key: cord-1039778-1jnopah2 authors: Rotimi, O.; Beatson, K.; Aderombi, A.; Lam, W.; Bajomo, O.; Kukreja, N. title: Surgical consent during the COVID-19 pandemic date: 2020-10-09 journal: Ann Med Surg (Lond) DOI: 10.1016/j.amsu.2020.10.011 sha: 36b10f7615e7cc2c91c4cab1da4e7c9c98d1fc3a doc_id: 1039778 cord_uid: 1jnopah2 BACKGROUND AND AIMS: During the COVID-19 pandemic, surgical practice may deviate with operative and non-operative management considered. Appropriate discussion of options with patients is paramount to quality surgical care. Intercollegiate and EAES guidelines recommend discussing and documenting risk of COVID-19 exposure in the consent process for patients undergoing surgery. MATERIALS AND METHODS: Closed-loop audit of consent forms for patients undergoing emergency and elective surgical procedures. Interventions implemented included education of wider surgical teams. Data was collected during a one-week period for each cycle and analysed using Chi-squared test. RESULTS: In cycle 1, 6/17 (35.3%) case notes documented discussion of COVID-19 risk. Following intervention, compliance improved to 23/29 (79.3%) cases in cycle 2 and 33/45 (73.3%) cases in cycle 3. CONCLUSION: Pre-intervention, our consenting practice was non-compliant. Our interventions led to significant and sustained improvements in practice. We recommend provision of wider surgical team education to facilitate good consenting practice. The World Health Organisation declared COVID-19 a pandemic on 11 March 2020. At the time of writing this paper, the number of cases worldwide has increased 200-fold, and the United Kingdom (UK) now has the highest number of confirmed deaths in Europe at 41,498 people (1) . As the health service endeavours to mitigate the transmission of the virus, surgical practice may deviate. Non-operative intervention is explored where appropriate, operations postponed where safe, and open procedures considered over laparoscopy to reduce occupational exposure (2) . With concern over asymptomatic and nosocomial transmission (3), post-operative inpatient admission may expose the patient to COVID-19. The European Association of Endoscopic Surgeons (EAES) and UK surgical colleges have published guidance on general surgery during the pandemic. These recommend discussion and documentation of the risk of COVID-19 in planning and consent (4, 5) . The aim of this audit is to assess our consent practice at a district general hospital against these guidelines during the COVID-19 pandemic. J o u r n a l P r e -p r o o f Closed loop retrospective and prospective cross-sectional analysis of consent for patients listed for emergency and elective surgical cases. Independent observers reviewed the consent forms for all elective and emergency patients over a 7-day period during cycle 1, 2 and 3. Evidence of discussion of risks to specific COVID-19 on the consent form was sought. There was a one-week interval following the intervention before data collection for cycle 2. A 3-month interval following completion of cycle 2 before data collection for cycle 3 was initiated. All emergency and elective patients who have undergone operations in General Surgery department were included, comprising of cases in Vascular, Breast and General/Colorectal Surgery. Following results from cycle 1, two interventions were implemented. A morning briefing in our department was held during the pandemic. Dissemination of findings during one of these sessions allowed education of the wider surgical team through open discussion. Additionally, visual prompts of guidance were strategically placed within the department to reinforce application of guidance. Following cycle 2, the same interventions were delivered in our audit meeting following current social distancing guidance. This was conducted 1 month prior to data collection for cycle 3. Data analysis included descriptive statistics and Chi-squared test J o u r n a l P r e -p r o o f The data above shows the demographics of each cycle of this audit. The vast majority of cases in cycle 1, 2 and 3 were general surgical procedures (65%, 69% and 80% respectively), in keeping with the hospital's norm. Emergency cases were more prevalent in our study than elective cases during cycle 1 and 2, however elective cases became more prevalent in cycle 3. Emergency cases represented 59% of cases in cycle 1 and cycle 2. In cycle 3, emergency cases represented 38% of cases. We found our consenting practice non-compliant, particularly with emergency procedures. There is evidence in the literature that challenges such as time constraints, impaired patient consciousness due to trauma or pain and sudden change in circumstance that may contribute to poorer consent practice (2, 8) . The stresses of busy on-call shifts can result in surgeons falling back on habit and discuss risks mechanistically. The oversight of not undertaking consent discussions on COVID-19 infection could have medicolegal implications, particularly in cases where non-operative management or postponement of surgery may be considered. In cases where operative management is pursued, the incidence of COVID-19 post-operatively is suggested to be as high as 17% when COVID-19 was more prevalent during the peak of the pandemic (9) . Therefore, it is a significant risk that all patients undergoing surgery should be consented for. Our interventions are simple and have led to significant improvement in practice overall, and within General/Colorectal, Vascular and Breast surgery. They have been shown to have long term impacts as adherence to audit standards have been maintained. There is potential to maintain and build on gains through default documentation of COVID-19 and J o u r n a l P r e -p r o o f organisational related risks in consent forms (10) . Our interventions, in addition to clear frameworks on detailing these risks, could further improve compliance to surgical guidance as well as the quality of consent discussions. As there is uncertainty whether future surges in COVID-19 cases may occur as government measures relax, continued consideration should be made to our discussions with patients as to risks of surgery. Given variation in consent practice between centres (11), our findings may represent an area for improvement in other surgical departments and specialties. There are limitations to our audit. First, there is a limited sample size in cycles 1 and 2. The sample sizes were a result of a significant reduction in elective procedures and patient presentation to emergency services within our trust during the pandemic period. Furthermore, this audit was designed to be a short cross-sectional analysis to determine adherence to guidance rather than ensure statistical power. This study highlights that simple interventions can improve consent discussions surrounding COVID-19. However, it assumes documentation is evidence of good quality discussion of risk and implications. Documentation of a risk may not correlate with the quality of information provided (8) . These limitations cannot be eliminated without being present in or recording all consent discussions them which may lead to logistical and confidentiality issues. The authors acknowledge these limitations exist and should be considered when interpreting our audit results. Interestingly, there has been recent guidance provided by the Royal College of Surgeons of England (RCSEng). We recognise the RCSEng tool recommending considerations that should be discussed when consenting practice during the COVID pandemic as an important step towards improving the patient-surgeon relationship and discussions around surgery during these uncertain times (12) . Going forward, the authors suggest this could be adapted into a user-friendly leaflet format to inform patients while minimising anxiety around hospital admissions at this time. The impact of COVID-19 on surgical services has been significant, however, guidance is in place to maintain quality of care. There is specific guidance on consenting patients on the risk associated with COVID-19, but factors during provision of emergency care may limit the frequency of this guidance being followed. Owing to uncertainty with how the current pandemic will unfold, we recommend simple interventions such as education of the surgical team, visual prompts and amended consent forms to improve adherence to surgical guidance in the era of COVID-19. Consideration of the Montgomery case implies patient should be consented for COVID-19 as this risk is now pertinent to all patients listed for surgery Simple interventions (education and visual prompts) can be extremely effective in improving long-term consenting practice J o u r n a l P r e -p r o o f The following information is required for submission. Please note that failure to respond to these questions/statements will mean your submission will be returned. If you have nothing to declare in any of these categories then this should be stated. All authors must disclose any financial and personal relationships with other people or organisations that could inappropriately influence (bias) their work. 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No formal ethical approval required J o u r n a l P r e -p r o o f Consent Studies on patients or volunteers require ethics committee approval and fully informed written consent which should be documented in the paper. Authors must obtain written and signed consent to publish a case report from the patient (or, where applicable, the patient's guardian or next of kin) prior to submission. We ask Authors to confirm as part of the submission process that such consent has been obtained, and the manuscript must include a statement to this effect in a consent section at the end of the manuscript, as follows: "Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request". Patients have a right to privacy. Patients' and volunteers' names, initials, or hospital numbers should not be used. 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OR developed the concept for the project, drafted and made corrections to the manuscript KB developed the concept of the project and made corrections to the manuscript OB, AA, WL and NK were involved in data collection and revision of the manuscript J o u r n a l P r e -p r o o f In accordance with the Declaration of Helsinki 2013, all research involving human participants has to be registered in a publicly accessible database. Please enter the name of the registry and the unique identifying number (UIN) of your study. World Health Organisation WHO Emergency surgery during the COVID-19 pandemic: what you need to know for practice COVID-19: the case for health-care worker screening to prevent hospital transmission Updated Intercollegiate General Surgery Guidance on COVID-19 -Royal College of Surgeons SAGES and EAES Recommendations Regarding Surgical Response to COVID-19 Crisis -SAGES Managing COVID-19 in Surgical Systems Global guidance for surgical care during the COVID-19 pandemic Informed consent: The view from the trenches COVID-19 in Post-Operative Patients: Imaging Findings Unknown Unknowns Patient consent in the post-Montgomery era: A national multi-speciality prospective study Tool 5: Consent to treatment, while COVID-19 is present in society -Royal College of Surgeons Unique Identifying number or registration ID Hyperlink to your specific registration