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## Complete Summary

#### GUIDELINE TITLE

Routine vitamin supplementation to prevent cancer and cardiovascular
disease: recommendations and rationale.

#### BIBLIOGRAPHIC SOURCE(S)

Routine vitamin supplementation to prevent cancer and cardiovascular
disease: recommendations and rationale. Ann Intern Med 2003 Jul
1;139(1):51-5. \[42 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12834319)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Cancer

-   Cardiovascular disease

#### GUIDELINE CATEGORY

Prevention

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To summarize the U.S. Preventive Services Task Force recommendations on
routine vitamin supplementation to prevent cancer and cardiovascular
disease and the supporting evidence

#### TARGET POPULATION

Adults seen in primary care settings in the United States

**Note**: The U.S. Preventive Services Task Force did not review
evidence regarding vitamin supplementation for patients with known or
potential nutritional deficiencies, including pregnant and lactating
women, children, the elderly, and people with chronic illnesses.

#### INTERVENTIONS AND PRACTICES CONSIDERED

Routine vitamin supplementation with:

-   Vitamins A, C, or E

-   Multivitamins with folic acid

-   Antioxidant combinations

-   Beta-carotene

#### MAJOR OUTCOMES CONSIDERED

**Key Question for Cancer:** Do antioxidant vitamin supplements reduce
all-cause mortality, cancer mortality, or the incidence of cancer or
certain precancerous lesions in the general adult population of the
United States?

**Key Question for Cardiovascular Disease:** Does supplementation with
vitamin A, vitamin C, vitamin E, beta-carotene, or a multivitamin reduce
cardiovascular death, all-cause mortality, or cardiovascular events in
the general adult population of the United States and in a population
with evidence of atherosclerotic heart disease?

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: Systematic
evidence reviews were prepared by the Oregon Health & Science University
Evidence-based Practice Center (EPC) for the Agency for Healthcare
Research and Quality (AHRQ) for use by the U.S. Preventive Services Task
Force (USPSTF) (see the \"Companion Documents\" field).

**Inclusion/Exclusion Criteria for Admissible Evidence**

*Cancer Literature*

The criteria for inclusion in the review were developed in consultation
with members of the USPSTF. English-language randomized controlled
trials and prospective cohort studies concerning adults in developed
countries were eligible for inclusion. Case-control studies were
excluded unless they were performed in the context of a prospective
cohort study (i.e., a nested case-control study). Studies of
supplementation with vitamin A, vitamin C, vitamin E, beta-carotene,
folic acid, combinations of these vitamins, or a multiple vitamin were
eligible if they reported a) the incidence of or mortality from any
invasive cancer other than nonmelanoma skin cancer or b) the incidence
of colonic polyps. Studies of other precancerous lesions, carcinoma *in
situ*, and regression of cancer or of precancerous lesions were
excluded.

The report included the results of review of randomized trials that
addressed the key question. The results of cohort studies were presented
to the USPSTF, but they were excluded from the report because they did
not contribute to the Task Force\'s recommendations.

*Cardiovascular Literature*

The scope of this review was developed with input from the USPSTF. The
Oregon Health & Science University Evidence-based Practice Center (EPC)
staff included reports of randomized trials and prospective cohort
studies from U.S. and European populations that assessed use of vitamin
supplements and reported the incidence of or death from cardiovascular
events. The EPC staff included only studies that measured intake of
vitamins from supplements, not from foods; most supplements provide
single or limited nutrient combinations whereas dietary sources are
nutritionally complex in nature and complicate data interpretation. Only
cohorts that reported specifically on vitamin supplement use with risk
ratios independent of dietary intake were included. Both primary and
secondary prevention trials were considered, but were analyzed
separately. Studies conducted in specific populations that were not
widely generalizable were excluded, such as a cohort with end-stage
renal disease. Only cohort studies rated as being of good to fair
quality by predetermined criteria from a system developed by the current
USPSTF were included. Studies were excluded if they contained no
original data, were not relevant (e.g., addressed vitamin deficiency
disease), did not report data on the specified outcomes, or took place
in an acute care setting. Case-control studies were excluded because of
retrospective data collection.

**Search Strategy**

*Cancer Literature*

The Cochrane Controlled Trials Registry (December, 2001) and the MEDLINE
database from 1966 to December, 2001 were searched using terms for the 5
nutrients (A, C, E, beta-carotene, and folate) as well as multivitamin
and antioxidant supplements and terms for cancer and precancerous
lesions. The reference lists of review articles were also searched and,
in several rounds of review of earlier manuscripts, experts were asked
for additional references. MEDLINE was searched again (December 2001)
using the acronyms or full titles of the major trials and cohort studies
to identify additional publications.

A supplemental electronic search was performed to update the literature
review through the end of 2002. The search was limited to publications
in English and studies involving human subjects. The MEDLINE search
terms included precancerous conditions, neoplasms, antioxidants,
vitamins/administration and dosage, and vitamins/therapeutic use, as
well as \"randomized\" or \"controlled\" or \"clinical\" trial.

*Cardiovascular Literature*

The Cochrane Controlled Trials Registry and MEDLINE were searched for
relevant papers published in English from 1966 to September 2001, using
Medical Subject Headings and keywords for the individual nutrients
(vitamin A, vitamin C, vitamin E, beta-carotene, folic acid), and for
multivitamin and antioxidant supplements, combined with terms for
cardiovascular disease (CVD), coronary artery disease, myocardial
infarction, and related risk factors (blood pressure, hypertension,
hyperlipidemia, homocysteine). The EPC staff examined reference lists of
review articles and asked experts for additional references. Finally,
MEDLINE was searched using the acronyms or full titles of the major
trials and cohort studies to identify additional publications.

**Study Selection**

Two reviewers applied the eligibility criteria listed above after
reviewing the titles and abstracts of retrieved citations and again
after selecting full-text articles for closer review.

#### NUMBER OF SOURCE DOCUMENTS

**Key Question for Cancer**: Ten randomized, controlled trials (RCTs)
were included from the first literature search. From the supplemental
literature search, ten studies met the inclusion criteria. Two studies
were new randomized controlled trials that were not included in the
earlier review, and the remaining eight were follow-up studies of two
large clinical trials.

**Key Question for Cardiovascular Disease**: 38 articles, representing
ten cohort studies and twenty randomized, controlled trials, were
selected for inclusion in evidence tables. An additional 25 articles
were included for background and context.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

The Task Force grades the **quality of the overall evidence** for a
service on a 3-point scale (good, fair, poor):

**Good**

Evidence includes consistent results from well-designed, well-conducted
studies in representative populations that directly assess effects on
health outcomes.

**Fair**

Evidence is sufficient to determine effects on health outcomes, but the
strength of the evidence is limited by the number, quality, or
consistency of the individual studies, generalizability to routine
practice, or indirect nature of the evidence on health outcomes.

**Poor**

Evidence is insufficient to assess the effects on health outcomes
because of limited number or power of studies, important flaws in their
design or conduct, gaps in the chain of evidence, or lack of information
on important health outcomes.

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis of Randomized Controlled Trials\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: Systematic
evidence reviews were prepared by the Oregon Health & Science University
Evidence-based Practice Center (EPC) for the Agency for Healthcare
Research and Quality (AHRQ) for use by the U.S. Preventive Services Task
Force (USPSTF) (see the \"Companion Documents\" field).

**Evidence Abstraction**

*Cancer Literature*

Two reviewers independently abstracted descriptive data from the
included trials, using one form for abstraction of information about the
study design and another form for results. To assess study quality, the
EPC staff used the system developed by the USPSTF, which includes a set
of 6 criteria to rate the internal validity of each study as \"good,\"
\"fair,\" or \"poor.\" For clinical trials, study quality was assessed
using the Jadad score. The summarized results of studies were organized
in evidence tables by type of study, nutrient, and outcome. For
supplement/outcome combinations with sufficient evidence, the EPC staff
assessed heterogeneity among studies and conducted meta-analyses using a
pairwise, sequential procedure based on maximum likelihood methods.

*Cardiovascular Literature*

The EPC staff abstracted the following descriptive information:
population, setting, sample size, supplement (dose, formulation, and
frequency), control group intervention, length of follow-up, follow-up
rate, confounding factors, factors controlled for in analyses, method of
ascertaining compliance, compliance rate, and adverse effects. They also
recorded data on the following outcomes: cardiovascular events,
myocardial infarction, restenosis, change in angina, cardiovascular
mortality, and all-cause mortality. Study quality was assessed using the
standards of the current USPSTF system. For randomized controlled
trials, study quality was summarized using the Jadad score, which rates
trials on a scale of 1 to 5 on the basis of adequacy of randomization
method, blinding, and other criteria. Data abstraction and quality
assessment were conducted independently by at least 2 reviewers.
Disagreements were resolved by consensus or by a third reviewer.
Finally, the EPC staff summarized the strength, level, and quality of
the overall evidence tables for the effectiveness of each of the vitamin
supplements to prevent cardiovascular disease (CVD).

**Preparation of the Systematic Evidence Reviews**

AHRQ staff and USPSTF members participated in the initial design of the
study and reviewed interim analyses and the final manuscripts for both
Systematic Evidence Reviews.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Balance Sheets\
Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

When the overall quality of the evidence is judged to be good or fair,
the U.S. Preventive Services Task Force (USPSTF) proceeds to consider
the magnitude of net benefit to be expected from implementation of the
preventive service. Determining net benefit requires assessing both the
magnitude of benefits and the magnitude of harms and weighing the two.

The USPSTF classifies benefits, harms, and net benefits on a 4-point
scale: \"substantial,\" \"moderate,\" \"small,\" and \"zero/negative.\"

\"Outcomes tables\" (similar to \'balance sheets\') are the USPSTF\'s
standard resource for estimating the magnitude of benefit. These tables,
prepared by the topic teams for use at USPSTF meetings, compare the
condition specific outcomes expected for a hypothetical primary care
population with and without use of the preventive service. These
comparisons may be extended to consider only people of specified age or
risk groups or other aspects of implementation. Thus, outcomes tables
allow the USPSTF to examine directly how the preventive services affects
benefits for various groups.

When evidence on harms is available, the topic teams assess its quality
in a manner like that for benefits and include adverse events in the
outcomes tables. When few harms data are available, the USPSTF does not
assume that harms are small or nonexistent. It recognizes a
responsibility to consider which harms are likely and judge their
potential frequency and the severity that might ensue from implementing
the service. It uses whatever evidence exists to construct a general
confidence interval on the 4-point scale (e.g., substantial, moderate,
small, and zero/negative).

Value judgments are involved in using the information in an outcomes
table to rate either benefits or harms on the USPSTF´s 4-point scale.
Value judgments are also needed to weigh benefits against harms to
arrive a rating of net benefit.

In making its determinations of net benefit, the USPSTF strives to
consider what it believes are the general values of most people. It does
this with greater confidence for certain outcomes (e.g., death) about
which there is little disagreement about undesirability, but it
recognizes that the degree of risk people are willing to accept to avert
other outcomes (e.g., cataracts) can vary considerably. When the USPSTF
perceives that preferences among individuals vary greatly, and that
these variations are sufficient to make trade-off of benefits and harms
a \'close-call\', then it will often assign a C recommendation (see the
\"Recommendation Rating Scheme\" field). This recommendation indicates
the decision is likely to be sensitive to individual patient
preferences.

The USPSTF uses its assessment of the evidence and magnitude of net
benefit to make recommendations. The general principles the USPSTF
follows in making recommendations are outlined in Table 5 of the
companion document cited below. The USPSTF liaisons on the topic team
compose the first drafts of the recommendations and rationale
statements, which the full panel then reviews and edits. Recommendations
are based on formal voting procedures that include explicit rules for
determining the views of the majority.

From: Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM,
Atkins D. Current methods of the U.S. Preventive Services Task Force: a
review of the process. Methods Work Group, Third U.S. Preventive
Services Task Force. *Am J Prev Med* 2001 Apr;20(3S):21-35.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

The Task Force grades its **recommendations** according to one of 5
classifications (A, B, C, D, I) reflecting the strength of evidence and
magnitude of net benefit (benefits minus harms):

**A**

The USPSTF strongly recommends that clinicians provide \[the service\]
to eligible patients. The USPSTF found good evidence that \[the
service\] improves important health outcomes and concludes that benefits
substantially outweigh harms.

**B**

The USPSTF recommends that clinicians provide \[this service\] to
eligible patients. The USPSTF found at least fair evidence that \[the
service\] improves important health outcomes and concludes that benefits
outweigh harms.

**C**

The USPSTF makes no recommendation for or against routine provision of
\[the service\]. The USPSTF found at least fair evidence that \[the
service\] can improve health outcomes but concludes that the balance of
benefits and harms is too close to justify a general recommendation.

**D**

The USPSTF recommends against routinely providing \[the service\] to
asymptomatic patients. The USPSTF found at least fair evidence that
\[the service\] is ineffective or that harms outweigh benefits.

**I**

The USPSTF concludes that the evidence is insufficient to recommend for
or against routinely providing \[the service\]. Evidence that \[the
service\] is effective is lacking, of poor quality, or conflicting and
the balance of benefits and harms cannot be determined.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Comparison with Guidelines from Other Groups\
External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

[Peer Review]{.underline}. Before the U.S. Preventive Services Task
Force (USPSTF) makes its final determinations about recommendations on a
given preventive service, the Evidence-based Practice Center and the
Agency for Healthcare Research and Quality send a draft systematic
evidence review to 4 to 6 external experts and to federal agencies and
professional and disease-based health organizations with interests in
the topic. They ask the experts to examine the review critically for
accuracy and completeness and to respond to a series of specific
questions about the document. After assembling these external review
comments and documenting the proposed response to key comments, the
topic team presents this information to the Task Force in memo form. In
this way, the Task Force can consider these external comments and a
final version of the systematic review before it votes on its
recommendations about the service. Draft recommendations are then
circulated for comment from reviewers representing professional
societies, voluntary organizations and Federal agencies. These comments
are discussed before the whole USPSTF before final recommendations are
confirmed.

[Recommendation of Others]{.underline}. Recommendations for routine
vitamin supplementation from the following groups were discussed: the
American Academy of Family Physicians; the Canadian Task Force on
Preventive Health Care; the American Cancer Society and the American
Heart Association.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The U.S. Preventive Services Task Force (USPSTF) grades its
recommendations (A, B, C, D, or I) and the quality of the overall
evidence for a service (good, fair, poor). The definitions of these
grades can be found at the end of the \"Major Recommendations\" field.

The USPSTF concludes that the evidence is insufficient to recommend for
or against the use of supplements of vitamins A, C, or E; multivitamins
with folic acid; or antioxidant combinations for the prevention of
cancer or cardiovascular disease. **I recommendation**.

*The USPSTF found poor evidence to determine whether supplementation
with these vitamins reduces the risk for cardiovascular disease or
cancer. The available evidence from randomized trials is either
inadequate or conflicting, and the influence of confounding variables on
observed outcomes in observational studies cannot be determined. As a
result, the USPSTF could not determine the balance of benefits and harms
of routine use of supplements of vitamins A, C or E; multivitamins with
folic acid; or antioxidant combinations for the prevention of cancer or
cardiovascular disease.*

The USPSTF recommends against the use of beta-carotene supplements,
either alone or in combination, for the prevention of cancer or
cardiovascular disease. **D recommendation.**

*The USPSTF found good evidence that beta-carotene supplementation
provides no benefit in the prevention of cancer or cardiovascular
disease in middle-aged and older adults. In 2 trials restricted to heavy
smokers, beta-carotene supplementation was associated with higher
incidence of lung cancer and higher all-cause mortality. The USPSTF
concludes that beta-carotene supplements are unlikely to provide
important benefits and might cause harm in some groups.*

**Clinical Considerations**

-   The USPSTF did not review evidence regarding vitamin supplementation
    for patients with known or potential nutritional deficiencies,
    including pregnant and lactating women, children, the elderly, and
    people with chronic illnesses. Dietary supplements may be
    appropriate for people whose diet does not provide the recommended
    dietary intake of specific vitamins. Individuals may wish to consult
    a health care provider to discuss whether dietary supplements are
    appropriate.

-   With the exception of vitamins for which there is compelling
    evidence of net harm (e.g., beta-carotene supplementation in
    smokers), there is little reason to discourage people from taking
    vitamin supplements. Patients should be reminded that taking
    vitamins does not replace the need to eat a healthy diet. All
    patients should receive information about the benefits of a diet
    high in fruits and vegetables, as well as information on other foods
    and nutrients that should be emphasized or avoided in their diet
    (see 2002 USPSTF recommendations on counseling to promote a healthy
    diet).

-   Patients who choose to take vitamins should be encouraged to adhere
    to the dosages recommended in the Dietary Reference Intakes (DRI) of
    the Institute of Medicine. Some vitamins, such as A and D, may be
    harmful in higher doses; therefore, doses greatly exceeding the
    Recommended Dietary Allowance (RDA) or Adequate Intake (AI) should
    be taken with care while considering whether potential harms
    outweigh potential benefits. Vitamins and minerals sold in the
    United States are classified as \"dietary supplements,\" and there
    is a degree of quality control over content if they have a U.S.
    Pharmacopeia (USP) seal. Nevertheless, imprecision in the content
    and concentration of ingredients could pose a theoretical risk not
    reflected in clinical trials using calibrated compounds.

-   The adverse effects of beta-carotene on smokers have been observed
    primarily in those taking large supplemental doses. There is no
    evidence to suggest that beta-carotene is harmful to smokers at
    levels occurring naturally in foods.

-   The USPSTF did not review evidence supporting folic acid
    supplementation among pregnant women to reduce neural tube defects.
    In 1996, the USPSTF recommended folic acid for all women who are
    planning, or capable of, pregnancy (see 1996 USPSTF information on
    screening for neural tube defects).

-   Clinicians and patients should discuss the possible need for vitamin
    supplementation when taking certain medications (e.g., folic acid
    supplementation for those patients taking methotrexate).

**[Definitions]{.underline}**:

The Task Force grades its **recommendations** according to one of 5
classifications (A, B, C, D, I) reflecting the strength of evidence and
magnitude of net benefit (benefits minus harms):

**A**

The USPSTF strongly recommends that clinicians provide \[the service\]
to eligible patients. The USPSTF found good evidence that \[the
service\] improves important health outcomes and concludes that benefits
substantially outweigh harms.

**B**

The USPSTF recommends that clinicians provide \[this service\] to
eligible patients. The USPSTF found at least fair evidence that \[the
service\] improves important health outcomes and concludes that benefits
outweigh harms.

**C**

The USPSTF makes no recommendation for or against routine provision of
\[the service\]. The USPSTF found at least fair evidence that \[the
service\] can improve health outcomes but concludes that the balance of
benefits and harms is too close to justify a general recommendation.

**D**

The USPSTF recommends against routinely providing \[the service\] to
asymptomatic patients. The USPSTF found at least fair evidence that
\[the service\] is ineffective or that harms outweigh benefits.

**I**

The USPSTF concludes that the evidence is insufficient to recommend for
or against routinely providing \[the service\]. Evidence that \[the
service\] is effective is lacking, of poor quality, or conflicting and
the balance of benefits and harms cannot be determined.

The Task Force grades the **quality of the overall evidence** for a
service on a 3-point scale (good, fair, poor):

**Good**

Evidence includes consistent results from well-designed, well-conducted
studies in representative populations that directly assess effects on
health outcomes.

**Fair**

Evidence is sufficient to determine effects on health outcomes, but the
strength of the evidence is limited by the number, quality, or
consistency of the individual studies, generalizability to routine
practice, or indirect nature of the evidence on health outcomes.

**Poor**

Evidence is insufficient to assess the effects on health outcomes
because of limited number or power of studies, important flaws in their
design or conduct, gaps in the chain of evidence, or lack of information
on important health outcomes.

#### CLINICAL ALGORITHM(S)

Not applicable

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is identified in the
\"Major Recommendations\" field.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

The U.S. Preventive Services Task Force (USPSTF) found poor evidence to
determine whether supplementation with the vitamins A, C or E;
multivitamins with folic acid; or antioxidant combinations reduces the
risk for cardiovascular disease or cancer. The available evidence from
randomized trials is either inadequate or conflicting, and the influence
of confounding variables on observed outcomes in observational studies
cannot be determined. As a result, the USPSTF could not determine the
balance of benefits and harms of routine use of these vitamins
supplements.

#### POTENTIAL HARMS

There are several known adverse effects caused by excessive doses of
vitamins; for example, moderate doses of vitamin A supplements may
reduce bone mineral density, and high doses may be hepatotoxic or
teratogenic. A small but significant increase in lung cancer mortality
observed in trials of smokers has been ascribed to beta-carotene
supplementation; adverse effects of beta-carotene supplementation on
non-smokers have not been observed on other trials. The adverse effects
of vitamin supplementation were not reported in most studies reviewed by
the U.S. Preventive Services Task Force. More studies are needed to
better understand the harms of vitamin supplementation.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The U.S. Preventive Services Task Force (USPSTF) recommendations are
    independent of the U.S. government. They do not represent the views
    of the Agency for Healthcare Research and Quality (AHRQ), the U.S.
    Department of Health and Human Services, or the U.S. Public Health
    Service.

-   The value of vitamins naturally occurring in food, the use of
    vitamin supplements for the prevention of other conditions (e.g.,
    neural tube defects), and the use of vitamin supplements for the
    secondary prevention of complications in patients with existing
    disease are outside the scope of these guidelines.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The experiences of the first and second U.S. Preventive Services Task
Force (USPSTF), as well as that of other evidence-based guideline
efforts, have highlighted the importance of identifying effective ways
to implement clinical recommendations. Practice guidelines are
relatively weak tools for changing clinical practice when used in
isolation. To effect change, guidelines must be coupled with strategies
to improve their acceptance and feasibility. Such strategies include
enlisting the support of local opinion leaders, using reminder systems
for clinicians and patients, adopting standing orders, and audit and
feedback of information to clinicians about their compliance with
recommended practice.

In the case of preventive services guidelines, implementation needs to
go beyond traditional dissemination and promotion efforts to recognize
the added patient and clinician barriers that affect preventive care.
These include clinicians\' ambivalence about whether preventive medicine
is part of their job, the psychological and practical challenges that
patients face in changing behaviors, lack of access to health care or of
insurance coverage for preventive services for some patients, competing
pressures within the context of shorter office visits, and the lack of
organized systems in most practices to ensure the delivery of
recommended preventive care.

Dissemination strategies have changed dramatically in this age of
electronic information. While recognizing the continuing value of
journals and other print formats for dissemination, the Agency for
Healthcare Research and Quality will make all U.S. Preventive Services
Task Force (USPSTF) products available through its [Web
site](http://www.preventiveservices.ahrq.gov/). The combination of
electronic access and extensive material in the public domain should
make it easier for a broad audience of users to access U.S. Preventive
Services Task Force materials and adapt them for their local needs.
Online access to U.S. Preventive Services Task Force products also opens
up new possibilities for the appearance of the annual, pocket-size
*Guide to Clinical Preventive Services*.

To be successful, approaches for implementing prevention have to be
tailored to the local level and deal with the specific barriers at a
given site, typically requiring the redesign of systems of care. Such a
systems approach to prevention has had notable success in established
staff-model health maintenance organizations, by addressing organization
of care, emphasizing a philosophy of prevention, and altering the
training and incentives for clinicians. Staff-model plans also benefit
from integrated information systems that can track the use of needed
services and generate automatic reminders aimed at patients and
clinicians, some of the most consistently successful interventions.
Information systems remain a major challenge for individual clinicians\'
offices, however, as well as for looser affiliations of practices in
network-model managed care and independent practice associations, where
data on patient visits, referrals, and test results are not always
centralized.

#### IMPLEMENTATION TOOLS

Foreign Language Translations\
Patient Resources\
Personal Digital Assistant (PDA) Downloads\
Pocket Guide/Reference Cards

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Routine vitamin supplementation to prevent cancer and cardiovascular
disease: recommendations and rationale. Ann Intern Med 2003 Jul
1;139(1):51-5. \[42 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12834319)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 Jul 1

#### GUIDELINE DEVELOPER(S)

United States Preventive Services Task Force - Independent Expert Panel

#### GUIDELINE DEVELOPER COMMENT

The U.S. Preventive Services Task Force (USPSTF) is a
Federally-appointed panel of independent experts. Conclusions of the
U.S. Preventive Services Task Force do not necessarily reflect policy of
the U.S. Department of Health and Human Services (DHHS) or its agencies.

#### SOURCE(S) OF FUNDING

United States Government

#### GUIDELINE COMMITTEE

U.S. Preventive Services Task Force (USPSTF)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Task Force Members*: Alfred O. Berg, MD, MPH (Chair); Janet D. Allan,
PhD, RN, CS (Vice-chair); Paul Frame, MD; Charles J. Homer, MD, MPH\*;
Mark S. Johnson, MD, MPH; Jonathan D. Klein, MD, MPH; Tracy A. Lieu, MD,
MPH\*; Cynthia D. Mulrow, MD, MSc\*; C. Tracy Orleans, PhD; Jeffrey F.
Peipert, MD, MPH\*; Nola J. Pender, PhD, RN\*; Albert L. Siu, MD, MSPH;
Steven M. Teutsch, MD, MPH; Carolyn Westhoff, MD, MSc; Steven H. Woolf,
MD, MPH

\**Members of the Task Force at the time this recommendation was
finalized*.

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The U.S. Preventive Services Task force has an explicit policy
concerning conflict of interest. All members and evidence-based practice
center (EPC) staff disclose at each meeting if they have an important
financial conflict for each topic being discussed. Task Force members
and EPC staff with conflicts can participate in discussions about
evidence, but members abstain from voting on recommendations about the
topic in question.

From: Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM,
Atkins D. Current methods of the U.S. Preventive Services Task Force: a
review of the process. Methods Work Group, Third U.S. Preventive
Services Task Force. *Am J Prev Med* 2001 Apr;20(3S):21-35.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [U.S. Preventive Services Task
Force (USPSTF) Web site](http://www.ahrq.gov/clinic/uspstf/uspsvita.htm)
and the [National Library of Medicine\'s Health Services/Technology
Assessment Text (HSTAT) Web
site](http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat3.chapter.26913).

Print copies: Available from the Agency for Healthcare Research and
Quality (AHRQ) Publications Clearinghouse. For more information, go to
<http://www.ahrq.gov/news/pubsix.htm> or call 1-800-358-9295 (U.S.
only).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Evidence Reviews:

-   Morris C, Carson S. Routine vitamin supplementation to prevent
    cardiovascular disease: summary of the evidence for the U.S.
    Preventive Services Task Force. Ann Intern Med. 2003.
    Jul;139(2):56-69.

-   Ritenbaugh C, Streit K, Helfand M. Routine vitamin supplementation
    to prevent cancer: a summary of the evidence from randomized control
    trials for the U.S. Preventive Services Task Force. Rockville (MD):
    Agency for Healthcare Research and Quality (AHRQ), 2003. 36 p.

-   Shetty P, Atkins D. Routine Vitamin supplementation to prevent
    cancer: update of evidence from randomized controlled trials,
    1999-2002. Rockville (MD): Agency for Healthcare Research and
    Quality (AHRQ), 2003. 16 p.

Electronic copies: Available from the [U.S. Preventive Services Task
Force (USPSTF) Web site](http://www.ahrq.gov/clinic/uspstfix.htm).

Background Articles:

-   Woolf SH, Atkins D. The evolving role of prevention in health care:
    contributions of the U.S. Preventive Services Task Force. Am J Prev
    Med 2001 Apr;20(3S):13-20.

-   Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM,
    Atkins D. Current methods of the U.S. Preventive Services Task
    Force: a review of the process. Methods Work Group, Third U.S.
    Preventive Services Task Force. Am J Prev Med 2001 Apr;20(3S):21-35.

-   Saha S, Hoerger TJ, Pignone MP, Teutsch SM, Helfand M, Mandelblatt
    JS. The art and science of incorporating cost effectiveness into
    evidence-based recommendations for clinical preventive services.
    Cost Work Group of the Third U.S. Preventive Services Task Force. Am
    J Prev Med 2001 Apr;20(3S):36-43.

Electronic copies: Available from [U.S. Preventive Services Task Force
(USPSTF) Web site](http://www.ahrq.gov/clinic/cps3dix.htm#Background).

The following are also available:

-   The guide to clinical preventive services, 2006. Recommendations of
    the U.S. Preventive Services Task Force. Rockville (MD): Agency for
    Healthcare Research and Quality (AHRQ), 2006. 228 p. Electronic
    copies available from the [AHRQ Web
    site](http://www.ahrq.gov/clinic/pocketgd.htm).

-   A step-by-step guide to delivering clinical preventive services: a
    systems approach. Rockville (MD): Agency for Healthcare Research and
    Quality (AHRQ), 2002 May. 189 p. Electronic copies available from
    the [AHRQ Web site](http://www.ahrq.gov/ppip/manual/). See the
    related QualityTool summary on the [Health Care Innovations Exchange
    Web site](http://innovations.ahrq.gov/content.aspx?id=542).

-   Routine vitamin supplementation to prevent cancer and cardiovascular
    disease. What\'s new from the third USPSTF. Rockville (MD): Agency
    for Healthcare Research and Quality; 2003 Jun. Electronic copies:
    Available from [USPSTF Web
    site](http://www.ahrq.gov/clinic/3rduspstf/vitamins/vitaminswh.htm).
    See the related QualityTool summary on the [Health Care Innovations
    Exchange Web site](http://innovations.ahrq.gov/content.aspx?id=950).

Print copies: Available from the Agency for Healthcare Research and
Quality Publications Clearinghouse. For more information, go to
<http://www.ahrq.gov/news/pubsix.htm> or call 1-800-358-9295 (U.S.
only).

The [Electronic Preventive Services Selector
(ePSS)](http://epss.ahrq.gov/PDA/index.jsp), available as a PDA
application and a web-based tool, is a quick hands-on tool designed to
help primary care clinicians identify the screening, counseling, and
preventive medication services that are appropriate for their patients.
It is based on current recommendations of the USPSTF and can be searched
by specific patient characteristics, such as age, sex, and selected
behavioral risk factors.

#### PATIENT RESOURCES

The following is available:

-   The Pocket Guide to Good Health for Adults. Rockville (MD): Agency
    for Healthcare Research and Quality (AHRQ); 2003.

Electronic copies: Available from the [U.S. Preventive Services Task
Force (USPSTF) Web site](http://www.ahrq.gov/ppip/adguide/). Copies also
available in Spanish from the [USPSTF Web
site](http://www.ahrq.gov/ppip/spadguide/). See the related QualityTool
summary on the [Health Care Innovations Exchange Web
site](http://innovations.ahrq.gov/content.aspx?id=699).

Print copies: Available from the Agency for Healthcare Research and
Quality (AHRQ) Publications Clearinghouse. For more information, go to
<http://www.ahrq.gov/news/pubsix.htm> or call 1-800-358-9295 (U.S.
only).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This summary was completed by ECRI on June 24, 2003. This summary was
verified by the developer on June 26, 2003.

#### COPYRIGHT STATEMENT

Requests regarding copyright should be sent to: Gerri M. Dyer,
Electronic Dissemination Advisor, Agency for Healthcare Research and
Quality (formerly the Agency for Health Care Policy and Research),
Center for Health Information Dissemination, Suite 501, Executive Office
Center, 2101 East Jefferson Street, Rockville, MD 20852; Facsimile:
301-594-2286; E-mail: <gdyer@ahrq.gov>.

### DISCLAIMER

#### NGC DISCLAIMER

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All guidelines summarized by NGC and hosted on our site are produced
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Guidelines represented on the NGC Web site are submitted by guideline
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Date Modified: 11/3/2008