The GUIDANCE study

Guillaume Charpentier, Kris Doggen, Noëmi Debacker, Kees Gorter, Odile Juy Christiane Kellner, Kamlesh Khunti, Oliver Kuß, Ulf

Lindblad, Arne Melander, Lena Minning, Ulrich Müller, John Nolan, Agnieszka Pazderska, Massimo Porta, Guy Rutten, Margaret Stone,

Marina Trento

Kamlesh KhuntiUniversity of Leicester, UK

on behalf of the GUIDANCE Study Group

Declaration of interestReceived funds for research, acted asconsultant to or received honorariafrom AstraZeneca, BMS, BI, Lilly, MSD,Novartis, NOVO Nordisk, Sanofi,Takeda and Unilever.

Outline

• Context• Background and rationale• Objectives• Methods• Preliminary findings• Discussion and future work

Context: the GUIDANCE programme

GUIDELINE ADHERENCE to ENHANCE CARE:An investigation of the quality of care of people with type

2 diabetes in eight European countries, including adherence to guidelines:

• Belgium• England and Wales• France• Germany

• Ireland• Italy• Netherlands• Sweden

Context: the GUIDANCE programme

Two stages:Guideline review

– Aims: to assess the quality of guidelines for the management of type 2 diabetes published in 8 European countries and to compare process and outcome recommendations provided in these guidelines

Cross sectional study

– Data collection from patients, physicians and medical records in 8 European countries

Recommendations for intermediate outcomes (Stone M et al. Diab Res Clin Pract 2010;87:252)

Background and rationale [1]Type 2 diabetes: an important problem

• Increasing prevalence

• Association with morbidity and mortality

• Effective management can improve patient outcomes and reduce costs

• Considerable agreement about strategies for effective management

Background and rationale [2]Quality of care

• Can be measured in terms of adherence to recommendations

• Evidence-based recommendations availablebut• Adherence can be inhibited by patient,

practitioner and system barriers• General shortage of studies comparing data

from European countries

Background and rationale [3]Previous studies:

Paper Study information Summary of relevant findings Notes

Donker GA et al. Family Practice 2004; 21: 364-369

5 European countries. Primary care data for 1999. Sample size 18,828

Differences between countries, e.g. for insulin prescribing in elderly

Aggregated (not individual patient level) data.

Gorter KJ et al. Primary Care Diabetes 2010; 4: 17-23

Feasibility study in primary care in 12 European countries. Sample size 103

Some observed variations in indicators of metabolic wellbeing

Pilot level data; full study planned.

Álvarez Guisanola F et al, Diabetes, Obesity and Metabolism 2008; 10 (suppl 1): 25-32

Recruitment 2006-7 from 7 countries in Europe. 12-month data. Sample size 1,709

Some between –country variations , e.g. percentage meeting HbA1c targets

Focus mainly on hypoglycaemia, but characteristics of sample also reported

Gakidou E et al. Bull World Health Organ 2011; 89; 172-183

7 countries, only 2 from Europe. Overall sample 10,849 cases with diabetes

Variations in proportions meeting targets, e.g. blood glucose control

National health examination survey data used.

Objectives

• Primary objective: to assess the quality of care of people with type 2 diabetes in clinical practice in 8 European countries, including adherence to recommendations provided in clinical guidelines

• Secondary objective: to identify and understand patient and physician barriers to the achievement of recommended targets

Study design

Cross-sectional design with data collection based on:• Retrospective review of medical records• Physician questionnaires

• Study specific

• Patient questionnaires• Study specific• Diabetes Treatment Satisfaction Questionnaire

(DTSQ)• EuroQoL visual scale

Sample size

• Wide representative sample of physicians

• Target of 1000 patients from each country

Methods:recruitment and data collection

Concurrent data collection in participating countries

• Recruitment of sites and physicians from primary and secondary care. Physician questionnaires completed.

• Patient consent and questionnaires completed.

• Retrospective data collection from medical records.

Methods:data collation and analysis

• Data from all participating countries sent to co-ordinating centre

• Data cleaning and statistical analysis conducted at co-ordinating centre

• ADA guidelines to assess adherence to recommendations

Findings: scope of presentationData for current presentation derived mainly from medical records review:

• Numbers recruited• Characteristics of sample • Observed values

- Whole sample- Variations between countries

• Adherence to recommendations- Process and outcome measures

• Analysis by groups e.g. age, gender, BMI

Sample recruited

• Total sample:– Physicians = 428– Patients = 7597

• Good rates of uptake

Belgium France Germany Ireland Italy Sweden TheNetherlands UK

1044 1056 959 950 984 550 1021 1033

Characteristics of the sample [1]

Variable Whole sample Between-country range

Recruitment from primary care (%) 73.7 12 (Italy) - 100 (Netherlands & Sweden)

Age in years (mean) 66 64 (UK) - 69 (Belgium)

Male (%) 55.2 48.3 (Germany) - 59.8 (UK)

Years diagnosed (mean) 8.8 6.2 (Netherlands) - 13.0 (Italy)

Current smoker (%) 11.9 9.2 (Germany) - 14.2 (Sweden)

Characteristics of the sample [3]

Medical history Whole sample (%) Between-country range (%)

CHD 18.2 14.5 (Netherlands) - 28.9 (Germany)

Stroke 4.9 2.4 (UK) - 8.9 (Belgium)

Peripheral arterial disease 6.6 1.5 (UK) - 10.2 (Belgium)

Congestive heart failure 5.0 0.9 (Italy) - 18.8 (Germany)

Depression(currently treated) 9.1 4.5 (Germany) - 15.2 (UK)

Adherence to recommendations: process measures (from medical records)

Process recorded in past 12m Whole sample (%)

Between-country range (%)

HbA1c checked 97.6 94.7 - 99.3

BP checked 98.3 94.1 - 99.5

HDL checked 86.5 63.1 - 98.9

LDL checked 82.6 63.6 - 97.2

Weight/ BMI checked 95.4 86.9 - 99.0

Waist size checked 33.4 11.1 - 65.1

Serum creatinine checked 92.6 89.4 - 97.9

Microalbuminuria checked 59.4 26.7 - 90.3

Eyes checked 74.8 58.0 - 88.6

Foot sensation checked 67.1 47.8 - 89.5

Observed valuesVariable (continuous) Whole sample:

Mean (SD)Between-country range:

HbA1c (%) 7.1 (1.8) 6.2 – 7.5

BMI (kg/m2) 30.0 (5.8) 29 - 32

Waist Circumference (cm) 104.0 (14.0) 101 - 107

Total Cholesterol (mmol/l) 4.6 (1.1) 4.0 – 5.3

HDL (mmol/l) 1.4 (2.4) 1.2 – 2.2

LDL (mmol/l) 2.6 (1.3) 2.1 – 3.2

FPG (mmol/l) 7.7 (3.1) 7.2 – 8.6

Systolic BP (mmHg) 136 (16) 134 - 140

Diastolic BP (mmHg) 78 (9.4) 76 - 82

Adherence to recommendations:outcome measures

Variable Whole sample (%)

Between-country range (%)

HbA1c (<7%) 55.2 35.7 - 78.0

Not overweight (BMI <25) 14.7 10.5 - 20.6

Men: waist circumference <94 cm 15.4 6.6 - 19.0

Women: waist circumference <80cm 5.0 4.1 - 8.5

Men: HDL >1 mmol/l 66.3 50.2 - 76.2

Women: HDL > 1.3 mmol/l 50.9 33.8 - 59.7

LDL <2.5 mmol/l 50.5 26.7 - 73.7

Systolic BP <130 mmHg 29.1 26.3 - 35.3

Diastolic BP <80 mmHg 44.3 22.4 - 59.2

Process measures (patient-reported)

Process reported in past 12m Whole sample (%)

Between-country range (%)

Glucose monitoring: blood or urinepatients on insulin 92.3 84.3 - 96.9

Education(group or individual) 91.4 67.3 - 98.7

Smoking advice smokers only 46.6 12.0 - 61.5

Analysis of adherence data for combined sample by groups: HbA1c

Group % with HbA1c <7% 95% CI

Age >65 yrs 56.7 55.2-58.1

Age <65 yrs 53.1 51.3-54.9

Men 55.8 54.3-57.3

Women 54.3 52.6-56.0

Recruited from primary care 61.0 59.7-62.3

Recruited from secondary care 39.0 36.8-41.1

BMI >30 50.5 48.7-52.4

BMI <30 58.4 56.7-60.2

Analysis of adherence data for combined sample by groups: systolic blood pressure

Group % with systolic BP <130mmHg 95% CI

Age >65 yrs 25.4 24.1 - 26.7

Age <65 yrs 34.4 32.7 - 36.1

Men 29.1 27.7 - 30.5

Women 28.8 27.2 - 30.3

Recruited from primary care 27.5 26.4 - 28.7

Recruited from secondary care 33.2 31.1 - 35.3

BMI >30 27.3 25.7 - 28.9

BMI <30 32.3 30.7 - 34.0

Medication Medication Whole

sample (%) Between-country range (%)

Any insulin 26.1 16.3 (Netherlands) - 39.0 (Italy)

Sulphonylureas 33.4 19.1 (Sweden) - 46.5 (France)

Biguanides 66.8 53.4 (Germany) - 78.8 (France)

Meglitinides 5.8 0.3 (Netherlands) – 7.5 (France)

Thiazolidinediones 5.7 1.5 (Sweden) - 10.4 (France)

Alpha-glucosidase-inhibitors 1.2 0.0 (Netherlands, Sweden)-3.9 (France)

DPP-4 inhibitors 4.3 1.2 (Italy) – 10.5 (France)

GLP-1 analogues 2.6 0.2 (Netherlands) - 7.5 (UK)

Blood pressure lowering 80.9 71.7 (Netherlands) - 89.5 (Germany)

Lipid lowering 67.6 46.5 (Germany) - 84.0 (Ireland)

Mean number OHAs/person 1.2 0.9 – 1.6

Insulin Type

Type % on insulin(any type)

NPH 2.7

Long acting analogues 15.3

Short acting analogues 8.8

Short acting Human insulin 3.4

Mixtures 21.5

Mean number injections/day (SD) 2.6 (1.3)

Medication by groups: blood pressure lowering

Group% on BP lowering

medication(any type)

95% CI

Age >65 yrs 86.4 85.4 - 87.4

Age <65 yrs 72.9 71.3 - 74.5

Men 80.1 78.9 - 81.3

Women 81.9 80.6 - 83.2

Recruited from primary care 80.7 79.7 - 81.8

Recruited from secondary care 81.5 79.8 - 83.2

Complications and HbA1c

Macrovascularcomplications % Mean HbA1c % (SD)

None recorded 72.9 7.02 (1.22)

One or two recorded 25.3 7.10 (1.20)

Three or more recorded 1.8 7.52 (1.36)

Microvascularcomplications % Mean HbA1c

None recorded 84.3 6.98 (1.17)

Any recorded 15.7 7.45 (1.41)

Discussion: summary

• In a large sample from a range of European countries, high levels of adherence to recommendations for process measures

• Achievements in intermediate targets sub-optimal and large variations between countries

• Substantial variations in pharmacotherapy

• Differences may relate to national health care practices, case mix and some differences in guideline recommendations

Ongoing and future work on the dataset• Further analysis and interpretation of data from

physician and patient questionnaires regarding barriers to adherence

• Further analysis with adjustment for confounders

• Detailed topic-specific analysis, e.g. Pharmaco-epidemiology, prevention of complications, hypoglycaemia

• Detailed analysis of data for individual countries, e.g. comparison with national recommendations

Acknowledgements:contributors to the GUIDANCE Study

Ireland: John Nolan Agnieszka PazderskaJeremy Towns

UK:Kamlesh KhuntiMargaret Stone Navneet Aujla

The Netherlands:Guy RuttenKees Gorter

Germany:Ulrich MüllerChristiane Kellner

Italy:Massimo PortaMarina Trento

Sweden:Ulf LindbladArne MelanderPaolina Weidinger

France:Guillaume CharpentierOdile JuyLydie CanipelHeloise Laroye

Belgium:Kris DoggenNoëmi DebackerNathalie Clochard

Statistics:Oliver KußLena Minning

Co-ordination: Monica Buckley

AcknowledgementsFunding

EASD from an unrestricted grant from Merck & Co. Inc, USA.

Thank you for your attention

on behalf of the GUIDANCE study team