key: cord-322957-clf8f90t
authors: Crespo, Javier; Andrade, Raúl; Parras, Fernando Alberca de las; Balaguer, Francesc; Acosta, Manuel Barreiro-de; Bujanda, Luís; Gutiérrez, Ana; Jorquera, Francisco; Iglesias-García, Julio; Sánchez-Yagüe, Andrés; Calleja, José Luis
title: Resumption of activity in gastroenterology departments. Recommendations by SEPD, AEEH, GETECCU and AEG
date: 2020-04-28
journal: nan
DOI: 10.1016/j.gastre.2020.04.001
sha: 
doc_id: 322957
cord_uid: clf8f90t

Abstract The set of measures proposed by SEPD, AEEH, GETECCU and AEG are aimed to help departments in their resumption of usual activity. We have prepared a number of practical recommendations regarding patient management and the stepwise resumption of healthcare activity. These recommendations are based on the sparse, changing evidence available, and will be updated in the future according to daily needs and the availability of expendable materials to suit them; in each department they will be implemented depending upon the cumulative incidence of SARS-CoV-2 infection in each region, and the burden the pandemic has represented for each hospital. The general objectives of these recommendations include: • To protect our patients against the risks of infection with SARS-CoV-2 and to provide them with high-quality care. • To protect all healthcare professionals against the risks of infection with SARS-CoV-2. • To resume normal functioning of our departments in a setting of ongoing risk for infection with SARS-CoV-2.

3 each region, and the burden the pandemic has represented for each hospital. The general objectives of these recommendations include:

•

To protect our patients against the risks of infection with SARS-CoV-2 and to provide them with high-quality care.

• To protect all healthcare professionals against the risks of infection with SARS-CoV-2.

• To resume normal functioning of our departments in a setting of ongoing risk for infection with SARS-CoV-2.

Keywords: SARS-CoV2. Gastroenterology departments. Recommendations.

resumption.

Restablecimiento de la actividad en los servicios de Digestivo. Recomendaciones de la SEPD, AEEH, GETECCU y AEG

El artículo recoge el conjunto de medidas propuestas por la SEPD, la AEEH, GETECCU y la AEG que pretenden servir de ayuda a los servicios en su reincorporación a la actividad habitual. Hemos confeccionado una serie de recomendaciones prácticas respecto al manejo y a la reintroducción progresiva de la actividad asistencial. Estas recomendaciones están guiadas por la escasa y cambiante evidencia disponible y serán objeto de futuras actualizaciones, en base a las necesidades diarias y la disponibilidad del material fungible para adecuarse a las mismas; y se podrán implementar en cada servicio en función de la incidencia acumulada de SARS-CoV-2 en cada región y de la carga que la epidemia ha ocasionado en cada uno de los hospitales. Los objetivos generales de estas recomendaciones son:

• Proteger a nuestros pacientes de los riesgos de la infección por SARS-CoV-2 y prestarles una atención de calidad. • Recuperar el normal funcionamiento de nuestros servicios en un entorno de riesgo continuado de infección por SARS-CoV-2.

Palabras clave: SARS-CoV-2. Servicios de Digestivo. Recomendaciones.

Restablecimiento.

Infection with the SARS-CoV-2 coronavirus and its potentially resulting disease, designated COVID-19, is causing significant concern among the general population, and -needless to say-healthcare professionals and patients (1, 2) . In this regard, it has had a highly significant impact on our gastroenterology and hepatology departments, which have reduced both their hospitalization activity (by more than 50 %) and the number of diagnostic/therapeutic endoscopic procedures (by more than 50 %, unpublished data). Besides affecting our activity, it also affected our work, with high numbers of gastroenterologists being moved to COVID areas. Finally, some -in fact many-of our colleagues have fallen ill as a consequence of caring for patients infected with SARS-CoV-2. Let us not forget that some of the procedures we carry out on a daily basis are associated with a high risk for COVID-19 transmission (3) (4) (5) . Even if its incidence diminishes considerably, it will stay with us over the coming months, which should prompt us to take extreme precautions in a micro-environment with a high risk for coronavirus transmission as is the case with hospitals.

Times of crisis are usually accompanied by opportunities or else appropriate to reformulate activities and the way they are performed. In this crisis we had to respond to the exigencies of COVID-19, but must also carry on providing essential care as defined within our specialty. Because of this, this document also reflects on the opportunity to incorporate telemedicine into our usual practice in order to enhance Page 5 of 47 J o u r n a l P r e -p r o o f 5 the care we provide to our chronic patients. Since the present situation lacks consistency (different Autonomous Communities, hospitals, SARS-CoV-2 incidences, public/private centers, etc.), the right time to implement these recommendations may vary. Be it as it may, we propose that the transition from the current state of alarm, which has brought activity in our departments to a virtually complete standstill, to a more normal situation be accomplished in three phases: activity resumption phase, stabilization phase, and normalization phase. The length of these phases is difficult to foretell in such dynamic, highly changing scenario, but will not foreseeably be shorter than 2-4 months. Furthermore, when will the human and space resources redeployed to caring for COVID-19 patients be recovered by our departments remains yet unknown.

The set of measures proposed by SEPD, AEEH, GETECCU and AEG are aimed to help departments in their resumption of usual activity. We have prepared a number of practical recommendations regarding patient management and the stepwise resumption of healthcare activity. These recommendations are based on the sparse, changing evidence available, and will be updated in the future according to daily needs and the availability of expendable materials to suit them; in each department they will be implemented depending upon the cumulative incidence of SARS-CoV-2 infection in each region, and the burden the pandemic has represented for each hospital. The general objectives of these recommendations include:

 To protect our patients against the risks of infection with SARS-CoV-2 and to provide them with high-quality care.

7 footwear (if possible, specific for hospital use; otherwise, with shoe covers). In addition to providing protection, these measures will prevent care providers from serving as vectors for transmission in and out of hospitals.

c. All healthcare personnel with respiratory symptoms and/or fever and/or suspicion of recent contact with someone infected with SARS-CoV-2 must report it at the earliest possible time to the head of their department. Under no circumstances whatsoever must they go to their workplace in case of suspicion. i. Wherever possible, pharmacy departments shall facilitate drug dispensation for longer periods, even home delivery, as is now the case with some hospitals.

Resuming activity should lead us to pender over the structure of our traditional consultation schedules. The use of telematic tools (consultations over the phone, video calls, other) should be promoted both for patient care and work meetings, as it significantly decreases exposure for both patients and care providers (9) . Objectives will be dependent on the current phase: in the first phase the primary goal is to reduce the risk for SARS-CoV-2 contagion among patients and professionals. In the second phase, and most particularly in the normalization phase, objectives will include: a) reducing non-value-added, on-site care (reporting normal results, further prescribing the same therapy, ordering supplementary examinations, etc.); b) facilitating care for patients unable to attend for work reasons; and c) reducing usual overcrowding in our clinics. Some of the requirements telemedicine must meet are as follows (10, 11) :

 Telemedicine should be considered for all intents and purposes a medical act.

This type of visit must be included in electronic records and appear in the agenda as an "off-site" visit. The electronic medical record may include screen captures of the prescriptions. Having contact information available is important so that instructions and prescriptions may be mailed in writing and a follow-up strategy may be established.

 Ideally, telematic visits should be interspersed among in-person appointments in order to prolong intervals between the latter, thus reducing the number of people in waiting rooms.

 Appropriate coordination should be sought with primary care centers. We suggest appointing a department coordinator for each primary care center, who should currently favor telematic visits rather than referrals.

a. Differentiated circuits must be maintained for patients with and without COVID-19.

b. All admissions other than those strictly necessary should be avoided.

c. In all patients admitted to hospital infection with SARS-CoV-2 must be ruled out regardless of symptoms. PCR is currently the most suitable technique but each hospital should follow their own previously approved protocol.

d. Since the risk of community transmission still lingers on, further rapid testing for SARS-CoV-2 at 10-14 days after admission is advisable to minimize the risk for in-hospital outbreaks. Similarly, patients discharged after more than [10] [11] [12] [13] [14] days in hospital must be tested to prevent community outbreaks.

e. For patients who remain hospitalized:

-Only one adequately equipped physician shall enter the room.

Stethoscopes and any other non-expendable materials coming in contact with patients will be subsequently cleaned with hydroalcoholic solution (or a disinfectant).

-Attempts should be made to monitor patients using telematic or telephony devices.

-Limit to a minimum all testing involving patient transportation within hospitals.

-Invasive procedures such as placement of nasogastric or bladder tubes should be avoided whenever possible, as well as ordering excessive lab tests.

-Foster early discharge and home hospitalization.

f. The number of visits to inpatients must be minimized; this is particularly relevant for immunosuppressed patients. In no case should patients be accompanied by more than one person at a time.

g. It is advisable that patients visiting day hospitals to receive intravenous medications be tested for temperature before entering the facility, and that infusion chairs be at least 2 meters away from each other. Turns should be established if this is unfeasible. Chairs and rooms should be adequately cleaned after infusion completion (12) . It is advisable that patients attend alone whenever possible.

h. In case of day-hospital overcrowding efforts will be made to prescribe drugs with subcutaneous formulation.

Once the confinement phase is over, massive screening will likely be a most effective measure to gain insight into the population's immune status regarding SARS-CoV-2

infection. Knowledge of this immune status will be particularly relevant in areas with high infection rates and, above all, among those who provide care for the rest of citizens. Because of this we recommend:

a. Regular, universal screening of professionals. Such screening will reveal immunization level, and will likely help establish the risk run by care providers, a key aspect for the management of a potential recurrence of the pandemic.

b. Universal screening of all patients who must undergo examinations involving SARS-CoV-2 infection transmission risks.

c. Systematic screening for SARS-CoV-2 among particularly vulnerable patients.

Ideally, such screening should be primarily offered to:

i. Patients on biologics or immunosuppressants:

-Inflammatory bowel disease.

-Autoimmune liver disease.

-Other.

ii. Patients with immunosuppression secondary to their underlying disease:

-Compensated and, most particularly, decompensated liver cirrhosis.

iii. Patients with liver cancer.

iv. Transplant recipients.

Two important considerations apply regarding the above screening:

 Obviously, a systematic screening of all these populations cannot be carried out simultaneously, hence we recommend setting up local screening plans.

 Screening is for the asymptomatic population; should a patient present with symptoms suggestive of infection with SARS-CoV-2, he or she should be diagnosed (PCR and/or serologic tests and/or chest x-rays and/or chest CT scan); in no case should the patient undergo an elective dianostic test.

In our view, the best screening strategy should be established at any given time depending on the availability of rapid antibody tests and/or PCR and/or serological techniques such as ELISA, as well as on endemic evolution.

 Interpretation of results obtained in asymptomatic patients without previous close contacts.

-IgG negative, IgM negative. Individual with no prior exposure to SARS-CoV-2.

-IgM positive, IgG negative or positive. Recent, potentially active infection.

A PCR shall be made to rule out active infection.  Activity shall be immediately resumed (first phase) for patients with urgent or preferential indications, and/or for undelayable therapeutic procedures.

 The rate of activity resumption shall depend on local characteristics, both regarding pandemic incidence and healthcare personnel/ancillary staff availability.

 Transient elastography is only exceptionally an urgent procedure.

 Both the patient and physician must wear surgical masks during the examination.

 Activity shall be gradually resumed, preferentially starting in the second phase.

 High-risk examinations beause of aerosol formation.

 Only exceptionally urgent.

 Resumption shall be held off until the third phase.

 Should an urgent indication arise in the first phase (highly unlikely), the course of action shall be the same as for gastroscopy, including screening for SARS-CoV-2 and using appropriate protective equipment.

 High-risk examinations beause of aerosol formation.

 Only exceptionally urgent.

 They may be substituted for by other testing modalities (fecal antigens, commercial tests).

 These tests shall not be resumed until the third phase.

 Portal hemodynamics is a moderate-risk study regarding SARS-CoV-2 transmission (position and duration).

 During the first phase of activity resumption in our departments a conservative attitude is advisable, prescribing this examination only in two situations:

-Liver biopsy in cases of severe acute liver failure where the test may play a key role.

-Urgent placement of TIPS for intractable bleeding secondary to portal hypertension.

 In the second phase it seems reasonable to perform any necessary procedures to assess portal hypertension in patients with hepatocellular carcinoma potentially amenable to surgical resection.

 Finally, during the third phase (normalization) all indicated procedures will be carried out the same as before the crisis.

The COVID-19 pandemic represents an unprecedented challenge to our health system, and as regards specifically patients with inflammatory bowel disease (IBD) multiple concerns arise in connection with their management, as many are on treatment with immunity-impairing therapies. Furthermore, IBD is a condition that evolves in flares alternating with remission periods, and may have potential complications that often require urgent, or at least preferential, care.

A variable proportion of patients have digestive complaints such as nausea, vomiting, bowel habit changes, or abdominal pain (13) . These symptoms are common in patients with IBD, hence the importance of excluding COVID in our patients. Furthermore, the virus has been reported to be present in the stools of COVID-19 patients, regardless of the presence of diarrhea, and to persist there even after respiratory symptoms are over or detection in the oropharynx is no longer feasible, its significance being uncertain concerning infectivity during endoscopic procedures or potential fecal-oral transmission (14) .

The first question we posed ourselves from the start of the pandemic was whether patients with IBD are at increased risk of infection. Patients with IBD do not seem to have a greater risk for infection with SARS-CoV-2 or for development of COVID-19.

According to data from Bergamo in Lombardy, a region especially affected of Italy, no patient among their 522 cases of IBD was diagnosed with, or admitted to hospital for COVID-19 (15) . A possible reason explaining this lower number of cases of COVID-19 in IBD patients may be this population's adherence to protective measures.

Another common question is whether COVID-19 may cause an IBD flare-up; current evidence does not seem to support that, albeit available data are scarce and caution is here advisable (16) .

Finally, the next question we posed ourselves was whether suffering from IBD may condition the course of COVID-19. Answering this is difficult since multiple factors may play a role: age, comorbidities, inflammatory activity, and trestments received, the available information being limited about these. There is an international registry called SECURE-IBD (17) that aims to collect the data of patients diagnosed with IBD

where COVID-19 has been confirmed (positive testing) (1). At the time of writing these recommendations a total of 457 patients have been recorded, 78 of them from Spain.

The overall rate of hospitalization has been 30 %, and those of ICU admissions, ventilation requirement, and mortality have been 4 %, 4 %, y 3 %, respectively.

Therefore, it seems that the course of COVID-19 in patients with IBD is not worse than in the general population, but we should bear in mind that our IBD patients are younger than the general population. In this respect the fact should be highlighted that patients with moderate-high activity required ICU care/ventilation or died (pooled variable) in 17 % of cases, versus 5 % for patients with remission or low activity, with 27 % of subjects with an untoward outcome being on steroids.

Below we include a table with a theoretical stratification of the risk for poor outcomes based on recommendations by the British Society of Gastroenterology (BSG) (18), although, again, the dearth of data available about the therapies used for IBD should be borne in mind (Table 1) . Drug half-life must be taken into account, and so patients who discontinued immunosuppressants or biologics within the last 3 months remained exposed to their effects when it comes to risk categorization.

Recommendations concerning the treatment of IBD are based on those issued by the International Organization for the study of IBD (IOIBD), BSG, and American

Gastroenterology Association (AGA) (19) , differentiating between uninfected, SARS-CoV-2 infected, and COVID-19 patients.

General recommendations regarding the treatment of patients with IBD, which must remain in force during the gradual resumption of activities:

a. Patients must not discontinue medication or visits to the infusion center, or start self-medication, without consulting with their doctor first.

b. Medication must be available at home in case an isolation period is required.

c. Smoking should be stopped as it increases the risk and severity of COVID-19.

Smoking augments gene expression of angiotensin converting enzyme 2 (ACE2), the receptor for viral entry (20) .

a. In case of suspect symptoms and a negative SARS-CoV-2 PCR, the potential for false negative results should be considered, as well as a repeat test.

b. Treatment must be maintained to prevent non-adherence-related relapse, which may represent a higher risk of infection because of steroid or hospitalization needs. e. When planning to initiate therapy with biologics or immunosuppressants, it is advisable that SARS-CoV-2 testing be included in the previous assessment routine (21) .

f. Steroids use should be minimized. If required, rapid tapering by 10 mg/week is advisable.

a. If the patient is on steroids, reduce dose to below 20 mg or switch to budesonide should the clinical scenario allow. Clostridium difficile, which requires specific treatment.

IBD patients already underwent specific follow-up prior to the COVID-19 crisis. Most IBD units have clinics or free-access mechanisms in case of flare-ups to avoid visits to the emergency room (ER) (23) . Two further characteristics should be considered:

nursing consultation (24) and telemedicine, long implemented in our IBD units pioneered in our country by GETECCU platforms such as TECCU (25) .

In an initial phase it is recommended that all scheduled follow-up visits take place telematically. The duration of follow-up for patients in remission according to their medication should be met or at least deviated the least possible from the standards published and accepted by GETECCU (26) . In the initial phase it is recommended that patients with severe disease requiring specific physical examinations attend. In the stabilization phase patient numbers will be adjusted according to the above indications.

Non-scheduled consultations. During the initial and stabilization phases, aiming to avoid physical visits to hospital, patients with urgent consultations should be advised to contact the IBD unit via the nursing clinic, telephone, or email. Should the issue be serious or unsolvable through telematic means a visit will be scheduled according to the above indications. Infection with SARS-CoV-2 must be ruled out if fever and diarrhea are present. (27) .

a. It is recommended that patients with severe Crohn's disease or ulcerative colitis flare-ups refractory to outpatient management be admitted to hospital.

Also patients with subocclusion and with septic complications.

b. In case of high suspicion of COVID-19 despite a negative test result on admission, it is advisable to place the patient in a pre-COVID-19 area and then repeat testing given the potential for false negative results (28) . e. Consider reducing and facilitating bureaucratic aspects using sponsor amendments given the care burden and activity reassignments of participating physicians.

Probably, from a healthcare perspective, managing endoscopy units is the most challenging activity of any gastroenterology department. Patient presence is mandatory, work there involves risk for both patients and care providers (and society at large), and no published or accessible protocols deal with activity resumption.

On the way back to normalization, we must bear in mind that the latter does not result from overcoming the pandemic but rather a reduction in infection rate allowing to decrease hospital overload, which may in turn permit a recovery of regulated activity.

Therefore, one must at all times recall that the risk of infection may persist both for patients and care workers. In general, social distancing and the use of adequate personal protective equipment must be maintained. It is crucial that consideration be given to the amount of hospital resources devoted to caring for patients with COVID-19, and how their recovery for the care of non-COVID patients is anticipated. When opening agenda windows the hospital's contingency plan to reclaim non-COVID areas as COVID areas should a new peak occur has to be taken into consideration.

Furthermore, the number of professionals available at the unit itself and their risk of infection must also be weighed up. A key point is the need for endoscopy units to have available all the materials necessary for a potential increase in activity (at least 3 PPEs, for physician, nurse, and assistant, per procedure (4 if additional staff is required:

anesthetist, nurse, etc.). Without this minimum of materials (defined below in the present document) no endoscopic procedure should be performed.

In preparation for activity resumption we should bear in mind a number of variables: 

A key point is the adjustment of the appointment schedule, which depends on the duration of endoscopic procedures (Table 4 ). At present the times necessary to change clothes, clean instruments and room, disinfect, avoid waiting room overcrowding, etc., should be estimated. Our proposal, considering transmisison risks and the need for cleaning and/or protective measures in case of examining a high-risk patient, is as follows (29): a. Phase I: attempt to reach 50 % of usual activity at the endoscopy unit.

b. Phase II and III: attempt to reach 75 % of usual activity at the endoscopy unit.

In order to define intervals between procedures when examining high-risk patients at least 45 minutes should be added to the established duration according to the EFICAD study (Table 4) .

a. Appointments: patients will be called up on the day before endoscopy to fill out a risk checklist, which will be done again on the day of the procedure. The ideal scenario we must doubtless pursue is the running of a SARS-CoV-2 test in all patients before the treatment (see above) (30, 31) .

b. Access to the endoscopy unit: a surgical mask and gloves (or hydroalcoholic solution for hand washing) will be placed on the patient, and temperature will be measured.

c. The patient shall attend at most with one companion, who will not enter the unit unless the patient requires specific help. Social distancing is key.  Risk by patient type. The risk of transmission by patient type may be seen in Table 5 .

 Risk by procedure type. Two kinds of procedure must be differentiated according to their potential to generate aerosols (32):

i. Aerosol-generating procedures, namely those involving upper endoscopy (ERCP, gastroscopy, upper echoendoscopy, upper enteroscopy); these are deemed to be high-risk. When possible, sedation must be used for all upper examinations in order to reduce the risk for aerosol formation.

ii. Non-aerosol generating procedures, namely those involving lower endoscopy (colonoscopy, lower enteroscopy, lower echoendoscopy) or ostomy; these are deemed to be low-risk.

a. Some level of protection must be used during access to the endoscopy unit, including common areas (administrative area, corridor, living area, washing area, recovery room, etc.). A mask, body protection with scrubs and overcoat, and hospital-specific footwear. Continuous use of gloves would not be required but regular hand washing would.

b. Once in the room the protective level will vary according to the risk allotted to each patient and procedure (32, 33, 34) : -Perform the endoscopic study in a hospital-designated room (usually in the surgical area).

-Perform the endoscopic study within the endoscopy unit. In this case, it would be advisable to designate one specific room for these patients, with the procedures being undertaken at the end of the agenda in order to allow time and resources to clean the specific room. properties, which will minimize transmission risk for any type of virus.

b. Channel cleaning brushes must be single-use, and plastic connections to aspiration must be disposed of.

c. Endoscopes must travel to cleaning areas in a closed container (e.g., plastic bag); upon entering the disinfection room they must undergo immediate manual washing before entering the automated washing system. 

With telematic and phone-based care, during the present pandemic we have learned that patient acceptance is very high and their response to disease has changed.

Patients are now more reluctant to undergo procedures unless they are absolutely necessary. Hence, the possibility and/or need emerges to clear the scheduled wait list.

In this context patients could be contacted before their assigned appointment by a unit physician to assess their need for the scheduled procedure according to indication and clinical status. The possibility that the procedure could be delayed because of the pandemic should be laid out for their consideration.

Recommendations in case of patients with stable chronic liver disease (Table 6) There is no evidence that patients with stable chronic liver disease of any origin will be more susceptible to infection with SARS-COV-2, even though many of them have comorbidities such as hypertension and diabetes mellitus, which are associated with greater severity, particularly in patients with advanced fat deposition disease (37 

Immunocompromised patients might be more susceptible to SARS-CoV-2 infection, even though solid evidence is lacking in this respect. However, some data suggest that immune response is a key factor in pulmonary involvement, and so immunosuppression may even be protective (39, 40, 41) . In fact, post-transplant immunosuppression has not represented a risk factor for mortality during the SARS or MERS C coronavirus pandemic (40 

In case the LT program was interrupted and resumption is under consideration, its restart will be subjected to the availability of an adequate number of ICU/CCRU beds and COVID-19-free hospitalization areas. The course of the pandemic shall always be taken into account.

 Regarding donation, we shall preferentially use excellent donors with no risk factors whatsoever for COVID-19.

 In case of an offer, a coordinator will interview the potential recipient over the phone to assess the presence of COVID-19.

 Performing an RT-PCR test on nasopharyngeal exudate samples from both donor and recipient is key to rule out COVID-19; also a pulmonary assessment of the recipient should be undertaken (this will be according to each transplant group). In all cases a second recipient should be ready for the procedure.

 When possible, acording to each center, the candidate recipient should undergo testing for measuring antibodies (IgM and IgG) in capillary blood, which will supplement the information obtained with the RT-PCR. This obviously extends and complicates logistics, but is indispensable.

 Confirmed COVID-19 cases must be excluded as donors until at least 21 days after symptom disappearance and therapy completion. Cases deemed cured are described in the ONT document of April 13, 2020 (42) , as well as other technical issues whose review we deem advisable. 

The recommendations expressed in this document are aimed at helping departments in the resumption of their usual healthcare activity, which has been almost completely postponed in some of them. We are facing a changing reality that demands considerable plasticity of all of us; a relevant part of our way of working will change, and we must play a leading role in this process. For the above recommendations we have relied on pragmatism, although the scarce, changing evidence available will require future updates. The start of this journey towards a changing normality in every department will depend on the cumulative incidence of SARS-CoV-2 infection in each region, as well as on the burden the pandemic has inflicted on each hospital. 

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