key: cord-0862619-rfnldkqs
authors: Malhotra, Karan; Mangwani, Jitendra; Houchen-Wollof, Linzy; Mason, Lyndon W
title: Rate of COVID-19 infection and 30 day mortality between Blue and Green (Dedicated COVID-19 safe) pathways: Results from Phase 1 and 2 of the UK Foot and Ankle COVID-19 National (UK-FAlCoN) Audit
date: 2022-02-25
journal: Foot Ankle Surg
DOI: 10.1016/j.fas.2022.02.017
sha: c45cfbfe935ce8f931a6070a265410b1f86d6eb4
doc_id: 862619
cord_uid: rfnldkqs

OBJECTIVES: The primary aim was to determine the differences in COVID-19 infection rate and 30-day mortality in patients undergoing foot and ankle surgery between different treatment pathways over the two phases of the UK-FALCON audit, spanning the first and second national lockdowns. SETTING: This was an ambispective (retrospective Phase 1 and prospective Phase 2) national audit of foot and ankle procedures in the UK in 2020 completed between 13(th) January 2020 and 30(th) November 2020. PARTICIPANTS: All adult patients undergoing foot and ankle surgery in an operating theatre during the study period were included from 46 participating centres in England, Scotland, Wales and Northern Ireland. Patients were categorised as either a green pathway (designated COVID-19 free) or blue pathway (no protocols to prevent COVID-19 infection). RESULTS: 10,846 patients were included, 6,644 from phase 1 and 4,202 from phase 2. Over the 2 phases the infection rate on a blue pathway was 1.07% (69/6,470) and 0.21% on a green pathway (9/4,280). In phase 1, there was no significant difference in the COVID-19 perioperative infection rate between the blue and green pathways in any element of the first phase (pre-lockdown (p=.109), lockdown (p=.923) or post-lockdown (p=.577)). However, in phase 2 there was a significant reduction in perioperative infection rate when using the green pathway in both the pre-lockdown (p<.001) and lockdown periods (Odd’s Ratio 0.077, p<.001). There was no significant difference in COVID-19 related mortality between pathways. CONCLUSIONS: There was a five-fold reduction in the perioperative COVID-19 infection rate when using designated COVID-19 green pathways over the whole study period; however the success of the pathways only became significant in phase 2 of the study, where there was a 13-fold reduction in infection rate. The study shows a developing success to using green pathways in reducing the risk to patients undergoing foot and ankle surgery.

Informed consent and proceeding with surgical intervention during the COVID-19 pandemic has been an evolving and difficult process. In the setting of reduced resources and unknown risk of perioperative COVID-19 infection to the patient and healthcare professionals, decisions to initially limit elective surgery were undertaken by multiple governing bodies. [1] In the UK, NHS England asked NHS hospitals to reduce all elective activity, to the point of postponing all non-urgent elective procedures by the 15 th April 2020, for a period of at least three months. We reported on the first COVID-19 wave in the UK on our phase 1 study from the UK FalCoN audit, which was undertaken to observe the national surgical activity in foot and J o u r n a l P r e -p r o o f ankle surgery during the period of national lockdown. This audit revealed a significant reduction in surgical activity during lockdown, however in the postlockdown period there was normalisation of activity in trauma and diabetic foot and ankle surgery. [2] Less than a quarter of elective activity had resumed to its prelockdown levels by the end of the study. The audit also provided data regarding COVID-19 perioperative infection and mortality to aid discussions of informed consent. [3] In an attempt to enable safe resumption of elective activity, the British Orthopaedic Association (BOA) and the National Institute for Health and Care Excellence (NICE) produced recommendations on recovery pathways. [4, 5] Development of COVID-19 safe pathways (otherwise termed 'green pathways' or COVID-19 free pathways) forms the basis of the recommendations. Ding et al. published the guiding principles for restarting elective surgeries in a safe and acceptable manner which included upto date disease awareness, projection, a fair and transparent system to prioritise cases, optimization of peri-operative workflows and continuous data gathering. [6] Despite this, published results on COVID-19 safe pathways have been limited. To date, one large multicentre study and three small single centre studies have reported on the apparent success of COVID-19 safe pathways. [7] [8] [9] [10] [11] 

The primary aim of our study was to determine the differences in COVID-19 infection and 30-day mortality rate in patients undergoing foot and ankle surgery between green (COVID-19 safe pathway) and blue COVID-19 pathway over the two phases of the UK-FAlCoN audit, spanning the first and second UK national lockdowns. J o u r n a l P r e -p r o o f

This was an ambispective (retrospective Phase 1 and prospective Phase 2) national audit of foot and ankle procedures in the UK in 2020. The audit period for Phase 1 was between 13 th January 2020 and 31 st July 2020. This phase encompassed the first UK national lockdown. Phase 2 was between 1 st September 2020 and 30 th November 2020 and captured the second UK national lockdown. All patients aged 16 years and over who underwent a foot and ankle surgical procedure in an operating theatre from a participating trust were included in the audit.

For the purposes of categorisation, patients were considered to be in the COVID-19 positive cohort if they were first diagnosed with COVID-19 infection between 7 days prior to their surgery and 30 days after their surgery. Patients who did not contract COVID-19 or who contracted COVID-19 outside of this time window were analysed in the non-COVID-19 cohort. These thresholds are in keeping with previous COVID-19 surgical studies. [2, 3, [12] [13] [14] Patients were also categorised by whether they were managed on a COVID-19 safe pathway ("green" pathway), or a non-COVID-19 safe pathway ("blue" pathway), in line with recommendations from the BOA and the NICE. [4, 5] All patients were admitted to hospital, and the days in hospital before discharge were recorded.

All cases which were admitted and discharged on the day of surgery were recorded as zero days.

J o u r n a l P r e -p r o o f

Data was collected and anonymised by each participating NHS trust and transmitted securely to the primary trust site (University Hospitals of Leicester NHS trust). Data governance was dictated by the European general data protection regulations and the study was approved and registered as a clinical audit in the lead centre (Ref No. 10795 ). In addition, each participating trust obtained local audit approval.

Data was collected at the originating trusts on a purpose-designed encrypted spreadsheet. This was securely transferred to the lead trust and data was checked for integrity. Data queries and missing data were resolved with the submitting trust where possible. The final data was then uploaded to the Research Electronic Data Capture web application (REDCap, Vanderblit, Tennessee).

Phase 2 followed the protocol of Phase 1, which has been previously published. [2, 3] After our experience with Phase 1, minor modifications were made to the data collection spreadsheet and data guide to improve consistency of data reported. Data was collected on demographics, co-morbidities, physiological condition, operative treatment, complications, COVID-19 status, and patient pathway. Full details of the protocol can be found in the supplementary material.

COVID-19 identification was standardised as per national government guidelines.

For Phase 2, this meant that the diagnosis of COVID-19 was based on laboratory detection of SARS-Cov-2 viral RNA by quantitative RT-PCR. In the early part of Phase 1 limited testing was available and therefore patients were diagnosed with COVID-19 on the basis of typical clinical or radiological features. [15] For both phases, time periods were subcategorised to reflect their relationship to the UK National Lockdowns. Therefore, for Phase 1 there were 3 subcategories: 'Phase J o u r n a l P r e -p r o o f 1 Pre-lockdown' (13 th January 2020 to 22 nd March 2020), 'Phase 1 Lockdown' (23 rd March 2020 to 11 th May 2020), and 'Phase 1 Post-lockdown (12 th May 2020 to 31 st July 2020). For Phase 2 there were 2 subcategories: 'Phase 2 Pre-lockdown' (1 st August 2020 to 4 th November 2020) and 'Phase 2 Lockdown' (5 th November 2020 to 30 th November 2020).

The designation of the pathway type (green / blue) each patient followed was determined by each contributing trust in line with national guidance and according to their specific protocols. Criteria for a green pathway included: isolation and testing of patients prior to admission for surgery, operating in protected theatres, and segregation of patients from patients on blue pathways.

Demographics and data regarding admission, length of surgery and length of stay were captured as continuous data, or dates. Pathway type, COVID-19 category, and treatment type for patients contracting COVID-19 were collected as categorical data.

Further categorical data was captured detailing whether patients underwent surgery for trauma, elective procedures, or emergency diabetic foot conditions; this was further subcategorised by anatomical region and type of procedure. Patient comorbidities, ASA grade, type of anaesthetic, urgency of surgery, complications and mortality were also captured.

This study was conducted in accordance with STROBE guidelines. [16] Continuous variables are presented as means with 95% confidence intervals (95% CI); categorical data as presented as number and percentages. Data was tested for normality and parametric continuous data was analysed using an independent samples t-test and ANOVA. Categorical data was analysed using a chi-squared test J o u r n a l P r e -p r o o f (Fisher's exact test used for sample sizes less than 5). Where appropriate, Odds Ratios are presented with 95% confidence intervals. For all statistical analysis, a two-tailed p value of <0.05 was considered significant. Phase 1 and Phase 2, and their subphases, had differing numbers of patients and the duration of subphases was different. Therefore, in order to make more accurate comparisons, the incidence of COVID-19 has been expressed as a percentage of infections per patient per week. All data was analysed using SPSS version 26.0 (SPSS Inc, IBM, Chicago, IL).

This study was a collaborative effort of the Outcomes committee and Scientific committee of the British Orthopaedic Foot and Ankle Society who were involved in study design, data analysis, data interpretation, and writing of the report. The funders of the study had no role in the aforementioned aspects of the study. The corresponding author and analysis group had full access to all the data in the study and the corresponding author and the writing committee had final responsibility for the decision to submit for publication.

From across the UK a total of 46 sites submitted data on 12,190 cases. A total of 43 sites participated in Phase 1 and 37 sites supplied data for Phase 2. After exclusion of cases in accordance with the audit protocol and collating data on patients who had multiple operations, a total of 10,846 patients were available for analysis: 6,644 from Phase 1 and 4,202 from Phase 2. The breakdown of exclusions is illustrated in Figure 1 . In total a complete dataset was available for 9,750 patients (89.9%). The most common missing variables were ethnicity and length of surgery, accounting for J o u r n a l P r e -p r o o f 8.5% (918 cases) and 5.5% (600 cases) of missing data, respectively. For patients contracting COVID-19, details were available for comorbidities, mortality, complications, and COVID-19 treatment for all patients. All patients included in this study were admitted to a ward on either a blue or green pathway. Table 1 and Figure 2 illustrate the proportion of patients on blue and green pathways at differing points in the study, and the associated COVID-19 infection rates. Overall, during Phase 1 there was no statistically significant difference in COVID-19 infection rate between patients on blue and green pathways. However, during Phase 2, being on a green pathway was associated with a significantly lower incidence of contracting COVID-19 (Odds ratio: 0.077, 95% CI 0.027 to 0.215). 

The total 30-day mortality rate for the entire audit was 0.36% (39/10,741). The blue pathway had a 30-day mortality rate of 0.54% (35/6426), and the green pathway 30day mortality rate was 0.09% (4/4,280) . In comparing the pathways, the difference observed in all-cause mortality rate was statistically significant (p<.001). Overall mortality in patients who were diagnosed with COVID-19 was 14.10% (11/78).

Comparing the mortality in COVID-19 patients between pathways showed no statistically significant difference (p=.784). A breakdown of mortality rate by time period sub-phases and pathway can be seen in Table 3 . The COVID-19 related mortality rate reduced from 25.71% (9/35) in the first phase of the study to 4.65% Although a number of comorbidities showed a statistical difference between the pathways, no meaningful differences were found. 19 infection rate they observe between pathways. [17] J o u r n a l P r e -p r o o f Guidelines instituted by the UK national governing bodies on the formation of green pathways did not occur until after the first UK national lockdown. [4, 5] Prior to this time, hospitals arranged "green" pathways based on local policies and availability of resources as reported in a number of small studies. [7] [8] [9] A number of authors concluded that the use of "COVID-19 free" pathways (green pathways) were key to the resumption of elective services. [7, 8, 10] In the first phase of our study, we did not find significant differences in COVID-19 infection rate between pathways. This is Although the overall all-cause mortality between pathways revealed a significant increase in mortality in the blue pathway as compared to the green, the COVID-19 related mortality was not significantly different. The most significant factor influencing mortality related to COVID-19 was the time-period studied. Our study on the first wave reported a COVID-19 related mortality of 25.71% (9/35). [3] However, this significantly reduced to 4.65% (2/43) in the second wave as reported in the current study. In our first study, we had already indicated a reduction in mortality rate across J o u r n a l P r e -p r o o f the sub-phase time periods, and this reduction has continued into the second phase.

The trend toward the reduction in mortality has been associated with the rapidly evolving treatment of COVID-19 complications, including the use of antivirals, antiinflammatory drugs and immunomodulation therapies, dexamethasone, convalescent plasma, and the early start of anticoagulant regimens. When comparing both the categorical and continuous data variables between the pathways collected in the audit, the majority were statistically significant. However, the clinical differences were small. The patients on the green pathway were older, more likely to be female, had lower number of operations per patient, had longer time between listing and surgery, had shorter length of stay and had fewer comorbidities. These differences are likely to represent the significantly greater elective patient numbers in the green pathways than trauma and diabetic surgical patients. These differences are more apparent toward the end of the study period as the shift from blue to green pathways for elective patients becomes greater. The most obvious differences between the pathways is in the history of smoking, hypertension, diabetes, malignancy, coronary heart disease, hypertension, chronic liver disease, chronic obstructive pulmonary disease and chronic kidney disease. [23] Our review found minimal differences between the pathways in regard to comorbidities. Therefore, the differences seen in COVID-19

infections between the pathways should not be assumed to be in relation to other patient factors.

Our audit has limitations. This was an audit with both retrospective (phase 1) and prospective (phase 2) of observational data, which underwent retrospective analysis.

Although it is the largest audit of its kind in foot and ankle surgery in the UK, it still does not fully represent the UK practice. However, with a large cohort size of over 10,000 patients we feel that the data presented is a satisfactory surrogate for UK practice. As stated in our first study, we included patients who had COVID-19 between seven days prior and 30 days after their procedure. This has become the standard metric for perioperative infection; however there may still be patients who fall outside this period who had a perioperative infection. In first phase of our study COVID-19 swab testing was not widespread and patients were considered to have J o u r n a l P r e -p r o o f COVID-19 based on symptomstherefore it is possible that the incidence of COVID-19 was higher than reported for this time-period. Similarly, in phase 2, nonsymptomatic SARS-Cov-2 testing had become more widespread thus increasing the possible incidence of detection of SARS-Cov-2, thus increasing the incidence of reported COVID-19 infection. Although the pathways were defined by national guidance; during earlier phases of the study, the pathways were determined by local guidelines. Therefore, the reported pathways in early sub-phases of the study may not fully represent the pathways as we consider them now.

There was a five-fold overall reduction in the perioperative COVID-19 infection rate when using designated COVID-19 green pathways. However, the success of the pathways only became significant in phase 2 of the study where the reduction in COVID-19 infection rate was 13-fold. There was no difference in COVID-19 related mortality between the pathways, however the COVID-19 mortality rate markedly improved over the course of the study period. The study shows a developing success in using green pathways in reducing the risk to patients undergoing foot and ankle surgery and should be continued as elective services resume. 

Impact of COVID-19 on orthopaedic care: a call for nonoperative management

The UK foot and ankle COVID-19 national (FAlCoN) audit -Regional variations in COVID-19 infection and national foot and ankle surgical activity

The UK Foot and Ankle COVID-19 National (FAlCoN) audit. Bone Jt Open

Re-starting non-urgent trauma and orthopaedic care: Full guidance

COVID-19 rapid guideline: arranging planned care in hospitals and diagnostic services

Orthopaedic surgery after COVID-19 -A blueprint for resuming elective surgery after a pandemic

Trauma surgery at a designated COVID-19-free site during the pandemic: a safe model and a possible way to restart routine elective surgery

Elective orthopaedic surgery with a designated COVID-19-free pathway results in low perioperative viral transmission rates

Evaluating the efficacy of a two-site ('COVID-19' and 'COVID-19-free') trauma and orthopaedic service for the J o u r n a l P r e -p r o o f management of hip fractures during the COVID-19 pandemic in the UK

Should we be re-starting elective surgery? Anaesthesia

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Delaying surgery for patients with a previous SARS-CoV-2 infection

Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans

Observational studies: getting clear about transparency

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study

Trend towards reduction in COVID-19 in-hospital mortality

Dexamethasone in Hospitalized Patients with Covid-19 -Preliminary Report

Mortality Benefit of Convalescent Plasma in COVID-19: A Systematic Review and Meta-Analysis

The Impact of Anticoagulation on COVID-19 (SARS CoV-2) Patient Outcomes: A Systematic Review

Being a foot and ankle surgeon in Italy in the era of COVID-19

Clinical determinants of the severity of COVID-19: A systematic review and meta-analysis

J o u r n a l P r e -p r o o f J o u r n a l P r e -p r o o f