Powered by KData Clinical - ESTS 2016Silver... · Primary lung cancer per contributing nations 51...

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Powered by KData Clinical

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EUROPEAN SOCIETY

OF THORACIC SURGEONS

DATABASE COMMITTEE Dr. Pierre-Emmanuel Falcoz (France) ESTS Director of Audit and Database [email protected] Dr. Alessandro Brunelli (UK) [email protected]

Dr. Dirk Van Raemdonck (Belgium) [email protected]

Dr. Herbert Decaluwe (Belgium) [email protected]

Dr. Gonzalo Varela (Spain) [email protected]

Dr. Michele Salati (Italy) [email protected]

Dr. Enrico Ruffini (Italy) [email protected]

Dr. Pierluigi Filosso (Italy) [email protected]

Dr. Marco Scarci (UK) [email protected]

Dr. Andrea Billè (Italy) [email protected]

Dr. Xavier Benoit D’journo (France) Xavier.D'[email protected]

Dr Zalan Szanto (Hungary) [email protected]

Dr Ricardo Terra (Brazil) [email protected]

Past members of the ESTS Database Committee Dr. Richard Berrisford (UK); Dr. Tom Treasure (UK); Dr Marcel Dahn (Fr); Dr Gaetano Rocco (It)

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mailto:[email protected]





INDEX Message from the President of ESTS

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Message from Director of ESTS DatabaseThe European Society of Thoracic Surgeons Database Key messages from This Report

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List of Contributing Centres

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PART 1 - European Database Cumulative Activity (2007-2015)

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Overall age and gender distributions 17 Total surgical activity within the entire dataset 19 Lung resections 24 Primary lung cancer 35 Comparisons of outcomes between 2007-2011 vs 2012-2015 in the total dataset

Hospital mortality trending presented as CUSUM plots 40 42

PART 2 - Nation-specific Activity & Comparative Analysis between Contributing Countries

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Number of units enrolled in the ESTS database as of December 2015, by country 46 Epidemiologic data 47 Primary lung cancer per contributing nations 51 Observed versus predicted in-hospital mortality rates of major lung resections in different

European countries

PART 3 – Thymoma Section

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Message from the clinical leader 57 Thymoma Section fields

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PART 4 - Appendices 77

Appendix 1: Database format and submission of data 78 Appendix 2: Definition of major cardiopulmonary complications listed in the

database 86

Appendix 3 ESTS institutional accreditation program 88 Appendix 4 ESTS dataset

Appendix 5 KData Standard Operating Procedure for Data Import Appendix 6 KData Clinical Compliance with Data Protection Legislation

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Message from the President of ESTS

Dear Members of the ESTS, As surgeons we are deciding every day on the most correct diagnosis, therapies and perioperative care for our patients. Due to the characteristics of our surgical activity, decisions have to be based sometimes on individual non-quantified previous experience but continuous improvement of health care quality requests accurate data for decision making. The ESTS Database was established by Richard Berrisford in 2001. A small number of surgeons and units were recruited and invited to share data. The current version of the “Silver Book” is reporting the analysis of more than 100,000 procedures including over 74,000 lung resections. Today, 235 units -not only from European countries- are voluntarily reporting their surgical activities and outcomes, with approximately 144 contributing more than 100 cases. Besides the usual reports on the overall surgical activity and lung cancer resection, for the third consecutive year a separate thymoma section is included in the report. We are also working on new sections for chest wall, mesothelioma and oesophageal cancer which will be, hopefully, presented in future editions. This year’s report includes CUSUM plots for hospital mortality after lobectomy. Two different periods of time have been analysed for cases operated on by open or VATS

approach. These plots can be useful tools for quality assessment since variations in mortality are graphically depicted and new hypothesis to explain unexpected changes can be tested in future analysis. I’d like to thank all database members for their effort to contribute every day to this project. Pierre Emmanuel Falcoz is enthusiastically leading the Database Committee and doing a great job. Contributions of all Database Committee members, especially Alessandro Brunelli, Michele Salati and Enrico Ruffini have to be also acknowledged. If you are reading this report and still not being a Database member, you’ll have a great opportunity to be part of this initiative just showing up at the KData Database booth during the forthcoming 24th European Conference on General Thoracic Surgery or visiting http://www.ests.org/collaboration/database_registration_form.aspx

Gonzalo Varela President of the ESTS

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http://www.ests.org/collaboration/database_registration_form.aspx

http://www.ests.org/collaboration/database_registration_form.aspx

Message from the Director of ESTS Database Dear ESTS members, The current Silver Book is the seventh annual report of the ESTS Thoracic database. This year, the collection of data ranges from July 2007 to December 2015, in 235 contributing units throughout Europe, among which 144 are contributing for more than 100 cases. It provides the most current appraisal of the thoracic surgical activity in Europe, in the framework of a comprehensive, European-wide, population dataset. Why am I very proud of this seventh edition? - Not only because TOGETHER, we reach the MILESTONE of the HUNDRED THOUSAND PATIENTS included in the ESTS database, which was one of my wishes on the beginning of my Directorship 4 years ago. The exact number of patients included this year for data analysis is 100,043, as up to December 2015! - But also and above all, because the so-called “Hungarian Model” (core dataset of the ESTS database convertible in any language developed in partnership with the ESTS database committee, the Hungarian Society and KData) has proven its worth when the Brazilian Society of Thoracic Surgery adopted it for its own use. Thanks to the hard work of Dr Ricardo Terra, 5 Brazilian centers were able to import their

data about 902 major lung resections into the ESTS registry for 2015. After a few years of France being the only country with full National Registry contributing to the ESTS database, Hungary has “join the club” 2 years ago. Brazil will follow in a very near future… I am truly confident that it is the beginning of a widespread diffusion of our European Thoracic Surgical database model. The aim of the report is to provide an “epidemiologic” overview of thoracic surgery activity in Europe. Although the structure of the current report remains the same as last year’s, we thought it was worthwhile to add some more analysis focusing on VATS data. Hence, you will find some CUSUM analyses inside the 2016 report that will enhance the comprehensiveness of the entire report. This year, the Silver Book will be entirely paperless! The complete online version could be found and downloaded for each ESTS Database user on the ESTS website (http://www.ests.org/collaboration/ database_reports.aspx) Importantly, a short, thin and sharp version can be downloaded during the ESTS Lisbon meeting on your mobile device. Nevertheless, the main focus still remains on LUNG RESECTIONS, considered as the most representative procedures of our specialty (and those currently under consideration for the European Accreditation

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http://www.ests.org/collaboration/%20database_reports.aspx

http://www.ests.org/collaboration/%20database_reports.aspx

program). As will be seen from the following pages, the complete current report is divided in four parts. The first (Part 1) focuses on the overall European database cumulative thoracic surgical activity from 2007 (time when the on-line database has been launched) to December 2015. This section is split in three main chapters providing epidemiologic information on: 1°) total surgical activity; 2°) lung resection as a whole; 3°) primary lung cancer surgery. At the end of the first part, we report a comparison of outcomes between 2007-2011 versus 2012-2015 on the total dataset, in terms of 30-day mortality and prolonged air leak. The second section (Part 2) deals with nation-specific activities and comparative analysis between contributing countries. This section is split in two chapters: the first one shows the distribution of patients (proportion of elderly, measurement of preoperative DLCO, percentage of mediastinal staging, e.g.) in the contributing countries whereas the second chapter has a particular focus on primary lung cancer surgery per contributing nations. Last but not least, an unadjusted and risk-adjusted outcomes rate of in-hospital mortality is presented. The third section (Part 3) focuses on thymoma’s surgical activity in Europe. Finally, the last section (Part 4) shows online several appendices among which the ESTS dataset (global, follow-up, Thymoma, Mesothelioma, Neuro Endocrine Tumors NETs, Chest Wall specific).

One of the main challenges of next years will be to increase the visibility of the SATELLITE DATABASES. Indeed, it has become clear that some sections of the Database require an increased level of detail. That’s why the ESTS Database Committee started 3 years ago the process of up-grading the clinical content of the core dataset (mainly devoted to lung cancer) by inviting Leading Clinicians to take charge of a particular area of Thoracic Surgery with the objective of improving a given section of the ESTS Database. The first Clinical area to be revamped was the Thymic Tumors registry, which was launched in 2013. The Mesothelioma registry has been launched after the ESTS Lisbon Meeting in 2015. The Neuro-Endocrine Tumors and the Chest Wall Injuries and Malformations registries are currently in the “work-in-progress” phase, and will be officially available for consultation later in the year. It will be my pleasure to see you in Naples! Together we go forward…

Prof. Pierre-Emmanuel Falcoz

Director of ESTS Audit and Database

[email protected]

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The European Society of Thoracic Surgeons Database The European Society of Thoracic Surgeons Database was founded in 2001 by the ESTS Database Committee with the aim to develop risk-adjusted instruments for assessing the performance of thoracic surgery units across Europe. The first version of the Database lead to the publication of the first risk- adjusted multinational risk-score for mortality (Berrisford R et al. Eur J Cardiothorac Surg 2005; 28:305-311) which has been already applied to compare the performance of different units (Brunelli A et al. Eur J Cardiothorac Surg 2008; 33:284-288). The second version of the Database was launched online in July 2007 and has so far accrued approximately 205 general thoracic surgical units. Data is anonymously reported, independently accessed and encrypted to other users. Participation to the Database project is totally free and voluntary, but strongly recommended by our Society. Infact participation to the ESTS Database with at least 100 Major Lung Resections per year for at least 2 consecutive years is one of the key requirements for the ESTS Accreditation Program. You can access the Database from ESTS website or by using the address: https://ests.kdataclinical.it To join the Database you need your own personal login account that you can request by downloading and completing an application form from the ESTS homepage (http://www.ests.org). Once data is being recorded on the System (powered by KData Clinical software), you will be able to visualize your up-to-date summary of your surgical activity; called Clinical Care Analysis CCA, it includes a few surgical activity indicators (Total N Procedures, Types Lung Procedures, VATS, Outcome at discharge, CPS and eligibility for ESTS Accreditation)

To the benefit of your patients, your practice and your specialty, your data will contribute to the followings:

• Development of European benchmarks of performance through the analysis of outcomes and processes of care indicators.

• Performance assessment by risk-adjusted outcome and/or process indicators, which will allow you to compare your own institutional performance against European benchmarks.

• Analysis and development of new potential outcomes and processes of care indicators that may complement/substitute current quality of care measures.

• Autocalculation of the Composite Performance Score.

• Feedback to document quality efforts and areas for improvement in quality of care.

• Data for research projects, which can be used to assess new technologies/pathways of care that can ultimately lead to improved patient care and outcomes.

• Maintain your own data if data is requested or mandated by third parties.

• Use for local hospital administration resource allocation.

• Use for individual negotiations, public relations and expert witness.

• Opportunity to participate in a European quality improvement effort for general thoracic surgery that has a positive impact at the local, national and international levels.

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https://ests.kdataclinical.it/

http://www.ests.org/

Participants benefits • Participation to the ESTS Database is

a pre-requisite to participate in the European Institutional Quality Certification Program.

• Participation will be acknowledged and, if requested, local institutional administrations made aware that your unit is enrolled in a European Thoracic Database aimed at implementing quality of care monitoring and improvement programs endorsed by ESTS and pre-requisite for future clinical Institutional European Accreditation.

• Your own data, collected in a standardized ESTS-endorsed Dataset, can be downloaded at local level and used for your internal quality analyses or institutional research purposes.

• Participants can visualize in the CCA (currently it includes: Total N Procedures, Types Lung Procedures, VATS, Outcome at discharge, CPS and eligibility for ESTS Accreditation) and be first to know aboutthe quality of their data and their performance against European benchmarks.

• Participants can propose their own research projects based on the total data present in the database. Projects should be submitted to the ESTS database Committee for peer review and, if accepted, the requested and anonymized data will

be provided to the proponent of the project. ESTS will retain the responsibility for the final analysis and interpretation of results. The proponent of the project will be the first Author of the final manuscript and he/she will be allowed to include, if requested, two additional colleagues, who helped in the elaboration of the manuscript. The members of the Database Committee who contributed to the review process and assisted in the development of the manuscript will be also included in the list of Authors. As the ESTS Database approached a more mature stage, and more demanding aspects of data management were required, it was been decided to make use of professional expertise in running and managing contents, data flow, data merge and so on of our Registry; in Nov 2009 the ESTS Council awarded this task to Dendrite Clinical System Italia srl, now renamed KData Clinical srl, following a management by-out in July 2015 Since 1993 Dendrite, and now KData Clinical, have established a highly respected track record in setting up and running a variety of International Registries, with an underlying philosophy of long term partnership with numerous Clinical Associations within and outside Europe.

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The main reasons for their widespread activity in this field include:

• Bottom-up approach to data management: the range of products and services starts from database and electronic patient records and serves Clinicians daily needs; it escalates to hospital-wide systems, to regional, national and finally to international registries.

• User-friendly inclusion of all who wish to participate: the Import Data process, governed by a Standard Operating Procedure SOP (see Appendix N.4) allows any Contributor to use his chosen type of tool to collect data, and KData will perform the correspondence and data merge required to add their data to the main ESTS Database, if there is clinically correct conformity with the required ESTS dataset.

• Automatically up-dated clinical statistical analysis shown in the CCA screen, integrated in the data collection section of the ESTS Registry.

• Contributors can retain, download and use own data, from the ESTS site, in MS Excel format, which lends itself to be analyzed by any clinical software product.

• Unblemished track record of data handling integrity: not ever lost, leaked or misplaced third Party data to date

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KEY MESSAGES FROM THIS REPORT The ESTS database is growing faster and faster: from 56,656 procedures in 2012 to 82,608 in 2014 and to 100,043 as up to December 2015. The majority of contributions to the ESTS database is direct from willing units and participants; to date, only two nations (France with “Epithor” and Hungary with the new “Hungarian Model”) contribute to the database as a whole. However we have now 5 additional Centres form Brazil who have added retrospective and prospective data about Major Lung Resections, with 1367 cases registered, of which 902 were anatomic lung resections. More countries are expected in a near future… Completeness of the database is almost 100% in the major fields of the database, except for 30-day mortality. A huge effort should be made concerning this variable!

1) 235 Thoracic Surgery Units contributed to the 2016 Report; 144 Units contributed more than 100 cases a year.

2) The Overall Age Distribution showed a general increase of the average age, with 31.3% of Patients being in the 61-70 age group.

3) Lung Procedures represented 80.3% of the total, of which 35,509 (57.7%) were lobectomies.

4) Of all lung resections, 13594 (21.7%) were VATS. However when filtering only on lobectomy / bilobectomy procedures, the distribution of VATS was 12.9%.

5) Unadjusted in-hospital mortality

ranged between 6% (pneumonectomies) and 1.6% (wedge resections) with 2.5% as average across the board.

6) Comparison between two observation periods (2007-11 and 2012-15, all procedures) showed some interesting differences: non-adjusted mortality decreased from 4.6% to 2%, and prolonged air leak (> 5days) increased from 5.5% to 7.2%.

7) When evaluating data in a nation-by-nation mode, 35.3% of Italian patients were older than 70 years of age. Interestingly, over 90% of patients showed DLCO measurements in Austrian, Belgian, Slovakian and British records.

8) The VATS and the Predicted/Observed Mortality Rates distribution highlighted a remarkably wide range between different Countries warranting further evaluation.

9) Thymus Section: 1°) the 2015 Reports has collected prospectively over 500 Thymomas between Jan 2007 and April 2015; 2°) Missing and Unknown Data is still cause of concern, and needs to improve; 3°) About 70% of patients had Thymomas, at an early cancer stage (I/II); 4°) VATS was the modality of choice in almost 17.6% of Procedures, with median sternotomy being the surgical approach of choice in 57% of procedures; 5°) Complete resection was achieved in 89% of cases; 6°) 30 days mortality was 0.8%.

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10) 30-day mortality of the entire ESTS database decreased by 2 along the study period (2007-2015). This virtuous process implicitly means that “the longer the participation in the ESTS database, the better the outcome”.

11) Outcomes measured with feedback programs, benchmark and self-assessment capabilities – such as the ESTS database – are effective in improving surgical safety and patient care.

12) The ESTS database is a useful tool for surgeons as a benchmark of the thoracic surgical practice in Europe.

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Institutions that contributed to the ESTS Registry

Country City Institution

ALBANIA TIRANA University Hospital of Lung Diseases "Shefqet Ndroqi" AUSTRIA VIENNA Otto Wagner Hospital BELGIUM ANTWERP University Hospital of Antwerp BELGIUM GENK ZOL St. - Jan Genk BELGIUM BRUSSELS Cliniques Universitaires Saint- Luc BELGIUM BRUSSELS Hopital Academique Erasme BELGIUM LEUVEN University Hospitals Leuven BRAZIL Sao Paulo Hospital das Clinicas da Faculdade de Medicina da

Universidade de Sao Paulo - Instituto do Coração BRAZIL Porto ALegre Pavilhão Pereira Filho - Santa Casa de Porto ALegre BRAZIL Brasilia Hospital Santa Luzia BRAZIL Nazaré, Salvador Hospital Santa Isabel BRAZIL Sao Paulo University of Sao Paulo BRAZIL Bahia University of Salvador FRANCE AVIGNON CHG- Avignon FRANCE BAYONNE CHG- Bayonne FRANCE BESANÇON CHU Jean Minjoz FRANCE BEUVRY Clinique Ambroise Paré FRANCE BOIS GUILLAUME CMC du Cèdre FRANCE BORDEAUX CHU Haut Lévêque FRANCE BORDEAUX Clinique Bordeaux Nord FRANCE CAEN CHU Côte de Nacre Caen FRANCE CERGY PONTOISE CH René Dubos FRANCE CHAMBÉRY CH- Chambèry FRANCE CLAMART HIA Percy FRANCE CLERMONT FERRAND CHU Gabriel Montpied FRANCE DIJON CHU du Bocage FRANCE ERMONT Clinique Claude Bernard FRANCE GRENOBLE CHU Michallon FRANCE GRENOBLE Clinique Belledonne FRANCE LA ROCHELLE Hôpital St Louis FRANCE LE HAVRE Clinique Petit Col Moulin FRANCE LE PLESSISROBINSON Marie Lannelongue Hospital FRANCE LILLE CHU Calmette FRANCE LILLE Clinique de la Louvière

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FRANCE LILLE Polyclinique du Bois FRANCE LYON CHU Lyon Sud FRANCE LYON Clinique St Louis FRANCE LYON Hôpital privé Jean Mermoz FRANCE MARSEILLE CHU Ste Marguerite FRANCE MARSEILLE HIA Alphonse LAVERAN FRANCE MAXEVILLE Médipole Gentilly FRANCE MEAUX CH - Meaux FRANCE METZ Hôpital Belle-Isle FRANCE MONTPELLIER CHU de Montpellier FRANCE MONTPELLIER Clinique du Millénaire FRANCE MORLAIX CMC de la Baie de Morlaix FRANCE NANCY CHU Central de FRANCE NANTES CHU - Nantes FRANCE NANTES Clinique St Augustin FRANCE NANTES Nouvelle Clinique Nantaise FRANCE NICE CHU Pasteur FRANCE NICE Clinique Saint Georges FRANCE NIMES Clinique les Franciscaines FRANCE PARIS HEGP FRANCE PARIS Hôtel Dieu FRANCE PARIS IMM FRANCE PAU CHG - Pau FRANCE POITIERS CHU - Pointers FRANCE QUIMPER Clinique Quimper sud FRANCE REIMS Clinique Courlancy FRANCE ROUEN CHU Charles Nicolle FRANCE SAINT BRIEUC Hopital Yves le Foll FRANCE SAINT CLOUD Clinique du Val D'or FRANCE SAINT ETIENNE CH Privé de la Loire FRANCE SAINT ETIENNE CHU – Saint Etienne FRANCE SAINT GRÉGOIRE CH Privé Saint Grégoire FRANCE STRASBOURG CHU - Strasbourg FRANCE STRASBOURG Clinique St Odile FRANCE TALANT Clinique Bénigne Joly FRANCE TOULOUSE CHU Larrey FRANCE TOULOUSE Clinique Pasteur FRANCE TOURS CHU Trousseau FRANCE VALENCIENNES Clinique Teissier FRANCE VANNES Clinique Océane

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GERMANY BREMEN Klinikum Bremen-Ost - Bremen GERMANY MONCHENGLADBACH Maria Hilf Kliniken

GERMANY DELMENHORST Klinik f. Thoraxchirurgie, Klinikum Delmenhorst gGmbH

GREECE ATHENS Evangelismos GREECE THESSALONIKI Ahepa University Hospital GREECE ATHENS Hygeia Hospital HUNGARY BUDAPEST National Institute of Oncology

HUNGARY DEBRECEN University Of Debrecen HUNGARY SZEGED University of Szeged, Department of Surgery HUNGARY PÉCS University of Pecs, Department of Surgery HUNGARY GYŐR Pamok Györ Hungars HUNGARY KECSKEMÉT Bàcs Kiskun County Hospital HUNGARY GYÓR Petz Aladar Teaching Hospital (PAMOK) HUNGARY MISKOLC Semmelweis Teaching Hospital of Miskolc HUNGARY SZOLNOK Hetenyi Geza County Hospital of Szolnok HUNGARY SZOMBATHELY Teaching Hospital Markusovszky ITALY NAPLES National Cancer Institute Pascale Foundation, Napoli ITALY ANCONA Ospedali Riuniti Umberto I - GM Lancisi – G Salesi

Ancona ITALY MILANO Fondazione Ospedale Maggiore Policlinico ITALY PARMA University Hospital Parma ITALY TORINO A. O. Universitaria Molinette San Giovanni Battista ITALY FOGGIA A. O. Universitaria Foggia – Dip. Chirurgia Toracica ITALY MILANO Azienda Ospedaliero San Paolo ITALY BOLOGNA Discipline Chirurgiche, Rianimatorie Trapianti

Univ.Bologna ITALY GENOVA San Martino - Genoa ITALY SIENA University Hospital Siena ITALY LECCE V. Fazzi Hospital NETHERLANDS AMSTERDAM VUMC Dept of Surgery NETHERLANDS BREDA Amphia Hospital NETHERLANDS HAARLEM Kennemer Gasthuis PORTUGAL LISBON Santa Martha Hospital, Lisbon

PORTUGAL VILA NOVA DE GAIA Centro Hospitalar de Vila Nova de Gaia Espinho

ROMANIA BUCHAREST Institute of Oncology Bucharerst

ROMANIA BUCHAREST Marius Nasta Institute of Pneumonology ROMANIA DROBETA-TURNU

SEVERIN County Emergency Hospital

ROMANIA TIMISOARA Clinical Muncipal Emergency Hospital

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Please note that Only units contributing more than 100 patients (as of December 31th 2015) in the registry are shown

SLOVAKIA BRATISLAVA University Hospital Bratislava , Slovacchia SLOVENIA LJUBLJANA University Medical Centre Ljubljana SPAIN BARCELONA Hospital Clinic SPAIN BARCELONA Sagrat Cor University Hospital SPAIN HEBRON HG Vall d'Hebron SPAIN MADRID H. Clinico San Carlos SPAIN MADRID Hospital general Universitario Gregorio Maranon SPAIN NAVARRA Clinica Universitaria De Navarra SPAIN SALAMANCA University Hospital Salamanca SPAIN SEVILLA HHUU Virgen del Rocio SPAIN VALENCIA General University Hospital Valencia SPAIN SEVILLA Hospital Virgen Macarena SPAIN PALMA Hospital Universitari Son Espases SPAIN SAN SEBASTIAN University Hospital Donostia TURKEY BURSA Uludag University, School of Medicine TURKEY ISTANBUL Istanbul School of Medicine TURKEY ISTANBUL Istanbul University, Cerrahpasa Medical Faculty TURKEY ISTANBUL Sureyyapasa Chest Disease & Thoracic Surgery

Hospital UK EXETER Royal Devon & Exeter NHS Foundation Trust UK LEEDS St. James's University Hospital

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PART 1

EUROPEAN DATABASE

CUMULATIVE ACTIVITY (2007-2015)

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Overall age and gender distributions Age (years)

Occurrences Percent ≤20 2575 2.6 21-30 4144 4.1 31-40 4788 4.8 41-50 10095 10.1 51-60 24162 24.2 61-70 31708 31.7 71-80 19678 19.7 >80 2750 2.8 Unknown 143 0.1 Total 100043 100.0

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Gender according to age distribution (years)

Male (%) Female (%) ≤ 20 2.9 2.0 21-30 4.1 4.2 31-40 4.1 6.1 41-50 8.5 12.9 51-60 23.1 26.2 61-70 33.3 28.7 71-80 21.1 17.0 >80 2.8 2.7 Unknown 0.1 0.2

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Total surgical activity within the entire dataset Group Definitions

Group Definition Occurrences Percent Lung 78414 78.4 Pleura 7900 7.9 Chest Wall 2534 2.5 Trachea - Bronchus 946 1.0 Mediastinum 7673 7.7 Upper GI 413 0.4 Diaphragm 202 0.2 Unknown 1961 2.0 Total 100043 100

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Lung Subgroup

Occurrences Percent Lung Biopsy 1557 2.0 Lung Excision 74861 95.5 Lung Lesion 1203 1.5 Lung Repair 475 0.6 Lung Transplant 142 0.2 Unknown 176 0.2 Total 78414 100.0

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Mediastinum Subgroup

Occurrences Percent Mediastinoscopy 3921 51.1 Mediastinotomy 425 5.5 Mediastinum 3000 39.1 Thoracic Duct 17 0.2 Thyroid 240 3.1 Unknown 70 0.9 Total 7673 100

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Pleura Subgroup

Occurrences Percent Decortication 1210 15.3 Pleural Biopsy 2145 27.2 Pleurectomy/Pleurodesis 2306 29.2 Thoracocentesis / Chest Tube 1921 24.3 Aspiration 96 1.2 Pleuro-Peritoneal Shunt 8 0.1 Unknown 214 2.7 Total 7900 100.0

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Chest Wall Subgroup

Occurrences Percent Chest Wall 1519 59.9 Costal Cartilage 78 3.1 Chest wall Incision 353 13.9 Reconstruction 263 10.4 Rib 225 8.9 Thoracoplasty 70 2.8 Unknown 26 1.0 Total 2534 100.0

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Lung resections Types of lung resections performed, including all diagnoses

Occurrences Percent Bilobectomy 2616 3.5 Lobectomy 42213 56.4 Lung Volume Reduction 279 0.4 Pneumonectomy 5734 7.7 Segmentectomy 5020 6.7 Wedge 17168 22.9 Unknown 1831 2.5 Total 74861 100.0

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Distribution of lobectomy by site of resection

Lobectomy Procedure Site Occurrences Percent RUL 14743 34.9 RML 2780 6.6 RLL 7008 16.6 LUL 10217 24.2 LLL 6867 16.3 Unknown 598 1.4 Total 42213 100.0

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Distribution of bilobectomy by site of resection

Bilobectomy Procedure Site Occurrences Percent RUM 1066 40.8 RLM 1513 57.8 Unknown 37 1.4 Total 2616 100.0

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Distribution of pneumonectomy by side

Pneumonectomy Side Occurrences Percent L 3393 59.2 R 2230 38.9 Unknown 111 1.9 Total 5734 100

Pneumonectomy Qualifier Occurrences Percent Alone 3679 64.2 Completion 237 4.1 Intrapericardial 508 8.9 Pleuropneumonectomy 219 3.8 Sleeve Resection 58 1.0 Diaphragm Resection 3 0.1 Atrial Resection 87 1.5 SVC Resection / Reconstruction 79 1.4 Vertebral resection 161 2.8 Unknown 703 12.3 Total 5734 100

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VATS as a proportion of all lung resections

VATS Occurrences Percent(%) No 55266 73.8 Yes 18861 25.2 Unknown 734 1.0 Total 74861 100

Note the increase from 21.7% to 25.2% !!!!

No Yes Yes (%) 2007-2011 30957 4663 13.1% 2012-2015 24309 14198 36.9% Total 55266 18861 25.4%

VATS as a proportion of lobectomy

No Yes Yes (%) 2007-2011 19681 1114 5.4% 2012-2015 14830 6134 29.3% Total 34511 7248 17.4%

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Lung resections pathology

Morphology Occurrences Percent (%) Non Neoplastic 9410 12.6 Neoplastic Benign 2632 3.5 Neoplastic Malignant Primary 50001 66.8 Neoplastic Malignant Secondary 10247 13.7 Unknown 2571 3.4 Total 74861 100.0

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Incidence of coronary artery disease by procedure

Lung Excision Procedure CAD NO CAD YES Unknown Total Bilobectomy 1900 190 526 2616 Lobectomy 30042 3311 8860 42213 Lung Volume Reduction 200 10 69 279 Pneumonectomy 4265 381 1088 5734 Segmentectomy 3520 297 1203 5020 Wedge 12100 849 4219 17168 Unknown 308 43 1480 1831 Total 52335 5081 17445 74861

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Distribution of ASA score by type of operation

Lung Excision Procedure ASA 1 ASA 2 ASA 3 ASA 4 ASA 5 Unknown Total Bilobectomy 485 1362 679 28 2 60 2616 Lobectomy 8236 21878 10691 338 17 1053 42213 Lung Volume Reduction 58 92 101 17 0 11 279 Pneumonectomy 991 2945 1534 131 12 121 5734 Segmentectomy 1068 2600 1154 46 1 151 5020 Wedge 4062 8256 4041 206 9 594 17168 Others 728 610 328 48 2 115 1831 Total 15628 37743 18528 814 43 2105 74861

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Distribution of ECOG score by type of operation Lung Excision Procedure ECOG 0 ECOG 1 ECOG 2 ECOG 3 ECOG 4 Unknown Total Bilobectomy 1166 1005 184 31 3 227 2616 Lobectomy 19766 15338 2773 309 57 3970 42213 Lung Volume Reduction 67 113 54 11 0 34 279 Pneumonectomy 2383 2240 461 86 37 527 5734 Segmentectomy 2478 1677 348 50 9 458 5020 Wedge 7687 6027 1297 258 48 1851 17168 Unknown 960 502 134 46 9 180 1831 Total 34507 26902 5251 791 163 7247 74861

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Cardiopulmonary morbidity rate in different types of lung resections

CM No CM No (%) CM Yes CM Yes(%) Unknown Unknown (%) Total Bilobectomy 1769 67.6 698 26.7 149 5.7% 2616 Lobectomy 32005 75.8 7315 17.3 2893 6.9% 42213 Lung Volume Reduction 236 84.6 30 10.8 13 4.7% 279 Pneumonectomy 3878 67.6 1492 26.0 364 6.3% 5734 Segmentectomy 4127 82.2 520 10.4 373 7.4% 5020 Wedge 14688 85.6 840 4.9 1640 9.6% 17168 Unknown 1350 73.7 87 4.8 394 21.5% 1831 Total 58053 10982 5826 74861

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Incidence of prolonged air leak (> 5days) in different types of lung resections

Air Leak > 5 days Lung Excision - PROCEDURE No (%) Yes (%) Unknown (%) Bilobectomy 82.8 11.5 5.7 Lobectomy 84.3 8.9 6.9 Lung Volume Reduction 72.4 22.9 4.7 Pneumonectomy 93.2 0.5 6.3 Segmentectomy 86.1 6.4 7.4 Wedge 87.1 3.4 9.6 Total 85.4 6.9 7.8

Incidence of bronchopleural fistula (BPF) in pneumonectomy

Bronchopleural fistula BPF No BPF Yes Unknown Total Pneumonectomy (N) 5258 112 364 5734 Pneumonectomy (%) 91.7 2 6.3 100

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Primary lung cancer Lung resection for primary lung cancer: Types of procedures

Occurrences Percent Bilobectomy 2294 4.6 Lobectomy 35588 71.2 Lung Volume Reduction 3 0.0 Pneumonectomy 5233 10.5 Segmentectomy 2519 5.0 Wedge 3991 8.0 Unknown 373 0.8 Total 50001 100

Bilobectomy – Lobectomy qualifier Occurrences Percent Alone 33493 88.4 Chest Wall 920 2.4 Superior Sulcus Tumor 302 0.8 Sleeve 1364 3.6 Diaphragm Resection 38 0.1 Atrial Resection 39 0.1 SVC Resection / Reconstruction 50 0.1 Vertebral Resection 366 1.0 Unknown 1310 3.5 Total 37882 100

37

Distribution of lobectomy/bilobectomy by site of resection

Lobectomy procedure site Occurrences Percent RUL 12979 36.5 RML 1912 5.4 RLL 5770 16.2 LUL 8953 25.2 LLL 5487 15.4 Unknown 487 1.4 Total 35588 100

Bilobectomy procedure site Occurrences Percent RUM 915 39.9 RLM 1350 58.9 Unknown 29 1.3 Total 2294 100

38

Distributions of pneumonectomy

Pneumonectomy Qualifier Occurrences Percent Alone 3389 73.6 Completion 188 4.1 Intrapericardial 465 10.1 Pleuropneumonectomy 181 3.9 Sleeve Resection 57 1.2 Diaphragm Resection 2 0.0 Atrial Resection 86 1.9 SVC Resection / Reconstruction 79 1.7 Vertebral resection 157 3.4 Total 4604 100

Pneumonectomy side Occurrences Percent L 3088 59.0 R 2046 39.1 Unknown 99 1.9 Total 5233 100

39

Distribution of VATS procedures in total lung resections

VATS Occurrences Percent No 40613 81.2 Yes 8827 17.7 Unknown 561 1.1 Total 50001 100

Distributions of VATS procedures in lobectomy/bilobectomy

VATS Occurrences Percent No 31248 82.5 Yes 6242 16.5 Unknown 392 1.0 Total 37882 100

40

Unadjusted in-hospital mortality rates in primary lung cancer resections

Outcome at Discharge - Died in Hospital N Died in Hospital Percent Bilobectomy 2166 88 3.9% Lobectomy 34068 666 1.9% Pneumonectomy 4807 314 6.1% Segmentectomy 2430 44 1.8% Wedge 3862 53 1.4% Total 47333 1165 2.4%

Overall unadjusted in-hospital mortality calculated in the total dataset (Only centers with yearly major resections N>50 were included) Please note that most of the units are within the limits. Only 19 Units are above the 95% upper limit whereas 31 are below the 95% lower limit

41

Comparisons of outcomes between 2007-2011 vs 2012-2015 in the total dataset*

* Due to missing data, the 30-day mortality was only evaluated in 45.427 patients. Cumulative non-adjusted 30-day mortality

Cumulative non-adjusted 30-day mortality Alive Died Died Percent 2007-2011 19566 837 4.1% 2012-2015 24506 518 2.1% Total 44072 1355 3.0%

42

Prolonged air leak (LOBECTOMY ONLY)

Air leak > 5 Days No Yes Yes (%)

2007-2011 18551 1778 8.7% 2012-2015 17024 1967 10.4% Total 35575 3745 9.5%

43

Hospital Mortality trending presented as CUSUM plots

Cumulative sum (CUSUM) techniques offer the possibility of checking a process along time and knowing if its quality is kept constant, improves or deteriorates. In the last case, corrective measures can be implemented and their efficacy investigated. We have used risk-adjusted expected minus observed CUSUM charts in this report. The results of the analysis are presented in graphs, were the horizontal axis represents the cases over time and the vertical axis shown the difference between the calculated risk of the outcome for a single individual and its occurrence.

In the next figures, risk-adjusted CUSUM graphs for hospital mortality are presented for non-extended lobectomy performed through open approach or VATS in two different periods of time: 2007-2010 and 2011-2015. It is to note that in the case of VATS, after case number 1500 in the database a persistent improvement in quality is detected (lower mortality). The same can be seen in open-approached cases

VATS 2007-2010

44

VATS 2011-2015

In the period 2011-2015 after case 7000. Curiously, in cases not approached by VATS in the period 2007-2010, an increase in mortality was noted after case 950, probably meaning that easiest cases were shifted to VATS in most institutions.

NO VATS 2007-2010

45

NO VATS 2011-2015

46

PART 2

NATION-SPECIFIC ACTIVITY

&

COMPARATIVE ANALYSIS

BETWEEN CONTRIBUTING COUNTRIES

Only countries contributing more than 100 lung resections were included

47

Number of Units enrolled in the ESTS database as of December 2015, by Country

48

Epidemiologic data Proportion of elderly patients (older than 70 years of age) operated on in different European countries

(°): Country with less than 500 patients included, results must be interpreted with caution

49

Percentage of patients submitted to major anatomic lung resections with preoperative measurement of DLCO in different European Countries.


50

Percentage of patients with primary neoplastic disease and suspicious clinical N2 stage (enlarged >1cm mediastinal nodes at CT scan or PET positive mediastinal nodes) who underwent at least one preoperative invasive mediastinal staging procedure (EBUS, EUS, mediastinoscopy, mediastinotomy, VATS, TEMLA etc.)


51

Percentage of patients submitted to lymph node dissection during major lung resection for malignant primary neoplastic disease grouped by Countries Lymph node dissection more extended than sampling alone or selected biopsy (as defined and recommended by the ESTS guidelines for intra-operative mediastinal staging) in lung cancer patients was a frequent procedure in all countries. This variable will be included in the composite performance score (CPS) used for the ESTS quality certification program.


52

Primary lung cancer per contributing Nations Percentage of lung excision procedures

Nation° Bilobectomy Lobectomy Pneumonectomy Segmentectomy Wedge Unknown ALBANIA° 6.9 62.6 25.2 2.3 3.1 0.0 AUSTRIA° 7.1 79.1 7.4 2.5 3.7 0.3 BELGIUM 6.0 69.3 12.0 4.3 8.4 0.1 BRAZIL 4.8 77.8 6.8 6.5 3.5 0.7 FRANCE 4.6 70.7 10.4 5.2 8.2 0.9 GERMANY° 4.7 65.7 13.1 13.4 3.1 0.0 GREECE° 3.9 54.8 15.7 17.8 7.8 0.0 HUNGARY 2.9 71.6 10.0 6.5 8.2 0.8 ITALY 4.0 74.3 8.7 3.9 8.8 0.3 NETHERLANDS 7.5 79.4 7.3 0.9 4.5 0.3 PORTUGAL° 4.6 66.8 3.3 3.6 12.1 9.8 ROMANIA 5.0 61.1 25.5 0.1 8.2 0.1 SLOVAKIA° 4.8 86.2 8.2 0.9 0.0 0.0 SLOVENIA° 6.4 84.4 9.2 0.0 0.0 0.0 SPAIN 4.5 71.9 9.6 4.5 9.4 0.1 TURKEY 8.1 70.0 13.2 3.5 5.1 0.0 UK 3.3 82.0 9.0 4.0 0.2 1.5


53

Proportion and type of estended resections amongst lobectomy and bilobectomy

Alone Chest Wall

Superior Sulcus Tumor Sleeve

Diaphragm Resection

Atrial Resection

SVC Resection /

Reconstruction Vertebral Resection Unknown

ALBANIA° 85.7 6.6 1.1 5.5 0.0 0.0 0.0 0.0 1.1 AUSTRIA° 97.9 0.0 0.4 0.4 0.0 0.0 0.0 0.4 1.1 BELGIUM 84.9 2.6 1.7 10.1 0.2 0.1 0.1 0.1 0.3 BRAZIL° 88.4 4.2 0.0 4.0 0.0 0.0 0.0 0.0 3.4 FRANCE 90.1 2.1 0.7 2.9 0.0 0.1 0.2 1.5 2.6 GERMANY° 80.6 9.9 0.4 5.9 2.0 0.8 0.4 0.0 0.0 GREECE° 92.0 4.4 0.9 0.9 0.4 0.9 0.0 0.0 0.4 HUNGARY 71.6 1.9 0.7 3.6 0.5 0.1 0.1 0.1 21.5 ITALY 95.4 2.1 0.1 1.7 0.0 0.0 0.0 0.1 0.6 NETHERLANDS 80.6 3.2 6.6 8.1 0.5 0.0 0.0 0.2 0.7 PORTUGAL° 88.1 2.7 0.9 7.3 0.9 0.0 0.0 0.0 0.0 ROMANIA° 83.0 6.9 2.5 7.6 0.0 0.0 0.0 0.0 0.0 SLOVAKIA° 96.7 1.9 0.0 1.0 0.0 0.0 0.0 0.0 0.5 SLOVENIA° 87.9 3.0 1.0 6.1 1.0 0.0 0.0 0.0 1.0 SPAIN 89.3 4.1 1.1 4.1 0.2 0.2 0.1 0.1 1.0 TURKEY 75.0 6.4 0.7 15.1 0.8 0.3 0.2 0.3 1.2 UK° 97.0 2.2 0.0 0.9 0.0 0.0 0.0 0.0 0.0

(°): Country with less than 500 patients included. Results must be interpreted with caution

54

Proportion of estended and type of resection amongts pneumonectomies

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ALBANIA° 36.4 3.0 39.4 6.1 0.0 0.0 3.0 0.0 0.0 12.1 AUSTRIA° 0.0 0.0 33.3 41.7 0.0 0.0 0.0 0.0 4.2 20.8 BELGIUM 48.3 9.6 32.8 1.7 0.7 0.0 0.3 0.0 0.7 6.0 BRAZIL° 67.7 0.0 22.6 0.0 0.0 0.0 3.2 0.0 0.0 6.5 FRANCE 77.2 0.9 0.1 3.1 1.1 0.0 2.2 2.3 4.6 8.5 GERMANY° 10.6 23.4 27.7 17.0 2.1 2.1 6.4 4.3 0.0 6.4 GREECE° 21.7 11.7 30.0 3.3 0.0 0.0 1.7 0.0 0.0 31.7 HUNGARY 51.7 11.2 16.7 2.6 0.3 0.0 0.3 0.0 0.0 17.2 ITALY 40.6 6.2 30.6 4.4 0.9 0.3 0.6 0.0 0.0 16.5 NETHERLANDS 36.2 10.6 21.3 8.5 0.0 0.0 0.0 0.0 0.0 23.4 PORTUGAL° 70.0 0.0 20.0 10.0 0.0 0.0 0.0 0.0 0.0 0.0 ROMANIA 17.4 4.4 18.5 3.3 4.4 0.0 0.5 0.0 0.0 51.6 SLOVAKIA° 84.2 0.0 15.8 0.0 0.0 0.0 0.0 0.0 0.0 0.0 SLOVENIA° 30.0 20.0 10.0 0.0 10.0 0.0 0.0 0.0 0.0 30.0 SPAIN 52.3 8.0 19.5 5.9 1.1 0.0 0.4 0.7 0.0 12.2 TURKEY 49.5 5.9 20.8 0.0 1.0 0.0 0.0 0.0 0.0 22.8 UK° 57.1 8.2 16.3 0.0 2.0 0.0 0.0 0.0 0.0 16.3

(°): Country with less than 500 patients included. results must be interpreted with caution

55

Percentage of VATS (LOBECTOMIES)

No Yes Unknown ALBANIA° 99.2 0.0 0.8 AUSTRIA° 65.2 34.8 0.0 BELGIUM 62.8 32.8 4.4 BRAZIL° 61.4 37.5 1.1 FRANCE 85.1 14.1 0.8 GERMANY° 88.3 10.6 1.1 GREECE° 88.8 11.0 0.3 HUNGARY 68.2 30.9 0.9 ITALY 79.7 17.2 3.1 NETHERLANDS 77.4 21.8 0.8 PORTUGAL° 70.4 29.6 0.0 ROMANIA 97.8 2.2 0.0 SLOVAKIA° 79.2 20.8 0.0 SLOVENIA° 75.2 24.8 0.0 SPAIN 82.0 18.0 0.0 TURKEY 82.4 17.3 0.3 UK 40.4 57.8 1.8

(°): Country with less than 500 patients included. results must be interpreted with caution

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Observed versus predicted in-hospital mortality rates of major lung resections in different European Countries Countries (risk adjustment according to Brunelli A et al. please see Appendix for details of risk models applied)

Predicted and Observed Mortality rates (%) Predicted Mortality Observed Mortality AUSTRIA° 2.60% 0.30% BELGIUM 2.90% 2.16% FRANCE 2.92% 2.85% GERMANY° 3.65% 6.15% GREECE° 3.08% 0.50% HUNGARY 2.38% 1.12% ITALY 3.17% 1.19% NETHERLANDS° 2.97% 2.44% PORTUGAL° 2.23% 0.71% ROMANIA° 3.39% 1.67% SLOVAKIA ° 2.30% 1.13% SPAIN 2.90% 2.22% TURKEY° 2.64% 1.96% UK° 1.98% 2.17%

Only nations with at least 100 patients (°): Country with less than 500 patients included. Results must be interpreted with caution

57

PART 3

THYMOMA SECTION (Database users only)

58

Message from Clinical Leader of the Thymoma section of ESTS Registry

The thymoma section of the 2016 ESTS silver book presents the updated data of the ESTS thymic prospective database, thanks to the help of the ESTS database committee and to the official platform of the ESTS Registry (Dendrite Clinical System, Italia srl). A substantial increase in the number of centres has been registered. We have almost 800 cases, resulting in a 60% increase as compared to the 2015 report. I would like to personally thank all the participating institutions who have contributed to the implementation of this very important ESTS project. Their effort in uploading the cases has been greatly appreciated and will be the base of future common projects The reader may scroll through the tables and graphs to have a look at the results, so there is no need to include additional details. I would just add a couple of comments: 1.The case implementation basically confirms the distribution of the most important clinico-pathologic characteristics of these tumors among the patient population. Notably, an increased incidence of thymic carcinoma (23%) is observed as compared with the commonly reported incidence (10%). Also, it is worth noticing an ever

increasing rate of minimally invasive approaches (VATS, RATS) which now represents 28% of all surgical accesses.

2.The completeness rates by the different datafields are improving as compared to the 2015 report, thanks to the commitment of the accruing centres, mostly ranging from 40% to 60%. There is certainly room for improvement and I am confident that this will occur in coming years. From the last year’s report and from the feedback of the participating centres some areas of possible improvement were identified and were addressed during this year. A) Starting this year, each participating institution will have a dedicated Clinical Care Analysis (CCA) or dashboard, on which it will be possible to have a visual feedback of the registered patients. The dashboard will show the accuracy and completeness of the centre’s database. It will be accessible only by the individual centre and by the database administrator. With this instrument, each centre may have an immediate visualization of the completeness of the inserted data. By providing this internal auditing, this resource will hopefully help increase the overall completeness rate and it will consequently decrease the amount of missing data.

59

B) In order to facilitate the patients upload, each participating centre are asked to complete a list of “essential” datafields (so called “core dataset”) in order to provide the essential information for the use of the single patient record for analysis. This “core” dataset represents the minimal information required to proceed with the analysis. The completion of the core dataset does not take too much time and further information may then be added at a later stage or when it becomes available. The Core Dataset includes the following datafields: 1. Gender (Male/Female) 2. Age at surgery 3. Date of surgery 4. Paraneoplastic associated syndromes (MG, etc) 5. Final pathologic diagnosis (thymoma, thymic carcinoma, NETT) 6. WHO thymoma histology 7. Pathologic Masaoka Stage 8. Final pathologic resection status (R0, R1, R2) 9. Pathologic TNM stage (IASLC/ITMIG staging, 8th Ed. TNM) 10. Outcome at discharge (Alive/dead) 11. Chemotherapy (pre/post) 12. Radiotherapy (pre/post) This resource will hopefully help increase the number of registered patients and will certainly facilitate the upload process. The combination of the core dataset and the CCA (Clinical Care Analysis or dashboard) should therefore increase the number of cases and the overall quality of the database.

C) In addition to the major effort for the improvement of the format and the quality of the database, we have worked with ITMIG (International Thymic Malignancy Interest Group) in order to have an optimal compatibility between the ESTS and the ITMIG databases. The optimal match between datafields in the two datasets is a fundamental pre-requisite for any further collaboration between the two organizations for common clinical and research projects. In summary, the 2016 report of the ESTS Registry-thymic section confirms the continuing interest in these rare tumors from the ESTS community. ESTS strongly believes that the society should maintain its role as the European Reference Authority for thymic tumors. The continuous expansion of the society to extra-EU countries is a further confirmation of the primary role of ESTS in supporting and promoting collaborative initiatives like the thymic database. Every ESTS center is therefore welcomed and strongly encouraged to upload his/her patients with thymic tumors to the ESTS Registry. The progressive increase in the number of cases will be essential for the optimal management of our patients with thymic tumors.

Dr. Enrico Ruffini

Chair of the ESTS Thymic Working Group

[email protected]

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Thymoma Section fields Thymic Tumors: prospective cases January 2007- April 2016 N=787 Demographics: gender and age groups

Gender Occurrences Percent Male 391 49.7 Female 396 50.3 Total 787 100.0

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Associated paraneoplastic syndromes

Diagnosis of paraneoplastic -Autoimmune syndrome Occurrences Percent None 194 59.5 Myasthenia Gravis 118 36.2 Red Cell Aplasia 3 0.9 Other autoimmune 14 4.3 Total number of patients 326 100

* Percentages calculated at the net of unknowns cases (N=461; 58.6%)

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Previous malignancy

Previous malignancy Occurrences Percent None 265 87.5 Breast 9 3.0 Lung 4 1.3 Colon 3 1.0 Prostate 3 1.0 Skin 1 0.3 Lymphoma 1 0.3 Other 19 6.3 Total number of patients 303 100


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Preoperative diagnosis

Biopsy Occurrences Percent No biopsy 233 74.7 FNA biopsy 23 7.4 Core biopsy 28 9.0 Mediastinotomy 12 3.9 VATS 9 2.9 Minithoracotomy 2 0.6 Other 5 1.6 Total 312 100.0


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Final pathologic diagnosis

Final pathologic diagnosis Occurrences Percent Thymoma 282 57.2 Thymic carcinoma 113 22.9 Neuroendocrine thymic tumour NETT 22 4.5 Thymic malignancy NOS 6 1.2 Other malignancy 12 2.4 Benign 58 11.8 Total 493 100.0


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WHO histology (thymoma only)

WHO histology Occurrences Percent A 31 11.9 AB 61 23.5 B1 61 23.5 B2 61 23.5 B3 46 17.7 Total 260 100.0

* Percentages calculated at the net of unknowns cases (N=22;7.8%)

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Tumor size

Tumor size Occurrences Percent <3 cm 59 13.4 3-5 cm 117 26.5 >5 cm 265 60.1 Total 441 100.0

* Percentages calculated at the net of unknowns cases (N=346; 44%)

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Invasion to surrounding organs

Adjacent organ microscopic invasion Occurrences Percent None 282 64.4 Not evaluated 25 5.7 Pleura 71 16.2 Pericardium 55 12.6 Phrenic nerve 22 5.0 Vascular 35 8.0 Lung 47 10.7 Other 19 4.3 Total number of patients 438


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Clinical (pre-treatment) stage according to Masaoka-Koga

Clinical (pre-treatment) Masaoka Stage Occurrences Percent I 214 60.3 IIa 39 11.0 IIb 27 7.6 III 44 12.4 IVA 25 7.0 IVB 6 1.7 Total 355 100.0


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Pathologic Masaoka-Koga stage Pathologic Masaoka Stage Occurrences Percent No pathology 28 7.2 I 157 40.6 IIa 72 18.6 IIb 49 12.7 III 43 11.1 IVA 25 6.5 IVB 13 3.4 Total 387 100.0


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Final pathologic resection status Final pathologic resection status Occurrences Percent R0 : complete resection 361 87.6 R1 : microscopic residual 35 8.5 R2 : macroscopic residual 16 3.9 Total 412 100.0


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Chemotherapy

Chemotherapy Occurrences Percent No chemo 276 79.1 Induction 19 5.4 Adjuvant 45 12.9 Both pre/post 9 2.6 Total 349 100.0


72

Radiotherapy

Radiation therapy Occurrences Percent No radiotherapy 269 74.7 Induction 5 1.4 Adjuvant 81 22.5 Both pre/post 5 1.4 Total 360 100.0


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Surgical approach

Surgical approach Occurrences Percent Sternotomy 238 50.9 Thoracotomy 65 13.9 Hemi-clamshell 11 2.4 Clamshell 4 0.9 VATS 104 22.2 VATS-robotic 27 5.8 Transcervical 7 1.5 Transcervical+sternal split 5 1.1 Sternotomy+thoracotomy 7 1.5 Total 468 100.0


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Extent of associated thymectomy

Extent of thymectomy Occurrences Percent None 24 5.8 Total 356 85.8 Partial 35 8.4 Total 415 100.0

* Percentages calculated at the net of unknowns cases (N=372; 47.3% )

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Resected structures associated with thymic tumor resection

954 Resected structures Occurrences Percent None 235 63.9 Pericardium 61 16.6 Pleura 60 16.3 Phrenic nerve 30 8.2 Lung wedge 56 15.2 Lung segmentectomy 2 0.5 Lung lobectomy 7 1.9 Lung pneumonectomy 2 0.5 Innominate 18 4.9 SVC 5 1.4 Pleural implants 10 2.7 Diaphragm 10 2.7 Extrapleural pneumonectomy 2 0.5 Total number of patients 368

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Outcome at hospital discharge

Outcome at Discharge Occurrences Percent Alive at Discharge 668 99.7 Died in Hospital 2 0.3 Total 670 100.0


Outcome at 30 days Outcome at 30 Days Occurrences Percent Alive at 30 Days 466 99.2 Dead at 30 Days 4 0.9 Total 470 100.0


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Data Completeness

Name of Field Unknown (%) Completeness(%) Diagnosis of paraneoplastic-Autoimmune syndrome 54.0% 46.0% Previous malignancy 61.5% 38.5% Biopsy (campo biopsy) 60.4% 39.6% Final pathologic diagnosis 37.4% 62.6% WHO histology 59.0% 41.0% Tumor size 44.0% 56.0% Adjacent organ microscopic invasion 44.3% 55.7% Clinical (pre-treatment) Masaoka Stage 54.9% 45.1% Pathologic Masaoka Stage 50.8% 49.2% Final pathologic resection status 47.6% 52.4% Chemotherapy 55.7% 44.3% Radiation therapy 54.3% 45.7% Surgical approach 40.5% 59.5% Extent of thymectomy 47.3% 52.7% Resected structures 53.2% 46.8% Outcome at hospital discharge 14.9% 85.1% Outcome at 30 Days 40.3% 59.7%

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PART 4

APPENDICES

(Database users only)

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Appendix 1: Database format and submission of data The first step is to request and obtain a login account through the relevant link found in the ESTS homepage (http//www.ests.org) or by directly sending an email to one of the members of the Database Committee. Once you have a valid login account you can proceed through the following data entry interface (accessible through https://ests.kdataclinical.it). The KData logon screen shown below has been engineered to provide enhanced security facilities:

• Limiting users to 3 logon attempts before locking the user-account • Giving information on previously successful and unsuccessful logon attempts • Requiring users to have an eight-character password that contains at least one

uppercase character, one lowercase character and one digit.

Once you have logged in you are presented with the Database main menu, from which you can add new data, view or edit a procedure, modify your account details, and export your data in Excel for your own purposes.

Clicking on the Search/Add tab opens the next screen “Patient Search”, where it is possible to search for patients already in the database or add new patients.

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https://ests.kdataclinical.it/

The function Search/Add (1) is for looking for an existing Patient or adding a new one; the function Add New Patients opens a new screen (2) to collect the unique identifying details of a New Patient where a set of mandatory data is required to add a new patient to the registry; you then save your New Patient by clicking the Add Patient (3) button as shown.

Once you have your New Patient you can select him/her for an appropriate Registry, or access a Patient/Procedure already existing in the Database.

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Access to the required Registry (For Example ESTS Core in our case) is obtained by choosing the appropriate “note” from the existing Note List and clicking on the green button “ Add Data to New Note” Steps: Select the “Note” (1) on Group ESTS Click on the Add Data to New Note button(2)

These steps will lead you to the Data Collection Section including the routine sections: Pre-op Op Post-Op Follow-up. For the following Registries: Core, Mesothelioma, Thymus, NETTs, Chest Wall Datasets. PLEASE NOTE that you need to save your data by clicking on the “save” button any time you have completed a section of the registry even if there are some triggers on the application that save the data automatically by default.

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Similar steps are available for the Follow-up section of the Core Dataset section as shown are below: Please note that the User needs to specify to which Procedure the current Follow-up Note is referring to: as shown here below there may be more than one procedure for the same Patient.

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The system permit to select the specific form: Core Dataset, Thymus, Mesothelioma,Netts and Chest Wall . All the form are defined on the ESTS Core Dataset but any type has specific fields.

In summary the first step after put in the demographics data or search a patient just saved is to select the specific note and in case of thymo or MEsothelioma or NEtts or chest wall is necessary select the specific note. In any case the total export permit to have a cumulative file with all type of procedures

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After is possible select the type of export : all procedures as in the follow case:

After you can open the file downloaded on the taskbar below

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Clinical Care Analysis CCA or System Dashboard. The first screen after logging in on the system shows a real-time representation of your Centre surgical activities:

It gets updated each time you add any data into it; it includes an enumeration of the total thoracic surgery recorded activities, with details about lung resections, proportion of VATS and outcome at discharge. Here we have shown the global set visible to the ESTS Database Director only. Each Centre Director can see her/his own Centre data, and nobody else. Specific analysis contents have being developed for the satellite Registries.

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Completeness and Composite Performance Score. The system auto-calculates both the Predicted Mortality (%) and Predicted Morbidity (%). Early outcomes, including in-hospital morbidity, in-hospital and 30-days mortality should be specified in the final section, before submitting the data. The system calculates the CPS automatically if there are more than 100 major lung excision procedures, and it shows the percentage of Data Completeness, as illustrated here below.

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Appendix 2: Definition of major cardiopulmonary complications listed in the database ARDS: Adult respiratory distress syndrome defined according to the American-European consensus conference. All of the following criteria should be met:

1. Acute onset 2. Arterial hypoxemia with PaO2/FIO2 ratio lower than 200 (regardless PEEP level) 3. Bilateral infiltrates at chest radiograph or CT scan 4. No clinical evidence of left atrial hypertension or pulmonary artery occlusive

pressure < 18 mmHg 5. Compatible risk factors

Initial ventilator support >48 hours: Patient initially was ventilated >48 hours in the postoperative period; ventilator support ends with removal of endotracheal tube or, if the patient has a tracheostomy tube, until no longer ventilator dependent. Reintubation: Patient was reintubated during the initial hospital stay after the initial extubation; this may include patients who have been extubated in the operating room and require intubation in the postoperative period Atrial Arrhythmia: new onset of atrial fibrillation/flutter (AF) requiring medical treatment or cardioversion. Does not include recurrence of AF which had been present preoperatively. Ventricular Arrhythmia: sustained ventricular tachycardia or ventricular fibrillation that has been clinically documented and treated by ablation therapy, implantable cardioverter defibrillator, permanent pacemaker, pharmacologic treatment or cardioversion. Bronchoscopy for atelectasis: postoperative atelectasis documented clinically or radiographically that needed bronchoscopy. Pneumonia: defined according to the last CDC criteria. Two or more serial chest radiographs with at least one of the following:

• New or progressive and persistent infiltrate • Consolidation • Cavitation

And at least one of the following: • Fever (>38°C or >100.4°F) with no other recognized cause • Leukopenia (<4000 WBC/mm3) or leukocytosis (>12,000 WBC/mm3) • For adults >70 years old, altered mental status with no other recognized cause

and at least two of the following: • New onset of purulent sputum, or change in character of sputum, or increased

respiratory secretions, or increased suctioning requirements 88

• New onset or worsening cough, or dyspnea, or tachypnea • Rales or bronchial breath sounds

Worsening gas exchange (e.g. O2 desaturations (e.g., PaO2/FiO2 < 240), increased oxygen requirements, or increased ventilator demand). Pulmonary embolism: confirmed by V/Q scan, angiogram or CT scan. DVT: deep venous thrombosis confirmed by Doppler study, contrast study or other study and that required treatment. Myocardial infarct: evidenced by one of the following criteria:

1. transmural infarction diagnosed by the appearance of a new Q wave in two or more contiguous leads on ECG.

2. Subendocardial infarction (non Q wave) evidenced by clinical, angiographic electrocardiographic signs.

3. Laboratory isoenzyme evidence of myocardial necrosis. Renal failure: defined as the onset of new renal failure in the postoperative period according to one of the following criteria:

1. increase of serum creatinine to greater than 2.0, or 2-fold the preoperative creatinine level.

2. a new requirement for dialysis postoperatively. Cerebrovascular complications: occurrence of one of the following central neurologic postoperative events not present preoperatively:

1. a central neurologic deficit persisting postoperatively for more than 72 hours 2. a transient neurologic deficit (transient ischemic attack or reversible ischemic

neurological deficit) with recovery within 72 hours 3. a new postoperative coma persisting at least 24 hours and caused by

anoxic/ischemic and/or metabolic encephalopathy, thromboembolic event or cerebral bleed.

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Appendix 3: ESTS institutional accreditation program The ESTS Council has approved an Institutional Accreditation program open to all thoracic surgery units participating to the ESTS Database. The aim of the program is to set standards of good clinical practice across Europe with the intent to improve the quality of care possibly according to published guidelines. To be certified units must participate to the ESTS Database since at least 2 years and have contributed a sufficient number of patients. This pre-requisite is necessary to calculate a reliable Composite Performance Score, which is the metrics used to evaluate the Institutional performance. A recent document from the STS Quality Measurement task force elegantly explained the conceptual framework and the statistical consideration in the development of Composite Performance Scores in Cardiac Surgery. Based on a similar methodology, ESTS has recently developed and published a Composite Performance Score (CPS) for lung surgery (Brunelli A et al. The European Thoracic Database project: Composite Performance Score to measure quality of care major lung resection. Eur J Cardiothorac Surg 2009; 35: 769-774). The method consists in developing standardized outcome and process indicators covering all temporal domains of the lung resection care. The indicators were selected based on their evidence-based level. For the preoperative domain, we selected the proportion of patients with DLCO measured before major lung resection, and the proportion of patients with clinically suspicious N2 nodes at CT scan or PET scan submitted to some type of preoperative mediastinal invasive staging. For the intraoperative domain, we selected the proportion of patients with primary neoplastic disease submitted to major anatomic resections and at least lobe-specific nodal dissection. For the postoperative domain, we selected the risk-adjusted in-hospital cardiopulmonary and mortality rates. Each of these indicators has been rescaled according to their standard deviation in the entire population to obtain individual standardized indicators. These were then summed to obtain the composite score for each unit. To derive the regression models for morbidity and mortality, univariate screening of the following variables: age, gender, BMI, type of resection, ppoFEV1, induction therapy, extended resection, presence of cardiac co-morbidity. Variables with p-level<0.1 were used as independent predictors in backward logistic regression analysis validated by bootstrap resampling technique. Only significant (p<0.05) and reliable (bootstrap significancy frequency >50%) were retained in the final model. Updated logistic regression equation for mortality (c-index 0.74; Hosmer Lemeshow statistics, p=0.9)) Logit: -4.74 -0.05xBMI+0.05xAge+ 0.8Xpneumonectomy (coded as 1 vs. 0 lobectomy) -0.92xVats+ 0.35Xcardiac comorbidity (coded as 1 and including CAD, any previous cardiac surgery, history and treatment for arrhythmia, congestive heart failure, hypertension) -0.013XppoFEV1% +0.24 * Extended Resection

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Updated logistic regression equation for cardiopulmonary morbidity (c-index 0.66; Hosmer-Lemeshow statistics, p=0.4) Logit: -1.48-0.009xBMI + 0.25Xpneumonectomy -0.615xVats+ 0.32Xcardiac comorbidity -0.017XppoFEV1% + 0.024Xage. Standardized scores are calculated by subtracting the observed risk-adjusted outcome or process incidence minus the average observed outcome or process incidence. The difference is then divided by the standard deviation of the observed outcome or process in the entire population. The 50th percentile of the CPS is the threshold selected by the Database Committee as a minimum criteria for accreditation and will be updated yearly. In the future, an automatic function will be implemented in the ESTS Database, which will allow the end-users to calculate their own CPS. In addition to their CPS, units must have certain structural, procedural and professional characteristics to be certified. These characteristics needs to be assessed and audited along a sample of data submitted to the database. To this purpose, ESTS has subcontracted an external auditing Company, which together with a thoracic surgeon will visit the applicant units and produce a report, which will be evaluated by the Database Committee. If the report will be judged satisfactory, the Accreditation will be granted by the ESTS Council. The following are the required structural/procedural/professional characteristics (based and modified from Brunelli A, Falcoz PE, D'Amico T,et al. European guidelines on structure and qualification of general thoracic surgery. Eur J Cardiothorac Surg. 2014;45:779-86). Hospital & Departmental structural criteria:

• Dedicated staff and institutional resources. • 1 fully equipped operating room per 300-400 major thoracic procedures per

year. • Access to ICU with experience in thoracic surgical cases. • Dedicated GTS ward, with full supporting paramedical staff and specialized

chest physiotherapists. • The size of the unit should reflect the procedural volume and postoperative

management policy. • Access to outpatient facilities and radiology. • GTS must have easy access to support facilities that must include:

hematological, microbiological and biochemical labs, respiratory pathophysiology lab, endoscopic examinations (bronchoscopy, esophagoscopy), cardiologic examination, cardiopulmonary exercise test, radiology including C scan and PET, cytology, histopathology and frozen section analysis.

• In-house facilities for research and education (meeting room, medical libraries, email and internet)

Procedures Volume: A suggested minimum volume of 150 +/- 50 major thoracic procedures per year is recommended. For esophageal resections a minimum volume of 20 +/- 5 procedures per year is recommended.

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For lung transplant a minimum volume of 10 procedures per year is recommended.

Qualification of surgeons: All surgeons must be qualified to perform thoracic surgery according to individual national or European legislation. The Head of the unit must have a minimum experience of 5 years of clinical practice as qualified thoracic surgeon. Costs: The costs for the inspection and auditing (1500 Euros) are the individual Unit’s responsibility. The accreditation will be valid for a 36 months period. After this period the unit must apply for recertification. ESTS accreditation will provide a number of benefits to certified institutions:

1. Accredited units will be announced during the ESTS Annual meeting and their names listed in the ESTS home page and ESTS Annual Report.

2. Participation to ESTS quality improvement initiatives 3. Participation to high-profile scientific projects supported by the ESTS scientific

committee 4. Accredited units may propose their own clinical research projects based on data

present in the ESTS database. The research projects will be then reviewed by the database committee and, if accepted, the unit will be granted full access to the data in the ESTS database needed for analysis.

Units Year of accreditation or

revalidation (3 year term)

Antwerp (BELGIUM) 2011 AND 2014 Ancona (ITALY) 2012 AND 2015 Sagrat Cor, Barcelona (SPAIN) 2012 Debrecen (HUNGARY) 2012 AND 2016 University Hospital Med School, Istanbul (TURKEY) 2012 Salamanca (SPAIN) 2012 AND 2015 Ospedale Maggiore, Milan (ITALY) 2013 AND 2016 Hospital Clinic Barcelona (SPAIN) 2013 AND 2016 Leuven (BELGIUM) 2013 AND 2016 University Hospital Cerrhapasa, Istanbul (TURKEY) 2013 Leeds (UNITED KINGDOM) 2016 Ospedale San Paolo, Milan (ITALY) 2016 Szeged (HUNGARY) 2016 For more information please go to: http://www.ests.org/_userfiles/pages/files/DB%20session-accreditation%20Lisbon%202015.pdf

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Appendix 4 : ESTS dataset

ESTS Preop Core

Date of thorsurgprocs

Age at surgery

Height

Weight

Bmi

Asa

1 - Normal healty individual, 2 - Mild systemic disease, 3 - Severe systemic disease not incapacitating, 4 - Incapacitating systemic disease - constant threat to life, 5 - Patient moribund - not expected to survive 24 hours

Mrcscore 0 - 1, 1 - 2, 2 - 3, 3 - 4, 4 - 5

Cardiaccomorbidity1

0 - None, 1 - Coronary Artery Disease, 2 - Any Previous Cardiac Surgery, 3 - Current Treatment for Hypertension, 4 - Current Treatment for Arrhythmia, 5 - Current Treatment for Cardiac Failure, 6 - Liver disease, 7 - Connective tissue disease, 8 - Myasthenia Gravis, 9 - Previous malignancy, 10 - Other

Cardiaccomorbidity2


Cardiaccomorbidity3


Othercomorbidities1 0 - None, 1 - Insulin-dependent Diabetes, 2 - Serum Creatinine > 2mg/dl, 3 - CVA, 4 - Chronic kidney failure, 5 - COPD, 6 - Gastric ulcer


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Ct 0 - X, 1 - 0, 2 - is, 3 - 1a, 4 - 1b, 5 - 2a, 6 - 2b, 7 - 3, 8 - 4, 9 - 1, 10 - 2

Cn 0 - X, 1 - 0, 2 - 1, 3 - 2, 4 - 3

Cm 0 - X, 1 - 0, 2 - 1a, 3 - 1b, 4 - 1

Pt 0 - X, 1 - 0, 2 - is, 3 - 1, 4 - 1a, 5 - 1b, 6 - 2, 7 - 2a, 8 - 2b, 9 - 3, 10 - 4

Pn 0 - X, 1 - 0, 2 - 1, 3 - 2, 4 - 3

Pm 0 - X, 1 - 0, 2 - 1, 3 - 1a, 4 - 1b

Urgency 0 - Elective, 1 - Urgent, 2 - Emergency

Ecog 0 - Fully Active, 1 - Light Work Only, 2 - Mobile>50% waking hours, 3 - Mobile < 50% waking hours, 4 - Immobile & unable to self-care

Fev1litres

Fev1percent

Fevclitres

Ppofev1percent

Fvcpercent

Fev1ldivfvcl

Dlcopercent

Ppodlcoperc

Vo2max

Atelectatic segments at operation

Previous surgery segments removed

Functioning segments resected

Other diagnosis

Diagnosis 0 - Lung Cancer (NSCLC), 6 - Empyema (Acute: Phase

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I/II), 1 - Lung Cancer (SCLC), 2 - Oesophageal Cancer, 3 - Mesothelioma, 4 - Lymphoma, 5 - Thymic Tumors, 7 - Empyema (Chronic), 8 - Chronic Pleural Inflammation, 9 - Pulmonary TB, 10 - COPD, 11 - Interstitial Lung Disease, 12 - Pneumothorax, 13 - Trauma, 14 - Achalasia, 15 - Gastro-Oesophageal Reflux, 16 - Paraoesophageal Hernia, 17 - Emphysema, 18 - Zenker's Diverticulum, 19 - Pulmonary Metastasis, 20 - Carcinaoid, 21 - Other

Morphology 0 - Non Neoplastic, 1 - Neoplastic Benign, 2 - Neoplastic Malignant Primary, 3 - Neoplastic Malignant Secondary

Ctnodes 0 - N2 nodes normal, 1 - N2 nodes > 1cm, 2 - CT not done

Pet scan 0 - No N2 Uptake, 1 - N2 Uptake, 2 - Not done

Pre-operative invasive mediastinal staging 0 - Not done, 1 - N2 node positive, 2 - N2 node negative

Lymphadenectomy

0 - No sampling at thoracotomy, 1 - Selected Biopsy, 2 - Nodal Sampling, 3 - Sistematic Nodal Dissection, 4 - Lobe-Specific Lymph Node Dissection, 5 - Extended Lymph Node Dissection

Neoadjuvant 0 - None, 1 - Chemotherapy, 2 - Radiotherapy, 3 - Both

Ct oesophagus 0 - is, 1 - 1, 2 - 2, 3 - 3, 4 - 4a, 5 - 4b

Cm oesophagus 0 - 1, 1 - 2

Cn oesophagus 0 - 0, 1 - 1, 2 - 2, 3 - 3

Pt oesophagus 0 - is, 1 - 1, 2 - 2, 3 - 3, 4 - 4a, 5 - 4b

Pn oesophagus 0 - 0, 1 - 1, 2 - 2, 3 - 3

Pm oesophagus 0 - 1, 1 - 2

Nsclcsubgroup 1 - Carcinoma in situ – Lepidic - Bronchioalveolar (BAC), 2 - Large cell, 3 - Adenocarcinoma, 4 - Neuroendocrine, 5 - Squamous cell, 6 - Mixed

Neuroendocrinesubgroup 1 - well diff, 2 - poorly diff, 3 - moderate

Diameter of lesion cm

Smokinghistory 0 - Never smoked, 1 - Past smoker (stopped >1month prior to surgery), 2 - Current smoker, 3 - Unknown

Pr 0 - 0, 1 - 1, 2 - 2

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ESTS Op Core

Date of procedure

Group definition 0 - Lung, 1 - Pleura, 2 - Chest Wall, 3 - Trachea - Bronchus, 4 - Mediastinum, 5 - Upper GI, 6 - Diaphragm

Group other procedure

Lung subgroup 0 - Lung Biopsy, 1 - Lung Excision, 2 - Lung Lesion, 3 - Lung Repair, 4 - Lung Transplant

Lung excision procedure 0 - Bilobectomy, 2 - Lung Volume Reduction, 1 - Lobectomy, 3 - Pneumonectomy, 4 - Segmentectomy, 5 - Wedge

Vats 0 - No, 1 - Yes

Bilobectomy lobectomy qualifier

0 - Alone, 1 - Chest Wall, 2 - Superior Sulcus Tumor, 3 - Sleeve, 4 - Diaphragm Resection, 6 - SVC Resection / Reconstruction, 7 - Vertebral Resection, 5 - Atrial Resection

Bilobectomy proc site 0 - RUM, 1 - RLM

Lung volume reduction qualifier 0 - Bilateral, 1 - Unilateral

Pneumonectomy qualifier

2 - Intrapericardial, 0 - Alone, 1 - Completion, 3 - Pleuropneumonectomy, 4 - Sleeve Resection, 5 - Diaphragm Resection, 6 - Atrial Resection, 7 - SVC Resection / Reconstruction, 8 - Vertebral Resection

Pneumonectomy side 0 - Left, 1 - Right

Wedge qualifier 0 - Multiple, 1 - Single

Subgroup lunglesion procedure 0 - Biopsy of Lung Lesion, 1 - Cauterisation of Lung Lesion, 2 - Enucleation of Lung Lesion, 3 - Excisions of Lung Lesion

Lobectomy proc site 0 - RUL, 1 - RML, 2 - RLL, 3 - LUL, 4 - LLL

Lung repair procedures 0 - Intracavitary Drainage, 1 - Repair of Bulla of Lung, 2 - Repair of Lung, 3 - Other

Repair bulla of lung qualifier 0 - Cavernostomising, 1 - Deflation, 2 - Excision, 3 - Ligation, 4 - Oversewing

Qualifier for repair of lung 0 - Laceration

Sub group lung transplant 0 - Bilateral Sequential Single Lung Transplant, 1 -

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procedures Harvesting Donor Lung, 2 - Single Lung Transplant, 3 - Lobar Lung Transplant, 4 - Split Lung Transplant

Pleura subgroup

0 - Decortication, 1 - Pleural Biopsy, 2 - Pleurectomy/Pleurodesis, 3 - Thoracocentesis / Chest Tube, 4 - Aspiration, 5 - Pleuro-Peritoneal Shunt, 5 - Extrapleural Pneumonectomy

Pleural biopsy procedure 0 - Biopsy of Pleural Lesion, 1 - Destruction of Pleural Lesion, 2 - Excision of Pleural Lesion, 3 - Pleural Biopsy

Pleurectomy pleurodesis old 0 - Pleural Catheter, 1 - Pleurectomy, 2 - Pleurodesis, 3 - Pleuroperitoneal Shunt

Qualifier for pleural catheterprocedure 0 - Attention to, 1 - Insertion, 2 - Removal

Qualifier for pleurectomy procedure 0 - Apical, 1 - Full, 2 - Partial

Thoracoscopy procedure 0 - Drainage of Empyema, 1 - Drainage of Haemothorax, 2 - Inspection only, 3 - Pleural Lavage

Chest wall subgroup 0 - Chest Wall, 1 - Costal Cartilage, 2 - Chest wall Incision, 3 - Reconstruction, 4 - Rib, 5 - Thoracoplasty

Chest wall procedures

0 - Biopsy of Chest Wall Lesion, 1 - Creation of Thoracic Stoma, 2 - Excision of Chest Wall Lesion, 3 - Repair of Chest Wall, 4 - Excision / Repair of Chest Wall, 5 - Correction of Chest Wall Defects

Qualifier excision of chest wall lesion

0 - Distant Flap, 1 - Local Flap, 2 - Microvascular Transferred Flap

Qualifier for repair of chest wall 0 - Plugging Flail Chest, 1 - Suture, 2 - Osteosynthesis

Excision repair qualifier 0 - Prostesis, 1 - Muscle Flap, 2 - Myocutaneus Flap, 3 - Omentum

Costalcartilageprocedure 1 - Excision of Costal Cartilage, 2 - Excision of Xifisternum, 3 - Fixation of Costal Cartilage

Chest wall incision procedures 0 - Exploratory Median Sternotomy, 1 - Exploratory Thoracotomy, 2 - Mini Thoracotomy, 3 - Previous Chest Wall Incision

Correction of chest wall defects qualifier

0 - Pectus Bar Removal, 1 - Pectus Carinatum Correction, 2 - Pectus Excavatum Correction, 3 - Pectus Silicon Implant, 4 - Pectus Arcuatum, 5 - Mixed deformity

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Rib procedures 0 - Rib Resection, 1 - Rib Resection for Drainage, 2 - Rib Fixation

Qualifier for rib resection 0 - Biopsy, 1 - For Pain, 2 - Fracture

Thoracoplasty procedures 0 - Plombage Procedure, 1 - Thoracoplasty Procedure

Qualifier for plombage 0 - Insertion of Plomb, 1 - Removal of Plomb

Qualifier for thoracoplasty 0 - Limited Thoracoplasty, 1 - Schede Thoracoplasty, 2 - Total Thoracoplasty

Costal cartilage procedures 1 - Excision of Costal Cartilage, 2 - Excision of Xifisternum, 3 - Fixation of Costal Cartilage

Qualifier pectus carenatum 0 - With Internal Fixation, 1 - Without INternal Fixation

Trachea bronchus subgroup 0 - Bronchoscopic Stent, 1 - Bronchus, 2 - Carina, 3 - Trachea

Bronchoscopic stent procedures 0 - Change of Stent, 1 - Placement of Stent, 2 - Removal of Stent, 3 - Repositioning of Stent

Change or placement or removal qualifier

0 - Carina, 1 - Lobar Bronchus, 2 - Main Bronchus, 3 - Trachea

Carina procedure 0 - Carina Reconstruction, 1 - Excision of Carina, 2 - Open Biopsy of Carinal Lesion, 3 - Open Resection of Carinal Lesion

Bronchus procedures

0 - Bronchoplastic Procedure, 1 - Open Biopsy of Bronchial Lesion, 2 - Open Excision of Bronchial Lesion, 3 - Open Repair of Fistula of Bronchus, 4 - Repair of Aquired Bronchooesophageal Fistula, 5 - Repair of Ruptured Bronchus

Trachea procedure

0 - Open Biopsy of Tracheal Lesion, 1 - Open Excision of Tracheal Lesion, 2 - Repair of Traumatic Rupture of Trachea, 3 - Resection of Tracheal Stenosis, 4 - Tracheal Reconstruction, 5 - Tracheopexy, 6 - Tracheostomy

Qualifier for tracheal reconstruction 0 - Flap, 1 - Patch

Qualifier for tracheostomy 0 - Closure, 1 - Permanent, 2 - Temporary

Mediastinum subgroup 0 - Mediastinoscopy, 1 - Mediastinotomy, 2 - Mediastinum, 3 - Thoracic Duct, 4 - Thyroid

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Mediastinoscopy procedures 0 - Cervical Mediastinoscopy, 1 - Extended Cervical Mediastinoscopy, 2 - TEMLA, 3 - VAMLA

Anterior mediastinotomy procedure qualifier

0 - Anterior Mediastinotomy W ITH Excision of Costal Cartilage, 1 - Anterior Mediastinotomy W ITHOUT Excision of Costal Cartilage

Mediastinum subgroup procedures

0 - Exploration of Mediastinum, 1 - Mediastinal Lesion - Biopsy, 2 - Mediastinal Lesion - Excision, 3 - Open Drainage of Mediastinum, 4 - Pericardial Lesion - Excision, 5 - Pericardial Window, 6 - Repair Cardiac Laceration, 7 - Thymectomy, 8 - Sympathectomy, 9 - Sympathicotomy, 10 - Clipping of Sympathic Chain

Pericardial window qualifier 0 - Subxiphoid, 1 - Transthoracic

Thymectomy qualifier 0 - Transcervical, 1 - Transsternal, 2 - Other

Ligation of thoracic duct procedure 0 - No, 1 - Yes

Thyroid procedures

0 - Excision of Ectopic Thyroid, 1 - Excision of Substernal Thyroid Tissue, 2 - Exploration of Thyroid Gland, 3 - Thyroid Isthmectomy, 4 - Thyroid Lobectomy, 5 - Thyroidectomy - Partial, 6 - Thyroidectomy - Subtotal, 7 - Thyroidectomy - Total

Qualifier thyroid lobectomy thyroidectomy partial

0 - Not Retrosternal, 1 - Retrosternal - Cervical Incision, 2 - Retrosternal - Sternotomy

Thyroidectomy subtotal total 0 - Not Retrosternal, 1 - Retrosternal - Cervical Incision

Upper gi subgroup 0 - Antireflux, 1 - Gastric, 2 - Oesophagectomy, 3 - Oesophagus (excluding resection), 4 - Upper GI Other

Minimally invasive procedure 0 - No, 1 - Yes

Antireflux procedures 0 - Gastropexy, 1 - Gastroplasty Longitudinal, 2 - Gastroplasty - VY, 3 - Partial Fundoplication, 4 - Posterior Gastropexy, 5 - Total Fundoplication

Gastropexy qualifier 0 - Anterior, 1 - Posterior

Gastroplasty longitudinal qualifier

0 - Collis-Belsey, 1 - Collis-Nissen, 2 - No Antireflux Procedure

Partial fundoplication qualifier 0 - Belsey

Gastric subgroup procedures 0 - Creation of Omental Flap, 1 - Partial

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Gastrectomy, 2 - Pyloroplasty, 3 - Total Gastrectomy

Pyloroplasty qualifier 0 - Finney, 2 - Pyloromyotomy, 1 - Heineke-Mikulicz

Total gastrectomy qualifier 0 - Anast. Oes/Duodenum, 1 - Interposition of Jejunum

Oesophagectomy procedures 0 - Partial Oesophagectomy, 1 - Pharyngolaryngooesophagectomy, 2 - Subtotal Eosophagectomy, 3 - Total Oesophagectomy

Partial oesophagectomy qualifier

0 - LTh Sub-Aortic Reconstruction, 1 - LTh Supra-Aortic Reconstruction Total Gastrectomy, 2 - RTh Ivor Lewis Total Gastrectomy

Subtotal eosophagectomy qualifier

0 - LTh Abd/Neck, 1 - McKeown (3 Stage), 2 - TransHiatal

Total oesophagectomy qualifier 0 - Colon INterposition, 1 - Gastric Pullup, 2 - Jejunal Interposition, 3 - Microvascular attached colon, 4 - Microvascular attached Jejunum

Oesophagus excluding resection procedures

0 - Biopsy of Oesophagus, 1 - Bypass of Oesophagus, 2 - Cardiomyotomy, 3 - Closure of Tracheooesophageal Fistula, 4 - Cricopharyngeal Myotomy, 5 - Drainage of Eosophagus, 6 - Myotomy & Excision-Pexy of Diverticulum of Oesophagus, 7 - Insertion of Prosthesis into Oesophagus (Laparotomy), 8 - Long Oesophagus Myotomy, 9 - Operation on Oesophageal Varicees, 10 - Removal of Foreign Body from Oesophagus (Open), 11 - Repair of Oesophageal Atresia, 12 - Repair of Oesophagus, 13 - Upper Pouch Myotomy

Bypass of oesophagus qualifier 0 - Colon, 1 - Stomach

Cardiomyotomy qualifier 0 - Heller, 3 - Heller - Nissen, 1 - Heller-Belsey, 2 - Heller Laparoscopic

Upper gi other procedure 0 - Diagnostic Laparoscopic, 1 - Exploratory Laparotomy, 2 - Insertion of Intercostal Drain, 3 - Supraclavicular Lymph Node Biopsy

Diaphragm group procedures 0 - Diagnostic Laparoscopic, 1 - Exploratory Laparotomy, 2 - Insertion of Intercostal Drain, 3 - Supraclavicular Lymph Node Biopsy

Plannedlungexcisionprocedure 0 - Bilobectomy, 2 - Lung Volume Reduction, 1 - Lobectomy, 3 - Pneumonectomy, 4 - Segmentectomy, 5 - Wedge

Reasonotherresection 1 - Oncologic, 2 - Technical

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Plannedaccess 1 - Thoracotomy, 2 - VATS, 3 - Robotic

Performedaccess 1 - Thoracotomy, 2 - VATS, 3 - Robotic

Reasonconversion 1 - Anatomy, 2 - Lymph nodes, 3 - Technical

Othersurgeon

Surgeon

Pleurectomypleurodesis * 0 - Pleurectomy, 1 - Chemical Pleurodesis, 2 - Mechanical Pleurodesis

Prevchestwallincqualifier * 0 - Debridement, 1 - Procedure for Sinus, 2 - Removal of Wires, 3 - Reopening, 4 - Repair with Flap, 5 - Resuture

* denotes fields multi choice

ESTS Postop Core

Date of discharge

Complication1

0 - None, 1 - Air Leak > 5 Days, 2 - Anastomotic Leak (Conservative), 3 - Anastomotic Leak (Requiring Surgery), 4 - ARDS, 5 - Atrial Arhythmia Rx Postop, 6 - Bronchopleural Fistula, 8 - Atelectasis, 9 - Cardiac Failure, 10 - Cerebro-Vascular Complications, 11 - Chylothorax, 12 - Conduit Ischaemia, 13 - Delirium, 14 - DVT, 15 - Empyema, 16 - Initial ventilation > 48 hours, 17 - Multisystem Failure, 18 - Myocardial Infarct, 19 - Phrenic nerve injury, 20 - Pneumonia, 21 - Pulmonary Embolism, 22 - Pulmonary Oedema, 23 - Recurrent Nerve Palsy, 25 - Renal Failure, 24 - Reintubate, 28 - Unexpected Admission to ICU, 26 - Reoperation for Bleeding, 27 - Tracheostomy, 29 - Ventricular Arrhythmia Rx Postop , 30 - Wound Infection, 31 - Other

Complication2

0 - None, 1 - Air Leak > 5 Days, 2 - Anastomotic Leak (Conservative), 3 - Anastomotic Leak (Requiring Surgery), 4 - ARDS, 5 - Atrial Arhythmia Rx Postop, 6 - Bronchopleural Fistula, 8 - Atelectasis, 9 - Cardiac Failure, 10 - Cerebro-Vascular Complications, 11 - Chylothorax, 12 - Conduit Ischaemia, 13 - Delirium, 14 - DVT, 15 - Empyema, 16 - Initial ventilation > 48 hours, 17 - Multisystem Failure, 18 - Myocardial Infarct, 19 - Phrenic nerve injury, 20 - Pneumonia, 21 - Pulmonary Embolism, 22 - Pulmonary Oedema, 23 - Recurrent Nerve Palsy, 25 -

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Renal Failure, 24 - Reintubate, 28 - Unexpected Admission to ICU, 26 - Reoperation for Bleeding, 27 - Tracheostomy, 29 - Ventricular Arrhythmia Rx Postop , 30 - Wound Infection, 31 - Other

Complication3

0 - None, 1 - Air Leak > 5 Days, 2 - Anastomotic Leak (Conservative), 3 - Anastomotic Leak (Requiring Surgery), 4 - ARDS, 5 - Atrial Arhythmia Rx Postop, 6 - Bronchopleural Fistula, 8 - Atelectasis, 9 - Cardiac Failure, 10 - Cerebro-Vascular Complications, 11 - Chylothorax, 12 - Conduit Ischaemia, 13 - Delirium, 14 - DVT, 15 - Empyema, 16 - Initial ventilation > 48 hours, 17 - Multisystem Failure, 18 - Myocardial Infarct, 19 - Phrenic nerve injury, 20 - Pneumonia, 21 - Pulmonary Embolism, 22 - Pulmonary Oedema, 23 - Recurrent Nerve Palsy, 25 - Renal Failure, 24 - Reintubate, 28 - Unexpected Admission to ICU, 26 - Reoperation for Bleeding, 27 - Tracheostomy, 29 - Ventricular Arrhythmia Rx Postop , 30 - Wound Infection, 31 - Other

Major cardiopulmonary complications 0 - No, 1 - Yes

Date of death

Cause of death 0 - Death Related to This Operation, 1 - Death Related to Another Operation, 3 - Death After Discharge Clearly Unrelated to This Operation

Outcome at discharge 0 - Alive at Discharge, 1 - Died in Hospital

Outcome at 30days 0 - Alive at 30 Days, 1 - Dead at 30 Days

Notes

Predicted morbidity

Predicted mortality

Unexpectedreturntoor 0 - No, 1 - Yes

Readmission to any hospital within 30days discharge

0 - No, 1 - Yes, 2 - Unknown

Outcome at 90 days 0 - Death, 1 - Alive, 3 - Unknown

* denotes multi-choice fields

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Appendix 5: KData CLinical Standard Operating Procedure SOP for successfully import Third Party Data into the ESTS Database

Requirements for the import of data into KData Systems

Scope of this document

This document is intended to outline the requirements for data-imports into the KData Systems. It will cover:

1. minimum requirements for file-formats

2. minimum requirements for each row of data

3. minimum requirements for supporting documentation

4. protocols for acceptance of the commission, the scope of the work and final delivery dates

5. completion and sign-off

File Formats In many cases the data must be viewed and manipulated in third-party software prior to import. This enables KData to examine the data in detail so that the final import database is the best fit to the data within the constraints of the system. It also allows some pre-import manipulation of the data to create the cleanest final import possible. The data also have to be transmuted into a file- format that is suitable for import – a tab-delimited text file.

The most common acceptable source data formats include:

• Microsoft Access

• Microsoft Excel

• Tab-delimited text files

However, any file that can be demonstrated to be compatible with standard Microsoft packages would also be acceptable. Comma-delimited files are not generally acceptable as the comma is used to sub-delimit fields where more than one response option may be selected. Comma- delimited files may be accepted as long as there are no multiple-response fields with comma delimiters or sub-delimiters other than commas.

Where there is more than one table of source data to be imported, it is essential that the tables of data required in the final import product are identified and that the inter-relationships between these tables are recorded explicitly, including the indices that are used to link the tables. This requirement applies most frequently to Access databases, but also applies to other file formats where multiple files are to be migrated into a single KData database.

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Minimum requirements for each row of data

• The first row in each data-file must contain headers.

• Each row of data in each file must include a unique patient-identifier1

• Each row of data in each file must include a key-date as an index (admission, operation, etc.)2

• Numbers containing decimals should be presented with a “.” Signifying the decimal position and no

thousand separators e.g., 10000.245

• Dates should be presented in long-date format, dd/mm/yyyy, format

• Date-time fields should be presented in dd/mm/yyyy hh:mm format using the 24-hour clock

• Where a data item may contain multiple responses each of those responses must be separated by a comma

• It is important that soft carriage-returns are removed from the data before delivery to KData.

These control characters cause configuration problems when the data are transferred into the file format that acts as the substrate for the import process as the carriage return is reserved as a row (record) delimiter.

Requirements for supporting documentation

A full data-dictionary is required, particularly where abbreviations or encoding systems have been used. This dictionary should include supporting information on the relationship between the individual data-items and patient’s progress i.e., are the data pre-operative, post-operative etc.

Where data are maintained in a language other than UK English, a full translation of all the headers and data items must also be provided. It is important to have full explanations for all headers:

• The meaning of the header

• The type of data4

Where data-items are coded (0, 1; Y, N; etc.) a comprehensive set of data-definitions must be supplied with, and at the same time as, the data to be imported5.

1 If the data lack an unique identifier such as a Hospital number or a Department number, then there must be sufficient patient-specific data to generate a unique identifier. An indication of the nature of the unique-identifier is very important i.e., is the identifier a hospital number, a national number or a database row ID. The minimum data-fields would be the patient’s Surname, Forename, Date of birth and Gender. In such cases, if an examination of the data demonstrates that there are a number of duplications then this will be reported back to the customer. Import will only progress if the customer accepts the implications of such duplications. The unique patient-identifier may be absent in individual data-files from a multiple file suite as long as there is a database key that allows the patient-records to be linked back to an unique identifier in one of the data-files.

2 Any row of data that lacks a key date will not appear in the final import. Null values in this field will be treated in a manner that is agreed with the customer at the time that the import is commissioned. See “Acceptance, scope and delivery of the import work”.

3 Carriage returns may be found frequently in text fields in Access databases, but may also lurk in other places in data-files. 4 Type of data is to include the clinical sense of the data (pre-operative, operative, post-operative, etc.), the scope of the data (mutually exclusive data, multiple choice data, date data, free text etc.).

5 Any data-point that contains data-options not included in the accompanying data-definition documentation will be treated in a manner that is agreed with the customer at the time that the import is commissioned. See “Acceptance, scope and delivery of the import work”.

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Acceptance, scope and delivery of the import work

Customers requesting data-imports will be given a copy of this document together with a copy of the attached Data-Import Commission document.

The customer will be asked to complete the Data-import Commission document with the assistance of a member of KData.

The Data-Import Commissioning document will define the scope of the requested work.

The Data-Import Commissioning document will define the agreed actions to be taken by KData if any of the requirement outlined in this document are breached6.

The Data-Import Commissioning form will set tentative delivery dates7.

The information in the Data-Import Commissioning document will be passed to the Sales Team for priority setting and scheduling. The results of these deliberations will be communicated to the customer, and, if the timescales are acceptable to the customer, KData will formally accept the work, confirming all delivery dates to the customer.

At delivery the imported data will be place in a dedicated area so that the import can be validated locally.

Completion and sign-off

At delivery of the import-product, the customer will be presented with both the data and a Sign-Off form.

The customer will be asked to review the data-import, and determine whether or not the work conforms to the standards defined in the Data-import Commissioning form. If the import-product is considered completed, according to agreed specifications, the customer will complete the Sign- Off form, and the project will be deemed completed.

If the import is not considered complete, then the customer will contact KData, and provide information on any perceived shortfalls or errors, with reference to the agreed specifications.

Thirty days after delivery of the import-product, should there have been no communication between the customer and KData regarding the status of the import-product, the project will be deemed completed.

Post-completion, further work on the same data, or extension of the same dataset will constitute a fresh import, and will be planned, scheduled and executed as such.

6 Any data that are delivered for import into the KData Systems and fail to meet any one of the criteria agreed in the Data-Import Commissioning document will be rejected. Should it be possible to perform a simple data-manipulation to reconfigure the data so that they become suitable for import, then customer will be presented with two options: to commission extra work from KData to reconfigure the data or to provide another data file in the correct format. Such a eventuality may involve re-evaluation of agreed delivery dates.

7 Delivery dates include both those dates on which the customer agrees to have the data-files and accompanying data-definition documentation delivered to KData Clinical, and the date on which KData Clinical agree to deliver the product of the import.

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Data-Import Commissioning document

Centre / Hospital [insert centre name] Speciality [insert specialty] Clinical contact [insert name]

[insert address] [insert telephone number] [insert e-mail address]

IT contact (if required)

[insert name] [insert address] [insert telephone number] [insert e-mail address]

Data import [insert description]

Data-file format [Excel; Access; tab-delimited text]

Data volumes [insert filename 1 / filenumber 1] [# columns] × [#rows]

[insert filename 2 / filenumber 2] [# columns] × [#rows]





Suggested date for data delivery to KData Clinical

[dd / mm / yyyy]

Requested delivery date for import-product

[dd / mm / yyyy]

Action for file-format exceptions [return to customer OR correct if possible] Action for individual data-field exceptions

[return to customer for advice OR reject & report OR amend, import and report]

Signed

Dated [dd / mm / yyyy]

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Data-Import Sign-Off form

Centre / Hospital [insert centre name]

Speciality [insert specialty]

Clinical contact [insert name]

Data import [insert description]

Expected delivery date [dd / mm / yyyy]

Actual delivery date [dd / mm / yyyy]

The commissioned import work described above has been assessed and complies with the agreed specifications outlined in the Data-Import Commissioning document.

This work is now considered completed.

Signed

Dated [dd / mm / yyyy]

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Appendix 6: K Data Clinical Compliance with Data Protection Legislation

STUDIO LEGALE MAGLIO & PARTNERS LUCERNA IURIS - INTERNATIONAL LEGAL NETWORK

*** In collaborazione con

Siegert & Kollegen -Fnehurg Alan Bensoussan Avocats -Pans Pinsent Masons Law Finn -London

PLMJ Sociedade de Advogados -Lishoa Landwell Glohal Ahogados -Barcelona

Singewald Consultants Group -Amsterdam Guilmot -Bassine Avocats -Bruxelles

Engstonn Advokats -Stockolm Procope &Homhorg Law ODices Ltd -Helsinki

Traple Konarski Podrecki Kancelaria Prawna - Krakow Spohn Richter &Partners Rechtsanwiilte OEG - lflen

VJT& Partners -Budapest A. & K. Metaxopoulos & Partners Law Firm -Athens

CMS von Erlach Henrici AG Rechtsanwalt - Ziirich Randa Havel Legal advocatnf kanceliir s.c.o.- Praha

A&L Goodhody - Duhlin Alrod Law Finn -Moscow

Angela Wang & Co. Sollicitors -Honk Kong -Shanghai Holding Redlich Law Fmn -Sydney

Russell Mc f'eagh Law Finn -Auckland Avish Kalicharan & Associates - Pretoria

f'e imno Advogados -Sfio Paulo Marval O'Farrell Maira! - Buenos Aires

Portilla Ruy-IJiazy Agui/BI; S.C. -Mexico IJ.E Stikeman Elliott LLP - Montreal Prescott Law Finn -New York

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Avvocato Marco Maglio Presidente def Giuri di Autodisciplina per direct marketing, telemarketing, vendite a distanza e dirette

K-data Clinical s.r.l. Via Orazio 31 00193 Roma - Italy

Milan, 26th April 2016

Re: declaration of assessment regarding the respect of data protection legislation

Dear Sirs,

with reference to the requirements provided by the current legislation on personal data, I was able to make the necessary checks on the procedures and the documentation according to the Legislation on data protection. This audit covered all aspects described in your assessment of impact of data processing and Privacy Impact Assessment Document which I have examined and verified its contents .

These are the basic result of the assessment on your processing:

Data protection assurance: 11 Measures successfully implemented Records

management: 18 Measures successfully implemented

Information security : 35 Measures successfully implemented Data sharing & subject access: 13 Measures successfully implemented

In detail here are the basic results of the assessment for yuor business:

DATA PROTECTION ASSURANCE

1. Your business has established an appropriate data protection policy.

2. Your business has nominated a data protection lead.

3. Your business provides data protection awareness training for all staff.

4. Your business has registered with the Data Protection Supervisory Authority.

5. Your business has made privacy notices readily available to individuals.

6. Your business has established a process to recognise and respond to individuals' requests to access their personal data.

7. Your business has established processes to ensure personal data is of sufficient quality to make decisions about individuals.

8. Your business has established a process to routinely dispose of personal data that is no longer required in line with agreed timescales.

9. Your business has established an information security policy supported by appropriate security measures.

10. Your business ensures an adequate level of protection for any personal data processed by others on your behalf or transferred outside the European Economic Area.

11. Your business has established a process to ensure new projects or initiatives are privacy-proofed at the planning stage.

RECORDS MANAGEMENT

1. You business has defined and allocated records management responsibilities.

2. Your business has approved and published an appropriate records management policy. This is subject to a regular review process.

3. Your business has identified records management risks as part of a

wider information risk management process.

4. Your business incorporates records management (RM) within a formal training programme. This comprises mandatory RM induction training with regular refresher material, and specialist training for those with specific RM functions.

5. Your business has established written agreements with third party service providers that include appropriate information security conditions.

6. Your business ensures the protection of personal data that is accessed by suppliers and

providers.

7. Your business carries out periodic checks on records security and there is monitoring of compliance with records management procedures. The outcomes of any records security checks or compliance monitoring is measured against key performance indicators to provide strategic oversight to those with overall responsibility for RM.

8. Your business has minimum standards for creation of paper or electronic records and has established processes to ensure that there is a legitimate purpose for using personal data prior to collecting it.

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9. Your business has identified manual and electronic records keeping systems throughout the organisation and a centralised record of those systems is actively maintained. 10. Your business has processes in place to ensure that personal data that is collected is accurate, adequate, relevant and not excessive. Routine weeding is also carried out to remove any personal data or records that are no longer relevant or out of date.

11. Your business has tracking mechanisms to record the movement of manual records and ensure their security between office and storage areas and also in instances where records are taken off-site.

12. Your business has appropriate measures in place for the transfer of electronic records off-site to protect personal data from loss of theft.

13. Your business stores paper and electronic records securely with appropriate environmental controls and higher levels of security around sensitive personal data.

14. Your business restricts access to records storage areas in order to prevent unauthorised access, damage, theft or loss. Access should be role based in line with the principle ofleast privilege and checked regularly.

15. Your business has a process to assign user accounts to authorised individuals and to remove them when no longer appropriate. Such access should be granted on the

16. Your business has business continuity plans in place. These should identify business critical records that are essential to the continued functioning or reconstitution of the organisation in the event of a disaster. Data that is stored electronically should be routinely backed-up to help restore information in the event of disaster.

17. Your business has a retention and disposal schedule in place which details how long manual and electronic records will he kept for.

18. Your business has defined confidential waste disposal processes in place to ensure that records are destroyed to an appropriate standard once a disposal decision has been made.

INFORMATION SECURITY

1. Your business has established a process to identify, assess and manage information security risks.

2. Your business ensures information security risks are assessed and appropriately

managed.

3. Senior management has approved and published an appropriate information security policy.

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4. Your business provides management direction and support for information security in accordance with business needs and relevant laws and regulations.

5. Your business has defined and allocated information security responsibilities.

6. Your business has established a management framework to coordinate and review the implementation of information security.

7. Your business has established written agreements with third party service providers that include appropriate information security conditions.

8. Your business ensures the protection of personal data that is accessed by suppliers and

providers. 9. Your business has established a process to report and recover from data security breaches. 10. Your business ensures the management of data security breaches, including communication of information security events and weaknesses. 11. Your business has established regular information security awareness training for all staff.

12. Your business ensures that employees and contractors are aware of and fulfil their information security responsibilities.

13. Your business has established entry controls to restrict access to premises and equipment on a need-to-know basis. 14. Your business prevents unauthorised physical access, damage and interference to personal

data. 15. Your business has established secure storage arrangements to protect records and equipment. 16. Your business prevents loss, damage, theft or compromise of personal data.

17. Your business has established a process to securely dispose of records and equipment when no longer required.

18. Your business has established a mobile working policy.

19. Your business ensures the security of mobile working and the use of mobile computing devices.

20. Your business has established a process to configure new and existing hardware to reduce vulnerabilities and provide only the functionality and services required.

21. Your business has established controls to manage the use of removable media.

22. Your business prevents unauthorised disclosure, modification, removal or destruction of personal data stored on media.

23. Your business has established a process to assign user accounts to authorised individuals, and to manage user accounts effectively to provide the minimum access to information.

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24. Your business limits access to personal data held in information systems. 25. Your business has established appropriate password security procedures and 'rules' for information systems and has a process in place to detect any unauthorised access or anomalous use.

26. Your business has established effective anti-malware defences to protect computers from malware infection.

27. Your business ensures that personal data is protected against malware.

28. Your business has established a process to routinely back-up electronic information to help restore information in the event of disaster.

29. Your business ensures protection against the loss of personal data.

30. Your business has established a process to log and monitor user and system activity to identify and help prevent data breaches.

31. Your business records events and generates evidence.

32. Your business has established a process to ensure software is kept up-to-date and the latest security patches are applied.

33. Your business prevents the exploitation of technical vulnerabilities.

34. Your business has established boundary firewalls to protect computers from external attack and exploitation.

35. Your business ensures the protection of personal data in networks.

DATA SHARING & SUBJECT ACCESS

1. Your business has communicated policies, procedures and guidance to all staff which clearly set out when it is appropriate to share or disclose data.

2. Your business has assigned responsibility to an appropriate member of staff for ensuring effective data sharing.

3. Your business provides adequate training on an ongoing basis for staff that are regularly required to make decisions regarding whether or not personal data should be shared with third parties.

4. Your business maintains a log of all decisions to share personal data and this is reviewed

regularly.

5. Your business has agreed data sharing agreements with an appropriate legal basis with all parties with whom personal data is routinely shared or where large quantities of data are to be transferred. These agreements are regularly reviewed.

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6. Your business informs individuals about the sharing of their personal data.

7. Your business has considered whether you need to provide Italian Supervisory Authority with a description of the individuals or organisations to whom you intend or may wish to disclose personal data. 8. Your business has appropriate security measures in place to protect data in transit, received by your business and transferred to another business.

9. Your business has a documented process for processing subject access requests which has been effectively implemented.

10. Your business has measures in place to ensure requests are appropriately recognised, timescales are met and the appropriate information is provided.

11. Your business has appropriately resourced and trained all personnel assigned responsibility for processing subject access requests.

12. Your business has made all personnel aware of their responsibility to support subject access requests and where in the organisation they should direct requests to.

13. The process is monitored and reviewed and, where necessary, additional measures have been implemented to improve compliance.

Consequently I here confirm that KData Clinical S.r.l. fully respects the security measures and the data protection legislation .

Kind regards

Avv. Marco Maglio

Data Privacy Auditor

lapp Member

Piazza Sant'Agostino, 24 - 20123 Milano - tel. +39.02.43510840

fax + 39.02.45075007 e.mail: avvocato@maglio. eu - www.lucernairis.eu

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http://www.lucernairis.eu/

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