Journal of Thrombosis and Haemostasis, 2: 21462151

ORIGINAL ARTICLE

The influence of venous thromboembolism on quality of life

and severity of chronic venous disease
S . R . K A H N , C . E . M L A N , * D . L . L A M P I N G , X . K U R Z , A . B E R A R D and L . A B E N H A I M F O R T H E V E I N E S
STUDY GROUP
Center for Clinical Epidemiology & Community Studies, Jewish General Hospital, and Department of Epidemiology and Biostatistics, McGill
University, Montreal, Canada; *Genetic and Genomic Biology, Hospital for Sick Children, University of Toronto, Canada; Health Services
Research Unit, London School Hygiene & Tropical Medicine, London, UK; Department of Pharmacology, University of Liege, Liege, Belgium; and
Faculty of Pharmacy, University of Montreal, and Research Center, Ste-Justines Hospital, Montreal, Canada

To cite this article: Kahn SR, Mlan CE, Lamping DL, Kurz X, Berard A, Abenhaim L for the VEINES Study Group. The influence of venous
thromboembolism on quality of life and severity of chronic venous disease. J Thromb Haemost 2004; 2: 214651.

disease-specic quality of life (VEINES-QOL, P 0.0002;

Summary. Background: It is not known whether burden-of-
illness diers in chronic venous disease patients with prior
venous thromboembolism compared with patients with other
forms of chronic venous disease. Objective: To compare
severity of disease and quality of life in chronic venous disease
patients with and without prior venous thromboembolism.
Patients and methods: The VEINES Study population is an
international cohort of 1531 outpatients with chronic venous
disease in Belgium, France, Italy and Canada. Clinical severity
of chronic venous disease graded using the seven-category
CEAP scale, and quality of life using standardized generic
(SF-36) and venous disease-specic (VEINES-QOL/Sym)
questionnaires were compared in patients with and without
venous thromboembolism. Multivariable analyses with adjust-
ment for known confounders were used to examine associations
between venous thromboembolism and quality of life.
Results: One hundred and fty-one (10%) patients had prior
venous thromboembolism. These patients had more severe
chronic venous disease than those without venous thrombo-
embolism (P < 0.0001), including a higher frequency of healed
or active ulcers (29% vs. 7%, respectively). Multivariable
analyses controlling for age, sex, country, education, body mass
index, years of chronic venous disease and comorbid conditions
demonstrated that prior venous thromboembolism was an
independent predictor of poorer generic quality of life (SF-36
Mental Component Summary score, P 0.047; SF-36 Phys-
ical Component Summary score, P 0.012) and venous
Correspondence: Susan R. Kahn, Center for Clinical Epidemiology
and Community Studies, Sir Mortimer B. Davis Jewish General
Hospital, 3755 Cote Ste. Catherine Rm. A-127, Montreal, Quebec
H3T 1E2, Canada.
Tel.: +1 514 340 8222, ext. 4667; fax: +1 514 7564; e-mail: susan.
kahn@mcgill.ca
Received 21 March 2004, accepted 10 June 2004
VEINES-Sym, P 0.009). Conclusions: Disease severity is
worse and quality of life poorer in chronic venous disease
patients with prior venous thromboembolism compared with
patients with other forms of chronic venous disease. Our
ndings support the need for further research of interventions to
prevent and treat the long-term complications of venous
thromboembolism.
Keywords: post-thrombotic syndrome, quality of life, venous
thromboembolism.
Introduction
Chronic venous disease (CVD) is a common condition that
affects millions of people worldwide [13]. It has been estimated
that as many as 20% of cases of CVD develop as a consequence
of prior deep venous thromboembolism (VTE) and, as such,
are considered to represent the post-thrombotic syndrome [2,4].
About one-third of patients develop the post-thrombotic
syndrome within 12 years after acute deep venous thrombosis
[57]. While known to be a burdensome condition that
diminishes quality of life (QOL) [810], it is not known whether
severity of illness differs in patients with the post-thrombotic
syndrome compared with patients with other forms of CVD.
The objective of this study was to examine, within a large
international cohort of patients with CVD, the inuence of
prior VTE on disease severity and QOL.
Methods
Study design
The VEnous Insufciency Epidemiological and Economic
Study (VEINES) is an international prospective cohort study
conducted in Belgium, Canada, France and Italy from 1994 to

2004 International Society on Thrombosis and Haemostasis


1997 [11]. Its main objective was to describe and compare
clinical presentations of CVD with regards to natural history,
QOL, healthcare utilization, risk factors and clinical outcomes.
Secondary objectives were to develop and validate a disease-
specic measure of QOL in CVD [12,13]. The population from
which the inception study cohort was sampled consisted of
patients suffering from a chronic venous-related leg disorder
who spontaneously consulted a general practitioner or special-
ist (e.g. angiologist, phlebologist, vascular surgeon) for that
disorder in Belgium, Canada, France and Italy during the study
period. Such patients were prospectively and consecutively
registered at physician practices participating in the VEINES
Study, with the aim of registering 25 patients per physician.
Information collected on the registration forms included date
of consultation, age, sex, presence of venous symptoms, and
presence of varicose veins, skin changes and ulcer. A total of
5688 patients were registered. Sampling of the registered
patients for inclusion in the study cohort was performed as
follows. First, patients aged < 18 years or > 75 years were
excluded. Next, all male patients and all patients with venous
ulcer were placed at the top of the list, in order to obtain a
sufcient number of these patients for the planned analyses,
followed by a random selection of all other patients registered
by the study physician, to a maximum of 15 patients per
physician. The study physicians then contacted each patient,
starting from the top of the list. Patients were excluded if they
had medical conditions that are characteristically associated
with leg edema (right-sided congestive heart failure, nephrotic
syndrome, limb paralysis), life-threatening illness or a serious
psychiatric disorder, or if they had a language barrier, no
phone, or did not provide consent. If a patient did not meet any
of the studys exclusion criteria, and if they agreed to
participate in the study, an appointment to attend the inclusion
(baseline) visit was arranged. The baseline visit consisted of a
medical interview and a physical examination of the lower
extremities by the clinician. QOL questionnaires were mailed to
patients for completion just before the baseline visit.
Approval was obtained from the relevant research ethics
committees in each country and written informed consent was
obtained from all patients prior to study entry.
Prior deep venous thromboembolism
Based on the medical history and a review of the patients
records, physicians reported whether there was a prior episode
of objectively documented VTE.
Clinical classification
At the baseline visit, the participating physician examined the
patients legs and classied the clinical category of CVD using
the C (clinical) component of the CEAP classication [14],
which categorizes patients into one of seven classes based on
the following clinical signs: Class 0, no visible or palpable signs
of venous disease (i.e. symptoms only); Class 1, telangiectasias
or reticular veins; Class 2, varicose veins; Class 3, edema; Class

2004 International Society on Thrombosis and Haemostasis
Quality of life in venous thromboembolism 2147
4, skin changes due to venous disease; Class 5, skin changes
with healed ulceration; Class 6, skin changes with active
ulceration. In this classication, severity or type of symptom is
not considered. Each category can include signs present in a
lower order category (e.g. edema could be present in Classes 4,
5, or 6). If both legs were affected, the highest class was
recorded.
Quality of life and patient-reported symptoms
Standardized, self-administered generic and disease-specic
instruments were used to measure generic and venous disease-
specic QOL. These included the Short-Form Health Survey-
36 (SF-36) [15] and VEINES-QOL [13], respectively. The
SF-36 is the current generic gold standard measure of physical
(SF-36 PCS) and mental (SF-36 MCS) QOL. The VEINES-
QOL is a 26-item questionnaire that measures venous symp-
toms (heavy legs, aching legs, swelling, night cramps, heat or
burning sensation, restless legs, throbbing, itching, tingling,
intensity of leg pain), limitations in daily activities due to CVD,
psychological impact of CVD, change over the past year and
time of day leg problem is most intense. The VEINES-Sym is a
validated subscale of the VEINES-QOL that measures venous
symptoms. The four language versions (English, French,
French Canadian and Italian) of the VEINES-QOL have been
comprehensively evaluated and shown to be acceptable,
reliable, valid and responsive [13]. For all QOL measures,
lower scores indicate poorer quality of life.
Statistical analysis
SAS software (SAS Institute; Cary, NC, USA) was used for all
analyses. Standard statistical tests (Pearson v2 test and analysis
of variance) were used to compare frequency distributions and
mean values of patient variables, including QOL scores, by
VTE status. The JonckherreTerpstra test for trend, as
provided by the SAS PROC FREQ procedure, was used to
test for differences in the distribution of VTE in the seven
CEAP classes. To prevent poor approximations to the v2
distribution due to the presence of sparse cells, the Monte Carlo
option provided by SAS software was used to estimate exact
P-values when observed cell counts were < 10. The clinical
variables of interest were age, sex, body mass index (BMI),
country, education, years since onset of CVD, and three, non-
mutually exclusive composite comorbidity variables: edema-
related comorbidity (included conditions which may, at times,
be associated with lower limb swelling, e.g. heart disease,
obstructive lung disease, chronic renal disease, hypothyroidism,
lymphedema), arthroses-related comorbidity (conditions asso-
ciated with lower limb pain, e.g. arthritis or other musculoske-
letal conditions affecting lower limbs), and other comorbidity
(conditions unlikely to produce leg symptoms).
Multivariate regression analyses were performed using a
generalized linear model with log-link to examine the effect of
prior VTE on QOL. In separate models, the dependent variable
was one of four QOL scores: SF-36 MCS, SF-36 PCS,
2148 S. R. Kahn et al

VEINES-QOL and VEINES-Sym. For all models, the inde- Table 1 Characteristics of study population*
pendent variables were VTE and the clinical variables listed Age, years; mean (SD) 54.0 (13.8)
above. n (%)
Due to missing values, sample size was reduced in models Sex
that included education (N 1353), years since onset of CVD Men 340 (22%)
Women 1191 (78%)
(N 1452), and BMI (n 1482). For missing QOL data, the Country
standard method [16] for imputing a person-specic estimate Belgium 484 (32%)
where the respondent answered at least 50% of the items in a France 593 (39%)
scale was used; otherwise, data for the whole questionnaire Italy 359 (23%)
were considered missing. Canada 95 (6%)
Years since onset venous disorder (n 1452)
< 1 year 30 (2%)
Role of the funding source 14 years 240 (16%)
59 years 241 (17%)
The study sponsor had no role in the design or conduct of the 10 years 941 (65%)
study, the collection, management, analysis and interpretation Education (n 1353)
Primary school 287 (21%)
of data, in the preparation, review or approval of the Secondary school 667 (49%)
manuscript or in the decision to submit the paper for College or higher 399 (30%)
publication. CEAP clinical class
0 58 (4%)
1 204 (13%)
Results 2 369 (24%)
3 196 (13%)
There were 1531 patients enrolled in the VEINES Study: 593 in 4 558 (37%)
France, 484 in Belgium, 359 in Italy, and 95 in Canada. 5 111 (7%)
Characteristics of the study participants are shown in Table 1. 6 35 (2%)
Most patients had longstanding CVD and were clustered in Prevalence of comorbid conditions
Hypertension 392 (26%)
CEAP classes 2, 3 or 4. The most common comorbid
Arthritis 345 (23%)
conditions were hypertension (26%) and arthritis (23%). Heart disease 119 (8%)
A history of prior VTE was documented in 151 (10%) study Diabetes 78 (5%)
patients. Compared with patients without VTE, these patients Chronic lung disease 72 (5%)
were older (P < 0.0001), more likely to be male (P 0.006), Hypothyroidism 59 (4%)
Chronic liver disease 17 (1%)
had CVD that was more longstanding (P 0.014), fewer years
Chronic kidney disease 11 (1%)
of education (P 0.007), higher BMI (P < 0.001) and a
higher frequency of each of the composite comorbidity types With the exception of age, gures are numbers of patients with per-
centages in parentheses. *N 1531 unless otherwise indicated. CEAP
(Table 2).
class denition: Class 0, no clinical signs (i.e. symptoms only); Class 1,
Patients with VTE had more severe CVD than patients telangiectasias or reticular veins; Class 2, varicose veins; Class 3,
without VTE (P < 0.0001) (Fig. 1). Almost 30% of patients edema; Class 4, skin changes due to venous disease; Class 5, skin
with VTE had healed or active ulcers (CEAP class 5 and 6, changes with healed ulceration; Class 6, skin changes with active
respectively), compared with only 7% of patients without ulceration.
VTE.
QOL scores are shown in Table 3. Both generic (SF-36 PCS
and SF-36 MCS) and disease-specic (VEINES-QOL, VE- QOL scores had adjusted P-values of 0.047, 0.012, 0.0002 and
INES-Sym) QOL scores were signicantly lower, indicating 0.009 for SF-36 MCS, SF-36 PCS, VEINES-QOL and
poorer QOL, in patients with prior VTE compared with VEINES-Sym scores, respectively. In models adjusted for
patients without prior VTE (MCS, P 0.007 for difference; CEAP clinical severity class in addition to the above variables,
PCS, P < 0.0001 for difference; VEINES-QOL, P < 0.0001 prior VTE remained an independent predictor of lower scores
for difference; VEINES-Sym, P < 0.0001 for difference). for SF-36 MCS (P 0.034), SF-36 PCS (P 0.046),
Using standard criterion-based interpretation guidelines for VEINES-QOL (P 0.003) and VEINES-Sym (P 0.035).
SF-36 scores [15], PCS scores for patients with and without
VTE represent a difference of 25% vs. 15% of patients unable
Discussion
to work, respectively, whereas MCS scores for patients with
and without VTE represent a difference of 33% vs. 28% of In a large, international cohort of patients with CVD, we found
patients reporting substantial life stress, respectively. Multivar- that patients with prior VTE had more severe venous disease
iable analyses adjusted for age, sex, country, duration of CVD, than those without prior VTE, as manifested by higher
level of education, BMI and comorbidity demonstrated that physician-assigned clinical severity category and a 4-fold higher
prior VTE was an independent predictor of poorer QOL. prevalence of venous ulcers. Furthermore, patients with VTE
Parameter estimates for prior VTE as a predictor of lower had signicantly poorer self-reported generic and venous

2004 International Society on Thrombosis and Haemostasis

 Quality of life in venous thromboembolism 2149

Table 2 Baseline characteristics of patients with and without venous Table 3 Quality of life scores in patients with and without venous
thromboembolism thromboembolism
Prior venous Prior venous
thromboembolism thromboembolism

Yes No Yes No
(n 151) (n 1380) P-value QOL score, mean (SD) (n 151) (n 1380) P-value

Age, mean (SD) 60.3 (12.1) 53.3 (13.8) < 0.0001 Generic QOL
Female, n (%) 69 79 0.006 SF-36 MCS 41.8 (10.8) 44.3 (11.0) 0.007
Years since onset CVD n 133 n 1187
< 1 years (%) 2 2 0.014 SF-36 PCS 40.6 (10.5) 45.9 (9.6) < 0.0001
14 years (%) 9 17 n 133 n 1187
59 years (%) 12 17 Disease-specic QOL
10 years (%) 77 64 VEINES-QOL 47.4 (6.4) 50.2 (5.9) < 0.0001
Education n 142 n 1294
Primary school (%) 24 21 0.007 VEINES-Sym 47.9 (6.7) 50.2 (6.6) < 0.0001
Secondary school (%) 58 48 n 141 n 1281
College or higher (%) 18 31
Body mass index, mean (SD) 28.1 (5.3) 25.9 (5.0) < 0.001 MCS and PCS are Mental Component Score and Physical Compo-
Edema-related comorbidity (%) 52 40 0.004 nent Score of the SF-36 generic quality of life measure. VEINES-QOL
Arthroses-related comorbidity (%) 42 31 0.004 is a venous disease-specic QOL measure; VEINES-Sym is a valid-
Other comorbidity (%) 36 21 < 0.0001 ated 10-item symptom subscale of VEINES-QOL. Lower scores for
all measures poorer quality of life.
For denitions of comorbidity, see text.

population each year in North America [19]. Rates are higher

in the elderly and in patients with cancer or those undergoing
40%
surgery. It is believed that VTE leads to CVD via the
35% development of venous hypertension, which occurs in response
to persistent venous outow obstruction, venous valvular
30%
incompetence, or both [5].
25% Prospective cohort studies of patients with venous throm-
Percent

20%
15% VTE
No VTE
10%
5%
0%
0 1 2 3 4 5 6
CEAP Clinical Class
Fig. 1. Clinical severity of chronic venous disease in patients with and
without prior venous thromboembolism. VTE, Venous thromboembo-
lism; CEAP classication described in Notes, Table 1. Clinical severity
worse (i.e. higher CEAP class) in patients with VTE vs. patients without
VTE, P < 0.0001 for trend.
disease-specic QOL, even after adjustment for confounding
variables.
Our ndings indicate that CVD is not a homogeneous
condition with a uniform natural history: CVD patients with
prior VTE fare worse than patients with other forms of CVD.
The etiological classication of CVD includes congenital,
primary, and secondary causes, of which primary CVD (i.e.
venous dysfunction of unknown cause) is the most common
[2,14]. VTE, the most important secondary cause of CVD
[17,18], is a common, serious, acute vascular disorder that is
diagnosed in approximately 100 persons per 100 000
bosis have demonstrated that 2050% will develop the chronic
post-thrombotic syndrome within 12 years of the acute
thrombosis [6,7]. Factors that lead to its development are
poorly understood, and many clinicians are unaware of the
condition or discount it as being primarily a cosmetic problem
[5]. Our results demonstrate that the post-thrombotic syndrome
is a particularly severe form of CVD, and support the need for
further study of measures to prevent and treat this condition.
In parallel with worse clinical severity, we show that QOL is
signicantly poorer in CVD patients with prior VTE compared
with those without prior VTE. Patient-reported QOL is an
important component in evaluating health outcomes. In
particular, for chronic conditions such as CVD, assessment
of QOL provides important information on burden-of-illness
that may not be adequately captured by traditional physician-
based measures of disease severity [12,20]. We and others have
previously shown that severity of CVD inuences generic
[21,22] and venous disease-specic [22] QOL. We have also
shown that patients with venous thrombosis who developed the
post-thrombotic syndrome experienced poorer QOL than
those who recovered without sequelae [8]. In the present study,
we demonstrate that a history of prior VTE in patients with
CVD predicts poorer and clinically signicant QOL, even after
adjustment for variables that have been shown to be associated
with QOL in CVD patients [22].
Our study has a number of strengths. The study cohort was
large, international in scope, and randomly sampled from

2004 International Society on Thrombosis and Haemostasis

2150 S. R. Kahn et al
almost 6000 consecutive patients presenting with symptoms or
signs of CVD. We used validated measures of generic and
disease-specic QOL which were completed by study partici-
pants before the clinical visit. Nevertheless, it is important to
consider potential study limitations. By design, we intentionally
prioritized recruitment of male and ulcer patients in order to
ensure adequate numbers of these patients for the VEINES
analyses, hence, although proportionally few in number, such
patients were over-represented in the nal study population
relative to the source population. We did not systematically
collect data on non-VTE etiologies of CVD, or its anatomical
extent or physiology. However, prior VTE was detected in 10%
of our study cohort, a rate similar to that reported in other
studies of patients with CVD [2,4], and our study population
was randomly sampled from a large number of consecutive
CVD patients, hence we believe that our sample is likely to be
representative of the typical spectrum of CVD patients. While
it is possible that knowledge of prior VTE could have biased
physicians clinical assessments of CVD severity, we believe this
is unlikely for three reasons: the question addressing prior VTE
in the baseline data form was only one of many questions
relating to various clinical aspects of CVD; there are no prior
data suggesting that patients with previous VTE have more
severe CVD than patients with other forms of CVD; and false
positive diagnosis of healed or active ulcer, the most severe
clinical categories, would be highly unlikely. Also, the accuracy
of the clinical severity assessments was corroborated by our
nding that patients with prior VTE also reported poorer
QOL. Although we cannot formally exclude a positive referral
bias for VTE cases, we believe that it is unlikely, because
whether patients had a history of thrombosis was not known at
the time of study registration and was not a factor that
determined their eligibility to participate, and the rate of prior
VTE in our study cohort was similar to (i.e. not higher than)
that reported in other population-based studies of patients with
chronic venous disease. Finally, as this was an epidemiological
study that involved collection of large amounts of clinical,
economic and quality of life data, it was not feasible to obtain
detailed data on specic diagnostic testing performed or the
anatomical extent of thrombosis. However, as the reported rate
of prior VTE was similar to that described in other populations
of patients with CVD, we feel condent that the diagnosis was
adequately accurate. Further, misclassication of diagnosis
would tend to bias results to the null, whereas we found
signicant differences between patients with and without prior
VTE.
In conclusion, we found that among patients with CVD,
those with prior VTE had signicantly worse disease
severity and poorer QOL than patients without prior
VTE, indicating that burden-of-illness is more severe in
such patients. As VTE is a common cardiovascular condi-
tion and the post-thrombotic syndrome is a frequent chronic
complication of VTE, our ndings support the need for
wider implementation of proven methods to prevent VTE
and further research of interventions to prevent and treat
the long-term complications of VTE.
Acknowledgements
This study was carried out as part of the VEINES study, an
international research program on chronic venous disorders of
the leg supported by an unrestricted grant from IRIS to the
Jewish General Hospital (coordinated by L.A.). The work
reported in this paper is based on subsequent analyses of data
to examine the inuence of venous thromboembolism on
quality of life and severity of chronic venous disease; it is not a
drug study and no product is mentioned in the text. The
unrestricted grant from IRIS provided: support for attending
conferences to D.L.L., X.K., S.R.K. and L.A., and consulting
fees to L.A. and D.L.L. A.B. and C.E.M. have no potential
competing interests to disclose. The active collaboration of all
general practitioners and specialists who participated as
investigators in the VEINES study in Belgium, Canada, France
and Italy is gratefully acknowledged. S.R.K. is a recipient of a
Clinical Research Scientist Award from the Fonds de la
Recherche en Sante du Quebec. A.B. is a recipient of a
Research Scientist Award from the Canadian Institute of
Health Research and the Canadian Foundation for Health
Research (CIHR/Rx & D). The VEINES Study was supported
by an unrestricted grant from the Institut de Recherches
Internationales Servier (IRIS).
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