BJOG: an International Journal of Obstetrics and Gynaecology DOI: 1 0 .1 1 1 1 / j . 1 4 7 1 - 0 5 2 8 . 2 0 0 4 . 0 0 2 4 0 .

x
October 2004, Vol. 111, pp. 1133 – 1138

Informed consent for elective and emergency surgery:

questionnaire study
a a a b
Andrea Akkad, Clare Jackson, Sara Kenyon, Mary Dixon-Woods,
b a
Nick Taub, Marwan Habiba
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 procedures, their benefits and complications as well as

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 introduc-tion
of longer and more complex forms and procedures. In the
UK, the Department of Health (DoH) has pub-lished
national guidelines for obtaining valid consent to
1
treatment, to ensure that specific information about
a
Division of Obstetrics and Gynaecology, University of
Leicester, UK
b emergency surgery, focussing on competent adults. This
Department of Health Sciences, University of Leicester,
UK
Correspondence: Mr M. Habiba, Division of Obstetrics and Gynaecology,
Department of Cancer and Molecular Medicine, University of Leicester,
Robert Kilpatrick Building, Leicester LE2 7LX, UK.
D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology
2
alternative treatment is imparted to the patient. Whether
these processes truly address patients’ needs is unknown,
partly because the research field is dominated by mea-
surements of information and recall, rather than address-
3,4
ing issues of patient-defined priorities and values. 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
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
www.blackwellpublishing.com/bjog
1134 A. AKKAD ET AL.

situations of increased vulnerability. These issues ap-
peared to be particularly prominent in accounts of patients
who had undergone emergency surgery.
METHODS
The content of the questionnaire was developed using
themes which had emerged from semi-structured inter-
views 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 investiga-tors
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 pro-
cess, and their overall satisfaction with the experience
(Tables 1 – 4).
2. Patients’ views on what is important for adequate con-
sent, whether it was achieved, and how this influenced
patient satisfaction with the process (Tables 5 and 6).
To determine which items were linked to patients’
satisfaction, the following demographic and procedural
variables were analysed: age, Townsend social deprivation
5
score, 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 multi-
variable 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
Of the 1040 patients approached, 34 opted out. Ques-
tionnaires 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
6
material deprivation — measured by Townsend score
Table 1. Responses to factual and procedural questions by patients
undergoing elective or emergency surgery. Responses are given in n (%).
Question Elective Emergency P

With the approval of the local Ethics Committee, 1040 (n ¼ 499) (n ¼ 233)
consecutive women who had undergone elective or emer- Overall satisfaction with the process of giving consent
gency surgery in obstetrics and gynaecology at a large Very satisfied/satisfied 394(80) 144 (63) <0.0001
Neither satisfied nor dissatisfied 80(16) 71 (30)
teaching hospital in the East Midlands between 1 Novem- Dissatisfied/very dissatisfied 21(4) 15 (7)
ber 2002 and 30 April 2003 were contacted by letter within Missing 4 3
two to four weeks of surgery. They were invited to
participate in the study, and an opt-out card was provided Who asked you to sign the consent form?
for those who did not wish to participate. The surgeon 249(50) 95 (41) 0.0003
Another doctor 139(28) 53 (23)
The questionnaire was sent to participants who did not Other/not sure 111(22) 85 (36)
opt out. Non-responders received two reminders. All sur-
veyed patients had recent experience of giving consent to When did you sign the consent form?
surgery using the newly introduced DoH consent form 1 >24 hours before operation 281(56) 21 (9) <0.0001
(consent form for adults with capacity to give consent, who <24 hours before operation 207(42) 206 (89)
will not or may not retain consciousness throughout the Not sure 9(2) 5 (2)
2 Missing 2 1
procedure).
All questionnaires were anonymised and entered into a Was the amount of time you had to think about the consent form before
Microsoft Access database. We analysed the data using you signed. . .
frequency tables, single-variable and multivariable Enough 364(74) 136 (60) 0.001
analyses to assess differences between patients undergoing Not enough 90(18) 53 (23)
2 Too long 6(1) 4 (2)
elective and emergency surgery. We used C test and Mann Not sure 36(7) 34 (15)
– Whitney U test to compare categorical and continuous Missing 3 6
variables, respectively. Odds ratios (OR) for differences
between the emergency and elective groups were Did you have a partner/relative/friend with you when you signed the
consent form?
calculated using logistic regression. For all odds ratios,
Yes 199 (40) 172 (74) <0.0001
elective patients form the reference group.
D RCOG 2004 Br J Obstet Gynaecol 111, pp. 1133 – 1138
 CONSENT TO ELECTIVE AND EMERGENCY SURGERY 1135

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 ¼ 499) Emergency (n ¼ 233) OR (95% CI) P

Patients’ recall of consent form
Remember at least something about signing consent form 475 (96) 207 (90) 0.34 (0.18, 0.65) 0.001
Read at least some of consent form — handwritten part 402 (83) 114 (51) 0.22 (0.16, 0.31) <0.0001
Found handwritten part of consent form easy to understand 342 (74) 97 (52) 0.38 (0.27, 0.54) <0.0001
Read at least some of consent form — printed part 344 (75) 96 (44) 0.26 (0.18, 0.36) <0.0001
Found printed part of consent form easy to understand 305 (71) 89 (49) 0.39 (0.28, 0.60) <0.0001

Not read consent form (fully) because. . .

I was feeling too ill 5 (1) 51 (22) 27.67 (10.88, 70.46) <0.0001
I wasn’t given a chance 56 (11) 42 (18) 1.74 (1.13, 2.69) 0.011
I trusted the doctor 158 (32) 72 (31) 0.97 (0.69, 1.35) NS
I had a verbal explanation 219 (44) 117(50) 1.29 (0.94, 1.76) NS
Form was too long 64 (13) 28 (12) 0.93 (0.58, 1.49) NS
Form was standard 28 (6) 12 (5) 0.91 (0.46, 1.83) NS

(43% vs 27%, P ¼ 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/mid-
wifery 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 understand-
ing what they were signing (Table 5), but one-fifth (21%)

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 state Elective (n ¼ 499) Emergency (n ¼ 233) OR (95% CI) P

Feeling in pain, unwell, drugged, tired or exhausted 93 (19) 160 (69) 9.57 (6.69, 13.67) <0.0001
at the time of signing consent form
Feeling scared or frightened by signing consent form 160 (33) 121 (55) 2.52 (1.82, 3.49) <0.0001
Feeling under pressure by signing consent form 79 (17) 64 (29) 2.09 (1.43, 3.05) <0.0001
Feeling in control by signing consent form 214 (45) 52 (23) 0.37 (0.26, 0.53) <0.0001
Feeling reassured by signing consent form 218 (46) 67 (31) 0.53 (0.37, 0.74) <0.0001
Feeling relieved by signing consent form 152 (32) 68 (31) 0.95 (0.68, 1.35) NS

D RCOG 2004 Br J Obstet Gynaecol 111, pp. 1133 – 1138

1136 A. AKKAD ET AL.

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 ¼ 499) Emergency (n ¼ 233) OR (95% CI) P
I had no choice about signing the consent form
Strongly agree/agree 128 (24) 92 (40) 2.11 (1.46, 2.86) <0.0001
Neither agree nor disagree 97 (20) 47 (20)
Disagree/strongly disagree 272 (56) 91 (40)
Missing 2 3

I would have signed it whatever was on it

Strongly agree/agree 75 (15) 83 (37) 3.14 (2.18, 4.52) 0.001
Neither agree nor disagree 51 (11) 30 (13)
Disagree/strongly disagree 360 (74) 115 (50)
Missing 13 5

Signing the consent form was a waste of time

Strongly agree/agree 29 (6) 17 (8) 1.27 (0.68, 2.37) NS
Neither agree nor disagree 77 (16) 55 (24)
Disagree/strongly disagree 383 (78) 157 (68)
Missing 10 4

Hospitals should get rid of consent forms for the type of surgery I had
Strongly agree/agree 18 (4) 30 (13) 3.93 (2.14, 7.22) 0.001
Neither agree nor disagree 78 (16) 60 (26)
Disagree/strongly disagree 394 (80) 140 (61)
Missing 9 3

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
¼ 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 impor-
tant by the majority in both groups (93% vs 98%, P ¼
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 con-tents (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).

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 ¼ 499) Emergency (n ¼ 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

D RCOG 2004 Br J Obstet Gynaecol 111, pp. 1133 – 1138


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).
Variable OR (95% CI)
for satisfaction
Was seen by a familiar doctor 1.94 (1.25, 2.99)
Received detailed information 1.95 (1.27, 2.99)
about the procedure
Someone checked she understood 3.09 (1.99, 4.78)
the information
Consent form read 1.80 (1.15, 2.83)
Agreed with everything on the form 3.49 (1.97, 6.19)
Family member checked form 0.54 (0.31, 0.92)
There was no evidence of lack of fit for this model in the
2
Hosmer – Lemeshow statistic (P ¼ 0.246). Nagelkerke R
was 0.26.
DISCUSSION
This study was conducted at a hospital with a clear and
widely disseminated consent policy, implemented following
1 preliminary evidence of impaired cognitive performance in
the publication of the DoH guidelines, 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 circum-stances.
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
6 going to happen to them — preferably by a familiar health
patients’ recall of such events may not be perfect.
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 con-
sent forms in emergency situations has been previously
7
reported. 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
D RCOG 2004 Br J Obstet Gynaecol 111, pp. 1133 – 1138
CONSENT TO ELECTIVE AND EMERGENCY SURGERY 1137
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
P
signing the form, and many would have signed it regard-
less of its content. Many did not read or understand the
consent form, or did not feel they had an opportunity to ask
0.003 questions. These findings suggest important problems for
0.002
emergency patients, and indicate that different types of
<0.0001 patients may have different requirements, which is in direct
contrast to the current approach of standardising the
0.01 consent process, as — despite the availability of four
<0.0001 different consent forms (for adults with capacity to con-
0.024
sent whose procedure will involve receiving anaesthetic
care, for children, for patients expected to remain
conscious throughout the procedure, and for patients
lacking the ca-pacity to consent) — there is no provision
for differing clin-ical circumstances.
These findings also raise questions about the validity of
consent from emergency patients. There is limited guid-
ance as to the validity of consent obtained in emergen-cy
situations, although the DoH Reference Guide states that
the presence of confusion, shock, fatigue, pain or in-
fluence of medication should not be assumed to dimin-ish
1
patients’ capacity to consent. However, there is some
8
very ill patients, making clear verbal communication
7
crucial.
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 pro-
viders, 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
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
9
may reduce anxiety and improve satisfaction. Perhaps more
important is an emphasis on specific verbal
1138 A. AKKAD ET AL.
7,10,11
techniques, 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 under-
standing 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 con-
sent, 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 dif-fering needs of
elective and emergency patients.
Acknowledgements
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 Exec-
utive Office, who provided the funding for this project.
Conflict of interest
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.
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