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Study Title and Description

Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART).



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART).
Author Burr ML., Fehily AM., Gilbert JF., Rogers S., Holliday RM., Sweetnam PM., Elwood PC., Deadman NM.
Country MRC Epidemiology Unit, Cardiff.
Year 1989
Numbers Pubmed ID: 2571009
15251 (internal)

Secondary Publication Information
UI Title Author Country Year
Secondary prevention of CHD in UK men: the Diet and Reinfarction Trial and its sequel. Burr ML. Department of Epidemiology, Statistics and Public Health, Cardiff University, Cardiff CF14 4YS, UK. burrml@cf.ac.uk 2007
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The long-term effect of advice to eat more fish on blood pressure in men with coronary disease: results from the diet and reinfarction trial. Ness AR., Whitley E., Burr ML., Elwood PC., Smith GD., Ebrahim S. Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol, BS8 2PR, UK. 1999
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The long-term effect of dietary advice in men with coronary disease: follow-up of the Diet and Reinfarction trial (DART). Ness AR., Hughes J., Elwood PC., Whitley E., Smith GD., Burr ML. Department of Social Medicine, University of Bristol, Bristol, UK. Andy.Ness@bris.ac.uk 2002
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Fish + Fish oil Fish advice, either alone or in combination with fiber advice, fat advice, or both fiber and fat advice.
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2 No intervention Fat advice, fiber advice, fiber and fat advice, or no advice.
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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Country in which study conducted (where subjects live) UK
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: The subjects were men under 70 years of age, admitted to 21 hospitals with a diagnosis of acute MI according to World Health Organisation criteria. Diabetic patients, men awaiting cardiac surgery, and men who already intended to eat one of the intervention diets were excluded.
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Study Population Secondary Prevention (history of CVD event)
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Comment about study design: Ness 2002 was based on a followup questionnaire in 1999-2000.
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Duration of Intervention 2 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... Previous MI
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... fat, fiber; fat, no fiber; no fat, fibre; no fat, no fiber
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Study start date(s) 1987 (Approx)
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Baseline Characteristics
Question Fish + Fish oil No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions nd nd
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nd nd
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nd nd
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22.7 24.6
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nd nd
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100 100
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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Baseline characteristics, continuous 56.7 56.4
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129.7 130.1
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79.3 80.2
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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25.8 26.0
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21.4 21.0
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12.4 12.5
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Male, percent 100 100
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Race ND ND
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake nd nd
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Does this study report baseline omega-3 biomarker data? No No
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Results & Comparisons


Results Data
Outcome: Death      Population: 45061
Time Point Measure Fish + Fish oil No intervention


2 years

N Enrolled 1015 1018
Counts 78 116
Percentage 7.7 11.4


5 years

N Enrolled 1015 1018
Counts 83 75


10 years

N Enrolled 1015 1018
Counts 107 104


>10 years

N Enrolled 1015 1018
Counts 86 88


overall years

N Enrolled 1015 1018
Counts 354 384
Outcome: Death      Population: 45062
Time Point Measure Fish + Fish oil No intervention


2 years

N Enrolled 1015 1018
Counts 5 2


5 years

N Enrolled 1015 1018
Counts 2 0


10 years

N Enrolled 1015 1018
Counts 12 7


>10 years

N Enrolled 1015 1018
Counts 10 14


overall years

N Enrolled 1015 1018
Counts 29 23
Outcome: cardiac      Population: 45067
Time Point Measure Fish + Fish oil No intervention


2 years

N Enrolled 1015 1018
Counts 127 149
Percentage 12.5 14.6
Outcome: Death      Population: 45074
Time Point Measure Fish + Fish oil No intervention


2 years

N Enrolled 1015 1018
Counts 94 130
Percentage 9.3 12.8


5 years

N Enrolled 1015 1018
Counts 130 97


10 years

N Enrolled 1015 1018
Counts 163 159


>10 years

N Enrolled 1015 1018
Counts 143 166


overall years

N Enrolled 1015 1018
Counts 530 553
Outcome: bp      Population: 44916
Time Point Measure Fish + Fish oil No intervention


0 years

N Analyzed 1015 1018
Mean 129.7 130.1
SD 21.4 21.0


0.5 years

N Analyzed 1015 1018
Mean nd nd
SD nd nd


2 years

N Analyzed 1015 1018
Mean nd nd
SD nd nd
Outcome: bp      Population: 44917
Time Point Measure Fish + Fish oil No intervention


0 years

N Analyzed 1015 1018
Mean 79.3 80.2
SD 12.4 12.5


0.5 years

N Analyzed 1015 1018
Mean nd nd
SD nd nd


2 years

N Analyzed 1015 1018
Mean nd nd
SD nd nd

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? UNCLEAR
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Was ALLOCATION adequately concealed (prior to assignment)? HIGH no blinding
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Were PARTICIPANTS adequately BLINDED? HIGH no blinding
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Were OUTCOME ASSESSORS adequately BLINDED? HIGH no blinding
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Yes Lipid information not reported for fish oil vs. no fish oil; was reported for fiber and fat.
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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Group SIMILARITY AT BASELINE (**OMEGA-3**) UNCLEAR
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
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Quality Rating
Guideline Used Overall Rating