Introduction
The American Diabetes Association (ADA) has been actively involved in the
development and dissemination of diabetes care standards, guidelines, and
related documents for many years. These statements are published in one or more
of the Association’s professional journals. This supplement contains the latest
update of ADA’s
major position statement, “Standards of Medical Care in Diabetes,” which
contains all of the Association’s key recommendations. In addition, contained
herein are selected position statements on certain topics not adequately
covered in the “Standards.” ADA hopes that this is a convenient and
important resource for all health care professionals who care for people with
diabetes. ADA Clinical Practice Recommendations consist of position statements
that represent ofï¬cial ADA
opinion as denoted by formal review and approval by the Professional Practice
Committee and the Executive Committee of the Board of Directors. Consensus
reports and systematic reviews are not ofï¬cial ADA recommendations; however, they are
produced under the auspices of the Association by invited experts. These
publications may be used by the Professional Practice Committee as source
documents to update the “Standards.” ADA
has adopted the following deï¬nitions for its clinically related reports. ADA position statement. An ofï¬cial point of
view or belief of the ADA.
Position statements are issued on scientiï¬c or medical issues related to
diabetes. They may beauthored or unauthored and are published in ADA journals and other
scientiï¬c/medical publications as appropriate. Position statements must be
reviewed and approved by the Professional Practice Committee and, subsequently,
by the Executive Committee of the Board of Directors. ADA position statements are typically based
on a systematic review or other review of published literature.
They are reviewed on an annual basis and updated as needed. A list of recent
position statements is included on p. S100 of this supplement. Systematic review. A balanced review and analysis of the
literature on a scientiï¬c or medical topic related to diabetes. Effective January 2010, technical reviews are replaced with
systematic reviews, for which a priori search and inclusion/ exclusion criteria
are developed and published. The systematic review provides a scientiï¬c
rationale for a position statement and undergoes critical peer review before
submission to the Professional Practice Committee for approval. A list of past
technical reviews is included on page S99 of this supplement. Consensus report. A comprehensive examination by a panel of
experts (i.e., consensus panel) of a scientiï¬c or medical issue related to
diabetes. Effective January 2010, consensus statements were renamed consensus
reports. The category now also includes task force, workgroup, and expert
committee reports. Consensus reports do not have the Association’s name
included in the title or subtitle and include a disclaimer inthe introduction
stating that any recommendations are not ADA
position. A consensus report is typically developed immediately following a
consensus conference at which presentations are made on the issue under review.
The statement represents the panel’s collective analysis, evaluation, and opinion
at that point in time based in part on the conference proceedings. The need for
a consensus report arises when clinicians or scientists desire guidance on a
subject for which the evidence is contradictory or incomplete. Once written by
the panel, a consensus report is not subject to subsequent review or approval
and does not represent ofï¬cial Association opinion. A list of recent
consensus reports is included on p. S102 of this supplement.
Professional Practice Committee. The Association’s
Professional Practice Committee is responsible for reviewing ADA systematic reviews and position
statements, as well as for overseeing revisions of the latter as needed.
Appointment to the Professional Practice Committee is based on excellence in
clinical practice and/or research. The committee comprises physicians, diabetes
educators, registered dietitians, and others who have expertise in a range of
areas, including adult and pediatric endocrinology, epidemiology, and public
health, lipid research, hypertension, and preconception and pregnancy care. All
members of the Professional Practice Committee are required to disclose
potential conflicts of interest (listed on page S97). Grading
ofscientiï¬c evidence. There has been considerable evolution in the
evaluation of scientiï¬c evidence and in the development of evidence-based
guidelines since the ADA
ï¬rst began publishing practice guidelines. Accordingly, we developed a
classiï¬cation system to grade the quality of scientiï¬c evidence supporting ADA recommendations for all new and revised ADA position statements.
Recommendations are assigned ratings of A, B, or C, depending on the quality of
evidence (Table 1). Expert opinion (E) is a separate category for
recommendations in which there is as yet no evidence from clinical trials, in
which clinical trials may be impractical, or in which there is conflicting
evidence. Recommendations with an “A” rating are based on large well-designed
clinical trials or well-done meta-analyses. Generally, these recommendations
have the best chance of improving outcomes when applied to the population to
which they are appropriate. Recommendations with lower levels of evidence may
be equally important but are not as well supported. The level of evidence
supporting a given recommendation is noted either as a heading for a group of
recommendations or in parentheses after a given recommendation. Of course,
evidence is only one component of clinical decision-making. CliniS1
Introduction
Table 1—ADA evidence-grading system for clinical practice recommendations Level
of evidence A
Description Clear evidence from well-conducted, generalizable, randomized
controlled trials that are adequately powered, including: Evidence from a
well-conducted multicenter trial Evidence from a meta-analysis that
incorporated quality ratings in the analysis Compelling nonexperimental
evidence, i.e., the “all or none” rule developed by the Centre for
Evidence-Based Medicine at Oxford Supportive evidence from well-conducted
randomized controlled trials that are adequately powered, including: Evidence
from a well-conducted trial at one or more institutions Evidence from a
meta-analysis that incorporated quality ratings in the analysis Supportive
evidence from well-conducted cohort studies, including: Evidence from a
well-conducted prospective cohort study or registry Evidence from a
well-conducted meta-analysis of cohort studies Supportive evidence from a
well-conducted case-control study Supportive evidence from poorly controlled or
uncontrolled studies, including: Evidence from randomized clinical trials with
one or more major or three or more minor methodological flaws that could
invalidate the resultsEvidence from observational studies with high potential
for bias (such as case series with comparison to historical controls) Evidence
from case series or case reports Conflicting evidence with the weight of
evidence supporting the recommendation Expert consensus or clinical experience cians
care for patients, not populations; guidelines must always be interpreted with
the needs of the individual patient in mind. Individual circumstances, such as
comorbid and coexisting diseases, age, education, disability, and, above all,
patients’ values and preferences, must also be considered and may lead to
different treatment targets and strategies. Also, conventional evidence
hierarchies, such as the one adapted by the ADA, may miss some nuances that are important
in diabetes care. For example, while there is excellent evidence from clinical
trials supporting the importance of achieving glycemic control, the optimal way
to achieve this result is less clear. It is difï¬cult to assess each component
of such a complex intervention. ADA
will continue to improve and update the Clinical Practice Recommendations to
ensure that clinicians, health plans, and policymakers can continue to rely on
them as the most authoritative and current guidelines for diabetes care. Our
Clinical Practice Recommendations are also available on the Association’s
website at www.diabetes.org/diabetescare.