International Delphi Expert Consensus on Safe Return to Surgical and Endoscopic Practice

From the Coronavirus Global Surgical Collaborative

Horacio J. Asbun, MD, FACS; Mohammad Abu Hilal, MD, PhD, FACS, FRCS; Filipe Kunzler, MD; Domenech Asbun, MD; Jaap Bonjer, MD, PhD, MBA, FRCSC; Kevin Conlon, MD, FRCSI, FACS, FRCSG, FTCD; Nicolas Demartines, MD, FACS, FRCS; Liane S. Feldman, MDCM, FACS, FRCS; Salvador Morales-Conde, MD, PhD; Andrea Pietrabissa, MD, FACS; Aurora D. Pryor, MD, FACS; Christopher M. Schlachta, BSc, MDCM, FRCSC, FACS; Patricia Sylla, MD, FACS, FASCRS; Eduardo M. Targarona, MD, PhD, FACS; Yolanda Agra, MD, PHD, MHRs; Marc G. Besselink, MD, Msc, PhD; Mark Callery, MD, FACS; Sean P. Cleary, MD, FACS; Luis De La Cruz, MD; Philippe Eckert, MD; Chad Evans, BA; Ho-Seong Han, MD, MS, (Gen Surg), PhD; Daniel B. Jones, MD, MS, FASMBS; Tong Joo Gan, MD, MHS, FRCA, MBA; Daniel Koch, MD; Keith D. Lillemoe, MD, FACS; Davide Lomanto, MD, PhD, FAMS; Jeffrey Marks, MD, FACS; Brent Matthews, MD, FACS; John Mellinger, MD, FACS; William Scott Melvin, MD, FACS; Eduardo Moreno-Paquentin, MD, FACS; Claudio Navarrete, MD; Timothy M. Pawlik, MD, PhD, MPH; Patrick Pessaux, MD, PhD; Walter Ricciardi, MD, MPH, MSc; Steven Schwaitzberg, MD, FACS; Paresh Shah, MD, FACS; Joseph Szokol, MD; Mark Talamini, MD, FACS; Ricardo Torres, MD; Alessandro Triboldi; Suthep Udomsawaengsup, MD, FRCST, FACS; Federica Valsecchi, PhD; Jean-Nicolas Vauthey, MD, FACS; Michael Wallace, MD; Steven D. Wexner, MD, PhD, FACS, FRCS, FRCS; Michael Zinner, MD, FACS; Nader Francis, MBChB, FRCS, PhD

Disclosures

Annals of Surgery. 2021;274(1):50-56. 

In This Article

Discussion

The CVGSC recommendations represent a cohesive international effort to provide guidance on the resumption of hospital surgical and endoscopic activities taking into account the serious burden on our healthcare systems and society caused by the COVID-19 pandemic. At the time the recommendations were drafted, over 5.4 million cases of COVID-19 infections had been reported worldwide, leading to more than 340,000 related deaths and a significant burden on hospital admissions.[10] Both the volume of critically ill patients and the uncertainty about characteristics specific to COVID-19 present unprecedented challenges that have left healthcare systems disoriented worldwide.[11–13] This was exacerbated by the significant need to reallocate healthcare resources, which has led to a profound disruption in surgical and endoscopic services.[14] A recent estimate notes that over 28 million patients are awaiting treatment, a number which continues to grow in the setting of new restrictions on delivery of care and a pandemic that is still evolving[15] As this progression continues, it is clear that ongoing changes in procedure-based specialties must include safety, economic, logistic, and ethical considerations.[16–19]

The same considerations are central to strategies for managing the backlog of patients awaiting surgery. Many countries in quarantine are evaluating ways to ease social restrictions.[20–22]

Given the lack of evidence to guide the surgical community on how to safely resume surgical activities amid the COVID-19 pandemic, the CVGSC recommendations were developed with rigorous adherence to Delphi methodology of establishing expert consensus. This methodology overcomes limitations inherent to group pooling and discussion by virtue of its structure and element of anonymity.[23] These shortcomings include undue influence by certain individuals, pressure to conform to the group, and noncontributory discussions that deviate from stated objectives. The structured nature of the Delphi process facilitates controlled feedback, reiteration of concept and reassessment of opinion, and the ability to apply statistical analysis techniques.[6,24]

A threshold of ≥80% of votes in agreement was used to qualify a statement as having reached group consensus. In Delphi methodology, there is no validated level of agreement to be attained.[25] Given the lack of evidence in this field, investigators aimed to achieve a strong consensus by choosing a higher agreement threshold than those often employed (around 70%–75%).

It was important to begin the Delphi process by ensuring agreement on the nomenclature that is related to the urgency of care. The definitions established in Statement 1.1 to 1.3 ("urgent," "semi-elective," "elective") serve to differentiate between procedures based on the consequence of their being delayed. The complexity of surgical diseases includes the consideration of the many factors that affect outcomes, from patient comorbidities to the availability of treatment options, to patient preference. It is therefore difficult to define the procedure's urgency. The definitions do not represent further nuances of the disease process, such as whether a malignancy is present or not.

Consensus was established for all three definitions in D1. The topic was revisited during discussion of Statement 3.1 in VM3. The final wording of Statement 3.1 reflects the position that the procedures with most flexibility in rescheduling should be those procedures with least expected negative consequence after a delay, independent of the diagnosis. Other factors remain an important part of decision making, such as the phase of the pandemic and available medical supplies.

The authors acknowledge that the true impact of this pandemic will be extensive and long-lasting but it was felt that measuring the impact of COVID-19 was an essential step to adjust current recommendations, and to prepare for potential future major disruptions in healthcare. Recommendations are provided in Domain 2 on how to gather information that can be used to assess this impact, immediately and prospectively. This approach involves a multifaceted analysis including data from screening radiology and endoscopy, cancer stage at presentation, and trends in case volume. Furthermore, there is emphasis on tracking patients whose plans for intervention were altered, which will avoid losing patients to follow-up.

The authors agree that the leadership role of surgeons, endoscopists, and other interventional providers extend far beyond their procedural rooms. Physician leaders are encouraged to actively participate in the decision-making that can shape local, regional, and global policies. At the same time, the global extent of COVID-19 and its effect across medical specialties necessitates a collaborative mindset. Statements in Questions 2B, 6, 9, and others highlight the importance of multidisciplinary communication and shared decision-making.

Protection of patients and staff was another important domain that underpinned several statements in this study reporting on measures that support infection prevention and control. This is achieved through adequate protection of COVID-19-negative healthcare workers and patients, and successful isolation of COVID-19-positive individuals. The pathways outlined aim to minimize exposure to the virus by strictly controlling the risk of transmission throughout the perioperative pathway. Domain 4 elaborates on important measures necessary to protect both patients, visitors and staff as hospitals consider returning to more active surgical/endoscopic schedules. Of note, it was recommended that visitors should not be allowed in the hospital during periods when the local burden of cases is high.

These recommendations are in overall agreement with the principles and guidelines previously published by the American College of Surgeons (ACS), American Center for Disease Control and Prevention (CDC), and European Centre for Disease Prevention and Control (ECDC).[3,26,27] However, they provide detailed information encompassing a wide variety of subjects on a single document and elaborate on how to address education, training, and research during the pandemic.

Much discussion was generated in the final round regarding the screening and testing for COVID-19 among staff and patients. This is a complex issue for many reasons: no tests are well-validated with concurrent high sensitivity/specificity,[28,29] signs and symptoms vary widely,[30] there is no good evidence on optimal protocols, and the current data is part of a dynamic and constantly evolving field.

According to a symptom-based approach to testing, the CDC recommends that staff should return to work at least 10 days after the beginning and 3 days after resolution of symptoms.[27] The ECDC recommends 8 days after onset and 3 days after resolution[26] of symptoms, and the United Kingdom National Health Service (NHS) recommends self-isolation until resolution of fever, at least 7 days after symptom onset.[31] The World Health Organization (WHO) recommends self-isolation for 14 days after onset.[32] There are likewise discrepancies between recommendations for test-based approaches offered by these major organizations.

The differences between guidelines on this important topic reflect the difficulty in delineating the best testing strategies. During the discussions in VM3, much debate revolved around the timing of testing before a procedure. It was decided that, ideally, the testing should take place as near to the procedure as possible. For practical reasons, however, it was agreed that it would be acceptable to perform screening of patients within 72 hours of the procedure. The debate surrounding this topic was the basis for the discussion and revision of a statement in D1 (Statement 5.7) that was initially discarded. It was approved after further discussion in VM3. The authors furthermore felt that it was beyond their area of expertise to give more extensive recommendations on screening and testing of healthcare staff. Thus, awareness and adherence to local policies is recommended (Statement 4.17).

The recommendations acknowledged the need for a patient-centered approach during different phases of the pandemic. Recommendations that underscore this approach include the designation of patient advocates (Statement 6.8), establishment of proper communication pathways (Statement 2.11), and consent forms updated with risks specific to the pandemic (Statement 5.9). The involvement of patient representatives in the consensus process was essential to ensure that patients' views were incorporated into decision-making.

Weaknesses inherent to these recommendations include the reliance on expert opinion and discussion to formulate recommendations. These recommendations were also drafted in the setting of a rapidly evolving pandemic of unprecedented proportions. There is a lack of empirical data to support many of the underlying statements.

The selection of experts is another critical aspect within consensus statements development. The group of experts involved in this research was all recommended by their peers as international leaders in their fields and were distributed across four continents. The experts represented a wide range of opinion leaders, policymakers, government advisors in health policy, in addition to multispecialty clinical team leaders to ensure generalizability and validity of the results in this study. The inclusion of patients' representatives adds relevance to this patient-centered collaborative project. At the time the manuscript was drafted, COVID-19 had mainly affected the countries from where the expert representatives were included. The explanations for the initial preferential spreading pattern of COVID-19 to high-income countries include higher connectivity, colder climate, age profile and body habitus.[33,34]

The response rate among the participants in D1 and D2 was 100%. The entire process, from formulation of questions to finalizing statements, took less than four weeks (April 27–May 22). Both of these factors reflect hard work and commitment on behalf of the group of experts, underscoring the importance of the topics discussed.

The recommendations formulated by this international expert consensus group create a framework for resumption of surgical, endoscopic, and other procedural activities significantly impacted by the COVID-19 pandemic. The statements have the potential for wide application across different healthcare systems globally. The participation of leaders from a variety of surgical and endoscopic organizations in the creation of this manuscript gives an opportunity for a wider, systematic, distribution of these recommendations by the supporting societies.

The recommendations presented here give hospitals a stepwise approach to the COVID-19 crisis, serving as a reference on how to resume surgical and endoscopic activities contingent on the status of disease burden. It seems clear that the COVID-19 pandemia will have multiple recurrent outbreaks. The recommendations outlined in this manuscript will remain relevant at each of the recurrent outbreaks. Given the dynamic nature of the current global crisis, these statements will likely require re-evaluation as more objective information becomes available.

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