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An Independent and External Validation of QRISK2 Cardiovascular Disease Risk Score: a Prospective Open Cohort Study

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An Independent and External Validation of QRISK2 Cardiovascular Disease Risk Score: a Prospective Open Cohort Study RESEARCH BMJ: first published as 10.1136/bmj.c2442 on 13 May 2010. Downloaded from An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study Gary S Collins, senior medical statistician,1 Douglas G Altman, director, professor of statistics in medicine1 Centre for Statistics in Medicine, ABSTRACT sheet No 317). In the United Kingdom, there are Wolfson College Annexe, Objective To evaluate the performance of the QRISK2 almost 200 000 deaths each year relating to diseases University of Oxford, Oxford OX2 6UD score for predicting 10-year cardiovascular disease in an of the heart and circulatory system, with more than Correspondence to: G Collins independent UK cohort of patients from general practice one in three deaths associated with cardiovascular dis- [email protected] records and to compare it with the NICE version of the ease (www.heartstats.org). General practitioners need Framingham equation and QRISK1. Cite this as: BMJ 2010;340:c2442 an accurate and reliable tool to help them identify doi:10.1136/bmj.c2442 Design Prospective cohort study to validate a patients at high risk of having a cardiovascular event. cardiovascular risk score. Numerous multivariable risk scores have been devel- Setting 365 practices from United Kingdom contributing oped to estimate a patient’s 10 year risk of cardio- to The Health Improvement Network (THIN) database. vascular disease based on certain key known risk Participants 1.58 million patients registered with a factors,12 including the Framingham risk score3 and general practice between 1 January 1993 and 20 June the Reynolds risk score,4 both developed using patient 2008, aged 35-74 years (9.4 million person years) with data from US, the SCORE system using patients from http://www.bmj.com/ 71 465 cardiovascular events. multiple European countries,5 and ASSIGN using Main outcome measures First diagnosis of cardiovascular patients from Scotland.6 In the United Kingdom, disease (myocardial infarction, angina, coronary heart until recently the National Institute for Health and disease, stroke, and transient ischaemic stroke) recorded Clinical Excellence (NICE) recommended use of the in general practice records. long established Framingham equation to inform a Results QRISK2 offered improved prediction of a patient’s patient treatment plan about cardiovascular risk.3 10-year risk of cardiovascular disease over the NICE NICE have now ceased recommending any single on 26 September 2021 by guest. Protected copyright. version of the Framingham equation. Discrimination and risk score equation, leaving healthcare professionals calibration statistics were better with QRISK2. QRISK2 to choose the tool they consider to be most explained 33% of the variation in men and 40% for appropriate.7 women, compared with 29% and 34% respectively for the The QRISK1 risk score, derived by the QRE- NICE Framingham and 32% and 38% respectively for SEARCH organisation of the University of Notting- QRISK1. The incidence rate of cardiovascular events (per ham, is a model to predict the 10 year risk of 1000 person years) among men in the high risk group was developing cardiovascular disease. It was developed8 27.8 (95% CI 27.4 to 28.2) with QRISK2, 21.9 (21.6 to and validated910 on large general practice databases 22.2) with NICE Framingham, and 24.8 (22.8 to 26.9) with in the United Kingdom using data from three million QRISK1. Similarly, the incidence rate of cardiovascular patients with 17.5 million person years of observation. events (per 1000 person years) among women in the high QRISK1 includes traditional risk factors such as age, risk group was 24.3 (23.8 to 24.9) with QRISK2, 20.6 sex, systolic blood pressure, smoking status, and total (20.1 to 21.0) with NICE Framingham, and 21.8 (18.9 to serum cholesterol:high density lipoprotein ratio that 24.6) with QRISK1. are included in the long established Framingham equa- Conclusions QRISK2 is more accurate in identifying a high tions, but it also includes body mass index, family his- risk population for cardiovascular disease in the United tory of cardiovascular disease, social deprivation Kingdom than the NICE version of the Framingham (Townsend score), and use of antihypertensive treat- equation. Differences in performance between QRISK2 ment. Performance data comparing QRISK1 with the and QRISK1 were marginal. Framingham equation indicated that QRISK1 is a more accurate tool to predict the development of INTRODUCTION cardiovascular disease in the United Kingdom.911 Cardiovascular disease is an important health concern QRISK2, the successor to QRISK1, is a new multi- globally, with just under a third of all deaths attributed variable risk score that contains all the risk factors that to cardiovascular disease in 2004 (www.who.int, fact are in QRISK1 but also includes self assigned ethnicity BMJ | ONLINE FIRST | bmj.com page 1 of 9 RESEARCH and conditions associated with cardiovascular risk Summary of risk factors in QRISK1, QRISK2, and Framingham equation (including diagnosed type 2 diabetes, treated hyperten- BMJ: first published as 10.1136/bmj.c2442 on 13 May 2010. Downloaded from QRISK1 sion, rheumatoid arthritis, renal disease, and atrial Age (continuous) fibrillation).12 QRISK2 also contains interactions Ratio of total serum cholesterol:high density lipoprotein (continuous) between age and Townsend score, body mass index, Systolic blood pressure (continuous) systolic blood pressure, family history, smoking status, treated hypertension, diagnosis of type 2 diabetes, and Smoking status (current smoker/non-smoker (including former smoker)) atrial fibrillation (see box for variables included in Body mass index (continuous) QRISK1, QRISK2 and NICE Framingham). All con- Family history of coronary heart disease in first degree relative under 60 years (yes/no) tinuous risk factors were carefully handled and kept Townsend deprivation score (output area level 2001 census data evaluated as continuous continuous throughout the model building process, variable) fractional polynomials were used to model nonlinear 13 Receiving treatment for blood pressure at baseline (at least one current prescription of at risk relations where appropriate. Technical details of least one antihypertensive agent) (yes/no) the actual QRISK2 model can be found on the QRE- SEARCH website (www.qresearch.org). Systolic blood pressure × Receiving treatment for blood pressure at baseline After the development of a new multivariable risk QRISK2 score, it needs to be subjected to external Age (continuous) validation.14 15 The performance of a risk score is typi- Ratio of total serum cholesterol:high density lipoprotein (continuous) cally overestimated in the original data used to develop 14 Systolic blood pressure (continuous) the score. External validation is a crucial step to pro- Smoking status (current smoker/non-smoker (including former smoker)) vide sufficient evidence about the performance of the risk score on a cohort not used in the score’s Body mass index (continuous) development.2 14-16 It is disappointing, however, that Family history of coronary heart disease in first degree relative under 60 years (yes/no) most risk scores that are published fail to undergo this Townsend deprivation score (output area level 2001 census data evaluated as continuous extra step. Studies that develop and validate risk scores variable) are far too often of low quality, poorly designed, use Treated hypertension (diagnosis of hypertension and at least one current prescription of at inappropriate statistical techniques, and are based on least one antihypertensive agent) (yes/no) small selective cohorts with insufficient numbers of 14 15 17-19 Self assigned ethnicity (white (or not recorded)/Indian/Pakistani/Bangladeshi/other events. Furthermore, it is likely that many of Asian/black African/black Caribbean/other (including mixed)) the risk scores published each year are opportunisti- http://www.bmj.com/ Type 2 diabetes (yes/no) cally produced to maximise the output from a clinical study for which developing a risk score was not Rheumatoid arthritis (yes/no) declared a priori before collecting the data.20 Guiding Atrial fibrillation (yes/no) efficient clinical decision making requires that the Renal disease (yes/no) assessment of risk be accurate, yet many risk scores in Age × body mass index use have not adequately shown this essential quality. Age × Townsend score Low quality risk scores may be used clinically to stra- on 26 September 2021 by guest. Protected copyright. tify patients into risk groups or as inclusion or exclu- Age × systolic blood pressure sion criteria for randomised controlled trials. × Age family history of cardiovascular disease This article describes the results from an indepen- Age × smoking current dent and external validation of QRISK2 and compares Age × treated hypertension the performance of QRISK2 against QRISK18 and an 3 Age × type 2 diabetes adjusted version of the Framingham equation pre- viously recommended by NICE.21 Age × atrial fibrillation Framingham equation (version recommended by NICE) METHODS Age (continuous) Study population Ratio of total serum cholesterol/high density lipoprotein (continuous) Study participants were patients registered between Systolic blood pressure (continuous) 1 January 1993 and 20 June 2008 and recorded on Smoking status (current smoker (or quit within last year)/non-smoker) the THIN database (www.thin-uk.com). Patients were excluded if they had a prior diagnosis of cardiovascular
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