Abstract:
This
study aimed to assess the degree to which the frequent and
serious complications of total hip replacement surgery were
documented by the consenting surgeon. The consent forms of
one hundred patients undergoing primary total hip replacement at
a specialist orthopaedic hospital were prospectively analysed.
The documentation of the risks of surgery was extremely
variable. Documentation of the risks of DVT(97%), PE(92%),
infection (98%) and dislocation (97%) approached 100% of the
consent forms audited. However the documentation of other
risks of surgery such as fracture (35%), leg length discrepancy
(75%), nerve injury (71%), vascular injury (70%) and
loosening/need for revision surgery (62%) was not as
comprehensive. The failure to mention the complications of
surgery when carrying out an informed consent may result in the
surgeon being held liable for a negligent failure to inform.
Following this audit, specific stickers that detail all the
frequent and serious risks of total hip replacement surgery have
been introduced to ensure that the documentation of an informed
consent is rigorous for all patients. The further
standardisation of the consent process appears inevitable in
today’s increasingly litigious environment.
J.Orthopaedics 2009;6(2)e10
Keywords:
hip;
replacement; consent; total; complications
Introduction:
Consent
is an important part of the surgical process. New
guidelines in the UK regarding informed consent mean that
doctors must tell patients about any frequent or serious
complications that could result from an operative procedure
(1-3), Consent is only considered legally binding if it is
‘informed’. Courts now expect that the
“reasonable” doctor would notify the patient of the frequent
and serious risks associated with the relevant surgical
procedure (4).
Total
hip replacement (THR) is a common procedure with over fifty
thousand primary procedures and over five thousand revision
procedures being carried out every year in the UK (5). In
the USA from 1990 to 2002 the rate of primary THR per 100,000 of
the population has increased by approximately 50%, while the
revision rates do not appear to be declining with time, meaning
that the number of hip revisions appears likely to increase
significantly over the years ahead(6).
The
British Orthopaedic Assocation’s (BOA) online form for THR
consent include common risks (2-5%) which are made up of deep
vein thrombosis (DVT)/pulmonary embolus (PE), bleeding, pain,
wear/loosening, altered leg length, dislocation. Also
included is the less common risk (1-2%) of infection and the
rare risks (<1%) which include altered wound healing, nerve
damage, bone damage (fracture), blood vessel damage and death
(7).
In
the UK 1.14% of patients undergoing primary THR experienced an
adverse intraoperative event, these consisted of different types
of fracture (5). The intraoperative fractures consisted of
the following: calcar crack (32%), pelvic penetration (17%),
shaft fracture (6%), shaft penetration (9%), trochanteric
fracture (19%) and other (23%). The rate of nerve palsy
following THR does vary in the literature but is approximately
1% ((8), while serious vascular injuries following THR are
extremely rare (9).
Many
factors can affect the survival rate of hip prostheses including
patient age and the type of components used (10). An
excellent survival rate is generally seen as ≥90% at 15
years. The UK Joint Registry figures reveal the
indications for revision hip surgery being aseptic loosening
(60%), lysis (21%), pain (20%), dislocation (14%), wear (13%),
periprosthetic fracture (8%), infection (8%), malalignement
(6%), fractured components (3%), incorrect sizing (1%),
dissociation (1%), and other (5%).
The
purpose of this audit was to examine the extent to which a fully
informed consent was documented for patients undergoing primary
THR in our institution and to examine whether a marked
difference in the documentation of complications was observable
between consultants and surgeons in training.
Materials
and Methods:
A
prospective audit of consent forms of 100 consecutive primary
THRs over a two month period from August to October 2008 was
performed. Our institution is a tertiary referral centre
and teaching hospital where over six hundred primary THRs are
performed every year. There is a dedicated pre-operative
admission clinic (POAC) which all patients attend prior to their
admission, the consent forms are completed here as well as any
neccessary pre operative medical tests and documentation.
The consenting surgeons are all fully trained to undertake a
primary THR unsupervised. The POAC involves the whole
multidisciplinary team including surgeons, junior medical staff,
nursing staff, physiotherapists and occupational therapists.
The audit included only patients undergoing primary THR.
All patients were adults. The patient details, the grade
of consenting doctor, the aim of surgery, and the serious and
frequent risks of surgery that were documented on the consent
form were recorded. We hypothesised that the documentation
of consent would not vary a great deal from patient to patient.
Results :
The results
documented in table (i) indicate the variability in the consent
process.
Risk
of surgery
|
%
cases with specific risk documented on consent form
|
Included
in BOA guidelines (BOA risk category)
|
Fracture
|
35
|
Yes
(<1%)
|
Neurological
damage
|
71
|
Yes
(<1%)
|
Vascular
damage
|
70
|
Yes
(<1%)
|
Leg
length discrepancy
|
75
|
Yes
(2-5%)
|
DVT
|
97
|
Yes
(2-5%)
|
PE
|
92
|
Yes
(<1%)
|
Infection
|
98
|
Yes
(1-2%)
|
Dislocation
|
97
|
Yes
(2-5%)
|
Failure/loosening/need
for revision surgery
|
62
|
Yes
(2-5%)
|
Death
|
7
|
Yes
(<1%)
|
Anaesthetic
risks
|
14
|
No
|
Medical
complications
|
33
|
No
|
Ongoing
Pain
|
34
|
Yes
(2-5%)
|
Stiffness
|
27
|
No
|
Wound
healing problems
|
2
|
Yes
(<1%)
|
Others
(limp/amputation/Girdlestone’s)
|
11
|
No
|
Table (i)
– The rate of documentation of the risks of THR
Table
(i) shows the rate at which specific risk were documented on
consent forms and compares this to the BOA guidance on consent
for THR. Documentation of the risks of DVT(97%), PE(92%),
infection (98%) and dislocation (97%) approached 100% of the
consent forms audited. The documentation of other risks of
surgery such as fracture (35%), leg length discrepancy (75%),
nerve injury (71%), vascular (70%) and loosening/need for
revision surgery (62%) was not as comprehensive. Several
of the risks mentioned by surgeons are not included in the BOA
guide consent form such as anaesthetic risks (14%), medical
complications (33%), stiffness (27%) and limp/amputation/girdlestone’s
(11%).
A
break down of the percentage of adverse events documented by
consultants surgeons versus surgeons in training is displayed in
table (ii).
Risk of surgery
|
%documented by Consultant
|
%documented by surgeon in training
|
Fracture
|
38
|
31
|
Neurological damage
|
60
|
84
|
Vascular damage
|
56
|
84
|
Leg length discrepancy
|
80
|
69
|
DVT
|
98
|
96
|
PE
|
93
|
91
|
Infection
|
98
|
98
|
Dislocation
|
98
|
96
|
Failure/loosening/need for revision
surgery
|
73
|
49
|
Death
|
9
|
4
|
Anaesthetic risks
|
11
|
18
|
Medical complications
|
53
|
9
|
Ongoing Pain
|
27
|
42
|
Stiffness
|
25
|
29
|
Wound healing problems
|
0
|
4
|
Others (limp/amputation/Girdlestone’s)
|
16
|
9
|
Table
(ii) – The rate of documentation of risks by consultants
versus surgeons in training
The
consultant group were better than the surgeon in training group
as regards documenting the following risks: loosening/need for
revision surgery (p=0.02) and medical complications
(p<0.0001). Neurovascular complications were better
documented in the surgeon in training group than the consultant
group (p<0.01). All statistical tests were performed
using a 2 by 2 contingency table and a chi squared test.
Discussion :
Our
results show that it is rare for all the serious complications
of surgery to be fully documented on the consent form.
Whilst there are several key areas that warrant discussion, the
most striking finding is that no one adverse event achieved 100%
documentation in all 100 consents audited. While there is
some degree of overlap between certain risks of surgery, for
example a pulmonary embolus can also result in death, this does
not fully account for the frequency at which certain risks were
not documented on consent forms. Consultants will have
been exposed to more complications over their longer careers and
this accounts for their superior documentation of certain risks,
however it does not explain why the surgeons in training were
better at documenting the risk of neurovascular injuries.
The
BOA guide consent form serves as a useful standard for
comparison, while it is also interesting that several of the
risks mentioned by surgeons in our study are not included in the
BOA guide consent form. As previously unencountered
complications of surgery become apparent over time, for example
pseudotumours associated with metal-on-metal hip resurfacings
(11) and squeaking associated with ceramic-on-ceramic total hip
replacement (12), it is clear that the consent process needs to
be constantly updated to remain as comprehensive and
‘informed’ as possible. The BOA consent form does not
leave room for mention of which design of implant is to be used,
for example whether an experimental implant or an implant with
no 10 year survivorship data is to be used. In the future
if an experimental implant were to catastrophically fail early
as the 3M Capital hip system did (Roirdan P et al. Lessons of a
hip failure. BMJ. 1998 June 27, 316(7149).) then the
medico-legal implications for surgeons could be serious.
The
variabilty in the documentation of the consent process is
unlikely to be an isolated phenomenon for primary THR, it is
likely that this occurs across the board for a variety of
surgical procedures and in a variety of surgical specialties.
It is also unlikely that this problem is confined to our
institution. We conducted a survey of the consent forms
used for THR at ten orthopaedic centres in the UK and found that
only one used PSCFs (Procedure-specific consent forms).
Following this audit, practice has changed at our institution to
incorporate the use of specific stickers in consenting for
primary THR. These stickers ensure that serious risks are
now always documented on the consent forms for patients
undergoing primary THR. It is also to be suggested that
this change of practice be included in the induction procedure
for new doctors in our NHS Trust.
Our
study only analyses what has been documented on consent forms.
It does not analyse what has been documented elsewhere in the
notes or what the patient recalls from various discussions with
the surgical team. Other studies have shown that patient recall
of the information at the consent interview is generally poor
(13); while even if a risk was discussed, if it was not
documented then it might as well have not been discussed in the
eyes of the courts. Our study could be improved by
increasing the number of consent forms analysed and by repeating
the audit with the new system in place to see whether the
stickers are used for all consent forms.
Obtaining
consent is a crucial part of the surgical process. In the
UK the General Medical Council (GMC) stipulates that (3):
“In
order to have effective discussion with patients about risk, you
must identify the adverse outcomes that may result from the
proposed options. This includes the potential outcome of
taking no action. Risks can take a number of forms; but
will usually be side effects, complications or the failure of an
intervention to achieve the desired aim. Risks can vary
from common but minor side effects, to rare but serious adverse
outcomes possibly resulting in permanent disability or death.”
And:
“You
must tell patients if an investigation or treatment might result
in a serious adverse outcome, even if the likelihood is very
small. You should also tell patients about less serious
side effects or complications if they occur frequently, and
explain what the patient should do if they experience any of
them.”
Poor
communication is often an important factor in the origins of
complaints and litigation (14). A recent survey of the
American Association of Hip and Knee Surgeons (AAHKS) revealed
that the most frequently cited sources of litigation were (in
descending order of occurrence) nerve injury, leg length
discrepancy, infection, vascular injury and dislocation of
implant (15). This study also remarked that the incidence
of malpractice claims could well be decreased by improving
patient education and counselling during the the process of
obtaining an informed consent. As regards nerve palsy
following THR, what is often considered negligent medico-legally
is not that a palsy has occurrred, but the faulty management of
the palsy postoperatively, however the preoperative warning of
the risk of palsy should always be given (8).
There
are many examples of ways in which improving informed consent in
orthopaedics can reduce the likelihood of future malpractice
claims (16, 17). This is a general concept for all types
of surgery, methods that increase the patient’s understanding
of the surgical procedure (in this case cataract surgery) are
likely to result in more satisfied patients (18).
Failure
to mention the complications of surgery when carrying out an
informed consent not only results in patient dissatisfaction
when complications occur, but may also result in the surgeon
being held liable for a negligent failure to inform (1, 19, 20).
Therefore a patient now need only establish breach of duty for
failing to disclose a risk. Causation can be established by the
patient simply stating that he or she would have thought about
the risk and postponed or cancelled the surgery. In the case of
the Chester ruling, if a patient experiences an adverse outcome,
they need only demonstrate that they would not have gone ahead
with a procedure at the time (regardless of the necessity) if
they had been informed of the risks irrespective of their
frequency to prove negligence at the time of consent (21). In
Chester, it was suggested that the patient would have sort a
second opinion. It is therefore obligatory that doctors record
in the notes exactly what risks have been discussed with the
patient, as this is the crucial evidence to assist in defending
a breach of duty allegation (19). Patient information
leaflets are useful tools for the surgeon to improve the recall
of the information given to the patient (22) and it is important
to document when these leaflets are given to patients, however
they should not be a substitute for the rigorous documentation
of the risks associated with surgery.
PSCFs
are a possible solution (20) and would certainly result in more
routinely rigorous documentation on consent forms. However
there may be a tendency for the consenting surgeon to explain
the risks less thoroughly if they are all listed on the PSCF,
and the PSCF may result in excessive patient anxiety if, for
example, the risk of death has to be mentioned for every
surgical procedure. The British Orthopaedic Association
has recently endorsed a website that allows surgeons free access
to a bank of pre-written consent forms (7) with the aim being to
improve the level of information received by the patient and
lessen the risk of successful litigation against surgeons and
NHS Trusts.
However,
pre-written consent forms, whilst still in their infancy, could
also include some notification that other procedures and
non-operative treatments have been discussed. Thus when
complete, the consent is a documentation that the patient has
not only been informed of serious and common adverse outcomes,
but also that they have been informed of any alternative
treatments.
Despite
the ease of use of PSCF, many respondents in a recently
published survey (20) expressed confusion at the ‘tick the
box’ style. The opponents to a standardised consent form
suggested that ticking the box did not constitute a medical
discussion surround said adverse outcomes. However, PSCFs can in
fact be used as not only a prompt for a thorough and detailed
consent of a patient but can also conform to the standard of
that expected within the United Kingdom - the Bolam test (13).
In Bolam v Friern Hospital Management Committee, it was accepted
that if a doctor reaches the standard of “a responsible body
of medical opinion” then there can no negligence (13). Our
audit suggests that common adverse outcomes are at times often
omitted from a non-procedure specific consent form.
A
negligent failure to inform promises to be an increasingly
significant future source of medical litigation; Smallwood and
Skene compared recent events in Australia to those in the UK,
remarking on the trend of judges to apply a tougher standard to
the information that doctors should give their patients (23).
In this context improving the documentation of the process of
consent is in the interests of both doctors and patients. Our
findings suggest that improvement can and should be made.
Methods that improve the documentation of the risks of surgery
do not have to result in less satisfactory discussions between
the patient and the surgeon.
Acknowledgements:
We
would like to thank all the hip and knee surgeons at the
Nuffield Orthopaedic centre for their help in carrying out this
work.
Conflicts of
interest:
none declared
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|