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There is also some evidence that the severity of venous incompetence, as indicated
by objective measures such as the ambulatory venous pressure of the foot, may be related
to the risk of ulceration. In one study of 220 unselected patients with venous problems
(54), no ulceration occurred in limbs with ambulatory venous pressure !30 mmHg.
A consistent increase in the prevalence of ulceration occurred with higher ambulatory
venous pressure, ranging from 14% in limbs with pressure between 31 and 40 mmHg to
100% in limbs with pressure O90 mmHg. This relationship occurred in both those with
superficial venous reflux and those with deep venous reflux with or without occlusion.
Deep vein thrombosis (DVT) is known to be an antecedent risk factor for the skin
changes, edema and ulceration associated with venous disease in the legs. Under these
circumstances the venous condition is often referred to as the post thrombotic syndrome.
Although most studies do not separately identify ulcers, or the number of ulcers are too
small for meaningful analysis, the results linking DVT and the postthrombotic syndrome
(55,56) are probably also meaningful in relation to ulcer alone.
In the population-based study of chronic venous ulcers in Perth, Western Australia,
(50) 17% of patients had a history of DVT and a large number had a history of conditions
that might predispose to DVT. Although this prevalence seemed relatively high, results
were unfortunately not available from a healthy comparison group. On the other hand, in
a population based study of 3,600 people in Copenhagen, Denmark, various risk factors
were related to the occurrence of objective signs of venous disease (57). Previous
thromboembolism (history of DVT or pulmonary embolism) was related to the occurrence
of venous disease, independently of age, sex and other possible risk factors. The incidence
of ulcers has been shown in follow-up studies of patients having a diagnosis of DVT
(55,56) to be around 1% to 2% per annum.
11 year incidence %
0
10
20
30
40
50
Skin changes
Ulcer changes
None Moderate Severe
Varicose veins at baseline
Figure 3 Incidence of skin changes and chronic ulceration during 11 years of follow up by
severity of varicose veins at baseline: Basle Study. Source: Adapted from Ref. 59.
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Arterial disease per se in the lower limbs is considered to be a cause of chronic leg
ulceration, but the extent to which arterial disease might increase the risk of venous
ulceration is less clear. Some studies have reported a relatively high prevalence of arterial
disease in leg ulcer patients (40,42) but this may be partly accounted for by the presence of
patients with ulcers primarily of arterial origin. Also, no comparisons were made with the
occurrence of ulcers in a healthy control group. However, in a case control comparison in
Edinburgh, Scotland, arterial disease (angina, intermittent claudication, hypertension, and
low ankle brachial pressure index) did not occur more commonly in 331 leg ulcer patients
compared to an equal number of age and sex matched population controls (58).
Finally, several other factors may be possible contributory factors to the
development of venous ulceration. These include minor trauma, edema (not necessarily
related to venous insufficiency), obesity, and co-existing conditions such as arthritis or
neuropathies. However, the extent to which these factors are important is not well
established.
CONCLUSION
In conclusion, varicose veins are an extremely common disorder in the population in
which the risk factors are not well established. Further epidemiological research, including
genetic studies, are required to elucidate the aetiology of this condition. Venous ulceration
is the most serious complication in which the prognosis is often poor. In order to prevent
ulceration, further research is required to establish the risks of this condition, particularly
in subjects with varicose veins. The prevalence of venous disorders increases with age so
that the changing age structure of the population will result in an increasing burden of
these conditions in society.
KEY POINTS
† Varicose veins occur commonly in the general population affecting around one
quarter to one-third of adults in western countries. The prevalence in most
surveys is higher in females than males.
† Minor varicosities such as reticular varices and telangiectasia are almost the
norm and occur in around 80% of adults.
† In individuals with no obvious trunk varices, around one-third have significant
valvular reflux in at least one segment of either leg.
† Venous abnormalities, including valvular reflux, may begin in childhood and,
although prevalence increases with age, limited evidence suggests that the risk of
acquiring venous disease is constant throughout life.
† Number of pregnancies and obesity (only in women) have been shown
consistently to be risk factors for varicose veins. Limited evidence suggests
that inherited factors, prolonged standing and/or sitting and constipation may
be important.
† The frequency of skin changes associated with varicose veins, such as hyper/hypo-
pigmentation, eczema and edema, varies greatly between surveys but the
prevalence appears to increase with the severity of the varicosities.
† Venous ulcers, which account for about 75% of all chronic ulcers, occurs in 1% of
the adult population during their lifetime. The prevalence of open ulceration is
about 0.3%.
Epidemiology of Venous Disorders 49
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† Ulceration is more common in women than men and is relatively uncommon
below the age of 60 years. The prognosis is poor with only half healed within
four months and two thirds having more than one episode of active ulceration.
† Although DVT and raised ambulatory venous pressure increase the risk of
ulceration, otherrisk factors that might lead to an ulcer developing in patients with
varicose veins are not well established.
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30. Sadick NS. Predisposing factors of varicose veins and telangiectatic leg veins. J Dermatol Surg
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39. Callam MJ, Ruckley CV, Harper DR, Dale JJ. Chronic ulceration of the leg: extent of the
problem and provision of care. Br Med J 1985; 290:1855–1856.
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41. Henry M. Incidence of varicose ulcers in Ireland. Irish Med J 1986; 79:65–67.
42. Baker SR, Stacey MC, Singh G, Hoskin SE, Thompson PJ. Aetiology of chronic leg ulcers.
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44. Lindholm C, Bjellerup M, Christensen OB, Zederfeldt B. A demographic survey of leg and foot
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46. Andersson E, Hansson C, Swanbeck G. Leg and foot ulcer prevalence and investigation of the
peripheral arterial and venous circulation in a randomised elderly population. An
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defined population of industrial workers. Phlebology 1996; 11:50–54.
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an elderly population. Scand J Primary Health Care 2000; 18:58–60.
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53. Heit JA, Rooke TW, Silverstein MD, et al. Trends in the incidence of venous stasis syndrome
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56. Mudge M, Leinster SJ, Hughes LE. A prospective 10-year study of the post-thrombotic
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5
Health Economics and Quality of Life—
Impact of Venous Disorders
Meryl Davis, Fiona J. Tsang, and Alun H. Davies
West of London Vascular Service, Charing Cross Hospital, London, U.K.
INTRODUCTION
Health is a difficult entity to evaluate and this particularly holds true for venous disease.
There is a lack of precise classification for venous disease and, as a consequence, an
underestimate of the impact on the health economy of a nation. Using The International
Classification of Disease (ICD-9), venous disease includes categories numbers 454
(varicose veins of the lower extremities), 459 (venous insufficiency and postphlebitic
syndrome), and 451 (phlebitis and thrombophlebitis).
HEALTH ECONOMICS
Most medical practitioners will have some involvement in health economics during their
career with the aim being to optimize the resources available. This can be described in
terms of efficiency (technical, productive, and allocation) or in terms of cost.
Efficiency
1. Technical efficiency—the relationship between the resource available and the
health outcome
2. Productive efficiency—the relationship between different patterns of the
resource available and health outcome
3. Allocation efficiency—the relationship between the cost and the outcome at a
social level
Chronic venous insufficiency and venous leg ulceration are debilitating conditions.
In developed countries chronic venous insufficiency affects approximately 5% of the adult
population with leg ulcers affecting between 0.2 and 0.5% of the population. Venous
disease consumes 1–2% of the health care budgets of European countries. The extent of
the disease burden in developing countries is not known. In 1992 it was estimated that
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venous disease cost 318–1135 million ECUs per annum (1). Venous ulcers are a chronic
and often recurring disease; in the United Kingdom approximately 1,00,000 patients have
active leg ulcers. The cost to the National Health Service is approximately £400 million
per annum and represents 2.0% of the costs for all conditions (2). Venous diseases absorb
approximately 1% of hospital in patient costs in the major EEC countries. Treating venous
disease is one of the most time-consuming of district nurses’ activities. In 1992 it was
estimated that district nurses spend 30–50% of their time dealing with patients with leg
ulcers, which translates into a figure of £180 million (3). Table 1 summarizes the overall
costs of venous diseases of the legs based on 1989 figures.
The “cost of illness” incorporates the costs of productive capacity lost as a
consequence of illness. These are usually described as “indirect” costs in contrast to the
“direct” costs of healthcare services. In 1989 the indirect costs of invalidity in the United
Kingdom was estimated at £73 million (Table 2).
Leg ulcers are treated by many medical specialities with a majoritybeing treatedin the
community, therefore a true perspective of the disease is difficult to gain. Approximately
75% of chronic leg ulcers are treated solely in the community, subsequently there is a lack of
awareness of the magnitude of the problem as a user of health resources (4).
Chronic leg ulcers are perceived as a disease of the elderly with the peak prevalence
being in the seventh and eighth decade and is estimated at between 0.18 and 1.9 per 1000.
The costs of leg ulcer treatment are considerable, with an unhealed leg ulcer estimated to
be £1067 per year with an annual total cost to the NHS approximately £300 million (3).
In 1995 the total direct and indirect costs of treating two hundred patients with venous
ulcers over twenty-four weeks were greater than £1,93,000. The costs per healed ulcer was
calculated at £1654 (in 1995), however, this only represented 59% of the patients, for the
41% of ulcers which were not healed the cost continued to rise (5). It has been calculated
that in 1998 the mean cost per ulcer clinic attendance was £29.90 while the mean cost per
home visit was £10.60. The median healing times were 20 and 43 wk for patients in the
Table 2 Indirect Costs in 1989 of Invalidity Attributed to Venous Diseases in the U.K.
Days of invalidity As % of invalidity Cost £ million
All venous diseases 1.8 million 0.4 73
ICD 454 818,000 0.2 33
ICD 459 903,000 0.2 36
Source: From Ref. 1.
Table 1 The Cost of Venous Diseases of the Legs in the U.K.
Cost UK £ million
Hospital inpatient 89
Hospital outpatient n/a
District nursing services 180
General practitioners 8
Prescription medicines 7
Compression hosiery 10
Total £294 million
Note: Venous diseases includes varicose veins, venous insufficiency, post phlebitic syndrome and phlebitis and
thrombophlebitis.
Davis et al.54
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clinic and control groups, respectively. These figures again are inaccurate as they fail to
take into account the personal costs due to invalidity and time spent receiving
treatment (3).
Approximately 15–20% of the adult population have varicose veins with an annual
incidence of 2.5% (6). This translates into 60,000 varicose veins operations in the National
Health Service and a further 15,000 operations in the private sector (7).
The National Institute for Clinical Excellence (NICE) offers advice on providing the
best attainable standards of care. Clinical effectiveness is insufficient for maintaining or
introducing a clinical procedure; cost must also enter the decision making process. NICE
and its advisory bodies have adopted a ratio up to £15,000/quality adjusted life year
(QALY) as a figure at which they would be unlikely to reject a procedure solely on the
grounds of cost ineffectiveness. Values achieved in the region of £25,000–£35,000/QALY
would need special reasons to be accepted as cost effective (8). In a randomized trial of
treatment for symptomatic, uncomplicated varicose veins, surgery was both clinically and
cost effective. Surgical treatment produced an estimated incremental benefit of 0.083
quality adjusted life years resulting in an incremental cost effectiveness ratio of £4682 per
quality adjusted life year (9).
QUALITY OF LIFE
Quality of life as defined by the World Health Organization is a state of complete
physical, mental and social well being, and not merely the absence of disease. However,
Price described quality of life as the impact of an illness and its treatment on disability
and daily living (10). Quality of life assessment is of value in demonstrating the benefit
of interventions of patients and can be used to plan care.
The criteria for an ideal quality of life measure are:
† Equally applicable to any disease process or outcome
† Equally applicable across all levels and degrees of invalidity
† Proven validity with a high level of convergence within patient groups when
applied across geographic, linguistic and cultural boundaries (11)
Currently there is no single quality of life tool that fulfils the above criteria; this
means that a generic tool has to be adopted, and options include the Nottingham Health
Profile (NHP) or the Short Form Survey (SF-36/SF-12). The International Quality of Life
Assessment (IQOLA) project was an undertaking to translate and adapt the SF-36
questionnaire and validate it in all major languages thereby making it an international
scale of health related quality of life (12).
Studies on the impact of chronic venous disease on quality of life are scarce.
Instruments used to measure quality of life are classified into generic and disease-
specific instruments. Generic instruments allow comparison across populations of
patients with different diseases, whereas disease-specific instruments are sensitive to key
dimensions of quality of life that are affected by specific diseases. Therefore combining
the two is a preferred strategy when examining quality of life. In a review article
twenty-five studies were identified which described the development or use of a quality
of life instrument in patients with chronic venous disease. The findings are summarized
in Table 3 (13).
Ten disease-specific questionnaires were identified which measured quality of life in
specific groups with chronic venous disease and are summarized in Table 4. The use of a
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wide range of instruments in the studies indicates a lack of consensus concerning the ideal
way to measure quality of life in the field of chronic venous disease. The majority of
studies used generic quality of life measures such as the SF-36 which allowed comparison
of patients with venous disease with a healthy population.
Table 3 Studies on the Quality of Life in Patients with Chronic Venous Disease
Author (year) Sample size Method of evaluation Note
Chronic venous
insufficiency
Franks (1992) (17) 114 QoL questionnaire for patients
with venous disease and
symptom rating test
Launois (1996) (18) 2001 CIVIQ
Augustin (1997) (19) 246 Freiburger questionnaire of
quality of life in venous diseases
Patients matched
with healthy con-
trols
Klyscz (1998) (20) 142 Tubingen questionnaire for
measuring QoL in patients with
CVI (TLQ-CVI)
Evaluated in 4
countries
Lamping (1998) (21) 615 VEINES-QOL
Venous thrombosis
Beyth (1995) (22) 124 Interview with symptoms and
SF-36 items
Mathias (1999) (23) 111 QoL questionnaire for patients
with DVT
Ziegler (2001) (24) 161 CIVIQ (modified) All patients had
post-thrombotic
syndrome
Kahn (2002) (25) 41 SF-26, VEINES QOL 19 with PTS, 22
without PTS
Venous leg ulceration
Hyland (1986) (26) 50 QoL questionnaire for patients
with leg ulcers
Lindholm (1993) (27) 125 NHP
Phillips (1994) (28) 73 Interview
Franks (1994) (29) 185 SRT, adapted version of QoL
questionnaire
Charles (1995) (30) 4 Interview
Walters (1999) (31) 233 SF-36, EQ, SF-MPQ, FAI
Smith (2000) (14) 98 SF-36 and the Charing Cross
venous ulcer questionnaire
Franks (2001) (32) 383 NHP
Varicose venis
Garratt (1993) (33) 281 SF-36 and QoL questionnaire for
patients with varicose veins
542 controls
Kurz (2001) (34) 1054 SF-36, VEINES QoL 259 controls
Abbreviations: CIVIQ, chronic lower limb venous insufficiency; CVI, chronic venous insufficiency; DVT, deep
vein thrombosis; EQ, Euro-QoL; FAI, Frenchay Activities Index; NHP, Nottingham Health Profile; PTS, post
thrombotic syndrome; QoL,quality of life; SF-36, shortform 36; SF-12,short form12; SF-MPQ, McGill shortform
pain questionnaire; VAS, visual analoguescore; VEINES-QOL,venous insufficiencyepidemiologic and economic
study questionnaire.
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Some major areas of quality of life affected by chronic venous disease can be
identified. Patients with venous thrombosis report pain and impairment of physical
function with low health perceptions and high health distress. Impairment of quality of life
is related to severity of symptoms and the presence of postthrombotic syndrome. Patients
with venous leg ulceration report impairment in physical functioning and mobility, with
negative emotions and social isolation. Patients with varicose veins have a lower health
perception and real impairment of quality of life. Using the SF-36 to assess patients with
varicose veins, females scored on average less (i.e., worse function and health) than
Table 4 Disease-Specific Quality of Life Instruments
Questionnaire and
population studied
Criteria
Author (year) (Ref.) Social Physical Psychological Other
Chronic venous
insufficiency
Franks (1992) (17) Health questionnaire for
venous disease
**
Launois (1996) (18) CIVIQ (for chronic venous
insufficiency)
** *
Augustin (1997) (19) The Freiburger question-
naire of QoL in venous
disease (German)
** *
Klyscz (1998) (20) The Tubingen questionnaire
for chronic venous insuf-
ficiency (TLQ-CVI)
(German)
** * *
Lamping (1998) (21) VEINES-QoL (for chronic
vascular disorders of the
leg)
** *
Venous thrombosis
Mathias (1999) (23) Health related QoL
questionnaire for DVT
** *
Venous leg
ulceration
Hyland (1986) (26) Self-report QoL
questionnaire for patients
with leg ulcers
** *
Franks (1994) (29) Health questionnaire for leg
ulcers
**
Smith (2000) (14) Charing Cross venous ulcer
questionnaire
** * *
Varicose veins
Garratt (1993) (33) Aberdeen Varicose Vein
Questionnaire (AVVQ)
**
Smith (2000) (14) Aberdeen Varicose Vein
Questionnaire (AVVQ)
** * *
Abbreviations: CIVIQ, chronic lower limb venous insufficiency; CVI, chronic venous insufficiency; TLQ-CVI,
tubingen questionnaire for measuring quality of life in patients with chronic venous insufficiency; VEINES-QOL,
venous insufficiency epidemiologic and economic study questionnaire; QoL, quality of life; DVT, deep vein
thrombosis; AVVQ, aberdeen varicose vein questionnaire.
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