simple measures such as wearing a well-fitting bra and using over-the-counter analgesics such as paracetamol. Quality: 7 Recommend: Yes 21

22 3. Nipple discharge: bilateral discharge sufficient to stain clothes in patients aged < 50 years bloodstained discharge in patients aged < 50 years (urgent referral required if discharge is unilateral) any nipple discharge in patients over 50 years of age. 22

23 Referral guidelines for suspected cancer - UK Department of Health UK Guidelines for urgent referral: 1. Patients with a discrete lump in the appropriate age group (for example age > 30). 2. Signs which are highly suggestive of cancer such as: ulceration skin nodule skin distortion nipple eczema recent nipple retraction or distortion (< 3 months). Conditions that require referral but not necessarily urgently: 1. Lump discrete lump in a younger woman (for example age < 30 years) asymmetrical nodularity that persists at review after menstruation abscess persistently refilling or recurrent cyst. 2. Pain intractable pain not responding to reassurance, simple measures such as wearing a well supporting bra and common drugs. Quality: 7 Recommend: Yes Note: The guidelines for urgent referral of patients with suspected breast cancer in this document are based on recommendations set out in Guidelines for Referral of Patients with Breast Problems second edition 1999 prepared by Joan Austoker and Robert Mansel under the auspices of the NHS Breast Screening Programme and the Cancer Research Campaign. 23

24 3. Nipple age < 50 with bilateral discharge sufficient to stain clothes. 4. Discharge age < 50 with bloodstained discharge age > 50 with any nipple discharge. 24

25 Table 3: Recommendations from UK and international referral guidelines for patients with suspected lower gastrointestinal cancer Title Diagnosis and management of colorectal cancer - SIGN clinical guideline UK Recommendations for primary care and referral: 1. Patients over the age of 40 who present with new onset, persistent or recurrent rectal bleeding should be referred for investigation. Grade B 2. Review of the patient by a regional clinical genetics service is recommended for accurate risk assessment if family history of colorectal cancer is the principal indication for referral for investigation. Grade C 3. General practitioners should perform an abdominal and rectal examination on all patients with symptoms indicative of colorectal cancer. A positive finding should expedite referral, but a negative rectal examination should not rule out the need to refer. Grade B 4. All symptomatic patients should have a full blood count. In cases of anaemia the presence of iron deficiency should be determined. Grade B Quality: 7 Recommend: Yes Grades of recommendation: Grade B refers to a body of evidence including studies rated as 2 ++, directly applicable to the target population, and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 1 ++ or 1 +. Grade C refers to a body of evidence including studies rated as 2 +, directly applicable to the target population and demonstrating overall consistency of results; or extrapolated evidence from studies rated as Levels of evidence: 1 ++ : High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias + 1 : Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 2 ++ : High quality systematic reviews of casecontrol or cohort studies OR high quality casecontrol or cohort studies with a very low risk of confounding or bias and a high probability that 25

26 Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002) - The British Society of Gastroenterology (BSG) and the Association of Coloproctology for Great Britain and Ireland (ACPGBI) UK Guidance on large bowel surveillance for individuals with a family history indicating a moderate risk: 1. Referrals on the basis of family history are best coordinated through centres with a specialist interest, such as regional genetics services or medical/surgical gastroenterology centres. Such centralisation enables audit of family history ascertainment, assigned level of risk, collection of outcome data and research. Grade C the relationship is causal. 2 + : Well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal. Quality: 5 Recommend: Yes, with modifications The strength of each recommendation is dependent upon the category of the evidence supporting it. Grade C is based on evidence obtained from expert committee reports or opinions or clinical experiences of respected authorities. 26

27 Suspected cancer in primary care: guidelines for investigations, referral and reducing ethnic disparities - New Zealand Guidelines Group New Zealand Recommendations for urgent referral (within 2 weeks): 1. A person aged 40 years and older reporting rectal bleeding with a change of bowel habit towards looser stools and/or increased stool frequency persisting for 6 weeks or more should be referred urgently to a specialist.* Grade C 2. A person aged 60 years and older with rectal bleeding persisting for 6 weeks or more without a change in bowel habit and without anal symptoms should be referred urgently to a specialist.* Grade C 3. A person aged 60 years and older with a change in bowel habit to looser stools and/or more frequent stools persisting for 6 weeks or more without rectal bleeding should be referred urgently to a specialist.* Grade C 4. A person presenting with a palpable rectal mass (intraluminal and not pelvic), should be referred urgently to a specialist, irrespective of age. Note that a pelvic mass outside the bowel should be referred urgently to a urologist or gynaecologist.* Grade C 5. A man of any age with unexplained iron deficiency anaemia and a haemoglobin of 110 g/l or below, should be referred urgently to a specialist.* Grade C 6. A non-menstruating woman with unexplained iron Quality: 7 Recommend: Yes, with modifications Grades of recommendation: Grades indicate the strength of the supporting evidence, rather than the importance of the recommendations. Grade C refers to recommendations supported by international expert opinions. Good practice points are developed, where no evidence is available, based on the opinion of the Guideline Development Team, or feedback from consultation within New Zealand. *Recommendation consistent with: Referral guidelines for suspected cancer. NICE clinical guideline **Unexplained iron deficiency anaemia means unrelated to other sources of blood loss, for example, non-steroidal anti-inflammatory drug treatment or blood dyscrasia. 27

28 deficiency anaemia and a haemoglobin of 100 g/l or below, should be referred urgently to a specialist.* Grade C Good practice points for urgent referral (within 2 weeks): 1. A person presenting with a right-sided abdominal mass, should be referred urgently for a surgical opinion. 2. A menstruating woman with unexplained iron deficiency anaemia** and a haemoglobin of 100 g/l or below, should be referred urgently to a specialist. Recommendations for referral/investigation: 1. For a person with equivocal symptoms, a complete blood count may help in identifying the possibility of colorectal cancer by demonstrating iron deficiency anaemia. This should determine if a referral is needed and whether the person should be urgently referred to a specialist.* Grade C 2. For a person where the decision to refer to a specialist has been made, a complete blood count may be considered to assist specialist assessment in the outpatient clinic.* Grade C 3. For a person where the decision to refer to a specialist has been made, no examinations or investigations other than an abdominal and rectal 28

29 examination, and a complete blood count should be undertaken as this may delay referral.* Grade C Good practice points for referral/investigation: 1. A person at low risk of colorectal cancer with a significant symptom (rectal bleeding or a change in bowel habit) and a normal rectal examination, no anaemia and no abdominal mass, should be managed by a strategy of treat, watch and review in 3 months. 2. In a person presenting with a left-sided abdominal mass, faecal loading should first be excluded as the cause. A referral should then be made for a surgical opinion. 3. Faecal occult blood and carcinogenic embryonic antigen testing are of little value in a person with symptoms suggestive of colorectal cancer and should not be used. 4. A person with any unexplained gastrointestinal symptoms and known high-risk factors, for example, familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, other familial colorectal syndromes or a past history of lower gastrointestinal cancer should be referred to a specialist. 29

30 Referral guidelines for suspected cancer - NICE clinical guideline UK General recommendations: 1. A patient who presents with symptoms suggestive of colorectal or anal cancer should be referred to a team specialising in the management of lower gastrointestinal cancer, depending on local arrangements. Grade D Specific recommendations: 1. In patients aged 40 years and older, reporting rectal bleeding with a change of bowel habit towards looser stools and/or increased stool frequency persisting for 6 weeks or more, an urgent referral should be made. Grade C 2. In patients aged 60 years and older, with rectal bleeding persisting for 6 weeks or more without a change in bowel habit and without anal symptoms, an urgent referral should be made. Grade C 3. In patients aged 60 years and older, with a change in bowel habit to looser stools and/or more frequent stools persisting for 6 weeks or more without rectal bleeding, an urgent referral should be made. Grade C 4. In patients presenting with a right lower abdominal mass consistent with involvement of the large bowel, an urgent referral should be made, irrespective of age. Grade C Quality: 7 Recommend: Yes Grades of recommendation: Grade C is directly based on: category III evidence, or extrapolated recommendation from category I or II evidence. Grade D is directly based on: category IV evidence, or extrapolated recommendation from category I, II, or III evidence. Levels of evidence: Ia: Evidence from systematic review or metaanalysis of randomised controlled trials Ib: Evidence from at least one randomised controlled trial IIa: Evidence from at least one well-designed controlled study without randomisation IIb: Evidence from at least one well-designed quasi-experimental study, such as a cohort study III: Evidence from well-designed nonexperimental descriptive studies, case-control studies, or case series IV: Evidence from expert committee reports, opinions and/or clinical experience of 30

31 5. In patients presenting with a palpable rectal mass (intraluminal and not pelvic), an urgent referral should be made, irrespective of age. (A pelvic mass outside the bowel would warrant an urgent referral to a urologist or gynaecologist.) Grade C 6. In men of any age with unexplained iron deficiency anaemia and a haemoglobin of 11 g/100 ml or below, an urgent referral should be made. Grade C 7. In non-menstruating women with unexplained iron deficiency anaemia and a haemoglobin of 10 g/100 ml or below, an urgent referral should be made. Grade C Recommendations for patients with risk factors: 1. In patients with ulcerative colitis or a history of ulcerative colitis, a plan for follow up should be agreed with a specialist and offered to the patient as a normal procedure in an effort to detect colorectal cancer in this high-risk group. Grade C 2. There is insufficient evidence to suggest that a positive family history of colorectal cancer can be used as a criterion to assist in the decision about referral of a symptomatic patient. Grade C respected authorities. 31

32 Clinical Practice Guidelines for the prevention, early detection and management of colorectal cancer - National Health and Medical Research Council Australia Investigation: 1. In symptomatic patients aged over 40 years, referral to a specialist should be considered and consideration of full examination of the colon with colonoscopy is recommended. Level III-3; Equivocal Quality: 7 Recommend: Yes, with modifications Levels of evidence: Level III-3 refers to evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group. Grades of recommendation: Strength of evidence was determined by the expert advisory panel. Equivocal refers to situations where there is lack of higher levels of evidence (such as III-3 or IV) OR equivocal level I or II evidence for and against clinical question no recommendation for or against, as evidence is inconclusive recommend further research. 32

33 Guidance on cancer services: improving outcomes in colorectal cancers - NICE UK Action should be taken to improve recognition of potential symptoms of colorectal cancer in primary care and in the community. Efficient systems should be set up to ensure that patients who may have colorectal cancer are rapidly referred for endoscopy. Criteria for urgent referral: Age threshold Quality: 7 Recommend: Yes rectal bleeding WITH a change in bowel habit to looser stools and/or increased frequency of defecation persistent for 6 weeks a definite palpable right-sided abdominal mass a definite palpable rectal (not pelvic) mass rectal bleeding persistently WITHOUT anal symptoms* change of bowel habit to looser stools and/or increased frequency of defecation, WITHOUT rectal bleeding and persistent for 6 weeks iron deficiency anaemia All ages All ages All ages Over 60 years Over 60 years No age 33

34 WITHOUT an obvious cause (Hb < 11 g/dl in men or < 10 g/dl in postmenopausal women). criterion * Anal symptoms include soreness, discomfort, itching, lumps and prolapse as well as pain. Age 60 years is considered to be the maximum age threshold. Local Cancer Networks may elect to set a lower age threshold (such as 55 years or 50 years). Additional notes 1. Symptoms other than those in the list above, which should also prompt referral for endoscopy, include faecal incontinence and passing mucus via the rectum. 2. Patients with iron-deficiency anaemia (apart from menstruating women) should be referred for colonoscopy 3. The threshold for referral for investigation should be reduced if other members of the patient s family have had a diagnosis of colorectal cancer. 4. GPs should not refer patients with suspected colorectal cancer to a specific clinician (as opposed to a diagnostic clinic) who is not a core member of a colorectal cancer multidisciplinary team 34

35 Referral Guidelines for Suspected Cancer - UK Department of Health Patients with non-specific symptoms: 1. The most common non-specific symptoms of colorectal cancer for example, tiredness are due to iron-deficiency anaemia caused by undetected blood loss, particularly in older men or postmenopausal women; patients with bowel polyps or cancer may have no other symptoms. Trusts should agree specific local guidelines which ensure that such patients are referred promptly to the endoscopy service. 2. People with two first-degree relatives with colorectal cancer, or one first-degree relative whose colorectal cancer is diagnosed before the age of 45, have a lifetime risk of death from colorectal cancer of 1 in 6, or 1 in 10, respectively. The British Society of Gastroenterology (BSG) and the Association of Coloproctology for Great Britain and Ireland (ACPGBI) guidelines suggest that people who meet these criteria should be referred for colonoscopy at years of age, or as soon thereafter as the risk is recognised. Guidelines for urgent referral: It is recommended that the following symptom and sign combinations when occurring for the first time should be used to identify patients for urgent referral under the 2 week standard: Quality: 6 Recommend: Yes 35

36 - UK Age threshold rectal bleeding WITH a change in bowel habit to looser stools and/or increased frequency of defecation persistent for 6 weeks a definite palpable right-sided abdominal mass a definite palpable rectal (not pelvic) mass rectal bleeding persistently WITHOUT anal symptoms* change of bowel habit to looser stools and/or increased frequency of defecation, WITHOUT rectal bleeding and persistent for 6 weeks. All ages All ages All ages Over 60 years Over 60 years Iron deficiency anaemia WITHOUT an obvious cause (Hb < 11 g/dl in men or < 10 g/dl in postmenopausal women). Note: Patients with the following symptoms and no 36

37 abdominal or rectal mass, are at very low risk of cancer: rectal bleeding with anal symptoms* change in bowel habit to decreased frequency of defecation and harder stools abdominal pain without clear evidence of intestinal obstruction. * Anal symptoms include soreness, discomfort, itching, lumps and prolapse as well as pain. Age 60 years is considered to be the maximum age threshold. Local Cancer Networks may elect to set a lower age threshold (such as 55 years or 50 years). 37

38 Appendix 1: Scottish Cancer Group Referral Guideline Source of problem Who to refer Who to manage in primary care Lump 1. women with any new discrete lump 2. women with any new lump in pre-existing nodularity 3. women with any new asymmetrical nodularity that persists at review after menstruation 4. women with a non lactational abscess or mastitis which does not settle after one course of antibiotics 5. abscess in patient > 40 years even after settled (for mammogram) 6. women with any cyst persistently refilling or recurrent cyst 7. women with unilateral axillary lymph node lump 1. young women < 35 years with longstanding tender, lumpy breasts 2. older women with symmetrical nodularity if no localised abnormality 3. young girls with tender developing breasts 4. women with bilateral fatty gynaecomastia without focal abnormality Pain 1. post-menopausal women with unilateral persistent pain 2. women with pain associated with a lump 3. women with intractable pain that interferes with a patient s lifestyle or sleep and which has failed to respond to reassurance or simple measures such as wearing a well-supporting bra and common drugs 1. women with moderate degrees of breast pain no discrete palpable 38

39 Source of problem Who to refer Who to manage in primary care 1. women < 50 years with nipple discharge from > 1 Nipple symptom 1. women < 50 years with persistent discharge, which is: bloodstained; (dipstick for blood) or single duct duct, intermittent - not bloodstained (urine dipstick for blood) 2. women with bilateral troublesome discharge sufficient to stain outer clothes (would consider surgery) 2. women with longstanding nipple retraction 3. all women > 50 years with discharge 4. women with new nipple retraction 5. women with nipple eczema if not elsewhere or unresponsive to topical steroids Skin changes 1. women with skin tethering 2. fixation 3. women with ulceration 4. women with abscess or breast inflammation if not settled after one course of antibiotics 5. women > 40 with abscess or inflammation even after settled to exclude underlying cause (mammogram) 1. women with obvious simple skin lesions, such as sebaceous cysts should be managed as when present elsewhere and not referred to a breast clinic 39