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Country Delegates Workshop 13-14 March, 2013 Overview of existing breast cancer screening guidelines Federici Antonio Ministry of Health- Italy

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Country Delegates Workshop 13-14 March, 2013

Overview of existing breast cancer screening guidelines

Federici Antonio Ministry of Health-

Italy

AGENDA

THE STUDY (Quality appraisal of guidelines for

breast, colorectal and cervical cancer screening)

REMARKS & SUGGESTIONS

THE STUDY (Quality appraisal of guidelines for

breast, colorectal and cervical cancer screening)

REMARKS & SUGGESTIONS

The study

• The mandate: 1.

National Plan: strengthening of governance by generating knowledge

2.

from MoH to Lazio Region Health-Agency (Giorgi Rossi team)

The rationale: 1.

quality of a GL ;

2.

operational use in the day-by day practice3.

variance of professional’s behaviour and GLs’

The objective: to collect SPs’

guidelines and their quality appraisal.

The mandate: 1.

National Plan: strengthening of governance by generating knowledge

2.

from MoH to Lazio Region Health-Agency (Giorgi Rossi team)

The rationale: 1.

quality of a GL ;

2.

operational use in the day-by day practice3.

variance of professional’s behaviour and GLs’

The objective: to collect SPs’

guidelines and their quality appraisal.

Remarks & Suggestions

The study

• The method 1.

literature search of the major databases & websites (since yr 2000; only Italian or English; keywords by the Editorial Group of the Cochrane Collaboration)

2.

Guideline quality assessment, using the instrument developed by the AGREE Collaboration

The method 1.

literature search of the major databases & websites (since yr 2000; only Italian or English; keywords by the Editorial Group of the Cochrane Collaboration)

2.

Guideline quality assessment, using the instrument developed by the AGREE Collaboration

Remarks & Suggestions

AGREE Appraisal of Guidelines forResearch and Evaluation

DOMAINS

scope and purpose

stakeholder involvement

rigour of development

clarity and presentation

Applicability

editorial independence

The study

Main results: breast

•Relevant documents identified: 32 breast [33 cervix; 18 colon]–

Several areas of disagreement and /or variability

•Assessable by AGREE: 12 [19 cervix; 12 colon]

Main results: breast

•Relevant documents identified: 32 breast [33 cervix; 18 colon]–

Several areas of disagreement and /or variability

•Assessable by AGREE: 12 [19 cervix; 12 colon]

Suggestion&remarks

Main areas of disagreement (1)

Organization•

Starting age:

40, 45, 50•

Stopping age:

69, 74, none•

Interval:

1 to 3 yy

First level test :•

Two or one projections

Use of digital mammography (only since early 2000s)

Clinical exam (only 3 ggll)•

Ultra sounds (only 2 ggll)

One or Two readings

The study Remarks & Suggestions

Assessment and Pathology

Criteria for use of FNAB or FNAC

Use of VACNB•

Use of MRI (pre-

surgery )

Main areas of disagreement (2)

The study Remarks & Suggestions

Surgery (points relevant for diagnostic pathway)

Sentinel node in DCIS

Cosmetic (simultaneous)

Familial •Many GGLL refer to specific documents•Criteria:

Great variability in the definition of intermediate risk and referral to screening or not

High agreement for genetic risk

Main features (3)

The study Remarks & Suggestions

breast screening quality appraisal AGREE(1)

The study Remarks & Suggestions

objectives of GGLL

clinical question

target patients

FONCAM 2005 ss Italy 2 3,5 2EU 2006 gov International 2,5 3,5 3NHS BSP 2010 gov UK 3,5 3,5 4GISMa 2006 ss Italy 4 3 4ACP 2007 ss USA 4 4 4SIRM 2004 ss Italy 3,5 3,5 2RER 2008 gov Italy 1,5 3 1USPSTF 2009 gov USA 4 4 3,5ACS 2003+2004 ss USA 4 4 4ACR 2008 ss USA 2,5 3 1ANAES 2000 gov France 3 3 4ISPO 2010 gov Italy 3,5 3,5 4

3,00 3,42 3,253,33 3,50 2,83

mean all 3,17 3,46 3,04

mean governmental bodiesmean scientific societies

scope and purpose

breast screening quality appraisal AGREE(2)

The study Remarks & Suggestions

profes-sionals patients

GGLL users

pilot w ith users

FONCAM 2005 sci soc Italy 1,5 1 1EU 2006 gov International 3 1 2NHS BSP 2010 gov UK 3 2 2,5GISMa 2006 sci soc Italy 4 4 3,5ACP 2007 sci soc USA 1 1 1SIRM 2004 sci soc Italy 1,5 1 1RER 2008 gov Italy 3 1 1,5USPSTF 2009 gov USA 3 2 2,5ACS 2003+2004 sci soc USA 3,5 2,5 2,5ACR 2008 sci soc USA 1 1 1ANAES 2000 gov France 3 1 3ISPO 2010 gov Italy 4 1,5 3

3,17 1,42 2,422,08 1,75 1,67

mean all 2,63 1,58 2,04

mean govmean sci soc

stakeholder involvement

breast screening quality appraisal AGREE(3)

The study Remarks & Suggestions

syste-matic

reviewselection criteria

methods for recom-mendation

s

health benefits, risk and

side effects

link evidence -

recom-mendation

sexternal review

updating proce-dures

FONCAM 2005 sci soc Italy 1 1 1 3 1,5 1 1EU 2006 gov International 2,5 2 2 2 2 3,5 3NHS BSP 2010 gov UK 2,5 2 2,5 3,5 3 2,5 2,5GISMa 2006 sci soc Italy 2,5 2 2,5 4 3,5 3 1,5ACP 2007 sci soc USA 3,5 3,5 3 3 3,5 1 1SIRM 2004 sci soc Italy 2 1,5 2 2,5 2,5 2 1RER 2008 gov Italy 2 1,5 2 2,5 2 1 1USPSTF 2009 gov USA 3,5 2,5 3,5 4 3,5 1 1ACS 2003+2004 sci soc USA 3,5 3 2 3,5 4 3 1,5ACR 2008 sci soc USA 1 1 2 1,5 2 1 1,5ANAES 2000 gov France 4 4 4 3 4 1 1ISPO 2010 gov Italy 3 3 3,5 4 3 3,5 1,5mean gov 2,92 2,50 2,92 3,17 2,92 2,08 1,67mean sci soc 2,25 2,00 2,08 2,92 2,83 1,83 1,25mean all 2,58 2,25 2,50 3,04 2,88 1,96 1,46

rigour of development

breast screening quality appraisal AGREE(4)

The study Remarks & Suggestions

recom-mendation

s not ambiguous

options specified

recom-mendation identifiable

tools for applicatio

n

FONCAM 2005 sci soc Italy 3 3,5 3 1,5EU 2006 gov International 2,5 2,5 1,5 4NHS BSP 2010 gov UK 3,5 3,5 3,5 3,5GISMa 2006 sci soc Italy 4 3,5 3,5 2,5ACP 2007 sci soc USA 3 2 3,5 2SIRM 2004 sci soc Italy 2,5 2 3 2RER 2008 gov Italy 3,5 4 3,5 3,5USPSTF 2009 gov USA 4 3 3,5 2ACS 2003+2004 sci soc USA 3,5 3,5 3,5 2ACR 2008 sci soc USA 1 1 1 1ANAES 2000 gov France 3 2 3 2ISPO 2010 gov Italy 3,5 2,5 3,5 2mean gov 3,33 2,92 3,08 2,83mean sci soc 2,83 2,58 2,92 1,83mean all 3,08 2,75 3,00 2,33

clarity and presentation

breast screening quality appraisal AGREE(5-6)

The study Remarks & Suggestions

barriers discussed

costs implicatio

ns identified

criteria for audit and monitorin

gindepen-

dence

competing interest

disclosureFONCAM 2005 sci soc Italy 1 1,5 2,5 3 1,5EU 2006 gov International 3 2 4 4 2,5NHS BSP 2010 gov UK 3 2,5 3,5 2,5 1GISMa 2006 sci soc Italy 3 3 2,5 3 2,5ACP 2007 sci soc USA 1 1 1,5 3 1SIRM 2004 sci soc Italy 2 1,5 1,5 2 1RER 2008 gov Italy 2 2 3,5 3 1USPSTF 2009 gov USA 2,5 3 2,5 3,5 2,5ACS 2003+2004 sci soc USA 1 1 2 2,5 1ACR 2008 sci soc USA 1,5 1 1,5 1 1ANAES 2000 gov France 1 1 2 3 1ISPO 2010 gov Italy 2 2,5 2 3,5 4mean gov 2,25 2,17 2,92 3,25 2,00mean sci soc 1,58 1,50 1,92 2,42 1,33mean all 1,92 1,83 2,42 2,83 1,67

applicability editorial

independence

breast screening quality appraisal AGREE

total

The study Remarks & Suggestions

Total std scoreFONCAM 2005 sci soc Italy 41 46,6EU 2006 gov International 58 65,9NHS BSP 2010 gov UK 63,5 72,2GISMa 2006 sci soc Italy 69 78,4ACP 2007 sci soc USA 51,5 58,5SIRM 2004 sci soc Italy 43,5 49,4RER 2008 gov Italy 49 55,7USPSTF 2009 gov USA 64,5 73,3ACS 2003+2004 sci soc USA 61 69,3ACR 2008 sci soc USA 29,5 33,5ANAES 2000 gov France 56 63,6ISPO 2010 gov Italy 66,5 75,6mean gov 59,58 67,72mean sci soc 49,25 55,95mean all 54,42 61,83

total

The study

Main results: breast

•In USA, most of the documents are from scientific societies, while in Europe most are from governmental agencies: two kinds of health systems produced different guidelines and/or documents reporting recommendations

Main results: breast

•In USA, most of the documents are from scientific societies, while in Europe most are from governmental agencies: two kinds of health systems produced different guidelines and/or documents reporting recommendations

Suggestion&remarks

EU cancer screening GLs: appraisal AGREE

(1)

The study Remarks & Suggestions

EU 2006: (breast)

EU 2008 (cervical)

EU 2010 (colorectal)

EU GGLL AGREE score improved from 2006 to 2010:1) better quality of methodology 2) more consistency between objective and contents,

from quality assurance of the single procedure to QA of the whole screening process

1.

The assessment of quality can’t be carried out by a single clinician and the decision making by a single specialist could be weak

2.

A GL must be a part of a more complex frame of managing clinical problems. –

A good-quality-GL is a tool for having standards to use in the evaluation of clinical processes, outputs and outcomes. Therefore it should be a part of a more complex system on improving quality, besides audit, training and so on. But the frame of governance is actually different if

we are

considering the management responsibility at local or regional level. Even different if we are at the policy making level.

3.

Not (only) wishing for the actual use of a GL: it is the case of managing the issue of knowledge in a broader scenario: that of governance

1.

The assessment of quality can’t be carried out by a single clinician and the decision making by a single specialist could be weak

2.

A GL must be a part of a more complex frame of managing clinical problems. –

A good-quality-GL is a tool for having standards to use in the evaluation of clinical processes, outputs and outcomes. Therefore it should be a part of a more complex system on improving quality, besides audit, training and so on. But the frame of governance is actually different if

we are

considering the management responsibility at local or regional level. Even different if we are at the policy making level.

3.

Not (only) wishing for the actual use of a GL: it is the case of managing the issue of knowledge in a broader scenario: that of governance

The

study Remarks & Suggestions

Travis P,. Towards better stewardship: concepts and critical issues.Geneva, WHO, 2002.

The governance

Stewardship: subfunctions 1.

Formulating strategic policy framework

2.

Generation of intelligence3.

Ensuring tools for implementation

4.

Ensuring a fit between policy objectives and organizational structure and culture;

5.

Building coalitions/building partnerships 6.

Ensuring accountability

Stewardship: subfunctions 1.

Formulating strategic policy framework

2.

Generation of intelligence3.

Ensuring tools for implementation

4.

Ensuring a fit between policy objectives and organizational structure and culture;

5.

Building coalitions/building partnerships 6.

Ensuring accountability

Novinskey CM,. Stewardship and cancer screening programs in Italy.IJPH -

Year 9, Volume 8, Number 2, 2011

Having a guideline makes difference only if it’s a tool in the tool-box of governance. For example, to finance Regions (or health services)

1.

Adherence= % of target population actually screened (3 screening as a whole) : already implemented since 2009

2.

% Early stage cancer (breast cancer screening) detected in the rounds following the first [stage II+ ≤

25%]: under evaluation for feasibility

Having a guideline makes difference only if it’s a tool in the tool-box of governance. For example, to finance Regions (or health services)

1.

Adherence= % of target population actually screened (3 screening as a whole) : already implemented since 2009

2.

% Early stage cancer (breast cancer screening) detected in the rounds following the first [stage II+ ≤

25%]: under evaluation for feasibility

The

study Remarks

& Suggestions

Included GGLL Author Acronym Year Country AGREE

Agence Nationale d’Accréditation et d’Evaluation en Santé

[44] ANAES 2000 France Yes

Royal College of Surgeons in Ireland [45] RCSI 2000 Ireland

Canadian Task Force on Preventive Health Care

[46] CTFPHC 2001 Canada

American Cancer Society[47-48] ACS 2003+2004 International Yes

Regione Toscana [22] PNLG 2003 Italy

Società

Italiana di Radiologia Medica[49] SIRM 2004 Italy Yes

Ministero Salute [2] ONS 2005 Italy yes

Forza Operativa Nazionale sul Carcinoma Mammario[51] FONCAM 2005 Italy Yes

Agence d'évaluation des technologies et des modes d'intervention en santé[50] AETMIS 2006 Canada

European Commission[52] EC 2006 EU Yes

National Institute for Health and Clinical Excellence[53-54] NICE 2006+2004 UK

World Health Organization [55] WHO 2006 International

American College of Physicians[56] ACP 2007 USA Yes

Regione Piemonte[57] CPO 2007 Italy

Included GGLL

Author Acronym Year Country AGREE

Gruppo Italiano Screening Mammografico[58] GISMA 2007 Italy Yes

American College of Radiology[59] ACR 2008 USA Yes

Associazione Italiana Oncologia Medica[60] AIOM 2008 Italy

Institute for Clinical Systems Improvement[61] ICSI 2008 International

Regione Emilia-Romagna[62] RER 2008 Italy Yes

Australian Institute of Health and Welfare [63] AIHW 2008 Australia

Cochrane Database of Systematic Reviews[16] Cochrane 2009 International

National Institute for Health and Clinical Excellence[64] NICE 2009 UK

Provincia autonoma di Trento[65] Trento 2009 Italy

U.S. Preventive Services Task Force[66] USPSTF 2009 USA Yes

Regione Toscana [43] ISPO 2010 Italy Yes

NHS Breast Screening Programme[67] NHSBSP 2010 UK Yes

32 found26 selected12 suitable for AGREE evaluation