The use of video information in obtaining consent for female sterilisation: a randomised study

The use of video information in obtaining consent forfemale sterilisation: a randomised study

Victoria Mason, Alec McEwan, David Walker, Steve Barrett, David James*

Hypothesis Providing additional information by video in addition to the standard consultation in womenrequesting sterilisation increases patients’ knowledge about the procedure with no change in anxietylevels.

Design Randomised control trial in 6 weeks.

Population Women requesting sterilisation (n ¼ 31).

Setting Gynaecology clinics in two teaching hospitals.

Methods Comparison of providing additional information by video in addition to the standard consultationwith the standard consultation.

Main outcome measures Patients’ knowledge of sterilisation, anxiety levels and acceptance of the videoapproach.

Results Women receiving video information as well as the standard consultation had significantly higherknowledge scores compared with women only receiving the conventional consultation. Women undergoinga conventional consultation (no video) in a nurse-led dedicated sterilisation clinic had significantly higherknowledge scores than women having their consultation in a general gynaecological clinic. There were nodifferences in anxiety levels between the groups. Information giving by video was acceptable to the majorityof women.

Conclusion Videos are a reliable and consistent method of delivering information to women requestingfemale sterilisation.

INTRODUCTION

Patients should be actively involved in decision making

about their health care1,2. Information is a key issue and

communication difficulties have been linked to anxiety,

depression, confusion and even hostility that can lead to

non-compliance and slower recovery3,4. Failure to provide

information is commonly cited in complaints and litigation.

Furthermore, in the United Kingdom, a signed consent

form is legally invalid unless it can be shown that the

patient was given sufficient comprehensible information

about any treatment5.

The General Medical Council’s document, ‘Seeking

Patients’ Consent: the ethical considerations’1, provides

general advice and a checklist for obtaining consent for a

treatment or investigation. This mandates that the doctor

must give a lot of information to the patient, but with

the potential risk that time constraints leave insufficient time

for questions and discussion. In addition, there is a danger of

information overload and with variations in doctors’ com-

munication skills this may result in an inadequate under-

standing and failure to provide informed consent. A

number of studies have shown that patients sign consent

forms without fully understanding what they are signing,

what they have been told or what the procedure entails4,6,7.

Informed consent requires that patients be given suffi-

cient and appropriate information including a clear descrip-

tion of treatment techniques and risk of side effects8.

Videos have been claimed to be more successful at holding

a patient’s interest when compared with other methods of

information delivery, allow patient control and superior

recall compared with other sources of information9,10.

We conducted a randomised control trial of providing

additional information by video in addition to the standard

consultation compared with the standard consultation alone

in women requesting sterilisation. The hypothesis to be

tested was that providing additional information by video in

addition to the standard consultation in women requesting

sterilisation increases patients’ knowledge about the proce-

dure with no change in anxiety levels.

METHODS

Ethical approval for the study was given by the Hospi-

tal’s Research and Ethics Committee.

BJOG: an International Journal of Obstetrics and GynaecologyDecember 2003, Vol. 110, pp. 1062–1071

D RCOG 2003 BJOG: an International Journal of Obstetrics and Gynaecology

PII: S1 4 7 0 - 0 3 2 8 ( 03 ) 0 3 9 4 1 - 7 www.bjog-elsevier.com

School of Human Development, University of Nottingham,

Queen’s Medical Centre, UK

* Correspondence: Professor D. James, School of Human Development,

University of Nottingham, Queen’s Medical Centre, Nottingham NG7

2UH, UK.

A flow diagram summarising the study is given in Fig. 1.

Women referred requesting sterilisation, who were En-

glish-speaking and suitable for a laparoscopic method, were

approached for recruitment to the study. Patients were re-

cruited at two gynaecology outpatient clinics—the Queen’s

Medical Centre (QMC), Nottingham and the City Hospital,

Nottingham (CHN). At the QMC, normally such patients are

seen by a doctor alongside other gynaecological consul-

tations. The CHN runs a nurse-led clinic, specifically for

sterilisation referrals. Otherwise, the research method was

the same at both hospitals.

Patients requesting a sterilisation were approached by

one of us (VM) to ask if they would be prepared to take

part in the study (VM). If they agreed to participate in the

study, they were randomised into either a test or control

group using a computer-generated randomisation pro-

gramme. The test group watched the video before the nor-

mal consultation by doctor or nurse. The control group just

had the conventional consultation by doctor or nurse. The

doctor or nurse was aware of the content of the video and

that the patient was participating in the study but was not

aware whether the patient had seen the video. Both groups

returned to be interviewed by the researcher (VM) after

their consultation.

An educational video was made by the Nottingham

University Audiovisual Department. AM wrote the script

and VM was the presenter. The video contained all the

information that should be provided during a consultation

about sterilisation. This included information about what

the procedure entailed, the risks, the advantages, the dis-

advantages and the alternatives. The video consisted of

diagrams, text, shots of the QMC Day Theatre and laparo-

scopic equipment, as well as the presenter (VM) talking

directly to camera. The programme lasted approximately 5

minutes. Copies are available from the authors, however,

the key points covered in the video were

� an explanation of the procedure� the failure rate (1 in 300)� the ectopic pregnancy rates� other risks� the effect on periods� alternatives to sterilisation� an explanation of the hospital process and aftercare

A video questionnaire (completed only by the test group)

was designed to elicit the patient’s opinions of the video

and her views on how information about sterilisation was

presented, overall, using this approach. The questions asked

are listed in Fig. 2.

A non-video questionnaire (completed only by the con-

trol group) was designed to elicit the patient’s opinions of

the face-to-face consultation, the possible use of videos and

her views on how well information about sterilisation was

presented by the healthcare professional. The questions

asked are listed in Fig. 3.

A sterilisation knowledge questionnaire (completed by

both test and control groups) was designed to test the

patient’s short term knowledge about the sterilisation

procedure and the alternatives. All the questions used were

answerable from the detailed information that was shown

in the video and also from information that should have

been discussed in the consultation. The questions asked are

listed in Fig. 4.

A questionnaire was used to collect socio-demographic

and educational information to ensure comparability of the

two groups. The questions asked are listed in Fig. 5.

The six-item version of Speilberger’s 20-item measure

of state anxiety was completed by both test and control

groups (Spielberger State Anxiety Inventory—Short Form).

This version, developed by Marteau and Bekker11, has

been shown to correlate well with the standard Spielberger

State Anxiety Inventory. However, it has the advantages of

being simpler and quicker to use8. The patients indicated

on a four-point scale (from ‘not at all’ to ‘very much’)

their current feelings in response to short statements (e.g.

‘I feel calm’, ‘I am worried’, ‘I am relaxed’).

The staff questionnaire was completed by the doctor

or the nurse after the consultation. It contained questions

about their perception of the patient’s understanding,

her interaction and her anxiety level. They are listed in

Fig. 6.

The researcher (VM) conducted an interview to facilitate

the completion of the video/non-video questionnaire

(above). The interview was recorded on audiotape, with

the patient’s agreement, and was later transcribed by the

researcher. Once this first questionnaire was completed, the

Fig. 1. Flow chart summarising the randomised trial.

VIDEO INFORMATION, COUNSELLING, CONSENT, FEMALE STERILISATION 1063

D RCOG 2003 Br J Obstet Gynaecol 110, pp. 1062–1071

audiotape was switched off and the other three question-

naires (knowledge, socio-demographic, Spielberger State

Anxiety Inventory) were completed by the patient.

The interviews using the first questionnaire were tran-

scribed and analysed using a framing technique where

the answers were coded and frequencies of the answers were

documented. For the knowledge questionnaire, the patient

was allocated one mark for each correct answer and the total

was then calculated. The Spielberger State Anxiety Inven-

tory was scored in the conventional way.

This was the first study of the use of video in obtaining

consent for sterilisation. Thus, there were no prior data to

Fig. 2. Questionnaire: video/study group.

1064 V. MASON ET AL.


allow a power calculation to determine the number of pa-

tients that should be recruited. Therefore, we pragmatically

chose a defined time period (six weeks between November

and December 2001) for this pilot study.

Statistical analysis was carried out using SPSS 10.1 for

windows. Non-parametric methods were used, namely, m2

for comparison of frequencies and Mann–Whitney U test

for comparison of medians.

RESULTS

Between November 2001 and December 2001, 31 of 38

women approached to participate in the study agreed

(81.6%). Of these, 22 agreed from 26 patients approached

at the QMC (84.6%) and 9 agreed from 12 patients

approached at the CHN (75%). Of the 31 women recruited,

15 were randomised into the test group and 16 into the

control group.

The socio-demographic data are summarised in Table 1.

There were no significant differences in the socio-demo-

graphic characteristics of the two groups.

The test group had a significantly better median score

for the knowledge questionnaire than the control group

( P < 0.001, u ¼ 17) (see Table 2). The maximum score

was 20. The test group had a median average score

of 90% (18/20) with only one participant scoring below

16/20, whereas the control group had a median score of

Fig. 3. Questionnaire: non-video/control group.



57.5% (11.5/20) with only three participants scoring

above 16/20.

The anxiety levels, as measured by the Spielberger State

Anxiety Inventory, were not significantly different between

the two groups (see Table 2). The median (range) for the

video and non-video groups were 9.0 (6–15) and 10.0

(6–15), respectively. Seven patients (46.6%) in the test

(video) group scored 7 and below on the Spielberger State

Anxiety Inventory compared with four patients (25%) of

the control (non-video) group. Both groups had 10 patients

scoring 10 and below.

Five (33.3%) of the video patients reported negative

feelings about watching the video before viewing it. Only

one of the five (6% of the group) still had negative

feelings afterwards. Eleven (68.8%) of the control group

said they would not have wished to see a video before

the consultation. These differences were not statistically

significant.

Both groups were asked whether they would have felt

more or less anxious if they had been in the other group.

The majority of the test group (n ¼ 12; 80%) thought they

would have been more anxious without the video (see

Table 2), while the majority of the control group (n ¼ 10;

62%) thought they would have felt no different if shown the

video. This difference is statistically different ( P < 0.0001,

u ¼ 31.5).

Fig. 4. Sterilisation knowledge questionnaire.



The groups were asked which method of giving in-

formed consent they would prefer in the future. Fourteen

of the test group (93%) chose video in combination with

consultation with the remaining one choosing video alone.

Eight of the control group (50%) chose consultation alone

and the other eight chose video and consultation. This

difference between the test and control groups is statisti-

cally significant ( P < 0.05; m2 ¼ 0.005; df ¼ 2). Overall,

71% of patients chose video and consultation and 74.2%

of the patients expressed a preference for a video in future

consent procedures.

The staff reported that they felt all patients understood

the information and were satisfied at the end of the con-

sultation in both groups. They felt that all but one patient

(in the control group) wanted to be actively involved in

the decision about their management. The staff thought

four patients (26.7%) in the test group were anxious com-

pared with only one (6.3%) in the control group. This is

not a statistically significant difference.

No differences in staff–patient interaction between the

groups were detected by the staff questionnaire.

Of the 31 participants, 22 were seen at the QMC and

9 were seen at the CHN. There were no significant

differences in the demographic data of the two hospital

groups.

There were no significant differences between the over-

all median knowledge scores of patients in the two hospi-

tals. Also, there were no significant differences in the

median knowledge scores of the test groups at each hos-

pital. However, the CHN control group had a significantly

Fig. 5. Socio-demographic questionnaire.



Fig. 6. Staff questionnaire.

Table 1. Comparison of socio-demographic characteristics between the two groups.

Video Standard Total P

Mean Age 33.1 34.2 33.7 0.30 t ¼ �0.590

Marital Status (%)

Married 40.0 37.5 38.7 0.98 m2 ¼ 0.983, df ¼ 2

Living with Partner 46.7 50.0 48.4

Living Alone 13.3 12.5 12.9

Ethnic Status (%)

British White 80.0 87.5 83.9 0.65 m2 ¼ 0.570, Fisher’s exact

test ¼ 0.654, df ¼ 1

Other 20.0 12.5 16.1

No. of Children (%)

1 20.0 31.3 25.8 0.45 u ¼ 102

2 46.7 43.8 45.2

3 20.0 12.5 16.1

4 0.0 12.5 6.5

5 13.3 0.0 6.5

Education (%)

No qualifications 13.3 12.5 12.9 0.86 u ¼ 116

GCSEs 53.3 56.3 54.8

A levels 6.7 12.5 9.7

Higher education 26.7 18.8 22.6



higher median knowledge score than the QMC control

group ( P ¼ 0.004, u ¼ 3.500, see Table 2).

DISCUSSION

Our pilot study in women requesting sterilisation

showed that using informational videos within the standard

treatment process results in increased patient knowledge

scores without any impact on patient anxiety levels. The

data about patients’ knowledge following standard/conven-

tional counselling were worrying with about one-third of

patients knowing 50% or less of the relevant information

about a procedure despite both the patients and staff be-

lieving they were fully informed. This is the first reported

use of videos in the context of obtaining consent for female

sterilisation.

Similar studies of the value of videos in different clinical

settings have produced conflicting results in terms of pa-

tients’ knowledge and understanding12. Fisher et al.13

found no difference in the increase of knowledge or change

in mood (using Nowlis Mood Adjective Checklist) with

using videos. Match-paired subjects were given genetic

counselling by either a conventional counselling session

with a physician or a videotape followed by a question and

answer session with a physician. Both counselling methods

were found to be equally effective in teaching about

genetics13. However, in a different setting, Cull et al.14

showed that videos made a significant difference with

increase of knowledge. Women referred for breast cancer

risk counselling were randomised into either ‘Video Before’

or ‘Video After’ counselling. Immediately after the counsel-

ling, the ‘Video Before’ group had a better understanding

than the ‘Video After’ group. However, at a 1-month follow

up, once both groups had watched the video, there were no

differences in the groups’ levels of understanding. Agre

et al.9 randomised patients attending for colonoscopy into

one of three information groups—group one by video and

discussion with a physician, group two by video only and

group three by discussion only. The results showed that

patients in groups one and two did significantly better on the

knowledge questionnaire than those belonging to group

three. Meade et al.15 compared in a randomised control

trail whether printed or videotaped information was more

effective in enhancing colon cancer knowledge. They

found both improved knowledge compared with no inter-

vention but that there was no difference in the increase in

knowledge whether patients were given written (with a low

reading level) or video information. However, written

information requires a basic level of literacy as well as the

motivation to read the material.

There is a similar disparity in the literature with respect

to patient anxiety levels with the use of videos. We found

no significant impact on anxiety levels with the use of

video compared with the conventional group, while the test

group did appear to have lower anxiety with lower scores

than the control group at a score of 7 and below but this

was not significant. Also, there were equal numbers in both

groups scoring 10 and below on the Spielberger State

Anxiety Inventory. This lack of any significant impact of

video use on anxiety is in keeping with the findings of

Fisher et al.13 and Cull et al.14. However, it differs from the

results found by Freeman-Wagg et al.16 and Thomas et al.8

who reported that the use of videos reduced anxiety. In

Freeman-Wagg’s randomised trial, all new referrals to a

colposcopy clinic were sent either just standard printed

information prior to their appointment or an explanatory

video. The level of anxiety was measured in each woman at

her first attendance using the short form of the Spielberger

State Anxiety Inventory. The group that was sent the video

had a significantly lower anxiety level on attendance16.

Thomas et al.8 assessed the benefits of preparatory infor-

mation on video for patients receiving chemotherapy or

radiotherapy for cancer treatment. Patients were random-

ised to either watching a video or not watching a video

after their first consultation and before treatment. In the

video group, the mean Hospital Anxiety and Depression

anxiety score was significantly lower during treatment

compared with the non-video group8.

In retrospect, several limitations were clear in the study.

The staff, knowing the patient was in the study, could have

improved the quality of the consultation process compared

with what was normal. However, if this were the case then

our study would have under-estimated the benefits of video

use. Although the doctors and nurses were meant to be

unaware of a patient’s group, they could have asked the

patient and theoretically this knowledge could have biased

their counselling.

It would have been helpful to have documented the length

of the consultations. Cull et al.14 suggested that videos

shorten consultation time. With different interview ques-

tionnaires for the two groups, the researcher was aware of

which group the patients were in. Although the interviews

Table 2. Knowledge scores.

Number Median IQR Minimum Maximum

Total

Video 15 18.00* 16.00– 18.00 12 20

Standard 16 11.50 10.00– 15.00 8 17

QMC

Video 12 18.00 16.25– 18.00 16 19

Standard 10 10.50 7.50– 12.00 8 15

City

Video 3 19.00 12.00– 20.00 12 20

Standard 6 15.50** 13.50– 17.00 12 17

QMC ¼ Queen’s Medical Centre.

IQR ¼ Interquartile range.

* P � 0.001 for video vs Standard Total.

** P � 0.005 for Standard QMC vs Standard City.



were kept strictly to the printed questions, there could

have been an interaction effect. One questionnaire would

have been preferable. There were no baseline knowledge

or anxiety scores taken from the patients when they ar-

rived so it was impossible to know how much the results

increased or decreased from the original levels. All pa-

tients were informed of the two arms of the trial. However,

we did not assess whether there was a ‘disappointment

factor’ operating in the control group that may have af-

fected the results. The interview and staff questionnaires

were developed without using a standard and validated

template. Therefore, the wording was not precisely quan-

tified leading to the potential for discrepancies. This means

personal interpretations by the respondents could have

biased the results.

The time restrictions on the study meant that the patient

recruitment numbers were small and this brings its own

limitations. For example, the trend in the anxiety results to

lower scores in the test group might have become statisti-

cally significant with larger numbers. However, over 1000

patients would have to be randomised to each arm of the

trial for the differences in anxiety results found in this study

for statistical significance.

It is possible that improved knowledge scores occur

simply because of repetition of information. The control

group heard this information only once from the healthcare

professional, whereas the test group heard it twice, from the

healthcare professional and in the video. However, even if

this is true, it still emphasises the additional benefit of the

use of the video in improved communication.

Clearly, the use of videos was acceptable to the patients

in our study. The video seems an ideal solution to the

dilemma of providing patients with consistent, structured,

clear and understandable advice to facilitate and increase

the patient’s active role in decision making. Schapira et al.17,

using a video as a decision aid for patients with prostate

cancer, showed that when the video was viewed before the

consultation it optimised the quality of the physician time

without sacrificing the delivery of information.

The use of this approach in a variety of settings is

pertinent currently in the UK with the introduction of

new consent procedures and concerns that more time will

be taken in obtaining the consent than formerly. Videos

could be used to allow more efficient use of the time of

healthcare professionals. Similarly, videos can be used to

more effectively train healthcare professionals to ensure

greater consistency and comprehensive coverage in face-to-

face discussions with patients. Dissemination of the infor-

mation can be via a variety of websites (e.g. hospital,

support groups, libraries) as well as to individual patients

prior to consultations.

This study was not designed to observe the differences

between the two types of clinics (nurse-led dedicated

sterilisation clinic vs the doctor-led gynaecology clinic).

Therefore, there are discrepancies in the numbers seen in

the two settings. However, there was a significant difference

between the two control groups in that the CHN patients had

a significantly higher knowledge level than those from the

QMC. It is interesting to speculate that a single nurse

working in a dedicated clinic might supply the information

to all sterilisation patients in a more consistent way com-

pared with a doctor in a general clinic faced with different

gynaecological problems and with increased time con-

straints and less frequent repetition of the information.

Further research into this area is clearly warranted. No

follow up study was conducted due to constrictions on time

available. Other potential areas for research include the

development of interactive components if the video was

converted to a CD-ROM and whether the video itself could

constitute an adequate information source to allow consent

without any significant consultation.

In conclusion, videos appear to be a reliable and consist-

ent method of delivering more information to women re-

questing female sterilisation and improving its retention. It

promotes active participation in healthcare decisions with-

out increasing the medical professional workload.

Acknowledgements

The authors would like to thank the following for

their help in this study: Mr R. Hayman, Dr J. Collier,

Dr C. Glazebrook, Mrs S. Griffiths and all the staff at

the two clinics.

References

1. Anonymous. Seeking Patients’ Consent: The Ethical Considerations.

London: GMC Publications, 1998.

2. Coulter A, Entwistle V, Gilbert D. Sharing decisions with patients: is

the information good enough? BMJ 1999;318:318– 322.

3. Givio P. What doctors tell patients with breast cancer about diagnosis

and treatment: finding from a study in general hospitals. Br J Cancer

1986;54:319 –326.

4. Williams OA. Patient knowledge of operative care. J R Soc Med

1993;86:328– 331.

5. Kerringan DD, Thevasagayam RS, Woods TO, et al. Who’s afraid of

informed consent? BMJ 1993;306:298 –300.

6. Montgomery C, Lydon A, Lloyd K, Psychological distress among can-

cer patients and informed consent. J Psychosom Res 1999;46:241– 245.

7. Pignone M, Harris R, Kinsinger L. Videotaped-based decision aid for

colon cancer screening. Ann Intern Med 2000;133:761– 769.

8. Thomas R, Daly M, Perryman B, Stockton D. Forewarned is fore-

armed — benefits of preparatory information on video cassette for

patients receiving chemotherapy or radiotherapy—a randomised con-

trolled trial. Eur J Cancer 2000;36:1536– 1543.

9. Agre P, Kurtz RC, Krauss BJ. A randomised trial using videotape to

present consent information for colonoscopy. Gastrointest Endosc

1994;40:271 –275.

10. Paivio A. Images in Mind. London: Harvester Wheatsheaf, 1991.

11. Marteau TM, Bekker H. The development of a six-item short-form

of the state scale of the Spielberger State –Trait Anxiety Inventory

(STAI). Br Psychol Soc 1992;31:301– 306.

12. Gagliano MD. A literature review on efficacy of video in patient

education. J Med Educ 1988;63:785– 792.



13. Fisher L, Rowley PT, Lipkin Jr M. Genetic counselling for thalasse-

mia trait following health screening in a health maintenance organi-

sation: comparison of programmed and conventional counselling. Am

J Hum Genet 1981;33:987–994.

14. Cull A, Miller H, Porterfield T, et al. The use of videotaped infor-

mation in cancer genetic counselling: a randomised evaluation study.

Br J Cancer 1998;77:830–837.

15. Meade CD, McKinney P, Barnas GP. Educating patients with limited

literacy skills: the effectiveness of printed and videotaped materials

about colon cancer. Am J Public Health 1994;84:119– 121.

16. Freeman-Wagg T, Walker P, Linehan J, Coffey C, Glasser B,

Sherr L. Anxiety levels in women attending colposcopy clinics

for treatment for cervical intraepithelial neoplasia: a randomised

trail of written and video information. Br J Obstet Gynaecol 2001;

108:482– 484.

17. Schapira MM, Meade C, Nattinger AB. Enhanced decision-making:

the use of a videotaped decision-aid for patients with prostate cancer.

Patient Educ Couns 1997;30:119– 127.

Accepted 29 July 2003



The use of video information in obtaining consent for female sterilisation: a randomised study

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