Appendix B Table 1Inclusion and Exclusion Criteria

CategoryInclusionExclusion
PopulationsEfficacy (KQs 1, 3): Community-dwelling adults (age ≥18 years) without chronic disease and without nutritional deficiencies.

Harms (KQs 2, 4): Community-dwelling adults and children (any age) without chronic disease.
Nonhuman populations; populations that only/exclusively included pregnant women, infants, individuals with a particular chronic disease, individuals receiving supplements as treatment for chronic disease (e.g., cancer, cardiovascular disease, HIV, end-stage renal disease, chronic kidney disease, tuberculosis), dialysis patients, individuals with clinical nutritional deficiencies, institutionalized individuals, organ transplant recipients, or hospitalized individuals.
Disease/ conditionKQs 1, 3: Primary prevention of cancer and cardiovascular disease; i.e., oncologic (breast, colorectal, lung, prostate, and gastric cancer; any other malignancy), cardiovascular (myocardial infarction, stroke).Secondary and tertiary prevention or nutritional deficiencies.
InterventionsKQs 1, 2: Multivitamins defined as three or more vitamins and/or minerals without herbs, hormones, or drugs, each at a dose less than the UL as determined by the Food and Nutrition Board.

KQ 3: Single nutrients and functionally related pairs each at a dose less than the UL as determined by the Food and Nutrition Board (i.e., calcium; folic acid; vitamins B1, B2, B6, B12, D, E, C, A; iron; zinc; magnesium; niacin; selenium; beta carotene; calcium/vitamin D; calcium/magnesium; folic acid/vitamin B12; and folic acid/vitamin B6).

KQ 4: Single nutrients and functionally related pairs each at a dose less than the UL as determined by the Food and Nutrition Board (i.e., calcium; folic acid; vitamins D, E, A; iron; selenium; beta carotene; and calcium/vitamin D).
Did not address the use of supplements separately from dietary intake.
ComparisonsNot specified.Not specified.
OutcomesEfficacy (KQs 1, 3): Primary or secondary endpoint of disease or condition including mortality, will also accept study-specified surrogate outcomes (but must also report disease outcome).

Harms (KQs 2, 4): Any harms (e.g., self-reported symptoms/adverse events, objective measurements such as blood or urine tests).
Efficacy (KQs 1, 3): Did not report disease or condition as primary or secondary outcome; precancerous outcomes (e.g., adenomas) without overt cancer outcomes.

Harms (KQs 2, 4): Not specified.
Study designsEfficacy (KQs 1, 3): Systematic reviews, RCTs.

Harms (KQs 2, 4): RCTs or observational studies (including case reports and case series), postmarket surveillance data.
Efficacy (KQs 1, 3): Narrative reviews, nonrandomized studies.

Harms (KQs 2, 4): Editorial, commentary, letter.

Abbreviations: KQ = key question; RCT = randomized, controlled trial; UL = upper intake level.

From: Appendix B, Detailed Methods

Cover of Vitamin, Mineral, and Multivitamin Supplements for the Primary Prevention of Cardiovascular Disease and Cancer
Vitamin, Mineral, and Multivitamin Supplements for the Primary Prevention of Cardiovascular Disease and Cancer: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet].
Evidence Syntheses, No. 108.
Fortmann SP, Burda BU, Senger CA, et al.

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