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APPENDIX D: Summary Evidence Tables forLMBPTM Lipid Biomarkers and Risk of Cardiovascular DiseaseNOTE: Scoring Information see: Christenson et al. 2011For brevity, apolipoprotein was shortened to ‘Apo’ in the abstraction tablesApolipoprotein-BBibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 1. Author(s): Steffen, et.al. - Year: 2014 - Publication: Arterioscler Thromb Vasc Biol- Affiliations: Dept of Laboratory Medicine and Pathology and Div of Biostatistics, School of Public Health, Uni of Minnesota, Minneapolis; Dept of Lab Medicine; National Institutes of Health Molecular Disease Branch, National Heart, Lung, and Blood Institute, Bethesda, MD; Uni of Washington School of Medicine, Div of Cardiology, Uni of Washington Medical Center, Seattle; Cardiovascular Health Research Unit, School of Public Health and Dept of Biostatistics; Uni of Washington, Seattle; Dept of Preventive Medicine, Feinberg School of Medicine, Northwestern Uni, Chicago, IL; Dept of Medicine, Div of Cardiology, Johns Hopkins University- Funding: This research was supported by the following contracts, N01-HC-95159 through N01-HC-95169 from the National Heart, Lung, and Blood Institute.- Design: Prospective cohort study - Facility/Setting: Multi-institutionaaal - Time period: 8.5-year follow-up -Population/Sample: 4679 Multi-Ethnic Study of Atherosclerosis (MESA) participants - Comparator: Standard lipid panel to evaluate the risk of CHD. - Study bias: None -Description: Compared the standard lipid panel with nonstandard measurements ApoB and the ratio of ApoB/ApoA-I as well as NMR spectroscopy-derived measures of total LDL-P and the ratio of LDL-P to HDL-particles (HDLP) for evaluating CHD risk. We then determined whether these lipoprotein measures may impart risk independent of cholesterol measures. - Duration: 8.5 years - Training: N/A - Staff/Other resources: NA - Associated Cost: Not provided - Description: Used the AHA/ACC risk calculator score as a baseline prediction model and determined whetherindividual additions of ApoB, ApoB/ApoA-I, LDL-P, orLDL-P/HDL-P improved CHD risk prediction. Recording Method:Cox proportional hazards analyses were conducted, and adjustments were made for sex, hypertension medication, systolic blood pressure, age, diabetes mellitus, smoking, and race/ethnicity, with individual adjustments for LDL-C, non-HDL-C, or TC/HDL-C, followed by a combination of TC, LDL-C, HDL-C, and triglycerides.- Number of Participants/ CVD events: 4679/ 233- Findings/Effect Size: Risk of Incident CHD for Lipoprotein Apo-B Markers Adjusted for Non-lipid Variables (sex, HT meds, systolic BP, age, DM, smoking, and race/ethnicity)+Specified Lipid Measures (TC+LDL-C+HDL-C+TGs)HR (95% CI): 1.23 (0.63 – 2.41) p-value: 0.55- Statistical Significance/Test(s): Risk of Incident CHD were calculated as Hazard Ratios with 95% confidence intervals and p- values. Adjustments were made for non- lipid measures, including sex, systolic blood pressure, hypertension medication use, age, and race/ethnicity.- Results/conclusion biases: NoneQuality Rating (10 point maximum): 9 (Good) Effect Size Magnitude Rating: Moderate Study (3 pts maximum): _3__ Practice (2 pts maximum): 1_ <10-yr follow-up Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _3_Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Type of Findings - Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 2. Author(s): Kappelle et al.,- Year: 2010- Publication: Journal of Internal Medicine- Affiliations: [1] Department of Endocrinology, [2] Nephrology, [3] Cardiology; University Medical Center Groningen and University of Groningen, Groningen, The Netherlands- Funding: Grants from the Netherlands Heart Foundation and the Jan Kornelis de Cock Foundation- Design: Prospective case-cohort study- Facility/Setting: Population study; residents of Groningen, Netherlands- Time period: median follow-up 7.9 yr (7.5-8.1 yrs range)-Population/Sample: Participants of the PREVEND study; 6948 subjects aged 28-75 years at baseline without previous cardiovascular disease and who did not use lipid powering drugs initially; 47.8% men in entire cohort; 253 first cardiac events (69.9%): 185 men (72.5%) and 68 (63.6%) women - Comparator: multivariate models accounting for CHD risk factors (hypertension, diabetes, obesity, smoking, age, sex, triglyceride, TC/HDL-C) - Study bias: None noted-Description: multivariate models accounting for CHD risk factors with addition of ApoB/ApoA-I ratio- Duration: median follow-up 7.9 yr (7.5-8.1 yrs range)- Training: Not provided- Staff/Other resources: Not provided- Cost: Not provided- Description: First MACE (combined endpoint of incident cardiovascular morbidity and mortality) included fatal/nonfatal MI, ischemic heart disease, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty: (1) Hazard ratio when ApoB/A-I and TC/HDL-C included in the same model- Recording Method: PRISMANT, the Dutch national registry of hospital discharge diagnoses; municipal register; death certificates - Number of Participants/ CVD events: 6948/ 362- Findings/Effect Size: Hazard ratios (HRs) of Apo-B and their ratios for major adverse CVD events (Adjusted for Non-lipid Variables (sex, age)+Specified Lipid Measures (TGs)HR* Apo-B(95% CI): 1.13(1.01-1.26); p<0.001*HRs are given per 1-SD increase for all variables.- Statistical Significance/Test(s): Cox proportional hazard analyses for association of MACEs and apolipoprotein ratios; hazard ratios per SD change; pair-wise models used to directly compare differences in HRs by means of Wald statistics; two-sided p<0.05 significant - Results/conclusion biases: statin treatment after baseline was not tracked; if statin treatment was started during follow-up, it could underestimate effectiveness of prediction of ApoB/A-I ratio Quality Rating: 7 (Fair) (10 point maximum)Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _2__Lack of generalizability and potential biasPractice (2 pts maximum): 1_<10 yr follow-upOutcome measures (2 pts. maximum): _2_Results/findings (3 pts maximum): _2_ Potential bias Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 3. Author(s): St-Pierre et.al. - Year: 2006 - Publication: American Journal of Cardiology - Affiliations: [1] The Institute on Nutraceuticals and Functional Foods, [2] The Lipid Research Center and CHUL Research Center, and the [3] Québec Heart Institute, Laval Hospital, Laval University, Ste-Foy, Québec, Canada. - Funding: Operating grant from the Canadian Institute for Health Research; training fellowship from Heart and Stroke Foundation of Canada - Design: Prospective cohort study - Facility/Setting: Population study; not provided - Time period: 13-year follow-up; 1985 to 1990-1998 -Population/Sample: 2,072 CHD-free men from the Quebec Cardiovascular Study; 35-64 years old at start; 173 nonfatal MI, 57 fatal coronary events - Comparator: multivariate model accounting for conventional risk factors (age, BMI, systolic blood pressure, cigarette smoking, diabetes, medication use, HDL-C, log-transformed triiglycerides) for CHD risk - Study bias: Only men -Description: multi-variable model accounting for conventional risk factors for CHD risk with addition of ApoB - Duration: 13 years follow-up - Training: Not provided - Staff/Other resources: Not provided - Cost: Not provided - Description: Occurrence of first CHD event (coronary death, MI) (1) Effect of apolipoprotein B on CHD risk associated with high Framingham risk score - Recording Method: Questionnaire data was confirmed by review of hospital records and death certificates - Number of Participants/ CVD events: 2,072/230- Findings/Effect Size: Relative risk (RR) of Apo-B and their ratios for CHD (Adjusted for Non-lipid Variables (sex, BMI, type 2 DM, Systolic BP, smoking)+Specified Lipid Measures (HDL, TGs) RR, 95% CI = 1.89 (1.31, 2.73)- Statistical Significance/Test(s): Student’s t-test; Wilcoxon’s test; Cox’s proportional hazard models (to estimate rates of CHD events); Lifetest procedure; ROC curves; likelihood ratio test - Results/conclusion biases: Translation of additive ApoB value unclear Quality Rating: 8 (Good) (10 point maximum) Effect Size Magnitude Rating: Moderate Study (3 pts maximum): _3__ Practice (2 pts maximum): 1_ Insufficient details provided for model based on Framingham risk score Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _2_ Data do not permit effect size calculation; potential bias Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 4. Author(s): Lamarche B et. al. - Year: 1996 - Publication: Circulation - Affiliations: [1] Lipid Research Center, Laval University Hospital Research Center, Ste-Foy [2]Dept of Social and Preventative Medicine, Laval University, and [3] Dept of Medicine, University of Montreal, Quebec, Canada - Funding: National health Research Development Program of Health and Welfare Canada; Heart and Stroke Foundation of Canada; Medical Research Council of Canada; Fournier Pharma/Jouveinal - Design: Prospective cohort study - Facility/Setting: Population study; not provided - Time period: 5-year follow-up -Population/Sample: Quebec Cardiovascular Study; 2,155 men free of CHD; 45-76 years with a mean of 56.5 yrs; 99% of French Canadian descent; 50 cases MI, 51 cases effort angina, 15 deaths to IHD-related causes - Comparator: multivariate model accounting for conventional risk factors (age, systolic blood pressure, total/DHL cholesterol ratio, diabetes mellitus, smoking, and medication use) for CHD risk - Study bias: only men of French-Canadian descent -Description: multi-variable model accounting for conventional risk factors for CHD risk with addition of ApoB ; total/HDL ratio used - Duration: 5 years - Training: Not provided - Staff/Other resources: Not provided - Cost: Not provided - Description: First onset ischemic heart disease (angina, coronary insufficiency, nonfatal MI, coronary death) (1) relative risk of IHD for an increase of 1 SD in each lipid (2) relative rate of IHD for synergistic effects of low and high ApoB and Total/HDL-C - Recording Method: Questionnaires; direct measurements; medical records; death certificate - Number of Participants/ CVD events: 2155/ 116- Findings/Effect Size: Five-Year Relative Rates (RR) of Ischemic Heart Disease According to Apolipoprotein B and A-I Levels After Control for nonlipid (age, systolic blood pressure, diabetes mellitus, smoking habits, and medication) and lipid (LDL, HDL, Total/HDL) variablesRR (95% CI) Apo-B: 1.41 (1.29 – 1.54) - Statistical Significance/Test(s): Proportional hazard models; hazard ratios by use of coefficients from proportional hazard models - Results/conclusion biases: Five year follow up may not be sufficient to determine full risk profile Quality Rating: 8 (Good) (10 point maximum) Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _2__ Population not generalizable Practice (2 pts maximum): 1_ <10-yr follow-up Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _3_ II. Apolipoprotein A-IBibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 1. Author(s): Kappelle et al.,- Year: 2010- Publication: Journal of Internal Medicine- Affiliations: [1] Department of Endocrinology, [2] Nephrology, [3] Cardiology; University Medical Center Groningen and University of Groningen, Groningen, The Netherlands- Funding: Grants from the Netherlands Heart Foundation and the Jan Kornelis de Cock Foundation- Design: Prospective case-cohort study- Facility/Setting: Population study; residents of Groningen, Netherlands- Time period: median follow-up 7.9 yr (7.5-8.1 yrs range)-Population/Sample: Participants of the PREVEND study; 6948 subjects aged 28-75 years at baseline without previous cardiovascular disease and who did not use lipid powering drugs initially; 47.8% men in entire cohort; 253 first cardiac events (69.9%): 185 men (72.5%) and 68 (63.6%) women - Comparator: multivariate models accounting for CHD risk factors (hypertension, diabetes, obesity, smoking, age, sex, triglyceride, TC/HDL-C) - Study bias: None noted-Description: multivariate models accounting for CHD risk factors with addition of ApoB/ApoA-I ratio- Duration: median follow-up 7.9 yr (7.5-8.1 yrs range)- Training: Not provided- Staff/Other resources: Not provided- Cost: Not provided- Description: First MACE (combined endpoint of incident cardiovascular morbidity and mortality) included fatal/nonfatal MI, ischemic heart disease, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty: (1) Hazard ratio when ApoB/A-I and TC/HDL-C included in the same model- Recording Method: PRISMANT, the Dutch national registry of hospital discharge diagnoses; municipal register; death certificates - Number of Participants/ CVD events: 6948/ 362- Findings/Effect Size: Hazard ratios (HRs) of Apo-B and their ratios for major adverse CVD events (Adjusted for Non-lipid Variables (sex, age)+Specified Lipid Measures (TGs)HR* Apo-AI (95% CI): 0.82(0.73-0.92) p<0.001; *HRs are given per 1-SD increase for all variables.- Statistical Significance/Test(s): Cox proportional hazard analyses for association of MACEs and apolipoprotein ratios; HRs per SD change; pair-wise models used to directly compare differences in HRs by means of Wald statistics; two-sided p<0.05 significant - Results/conclusion biases: statin treatment after baseline was not tracked; if statin treatment was started during follow-up, it could underestimate effectiveness of prediction of ApoB/A-I ratio Quality Rating: 7 (Fair) (10 point maximum)Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _2__Lack of generalizability and potential biasPractice (2 pts maximum): 1_<10 yr follow-upOutcome measures (2 pts. maximum): _2_Results/findings (3 pts maximum): _2_ Potential bias Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 2. Author(s): Lamarche B et. al. - Year: 1996 - Publication: Circulation - Affiliations: [1] Lipid Research Center, Laval University Hospital Research Center, Ste-Foy [2]Dept of Social and Preventative Medicine, Laval University, and [3] Dept of Medicine, University of Montreal, Quebec, Canada - Funding: National health Research Development Program of Health and Welfare Canada; Heart and Stroke Foundation of Canada; Medical Research Council of Canada; Fournier Pharma/Jouveinal - Design: Prospective cohort study - Facility/Setting: Population study; not provided - Time period: 5-year follow-up -Population/Sample: Quebec Cardiovascular Study; 2,155 men free of CHD; 45-76 years with a mean of 56.5 yrs; 99% of French Canadian descent; 50 cases MI, 51 cases effort angina, 15 deaths to IHD-related causes - Comparator: multivariate model accounting for conventional risk factors (age, systolic blood pressure, total/DHL cholesterol ratio, diabetes mellitus, smoking, and medication use) for CHD risk - Study bias: only men of French-Canadian descent -Description: multi-variable model accounting for conventional risk factors for CHD risk with addition of ApoB ; total/HDL ratio used - Duration: 5 years - Training: Not provided - Staff/Other resources: Not provided - Cost: Not provided - Description: First onset ischemic heart disease (angina, coronary insufficiency, nonfatal MI, coronary death) (1) relative risk of IHD for an increase of 1 SD in each lipid (2) relative rate of IHD for synergistic effects of low and high ApoB and Total/HDL-C - Recording Method: Questionnaires; direct measurements; medical records; death certificate - Number of Participants/ CVD events: 2155/ 116- Findings/Effect Size: Five-Year Relative Rates (RR) of Ischemic Heart Disease According to Apolipoprotein B and A-I Levels After Control for nonlipid (age, systolic blood pressure, diabetes mellitus, smoking habits, and medication) and lipid (LDL, HDL, Total/HDL) variablesRR (95% CI) Apo-A-I: 0.88 (0.81 – 0.97) - Statistical Significance/Test(s): Proportional hazard models; hazard ratios by use of coefficients from proportional hazard models - Results/conclusion biases: Five year follow up may not be sufficient to determine full risk profile Quality Rating: 8 (Good) (10 point maximum) Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _2__ Population not generalizable Practice (2 pts maximum): 1_ <10-yr follow-up Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _3_III: Apolipoprotein B/A-I ratioBibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 1. Author(s): Steffen, et.al. - Year: 2014 - Publication: Arterioscler Thromb Vasc Biol- Affiliations: Dept of Laboratory Medicine and Pathology and Div of Biostatistics, School of Public Health, Uni of Minnesota, Minneapolis; Dept of Lab Medicine; National Institutes of Health Molecular Disease Branch, National Heart, Lung, and Blood Institute, Bethesda, MD; Uni of Washington School of Medicine, Div of Cardiology, Uni of Washington Medical Center, Seattle; Cardiovascular Health Research Unit, School of Public Health and Dept of Biostatistics; Uni of Washington, Seattle; Dept of Preventive Medicine, Feinberg School of Medicine, Northwestern Uni, Chicago, IL; Dept of Medicine, Div of Cardiology, Johns Hopkins University- Funding: This research was supported by the following contracts, N01-HC-95159 through N01-HC-95169 from the National Heart, Lung, and Blood Institute.- Design: Prospective cohort study - Facility/Setting: Multi-institutionaaal - Time period: 8.5-year follow-up -Population/Sample: 4679 Multi-Ethnic Study of Atherosclerosis (MESA) participants - Comparator: Standard lipid panel to evaluate the risk of CHD. - Study bias: None -Description: Compared the standard lipid panel with nonstandard measurements ApoB and the ratio of ApoB/ApoA-I as well as NMR spectroscopy-derived measures of total LDL-P and the ratio of LDL-P to HDL-particles (HDLP) for evaluating CHD risk. We then determined whether these lipoprotein measures may impart risk independent of cholesterol measures. - Duration: 8.5 years - Training: N/A - Staff/Other resources: NA - Associated Cost: Not provided - Description: Used the AHA/ACC risk calculator score as a baseline prediction model and determined whetherindividual additions of ApoB, ApoB/ApoA-I, LDL-P, orLDL-P/HDL-P improved CHD risk prediction. Recording Method:Cox proportional hazards analyses were conducted, and adjustments were made for sex, hypertension medication, systolic blood pressure, age, diabetes mellitus, smoking, and race/ethnicity, with individual adjustments for LDL-C, non-HDL-C, or TC/HDL-C, followed by a combination of TC, LDL-C, HDL-C, and triglycerides.- Number of Participants/ CVD events: 4679/ 233- Findings/Effect Size: Risk of Incident CHD for Lipoprotein Apo-B Markers Adjusted for Non-lipid Variables (sex, HT meds, systolic BP, age, DM, smoking, and race/ethnicity)+Specified Lipid Measures (TC+LDL-C+HDL-C+TGs)HR (95% CI): 1.12 (0.64 – 1.98) - Statistical Significance/Test(s): Risk of Incident CHD were calculated as Hazard Ratios with 95% confidence intervals and p- values. Adjustments were made for non- lipid measures, including sex, systolic blood pressure, hypertension medication use, age, and race/ethnicity.- Results/conclusion biases: NoneQuality Rating (10 point maximum): 9 (Good) Effect Size Magnitude Rating: Moderate Study (3 pts maximum): _3__ Practice (2 pts maximum): 1_ <10-yr follow-up Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _3_Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Type of Findings - Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 2. Author(s): Kappelle et al.,- Year: 2010- Publication: Journal of Internal Medicine- Affiliations: [1] Department of Endocrinology, [2] Nephrology, [3] Cardiology; University Medical Center Groningen and University of Groningen, Groningen, The Netherlands- Funding: Grants from the Netherlands Heart Foundation and the Jan Kornelis de Cock Foundation- Design: Prospective case-cohort study- Facility/Setting: Population study; residents of Groningen, Netherlands- Time period: median follow-up 7.9 yr (7.5-8.1 yrs range)-Population/Sample: Participants of the PREVEND study; 6948 subjects aged 28-75 years at baseline without previous cardiovascular disease and who did not use lipid powering drugs initially; 47.8% men in entire cohort; 253 first cardiac events (69.9%): 185 men (72.5%) and 68 (63.6%) women - Comparator: multivariate models accounting for CHD risk factors (hypertension, diabetes, obesity, smoking, age, sex, triglyceride, TC/HDL-C) - Study bias: None noted-Description: multivariate models accounting for CHD risk factors with addition of ApoB/ApoA-I ratio- Duration: median follow-up 7.9 yr (7.5-8.1 yrs range)- Training: Not provided- Staff/Other resources: Not provided- Cost: Not provided- Description: First MACE (combined endpoint of incident cardiovascular morbidity and mortality) included fatal/nonfatal MI, ischemic heart disease, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty: (1) Hazard ratio when ApoB/A-I and TC/HDL-C included in the same model- Recording Method: PRISMANT, the Dutch national registry of hospital discharge diagnoses; municipal register; death certificates - Number of Participants/ CVD events: 6948/ 362- Findings/Effect Size: Hazard ratios (HRs) of Apo-B/Apo-A-I ratios for major adverse CVD events (Adjusted for Non-lipid Variables (sex, age)+Specified Lipid Measures (TGs)HR* Apo-B/Apo-A-I ratio(95% CI): 1.30(1.18-1.43); p<0.001*HRs are given per 1-SD increase for all variables.- Statistical Significance/Test(s): Cox proportional hazard analyses for association of MACEs and apolipoprotein ratios; hazard ratios per SD change; pair-wise models used to directly compare differences in HRs by means of Wald statistics; two-sided p<0.05 significant - Results/conclusion biases: statin treatment after baseline was not tracked; if statin treatment was started during follow-up, it could underestimate effectiveness of prediction of ApoB/A-I ratio Quality Rating: 7 (Fair) (10 point maximum)Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _2__Lack of generalizability and potential biasPractice (2 pts maximum): 1_<10 yr follow-upOutcome measures (2 pts. maximum): _2_Results/findings (3 pts maximum): _2_ Potential bias Bibliographic Information-Author (s)-Yr Published/Submitted-Publication -Author Affiliations-Funding Study-Design -Facility/Setting -Time Period -Population/Sample-Comparator-Study biasPractice-Description -Duration -Training-Staff/Other Resources-Cost Outcome Measures-Description (s) -Recording method Results/Findings- Number of Participants/ CVD events-Findings/Effect Size-Stat. Significance/Test(s) -Results/Conclusion Bias3. Author(s): Sierra-Johnson et al. -Year:2009-ublication: EuropeanHeart Journal-Affiliations:[1]Atherosclerosis Research Unit, Dept of Medicine Solna, Karolinska University Hospital Solna, Sweden;[2] Division of Cardiovascular Diseases, Dept of Internal Medicine, Mayo Clinic college of Medicine, Mayo Foundation, Rochester[3] AstraZeneca, So¨derta¨lje, Sweden-Funding: Faculty funds from the Board of Post-Graduate Education of the Karolinska Institutet; European Foundation for the Study of Diabetes Lilly Research Fellowship; Swedish Heart and Lung Foundation; Stockholm County Council; Swedish Research Council; Swedish Diabetes Association; American Heart Association; NIH; Swedish Council for Working Life and Social Research. -Design: Prospective cohort study-Facility/Setting: Population study; not provided-Time period:1988-1994;median follow-up was 124person months(interquartile range 75-25% 114-134 person-months)-Population/Sample:7,594 subjects (3,881 men, 3,713women) from the Third National Health and Nutrition Examination Survey (NHANESIII); US; adults aged 20-89;non-pregnant without missingdata;673cardiovasculardisease deaths;432 CHD deaths-Comparator: multivariate models accounting for conventional risk factors (total and HDL cholesterol, LDL, age, race, gender, dyslipidaemia, high blood pressure, smoking, diabetes, obesity, high CRP) for CHD risk-Study bias: Analysis could only be applied to a portion of the NHANES population because of limited measurement collection.-Description: multi-variable Cox-proportional hazards regression accounting for conventional risk factors for CHD risk with addition of ApoB/ApoA-I ratio; TC/HDL-C ratio used in adjustment-Duration: median follow-up was 124 person months (interquartile range 75-25%114-134 person-months)-Training: Not discussed; training would be needed for assays-Staff/Other resources: Not discussed-Cost: Not discussed-Description: First incident CHD event(CHD death) (1)predictive comparison; association with CHD after model adjusted for conventional risk factors-Recording Method: National Death Index; standard list of 113causes of death according to ICD-9 andICD-10 codes; used CVD and CHD codes- Number of Participants/ CVD events: 7594/ 673-Findings/Effect Size:Hazard ratios (HRs) of Apo-B/Apo-A-I ratios for CHD death (Adjusted for Non-lipid Variables (sex, race, age) +Specified Lipid Measures (TC, HDL-C) HR,95% CI Apo-B/Apo-A-I Ratio: 2.98,1.07-6.98-Statistical Significance/ Test(s): all analyses adjusted (weighted) to US population weights; HR calculated per SD increment; two-sided p-values<0.05; multi-variable Cox proportional hazards regressions used. Results/conclusion biases: Possible misclassification of endpointsQuality Rating: 9 (Good) (10 point maximum) Effect Size Magnitude Rating: SubstantialStudy (3 pts maximum): _2__ Large variability in follow-up times Practice (2 pts maximum): 2_ Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): 3__ Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 4. Author(s): Ingelsson et. al. - Year: 2007 - Publication: Journal of the American Medical Association - Affiliations: [1] The Framingham Study, Boston University School of Medicine, Framingham; [2] Lipid Metabolism Laboratory, Jean Mayer US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston; Departments of [3] Biostatistics, School of Public Health, [4] Mathematics and Statistics and [5] Preventative Medicine, Cardiology Section, School of Medicine, Boston University, Boston, MA; and [6] Cardiology Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA - Funding: Contract from the US Department of Agriculture Research Service; The Swedish Heart-Lung Foundation, Bergmarks Travel Grant; and grants from the National Heart, Lung, and Blood Institute - Design: Prospective cohort study - Facility/Setting: Population study; not provided - Time period: 1987-1991 to 2005; median follow-up of 15.0 yrs -Population/Sample: Framingham Offspring Study; 3,322 middle-aged white participants aged 30-74 yrs with no CVD at baseline; 291 CHD cases (198 men, 93 women) - Comparator: CHD risk scores using conventional risk factors; multivariate models accounting for conventional risk factors (baseline age, systolic blood pressure, antihypertensive treatment, diabetes, smoking, and TC:HDL) for CHD risk - Study bias: Population predominantly middle-aged whites of European descent, limiting generalizability to other age groups and ethnicities -Description: Net reclassification improvement of CHD risk by adding ApoB/A-I ratio to conventional risk factors 10-yr CHD risk score (without total cholesterol or HDL-C included); Incremental predictive ability of adding ApoB/A-I ratio to adjusted multivariate model - Duration: Median 15-yr follow-up; maximum follow-up of 19 yrs - Training: Not discussed; training would be needed for assays - Staff/Other resources: Not provided - Cost: Not provided - Description: Incidence of first CHD event (1) Net reclassification improvement for 10-yr CHD risk (2) Incremental predictive ability of when ApoB/A-I added to established conventional risk factors - Recording Method: Hospital and office visit records reviewed by end point adjudication committee; established diagnosis criteria for incident CHD; incident CHD included angina pectoris and coronary insufficiency along with MI and CHD death - Number of Participants/ CVD events: 3322/291- Findings/Effect Size: Hazard ratios (HRs) of Apo-B/Apo-A-I ratios for CHD prediction (Adjusted for Non-lipid Variables (age, systolic BP, anti HT treatment, DM, smoking) +Specified Lipid Measures (total cholesterol:HDL-C.) Overall grand mean estimate of risk ratios among men and women HR (95% CI) Apo-B/Apo A-I: 1.21 (0.96 – 1.52) - Statistical Significance/Test(s): 2-sided p-values of <0.05; multivariable Cox proportional hazard regressions; ROC curves; likelihood ratio χ2 statistic as indicator of goodness of fit; model calibration evaluated using Hosmer-Lemeshow χ2 statistic; asymptotic tests to determine significance of net reclassification improvement - Results/conclusion biases: An increasing proportion of participants receiving lipid-lowering treatment during follow-upQuality Rating: 9 (Good) (10 point maximum) Effect Size Magnitude Rating: Moderate Study (3 pts maximum): _2__ Limited generalizability Practice (2 pts maximum):_2_ Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _3_ Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 5. Author(s): Van der Steeg et al. - Year: 2007 - Publication: Annals of Internal Medicine - Affiliations: From Academic Medical Center, Amsterdam, and Leiden University Medical Center, Leiden, the Netherlands; Metabolic & Atherosclerosis Research Center, Cincinnati, OH; and Medical Research Council Epidemiology Unit and Institute of Public Health, Cambridge, U K - Funding: Medical Research Council (IK), Cancer Research UK, European Union, Stroke Association, British Heart Foundation, UK Dept of Health, Food standards Agency, and the Welcome Trust; education grant from the Future Forum; Netherlands Heart Foundation - Design: Nested case-control study - Facility/Setting: Population study; not provided - Time period: mean follow-up of 6 years -Population/Sample: Healthy men and women 45-79 years of age in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk; - Comparator: multivariate models accounting for conventional risk factors (sex, age, time of enrollment, diabetes, BMI, smoking, systolic blood pressure, C-reactive protein level, and either LDL and HDL, log-transformed triglyceride level, or total cholesterol-HDL cholesterol ratio) for CHD risk - Study bias: limited population -Description: multi-variable models accounting for conventional risk factors for CHD risk with addition of ApoB/ApoA-I ratio - Duration: mean follow-up of 6 years - Training: Not provided - Staff/Other resources: Not provided - Cost: Not provided - Description: First onset CAD (fatal and non-fatal events) (1) Odds ratio for future CAD events from conditional logistic regression after adding ApoB/A-I ratio and risk factor adjustments plus (a) tot-cholesterol:HDL ratio (b) FRS - Recording Method: Hospital National Health Service numbers, hospital admission or death - Number of Participants/ CVD events: 2380/869- Findings/Effect Size: Odds ratios (ORs) of Apo-B/Apo-A-I ratios for CVD events (Adjusted for Non-lipid Variables (age, systolic BP, anti HT treatment, DM, smoking, CRP) +Specified Lipid Measures (LDL-C, HDL-C, TGs) OR: 1.85 (95% CI: 1.15, 2.98) p<0.001 for linearity - Statistical Significance/Test(s): p<0.05 was significant; conditional logistic regression analyses, odds ratio, ROCs, AUCs - Results/conclusion biases: None notedQuality Rating: 7 (Fair) (10 point maximum) Effect Size Magnitude Rating: Moderate Study (3 pts maximum): 2 (Limited generalizability; limited population Practice (2 pts maximum): 1_ <10 year follow-up Outcome measures (2 pts. maximum): _1_ Recording methods not well described Results/findings (3 pts maximum): _3_ Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 6. Author: Ingelsson et al.- Year: 2005 - Publication: Journal of the American College of Cardiology - Affiliations: [1] Department of Public Health and Caring Sciences, Section of Geriatrics and the [2] Department of Medical Sciences, Uppsala University, Uppsala, Sweden; and [3] Astra Zeneca R and D, M?lndal, Sweden - Funding: Gustaf Adolf Johanssons Minnesfond, Josef och Linnea Carlssons Minnesfond, Primary Health Care in Uppsala County, Royal Scientific Society Foundation (Kungliga vetenskapssamh?llets fond), Swedish Heart Lung Foundation (Hj?rt-Lungfonden) and Thuréus Foundation - Design: Community-based prospective study - Facility/Setting: Population study; residents of Uppsala, Sweden - Time period: Median follow-up of 28.8 yrs (0.04-31.7 yrs range) -Population/Sample: 50-year old men at baseline from Uppsala, Sweden free from heart failure (HF) and valvular disease at baseline; 2,321 eligible for inclusion; 259 cases of definite HF; 840 subjects (36%) died during follow-up; evidence of MI in 409 of subjects and in 98 of the 259 HF cases - Comparator: multivariate models accounting for CHD risk factors (prior acute MI, hypertension, diabetes, ECG-LVH, smoking, BMI, serum cholesterol) - Study bias: Unknown generalizability to women or other age and ethnic groups; advanced age of participants may cause bias-Description: multivariate models accounting for CHD risk factors with addition of ApoB/ApoA-I ratio - Duration: Median follow-up of 28.8 yrs (0.04-31.7 yrs range) - Training: Not provided - Staff/Other resources: Not provided - Cost: Not provided - Description: Incidence of HF or MI at follow-up: (1) Cox proportional hazard ratio for HF corresponding to a 1-SD increase - Recording Method: review of medical records by two physicians; classifications based on European Society of Cardiology definitions - Number of Participants/ CVD events: 2,321/ 259- Findings/Effect Size: Hazard ratios (HRs) of Apo-B/Apo-A-I ratios for heart failure prediction (Adjusted for Non-lipid Variables (prior acute MI, HT, DM, ECG-LVH, smoking, BMI) +Specified Lipid Measures (serum cholesterol.)HR (95% CI): 1.31 (1.11-1.54) p<0.001 - Statistical Significance/ Test(s): Cox proportional hazard analysis; Nelson-Aalen curves; p<0.05 significant; two-tailed 95% confidence intervals and p-values - Results/conclusion biases: None notedQuality Rating: 7 (Fair) (10 point maximum) Effect Size Magnitude Rating: Moderate Study (3 pts maximum): _1__ Lack of generalizability and potential bias Practice (2 pts maximum): 1_ Serum cholesterol not well defined Outcome measures (2 pts. maximum): _2_ Results/findings (3 pts maximum): _3_Bibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Number of Participants/ CVD events- Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 7. Author(s): Wallidus et al.,- Year: 2004- Publication: Clinical Chemistry laboratory Medicine- Affiliations: King Gustaf V Research Institute, Stockholm, Sweden; AstraZeneca, Molndal, Sweden; CALAB Research, Stockholm, Sweden; Dept of Chemistry, Biotechnology, and Food science, Agricultural University of Norway; Preventive medicine clinic, Ulleval University Hospital, Oslo, Norway; Wake forest Uni School of Medicine, NC, USA; Mike Rosenblom Laboratory for Cardiovacular Research, McGill Uni Health Center, Montreal, Canada- Funding: NR- Design: Prospective cohort study- Facility/Setting: General outpatient population. Patients were referred from mainly from health checkups for laboratory testing. - Time period: follow-up 8.1 yr -Population/Sample: Apolipoprotein –related mortality Risk (AMORIS) Study Population. Over the age of 40 years. - Comparator: NA - Study bias: None noted-Description: TC and triglycerides valued were measured by convenient enzymatic methods. Apo B and Apo A-I were measured on fresh blood samples by immune-turbidimetric techniques. Predictive value for Apo-B/Apo-A-I ratios for coronary risk was calculated as relative risk ratios after adjusting for total cholesterol, triglycerides and age variables- Duration: follow-up 15 yr - Training: Not provided- Staff/Other resources: Not provided- Cost: Not provided- Description: Endpoint of the study was fatal myocardial infarction or sudden death due to AMI. Number of deaths /1000 observation years, as well as relative risks were calculated. Bias: Non fatal MI was not included as an endpoint.- Recording Method: Data were collected from the Sweden Death register.- Number of Participants/ CVD events: 12,6198/ 1,743- Findings/Effect Size: Relative Risk Ratios (RRs) of Apo-B/Apo-A-I ratios for acute myocardial infarction (AMI) (Adjusted for Non-lipid Variables -age +Specified Lipid Measures (serum total cholesterol and TGs)HR (95% CI): Men: 1.35 (1.27-1.43) p<0.0001Women: 1.27 (1.15-1.40) p<0.0001Overall ES among men and women: HR (95% CI): 1.32 (1.27-1.40) p<0.0001- Statistical Significance/Test(s): Relative risks based on COX models were calculated, together with 95% CI and p-values, RR were expressed with one standard deviation as unit change for each variable (RR/SD).- Results/conclusion biases: This study was not designed to examine all risk factors associated with CAD. Quality Rating: 8 (Good) (10 point maximum)Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _3__Lack of generalizability and potential biasPractice (2 pts maximum): 2_Outcome measures (2 pts. maximum): _1_Bias: Non fatal MI was not included as an endpoint.Results/findings (3 pts maximum): _2_ Potential bias IV. Non-HDL cholesterolBibliographic Information - Author (s) - Yr Published/Submitted - Publication - Author Affiliations - Funding Study - Design - Facility/Setting - Time Period - Population/Sample - Comparator - Study bias Practice - Description - Duration - Training - Staff/Other Resources - Cost Outcome Measures - Description (s) - Recording method Results/Findings - Type of Findings - Findings/Effect Size - Stat. Significance/Test(s) - Results/Conclusion Bias 2. Author(s): Kappelle et al.,- Year: 2010- Publication: Journal of Internal Medicine- Affiliations: [1] Department of Endocrinology, [2] Nephrology, [3] Cardiology; University Medical Center Groningen and University of Groningen, Groningen, The Netherlands- Funding: Grants from the Netherlands Heart Foundation and the Jan Kornelis de Cock Foundation- Design: Prospective case-cohort study- Facility/Setting: Population study; residents of Groningen, Netherlands- Time period: median follow-up 7.9 yr (7.5-8.1 yrs range)-Population/Sample: Participants of the PREVEND study; 6948 subjects aged 28-75 years at baseline without previous cardiovascular disease and who did not use lipid powering drugs initially; 47.8% men in entire cohort; 253 first cardiac events (69.9%): 185 men (72.5%) and 68 (63.6%) women - Comparator: multivariate models accounting for CHD risk factors (hypertension, diabetes, obesity, smoking, age, sex, triglyceride, TC/HDL-C) - Study bias: None noted-Description: multivariate models accounting for CHD risk factors with addition of ApoB/ApoA-I ratio- Duration: median follow-up 7.9 yr (7.5-8.1 yrs range)- Training: Not provided- Staff/Other resources: Not provided- Cost: Not provided- Description: First MACE (combined endpoint of incident cardiovascular morbidity and mortality) included fatal/nonfatal MI, ischemic heart disease, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty: (1) Hazard ratio when ApoB/A-I and TC/HDL-C included in the same model- Recording Method: PRISMANT, the Dutch national registry of hospital discharge diagnoses; municipal register; death certificates - Number of Participants/ CVD events: 6948/ 362- Findings/Effect Size: Hazard ratios (HRs) of Non-HDL-C for major adverse CVD events (Adjusted for Non-lipid Variables (sex, age)+Specified Lipid Measures (TGs)HR* Non-HDL-C (95% CI): Non-HDL-C: 1.25(1.11–1.41); p<0.001*HRs are given per 1-SD increase for all variables.- Statistical Significance/Test(s): Cox proportional hazard analyses for association of MACEs and apolipoprotein ratios; hazard ratios per SD change; pair-wise models used to directly compare differences in HRs by means of Wald statistics; two-sided p<0.05 significant - Results/conclusion biases: statin treatment after baseline was not tracked; if statin treatment was started during follow-up, it could underestimate effectiveness of prediction of ApoB/A-I ratio Quality Rating: 7 (Fair) (10 point maximum)Effect Size Magnitude Rating: ModerateStudy (3 pts maximum): _2__Lack of generalizability and potential biasPractice (2 pts maximum): 1_<10 yr follow-upOutcome measures (2 pts. maximum): _2_Results/findings (3 pts maximum): _2_ Potential bias ................
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