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1. Completion of hand-written surgical consent forms
is frequently suboptimal and could be improved by
using electronically generated, procedure-specific
forms*
E.R. St John a,e,*
, A.J. Scott a,b,e
, T.E. Irvine c
, F. Pakzad c
, D.R. Leff a,b
,
G.T. Layer c,d
a
Academic Surgical Unit, Division of Surgery and Cancer, Imperial College London, St Mary's Hospital, Paddington,
London, UK
b
Division of Surgery, Imperial College Healthcare NHS Trust, St Mary's Hospital, Paddington, London, UK
c
Department of Breast Surgery, Royal Surrey County Hospital, Guildford, UK
d
Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK
a r t i c l e i n f o
Article history:
Received 31 July 2015
Received in revised form
30 November 2015
Accepted 30 November 2015
Available online xxx
Keywords:
Consent
Consent forms
Surgery
Medical informatics
a b s t r a c t
Introduction: Completion of hand-written consent forms for surgical procedures may suffer
from missing or inaccurate information, poor legibility and high variability. We audited the
completion of hand-written consent forms and trialled a web-based application to
generate modifiable, procedure-specific consent forms.
Methods: The investigation comprised two phases at separate UK hospitals. In phase one,
the completion of individual responses in hand-written consent forms for a variety of
procedures were prospectively audited. Responses were categorised into three domains
(patient details, procedure details and patient sign-off) that were considered “failed” if a
contained element was not correct and legible. Phase two was confined to a breast surgical
unit where hand-written consent forms were assessed as for phase one and interrogated
for missing complications by two independent experts. An electronic consent platform was
introduced and electronically-produced consent forms assessed.
Results: In phase one, 99 hand-written consent forms were assessed and the domain failure
rates were: patient details 10%; procedure details 30%; and patient sign-off 27%. Laparo-
scopic cholecystectomy was the most common procedure (7/99) but there was significant
variability in the documentation of complications: 12 in total, a median of 6 and a range of
2e9. In phase two, 44% (27/61) of hand-written forms were missing essential complications.
There were no domain failures amongst 29 electronically-produced consent forms and no
variability in the documentation of potential complications.
*
This work has been presented, in part, at the Association of Surgeons of Great Britain and Ireland's International Surgical Congress,
April 2015, Manchester, UK and at the Association of Breast Surgeons Conference 2015, June 2015 Bournemouth, UK.
* Corresponding author. Academic Surgical Unit, 10th Floor QEQM, St Mary's Hospital, Praed Street, London W2 1NY, UK.
E-mail address: edward.stjohn@imperial.ac.uk (E.R. St John).
e
These authors contributed equally to this work.
Available online at www.sciencedirect.com
ScienceDirect
The Surgeon, Journal of the Royal Colleges
of Surgeons of Edinburgh and Ireland
www.thesurgeon.net
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e6
Please cite this article in press as: St John ER, et al., Completion of hand-written surgical consent forms is frequently suboptimal and
could be improved by using electronically generated, procedure-specific forms, The Surgeon (2015), http://dx.doi.org/10.1016/
j.surge.2015.11.004
http://dx.doi.org/10.1016/j.surge.2015.11.004
1479-666X/© 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland.
Published by Elsevier Ltd. All rights reserved.

2. Conclusion: Completion of hand-written consent forms suffers from wide variation and is
frequently suboptimal. Electronically-produced, procedure-specific consent forms can
improve the quality and consistency of consent documentation.
© 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and
Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Introduction
Obtaining a patient's informed consent involves much more
than having a patient sign a consent form. It is a two-way
dialogue between doctor and patient with the aim of facili-
tating their understanding of a procedure's risks, benefits and
alternatives in the context of their own life. Despite this, the
hand-written consent form still typically forms the centre-
piece of this dialogue, comprises the only written information
provided to a majority of patients and represents the sole
documented evidence of the consent process that can be
referred to for medico-legal purposes. This has acquired even
more importance following the recent UK Supreme Court
ruling in Montgomery vs. Lancashire Health Board.1
In March
2015 The Court rejected the “Bolam Test”, which judges the
actions of a doctor against a reasonable body of medical
opinion, in favour of requiring a doctor to take “reasonable care
to ensure that the patient is aware of any material risks involved in
any recommended treatment, and of any reasonable alternative or
variant treatments”. A material risk is further defined “as a risk
to which a reasonable person in the patient's position would be likely
to attach significance or a risk that a doctor knows e or should
reasonably know e would probably be deemed of significance by this
particular patient”.2
A thorough, accurate and legible consent
form can be used as evidence that such material risks have
been discussed.
Despite their importance, current hand-written consent
forms potentially suffer from significant disadvantages.
Firstly, hand-written forms may be illegible, particularly the
carbon copy version designated for the patient's records.
Secondly, there may be considerable variability in the content
of the forms as there is no standardisation for specific pro-
cedures and completion is performed by the surgeon on an ad
hoc basis. Thirdly, fields may be completed incorrectly or not
completed at all. Finally, we are gradually moving towards
electronic health records and the consent form will need to be
rendered digitally.3
An electronically generated consent form has the potential
to obviate many of these shortcomings. Legibility could be
ensured, variability could be minimised by pre-populated
procedure-specific elements and required information could
be mandated and even drawn from the electronic patient re-
cord. With the addition of touch screen technology to facili-
tate a digital signature the whole process could become paper-
less.
We performed a prospective audit of the quality of hand-
written consent forms for surgical procedures and piloted a
web-based system for the generation of procedure-specific
consent forms e OpInform.com.
Methodology
This investigation comprised two related phases carried out
sequentially at two separate NHS trusts between December
2012 and May 2014. In the first phase, we assessed the quality
of completion of standard hand-written consent forms during
a ten-week period. All available consent form type 1s (adult
consent to treatment) completed by surgical subspecialties for
operations during that period were included. Consent forms
were completed by doctors of senior house officer grade
(minimum one year clinical experience) or above. Non-
operative procedures (e.g, endoscopy, interventional radi-
ology) or consent forms 2 (parental consent on behalf of a
minor), 3 (consent when consciousness not impaired) or 4
(adults lacking capacity to consent) were excluded from the
investigation. Hand-written consent form 1s were generic pre-
printed proformas, based on the UK Department of Health's
recommended format, that contain blank elements required
to be completed by hand and signed off by both patient and
surgeon.4
Included consent forms were assessed by practising doc-
tors working at the Trust (foundation year one or higher) and
the surgeons completing the consent forms were excluded
from the process. Assessed criteria compromised the
completion of individual elements of the consent form that
were recorded as correct, incorrect, illegible or blank. As
shown in Table 1, these elements were then grouped into
three domains for the purpose of analysis e patient details,
procedure details and patient sign-off. Some form elements, such
as consent for blood transfusion or other procedures were not
assessed. A domain was considered “failed” if a single element
was not correctly documented or was illegible. Form fields
were rated as illegible if they contained text that was not
Table 1 e Individual form elements were grouped into
three domains and assessed as correct, incorrect, illegible
or blank.
Patient details Procedure details Patient sign-off
First name Procedure name Printed name
Surname Intended benefits Signature
Date of Birth
Hospital/NHS No.
Potential risks
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e62
Please cite this article in press as: St John ER, et al., Completion of hand-written surgical consent forms is frequently suboptimal and
could be improved by using electronically generated, procedure-specific forms, The Surgeon (2015), http://dx.doi.org/10.1016/
j.surge.2015.11.004

3. decipherable. In addition, the free-text entries contained in
the “potential complications” element of consent forms for
some specific procedures were analysed. The documentation
of a given complication was defined as being “heterogeneous”
if at least 25% of a procedure's consent forms differed in
whether or not they included the complication.
In the second phase of the investigation, we analysed the
potential complications element of standard hand-written
consent form 1s for missing risks and trialled an electronic,
procedure-specific consent platform. This phase was carried
out in a different NHS trust from phase one because of rota-
tion of the primary investigators. Furthermore, data collection
and the trial were restricted to the breast surgery unit to
facilitate detailed, expert-led analysis of the documentation of
potential complications and limit the number of procedures
the investigators would need to establish on the electronic
platform.
The quality of completion of all available hand-written
consent form 1s produced by surgeons from the breast sur-
gery unit during a ten-week period was assessed in the same
manner as described for the first phase. Furthermore, two
independent consultant breast surgeons assessed the docu-
mented risks to determine if essential complications were
missing. The assessors were blinded to other aspects of the
form including the operating surgeon and consenting sur-
geon. Forms were classified as missing complications only on
agreement of both assessors.
We developed an electronic, procedure-specific consent
platform e OpInform.com. The same surgeons in the breast
surgery unit who administered the hand-written consent
forms were given instruction on using the electronic platform
and trialled it during a six-week period. The quality of
completion and content of the electronically-produced con-
sent forms was prospectively assessed during the trial in the
same manner described for hand-written forms.
Results
Phase One e information in hand-written consent forms is
frequently missing or illegible and suffers from wide
variability
In phase one of the investigation we assessed the quality of
completion of hand-written consent forms generated by sur-
gical specialities in one NHS trust across a ten-week period.
Some 99 forms were appraised in total and the proportion of
consent forms from each speciality is detailed in Table 2.
General surgical, orthopaedic and gynaecological procedures
accounted for approximately 75%.
The failure rates for each domain of the consent forms are
given in Table 3. Some 10% of consent forms had incorrect,
illegible or missing responses in the patient details domain. The
failure rate for the procedure details domain was 30%. Of these
failures, 97% were due to illegible handwriting. The failure
rate for patient sign-off was 27% e the vast majority of which
were due to absence of printed name or date, though one form
had not actually been signed by the patient. Overall, only 47
(47%) of the consent forms had no domain failures.
The commonest homogenous procedures for which con-
sent forms were audited were laparoscopic cholecystectomy,
knee arthroscopy and hysterectomy. We analysed the number
of unique complications documented for each procedure.
Table 4 details the descriptive statistics for each procedure in
addition to the proportion of complications whose docu-
mentation was classified as heterogeneous (disagreement
between at least one-in-four forms). Even for these common
operations, there was a large degree of variation in the num-
ber of potential complications documented for a given pro-
cedure. For example, one consent form for laparoscopic
cholecystectomy documented three complications while
another form documented nine. Furthermore, the proportion
of heterogeneous complications was approximately 50% for
each procedure. This suggests that not only is the absolute
number of complications documented variable, there is also
little agreement between forms regarding the specific nature
of these complications.
Phase Two e important complications are frequently
missing from hand-written consent forms which could be
prevented by using electronic, procedure-specific forms
The second phase of the investigation was carried out at a
different NHS trust and was concerned with the prevalence of
failure to document potential complications on hand-written
consent forms. In addition, we piloted an electronic
procedure-specific consent platform. This phase of the
investigation was confined to consent forms produced by the
breast surgery unit to facilitate more detailed analysis of the
consent forms and limit the establishment of procedures on
the electronic platform to one surgical speciality.
Some 61 hand-written consent forms from the breast
surgery unit were assessed over ten weeks and, similarly to
phase one, the quality of completion was suboptimal with
high rates of failure in the patient details and procedure details
domains (Table 5a). Mastectomy (12/61) and wide local
Table 2 e The proportion of consent forms for procedures
from each speciality is given from the 99 assessed in
total.
Speciality Proportion of forms (%)
General 27
Orthopaedic 26
Gynaecology 22
Urology 14
Breast 4
Ear, Nose and Throat 2
Ophthalmology 1
Miscellaneous 3
Table 3 e The domain failure rates for hand-written
consent forms in phase one of the study.
Domain Failure rate (%)
Patient details 10
Procedure details 30
Patient Sign-Off 27
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e6 3
Please cite this article in press as: St John ER, et al., Completion of hand-written surgical consent forms is frequently suboptimal and
could be improved by using electronically generated, procedure-specific forms, The Surgeon (2015), http://dx.doi.org/10.1016/
j.surge.2015.11.004

4. excision (10/61) were the commonest procedures performed
and both demonstrated significant variability in the number
of potential complications documented with many classified
as heterogeneous (Table 5b). Assessment of the documented
risks of all 61 consent forms by two independent, blinded
consultant breast surgeons revealed that 44% (27/61) consent
forms were missing essential risks. Of these 27 forms, 67%
were missing more than one risk; the commonest being
infection (44%) and lymphoedema (26%).
To improve the quality of consent form completion and
reduce the variability in their contents, we developed a web-
based platform for generating procedure-specific consent
forms e OpInform.com. The platform is designed to produce
consent forms in portable document format (PDF) which
comply with the UK Department of Health's recommenda-
tions. We produced a database of common breast surgery
procedures with benefits and potential complications that
serves as the “back-end” to the platform. The supplementary
material contains screenshots from the platform and an
example consent form. The user selects the appropriate pro-
cedure and inputs the patient details into the electronic form
while suggested operation-specific risks and benefits are pre-
populated from the database. However, these suggestions can
be modified to create a bespoke consent form tailored to the
individual patient. The form is then printed for both the sur-
geon and patient to sign.
We prospectively re-audited the breast surgery unit's con-
sent forms for six weeks following the introduction of OpIn-
form.com and found no domain failures amongst the 29
consent forms produced using the electronic platform. Con-
sent forms for wide local excision were the commonest
audited (seven forms) and there was no variability between
forms in the number or nature of the potential complications
documented.
Discussion
Obtaining informed consent for a surgical procedure is crucial
from both a medico-legal and ethical standpoint. Failure to do
so adequately may expose a surgeon to accusations of negli-
gence or even battery and shows little respect for a patient's
autonomy. The hand-written consent form is currently cen-
tral to the consent process in the majority of institutions,
serving the not entirely aligned roles of medico-legal docu-
mentation and provision of written information to the patient.
It is difficult to estimate the impact of poorly completed con-
sent forms on patient complaints and negligence claims. Such
claims are rarely the result of a single cause and more
commonly arise from a multiplicity of factors, amongst which
issues of consent and inadequate clinical record keeping are
certainly prominent.5e7
A recent retrospective Australian
study by Gogos et al. found that 5% of patient complaints and
malpractice claims involved alleged deficiencies in the con-
sent process.6
In 71% of these cases the primary allegation was
that was that a resulting complication had not been
mentioned or fully understood e a poorly completed, illegible
consent form is unlikely to offer much defence for the
accused. Despite their importance, we have demonstrated
that the completion of hand-written consent forms is
frequently suboptimal and suffers from unacceptable
variability.
In phase one, we prospectively audited 99 consent forms
produced by multiple specialities and found less than half
contained complete, accurate and legible documentation
throughout. In phase two, analysis of a further 61 consent
forms produced by the breast surgery unit at a different UK
Table 4 e Free-text entries for potential complications were analysed for the commonest procedures in each subspecialty
during phase one of the study and descriptive statistics produced. The total number of unique complications documented
amongst all the consent forms for a particular procedure is reported. In addition, the median and range of the number of
documented risks is given. A potential complication for a given procedure was described as “heterogeneous” if at least a
quarter of forms disagreed regarding its inclusion. The number and proportion of heterogeneous complications is reported.
Procedure No. of forms Complications
Total unique Median Range Heterogeneous
Laparoscopic cholecystectomy 7 12 6 2e9 7 (58%)
Arthroscopy 4 6 5 3e5 3 (50%)
Hysterectomy 4 5 3.5 3e5 2 (40%)
Table 5a e The domain failure rate for hand-written
consent forms in phase two of the study.
Domain Failure rate (%)
Patient details 16
Procedure details 38
Patient Sign-Off 0
Table 5b e Free-text entries for potential complications were analysed for the commonest procedures in phase two of the
study.
Procedure No. of forms Complications
Total unique Median Range Heterogeneous
Mastectomy 12 13 5 3e9 8 (62%)
Wide local excision 10 16 9 9e15 4 (25%)
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e64
Please cite this article in press as: St John ER, et al., Completion of hand-written surgical consent forms is frequently suboptimal and
could be improved by using electronically generated, procedure-specific forms, The Surgeon (2015), http://dx.doi.org/10.1016/
j.surge.2015.11.004

5. trust revealed similar findings. Patient details were missing or
inaccurate in approximately 10% of forms which could have
repercussions as consent forms are often cross-referenced
with the patient identification bracelet during the WHO sur-
gical safety checklist.4
The documentation of the intended
procedure's name, benefits or potential risks was inadequate
in 30e40% of cases, largely due to illegible handwriting. The
assessment of legibility entails a degree of subjectivity but, as
medical trainees, the assessors in the present study could be
expected to have better comprehension than the average
layperson. We also found that the number of complications
documented for a given procedure varied widely, even for
common surgeries, and that the level of disagreement with
regards to the specific nature of these complications was high.
Of more concern, two experts agreed that 44% of the forms
assessed in phase two of the investigation were missing
essential complications. These were not esoteric; they were
common complications such as infection and lymphoedema
(in the context of axillary surgery). Users of the electronic
consent platform had the option to modify the pre-populated
suggested potential complications. However, using wide local
excision as a reference procedure, we found no variability in
the number or nature of complications documented on the
electronically-produced forms. This suggests that the vari-
ability in the documentation of potential complications on
hand-written forms is not due to inherent disagreement be-
tween surgeons regarding the potential complications of a
procedure or individual differences between patients. Rather,
it is a consequence of the ad hoc nature in which hand-written
forms are completed, from memory, often under considerable
timeepressure.
Other studies have investigated the quality of documen-
tation of hand-written consent. Rahman et al. and Thakkar
et al. both found that the legibility of forms for consent to
orthopaedic surgery was generally good but that there was a
high degree of variability regarding the inclusion of potential
complications.8,9
High variability and failure to document key
complications has been further demonstrated in consent for
urological and general surgical procedures and has lead to
calls for standardised, procedure-specific consent forms.10e14
Isherwood et al. improved the documentation of consent
forms for total hip replacements by creating a “complications
sticker” that listed the specific complications for the proce-
dure. In the UK, Barritt et al. developed Orthoconsent, a web-
based platform for the production of consent forms for or-
thopaedic surgery. This platform has been endorsed by the
British Orthopaedic Association and the authors demon-
strated that use of the Orthoconsent forms significantly
improved patients' knowledge of their planned procedure.15
In
the United States, Issa et al. have commercialised a web-
based, multi-speciality, procedure-specific consent system
(iMedConsent™) that is now employed in over 200 hospitals.10
However, the recent change in the UK law on consent stresses
that a surgeon must disclose risks that would probably be
deemed of significance by their specific patient.1,2
With this in
mind, legal commentators have cautioned against taking a
generic, pro forma-based approach to consent because of fear
that this could compromise effective patient dialogue and
prevent forms being individualised.2
However, it must also be
recognised that some type of reminder is helpful to prevent
key risks from being omitted in error. The ability to create a
bespoke form tailored to the individual is therefore crucial in
any consent platform.
OpInform.com is an internet-based platform for the crea-
tion of electronic, procedure-specific consent forms based
upon the UK Department of Health templates. We should
stress that, as an electronic consent platform, OpInform.com
does not attempt to re-invent the fundamentals of the con-
sent process. Rather it simply addresses the demonstrated
deficiencies of hand-written consent forms to the benefit of
both clinicians and patients. However, electronically-
generated consent forms could be produced faster than their
hand-written counterparts which may facilitate the consent-
ing of patients during an outpatient clinic rather than in an ad
hoc manner on the morning of surgery as is common practice.
This would allow patients time to consider the proposed
procedure without duress and consent could then be re-
confirmed on the day of surgery.
OpInform.com has two major advantages over other sys-
tems. Firstly, although suggested risks and benefits are pre-
populated for a specific procedure, these are completely
modifiable. In this way, we introduce the benefits of “semi-
standardisation” based upon the opinion of a body of rele-
vant consultant experts while maintaining the freedom to
tailor the form to the individual patient. Secondly, the system
is designed for pan-speciality use, rather than being
restrained to a particular cohort of procedures. Forms for
procedures that do not yet exist can be quickly added to the
database by using the “suggest an operation” link. Procedures
suggested for inclusion would subsequently be validated
prior to making them available to end-users. In their current
format the forms are printed after completion for the patient
and surgeon to sign, but implementation of a digital signa-
ture is feasible and would make the process truly paperless.16
The application could also be integrated into hospital elec-
tronic health record systems to allow patient details to be
automatically populated and the form to be saved in a pa-
tient's electronic notes.
Conclusion
In summary, we have demonstrated that the completion of
hand-written consent forms is frequently suboptimal and
suffers from wide variation. Against the backdrop of the ever-
increasing use of digital documentation in healthcare it is
perhaps surprising that electronic, procedure-specific consent
forms are not already the standard of care. This may be a
reflection of the lack of a pan-speciality platform that is fully
modifiable by the end-user. We believe that OpInform.com
meets these criteria and can push the consent process into the
digital age.
Conflict of interest
Edward St John conceived and designed OpInform.com while
Alasdair Scott is involved in the design process. Neither
author currently have any financial interests in the project.
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e6 5
Please cite this article in press as: St John ER, et al., Completion of hand-written surgical consent forms is frequently suboptimal and
could be improved by using electronically generated, procedure-specific forms, The Surgeon (2015), http://dx.doi.org/10.1016/
j.surge.2015.11.004

6. Acknowledgements
Loretta Lau, Clarisa Choh, Alice Thompson & Kirsty Dawson
for their help with data collection.
Appendix A. Supplementary data
Supplementary data related to this article can be found at
http://dx.doi.org/10.1016/j.surge.2015.11.004.
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t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e66
Please cite this article in press as: St John ER, et al., Completion of hand-written surgical consent forms is frequently suboptimal and
could be improved by using electronically generated, procedure-specific forms, The Surgeon (2015), http://dx.doi.org/10.1016/
j.surge.2015.11.004