DEVELOPMENT, TESTING AND DIFFUSION OF A COMMON SOFTWARE FOR QUALITY CONTROL ON HOME AND LEISURE ACCIDENT (HLA) DATA

Transcription

1 DEVELOPMENT, TESTING AND DIFFUSION OF A COMMON SOFTWARE FOR QUALITY CONTROL ON HOME AND LEISURE ACCIDENT (HLA) DATA Activity Report (EHLASS/ISS Quality Management Manual provided as separart document) Kuratorium für Schutz und Sicherheit (Austrian Institute for Safety and Prevention) - Institut "Sicher Leben" Injury Prevention Programme SI (2000CVG3-311)

2 Sicher Leben Authors Robert Bauer and Mathilde Sector - Institute "Sicher Leben", Vienna Institute "Sicher Leben" Austrian Institute for Home and Leisure Safety Ölzeltgasse 3, A-1031 Wien Tel Fax robert.bauer@sicherleben.at Internet: Co-Authors (alphabetic order) Johansen, Anne Mette T. National Institute of Public Health, Kopenhagen Kiosse, Stellina - Hellenic Society for Social Pediatrics and Health Promotion, Athens Mulder, Saajke Consumer Safety Institute, Amsterdam Nectoux, Marc - SC PSYTEL, Paris Software Development Marc Nectoux - PSYTEL, Paris Funding European Commission, Directorate General for Health and Consumer Protection Austrian Ministry for Education, Science and Culture 2

3 IPP/2000/1070 Quality Control - Error! Style not defined. CONTENTS CONTENTS...3 SUMMARY...5 PROJECT MANAGEMENT...7 PROJECT PARTNERS...9 INTRODUCTION...10 Scientific Bases and Aims...10 METHODS...12 Task Force Work Packages...12 Purpose of Work Package Purpose of Work Package Tools Development...13 Software Testing...13 Recommendations for Next Steps...15 RESULTS...16 General...16 Installation...16 Input Data Format...17 Operation...18 Program Menus (v2.1)...19 The Output...21 APPENDICES...24 Appendix 1: Work Package 1 - Quality Management Manual...24 Austrian Work Package 1 as model (EHLASS Austria)...29 Appendix 2: Work Package 2: Review of Quality Management Software and Manual

4 Sicher Leben Appendix 3. Un programme commun de control de la qualité du codage des données recueillies dans le systeme EHLASS Contexte Principes de développement Contrôle de la conformité et de cohérence des données Les contrôles monovariables Les contrôles logiques Les contrôles de cohérence Contrôle de la richesse informative Le programme développé Application aux données françaises de Utilisations du programme de contrôle commun Appendix 4: Réflexions sur le projet Common software for Quality control (QM) Appendix 5: Contrôles effectués dans le logiciel QC Le logiciel développé Principes des contrôles envisagés Détails des contrôles effectués CONTRÔLES DE CONFORMITÉ : DÉTAILS DES CONTRÔLES LOGIQUES : Description de l Etat Qualité Le listing des erreurs

5 IPP/2000/1070 Quality Control - Error! Style not defined. SUMMARY I.- The purpose of the quality control software (QC-CONTROL) is to assist those performing injury data collection to have access to a software which performs the minimum quality controls in a standardized process. The summary of all assessment results and quality indicators are given in a Quality Statement. This Quality Statement should be produced regularly as a feedback to each data transmission on both national or EU level, in order to assist in quality control and improvement. The QC-Software itself is only one implementation of a recommended set of controls that should be applied to the EHLASS data. Currently, the controls comprise formal, logical and information indicators on record and data set level. Controls of plausibility and representativity are suggested. The recommended controls could also be implemented in existing programs other than this software. The quality control software has been developed to assist injury data centers (NDAs) in gathering and providing high quality injury data. This software would be applicable for any injury database; EHLASS is presented here as an example. Therefore, the quality control principles are based on the 20 EHLASS variables; one can expand the checks to control customized variables. II. As a related Documents a QUALITY MANAGEMENT MANUAL (QM-Manual) for Data Collection for the European Home and Leisure Accident Surveillance System (EHLASS/ISS) was developed. This manual is an integral part of this project and is provided as a separate document. The overall objectives of this Quality Management (QM) approach is to facilitate the improvement of quality, comparability and representativity of the EHLASS data. In general concept Quality Management this is achieved by the standardization of processes and the provision of feedback tools between providers (suppliers) and customers (demanders). The EHLASS/ISS QM Manual should assist those performing injury data collection with common guidelines and tools for all steps of data collection, from the point of contact with the patient or respondent to the upload of the data into the central database. 5

6 Sicher Leben For each of the steps, specific tools for documentation and feedback of quality aspects are recommended (in the final version). The QM-Manual describes a standard process for a minimum quality control of EHLASS data collection in the Member States, in particular for hospital based data collection. The EHLASS/ISS QM-Manual and the QM software tool for systematic quality control of EHLASS/ISS data will be available on the CIRCA website of DG SANCO (for Win95, 98, NT, 2000). Keywords: datat quality control, coding,, data collection, quality manual 6

7 IPP/2000/1070 Quality Control - Error! Style not defined. PROJECT MANAGEMENT Project co-ordination: Robert Bauer, Mathilde Sector Institute "Sicher Leben" - Austrian Institute for Home and Leisure Safety Ölzeltgasse 3, A-1031 Wien Tel / Fax robert.bauer@sicherleben.at / Internet: Partners: DK, FR, GR, NL (see following chapter for details) Revised Timeline: Dec to June 2002 Proposed total budget: EUR Contracted funding: 70 % of total costs Partner Involvement: - Two workshops (all) - Two work packages (all) - Software: engineering and programming (FR) Coding expertise (DK) - Review of results and final reports (all) Proposed task list Step n 1: Existing tools analysis Aim: At first, the various control procedures or programs which are used by the teams in charge of the HLA data collection will be catalogued and reviewed in detail (this should be done on the basis of the national data collection plans provided to DG SANCO). As some teams (e.g. in Denmark, Sweden, Portugal, Greece and Austria) already use some specific control software we will try to extract the common features of these procedures and propose them as core elements of a common control software. Nevertheless, the experience from all EU countries, wherever similar codes and systems are in place, will be taken into account for the development of the proposed software. Thus, on-site trips will take place to assure the practicality and quality of the currently run systems. 7

8 Sicher Leben Step n 2: Wished controls analysis Aim: Establish a list of controls that the group of the actors wishes to be included in the program. In addition to the core elements of step.1, we propose two axes of development: - an axis "conformity to coding system" with regard to the tables of codes established in the coding version V2000. We shall add to it controls of inter-variable coherence and logical controls. A double checking mechanism for coding compatibility will be developed based on relevant current experience (e.g. in Greece). - an axis "information wealth" that takes into account the informative character of the record. This leads to create one "coding quality score" by attributing a score to each observation. When this quality score is lower than a chosen value, the complete observation might be rejected, otherwise the record is included into the database and errors are correcting automatically, if necessary. As a result, a quality report (diagnosis of errors) will be edited for every file that is submitted to the procedure, so as to be able to identify and correct the coding problems. Step n 3: Development of the control software Aim: Development of the control software and diffusable procedure by standard tools. Step n 4: Validation (testing) Aim: Test and validate the program with the project partners. Analyse test protocols, receive feed back from pilot sites and finally, include the necessary modifications into the program. 8

9 IPP/2000/1070 Quality Control - Error! Style not defined. PROJECT PARTNERS Denmark: National Institute of Public Health, Svanemollevej 25, 2100 Copenhagen Tel. (+45) , Fax (+45) (Anne Mette T. Johansen) France: SC PSYTEL, 36, Rue Irene blanc, F Paris Tel. (+33.1) , Fax (331) (Marc Nectoux) Greece: Hellenic Soc. f Social Pediatrics a. Health Promotion, 15, Oceanidon st., Athens , - Tel. (+301) , Fax (301) (Stellina Kiosse) The Netherlands: Consumer Safety Institute, Technical Safety Unit, PO Box , 1070 AD Amsterdam, Netherlands, Tel. (+31) , Fax (+31) (Saajke Mulder) Consulted for additional data acquisition and reports: Germany: Landesinstiut für den öffentliche Gesundheitsdiest (LOEGD), Westerfeldstrasse 35-37, DE Bielefeld - Tel.: + 49/521/ , Fax: +49/521/ (Doris Bardehle, Claus Martin Heyer) European Commission: Directorate-General Health and Consumer Protection Unit G3, Euroforum building, 10 rue Stumper-Office EUFO 3188, L-2557 LUXEMBOURG (Helmut Friza) 9

10 Sicher Leben INTRODUCTION SCIENTIFIC BASES AND AIMS For the moment, each member state (MS) applies its own validation policy for the coding of Home and Leisure Accident (HLA) data collected within the "Injury Prevention Programme" (IPP). It follows that the level of controls is rather different from one MS to another, which in turn reduces the global quality of the common European HLA database. Further, MS controls are mainly monovariate controls of correspondence to codes. Thus, we propose to develop and implement a common software for data quality control. We suggest to distinguish two axes to assess the quality of the data already coded: - An axis "conformity to coding system" with controls of inter-variables coherence and logical controls. - An axis "information wealth" that takes into account e.g. the number of variables coded as "unknown" or with an empty free text field (description of the accident). So each record sent to the European database can be assigned with a quality indicator (QI) that informs about the degree of conformity, coherence and information of the record. Also, the QI gives a measure of overall quality of a specific data set. This instrument can strengthen the credibility of the system and enhance interpretation of results. A quality statement (diagnosis of errors) will be edited for every file so that the national teams can take measures to improve the quality of the data collection. General Objectives to enhance harmonisation of the data collection process for HLA data by providing tools for a standardised documentation and quality control summarised in a QM-Manual Technically, the study resulted: in an easy-to-use software for automatic quality control of EHLASS/ISS data 10

11 IPP/2000/1070 Quality Control - Error! Style not defined. Specific Aims - a manual (checklist) - for the total data collection process - specific tools (recommendations and programmes) - for assessing and reporting data quality (logic, plausibility, information controls, and standardised result tables Products Common QM-Manual for HLA data collection and data quality control, comprising Common software tools for data quality analysis, including a Quality Statement proposal (common quality indicators for each data set) 11

12 Sicher Leben METHODS TASK FORCE WORK PACKAGES PURPOSE OF WORK PACKAGE 1 The main purpose of the project was to develop minimum Quality Management Guidelines (QM-Manual) for injury data collection in order to implement a common software for data quality control. The first step towards this goal was to distinguish the different steps of the quality management process from the point of data collection to the upload of the data into the EUPHIN/HIEMS or EUPHIN /INJURY database. For each of the steps, specific tools for documentation and feedback of quality aspects were recommended. These recommendations and tools were to be integrated in a common software, resulting in a set of data Quality Indicators. The summary of all assessment results and quality indicators would be represented in a Quality Statement for each national data set. The Quality Statement should be an integrated part of each data set delivered to the EU. We provided the partners an example of a quality management (QM) manual that we employ for EHLASS Austria. We asked the partners to critically review the EHLASS QM Manual and to provide feedback regarding national differences in quality management techniques (see Appendix 1: Work Package 1). PURPOSE OF WORK PACKAGE 2 We asked the partners to provide feedback on the draft version of the IPP Quality Control Manual, as well as on the draft QM software which included Quality Statements for Member States. The Quality Statement was to be an integrated part of each data set delivered to the EU. Recommendations for improving areas of low quality (eg. free text structuring, standard training of coding, etc.) were also requested and documented. See Appendix 2: Work Package 2. 12

13 IPP/2000/1070 Quality Control - Error! Style not defined. TOOLS DEVELOPMENT QM Manual: guideline and checklist for the total data collection process For the manual should to offer concise documentation and guidelines a procedural approach according international QM standard (ISO) was taken, allowing for authorisation, feedback and flexible update (see separate EHLASS/ISS QM Manual) Quality Control Software: for assessing and reporting data quality such as logic, plausibility, information controls, and standardised result tables for representativity check. See Appendix 3: Reflexion sur le projet by Marc Nectoux. 27/07/2001 See Appendix 4: Un programme commun de control de la qualité du codage des données recueillies dans le systeme EHLASS. December 2000 for the historical development of the software in coordination with Marc Nectoux, France. SOFTWARE TESTING The software was developed using an artifically constructed data set in order account for all the possible error causes and variation. Four examples (Version V.2000): XXXXXXXXXXXXXX A F1298F4305F1998EN DESCENDANT DU LIT CHUTE SUR DE LA MOQUET- TE ET CHOC CONTRE UN PLACARD G3110R0120Z XXX LA LESSIVEUSE S EST RENVERSEE. BRULURE AVEC DE L EAU CHAUDE C0098C0098A1500CHUTE DANS LES ESCALIERS EN PIERRE DANS L ENTREE DE SA RESIDENCE CHOC/PORTE VITREE 13

14 Sicher Leben The pre-final QC-Software was tested on home and leisure data from the EHLASS hospital in Bordaex Bordeaux, France. The complete pre- and after-test datasets are availble from the aozhors. 14

15 IPP/2000/1070 Quality Control - Error! Style not defined. RECOMMENDATIONS FOR NEXT STEPS Presently, no common control procedure for actively supporting and maintaining minimum requirements in the Member States has been implemented so far. We propose the Manual and Software presented in this report be the basis of a training Session for the Member States on Common Quality and Coding Standards for HLA Data Collection. Provision and training for the Coding Manual and the QM-Manual would improve the consistency of data collection methodology and coding practice between Member States. Training in these measures would improve the quality of the European HLA databases. 15

16 Sicher Leben RESULTS GENERAL The purpose of the quality control software is to assist those performing injury data collection to have access to a software which performs the minimum quality controls in a standardized process. The summary of all assessment results and quality indicators are given in a Quality Statement. This Quality Statement should be produced regularly as a feedback to each data transmission on both national or EU level, in order to assist in quality control and improvement. Please address questions or comments to: Institute SICHER LEBEN Dr. Robert Bauer robert.bauer@sicherleben.at INSTALLATION Installation requirements : Access 1997 (full installation) 1. Open the Zip file 2. Extract the data files in the C: drive, keeping the option Use defined path (which automatically creates a folder «QCdef021112» in the C: drive. 3. Double click on HLA-QC.mdb to start the program 16

17 IPP/2000/1070 Quality Control - Error! Style not defined. INPUT DATA FORMAT The input file must be in HLA V2000 format (version October 2002), ASCII, fixed length and without delimitor records file (see the description format). No. of characters Positions COUNTRY CODE HOSPITAL NUMBER CASE NUMBER SEX OF PATIENT DATE OF BIRTH (YYYYMMDD) DATE OF INJURY (YYYYMMDD) TIME OF INJURY DATE OF ATTENDANCE (YYYYMMDD) TIME OF ATTENDANCE DATE OF DISCHARGE (YYYYMMDD) TREATMENT AND FOLLOW-UP PLACE OF OCCURRENCE MECHANISM OF INJURY ACTIVITY SPORTS TYPE OF INJURY Type Type PART OF THE BODY INJURED Part Part PRODUCT INVOLVED IN THE ACCIDENT PRODUCT CAUSING THE INJURY OTHER PRODUCT ACCIDENT DESCRIPTION Bed-days are calculated as date of discharge minus date of admission. If the date of discharge is the same as date of admission the result is one bed-day Figure 1: HLA record format V2000 (version October 2002) Start the program by clicking on the arrow and under Path of file to be verified type in the file name of the file to be checked. Next, under Path where to put the corrected file specify how you would like the checked file to be named. For example: EHLASS_AT to be checked and call the new file EHLASS_Atchecked. 17

18 Sicher Leben OPERATION 1. Define path for data input file and corrected data ouput file (Figure 2) 2. Define the reporting year by giving the year of attendance (Figure 2) 3. Press Continue to start automatic data quality control (Figure 2) 4. Select an option the view the outputs and results (Figure 2): Summary error statistics (Figure 4 und Figure 5) Log files Corrected data file 5. Options (Figure 2) Review data format requirements Review data dictionary (EHLASS v.2000 codes; Figure 3) Online Documentation 18

19 IPP/2000/1070 Quality Control - Error! Style not defined. PROGRAM MENUS (V2.1) The following screen-shots show the menus currently impemented in the softwarwe v.2.1. Figure 2: QC-Software data input menu 19

20 Sicher Leben Figure 3: QC-Software data dictionary menu Figure 4: QC-Software Q-Statement page 1 Figure 5: QC-Software Q-Statement page 2 20

21 IPP/2000/1070 Quality Control - Error! Style not defined. THE OUTPUT Statistics for quality control (HLA v2000) by the Common Software for Quality Control (v2.1) Input file characteristics File name Oldest attendance Youngest attendance Number of date date records C:\ehlass20\ehlass97\bor0402.v2K Control on the entire file Number of concerned records % /Total Nb of records Duplicated records 0 00,00 Records with missing or non valid value ,00 Excluded records 0 00,00 Controls by variable Missing % Unknown % Other Non valid Variable specified range % Country 00,00 00,00 00,00 0 Sex 00,00 00,00 0 Date of birth 00,00 00,00 0 Date of injury 100,00 00,00 0 Time of injury 100,00 00,00 0 Date of attendance 00,00 00,00 0 Time of attendance 00,00 00,00 0 Date of discharge 00,31 00,00 0 Treatment 00,00 00,16 00,00 0 Place 00,00 00,00 00,00 0 Mechanism 00,00 00,00 00,

22 Sicher Leben Activity 00,00 00,08 00,00 0 Sport 29,21 00,00 00,00 0 Type of injury 1 00,00 00,31 05,48 0 Type of injury 2 00,08 00,08 0 Part of body 1 00,00 00,16 00,00 0 Part of body 2 00,00 00,00 0 Product involved 00,00 16,44 04,62 0 Product causing 00,00 08,14 05,32 0 Other product 99,30 00,00 0 Description 00,00 Average % by variable 12,75 01,49 01,55 00,00 Control between variables Nb of concerned records % / Nb total of records Error of chronology if dates given 0 00,00 Date of discharge given and Trt not=hospitalise 0 00,00 Date of attendance > Date of discharge 0 00,00 Activity not = Sport and code sport given 0 00,00 Activity = Sport and code sport not given ,21 % of records with a logical error at least 05,84 Corrected file characteristics File name Oldest attendance date Youngest attendance date Number of records C:\ehlass20\bor0402cor.txt Error file characteristics Entry file name Number of records in fatal error % of records in fata error 22

23 IPP/2000/1070 Quality Control - Error! Style not defined. C:\ehlass20\ehlass97\bor0402.v2K 0 00,00 Final Scores % Duplicate records 00,00 % Excluded records 00,00 % Records with missing or non valid value 100,00 % Records with logical error at least 05,84 Average % of missing by variable 12,75 Average % of non valid value by variable 00,00 23

24 Sicher Leben APPENDICES APPENDIX 1: WORK PACKAGE 1 - QUALITY MANAGEMENT MANUAL Table of Contents 1 GENERAL DESCRIPTION OF DATA COLLECTION General Information Project Staff Methodology Data Results (optional) DATA COLLECTION Data Collection Plan DATA COLLECTION Staff Training and Support Local Contact Point Data Aggregation National level NATIONAL DATA QUALITY ANALYSIS National Data Quality Analysis EU-LEVEL DATA QUALITY ANALYSIS Factory acceptance test Standard Test Analysis Upload of data Yearly Quality Analysis Statement per country in Data Dictionary

25 IPP/2000/1070 Quality Control - Error! Style not defined. Purpose of Project The main purpose of this project is to develop minimum Quality Management Guidelines (QM-Manual) for injury data collection in order to implement a common software for data quality control. The first step towards this goal is to distinguish the different steps of the quality management process from the point of data collection to the upload of the data into the EUPHIN/HIEMS or EUPHIN /INJURY database (see flow chart below). For each of the steps, specific tools for documentation and feedback of quality aspects are recommended. These recommendations and tools will be provided in a common software, resulting in a set of data Quality Indicators. The summary of all assessment results and quality indicators will be given in a Quality Statement for each national data set. This Quality Statement should be an integrated part of each data set delivered to the EU. We provide an example of a quality management (QM) manual that we employ for EHLASS Austria. Data Collection (Local level) Data Aggregation (National level) Data Analysis (EU-level) Figure 6: Levels of Quality Management in Injury Data Collection 25

26 Sicher Leben Purpose of Work Package The purpose of this Work Package is to design a systematic quality management tool. Therefore we would ask you to Critically review the EHLASS QM Manual Provide feedback regarding national differences in quality management techniques by completing tables 1-4, and provide comments regarding the usefulness of a QM Manual for all Member States 26

27 IPP/2000/1070 Quality Control - Error! Style not defined. QM Manual (Country) Please complete the tables 1-4 as best you can;if unable to complete a portion, please state why. General Description of Data Collection General Information Description Comment Country Name of Datasource Year of Data Collection Responsible Organization Responsible Authority Contact Person Year data collection started Project Staff Description Comment Number of staff full-time Number of staff part-time Methodology Description Comment Setting (data collected in): general hospital accident hospital other (please list) Method (data collected by): face to face interviews mail survey telephone survey Subjects (data collected in-patient from): out-patient Topics (data collected on): home and leisure work school traffic Data Description Comment Data set Number of variables collected Coding EHLASS coding manual year Computing (software) SPSS, Access Excel, other Export File Formats SPSS, Access Excel, other 27

28 Sicher Leben Results (optional) Expected cases in 2000: By kind of treatment Special programs (by extension of questionnaire) Special studies (by extension of data collection) number of out-patients number of in-patients Comment Data Collection Procedure Steps Tool Data Collection Plan Staff Training and Support Local Contact Point Data Aggregation National level National Data Quality Analysis Procedure Steps Tool National Data Quality Analysis EU-level Data Quality Analysis Procedure Steps Tool Factory acceptance test Standard Test Analysis Upload of data Yearly Quality Analysis Statement per country in Data Dictionary Comments (regarding usefulness, format, etc.): 28

29 IPP/2000/1070 Quality Control - Error! Style not defined. AUSTRIAN WORK PACKAGE 1 AS MODEL (EHLASS AUSTRIA) QM Manual AUSTRIA (Country) Data Collection Description General Information Description Appendix Country Austria Name of Datasource EHLASS Austria Year of Data Collection 1999 Responsible Organization Institute Sicher Leben Responsible Authority Ministry of Health Contact Person Robert Bauer (robert.bauer@sicherleben.at) First year of data collection 1996 Project Staff Description Appendix 1 part-time project leader 1 parttime project administrator (1 full time, 4 part-time) Methodology Description Appendix Setting (data collected in): 3 general hospitals (mainly accident dept.): Feldkirch, Linz, Klagenfurt) 1 special accident hospital: Vienna See for details on Austrian hospitals Method (data collected by): Subject (data collected from): Object (data collected on): face to face interviews with injury patients (or representative of patient in case of minors) in- and out patients home and leisure (HLA) accidents (nonlethal, non-intentional, non-occupational, non-traffic) DG SANCO Definition of HLA (see HLA Coding Manual) Data Description Appendix Data set 19 variables accord. to EHLASS data structure 1986 Data Set Description Coding accord. to EHLASS code table (coding manual V.86; modified to national needs Computing (software) SPSS, DB2/2, MS-Access Export File Formats SPSS (*.sav), Excel (*.xls), Access (*.mdb) Coding Manual EHLASS Austria 29

30 Sicher Leben Results (optional) Description Appendix Expected cases By kind of treatment 300 out-patients, 1x treated out-patients in-patients >1x treated in-patients (admitted) Special programs (by extension of questionnaire) Inline skating (150 cases) Cycling (600 cases) Ladders (200 cases) Special studies (by extension of data collection) Data Collection Plan Public tansport (40 cases) Burns and scalds Procedure Steps Tool Data Collection Plan Choice of data collection Publication.. method Sampling plan Publication Hospitals in Austria Hospital Discharge Registry Implementation of sampling Publication Hospitals in Austria Hospital Discharge Registry Hospital Contract Control of sampling Half-Year Quality Analysis Report (see 0) Data Collection Procedure Steps Tool Staff Training and Support Training Training Module Coding Manual Interviewer Manual Staff Feedback Interviewer Monthly Feedback Report Half-year Meeting (see 0) Sampling quotas Local Contact Point Hospital interview Interview coding form Manual Data Coding Interview coding form Aggregation and Transmission of data as a Monthly Package Coding Manual Data Entry Charge Sheet (unique id for each package) 30

31 IPP/2000/1070 Quality Control - Error! Style not defined. Data Aggregration National level Number coding forms with unique identifier Manual control of coding forms for completeness Manual correction when possible Data Entry - standardise to EU Database Format Data Storage Plan Completeness scoring Interviewer Monthly Feedback Report (inc. 0) Data Set and Data Type Definition (as part of Coding Manual) Data Storage Plan (data filed according to 0) National Data Quality Analysis Procedure Steps Tool National Data Quality Analysis EU-level Data Quality Analysis Data check for missing and for double counting of patient i.d. or unique id Data check for conformity and coherence Data check for information wealth and representativity Manual cross-check of activity at time of injury with free text Interviewer Comparison Analysis Yearly Aggregation of quality analysis Instructions and Checklist Software program to check and correct when possible Error / Correction Log Instructions and Checklist Software program to check and correct when possible Error / Correction Log Instructions and Checklist Software program to check and correct when possible Error / Correction Log Instructions and Checklist (e.g. on a 5% sample, twice a year) Half-Year Quality Analysis Report Yearly Quality Analysis Statement Procedure Steps Tool Factory acceptance test Acceptance report to national EHLASS centres Standard Test Analysis Instructions and Checklist Upload of data Yearly Quality Analysis Statement per country in Data Dictionary Data Set and Data Type Definition (as part of Coding Manual) Yearly Quality Analysis Statement 31

32 Sicher Leben APPENDIX 2: WORK PACKAGE 2: REVIEW OF QUALITY MANAGEMENT SOFTWARE AND MANUAL We would like to present you with the draft version of the QM Software, as well as the QM Draft Manual. This work is based on the feedback from the Work Package 1. Please do not hesitate to contact us if you have questions regarding this task. We appreciate your input and this will be instrumental in finalizing both of these project deliverables. 1. QM Software Comments (regarding usefulness, format, etc.): Suggested Edits: 2. QM Draft Manual Comments (regarding usefulness, format, etc.): Suggested Edits: 32