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Table 2 Risk-stratified treatment recommendations of the included guidelines.

From: Support of personalized medicine through risk-stratified treatment recommendations - an environmental scan of clinical practice guidelines

Guideline title NCEP NICE1 AHA1 AHA2
Risk assessment tools
Risk prediction model Framingham Risk Score 10-year risk of developing CVD, not referring to a specific risk model Framingham Risk Score Framingham Risk Score
Outcome of interest and its timeframe CHD (10 years) CVD (CHD and stroke, 10 years) CHD (10 years) CHD (10 years)
Information on validation of the model provided in the guideline Yes Unclear Yes Yes
Evidence of treatment effects
Treatment considered LDL-lowering therapy, therapeutic lifestyle change and LDL goals Statin Diet, weight management, physical activity, drug therapy and LDL-C goals Lifestyle management, pharmacotherapy and LDL-C target levels
Target population Adults Adults at risk of CVD Adult patients at increased risk of stroke Adult women 20 years and older
Type of studies considered in the evidence of treatment benefits Single or several RCTs Meta-analyses Single or several RCTs Meta-analyses Single or several RCTs Meta-analyses Single or several RCTs Meta-analyses
Type of studies considered in the evidence of treatment harms Observational studies Single or several RCTs Single or several RCTs Meta-analyses Treatment harms not reported Treatment harms not reported
Heterogeneity of treatment effects assessed in the guideline Yes Yes No No
Application of treatment evidence to baseline risks
Methods to apply treatment evidence to baseline risks Used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks Unclear, presumably used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks Not reported Not reported
Assumptions specified when applying treatment evidence 'For every 30-mg/dL change in LDL-C, the relative risk for CHD is changed in proportion by about 30%, and the relative risk is set at 1.0 for LDL-C = 40 mg/dL.' 'For every 1% reduction in LDL-C levels, relative risk for major CHD events is reduced by approximately 1%.' 'Statins do not differ in their relative effectiveness in a number of subgroups: in women compared with men at a similar level of cardiovascular risk; in people with diabetes compared with people without diabetes; or in people aged over 65 years compared with people aged under 65 years.' Not reported Not reported
Development of treatment thresholds
Risk stratification in which different treatments were recommended •10-year CHD risk > 20% •10-year CHD risk 10 to 20% •10-year CHD risk < 10% •10-year CVD risk ≥20% •0 to 1 CHD risk factor •≥2 CHD risk factors and 10-year CHD risk < 20% •≥2 CHD risk factors and 10-year CHD risk 10% to 20% •CHD or CHD risk equivalent (10-year risk > 20%) •10-year CHD absolute risk > 20% •10-year CHD absolute risk 10% to 20% •10-year CHD absolute risk < 10%
Methods to develop treatment thresholds Unclear Expert consensus Referring to NCEP ATP-III guideline Not reported
Explicitly planned benefit and harm assessment as the basis for making recommendations No No No No
Patient preferences considered when developing recommendations No No No No
Guideline title MSC1 NICE2 ACCP MSC2
Risk assessment tools
Risk prediction model Framingham Risk Score (for patients without diabetes) and UKPDS Risk Engine (for patients with diabetes) Framingham Risk Score Framingham Risk Score Framingham Risk Score or UKPDS Risk Engine for patients with diabetes
Outcome of interest and its timeframe CHD (10 years) CVD (CHD and stroke, 10 years) CHD (10 years) CHD (10 years)
Information on validation of the model provided in the guideline No Yes No No
Evidence of treatment effects
Treatment considered Lifestyle management, pharmacologic treatment and desirable lipid results Lifestyle advice and statin Aspirin and vitamin K antagonists Lifestyle management and antihypertensive drugs
Target population Men aged > 40 years and women aged > 50 years Adults aged 18 and older and who have established CVD or who are at high risk of developing CVD Patients at risk for coronary artery disease Non-pregnant adults (age 19 years and older) with hypertension
Type of studies considered in the evidence of treatment benefits Other guidelines Meta-analyses Meta-analyses Meta-analyses
Type of studies considered in the evidence of treatment harms Treatment harms not reported Meta-analyses Single or several RCTs Meta-analyses Treatment harms not reported
Heterogeneity of treatment effects assessed in the guideline No Yes Yes No
Application of treatment evidence to baseline risks
Methods to apply treatment evidence to baseline risks Not reported Not reported Unclear, presumably used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks Used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks
Assumptions specified when applying treatment evidence Not reported Not reported Not reported 'This assumes 20% risk reduction of CHD based on average outcomes for appropriately used blood pressure lowering medications and statin medications.'
Development of treatment thresholds
Risk stratification in which different treatments were recommended •Framingham CHD risk ≥20% without CHD •Framingham CHD risk 10% to 19% •Framingham CHD risk < 10% •CVD risk < 20% •CVD risk ≥20% Moderate risk for a coronary event (10-year risk of a cardiac event > 10%) Diagnosis of hypertension confirmed and CHD risk ≥20% over 10 years
Method to develop treatment thresholds Referring to 2005 British Columbia guideline Diabetes Care Referring to the NICE technology appraisal Statins for the Prevention of Cardiovascular Events Unclear, presumably putting benefits and harms on the same scale and find a balance between them Unclear
Explicitly planned benefit and harm assessment as the basis for making recommendations No Unclear No Unclear
Patient preferences considered when developing recommendations No No No No
Guideline title USPSTF UMHS1 ISCI MQIC
Risk assessment tools
Risk prediction model Framingham Risk Score Framingham Risk Score Framingham Risk Score Framingham Risk Score
Outcome of interest and its timeframe CHD (10 years) in men and stroke (10 years) in women Hard CHD (myocardial infarction and coronary death, 10 years) CHD (10 years) CHD (10 years)
Information on validation of the model provided in the guideline No No No No
Evidence of treatment effects
Treatment considered Aspirin Lifestyle changes, drug therapy and LDL-C goals Drug therapy and LDL goals Drug therapy and goal for LDL-C
Target population Men aged 45 to 79 years and women aged 55 to 79 years Adults 20 to 75 years of age without familial or severe dyslipidemias Adults 20 years and older and who are dyslipidemic Adults ≥18 years
Type of studies considered in the evidence of treatment benefits Meta-analyses Treatment benefits reported but study type unclear Single or several RCTs Meta-analyses Treatment benefits not reported
Type of studies considered in the evidence of treatment harms Observational studies Treatment harms reported but study type unclear Single or several RCTs Meta-analyses Treatment harms not reported
Heterogeneity of treatment effects assessed in the guideline Yes Yes No No
Application of treatment evidence to baseline risks
Methods to apply treatment evidence to baseline risks Used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks Used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks Used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks Not reported
Assumptions specified when applying treatment evidence There is 'a 32% risk reduction of MIs with regular aspirin use' (in men) and 'a 17% risk reduction of strokes with regular aspirin use' (in women). 'The risk for gastrointestinal bleeding increases with age.' Not reported Not reported Not reported
Development of treatment thresholds
Risk stratification in which different treatments were recommended •Men aged 45 to 59 years and 10-year CHD risk ≥4%; men aged 60 to 69 years and 10-year CHD risk ≥9%; men aged 70 to 79 years and 10-year CHD risk ≥12% •Women aged 55 to 59 years and 10-year stroke risk ≥3%; women aged 60 to 69 years and 10-year stroke risk ≥8%; women aged 70 to 79 years and 10-year stroke risk ≥11% •0 to 1 risk factors •2+ risk factors and 10-year CHD risk < 10% •2+ risk factors and 10-year CHD risk 10% to 20% •0 to 1 risk factor and 10-year CHD risk < 10% •2+ risk factors and 10-year CHD risk < 10% •2+ risk factors and 10-year CHD risk 10% to 20% •CHD or CHD equivalent and/or 10-year risk > 20% •CHD or CHD risk equivalents 10-year risk > 20% •2+ risk factors 10-year CHD risk ≤20% •0 to 1 risk factor
Method to develop treatment thresholds Putting benefits and harms on the same scale (events saved/in excess per 1,000 people) and find a balance between them Expert consensus and referring to NCEP ATP-III guideline Referring to NCEP ATP-III guideline Referring to ICSI Lipid Management in Adults guideline
Explicitly planned benefit and harm assessment as the basis for making recommendations Yes No No No
Patient preferences considered for the development of recommendations Yes No No No
Guideline title ES NICE3 MSC3 ADA
Risk assessment tools
Risk prediction model Framingham Risk Score, PROCAM and SCORE UKPDS Risk Engine UKPDS Risk Engine Not specified, presumably Framingham Risk Score
Outcome of interest and its timeframe 10-year CHD risk (Framingham and PROCAM) and 10-year total cardiovascular mortality (SCORE) CHD (10 years) in patients with diabetes CHD (10 years) in patients with diabetes CVD (CHD and stroke, 10 years)
Information on validation of the model provided in the guideline Yes Yes No No
Evidence of treatment effects
Treatment considered Aspirin, LDL-C goals and non-HDL-C goals Simvastatin and statin Statin and lipid targets Aspirin
Target population Patients at high metabolic risk for CVD People with type 2 diabetes Non-pregnant adults with type 2 diabetes Patients with type 1 or type 2 diabetes mellitus
Type of studies considered in the evidence of treatment benefits Single or several RCTs Meta-analyses Single or several RCTs Meta-analyses Single or several RCTs Meta-analyses
Type of studies considered in the evidence of treatment harms Treatment harms reported but study type unclear Single or several RCTs Treatment harms not reported Treatment harms reported but study type unclear
Heterogeneity of treatment effects assessed in the guideline No No No Yes
Application of treatment evidence to baseline risks
Methods to apply treatment evidence to baseline risks Not reported Not reported Not reported Unclear, presumably used evidence of relative risk reduction from RCT/meta-analysis and applied it to different absolute risks
Assumptions specified when applying treatment evidence Not reported Not reported Not reported Not reported
Development of treatment thresholds
Risk stratification in which different treatments were recommended •Individuals over age 40 and 10-year risk for CHD > 10% •10-year risk for CHD > 20% •10-year risk for CHD 10% to 20% •At least two major risk factors and 10-year risk for CHD < 10% The cardiovascular risk exceeds 20% over 10 years •Moderate risk (< 20% 10-year CHD risk) •High risk (≥20% 10-year CHD risk) •Adults with type 1 or type 2 diabetes at increased cardiovascular risk (10-year CVD risk > 10%) •Adults with diabetes and 10-year CVD risk < 5% •Adults with 10-year CVD risk 5% to 10%
Methods to develop treatment thresholds Unclear, presumably putting benefits and harms on the same scale and find a balance between them to recommend using aspirin; referring to NCEP ATP-III guideline on LDL-C and non-HDL-C goals Not reported Not reported Unclear, presumably putting benefits and harms on the same scale and find a balance between them
Explicitly planned benefit and harm assessment as the basis for making recommendations No No No No
Patient preferences considered when developing recommendations No Yes No No
Guideline title UMHS2 NSGC ASCO NICE4
Risk assessment tools
Risk prediction model NCI Breast Cancer Risk Assessment Tool The guideline mentioned different models NCI Breast Cancer Risk Assessment Tool Nottingham Prognostic Index
Outcome of interest and its timeframe Invasive breast cancer (5 years) Absolute risk of developing breast cancer or the likelihood of carrying a BRCA1 or BRCA2 mutation (unclear timeframe) Invasive breast cancer during the next 5-year period and up to age 90 (lifetime risk) Survival (10 years)
Information on validation of the model provided in the guideline No No Yes No
Evidence of treatment effects
Treatment considered Tamoxifen and raloxifene Tamoxifen; oral contraceptives; prophylactic mastectomy, prophylactic bilateral salpingo-oophorectomy Tamoxifen and raloxifene Aromatase inhibitors
Target population Adults age 18 and older (non-pregnant) Individuals at risk for hereditary breast and ovarian cancer Women at increased risk of breast cancer Women with breast cancer
Type of studies considered in the evidence of treatment benefits Treatment benefits reported but study type unclear Treatment benefits reported but study type unclear Single or several RCTs Meta-analyses Single or several RCTs
Type of studies considered in the evidence of treatment harms Treatment harms reported but study type unclear Treatment harms not reported Single or several RCTs Meta-analyses Single or several RCTs
Heterogeneity of treatment effects assessed in the guideline No No Yes No
Application of treatment evidence to baseline risks
Methods to apply treatment evidence to baseline risks Used evidence of relative risk reduction from the same risk profile population for which the recommendation was made Not reported Unclear Unclear
Assumptions when applying treatment evidence Not reported Not reported Not reported Not reported
Development of treatment thresholds
Risk stratification in which different treatments were recommended Women at high risk (5-year risk of invasive cancer ≥1.7%) The guideline made risk-stratified recommendations, but it is unclear how they defined high risk, moderate risk and low risk Premenopausal and postmenopausal women with a 5-year projected breast cancer risk ≥1.66% or with lobular carcinoma in situ •Postmenopausal women with estrogen-receptor-positive early invasive breast cancer not at low risk (those in the Excellent Prognosis Group or Good Prognosis Group in the Nottingham Prognostic Index) •Postmenopausal women with estrogen-receptor-positive early invasive breast cancer not at low risk and who have been treated with tamoxifen for 2 to 3 years
Method to develop treatment thresholds Expert consensus Not reported Expert consensus Unclear
Explicitly planned benefit and harm assessment as the basis for making recommendations No No Yes No
Patient preferences considered when developing recommendations No No No Yes
  1. CHD: coronary heart disease; CVD: cardiovascular disease; LDL: low-density lipoprotein; LDL-C: low-density lipoprotein cholesterol; MI: myocardial infarction; NCEP ATP-III: National Cholesterol Education Program Adult Treatment Panel III; NCI: National Cancer Institute; NICE: National Institute for Health and Clinical Excellence; HDL-C: high-density lipoprotein cholesterol; PROCAM: Prospective Cardiovascular Münster; RCT: randomized clinical trial; SCORE: Systematic Coronary Risk Evaluation; UKPDS: United Kingdom Prospective Diabetes Study.