Clinical trial NCT02557542
Conditions: Varicose Veins
Keywords: Varicose Veins; One Stop Clinic
Sponsor: Imperial College London
Start date: 2015-10-01; Completion date: 2021-03-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A pilot randomised controlled trial looking at the setting up of a one stop vein clinic for the treatment of varicose veins and assessing the quality-adjusted life years at 3 months of patients This will be a pilot study which is designed to provide enough information for a potentially larger multicentre randomised controlled study.

Detailed description:
OBJECTIVES

* Primary Objective

  o Measure the quality-adjusted life years (QALY) gained at 3 months (using EuroQoL's EQ-5D) \& AVVQ by patients randomised to treatment in the One Stop Vein Clinic with patients randomised to treatment in the normal care pathway
* Secondary Objective

  * Patient satisfaction with the service provided using the Picker patient experience questionnaire both post-operatively and at the 3 months follow-up (One Stop Vein Clinic versus Normal Care Pathway)
  * Measure and compare the quality of life scores using CIVIQ at 0 and 3 months in patients randomised to treatment in the One Stop Vein Clinic with patients randomised to the Normal Care Pathway
  * Record the time from referral to treatment (RTT)
  * Assess the cost-effectiveness of the One Stop Vein clinic compared to the normal care pathway
  * Record the time to return to normal activities and to work
  * Assess the estimated societal costs

BACKGROUND Varicose veins are very common conditions, affecting approximately 25% of the population. Over 35,000 varicose vein procedures are currently carried out in the UK. However, with the new 2013 NICE guidelines, the Department of Health has estimated that this is set to increase to 50,000 per year. Waiting for varicose vein interventions has been shown to be detrimental to the severity of the condition and the quality of life of patients. Progression of varicose veins can also lead to complications such as leg ulcerations and can be costly to the health service. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting. At present, patients referred to the Vascular unit for consideration of management of their varicose veins have to attend the outpatient clinic at least twice prior to be listed for their procedure.

At present, patients referred to the Vascular Outpatient Clinics for consideration for varicose vein management have an initial appointment where the severity of the venous insufficiency is assessed clinically and, subsequently, have a venous Duplex scan to evaluate the extent and cause of any venous incompetence. If any treatable lesion is found, they are then added to the waiting list to come for the eventual varicose vein procedure. This means, they have to attend at least two outpatient appointments and attend another appointment for their venous scans, before actually attending for their varicose vein procedure. Waiting for varicose vein interventions has been shown to lead to worsening of their conditions both clinically and radiologically. In addition, the quality of life of patients waiting for elective surgery is adversely affected.

In order to evaluate patients' ideas and expectations with respect to the provision of varicose vein service in the investigator's unit, they conducted a survey of patients attending the Vascular Outpatient Clinic between March and June 2014. One hundred and six patients completed the anonymous questionnaire. Most were females (62.4%) with a mean age of 51 ± 15 years. More than 90% of patients stated that the waiting time between a Vascular appointment and a venous scan should be no more than 1 month and 85% of patients believed varicose vein procedures should be received within 1 month of their Vascular clinic appointment. Ninety percent of patients were agreeable to attend a 'one-stop' vein clinic offering same day diagnosis and treatment. Patients were generally accepting of the fact that most procedures would be carried out under local anaesthetic (89%).

Hence, it appears that patients in this unit have a preference for a one stop clinic. This concept is not new and has been piloted in other specialities with good success - a one-stop carpal tunnel clinic as well as a one stop cataract clinic was shown to be feasible with good patient satisfaction. Both laparoscopic and open inguinal hernia repairs, where patients received a general anaesthetic, have been carried out successfully using a one stop model offering same day diagnosis and treatment. There is currently already a 'see and treat' service for skin lumps operating at many NHS Trusts and there is already a one stop carpal tunnel service being provided at the Imperial College NHS Trust. It would appear that these one stop clinics have the advantage of reducing the number of unnecessary hospital visits as well as possibly leading to cost savings to the health service.

As a result, the investigators intend to evaluate the one stop model within their own varicose vein service. They will assess the feasibility of having a one-stop vein clinic, where patients will be assessed, have their venous Duplex scans and, depending on the lesions shown, have their venous treatment on the same day.

The hypothetical benefits of such a stratagem are an improvement in patient satisfaction, a reduction in the number of appointments, the abolition of any waiting times as well as cost savings to the health savings.

METHODS GP referrals will be screened and patients meeting the inclusion criteria will be invited to take part in the trial .

They will be sent an information pack containing:

1. Information leaflet about the trial
2. Information about varicose veins, their treatments and a telephone number as a helpline
3. The Aberdeen Varicose Vein Questionnaire (AVVQ), the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) and EuroQoL's quality of life questionnaire (EQ-5D)
4. Consent form to participate in the study

Patients agreeing to be part of the trial will be consented and randomised either to:

1. The One Stop Vein Clinic (offering same day diagnosis and treatment); or
2. The normal care pathway

Once patients indicate their consent to participate, their General Practitioners (GP) will be sent a letter informing them of the patient's participation in this study.

Patients declining to partake in the randomised part of the study, but agreeable to complete study questionnaires while continuing down the normal care pathway, will also be consented. Further information will be provided to them when they attend for their clinic appointment and the consenting process will take place when they attend for their subsequent procedure

One Stop Vein Clinic Pathway

Patients attending the One Stop Vein Clinic will be reviewed by the Vascular Surgeon, who will confirm the patient's consent in the trial, then assess the degree of venous disease and fill in the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification and Varicose Clinical Severity Score (VCSS). If the patient's symptoms are deemed secondary to venous disease, they will be sent to have a Duplex scan to confirm the presence of the venous disease. The results will be reviewed by the Vascular Surgeons, and if the patients are suitable for endovenous ablation +/- avulsions or UGFS, they will be informed of the findings of the scan and proposed treatment. If they are happy to go ahead with the proposed intervention, they will be consented and transferred to the waiting area to wait for their intervention. If, however, they decline same day treatment, they will be put onto the conventional care pathway.

Another Vascular Surgeon will be carrying out the interventions in an 'office-based' environment under local anaesthetic. Once done, the patients will be asked to fill the Picker patient experience questionnaire. They will subsequently be discharged, similar to current practice, and will be given a diary card to fill for when they return to their normal activities and work.

Three (3) months post-operatively, they will be asked to fill the AVVQ, CIVIQ, EQ-5D and Picker patient experience questionnaires once more. This will be done by sending them the questionnaires by post.

The Normal Care Pathway (NCP)

In the normal care pathway, patients referred by their GP are seen in the outpatient clinic and, if their symptoms are suggestive of varicose vein disease, they are sent to have a venous duplex scan. This usually happens on a different day. Afterwards, they are seen back in the clinic (again on a different day) and, if the scan result suggests venous incompetence amenable to day case treatment, they are added to the waiting list. The eventual procedure takes place some time later (within 18 weeks from referral to treatment). After their procedure, they will be asked to fill a Picker patient experience questionnaire. On discharge, they will be given a diary card to fill for when they return to their normal activities and work.

At 3 months post intervention, patients randomised to the normal care pathway will be sent the QoL questionnaires again and asked to fill the AVVQ, CIVIQ, EQ-5D and Picker patient experience questionnaires. As there will be an inherent delay in the NCP pathway, the time from randomisation cannot be used as many patients will not have received their interventional treatment by then.

Inclusion and Exclusion Criteria

The inclusion criteria are:

1. Adults over the age of 18 years
2. Unilateral lower limb symptoms suggestive of venous disease on the referral letter

The exclusion criteria are:

1. Recurrent varicose veins
2. Known arterial disease or ABPI\<0.8
3. Current deep vein thrombosis
4. Patients who withdraw their consent
5. Inability to complete the questionnaire or attend follow up appointments
6. Currently enrolled in other venous study

PATIENT SELECTION This is a pilot randomised controlled study and patients will be selected following screening of the GP referral letter.

CONSENT As part of the consenting process, patients will be given three options.

1. Patients wishing to attend the One Stop Vein Clinic and participate in the study will be asked to indicate their consent by signing a consent form and filling in a reply slip. Patients will be randomised either to the One Stop Vein Clinic group or to the Normal Care Pathway (NCP) group.
2. Patients not wishing to attend the One Stop Vein Clinic and participate in the study will be asked to indicate this by filling in a reply slip. They will instead attend the normal care pathway. They will, however, be asked, if agreeable to complete the QoL and Picker patient experience forms.
3. Patients declining either the trial or simple service evaluation will be offered the NCP.

TREATMENT ALLOCATION Treatment received will depend on the findings on the venous Duplex scan. All treatments are minimally invasive with endovenous ablation procedures (either radio-frequency ablation, endovenous laser ablation or mechano-chemical ablation), avulsions or ultrasound-guided foam sclerotherapy. All procedures will be carried out under local anaesthetic and patients will be discharged home later that day, as is the current standard of care.

MEASUREMENT OF OUTCOMES

Primary Outcome

• Measure the quality-adjusted life years (QALY) gained at 3 months (by patients randomised to treatment in the One Stop Vein Clinic with patients randomised to treatment in the Normal Care Pathway)

Secondary Outcome

* Patient satisfaction with the service provided using the Picker patient experience questionnaire both post-operatively and at the 3 months follow-up (One Stop Vein Clinic versus Normal Care Pathway)
* Measure and compare the quality of life scores using EQ-5D, AVVQ and CIVIQ at 0 and 3 months in patients randomised to treatment in the One Stop Vein Clinic with patients randomised to the Normal Care Pathway
* Time from referral to treatment
* Assess the cost-effectiveness of the One Stop Vein clinic compared to the normal care pathway
* Record the time to return to normal activities and to work
* Assess the estimated societal costs

STUDY DURATION \& SAMPLE SIZE Following screening of their GP referral letter, patients with varicose vein disease will be invited to participate in the study. It is estimated that 12-14 patients will be invited on a weekly basis to participate in the study following screening. Out of those, only 8 patients is expected to agree to be randomised to the One Stop Vein Clinic or Normal Care Pathway. If the clinic is held weekly, approximately 416 patients could be recruited over the course of the year (8 patients X 52 weeks).

Statistical analysis suggests that the sample size of 208 patients per group would be able to power a potential phase 3 multicentre randomised controlled trial. Compared to a previous study conducted in the investigators' unit which involved 317 patients in total and looked at different quality of life scores and their responsiveness11, the coefficient of variation (ratio of standard deviation to mean) was found to increase at the follow-up period and to vary among the different scores used. With a larger sample size as in this pilot study, this variability would be reduced and result in a smaller coefficient of variation when looking at the follow-up scores. Hopefully, this will enable us to identify the QoL score with the least variability and use it as the primary outcome measure in a future Phase 3 study. A primary outcome measure with little variability would provide us with enough information to estimate an adequate sample size for any future randomised controlled trials.

For example, with a sample size of 208 patients and coefficient of variation of 0.5, a 15% reduction in the geometric mean (a measure of central tendency, similar to median) would be required compared to 25% from the Shepherd et al. study. With power at 85%, this would allow us to determine an adequate sample size.

Participants will be followed-up post-procedure for 3 months, including for patients randomised to the Normal Care Pathway (with potentially longer waiting time from referral to treatment). This means that the study period will be about 18 months. With 3 months for study start-up and 3 months to write the study up, the study will last for 24 months. Approximately 1,000 patients undergo varicose vein procedures at the Imperial College NHS Trust every year.

COST BENEFIT OF PROJECT The hypothesis is that along with improved patient satisfaction and improved waiting times for outpatient appointment, there will be cost savings derived from the One Stop Vein Clinic. On average, 1,000 patients are treated every year in the Imperial College NHS Trust and the cost of an outpatient attendance is approximately £93. Savings could be made if patients are seen and treated at their first appointment rather than having to attend another two appointments.

The potential cost saving is estimated to be in the order of £186,000 annually (£93 x 1,000 X 2).

Estimated societal costs. Data will be collected on time off from work and carer's duties (child/relative/friend). Additionally, data on income, cost of attending clinic and impact on family and colleagues will be assessed to estimate the societal cost of the two pathways.

Arms: arm 1: Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment arm 2: Patients randomised to this group will be invited to the Normal Care Pathway
Interventions: intervention 1: One Stop Vein Clinic intervention 2: Radiofrequency ablation intervention 3: Endovenous laser ablation intervention 4: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)
Intervention descriptions: intervention 1: Same day diagnosis and treatment intervention 2: Venous ablation intervention 3: Venous ablation intervention 4: Venous ablation

Protocol documents:
Prot_000.pdf: 
Pilot Randomised Controlled Trial Evaluating a 
One Stop Vein Clinic
Version Date: 06/03/2015
FULL TITLE
Pilot Randomised Controlled Trial Evalua4ng the poten4al beneﬁt of a One Stop Vein Clinic
DESCRIPTION
A pilot randomised controlled trial looking at the seAng up of a one stop vein clinic for the 
treatment of varicose veins and assessing the quality-adjusted life years at 3 months of 
pa4ents 
This will be a pilot study which is designed to provide us with enough informa4on for a 
poten4ally  larger mul4centre  randomised controlled study.
OBJECTIVES
•
Primary Objec4ve
•
Measure the quality-adjusted life years (QALY) gained at 3 


months (using EuroQoL’s EQ-5D) & AVVQ by pa4ents randomised to 
treatment in the One Stop Vein Clinic with pa4ents randomised to treatment 
in the normal care pathway 
•
Secondary Objec4ve
•
Pa4ent sa4sfac4on with the service provided using the Picker 
pa4ent experience ques4onnaire both post-opera4vely and at the 3 months 
follow-up (One Stop Vein Clinic versus Normal Care Pathway)
•
Measure and compare the quality of life scores using CIVIQ at 
0 and 3 months in pa4ents randomised to treatment in the One Stop Vein 
Clinic with pa4ents randomised to the Normal Care Pathway
•
Record the 4me from referral to treatment (RTT)
•
Assess the cost-eﬀec4veness of the One Stop Vein clinic 
compared to the normal care pathway
•
Record the 4me to return to normal ac4vi4es and to work 
•
Assess the es4mated societal costs
BACKGROUND
Varicose veins are very common condi4ons, aﬀec4ng approximately 25% of the popula4on1. 
Over 35,000 varicose vein procedures are currently carried out in the UK2. However, with 
the new 2013 NICE guidelines, the Department of Health has es4mated that this is set to 
increase to 50,000 per year. Wai4ng for varicose vein interven4ons has been shown to be 
detrimental to the severity of the condi4on and the quality of life of pa4ents3. Progression 
of varicose veins can also lead to complica4ons such as leg ulcera4ons and can be costly to 
the health service4. Over the past decade, new endovenous techniques have been 
introduced and these are felt to be cost-eﬀec4ve, especially, when performed in an 
outpa4ent or ‘oﬃce-based’ seAng5. At present, pa4ents referred to the Vascular unit for 
considera4on of management of their varicose veins have to adend the outpa4ent clinic at 
least twice prior to be listed for their procedure.
At present, pa4ents referred to the Vascular Outpa4ent Clinics for considera4on for varicose vein 
management have an ini4al appointment where the severity of the venous insuﬃciency is assessed 
clinically and, subsequently, have a venous Duplex scan to evaluate the extent and cause of any 
venous incompetence. If any treatable lesion is found, they are then added to the wai4ng list to 
come for the eventual varicose vein procedure. This means, they have to adend at least two 
outpa4ent appointments and adend another appointment for their venous scans, before actually 
adending for their varicose vein procedure. Wai4ng for varicose vein interven4ons has been shown 
to lead to worsening of their condi4ons both clinically and radiologically3. In addi4on, the quality of 
life of pa4ents wai4ng for elec4ve surgery is adversely aﬀected6.
In order to evaluate pa4ents’ ideas and expecta4ons with respect to the provision of 
varicose vein service in our unit, we conducted a survey of pa4ents adending the Vascular 
Outpa4ent Clinic between March and June 2014. One hundred and six patients completed the 
anonymous questionnaire. Most were females (62.4%) with a mean age of 51 ± 15 years. 
More than 90% of patients stated that the waiting time between a Vascular 
appointment and a venous scan should be no more than 1 month and 85% of 
patients believed varicose vein procedures should be received within 1 
month of their Vascular clinic appointment. Ninety percent of patients were 
agreeable to attend a ‘one-stop’ vein clinic offering same day diagnosis 
and treatment. Patients were generally accepting of the fact that most 
procedures would be carried out under local anaesthetic (89%). 
Hence, it appears that pa4ents in our unit have a preference for a one stop clinic. This 
concept is not new and has been piloted in other speciali4es with good success -  a one-stop 
carpal tunnel clinic as well as a one stop cataract clinic was shown to be feasible with good 


pa4ent sa4sfac4on7, 8. Both laparoscopic and open inguinal hernia repairs, where pa4ents 
received a general anaesthe4c, have been carried out successfully using a one stop model 
oﬀering same day diagnosis and treatment9, 10. There is currently already a ‘see and treat’ 
service for skin lumps opera4ng at many NHS Trusts and there is already a one stop carpal 
tunnel service being provided at the Imperial College NHS Trust. It would appear that these 
one stop clinics have the advantage of reducing the number of unnecessary hospital visits as 
well as possibly leading to cost savings to the health service7-10.
As a result, we intend to evaluate the one stop model within our own varicose vein service. 
We will assess the feasibility of having a one-stop vein clinic, where pa4ents will be 
assessed, have their venous Duplex scans and, depending on the lesions shown, have their 
venous treatment on the same day. 
The hypothe4cal beneﬁts of such a stratagem are an improvement in pa4ent sa4sfac4on, a 
reduc4on in the number of appointments, the aboli4on of any wai4ng 4mes as well as cost 
savings to the health savings. 
METHODS
GP referrals will be screened and pa4ents mee4ng the inclusion criteria will be invited to 
take part in the trial . 
They will be sent an informa4on pack containing:
•
Informa4on leaﬂet about the trial 
•
Informa4on about varicose veins, their treatments and a telephone 
number as a helpline
•
The Aberdeen Varicose Vein Ques4onnaire (AVVQ), the Chronic 
Venous Disease Quality of Life Ques4onnaire (CIVIQ) and EuroQoL’s quality of life 
ques4onnaire (EQ-5D)
•
Consent form to par4cipate in the study
Pa4ents agreeing to be part of the trial will be consented and randomised either to:
•
The One Stop Vein Clinic (oﬀering same day diagnosis and treatment); 
or
•
 The normal care pathway 
Once pa4ents indicate their consent to par4cipate, their General Prac44oners (GP) will be 
sent a leder informing them of the pa4ent’s par4cipa4on in this study. 
Pa4ents declining to partake in the randomised part of the study, but agreeable to complete 
study ques4onnaires while con4nuing down the normal care pathway, will also be 
consented. Further informa4on will be provided to them when they adend for their clinic 
appointment and the consen4ng process will take place when they adend for their 
subsequent procedure
One Stop Vein Clinic Pathway
Pa4ents adending the One Stop Vein Clinic will be reviewed by the Vascular Surgeon, who 
will conﬁrm the pa4ent’s consent in the trial, then assess the degree of venous disease and 
ﬁll in the Clinical-E4ology-Anatomy-Pathophysiology (CEAP) classiﬁca4on and Varicose 
Clinical Severity Score (VCSS). If the pa4ent’s symptoms are deemed secondary to venous 
disease, they will be sent to have a Duplex scan to conﬁrm the presence of the venous 
disease. The results will be reviewed by the Vascular Surgeons, and if the pa4ents are 
suitable for endovenous abla4on +/- avulsions or UGFS, they will be informed of the ﬁndings 
of the scan and proposed treatment. If they are happy to go ahead with the proposed 
interven4on, they will be consented and transferred to the wai4ng area to wait for their 
interven4on. If, however, they decline same day treatment, they will be put onto the 
conven4onal care pathway.
Another Vascular Surgeon will be carrying out the interven4ons in an ‘oﬃce-based’ 
environment under local anaesthe4c. Once done, the pa4ents will be asked to ﬁll the Picker 
pa4ent experience ques4onnaire. They will subsequently be discharged, similar to current 
prac4ce, and will be given a diary card to ﬁll for when they return to their normal ac4vi4es 


and work.
Three (3) months post-opera4vely, they will be asked to ﬁll the AVVQ, CIVIQ, EQ-5D and 
Picker pa4ent experience ques4onnaires once more. This will be done by sending them the 
ques4onnaires by post.
The Normal Care Pathway (NCP)
In the normal care pathway, pa4ents referred by their GP are seen in the outpa4ent clinic 
and, if their symptoms are sugges4ve of varicose vein disease, they are sent to have a 
venous duplex scan. This usually happens on a diﬀerent day. Arerwards, they are seen back 
in the clinic (again on a diﬀerent day) and, if the scan result suggests venous incompetence 
amenable to day case treatment, they are added to the wai4ng list. The eventual procedure 
takes place some 4me later (within 18 weeks from referral to treatment). Arer their 
procedure, they will be asked to ﬁll a Picker pa4ent experience ques4onnaire. On discharge, 
they will be given a diary card to ﬁll for when they return to their normal ac4vi4es and work.
At 3 months post interven4on, pa4ents randomised to the normal care pathway will be sent 
the QoL ques4onnaires again and asked to ﬁll the AVVQ, CIVIQ, EQ-5D and Picker pa4ent 
experience ques4onnaires. As there will be an inherent delay in the NCP pathway we can not 
use the 4me from randomisa4on as many pa4ents will not have received their 
interven4onal treatment by then.
Inclusion and Exclusion Criteria
The inclusion criteria are:
•
Adults over the age of 18 years
•
Unilateral lower limb symptoms sugges4ve of venous disease on the 
referral leder
The exclusion criteria are:
•
Recurrent varicose veins
•
Known arterial disease or ABPI<0.8 
•
Current deep vein thrombosis
•
Pa4ents who withdraw their consent
•
Inability to complete the ques4onnaire or adend follow up 
appointments
•
Currently enrolled in other venous study
PATIENT SELECTION
This is a pilot randomised controlled study and pa4ents will be selected following screening 
of the GP referral leder.
CONSENT
As part of the consen4ng process, pa4ents will be given three  op4ons. 
1.Pa4ents wishing to adend the One Stop Vein Clinic and par4cipate in the study will be 
asked to indicate their consent by signing a consent form and ﬁlling in a reply slip. Pa4ents 
will be randomised either to the One Stop Vein Clinic group or to the Normal Care Pathway 
(NCP) group.
2.Pa4ents not wishing to adend the One Stop Vein Clinic and par4cipate in the study will be 
asked to indicate this by ﬁlling in a reply slip. They will instead adend the normal care 
pathway. They will, however, be asked, if agreeable to complete the QoL and Picker pa4ent 
experience forms.
3. Pa4ents declining either the trial or simple service evalua4on will be oﬀered the NCP.
TREATMENT ALLOCATION
Treatment received will depend on the ﬁndings on the venous Duplex scan. All treatments 
are minimally invasive with endovenous abla4on procedures (either radio-frequency 
abla4on, endovenous laser abla4on or mechano-chemical abla4on), avulsions or ultrasound-
guided foam sclerotherapy. All procedures will be carried out under local anaesthe4c and 
pa4ents will be discharged home later that day, as is the current standard of care.


MEASUREMENT OF OUTCOMES
Primary Outcome
•
Measure the quality-adjusted life years (QALY) gained at 3 months (by 
pa4ents randomised to treatment in the One Stop Vein Clinic with pa4ents 
randomised to treatment in the Normal Care Pathway)
Secondary Outcome
•
Pa4ent sa4sfac4on with the service provided using the Picker 
pa4ent experience ques4onnaire both post-opera4vely and at the 3 months 
follow-up (One Stop Vein Clinic versus Normal Care Pathway)
•
Measure and compare the quality of life scores using EQ-5D, 
AVVQ and CIVIQ at 0 and 3 months in pa4ents randomised to treatment in 
the One Stop Vein Clinic with pa4ents randomised to the Normal Care 
Pathway
•
Time from referral to treatment
•
Assess the cost-eﬀec4veness of the One Stop Vein clinic 
compared to the normal care pathway
•
Record the 4me to return to normal ac4vi4es and to work 
•
Assess the es4mated societal costs
STUDY DURATION & SAMPLE SIZE
Following screening of their GP referral leder, pa4ents with varicose vein disease will be 
invited to par4cipate in the study. We es4mate that 12-14 pa4ents will be invited on a 
weekly basis to par4cipate in the study following screening. Out of those, we are 
an4cipa4ng only 8 pa4ents will agree to be randomised to the One Stop Vein Clinic or 
Normal Care Pathway. If the clinic is held weekly, we es4mate recrui4ng 416 pa4ents over 
the course of the year (8 pa4ents X 52 weeks). 
Sta4s4cal analysis suggests that the sample size of 208 pa4ents per group would be able to 
power a poten4al phase 3 mul4centre randomised controlled trial. Compared to a previous 
study conducted in our unit which involved 317 pa4ents in total and looked at diﬀerent 
quality of life scores and their responsiveness11, the coeﬃcient of varia4on (ra4o of 
standard devia4on to mean) was found to increase at the follow-up period and to vary 
among the diﬀerent scores used. With a larger sample size as in this pilot study, this 
variability would be reduced and result in a smaller coeﬃcient of varia4on when looking at 
the follow-up scores. Hopefully, this will enable us to iden4fy the QoL score with the least 
variability and use it as the primary outcome measure in a future Phase 3 study. A 
primary outcome measure with little variability would provide us with enough 
information to estimate an adequate sample size for any future randomised 
controlled trials.
For example, with a sample size of 208 patients and coefﬁcient of variation of 0.5, a 
15% reduction in the geometric mean (a measure of central tendency, similar to 
median) would be required compared to 25% from the Shepherd et al. study. With 
power at 85%, this would allow us to determine an adequate sample size.  
Par4cipants will be followed-up post-procedure for 3 months, including for pa4ents 
randomised to the Normal Care Pathway (with poten4ally longer wai4ng 4me from referral 
to treatment). This means that the study period will be about 18 months. With 3 months for 
study start-up and 3 months to write the study up, the study will last for 24 months. 
Approximately 1,000 pa4ents undergo varicose vein procedures at the Imperial College NHS 
Trust every year. 
COST BENEFIT OF PROJECT
Our hypothesis is that along with improved pa4ent sa4sfac4on and improved wai4ng 4mes 
for outpa4ent appointment, there will be cost savings derived from the One Stop Vein Clinic. 
On average, 1,000 pa4ents are treated every year in the Imperial College NHS Trust and the 
cost of an outpa4ent adendance is approximately £9312. Savings could be made if pa4ents 
are seen and treated at their ﬁrst appointment rather than having to adend another two 


appointments. 
The poten4al cost saving is es4mated to be in the order of £186,000 annually (£93 x 1,000 X 
2).
EsNmated societal costs.
Data will be collected on 4me oﬀ from work and carer’s du4es (child/rela4ve/friend). 
Addi4onally, data on income, cost of adending clinic and impact on family and colleagues 
will be assessed to es4mate the societal cost of the two pathways.
ETHICAL ARRANGEMENTS
The Chief Investigator has obtained approval from the National Research Ethics Service 
(NRES) Committee (REC Ref.: 14/LO/1295).  
Pa4ents will be screened and pa4ents thought eligible will be sent an informa4on pack with 
informa4on about the trial and varicose veins and its treatments. They will be invited to the 
clinic and would be asked to conﬁrm their consent by providing a wriden consent prior to 
par4cipa4ng in the trial. The Na4onal Health Service (NHS) Trust Research and Development 
approval will also be sought prior to star4ng the trial. 
DATA HANDLING & DISSEMINATION OF RESULTS
All pa4ent data will be anonymised and stored on a password protected access database 
under the guidelines of the Data Protec4on Act 1998. Pa4ent records will be kept on paper 
in the form of the diary card ques4onnaires and clinical scoring sheets, which will be kept in 
a locked ﬁlling cabinet at Charing Cross Hospital for 10 years in accordance with the Imperial 
College Trust Policy.
DISSEMINATION OF RESULTS
For Patients/Public
We will produce a short, easy to understand summary of our research ﬁndings that 
will be available from our website or that can be sent to interested parties. There will 
also be signiﬁcant patient and public engagement through new and existing 
conferences and open days.
For academics
Knowledge will be disseminated through peer-reviewed scientiﬁc publications in 
leading international, high impact journals (e.g. Lancet, BMJ, Annals of Surgery; 
Health Affairs; or relevant open access journals, where possible and appropriate), 
and presentations at local, national and international conferences. A balanced 
approach will be adopted to maximise the impact and output of the studies. In line 
with all research funded by the NIHR, we will produce a full and complete account of 
the research ensuring that the work is reported fully and publicly available.
For Health Managers
We will disseminate ﬁndings to a specialist audience, including health care 
commissioners, policy makers, Department of Health, and specialist providers. The 
study results will be presented to healthcare commissioners and policy makers at 
appropriate meetings and publications. A summary of results, in language 
appropriate for lay persons, will be sent to all relevant patient groups. We will provide 
details of simulations on a web based platform to facilitate the adoption of our model 
and methodology in other ﬁelds. The dissemination strategy for our ﬁndings will be 
aimed at reaching the largest possible stakeholder audiences.
CRITERIA FOR ELECTIVELY STOPPING THE TRIAL OR OTHER RESEARCH PREMATURELY
The trial may be stopped prematurely due to loss of equipoise or any major adverse eﬀect as 
a result of treatment in any of the treatment arms.
Adverse events
No signiﬁcant adverse events are expected.
Adverse Event (AE): any untoward medical occurrence in a pa4ent or clinical study subject.


Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or eﬀect 
that:
·         Results in death
·         Is life-threatening – refers to an event in which the subject was at risk of death at the 
Fme of the event; it does not refer to an event which hypotheFcally might have caused death 
if it were more severe
·         Requires hospitalisaNon, or prolongaNon of exisNng inpaNents’ hospitalisaNon
·         Results in persistent or signiﬁcant disability or incapacity
·         Is a congenital anomaly or birth defect
REPORTING PROCEDURES
All adverse events should be reported to the trial management commidee via the CI and via 
the trust da4x system.
Depending on the nature of the event the repor4ng procedures below should be followed.
Any ques4ons concerning adverse event repor4ng should be directed to the Chief 
Inves4gator in the ﬁrst instance. 
Adverse Events (AE)
All such events, whether expected or not, should be recorded. 
Serious Adverse Events (SAE)
An SAE form should be completed and faxed to the Chief Inves4gator within 24 hours.  
 All SAEs should be reported to the Sponsor where in the opinion of the Chief Inves4gator, 
the event was:
·         ‘related’, ie resulted from the administra4on of any of the research procedures; and
·         ‘unexpected’, ie an event that is not listed in the protocol as an expected occurrence
Reports of related and unexpected SAEs should be submided within 15 days of the Chief 
Inves4gator becoming aware of the event, using the NRES SAE form for non-IMP studies. 
Local inves4gators should report any SAEs as required by their Local Research Ethics 
Commidee, Sponsor and/or Research & Development Oﬃce.
In the event of any harm to par4cipants in the trial, Imperial College holds Public Liability 
(“negligent harm”) and Clinical Trial (“non-negligent harm”) insurance policies, which apply 
to this trial.  All issues will be reviewed by the TMC (AHD/CB/KD/RB), Prof Andrew Bradbury 
(Professor of Vascular Surgery) will be available as an independent advisor.
CO-APPLICANTS & RELEVANT EXPERTISE
Professor Alun Davies was the Chairman of the NICE Guideline Development Group on 
varicose veins, and a past president of European and UK Venous Forums. He has experience 
of running large mul4centre trials including the Vein Grar Surveillance Trial. He is presently 
Chairman of the trial steering commidee for the HTA CLASS trial, Chief Inves4gator of the 
NIHR funded EVRA trial and co-applicant on BASIL 2  and 3 trial. He is co chair of the 
European Venous Guidelines Commidee.
Mr Colin Bicknell is Senior Lecturer and a Consultant Vascular Surgeon at Imperial College 
Healthcare NHS Trust. He has signiﬁcant trial experience and is PI of the IDEAS trial, 
inves4ga4ng incen4ve for diabe4c eye screening, co-inves4gator of the AARDVARK trial for 
small abdominal aor4c aneurysms and the 15-year aneurysm-related mortality evalua4on of 
EndoVascular Aneurysm Repair randomised controlled trial – all NIHR funded trials. He 
works with AHD clinically and on a number of research topics.
Miss K Sritharan is Consultant Vascular surgeon with experience of recrui4ng to randomised 
controlled trials and performing venous interven4ons.
Dr David Epstein is an experienced health economist from the Department of Applied 
Economics at
the University of Granada, Spain.
Dr Rosalind Herbert is an academic GP at the Imperial College London with previous trial 
experience.


Mr Tristan R. A. Lane is a Vascular Trainee in the London Deanery and Post-doctorate 
Honorary Research Fellow in venous disease who has previously been involved in the AVULS 
and VVCVV randomised controlled trials and the eSCOPE prospec4ve observa4onal study. 
Mr Roshan Bootun is a Clinical Research Fellow in Vascular Surgery who is currently involved 
in the
randomised clinical trial of VNUS versus Clarivein in Varicose Vein (VVCVV) Trial
Ms Karen Dhillon is an experienced Research Nurse who is currently involved in the NIHR 
EVRA randomised controlled trial. She has previously managed vascular outpa4ent clinics 
and set-up and ran the Local anaesthe4c Varicose Veins Unit (LAVVU) at the Charing Cross 
Hospital.
Mr Paul Basse\ is an experienced Medical Sta4s4cian with previous trial experience.
Mrs Corine Ward and Mr Colin Price are pa4ents who have helped us with the design and 
direc4on of the study.
COST ESTIMATION
The es4mated dura4on of the study is 2 years. We an4cipate recrui4ng about 416 pa4ents 
for the one stop vein clinic and, also pa4ents who decline the one stop clinic and prefer to 
adend a clinic on the normal care pathway.
The salary contribu4ons for the CI (AHD) has been calculated at 0.05 FTE to represent the 
increased responsibility and an4cipated 4me commitment from the trial co-ordina4ng 
ins4tu4on (Imperial College London).
The salary contribu4on for CB, KS, TRAL, KD and RB has been calculated at 2% FTE. 
The salary of a research nurse has been included (1 FTE).
The cost for a health economist, sta4s4cian and primary care physician has been also been 
included.
Other costs include cost of the ques4onnaires, trial registra4on, consumables and for 
dissemina4on of the results at conferences.
CONFLICT OF INTEREST
Most of the clinical applicants have an extensive experience of trea4ng superﬁcial venous 
reﬂux using mul4ple endovenous interven4ons. Some of the applicants have extensive 
endovenous research programmes that adract research funding. Most of the applicants 
have given invited lectures at mee4ngs and many of the organisers of such events will have 
received industrial sponsorship. However, as the interven4on being evaluated in this study is 
a change in the service provision in varicose vein management, we do not believe that these 
personal interests represent a conﬂict of interest in this study.
regulatory issues
Ethics approval
The Chief Investigator has obtained approval from the National Research Ethics Service 
(NRES) Committee (REC Ref.: 14/LO/1295).  The study must be submitted for Site Speciﬁc 
Assessment (SSA) at each participating NHS Trust.  The Chief Investigator will require a 
copy of the Trust R&D approval letter before accepting participants into the study.  The study 
will be conducted in accordance with the recommendations for physicians involved in 
research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and 
later revisions.
Consent 


Consent to enter the study will be sought from each participant only after a full explanation 
has been given, an information leaﬂet offered and time allowed for consideration.  Signed 
participant consent will be obtained.  The right of the participant to refuse to participate 
without giving reasons will be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that speciﬁed in the protocol at any 
stage if he/she feels it is in the participant’s best interest, but the reasons for doing so should 
be recorded.  In these cases the participants remain within the study for the purposes of 
follow-up and data analysis.  All participants are free to withdraw at any time from the 
protocol treatment without giving reasons and without prejudicing further treatment.
Conﬁdentiality
The Chief Investigator will preserve the conﬁdentiality of participants taking part in the study 
and is registered under the Data Protection Act.
Indemnity
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study/ Imperial College Healthcare NHS Trust holds standard NHS 
Hospital Indemnity and insurance cover with NHS Litigation Authority for NHS Trusts in 
England, which apply to this study (delete as applicable)
Sponsor
Imperial College London will act as the main Sponsor for this study. 
 Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.  
Funding
Par4al funding for the study has been provided by the Graham-Dixon Charitable Trust. 
Audits 
The study may be subject to inspection and audit by Imperial College London under their 
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS 
Research Governance Framework for Health and Social Care (2nd edition). 
Patient with varicose vein
GP Referral
Varicose Vein Treatment
Outpatient Clinic
Venous Duplex Scan
Outpatient clinic
Normal Care Pathway
Same day outpatient clinic, venous duplex scan and varicose vein treatment


One Stop Vein Clinic
Not suitable for One Stop Vein Clinic
Normal Care Pathway
(off-trial)
Suitable for One Stop Vein Clinic
Letter Screening
Randomisation
Day of Treatment:
•
Picker questionnaire
•
AVVQ, CIVIQ and EQ-5D
•
CEAP and VCSS
•
Patients given diary card to ﬁll
Follow-up at 3 months:
•
Picker questionnaire
•
AVVQ, CIVIQ and EQ-5D
•
CEAP and VCSS
Day of Treatment:
•
Picker questionnaire
•
AVVQ, CIVIQ and EQ-5D
•
CEAP and VCSS
•
Patients given diary card to ﬁll
Day of Treatment:
•
Picker questionnaire
•
AVVQ, CIVIQ and EQ-5D
•
CEAP and VCSS
•
Patients given diary card to ﬁll
Follow-up at 3 months:
•
Picker questionnaire
•
AVVQ, CIVIQ and EQ-5D
•
CEAP and VCSS
APPENDIX 1: Quality of Life Questionnaire
EQ-5D Questionnaire
Under each heading, please tick the ONE box that best describes your health TODAY.


1.  MOBILITY
I have no problems in walking about
I have slight problems in walking about
I have moderate problems in walking about
I have severe problems in walking about
I am unable to walk about
2.  SELF-CARE
I have no problems washing or dressing myself
I have slight problems washing or dressing myself
I have moderate problems washing or dressing myself
I have severe problems washing or dressing myself
I am unable to wash or dress myself
3.  USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)
I have no problems doing my usual activities
I have slight problems doing my usual activities
I have moderate problems doing my usual activities
I have severe problems doing my usual activities
I am unable to do my usual activities
4.  PAIN/DISCOMFORT
I have no pain or discomfort
I have slight pain or discomfort
I have moderate pain or discomfort
I have severe pain or discomfort
I have extreme pain or discomfort
5.  ANXIETY/DEPRESSION
I am not anxious or depressed
I am slightly anxious or depressed
I am moderately anxious or depressed
I am severely anxious or depressed
I am extremely anxious or depressed


Appendix 2: Aberdeen Varicose Vein Questionnaire
YOUR VARICOSE VEINS
1.
Please draw in your varicose veins in the diagram(s) 
below:-
      Legs viewed
       Legs viewed
        from front
         from back
2.
In the last two weeks, for how many days did your 
varicose veins cause you pain or ache?
(Please tick one box for each leg)
R Leg
L Leg
None at all
Between 1 and 5 days
Between 6 and 10 days
For more than 10 days
3.
During the last two weeks, on how many days did 
you take painkilling tablets for your varicose veins?
(Please tick one box for each leg)
R Leg
L Leg
None at all
Between 1 and 5 days


Between 6 and 10 days
For more than 10 days
4.
In the last two weeks, how much ankle swelling have 
you had?
(Please tick one box)                                                            None at all 
Slight ankle swelling
Moderate ankle swelling (eg. causing you
to sit with your feet up whenever possible)
 
Severe ankle swelling  (eg. causing you
 difﬁculty putting on your shoes)
      
5.
In the last two weeks, have you worn support 
stockings or tights?
(Please tick one box for each leg)
R Leg
L Leg
No
Yes, those I bought myself without
a doctor's prescription
Yes, those my doctor prescribed for
me which I wear occasionally
Yes, those my doctor prescribed for
me which I wear every day
6.
In the last two weeks, have you had any itching in 
association with your varicose veins?
 (Please tick one box for each leg)


R Leg
L Leg
No
Yes, but only above the knee
Yes, but only below the knee
Both above and below the knee
7.
Do you have purple discolouration caused by tiny 
blood vessels in the skin, in association with your varicose 
veins?
(Please tick one box for each leg)
R Leg
L Leg
No
Yes
8.
Do you have a rash or eczema in the area of your 
ankle?
(Please tick one box for each leg)
R Leg
L Leg
No
Yes, but it does not require any treatment 
from a doctor or district nurse
Yes, and it requires treatment from 
my doctor or district nurse


9.
Do you have a skin ulcer associated with your 
varicose veins?
(Please tick one box for each leg)
R Leg
L Leg
No
Yes
10.
Does the appearance of your varicose veins cause 
you concern?
(Please tick one box)                                                                        No
Yes, their appearance causes
me slight concern
Yes, their appearance causes 
me moderate concern
 
Yes, their appearance causes 
me a great deal of concern
 
11.
Does the appearance of your varicose veins inﬂuence 
your choice of clothing including tights?
           (Please tick one box)                                                                         No
Occasionally
Often
Always
12.
During the last two weeks, have your varicose veins 
interfered with your work/ housework or other daily 
activities?
  (Please tick one box)                                                                          No
I have been able to work but my work 
has suffered to a slight extent
 I have been able to work but my work 


has suffered to a moderate extent
My veins have prevented me from 
working one day or more
13.
During the last two weeks, have your varicose veins 
interfered with your leisure activities (including sport, 
hobbies and social life)?
(Please tick one box)                                                                          No
Yes, my enjoyment has suffered 
to a slight extent
Yes, my enjoyment has suffered
to a moderate extent
Yes, my veins have prevented me taking 
part in any leisure activities
Appendix 3. Societal QuesNons
The following ques4ons is to try assess the possible impact on society of pa4ents having to 
take 4me oﬀ work or caring du4es to adend a varicose vein appointment.
What is your total family income?
What is your highest level of education attained?
•
Less than £20,000
•
£20,000 - £39,999
•
£40,000 - £59,999
•
£60,000 - £99,999
•
£100,000 and over
•
None
•
Primary education
•
Secondary education
•
Tertiary education


•
Post-graduate degree
•
Did you need to take time off work to attend your varicose vein 
appointment?
☐ Yes
☐ No (Go to Question 3)
•
Did you have to take half a day or full day off?
☐ Half-day
☐ Full day 
•
What is your hourly rate of pay at work?
……………………………………………………………….
•
Do you have care commitments (e.g., children or relatives)?
☐ Yes
☐ No 
•
Did you have to ask someone to look after your child/relative so 
you could attend your appointment?
☐ Yes
☐ No
•
Who did you ask?
………………………………………………………………..
•
How much did you have to pay them?
………………………………………………………………..
Appendix 4: Clinical assessment of Varicose Veins
Hospital Number---------------------------
MALE
FEMALE
Number of Pregnancies
Weight/ Kg
BMI>30
Yes
No
OCP or HRT
Yes
No
Smoker
Yes
No
Date of birth---------------------------------
Age -----------------------------------------


Occupa4on----------------------------------
Date------------------------------------------
Past Medical History
Yes 
No
Yes 
No
Bleeding disorder
!
! 
IHD
!
!
DVT/PE
!
! 
Leg ulcers
!
!
Diabetes
!
!
Hypertension
!
!
MedicaNons
--------------------------------------------------------------------------------------------------------------------------
----------------------------
Previous treatment to Varicose Veins
Side
Site
Date
Treatment type
Appendix 5: Pre OperaNve Clinical Assessment
Score
DeﬁniNon
0
AsymptomaNc
1
SymptomaNc, but able to carry out usual acNviNes with out compressive therapy
2
Able to carry out usual acNviNes only with compressive therapy and/or limb elevaNon
3
Unable to carry out usual acNviNes even with compression and/or elevaNon
Usual acNviNes = paNents acNviNes before the onset of disability due to venous disease


Appendix 6: Venous Clinical Severity Score (VCSS)
 Please indicate right or leg leg or bilateral (R, L or B)
Absent
Mild
Moderate
Severe
Pain
None
Occasional, non/ no analgesia restric4ng
With moderate ac4vity, occasional analgesia
Daily, severe limita4ons, regular analgesia
Varicose veins>4mm
None
Few
Mul4ple GSV
Extensive GSV and LSV
Venous oedema
None
Evening/ankle
Arernoon/ above knee
Morning/requiring eleva4on
Skin pigmenta4on
None
Limited and old/brown
Diﬀuse lower third/ purple
Wide/ purple
Inﬂamma4on
None
Mild celluli4s in marginal area
Moderate involving most of gaiter area 
Severe celluli4s or signiﬁcant eczema
Indura4on
None
 Focal <5cm
Medial or lateral less than lower 1/3
1/3 of lower leg or more
Number of ac4ve ulcers
0
1
2
3
Ac4ve ulcer dura4on
None
<3 months
>3 months 
<12 months


>12 months
Ac4ve ulcer diameter( cm)
None
<2
2-6
>6
Compression
Not used or non compliant
Intermident use
Stockings worn most days
Stockings worn daily
Total
Appendix 7: Clinical-ENology-Anatomy-Pathophysiology (CEAP ClassiﬁcaNon)
Clinical
0
1A
1S
2A
2S
3A
3S
4aA
4aS
4bA
4bS
5A
5S
6
ENology
Congenital
Primary
Secondary
No venous cause iden4ﬁed
Anatomy
Superﬁcial
Deep
Perfora4ng
No venous loca4on iden4ﬁed
Pathology
Reﬂux
Obstruc4on
Both
No venous pathology iden4ﬁed


Class 0 No visible or palpable veins
Class 1 Telangiectasia, re4cular veins 
Class 5 Skin changes and healed ulcera4on
Class 2 Varicose Veins
Class 6 Ac4ve venous ulcers
Class 3 Oedema without skin changes
Class 4 Skin changes ascribed to venous disease
A= Asymptoma4c
4a) Pigmenta4on or eczema
S= Symptoma4c
4b) Lipodermatoscerosis or atrophie blanche 
Appendix 8. CIVIQ-14 QuesNonnaire
C I V I Q-14
SELF-QUESTIONNAIRE PATIENTS
In English language for UK
Many people complain of leg pain. We would like to find out how often these leg 
problems occur and to what extent they affect the everyday lives of those who suffer 
from them.
Below you will find a list of symptoms, sensations or types of discomfort that you 
may be experiencing and which may make everyday life hard to bear to a greater or 
lesser extent. For each symptom, sensation, or type of discomfort listed, we 
would like you to answer in the following way:
Please indicate if you have experienced what is described in each sentence, and if 
the answer is ‘yes’, how intense it was. There are five possible answers, and we 
would like you to circle the one which best describes your situation.
•
Circle 1if you feel the symtom, sensation of discomfort 
described does not apply to you
•
•
C
i
r
c
l
e 
2
, 
3
, 


4 
o
r 
5
i
f 
y
o
u 
h
a
v
e 
f
e
l
t 
i
t 
t
o 
a 
g
r
e
a
t
e
r 
o
r 
l
e
s
s
e
r 
e
x
t
e
n
t
•
•
•


•
QUALITY OF LIFE WITH VENOUS INSUFFICIENCY
1) 
During the past four weeks, have you had any pain in your ankles or 
legs, and how severe has this pain been?
Circle the number that applies to you.
No 
pain
Slight 
pain
Moderate
pain
Considerable
pain
Severe
pain
1
2
3
4
5
2) 
During the past four weeks, how much trouble have you experienced 
at work or during your usual daily activities because of your leg 
problems?
Circle the number that applies to you.
No trouble
Slight trouble
Moderate trouble
Considerable trouble
Severe trouble


1
2
3
4
5
3) 
During the past four weeks, have you slept badly because of your leg 
problems, and how often?
Circle the number that applies to you.
Never
Rarely
Fairly
often
Very 
often
Every
night
1
2
3
4
5
During the past four weeks, how much trouble have you experienced 
carrying out the actions and activities listed below because of your leg 
problems?
For each statement in the table below, indicate how much trouble you have experiened by 
circling the number chosen.
No trouble
Slight trouble
Moderate trouble
Considerable trouble
Could not 
do it
4)  Climbing several flights of stairs
1
2
3
4


5
5)  Crouching,
Kneeling down
1
2
3
4
5
6)  Walking at a brisk pace
1
2
3
4
5
7)  Going out for the evening, going to a wedding, a party, a cocktail party…
1
2
3
4
5
8)  Playing a sport, exerting yourself physically
1
2
3
4
5
 Leg problems can also affect your mood. How closely do the following 
statements correspond to what you have felt during the past four weeks?
For each statement in the table below, circle the number that applies to you.
Not at all
A little
Moderately
A lot
Completely 
9)  I have felt nervous/tense
1
2
3
4
5
10)  I have felt I am a burden
1
2
3


4
5
11)  I have felt embarrassed about showing my legs
1
2
3
4
5
12)  I have become irritated easily
1
2
3
4
5
13)  I have felt as if I am handicapped
1
2
3
4
5
14)  I have not felt like going out
1
2
3
4
5
Appendix 9. Patient Diary 
Please indicate at what stage you were able to return to work and your normal daily 
activities (the activities you were able to do prior to your treatment)
Day I was able to resume my normal activities 
(please tick one box)
Day I returned to work (please tick one box)
Day of surgery
Day after surgery
2 days after surgery
3 days after surgery


4 days after surgery
5 days after surgery
6 days after surgery
7 days after surgery
8 days after surgery
9 days after surgery
10 days after surgery
>10 days after surgery
•
References
1.
Kelleher D, Lane TRA, Franklin IJ and Davies AH. Treatment options, clinical 
outcome (quality of life) and cost beneﬁt (quality-adjusted life year) in varicose vein 
treatment. Phlebology / Venous Forum of the Royal Society of Medicine. 2012; 27: 16-22.
2.
Marsden G, Perry M, Kelley K and Davies AH. Diagnosis and management of 
varicose veins in the legs: summary of NICE guidance. BMJ (Clinical research ed). 2013; 
347: f4279.
3.
Sarin S, Shields DA, Farrah J, Scurr JH and Coleridge-Smith PD. Does venous 
function deteriorate in patients waiting for varicose vein surgery? Journal of the Royal 
Society of Medicine. 1993; 86: 21-3.
4.
Gohel MS, Epstein DM and Davies AH. Cost-effectiveness of traditional and 
endovenous treatments for varicose veins. The British journal of surgery. 2010; 97: 1815-23.
5.
van den Bos R, Arends L, Kockaert M, Neumann M and Nijsten T. Endovenous 
therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009; 49: 230-9.
6.
Oudhoff JP, Timmermans DR, Knol DL, Bijnen AB and van der Wal G. Waiting for 
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consequences. BMC public health. 2007; 7: 164.
7.
Ball C, Pearse M, Kennedy D, Hall A and Nanchahal J. Validation of a one-stop 
carpal tunnel clinic including nerve conduction studies and hand therapy. Annals of the Royal 
College of Surgeons of England. 2011; 93: 634-8.
8.
Hughes EH, Forrest F and Diamond JP. 'One-stop' cataract surgery: the Bristol Eye 
Hospital experience 1997-1999. Eye (London, England). 2001; 15: 306-8.
9.
Putnis S, Merville-Tugg R and Atkinson S. 'One-stop' inguinal hernia surgery--day-
case referral, diagnosis and treatment. Annals of the Royal College of Surgeons of England. 
2004; 86: 425-7.
10.
Voorbrood CE, Burgmans JP, Clevers GJ, et al. One-stop endoscopic hernia surgery: 
efﬁcient and satisfactory. Hernia : the journal of hernias and abdominal wall surgery. 2013.
11.
Shepherd AC, Gohel MS, Lim CS and Davies AH. A study to compare disease-
speciﬁc quality of life with clinical anatomical and hemodynamic assessments in patients 


with varicose veins. J Vasc Surg. 2011; 53: 374-82.
12.
Payment by Results (PbR) tariff for payment of healthcare providers over 2013 to 
2014. In: Health Do, (ed.). 2013.