By A Daviesa, T Heatona, S Sabharwala, M Fertlemanb, M Danib and P Reillyc
aDepartment of Orthopaedics, Imperial College Healthcare NHS Trust, London, UK
bCutrale Perioperative and Ageing Group, Dept of Bioengineering, Imperial College London, UK
cFaculty of Engineering, Department of Bioengineering, Imperial College London, UK
Corresponding author e-mail: [email protected]
Published 05 June 2020
The outbreak of severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2), led to the coronavirus disease 2019 (COVID-19) pandemic and forced an unprecedented period of change to clinical practice across the United Kingdom. The World Health Organisation formally declared a global pandemic on 11th March 20201. On the 23rd March 2020, the UK Government announced restrictions on freedom of movement, enforceable in law. The public were advised to stay at home except for essential work, buying food, providing care and exercising once a day.
All non-urgent operating was postponed and many surgical staff were redeployed across hospitals2. The demand for intensive care beds increased because of respiratory complications in a proportion of patients suffering from COVID-19, and fewer critical care beds were available for patients undergoing surgery. In Wuhan, during the early stages of the outbreak, mortality among asymptomatic elective surgical patients was 20.5%3. Treatment pathways have since changed significantly and clinical guidelines recommend prioritisation of cases to reduce demands on resources and risks to patients4. However, mortality in trauma patients remains elevated5. Multinational collaborate work demonstrates a high risk of mortality in patients with confirmed SARS-CoV-2 infection undergoing elective and emergency surgery6. Adjusted mortality at 30 days was associated with the male sex, patients over 70 years, an American Society of Anaesthesiologists score of greater than two, emergency surgery and major surgery6.
At Imperial College NHS trust, orthopaedic trauma surgery admissions have continued, and patients undergo emergency and urgent surgery on a dedicated trauma list. The risk to patients of contracting COVID-19 while in hospital is an important consideration. A meta-analysis of studies from Chinese institutions during the early outbreak of COVID-19 attributed 44% of cases to nosocomial infections7. More recent work from the Netherlands indicates that a higher proportion of infections occurred in the community, and screening at a central London hospital demonstrated that infection rates among asymptomatic hospital staff mirrored those in the general population8,9. According to modelling by Public Health England, nosocomial infection accounts for 20% of inpatient infections10.
Given the substantial change in the provision of surgical care during the pandemic, it is important that the process of patient consent is updated to reflect the additional risks of surgery. Our institution has previously reported on the legal implications of failing to mention important complications of emergency orthopaedic surgery as part of the consent process11.
The aim of this study was to determine whether the documented consent process at our institution adequately informs patients regarding the risk of contracting COVID-19 in hospital, and the associated risks of clinical deterioration and death.
All orthopaedic trauma procedures were reviewed across a four week period from the start of 'lockdown' in the UK on the 23rd March. Operating list records were reviewed to identify all patients undergoing urgent orthopaedic procedures across two sites at our trust. Consent forms were analysed to identify whether the additional risks of surgery due to COVID-19 were communicated to patients. This included any mention of the risks of infection with COVID-19 and associated clinical deterioration, the risk of Intensive Care admission and death. Electronic patient note entries prior to the surgery were scrutinised to determine whether a discussion about COVID-19 was documented in an alternative format.
The consent process includes a paper consent form, completed by the surgeon and signed by the patient which is subsequently scanned into the electronic patient record. A four-week period was allowed between the study period and data collection to account for a reasonable scanning lead time.
During the first four weeks of the 'lockdown' from 23rd March to 19th April, 68 trauma operations were performed in 61 patients at St Mary’s and Charing Cross hospitals, compared to 121 operations during an identical period in 2019. In two patients, two procedures were performed during the same theatre episode and both procedures were included on a single consent form.
The mean age of patients included in this study was 48.6 years (range 3-98, SD 27.3), 36 males and 25 females. The first 46 consent forms were available for review. This included a ‘consent form 1’ in 30 cases for adult patients with the capacity to consent for the procedure. Parental agreement was documented in seven cases on a ‘consent form 2’. A ‘consent form 4’ was completed in the remaining nine cases where patients’ lacked the capacity to consent themselves.
One consent form documented a discussion regarding the risks of contracting COVID-19 but did not specifically include treatment on the Intensive Care Unit or death. COVID-19 was not mentioned on the remaining consent forms. During the inpatient stay swabs were taken in 21 patients to test for COVID-19 due to clinical concern regarding possible infection. Positive swabs were identified in two patients; one pre-operatively and one post-operatively.
The best practice for consent mandates that the risks inherent in a procedure, however small, should be discussed with the patient and the details of the consent discussion should be recorded12. The medicolegal perspective is clear; having a record of a comprehensive consent form is paramount. Alternatives to surgery must also be discussed. The Medical Protection Society advise that a consent form must document that a patient was aware of all the risks of an procedure in order to be valid13. It is clear that admission to hospital during the current pandemic carries an inherent risk of contracting COVID-19. Emergency orthopaedic admissions often involve older frailer patients with multimorbidity, who are more likely to die of COVID-1914. In some circumstances the benefits of any hospital treatment are outweighed by the risks, even when appropriate screening and precautions are taken. A signed consent form that fails to mention all the relevant risks of a procedure may be a record of invalid consent. We argue that patients should be fully counselled for contracting COVID-19 with all the possible consequences including intensive care support, and death, in order to provide informed consent for surgery in 2020.
Our consent process did not adhere to best practice. This is most likely because our practice has not kept pace with the rapidly expanding evidence base over the last three months. Early in the pandemic, it was believed that asymptomatic transmission did not occur, and that risk was low unless the individual had travelled to China or Italy. Thus, public health guidance and local clinicians were not initially aware of the high risks of local and hospital transmission. There was limited guidance on communicating risks with patients, and arguably a systemic lack of preparedness for pandemic working. However, transmission risks were widely covered in the media, and there has been an overall reduction in hospital emergency department attendances. This suggests that patients may have been less inclined to attend hospital, accepting the risks of delayed care, morbidity and mortality15.
The situation is unpredictable and there is a need for leaders and local clinicians to remain vigilant and adaptable to immediate changes in circumstances. Further large multicentre collaborative cohort studies will provide valuable evidence to inform the consent process as we enter new phases of the pandemic6. The risks of COVID-19 are expected to vary at a regional level as the pandemic continues. Active communication between surgical teams and infectious disease specialists within Trusts may improve the accuracy of information provided to patients16. The British Orthopaedic Association guidelines on restarting non-urgent trauma and orthopaedic care highlight the greater complexity of informed consent during COVID-19 and the need to discuss the risks of SARS-CoV-2 infection in patients undergoing surgery17.
This is a single centre study, involving a limited number of patients. However, the surgical team at this major trauma centre rotates on a daily basis and multiple surgeons were responsible for the consent forms across the study period. During the early phase of the COVID-19 pandemic patients were not adequately consented for the risks associated with the virus. Informed consent is a medico-legal requirement. Moreover, full discussion of the risks of surgical intervention is an important part of the relationship between surgeon and patient. Our practice has been updated as a consequence of this work. COVID-19 is a novel and potentially fatal threat, and patients should be fully aware of the additional risks prior to undergoing surgery.
- World Health Organisation (2020). Coronavirus Disease 2019. Situation Report 51. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200311-sitrep-51-covid-19.pdf?sfvrsn=1ba62e57_10.
- Royal College of Surgeons of England (2020). Good practice for surgeons and surgical teams. Available at: https://www.rcseng.ac.uk/standards-and-research/standards-and-guidance/good-practice-guides/coronavirus/covid-19-good-practice-for-surgeons-and-surgical-teams.
- Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, et al. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr;21:100331.
- Royal Collge of Surgeons of England (2020). Clinical guide to surgical prioritisation during the coronavirus pandemic. Available at: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/C0221-specialty-guide-surgical-prioritisation-v1.pdf.
- Maniscalco P, Poggiali E, Quattrini F, Ciatti C, Magnacavallo A, Vercelli A, et al. Proximal femur fractures in COVID-19 emergency: the experience of two Orthopedics and Traumatology Departments in the first eight weeks of the Italian epidemic. Acta Biomed. 2020;91(2):89-96.
- CovidSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2. Lancet. 2020 May 29 [Epub ahead of print].
- Zhou Q, Gao Y, Wang X, Liu R, Du P, Wang X, et al. Nosocomial Infections Among Patients with COVID-19, SARS and MERS: A Rapid Review and Meta-Analysis. medRxiv. 2020;04(14):20065730.
- Hunter E, Price DA, Murphy E, van der Loeff IS, Baker KF, Lendrem D, et al. First experience of COVID-19 screening of health-care workers in England. Lancet. 2020;395(10234):e77-e78.
- Kluytmans-van den Bergh MFQ, Buiting AGM, Pas SD, Bentvelsen RG, van den Bijllaardt W, van Oudheusden AJG, et al. Prevalence and Clinical Presentation of Health Care Workers With Symptoms of Coronavirus Disease 2019 in 2 Dutch Hospitals During an Early Phase of the Pandemic. JAMA Netw Open. 2020;3(5):e209673.
- Evans S, Agnew E, Vynnycky E, Robotham J. The impact of testing and infection prevention and control strategies on within-hospital transmission dynamics of COVID-19 in English hospitals Methods Model Description. medRxiv. 2020;05(12):20095562.
- Koizia L, Wilson F, Reilly P, Fertleman M. Delirium after emergency hip surgery – common and serious, but rarely consented for. World J Orthop. 2019;10(6):228-34.
- Royal College of Surgeons of England (2020). Good Surgical Practice: 3.5.1 Consent. Available at: https://www.rcseng.ac.uk/standards-and-research/gsp/domain-3/3-5-1-consent.
- Medical Protection Society (2020). Factsheet: Patient consent. Available at: https://www.medicalprotection.org/uk/articles/consent-uk.
- Banerjee A, Pasea L, Harris S, Gonzalez-Izquierdo A, Torralbo A, Shallcross L, et al. Estimating excess 1-year mortality associated with the COVID-19 pandemic according to underlying conditions and age: a population-based cohort study. Lancet. 2020;395(10238):1715-25.
- Rodríguez-Leor O, Cid-Álvarez B, Ojeda S, Martín-Moreiras J, Ramón Rumoroso J, López-Palop R, et al. Impact of the COVID-19 pandemic on interventional cardiology activity in Spain. REC Interv Cardiol. 2020;2:82-9.
- Leigh B. Consent in the Post-COVID-19 Era. The Transient Journal. May 2020. Available at: https://www.boa.ac.uk/resources/consent-in-the-post-covid-19-era.html.
- British Orthopaedic Association (2020). Re-starting non-urgent trauma and orthopaedic care: Full guidance. Available at: https://www.boa.ac.uk/resources/boa-guidance-for-restart---full-doc---final2-pdf.html.https://www.boa.ac.uk/resources/boa-guidance-for-restart---full-doc---final2-pdf.html.