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Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

Objectives  To evaluate women's experience of giving consent to obstetric and gynaecological surgery and to examine differences between those undergoing elective and emergency procedures.

Design  A prospective questionnaire study.

Setting  A large teaching hospital.

Population  1006 consecutive patients undergoing elective or emergency surgery in obstetrics and gynaecology.

Methods  Questionnaires were administered to women who had given consent to surgery following the introduction of national guidelines and consent form. Differences in responses between elective and emergency patients were assessed using frequencies, single and multivariable analyses.

Main outcome measures  Patients' experience and recall of the consent process, their overall satisfaction and their views on what is important for adequate consent.

Results  There were significant differences between patients undergoing elective or emergency surgery. Patients undergoing emergency surgery were less likely to have read (OR 0.22) or understood (OR 0.40) the consent form, and were more likely to report feeling frightened by signing it (OR 2.52). They were more likely to report they felt they had no choice about signing the consent form (OR 2.11), and that they would have signed regardless of its content (OR 3.14). Overall, significantly more patients undergoing elective (80%) or emergency (63%) surgery reported satisfaction with the consent process. Patients were more likely to report satisfaction if they read (OR 1.80) and agreed with (OR 3.49) the consent form, and if someone checked that they understood (OR 3.09).

Conclusion  Patients' needs may not be adequately addressed by current guidelines for consent to treatment, particularly in emergency circumstances. The introduction of more complex forms and procedures appears to conflict with patients' need for personal communication and advocacy. The implications on the ethical and legal standing of consent are considerable.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

Consent to treatment has recently become subject to heightened public interest. The ongoing debate in medico-legal circles has led to growing emphasis on the provision of more information, and has resulted in the introduction of longer and more complex forms and procedures. In the UK, the Department of Health (DoH) has published national guidelines for obtaining valid consent to treatment,1 to ensure that specific information about procedures, their benefits and complications as well as alternative treatment is imparted to the patient.2 Whether these processes truly address patients' needs is unknown, partly because the research field is dominated by measurements of information and recall, rather than addressing issues of patient-defined priorities and values.3,4 There is little published evidence about patients' experience of the consent process, and in particular, there is little evidence that distinguishes between the experiences of patients who have undergone elective compared with emergency surgery.

A new consent form for competent adults was among four recently introduced by the Department of Health. In this article, we report a questionnaire survey of patients' experiences of and views on giving consent to elective and emergency surgery, focussing on competent adults. This builds on an earlier qualitative study of women's views on consent to surgery, in which we found that patients' accounts suggest that current procedures of obtaining informed consent neither adequately reflected their own views and values, nor addressed their needs in situations of increased vulnerability. These issues appeared to be particularly prominent in accounts of patients who had undergone emergency surgery.

METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

The content of the questionnaire was developed using themes which had emerged from semi-structured interviews conducted with patients from the same unit in the preceding 12 months. A panel of eight patients, who had recently given consent to surgery, participated in the questionnaire development. The role of the panel was to ensure patient-centredness of the questionnaire, to give a patient's perspective on its readability and user-friendliness, and to identify any ambiguities or lack of clarity within the questions. The questionnaire was piloted with 17 patients prior to being finalised. The investigators and the patient panel reviewed feedback from the pilots, and, where appropriate, questions were modified accordingly.

In this article, we report on two themes covered by the questionnaire:

  • 1
    Patients' own experience and recall of the consent process, and their overall satisfaction with the experience (Tables 1–4).
  • 2
    Patients' views on what is important for adequate consent, whether it was achieved, and how this influenced patient satisfaction with the process (Tables 5 and 6).
Table 1.  Responses to factual and procedural questions by patients undergoing elective or emergency surgery. Responses are given in n (%).
QuestionElective (n= 499)Emergency (n= 233)P
Overall satisfaction with the process of giving consent
Very satisfied/satisfied394 (80)144 (63)<0.0001
Neither satisfied nor dissatisfied80 (16)71 (30) 
Dissatisfied/very dissatisfied21 (4)15 (7) 
Missing43 
 
Who asked you to sign the consent form?
The surgeon249 (50)95 (41)0.0003
Another doctor139 (28)53 (23) 
Other/not sure111 (22)85 (36) 
 
When did you sign the consent form?
>24 hours before operation281 (56)21 (9)<0.0001
<24 hours before operation207 (42)206 (89) 
Not sure9 (2)5 (2) 
Missing21 
 
Was the amount of time you had to think about the consent form before you signed…
Enough364 (74)136 (60)0.001
Not enough90 (18)53 (23) 
Too long6 (1)4 (2) 
Not sure36 (7)34 (15) 
Missing36 
 
Did you have a partner/relative/friend with you when you signed the consent form?
Yes199 (40)172 (74)<0.0001
Table 2.  Reading and understanding consent form: odds ratio with emergency status and reasons for not reading consent form. Responses are given in n (%).
 Elective (n= 499)Emergency (n= 233)OR (95% CI)P
Patients' recall of consent form
Remember at least something about signing consent form475 (96)207 (90)0.34 (0.18, 0.65)0.001
Read at least some of consent form—handwritten part402 (83)114 (51)0.22 (0.16, 0.31)<0.0001
Found handwritten part of consent form easy to understand342 (74)97 (52)0.38 (0.27, 0.54)<0.0001
Read at least some of consent form—printed part344 (75)96 (44)0.26 (0.18, 0.36)<0.0001
Found printed part of consent form easy to understand305 (71)89 (49)0.39 (0.28, 0.60)<0.0001
 
Not read consent form (fully) because…
I was feeling too ill5 (1)51 (22)27.67 (10.88, 70.46)<0.0001
I wasn't given a chance56 (11)42 (18)1.74 (1.13, 2.69)0.011
I trusted the doctor158 (32)72 (31)0.97 (0.69, 1.35)NS
I had a verbal explanation219 (44)117(50)1.29 (0.94, 1.76)NS
Form was too long64 (13)28 (12)0.93 (0.58, 1.49)NS
Form was standard28 (6)12 (5)0.91 (0.46, 1.83)NS
Table 3.  Patients' physical and emotional state at the time of signing consent form: odds ratio with emergency status. Responses are given in n (%).
Reported physical/emotional stateElective (n= 499)Emergency (n= 233)OR (95% CI)P
Feeling in pain, unwell, drugged, tired or exhausted at the time of signing consent form93 (19)160 (69)9.57 (6.69, 13.67)<0.0001
Feeling scared or frightened by signing consent form160 (33)121 (55)2.52 (1.82, 3.49)<0.0001
Feeling under pressure by signing consent form79 (17)64 (29)2.09 (1.43, 3.05)<0.0001
Feeling in control by signing consent form214 (45)52 (23)0.37 (0.26, 0.53)<0.0001
Feeling reassured by signing consent form218 (46)67 (31)0.53 (0.37, 0.74)<0.0001
Feeling relieved by signing consent form152 (32)68 (31)0.95 (0.68, 1.35)NS
Table 4.  Patients' agreement with statements on signing consent form, with odds ratio for agreement in emergency group. Responses are given in n (%). To calculate odds ratios, patients' responses were treated as binary variables, for example, patients who expressed agreement (strongly agree/agree) versus patients who did not (neither agree nor disagree/disagree/strongly disagree).
Do you agree with the following statements?Elective (n= 499)Emergency (n= 233)OR (95% CI)P
I had no choice about signing the consent form
Strongly agree/agree128 (24)92 (40)2.11 (1.46, 2.86)<0.0001
Neither agree nor disagree97 (20)47 (20)  
Disagree/strongly disagree272 (56)91 (40)  
Missing23  
 
I would have signed it whatever was on it
Strongly agree/agree75 (15)83 (37)3.14 (2.18, 4.52)0.001
Neither agree nor disagree51 (11)30 (13)  
Disagree/strongly disagree360 (74)115 (50)  
Missing135  
 
Signing the consent form was a waste of time
Strongly agree/agree29 (6)17 (8)1.27 (0.68, 2.37)NS
Neither agree nor disagree77 (16)55 (24)  
Disagree/strongly disagree383 (78)157 (68)  
Missing104  
 
Hospitals should get rid of consent forms for the type of surgery I had
Strongly agree/agree18 (4)30 (13)3.93 (2.14, 7.22)0.001
Neither agree nor disagree78 (16)60 (26)  
Disagree/strongly disagree394 (80)140 (61)  
Missing93  
Table 5.  Patients' views on the importance of specific issues in the consent process with the odds ratio of it actually happening when consenting to emergency surgery. Responses are given in n (%). The given n (%) represents the number of patients who rated the items as important or very important.
Was it important/very important to you to…Elective (n= 499)Emergency (n= 233)Did it happen?, OR (95% CI)P
Understand what you were signing?489 (98)220 (94)0.40 (0.24, 0.68)<0.0001
Have someone check you understood before signing the form?431 (86)205 (88)0.82 (0.58, 1.15)NS
Have someone read the consent form to you?223 (45)140 (60)1.12 (0.78, 1.56)NS
Have your partner/relative check the form before you sign it?214 (43)134 (58)1.19 (0.78, 1.81)NS
Have a chance to ask questions about the operation?488 (98)215 (93)0.22 (0.14, 0.34)<0.0001
Have detailed information about the operation?435 (87)166 (71)0.34 (0.24, 0.47)<0.0001
Have detailed information about complications?441 (88)200 (86)0.62 (0.44, 0.85)0.004
Have time alone with the form before signing it?276 (55)139 (60)0.99 (0.64, 1.53)NS
Table 6.  Factors affecting patients' satisfaction with their experience of giving consent: Variables in final regression model. To calculate odds ratios, patients' responses to the overall satisfaction question were treated as a binary variable, for example, patients who reported satisfaction (very satisfied/satisfied) versus those who did not (neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
VariableOR (95% CI) for satisfactionP
Was seen by a familiar doctor1.94 (1.25, 2.99)0.003
Received detailed information about the procedure1.95 (1.27, 2.99)0.002
Someone checked she understood the information3.09 (1.99, 4.78)<0.0001
Consent form read1.80 (1.15, 2.83)0.01
Agreed with everything on the form3.49 (1.97, 6.19)<0.0001
Family member checked form0.54 (0.31, 0.92)0.024

With the approval of the local Ethics Committee, 1040 consecutive women who had undergone elective or emergency surgery in obstetrics and gynaecology at a large teaching hospital in the East Midlands between 1 November 2002 and 30 April 2003 were contacted by letter within two to four weeks of surgery. They were invited to participate in the study, and an opt-out card was provided for those who did not wish to participate.

The questionnaire was sent to participants who did not opt out. Non-responders received two reminders. All surveyed patients had recent experience of giving consent to surgery using the newly introduced DoH consent form 1 (consent form for adults with capacity to give consent, who will not or may not retain consciousness throughout the procedure).2

All questionnaires were anonymised and entered into a Microsoft Access database. We analysed the data using frequency tables, single-variable and multivariable analyses to assess differences between patients undergoing elective and emergency surgery. We used χ2 test and Mann–Whitney U test to compare categorical and continuous variables, respectively. Odds ratios (OR) for differences between the emergency and elective groups were calculated using logistic regression. For all odds ratios, elective patients form the reference group.

To determine which items were linked to patients' satisfaction, the following demographic and procedural variables were analysed: age, Townsend social deprivation score,5 elective/emergency status, gynaecology/maternity patient and timing of consent. We also included the patients' statements on a range of processes surrounding consent. These variables were entered into a multivariable binary regression analysis. We finally produced a multivariable model using backward deletion of variables until all remaining were significant at the 5% level. A Hosmer–Lemeshow goodness-of-fit statistic was performed on the final regression model. All analyses were undertaken in SPSS version 11.5. Statistical significance was defined at the 5% level throughout.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

Of the 1040 patients approached, 34 opted out. Questionnaires were sent to 1006 patients. A total of 734 questionnaires were returned, giving a response rate of 71%. Non-responders were likely to be younger (mean age 36.9 vs 39.8, P < 0.0001), living in areas associated with material deprivation—measured by Townsend score6 (43%vs 27%, P= 0.047), of other than white–British ethnicity (25%vs 13%, P < 0.0001), obstetric patients (53%vs 33%, P < 0.001) and to have had emergency surgery (42%vs 32%, NS).

Elective patients were significantly more likely to report satisfaction with consent (80%) than emergency patients (63%) (Table 1). Over a fifth (22%) of elective and over a third (36%) of emergency patients either did not know who asked them to give consent, or indicated that they believed that it was a member of the anaesthetic or nursing/midwifery staff. A significant minority of emergency patients (23%) perceived the length of time available to consider the forms insufficient, as did just under a fifth (18%) of elective patients. Emergency patients were more likely to be accompanied by a relative or friend while giving consent than elective patients (74%vs 40%). The presence of the accompanying person was deemed important by 68% of emergency and 64% of elective patients.

Although most patients had some memory of signing the consent form, emergency patients were significantly less likely to remember signing it (OR 0.34) (Table 2). Almost half of emergency (49%) and 17% of elective patients reported that they had not read the handwritten entry—explaining the procedure, benefits and complications—on the consent form, and even more patients did not read the pre-printed text giving a general rubric about consent prescribed by the DoH (56% of emergencies and 25% elective patients). In both groups, the two leading reasons for not reading the consent form were having had a ‘verbal explanation’ and ‘trust in the doctor’(Table 2). Patients in the emergency group were significantly more likely to report ‘feeling too ill’ (22%vs 1%) or ‘not been given the chance’ (18%vs 11%) to read the form.

Patients undergoing elective surgery were significantly more likely to have found the printed text of the consent form easy to understand, although 29% reported it was not easy. Over half (51%) of patients in the emergency group did not find it easy to understand. In the emergency surgery group, 69% of patients reported being in pain, drugged, desperate or tired or unwell when asked to sign the consent form. Many reported feeling frightened or pressured by signing the form or to have felt lacking in control (Table 3). A substantial proportion (24% of elective and 40% of emergency patients) agreed or strongly agreed with the statement that they had no choice over signing the consent form (Table 4). Over a third (37%) of emergency patients reported that they would have signed the consent form whatever was written on it. However, only a minority (13% of emergency and 4% of elective patients) agreed that hospitals should get rid of consent forms for the type of operation they had.

Patients attached considerable importance to understanding what they were signing (Table 5), but one-fifth (21%) of emergency patients and 11% of elective patients (NS) stated they did not understand what they were signing. Most patients considered it important that someone checked their understanding, but this did not happen in a substantial minority of cases (31% of electives vs 40% of emergencies, P= 0.02). Emergency patients were more likely to want to have the form read to them than electives (60%vs 45%). Just under half (47%) of emergencies and just over half (55%) of electives reported that this happened (NS).

The opportunity to ask questions was considered important by the majority in both groups (93%vs 98%, P= 0.001). However, 29% of emergency patients and 11% of elective patients felt they were not given this opportunity (OR 0.22). Detailed information about the operation was rated as important (71% emergency vs 87% elective, P < 0.0001), but again emergency patients were significantly less likely to have received it (43% emergency vs 69% elective, OR 0.22). Just over half of all patients thought it important to have time alone with the consent form, but this only happened for 23% of patients, with no significant difference between the two groups (Table 5).

Emergency patients were significantly less likely to report satisfaction with the consent process than elective patients (OR 0.43). Overall, patients were significantly more likely to report satisfaction if they saw a familiar doctor (OR 1.94), if they received detailed information about the procedure they were to undergo (OR 1.95), if they read the consent form (OR 1.80) and agreed with its contents (OR 3.49). They were also more likely to be satisfied if someone checked they understood the information (OR 3.09), but less likely to be satisfied if a family member checked the form on their behalf (OR 0.54) (Table 6). There was no evidence of lack of fit for this model in the Hosmer–Lemeshow statistic (P= 0.246). Nagelkerke R2 was 0.26.

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

This study was conducted at a hospital with a clear and widely disseminated consent policy, implemented following the publication of the DoH guidelines,1 and local audit has demonstrated good adherence to procedures. Despite this, our data suggest that the process fails to meet many patients' needs, both in elective and emergency cases. Whereas practical constraints on the consent process in emergency situations might be expected, our data identify important difficulties in cases of elective surgery, where patients should be giving consent to treatment under optimal circumstances. Almost half of elective patients reported signing the consent form less than 24 hours prior to surgery, and one in five thought the time available to them insufficient and did not know who was asking them to give consent. These are disquieting findings, notwithstanding some evidence that patients' recall of such events may not be perfect.6

Our data suggest that a substantial proportion of both emergency and elective patients did not read the consent form. Preference for verbal information over written consent forms in emergency situations has been previously reported.7 Our study found that similar proportions of electives and emergencies apparently perceived that verbal information obviated the need to read the form. Clearly, some patients sign unread documents based solely on verbal communication, which has implications for the ethical and legal standing of the—increasingly complex—consent form. Furthermore, a quarter of elective patients and half of emergency patients reported that the form was not easy to understand, thus raising challenging questions about the process overall.

A large proportion of emergency patients felt frightened or under pressure when signing the form. This is perhaps unsurprising given that over two-thirds of emergency patients were already suffering distressing symptoms at the time when they were asked to sign the form, and that emergency situations are inherently stressful. A substantial proportion of emergencies felt they had no choice about signing the form, and many would have signed it regardless of its content. Many did not read or understand the consent form, or did not feel they had an opportunity to ask questions. These findings suggest important problems for emergency patients, and indicate that different types of patients may have different requirements, which is in direct contrast to the current approach of standardising the consent process, as—despite the availability of four different consent forms (for adults with capacity to consent whose procedure will involve receiving anaesthetic care, for children, for patients expected to remain conscious throughout the procedure, and for patients lacking the capacity to consent)—there is no provision for differing clinical circumstances.

These findings also raise questions about the validity of consent from emergency patients. There is limited guidance as to the validity of consent obtained in emergency situations, although the DoH Reference Guide states that the presence of confusion, shock, fatigue, pain or influence of medication should not be assumed to diminish patients' capacity to consent.1 However, there is some preliminary evidence of impaired cognitive performance in very ill patients,8 making clear verbal communication crucial.7

Although the questionnaire contained only a global satisfaction scale, it appears that the circumstances under which patients gave consent can influence satisfaction. Interestingly, items held as important by health care providers, such as being consented by the operating surgeon, or receiving detailed information about complications, did not significantly contribute to satisfaction in this model. The variables which best explained satisfaction were those relating to communication. Patients were more likely to be satisfied if they were informed in detail about what was going to happen to them—preferably by a familiar health care professional—and if they read the consent form and were in agreement with it. Having someone check they understood the information also contributed to satisfaction, but patients were less likely to report satisfaction if an accompanying person checked the consent form on their behalf. This is not surprising, as it appears that satisfaction was linked to factors that helped patients feel in control, and, with current practice, third parties are only called upon to assist with consent in extreme circumstances.

Although patients in emergency situations seem to place less emphasis on details, particularly in relation to possible complications, they do want to understand what is happening to them. Whether simplified consent documentation would aid understanding is unproven, but there is some evidence that it may reduce anxiety and improve satisfaction.9 Perhaps more important is an emphasis on specific verbal techniques,7,10,11 which are currently given little prominence in guidance on consenting. Advocacy also appears to be an important way of restoring some control, particularly in emergency situations. Patients appear to want their understanding to be checked and the opportunity to ask questions, and rely on health care providers to pay particular attention to their comprehension.

It is important to acknowledge that our study population was recruited solely from obstetrics and gynaecology, and the results may therefore not be applicable to male patients, or those from other specialities. There were also significant differences between responders and non-responders, which means that our findings may not be representative of the needs of all sections of the population. Additionally, the study did not take into account the contribution of doctors' attitudes to and understanding of issues surrounding consent, beyond the administration of forms, to the overall patient experience. Clearly, further research is needed to address these questions and allow more comprehensive and generalisable conclusions.

Despite the above limitations, this study has provided relevant insights into patients' views on giving consent. Our data suggest that, while most patients wish to retain consent forms as part of the process of consent, their experiences of consenting and of the current format of the consent form are very unsatisfactory. These findings suggest that current official guidance may be inadequate, particularly because it has made the information more complex, has standardised the process regardless of the underlying clinical situation and does not provide appropriate guidance on other aspects of the process that are important to patients. Clearly, what is required is a new approach which takes into account the preferences of patients themselves, and recognises the differing needs of elective and emergency patients.

Acknowledgements

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

The authors would like to thank the members of the Patient Panel for their valuable contribution to the design and development of the questionnaire.

They would also like to thank the Trent Regional Executive Office, who provided the funding for this project.

Conflict of interest

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

None. The design of the study, the collection, analysis and interpretation of data, the writing of the report and the decision to submit the paper for publication were all entirely independent of the funding body.

References

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. Conflict of interest
  9. References

Accepted 2 April 2004