National Clinical Guideline Centre 1 Draft for Consultation Lipid modification Cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease Clinical guideline Methods, evidence and recommendations February 2014 Draft for Consultation Commissioned by the National Institute for Health and Care Excellence Draft for consultation Contents 1 Disclaimer Healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient and/or their guardian or carer. Copyright National Clinical Guideline Centre, 2014 Funding National Institute for Health and Care Excellence National Clinical Guideline Centre, 2014 Draft for consultation Contents Contents National Clinical Guideline Centre ................................................................................................ 1 Guideline update ........................................................................................................................ 10 Guideline Development Group .................................................................................................... 11 Guideline Development Group members [2014] .......................................................................... 11 Technical team members [2014] ................................................................................................... 11 Co-optees [2014] ........................................................................................................................... 11 Peer reviewers [2014] ................................................................................................................... 11 Guideline Development Group members [2008] .......................................................................... 12 Co-optees [2008] ........................................................................................................................... 12 Technical team members [2008] ................................................................................................... 13 Acknowledgements [2014] ............................................................................................................ 14 Acknowledgements [2008] ............................................................................................................ 14 1 Introduction ........................................................................................................................ 15 1.1 Background ......................................................................................................................... 15 1.2 Management ....................................................................................................................... 15 2 Development of the guideline .............................................................................................. 17 2.1 What is a NICE clinical guideline? ....................................................................................... 17 2.2 Remit ................................................................................................................................... 17 2.3 Who developed this guideline? .......................................................................................... 18 3 Methods .............................................................................................................................. 21 3.1 Developing the review questions and outcomes ................................................................ 21 3.2 Searching for evidence ........................................................................................................ 24 3.2.1 Clinical literature search ......................................................................................... 24 3.2.2 Health economics literature search ....................................................................... 24 3.3 Evidence of effectiveness .................................................................................................... 24 3.3.1 Overview of reviewing the evidence of effectiveness ........................................... 24 3.3.2 Inclusion / exclusion criteria .................................................................................. 25 3.3.3 Methods of combining studies ............................................................................... 26 3.3.4 Types of studies ...................................................................................................... 27 3.3.5 Types of analysis ..................................................................................................... 27 3.3.6 Predictive test accuracy and discrimination for risk assessment tools .................. 28 3.3.7 Appraising the quality of the evidence by outcomes ............................................. 29 3.3.8 Grading the quality of clinical evidence ................................................................. 30 3.3.9 Risk of bias .............................................................................................................. 30 3.3.10 Inconsistency .......................................................................................................... 31 3.3.11 Directness ............................................................................................................... 31 National Clinical Guideline Centre, 2014 4 Draft for consultation Contents 3.3.12 Imprecision ............................................................................................................. 32 3.3.13 Quality assessment of risk assessment tools ......................................................... 33 3.3.14 Assessing clinical importance and relative importance of outcomes .................... 34 3.3.15 Evidence statements .............................................................................................. 34 3.4 Evidence of cost effectiveness ............................................................................................ 34 3.4.1 Literature review .................................................................................................... 35 3.4.2 Undertaking new health economic analysis .......................................................... 36 3.4.3 Cost-effectiveness criteria ...................................................................................... 37 3.4.4 In the absence of economic evidence .................................................................... 37 3.5 Developing recommendations ............................................................................................ 37 3.5.1 Research recommendations .................................................................................. 38 3.5.2 Validation process .................................................................................................. 39 3.5.3 Updating the guideline ........................................................................................... 39 3.5.4 Disclaimer ............................................................................................................... 39 3.5.5 Funding ................................................................................................................... 39 4 Guideline summary .............................................................................................................. 40 4.1 Key priorities for implementation ....................................................................................... 40 4.2 Full list of recommendations .............................................................................................. 40 4.3 Key research recommendations ......................................................................................... 49 4.4 How this clinical guideline was updated ............................................................................. 49 5 Identification of people requiring assessment of CVD risk [2008] .......................................... 51 5.1 Evidence statements for the identification of people at high risk of developing CVD ....... 51 5.2 Clinical effectiveness of identification of people requiring assessment of CVD risk .......... 51 5.3 Cost-effectiveness identification of people requiring assessment of CVD risk [2008] ....... 52 5.4 Conclusions ......................................................................................................................... 53 5.5 Recommendations [2008] ................................................................................................... 53 6 Full formal risk assessment of CVD risk ................................................................................. 54 6.1 Introduction ........................................................................................................................ 54 6.2 Clinical evidence .................................................................................................................. 54 6.2.1 Summary of included studies ................................................................................. 56 6.2.2 Summary of results ................................................................................................ 58 6.2.3 ROC curves ............................................................................................................