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

Authors


*Professor D. James, School of Human Development, University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, UK.

Abstract

Hypothesis Providing additional information by video in addition to the standard consultation in women requesting sterilisation increases patients' knowledge about the procedure with no change in anxiety levels.

Design Randomised control trial in 6 weeks.

Population Women requesting sterilisation (n= 31).

Setting Gynaecology clinics in two teaching hospitals.

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

Main outcome measures Patients' knowledge of sterilisation, anxiety levels and acceptance of the video approach.

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

Conclusion Videos are a reliable and consistent method of delivering information to women requesting female 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' communication skills this may result in an inadequate understanding 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 sufficient and appropriate information including a clear description 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 procedure with no change in anxiety levels.

METHODS

Ethical approval for the study was given by the Hospital's Research and Ethics Committee.

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

Figure 1.

Flow chart summarising the randomised trial.

Women referred requesting sterilisation, who were English-speaking and suitable for a laparoscopic method, were approached for recruitment to the study. Patients were recruited 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 consultations. 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 programme. The test group watched the video before the normal 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 disadvantages and the alternatives. The video consisted of diagrams, text, shots of the QMC Day Theatre and laparoscopic 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.

Figure 2.

Questionnaire: video/study group.

A non-video questionnaire (completed only by the control 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.

Figure 3.

Questionnaire: non-video/control group.

A sterilisation knowledge questionnaire (completed by both test and control group) 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.

Figure 4.

Sterilisation knowledge questionnaire.

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.

Figure 5.

Socio-demographic questionnaire.

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.

Figure 6.

Staff questionnaire.

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 audiotape was switched off and the other three questionnaires (knowledge, socio-demographic, Spielberger State Anxiety Inventory) were completed by the patient.

The interviews using the first questionnaire were transcribed 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 Inventory 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 allow a power calculation to determine the number of patients 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, χ2 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-demographic characteristics of the two groups.

Table 1.  Comparison of socio-demographic characteristics between the two groups.
 VideoStandardTotalP 
Mean Age33.134.233.70.30t=−0.590
Marital Status (%)
Married40.037.538.70.98χ2= 0.983, df = 2
Living with Partner46.750.048.4  
Living Alone13.312.512.9  
Ethnic Status (%)
British White80.087.583.90.65χ2= 0.570, Fisher's exact test = 0.654, df = 1
Other20.012.516.1  
No. of Children (%)
120.031.325.80.45u= 102
246.743.845.2  
320.012.516.1  
40.012.56.5  
513.30.06.5  
Education (%)
No qualifications13.312.512.90.86u= 116
GCSEs53.356.354.8  
A levels6.712.59.7  
Higher education26.718.822.6  

The test group had a significantly better median score for the knowledge questionnaire than the control group (P < 0.001, u= 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 57.5% (11.5/20) with only three participants scoring above 16/20.

Table 2.  Knowledge scores.
 NumberMedianIQRMinimumMaximum
  1. QMC = Queen's Medical Centre.

  2. IQR = Interquartile range.

  3. *P≤ 0.001 for video vs Standard Total.

  4. **P≤ 0.005 for Standard QMC vs Standard City.

Total
Video1518.00*16.00–18.001220
Standard1611.5010.00–15.00817
QMC
Video1218.0016.25–18.001619
Standard1010.507.50–12.00815
City
Video319.0012.00–20.001220
Standard615.50**13.50–17.001217

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= 12; 80%) thought they would have been more anxious without the video (see Table 2), while the majority of the control group (n= 10; 62%) thought they would have felt no different if shown the video. This difference is statistically different (P < 0.0001, u= 31.5).

The groups were asked which method of giving informed 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 statistically significant (P < 0.05; χ2= 0.005; df= 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 consultation 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 compared 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 overall median knowledge scores of patients in the two hospitals. Also, there were no significant differences in the median knowledge scores of the test groups at each hospital. However, the CHN control group had a significantly higher median knowledge score than the QMC control group (P= 0.004, u= 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/conventional 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 believing 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 patients' 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 counselling, 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 intervention 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 information on video for patients receiving chemotherapy or radiotherapy for cancer treatment. Patients were randomised 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 questionnaires for the two groups, the researcher was aware of which group the patients were in. Although the interviews 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 arrived so it was impossible to know how much the results increased or decreased from the original levels. All patients 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 affected the results. The interview and staff questionnaires were developed without using a standard and validated template. Therefore, the wording was not precisely quantified 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 statistically 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 information 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 compared with a doctor in a general clinic faced with different gynaecological problems and with increased time constraints 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 consistent method of delivering more information to women requesting female sterilisation and improving its retention. It promotes active participation in healthcare decisions without 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.

Ancillary