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Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living...

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Dose Adjustment for Normal Eating DAFNE Centre for Clinical Health Services Research & Development 31/03/09 A new approach to type 1 diabetes - Irish Study Update Dr Seán Dinneen
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Page 1: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Dose Adjustment for Normal Eating DAFNE

Centre for Clinical Health Services Research & Development

31/03/09

A new approach to type 1 diabetes - Irish Study Update

Dr Seán Dinneen

Page 2: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

SEP

“The aim of education for people with diabetes is to improve their knowledge and skills enabling them to take control of their own conditions and to integrate self-management into their daily lives”

NICE

Page 3: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

The goals of education

Competence:

• what individuals know or are able to do in terms of knowledge, skills and attitudes

Capability:

• the extent to which individuals can adapt to change, generate new knowledge, and continue to improve their performance

Fraser, Greenhalgh. BMJ 2001;323:799

Page 4: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

• Jean Phillipe Assal, Geneva; introduced the concept of TPE based (partly) on personal negative experiences

• Michael Berger (1944-2002), Dusseldorf; implemented the first structured education programme for patients with Type 1 diabetes

The “Founding Fathers” of TPE

Page 5: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Background

• 1970s: Self-management have been prominent elements of diabetes care in Germany

• Success prompted British Endocrinologists to trial a translated & modified version of the programme in the UK.

• Initial trial: ↓ in HbA1c levels without ↑ in hypoglycaemic episodes, ↑ patient satisfaction & QoL

• The number of DAFNE centres is ↑ every year. • The joint Diabetes UK / Department Health report on

Structured Patient Education in Diabetes (2005), stated that quality assurance (QA) is essential to ensuring the quality and validity of any diabetes education programme.

Page 6: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Irish DAFNE StudyHRB 2006• Aims: implementation &

evaluation of a SEP for people with T1D & to develop a new model of ongoing care based on peer-support and group follow-up

Sub-Studies• RCT of follow-up• Health Economics• Qualitative• Psychometric evaluation of

DSQOLS• Collaborations with DAFNE UK

Page 7: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

6

7

8

9

10

Beginning 6 months 12 months

Hb

A1c (

%)

Immediate DAFNE

Delayed DAFNE

n=144 participants in 3 centres

UK DAFNE Study

Page 8: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Irish DAFNE Study

• Establishment of a DAFNE Steering Group that involves a multi-disciplinary team across Ireland of Physicians, Psychologists, Health Economists, DNS, Dietitians, Biostatisticians & DAFNE experts from the UK

• Into year 3 of 5 years of research – with our HRB Mid-term review due in May 09

• Galway is the lead coordinating centre for this 6 site RCT study

• Recent NIHR funding has been awarded to DAFNE Research Group in the UK – this will allow further comparability and collaboration between the 2 groups

Page 9: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend
Page 10: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Study to date

• Over 400 participants through baseline

• 72 courses have been delivered among the study’s 6 sites

• Qualitative Study will be completed in May 09

• Starting to disseminate our results via papers, abstracts and oral presentations

• HRB Mid-term review to be held in 21st May –focusing on our strategic plans for years 4 and 5

Page 11: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Feedback from Galway Graduate

“…something that really makes a huge difference to me and I can imagine that it would do the same for a lot of people -it also leads to less appointments in the centre, meaning better care for those who need it and, I am sure, economic savings, which is good at any time, but particularly in a time of recession (this also means less time taken off work for the DAFNE graduates).

Living in County Clare, I know that most people in the county with Type 1 Diabetes attend the Limerick Diabetes centre where the DAFNE program does not occur. I know now why I was recommended to Galway rather than Limerick when I moved to Clare 2 years ago, even though Limerick is half the distance away.

I urge you to use whatever power you have to make the DAFNE course available to all people with Type 1 Diabetes so that not only they benefit from it, but the Irish Health System and Economy as a whole benefit too.”

Page 12: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Profiling participants at

baseline

Dr John NewellBiostatistics Unit,

Clinical Research Facility,School of Medicine,

National University of Ireland,

Page 13: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Variables of Interest

• Response variables: 1. HbA1c 2. number of Hypoglycaemic episodes (Hypos)3. Psycho-social (HADS,Paids,EQ5D)

• Explanatory variables:1. Patient Specific (Height, Weight, Gender)2. Clinical (Creatinine, HDL Cholesterol, …)3. Centre (clustering variable)

Page 14: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

12.010.89.68.47.26.0

Median

Mean

8.408.358.308.258.208.158.10

1st Q uartile 7.4000

Median 8.2000

3rd Q uartile 9.1000

Maximum 12.9000

8.1677 8.4271

8.0836 8.3000

1.2056 1.3895

A -Squared 1.94

P-V alue < 0.005

Mean 8.2974

StDev 1.2910

V ariance 1.6666

Skewness 0.613921

Kurtosis 0.364375

N 383

Minimum 5.7000

A nderson-Darling Normality Test

95% C onfidence Interv al for Mean

95% C onfidence Interv al for Median

95% Confidence Interv al for StDev

95% Confidence Intervals

Summary for HbA1c (%)

Page 15: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Tolerance (Confidence) Level: 95%

Proportion of Population Covered: 95%

N Mean StDev Tolerance Interval

383 8.29739 1.29096 ( 5.6028, 10.992)

Page 16: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

MaleFemale

13

12

11

10

9

8

7

6

5

HbA1c (%)

Boxplot of Baseline HbA1c by Gender

Unknown 0.5

Male 45.2

Female 54.3

%

Page 17: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

St Vincents_22%Kilkenny_7%Galway_19%Colmcilles_19%Belfast_11%Beaumont_20%

13

12

11

10

9

8

7

6

5

HbA1c (%)

Boxplot of Baseline HbA1c by Centre(box width proportional to Centre)

Page 18: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

MaleFemale

175

150

125

100

75

50

Weight (kgs)

Boxplot of Weight by Gender

Page 19: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

MaleFemale

200

190

180

170

160

150

Height (cms)

Boxplot of Height by Gender

Page 20: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

44403632282420

25

20

15

10

5

0

44403632282420

Female

BMI

Frequency

25

Male

25

Histogram of BMI by Gender

49% > 25

25.74 4.43

Mean StDev

59% > 25

26.5 3.97

Mean StDev

Page 21: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

MaleFemale

60

50

40

30

20

10

0

Years since diagnosis (yrs)

Boxplot of Years since diagnosis by Gender

Page 22: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

20100 1680 80400 906030

12

9

620

10

0

16

8

0

80

40

0

HbA1c (%)

HADS A Score

HADS D Score

Paid Score

EQ5D Score

Matrix Plot of HbA1c and Psycho-social Metrics

HbA1c (%) HADS A Score HADS D Score Paid Score

HADS A Score 0.108

0.037

HADS D Score 0.124 0.792

0.016 0.000

Paid Score 0.168 0.327 0.362

0.001 0.000 0.000

EQ5D Score -0.163 -0.355 -0.349 -0.205

0.002 0.000 0.000 0.000

Page 23: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Centre St. VincentsKilkennyGalwayColmcillesBelfastBeaumont

90

80

70

60

50

40

30

20

10

0

Individuals

None

Mild (1-2)

High (>3)

Unknown

Hypos

Chart of Hypos by Centre (previous year)

Page 24: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

St. VincentsKilkennyGalwayColmcillesBelfastBeaumont

90

80

70

60

50

40

30

20

10

0

% W

ithin Centre

None

Mild (1-2)

High (>3)

Unknown

Hypos

Chart of Hypos by Centre (Previous year)

Page 25: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

St. VincentsKilkennyGalwayColmcillesBelfastBeaumont

90

80

70

60

50

40

30

20

10

0

% W

ithin Centre

None

Mild (1-2)

High (>3)

Unknown

Hypos

1.32

7.89

14.47

76.32

2.33

20.9318.60

58.14

0.004.05

12.16

83.78

0.00

4.17

11.11

84.72

0.00

9.09

18.18

72.73

0.00

7.06

20.00

72.94

Chart of Hypos by Centre (Previous year)

Page 26: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Parallel Coordinates Plot

• Looking at the variables collectively

Page 27: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

20151050

13

12

11

10

9

8

7

6

5

HADS A Score

HbA1c (%)

Scatterplot of HbA1c vs HADS A Score

Hospital & Anxiety Depression Scale: Normal <8; Borderline 8-11; Moderate – Severe 11-21

Page 28: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

181614121086420

13

12

11

10

9

8

7

6

5

HADS D Score

HbA1c (%)

Scatterplot of HbA1c (%) vs HADS D Score

Hospital & Anxiety Depression Scale: Normal <8; Borderline 8-11; Moderate – Severe 11-21

Page 29: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

9080706050403020100

13

12

11

10

9

8

7

6

5

Paid Score

HbA1c (%)

Scatterplot of HbA1c (%) vs Paid Score

Problem Areas in Diabetes (PAID): > 40 is cut-off

Page 30: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

9080706050403020100

20

15

10

5

0

Paid Score

HADS A Score

Scatterplot of HADS A Score vs Paid Score

HADS: Normal <8; PAID > 40 is cut-off

Page 31: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

9080706050403020100

18

16

14

12

10

8

6

4

2

0

Paid Score

HADS D Score

Scatterplot of HADS D Score vs Paid Score

HADS: Normal <8; PAID > 40 is cut-off

Page 32: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

1101009080706050403020

13

12

11

10

9

8

7

6

5

EQ5D Score

HbA1c (%)

Scatterplot of HbA1c (%) vs EQ5D Score

Page 33: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

YesNoNA

80

40

0

Percent

20.3655

78.8512

0.78329

10.96617.04961

81.9843

1.56658

13.8381

84.5953

9.399488.09399

82.5065

Chart of Complications Prior/Post DAFNE Chart of Coronary Revascularisaation Chart of Peripheral Revascularisation Chart of CVA

Chart of Painful Neuropathy Chart of Foot Ulcer

Percent wit hin all dat a.

Chart of Amputation Toe Chart of Amputation > Toe

Chart of Retinopathy Chart of Proliferative

Percent wit hin all dat a.

Chart of Laser RX

Percent wit hin all dat a.

Chart of Registered Partially Sighted

Per cent wit hin all dat a.

Chart of Registered Blind Chart of Microalbuminuria Chart of Proteinuria Chart of Dialysis

Chart of Transplantation Chart of MI

Page 34: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Missing values

Page 35: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Summary

• Interesting patterns in variability across clinical and psycho-social measures when assessing diabetes severity

• ‘Missingness’ unlikely to be a problem

Page 36: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Spares

Page 37: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

unknownhighmildno

12.5

10.0

7.5

5.0

Hypo

HbA1c (%

)

unknownhighmildno

12.5

10.0

7.5

5.0

Hypo5

HbA1c (%

)Baseline HbA1c by Hypos in last year

Baseline HbA1c by Hypos in last 5 years

FIX THIS!!!

Page 38: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Parallel Coordinates plot

Page 39: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend
Page 40: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

20151050

12.5

10.0

7.5

5.0

AScore

HbA1c (%)

1612840

12.5

10.0

7.5

5.0

DScore

HbA1c (%)

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

Pearson correlation of HbA1c and Paid Score = 0.167

Plot of HbA1c vs PAID Score

Pearson correlation of HbA1c and AScore = 0.107

Plot of HbA1c vs Ascore (HADS data)

Pearson correlation of HbA1c & DScore = 0.123

Plot of HbA1c vs DScore (HADS data)

Pearson correlation of HbA1c and EQ5D Score = -0.163

Plot of HbA1c vs EQ5D Score

Page 41: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

10080604020

12.5

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7.5

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EQ5D Score

HbA1c (%)

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

Baseline HbA1c vs Paid Score (r=0.168, p=0.001) Baseline HbA1c vs EQ5D Score (r=-0.163, p=0.02)

Baseline HbA1c vs HADS Ascore (r=0.108, p=0.037) Baseline HbA1c vs HADS Dscore (r=0.124, p=0.016)

Page 42: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

20151050

13

12

11

10

9

8

7

6

5

HADS A Score

HbA1c (%)

Scatterplot of HbA1c Result vs HADS A Score

Page 43: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

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10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

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10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.168, p=0.001) Baseline HbA1c vs EQ5D Score (r=-0.163, p=0.02)

Baseline HbA1c vs HADS Ascore (r=0.108,p=0.04) Baseline HbA1c vs HADS Dscore (r=0.016, p=0.124)

Page 44: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.147, p=0.03) Baseline HbA1c vs EQ5D Score (r=-0.115, p=0.08)

Baseline HbA1c vs HADS Ascore (r=0.08, p=0.18) Baseline HbA1c vs HADS Dscore (r=0.116, p=0.08)

Page 45: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.381, p=0.002) Baseline HbA1c vs EQ5D Score (r=-0.226, p=0.065)

Baseline HbA1c vs HADS Ascore (r=0.163, p=0.19) Baseline HbA1c vs HADS Dscore (r=0.132, p=0.289)

Page 46: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.025, p=0.849) Baseline HbA1c vs EQ5D Score (r=-0.266, p=0.034)

Baseline HbA1c vs HADS Ascore (r=0.143, p=0.214) Baseline HbA1c vs HADS Dscore (r=0.148, p=0.225)

Page 47: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

highmild

no

Hypo5

10080604020

12.5

10.0

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EQ5D Score

HbA1c (%)

highmild

no

Hypo5

20151050

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Ascore

HbA1c (%)

high

mild

no

unknown

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1612840

12.5

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Dscore

HbA1c (%)

high

mild

no

Hypo5

Baseline HbA1c vs Paid Score (r=0.168, p=0.001) Baseline HbA1c vs EQ5D Score (r=-0.163, p=0.02)

Baseline HbA1c vs HADS Ascore (r=0.107,p=0.04) Baseline HbA1c vs HADS Dscore (r=0.016, p=0.124)

Page 48: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.147, p=0.03) Baseline HbA1c vs EQ5D Score (r=-0.115, p=0.08)

Baseline HbA1c vs HADS Ascore (r=0.08, p=0.18) Baseline HbA1c vs HADS Dscore (r=0.116, p=0.08)

Page 49: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.381, p=0.002) Baseline HbA1c vs EQ5D Score (r=-0.226, p=0.065)

Baseline HbA1c vs HADS Ascore (r=0.163, p=0.19) Baseline HbA1c vs HADS Dscore (r=0.132, p=0.289)

Page 50: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

high

mildno

unknown

Hypo5

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

high

mildno

unknown

Hypo5

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

high

mildno

unknown

Hypo5

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

high

mildno

unknown

Hypo5

Baseline HbA1c vs Paid Score (r=0.025, p=0.849) Baseline HbA1c vs EQ5D Score (r=-0.266, p=0.034)

Baseline HbA1c vs HADS Ascore (r=0.143, p=0.214) Baseline HbA1c vs HADS Dscore (r=0.148, p=0.225)

Page 51: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

20100 1680 80400 906030

12

9

620

10

0

16

8

0

80

40

0

HbA1c

HADS Ascore

HADS Dscore

Paid Score

EQ5D Score

Matrix Plot of HbA1c Result and Psychosocial Metrics

Page 52: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

20100 1680 80400 906030

12

9

620

10

0

16

8

0

80

40

0

HbA1c

HADS Ascore

HADS Dscore

Paid Score

EQ5D Score

Matrix Plot of HbA1c Result and Psychosocial Metrics

Page 53: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

806040200

12.5

10.0

7.5

5.0

Paid Score

HbA1c (%)

10080604020

12.5

10.0

7.5

5.0

EQ5D Score

HbA1c (%)

20151050

12.5

10.0

7.5

5.0

Ascore

HbA1c (%)

1612840

12.5

10.0

7.5

5.0

Dscore

HbA1c (%)

Baseline HbA1c vs Paid Score (r=0.168, p=0.001) Baseline HbA1c vs EQ5D Score (r=-0.163, p=0.02)

Baseline HbA1c vs HADS Ascore (r=0.108, p=0.037) Baseline HbA1c vs HADS Dscore (r=0.124, p=0.016)

Page 54: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Validating a diabetes specific quality of life measure in an

English speaking population: the Irish Dose Adjustment for Normal Eating (DAFNE) Study

Diabetes-Specific Quality of Life

Mary Clare O’ Hara

Page 55: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Background• Diagnosis with a chronic condition can be seen as a life-

changing event – Significant change in health status – adherence to a demanding regimen

• Diabetes diagnosis has significant implications– physiological (traditional focus was on reducing levels of

HbA1c & frequency of hypos)

– psychosocial adaptation (disease self-management, how self-management regimens affect virtually all aspects of daily life)

– Negative psychological outcomes, such as depression, anxiety, and distress can present (burden/ distress, emotional health, social, physical functioning)

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• Diabetes has been associated with reduced quality of life, (Goldney et al., 2004).

• Self-rated health status was significantly related with HbA1c levels amongst Type 2 diabetes patients, (Sakamaki et al., 2006).

• Physical, psychological and social quality of life are therefore viewed as critical outcomes of diabetes treatment and management, (Burroughs et al., 2004).

Quality of Life and Diabetes

Page 57: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Disease-specific QoL tools

• Aspects of health considered by patients and/ or clinicians to be of greatest importance

• More responsive/ sensitive to changes in health

• Assess patients concerns

• Making them important primary endpoints in clinical trials

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QoL Tools in Diabetes

Italy out-patients [37]Well-Being Enquiry for Diabetics

Germany in-patients and out-patients [35]Questionnaire on Stress in Patients with Diabetes-Revised

Germany general practice [34]Diabetes Specific Quality of Life Scale

USA out-patients [30]Diabetes-39

USA out-patients [36]

USA out-patients [39]

USA out-patients [40]

Diabetes Quality of Life Measure

USA out-patients [32]Diabetes Impact Measurement Scales

UK out-patients [8]

UK out-patients [8]

Out-patients [8]

Netherlands out-patients [36]

UK out-patients [5]

Denmark out-patients [5]

Diabetes Health Profile

UK out-patients [33]

UK educational open day

Audit of Diabetes-Dependent Quality of Life

USA out-patients [31]Appraisal of Diabetes Scale

SettingInstrument

Garratt AM et al., Diabetic Medicine 2002, 19, 1-11

Page 59: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

DSQoL (77 item scale)• Specific to type 1 diabetes• Developed with patients and health professionals• Developed in Germany• Translated from German to English but remains to be

validated within an English speaking population• Scale was altered slightly from the original to reflect to

linguistic differences and more culturally appropriate scale-items.

• 57 items form 8 dimension: social relations, leisure time flexibility, physical compliants, worries about the future, diet restrictions, daily hassels, fear of hypoglycemia and daily burdens & restrictions

• 10 goal/ preference items are weighted to 10 satisfaction item = PWTSS (preference-weighted treatment satisfaction score)

Page 60: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

ADDQoL (20 item scale)• Patient and health professional input & translated into more

than 20 languages & validated• 2 overview items - “present QoL”

- “impact of diabetes on QoL”• 18 items addressing social, physical & emotional

functioning. • Each item is scored on a 7-point scale & respondents

indicate the importance of the item in their daily lives

����

Not at all important

����

Somewhat important

����

Important

����

Very important

This aspect of my life is:

����

Very much

worse

����

Much worse

����

A little

worse

����

The same

����

A little better

����

Much better

����

Very much

better

If I did not have diabetes, my finances would be:

Page 61: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Characteristics of the sub-sample (n=42, 54.8% female)

19 - 6411.338.7Age (yrs)

20 – 424.525.9BMI (kg/m2)

5.8 – 13.51.58.6HbA1c (%)

2 - 3910.416.1Diabetes duration (yrs)

RangeSDMean

Page 62: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Impact of diabetes on individual life domains

-4.5

-4.0

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

Future

Freed

om to

eat

Do p

hysic

ally

Family

life

Trav

elSex

life

Work

ing li

fe

Holid

ays/ l

eisu

re

Conf

iden

ce in

abili

ty

Free

dom to

drin

kS

ocial

Life

Enjoym

ent of f

oodM

otiv

atio

n

Physic

al a

ppeara

nce

Finan

ces

Livin

g Cond

ition

s

Socie

ty r

eact

ion

Dep

enden

ce o

n oth

ers

Mean

Im

pact

Page 63: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Impact of diabetes on QoL at baseline (by complications)

Present QoL

Impact of diabetes

on QoL

Average weighted

impact-2.0

-1.5

-1.0

-0.5

0.0

0.5

1.0

1.5

Me

an

Im

pac

t

Page 64: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

DSQoL Subscales

0

10

20

30

40

50

60

70

80

Soc

ial R

elat

ions

Phys

ical

com

plain

ts

Leis

ure ti

me

flexi

bility

Daily

burd

ens

and r

estr

ictio

ns

Fear

of hyp

oglyc

aemia

Dai

ly h

assl

esD

iet r

estr

ictio

ns

Wor

ries

abo

ut fu

ture

%

Page 65: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Statistical analysis

• Internal consistency reliability coefficient (Cronbach’s α)

• Convergent validity assessed by correlation analysis (Pearson’s correlation coefficient)

Page 66: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

QoL subscales used & their homogeneity

0.83If I did not have diabetes, my family life would be… very much better -very much worse

This aspect of my life is… very important – not at all important

Impact of diabetes on QoL (18 items)

0.97It bothers me that I have to inject insulin before I know how much I would really like to eat or I really can eat

Daily burdens & restrictions (57 items)

0.95I am worried about having a severe episode of low blood sugar at night Fear of hypoglycaemia (11 items)

0.8It bothers me that I have to spend so much time on my diabetes treatment

Daily hassles (6 items)

0.9It bothers me that I cannot eat like other peopleDiet restrictions (9 items)

0.87I am often worried about the long-term complications of diabetesWorries about future (5 items)

0.86I suffer from thirst or having a dry mouthPhysical Complaints (9 items)

0.89Diabetes prevents me from spontaneous physical activitiesLeisure time flexibility (6 items)

0.9Because of diabetes it is much harder to make friends Social relations (11 items)

0.77For diabetes treatment it is especially important to me, or it would be my goal that … I can arrange my free time with flexibility.

How satisfied have you been over the last 4 weeks with… the flexibility in arranging your free time

PWTSS

Cronbach’s αExampleSubscale

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CorrelationADDQoL

• QoL, future QoL and AWI Score were significantly correlated (r = .387, .341 and .324 respectively)

DSQoL

• All subscales were significantly correlated to each other (r between .637 and .861)

Page 68: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Conclusion

• High degree of internal consistency are achieved by both ADDQoL & DSQoL

• High inter-correlations confirm that the subscales involved represent a homogeneous construct of diabetes specific quality of life

• Future research within the Irish DAFNE Study will enable the responsiveness and sensitivity to change of these 2 quality of life instruments to be assessed and compared.

Page 69: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

?

Page 70: Dose Adjustment for Normal Eating DAFNE - NUI Galway · 2009-04-03 · the DAFNE graduates). Living in County Clare, I know that mostpeople in the county with Type 1 Diabetes attend

Acknowledgements

Steering Group Members:

Sean Dinneen (UHG/ NUIG)

Lisa Daly (UHG)

Simon Heller (Sheffield)Donal O’Shea (SVUH) Molly Byrne (NUIG)

Kathy Murphy (NUIG)Dympna Casey (NUIG)John Newell (NUIG)

Mary Clare O’ Hara (UHG)

Executive Group Members:

Diarmuid Smith (Beaumont) Hamish Courtney (Royal)James Gibney (Tallaght)Seamus Sreenan (Blanch)Julia Lawton (Edinburgh)Florence Brown (Diabetes UK)Colm McGurk (Kilkenny)Lindsay Oliver (Northumbria)Gill Thompson (DAFNE)Eamon O’Shea (NUIG)Colin Bradley (UCC)Marie Clarke (UCL)Anna Clarke (DFI)

Educator Group Members:

Mary O’Scannail (Columcille’s)Cathy Breen (Columcille’s)Una McErlean (Royal)Ruth Boocock (Royal)Maeve Moran (SVUH)Joanne Kildunne (SVUH)Carmel Murphy (UHG)Bernie McDonnell (UHG)Áine Cunningham (UHG)Eimear Fanning (Beaumont)Sonya Brown (Beaumont)Kate O’ Connor (Kilkenny)Peggy Browne (Kilkenny)


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