First National Digital Mammography Survey in Portugal

- Findings and Recommendations -

A.Pascoal*, C.Reis, M.Oliveira, T.Sakellaris, J.Alves, M.Koutalonis

(*afiliated to FEUCP when the survey was performed.

Currently afiliated to King’s College Hospital)

1

Proteção Radiológica na Saúde, 18-20 Sep 2013, Lisbon Portugal

Introduction

2

Some facts about breast cancer

“…is the top cancer in women worldwide and is increasing particularly in developing countries”

WHO, 2011

3

Some facts about breast cancer

•  1500 breast deaths/year

•  4500 new cases/year

•  1% ♂ (male)

•  10% women will develop breast cancer

•  90% curable if diagnosed early

LPCC, 2011

4

Some facts about mammography

“the only screening method that has proven to be effective (…) can reduce mortality by 20 to 30% in women over 50 yrs old when screening coverage is over 70% (IARC, 2008).

“Mammography screening is very complex

and resource intensive.”

WHO, 2011

5

What may go wrong?

Missed breast cancers

•  Breast: dense, thick •  Tumor: subtle, masked, multicentric, multifocal •  Technique: positioning, exp factors, processing

•  Observer: perception issues, lack of experience

Kamal et al, 2007

6

What may go wrong?

Missed breast cancers? How can be reduced?

“(…) be strict about positioning and technical requirements to optimize image quality”

Annesa et al, 2003

7

Technological advances in mammography

8 8

Screen-Film Mammography

(SFM)

Computed Radiography

(CR)

Direct Radiography

(DR)

1960’s 1980’s 1990’s

International guidance on QA in mammography

9

EU Guidelines 2006

IAEA 2011

ACR Guidelines 1999

Manual de Boas Práticas em Radiologia

Minist. Saúde Desp. 258/2003

Objectives

10

How is mammography in Portugal?

11

?

Focus: digital mammography

How is mammography in Portugal?

12

People

Technology

Results Processes &

Methods

Goals

A broad perspective

Literature survey – peer review

•  Carvalho AF et al, Radiation Doses from Mammography in Portugal, Radiation Prot. Dosimetry 36 (2-4), 261-263 (1991)

•  Carvalho AF et al, Qualidade dos Aspectos Técnicos em Mamografia em Portugal, Acta Rad. Portuguesa, 35-38 (1995)

•  N. Machado et al, Results of radiation protection programs on mammography, Rad Prot Dos Vol. 116, No. 1–4, pp. 624–626 (2005)

•  Pascoal et al, Mamografia digital vs analógica: fundamentações da escolha, ARP, vol XVIII, 69, 21-22 (2006)

Curso Imagiologia Mamária, IPOFG, Lisboa 22.03.2012 A. Pascoal

(apascoal74@gmail.com) 13

Questions to be answered

1. How many mammography systems are installed in the country? What type of technology is available?

2. How is staff (radiographers and radiologists) being

trained in mammography? 3.  How is the performance of DM systems in clinical use?

4.  How do practice in mammography comply with international guidelines of best practice?

Is there room for improvement?

14

Methods

15

Phase 1 – characterisation of technology

•  Literature search

•  Information request –  healthcare authorities: DGS; 7 ARS –  Manufacturers and distributors

•  Questionnaires

16

Phase 2 – characterisation of practice

•  Targeted questionnaires –  breast radiographers –  chief radiographer –  breast radiologists

•  Data collected –  Type of institution –  Education and training –  Mammography technique in use –  Radiology practice (reading and interpretation) –  Quality control –  Views on impact of DM

17

Phase 3 – technical performance

•  Selection criteria – Type of technology (CR, DR) – Manufacturer – Geographical location – Type of provider (public, private, cooperative) – Practical issues (time and resources available)

18

19

CR Tube & generator -  Caracterização -  Exactidao -  Repetibilidade

X-ray beam dosimetry -  Caracterização -  Output -  HVL -  Dosimetria

Detector tests -  Aligment -  Uniformity -  Ghosting (DR) -  Image quality

(TORMAM, TORMAX) -  Detector response -  MTF, NPS, DQE -  AEC -  Interplate variability (CR) -  Fading (CR)

Compression device -  Thickness -  Pressure

Duration ~4h/unit

Phase 3 – technical performance

DR

Duration ~ 3h/unit

Results – fase 1 (technology)

20

Installed base of mammography systems

21

  Private   Public   Screening   Other   Total  

CR   211   33   28   15   287 (64%)   DR   47   16   3   1   67 (15%)   SFM   23   4     1   28 (6%)   Not known   57   3     3   63 (14%)   In transition   1         1 (0.3%)  

Total  339

(76.0%)  56

(12.6%)  31

(7.0%)  20

(4.4%)  446

(100%)  

* *

* number of DR systems more than doubled (31…76) in 2 years (2010-12)

Distribution of mammography systems

22

Computed Radiography

Direct Radiography

Portugal

Results – phase 2 (practice & organisational matters)

23

Response rate

•  Questionnaires sent to 269 hospitals & clinics •  Response rate: 24%

24

Norte   Centro   LVT   Alent   Algar   Mad   Total  #

centers  

Radiolo   15   11   30   3   8   2   69   53  

Radiog   26   13   50   10   15   4   118   65  

Chief Radiog   10   9   27   4   7   2   59   59  

Sample characteristics

25 25 North Centre LVT Alentejo Algarve Madeira

1.7% 1.7% 1.7%

10.0% 8.5%

32.2%

1.7% 6.8%

1.7%

6.8% 5.1%

6.8%

3.4%

1.7%

1.7%

6.8%

1.7%

Other Private Public Screening

•  Profile of the institutions that ?

Mammography workload

26

  Shifts/week   Hours/Shift   Exams/Shift  Mammography/Hour  

Public   5.8 ± 1.6   6.0 ± 0.2   17.7 ± 6.4   2.9 ± 1.1  

Private   8.3 ± 2.3   4.8 ± 0.5   19.7 ± 2.1   4.4 ± 0.5  

Screening   5.6 ± 2.3   7.0 ± 1.3   55.0 ± 3.2   8.1 ± 1.5  

Other   2.3 ± 0.7   3.3 ± 1.8   11.7 ± 6.4   3.6 ± 1.1  

Mammography guidance in use

27

Manufacturer 63%

Local protocol 29%

National Guideline

2%

International Guideline

6%

Training in mammography

28 23% 33%

77% 67%

Radiologists Radiographers

Training in DM

No Training in DM

~ 61% : Courses (PT and abroad) Manufacturer

Sessions 1w (93%)

~ 42% : Manufacturer Workshops

Short-term sessions 1-2d (73%)

Self-assessed training needs

No answer

Yes

No

Radiographers Radiologists

7% 1%

38% 48%

55% 51%

29

•  QC •  Intervention •  Optimisation •  Dosimetry

•  Artifact recognition •  Dosimetry •  Tomosynthesis

Radiologists practice (image viewing/reporting)

Hardcopy or softcopy?

Reporting time (digital compared to analogue)?

30

Both 14%

Hardcopy 33%

Electronic display 53%

Comparable 52% Less time

19%

More time 29%

Use of post processing tools (radiologists)

31

19.0% 18.6% 18.6%

10.2% 7.8% 5.7% 5.2% 4.8% 3.9% 3.3% 1.7% 1.3%

Quality assurance practice

32

Yes 71%

No 29%

0 2 4 6 8

10 12 14 16 18 20

Daily Weekly Monthly Quarterly 6-month. Annual Radiographer 7 6 8 0 4 0 Manufacturer 0 2 0 5 20 6 Eng. Hosp. 0 0 1 0 0 0 Med Physicist Hosp 0 1 0 0 4 1 Outsourcing 0 0 1 10 12 5

Reject analysis

•  Performed in 35% of institutions only – Various causes for rejects

33

12.7% 8.6%

18.2% 17.8% 21.0% 20.4%

1.3%

Technical parameters

Image processing

Artifacts Patient motion Skin folds No pectoral muscle

Other

Results – phase 3 (technical performance)

34

Technical performance assessment

35 35

52 Equipments (15% of total) •  18 DR (27%) •  34 CR (12%)

Alignment of light field to X-ray field

36

Alignment   CR   DR   Total  Pass   14% (4)   64% (9)   30% N=13  Fail   86% (25)   36% (5)   70% N=30  

Chest wall Chest wall

1/10/13 37

Expected

Causes •  Overuse of image plates

•  CR reader mechanical issues

Observed

Artefacts

MGD (PMMA phantom; AEC)

38

38

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0

M13

M

18

M11

M

44

M50

M

24

M46

M

9 M

23

M15

M

40

M51

M

49

M17

M

42

M1

M10

M

41

M48

M

2 M

19

M26

M

39

MG

D [m

Gy]

EUREF Acceptable EUREF Achievable This study

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0

M35 M31 M16 M36 M8 M12 M70 M6 M45 M25

MG

D [m

Gy]

Mamography unit ID

DR

CR

SdNR (PMMA phantom; AEC)

39 39

Mammography equipment

CR

Agfa

Fuji

Carestream/ Kodak

DR

GE 2000

GE DS

Fuji Amulet

Siemens Inspiration

Small breast Medium breast Large breast

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR < Accep/ Achiev Accep < SdNR <Achiev SdNR > Accep/ Achiev

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR (PMMA phantom; AEC)

40

Mammography equipment

CR

Agfa

Fuji

Carestream/ Kodak

DR

GE 2000

GE DS

Fuji Amulet

Siemens Inspiration

Small breast Medium breast Large breast

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

SdNR

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD

MGD > Accep/ Achiev Accep < MGD <Achiev MGD <Accep/ Achiev

Image Quality (TORMAM)

•  Image quality

•  200 images (under AEC) •  4 trained observers

41

CR - Image Quality & MGD (PMMA)

42

0

20

40

60

80

100

0.0

1.0

2.0

3.0

4.0

5.0

M13

M

11

M9

M22

M

24

M49

M

51

M20

M

15

M40

M

30

M50

M

43

M46

M

38

M34

M

17

M42

M

1 M

48

M27

M

19

M26

M

2 M

41

M29

M

5 M

39

Imag

e Q

ualit

y S

core

MG

D [m

Gy]

Mammography unit ID

MGD [mGy] TORMAM Score

DR - Image Quality & MGD (PMMA)

43

0

20

40

60

80

100

0.0

1.0

2.0

3.0

4.0

5.0

M35

M7

M3

M12

M45

M31

M6

M28

M36

M16

M47

M2

M33

M14

M32

M71

M25

M8

Imag

e Q

ualit

y S

core

MG

D [m

Gy]

Mammography Units (DR systems)

MGD [mGy] TORMAM Score

MGD (from clinical exposure data)

•  Exposure data collected from –  38 mammography systems

•  25 CR •  13 DR

–  2121 exams/patients

–  8484 exposures (= images)

44

MGD (from clinical exposure data)

45 45

0  

5  

10  

15  

20  

25  

30  

35  

0-­‐0,5  

0,6-­‐1  

1,1-­‐1,5  

1,6-­‐2  

2,1-­‐2,5  

2,6-­‐3  

3,1-­‐3,5  

3,6-­‐4  

4,1-­‐4,5  

4,6-­‐5  

5,1-­‐5,5  

5,6-­‐6  

6,1-­‐6,5  

6,6-­‐7  

7,1-­‐7,5  

7,6-­‐8  

8,1-­‐8,5  

8,6-­‐9  

9,1-­‐9,5  

9,6-­‐10  

10,1-­‐10,5  

10,6-­‐11  

11,1-­‐11,5  

Rela2ve  Freq

uency  (%

)  

DR:1,54 mGy (CC)

CR: 1,85 mGy (CC)

MGD,  mGy  

DR:1,68 mGy (MLO)

CR: 2,10 mGy (MLO)

Dose reference levels

•  MGD (from clinical exposure data) •  Exposure data of MLO projections

46

0

5

10

15

20

25

30

35

Rel

ativ

e Fr

eque

nce

[%]

Thickness [mm]

CR DR

Ref. establishment of DRL, IPEM

Dose reference levels

47

Dose Reference Levels CR

2.2 mGy

Dose Reference Levels DR

1.5 mGy

UK - 3.5 mGy (SFM) Young et al proposes 2.2 mGy (CR) and 1.5 mGy (DR)

Conclusions

48

Mammography equipment

•  Limited peer review data

•  No national equipment registry with updated information and relevant technical detail

•  The majority (76%) of mammography systems are CR technology

•  Number of DR systems more than doubled in 2 years (31…67)

49

Organisational matters

•  Workload is higher in private & screening centres

•  Use of equipment is based on manufacturers’ guidance

•  Training needs identified by radiologists and and radiographers (dosimetry, artefact recognition, tomosynthesis)

•  33% of radiologists still report on hardcopy format

50

Organisational matters

•  QC not performed in 30% of the participant centres

– Reject analysis is not implemented in the majority of centres

–  Lack of clarity regarding servicing (manufacturer) and QC (independent)

51

Equipment performance

•  Mean Glandular Dose (MGD) –  Higher MGD for CR systems compared to DR –  MGDPMMA< 2.5 mGy (EUREF acceptable ref.) for vast majority of

systems

•  SdNR lower than expected (AEC calibration?) particularly for CR systems

•  Image quality –  Wide range of image quality

•  CR systems (score 30 to 100) •  DR system (score 61 to 91)

52

Recommendations

53

Recommendations

To be discussed and formulated in collaboration

with you - the stakeholders.

54

Aknowledgments

55

Projecto financiado pela Fundação para a Ciência e Tecnologia (2010-2013) PTDC/SAU-BEB/100745/2008

Thank you

56

HOSPITAL DE SÃO JOÃO, E.P.E. INSTITUTO PORTUGUÊS DE ONCOLOGIA DO PORTO FRANCISCO GENTIL KRUG DE NORONHA, LDA. - PORTO SMIC - SERV. MÉD. DE IMAGEM COMPUTORIZADA GRUPO EUROMEDIC _C. MED. C. BRANCO - DUARTE JOAO & J CEDILE - C. DIAG. POR IMAGEM DE LEIRIA DIAGNOSTICUM - CLÍNICA DE DIAGNÓSTO HOSPITAIS UNIVERSITÁRIOS DE COIMBRA HOSPITAL STº ANDRÉ - LEIRIA INSTITUTO PORTUGUÊS DE ONCOLOGIA DE COIMBRA FRANCISCO GENTIL LPCC-NÚCLEO REGIONAL DO CENTRO PINHO E MELO STA CASA MISERICORDIA MEALHADA CEDIMA-CENTRO IMAGIOL.MEDICA, LDA CLIDIRAL - CLÍNICA DE DIAGNÓSTICO CUFBELÉM - CLÍNICA STA MARIA BELÉM CONS. RADIOLOGICO DR. SENA BATISTA GRUPO EUROMEDIC _MANUEL ESTEVES & LUIS FRAZAO LDA GRUPO EUROMEDIC_CRT - CENTRO DE RADIOLOGIA DE TOMAR GRUPO EUROMEDIC_DR.MESQUITA G.(FILHO)& A.-C.R.E.AV.REPUB.S.A GRUPO IMAG_CDRE - CENTRO DIAGNOSTICO RADIO ECOG ALGUEIRAO MEM MARTINS HOSPITAL DA LUZ, S.A. HOSPITAL FERNANDO FONSECA QUADRANTES-CLIN.MEDIC.DIAGNOST.,LDA SINDICATO DOS BANCÁRIOS DO SUL E ILHAS – CC E HOSPITAL UNIÃO MUTUALISTA N.SRA. DA CONCEIÇÃO - MONTEPIO BARREIRO LPCC - NÚCLEO REGIONAL DO SUL IRE-IMAGEM RADIOLOGICA ECOGRAFICA, LDA – LISBOA MATERNIDADE DR.ALFREDO DA COSTA C. HOSP. BAIXO ALENTEJO CENTRO DE RADIOLOGIA DE BEJA, LDA. GRUPO EUROMEDIC_CDI-CLINICA MANUFACTURERS AND DISTRIBUTORS OF MA

DIAGNOST.IMAGEM,LDA. HOSPITAL DO LITORAL ALENTEJANO CENTRO HOSPITALAR DO BARLAVENTO ALGARVIO IMAG-FERNANDO SANCHO, LDA HPP - HOSPITAL PRIVADO SÃO GONÇALO DE LAGOS LAGOA CENTRO _ M. CARMO A. CASTRO J. MAURICIO R A RADIOLOGIA ALBUFEIRA LDA MADEIRA MEDICAL CENTER HOSPITAL ESPIRITO SANTO GRUPO DR.CAMPOS COSTA CLÍNICA DR.PASSOS ANGELO HOSPITAL DO FUNCHAL CENTRO MÉDICO DR. VERÍSSIMO DE JESUS CLÍNIA- CLÍNICA MÉDICA DA LINHA HOSPITAL PARTICULAR DO ALGARVE ASSOCIAÇÃO ONCOLÓGICA DO ALGARVE HPP - HOSPITAL SANTA MARIA DE FARO HPP - LUSÍADAS CUF - INFANTE SANTO HOSPITAL S. TEOTÓNIO DE VISEU CUF-DESCOBERTAS CENTRO HOSPITALAR DE COIMBRA ESS-HOSPITAL DE SANTIAGO GRUPO ESFERA SAÚDE HOSPITAL ST ANTÓNIO CAPUCHOS INSTITUTO PORTUÊS DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL CENTRO HOSPITALAR DO PORTO- HOSPITAL GERAL DE STO ANTONIO DR. JOAO CARLOS COSTA GABINETE DE RADIOLOGIA DE ESPINHO, DR KRUG DE NORONHA GINOECO-SERVIÇOS MÉDICOS DE IMAGEM GRUPO ESS _HOSPITAL DA ARRÁBIDA - VN GAIA

Collaborative work

57