Realization of the clinical practice guidelines for diabetes in Finland – A case study of the usability of electronic patient information systems and national registers to support evidence based decision making in health care (ER12-9451)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Methodological, to study treatment guideline implementation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10A) INSULINS AND ANALOGUES

  INSULINS AND ANALOGUES

  (A10B) BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

  BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  All patients who have a diagnosis for diabetes (ICD-10 code E10*, E11*, E13* or E14*, or ICPC-2 code T89 or T90), a written prescription for diabetic medication; (ATC code A10A* or A10B*), HbA1c value ≥ 6.5%, glucose tolerance test ≥ 11 mmol/L or nutrition counselling related to diabetes in the electronic patient information systems within the selected study sites, or patients who have purchased prescriptions for diabetic medication (ATC code A10A* or A10B*) or who have special reimbursement for diabetes (refund code 103) in the Social Insurance Institution (SII) registers during 2009-2012.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  89000

Study design details

• Main study objective:
  To evaluate whether the electronic patient information systems and national registers can be used to support evidence based decision making in health care. To evaluate how the key elements of the Current Care guideline for diabetes are realized in practice and to investigate which factors explain successful implementa of treatment recommendations.
• Outcomes:
  - Diabetes medications and related measurements- Frequency of follow-up measurements - HbA1c and S-LDL- Follow-up measurements every 12 to 15 months - Follow-up measurements every 1-3 years- Treatment decisions (other than diabetes treatment) based on follow-up measurements, - Mortality- Health care resource use: visits, contacts and hospital/PHC inpatient admissions.- Amputations of the lower extremities- Absence from work- Severe hypoglycemic events
• Data analysis plan:
  The baseline characteristics will be presented as number of cases and percentages separately for each study site and for all sites combined. Appropriate statistical tests will be applied to statistically quantify any between site differences. Baseline characteristics include:• Age• Gender• Smoking• BMI• Dietary habits• Physical exercise• Concomitant disease • Concomitant medication• Laboratory measurementsRealization of current care guidelines will be evaluated for each site separately and for all sites combined. Appropriate statistical tests will be applied to statistically quantify between site differences. A (multi) logistic regression model will be used to model the study end-points with respect to the baseline covariates and study sites. When possible a binomial endpoint will be used (i.e. never vs. ever start of metformin or under 1 month vs. over 1 month to start of metformin).