The document discusses the American Diabetes Association's (ADA) process for developing clinical practice recommendations and position statements on diabetes care. It outlines the different types of reports ADA produces, including position statements, systematic reviews, and consensus reports. It also describes the evidence grading system ADA uses to rate the quality of evidence supporting its recommendations. The document concludes by listing potential conflicts of interest for members of the committee that reviews ADA's clinical practice guidelines.

1. Introduction
T
he American Diabetes Association Table 1—ADA evidence-grading system for clinical practice recommendations
(ADA) has been actively involved in
the development and dissemination
Level of
of diabetes care standards, guidelines,
evidence Description
and related documents for many years.
These statements are published in one or A Clear evidence from well-conducted, generalizable, randomized controlled trials
more of the Association’s professional that are adequately powered, including:
journals. This supplement contains the Evidence from a well-conducted multicenter trial
latest update of ADA’s major position Evidence from a meta-analysis that incorporated quality ratings in the analysis
statement, “Standards of Medical Care in Compelling nonexperimental evidence, i.e., the “all or none” rule developed by the
Diabetes,” which contains all of the Asso- Centre for Evidence-Based Medicine at Oxford
ciation’s key recommendations. In addi- Supportive evidence from well-conducted randomized controlled trials that are
tion, contained herein are selected position adequately powered, including:
statements on certain topics not adequately Evidence from a well-conducted trial at one or more institutions
covered in the “Standards.” ADA hopes that Evidence from a meta-analysis that incorporated quality ratings in the analysis
this is a convenient and important resource
B Supportive evidence from well-conducted cohort studies, including:
for all health care professionals who care for
Evidence from a well-conducted prospective cohort study or registry
people with diabetes.
Evidence from a well-conducted meta-analysis of cohort studies
ADA Clinical Practice Recommenda-
Supportive evidence from a well-conducted case-control study
tions consist of position statements that
represent official ADA opinion as denoted C Supportive evidence from poorly controlled or uncontrolled studies, including:
by formal review and approval by the Pro- Evidence from randomized clinical trials with one or more major or three or
fessional Practice Committee and the Ex- more minor methodological flaws that could invalidate the results
ecutive Committee of the Board of Evidence from observational studies with high potential for bias (such as case
Directors. Consensus reports and system- series with comparison to historical controls)
atic reviews are not official ADA Evidence from case series or case reports
recommendations; however, they are Conflicting evidence with the weight of evidence supporting the recommendation
produced under the auspices of the Asso-
ciation by invited experts. These publica- E Expert consensus or clinical experience
tions may be used by the Professional
and updated as needed. A list of recent sensus panel) of a scientific or medical
Practice Committee as source documents
position statements is included on p. S100 issue related to diabetes. Effective January
to update the “Standards.”
of this supplement. 2010, consensus statements are renamed
ADA has adopted the following defi-
nitions for its clinically related reports. Systematic review. A balanced review consensus reports. The category will also
and analysis of the literature on a scien- include task force, workgroup, and expert
ADA position statement. An official
tific or medical topic related to diabetes. committee reports. Consensus reports
point of view or belief of the ADA. Posi-
Effective January 2010, technical reviews will not have the Association’s name in-
tion statements are issued on scientific or
are replaced with systematic reviews, for cluded in the title or subtitle and will in-
medical issues related to diabetes. They
which a priori search and inclusion/ clude a disclaimer in the introduction
may be authored or unauthored and are
exclusion criteria are developed and pub- stating that any recommendations are not
published in ADA journals and other sci-
lished. The systematic review provides a ADA position. A consensus report is typ-
entific/medical publications as appropri-
scientific rationale for a position state- ically developed immediately following a
ate. Position statements must be reviewed
ment and undergoes critical peer review consensus conference at which presenta-
and approved by the Professional Practice
before submission to the Professional tions are made on the issue under review.
Committee and, subsequently, by the
Practice Committee for approval. A list The statement represents the panel’s col-
Executive Committee of the Board of Di-
of past technical reviews is included on
rectors. ADA position statements are lective analysis, evaluation, and opinion
page S97 of this supplement.
typically based on a systematic review at that point in time based in part on the
or other review of published literature. Consensus report. A comprehensive ex- conference proceedings. The need for a
They are reviewed on an annual basis amination by a panel of experts (i.e., con- consensus report arises when clinicians or
scientists desire guidance on a subject for
which the evidence is contradictory or in-
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
complete. Once written by the panel, a
DOI: 10.2337/dc10-S001. consensus report is not subject to subse-
© 2010 by the American Diabetes Association. Readers may use this article as long as the work is properly
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons. quent review or approval and does not
org/licenses/by-nc-nd/3.0/ for details. represent official Association opinion. A
care.diabetesjournals.org DIABETES CARE, VOLUME 33, SUPPLEMENT 1, JANUARY 2010 S1

2. Introduction
list of recent consensus reports is in- education, disability, and, above all, pa- Curt D. Furberg, MD, PhD, has been a
cluded on p. S96 of this supplement. tients’ values and preferences, must also member of the data safety monitoring
The Association’s Professional Prac- be considered and may lead to different committee for Wyeth.
tice Committee is responsible for review- treatment targets and strategies. Also,
conventional evidence hierarchies, such Sheila Y. Garris, MD, FACP, has been a
ing ADA systematic reviews and position
as the one adapted by the ADA, may miss speaker for Takeda, Osient, Glaxo-
statements, as well as for overseeing revi-
some nuances that are important in dia- SmithKline, and Novartis and has been
sions of the latter as needed. Appointment
betes care. For example, while there is ex- a speaker and consultant for Merck,
to the Professional Practice Committee is
cellent evidence from clinical trials Forrest*, and Daiichi Sankyo.
based on excellence in clinical practice
and/or research. The committee com- supporting the importance of achieving Silvio E. Inzucchi, MD, has been a con-
prises physicians, diabetes educators, and glycemic control, the optimal way to sultant/advisor for Takeda, Merck*,
registered dietitians who have expertise in achieve this result is less clear. It is diffi- Amylin, Daiichi Sankyo, and
a range of areas, including adult and pe- cult to assess each component of such a Medtronic; has accepted honoraria
diatric endocrinology, epidemiology, and complex intervention. from Novo Nordisk; and has received
public health, lipid research, hyperten- ADA will continue to improve and research funding from Eli Lilly*;
sion, and preconception and pregnancy update the Clinical Practice Recommen- Takeda, Merck, Amylin, and Boehringer
care. All members of the Professional dations to ensure that clinicians, health Ingelheim have provided educational
Practice Committee are required to dis- plans, and policymakers can continue to grants* to Yale University for work con-
close potential conflicts of interest (listed rely on them as the most authoritative and ducted by him.
below). current guidelines for diabetes care. Our
Clinical Practice Recommendations are Wahida Karmally, DrPH, RD, CDE,
Grading of scientific evidence. There also available on the Association’s website CLS, reports no duality of interest.
has been considerable evolution in the eval- at www.diabetes.org/diabetescare.
uation of scientific evidence and in the de- Antoinette Moran, MD, has been on the
velopment of evidence-based guidelines advisory committee for Bayer.
since the ADA first began publishing prac- DUALITIES OF INTEREST Peter D. Reaven, MD, has received re-
tice guidelines. Accordingly, we developed search support from Takeda* and Amy-
a classification system to grade the quality Professional Practice Committee lin*, is a member of the speaker’s
of scientific evidence supporting ADA Members bureau for Merck, and is on the advisory
recommendations for all new and revised John E. Anderson, MD, is on the speaker’s panel of and is a board member for Bris-
ADA position statements. bureau for Amylin/Eli Lilly*, Glaxo- tol-Myers Squibb.
Recommendations are assigned rat- SmithKline*, Daichi/Sankyo, and Novo
ings of A, B, or C, depending on the qual- Guillermo Umpierrez, MD, has received
Nordisk. research funding from sanofi-aventis*,
ity of evidence (Table 1). Expert opinion
(E) is a separate category for recommen- Joan Bardsley, RN, MBA, CDE, has re- Novo Nordisk*, Takeda*, and Eli
dations in which there is as yet no evi- ceived research funding from Novo Nor- Lilly*.
dence from clinical trials, in which disk*, has received honoraria from Novo Craig Williams, PharmD, has received
clinical trials may be impractical, or in Nordisk* and GlaxoSmithKline*, and research funding from Merck* and
which there is conflicting evidence. Rec- owns stock in Pfizer* and Amylin. speaker fees from Merck/Schering
ommendations with an “A” rating are Plough and has a relative employed by
John B. Buse, MD, PhD, has conducted
based on large well-designed clinical trials Pfizer.
research and/or consulted under con-
or well-done meta-analyses. Generally,
tract between the University of North David F. Williamson, PhD, reports no
these recommendations have the best
Carolina and Amylin*, Bayhill Thera- duality of interest.
chance of improving outcomes when
peutics, Becton Dickinson*, Bristol-
applied to the population to which they Peter Wilson, MD, has received research
Myers Squibb*, DexCom*, Eli Lilly*,
are appropriate. Recommendations funding from GlaxoSmithKline*.
GI Dynamics, GlaxoSmithKline*,
with lower levels of evidence may be
Halozyme*, Hoffman-LaRoche*, In- Carol H. Wysham, MD, has been a
equally important but are not as well
terkrin*, Johnson & Johnson*, Lipo- speaker for Eli Lilly*, Merck, Novo
supported. The level of evidence sup-
Science*, Mannkind*, Medtronic*, Nordisk, and sanofi-aventis and a con-
porting a given recommendation is
Merck*, Novartis*, Novo Nordisk*, sultant and speaker for Amylin Pharma-
noted either as a heading for a group of
Osiris*, Pfizer*, sanofi-aventis*, Tol- ceuticals*.
recommendations or in parentheses af-
erex*, Transition Therapeutics*, and
ter a given recommendation.
Wyeth; and owns stock in Insulet*.
Of course, evidence is only one com- American Diabetes Association Staff
ponent of clinical decision-making. Clini- Martha Funnell, MS, RN, CDE, has been M. Sue Kirkman, MD, and Stephanie A.
cians care for patients, not populations; on the advisory board for Novo Nor- Dunbar, MPH, RD, report no duality of
guidelines must always be interpreted disk, Eli Lilly, HDI Diagnostics, Intuity interest.
with the needs of the individual patient in Medical, GlaxoSmithKline, and Mann-
mind. Individual circumstances, such as kind and has been a consultant for ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
comorbid and coexisting diseases, age, sanofi-aventis. *Amount $10,000/year.
S2 DIABETES CARE, VOLUME 33, SUPPLEMENT 1, JANUARY 2010 care.diabetesjournals.org