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ORIGINAL ARTICLE

Consenting For Total Hip Replacement – An Audit Of Practice At A Specialist Centre

Benjamin JF Dean, David S Baxter, Erlick Pereira, Jon Matthews, Hemant Pandit, Max Gibbons.

Nuffield Orthopaedic Centre, Oxford

Address for Correspondence:
BJF Dean
Flat3, 298 Banbury rd, Oxford, OX2 7ED
Phone:    01865516621

E-mail: bendean@doctors.net.uk

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

Reference :

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This is a peer reviewed paper 

Please cite as: Benjamin JF Dean: Consenting For Total Hip Replacement – An Audit Of Practice At A Specialist Centre

J.Orthopaedics 2009;6(2)e10

URL: http://www.jortho.org/2009/6/2/e10

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