Informed consent for Orthopaedic surgeons in the time of COVID-19: Addressing ‘the elephant in the room’

In common with other countries, elective procedures have been largely suspended in the National Health Service (NHS) in the UK in response to the challenges of the COVID-19 pandemic. In the area of orthopaedics, nationally prioritised urgent and emergency surgical procedures have continued,1 but reduced theatre capacity, staff re-allocation and, most importantly, the increased risk of infection have resulted in major changes in how acute orthopaedic pathologies are treated. For instance, non-operative management of fractures or soft tissue injuries has been advised, where appropriate, following a reasoned pragmatic discussion with the patient.2 Recently published guidelines on the types of orthopaedic injuries deemed ‘surgically necessary’ for urgent elective procedures3 are helpful, but it is still the responsibility of the clinician to recognise injuries that, if left untreated acutely, could lead to significant long-term health consequences or chronic pain.

The doctor-patient conversation that occurs following the diagnosis of such an injury is important to fulfilling ethical and professional responsibilities and reducing medico-legal risk. Understanding the patient’s future goals and expectations influences management and is vital to shared decision-making. Surgeons need to enable patients to be fully informed by giving them high quality information about the current evidence base regarding the proposed treatment and the available alternatives and risks.4

These kinds of conversations are more fraught than they were pre-COVID-19, where, for example, death as an outcome of a low-risk procedure in a low-risk patient might reasonably have been presented as a very uncommon complication. Now, the risks of post-operative morbidity and mortality, even after relatively routine procedures, have become much greater. An honest conversation should include discussion of the additional dangers and uncertainties.

One risk clearly relates to that of contracting COVID-19 while being treated surgically. A British Orthopaedic Association update has provided useful guidance to clinicians for risk-stratifying patients into Low, Medium, High, and Very High risk categories for contracting COVID-19 based on the following factors: increased age (>65 years) and presence of any chronic lung condition, diabetes mellitus, severe obesity, significant heart disorders, cirrhosis and/or immunosuppression.5 This guidance should be helpful in ensuring patients understand the pertinent factors related to the long-term consequences of treating their condition conservatively versus the risk of catching the disease through surgical intervention.

A second set of risks relates to patients who are already COVID-19 positive and require surgery. Here, the relative lack of data regarding the transmission and clinical course of COVID-19 in surgical patients, and the current gaps in the literature with regards to even short-term outcomes of surgery, pose real challenges to providing patients with accurate information. A small study from Wuhan, China, retrospectively reviewed 34 patients who underwent surgery during the incubation period of COVID-19. Although the study had many limitations, the results were unsettling: 44.1% of patients required ICU care and 20.5% died.6 Two further studies in patients with COVID-19 either in the preoperative or near-postoperative period in Italy and across 24 countries have since shown similar results, with rates of both mortality and complications multiple times higher than in those without the disease.7,8 Furthermore, an audit in our own hospital reviewing mortality following surgical treatment of fragility femoral fractures in nine COVID-19 positive patients showed a 30-day mortality rate of 44.4% compared to a pre-pandemic average of 6.6%.9 These patients were frail at baseline and at exceptionally high risk for the most serious sequelae of COVID-19. However, the differences in these rates is sobering.

As the NHS begins to resume elective surgery, the challenges of having high quality conversations that can form the basis of informed consent about urgent and elective procedures are becoming more pressing. At the same time, many of these conversations are happening in remote formats, in the interests of keeping face-to-face contacts, and the associated infection risks, to a minimum.

Locally, we are setting up protocols to help surgeons during these consultations. These require, for instance, that all orthopaedic surgeons have the use of a portable computer with facilities to perform video consultations with patients. Consultations must be regarded as opportunities to discuss risks and benefits of surgery in detail. We propose dividing the conversation into three parts: Pre-operative, Operative, and Post-Operative, as shown in Table 1 (below). We recommend that each section should be reflected in the written consent form for all orthopaedic procedures performed during the pandemic. Discussing these stages systematically is important to educating patients about current changes across the healthcare system related to COVID-19. It can also help to prompt sharing of information about how any potential surgical complications may be addressed more slowly or in different locations compared to pre-pandemic times. Such a guided discussion should allow a more fluent, focused, and fully informed conversation.

As the pandemic evolves, a key responsibility will be ensuring that the evidence base continues to evolve too, both about the risks of surgery and about how best conversations that can facilitate shared decision-making and informed consent can be achieved.

 

Table 1: Changes to care to emphasize during consultations for patients having surgery during the COVID-19 pandemic

Pre-Operative

Operative

Post-operative

  • Most of your consultations will occur by video, telephone or by email and letter.
  • We may also ask you to email or post medical information to us.
  • You will be sent a copy of your consent form that explains your operation.  You will have the opportunity to discuss this with your surgeon if you so wish.
  • Your anaesthetic assessment will be by video or telephone with a nurse, and, if necessary, an anaesthetist.
  • We will arrange for you to have coronavirus testing before your operation.
  • Your operation will likely be postponed if you test positive or are unwell.
  • Routinely, we will ask you go into strict isolation before a procedure unless it is an emergency. You will be given clear information about this.
  • Your operation may not take place on the site that you were expecting. We may be operating at your base hospital or at a local, independent hospital to reduce the risk of developing COVID-19.
  • Circumstances will be very different in the hospital. Wards will be reorganised, and staff may be wearing protective equipment.
  • You may not meet your surgeons until the day of treatment, and they might not be the ones you expected. They will, however, be experienced and trained to perform your operation.
  • It is likely you will not be able to have your family and friends visit whilst in hospital.

 

  • You will be discharged from hospital when you are ready, or may be moved elsewhere to a ‘step-down’ unit to complete your recovery.
  • Your follow up may be through video or telephone consultation.
  • Some follow up care, or emergency admission may need to happen at your local hospital.
  • A period of isolation (for example, 14 days) is likely to be mandatory after your procedure.

 

 

Sohail Yousaf, Syed Hassan, Paul Hamilton, & Andrea Sott

Mr. Syed Hassan is an Orthopaedic Registrar and Mr. Sohail Yousaf, Mr. Paul Hamilton, and Ms. Andrea Sott are Trauma and Orthopaedic Surgeon Consultants at Epsom and St. Helier University Hospitals NHS Trust.

 

References:

    1. NHS England: Clinical guide to surgical prioritisation during the coronavirus pandemic. (2020).
    2. BOAST – Management of patients with urgent orthopaedic conditions and trauma during the coronavirus pandemic. 2020.
    3. DePhillipo NN, Larson CM, O’Neill OR, et al. Guidelines for Ambulatory Surgery Centers for the Care of Surgically Necessary/Time-Sensitive Orthopaedic Cases during the COVID-19 Pandemic. J Bone Jt Surg 2020 Apr 13.
    4. Ricketts D, Roper T, Rogers B, et al. Informed consent: the view from the trenches. Ann R Coll Surg Engl 2019;101:44–49.
    5. The OpenSAFELY Collaborative. OpenSAFELY: factors associated with COVID-19-related hospital death in the linked electronic health records of 17 million adult NHS patients. 2020.  doi:10.1101/2020.05.06.20092999.
    6. Lei S, Jiang F, Su W, et al. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine 2020;21: 100331.
    7. Doglietto F, Vezzoli M, Gheza F, et al. Factors Associated With Surgical Mortality and Complications Among Patients With and Without Coronavirus Disease 2019 (COVID-19) in Italy. JAMA Surg 2020. doi:10.1001/jamasurg.2020.2713.
    8. COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. The Lancet 2020. doi:10.1016/S0140-6736(20)31182-X.
    9. The National Hip Fracture Database.
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2 thoughts on “Informed consent for Orthopaedic surgeons in the time of COVID-19: Addressing ‘the elephant in the room’

  1. I have written to PHE asking them to provide the reagent needed for staff to be tested on surgical wards. The tests for patients are in place but nit for staff and surgery could be made much safer with regular staff testing. I will not have TKR until this is in place. There must still be shortages or PHE would surely have done this by now.

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