Hartwig Huland, Systematic, standardized outcome ......Martini-Klinik Station 1 73,48 Martini-Klinik...

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 1

Huland Kopenhagen 2018

Systematic, standardized outcome measurementfor clinical science and quality control


>10% of all RP in Germany

Open

DV

Martini-Klinik

Radical Prostatectomy

0

200

400

600

800

1000

1200

1400

1600

1800

2000

2200

2400

Foundation M-K


Number RP/year

2012 Median 84,0

2013 Median 78,0

2014 Median 89,5

Mayo Clinic

Johns Hopkins

60 % GKV

Martini- Klinik

Radical Prostatectomy/year

Prostate Cancer Centers Germany

4

Martini-KlinikPatient satisfaction

Would you recommend the hospital to friends or family?

10080 900

98,89Martini-Klinik Station 4

89,66

89,22

99,55

89,66

88,46

90,5691,3091,46

84,6284,6284,65

87,50

85,00

82,14

85,00

82,81

83,98

85,58

84,38

82,86

81,94

83,65

85,76

86,0586,19

83,00

85,94

82,61

UKE Mean

82,69

83,00

86,23

79,7380,00

81,25

Martini-Klinik Station 1

73,48

Martini-Klinik Station 3

89,23

100,00

76,92

79,1778,83

Source: Patient Satisfaction Survey University Hospital Hamburg-Eppendorf

5

1.Specialized on Prostate Cancer2005 founded at the University Hospital Hamburg-Eppendorf

• Diagnostic: PCa early detection/ all types of imaging: US, MRT• Local therapy: open RP .+ robot ass.RP., RTx, HDR-, LDR- Brachy- therapy

– focal therapy, immuno therapy, AS• Therapy of metastatic/cr. PC• Clinical, basic science research• Psychooncology, life style-complementary medicine

Integrated Practice Unit = IPU

Martini-Klinik

6

2.Faculty System11 tenured positions

Prof. Dr. GraefenProf. Dr. HaeseProf. Dr. HeinzerProf. Dr. HulandDr. MichlPD Dr. SalomonProf. Dr. SchlommProf. Dr. SteuberDr. ThederanProf. Dr.TilkiPD Dr. Budäus

All have their dedicated fields of prostate cancer reserach

Each patient has only one contact person „his doctor“

All are high volume surgeons - all doing 200-300 RP pro year

Martini-Klinik

7

3. Martini-Database since 1992

Martini-Database

Database-Problems

Database-Supporter

• Prostate Carcinoma Database since 1992• Profound preop. data from each patient and his tumor

(risk classification)• Outcome-Data from 22.956 Pat. after RP (Jan. 2017)

• No money: not from the administration or grants• No IT -System• No motivation of the staff• Critic of the referring urologists

Martini-Klinik


▪ Prostate Cancer Database since 1992

▪ PROM = Patient Reported Outcome Measurement

Martini-Database

Most of our recent patients online

9Martini-Database

PROM = Patient Reported Outcome Measurement

• 1week after catheter ex • early continence• 4 questions

• 6 moths post op • Grad3/4 Clavien Dindo • Complications

• Yearly for 10 years • 26 validated questions– EPIC 26

• Functional Outcome– Bladder function – Bowel function– Erectile function– Hormone Therapy

• Yearly, lifelong • 7 questions • Oncologic Outcome


69 94 80 120133192211319381485538561673791

1024133615581757

1976212221422079210222062321

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

22000

Pa

tie

nte

na

nza

hl

OP year

RP'sper year

RP's: n=25272BCR: n=4404Metastases: n=985Other Cause Mort.: n=1266PCa Mortality: n=321

Pat. Withcomplete follow-up

75.5%

> 22 956 pts. have contributed so far relevant data

Martini-Database

Pat. withfollow up


approx. 1,400 questionnaires / month

Outcome study group: 2 Database manager1 IT expert1 Biostatician

An investment is necessary

Martini-Database

12Database Outcome measurement

Clinical research

Pat. information/counselling

Valu - based Health Care

Quality control

Basic science

3

2

1

4

5

13Database has contributed to high scientific output

86

70

63

46

4037

42

32

18

0

10

20

30

40

50

60

70

80

90

100

2008 2009 20152007 20112006 2010 20142012

year

Number of publications / year

2005 2013

40

58

300 – 400Impact f. points / year

14Basic science: ICGC, TCGA

15Basic science: ICGC, TCGA

Hamburg TMA plus DatabaseSamples of 18 000 RP Pat. and their Outcome Data

Study cohort on TMABiochemical relapse

among categories

(n=11152) (n=1824)

Follow-up (mo)

Mean 53.4 -

Median 36.8 -

Age (y)

70 1439 232

Pretreatment PSA (ng(ml)

20 720 309

pT category (AJCC 2002)

pT2 7370 570

pT3a 2409 587

pT3b 1262 618

pT4 63 49

Gleason grade

≤3+3 2859 193

3+4 1565 573

4+3 6183 849

≥4+4 482 208

pN category

pN0 6117 1126

pN+ 561 291

Surgical margin

negative 8984 1146

positive 1970 642

No. of patients (%)

a) b)

c)

d)

e)

12 000 Prostate Carcinoma

600 normal Prostate tissue

180 normal Prostate

(Cystoprostatectomy)

16

BCR-free survival Cancer-specific survival

pT-stage10 year

cancer-specific survival

pT2 98,0%

pT3a 96,0%

pT3b 85,0%

pT4 72,0%

pT-stage 10 year BCR-free

pT2 87,0%

pT3a 53,0%

pT3b 28,5%

pT4 9,4%

Patient counselling


0%

20%

40%

60%

80%

100%

Alt

er

zu

r O

P

18

100,096,4

98,595,6

98,5100,099,094,6

99,199,0

6,310,7

14,9

2,2

10,4

3,28,67,55,64,8

0%

20%

40%

60%

80%

100%

Surgeon954 6 10872 31

R1

Nerversparing (NE) and positive margin (R1) pT2 PCa

Δ-0.5 Δ-2.1 Δ-2.4 Δ+4.6 Δ-2.0 Δ+6.3 Δ-0.2 Δ+2.4 Δ+0.2 Δ-2.1

NE

R1

Internal quality control of all surgeons every 6 months


PSA recurrence free survival – pT2

Surgeon

Internal quality control of all surgeons every 6 months

20

One week letter:Continence 1 week after removing the catheter

0%

20%

40%

60%

80%

100%

1095 8762 Surgeon

Vorlagen

≥4 2/3 0/1pads

421 3


*Individuel adapted, intraprostatic

apex preparation

71% Continence after1 week. Identical postive margin rate

13.7% / 14.2% (pT2-4 )

Lee et al. Urology 2006

Internal quality control every 6 months

22

789679

562

21451983

1032

547486382320

15421759

1336

0

20

40

60

80

100

2006 201020092008200720052004200320022001 201120001999

Frequency of continence (%)

Year

Significantly improving continence rates over time

An

nu

al N

o. r

adic

al p

rost

atec

tom

ies

20062000

1998

1992

2005 2008

Average continence1 year after RP, Germany

Surgeon

23

Variations in outcome -national and international

1yr severe erectile dysfunction1 yr full continence 1yr severe urinary incontinence

Ø

56,7 %

Ø

75,5 %

Ø

80,0 %

Ø

50,0 %

Ø

4,5 %

Ø

10,0 %

34,7 %

93,5 %

0,4 %

1. Swedish data rough estimates from graphsSource: National quality report for the year of diagnosis 2012 from the National Prostate Cancer Register (NPCR) Sweden, Martini Klinik, BARMER GEK Report Krankenhaus 2012, Patient-reported outcomes (EORTC-PSM), 1 year after treatment, 2010

http://upload.wikimedia.org/wikipedia/commons/b/ba/Flag_of_Germany.svghttp://upload.wikimedia.org/wikipedia/commons/b/ba/Flag_of_Germany.svghttp://upload.wikimedia.org/wikipedia/commons/4/4c/Flag_of_Sweden.svghttp://upload.wikimedia.org/wikipedia/commons/4/4c/Flag_of_Sweden.svghttp://upload.wikimedia.org/wikipedia/commons/b/ba/Flag_of_Germany.svghttp://upload.wikimedia.org/wikipedia/commons/4/4c/Flag_of_Sweden.svg


Some examples (ICHOM)

variation in 30-day mortality rate from heart attack in US

variation in bypass surgery mortality in the UK

variation in complication rates from radical prostatectomies in the Netherlands

variation in reoperation rates after hip surgery in Germany

variation in mortality after colon cancer surgery in Sweden

9x

18x

20x

Source: International Consortium for Health Outcomes Measurement

2x

4x

Variation in outcome: best/worst

http://upload.wikimedia.org/wikipedia/commons/2/20/Flag_of_the_Netherlands.svghttp://upload.wikimedia.org/wikipedia/commons/a/ae/Flag_of_the_United_Kingdom.svghttp://upload.wikimedia.org/wikipedia/commons/2/20/Flag_of_the_Netherlands.svghttp://upload.wikimedia.org/wikipedia/commons/b/ba/Flag_of_Germany.svghttp://upload.wikimedia.org/wikipedia/commons/4/4c/Flag_of_Sweden.svg


Traditional instruments for quality control and certification in health care

Process / management control

Certification, audits, quality report

Minimal surgical volume regulation

Regionalisation

No Outcome

Variation in outcome


low vs. high surgeon volume (> 40 RRPs/ year)

Transfusion rate OR 8,6

Perioperative complications, p < 0.001

numbers of LN : p < 0,009

Positive surgical margins: p < 0.001

Biochemical recurrence: p < 0.001

Risk of adjuvant therapy: p < 0.001)

Late urinary complications : p < 0.001

Potency- and Continence after 1 year: p < 0.005

Surgeon volume and

outcome

High volume


Value =

Cost of delivering those outcomes

Patient health outcomesachieved

Outcome measurements are the powerful lever to unlock a

value-based healthcare system

“Stern” Interview- März 2013: Es ist unethisch, keine Outcome Messungen zu haben

Redefining Healthcare; M. E. Porter & E. O. Teisberg 2006

Value-based Healthcare (VBHC)


International Consortium of Health Outcomes Measurement



Value-based Healthcare System:

ICHOM-Standard Set for most diseases

Systematic,

standardised ,

risk adapted ,

transparent,

international comparable

Outcome-analysís by the use of PROM

Minimal Data Set per disease:

Only outcome data-which matters for the patients



ICHOM’s first Standard Sets

What should be documented before and after treatment ?

A minimal Standard Set for cross disciplinary Outcome Measurement - identical for all treatment options including AS


31

March 2013Invitation to experts to jointhe working groupby H.Huland / M.Graefen

Mai 2013Meeting of the working group at the AUA,San Diego

Mai-Dec. 20136 Telephone conferences,multiple surveysof the working group

Nov. 2013 Manual Loc. Prostate Cancer2nd ICHOM conference ,Harvard Boston

Prostate Cancer Working Group: 28 Pers. 9 countries: Urology, Radiotherapy, Exp. nat. Registries , Pat. Represent.


PCO-CRV Leadership Team

Prostate Cancer Outcomes-Compare And Reduce Variation PCO-CRV Trial

C . M O O R E S . E V A N SH . H U L A N DM . L I T W I NJ . M I L L A R J . L E W I S

• To describe international patterns of presentation, care, and patient-reported outcomes for men diagnosed with localized prostate cancer.

• To provide feedback on quality metrics and outcomes; thereby identifying organisations with better and worse outcomes and to identify contributing structure and process factors.

M O V E M B E R

P. V I L A N T I

I N T E R N A T I O N A L S T U D Y S I T E S : 1 4 0 I N S T . 1 4 C O U N T R I E S


I n t e r n a t i o n a l s t u d y s i t e s : 1 4 0 I n s t . 1 4 C o u n t r i e s

Prostate Cancer Outcomes-Compare And Reduce Variation


Outcome Measurement

with transparent results

Requires an investment, but it pays off

It is intellectual fun

Enables medical progress

Improves Quality

Reduce overall costs

Can be the basis for a great success for the clinic

We should do it for our patients

Martini-Prinzip

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 35Martini-Prinzip


Prostate Cancer Outcome (PCO) Study

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 39Value-based Healthcare (VBHC)

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 402017 – standard sets for 50%

of the world wide diseases

201

7

50%

201

6

46%

201

5

40%

201

4

29%

201

3

14%

Krankheitslast in

Industrienationen

4

Krankheitsbilder

2013 2014 2015 2016 2017

12

Krankheitsbilder

24

Krankheitsbilder 40

Krankheitsbilder

50+

Krankheitsbilder


With a vision of systematically measuring clinical and patient outcomes for men with

localised disease, comparing health outcomes, sharing results and mobilising the exchange of knowledge in a global population, PCO-CRVs Study Objectives

are:

Prostate Cancer Outcomes-Compare And Reduce Variation PCO-CRV Trial

42

Theodor Billroth, 1860

Quote by a visionary German surgeon 150 years ago

Soon, there will be a time where our scholars and colleagues will not be satisfied with general comments

on surgical quality outcome-instead they will call any physician a charlatan who is

incapable to quantify his results.

““


▪ > 5,000 Prostata(cancer?) Patienten

▪ > 1,500 Prostata Biopsien (MRI-Fusion/konv./ Elastographie)

▪ > 2,400 Radicale Prostatektomien

▪ > 400 primäre Bestrahlung

▪ klinische Studien (> 700 Patienten rekrutiert)

▪ Wiss. Output (2015: 87 Publikationen, 560 Impact Punkte)

EIN Jahr in der Martini-Klinik

Martini-Prinzip


Vickers, JNCI 2007

Individuelle Lernkurve

High volume


Neurovascular Structure Adjacent Frozen-Section Examination

positive margins =

no nerve sparing

negative margins =

nerve sparing

NeuroSAFE


StagingNerve

Preservation

Positive

Surgical

Margins

pT2 99 / 92 7 / 12

pT3a 94 / 72 21 / 32

pT3b 88 / 40 47 / 51

NeuroSAFE 97 %

Control 81 %

79,8%

Impact on nerve preservation

Nerve preservation

all stages

Schlomm, Eur Urol 2012

Nerve preservation in:

- 25.561 cases in germany 2012: 32.8 %

- 18.355 AOK-Patients 2008-2011

treated in 245 hospitals with

> 30 cases per year 37.8 %

- Barmer GEK Report 2012: 47.4 %

NeuroSAFE


Quelle *3: BARMER GEK Krankenhaus Bericht 2012

Quelle *4: Martini-Klinik Datenbank

Outcome

600

Martini-Klinik 2013

n = 2147

88.2 %

4.2 %

7.6 %

NeuroSAFE Reduces

Radiation Therapy

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 50Anteil Martini-Klinik /

Prostatektomien in Deutschland

10000

11000

12000

13000

14000

15000

16000

17000

18000

19000

20000

21000

22000

23000

24000

25000

26000

27000

28000

29000

30000

31000

32000

33000

34000

0,00

1,00

2,00

3,00

4,00

5,00

6,00

7,00

8,00

9,00

10,00

11,00

12,00

13,00

14,00

15,00

16,00

17,00

2005 2006 2007 2008 2009 2010 2011 2012

RRP in Deutschland / Anteil MKMarktanteil

Martini-Prinzip


Vorteile auch für die Kern-Urologie

1. Ein Oberarzt der Urologie rotiert für mind.1-2Jahre

in die Martini-Klinik mit ca 200 RP /Jahr

2. 1 bis 2 Assistenten der Urologie rotieren ca1-Jahr

in die MK mit intensiver klinischer und wissensch.

Ausbildung (1bis 2 Jahre Facharzt Anerkennung)

3. Gemeinsame Projekte: Kongresse,

Fortbildung, Forschungsprojekte, Drittmittel ,

Vorträge , Publikationen, Auslandsjahr der Ass.

ect.

4. Gewinnabführung an das UKE

Martini-Prinzip


Die chirurgisch-onkologischen Ergebnisse verbessern sich mit steigender Opeartionszahl

Source: Vickers et al., J Natl Cancer Inst 2007; 99: 1171–1177

23

50–

99

18

29

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 53Martini-Klinik Patients Travel!

73 72 69 6962 58 59 56 56

15 13 15 1519

21 18 20 19

8 11 11 10 13 14 14 15 17

3 3 3 4 4 5 5 6 61 2 2 2 2 2 3 3 3

0%

20%

40%

60%

80%

100%

2005 2006 2007 2008 2009 2010 2011 2012 2013

Hamburg Region Within 300 Km 300 - 600 Km 600 - 900 Km International

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 5409/2017 Additional Ward

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 552020 New Martini-Klinik


Some ideas to establish general

Outcome Measurement in health care systems

OM results for:

- Certification for Centers - Reimbursement for treatments

e.g. not the number of cases but quality counts

OM results transparently reported e.g. on websites of :

- patients

- physicians

- health insurance companies

- hospitals

57

2.2132.1022.0792.1422.1221.9761.7571.5561.3361.024791673561538485381211

8094690

1.000

2.0003.0004.0005.000

6.0007.0008.000

9.00010.00011.00012.000

13.00014.00015.000

16.00017.00018.00019.000

98.6

1997 19981994

98.4

19931992

99.098.298.699.3

1996 2006

95.6

2003

96.9

2005

95.7

97.9

2000

98.2

1999

95.2

2001 2004 2007

95.3

95.8

2002

97.8

98.4

2008

Patient number

1995

99.0

89.6

2012 2013

93.4

20112009

94.9

2014

83.7

2015

91.9

94.1

2010

94.6

319

OP year

120 192133

23.000 patients have contributed so far relevant data to Martini database

1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015189.2 181 192.8 178.3 179.2 180.4 170.2 156.7 144.7 144 132.1 120.4 108.7 96.7 84.9 80.7 72 60 48.1 36.2 24.8 13.6 8.9 1.4

Dat

abas

e-

Sup

po

rte

r

RP's / year

% patient with follow-up information per year

Database: RP (total n= 22 956) high follow-up rate (75.5%)

58

Each faculty member has a dedicated field of supra-specialization in prostate cancer

• (Study Outcome Group, Robotic Surgery)Prof. M. Graefen

Prof. H. Heinzer

Prof. H. Huland

Prof. A. Haese

Prof. T. Steuber

Prof. T. Schlomm

PD Dr. G. Salomon

Dr. U. Michl

Dr. I. Thederan

PD Dr. L. Budäus

Prof. Dr. D. Tilki

• (Resident Education, Events)

• (International Outcome Standardization)

• (Robotic Surgery, Serum/Urine Marker)

• (Advanced PCa)

• (Basic Science, Genom Analysis)

• (Focal Therapy, Imaging)

• (QoL, Functional Data)

• (Complementary Medicine, Nutrition)

• (Imaging)

• (Clinical Science , International Cooperations)

59Martini-Klinik

Associated Faculty

• AnästhesiologyDr. von Breunig

Prof.Dr. Sauter

Dr. Schwarz

PD.Dr. Beyersdorff

Dr. Krüger,

Dr. Schöllermann

• Pathology

• Radiation Therapy

• Radiology

• Psychooncology

Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 60Top 10 academic PCa center 2015


Laborjournal 7/8 2012

„...most cited

German speaking

Urologists.“

Database Outcome measurement


Continence (%) 1 year after RP

Surgeon

Significantly improving continence rates over time

9


0

10

20

30

40

50

60

70

80

90

100

%

R1 pT2 aktuell

R1 pT2 zuvor

NE pT2 aktuell

NE pT2 zuvor

pT2 Tumor

Δ+0.5

Δ+2.1

Δ-2.4

Δ+4.6

Δ+2.0

Δ+6.3

Δ+0.2

Δ+2.4

Surgeon

Nerversparing (NE) and positive margin (R1)

current - before -

1 2 3 4 5 6 7 8



More than 50% of all RP in Germany were done in hospitalwith less 50 RP per year

0

500

1000

1500

2000

2500

1 9

17

25

33

41

49

57

65

73

81

89

97

10

5

11

3

12

1

12

9

13

7

14

5

15

3

16

1

16

9

17

7

18

5

19

3

20

1

20

9

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7

22

5

23

3

24

1

24

9

25

7

26

5

27

3

28

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3

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1

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1

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9

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7

38

5

39

3

# hospitals

# prostaectomies per year

High/low volume


low vs. high hospital volume(> 54-141 RRPs/ year)

30 day mortality : RR 1.51

Blood transfusion : p < 0.001

Intraoperative complications : p < 0.01

Postoperative complications : p < 0.001

Late urinary complications : p < 0.001

risk of adjuvant therapy : p < 0.001

IMC : low: 19%, high: 1.3%, p < 0.001

High volume

66

789679

562547486

382320

230195142120819469

18

364

686

1.500

500

1.000

0

2.500

2.000

2004 20072002 20112010200820032001200019991996 1998 200919971992

151

1.973

225

1.755

19941993 1995

RP in HH/Martini-Klinik, 1991-2011 n=14682

20062005

1.335

1.541

2.225

1.024

DaVinciTotal Number Nerve-sparing

Patient counselling


▪ Revision < 0.2 %

▪ Colon/ureter injury < 0.2 %

▪ death 0 %

▪ blood transfusion < 5 %

▪ MRSA < 0.1 %


Prof. Hartwig Huland Qualitätskontrolle und Fortschritt Nr. 68Measure what you are Doing!Internal quality control every 6 months

Hartwig Huland, Systematic, standardized outcome ......Martini-Klinik Station 1 73,48 Martini-Klinik...

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