CHOLEcystitis COVID-19 pandemic: The CHOLECOVID Audit Links/CC Protocol.pdf · cholecystectomy...

CHOLECOVID Study Protocol Version 121 25th June 2020

CHOLECOVID International multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom

1

An international multi-centre appraisal of

the management of acute CHOLEcystitis

during the COVID-19 pandemic The

CHOLECOVID Audit

Study Protocol Version 121

25th June 2020

CHOLECOVID Collaborative

Website wwwcholecovidorg

General email cholecovidgmailcom

REDCap queries redcapcholecovidgmailcom

Twitter CHOLECOVID

Key Study Dates

Study Registrations Opens 1 May 2020

Retrospective Data Collection Period 1 12 Sep 2019 to 12 Nov 2019 (+ 30 day follow-up)

Retrospective Data Collection Period 2 12 Mar 2020 to 12 May 2020 (+ 30 day follow-up)

New Site Registration Deadline 12 August 2020

REDCap Database Entry Deadline 12 September 2020



2

Table of Contents

CHOLECOVID Steering Group 3

Collaborative Partners 4

Study Delivery Timeline 6

Introduction 7

Methods 8

1 Summary 8

2 Study Aims 8

3 Project Timeline 9

4 Design 9

5 Setting 9

6 Patients 10

7 Definition of Acute Cholecystitis 10

8 Eligibility Criteria 10

9 Data Collection 11

10 Local Project Registration and Ethics 12

11 Analysis Plan 12

12 Authorship 13

13 Expected Outputs 15

Appendix A Case Report Form 16

Appendix B Data Dictionary 17

Appendix C CHOLECOVID Site Survey 27

Appendix D Tokyo Guidelines Audit Standard Adaptation 28

Appendix E Charlson Comorbidity Index Score 29

Appendix F KDIGO Clinical Practice Guidelines for AKI 30

Appendix G Tokyo Guidelines for Severity Grading of Acute Cholecystitis 31

Appendix H Clavien-Dindo Grading of Surgical Complications 32

Appendix I CHOLECOVID PI REDCap Guide 33

Appendix J NHS Health Research Authority Outcome 40

Appendix K References 41



3

CHOLECOVID Steering Group

Name Organisation Twitter

Dr Harry V M Spiers Manchester University NHS

Foundation Trust UK

Harryvmspiers

Miss Rebecca Varley Manchester University NHS

Foundation Trust UK

Varley_RJ

Waheed-Ul-Rahman Ahmed University of Oxford UK WaheedURAhmed1

Dr Omar Kouli Greater Glasgow and Clyde

NHS Foundation Trust UK

Kouli_omar

Mr Daniel Ahari University of Manchester UK AhariDaniel

Miss Leah Argus University of Manchester UK Leahargus

Mr Kenneth McLean University of Edinburgh UK Kennethmclean92

Mr Sivesh Kamarajah Newcastle Upon Tyne Hospitals


Siveshk

Dr Matthew Goldsworthy Manchester University NHS

Foundation Trust UK

MattGoldsworthy

Mr Peter Coe Leeds Teaching Hospitals NHS

Trust UK

Petecoe1

Mr Majid Rashid NHS Fife UK -

Mr Ewen Griffiths University Hospitals Birmingham


EwenGriffiths

Mr Anthony Chan Manchester University NHS

Foundation Trust UK

Anthonykcchan

Mr Christian Macutkiewicz Manchester University NHS

Foundation Trust UK

SurgeryHPB

Mr Saurabh Jamdar Manchester University NHS

Foundation Trust UK

Saurabh_Jamdar

Mrs Catherine Fullwood University of Manchester UK -

Mr Michael Wilson NHS Forth Valley UK WilsonMSJ

Professor Giles Toogood Leeds Teaching Hospitals NHS

Trust UK

-

Professor Ajith Siriwardena Manchester University NHS

Foundation Trust UK

-

Key Contacts

For guidance relating to mini-team setup and audit registration please contact your local principal investigator (PI)

If you would be interested in signing up as PI for a new centre not currently involved or for any general enquiries

regarding the protocol please contact us via email (cholecovidgmailcom) or Twitter (CHOLECOVID)



4

Collaborative Partners

Association of Upper Gastrointestinal Surgery of Great Britain and Ireland wwwaugisorg Twitter augishealth Great Britain and Ireland Hepato-Pancreato-Biliary Association wwwgbihpbaorguk Twitter GBIHPBAnews

Americas Hepato-Pancreato-Biliary Association wwwahpbaorg Twitter AHPBA

Asian-Pacific Hepato-Pancreato-Biliary Association wwwa-phpbaorg Association of Surgeons of Great Britain and Ireland wwwasgbiorguk Twitter asgbi

Royal College Surgeons of England wwwrcsengacuk Twitter RCSNews Scottish Surgical Research Group wwwscottishsurgeonscom Twitter ScotSRG



5

Kent Surrey amp Sussex Surgeons Research Collaborative wwwksssurgeonscom Twitter kssresearch The Roux Group wwwrouxgrouporguk Twitter roux_group London Surgical Research Group wwwlsrgorguk

The University of Manchester wwwmanchesteracuk Twitter OfficialUoM



6

Study Delivery Timeline

Dates Description

1st May 2020 CHOLECOVID Study Launched

8th June 2020 First Principal Investigator (PI) REDCap Accounts Generated (then on a rolling twice-weekly basis for all new PIs ndash Tuesday and Fridays)

12th June 2020 First Collaborator REDCap Accounts Generated (then on a rolling twice-weekly basis for all new collaborators ndash Tuesday and Fridays)

18th June 2020 ndash 12th September 2020

REDCAP Data Collection Database Active Period

12th August 2020 Recruitment of New Sites closes

12th September 2020 REDCap Database Locked Final Data Submission Deadline

September 2020 Data Analysis

October 2020 Planned Dissemination of Results



7

Introduction

Acute cholecystitis is inflammation of the gallbladder typically due to gallstones [12]

Internationally accepted guidelines provide information on standards for diagnosis and

optimum management [34] In patients without major co-morbidity laparoscopic

cholecystectomy during the index admission is the recommended treatment for acute

cholecystitis [567] A meta-analysis of randomized trials demonstrated that delayed

laparoscopic cholecystectomy increased the total hospital stay compared to an early

laparoscopic cholecystectomy after acute cholecystitis [8] Treatment with antibiotics

may be used as a temporising option or as an attempt to control symptoms in patients

who are unfit for surgery Radiologically guided percutaneous cholecystostomy can

also be a treatment option in patients who are unfit for surgery [9] Percutaneous

cholecystostomy is a recognised alternative treatment to cholecystectomy in high-risk

patients and can be used as a definitive option [101112] Although evidence is

limited this option is supported by international guidelines [13] The only randomised

controlled trial to compare laparoscopic cholecystectomy to percutaneous

cholecystostomy reported complications in 44 of the 68 patients (65) in the

percutaneous drainage arm compared to 8 of the 66 patients (12) in the group

undergoing surgery [14]

The outbreak of the novel coronavirus Severe Acute Respiratory Syndrome

Coronavirus 2 (SARS-CoV-2 or COVID-19) has posed a significant challenge to

surgical healthcare systems across the world [15] The World Health Organization

declared a global pandemic due to SARS-CoV-2 on 12th March 2020 [16]

To cope with this unprecedented pandemic healthcare systems across the world cut

back or completely stopped elective surgery reduced non-elective surgery and

adopted non-surgical modes of treatment In the United Kingdom the Royal College

of Surgeons of England advised that non-operative treatment options should be

considered wherever possible for emergency presentations [17] In the case of acute

cholecystitis recommended non-operative management constitutes antibiotics alone

with percutaneous cholecystectomy in select patients [17] Similar guidance was

provided by the American College of Surgeons [18] and the Royal Australasian

College of Surgeons [19]

This study is an audit of the hospital management of patients with acute cholecystitis during the time of the COVID-19 pandemic The audit assesses treatment options and compares outcome to the reference standard of the Tokyo guidelines [34]



8

Methods

1 Summary

CHOLECOVID is an international multi-centre audit regarding the management of

acute cholecystitis during the COVID-19 pandemic lsquoMini-teamsrsquo of collaborators will

participate at each hospital with members ranging from medical students and

traineesresidents to supervising consultantsattending will participate at each

hospital They will retrospectively collect data on patients admitted to hospital with

acute cholecystitis during two separate data periods (a specified pre COVID-19

pandemic period and a specified period during the COVID-19 pandemic) Each centre

will be required to complete a survey detailing their local acute cholecystitis

management practices

Each mini-team consists of up to five members including a principal investigator (PIhospital lead) and

up-to four additional collaborators (data collectors) ndash all five members will be involved in the data

collection at each site supported by a supervising consultant where appropriatepossible No more

than one mini-team will be collecting data at any one hospital site All collaborating members will be

listed as PubMed-citable collaborators on any resulting outputs providing data completeness is met

(discussed in Authorship section)

2 Study Aims

Primary aim

To audit compliance to Tokyo Guidelines [34] (Appendix C) regarding the

management of acute cholecystitis

Secondary aims

bull To characterise severity of acute cholecystitis admitted to hospital during the

COVID-19 pandemic

bull To explore changes in management and outcomes associated with acute

cholecystitis during the COVID-19 pandemic



9

3 Project Timeline

Collaborators at each participating site will retrospectively collect data covering all

admissions with acute cholecystitis over two pre-specified 2-month periods

1 Period 1 12 September 2019 ndash 12 November 2019 (+ 30 Day Follow-up)

2 Period 2 12 March 2020 ndash 12 May 2020 (+ 30 Day Follow-up)

Each patient will be followed up for 30-days from the first day of index admission If

the patient undergoes cholecystectomy within that 30-day follow up period they will

be followed up for 30-days post-operatively This will allow comparison between the

management and outcomes of patients with acute cholecystitis before and during the

COVID-19 pandemic The deadline for entering new patients to REDCap will be 12th

September 2020

4 Design

CHOLECOVID is an international multi-centre audit

5 Setting

CHOLECOVID is open to any hospitalsite in the world that treats patients with

acute cholecystitis In order to describe local processes and resources each site will

be asked to complete an online site survey questionnaire to understand local

management of acute cholecystitis (Appendix D) All participating centres will be

required to register the study according to local regulations evidence of which will be

uploaded onto REDCap prior to commencement of data collection from each

respective site

Clarification Note

Period 1 is a specified 2-month period prior to the declaration of the pandemic Period 2 is a specified 2-month period during the pandemic ie from the date of declaration of the pandemic for 2 months Each site will collect data simultaneously for both periods 30-day follow up is from day of index admission If the patient undergoes cholecystectomy within the 30-day follow up period they should be followed up for 30-days post-operatively even if this extends beyond the original 30-day follow up period



10

6 Patients

Patients admitted to hospital with a clinical diagnosis of acute cholecystitis constitute

the study population

7 Definition of Acute Cholecystitis

Acute inflammation of the gallbladder with pain for over 24 hours often with systemic

upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive

protein (CRP) and at least one imaging modality with findings characteristic of acute

cholecystitis [34]

8 Eligibility Criteria

Inclusion criteria

bull All adult patients (greater than or including 18 years of age)

bull Admitted to hospital within the pre-specified data collection periods

bull Clinical features of acute cholecystitis including local signs of inflammation

(eg right upper quadrant pain Murphyrsquos sign) and pyrexia andor raised

inflammatory markers (WCC CRP)

bull Documented diagnosis of acute cholecystitis as demonstrated by at least one

radiological test (USS MRCP or Computed Tomography (CT))

Exclusion criteria

bull Patients less than 18 years of age

Completion of the short site survey can be done by a PIsupervising consultant (preferred) or

trainee that is familiar with the acute cholecystitis management practices at your site Completion

of the site survey is necessary before the site is granted access to the CHOLECOVID Data

Collection form on REDCap



11

9 Data Collection

Data will be collected and stored online via the Research Electronic Data Capture

(REDCap) web application [2021] hosted and managed by the University of

Manchester United Kingdom No patient identifiable data will be uploaded or stored

on the REDCap database A designated local principal investigator (PI) and a

maximum of four additional collaborators will be identified per site making a total of

five collaborators at each participating site Additional collaborators may be allowed

in certain cases such as at particularly high-volume centres only after discussion

with and at the discretion of the CHOLECOVID Steering Group

Data will be collected in the following categories

1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up

Data will be collected on audit standards and confounding factors for management

and outcomes related to acute cholecystitis to permit accurate risk adjustment of

outcomes This will include COVID-19 status on admission and during in-patient

course Without appropriately adjusting for risk factors it is likely that any findings

would be biased and unable to be appropriately analysed on a national and

international scale Data will be collected according to the case report forms and

data dictionary outlined in Appendix A and B

Top tip

Data collectors should use a combination of printed copies of the CHOLECOVID Case Report Form

(Appendix A) alongside the Data Dictionary (Appendix B) to successfully record data on all eligible

patients

You should collect data on all patients meeting the inclusion criteria All eligible patients must be

included All four inclusion criteria must be met for all patients uploaded onto the REDCap

database



12

10 Local Project Registration and Ethics

All participating centres will be required to register the study according to local

regulations evidence of which will be uploaded to REDCap prior to commencement

of data collection It may be necessary to obtain formal research ethics approval in

some participating countries In the United Kingdom this project should be

registered as a clinical audit or service evaluation (as per NHS Health Research

Authority Guidance ndash Appendix J)

The principal investigator at each site is responsible for obtaining necessary local

approvals (eg audit approval service evaluation research ethics committee or

institutional review board approval) Principal investigators should discuss with their

head of department to expedite the approval process wherever possible in view of

the urgency of the global pandemic Regardless of the approval pathway chosen it

should be stressed that this is an investigator-led non-commercial study which

requires no changes to normal patient care and only routinely available non-

identifiable data will be collected No patient identifiable data will be uploaded or

stored on the REDCap database

Seek advice from PIsupervising consultant on how you may register the study at your hospital

and what approvals would be required These must be added to the REDCap database as

evidence by the PI You may also seek advice from your local audit department or get in touch

with the CHOLECOVID Collaborative should you require any further advice

11 Analysis plan

A full data analysis plan will be written Initially data will be reported using

descriptive analyses Comparisons between groups and to reference standards will

be undertaken using appropriate non-parametric analyses There will be no

comparison of data between individual sites



13

12 Authorship

All research outputs from the CHOLECOVID study will be authored as per the

National Research Collaborative (NRC) authorship guidelines [24] All collaborators

will be listed as PubMed-citable collaborators within the CHOLECOVID Collaborative

in accordance with the roles defined below (so long as the minimum requirements for

authorship are met)

A designated principal investigator (PI) hospital lead and a further four collaborators

(data collectors) will be identified per site making a total of five collaborators at each

participating site

bull Local Principal Investigator (hospital lead) A single lead point of contact

for data collection at each site who has overall responsibility for site

governance registration and supporting data collection PIs are recommended

to be either a consultant or trainee at each site and only one person can fulfil

this role Minimum requirements for authorship include

o Primary person responsible in obtaining local approvals for conduct of

the CHOLECOVID audit (eg registration of the audit seeking

Caldicott guardian (or equivalent) permission to upload data to

REDCap)

o Successful completion of data collection at a centre which meets the

criteria for inclusion within the CHOLECOVID dataset

o Coordination of presentation of local results at their centre from the

CHOLECOVID audit (or otherwise arranges another collaborator to

present on their behalf)

bull Local collaborators (data collectors) A team of up to four data collectors

per centre although this should be appropriate to the anticipated case load)

To be credited with authorship all collaborators must provide a valid ORCID identifier to their PI

(httpsorcidorgregister)

bull The ORCID digital identifier is free-of-charge and widely administered and used within

research often required by journals (it is structured as a 16-digit number eg 0124-7425-9282-

7824)

bull CHOLECOVID will be using ORCID identifiers to generate authorship lists for all papers by

downloading the name of the collaborator using their individual ORCID (and so this is

mandatory for collaborators to be credited with compulsory)

bull The only compulsory information you are required to provide on your ORCID profile is your

name (as you wish it to be displayed on the CHOLECOVID authorship list) with visibility

settings set to Everyone



14

Minimum requirements for authorship on CHOLECOVID outputs include

o Compliance with local audit approval processes and data governance

policies

o Active involvement in data collection over at least one data collection

period at a centre which meets the criteria for inclusion within the

CHOLECOVID dataset

o Collaboration with the hospital lead to ensure that the audit results are

reported back to the audit office clinical teams

bull Supervising Consultant Where the Principal Investigator at the centre is not

a consultant data collection in each hospital must be supervised and

supported by a named consultant Minimum requirements for authorship on

CHOLECOVID outputs include

o Sponsorship of local study registration and responsibility to ensure

local collaborators act in accordance with local governance guidelines



o Facilitation of local result presentation and support of appropriate local

interventions

o Completion of workplace-based assessments for data collectors if

requested



15

Centres who do not upload patients meeting the eligibility criteria OR with gt5 of

missing data uploaded will be excluded from the analysis and the contributing data

collectors excluded from authorship Sponsorship through the audit approval project

registration process by a consultant does not constitute authorship nor does

inclusion of a consultantsrsquo patients in the audit serve sufficient for authorship

Criteria for site inclusion within CHOLECOVID

bull Successful in obtaining all relevant local approvals for conduct of the CHOLECOVID Study

bull Have completed the short site survey

bull Successful data collection of at least one eligible patient per period for each site

bull Individual sites must also ensure

1) They obtain gt95 data completeness for all required field

2) All data has been uploaded by the specified database closure deadline

Should these criteria not be met the contributing mini-team and any data they contribute may not be

included in the final study and they may be removed from any authorship lists You are advised to get

in touch with us as soon as possible so we may support you with ensuring your site is able to

successfully collect data towards the CHOLECOVID Study

13 Expected Outputs

All data will be reported as a whole cohort Unit level data for comparison will be fed

back to collaborators to support local service improvement This project will be

submitted for presentation at national and international conferences Manuscript(s)

will be prepared following close of the project

PRIVATE AND CONFIDENTIAL PATIENT INFORMATION

16

Appendix A CHOLECOVID Case Report Form To be used with Appendix B (Data Dictionary) for more detail REDCap Unique ID

Section 1 Baseline Demographics

Data Collection Period Period 1 (120919 ndash 121119) Period 2 (120320 ndash 120520)

Inclusion Criteria (All four must be met)

Age 18 or over Admitted to hospital Clinical features of acute cholecystitis (AC)

One or more radiological tests confirming AC

Age (years) _ _ _ Gender Male

Female Pregnant

Yes No

BMI (kgm2)

lt 185 185 ndash 249 25 ndash 299 30 ndash 399 ge 40

Underlying Co-morbidities (Tick all that apply)

MI Congestive Heart Failure Peripheral Vascular Disease CVATIA Dementia COPD Connective Tissue

Disease Peptic Ulcer Disease T1DMT2DM Moderate-to-Severe CKD Hemiplegia Leukaemia Lymphoma Solid Tumour Liver Disease AIDS

If T1DM T2DM Severity

Diet-controlled Uncomplicated End-organ damage

If Solid Tumour Spread Localised Metastatic

If Liver Disease Severity Mild Moderate Severe

Total Charlson Comorbidity Index Score (Calculator

bitlycci_calc) _ _ points

Section 2 Diagnosis

Admission Blood Tests (Please complete all)

Hb _ _ _ gL WCC _ _ _ x109L (1dp) CRP _ _ _ mgL Platelets _ _ _ _ mm3

ALP _ _ _ IUL ALT _ _ _ IUL Bilirubin _ _ _ micromolL (1dp) INR _ _ _ (1dp)

Evidence of AKI at Index Admission No AKI Stage 1 Stage 2 Stage 3

Radiological Investigations Performed During Index Admission (Tick all that apply)

Abdominal Ultrasound (US) (if yes day post-admission ______) CT (if yes day post-admission ______)

MRCP (if yes day post-admission ______)

If US Findings

(Tick all that apply)

Acute cholecystitis Gallstones Gallbladder sludge CBD dilation (gt6mm) CBD stone Gallbladder wall thickening

No acute findings

First Investigation Performed During Index Admission

US CT MRCP

If CT Findings



No acute findings

If CBD stone ERCP at Index Admission

Yes No

If MRCP Findings



No acute findings

HDU or ITU Admission During Index Admission

Yes No

Day of First HDU or ITU Admission Day _ _

Tokyo Severity Grade

Grade I (mild) Grade II (mild) Grade III (severe)

If HDU or ITU Total Duration

_ _ days

Section 3 Intervention

Trial of Conservative Management

(During Index Admission)

Yes No

Antibiotics Given

Yes ndash IV and oral (days given______) Yes ndash intravenous only (days given______)

Yes ndash oral only (days given______)

Intervention Tried During Index Admission Cholecystostomy Cholecystectomy

Conservative Management Only Palliative Care Only

Cholecystostomy

Inserted During Index Admission

Yes (days post-admission ______) No

Approach Transhepatic Transperitoneal

Tube size _ _ Fr

Tubogram

Yes (days after insertion ______) No

Complications (Tick all that apply)

Bleed Bile Leak Dislodgement Occlusion Intra-abdominal Collection

Viscus Perforation None

Total Duration Cholecystostomy In-Situ _ _ days Discharged With Cholecystostomy Yes No

Further Intervention Required Yes - Further cholecystostomy Yes ndash Cholecystectomy No

Cholecystectomy

Performed During Index Admission Yes (days post-admission ______) No

Surgical Details

Cholecystectomy Subtotal Cholecystectomy

Abandoned Intraoperatively

Surgical Modality

Minimally-invasive Minimally-invasive Converted to Open

Open

Highest ClavienndashDindo Grade (at 30-days after cholecystectomy) None I II III-A III-B IV-A IV-B V (death)

IF Death Occurred Numbers of Days After Surgery Death Occurred _ _ days

Postoperative Biliary Complications (Tick all that apply) Bile Leak Bile Duct Injury No Biliary Complications

Pulmonary Complications

Pulmonary Complications During Index Admission (Tick all that apply Day Diagnosed after Index Admission)

Pneumonia (day diagnosed______) ARDS (day diagnosed______) Unexpected Ventilation ( Non-invasive Invasive) PE (day diagnosed______)

IF unexpected ventilation day of start _ _ days

Section 4 COVID-19 Status To be completed for Period 2 patients

COVID-19 Status 7-days Prior to Index Admission

Positive Negative Unknown If Positive

Method of Diagnosis (Tick all that apply)

Positive nasaloral swab or bronchoalveolar lavage Chest X-Ray CT Clinical Diagnosis

Patient Considered to be COVID-19 Positive at Any Point During 30-days following Index

Admission

Yes No If Positive



Tested Positive for COVID-19 During Index Admission After Initial Negative Screen Yes No Not Applicable

Patient COVID-19 Swabbed Prior to Surgery Yes (number of days after admission testing performed prior to surgery______) No

Section 5 30-day Follow-Up

Index admission length of stay _ _ days Still inpatient Death during index admission Yes (days post-admission ______) No

Unplanned readmissions within 30-days follow-up of index admission

_ _ readmissions

IF No Cholecystectomy During Index admission Cholecystectomy

plan at discharge

Booked for elective cholecystectomy To reassess in outpatients department Not For Cholecystectomy Unclear


17

Appendix B Data Dictionary

Baseline

Demographics Data

Fields

Required data (definition comment)

1 Data collection

period Period 1 (120919 ndash 121119) (prior to COVID) Period 2 (120320 ndash 120520) (during COVID)

2 Inclusion Criteria

1) Age 18 or over

2) Admitted to hospital during the study period

3) Clinical features of acute cholecystitis

4) One or more radiological tests confirming acute cholecystitis

Index admission refers to the first time the patient was admitted to the hospital for acute cholecystitis during the study period

3 Age Years (Whole number at time of admission)

4 Gender Male Female

5 Pregnant Yes No

6 Body Mass Index

(BMI) lt185 (underweight) 185 - 249 (normal) 25 - 299 (overweight) 30 - 399 (obese) ge 40 (morbidly obese)

7 Underlying co-

morbidities

(select all that apply)

Myocardial Infraction (MI)

Congestive Heart Failure (CHF)

Peripheral Vascular Disease (PVD)

Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA)

Dementia

Chronic Obstructive Pulmonary Disease (COPD)

Connective Tissue Disease

Peptic Ulcer Disease

Must have all four patients not meeting all four criteria must not be included



18

Diabetes Mellitus (Type 1 or Type 2) If yes Diet-Controlled Uncomplicated End-Organ Damage (Note Diet-

Controlled diabetes scores 0 points)

Moderate to Severe Chronic Kidney Disease (CKD)

Hemiplegia

Leukaemia

Malignant Lymphoma

Solid Tumour If yes Localised Metastatic

Liver Disease If yes Mild Moderate Severe

Acquired Immunodeficiency Syndrome (AIDS)

None of the Above

Definitions for Moderate-to-Severe CKD Moderate CKD defined as creatinine gt3mgdL (270 μmolL) Severe CKD

defined as on dialysis status post kidney transplant uraemia

Definitions for Diabetes Mellitus Uncomplicated is defined as medically managed and no end-organ damage

Definitions for Liver Disease Mild defined as chronic hepatitis or cirrhosis without portal hypertension Moderate

defined as cirrhosis and portal hypertension but no variceal bleeding history Severe defined as cirrhosis and portal

hypertension with variceal bleeding history

8 Total Charlson

Comorbidity Index

Score

Number (Whole number minimum 0 points - maximum 37 points)

We recommend collaborators use the following online CCI calculator when calculating a total score bitlycci_calc

Full Charlson Comorbidity Index (CCI) scoring system is also found in Appendix E



19

Diagnosis Data

Fields Required data (definition comment)

1 Admission Blood

tests

(Please complete

all)

Haemoglobin (Hb) (record in gramLitre (gL))

Normal range Male (130 to 180 gramLitre) amp Female (115 to 165 gramLitre)

White Cell Count (WCC) (record in x 109Litre to one decimal place)

Normal range 40 to 110 x 109Litre

C-reactive Protein (CRP) (record in milligramLitre(mgL))

Normal range lt 4 milligramLitre

Platelets (record in cubic milli-meter(mm3))

Normal range 150 to 450mm3

Alkaline Phosphate (ALP) (record in International UnitsLitre (IUL))

Normal range 44 to 147 IUL

Alanine Transaminase (ALT) (record in International UnitsLitre (IUL))

Normal range Male (lt 50 IUL) amp Female (lt 35 IUL)

Bilirubin (record in micromoleLitre (μmolL) to one decimal place)

Normal range lt 210 μmolL)

Internationalised Normal Ratio (INR) (record to one decimal place)

2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)

No AKI Stage 1 Stage 2 Stage 3

Please note AKI stages are defined as per the KDIGO guidelines provided in Appendix F

3 Radiological

Investigations

performed during

index admission

Abdominal Ultrasound Scan (US) Computed Tomography (CT) Magnetic resonance

cholangiopancreatography (MRCP)

(tick all that apply)

Please include only those radiological investigations performed during the index admission



20

4 Which radiological

investigation was

performed first

IF more than one radiological investigation selected



5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission

Number (Whole number where 0 = same day as index admission 1 = first day after index admission

etc)

Ultrasound

findings

Acute cholecystitis Gallstones Gallbladder sludge Common Bile Duct Dilation (CBD) (gt6mm)

Common Bile Duct (CBD) Stone Gallbladder wall thickening (ge 3mm or reported as thick walled)

No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission

Shown on Data Collection Form if selected radiological investigations indicate common bile duct stone

9 Tokyo Severity

Grade

Grade I (mild) Grade II (moderate) Grade III (severe)

Tokyo Severity Grading system guide is detailed in Appendix G

10 Critical care (ie

HDU or ITU)

admission during

index admission

Yes No

Please record if patient was admitted to HDU or ITU during their index admission

11 Day of first critical

care admission

Number

Number of times patient was admitted to HDU or ITU during their index admission

where 0 = same day as index admission 1 = first day after index admission etc

12 Total length of

stay in critical care

Number (Whole number of days)

If appropriate this should include combined duration from multiple admissions to HDU or ITU

Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No

2 Antibiotics given Yes - Intravenous (IV) and oral Yes ndash IV only Yes ndash Oral only No

3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used

Duration antibiotics given (whole number of days)

If patient is on antibiotics at the end of the 30-day follow-up period please enter 31



22

4 Outcome of trial of

conservative

management

IF trial of conservative management lsquoYesrsquo selected

Conservative Management Only Cholecystostomy Cholecystectomy Palliative Care Only

5 First intervention

IF trial of conservative management lsquoNorsquo selected

Cholecystostomy Cholecystectomy Palliative Care

If yes to Cholecystostomy

6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after

admission Number (0 = same day as index admission 1 = first day after index admission etc)

8 Approach Transhepatic Transperitoneal

9 Tube size Number (Whole number in French (Fr) scale)

10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram

Days after insertion of cholecystostomy

(where 0 = same day as index insertion 1 = first day after index insertion etc)

12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion

Intra-abdominal collection

Viscus perforation

None

13 Duration of

cholecystostomy


If cholecystostomy still in-situ at the end of the 30-day follow-up period please enter 31



23

14 Discharged with

cholecystostomy Yes No

15 Further

intervention

required

Yes No

16 Further

intervention type Further Cholecystostomy Cholecystectomy

If yes to Cholecystectomy

17 Cholecystectomy

during index

admission

Yes No

18 Days after index

admission Number (Whole number where 0 = same day as index admission 1 = first day after index admission etc)

19 Type Cholecystectomy Subtotal Cholecystectomy Abandoned intraoperatively

20 Modality

Laparoscopic (performed exclusively using instruments inserted into the abdomen through small ports)

Laparoscopic converted to open (surgery planned to be performed laparoscopically but for unforeseen reasons the

decision was made to change to an open approach)

Open (performed exclusively using instruments inserted into the abdomen through a surgical incision)

21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)

None (no complications) I II III-A III-B IV-A IV-B V (death) (IF death Number of days after surgery

death occurred)

Please note 30-day post-operative complication defined as per the Clavien-Dindo classification found in Appendix H

22 Postoperative

biliary

complications

IF postoperative complications (ie Clavien-Dindo 1 or higher)

Bile leak

Bile duct injury

No Biliary Complications



24


23 Pulmonary

complications

Pneumonia (IF selected Day of Diagnosis of Pneumonia)

Acute Respiratory Distress Syndrome (IF selected Day of Diagnosis of ARDS)

Unexpected Ventilation (IF selected Day of start of Unexpected Ventilation)

Pulmonary Embolism (IF selected Day of Diagnosis of PE)

No Pulmonary Complications


24 Type of ventilation

IF Unexpected Ventilation

Non-invasive Invasive

COVID-19 Status

(Period 2 Only) Data

Fields


1 COVID-19 status

7-days prior to

index admission

Positive Negative Unknown

2 Method of

diagnosis (tick all

that apply)

Positive nasooropharyngeal swab or bronchoalveolar lavage

Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen

Yes No Not applicable

6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery

Number (where 0 = same day as COVID-19 testing 1 = first day after COVID-19 testing etc)

30-Day Follow-Up

Data Fields Required data (definition comment)

1 Index admission

length of stay


If patient has not been discharged by the end of the 30-day follow-up period please enter 31

2 Did this patient die

within 30-days of

index admission

Yes No

3 Days after index

admission

Number (where 0 = death occurred same day as index admission 1 = death occurred first day after index admission

etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission

Number (Whole number of times)

5 Cholecystectomy

plan at discharge

Booked for elective cholecystectomy To reassess in Outpatient Department Not for cholecystectomy

Unclear


CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic

General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom

27

Appendix C CHOLECOVID Site Survey

Please note a supervising consultant trainee (preferably) at your site must complete

this survey as a pre-requisite to register your site to partake in CHOLECOVID

Period 1 Survey

Please detail below the local acute cholecystitis management practices in place at your site during Period 1 (120919- 121119 ie prior to COVID-19 Pandemic)

Number of consultants at site

routinely performing laparoscopic

cholecystectomy

1 2 3 4 5 ge 6

Daily lsquohotrsquo emergency

gallbladder operating list available

Yes (number of sessions per week _________)

No

On-site interventional

radiology service able to perform

cholecystostomy

Yes No

If no daily lsquohotrsquoemergency

operating list access to emergency

operating list for emergency gall bladder surgery

Yes No

On-site Endoscopic Retrograde

Cholangiopancreatography (ERCP)

service

Yes No Specialty or non-

specialty emergency on-call

Specialty (ie separate UGIHPB and colorectal on-call

Non-specialty (ie non-separated on-call)

Period 2 Survey Please detail below the local acute cholecystitis management practices in place at your site during Period 2

(120320- 120520 ie during COVID-19 Pandemic)



cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service





Has your hospital site been affected by

COVID-19 Yes No

Have you adopted new guidance for the management of acute

cholecystitis as a result of COVID-19

Yes No

Has a lack of PPE prevented you from

performing cholecystectomy at

any point

Yes No

If new guidance has been adopted which guidance have you

most closely followed

International National

Regional Local (ie your hospital)

Collegiate Intercollegiate Organisation (eg ASGBI)


CHOLECOVID International multi-centre appraisal of the m multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic General e-mail cholecovidgmailcom REDCap Queries redcapcholecovidgmailcom

28

Appendix D Tokyo Guidelines 2018 - Audit Standard Adaptation Tokyo guidelines 2018 for Management of Acute Cholecystitis (AC)

Standard

1 Early laparoscopic cholecystectomy is

recommended for mild AC

Tokyo Guidelines (2018)

bull Grade I (mild) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if the

CCI score suggests the patient can withstand surgery

2 For moderate AC laparoscopic

cholecystectomy should be performed if

the patient can withstand surgery

otherwise conservative therapy or biliary

drainage


bull Grade II (moderate) AC Laparoscopic cholecystectomy should ideally be performed soon after onset if

the CCI score suggests the patient can withstand surgery and the patient is in an advanced surgical

center If the patient cannot withstand surgery conservative treatment and biliary drainage should be

considered

3 For severe AC early laparoscopic

cholecystectomy can be performed in a

setting where ICU management is

available otherwise conservative

treatment should be performed or

biliary drainage where possible


bull Grade III (severe) AC If it is decided the patient can withstand surgery early laparoscopic

cholecystectomy can be performed by a specialist surgeon with extensive experience in a setting that

allows for intensive care management If it is decided that the patient cannot withstand surgery

conservative treatment including comprehensive management should be performed Early biliary

drainage should be considered if it is not possible to control the gallbladder inflammation

Recommendations based on Level D evidence Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the

management of acute cholecystitis J Hepatobiliary Pancreat Sci 20182555-72




29

Appendix E Charlson Comorbidity Index Score Please use online calculator available here httpsbitlycci_calc

Co-Morbidity Scoring

Age

0 Points (lt50 years)

1 Point (50 ndash 59 years)

2 Points (60 ndash 69 years)


4 Points (ge 80 Years)

Previous Myocardial Infarction (MI) 1 Point

Congestive Heart Failure (CHF) 1 Point

Peripheral Vascular Disease 1 Point

Previous Cerebrovascular Accident (CVA) or Transient

Ischaemic Attack (TIA) 1 Point

Dementia 1 Point

COPD 1 Point

Connective Tissue Disease 1 Point

Peptic Ulcer Disease 1 Point

Liver Disease 1 Point (Mild)

3 Points (Moderate to Severe)

Diabetes Mellitus

0 Point (None or diet-controlled)

1 Point (Uncomplicated)

2 Points (End-Organ Damage)

Hemiplegia 2 Points

Moderate to Severe Chronic Kidney Disease

Moderate = creatinine gt3 mgdL (027 mmolL) Severe = on dialysis

status post kidney transplant uremia

2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)

6 Points (Metastatic)

Leukaemia 2 Points

Lymphoma 2 Points

Acquired Immunodeficiency Syndrome (AIDS) 6 Points

Total Charlson Comorbidity Index (Max score 37 points)



30

Appendix F KDIGO Clinical Practice Guidelines for

Acute Kidney Injury

Grade Serum creatinine Urine output

I 15 ndash 19 times baseline OR

03 mgdl ( 265 moll) increase

lt 05 mlkgh for 6 - 12 hours

II 20 ndash 29 times baseline lt 05 mlkgh for 12 hours

III 30 times baseline OR

Increase in serum creatinine to 40 mgdl

( 3536 moll) OR Initiation of renal replacement therapy (eg dialysis and transplantation) OR Decrease in eGFR to lt 35 mlmin per 173 m2

lt 03 mlkgh for 24 hours OR

Anuria for 12 hours



31

Appendix G Tokyo Guidelines for Severity Grading

of Acute Cholecystitis

Grade I (mild) No organ dysfunction and mild inflammatory changes in the

gallbladder

Grade II (moderate) Associated with any one of the following conditions

(1) Elevated WBC count (gt18000mm3)

(2) Palpable tender mass in RUQ

(3) Duration gt72h

(4) Marked local inflammation (gangrenousemphysematous cholecystitis

pericholecystichepatic abscess biliary peritonitis)

Grade III (severe) Associated with dysfunction of any one of the following

organssystems

(1) Cardiovascular hypotension requiring treatment with vasopressors

(2) Neurological decreased level of consciousness

(3) Respiratory PaO2FiO2ratio lt300

(4) Renal dysfunction oliguria creatinine gt20 mgdl

(5) Hepatic dysfunction PT-INR gt15

(6) Haematology



32

Appendix H Clavien-Dindo Grading of Surgical

Complications

Grade Definition

Grade I Any deviation from the normal post-operative course not requiring

surgical endoscopic or radiological intervention This includes the

need for certain drugs (eg antiemetics antipyretics analgesics

diuretics and electrolytes) treatment with physiotherapy

and wound infections that are opened at the bedside

Grade II Complications requiring drug treatments other than those allowed

for Grade I complications this includes blood transfusion and total

parenteral nutrition (TPN)

Grade III Complications requiring surgical endoscopic or radiological

intervention

bull Grade IIIa - intervention not under general anaesthetic

bull Grade IIIb - intervention under general anaesthetic

Grade IV Life-threatening complications this includes CNS complications

(eg brain haemorrhage ischaemic stroke subarachnoid

haemorrhage) which require intensive care but excludes transient

ischaemic attacks (TIAs)

bull Grade IVa - single-organ dysfunction (including dialysis)

bull Grade IVb - multi-organ dysfunction

Grade V Death of the patient



33

Appendix I CHOLECOVID REDCap Guide for PIs

Setting up your REDCap account

1) Click on the link lsquoSet your new REDCap passwordrsquo in the email This will

take you to the password setup page in REDCap

2) You will see your username in the dialog box Select the password field to

set your password

3) The requirements for the password are that it should be AT LEAST 9

CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case

letter one upper-case letter and one number

4) Click lsquoSubmitrsquo after you have entered and confirmed your password

5) This takes you to the REDCap welcome page shown below which gives you

all the details of REDCap

6) If you click on lsquoMy Projectsrsquo (where the red arrow above is pointing to) it will

ask you to set a security question This question helps with recovering your

password if you forget it so it is advisable that you select a security

question and set an answer and save it

TOP TIP

Collaborators frequently forget their passwords or lock their accounts To prevent any delays with data

collection it is vital that collaborators set their security question as soon as they are given access to

their account



34

How to Add Collaborators on to REDCap

Step 1 Login on to REDCap at httpswwwredcaprssmhsmanacuk

Step 2 Click on the project ldquoCHOLECOVID Local PI Team Registrationrdquo



35

Step 3 Click on the ldquoAddEdit Recordsrdquo button on the left of your Project Home

Screen

Step 4 To add a hospitalsite you would like to register click on the lsquoAdd new

recordrsquo button or to edit details of an existing centre click on the lsquoselect recordrsquo

drop-down menu



36

Step 5 Click on the lsquoSite Datarsquo status button shown below to complete the first of

the three forms under the lsquoCHOLECOVID Local PI Team Registrationrsquo project

Step 6 Add your site details and upload evidence of Ethical or AuditCaldicott

Approvals as required at each centre or any evidence from ethical departments

waiving the need for ethical approvals



37

Step 7 Click on the second form ldquoCollaborator Detailsrdquo on the left side of the

screen Add details of the collaborators including First amp Last name Grade a valid

E-mail and ORCIDs

IMPORTANT NOTE

To be credited with authorship all PIs must enter a valid ORCID for EACH collaborator in the

Collaborator Details Form (Collaborators can register an ORCID identifier at

httpsorcidorgregister)



7824)









38

TOP TIP

Ensure you double-check correct full name e-mal address and ORCID for all collaborators to avoid

delays with them receiving their REDCap account

Step 8 The third form ldquoSite Surveyrdquo is compulsory before redcap accounts can be

generated for all collaborators at a site



39

Frequently Asked Questions (FAQs)

1) When do collaborators get REDCap access

After you have filled in the site data (and uploaded evidence of ethical or

auditCaldicott approvals) collaborator details and completed the site survey on

REDCap they should get login details to access the project after we run the next

round of approvals internally through REDCap (usually every couple of days)

2) I do not have ethicalaudit approval yet can we still collect data

No data collection can only start once appropriate approvals have been granted and

uploaded on to REDCap

3) I have not completed the site survey can our site still collect data

Yes however REDCap accounts will only be generated for collaborators once the

site survey has been completed and uploaded onto REDCap To aid you with having

(often busy) consultants complete the site survey the site survey CRF is attached in

Appendix D this may be printed off and provided to consultants in person

Alternatively you may have a trainee complete the CRF or yourself as PI providing

you are familiar with the sitersquos practices

4) I do not have Caldicott approval yet (UK centres only) can we still

collect data

Yes data collection can be started given that you have ethicalaudit approval (but

not Caldicott approval yet) but it cannot be uploaded on REDCap The data will need

to be collected and stored on a secure NHS device It can then be transferred on to

REDCap once Caldicott approval is granted

5) In centres where the audit department has waived registration what

proof do I need to put on REDCap

You can upload a screenshot of the email demonstrating this on REDCap



40

Appendix J NHS Health Research

Authority Outcome

The NHS Health Research Authority questionnaire (httpwwwhra-

decisiontoolsorgukresearch accessed 1st May 2020) deemed that this study was

not research as the participants are not randomized to different groups there is no

change in treatment or patient care and the findings cannot be regarded as wholly

generalizable



41

Appendix K References

1 Roberts SE Samuel DG Williams JG et al Survey of digestive health across

Europe Final report United Eur Gastroenterol J 20142539-543

2 Strasberg SM Clinical practice Acute calculous cholecystitis N Engl J Med

20083582801-2811

3 Okamoto K Suzuki K Takada T et al Tokyo Guidelines 2018 flowchart for the


4 Yamashita Y Takada T Kawarada Y et al Surgical treatment of patients with acute

cholecystitis Tokyo guidelines J Hepatobiliary Pancreat Surg 2007 14 91ndash7

5 Gurusamy KS Davidson C Gluud C et al Early versus delayed laparoscopic

cholecystectomy for people with acute cholecystitis Cochrane Database Syst Rev

20136CD005440

6 Cao AM Eslick GD Cox MR Early cholecystectomy is superior to delayed

cholecystectomy for acute cholecystitis a meta-analysis J Gastrointest

Surg201519(5)848-857

7 Wu XD Tian X Liu MM et al Mata-analysis comparing early versus delayed

laparoscopic cholecystectomy for acute cholecystitis Br J Surg 2015102(11)1302-

1313

8 Menahem B Mulliri A Fohlen A et al Delayed laparoscopic cholecystectomy

increases the total hospital stay compared to an early laparoscopic cholecystectomy

after acute cholecystitis an updated meta-analysis of randomized controlled trials

HPB(Oxford) 201517(10)857-862

9 Chok KS Chu FS Cheung TT et al Results of percutaneous transhepatic

cholecystostomy for high surgical risk patients with acute cholecystitis A N Z J Surg

2010 80 280ndash283

10 Al-Jundi 2012 - Al-Jundi W Cannon T Antakia R et al Percutaneous

cholecystostomy as an alternative to cholecystectomy in high risk patients with biliary

sepsis a district general hospital experience Ann R Coll Surg Engl 2012 94 99ndash

101

11 Hsieh 2012 - Hsieh YC Chen CK Su CW et al Outcome after percutaneous

cholecystostomy for acute cholecystitis a single-center experience J Gastrointest

Surg 2012 16 1860ndash1868

12 Li M Li N Ji W et al Percutaneous cholecystostomy is a definitive treatment for

acute cholecystitis in elderly high-risk patients Am Surg 2013 79 524ndash527



42

13 Itoi T Tsuyuguchi T Takada T et al TG13 indications and techniques for biliary

drainage in acute cholangitis (with videos) J Hepatobiliary Pancreat Sci 2013 20

71ndash80

14 Loozen C van Santvoort H van Duijvendijk et al laparoscopic cholecystectomy

versus percutaneous catheter drainage for acute cholecystitis in high risk patients

(CHOCOLATE) multicentre randomised clinical trial BMJ 2018363

15Gorbalenya AE Baker SC Baric RS et al (March 2020) The species Severe acute

respiratory syndrome-related coronavirus classifying 2019-n CoV and naming it

SARS-CoV-2 Nature Micobiol 2020 5 536ndash544

16 httpwwweurowhointenhealth-topicshealth-emergenciescoronavirus-covid-

19newsnews20203who-announces-covid-19-outbreak-a-pandemic [accessed 1st

May 2020]

17 Royal College of Surgeons of England Updated Intercollegiate General Surgery

Guidance on COVID-19 London Royal College of Surgeons of England 2020

[viewed 24 April 2020] Available at httpswwwrcsengacukcoronavirusjoint-

guidance-for-surgeons-v2 [accessed 1st May 2020]

18 American College of Surgeons COVID-19 Guidelines for Triage of Emergency

General Surgery Patients Chicago IL American College of Surgeons

2020 httpswwwfacsorgcovid-19clinical-guidanceelective-caseemergency-

surgery [accessed 24th April 2020]

19 Royal Australasian College of Surgeons COVID-19 Guidelines for General Surgery

East Melbourne Royal Australasian College of Surgeons

2020 httpswwwgeneralsurgeonscomaumediafilesNewsDOC202020-03-

2920COVID-1920Guidelines20for20General20Surgery_FINALpdf

[accessed 24 April 2020]

20 Harris PA Taylor R Thielke R et al Research electronic data capture (REDCap)--a

metadata-driven methodology and workflow process for providing translational

research informatics support J Biomed Inform 200942(2)377ndash381

21 Harris PA Taylor R REDCap Consortium et al The REDCap consortium Building

an international community of software partners J Biomed Inform 201995103208

22 Vohra RS Spreadborough P Johnstone M et al Protocol for a multicentre

prospective population-based cohort study of variation in practice of

cholecystectomy and surgical outcomes (The CholeS study) BMJ Open

20155(1)e006399



43

23 CholeS Study Group West Midlands Research Collaborative Population-based

cohort study of outcomes following cholecystectomy for benign gallbladder diseases

Br J Surg 2016103(12)1704-1715

24 National Research Collaborative amp Association of Surgeons in Training Collaborative

Consensus Group Recognising contributions to work in research collaboratives

guidelines for standardising reporting of authorship in collaborative research Int J

Surg 201852355-360

An international multi-centre appraisal of the management of acute CHOLEcystitis during the COVID-19 pandemic The CHOLECOVID Audit

Acute inflammation of the gallbladder with pain for over 24 hours often with systemic upset (pyrexia tachycardia) elevated white cell count (WCC) elevated c-reactive protein (CRP) and at least one imaging modality with findings characteristic of



2

Table of Contents

CHOLECOVID Steering Group 3

Collaborative Partners 4

Study Delivery Timeline 6

Introduction 7

Methods 8

1 Summary 8

2 Study Aims 8

3 Project Timeline 9

4 Design 9

5 Setting 9

6 Patients 10

7 Definition of Acute Cholecystitis 10

8 Eligibility Criteria 10

9 Data Collection 11

10 Local Project Registration and Ethics 12

11 Analysis Plan 12

12 Authorship 13

13 Expected Outputs 15

Appendix A Case Report Form 16

Appendix B Data Dictionary 17

Appendix C CHOLECOVID Site Survey 27

Appendix D Tokyo Guidelines Audit Standard Adaptation 28

Appendix E Charlson Comorbidity Index Score 29

Appendix F KDIGO Clinical Practice Guidelines for AKI 30

Appendix G Tokyo Guidelines for Severity Grading of Acute Cholecystitis 31

Appendix H Clavien-Dindo Grading of Surgical Complications 32

Appendix I CHOLECOVID PI REDCap Guide 33

Appendix J NHS Health Research Authority Outcome 40

Appendix K References 41



3




Foundation Trust UK

Harryvmspiers


Foundation Trust UK

Varley_RJ




Kouli_omar






Siveshk


Foundation Trust UK

MattGoldsworthy


Trust UK

Petecoe1




EwenGriffiths


Foundation Trust UK

Anthonykcchan


Foundation Trust UK

SurgeryHPB


Foundation Trust UK

Saurabh_Jamdar




Trust UK

-


Foundation Trust UK

-

Key Contacts






4








5





6


Dates Description












7

Introduction


































8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





3




Foundation Trust UK

Harryvmspiers


Foundation Trust UK

Varley_RJ




Kouli_omar






Siveshk


Foundation Trust UK

MattGoldsworthy


Trust UK

Petecoe1




EwenGriffiths


Foundation Trust UK

Anthonykcchan


Foundation Trust UK

SurgeryHPB


Foundation Trust UK

Saurabh_Jamdar




Trust UK

-


Foundation Trust UK

-

Key Contacts






4








5





6


Dates Description












7

Introduction


































8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





4








5





6


Dates Description












7

Introduction


































8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





5





6


Dates Description












7

Introduction


































8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





6


Dates Description












7

Introduction


































8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





7

Introduction


































8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





8

Methods

1 Summary
















2 Study Aims

Primary aim



Secondary aims


COVID-19 pandemic





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





9

3 Project Timeline










September 2020

4 Design


5 Setting







respective site

Clarification Note




10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





10

6 Patients







cholecystitis [34]


Inclusion criteria








Exclusion criteria








11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





11

9 Data Collection










1 Demographics

2 Diagnosis

3 Intervention

4 COVID-19 status

5 Follow Up








Top tip



patients



database



12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





12





















11 Analysis plan







13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





13

12 Authorship





authorship are met)



participating site









REDCap)












7824)









14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





14



policies



CHOLECOVID dataset












interventions


requested



15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





15

















13 Expected Outputs






16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360




16








Female Pregnant

Yes No

BMI (kgm2)











Section 2 Diagnosis








If US Findings



No acute findings


US CT MRCP

If CT Findings



No acute findings


Yes No

If MRCP Findings



No acute findings


Yes No





_ _ days




Yes No

Antibiotics Given





Cholecystostomy




Tube size _ _ Fr

Tubogram







Cholecystectomy


Surgical Details



Surgical Modality


Open














Admission

Yes No If Positive








_ _ readmissions


plan at discharge



17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360




17


Baseline

Demographics Data

Fields


1 Data collection



1) Age 18 or over







5 Pregnant Yes No

6 Body Mass Index


7 Underlying co-

morbidities






Dementia







18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





18




Hemiplegia

Leukaemia

Malignant Lymphoma




None of the Above







8 Total Charlson

Comorbidity Index

Score






19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





19

Diagnosis Data


1 Admission Blood

tests

(Please complete

all)
















2 Acute Kidney

Injury (AKI) at

index admission

(As per KDIGO

Guidelines)



3 Radiological

Investigations

performed during

index admission







20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





20


investigation was

performed first




5 If Abdominal

Ultrasound Scan

(US) performed

Days after

index

admission


etc)

Ultrasound

findings



No acute findings


6 If Computed

Tomography (CT)

preformed

Days after

index

admission


etc)

CT

findings



No acute findings


7 If Magnetic

resonance

cholangiopancreat

ography (MRCP)

Performed

Days after

index

admission


etc)

MRCP

findings



No acute findings


8 Endoscopic

Retrograde

Cholangio-

Yes No



21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





21

Pancreatography

(ERCP) for CBD

stone during index

admission


9 Tokyo Severity

Grade




HDU or ITU)

admission during

index admission

Yes No



care admission

Number



12 Total length of




Intervention Data


1 Trial of

conservative

management

(during index

admission)

Yes No


3 Total duration of

antibiotics from

index admission

(days)

If antibiotics used





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





22


conservative

management







6 Cholecystostomy

inserted during

index admission

Yes No

7 Days after




10 Tubogram Yes No

11 Tubogram

performed days

after insertion of

cholecystostomy

If yes to Tubogram



12 Complications

Bleed

Bile Leak

Dislodgement

Occlusion


Viscus perforation

None

13 Duration of

cholecystostomy





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





23

14 Discharged with


15 Further

intervention

required

Yes No

16 Further



17 Cholecystectomy

during index

admission

Yes No

18 Days after index



20 Modality





21 Highest 30-day

post-operative

complication

grade (Clavien-

Dindo

classification)


death occurred)


22 Postoperative

biliary

complications


Bile leak

Bile duct injury




24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





24


23 Pulmonary

complications










COVID-19 Status


Fields


1 COVID-19 status

7-days prior to

index admission


2 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

3 Was patient

considered to be

positive for

COVID-19 at any

point during 30-

days following

index

admission

Yes No Unknown



25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





25

4 Method of

diagnosis (tick all

that apply)


Chest X-Ray

CT Chest

Clinical diagnosis

5 Tested positive

for COVID-19

during index

admission after

an initial

negative screen


6 Was patient

tested for

COVID-19 (ie

swab) prior to

surgery

Yes No

7 Number of days

testing

performed prior

to surgery


30-Day Follow-Up


1 Index admission

length of stay




within 30-days of

index admission

Yes No

3 Days after index

admission


etc)



26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





26

4 Number of

unplanned

readmissions

within 30-days of

index admission


5 Cholecystectomy

plan at discharge


Unclear




27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360






27




Period 1 Survey




cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service









cholecystectomy

1 2 3 4 5 ge 6




No



cholecystostomy

Yes No




Yes No



service






COVID-19 Yes No



Yes No



any point

Yes No








28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





28


Standard










drainage





considered


















29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360






29



Age











Dementia 1 Point

COPD 1 Point





Diabetes Mellitus




Hemiplegia 2 Points




2 Points

Solid Tumour

0 Point (None)

2 Point (Localised)


Leukaemia 2 Points

Lymphoma 2 Points





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





30


Acute Kidney Injury










Anuria for 12 hours



31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





31




gallbladder




(3) Duration gt72h




organssystems






(6) Haematology



32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





32


Complications

Grade Definition










intervention












33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





33






set your password











TOP TIP



their account



34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





34






35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





35


Screen



drop-down menu



36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





36








37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





37



E-mail and ORCIDs

IMPORTANT NOTE






7824)









38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





38

TOP TIP







39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





39


















collect data










40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





40


Authority Outcome





generalizable



41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





41





20083582801-2811







20136CD005440



Surg201519(5)848-857



1313




HPB(Oxford) 201517(10)857-862



2010 80 280ndash283




101



Surg 2012 16 1860ndash1868





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





42



71ndash80









May 2020]






















20155(1)e006399



43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360





43



Br J Surg 2016103(12)1704-1715




Surg 201852355-360



CHOLEcystitis COVID-19 pandemic: The CHOLECOVID Audit Links/CC Protocol.pdf · cholecystectomy...

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Transcript of CHOLEcystitis COVID-19 pandemic: The CHOLECOVID Audit Links/CC Protocol.pdf · cholecystectomy...