Impact of Semi-automated Proposal and Optimization of Diagnoses and Surgical Procedures for Precoding: a Randomized Controlled Trial
Conditions: Diagnosis-Related Groups, Healthcare Common Procedure Coding System
Sponsor: Thomas Steffen

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Protocol: Semi-automated Precoding  
Impact of Semi-automated proposal and optimization of diagnoses 
and surgical procedures for precoding: a randomized controlled trial 
 
 
 
 
Study Type: 
 Other Clinical Trial according to ClinO, Chapter 4 
 
Risk Categorization:  
Not applicable 
 
Study Registration: 
Intended registry: clinicaltrials.gov 
Intended Registration: FOPH portal SNCTP (Swiss National 
Clinical Trial Portal) 
 
Sponsor/Investigator  
Dr. Thomas Steffen 
 
 
 
 
Department of Surgery 
 
 
 
 
Kantonsspital St. Gallen, St. Gallen, Switzerland 
 
 
 
 
E-mail: Thomas.Steffen@kssg.ch 
 
 
 
 
Phone: +41714941314 
 
Investigated Intervention: 
Daily monitoring and optimization of DRG coding 
 
Protocol ID 
 
 
Not applicable 
 
Version and Date: 
 
Version 2 (dated 24/05/2019) 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document is confidential and the property of the Sponsor. The 
information may not - in full or in part - be transmitted, reproduced, published, or disclosed to 
others than the applicable Competent Ethics Committee(s) and Regulatory Authority(ies) without 
prior written authorisation from the sponsor except to the extent necessary to obtain informed 
consent from those who will participate in the study. 
 
 

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PROTOCOL SIGNATURE FORM    
 
 
Study Title 
Impact of Semi-automated proposal and optimization of 
diagnoses and surgical procedures for precoding: a 
randomized controlled trial 
Study ID 
Not applicable 
 
The Sponsor-Investigator has approved the protocol version 2 (dated 24/05/2) and confirm hereby 
to conduct the study according to the protocol, current version of the World Medical Association 
Declaration of Helsinki, and ICH-GCP guidelines as well as the local legally applicable 
requirements. 
 
 
Sponsor-Investigator: 
 
Name: Dr. Thomas Steffen 
Date: 
 _________________________ 
Signature:  ___________________________  
 
 
Co-Investigator: 
 
Name: PD Dr. Ignazio Tarantino 
Date: 
 _________________________ 
Signature:  ___________________________  
 
 

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TABLE OF CONTENTS 
TABLE OF CONTENTS 
2 
GLOSSARY OF ABBREVATIONS 
3 
1 STUDY SYNOPSIS 
4 
2 BACKGROUND AND RATIONALE 
5 
3 STUDY OBJECTIVES AND DESIGN 
5 
3.1 Hypothesis and primary objective 
5 
3.2 Primary and secondary endpoints 
6 
3.3 Study design 
6 
3.4. Study intervention 
6 
4 STUDY POPULATION AND STUDY PROCEDURES 
7 
4.1 Inclusion and exclusion criteria, justification of study population 
7 
4.2 Recruitment, screening and informed consent procedure 
8 
4.3 Study procedures 
8 
4.4 Withdrawal and discontinuation 
8 
5 STATISTICS AND METHODOLOGY 
8 
5.1. Statistical analysis plan and sample size calculation 
8 
5.2. Handling of missing data and drop-outs 
9 
5.3. Randomization 
9 
6 REGULATORY ASPECTS AND SAFETY 
9 
6.1 Local regulations / Declaration of Helsinki 
9 
6.2 (Serious) Adverse Events 
9 
6.3 (Periodic) safety reporting 
9 
6.4 Radiation 
10 
6.5 Pregnancy 
10 
6.6 Amendments 
10 
6.7 (Premature) termination of study 
10 
6.8 Insurance 
10 
7 FURTHER ASPECTS 
10 
7.1 Overall ethical considerations 
10 
7.2 Risk-benefit assessment 
10 
8 QUALITY CONTROL AND DATA PROTECTION 
10 
8.1 Quality measures 
10 
8.2 Data recording and source data 
10 
8.3 Confidentiality and coding 
11 
8.4 Retention and destruction of study data and biological material 
11 
9  MONITORIMG AND REGISTRATION 
11 
10. FUNDING / PUBLICATION / DECLARATION OF INTEREST 
11 
11. REFERENCES 
11 
 
 

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GLOSSARY OF ABBREVATIONS 
 
AE 
Adverse Event 
ASR/DSUR 
Annual Safety Repot / Development Safety Report 
BASEC 
Business Administration System for Ethical Committees 
CRF 
Case Report Form 
CTCAE 
Common Terminology Criteria for Adverse Events 
FADP 
Federal Act on Data Protection (in German: DSG, in French: LPD, in Italian: LPD) 
eCRF 
electronic Case Report Form 
FOPH 
Federal Office of Public Health 
GCP 
Good Clinical Practice 
HRA 
Human Research Act (in German: HFG, in French: LRH, in Italian: LRUm) 
ICH 
International Conference on Harmonisation  
ClinO 
Ordinance on Clinical Trials in Human Research (in German: KlinV, in French: 
OClin, in Italian: OSRUm) 
SAE 
Serious Adverse Event 
 
 
 
 

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1 
STUDY SYNOPSIS 
Sponsor / 
Sponsor-
Investigator 
Name(s) and contact details of Sponsor / Sponsor-Investigator 
Study Title 
Impact of Semi-automated proposal and optimization of diagnoses and surgical procedures 
for precoding: a randomized controlled trial 
Short Title / 
Study ID 
Semi-automated Precoding 
Protocol Version 
and Date 
Version 2 (dated 24/05/2019) 
Study 
Registration 
Intended: https://clinicaltrials.gov/ 
Study Category 
and Rationale 
Not applicable 
Background and 
Rationale  
In a DRG system, insufficient or incorrect coding negatively impacts reimbursement. 
Assuming the DRG system in use to be optimal, the quality and efficacy of treatment could 
be improved if reporting and demission are electronically controlled and adjusted to the DRG 
system in use. In the long term, a fair reimbursement might reduce the pressure on the 
staffing ratio and thus increase the patient safety.  
Risk / Benefit 
Assessment 
The participants are not exposed to any intervention. A more accurate reporting and a 
treatment more adherent to the pre-setting of the DRG system in use by specially trained 
physicians should not impose any risk to the participants.  
Objective(s) and 
Endpoint(s) 
Primary endpoint: 
 
Total reimbursement per day of hospital stay 
Secondary endpoints: 
 
Length of hospital stay  
 
Total reimbursement per case 
 
Case mix index 
 
Severity of perioperative complications 
 
Readmission rate (safety endpoint) 
Study Design 
monocentric, randomized two-arm un-blinded study 
Statistical 
Considerations 
Continuous data are analysed using non-parametric Mann-Whitney U-tests because of 
skewed distributions of the data. Categorical data will be analysed using Chi-square-
statistics.  
Inclusion- / 
Exclusion 
Criteria 
All inpatients hospitalized at the department of surgery undergoing any surgical procedure 
not eligible for ambulant operation at the Kantonsspital St. Gallen are included. No exclusion 
of vulnerable patients is planned.  
Number of 
Participants with 
Rationale 
According to a simulation study, a total of 1200 patients and 600 patients per arm are 
needed to detect an increase of 5% in the reimbursement per day of hospital stay with a 
power of 90%. 
Study 
Intervention 
In the intervention arm, reporting and the time of demission are crosschecked and corrected 
by physicians with special awareness of the DRG system during the hospital stay 
(preliminary precoding).  
Control 
Intervention 
In the control arm the coding for DRG grouping is performed after the patient’s demission. 
Reports are not screened for conformability to the DRG coding system. 
Study 
procedures 
In the intervention arm, reporting and the time of demission are crosschecked and corrected 
by physicians with special awareness of the DRG system during the hospital stay 
(preliminary precoding).  
Study Duration 
and Schedule 
Planned 06/2019 of First-Participant-In 
Planned 01/2020 of Last-Participant-Out 
Investigator 
Dr. Thomas Steffen, Department of Surgery,  
Kantonsspital St. Gallen, St. Gallen, Switzerland 
E-mail: Thomas.Steffen@kssg.ch 
Phone: +41714941314 

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Study Centre(s) 
Kantonsspital St. Gallen, St. Gallen, Switzerland 
Data privacy 
No additional data exceeding the routine clinical data are generated. The electronic 
processing of these routine clinical data will be performed in the clinical database of the 
surgical department which is password-protected. As an additional measure of data privacy, 
only physicians involved in the study will granted access to the results of electronic data 
processing.  
Ethical 
consideration 
The intervention assessed in this study consists of measures of quality control based on the 
DRG grouping. All data used for this study are already available to every physician involved in 
the treatment. For patients who are in the treatment group, treatment and reports are more 
extensively controlled by physicians. Thus the risk to overlook faults in documentation or 
treatment is likely to be reduced. If a more close implementation of the DRG Grouping transfers 
into less severe morbidity, a potential benefit for the participant would result. 
GCP Statement 
This study will be conducted in compliance with the protocol, the current version of the 
Declaration of Helsinki, the ICH-GCP, the HRA as well as other locally relevant legal and 
regulatory requirements.  
 
2 
BACKGROUND AND RATIONALE  
Increasing cost pressure on health care providers in combination with further developments in 
reimbursement systems over the past decades led to reductions of staffing ratio with possible 
negative consequences on patients’ safety in hospital environments. Diagnosis-related group 
(DRG) as a system to classify hospital cases was intended to identify “the products” that a hospital 
provides. DRG systems are widely spread in the world and used for reimbursement since the 
early 1970s. In the United States of America, the system was developed to use it explicitly for 
reimbursement in 1982. Roughly, DRGs are assigned by a "grouper" program based on the 
International Classification of Diseases (ICD) diagnoses and procedures, age, sex, discharge 
status, and the presence of complications or comorbidities. In a DRG system insufficient or 
incorrect ICD coding directly leads to a negative impact on reimbursement which may increase 
the pressure on staffing ratio again. This leads to a negative spiral with potentially impaired patient 
safety. Complications and comorbidities are at risk of both, underrecognition and incomplete 
coding. Furthermore, in surgery chronic diagnoses are often coded insufficiently. This may be a 
barrier of proper diagnosis and consequently optimal treatment strategies for the individual 
patient. Another barrier may include the perception that some specific diagnoses are not essential 
to make or code because “nothing can be done” or because it is not considered relevant for the 
actual medical problem [1]. The ICD is a defined list of diagnoses that are used for standardized 
diagnoses coding. The CHOP Code Catalogue is the official Swiss catalogue of medical 
treatments. Both coding systems are the basis for DRG coding in Switzerland and accordingly in 
many other countries with different catalogues of medical treatment. Besides the actual DRG 
code, it seems that further factors like quality of documentation and medical coding influence the 
financial proceeds of a hospital case [2–7]. 
Therefore the main aim of present project is to determine if daily monitoring and optimization of 
DRG coding of individual cases lead to better reimbursement.  
3 
STUDY OBJECTIVES AND DESIGN  
3.1 Hypothesis and primary objective 
The hypothesis of present study is that the daily monitoring and optimization of DRG coding is 
associated with higher reimbursement. Therefore, the primary objective is to determine if the daily 
monitoring and optimization of DRG coding of individual cases leads to better proceeds per day.  
 

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Secondary objectives: 
Comparing the following parameters with and without daily monitoring and optimization of DRG 
coding: 
1. Length of hospital stay including entry and demission date 
2. Total reimbursement per case 
3. Case mix index 
4. Severity of perioperative complications 
5. Readmission rate  
 
3.2 Primary and secondary endpoints 
Primary endpoint  
The primary endpoint is defined as the total reimbursement divided by the length of hospital stay 
including the entry and the demission day. Reimbursement per day was defined as the primary 
endpoint because it better reflects the ratio of costs and reimbursement in contrast to simple total 
reimbursement. When analysing the reimbursement in 2018, the distribution of total 
reimbursement per patient was extremely skewed. Hence, to achieve a reasonable power for 
statistical significance a high number of study participants would be needed.  
The total reimbursement according to the DRG coding of each included patient will be provided 
by the financial department. At the end of the study the financial department will provide the total 
reimbursement for all included patients. The length of hospital stay of each patient will be 
extracted from the clinical database of the surgical department which is updated and monitored 
on a daily base. In cases of readmission within 18 days because of a related diagnosis the cases 
are aggregated.  
 
Secondary endpoints 
1. Length of hospital stay: The number of days of the hospital stay including the entry and 
the demission day will be extracted from the clinical database of the surgical department 
2. Total reimbursement per case: At the end of the study a list of included patients will be 
sent to the financial department. Based on this list, the financial department will provide 
the total reimbursement per case measured in Swiss Francs. 
3. Case mix index: At the end of the study a list of included patients will be sent to the 
financial department. Based on this list, the financial department will provide the effective 
cost weight of each patient. 
4. Severity of perioperative complications: The severity of perioperative complications are 
already routinely recorded applying the Clavien-Dindo-Classification. This standardized 
classification is chosen to ascertain external and internal comparability. Perioperative 
complications of all operated patients are routinely recorded by a dedicated physician and 
stored in the clinical database of the surgical department.  
5. Readmission rate: On a daily basis, all admissions and readmissions are routinely 
presented and discussed during the morning meeting of the surgical clinic. The list of 
readmissions will be cross checked with the randomisation list and the demission of the 
included patients.  
 
3.3 Study design  
This is a monocentric, randomised two-arm un-blinded study.  
3.4. Study intervention 

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First, based on the randomisation list, for all patients randomized into the group with 
daily monitoring and optimization of DRG coding (treatment group), dedicated 
physicians control if all relevant diagnoses and procedures are correctly coded in the 
operation management software. If necessary, additional codable diagnoses and 
procedures are discussed with the operating surgeon and if appropriate the coding is 
changed accordingly. Finally, the internal coherence of the coding and the wording of 
the operation report are crosschecked. Therefore, the electronic signature procedure of 
operation reports will be adopted such that the report will not be sent before one of the 
dedicated physicians approved its final version. 
Second, the dedicated physicians control if relevant diagnoses and procedures are correctly 
recorded in the drafts of the discharge reports. Therefore, patients in the treatment group are 
visited daily. In addition, the patient records are inspected and their relevance for the DRG coding 
is assessed. If necessary, relevant diagnoses are incorporated in the draft of the discharge report. 
Additionally, the matching between diagnoses and procedures listed in the discharge report is 
crosschecked. The optimal time of discharge of each patient is evaluated on a daily base. 
To support the process described above, for all patients randomized into the group with 
daily monitoring and optimization of DRG coding (treatment group), a pdf file with the 
current DRG grouping according to the procedures and diagnoses routinely coded in 
the Operation management software is created. Based on these procedures and 
diagnoses, the current DRG grouping status is estimated. Based on the estimated DRG 
grouping status, the actual length of stay is compared with the lower and upper limit and 
the mean length of stay determined by the associated actual DRG group. Additionally, 
based on routinely and systemically collected data in the clinical database of the 
surgical department, potential secondary diagnoses relevant for reimbursement are 
generated by computerized algorithms. For each potential secondary diagnosis, the 
hypothetical DRG Grouping considering the already coded procedures and diagnoses is 
estimated. The possible secondary diagnoses are deducted from laboratory 
measurements, from the extended Charlson comorbidity score routinely evaluated 
preoperatively by the department of anaesthesiology, and from the recording of 
perioperative complications.  
Third, final discharge reports of patients randomized into the group with daily monitoring 
and optimization of DRG coding (treatment group), are controlled to ascertain the 
completeness of diagnoses and procedures and their concordance. Therefore, the 
electronic signature procedure of discharge reports will be adopted such that the report 
will not be sent before one of the dedicated physicians approved its final version.  
 
In patients randomized into the control group none of the above described intervention 
steps will be performed. In these patients, the actual clinical routine will apply.  
 
4 
STUDY POPULATION AND STUDY PROCEDURES 
4.1 Inclusion and exclusion criteria, justification of study population 
All patients undergoing any elective or emergency surgical procedure not eligible for ambulant 
operation at the Kantonsspital St. Gallen, Department of Surgery are eligible for study. All patients 
screened for the trial are documented in the screening log. Patients meeting the inclusion criteria 
are enrolled in the trial.  
 
Inclusion criteria 
- 
Inpatients undergoing any surgical procedure not eligible for ambulant operation  

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- 
Operation performed at the Kantonsspital St. Gallen 
- 
Patients hospitalised at the department of surgery at the Kantonsspital St. Gallen 
beginning from the starting day of the trial 
Exclusion criteria  
- 
Outpatients 
- 
Patients who undergo operations at the hospital of Flawil or Rorschach but not at the 
Kantonsspital St. Gallen 
- 
Patients operated by the department of surgery but hospitalized at any other department 
of the Kantonsspital St. Gallen 
 
4.2 Recruitment, screening and informed consent procedure 
For quality control reasons, data from all operations performed by the department of surgery at 
the Kantonsspital St. Gallen are imported regularly from the operation management system 
(eOPPs) into the clinical database of the surgical department on a daily base. The database is 
already used to analyse morbidity and mortality on a daily base.  
In this database, every added operation of all patients hospitalized after the starting date of the 
study will be screened electronically by a sql script if the inclusion- and exclusion criteria apply on 
a daily base. The result of the screening is documented in a sql table and depicted in the database 
by a special form, where the screening results are shown as read-only data.  
Informed consent is not necessary because this study exclusively aims to optimize already quality 
control. No intervention interfering with the medical treatment is performed.  
4.3 Study procedures 
The overall study duration is expected to be 7 months. The recruitment period is expected to be 
6 months. Patients still hospitalized one month after the end of the recruitment period will be 
secondarily excluded.  
4.4 Withdrawal and discontinuation 
Patients still hospitalized one month after the end of the recruitment period will be excluded. 
Patients who are initially hospitalized at the surgical department of the Kantonsspital St. Gallen 
and thereafter transferred to another department will be excluded from the analysis.  
5 
STATISTICS AND METHODOLOGY 
5.1. Statistical analysis plan and sample size calculation 
Statistical analyses will be performed by Dr. med. Rene Warschkow, MSci in biostatistics 
(Heidelberg University/Germany). Dr. Warschkow performed the sample size calculation. Sample 
size calculation and statistical analyses will be performed using the R statistical software.  
 
Sample size calculation 
Sample size calculation was performed in a separate simulation study using the total 
reimbursement divided by the length of hospital stay for the surgical department of the 
Kantonsspital St. Gallen in 2018. Sample size estimation was based on a two-sided significance 
level of α = 0.05 and a power of 90%. The increase in reimbursement was assumed to be 5% in 
the intervention group. Furthermore, in 15% of patients a shortening of the length of stay by one 
day was assumed in the intervention group. Randomization was 1:1. A drop-out rate of 10% was 
assumed. Based on this assumptions, a total of 1200 patients (600 per group) would be needed 

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to prove a significant increase in the total reimbursement divided by the length of hospital stay. 
According to the case load in 2018, the recruitment period would last 6 months.  
 
Statistical analysis plan 
The primary endpoint total reimbursement divided by the length of hospital stay will be analysed 
by a nonparametric Mann-Whitney U-test. For the secondary endpoints Length of hospital stay, 
total reimbursement per case, and Case mix index the Mann-Whitney U-test will be applied too. 
For the secondary endpoint severity of complications both a Mann-Whitney U-test and a Chi-
Square test will be applied. For the secondary endpoint rehospitalisation rate, a Chi-Square test 
will be applied. Auxiliary multivariable analyses for continuous outcomes will be performed using 
the mean ranks.  
No interim analysis and no multiple testing is planned.  
5.2. Handling of missing data and drop-outs 
In case of missing data and drop-outs a complete case analysis is performed. 
5.3. Randomization 
Randomization will be performed using the R sample function. 1:1 Randomisation will be 
performed in random block sizes of 4, 6 and 8. Randomisation will be performed automatically 
by the same sql script which is used for screening. 
 
6 
REGULATORY ASPECTS AND SAFETY 
6.1 Local regulations / Declaration of Helsinki 
This study is conducted in compliance with the protocol, the current version of the Declaration of 
Helsinki, the ICH-GCP If the clinical trial is not conducted according to ICH-GCP guidelines, the 
paragraph above must be adapted accordingly (ClinO Art. 5, Abs 2), the HRA as well as other 
locally relevant legal and regulatory requirements.  
6.2 (Serious) Adverse Events 
Due to the character of the invention, causal relationships between any Serious Adverse 
Event (SAE) or Adverse Event (AE) and the intervention can generally be ruled out.  
 
Reporting of SAEs (see ClinO, Art. 63) 
All SAEs are documented and reported immediately (within a maximum of 24 hours) to the 
Sponsor-Investigator of the study. 
If it cannot be excluded that the SAE occurring in Switzerland is attributable to the intervention 
under investigation, the Investigator reports it to the Ethics Committee via BASEC within 15 days. 
 
Follow up of (Serious) Adverse Events 
Describe the follow up procedures of participants terminating the study with reported ongoing 
(S)AEs until resolution or stabilisation.  
6.3 (Periodic) safety reporting 
One safety report is submitted once 3 Months after the starting date of the study to the local Ethics 
Committee by the Investigator (ClinO, Art. 43 Abs). 

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6.4 Radiation 
No radiation is performed in this study. 
6.5 Pregnancy  
No reporting of pregnancies is planned.  
6.6 Amendments 
Substantial changes to the study setup and study organization, the protocol and relevant study 
documents are submitted to the Ethics Committee for approval before implementation. 
Substantial amendments are changes that affect the changes in the protocol that affect study 
objective(s) or central research topic, changes of study site(s) or of study leader and sponsor 
(ClinO, Art. 29). 
6.7 (Premature) termination of study 
Upon regular study termination, the Ethics Committee is notified via BASEC within 90 days (ClinO, 
Art. 38).  
Upon premature study termination or study interruption, the Ethics Committee is notified via 
BASEC within 15 days (ClinO, Art. 38). 
 
6.8 Insurance 
As no study-related damage or injuries can occur, no insurance is necessary.  
7 
FURTHER ASPECTS 
7.1 Overall ethical considerations 
The intervention assessed in this study consists of measures of quality control based on the DRG 
grouping. All data used for this study are already available to every physician involved in the 
treatment.  
7.2 Risk-benefit assessment  
For patients who are in the treatment group, treatment and reports are more extensively controlled 
by physicians. Thus the risk to overlook a fault in documentation or treatment is likely to be 
reduced. If a more close implementation of the DRG Grouping transfers into less severe 
morbidity, a potential benefit for each participant can be assumed.  
8 
QUALITY CONTROL AND DATA PROTECTION 
8.1 Quality measures  
For quality assurance the sponsor or the Ethics Committee may visit the research site. Direct 
access to the source data and all study related files is granted on such occasions. All involved 
parties keep the participant data strictly confidential.  
8.2 Data recording and source data 
The result of the screening and randomisation is documented in a read-only sql table in an already 
implemented clinical database of the department of surgery. In this password-protected database, 

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an audit trail is implemented. Data concerning primary and secondary outcomes are provided by 
the financial department upon request at the end of the study. No  
8.3 Confidentiality and coding 
Trial and participant data will be handled with uttermost discretion and is only accessible to 
authorised personnel who require the data to fulfil their duties within the scope of the study. 
Participant identification data are protected from unauthorised or accidental disclosure, alteration, 
deletion, copying and theft by password protection, limited access to the database, hourly backup, 
and by hosting the database on an exclusive server without internet connection.  
8.4 Retention and destruction of study data and biological material 
All study data are electronically archived for 10 after study termination or premature termination 
of the study. 
9  MONITORIMG AND REGISTRATION 
No regular monitoring visits at the investigator’s site are planned. Source data/documents are 
accessible to the sponsor or the Ethics Committee. Registration in a national language in the 
Swiss National Clinical trial Portal (SNCTP via BASEC) will be performed. In addition, the study 
will be registered at clinicaltrials.gov.  
10. FUNDING / PUBLICATION / DECLARATION OF INTEREST 
No funding is planned. The findings will be published to an adequate peer reviewed journal with 
the following authorship:  
Steffen T, Warschkow R, Widmann B, Roeske S, Bock S, Tarantino I 
 
11. 
REFERENCES 
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3. 
Fetter RB, Freeman JL. Diagnosis related groups: product line management within 
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4. 
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Diagnosis-related group refinement with diagnosis- and procedure-specific comorbidities 
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5. 
Hughes JS, Lichtenstein J, Fetter RB. Procedure codes: potential modifiers of diagnosis-
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Hughes JS, Lichtenstein J, Magno L, Fetter RB. Improving DRGs. Use of procedure codes 
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Geuss S, Jungmeister A, Baumgart A, Seelos R, Ockert S. [Prospective DRG coding : 
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Chir Z Alle Geb Oper Medizen 2018;89:138–45. doi:10.1007/s00104-017-0555-4. 
8. 
Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new 
proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 
2004;240:205–13. 

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9. 
[9] Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The 
Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 
2009;250:187–96. doi:10.1097/SLA.0b013e3181b13ca2. 
10. OnlineGrouper n.d. https://grouper.swissdrg.org/swissdrg/single (accessed May 8, 2019). 
11. ICMJE | Recommendations n.d. http://www.icmje.org/recommendations/ (accessed May 12, 
2019). 
12. Common Terminology Criteria for Adverse Events (CTCAE) 
https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf 
13. Declaration of Helsinki 
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
medical-research-involving-human-subjects/ 
14. Federal Act on Data Protection (FADP) 
https://www.admin.ch/opc/en/classified-compilation/19920153/index.html 
15. Human Research Act (HRA) 
https://www.admin.ch/opc/de/classified-compilation/20061313/index.html 
16. International Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical 
Practice 
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2
__Step_4_2016_1109.pdf 
17. International Conference on Harmonization (ICH) E2A Clinical Safety Data Management: 
Definitions and Standards for Expedited Reporting 
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC
500002749.pdf 
18. Ordinance on Clinical Trials in Human Research (ClinO) 
https://www.admin.ch/opc/de/classified-compilation/20121176/index.html