IMPACT OF THE INFORMED CONSENT PROCESS ON PATIENTS UNDERSTANDING OF VARICOSE VEINS AND THEIR TREATMENT

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Impact of the informed consent process onpatients' understanding of varicose veins andtheir treatment

ABSTRACT

Aim It is particularly important that patients have reasonable understanding of therisks, benefits and nature of elective surgery.This study sought to analyse this levelof understanding in patients undergoing varicose vein surgery.

Methods Eighty two patients completed a questionnaire in the vascular outpatient clinicand were asked to complete a telephone questionnaire following the clinic.

Results Pain (n=46) was the primary reason patients considered varicose vein surgeryfollowed by appearance (n =32). Most patients felt that varicose veins placedthem at high risk of leg ulcers (n=46) and DVT (n=4i). A high level of expectationthat surgery would significantly affect pain and flares was recorded. While theoutpatient visit did not materially change these misconceptions, an educationalleaflet significantly enhanced the recall of complications (P=0.028) in patients whoremembered receiving a leaflet.

Conclusion Patients attending varicose vein clinics have an unrealistic expectation of thebenefits of surgery and fail to understand the benign nature oftheir condition. Theoutpatient process has little effect on patient-held beliefs.

Keywords varicose veins, informed consent, leaflet.

MF Dillon,CJ Carr,TMF Feeley,S Tierney

Dept of General andVascular Surgery,Adelaide & MeathHospital & TrinityCollege Dublin,Tallaght, Dublin 24

INTRODUCTIONInformed consent is an essential component of

good surgical practice, with the level of information

transferred expected to be significantly higher in

elective procedures. Conventional processes of

obtaining informed consent may be inadequate

to enable patients to understand important facts

regarding their proposed surgery.'' 2 This may affect

patients' ability to make reasoned decisions about

potentially harmful interventions.

In addition, it is the responsibility of the surgeon not

only to provide accurate information, but to address

incorrect preconceptions that patients may have

regarding their condition. Varicose veins, in particular,

are often viewed by the public as contributing to

a whole range of lower leg symptoms and as the

precursor of serious medical conditions. There is

no objective evidence to support this and varicose

veins are considered by the medical community as a

benign condition. The primary indication for varicose

vein surgery is therefore for quality of life reasons. 3

In this study,the level of incorrect preconceptions

of patients seeking varicose vein surgery was

determined. The effectiveness of the outpatients'

visit and an educational leaflet in increasing patients'

knowledge of this procedure was analysed.

METHODS

A questionnaire was administered at randomly

selected vascular clinics to patients referred with

varicose veins during the time period of January

to December 2003. All new patients referred with

this condition were eligible for the study. The initial

questionnaire was completed by all patients who

received it. Data collected included patient age, sex

and educational level as well as previous sources

of information on varicose veins.Their reasons

for seeking treatment were assessed, as was their

expectations of the outcome of surgery. Their

perception of any serious threat to health due to

varicose veins was also recorded.

At the outpatient consultation the patient was

assessed by a vascular surgical trainee. They were

then seen by one of two consultants who also

assessed the patient. If suitable for surgery, the

consultant discussed with them the nature and

consequences of surgery. Following this, possible

IRISH JOURNAL OF MEDICAL SCIENCE • VOLUME 174 • NUMBER 3 23

MF DILLON ET AL

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complications of surgery were outlined. As patients

were leaving the clinic, the nurse on duty gave them

an educational leaflet on varicose veins to take

away and read. The leaflet was designed by the two

consultant surgeons and entitled 'Varicose vein

surgery: What you need to know'. It was designed

to reinforce the consultative process and to address

questions raised by patients in the past. In the leaflet,

the functional insignificance of varicose veins, the

perioperative procedure, a description of the surgery

itself, expected recovery time and complications

from surgery were all described in detail.

After an interval of least two weeks and prior to

the procedure itself, patients were contacted by

telephone by a single author (MD) and asked a set

of standard questions. The majority of questions

were the same as the original questionnaire, though

adapted for verbal response and were designed

to assess their current understanding of varicose

veins and varicose vein surgery. In addition, patients

were also asked to rate their satisfaction with the

outpatient process and educational leaflet. Those

unable to be contacted by telephone were sent the

second questionnaire in written form.

Data were entered onto an excel spreadsheet (MS,

Dublin, Ireland). Statistical analysis was performed

using SPSS (Version ii, Chicago, USA). Categorical

variables were compared with the Chi Squared test

or Fisher's exact test.

RESULTS

Patients

Of the 82 that completed the initial questionnaire, 67

completed the second questionnaire (66 by telephone,

one by return of a written questionnaire). Fourteen

patients were uncontactable, and one declined the

second interview. In our patient population there were

57 females (70%) and 25 males (30%) with a median

age of 46 years (range 17-72 years). Thirty-seven

patients had either completed secondary education

or had attended third level, 41 had primary school

education or some secondary education and four did

not record their educational level. Not all questions on

each questionnaire were answered by all participants

and results are expressed as a percentage of those

who completed each question.

Prior sources of information

The primary source of information, prior to attending

outpatients, was the primary care physician, who

was listed as the only source of information by 69%

of patients (n = 56/81). Of those that mentioned the

primary physician as a source of information, 57%

reported this source as `excellent' or `very good,

with 24% reporting that the primary care physician

was of little or no help to them. Other sources of

information included nurses (n=4), other doctors

(n=5),friends (n=7), internet (n =1), magazines (n =2)

and family (n=5). Fifty-four patients reported talking

to someone who had varicose vein surgery, and 39

patients said that those they had spoken to had

recommended surgery to them.

The patients' subjective level of knowledge

before and after consultation is demonstrated in

Table 1. While there was an increase in the level

of knowledge that patients felt they possessed

following the outpatient process, this was not

significant (p =o.1, XZ test for trend).

Reasons for attendance

The principal reason patients sought a consultation

for surgery was pain (59%, n=46/78). In contrast,

appearance was cited as a cause in 41% (n=32/78)

of patients. Other reasons for attendance are listed

in Table 2. Forty-one per cent of patients stated that

their varicose veins caused them significant personal

anxiety.

Medical health issues

Table 3 demonstrates patients' response to the

question eliciting their concerns about the risks

associated with having varicose veins. Patients were

asked if they felt that having varicose vein placed

them at 'high risk' of certain medical conditions.

The majority of respondents felt that their varicose

veins put them at high risk of ulcers (56%) and

DVTs (5o%). This was not decreased significantly

by the outpatient process. Thirty-two per cent of

respondents believed that varicose veins put them at

high risk of bleeding from minor injuries. A further

33% believed that they were at risk of gangrene.

Expectations of surgery

The expectations patients had of the outcome of

surgery are demonstrated in Table 4. The expectation

that symptoms otherthan appearance would

improve with surgery consistently remained very

high both before and after the clinic. The majority

of patients both before (79%; n=57/72) and after

clinic (71 %; n =44./62) rightly believed that their post-

operative recovery would take less than two weeks.

However, after the consultation, 27% (n=17/62) of

patients believed that they would need to take a

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IMPACT OF THE INFORMED CONSENT PROCESS ON PATIENTS UNDERSTANDING OF VARICOSE VEINS AND THEIR TREATMENT r

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month or more off work compared to 21% (n=15/72)

before clinic.

Complications of surgery

Patients were asked in the follow-up questionnaire

whether they knew any complications of the surgery

itself. Only 18 patients could list any potential

adverse effects and the highest specific complication

recalled was numbness (five patients).Three patients

mentioned infection, and three patients mentioned

bruising/pain.

Satisfaction levels and educational leaflet

Satisfaction ratings were high. Eighty-two per cent

(n=S5/67) of patients reported that they were happy

with the information received in outpatient clinic

(including the leaflet if it was received.) Fifty patients

remembered getting an educational leaflet whereas

17 did not. Of those that got leaflets, 21 (42%)

stated that they read them carefully. The level of

information was deemed `enough' by 39 (78%) and it

was considered 'useful' by 40 (8o%) of patients who

received it.

The addition of a leaflet did not materially affect the

majority of their preconceptions. However, it was of

particular interest that while only one (6%) of the

group who said that they did not recall receiving

a leaflet could mention a complication of surgery,

17 of the 50 (34%) who did recall receiving leaflets

could (p=o.o28), suggesting a leaflet of this kind is

valuable in enhancing patient awareness regarding

complications. There was no significant difference

between the proportions of patients committed to

surgery in the group who recalled getting a leaflet

versus the group who did not (p=o.4).

Patients' level of understanding was not significantly

associated with level of education or intention

to proceed with surgery. Of the 26 who were

committed to having surgery, only 9 (35%) could list

a complication. In comparison, 9 of the 38 (24%) who

had decided against surgery, or had yet to make a

decision, could list complications (p=o.3, NS).

•

The task of obtaining properly informed consent

remains an important pillar of medical practice.

Not only does this good practice result in better

patient care but it may limit exposure to civil action.

Unrealistic expectations cultivated in a patient by an

inadequate transfer of information may, at the very

least, result in patient dissatisfaction and lasting

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POST CLINIC N=67

Pain/bruising 3

Infection 3

Bleeding 1

Numbness 5

Recurrence 2

General anaesthetic 4

DVT 3

Death 1

MF DILLON ET AL

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damage to the relationship of trust between doctor

and patient.The Edinburgh study 3 has demonstrated

that patients' perceptions and understanding of

varicose veins are quite poor. It also demonstrated

that symptoms attributed to varicosities are just

as common in the general population. There is no

strong evidence that any of these symptoms are in

fact related to varicose veins or relieved by surgical

treatment.

The difficulties of obtaining informed consent have

been demonstrated in other studies. Cassileth

et al, 2 found that only 6o% of patients correctly

described what their treatment would involve, 59%

the essential purpose of their treatment and only

55% could list a single major risk or complication. We

previously demonstrated that 27% of patients, despite

going through a laparoscopy for acute abdominal

pain, were not aware after discharge from hospital

what operation had taken place. 4 Lengthy educational

process and extraordinary efforts may still be not

enough to convey even the most essential of facts.

The patients attending our clinic reported a high

dependence on doctors for information. GPs were

overwhelmingly the primary source of information

about varicose veins prior to clinic, with very few

patients relying on the internet or modern media

techniques. In the present study, more patients who

were considering surgery for varicose veins cited

pain rather than appearance as the motivation for

attending outpatient's clinic. A high proportion

of patients also felt that their condition placed

them at high risk of serious medical conditions,

particularly leg ulcers and DVT. Most patients had a

high expectation that varicose vein surgery would

cure them of pain and other symptoms. In addition,

this study highlights that significant efforts to

bring patients expectations into line with surgical

outcomes may not be effective. Despite a lengthy

process involving a general practitioner, two hospital

doctors and an educational leaflet, the majority

of patients still held firm to their misconceptions

regarding varicose vein and varicose vein surgery.

Following the clinic, the majority still retained the

belief that their condition puts them at high risk of

conditions such as leg ulcers, DVTs, and gangrene and

expected that surgery would impact favourably ona whole range of lower leg symptoms. Furthermore,only a very small number of patients could list any

of the potential risks or complications associated

with varicose vein surgery. This inability to recall

complications, even when specifically detailed, has

been noted in other studies. 1 . 2 . 5 .6 Our data highlight

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the importance of careful written documentation of

the consent process, as patient recall of this process

may not be reliable.

The recall of complications was found to be

significantly enhanced in the subgroup of patients

that recalled getting a leaflet. The primary emphasis

of the leaflet was on the practical aspect of the

perioperative period, and highlights the possible

complications. Various studies have evaluated the

effect of leaflets on patient understanding. It has

been demonstrated that the average patient finds

many of these leaflets difficult to read or understand?

Notwithstanding this, being given an educational

leaflet appears to increase patients' satisfaction, 8

though its impact on level of knowledge is less clear.It has been shown in our study that this additional

educational method is beneficial and facilitates a

more realistic expectation of surgery from patients.

26 IRISH JOURNAL OF MEDICAL SCIENCE • VOLUME 174 • NUMBER 3

IMPACT OF THE INFORMED CONSENT PROCESS ON PATIENTS' UNDERSTANDING OF VARICOSE VEINS AND THEIR TREATMENT

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Many factors culminate in poor overall

understanding demonstrated by the patients

regarding their condition. The stress and the time

limitations of a hospital consultation may be one

factor. The fact that some patients arrive expecting

surgery while others seek advice and reassuranceand some relief of symptoms may be a further

reason. Surgeons may concentrate on the issues

around surgery itself without due regard to exploring

unsubstantiated fears which motivate patients

to seek surgery in the first instance. There is also

evidence that memory may be selective, 5 and that

patients preferentially retain information that

supports the decision for surgery. 8 It is important

to realise also that high satisfaction rating with the

educational process, as in our study, is not a marker

of overall information levels among patients.

This study demonstrates that, even in the context of

a specialised unit with an awareness of the problem,

patient education and fully informed consent for

elective surgery is difficult to achieve. Extraordinary

and imaginative efforts will be required to address

this problem effectively. This is likely to require a

multimodal approach which may include enhanced

consent forms, specialised communication

training to surgeons or the involvement of trained

nurse practitioners. The use of modern media

techniques, such as the distribution of videos

and tape recordings of the initial consultation to

patients 9 may also prove beneficial. It continues to

be of fundamental importance not only to make a

particular effort to ensure that patients understand

the information given to them, but also to ensure that

the process is carefully documented at every stage.

CONCLUSION

Despite a lengthy educational process, most patientsattending varicose vein clinic remain poorly informed

as to the nature and medical significance of their

condition. In order to prevent patients having

unrealistic expectations of surgery, and to ensure

valid consent, extraordinary care needs to be taken to

educate and inform patients.

REFERENCES

1. Y Godwin. Do they listen? A review of informationretained by patients following consent for reductionmammoplasty. BrJ Plastic Surgery 2000; S3:121-5

2. Cassileth BR, Zupkis RV, Sutton-Smith K et al. Informedconsent- why are its goals imperfectly realised. N EnglJMed. 1980;302:896-goo

3. Bradbury A, Evans C, Allen Petal. What are thesymptoms of varicose veins? Edinburgh vein study crosssectional population survey. BrMedJ 1 999;3i 8 :353 -6

4. Murphy SM, Donnelly M, Fitzgerald T,Tanner WA, KeaneFB,Tierney S. Patients' recall of clinical informationfollowing laparoscopy for acute abdominal pain. BrJSurg. 2004; 9 1 (4): 485-8

5. Herz DA, Looman JE, Lewis SK et al. Informed consent. Isit a myth? Neurosurgery 1 992 ;30 :453 -8

6. PriIuck IA, Robertson DM, Buettner H. What patientsrecall of the preoperative discussion after retinaldetachment surgery. Am J Opthalmology 1979;87:62o-3

7. Zion AB, Aiman J. Level of reading difficulty in theAmerican College of Obstetricians and Gynecologistspatient education pamphlets. Obstet Gynecol1 989;74:955 -6o

8. Edwards HM. Satisfying patients' need for surgicalinformation. BrJ Surg 1 990 ;77:463 -5

9. Bruera E, Pituskin E, Calder K et al. The addition of anaudiocassette recording of a consultation to writtenrecommendations for patients with advanced cancer: Arandomised, controlled trial. Cancer 1999;86(11):242o-5

Correspondence to: Mr S Tierney, Department of Surgery,Adelaide & Meath Hospital, Tallaght, Dublin 24.Tel: +353 7 4 74 2273 Fax: +353 7 4 74 2212email: Sean.Tierney@amnch.ie

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