The GUIDANCE study. Kamlesh Khunti University of Leicester, UK. on behalf of the GUIDANCE Study Group

Transcription

1 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 Khunti University of Leicester, UK on behalf of the GUIDANCE Study Group

2 Declaration of interest Received funds for research, acted as consultant to or received honoraria from AstraZeneca, BMS, BI, Lilly, MSD, Novartis, NOVO Nordisk, Sanofi, Takeda and Unilever.

3 Outline Context Background and rationale Objectives Methods Preliminary findings Discussion and future work

4 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

5 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

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

7 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

8 Background and rationale [2] Quality of care Can be measured in terms of adherence to recommendations Evidence-based recommendations available but Adherence can be inhibited by patient, practitioner and system barriers General shortage of studies comparing data from European countries

9 Background and rationale [3] Previous studies: Paper Study information Summary of relevant findings Notes Donker GA et al. Family Practice 2004; 21: European countries. Primary care data for 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: 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): Recruitment 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; 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.

10 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

11 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

12 Sample size Wide representative sample of physicians Target of 1000 patients from each country

13 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.

14 Methods: data collation and analysis Data from all participating countries sent to coordinating centre Data cleaning and statistical analysis conducted at co-ordinating centre ADA guidelines to assess adherence to recommendations

15 Findings: scope of presentation Data 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

16 Sample recruited Total sample: Physicians = 428 Patients = 7597 Belgium France Germany Ireland Italy Sweden The Netherlands UK Good rates of uptake

17 Characteristics of the sample [1] Variable Whole sample Between-country range Recruitment from primary care (%) (Italy) (Netherlands & Sweden) Age in years (mean) (UK) - 69 (Belgium) Male (%) (Germany) (UK) Years diagnosed (mean) (Netherlands) (Italy) Current smoker (%) (Germany) (Sweden)

18 Characteristics of the sample [3] Medical history Whole sample (%) Between-country range (%) CHD (Netherlands) (Germany) Stroke (UK) (Belgium) Peripheral arterial disease (UK) (Belgium) Congestive heart failure (Italy) (Germany) Depression (currently treated) (Germany) (UK)

19 Adherence to recommendations: process measures (from medical records) Process recorded in past 12m Whole sample (%) Between-country range (%) HbA1c checked BP checked HDL checked LDL checked Weight/ BMI checked Waist size checked Serum creatinine checked Microalbuminuria checked Eyes checked Foot sensation checked

20 Observed values Variable (continuous) Whole sample: Mean (SD) Between-country range: HbA1c (%) 7.1 (1.8) BMI (kg/m 2 ) 30.0 (5.8) Waist Circumference (cm) (14.0) Total Cholesterol (mmol/l) 4.6 (1.1) HDL (mmol/l) 1.4 (2.4) LDL (mmol/l) 2.6 (1.3) FPG (mmol/l) 7.7 (3.1) Systolic BP (mmhg) 136 (16) Diastolic BP (mmhg) 78 (9.4) 76-82

21 Adherence to recommendations: outcome measures Variable Whole sample (%) Between-country range (%) HbA1c (<7%) Not overweight (BMI <25) Men: waist circumference <94 cm Women: waist circumference <80cm Men: HDL >1 mmol/l Women: HDL > 1.3 mmol/l LDL <2.5 mmol/l Systolic BP <130 mmhg Diastolic BP <80 mmhg

22 Process measures (patient-reported) Process reported in past 12m Whole sample (%) Between-country range (%) Glucose monitoring: blood or urine patients on insulin Education (group or individual) Smoking advice smokers only

23 Analysis of adherence data for combined sample by groups: HbA1c Group % with HbA1c <7% 95% CI Age >65 yrs Age <65 yrs Men Women Recruited from primary care Recruited from secondary care BMI > BMI <

24 Analysis of adherence data for combined sample by groups: systolic blood pressure Group % with systolic BP <130mmHg 95% CI Age >65 yrs Age <65 yrs Men Women Recruited from primary care Recruited from secondary care BMI > BMI <

25 Medication Medication Whole sample (%) Between-country range (%) Any insulin (Netherlands) (Italy) Sulphonylureas (Sweden) (France) Biguanides (Germany) (France) Meglitinides (Netherlands) 7.5 (France) Thiazolidinediones (Sweden) (France) Alpha-glucosidaseinhibitors (Netherlands, Sweden)-3.9 (France) DPP-4 inhibitors (Italy) 10.5 (France) GLP-1 analogues (Netherlands) (UK) Blood pressure lowering (Netherlands) (Germany) Lipid lowering (Germany) (Ireland) Mean number OHAs/person

26 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)

27 Medication by groups: blood pressure lowering Group % on BP lowering medication (any type) 95% CI Age >65 yrs Age <65 yrs Men Women Recruited from primary care Recruited from secondary care

28 Complications and HbA1c Macrovascular complications % Mean HbA1c % (SD) None recorded (1.22) One or two recorded (1.20) Three or more recorded (1.36) Microvascular complications % Mean HbA1c None recorded (1.17) Any recorded (1.41)

29 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 suboptimal 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

30 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. Pharmacoepidemiology, prevention of complications, hypoglycaemia Detailed analysis of data for individual countries, e.g. comparison with national recommendations

31 Acknowledgements: contributors to the GUIDANCE Study Ireland: John Nolan Agnieszka Pazderska Jeremy Towns UK: Kamlesh Khunti Margaret Stone Navneet Aujla The Netherlands: Guy Rutten Kees Gorter Germany: Ulrich Müller Christiane Kellner Italy: Massimo Porta Marina Trento Sweden: Ulf Lindblad Arne Melander Paolina Weidinger France: Guillaume Charpentier Odile Juy Lydie Canipel Heloise Laroye Belgium: Kris Doggen Noëmi Debacker Nathalie Clochard Statistics: Oliver Kuß Lena Minning Co-ordination: Monica Buckley

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

33 Thank you for your attention on behalf of the GUIDANCE study team