A risk assessment strategy to re-introduce elective neurosurgery patients during COVID-19

Abstract Objectives To demonstrate the utilisation of a risk assessment protocol designed to prioritise elective neurosurgical patients against the risks of COVID-19. This tool can be applied to all other surgical specialties. Design Prospective case series of 166 patients. Setting Single-centre tertiary neurosurgical department. Participants All patients awaiting an elective neurosurgical procedure were included in this study. All emergency or life-threatening neurosurgical pathologies affecting patients were excluded. Main outcome measures The risk assessment tool identified patients with progressive neurology and stratified need for surgery against risk of harm during the COVID-19 pandemic. Results Using our risk stratification tool, 6.6% patients required expedited surgery and a further 11.4% patients were removed completely from the waiting list. The majority of patients 47%, required surgery within 3 months. Conclusions This simple tool encourages surgical departments to establish contact with patients during COVID-19. The clinician acquires up-to-date information regarding patient symptomatology and subsequently determines surgical priority, a timescale required for surgery and overall uses of NHS resources efficiently. We recommend the use of this tool for all neurosurgical departments, with a wider application to other surgical specialties during the ongoing pressures of elective backlogs secondary to the persistent COVID-19 pandemic.


Introduction
][3][4] Over the past 11-months, dating back to the first reported case of coronavirus disease 2019 (COVID-19) in the United Kingdom (UK), January 29 until the current day of March 19, 2021, the total number of lab-confirmed UK cases were 4,285,684 and COVID-19 deaths within 28-days of positive test were 126,026. 5In March 2020, the government instructed the first lockdown measures with particular emphasis on all private and NHS care to cancel all non-essential and elective services by March 23, 2020. 6Such drastic measures initially reduced the number of daily COVID-19 deaths to 21 (12 July 2020), a significant improvement from the peak of daily 1,173 deaths on April 21, 2020. 5owever, the more devastating second wave was managed initially with enhanced social distancing measures (tiered lockdowns), track and trace phone applications and local lockdowns aiming to contain the virus to prevent a repeat of the first 6-months COVID-19 impact on the UK population, but eventually resulted in a second national lockdown on the 4 January 2021. 7Nonetheless, such restrictions impacted on healthcare, with all non-emergency patients continuing to suffer as a consequence. 8More specifically, the impact on neurosurgery required re-adjusting bed capacity states and in some cases the on-call structure. 9This acute re-organisation triggered great strain on patients suffering with neurosurgical pathologies and resulted in psychological stress, reduced quality of life and poorer symptom control.The medico-legal implications of delaying elective and non-emergent surgery resulted in the Society of British Neurological Surgeons (SBNS), British Association of Spinal Surgeons (BASS) and Royal College of Surgeons (RCS) collectively implementing a plan of prioritisation.The new powers under the Coronavirus Act 2020, provided additional indemnity coverage for clinical negligence liabilities. 10COVID-19 remains a current problem and will continue to do so for the foreseeable future.In light of the ongoing viral spread, adaptability and flexibility is key to restoring non-emergent and elective provisions in neurosurgery, with the acceptance that COVID-19 will continue to spread in the coming months and possibly years.
Introducing elective and non-emergent cases will have to be designed in a structured manner taking into account the provisions of personal protective equipment (PPE), efficient testing strategies, patient guidance to self-isolate, colour-coding at-risk patients versus asymptomatic patients and using private healthcare setups as a 'green' or clean fields to minimise exposure to high-risk patients, wards and healthcare professionals.Currently, no such published setup exists to introduce a risk assessment criteria that plans to encompass a strategy to prioritise non-emergent patients for surgery.The aim of our observational study is to introduce a simple, yet effective risk assessment tool to reintroduce non-emergent patients in the 'new normal COVID-19 era' and below we discuss our results to date.

Methods
We prospectively collected patient data from the 26 May 2020 until 27 August 2020.Data gathered contained information regarding: demographics, surgical procedure, symptomatology, initial listing date and review date, risk assessment and decision for management.All risk assessments were completed under the guidance of the risk assessment tool, which was completed during telephone or video consultation.
Descriptive statistics using Microsoft Excel was used to analyse the data.
Ethical approval was not required for this study.

Patient and public involvement
Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research.

Data sharing
No additional data available.

Results
A total of 166 patients were included in the study and risk assessed using the form in Supplementary Appendix 1.The oldest patient was 86 and youngest 26 years of age.There was a slight increased incidence of female patients (54.8%), although the mean age was higher in male patients of 63.6 years compared to 59.8 years for female patients.63.9% of patients suffered with one or more co-morbidities, which included: asthma, chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), hypertension, ischaemic heart disease (IHD), age >70, Black Asian and Minority Ethnic (BAME), obesity and chronic kidney disease (CKD) (Table 1).
Patients with co-morbidities underwent a further risk assessment to sub-categorise the risk of undergoing surgery during the COVID-19 pandemic (Table 1).The risk assessment stratified patients into 4 categories: low-risk (no risk factors), medium-risk (1 risk factor), high-risk (2 risk factors) and very high-risk (3 or more risk factors).In both male and female patients the most prevalent risk group was medium-risk at 35.5% (59/166), with 45.8% of patients male (27/59) and 54.2% female (32/59).Only 19 patients suffered with 3 or more co-morbidities, while 60 patients had no co-morbidities (Table 1).
A vital component to the risk assessment was evaluating the progression of symptomatology (Table 2).Three categories were used: progression/worsening symptoms, no change and improvement of symptoms.
Our results showed that 45.2% (75/166) of patients had static symptoms, while 44% (73/166) of patients felt their symptomshad progressed (Table 2).Only 8.4% (14/166) of patients claimed their symptoms had improved compared to last clinical review.Of the 14 patients that improved, 13 were awaiting spinal surgery/fixation for degenerative spinal disease and one patient was awaiting a cranioplasty.On review of symptoms, patients were questioned about symptoms of COVID-19, contact with others diagnosed with COVID-19 or being diagnosed with COVID-19.Overall, 9 patients confirmed they had suffered with COVID-19 symptoms, 3 patients complained of progressive neurological symptoms, 2 were male and 1 female patient.
In order to stratify the risk of patients awaiting surgery in the context of SARS-COv2, we subgrouped patients into 3 further categories based on risk of harm to the patient.Categories included: unlikely to harm, small chance of harm and serious harm (Table 3).
Our results showed that only 8.4% (14/166) of patients were at serious risk of harm if surgery was delayed, 52.4% (87/166) of patients were graded as small chance of harm and 33.7% (56/ 166) unlikely to harm (Table 3).
Following this, patients were prioritised for surgical procedures, using 4 timescales: <4-weeks, <3-months, within 3-6 months and removal from waiting list with further clinic review in 6-months (Table 4).
In total, 6.6% of patients required non-urgent surgery to be expedited, while 11.4% of all patients were removed from the waiting list and rearranged for a further clinic review (Table 4).As expected, the highest number of patients 47% (78/166), were prioritised for surgery within 3-months, while the remaining non-urgent procedures were scheduled for 3-6 months 35% (58/ 166) (Table 5).
Of the 7 patients highlighted for surgery within 4-weeks, all described deteriorating neurological symptoms and categorised as serious risk.In addition, of the 7 patients highlighted for surgery <4-weeks, 4 described new symptoms alongside progressive neurology (Table 6).
In total, 18 patients were removed from operating waiting list and 67% of patients had subjectively better symptoms and no longer required surgical intervention.However, 22% of patients continued with the same symptoms and no longer wanted surgery, while 11% of patients with worsening symptoms decided against surgical intervention.One patient, 59 years of age categorised as high-risk, decided against proceeding with an ACDF and one patient 81 years of age refused a CSF drainage test for normal pressure hydrocephalus, categorised as medium risk.All other patients were awaiting thoracic/lumbar surgery for degenerative spinal disease and removed from the waiting list for a 6-month outpatient follow-up.

Discussion
We have designed a simple risk stratification assessment for both neurosurgery and allied specialties with the aim of re-introducing elective surgery during the global pandemic.By carrying out telephone or video clinics we evaluated patient's symptomatology, symptom-impact on quality-of life, co-morbidity risk relative to COVID-19 and established patient's exposure to COVID-19.From this, we recognised the risk and harm if surgery is delayed and triaged into urgent to non-urgent categories in order to maintain optimum care for our outpatients.To date, no such risk assessment tool exists to streamline patients into an elective priority scale.
The SARS-CoV-2 global pandemic, has had a dramatic impact upon operative volume for non-urgent cases. 11The current consensus within all surgical specialties in the UK advocates that all non-urgent surgery should be thoroughly evaluated before reinstituting resources towards re-building a service. 12As such, elective surgery in neurosurgery and all disciplines have been curtailed to allow for reallocation of resources towards COVID-19 hospital strategies, thus minimising exposure for patients and staff to COVID-19 and most importantly ensuring maximum safety for all patients. 13The risks of surgery are particularly important in the context of general anaesthetic, and certain risk factors such as: male sex, age >70, co-morbidities such as hypertension, diabetes, asthma/COPD, cancer surgery and those needing emergency surgery, which are highlighted as concerning for pulmonary complications secondary to SARS-CoV-2. 14An international multicentre cohort study has reported an overall 30-day mortality rate of 23.8%, with an 18.9% mortality in elective patients. 14As a result, the decision to re-establish surgical services is no longer unilateral and hinges on multiple variables such as: patient factors, surgical factors, hospital factors and national level guidance. 6he improved availability of PPE, increased awareness to social distancing and hygiene and the more humane doctor's approach to patients and relatives during COVID-19 has started to increase patient confidence to re-attend hospitals. 15Efficient testing facilities for polymerase chain reaction (PCR) diagnostic evaluation of throat swabs and blood-antibody tests has further increased the confidence of hospital staff. 16,17For consent, the balance of risks associated with SARS-CoV-2 infection against delaying surgery in individual patients must now be considered as the 'new-normal'.COVID-19 will continue through the year 2021 and subsequent years until vaccines and newer treatment strategies are safe with the potential for updated vaccines to protect against cross-country varying strains. 18,19rom a hospital's perspective, the current national healthcare strategy to restarting elective surgery safely is the packaged approach of: patient self-isolation for 14-days prior to surgery, an up-to-date COVID-19 swab within 72-hours of surgery and creating a post-operative 'green' ward. 20However, an important consideration for surgical decision-making is the patient's perspective and opinion of COVID-19, which requires clear perioperative guidance during this pandemic. 21,22Utilising guidance from the Society of British Neurological Surgeons (SBNS), British Association of Spine Surgeons (BASS), NHS England and Royal College of Surgeons of England, we developed a simple and effective risk assessment form that takes into account the patient's decision, the risks of COVID-19 and the risk of harm to reach an achievable timescale to implement surgery. 22,23ur results, showed that 18 patients were willing to come off the waiting lists, while 14 neurosurgical patients required expedited elective surgery.This risk assessment tool safety-netted patients from developing neurological deterioration (Supplementary Appendix 1).Furthermore, this risk assessment strategy has also been applied to multiple surgical specialties within our hospital, ranging from general surgery to ear, nose and throat surgery.The importance of this tool is necessary to prevent the conversion of elective into emergency admissions, but to circumvent the ongoing COVID-19 pandemic implications for elective patients that will likely disrupt our services for longterm.D'Amico et al, have posited a strategy to reopening neurosurgical practice in theory, 24 but focus on 5 general priorities ranging from elective (priority 0) to emergency (priority 4).Furthermore, stage III in their milestone theory suggests the lifting of all physical distancing recommendations after effective prophylaxis and treatments have been developed. 24Hill et al, have evaluated multiple variables to plan the exit strategy of COVID-19 and resume nonemergency neurosurgery. 6Their study designed a thorough 3 phase scheme to reach the new normal and re-establishing services. 6However, no attention has been focussed towards re-connecting with elective outpatients in order to re-prioritise and schedule surgical intervention accordingly.
In the UK, the Federation of Surgical Specialty Associations (FSSA) developed a clinical guide for surgical prioritisation, stratifying conditions into priority groups 1-4 and advocating continued local practice. 12The merit of the FSSA guideline provides a generic overview of neurosurgical conditions encapsulating multiple sub-specialist areas and pathologies.However, our experience showed that the FSSA guideline had some limitations and could not be solely relied upon.Thus, symptomatic change in low-priority conditions was not considered and subsequently no standardised assessments to stratify patients from category 3 and 4 into priority groups 1a, 1b and 2 were provided. 12An example noted in our study was a patient diagnosed with normal pressure hydrocephalus (NPH) with the worsening triad of symptoms.Originally categorised as priority group 4 as per the FSSA guideline, NPH would not fall under 'acute hydrocephalus or raised intracranial pressure'. 12Applying our risk stratification protocol, we identified the patient at risk of deterioration and subsequently re-prioritised to category 2, providing a safety-net for patient care.
Globally, the COVID-19 pandemic affected countries and societies in different aspects. 25Surgical practice was not exempt and elective surgery significantly suffered with an estimated $50.7 billion per month lost, from March 1 to June 30, 2020 in the United States. 26The FSSA is an invaluable multi-specialty collaborative that promotes and protects high standards in the practice of surgery in the UK.Nonetheless, the surgical prioritisation schedule only takes into account the demand within the UK and cannot be applied to an international scale with differing population needs, economic burden and overall access to care. 25Our risk assessment strategy has worked effectively, but no data exists to comment on the outcomes implementing FSSA guidelines.Our stratification tool is the only study to date to promote patient interaction for clinical updates and necessitate a careful consideration for the individual using a standardised assessment regardless of specialty.The authors recommend this method to maintain patient safety for neurosurgical patients and other surgical specialties within the UK and internationally.
The future has undoubtedly changed and adapting to the evolving environment is the logical approach.Using our risk assessment tool the majority of patients can be assessed via telephone or video clinics using NHS-approved web platforms such as Attend Anywhere and AccuRx, thus minimising travel and exposure for patients. 27The financial implications would also benefit both the patients travelling and parking costs as well as their waiting times, but minimises hospital facility use.We aim to continue using our telemedicine clinics in accordance with the risk assessment tool proposed and certify the status of elective surgical patients in times of COVID-19.

Conclusion
COVID-19 has perpetuated an uncertain future, with hypothesised epidemiological models aiming to predict future recurrence and waves of spread.Elective surgery has dramatically reduced and impacted on patient quality-of-life, increased waiting lists and costed the NHS millions of pounds.The 'new normal' approach must be adapted into the normal daily life of hospitals and surgeons to maintain safety of patients.The risk assessment tool designed is aimed at keeping contact with patients lost to waiting lists during COVID-19, whilst prioritising those in need of surgery due to limited services.We propose that our simple, yet efficient proforma can be applied to neurosurgical patients as well as all other surgical patients in order to resume non-emergent services within the constraints of COVID-19.
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Disclosure statement
All authors have completed the ICMJE uniform disclosure form at www. icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.No potential conflict of interest was reported by the author(s).

Author contributions and guarantor information
Amir Saam Youshani: ASY Chelsea Whittle: CW Kaushik Ghosh: KG (corresponding author) KG conceptualised the study.CW was involved with data curation.ASY analysed the data and developed the manuscript.ASY and KG performed the literature search and drafted the manuscript.ASY, CW and KG approved the final manuscript for submission.KG supervised the overall project and study.'The corresponding author attests that all listed authors meet authorship criteria and that no other meeting the criteria have been omitted'.

Copyright/license for publication
The Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in all forms, formats and media (whether known now or created in the future), to (i) publish, reproduce, distribute, display and store the Contribution, (ii) translate the Contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or, abstracts of the Contribution, (iii) create any other derivative work(s) based on the Contribution, (iv) to exploit all subsidiary rights in the Contribution, (v) the inclusion of electronic links from the Contribution to third party material where-ever it may be located; and, (vi) licence any third party to do any or all of the above.

Table 1 .
Demographics, co-morbidity risk assessments and surgical procedures reviewed for patients awaiting surgery.

Table 2 .
Showing patients symptomatology progression whilst awaiting surgery.

Table 3 .
Harm risk stratification table showing the number of patients who described worsening symptomatology in risk assessment clinic review.

Table 4 .
Timescale prioritisation table for patients risk assessed in clinic.

Table 5 .
Patients highlighted with progressive symptoms with either serious harm risk or expedited operation within 4-weeks.

Table 6 .
Patients assessed using the COVID-19 risk assessment tool and removed from the surgical waiting list.