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

Transcription

1 EVIDENCE TABLES Table 1: Recmmendatins frm United Kingdm (UK) and internatinal referral guidelines fr patients with suspected lung cancer Title, authrs, date and cuntry Lung cancer: the diagnsis and treatment f lung cancer - NICE clinical guideline UK Recmmendatins and gd practice pints Referral and indicatins fr chest radigraphy: 1. Urgent referral fr a chest X-ray shuld be ffered when a patient presents with: [2005] haemptysis, r any f the fllwing unexplained r persistent (that is, lasting mre than 3 weeks) symptms r signs: - cugh - chest/shulder pain - dyspnea - weight lss - chest signs - harseness - finger clubbing - features suggestive f metastasis frm a lung cancer (fr example, in brain, bne, liver r skin) - cervical/supraclavicular lymphadenpathy. 2. If a chest X-ray r chest cmputed tmgraphy (CT) scan suggests lung cancer (including pleural effusin and slwly reslving cnslidatin), patients shuld be ffered an urgent referral t a member f the lung cancer multidisciplinary team (MDT), usually a chest physician. [2005] Cmments Quality: 7 Recmmend: Yes [2005]: means that the evidence has nt been updated and reviewed since Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 1

2 authrs, date and cuntry Recmmendatins and gd practice pints 3. If the chest X-ray is nrmal but there is a high suspicin f lung cancer, patients shuld be ffered urgent referral t a member f the lung cancer MDT, usually the chest physician. [2005] 4. Patients shuld be ffered an urgent referral t a member f the lung cancer MDT, usually the chest physician, while awaiting the result f a chest X-ray, if any f the fllwing are present: persistent haemptysis in smkers/ex-smkers lder than 40 years signs f superir vena cava bstructin (swelling f the face/neck with fixed elevatin f jugular venus pressure) stridr. [2005] 5. Where a chest X-ray has been requested in primary r secndary care and is incidentally suggestive f lung cancer, a secnd cpy f the radilgist s reprt shuld be sent t a designated member f the lung cancer MDT, usually the chest physician. The MDT shuld have a mechanism in place t fllw up these reprts t enable the patient s GP t have a management plan in place. [2005] Cmments Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 2

3 authrs, date and cuntry Suspected cancer in primary care: guidelines fr investigatins, referral and reducing ethnic disparities - New Zealand Guidelines Grup New Zealand Recmmendatins and gd practice pints Urgent referral (within 2 weeks): 1. A persn shuld be referred urgently t a specialist if they have: Grade C persistent haemptysis and are smkers r ex-smkers aged 40 years r lder a chest x-ray suggestive f lung cancer (including pleural effusin and slwly reslving cnslidatin) 2. A persn shuld be referred urgently fr a chest x-ray if they have: Grade C r unexplained haemptysis any f the fllwing unexplained, persistent (lasting mre than 3 weeks r less than 3 weeks in peple with knwn risk factrs ) symptms and signs: - chest and/r shulder pain - shrtness f breath - weight lss/lss f appetite - abnrmal chest signs - harseness - finger clubbing - cervical and/r supraclavicular lymphadenpathy - cugh - features suggestive f metastasis frm a lung cancer (fr example in brain, bne, liver r skin). Current r ex-smkers, smking-related chrnic bstructive pulmnary disease, previus expsure t asbests, histry f cancer (especially head and neck cancer) Cmments Quality: 7 Recmmend: Yes, with mdificatins Grades f recmmendatin: All grades indicate the strength f the supprting evidence, rather than the imprtance f the recmmendatins. Grade C refers t recmmendatins supprted by internatinal expert pinin. Gd practice pints are develped, where n evidence is available, based n the pinin f the Guideline Develpment Team, r feedback frm cnsultatin within New Zealand. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 3

4 authrs, date and cuntry Recmmendatins and gd practice pints 3. A persn shuld be referred urgently t a specialist if they have a nrmal chest x-ray, but there is a high suspicin f lung cancer. Grade C This guideline further addressed a number f areas that were nt cvered in the NICE recmmendatins. This resulted in the develpment f fur gd practice pints (based n clinical expert pinin). Gd practice pints :cancer: referral/investigatin The smking status f all patients shuld be recrded and regularly updated in the practice ntes. After urgent referral fr chest x-ray, the chest x-ray shuld be cmpleted and reprted within ne week. A persn with risk factrs* fr lung cancer wh has cnslidatin n an initial chest x-ray shuld have a repeat chest x-ray within 6 weeks t cnfirm reslutin. Sputum cytlgy is nt recmmended fr the investigatin f lung cancer. *Current r ex-smkers, smking-related chrnic bstructive pulmnary disease, previus expsure t asbests, histry f cancer (especially head and neck cancer) Cmments Management f patients with lung cancer - SIGN clinical guideline Symptms and signs: 1. Patients shuld be referred urgently fr a chest X-ray if they have experienced unexplained r persistent haemptysis. Grade D Quality: 7 Recmmend: Yes Grades f recmmendatin: Grades indicate the strength f the Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 4

5 authrs, date and cuntry - UK Recmmendatins and gd practice pints 2. Patients shuld be referred fr a chest X-ray if any f the fllwing symptms persist fr mre than 3 weeks withut an bvius cause: Grade D cugh chest/shulder pain dyspnea weight lss chest signs harseness finger clubbing features suggestive f metastases frm lung cancer (fr example brain, bne, liver r skin) persistent cervical/supraclavicular lymphadenpathy. Referral t a respiratry physician: 3. Patients shuld be referred urgently t a chest physician if they have any f the fllwing: Grade D persistent haemptysis in smkers r ex-smkers ver 40 years f age a chest X-ray suggestive r suspicius f lung cancer (including pleural effusin and slwly reslving r recurrent cnslidatin) signs f superir vena caval bstructin (swelling f the face and r neck with fixed elevatin f jugular venus pressure) stridr (emergency referral). 4. Even with a nrmal chest X-ray, patients wh have experienced unexplained, nn-specific symptms, such as fatigue ptentially attributable t lung cancer, fr mre than 6 weeks shuld be Cmments supprting evidence, rather than the clinical imprtance f the recmmendatins. Grade D refers t refers t recmmendatins supprted by evidence frm level 3 r 4; r extraplated evidence frm studies rated as 2 +. Gd practice pints are recmmended best practice based n the clinical experience f the guideline develpment grup. Levels f evidence: 2 + : Well-cnducted case-cntrl r chrt studies with a lw risk f cnfunding r bias and a mderate prbability that the relatinship is causal 3: Nn-analytic studies, such as case reprts, case series 4: Expert pinin. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 5

6 authrs, date and cuntry Recmmendatins and gd practice pints referred urgently t a respiratry physician. Grade D Gd practice statement Patients referred t a respiratry physician shuld be seen prmptly, ideally within 2 weeks. Cmments Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 6

7 authrs, date and cuntry Referral guidelines fr suspected cancer - NICE clinical guideline UK Recmmendatins and gd practice pints General recmmendatins: 1. A patient wh presents with symptms suggestive f lung cancer shuld be referred t a team specialising in the management f lung cancer, depending n lcal arrangements. Grade D Specific recmmendatins: 2. An urgent referral fr a chest X-ray shuld be made when a patient presents with: Grade D haemptysis, r any f the fllwing unexplained persistent (that is, lasting mre than 3 weeks) symptms and signs: - chest and/r shulder pain - dyspnea - weight lss - chest signs - harseness - finger clubbing - cervical and/r supraclavicular lymphadenpathy - cugh with r withut any f the abve - features suggestive f metastasis frm a lung cancer (fr example, in brain, bne, liver r skin). A reprt shuld be made back t the referring primary healthcare prfessinal within 5 days f referral. 3. An urgent referral shuld be made fr either f the fllwing: Grade D persistent haemptysis in smkers r ex-smkers wh are aged 40 years and lder a chest X-ray suggestive f lung cancer (including pleural Cmments Quality: 7 Recmmend: Yes The referral timelines used in the guideline are as fllws: immediate: an acute admissin r referral ccurring within a few hurs, r even mre quickly if necessary urgent: the patient is seen within the natinal target fr urgent referrals (currently 2 weeks) nn-urgent: all ther referrals. Other definitins: Unexplained refers t a symptm(s) and/r sign(s) that has nt led t a diagnsis being made by the primary care prfessinal after initial assessment f the histry, examinatin and primary care investigatins (if any). Persistent refers t the cntinuatin f specified symptms and/r signs beynd a perid that wuld nrmally be assciated with self-limiting prblems. The precise perid will vary depending n the severity f symptms and assciated features, as assessed by the healthcare prfessinal. In many cases, the upper limit the prfessinal will permit symptms and/r signs t persist Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 7

8 authrs, date and cuntry Recmmendatins and gd practice pints effusin and slwly reslving cnslidatin). 4. Immediate referral shuld be cnsidered fr the fllwing: Grade D signs f superir vena caval bstructin (swelling f the face and/r neck with fixed elevatin f jugular venus pressure) stridr. Investigatins: 5. Unexplained changes in existing symptms in patients with underlying chrnic respiratry prblems shuld prmpt an urgent referral fr chest X-ray. Grade D 6. If the chest X-ray is nrmal, but there is a high suspicin f lung cancer, patients shuld be ffered an urgent referral. Grade D 7. In individuals with a histry f asbests expsure and recent nset f chest pain, shrtness f breath r unexplained systemic symptms, lung cancer shuld be cnsidered and a chest X-ray arranged. If this indicates a pleural effusin, pleural mass r any suspicius lung pathlgy, an urgent referral shuld be made. Grade C Cmments befre initiating referral will be 4 6 weeks. Grades f recmmendatin: Grade C is directly based n: categry III evidence, r extraplated recmmendatin frm categry I r II evidence Grade D is directly based n: categry IV evidence, r extraplated recmmendatin frm categry I, II, r III evidence. Levels f evidence: Ia: Evidence frm systematic review r meta-analysis f randmised cntrlled trials Ib: Evidence frm at least ne randmised cntrlled trial IIa: Evidence frm at least ne welldesigned cntrlled study withut randmisatin IIb: Evidence frm at least ne welldesigned quasi-experimental study, such as a chrt study III: Evidence frm well-designed nnexperimental descriptive studies, casecntrl studies, r case series IV: Evidence frm expert cmmittee reprts, pinins and/r clinical experience f respected authrities. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 8

9 authrs, date and cuntry Clinical Practice Guidelines fr the Preventin, Diagnsis and Management f Lung Cancer - Natinal Health and Medical Research Cuncil Australia Lung cancer. Practice rganizatin - Alberts WM, Bepler G, Hazeltn T, Ruckdeschel JC, Williams JH Jr US Recmmendatins and gd practice pints All individuals with suspected lung cancer shuld be referred t a specialist with expertise in the management f lung disease fr an pinin. Level IV evidence Referral pattern 1. All patients with knwn r suspected lung cancer shuld be referred t a multidisciplinary team f physicians r a physician with experience in the management f lung cancer. (Quality f evidence: pr; net benefit: substantial; strength f recmmendatin: C) 2. Fr patients in whm tissue diagnsis r staging remains incmplete, referral shuld be t a specialist with expertise in these areas. When cmpleted, the chice f referral may vary with the interventins(s) prpsed. (Quality f evidence: pr; net benefit: mderate; strength f recmmendatin: C) Cmments Quality: 7 Recmmend: Yes, with mdificatins Levels f evidence: Level IV refers t evidence btained frm case series, either pst-test r pre-test and pst-test. Quality: 7 Recmmend: Yes, with mdificatins Grades f recmmendatin: Grade C recmmendatin indicates that there was cnsensus amng the panel t recmmend [the service] but that the evidence that [the service] is effective is lacking, f pr quality, r cnflicting, r the balance f benefits and harm cannt be reliably determined frm available evidence. Definitin f net benefit types: The levels f net benefit are based n clinical assessment. Estimated net benefit may be dwngraded based n uncertainty in estimates f benefits and harms. Substantial benefit: Benefit greatly utweighs harm. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 9

10 authrs, date and cuntry Recmmendatins and gd practice pints Cmments Mderate benefit: Benefit utweighs harm. Small/weak benefit: Benefit utweighs harm t a minimally clinically imprtant degree. Nne/negative benefit: Harms equal r utweigh benefit, less than clinically imprtant. Referral Guidelines fr Suspected Cancer - UK Department f Health UK Guidelines fr urgent referral Nte: In mst cases where lung cancer is suspected it is apprpriate t arrange an urgent chest x-ray befre urgent referral t a chest physician. 1. Urgent referral fr a chest x-ray haemptysis unexplained r persistent (mre than 3 weeks) - cugh - chest/shulder pain - dyspnea - weight lss - chest signs - harseness - finger clubbing - features suggestive f metastasis frm a lung cancer (fr example brain, bne, liver r skin) - persistent cervical/supraclavicular lymphadenpathy. Quality: 7 Recmmend: Yes Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 10

11 authrs, date and cuntry Recmmendatins and gd practice pints 2. Urgent referral t a chest physician Any f the fllwing: chest x-ray suggestive/suspicius f lung cancer (including pleural effusin and slwly reslving cnslidatin). persistent haemptysis in smkers/ex-smkers ver 40 years f age. signs f superir vena caval bstructin (swelling f face/neck with fixed elevatin f jugular venus pressure). stridr (cnsider emergency referral). Cmments Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 11

12 Table 2: Recmmendatins frm UK and internatinal referral guidelines fr patients with suspected breast cancer Title, authrs, date and cuntry Healthcare guideline: diagnsis f breast disease - Institute fr Clinical Systems Imprvement USA Recmmendatins and gd practice pints Clinical highlights: 1. Patients with a bldy r clear discharge shuld be referred t a radilgist and/r surgen fr further evaluatin. 2. A persistent mass with negative imaging des nt rule ut malignancy and requires a referral t a surgen. Cmments Quality: 6 Recmmend: Yes, with mdificatins Anntatins: The wrk grup utilised infrmatin frm current and ptimal practices t develp r revise clinical patient pathways and algrithms, and t draft anntatins. Suspected cancer in primary care: guidelines fr investigatins, referral and reducing ethnic disparities - New Zealand Guidelines Grup New Zealand Recmmendatins fr urgent referral (within 2 weeks): 1. A wman with a palpable hard, fixed r tethered breast lump shuld be referred urgently t a specialist.* Grade C 2. A persn presenting with unilateral eczematus skin r nipple change that des nt respnd t tpical treatment, r with nipple distrtin f recent nset, shuld be referred urgently t a specialist.* Grade C 3. A persn presenting with spntaneus unilateral bldy nipple discharge shuld be referred urgently t a specialist.* Grade C Recmmendatins fr referral/investigatin: 1. A palpable breast lump in a wman shuld be investigated. Grade C 2. A wman with an abscess r mastitis which des nt settle after ne curse f antibitics shuld be referred t a specialist. Grade C Quality: 7 Recmmend: Yes, with mdificatins Grades f recmmendatin: Grades indicate the strength f the supprting evidence, rather than the imprtance f the recmmendatins. Grade C refers t recmmendatins supprted by internatinal expert pinins Gd practice pints are develped, where n evidence is available, based n the pinin f the Guideline Develpment Team, r feedback frm cnsultatin within New Zealand. *Recmmendatin cnsistent with: Referral guidelines fr suspected cancer. NICE clinical guideline Recmmendatin cnsistent with: Scttish Intercllegiate Guidelines Netwrk. Management f breast cancer in wmen. Natinal clinical guideline N. 84. Edinburgh: SIGN; Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 12

13 authrs, date and cuntry Familial breast cancer: The classificatin and care f wmen at risk f familial breast cancer in primary, secndary and tertiary care Recmmendatins and gd practice pints 3. A wman ver 40 years f age with a breast abscess that has settled shuld be referred fr mammgraphy. Grade C 4. Persistent, unilateral, unexplained breast pain in a pstmenpausal wman shuld be investigated. Grade C 5. Fr a persn presenting slely with breast pain, with n palpable abnrmality, referral t a specialist may be cnsidered in the event f failure f initial treatment and/r unexplained persistent symptms. Initial mammgraphy is nt recmmended.* Grade C Gd practice pints fr referral/investigatin 1. An adult man with a unilateral, firm subarelar mass shuld be referred t a specialist.* 2. Fr a persn presenting with symptms and/r signs suggestive f breast cancer, investigatin may be instigated by the practitiner, but shuld nt delay referral t a specialist. 3. A wman under 30 years f age presenting with generalised lumpiness in the breast tissue, where a fcal area f cncern, unchanged fllwing a menstrual perid, is identified, shuld be referred t a specialist. If a wman has a family histry f premature breast cancer an earlier referral fr investigatin shuld be cnsidered. When a wman presents with breast symptms r has cncerns abut relatives with breast cancer, a first- and secnd-degree family histry shuld be taken in primary care t assess risk, because this allws apprpriate classificatin and care. Cmments Quality: 7 Recmmend: Yes Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 13

14 authrs, date and cuntry - NICE clinical guideline UK Recmmendatins and gd practice pints Referral frm primary care: 1. Wmen wh meet the fllwing criteria shuld be ffered referral t secndary care: r r ne first-degree female relative diagnsed with breast cancer at yunger than age 40 years, r ne first-degree male relative diagnsed with breast cancer at any age, r ne first-degree relative with bilateral breast cancer where the first primary was diagnsed at yunger than age 50 years tw first-degree relatives, r ne first-degree and ne secnddegree relative, diagnsed with breast cancer at any age, r ne first-degree r secnd-degree relative diagnsed with breast cancer at any age and ne first-degree r secnddegree relative diagnsed with varian cancer at any age (ne f these shuld be a first-degree relative) three first-degree r secnd-degree relatives diagnsed with breast cancer at any age. Cmments Referral guidelines fr suspected cancer - NICE clinical guideline UK 2. Direct referral t a specialist genetics service shuld take place where a high-risk predispsing gene mutatin has been identified (fr example, BRCA1, BRCA2 r TP53). General recmmendatins: 1. A patient wh presents with symptms suggestive f breast cancer shuld be referred t a team specialising in the management f breast cancer. Grade D 2. In mst cases, the definitive diagnsis will nt be knwn at the time f referral, and many patients wh are referred will be fund nt t have cancer. Hwever, primary healthcare Quality: 7 Recmmend: Yes Grades f recmmendatin: Grade C is directly based n: categry III evidence, r extraplated recmmendatin frm categry I Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 14

15 authrs, date and cuntry Recmmendatins and gd practice pints prfessinals shuld cnvey ptimism abut the effectiveness f treatment and survival because a patient being referred with a breast lump will be naturally cncerned. Grade C 3. Peple f all ages wh suspect they have breast cancer may have particular infrmatin and supprt needs. The primary healthcare prfessinal shuld discuss these needs with the patient and respnd sensitively t them. Grade D 4. Primary healthcare prfessinals shuld encurage all patients, including wmen ver 50 years ld, t be breast aware in rder t minimise delay in the presentatin f symptms. Grade D Specific recmmendatins: 1. A wman s first suspicin that she may have breast cancer is ften when she finds a lump in her breast. The primary healthcare prfessinal shuld examine the lump with the patient s cnsent. The features f a lump that shuld make the primary healthcare prfessinal strngly suspect cancer are a discrete, hard lump with fixatin, with r withut skin tethering. In patients presenting in this way an urgent referral shuld be made, irrespective f age. Grade C 2. In a wman aged 30 years and lder with a discrete lump that persists after her next perid, r presents after menpause, an urgent referral shuld be made. Grade C 3. Breast cancer in wmen aged yunger than 30 years is rare, but des ccur. Benign lumps (fr example, fibradenma) are cmmn, hwever, and a plicy f referring these wmen urgently wuld nt be apprpriate; instead, nn-urgent referral shuld be cnsidered. Hwever, an urgent referral shuld be Cmments r II evidence Delete space fr cnsistency with thers Grade D is directly based n: categry IV evidence, r extraplated recmmendatin frm categry I, II, r III evidence Delete space Grade B (DS) is directly based n categry II evidence (evidence frm level 2 studies, r systematic reviews f level 2 studies) DS refers t diagnstic studies. Levels f evidence: Ia: Evidence frm systematic review r metaanalysis f randmised cntrlled trials Ib: Evidence frm at least ne randmised cntrlled trial IIa: Evidence frm at least ne well-designed cntrlled study withut randmisatin IIb: Evidence frm at least ne well-designed quasi-experimental study, such as a chrt study III: Evidence frm well-designed nnexperimental descriptive studies, case-cntrl studies, r case series IV: Evidence frm expert cmmittee reprts, pinins and/r clinical experience f respected authrities. Level-2 studies are studies that have nly ne f the fllwing: narrw ppulatin (the sample des nt Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 15

16 authrs, date and cuntry Recmmendatins and gd practice pints made in wmen aged yunger than 30 years: with a lump that enlarges, Grade C r with a lump that has ther features assciated with cancer (fixed and hard), Grade C r in whm there are ther reasns fr cncern such as family histry. Grade D 4. The patient s histry shuld always be taken int accunt. Fr example, it may be apprpriate, in discussin with a specialist, t agree referral within a few days in patients reprting a lump r ther symptm that has been present fr several mnths. Grade D 5. In a patient wh has previusly had histlgically cnfirmed breast cancer, wh presents with a further lump r suspicius symptms, an urgent referral shuld be made, irrespective f age. Grade C 6. In patients presenting with unilateral eczematus skin r nipple change that des nt respnd t tpical treatment, r with nipple distrtin f recent nset, an urgent referral shuld be made. Grade C 7. In patients presenting with spntaneus unilateral bldy nipple discharge, an urgent referral shuld be made. Grade C 8. Breast cancer in men is rare and is particularly rare in men under 50 years f age. Hwever, in a man aged 50 years and lder with a unilateral, firm subarelar mass with r withut nipple distrtin r assciated skin changes, an urgent referral shuld be made. Grade C Cmments reflect the ppulatin t whm the test wuld apply) use a pr reference standard (defined as that where a test is included in the reference, r where the testing affects the reference ) the cmparisn between the test and reference standard is nt blind are case-cntrl studies. Investigatins: Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 16

17 authrs, date and cuntry Recmmendatins and gd practice pints 9. In patients presenting with symptms and/r signs suggestive f breast cancer, investigatin prir t referral is nt recmmended. Grade D 10. In patients presenting slely with breast pain, with n palpable abnrmality, there is n evidence t supprt the use f mammgraphy as a discriminatry investigatin fr breast cancer. Therefre, its use in this grup f patients is nt recmmended. Nn-urgent referral may be cnsidered in the event f failure f initial treatment and/r unexplained persistent symptms. Grade B (DS) Cmments Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 17

18 authrs, date and cuntry Management f breast cancer in wmen - SIGN clinical guideline UK Clinical practice guidelines fr the management and supprt f yunger wmen with breast cancer - Natinal Health and Medical research Cuncil Australia Recmmendatins and gd practice pints Triggers fr prmpt referral t a breast clinic: Referral frm primary t specialist care shuld be made in accrdance with the Scttish Cancer Grup referral guideline (see Appendix 1). Yunger age has been assciated with physician delay in referral fr investigatin f breast symptms. Fr this reasn, yung wmen presenting with breast symptms shuld be evaluated by means f the triple test apprach t exclude r establish a diagnsis f cancer. Level III-2 Cmments Quality: 7 Recmmend: Yes Gd practice pints are recmmended best practice based n the clinical experience f the guideline develpment grup. Quality: 6 Recmmend: Yes, with mdificatins Level III-2 refers t evidence which is btained frm cmparative studies with cncurrent cntrls and allcatin nt randmised (chrt studies). Clinical practice guidelines fr the management f early breast cancer: Secnd editin - Natinal Health and Medical research Cuncil Australia Key pint (nt recmmendatin): When rganising referral fr wmen with breast cancer, GPs shuld cnsider bth the preferences f the patient and the fact that patient utcmes are better if treated by clinicians wh are part f a multidisciplinary team. Quality: 7 Recmmend: Yes, with mdificatins Guidance n cancer service: imprving utcmes in breast cancer Cnditins that require urgent referral (within 2 weeks): 1. Patients aged 30 r ver (the precise age criterin t be agreed by each netwrk) with a discrete lump in the breast. Quality: 7 Recmmend: Yes Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 18

19 authrs, date and cuntry - NICE UK Recmmendatins and gd practice pints 2. Patients with breast signs r symptms which are highly suggestive f cancer. These include: ulceratin skin ndule skin distrtin nipple eczema recent nipple retractin r distrtin (< 3 mnths) unilateral nipple discharge which stains clthes. Cnditins that require referral, nt necessarily urgent: 1. Breast lumps in the fllwing patients, r f the fllwing types: discrete lump in a yunger wman (age < 30 years) asymmetrical ndularity that persists at review after menstruatin abscess persistently refilling r recurrent cyst. 2. Intractable pain which des nt respnd t simple measures such as wearing a well-fitting bra and using ver-the-cunter analgesics such as paracetaml. Cmments 3. Nipple discharge: bilateral discharge sufficient t stain clthes in patients aged < 50 years bldstained discharge in patients aged < 50 years (urgent referral required if discharge is unilateral) any nipple discharge in patients ver 50 years f age. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 19

20 authrs, date and cuntry Referral guidelines fr suspected cancer - UK Department f Health UK Recmmendatins and gd practice pints Guidelines fr urgent referral: 1. Patients with a discrete lump in the apprpriate age grup (fr example age > 30). 2. Signs which are highly suggestive f cancer such as: ulceratin skin ndule skin distrtin nipple eczema recent nipple retractin r distrtin (< 3 mnths). Cnditins that require referral but nt necessarily urgently: 1. Lump discrete lump in a yunger wman (fr example age < 30 years) asymmetrical ndularity that persists at review after menstruatin abscess persistently refilling r recurrent cyst. 2. Pain intractable pain nt respnding t reassurance, simple measures such as wearing a well supprting bra and cmmn drugs. 3. Nipple age < 50 with bilateral discharge sufficient t stain clthes. Cmments Quality: 7 Recmmend: Yes Nte: The guidelines fr urgent referral f patients with suspected breast cancer in this dcument are based n recmmendatins set ut in Guidelines fr Referral f Patients with Breast Prblems secnd editin 1999 prepared by Jan Austker and Rbert Mansel under the auspices f the NHS Breast Screening Prgramme and the Cancer Research Campaign. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 20

21 authrs, date and cuntry 4. Discharge Recmmendatins and gd practice pints Cmments age < 50 with bldstained discharge age > 50 with any nipple discharge. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 21

22 Table 3: Recmmendatins frm UK and internatinal referral guidelines fr patients with suspected lwer gastrintestinal cancer Title, authrs, date and cuntry Diagnsis and management f clrectal cancer - SIGN clinical guideline UK Recmmendatins and gd practice pints Recmmendatins fr primary care and referral: 1. Patients ver the age f 40 wh present with new nset, persistent r recurrent rectal bleeding shuld be referred fr investigatin. Grade B 2. Review f the patient by a reginal clinical genetics service is recmmended fr accurate risk assessment if family histry f clrectal cancer is the principal indicatin fr referral fr investigatin. Grade C 3. General practitiners shuld perfrm an abdminal and rectal examinatin n all patients with symptms indicative f clrectal cancer. A psitive finding shuld expedite referral, but a negative rectal examinatin shuld nt rule ut the need t refer. Grade B 4. All symptmatic patients shuld have a full bld cunt. In cases f anaemia the presence f irn deficiency shuld be determined. Grade B Cmments Quality: 7 Recmmend: Yes Grades f recmmendatin: Grade B refers t a bdy f evidence including studies rated as 2 ++, directly applicable t the target ppulatin, and demnstrating verall cnsistency f results; r extraplated evidence frm studies rated as 1 ++ r 1 +. Grade C refers t a bdy f evidence including studies rated as 2 +, directly applicable t the target ppulatin and demnstrating verall cnsistency f results; r extraplated evidence frm studies rated as Levels f evidence: 1 ++ : High quality meta-analyses, systematic reviews f RCTs, r RCTs with a very lw risk f bias 1 + : Well-cnducted meta-analyses, systematic reviews, r RCTs with a lw risk f bias 2 ++ : High quality systematic reviews f case-cntrl r chrt studies OR high quality case-cntrl r chrt studies with a very lw risk f cnfunding r bias and a high prbability that the relatinship is causal. 2 + : Well-cnducted case-cntrl r chrt studies Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 22

23 authrs, date and cuntry Guidelines fr clrectal cancer screening and surveillance in mderate and high risk grups (update frm 2002) - The British Sciety f Gastrenterlgy (BSG) and the Assciatin f Clprctlgy fr Great Britain and Ireland (ACPGBI) UK Recmmendatins and gd practice pints Guidance n large bwel surveillance fr individuals with a family histry indicating a mderate risk: 1. Referrals n the basis f family histry are best crdinated thrugh centres with a specialist interest, such as reginal genetics services r medical/surgical gastrenterlgy centres. Such centralisatin enables audit f family histry ascertainment, assigned level f risk, cllectin f utcme data and research. Grade C Cmments with a lw risk f cnfunding r bias and a mderate prbability that the relatinship is causal. Quality: 5 Recmmend: Yes, with mdificatins The strength f each recmmendatin is dependent upn the categry f the evidence supprting it. Grade C is based n evidence btained frm expert cmmittee reprts r pinins r clinical experiences f respected authrities. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 23

24 authrs, date and cuntry Suspected cancer in primary care: guidelines fr investigatins, referral and reducing ethnic disparities - New Zealand Guidelines Grup New Zealand Recmmendatins and gd practice pints Recmmendatins fr urgent referral (within 2 weeks): 1. A persn aged 40 years and lder reprting rectal bleeding with a change f bwel habit twards lser stls and/r increased stl frequency persisting fr 6 weeks r mre shuld be referred urgently t a specialist.* Grade C 2. A persn aged 60 years and lder with rectal bleeding persisting fr 6 weeks r mre withut a change in bwel habit and withut anal symptms shuld be referred urgently t a specialist.* Grade C 3. A persn aged 60 years and lder with a change in bwel habit t lser stls and/r mre frequent stls persisting fr 6 weeks r mre withut rectal bleeding shuld be referred urgently t a specialist.* Grade C 4. A persn presenting with a palpable rectal mass (intraluminal and nt pelvic), shuld be referred urgently t a specialist, irrespective f age. Nte that a pelvic mass utside the bwel shuld be referred urgently t a urlgist r gynaeclgist.* Grade C 5. A man f any age with unexplained irn deficiency anaemia and a haemglbin f 110 g/l r belw, shuld be referred urgently t a specialist.* Grade C 6. A nn-menstruating wman with unexplained irn deficiency anaemia and a haemglbin f 100 g/l r belw, shuld be referred urgently t a specialist.* Grade C Cmments Quality: 7 Recmmend: Yes, with mdificatins Grades f recmmendatin: Grades indicate the strength f the supprting evidence, rather than the imprtance f the recmmendatins. Grade C refers t recmmendatins supprted by internatinal expert pinins. Gd practice pints are develped, where n evidence is available, based n the pinin f the Guideline Develpment Team, r feedback frm cnsultatin within New Zealand. *Recmmendatin cnsistent with: Referral guidelines fr suspected cancer. NICE clinical guideline **Unexplained irn deficiency anaemia means unrelated t ther surces f bld lss, fr example, nn-steridal anti-inflammatry drug treatment r bld dyscrasia. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 24

25 authrs, date and cuntry Recmmendatins and gd practice pints Gd practice pints fr urgent referral (within 2 weeks): 1. A persn presenting with a right-sided abdminal mass, shuld be referred urgently fr a surgical pinin. 2. A menstruating wman with unexplained irn deficiency anaemia** and a haemglbin f 100 g/l r belw, shuld be referred urgently t a specialist. Recmmendatins fr referral/investigatin: 1. Fr a persn with equivcal symptms, a cmplete bld cunt may help in identifying the pssibility f clrectal cancer by demnstrating irn deficiency anaemia. This shuld determine if a referral is needed and whether the persn shuld be urgently referred t a specialist.* Grade C 2. Fr a persn where the decisin t refer t a specialist has been made, a cmplete bld cunt may be cnsidered t assist specialist assessment in the utpatient clinic.* Grade C 3. Fr a persn where the decisin t refer t a specialist has been made, n examinatins r investigatins ther than an abdminal and rectal examinatin, and a cmplete bld cunt shuld be undertaken as this may delay referral.* Grade C Gd practice pints fr referral/investigatin: 1. A persn at lw risk f clrectal cancer with a significant symptm (rectal bleeding r a change in bwel habit) and a nrmal rectal examinatin, n anaemia and n abdminal mass, shuld be managed by a strategy f Cmments Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 25

26 authrs, date and cuntry Recmmendatins and gd practice pints treat, watch and review in 3 mnths. 2. In a persn presenting with a left-sided abdminal mass, faecal lading shuld first be excluded as the cause. A referral shuld then be made fr a surgical pinin. 3. Faecal ccult bld and carcingenic embrynic antigen testing are f little value in a persn with symptms suggestive f clrectal cancer and shuld nt be used. 4. A persn with any unexplained gastrintestinal symptms and knwn high-risk factrs, fr example, familial adenmatus plypsis, hereditary nnplypsis clrectal cancer, ther familial clrectal syndrmes r a past histry f lwer gastrintestinal cancer shuld be referred t a specialist. Cmments Referral guidelines fr suspected cancer - NICE clinical guideline UK General recmmendatins: 1. A patient wh presents with symptms suggestive f clrectal r anal cancer shuld be referred t a team specialising in the management f lwer gastrintestinal cancer, depending n lcal arrangements. Grade D Specific recmmendatins: 1. In patients aged 40 years and lder, reprting rectal bleeding with a change f bwel habit twards lser stls and/r increased stl frequency persisting fr 6 weeks r mre, an urgent referral shuld be made. Grade C 2. In patients aged 60 years and lder, with rectal bleeding persisting fr 6 weeks r mre withut a change in bwel Quality: 7 Recmmend: Yes Grades f recmmendatin: Grade C is directly based n: categry III evidence, r extraplated recmmendatin frm categry I r II evidence. Grade D is directly based n: categry IV evidence, r extraplated recmmendatin frm categry I, II, r III evidence. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 26

27 authrs, date and cuntry Recmmendatins and gd practice pints habit and withut anal symptms, an urgent referral shuld be made. Grade C 3. In patients aged 60 years and lder, with a change in bwel habit t lser stls and/r mre frequent stls persisting fr 6 weeks r mre withut rectal bleeding, an urgent referral shuld be made. Grade C 4. In patients presenting with a right lwer abdminal mass cnsistent with invlvement f the large bwel, an urgent referral shuld be made, irrespective f age. Grade C 5. In patients presenting with a palpable rectal mass (intraluminal and nt pelvic), an urgent referral shuld be made, irrespective f age. (A pelvic mass utside the bwel wuld warrant an urgent referral t a urlgist r gynaeclgist.) Grade C 6. In men f any age with unexplained irn deficiency anaemia and a haemglbin f 11 g/100 ml r belw, an urgent referral shuld be made. Grade C 7. In nn-menstruating wmen with unexplained irn deficiency anaemia and a haemglbin f 10 g/100 ml r belw, an urgent referral shuld be made. Grade C Recmmendatins fr patients with risk factrs: 1. In patients with ulcerative clitis r a histry f ulcerative clitis, a plan fr fllw up shuld be agreed with a specialist and ffered t the patient as a nrmal prcedure in an effrt t detect clrectal cancer in this high-risk grup. Grade C Cmments Levels f evidence: Ia: Evidence frm systematic review r metaanalysis f randmised cntrlled trials Ib: Evidence frm at least ne randmised cntrlled trial IIa: Evidence frm at least ne well-designed cntrlled study withut randmisatin IIb: Evidence frm at least ne well-designed quasi-experimental study, such as a chrt study III: Evidence frm well-designed nn-experimental descriptive studies, case-cntrl studies, r case series IV: Evidence frm expert cmmittee reprts, pinins and/r clinical experience f respected authrities. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 27

28 authrs, date and cuntry Recmmendatins and gd practice pints Cmments 2. There is insufficient evidence t suggest that a psitive family histry f clrectal cancer can be used as a criterin t assist in the decisin abut referral f a symptmatic patient. Grade C Clinical Practice Guidelines fr the preventin, early detectin and management f clrectal cancer - Natinal Health and Medical Research Cuncil Australia Investigatin: 1. In symptmatic patients aged ver 40 years, referral t a specialist shuld be cnsidered and cnsideratin f full examinatin f the cln with clnscpy is recmmended. Level III-3; Equivcal Quality: 7 Recmmend: Yes, with mdificatins Levels f evidence: Level III-3 refers t evidence btained frm cmparative studies with histrical cntrl, tw r mre single arm studies, r interrupted time series withut a parallel cntrl grup. Grades f recmmendatin: Strength f evidence was determined by the expert advisry panel. Equivcal refers t situatins where there is lack f higher levels f evidence (such as III-3 r IV) OR equivcal level I r II evidence fr and against clinical questin n recmmendatin fr r against, as evidence is incnclusive recmmend further research. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 28

29 authrs, date and cuntry Guidance n cancer services: imprving utcmes in clrectal cancers - NICE UK Recmmendatins and gd practice pints Actin shuld be taken t imprve recgnitin f ptential symptms f clrectal cancer in primary care and in the cmmunity. Efficient systems shuld be set up t ensure that patients wh may have clrectal cancer are rapidly referred fr endscpy. Criteria fr urgent referral: Age threshld Cmments Quality: 7 Recmmend: Yes rectal bleeding WITH a change in bwel habit t lser stls and/r increased frequency f defecatin persistent fr 6 weeks a definite palpable right-sided abdminal mass a definite palpable rectal (nt pelvic) mass rectal bleeding persistently WITHOUT anal symptms* change f bwel habit t lser stls and/r increased frequency f defecatin, WITHOUT rectal bleeding and persistent fr 6 weeks irn deficiency anaemia WITHOUT an bvius cause (Hb < 11 g/dl in men r < 10 g/dl in pstmenpausal wmen). All ages All ages All ages Over 60 years Over 60 years N age criterin Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 29

30 authrs, date and cuntry Recmmendatins and gd practice pints * Anal symptms include sreness, discmfrt, itching, lumps and prlapse as well as pain. Age 60 years is cnsidered t be the maximum age threshld. Lcal Cancer Netwrks may elect t set a lwer age threshld (such as 55 years r 50 years). Additinal ntes 1. Symptms ther than thse in the list abve, which shuld als prmpt referral fr endscpy, include faecal incntinence and passing mucus via the rectum. 2. Patients with irn-deficiency anaemia (apart frm menstruating wmen) shuld be referred fr clnscpy 3. The threshld fr referral fr investigatin shuld be reduced if ther members f the patient s family have had a diagnsis f clrectal cancer. 4. GPs shuld nt refer patients with suspected clrectal cancer t a specific clinician (as ppsed t a diagnstic clinic) wh is nt a cre member f a clrectal cancer multidisciplinary team Patients with nn-specific symptms: 1. The mst cmmn nn-specific symptms f clrectal cancer fr example, tiredness are due t irndeficiency anaemia caused by undetected bld lss, particularly in lder men r pst-menpausal wmen; patients with bwel plyps r cancer may have n ther symptms. Trusts shuld agree specific lcal guidelines which ensure that such patients are referred prmptly t the endscpy service. Cmments Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 30

31 authrs, date and cuntry Referral Guidelines fr Suspected Cancer - UK Department f Health UK Recmmendatins and gd practice pints 2. Peple with tw first-degree relatives with clrectal cancer, r ne first-degree relative whse clrectal cancer is diagnsed befre the age f 45, have a lifetime risk f death frm clrectal cancer f 1 in 6, r 1 in 10, respectively. The British Sciety f Gastrenterlgy (BSG) and the Assciatin f Clprctlgy fr Great Britain and Ireland (ACPGBI) guidelines suggest that peple wh meet these criteria shuld be referred fr clnscpy at years f age, r as sn thereafter as the risk is recgnised. Guidelines fr urgent referral: It is recmmended that the fllwing symptm and sign cmbinatins when ccurring fr the first time shuld be used t identify patients fr urgent referral under the 2 week standard: Age threshld Cmments Quality: 6 Recmmend: Yes rectal bleeding WITH a change in bwel habit t lser stls and/r increased frequency f defecatin persistent fr 6 weeks a definite palpable right-sided abdminal mass a definite palpable rectal (nt pelvic) mass rectal bleeding persistently WITHOUT anal symptms* All ages All ages All ages Over 60 years Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 31

32 authrs, date and cuntry Recmmendatins and gd practice pints change f bwel habit t lser stls and/r increased frequency f defecatin, WITHOUT rectal bleeding and persistent fr 6 weeks. Over 60 years Cmments Irn deficiency anaemia WITHOUT an bvius cause (Hb < 11 g/dl in men r < 10 g/dl in pstmenpausal wmen). Nte: Patients with the fllwing symptms and n abdminal r rectal mass, are at very lw risk f cancer: rectal bleeding with anal symptms* change in bwel habit t decreased frequency f defecatin and harder stls abdminal pain withut clear evidence f intestinal bstructin. * Anal symptms include sreness, discmfrt, itching, lumps and prlapse as well as pain. Age 60 years is cnsidered t be the maximum age threshld. Lcal Cancer Netwrks may elect t set a lwer age threshld (such as 55 years r 50 years). Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 32

33 Table 4: Recmmendatins frm UK and internatinal referral guidelines fr patients with suspected esphaggastric, hepatbiliary and pancreatic cancers Title, authrs, date and cuntry Recmmendatins and gd practice pints Cmments Referral guidelines fr suspected cancer - NICE clinical guideline UK General recmmendatins: A patient wh presents with symptms suggestive f upper gastrintestinal cancer shuld be referred t a team specialising in the management f upper gastrintestinal cancer, depending n lcal arrangements. Grade D Specific recmmendatins: An urgent referral fr endscpy r t a specialist with expertise in upper gastrintestinal cancer shuld be made fr patients f any age with dyspepsia wh present with any f the fllwing: chrnic gastrintestinal bleeding dysphagia prgressive unintentinal weight lss persistent vmiting irn deficiency anaemia epigastric mass suspicius barium meal result. Grade C In patients aged 55 years and lder with unexplained and persistent recent-nset dyspepsia alne, an urgent referral fr endscpy shuld be made. Grade D In patients aged less than 55 years, endscpic investigatin f dyspepsia is nt necessary in the absence f alarm symptms. Grade D In patients presenting with dysphagia (interference with the swallwing mechanism that ccurs within 5 secnds Quality: 7 Recmmend: Yes Dyspepsia in unselected patients in primary care is defined bradly t include patients with recurrent epigastric pain, heartburn r acid regurgitatin, with r withut blating, nausea r vmiting. Unexplained is defined as a symptm(s) and/r sign(s) that has nt led t a diagnsis being made by the primary care prfessinal after initial assessment f the histry, examinatin and primary care investigatins (if any). In the cntext f this recmmendatin, the primary care prfessinal shuld cnfirm that the dyspepsia is new rather than a recurrent episde and exclude cmmn precipitants f dyspepsia such as ingestin f nn steridal anti-inflammatry drugs (NSAIDs). Grades f recmmendatin: Grade C is directly based n: categry III evidence, r extraplated recmmendatin frm categry I r II evidence Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 33

34 authrs, date and cuntry Recmmendatins and gd practice pints f having cmmenced the swallwing prcess), an urgent referral shuld be made. Grade C Helicbacter pylri status shuld nt affect the decisin t refer fr suspected cancer. Grade C In patients withut dyspepsia, but with unexplained weight lss r irn deficiency anaemia, the pssibility f upper gastrintestinal cancer shuld be recgnised and an urgent referral fr further investigatin cnsidered. Grade C In patients with persistent vmiting and weight lss in the absence f dyspepsia, upper gastr-esphageal cancer shuld be cnsidered and, if apprpriate, an urgent referral shuld be made. Grade C An urgent referral shuld be made fr patients presenting with either: unexplained upper abdminal pain and weight lss, with r withut back pain, r an upper abdminal mass withut dyspepsia. Grade C In patients with bstructive jaundice an urgent referral shuld be made, depending n the patient s clinical state. An urgent ultrasund investigatin may be cnsidered if available. Grade C Cmments Grade D is directly based n: categry IV evidence, r extraplated recmmendatin frm categry I, II, r III evidence. Levels f evidence: Ia: Evidence frm systematic review r meta-analysis f randmised cntrlled trials Ib: Evidence frm at least ne randmised cntrlled trial IIa: Evidence frm at least ne welldesigned cntrlled study withut randmisatin IIb: Evidence frm at least ne welldesigned quasi-experimental study, such as a chrt study III: Evidence frm well-designed nnexperimental descriptive studies, casecntrl studies, r case series IV: Evidence frm expert cmmittee reprts, pinins and/r clinical experience f respected authrities. Risk factrs: In patients with unexplained wrsening f their dyspepsia, an urgent referral shuld be cnsidered if they have any f the fllwing knwn risk factrs: Barrett s esphagus knwn dysplasia, atrphic gastritis r intestinal metaplasia peptic ulcer surgery mre than 20 years ag. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 34

35 authrs, date and cuntry Recmmendatins and gd practice pints Grade C Investigatins: Patients being referred urgently fr endscpy shuld ideally be free frm acid suppressin medicatin, including prtn pump inhibitrs r H 2 receptr antagnists, fr a minimum f 2 weeks. Grade C In patients where the decisin t refer has been made, a full bld cunt may assist specialist assessment in the utpatient clinic. This shuld be carried ut in accrdance with lcal arrangements. Grade D All patients with new-nset dyspepsia shuld be cnsidered fr a full bld cunt in rder t detect irn deficiency anaemia. Grade D Cmments Suspected cancer in primary care: guidelines fr investigatins, referral and reducing ethnic disparities - New Zealand Guidelines Grup New Zealand Gastric and esphageal cancer Urgent referral (within 2 weeks) Recmmendatins: A persn f any age with dyspepsia shuld be referred urgently fr endscpy r t a specialist if they have any f the fllwing: gastrintestinal bleeding dysphagia prgressive unexplained weight lss persistent vmiting irn deficiency anaemia epigastric mass.* Grade C A persn aged 55 years r lder with unexplained and persistent recent-nset dyspepsia slely, shuld be referred urgently fr endscpy.* Grade C A persn with dysphagia (specifically, interference with Quality: 7 Recmmend: Yes, with mdificatins Grades f recmmendatin: All grades indicate the strength f the supprting evidence, rather than the imprtance f the recmmendatins. Grade C refers t recmmendatins supprted by internatinal expert pinin. Gd practice pints are develped, where n evidence is available, based n the pinin f the Guideline Develpment Team, r feedback frm cnsultatin within New Zealand. Evidence Tables - Scttish referral guidelines fr suspected cancer (August 2014) 35