Framingham

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The Framingham Heart Study: a cohort of initially 5209 men and women aged 30 to 62 from Framingham, Massachusetts followed-up from 1971 to assess the determinants of cardiovascular disease.

Thomas Royle Dawber was the chief epidemiologist early on, and carried the study forward for longer than the initial 20 year intention of the project.

See Framingham Study website and also Busselton - Western Australia.

From the Framingham study a cardiovascular risk score was developed that has been widely adopted, modified and validated outside the original white middle class study population.

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Use the ETHRISK modified Framingham score (NICE guidelines recommended this) or preferably for greater accuracy the QRISK2 score

Refinement of Framingham calculations for UK populations

By 2005, it had become clear that the Framingham calculations and calculators understimate cardiovascular morbidity in some ethnic population groups in the UK, particularly Asian populations. A new version based on the UK population was formulated to improve on this for the UK.

LogoWarningBox4.pngLinks from this page can not be checked for compliance against medical device law applicable to stand alone software in relevant jurisdictions:
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In Europe a medical algorithm or clinical decision assistance tool implemented in software (eg an app) that serves a therapeutic purpose such as calculating a drug dose, if made generally available or marketed is regarded as a medical device. In house medical devices manufactured by a health organisation and not generally available or marketed are exempt.

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The FDA has consulted on a similar requirement but the outcome has been slightly different and appears to depend upon if a human (however ill qualified to do so) can interpret and is necessary to implement the software output. Closed systems are completely regulated. A draft implementation document was published in August 2016

A ETHRISK calculator on-line at Bristol became available in June 2006. The calculator software runs on the Bristol server, so the medical algorithm implementation embodied in it is not available for general inspection.

Variables

  • Age (continuous)
  • Ratio of total serum cholesterol/high density lipoprotein (continuous)
  • Systolic blood pressure (continuous)
  • Smoking status (current smoker (or quit within last year)/non-smoker)
  • Sex (male/female)
  • Left ventricular hypertrophy (yes/no)
  • Type 2 diabetes (yes/no)
  • Age x type 2 diabetes
  • Left ventricular hypertrophy x age
  • Age x sex

It has now been shown that previous concerns that in the UK population that the effect of using the score was likely to be more use of statins were not only true, but that the score created more high risk patients than subsequent more refined decision support tools[1] and so resulted in unnecessary use of statins.

References