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TITLE: MANAGEMENT OF
PATIENTS WITH DIABETES MELLITUS IN THE PRIMARY CARE SETTING – UPDATE03
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Citation:
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Management of Diabetes Mellitus. Washington, DC:
VA/DoD Clinical Practice Guideline Working Group, Veterans Health
Administration, Department of Veterans Affairs and Health Affairs,
Department of Defense, December 1999 (Update 2003). Office of Quality and
Performance publication 10Q-CPG/DM-03.
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Completion Date:
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March 2003
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Release Date:
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October 2003
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Source(s):
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The Diabetes Mellitus Guideline was developed by
and written for clinicians by the Department of Veterans Affairs (VA),
Department of Defense (DoD), Health Care Financing Administration (HCFA),
Centers for Disease Control and Prevention and the National Institutes of
Health (NIH)
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Adaptation:
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The guideline draws heavily from ADA (American
Diabetes Association) and National Cholesterol Education Program guidelines
and National Kidney Foundation guidelines for Diabetics. The guideline integrates
the recommendations developed by VHA's Medical Advisory Panel (MAP) and the
Pharmacy Benefits Management Strategic Health Group.
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Guideline Status:
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This is the current release of the guideline update
-2003. An update is targeted for 2006.
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Developer(s):
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Veterans Health
Administration (VHA), Department of Veterans Affairs (VA) - Federal
Government Agency [U.S.]
Department of Defense (DoD) - Federal Government Agency [U.S.]
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Funding Source:
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United States Government
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Committee:
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The Management of Diabetes Mellitus Working Group
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Group Composition:
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The list
of contributors
to this guideline includes nurses, therapists, endocrinologists,
intensivists, internal medicine and primary care physicians, and experts
in the field of guideline and algorithm development.
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Disease/Condition:
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Diabetes Mellitus (DM)
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Category:
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Diagnosis; Treatment; Early Recognition and
Treatment of Co-morbid Conditions, Management; Evaluation
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Intended Users:
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While designed for use by primary care providers in
an ambulatory care setting, the modules can also be used to coordinate and standardize
care within subspecialty teams and as teaching tools for students and house
staff,
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Target Population:
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Any person who is eligible for care in the VA or
DoD health care delivery system.
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Contact
Person(s):
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VA:
Leonard
Pogach, MD
National Program Director, Diabetes
VA New Jersey Health Care System
Room 9-160 (111)
385 Tremont Avenue
East Orange, New Jersey 07018
Phone: (973) 676-1000 ext. 1693
Email:leonard.pogach@med.va.gov
DoD:
Curtis Hobbs, LTC (P), MD, USA
Chief, Endocrinology
Madigan Army Medical Center
9040 A Reid Street
Tacoma, WA 98433
Ph: 253-968-0438
Email: curtis.hobbs@nw.amedd.army.mil
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GOALS/OBJECTIVES
- To promote evidence-based management of
individuals with diabetes
- To identify the critical decision points in
management of patients with Diabetes Mellitus, such as glycemic
control, evaluation of the eyes and feet, and co-morbid conditions (
e.g. hypertension, hyperlipidemia and renal disease).
- To allow flexibility so that local policies or
procedures, such as those regarding referrals to or consultation with
diabetes teams, ophthalmology, optometry, podiatry, nephrology, and
endocrinology can be accommodated.
- To decrease the development of complications
- To improve local management of patients with
diabetes and thereby improve patient outcomes
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INTERVENTIONS
AND PRACTICES
The guideline consists
of 7 modules addressing:
Management of Diabetes in the Primary Care Setting. Each module uses a risk stratification
approach to identify persons with diabetes who have a greater probability
of developing complications and who therefore would benefit from more
intensive intervention. An aggressive approach is recommended for
evaluating and reducing complications.
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OUTCOMES
CONSIDERED
Early diagnosis and
treatment of DM delay, if not prevent, a significant percentage of the
instances of visual loss, chronic renal failure, foot ulcers and lower
extremity amputations, as well as admissions for metabolic control.
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MAJOR RECOMMENDATIONS
The guideline is
presented in an algorithmic format that allows the practitioner to follow
in the recognition and treatment of DM. Recommendations are made with
regard to the intent to establish verifiable treatment objectives for
veterans with diabetes that will lead to a reduction in limb loss, visual
loss, chronic renal insufficiency and cardiovascular disease.
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CLINICAL ALGORITHM ARE PROVIDED FOR:
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TYPE
OF EVIDENCE
The majority of the literature supporting the science for the 1999 version
of these guidelines are based upon key clinical randomized controlled trials
and longitudinal
studies published from 1992 through March 1999. Where existing literature
is ambiguous or conflicting, and where scientific data are lacking on an
issue, recommendations are based on the expert panel's opinion and clinical
experience.
The search
for the 2003 update of these guideines used well-known and widely available
databases that were appropriate for the clinical subject. In addition to
Medline/PubMed,
the following databases were searched: Database of Abstracts of Reviews
of Effectiveness (DARE) and Cochrane Central Register of Controlled Trials
(CCTR). For Medline/PubMed, limits were set for language (English), date
of publication (1999 through May 2002) and type of research (RCT and
meta-analysis). For the CCTR, limits were set for date of publication (1990
through 2002). |
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DESCRIPTION
OF METHODS TO COLLECT EVIDENCE
Published, peer-reviewed, RCTs were considered to constitute the strongest
level of evidence in support of guideline recommendations. This decision
was based on the judgment that RCTs provide the clearest, scientifically
sound basis for judging comparative efficacy. The Working Group made this
decision recognizing the limitations of RCTs, particularly considerations
of generalizability with respect to patient selection and treatment quality.
Meta-analyses that included random controlled studies were also considered
to be the strongest level of evidence, as well as reports of evidence-based
systematic reviews. A systematic search of the literature was conducted.
It focused on the best available evidence to address each key question and
ensured
maximum
coverage of studies at the top of the hierarchy of study types: evidence-based
guidelines, meta analyses, and systematic reviews. When available, the
search sought out critical appraisals already performed by others that
described explicit criteria for deciding what evidence was selected and
how it was determined to be valid. The sources that have already undergone
rigorous critical appraisal include Cochrane Reviews, Best Evidence, Technology
Assessment, and EPC reports.
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METHODS
TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE
The Grading Scheme Used for the Guideline
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TABLE 1: Quality of Evidence (QE)
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I
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At least one properly done RCT
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II-1
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Well designed controlled trial without randomization
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II-2
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Well designed cohort or case-control analytic study
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II-3
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Multiple time series, dramatic results of
uncontrolled experiment
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III
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Opinion of respected authorities, case reports, and
expert committees
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TABLE 2: Overall Quality
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Good
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High grade evidence (I or II-1) directly linked to
health outcome
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Fair
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High grade evidence (I or II-1) linked to
intermediate outcome; or
grade evidence (II-2 or II-3) directly linked
to health outcome
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Poor
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Level III evidence or no linkage of evidence to
health outcome
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TABLE 3: Net Effect of the Intervention
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Substantial
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More than a small relative impact on a frequent
condition with a substantial burden of suffering; or
A large impact on an infrequent condition with
a significant impact on the individual patient level.
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Moderate
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A small relative impact on a frequent condition with
a substantial burden of suffering; or
A moderate impact on an infrequent condition
with a significant impact on the individual patient level.
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Small
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A negligible relative impact on a frequent condition
with a substantial burden of suffering; or
A small impact on an infrequent condition with
a significant impact on the individual patient level.
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Zero or Negative
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Negative impact on patients; or
No relative impact on either a frequent
condition with a substantial burden of suffering; or an infrequent
condition with a significant impact on the individual patient level.
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TABLE 4: Grade the Recommendation
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A
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A strong recommendation that the intervention is
always indicated and acceptable
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B
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A recommendation that the intervention may be
useful/effective
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C
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A recommendation that the intervention may be
considered
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D
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A recommendation that a procedure may be considered
not useful/effective, or may be harmful
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I
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Insufficient evidence to recommend for or against -
the clinician will use clinical judgment
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REVIEW
METHODS
Peer Review
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ENDORSERS
VHA 's National Clinical Practice Guideline Council
DoD/VA Clinical Practice Guidelines Working Group
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QUALIFYING
STATEMENTS
Clinical practice guidelines, which are increasingly being used in health
care, are seen by many as a potential solution to inefficiency and
inappropriate variations in care. Guidelines should be evidenced-based as
well as based upon explicit criteria to ensure consensus regarding their
internal validity. However, it must be remembered that the use of
guidelines must always be in the context of a health care provider's
clinical judgment in the care of a particular patient. For that reason, the
guidelines may be viewed as an educational tool analogous to textbooks and
journals, but in a more user-friendly tone.
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GUIDELINE
AVAILABILITY
Electronic copies available from:
The Office of Quality and Performance web site.
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Copy Statement: No
copyright restrictions apply
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