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A novel hospital capacity versus clinical justification triage score (CCTS) for prioritization of spinal surgeries in the “new normal state" of the COVID-19 pandemic

Introduction During the Coronavirus disease 2019 outbreak, while healthcare systems and hospitals are diverting their resources to combat the pandemic, patients who require spinal surgeries continue to accumulate. The aim of this study is to describe a novel hospital capacity versus clinical justification triage score (CCTS) to prioritize patients who require surgery during the “new normal state” of the COVID-19 pandemic. Methodology A consensus study using the Delphi technique was carried out among clinicians from the Orthopaedic Surgery, Neurosurgery, and Anaesthesia departments. Three rounds of consensus were carried out via survey and Webinar discussions. Results A 50-points score system consisting of 4 domains with 4 subdomains was formed. The CCTS were categorized into the hospital capacity, patient factors, disease severity, and surgery complexity domains. A score between 30 and 50 points indicated that the proposed operation should proceed without delay. A score of less than 20 indicates that the proposed operation should be postponed. A score between 20 and 29 indicates that the surgery falls within a grey area where further discussion should be undertaken to make a joint justification for approval of surgery. Conclusion This study is a proof of concept for the novel CCTS scoring system to prioritize surgeries to meet the rapidly changing demands of the COVID-19 pandemic. It offers a simple and objective method to stratify patients who require surgery and allows these complex and difficult decisions to be unbiased and made transparently among surgeons and hospital administrators.


Introduction
The coronavirus disease 2019 (COVID-19) has been declared as a global health emergency by the World Health Organization (WHO) on 11 March 2020 [1]. As of 22 June 2020, the WHO reported more than 8.8 million cases of COVID-19 infections globally, with approximately 460,000 deaths [1,2]. In this pandemic disease state, many healthcare systems and hospitals have cancelled their elective nonurgent surgical cases to divert resources for the management of the increasing number of COVID-19 patients [3,4].
National Health Service (NHS) in United Kingdom defines obligatory in-patients (emergency patients) as those who continue to require surgical management, whom treatment should be expedited to avoid pre-operative delay. Urgent elective care was defined as patients with spinal conditions that may lead to neurological deterioration if not operated on in the near future, while routine elective care was defined as patients with stable spinal conditions that can continue conservative treatment. NHS recommends delaying all elective spinal surgery, and only emergent and urgent surgery should be performed [5]. Similarly, the American Academy of Orthopaedic Surgeons (AAOS) recommends their members to cancel all elective Orthopaedic surgeries [6], and the North American Spine Society (NASS) recommended that all elective spinal surgeries where spinal pain and dysfunction can be reasonably managed without surgical procedures should be postponed [7]. Based on NHS, AAOS, and NASS guidelines, Singapore Spine Society (SSS) defined emergency surgical conditions as unstable spinal fractures resulting from either trauma or pathological causes in patients with neurological deficits, cauda equina syndrome, or spinal infection, and has recommended that these cases should not be postponed despite the ongoing crisis [8]. The downstream effect of these changes is the accumulation of a large number of patients who require spinal surgery when COVID-19 measures ease.
The difficulty one anticipates after the COVID-19 outbreak stabilizes is the management of patients whose elective surgeries were postponed. While we should strive to provide timely treatment for these patients, one must be cognizant of the possibility of a second or even third wave of COVID-19 cases until a vaccine or herd immunity is attained [9]. A triage algorithm is needed to ensure patients who require surgery more urgently or less resource-dependent are prioritized, to allow the healthcare system to maintain its capacity for a rapid response against the surges in COVID-19 infections and the institute financial viability. The aim of this paper is to propose a generic scoring system for spine surgery triage to assist healthcare institutions and physicians'decision-making in prioritizing the large number of patients who require surgeries during the "new-normal state" of COVID-19.

Methods
A consensus study based on expert opinion using the Delphi method [10,11] was performed in a university academic medical centre. Faculties from the orthopaedic surgery, neurosurgery, anaesthesia, surgical intensive care, and operating theatre (OT) committee were invited. After the study objectives, the structure of the scoring system, and initial parameters were determined by the lead author, the proposed system was refined using the Delphi method, spread across three rounds of analyses (Fig. 1). A detailed description of the Delphi process is found in the appendix of this paper.

Results
A total of 15 faculties participated in the Delphi process to devise the scoring system, of whom 8 were Orthopaedic Spine surgeons, 4 were Neurosurgery Spine surgeons, and 3 were Anaesthetists. Of the 3 Anaesthetists, one is the clinical director for the Anaesthesia department, one is the director for the Surgical Intensive Care Unit (SICU) and one is the chairman of the hospital Operative Theatre (OT) committee, who is in charge of the overall function of all operating theatre in the university hospital.

Analysis of the survey
In the initial phases, 17 subdomains and 63 factors were identified ( Table 1). The faculties ranked each subdomain factors in isolation, with an average spread of the score on either end of the spectrum within each subdomain from a mean of 1.3 ± 2.1to 9.7 ± 0.4. Table 2 shows the results of the average score ranking from the faculties on each factor.
Factors with a similar score were either regrouped as one factor, or removed from the scoring system. Subgroup analysis showed good concordance of ranking for surgery priority     of each factor among the faculties from Orthopaedic Surgery, Neurosurgery, and Anaesthesiology (Table 2). Spinal metastasis and primary bone tumour showed discordances (p value 0.010) between the surgeons and the anaesthetists.

The final scoring system
A scoring system, consisting of 4 domains with 4 subdomains and 49 subdomains based on patients' conditions and hospital resources was created to triage operation suitability to proceed for surgery during the COVID-19 pandemic. The 4 domains were as follows ( Table 3): 1) Hospital capacity 2) Patient factor 3) Disease severity 4) Surgery complexity The hospital capacity domain consisted of 4 subdomains and its subdomain factors. The 4 subdomains were: Hospital and equipment preparedness, ward requirement for postoperative care, anticipated post-operative hospitalization stay duration, and type of anaesthesia required for surgery.
The patient factor domain consisted of 4 subdomains and its subdomain factors. The 4 subdomains were: The patient'sCOVID-19 status, patient's comorbidities classified by the American Society of Anaesthesiologist (ASA) [12] classification, surgery waiting time, and the number of times the patient's surgery has been cancelled due to lack of hospital resources during the COVID-19 pandemic.
The disease severity domain consists of 4 subdomains and its subdomain factors. The 4 subdomains were: Type of pathology, type of nerve deficit, severity of the condition, and pain score using the visual analogue score (VAS) [13]. To ensure that the severity of the disease is classified objectively, existing and well-validated scoring systems are referenced in the score table, depending on the type of spinal pathology to aid in decision-making. These include the thoracolumbar injury classification score (TLICS) [14] for spinal fractures, American Spinal Injury Association (ASIA) [15] classification for spinal cord injuries, Japan Orthopaedic Association (JOA) [16] score for cervical myelopathy, spinal instability neoplastic score (SINS) [17] for metastatic spinal disease, and patient outcome scores such as the Neck Disability Index (NDI) [18] and Oswestry Disability Index (ODI) [19]for spinal disorders were utilized. The cut-offs for each score representing severe, moderate, and mild disease were reported in Table 3. The exception to this severity grading is that of patients with early-onset scoliosis, where treatment is time-sensitive and delay of treatment may result in cardiopulmonary compromise and increased mortality [20,21]. For this reason, patients with EOS were categorized as severe under the disease severity subdomain.
The surgery complexity domain consists of 4 subdomains and its subdomain factor-groups. The 4 subdomains were: Surgical technique complexity, number of spinal segments involved, estimated operation duration, and potential blood transfusion required. Table 3 shows the details of the individual subdomain factors.
A trial of mock calculation using the score table on various patient scenarios was performed, and increases in weightage of certain subdomain factors were made to meet the faculties' consensus and recommendations by the various societies and guidelines. A 300% increase in weightage in the subdomain factors in hospital and equipment preparedness, type of pathology, type of nerve deficit, and severity of the condition was made. A total of 50 points were created for the scoring system. The average surgical score obtained from the hypothetical patient scenarios during an acute hospital capacity shortage state for cauda equina syndrome, unstable spinal fractures, single-level cervical myelopathy, lumbar prolapsed intervertebral disc, lumbar spondylolisthesis, adult or children deformity without neurological deficits were calculated as 33, 32, 28, 25, 20, 11 and 9 points, respectively ( Table 4, Fig. 2). The estimated score for a patient with EOS was 20 points.

Interpretation of scores
A score of 30-50 obtained from Table 3 indicates that the surgery is of the emergency or high priority category and the proposed operation should proceed without delay, even during the state of acute shortage of hospital capacity. These include patients suffering from cauda equina syndrome, unstable spine fractures with cord injury, and spinal infection (Table 4, Fig. 2). A score of less than 20 would indicate that the surgery is not urgent but of an elective nature with a high resource burden, and the proposed operation should be postponed until hospital capacity returns to normal. These include patients with adult or paediatric spinal deformity without neurological deficits. A score of 20-29 indicates a grey area, where further discussion between various spine consultants, the chief of the division, or the Operating Theatre (OT) committee should be undertaken to make a joint justification for approval of surgery during the state of acute hospital resource shortage. These include patients suffering from cervical myelopathy, lumbar prolapsed intervertebral disc, or degenerative lumbar disease with significant neurological deficits such as patients with acute foot drop. The score obtained from Table 3 would increase as hospital capacity returns to normal. A higher score indicates a higher priority for the proposed surgery to proceed. This interpretation of the score obtained a 100% agreement among all the faculties in the study. General ward (GW) 9.5 (5-10) 9.8 (9-10) 9.8 (8-10) 8.3 (5-10) 0.331 High dependency Unit (HD) 6.1 (4-10) 6.3 (5-9) 5.8 (4-10)

Discussion
The "flattening the curve" approach using early infection detection, social distancing, and isolation has been the strategy of choice to reduce mortality rates from the COVID-19 pandemic [22]. Higher COVID-19 mortality rates were seen when healthcare systems unable to support the high numbers of COVID-19 patients [23,24]. As the hospitals' capacity was stretched to the limit, all elective surgeries were cancelled to preserve its resource capacity. This has led to a downstream effect of a large backlog of patients who requires elective surgeries when the COVID-19 measures ease. Using a susceptible-infectious-recovered model, Leung et al. [25] predicted a possible second wave of COVID-19 infections. It is hence evident that when countries manage to control their first wave of COVID-19 infections, one must anticipate and place measures in place to ensure the hospitals' capacity will be able to tackle a possible second or third wave of COVID-19 infections until a vaccine is available or herd immunity occurs [9]. In this study, we proposed a 50-point triage system, with 4 domains, 4 subdomains, and 49 subdomain factors to triage the priority for patients' spinal surgery and objectively match the hospital resource allocations. This allows for the often complex and difficult decision of assessing the relative importance of different patients to be transparent and unbiased among surgeons, hospital administrators, and patients. It provides the evaluation of factors including operating theatre constraints, resource requirements for post-operative patient care, and the number of times the patients' surgery  Values are presented as mean (Range) * p values < 0.05, indicating that there was a statistically significant difference between groups  had been cancelled due to lack of hospital capacity to be reviewed, which were otherwise not considered in the established disease severity classification. Furthermore, the separation of providing care and making difficult triage decisions by the clinician can significantly reduce physician burnout and moral injury [3,26,27]. In the Médecins Sans Frontières organization, guidelines and recommendations exist to assist surgeons in prioritization during wartime surgery, in the face of limited resources [28]. During the COVID-19 pandemic, Prachand et al. [29] described a generalized 5-point scale scoring system to assist in decision-making for all types of surgeries [3], which may not be suitable for use to triage the multitude of factors needed for considerations in spinal surgery.
The hospital capacity domain in the scoring system is a surrogate marker for whether the hospital has enough capacity to support elective surgeries. Factors such as anticipated duration of hospitalization stay, intensive care unit (ICU) stay, and the adequacy of hospital equipment will determine if the hospital can support the additional burden of an elective surgical patient places on the healthcare system, potentially risking the diversion of scarce resources away from COVID-19 patients. In Italy, when the public health needs for COVID-19 patients have exceeded the capabilities of the healthcare systems, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) has published recommendations and ethical considerations to aid physicians in the decision-making process of prioritization [30]. In Australia, it has been reported that a maximal surge of COVID-19 cases would require an increase of 191% in ICU beds, 120% increase in invasive ventilators, 245% increase in senior doctors, and 269% increase in ICU nurses [31]. The incorporation of the hospital capacity domain to monitor the hospital equipment resources, ICU availability, hospital beds and ventilators in general anaesthesia requirements allow for flexibility in this triage system to meet the needs of this fluid state of COVID-19 situation.
The patient factors domain was designed to assess the overall risk profile of a patient for complications arising from spinal surgery and the duration that the patient has endured while waiting for surgical intervention. Patients' comorbidities have been reported as risk factors for postoperative complications arising from a variety of spinal surgeries [32][33][34][35]. We used the American Society of Anaesthesiologists (ASA) classification, a well-validated simple tool, to assess the patients' comorbidities. It has been reported that a higher ASA grade predicts increased post-operative revision surgeries, length of hospitalization stay, wound complications, cardio-respiratory complications, and mortality, which in turn translates to an increased strain on the hospitals' resources [36]. Surgery waiting time, the number of times surgery has been postponed due to the pandemic, and the patient's COVID status should be taken into consideration as well. This is similar to the situation in organ transplantations, where these factors come into play for decision-making and surgical waiting time should be accounted for in prioritization of surgery [37,38].
The disease severity domain is the most important consideration in determining the priority of surgery. It carries the highest weightage in the CCTS to provide the differentiating power required to meet the recommendations set by the established international academic societies and the consensus obtained by the faculties in the study. Due to the impracticality to include all published spinal disease-specific score system into the CCTS, we designed the disease severity domain in the CCTS to be broad-based with subdomain categories as the type of spinal pathology, nerve deficit, the severity of condition and pain score. The severity of the condition subdomain was categorized into mild, moderate, and severe which was intentionally kept open to interpretation by the user and based on the surgeon's clinical judgment. Validated scoring systems that define the severity of disease were enclosed as an appendix and were recommended to be utilized in conjunction with the CCTS to avoid subjectivity. These include the thoracolumbar injury classification system (TLICS) [14], spinal instability neoplastic score (SINS) score [17], Japanese Orthopaedic Association (JOA) score [16], MRI grading systems for central canal [39] and foraminal stenosis [40], Cobb angles, Neck disability index (NDI) [18], and Oswestry disability index (ODI) [19]. The visual analogue score (VAS) pain score was incorporated for pain subdomain in our score [13], as Matamalas reported that patient-reported pain score was a predominant driving force for patients to demand for surgery [41].
The surgical complexity domain was designed to include factors of surgical technique, number of spinal segments involved in surgery, the estimated operation time, and the potential need for post-operative blood transfusion. The complexity of surgery reflects the potential risk of patients developing intra-and post-operative complications, which in turn requires additional hospital resources. Horn et al. [42] reported that with an increased number of spinal levels involved and longer duration of surgery, there is an increased risk of intra-and post-operative complications, leading to increased clinical and economic burden to the hospital. This increased inpatients' hospitalization and ICU stay put further strain on the scarce resources of the hospital. Blood transfusion requirement is another important consideration. In addition to the fact that blood donation and supplies have dwindled during the COVID-19 pandemic, Hu et al. [43] reported in a meta-analysis that patients requiring blood transfusion had a 3 times increase in the risk of developing post-operative infection after spinal surgery.
One of the limitations of the scoring system is that the weightage of various factors, in theory, might be different in reality. As this is a proof of concept study, future studies would ASD without deficits ASD without deficits ASD without deficits be required to validate this scoring system. Secondly, the scoring system might appear to be too complex to allow easy implementation. However, since this scoring system aims to be as objective and precise as possible, using a large 50-point-based system allows for the capability to differentiate many combinations of factors to cater to many different real-life patient scenarios.

Conclusion
In conclusion, this study is a proof of concept for the novel CCTS system to triage the priority for patients' spinal surgery and objectively match the hospital resource allocations during the COVID-19 pandemic. It is simple, objective, and allows for the otherwise complex and difficult decision to become transparent and unbiased among clinicians, hospital administrators, and patients. It matches patient care to hospital resource capacity and reduces physician burnout and moral injury. The scoring system can also be easily modified to apply to other surgical specialties. As the hospital capacity and patient factor domain remain as constant universal considerations in this pandemic, only minor changes to the disease severity and surgery complexity domains for the specific specialty are required. A score range with recommendations to "defer surgery", "consider for surgery," and "proceed to list for surgery", respectively, was defined. The third round of consensus was obtained from the survey via email correspondence. Each faculty received the revised score, a table with hypothetical patient scenarios calculations, and the proposed interpretation of the score range. The faculties were asked to indicate whether they agree or disagree with the interpretation of the proposed scoring table and score range. A consensus was defined a priori as 80% agreement across the faculties 13 .