JOURNAL OF VASCULAR SURGERY
Volume 53, Number 16S
Gloviczki et al 7S
Table I. Grading recommendations according to evidencea
|
Description of |
|
Methodologic quality of |
|
Grade |
recommendation |
Benefit vs risk and burdens |
supporting evidence |
Implications |
|
|
|
|
|
1A Strong recommendation, high-quality evidence
1B Strong recommendation, moderate quality evidence
1C Strong recommendation, low-quality or very low-quality evidence
2A Weak recommendation, high-quality evidence
2B Weak recommendation, moderate-quality evidence
2C Weak recommendation, low-quality or very low-quality evidence
Benefits clearly outweigh |
RCTs without important |
Strong recommendation, can apply |
risk and burdens, or vice |
limitations or overwhelming |
to most patients in most |
versa |
evidence from observational |
circumstances without |
|
studies |
reservation |
Benefits clearly outweigh |
RCTs with important limitations |
Strong recommendation, can apply |
risk and burdens, or vice |
(inconsistent results, |
to most patients in most |
versa |
methodologic flaws, indirect, |
circumstances without |
|
or imprecise) or exceptionally |
reservation |
|
strong evidence from |
|
|
observational studies |
|
Benefits clearly outweigh |
Observational studies or case |
Strong recommendation but may |
risk and burdens, or vice |
series |
change when higher quality |
versa |
|
evidence becomes available |
Benefits closely balanced |
RCTs without important |
Weak recommendation, best action |
with risks and burden |
limitations or overwhelming |
may differ depending on |
|
evidence from observational |
circumstances or patients’ or |
|
studies |
societal values |
Benefits closely balanced |
RCTs with important limitations |
Weak recommendation, best action |
with risks and burden |
(inconsistent results, |
may differ depending on |
|
methodologic flaws, indirect, |
circumstances or patients’ or |
|
or imprecise) or exceptionally |
societal values |
|
strong evidence from |
|
|
observational studies |
|
Uncertainty in the estimates |
Observational studies or case |
Very weak recommendations; other |
of benefits, risks, and |
series |
alternatives may be equally |
burden; benefits, risk, and |
|
reasonable |
burden may be closely |
|
|
balanced |
|
|
RCT, Randomized controlled trial.
aAdapted from Guyatt et al.48 Used with permission.
indicating the need for investigation and care. The term chronic venous disorder is reserved for the full spectrum of venous abnormalities and includes dilated intradermal veins and venules between 1 and 3 mm in diameter (spider veins, reticular veins, telangiectasia; CEAP class C1).
Varicose veins can progress to a more advanced form of chronic venous dysfunction such as chronic venous insufficiency (CVI).55,56 In CVI, increased ambulatory venous hypertension initiates a series of changes in the subcutaneous tissue and the skin: activation of the endothelial cells, extravasation of macromolecules and red blood cells, diapedesis of leukocytes, tissue edema, and chronic inflammatory changes most frequently noted at and above the ankles.41,53 Limb swelling, pigmentation, lipodermatosclerosis, eczema, or venous ulcerations can develop in these patients.
THE SCOPE OF THE PROBLEM
In the adult Western population, the prevalence of varicose veins is 20% (range, 21.8%-29.4%), and about 5% (range, 3.6%-8.6%) have venous edema, skin changes or venous ulcerations. Active venous ulcers are present in up to 0.5%, and between 0.6% and 1.4% have healed ulcers.57 On the basis of estimates of the San Diego epidemiologic study, more than 11 million men and 22 million women between the ages of 40 and 80 years in the United States have varicose veins, and 2 million adults have advanced
CVD, with skin changes or ulcers.1 The incidence of postthrombotic venous ulcers has not changed in the past 2 decades for women, and it recently increased in men.58 In the United States each year, at least 20,556 patients receive a new diagnosis of venous ulcers.3
The Bonn Vein Study,59 which enrolled 3072 randomly selected participants (1722 women and 1350 men), aged from 18 to 79 years, found symptoms of CVD in 49.1% of men and in 62.1% of women. Also reported were varicose veins without edema or skin changes in 14.3% (12.4% men, 15.8% women), edema in 13.4% (11.6% men, 14.9% women), skin changes in 2.9% (3.1% men, 2.7% women), and healed or active ulceration in 0.6% or 0.1%, respectively. A French cross-sectional survey found varicose veins in 23.7% of men and 46.3% of women.60
The National Venous Screening Program, under the auspices of the AVF, screened 2234 Americans for venous disease.61 The participants’ mean age was 60 years, 77% were women, and 80% were white. The CEAP clinical classification of C0 to C6 was 29%, 29%, 23%, 10%, 9%, 1.5%, and 0.5%, respectively. Reflux or obstruction was noted in 37% and 5% of participants, respectively.
Progression of primary varicosity to severe CVI and venous ulcer is not rare: in the North American subfascial endoscopic perforator surgery (SEPS) registry, more patients with advanced CVI had primary venous disease than post-thrombotic syndrome (70% vs 30%).62 Bauer63 had