Assessing the quality of consent in elective hip and knee arthroplasty: Do modern orthopaedic surgeons make the cut?

Abstract

Introduction

Improper consent is a failure of clinical care and also a major cause of litigation within health care authorities. 4% of surgical negligence claims are attributed to improper consenting in the NHS, with an average settlement fee of approximately £40,000 per claim. Improving quality of consenting therefore not only improves patient care but could also reduce healthcare cost.

Method

A retrospective analysis of 100 elective hip and knee arthroplasties at a district general hospital in the South of England. Clinic letters and consent forms were reviewed, using the British Orthopaedic Association (BOA) consent proforma as a comparison standard. Quality of consent was reviewed based upon inclusion of BOA suggested risks.

Results

40% of hip arthroplasty clinic letters and 20% of knee arthroplasty clinic letters did not include a risk discussion. Common risks on consent forms when compared to BOA standards were 84.8% compliant in knees and 88.8% in hips. Less common risks on consent forms were 100% compliant in knees and 96% in hips. Rare risks on consent forms were 74.8% compliant in knees and 57.7% in hips. Notably blood clots and infection were consented for in almost all patients. Risk of death meanwhile, was only consented for 62% of the time, across both procedures.

Conclusion

Standard of consenting in this audit falls short of BOA standards. Improvement is needed to improve patient care and avoid medical litigation. An integrated electronic form linking consent process of both outpatient and pre-operative review could be a beneficial intervention.

1. Introduction

Since the 2019 revision of GMC guidelines on consenting, UK doctors have been expected to provide information based on the Montgomery principle.¹ This describes a duty for doctors to take reasonable care to ensure that patients are aware of any “material risks” of a recommended treatment, as well as any reasonable alternative therapies.¹ Whether a risk is material doesn't only depend on frequency of occurrence. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk. Additionally, doctors should reasonably be aware whether patients undergoing a procedure would be likely to attach significance to the risk. Simply providing the information or having a signed consent form may not be enough to evidence consent but can be helpful as part of the process.

Most information surrounding risk discussion and consent is provided face-to-face,² under potentially stressful conditions for the patient, that may affect retention. As such, it is understandable why concerns regarding consent provide one of the most common sources of litigation for the National Health Service (NHS).³ Issues surrounding consent make up 4% of all surgical negligence claims - averaging £40,322 per claim.⁴ The 2015 GIRFT report⁵ on orthopaedic services identified areas of unjustifiable variation in service provision, the resolution of which would provide cost savings (in part from reduced litigation) and improve service quality. With primary care referrals to orthopaedics set to increase by 7–8% per annum and 25% of all surgical interventions being related to trauma and orthopaedics, the scope for negligence claims in relation to elective orthopaedic consenting has never been higher. The NHS Litigation Authority (now NHS Resolution), estimated that in 2012/13 there were £23bn worth of potential negligence claims against the NHS.⁶ Between 2007 and 2012, hip and knee procedures accounted for 32% of all orthopaedic claims.⁵ Additionally, in the 3 years leading up to 2012, orthopaedic litigation costs increased by £30 m per annum, with most claims being labelled as ‘avoidable’.⁵

More recently, in the 2019/20 NHS Resolution Annual Report and Accounts,⁶ potential negligence claims had risen to £84bn, with £2.3bn paid out. 323 claims were for values of over £2 m, with orthopaedics tied with emergency medicine for 12% of all claims pursued, by number.⁶ Perhaps more important than the economic impact, is the impact on patient care. For example, proper informed consent has been shown to reduce pre-procedural anxiety in patients.⁷ One paper also concluded that consent that is presented to patients in both a written and oral form reduces anxiety.⁸ It is clear that despite increased awareness and education about the importance of consent there is scope for further improvement.

2. Method

We performed a retrospective analysis of 100 of the most recent elective arthroplasties (50 hips and 50 knees) at a district general hospital in the South of England between January 17, 2020 and March 11, 2020. The surgeons involved comprised a diverse mix of training backgrounds and demographics, representative of the majority of trusts around the UK. Using electronic and physical documentation, data was collected from both clinical letters and consent forms. The grade of the consenting surgeon was noted in both instances. Pre-operative clinic letters were reviewed, recording the presence of a risk discussion and whether procedure specific risks had been discussed. Particular risks discussed at pre-operative clinic were not further sub-analysed. The consent form was then compared against the BOA endorsed arthroplasty consent proforma to examine whether the suggested specific risks were appropriately documented. All consent forms were checked for patient signatures and dates, confirming that the discussion had taken place prior to the procedure being carried out.

The BOA endorsed consent proforma used for comparison includes similar risks for both hip and knee arthroplasty (Table 1). They are stratified by incidence as “common” (incidence 2–5%), “less common” (incidence 1–2%), and “rare” (incidence < 1%) by the BOA. “Common” risks include blood clots; bleeding; pain; prosthetic wear/loosening/need for revision; altered leg length (common in hip arthroplasty, rare in knee arthroplasty), joint dislocation (common in hip arthroplasty, rare in knee arthroplasty), and stiffness (knee arthroplasty only). “Less common” risks include infection, while “rare” risks include altered wound healing; nerve or vessel damage; bone damage or fracture; and death. The proforma has a reading age of 14 years and encompasses the generic principles outlined in the United Kingdom Department of Health (UKDH) and General Medical Council (GMC) documents on informed consent.^9,10 This includes information on who can be expected to treat the patient, as well as the type of anaesthesia, risks and complications, benefits of the treatment, alternative treatments, and post-operative limitations.

Table 1.

British Orthopaedic Association procedural risks for hip and knee arthroplasties.

Risks	Hip	Knee
Common (2–5%)	Blood Clots	Bleeding
	Bleeding	Pain
	Pain	Deep Vein Thrombosis
	Altered Leg Length	Knee Stiffness
	Joint Dislocation	Prosthesis Wear
Less Common (1–2%)	Infection	Infection
Rare ( < 1%)	Altered Wound Healing Nerve Damage Bone Damage Blood Vessel Damage Pulmonary Embolism Death	Altered Leg Length Joint Dislocation Nerve Damage Bone Damage Blood Vessel Damage Pulmonary Embolism Death

See Table 1. British Orthopaedic Association procedural risks for hip and knee arthroplasties.

3. Results

In preoperative clinics for both elective hip and knee arthroplasties, 96% were dictated by consultants with the remaining 4% being by specialist registrars/fellows (SpRs). The extent of discussion around procedure-specific risks is summarised in Table 2.

Table 2.

Risks discussed at preoperative clinic.

Discussion	Hip Arthroplasty %	Knee Arthroplasty %
Procedure-specific risks	28	32
Non-specific risks	26	48
No discussion of risks	46	20

See Table 2: Risks Discussed at Preoperative Clinic.

100% of elective consent forms assessed were signed on the day of surgery. In hip arthroplasty, 82% of consenting was done by SpRs, 14% by consultants, and 4% by senior house officers (SHOs). In knee arthroplasty, 64% of consenting was carried out by SpRs, 34% by consultants, and 2% by SHOs. Table 3 shows the frequency with which each BOA specific risk was mentioned on the consent form. Table 4 shows the frequency with which risks were documented, grouped by rate of occurrence.

Table 3.

The frequency with which specific risks were mentioned on the pre-operative consent form.

Risk	Hip Arthroplasty %	Knee Arthroplasty %
Pain	54	84
Bleeding	88	94
Clots	100	100
Stiffness	n/a	84
Wear/loosening/revision	74	82
Altered wound healing	58	68
Dislocation	86	30
Altered leg length	96	2
Infection	100	96
Bone damage/fracture	74	74
Nerve damage	90	90
Vessel damage	90	88
Death	62	62

Table 4.

Frequency of risk documentation grouped by rate of occurrence.

	Hip	Knee
Common (2–5%)	84.8% (n = 5)	88.8% (n = 5)
Less Common (1–2%)	100% (n = 1)	96% (n = 1)
Rare (<1%)	74.8% (n = 5)	57.7% (n = 6)

See Table 3: The frequency with which specific risks were mentioned on the pre-operative consent form.

See Table 4: Frequency of risk documentation grouped by rate of occurrence.

4. Discussion

From our sample, it is evident that discussion of risks for elective arthroplasty falls short when compared to the BOA's endorsed standard. On review of the quality of consent discussions at the preoperative arthroplasty clinic there was a low frequency of documentation that a discussion regarding risk had occurred and in particular which specific risks had been outlined to the patient. This is disappointing as the clinic setting has been shown to be superior to the pre-operative ward with regards to patient understanding and retention of information given to them during the consent process.¹¹ As is the case whenever examining documentation, it may be the case these discussions were had but not documented. Nonetheless, with a focus on the medico-legal impact that lack of proper patient discussion and consent, verbal discussion without documentation is void. This could pose substantial problems in the instance that these cases were brought to court.

From our data it is apparent that there is a high level of variation in risk discussion and quality of consenting. Studies suggest that deficiencies and variation may be due to multiple factors. These include consenting by junior staff, deficient documentation and the use of abbreviations.^{12, 13, 14} Interestingly in our study only a small proportion of the consent forms and none of the pre-admission clinics were completed by SHOs. Therefore, we would not be able to pertain all blame on just being junior. Additionally, while information may not be volunteered by the consenting doctor, there is variation in patients with respect to how much they wish to know, and whether they fully comprehend the explanations given. One solution to this could be integrating and linking the consent process. With a similar discussion and documentation happening at both the pre-operative clinics and the day of surgery, patient understanding would be better. In turn lead, this could lead to better patient reassurance.

Patient recall of procedural risks has been shown to decrease with increased time from consent to operation, as well as even more precipitously post-operatively.^12,15 Our study did not particularly look at time from risk discussion to surgery, however this would be an additional factor that could be altered to improve consent. By moving clinic appointments as close as possible to the date of operation, patients would have increased recall of risks, which could act also as a reassuring factor. This intervention would be very difficult to implement in an NHS system, with waiting times for operations already increasingly long. Repetition has also been linked to improved recall.¹⁶ This adds value to an integrated system whereby risks are discussed preoperatively in both clinic and on the day of theatre.

In elective hip and knee surgery, successful litigation frequently comes from infections, injury to nerves or vessels (for hip surgery, the sciatic nerve in particular), leg-length discrepancy, intraoperative fracture, and thromboembolic events.¹⁷ Reviewing our data, generally these were well accounted for in our sample. Infections were consented for 100% of the time in both operations, with damage to surrounding structures also being mentioned in a large majority of documentation.

Whilst our doctors performed well at consenting for the complications of bleeding, clots and infection, there were an unacceptable number of patients who were not consented for important complications. For instance, only 54% of patients who underwent hip arthroplasty were consented for the common risk of pain. Leg length discrepancy was only accounted for in 2% of knee arthroscopies. In both hip and knee arthroplasties death was only mentioned in the consent paperwork 62% of time. Following the Montgomery principle these are both complications that any patient would reasonably attach significance to.

This paper is limited in that it only contains data from two specific procedures in one surgical centre. Of course, in order to increase the applicability of our findings to orthopaedic surgery in general, it would be beneficial to repeat a similar audit at different centres. Another area for further research on this topic could be to assess recall of risks by patients who have been consented. This would be useful in ascertaining just how informed out consent procedure really is.

This leads to our consideration about how we could improve the consenting of orthopaedic arthroscopies. We have identified that poor quality of consenting can lead to medico-legal issues. Moreover, the standard of consenting in this study is not up to the required standard. As such we have devised the following recommendations to help consenting in the future:

4.1. Setting

Obtaining consent in the much calmer clinic environment has been shown to reduce litigation risk, as compared to preoperative waiting areas¹⁷. This is in addition to dictating discussions regarding risk in the clinic letter or operative note, as compared to having a signed surgical consent form alone. We recommend that consent forms should be signed in clinic with specific time set aside to do so, with patients given more time to digest and understand information surrounding risks. This will allow any questions to form and be answered either at clinic or on the day of surgery. The obvious barrier to this is time constraint in what can already be an incredibly busy clinic. Patient understanding may also be augmented by provision of informative booklets at the preoperative clinic.

4.2. National, standardised consent form specific to each joint

Consent forms themselves can also be improved, with procedure-specific consent forms better informing patients and reducing the burden of litigation.^4,18 The BOA's accredited consent forms were found to increase patient understanding of their procedures compared to manually completed forms.^{9,19, 20, 21} Using a standardised consent form can help reduce the risk of risks not being appropriately discussed.

4.3. Use of electronic consent forms

Building on the point of improving the consent form itself, electronic consent forms could be used as opposed to handwritten ones. These been shown to be standardised, legible, and understandable to patients, assisting in fully informing end users.²² It would also help with the issue of having to find consent forms which can often be a challenge!

4.4. Reviewed by consultant in charge of the list

With likelihood of worse consenting being inversely related to the seniority of the doctor performing consent, it would be prudent that consent forms are checked over by a consultant prior to surgery. This could be on the day of surgery and simply be a case of countersigning the consent form based upon the risks documented. Thereby, had any risks been misidentified or forgotten, it gives an extra barrier to reducing the risk of miscommunication and malpractice lawsuits. It should be noted that this feature should not be compulsory but rather accessory to better consenting. This is because the consultant is not always present in the list and some operations occur overnight, out of hours or as an emergency and should not be delayed based upon the lead consultant signing.

4.5. Integrated as part of a pre-operative pathway

For each of these recommendations, the aim is to provide a streamlined fail-safe service whereby the end goal is that patients understand the risks prior to surgery, improving reassurance and reducing medico-legal cases. In order to promote this end goal, consent should not be viewed as an isolated intervention but rather a process of allowing patients to understand the risks. Integrating all discussions is something that could definitely improve this process. An integrated electronic consent system using procedure specific consent forms which combine communication from both pre-operative outpatient clinic and inpatient hospital attendance would therefore be an ideal solution.

5. Conclusion

Our study has evaluated the consent process for hip and knee arthroplasties at one district general hospital. We conclude that consent in our sample size falls short of BOA standards. Whilst consent was often completed by appropriately senior staff, there was much scope for improvement. Particularly the lack of risk discussion at the preoperative clinic and failure to consent some important risks such as death. We have discussed 5 interventions that could help improve consenting in future. In summary we recommend implementing an integrated process of risk discussion across occuring across multiple pre-operative settings using electronic, procedure specific consent forms.

Conflict of interest

None to report.

Funding

None to report.

Ethical approval

Not applicable.

Informed consent

Not applicable.

Declaration of competing interest

The authors have no relevant financial or non-financial interests to disclose.

The authors have no conflicts of interest to declare that are relevant to the content of this article.

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.

The authors have no financial or proprietary interests in any material discussed in this article.