key: cord-282982-dc5m81bx
authors: Rouillard, Smita; Liu, Vincent X.; Corley, Douglas A.
title: COVID-19: Long-term Planning for Procedure-based Specialties During Extended Mitigation and Suppression Strategies
date: 2020-05-18
journal: Gastroenterology
DOI: 10.1053/j.gastro.2020.05.047
sha: 
doc_id: 282982
cord_uid: dc5m81bx

nan

The COVID-19 pandemic has placed patients and their communities at tremendous risk from acute illness as well as economic uncertainty. 1 Given varying degrees of mitigation and suppression may persist for 1-2 years, there is a critical need for pragmatic approaches for reopening procedural and surgical units, addressing backlogs, and establishing standards of care which balance patient risk and benefit, while maintaining the procedural volumes needed for patient care during this time of ongoing disease control measures. This commentary will: define mitigation/suppression; describe its effects on procedure-related health care backlogs; and discuss strategies for risk stratification and patient care. These will be supplemented by relevant examples from a large region of Kaiser Permanente, an integrated healthcare system that cares for approximately 1 of every 30 people in the United States.

The successful management of epidemics from the World Health Organization 2 and the Imperial College COVID-19 Response Team 3 suggests several initial phases and recommended actions:

• Emergence of infection (recommended action of early detection);

• Localized transmission (recommended action of containment, using countermeasures such as isolation, contact tracing, and testing);

• Amplification and rapid spread (recommended action is control measures such as mitigation and suppression).

Mitigation permits a controlled outbreak; it slows viral spread to "flatten the curve" with the aim of maintaining levels of illness within existing healthcare system capacity, using measures such as quarantine of infected patients and their contacts and social distancing of those at increased risk of severe disease. Suppression, a more aggressive control approach, seeks to minimize cases, even to reverse epidemic growth, using additional measures such as social distancing of the entire population, with closures of schools and businesses (including elective medical visits). 4 Healthcare systems have radically restructured their operations to brace for surges in acute COVID-19 hospital demand and in response to regional mitigation and suppression measures.

These measures included deferrals of routine elective and semi-elective healthcare, including the majority of endoscopic and surgical interventions 5 for screening, diagnosis, and treatment.

These actions may impact patients' health and, for many systems, modify revenues needed to sustain healthcare delivery during and after the pandemic.

At Kaiser Permanente in Northern California (KPNC), a Kaiser Permanente region serving 4.5 million members, early surges of COVID-19 inpatients in two medical centers led to regional mitigation/suppression measures and the rapid cancellation of elective procedures/surgeries throughout our 21 hospital system in March 2020, aligned with recommendations from the Centers for Disease Control and Prevention (CDC), gastrointestinal specialty societies, and the American College of Surgery. 6 , 7,8 The resulting number of deferred elective procedures across our system by May, 2020 is substantial, since we typically have approximately 10,000 gastrointestinal procedures and 30,000 elective surgeries per month.

As communities begin relaxing COVID-19 mitigation and suppression measures, healthcare systems are preparing to reinstate elective procedures and surgeries. Addressing ongoing healthcare needs, ongoing mitigation/suppression, and procedure backlogs will require three primary components: telehealth to continue social distancing and maintain mitigation, risk stratification to maximize benefit of procedures being scheduled, risk stratification to minimize harm, and methods for optimizing healthcare capacity and safety to provide relevant services to the most people possible.

Multispecialty collaborations and virtual care platforms will continue to be essential during ongoing mitigation/suppression for maintaining specialty and peri-procedural care in almost all healthcare settings. Telehealth (video or telephone) visits accounted for approximately 18% of specialty care visits prior to March 1, 2020 in KPNC; in contrast, by the week of April 19, they accounted for approximately 76% of visits (albeit at a decline in total specialty visits from approximately 300,000 per month to approximately 150,000 per month). Between March 16, 2020 and April 17, 2020, at KPNC, gastroenterologists and surgeons received nearly 6,000 and 30,000 outpatient referrals respectively, and were able, using tele-and video-based consultations, to disposition >80% of referrals for procedures within 3 days of receipt, addressing urgent indications and deferring non-time sensitive cases.

Although elective procedural volume decreased markedly over this period, urgent or emergent procedural and surgical caseloads (typically accounting for 30-40% of our procedural/surgical volume) remained stable. This suggests that, even during high levels of mitigation/suppression, a combination of telehealth and highly selected office visits can allow the prompt evaluation and scheduling of critical procedures and surgeries (including cancer-related care) despite decreased procedural volumes.

The likely benefit of procedures varies markedly by indication and includes both disease morbidity (e.g. amelioration of symptoms) and mortality (i.e. likelihood of earlier intervention decreasing the likelihood of disease progression). Recent publications for gastrointestinal procedures provide important information regarding patient benefit for the most common indications for colonoscopy: screening, surveillance, and follow-up of fecal immunochemical test (FIT) results. Higher risk patients include FIT positive patients who are approaching six months from their test (after which there is a significantly increased risk of disease progression) 9-12 ; symptomatic patients (e.g. dysphagia, weight loss, gastrointestinal bleeding, inflammatory bowel disease flare, etc.); laboratory abnormalities suggestive of acute disease (e.g. acute or progressive iron deficiency anemia, abnormal imaging, obstructive jaundice, etc.); and patients with large or incompletely resected polyps. 13 Understanding disease risk around these factors can inform prioritization of COVID-19 relative procedure backlogs during re-opening and ongoing mitigation/suppression control measures, which may include repeated partial closures during local increases of disease incidence (Table   1 ). For example, a risk measurement process at KPNC to identify and schedule pending routine and high risk (FIT +, post cancer, high risk adenoma follow up) patients awaiting colonoscopy across all 21 facilities in KPNC in late 2019 and in early 2020 resulted in a 33 percent reduction in such patients within 10 weeks, from approximately 11,000 to 8000. However, after California's shelter in place orders were implemented, the number of patients awaiting colonoscopy initially plateaued and then rapidly rose to over 12,000, exceeding the pre-COVID numbers. These risk measurement methods can now be used to prioritize patients for early scheduling of high-risk patients (Table 1) .

Procedure-related harm during a pandemic includes: 1) patient infection risk; 2) medical staff infection risk; and 3) procedure-related complications. While COVID-19 hospitalizations began subsiding in parts of California in late April, new cases continue to arise, lending considerable uncertainty to estimates of community transmission risk. Because patients presenting for procedures/surgery may also be at risk for COVID-19-related complications, KPNC is using regional data to identify patient characteristics associated with COVID-19 deterioration. Among 2,168 KPNC patients with COVID-19 positive tests in our system at the time of analysis, we corroborated external reports that younger age and lower comorbid disease burden are associated with lower rates of hospitalization, critical care, mechanical ventilation, and death. 14 These data assist our clinicians in stratifying patients based on their risk of COVID-19 complications.

Given endoscopic procedures are generally low risk, even among persons with high comorbidities, risk is primarily related to identification of a disorder amenable to surgery. For relevant indications (e.g. evaluation of a colon mass seen on radiologic imaging), if such patients are unlikely to tolerate surgery, they are less likely to benefit from endoscopy. To assess surgical risk for all types of operations, we developed a risk score incorporating age, comorbid disease burden, and surgical venue for predicting post-surgical major morbidity or mortality using National Surgical Quality Improvement Program (NSQIP) definitions. This model demonstrated good discrimination for identifying patients at risk for post-surgical complications (c-statistic of 0.77 in training and test sets including a total of 144,784 patients) and is now being automatically calculated in our surgical reopening electronic health record dashboards. Detailed online tools from the NSQIP risk calculator are available to quantify patient surgical risk. 15 Applying such risk tools to our deferred surgical cases (all types of surgery), 39% of patients were at low COVID-19-related-risk; for surgical risk 76% were low-risk, 23% medium-risk, and 1% high risk. These perioperative risk scores help contextualize discussions between surgeons and patients related to surgical timing during the reopening period.

Mitigation/Suppression) With evolving decisions in many states to gradually ease mitigation and suppression restrictions, strategies are needed for optimizing procedure safety and throughput to complete new and deferred procedures. In California, for example, in response to a recent statewide declaration to resume elective procedures 16 , hospitals are preparing for surgical reopening. This requires a careful assessment of aggregate procedural/surgical capacity to ensure that local constraints can be addressed by conducting procedures at local or other hospitals with available capacity.

PPE availability is an overarching consideration for procedural/surgical reopening given desires for the safety of the medical staff and the challenges of maintaining a stable supply chain in the COVID-19 era. Thus, it is important for facilities to use PPE forecasts that account for increasing usage with surgical reopening, the number of surgical team members per case, and the type of PPE needed (airborne or standard surgical) to balance resources while accounting for the ongoing risk of COVID-19 surge. KPNC, using this type of forecasting, has successfully modulated procedure volume, continuing PPE conservation and stewardship efforts using CDC guidelines for extended use and reuse to protect patients and providers.

Increasing procedural capacity and safety will likely depend, in part, upon pre-procedural screening for infection. Throughput for gastrointestinal procedures was challenged by the GI multi-society recommendations for airborne precautions for all patients, extending room dwell time for 45 minutes after each case to allow for adequate air exchanges. 17 Thus, expansion of SARS-CoV-2 pre-procedure testing prior to bowel preparation can allow for more standard room turnaround times and use of standard PPE rather than airborne precautions for test negative patients. Similarly, for surgical cases, as testing capacity increases, preoperative SARS-CoV-2 testing can clarify airborne PPE requirements for high-risk procedures (i.e., endotracheal intubation, airway procedures) and to ensure that those with an anticipated ICU stay are at low risk for COVID-19 complications during recovery. 18 There is a complex interaction between test performance characteristics, background prevalence, and the potential for false negative (or positive) tests. This may influence confidence in using lower levels of PPE in test-negative persons, for conservation of this vital resource, particularly in regions with a very high prevalence of active infections. Performance characteristics depend, in part, on the test used (some rapid point of care tests may have lower sensitivity); adequacy of sample acquisition; and disease burden (a person with lower viral burden may be both less infectious and less likely to test positive). A disease prevalence of 3%, for example, would result in a negative predictive value of 99.7% for a test with 90% sensitivity (and 90% specificity) and 99.0% for a test with 70% sensitivity. After taking into account that patients with symptoms typical of infection can be treated as COVID positive, as regards PPE precautions, however, the joint probability appears extremely low of: a person being infected; being asymptomatic; having a false negative test; and standard PPE usage in this patient leading to spread of disease within a healthcare setting. To minimize false negative testing, we recommend using higher sensitivity tests (and updating test type as methods improve), having testing performed by trained personnel for adequate sampling, and adjusting evaluations as needed if community prevalence surges (thereby potentially increasing the proportion of total people tested who have a false negative test).

The current KPNC framework integrates all these factors for reopening procedural/surgical care (Table 1) . Because care in the COVID-19 era engenders novel types of risks for patients and providers, this framework is designed to facilitate shared decision-making between procedurebased physician and patients for procedural timing. Using the described evaluations of benefit and risk, 19 prior to rescheduling KPNC is currently having its procedure-based specialists, including gastroenterologists and surgeons, review each case, leverage expert internal guidance, and engage with their patients in shared decision making to assess whether a delay is in the patient's best interests.

We will initially focus on prioritizing procedures among patients with high medical urgency/likely benefit (based on internal expert opinion, gastrointestinal society guidelines, and the ACS "Elective Case Triage Guidelines for Surgical Care" 20 ) and low COVID-19 and procedural-risk.

Together, our clinicians have also worked across specialties to identify medically urgent noncancer-related procedures needed for diagnosis or treatment for both gastrointestinal diseases (Table 1 ) and general surgical procedures across multiple specialties (e.g. bucket handle tears, bilateral ureteral stones, and aortic aneurysms >6.5 cm).

For patients with low medical urgency and high COVID-19 or surgical risks, we will discuss the risks and benefits of non-surgical care pathways. Older patients likely to proceed to surgery, who may be at higher risk of COVID-19 complications, will be encouraged to await vaccine availability or will participate in the ACS geriatric surgery verification program based on risk and frailty. Special considerations will be given to those expected to need skilled nursing facility recovery given the emerging risks of COVID-19 now recognized in these facilities. Patients with high medical urgency and high procedural/surgical risk will continue to receive interventions to optimize their health -including for diabetes, hypertension, anemia, obesity, and smokingwhile awaiting their surgical date.

Discussions with patients who have low medical urgency and low risk will focus on nonprocedural treatment options given the potential for extended procedural/surgical waiting times.

Disagreements between surgeons and their patients about the timing and risks of surgery will be assessed by second opinion or through local multidisciplinary teams. Alternative methods, for example, can be used for lower-risk patients needing screening and surveillance endoscopic examinations. Patients originally scheduled for screening colonoscopy can instead utilize a FIT testing approach while awaiting colonoscopy. This allows higher-risk patients to complete colonoscopies, while providing average-risk patients with guideline concordant care. Fecal testing can particularly be recommended to patients whose risk of complications from COVID -19 risk is high, such as those over age 60 and those 50-59 with at least one serious comorbidity. Concordant with recent gastrointestinal society guidelines, patients with a history of 1-2 small adenomas scheduled for follow up five years after their initial exam can instead be recommended for testing at 7-10 years, given their long-term risk appears comparable to people without any adenomas. 21

COVID-19 has resulted in tremendous disruptions to routine healthcare and elective procedures, challenging our existing approaches for optimal peri-procedural and procedural planning and care. In the setting of ongoing, albeit lower, rates of COVID-19, reopening deferred procedures/surgeries requires a balanced and data-driven framework that prioritizes the timing of procedures based on medical urgency (patient likelihood of benefit), COVID-19 risk, procedural risk, and the availability of PPE and preoperative SARS-CoV-2 testing. This framework may help minimize the potential impact of deferred care, and diminish additional waves of adverse outcomes among those impacted by the COVID-19 pandemic, until the threat of recurrent viral infection surges abates. The uncertainty of this pandemic calls for healthcare systems to prepare for sustained mitigation/suppression and the commitment of physicians and patients to discuss critical peri-procedural and procedural decisions together. * The availability of personal protective equipment is a key overarching consideration for effective and sustainable procedure/surgical re-opening. Additional factors for consideration include anesthetic approach, home versus inpatient recovery, local COVID-19 case activity, public health agency guidance and regulations, and regional aggregate procedural-related care availability.

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