Epidemiological Studies of Health Effects of General Examinations
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The effect of systematic health examinations and screening of the general population is under
      debate. Recently, a large Danish randomized study found that systematic screening of risk
      factors and lifestyle advice in the general population did not have a preventive effect on
      coronary heart disease, stroke or all-cause mortality. However, there are still very few
      completed randomized studies, and the effect on other diseases remains unclear. The purpose
      is to investigate whether repeated health examinations with screening of various risk factors
      in an unselected population prevent long-term incidence of ischemic heart disease, stroke,
      total and cause-specific mortality, diabetes, dementia, chronic obstructive pulmonary disease
      and various forms of cancer. A preliminary protocol was submitted and approved by the Danish
      Data Protection Agency before the registry-based data on primary and secondary outcomes were
      received by the investigator.
    

Detailed description: 
      Introduction The effect of systematic health examinations and screening of the general
      population is under debate. Recently, a large Danish randomized study found that systematic
      screening of risk factors and lifestyle advice in the general population did not have a
      preventive effect on coronary heart disease, stroke or all-cause mortality. However, there
      are still very few completed randomized studies, and the effect on other diseases remains
      unclear.

      Purpose The purpose is to investigate whether repeated health examinations with screening of
      various risk factors in an unselected population prevent long-term incidence of ischemic
      heart disease, stroke, total and cause-specific mortality, diabetes, dementia, chronic
      obstructive pulmonary disease and various forms of cancer.

      Research question Can health examinations with screening of various risk factors prevent the
      long-term incidence of ischemic heart disease, stroke, total and cause-specific mortality,
      diabetes, dementia, chronic obstructive pulmonary disease and various forms of cancer?

      Data and method For the Danish Monica1 study, a random sample of the general population
      (adults) in Copenhagen County in 1982 and 1983 was extracted, consisting of a total of 17,845
      people. These individuals were randomly divided into two groups, one group was offered a
      general medical examination while participating in the study, while the control group was not
      invited and remained unaware of the intervention. The intervention was thus an examination
      with measuring of e.g., blood pressure, cholesterol level and body mass index as well as
      subsequent conversation with a nurse. Participants were invited 3 times at 5-year intervals.
      Data from the intervention group (4,807 people) and the control group (13,038 persons) will
      be linked to register data from the Danish Civil Registration Register, the Cause of Death
      Register, the National Patient Register, the Diabetes Register and the Cancer Register. The
      effect of the intervention will be examined using Cox regression with intention-to-treat
      analysis.
    

Intervention name(s): General health checks
Intervention type(s): Other
Intervention description(s): The intervention group is invited to up to three general health checks over a 10-year period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention