six sigma for clinicians what does it really mean?

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SIX SIGMA FOR CLINICIANS What does it really mean? SIX SIGMA IN HEALTHCARE New Orleans, Louisiana March 3-4, 2005 Larry V. Staker MD, FACP CMO Deseret Mutual Salt Lake City, Utah

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Page 1: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA FOR CLINICIANSWhat does it really mean?

SIX SIGMA IN HEALTHCARENew Orleans, Louisiana

March 3-4, 2005

Larry V. Staker MD, FACP

CMO Deseret Mutual

Salt Lake City, Utah

Page 2: SIX SIGMA FOR CLINICIANS What does it really mean?

“If to do were as easy as to knowwhat were good to do, then chapelshad been churches and poor men’scottages, princes palaces.”

Merchant of VeniceWilliam Shakespeare

© Larry V. Staker MD

Page 3: SIX SIGMA FOR CLINICIANS What does it really mean?

Clinicians Six Sigmaor

Clinical Practice Improvement

PEDAGOGY

(are there better ways to teach)

Page 4: SIX SIGMA FOR CLINICIANS What does it really mean?

SIXSIGMA

EBM

STANDARDS

MEASUREMENT

OUTCOMES

ACCOUNTABILITY

$ENSE

1

2

3

4

6

5

Page 5: SIX SIGMA FOR CLINICIANS What does it really mean?

1

METHODS

Start with Evidence Based Medicinefor

“CLINICAL PRACTICE IMPROVEMENT”

Page 6: SIX SIGMA FOR CLINICIANS What does it really mean?

Evidence Based Medicine

SUMSwith disease without disease

test pos a b a+btest neg c d c+d

a+c b+d a+b+c+d

NUMBERS2 x 2 TABLE

SUMSwith disease without disease

test pos a b a+btest neg c d c+d

a+c b+d a+b+c+d

NUMBERS2 x 2 TABLE

Page 7: SIX SIGMA FOR CLINICIANS What does it really mean?

UNDERSTANDING2 x 2 TABLES

SUM RATIOa b a+bc d c+d

a+c b+d T=(a+b)+(c+d)a/(a+c) d/(b+d)c/(a+b) b/(c+d)LR (+) LR (-) Likelihood

sens/(1-spec) (1-sens)/spec Ratios

(a+c)/T

NUMBER PERCENT / RATEa/(a+b)d/(c+d)

Page 8: SIX SIGMA FOR CLINICIANS What does it really mean?

IMPROVING DIAGNOSTIC SKILLS The Basic Tool is a 2 x 2 Table

AImproving Diagnostic Skills

A TOOL FOR DETERMINING THE USEFULNESS OF A DIAGNOSTIC TEST (enter numbers in white boxes) © Larry V. Staker MD

SUMS RATIOSwith disease without disease

test pos 475.0 50.0 525 90.5% PPV 90.5%test neg 25.0 450.0 475 94.7% NPV 5.3%

500 500 1000 50.0% PTPSnOUT SENS

True (+) rate 95.0% 10.0% False (+) rate

False (-) rate 5.0% 90.0% True (-) rateSPEC SpIN

LR (+) LR (-)9.50 0.06

sens/(1-spec) (1-sens)/spec

NUMBERS PERCENTS / RATES / PROPORTIONS

Likelihood Ratios

Post Test Probability given positive result

(1/NPV) = Post Test Probability given negative result

Pre Test Probability of disease estimated from Hx / PE

THE BASIC TOOL FOR IMPROVING DIAGNOSTIC SKILLS

POST TEST PROBABILITY (pos)POST TEST PROBABILITY (neg)

PRE TEST PROBABILITY

LIKELIHOODRATIOS

Page 9: SIX SIGMA FOR CLINICIANS What does it really mean?

A SOURCE OF INFORMATIONTO IMPROVE SKILLS

OF DIAGNOSIS

ISBN = 9-943126-74-6

DIAGNOSTIC STRATEGIESFor Common Medical Problems

Second Edition

Edited By: Edgar R Black MDPublisher: American College of Physicians

TEST SEN SPECETT and ST Seg ?

0.5 - 0.99 86.0% 77.0%1.0 - 1.49 65.0% 89.0%

1.50 - 1.99 42.0% 98.0%2.0 - 2.49 33.0% 99.0%

>= 2.5 20.0% 99.5%ETT and

Thallium 88.0% 91.0%SPECT 90.0% 72.0%

Adenosine 89.0% 83.0%Dipyridamole-o 87.0% 75.0%Dipyridamole-iv 90.0% 78.0%

Dobutamine 91.0% 86.0%Stress ECHO 81.0% 89.0%Dobutamine ECHO 81.0% 83.0%

Page 10: SIX SIGMA FOR CLINICIANS What does it really mean?

THE OUTPUT OF THE TOOLpost-test probabilities and likelihood ratios

PreTOR PostTLR © Larry V. Staker MDDisease Pos Test

PreTProb Pre:1 Post:1 PTP Disease - Pos Test

75.0% 7.5 2.5 3.00 28.50 96.6% 21.6% CI 95 ( 95.5% 97.7% )10.0% 1 9 0.11 1.06 51.4% 41.4% CI 95 ( 48.3% 54.4% )20.0% 2 8 0.25 2.38 70.4% 50.4% CI 95 ( 67.5% 73.2% )

30.0% 3 7 0.43 4.07 80.3% 50.3% CI 95 ( 77.8% 82.7% )40.0% 4 6 0.67 6.33 86.4% 46.4% CI 95 ( 84.2% 88.5% ) PostTLR50.0% 5 5 1.00 9.50 90.5% 40.5% CI 95 ( 88.7% 92.3% ) >2560.0% 6 4 1.50 14.25 93.4% 33.4% CI 95 ( 91.9% 95.0% )70.0% 7 3 2.33 22.17 95.7% 25.7% CI 95 ( 94.4% 96.9% )

80.0% 8 2 4.00 38.00 97.4% 17.4% CI 95 ( 96.5% 98.4% )90.0% 9 1 9.00 85.50 98.8% 8.8% CI 95 ( 98.2% 99.5% )

PreTOR PostTLR © Larry V. Staker MDDisease Neg Test

PreTProb Pre:1 Post:1 PTP Disease - Neg Test

75.0% 7.5 2.5 3.00 0.17 14.3% 60.7% CI 95 ( 12.1% 16.5% )10.0% 1 9 0.11 0.01 0.6% 9.4% CI 95 ( 0.1% 1.1% )20.0% 2 8 0.25 0.01 1.4% 18.6% CI 95 ( 0.6% 2.1% )

30.0% 3 7 0.43 0.02 2.3% 27.7% CI 95 ( 1.4% 3.3% )40.0% 4 6 0.67 0.04 3.6% 36.4% CI 95 ( 2.4% 4.7% ) PostTLR50.0% 5 5 1.00 0.06 5.3% 44.7% CI 95 ( 3.9% 6.6% ) <0.2560.0% 6 4 1.50 0.08 7.7% 52.3% CI 95 ( 6.0% 9.3% )70.0% 7 3 2.33 0.13 11.5% 58.5% CI 95 ( 9.5% 13.5% )

80.0% 8 2 4.00 0.22 18.2% 61.8% CI 95 ( 15.8% 20.6% )90.0% 9 1 9.00 0.50 33.3% 56.7% CI 95 ( 30.4% 36.3% )

Test

Treat

Treat

PreTOdds

PreTOdds

BENEFIT OF NEGATIVE TEST

Observe

BENEFIT OF POSITIVE TEST

Observe

Test

CONFIDENCE INTERVALSLR rule: +>25; -<0.25

Page 11: SIX SIGMA FOR CLINICIANS What does it really mean?

IMPROVING TREATMENT SKILLS The Basic Tool is a 2 x 2 Table

BChoosing Best Treatment

Enter numbers in white boxes © Larry V. Staker MD

SUMS MULT DIFF RECP RELATIONSHIPSTTG NTTG PROPORTIONS

experiment 140 20 160 87.5% ODDS

control 35 125 160 21.9% ODDS RATIOS

SUM 320

PERCENT 400.0% 0.0%MULTIPLICATION 17500 a*d c*b 700

DIFFERENCE 65.6% |EER-CER| ABI1.5 1/ABI NNT

RATIO 25 (a*d)/(c*b) ROR

BASIC TOOL FOR EVALUATING EFFECTIVENESS OF TREATMENT

NUMBERS

a/(a+b) TTG or EER

PERCENTS / RATES / PROPORTIONS

c/(c+d) NTTG or CER

RECIPROCAL

RB = EER/CER |ABI/CER| RBI

RBI, ABI, and NNT

Page 12: SIX SIGMA FOR CLINICIANS What does it really mean?

THE OUTPUT OF THE TOOLevaluation standards of peer review journals

FormulasSE Ln Ln SE

p1=a/(a+b) 0.035 EER 50.0% 43.1% 56.9% EER Experiment Event Ratep2=c/(c+d) 0.029 CER 15.6% 10.0% 21.3% CER Control Event RateI EER-CER I 0.036 ARR 34.4% 27.3% 41.5% ARR Absolute Risk Reduction1/ARR NNT 2.9 2.4 3.7 NNT Number Needed to TreatEER/CER RR 320.0% 217.6% 470.7% RR Relative Risk

0.197 1.1632 CI95 LnRR 0.777 1.549 CI95 LnRR Natural Log RBI EER-CER I /CER RRR 220.0% 117.6% 370.7% RRR Relative Risk Reduction(a*d)/(c*b) ROR 5.4 3.2 9.0 ROR Relative Odds Ratio

0.260 1.686 CI95 LnOR 1.178 2.195 CI95 LnOR Natural Log OR

CI-95Standard Error Calculation Enumerative Statistical Analysis

RBI, ABI, and NNT or

RRR, ARR, and NNT

CONFIDENCEINTERVALS

Page 13: SIX SIGMA FOR CLINICIANS What does it really mean?

PDSA

HEARING, SEEING and MEASURING

The Voice Of The Process

VOP

Page 14: SIX SIGMA FOR CLINICIANS What does it really mean?

PDSA

STUDY

PLAN

DO

ACT

PROCESSIMPROVEMENT

Page 15: SIX SIGMA FOR CLINICIANS What does it really mean?

PDSA: Minimize Variation

– There will always be some variation in a process

– But we can work to minimize variation around a mean or target

40

45

50

55

60

65

70

1 11 21 31 41 51 61 71 81

GOAL= reduce variation

Mean

UCL

LCL

Page 16: SIX SIGMA FOR CLINICIANS What does it really mean?

RAPID CYCLE TESTING

Discovery Learning

P

D

S

A

P

D

S

A

P

D

S

A

P

D

S

A

Thomas W. Nolan Ph.D.

Page 17: SIX SIGMA FOR CLINICIANS What does it really mean?

THE GAME OF IMPROVEMENTThe Work or

Process Base

The Measurement of Population Base

The Benchmark orEvidence Base

The Result or Outcome Base

© Larry V. Staker MD

TTG

1

2 4

3

5

Page 18: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA

HEARING, SEEING, and MEASURING

Voice Of The CustomerDefects Reduction Error Free Yield

VOCSigma Metric

Page 19: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA

1a

1b

1c2

3

4

5

PROCESSIMPROVEMENT

DEFINECORE PROCESSES

DEFINEKEY

CUSTOMERS

DEFINECUSTOMER

REQUIREMENTS

MEASURECURRENT

PERFORMANCE

ANALYZE

IMPROVE

CONTROLINTEGRATE

EXPANDP

D

C

A

Page 20: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA: Customer ServiceThe process shown here is stable.

But why does it need to be improved?

} CustomerNeed

Time

LSL

USL

UCL

LCL

Page 21: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA and PDSA

STUDY

PLAN

DO

ACT

1a

1b

1c2

3

4

5

PROCESSIMPROVEMENT

IDENTIFYCORE PROCESSES

IDENTIFYKEY

CUSTOMERS

DEFINECUSTOMER

REQUIREMENTS

MEASURECURRENT

PERFORMANCE

ANALYZE

IMPROVE

CONTROLINTEGRATE

EXPAND

Page 22: SIX SIGMA FOR CLINICIANS What does it really mean?

Although we may do a good job of teaching the best medical practice or treatment available today, we do a poor job of teaching ourselves how to decide when what we learnedin the past is no longer good enoughand needs to be changed.

Page 23: SIX SIGMA FOR CLINICIANS What does it really mean?

2

STANDARDS

NATIONALLY RECOGNIZED

“Evidence-Based”

Page 24: SIX SIGMA FOR CLINICIANS What does it really mean?

CLINICAL STANDARDS

Page 25: SIX SIGMA FOR CLINICIANS What does it really mean?

ATP III - Standards

Page 26: SIX SIGMA FOR CLINICIANS What does it really mean?

STANDARDS FORDIABETES CARE

1. HbA1c <= 7.0

2. LDLC <= 100

3. BP <= 135/85

4. Eye Exam Every year

5. Foot Exam Every visit

6. Microalbumin / Creat Once a year

Page 27: SIX SIGMA FOR CLINICIANS What does it really mean?

USING STANDARDS

1. Find an acceptable evidence-based Standard

2. Hold yourself to that Standard

3. Measure performance by that Standard

4. Evaluate and grade against the Standard (TTG)

5. Make $ense using the Standard

6. Negotiate Pay for Performance (P4P) from TTG

Page 28: SIX SIGMA FOR CLINICIANS What does it really mean?

3

MEASUREMENT

Start by teaching the use of simpleMeasurement Tools

Page 29: SIX SIGMA FOR CLINICIANS What does it really mean?

WHAT AND HOW WE MEASURE

SATISFACTION

COST QUALITY

PHYSICIANPERFORMANCE

WORK

Page 30: SIX SIGMA FOR CLINICIANS What does it really mean?

WHAT AND HOW WE MEASURE

PHYSICIANPERFORMANCE

COST QUALITY

SATISFACTION

WORK

Page 31: SIX SIGMA FOR CLINICIANS What does it really mean?

WHAT AND HOW TO MEASURE

OUTCOMESCOST QUALITY

SATISFACTION

Page 32: SIX SIGMA FOR CLINICIANS What does it really mean?

© Larry V. Staker MD

UNDERSTANDING VARIATION

SPECIAL CAUSE VARIATION SPECIAL CAUSE VARIATION

COMMON CAUSE VARIATION

Page 33: SIX SIGMA FOR CLINICIANS What does it really mean?

© Larry V. Staker MD

HOW WE MEASURETime Sequence Data Display

TIME

KPVMEDIAN

SPECIAL CAUSE VARIATION

SPECIAL CAUSE VARIATION

COMMON CAUSE VARIATION

UCL

LCL

COMMON CAUSE VARIATION

Page 34: SIX SIGMA FOR CLINICIANS What does it really mean?

Intraoccular Traumatic Test

Rapid Feedback of Information

Time Ordered Sequence

LINE AND SPEC CHART

LEARNING TO USE

Page 35: SIX SIGMA FOR CLINICIANS What does it really mean?

LINE CHART

KPV PLOTTED IN TIME ORDERED SEQUENCE

60

80

100

120

140

160

180

200

60

80

100

120

140

160

180

200

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

81 98 110 99 110108120 96 90 91 85 108 99 92 107102 83 92 125 98 102102109 95 116102106 98 80 130113

FB

S

dayfbs

Page 36: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHARTPATIENT

60

80

100

120

140

160

180

200

60

80

100

120

140

160

180

200

1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031

FB

S

TREATMENT GOAL (TG)

UPPER SPECIFICATION LIMIT (USL)

LOWER SPECIFICATION LIMIT (LSL)

day

Page 37: SIX SIGMA FOR CLINICIANS What does it really mean?

TREATMENT TO GOAL

SUPERIMPOSE

SPECIFICATION CHARTS ON LINE RUN OR CONTROL CHARTS

and use

THE INTEROCULAR TRAUMATIC TEST

( ITT )

Joseph Berkson MD, PhD. Mayo Clinic

Page 38: SIX SIGMA FOR CLINICIANS What does it really mean?

© Larry V. Staker MD

LINE AND SPEC CHART

KPV PLOTTED IN TIME ORDERED SEQUENCE

60

80

100

120

140

160

180

200

60

80

100

120

140

160

180

200

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

81 98 110 99 110108120 96 90 91 85 108 99 92 107102 83 92 125 98 102102109 95 116102106 98 80 130113

FB

S

TREATMENT GOAL

USL

LSL

dayfbs

Page 39: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHART Diabetes Mellitus

PATTERN: INTERVENTION:

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

60

80

100

120

140

160

180

200

3

4

5

6

7

8

9

10

11

DAY OF MONTH

FG (mg/dl) FG (mmol/l)

USL

CL

LSL

Page 40: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHART Diabetes Mellitus

PATTERN: INTERVENTION:

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

60

80

100

120

140

160

180

200

3

4

5

6

7

8

9

10

11

DAY OF MONTH

FG (mg/dl) FG (mmol/l)

USL

CL

LSL

Page 41: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHART Diabetes Mellitus

PATTERN: INTERVENTION:

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

60

80

100

120

140

160

180

200

3

4

5

6

7

8

9

10

11

DAY OF MONTH

FG (mg/dl) FG (mmol/l)

USL

CL

LSL

Page 42: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHART Diabetes Mellitus

PATTERN: INTERVENTION:

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

60

80

100

120

140

160

180

200

3

4

5

6

7

8

9

10

11

DAY OF MONTH

FG (mg/dl) FG (mmol/l)

USL

CL

LSL

Page 43: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHART Diabetes Mellitus

PATTERN: INTERVENTION:

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

60

80

100

120

140

160

180

200

3

4

5

6

7

8

9

10

11

DAY OF MONTH

FG (mg/dl) FG (mmol/l)

Page 44: SIX SIGMA FOR CLINICIANS What does it really mean?

SPECIFICATION CHART Diabetes Mellitus

PATTERN: INTERVENTION:

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

60

80

100

120

140

160

180

200

3

4

5

6

7

8

9

10

11

DAY OF MONTH

FG (mg/dl) FG (mmol/l)

USL

CL

LSL

Page 45: SIX SIGMA FOR CLINICIANS What does it really mean?

Peak Flow in AsthmaRun Chart - Ashtm a

0

50

100

150

200

250

300

350

400

450

500

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Day

Pe

ak

Flo

w

Page 46: SIX SIGMA FOR CLINICIANS What does it really mean?

Peak Flow in AshtmaRun Chart - Ashtm a

0

50

100

150

200

250

300

350

400

450

500

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Day

Pe

ak

Flo

w

Page 47: SIX SIGMA FOR CLINICIANS What does it really mean?

Peak Flow in AsthmaASTHMA - Control Chart (X)

UCL=381.85

LCL=290.65

CEN=336.25

UCL=395.48

LCL=202.02

CEN=298.75

UCL=459.85

LCL=387.65

CEN=423.75

0

50

100

150

200

250

300

350

400

450

500

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Day

Page 48: SIX SIGMA FOR CLINICIANS What does it really mean?

4

OUTCOMES

Doing what you do better

Page 49: SIX SIGMA FOR CLINICIANS What does it really mean?

The best sources of clear learningobjectives in clinical medicine are theproblems presented by our own patients.

Page 50: SIX SIGMA FOR CLINICIANS What does it really mean?

160 Diabetic Patients

Three Rapid Improvement Cycles

1. Patient self monitoring

2. Improved process of care

3. Use of best medication

Page 51: SIX SIGMA FOR CLINICIANS What does it really mean?

DATA COLLECTIONPN DATE FBS HbA1c10251 4/8/1992 132 20.510063 4/8/1992 339 19.410163 4/20/1992 251 10.710075 4/23/1992 368 12.310719 4/23/1992 219 11.310251 5/6/1992 381 15.310025 6/1/1992 92 7.110719 6/2/1992 180 9.910063 6/3/1992 91 15.910248 6/9/1992 378 16.410251 6/10/1992 369 15.510075 6/29/1992 303 13.110163 7/1/1992 256 10.710491 7/9/1992 147 9.610075 7/23/1992 220 11.710248 8/14/1992 149 15.110251 8/26/1992 348 15.410191 9/10/1992 276 15.410719 9/10/1992 184 9.1

Page 52: SIX SIGMA FOR CLINICIANS What does it really mean?

POPULATION BASED DATA

1992 - 1994

50 150 250 3500

20

40

60

80

100

0

20

40

60

80

100

BLOOD SUGAR

NU

MB

ER

COUNT : 631 MEDIAN : 168MEAN : 189MODE : 126STDEV : 84

NORMAL RANGE

© Larry V. Staker MD

Page 53: SIX SIGMA FOR CLINICIANS What does it really mean?

DIABETES SPEC CHARTPATIENT

60

80

100

120

140

160

180

200

60

80

100

120

140

160

180

200

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

FB

S

MONTH

© Larry V. Staker MD

Page 54: SIX SIGMA FOR CLINICIANS What does it really mean?

DIABETES SPEC CHART

KW D M N I D

0

50

100

150

200

250

300

350

400

0

50

100

150

200

250

300

350

400

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

374 219 180 184 182 265 198 190 191 173 153 144 133 143 132 150 136 129 120 111 124 141 120 149 118 141 130 131 128 120 133

FB

S

SPC

© Larry V. Staker MD

Page 55: SIX SIGMA FOR CLINICIANS What does it really mean?

DIABETES SPEC CHART

N N D M I D

0

50

100

150

200

250

300

350

400

0

50

100

150

200

250

300

350

400

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

264274225231228166126139148105141 83 136151117116121126101121145122144113 69 122145126159181139

FB

S

SPC

© Larry V. Staker MD

Page 56: SIX SIGMA FOR CLINICIANS What does it really mean?

DIABETES SPEC CHART D B D M B I D S

0

50

100

150

200

250

300

350

400

0

50

100

150

200

250

300

350

400

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

219228275252276246133182140176147138110 98 118140110146120128138 92 90 118126109122132103112117

FB

S

SPC

© Larry V. Staker MD

Page 57: SIX SIGMA FOR CLINICIANS What does it really mean?

DIABETES SPEC CHART JF D M BIDS

60

80

100

120

140

160

180

200

60

80

100

120

140

160

180

200

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

81 98 110 99 110108120 96 90 91 85 108 99 92 107102 83 92 125 98 102102109 95 116102106 98 80 130113

FB

S

OCTOBER

© Larry V. Staker MD

Page 58: SIX SIGMA FOR CLINICIANS What does it really mean?

FBS IN PATIENTS WITH DIABETES

0

50

100

150

200

250

YR 92 93 94 95 96217 189

176 171 166

DISPLAY OF MEAN OF ALL FBS DONE EACH YEAR

0

50

100

150

200

250

© Larry V. Staker MD

Page 59: SIX SIGMA FOR CLINICIANS What does it really mean?

HbA1c IN PATIENTS WITH DIABETES

REF RANGE: 4.8% - 7.8% ION EXCHANGE METHOD

NOTE: 1.0% CHANGE IN HbA1c = 30 MG/DL CHANGE IN FBS

DISPLAY OF MEAN OF ALL Hb A1c DONE EACH YEAR

0

2

4

6

8

10

12

YR 92 93 94 95 96

11.5 11.2

9.5 9.4 8.9

0

2

4

6

8

10

12

© Larry V. Staker MD

Page 60: SIX SIGMA FOR CLINICIANS What does it really mean?

HYPOTHESIS TESTINGHo: μA = μB or Ho: σA = σB

CYCLE 2 CYCLE 3 CYCLE 4 OUTCOME

Z Z Z Z Z Z Z Z Z93-92 94-93 95-94 96-95 97-96 98-97 99-98 00-99 00-950.999759 1.000000 0.674829 0.518497 1.000000 1.000000 1.000000 0.594465 1.000000

T T T T T T T T T93-92 94-93 95-94 96-95 97-96 98-97 99-98 00-99 00-950.013251 0.000005 0.628359 0.841768 0.000010 0.000205 0.000086 0.863190 0.000116

F F F F F F F F F93-92 94-93 95-94 96-95 97-96 98-97 99-98 00-99 00-950.252622 0.083474 0.529625 0.664346 0.000938 0.003996 0.244735 0.253290 0.000291

Improvement 1995-2000Hold Gains

BASELINE CYCLE 1

DCCT Published NEJM - 1993 Use of DM Spec and Run Charts

Improve DM Care

Use Best Meds

Page 61: SIX SIGMA FOR CLINICIANS What does it really mean?

1992 1993 1994 1995 1996 1997 1998 1999 2000

Percent TTG (Yeild) 13.3% 20.4% 38.6% 41.4% 37.7% 59.2% 73.4% 60.8% 63.8%Sigma 0.4 0.7 1.2 1.3 1.2 1.7 2.1 1.8 1.9

N 1000 1000 1000 1000 1000 1000 1000 1000 1000D or DPTO 866.667 795.580 613.757 585.586 623.188 407.692 266.254 391.534 361.963

eRATE or %d or %NTTG 86.7% 79.6% 61.4% 58.6% 62.3% 40.8% 26.6% 39.2% 36.2%Yield Probability 0.00

Number of Projects 9

Nth Root of Yield Probability 0.40Estimated Ave TTG (Yeild) 40.3%

DPMO MILLION DPKO THOUSAND %TTG %NTTG SIGMABASELINE PERFORMANCE

597483 1000000 597.483 1000 40.25% 59.75% 1.3TEN FOLD IMPROVEMENT

59748 1000000 59.748 1000 94.03% 5.97% 3.1

298742 1000000 298.742 1000 70.13% 29.87% 2.0TWO FOLD IMPROVEMENT

This tool calculates SIGMA for multiple clinical outcomes from input of percent treated to goal (TTG). It also allows forcasting or projection of overall DPKO, %TTG, eRATE (%NTTG) and SIGMA for ten fold and two fold improvement.

HbA1c <= 8.0

If you know the percent of patients treated to goal use this tool.

© Larry V. Staker MD

ESTIMATED NORMALIZED TTG and CALCULATION OF OVERALL SIGMAEnter Percent TTG (as a number like 75.5) in fields colored green

EVALUATION OF OVERALL SIX SIGMA PERFORMANCE

Page 62: SIX SIGMA FOR CLINICIANS What does it really mean?

1992 1993 1994 1995 1996 1997 1998 1999 2000

Percent TTG (Yeild) 8.1% 6.6% 20.1% 26.1% 22.5% 36.5% 50.2% 36.5% 38.7%Sigma 0.1 0.0 0.7 0.9 0.7 1.2 1.5 1.2 1.2

N 1000 1000 1000 1000 1000 1000 1000 1000 1000D or DPKO 918.519 933.702 798.942 738.739 775.362 634.615 498.452 634.921 613.497

eRATE or %d or %NTTG 91.9% 93.4% 79.9% 73.9% 77.5% 63.5% 49.8% 63.5% 61.3%Yield Probability 0.00

Number of Projects 9

Nth Root of Yield Probability 0.23Estimated Ave TTG (Yeild) 22.8%

DPMO M DPKO K %TTG %NTTG SIGMABASELINE PERFORMANCE

772255 1000000 772.255 1000 22.77% 77.23% 0.8TEN FOLD IMPROVEMENT

77225 1000000 77.225 1000 92.28% 7.72% 2.9

386127 1000000 386.127 1000 61.39% 38.61% 1.8TWO FOLD IMPROVEMENT

This tool calculates SIGMA for multiple clinical outcomes from input of percent treated to goal (TTG). It also allows forcasting or projection of overall DPKO, %TTG, eRATE (%NTTG) and SIGMA for ten fold and two fold improvement.

HbA1c <= 7.0

If you know the percent of patients treated to goal use this tool.

© Larry V. Staker MD

ESTIMATED NORMALIZED TTG and CALCULATION OF OVERALL SIGMAEnter Percent TTG (as a number like 75.5) in fields colored green

EVALUATION OF OVERALL SIX SIGMA PERFORMANCE

Page 63: SIX SIGMA FOR CLINICIANS What does it really mean?

5

ACCOUNTABILITY

A PERSONAL GRADING SYSTEM

“HOW AM I DOING?”

Page 64: SIX SIGMA FOR CLINICIANS What does it really mean?

The Sigma Metric: for Motorola

Percent DPMO 30.23% 697,672 1

69.15% 308,537 2

93.32% 66,807 3

99.38% 6,210 4

99.977% 233 5

99.9997% 3.4 6

ProcessCapability

Defects perMillion Opportunities

(distribution shifted ±1.5 s )

Increase in Sigmarequires exponentialdefect reduction

Error Free Yield

MANUFACTURING

Page 65: SIX SIGMA FOR CLINICIANS What does it really mean?

DPMO

1

10

100

1000

10000

100000

1000000

1 2 3 4 5 6

DPMO

DPMO6976723085376680762102333.4

Lo

g S

cale

Sigma

Exponential Defect Reduction

Page 66: SIX SIGMA FOR CLINICIANS What does it really mean?

The Sigma Metric: for Doctors

Percent DPHO GRADE

30.23% 69.7672 1 F

69.15% 30.8537 2 C

93.32% 6.6807 3 A

99.38% 0.6210 4

99.977% 0.0233 5

99.9997% 0.00034 6

ProcessCapability

Defects perHundred Opportunities

(distribution shifted ±1.5 s )

Increase in Sigmarequires exponentialdefect reduction

Error Free Yield or

TTG

Page 67: SIX SIGMA FOR CLINICIANS What does it really mean?

CALCULATION OF SIGMA

SIGMA = NORMSINV (1 - ( #defects / #observations)) + 1.5

The “Sigma Metric” allows reliable comparison of improvement

Page 68: SIX SIGMA FOR CLINICIANS What does it really mean?

6

$ENSE

MAKING THE BUSINESS CASE

“Breakeven and ROI”

Page 69: SIX SIGMA FOR CLINICIANS What does it really mean?

RETURN ON INVESTMENT

A Profitability Ratio

Net Profit (from Profit and Loss Statement)________________________________________

Net Worth (from Balance Sheet)

Page 70: SIX SIGMA FOR CLINICIANS What does it really mean?

Return On Investment- the profitability ratio –

value = ?? 0.10 ??

$ (Savings from best care)

$ (Investment in Equipment + Care)_______________________________

Page 71: SIX SIGMA FOR CLINICIANS What does it really mean?

Types of Economic Evaluations

• Cost Comparison Analysis

• Cost Benefit Analysis

• Cost Effectiveness Analysis

• Cost Utility Analysis

• Cost Outcomes Analysis

Page 72: SIX SIGMA FOR CLINICIANS What does it really mean?

Cost Comparison Analysis

• Comparison of costs and of two or more alternative therapies that have identical outcomes

• Examples– Generic versus brand name

– Different routes of administration

Page 73: SIX SIGMA FOR CLINICIANS What does it really mean?

COST COMPARISON ANALYSIS

$800414.0CAD47.8%0.9295.0%19.060.234.7683.0%81.0%Dobutamine ECHO

$400414.0CAD46.1%0.8596.7%29.450.217.3689.0%81.0%Stress ECHO

$1,200414.0CAD29.5%0.4296.3%26.000.106.5086.0%91.0%Dobutamine

$1,200414.0CAD33.9%0.5194.2%16.360.134.0978.0%90.0%Dipyridamole-iv

$1,200414.0CAD40.9%0.6993.3%13.920.173.4875.0%87.0%Dipyridamole-o

$1,200414.0CAD34.6%0.5395.4%20.940.135.2483.0%89.0%Adenosine

$1,200414.0CAD35.7%0.5692.8%12.860.143.2172.0%90.0%SPECT

$1,000414.0CAD34.5%0.5397.5%39.110.139.7891.0%88.0%Thallium

        ETT and

414.0CAD76.3%3.2299.4%160.000.8040.0099.5%20.0%>= 2.5

414.0CAD73.0%2.7199.2%132.000.6833.0099.0%33.0%2.0 - 2.49

414.0CAD70.3%2.3798.8%84.000.5921.0098.0%42.0%1.50 - 1.99

414.0CAD61.1%1.5795.9%23.640.395.9189.0%65.0%1.0 - 1.49

414.0CAD42.1%0.7393.7%14.960.183.7477.0%86.0%0.5 - 0.99

 $300  NEGNEGPOSPOS  ETT and ST Seg ↓

CostTestICD9DxPTProbPTLRPTProbPTLRLR -LR +SPECSENTEST

Page 74: SIX SIGMA FOR CLINICIANS What does it really mean?

Incremental Cost EffectivenessPresentation of Results

CA - CB

EOA - EOB

=

Cost for an additionalunit of effectiveness

Example:

CA - CB

EOA - EOB

=

$3194A - $2617B

45.6A - 42.9B

= $214 to gain anadditional unit ofeffectiveness with A

Page 75: SIX SIGMA FOR CLINICIANS What does it really mean?

IMPROVING SKILLS OF MANAGING COST

CEvaluation of Cost of Care

TEST SEN SPEC LR + LR - PostTLR PostTProb PostTLR PostTProb Dx ICD9 Cost/TestETT and ST Seg ? POS POS NEG NEG

0.5 - 0.99 86.0% 77.0% 3.74 0.18 5.61 84.9% 0.27 21.4% CAD 414.0 $3001.0 - 1.49 65.0% 89.0% 5.91 0.39 8.86 89.9% 0.59 37.1% CAD 414.0 $300

1.50 - 1.99 42.0% 98.0% 21.00 0.59 31.50 96.9% 0.89 47.0% CAD 414.0 $3002.0 - 2.49 33.0% 99.0% 33.00 0.68 49.50 98.0% 1.02 50.4% CAD 414.0 $300

>= 2.5 20.0% 99.5% 40.00 0.80 60.00 98.4% 1.21 54.7% CAD 414.0 $300ETT and

Thallium 88.0% 91.0% 9.78 0.13 14.67 93.6% 0.20 16.5% CAD 414.0 $1,000SPECT 90.0% 72.0% 3.21 0.14 4.82 82.8% 0.21 17.2% CAD 414.0 $1,200

Adenosine 89.0% 83.0% 5.24 0.13 7.85 88.7% 0.20 16.6% CAD 414.0 $1,200Dipyridamole-o 87.0% 75.0% 3.48 0.17 5.22 83.9% 0.26 20.6% CAD 414.0 $1,200Dipyridamole-iv 90.0% 78.0% 4.09 0.13 6.14 86.0% 0.19 16.1% CAD 414.0 $1,200

Dobutamine 91.0% 86.0% 6.50 0.10 9.75 90.7% 0.16 13.6% CAD 414.0 $1,200Stress ECHO 81.0% 89.0% 7.36 0.21 11.05 91.7% 0.32 24.3% CAD 414.0 $500Dobutamine ECHO 81.0% 83.0% 4.76 0.23 7.15 87.7% 0.34 25.6% CAD 414.0 $800

COST MINIMIZATION and COST EFFECTIVENESS ANALYSES

LR rule: +>25; -<0.25

Page 76: SIX SIGMA FOR CLINICIANS What does it really mean?

IMPROVING SKILLS OF MANAGING COST

TOOL FOR EVALUATION OF COST AND EFFECTIVENESS OF TREATMENT TO GOAL (TTG) [Gives Cost of Quality] © Larry V. Staker MDEnter Numbers in Red Boxes:

POPULATION WITH A DISEASE PROPORTION $300 cost visits/yrTTG NTTG n p $1,000 cost Rx/yr

experiment a 140 20 b 160 a+b 87.5% EER or %TTG $500 cost tests/yr

control c 25 135 d 160 c+d 15.6% CER or %NTTG $1,800 TOTALPanel Size Totals: 165 155 320 (a+b)+(c+d) 5.3% Prevalence

3000 a+c b+d0.5 2.7

FormulasSE Ln Ln SE

p1=a/(a+b) 0.026 EER 87.5% 82.4% 92.6% EER Experiment Event Ratep2=c/(c+d) 0.029 CER 15.6% 10.0% 21.3% CER Control Event RateI EER-CER I 0.027 ARR 71.9% 66.6% 77.2% ARR Absolute Risk Reduction1/ARR NNT 1.4 1.3 1.5 NNT Number Needed to TreatEER/CER RR 560.0% 388.8% 806.5% RR Relative Risk

0.186 1.7228 CI95 LnRR 1.358 2.088 CI95 LnRR Natural Log RBI EER-CER I /CER RRR 460.0% 288.8% 706.5% RRR Relative Risk Reduction(a*d)/(c*b) ROR 37.8 20.1 71.2 ROR Relative Odds Ratio

0.323 3.632 CI95 LnOR 2.999 4.266 CI95 LnOR Natural Log OR

COST ANALYSISOUTCOME

$2,504Δ SIGMA: $704

Standard Error Calculation Enumerative Statistical AnalysisCI-95

Cost of Poor Quality

Page 77: SIX SIGMA FOR CLINICIANS What does it really mean?

THE SIX SIGMA METHOD

Healthcare Delivery Systems

Larry V. Staker MD, FACP

Page 78: SIX SIGMA FOR CLINICIANS What does it really mean?

The Acronym is DMAIC

1

2

3

4

5

DEFINE

MEASURE

ANALYZE

IMPROVE

CONTROL

Page 79: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA

1a

1b

1c2

3

4

5

PROCESSIMPROVEMENT

DEFINECORE PROCESSES

DEFINEKEY

CUSTOMERS

DEFINECUSTOMER

REQUIREMENTS

MEASURECURRENT

PERFORMANCE

ANALYZE

IMPROVE

CONTROLINTEGRATE

EXPANDP

D

C

A

Page 80: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA

hearingseeing

and measuring

The Voice Of The CustomerVOC

Page 81: SIX SIGMA FOR CLINICIANS What does it really mean?

SIPOC - Process Analysis

SUPPLIERS

CUSTOMERS

OutputsInputs PROCESS

Page 82: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA: Minimize Defects

Percent DPMO 30.23% 697,672 1

69.15% 308,537 2

93.32% 66,807 3

99.38% 6,210 4

99.977% 233 5

99.9997% 3.4 6

ProcessCapability

Defects perMillion Opportunities

(distribution shifted ±1.5 s )

Increase in Sigmarequires exponentialdefect reduction

Error Free Yield

Page 83: SIX SIGMA FOR CLINICIANS What does it really mean?

The Sigma Metric: for Doctors

Percent DPHO GRADE

30.23% 69.7672 1 F

69.15% 30.8537 2 C

93.32% 6.6807 3 A

99.38% 0.6210 4

99.977% 0.0233 5

99.9997% 0.00034 6

ProcessCapability

Defects perHundred Opportunities

(distribution shifted ±1.5 s )

Increase in Sigmarequires exponentialdefect reduction

Error Free Yield or

TTG

Page 84: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA: Customer ServiceThe process shown here is stable.

But why does it need to be improved?

} CustomerNeed

Time

LSL

USL

UCL

LCL

Page 85: SIX SIGMA FOR CLINICIANS What does it really mean?

SIX SIGMA

DATA DRIVEN

Voice Of The CustomerDefects Reduction Error Free Yield

VOCSigma Metric

Page 86: SIX SIGMA FOR CLINICIANS What does it really mean?

REFERENCES

Staker LV. Practice Based Learning For Improvement: The pursuit of clinical excellence. Texas Medicine; V96, N10, Oct 2000, page 53-60.

Staker LV. Changing Clinical Practice by Improving Systems: The pursuit of clinical excellence through practice-based measurement for learning and improvement. QualityManagement in Health Care; V9, N1, Fall 2000, page 1-13.

Page 87: SIX SIGMA FOR CLINICIANS What does it really mean?

REFERENCE

Carey, Raymond G. Improving Healthcare with Control Charts: Basic and Advanced SPC Methods and Case Studies. ASQ Quality Press, Milwaukee, WI. September, 2002, 194 pages. ISBN 0-87389-562-2

Chapter 10, pages 159-183 by Larry V. Staker MDThe Use of Run Charts and Control Charts in the Improvement of Clinical Practice.