quality control manual d c european l a s...

QUALITY MANAGEMENTMANUAL

EHLASS/ISS DATA COLLECTION

Name / Organisation Date SignatureCreated by: IPP Project 2000/1070 30.06.2002 [email protected] by: N.N. / IPP SecretariateApproved by: H. Friza / EC DG SANCO

R:\IPP\PROJ_2000\QUALITY_CONTROL_1070\report\qm_manual_v0.1.doc 02.04.03

QUALITY CONTROL MANUAL

DATA COLLECTION FOR THEEUROPEAN HOME AND LEISURE ACCIDENT SURVEILLANCE

SYSTEM (EHLASS/ISS)

V0.1 September 2002D R A F T

Injury Prevention ProgrammeSI2.298818 (2000CVG3-311)

Note:

Version V0.1 of this Manual is an integral part of the Injury Prevention Program (IPP)project „Development, testing and diffusion of a common software for quality control“.Currently it is therefore mainly about the documentation of this software.In order to demonstrate the purpose of the Manual in its full scope we tried to at leastreference the main requirements for participation in the European Home and LeisureAccident Surveillance System (EHLASS) or the ISS (Injury Surveillance System).Version V1.0 of this Manual is based on EHLASS V.96 Coding Manual and data setstructure. Recent updates of the Coding Manual and data set structure (to V.2000)have been considered as far as possible.Further updates, finalization, implementation and maintenance of this QM-Manualcould be part of the implementation phase of the project (approval provided).

INTROIssue Nr.: 01 of 2



R:\IPP\PROJ_2000\QUALITY_CONTROL_1070\report\qm_manual_v0.1.doc

CONTENTS

EHLASS / ISS Background

Abbreviations

External Resources and Documents

Procedures

P-1: Reporting and EHLASS data analysis Reference

P-2: Standard Data Quality Control (QC-Software)

P-3: Maitenance and Training of the QM System

P-4a: Transmission and Upload of Data and Meta-Data -central

P-4b: Transmission and Upload of Data and Meta-Data –decentral (disabled)

P-5: Coding and Data Entry

Toolbox

T-1: Data and Data Dictionary Upload Forms

T-2: QC-Software and Manual

T-3: QM System Training Package

T-4: Coding Manual – Master

T-5: Coding Manual – MS Versions

T-6: Reference Reports

T-7: ISS based Auto-reporting Tool

T-8: Data Mining Tools

T-9: Catchment population -- Method and Practice Reference

T-10: Interview Form (EHLASS Questionnaire) - paper

T-11: Interview Form (EHLASS Questionnaire) – electronic

T-12: Data Entry Check Tool





ABOUT THIS MANUAL

1.1 Purpose of the Manual

The overall objectives of this Quality Management (QM) approach is to facilitate theimprovement of quality, comparability and representativity of the EHLASS data. Ingeneral concept Quality Management this is achieved by the standardization of proc-esses and the provision of feedback tools between providers (suppliers) and custom-ers (demanders).The QM Manual should assist those performing injury data collection with commonguidelines and tools for all steps of data collection, from the point of contact with thepatient or respondent to the upload of the data into the central database (Figure 4).For each of the steps, specific tools for documentation and feedback of quality as-pects are recommended (in the final version). The QM-Manual describes a standardprocess for a minimum quality control of EHLASS data collection in the MemberStates, in particular for hospital based data collection.

Central Database

(EU level)

National Database

(Member State level)

Site of Data Collection

(Local level)

Figure 1: Levels and Feedback Loops for Quality Management in the EHLASSData Collection





1.2 Structure of the Manual

1.2.1 Procedures

The general approach in Quality Management (QM) is to split a complex process intodistinct and better defined procedures or modules. The QM Manual reflects this ap-proach by assigning a chapter to few identified routine procedures of the EHLASSdata collection process. These procedures may be applicable on all or only on someof the levels of data transmission. Accordingly they may fall into the respective re-sponsibilities of the Central, National and/or Local Data Administer (CDA, NDA, LDA;the CDA stands for group of respective expert that act on EU level):

Procedure EUCDA

NationalNDA

LocalLDA

1. Reporting and EHLASS data analysis + +

2. Maintenance and Training of the QM System + + +

3. Standard Data Quality Control Tool (QC-Software) + +

4. Data and Data Dictionary Upload + +

5. Coding and Data Entry Tools + + +

Figure 2: Procedures and Responsibilities in Data Collection for the ISS

The delimitation and sequence of these procedure is of course disputable. The tableabove is meant to illustrate the top-down approach in Quality Management and alsoreflects the current and near future availability of respective standards and tools:1. Reporting and EHLASS data analysis: Quality related goals and standards are

developed by experts at EU level and enforced by the CDA. Usually aggregatedstatistics and comparative reports give the first indication on desirable goals andstandards in respect to data quality.

2. Maintenance and Training of the QM System (QMS): Once Quality related goalsand standards are set (and implemented) maintenance of the QMS is crucial inorder to have a living and accepted system. A training session and CD-ROM isbeing developed for this purpose (IPP/2002), comprising the overall QM processand having special emphasis on Coding practice1. A group of NDAs (QM Group)is envisioned to be charge of the QM Maintenance.

3. Standard Data Quality Control Tool (QC-Software): A common standard for Qual-ity Control of the EHLASS data is available and is considered to facilitate har-monization of data quality by regular feedback of „Quality Statements“ between al

1 http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm





levels of data transmission.4. Data and Meta-Data Upload: The main objective of the „Data and Meta Data Up-

load“ procedure is to facilitate in the future a decentral upload by the NDA – aspotentially provided already by the ISS (but currently not operational due to con-flicting coding sets in the ISS and the Coding Manual).

5. Coding and Data Entry Tools: This procedure deals with another crucial step im-portant for data quality - and with some tools already available.

1.2.2 Toolbox

The practical part of this Manual is the „Toolbox“. It is an inventory of already avail-able and prospective examples, reference documents or software tools meant as theactual reference and working document for the NDAs. Most of the tools have beendeveloped in projects of DG SANCO‘s Injury Prevention Program (IPP).2

Each Tool in Toolbox links to a respective procedure or sub-procedure (step) of theQM Manual.

Procedure Step Level Tool Status Tool-boxNo.

Reporting and StatisticalAnalysis

Yearly national report NDA Reference Reports Enabled 6

NDA ISS based Auto-reporting Tool(for NDA adaptation)

In planning 7

ISS Report CDA ISS based Auto-reporting Tool In planning 7

Statistical analysis CDA/NDA/

Data Mining Tools (EHLASScompound indicators)

Enabled 8

Catchment / Reference populationcalculation

NDA Method and Practice Reference Testing 9

Training of the QM System Standard QM and coding training forcentral and decentral use

ALL Standard QM Training Package In progress 3

CDA Coding Manual – Master Enabled 4

NDA Coding Manual – MS Versions Enabled 5Standard Data QualityControl

Standardardized data quality check ALL QC-Software and Q- Statement

Data and Data DictionaryUpload -

A. Central Transmission to CDA by NDA CDA/NDA

Data and Meta-DataTransmission Form

Enabled 1

Standard data quality control andfeedback

CDA QC-Software and Q- Statement Enabled 2

FAT and HIEMS aggregation CDA FAT Protocol Enabled 1a

B. Decentral Standard data quality control by NDA NDA QC-Software and Q- Statement Enabled 2Online upload of ISS data and NDA ISS Manual and online Help Disabled 3

Figure 3: Overview of QM procedures, steps and tools (template, not updated!)

2 http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm





1.3 Maintenance and Update

This Manual will be circulated throughout the Injury Network for input and feedback.After approval by the Network and the Commission Version V.1 and subsequent up-dates will be disseminated by the current network secretariat to the NDAs (and thecurrent version will also be available for download from the DG SANCO CIRCA web-site (see chap. External Documents and Resources)Updates will be authorized according to the following path and will replace the formerversion of the respective procedure:

Name / Organization Date Signature

Created by: CDA on behalf of EHLASS QMGroup of NDAs

Checked by: IPP Secretariat

Approved by: EU Commission





EHLASS / ISS Background

1 Health Monitoring and Injury Indicators

1.1 EHLASS History

Home and Leisure Accident data collection in 2002 takes place in the framework ofthe Injury Prevention Program 1999-2003. The Injury Prevention Program (IPP) ofthe European Commission (EC) follows the European Home and Leisure AccidentSurveillance System (EHLASS). EHLASS was designed more than ten years ago bythe EC to support Member States to collect data about Home and Leisure Accidents– and product related injuries in particular - for themselves. The Injury PreventionProgram was created in 1999 to increase the European added value; and Injury Pre-vention activities will continue under the new Public Health Program (2003-2008).These continued activities of the EC acknowledge the importance of Injury Preven-tion in Europe: “the positive impact on cost reduction, years of life gain and last, butnot least, reduction of burden on European Citizens can expected to be relativelyhigh.”The overall concept and process of EU Health Monitoring, as stated in the HealthMonitoring Program 1997-20023, was based on three pillars:A. Establishment of Community Health Indicators – ECHI (European Community

Health Indicators)B. Development of a Community-wide network for sharing health data - EUPHIN-

HIEMS (Health Information and Exchange Monitoring System)C. Analyses and reporting

ECHIEuropean

CommunityHealth

Indicators

EUPHIN Public Health Indicator Network

EUPHIN-ISSInjury Surveillance System

(EHLASS raw data)

EUPHIN-HIEMSHealth Information and Exchange Monitoring System

...HLA

Home and Leisure Accident (EHLASS)aggregated data

Figure 4: EHLASS Data Collection within EU Health Monitoring

3 europa.eu.int/comm/health/ph_overview/previous_programme/monitoring/monitoring_en.htm





1.2 Developing health indicators and data collection

Also in the new Public Health Program (2003-2008) the European Commission aimsat producing comparable information on health and health-related behavior of thepopulation, on diseases and health systems. „This will be based on European-widecommon agreed indicators with regard their definition, their collection and use.“A first set of European Community Health Indicators (ECHI) was produced andwidely disseminated already by the Health Monitoring Program. The objective by theend of this program is to continue the work on specific indicators in order to completethe European Community Health Indicators list that will serve as a basis for theEuropean health information and knowledge system including their operational defi-nitions. 4

This is true also for Home and Leisure Accidents that are not in the full list of ECHIindicators but listed among the priority issues which many MS public health policiesshare in health promotion and disease prevention, i.e. the areas where national andregional health authorities can be quite effective, outside the health care field.Basically, at the time being no population based indicators for Home and Leisure Ac-cidents are available. However, a well established system of Home and Leisure Ac-cidents data collection (and other injuries in the future) is there for indicator develop-ment.

2 The central EHLASS / ISS DatabaseWithin the Public Health Program 2003-2008 the EHLASS Data Collection willstill feed the Injury Surveillance System(ISS), with the ISS being integrated inthe overall concept and process of EUHealth Monitoring (Figure 4). However,the main goal for the ISS developmentin the Program is• to extend the current ISS data col-

lection (which covers Home and Lei-sure Accidents data only) to all inju-ries

• and to adjust the data collection system for population based indication of injuriesin the ECHI context.

The unique feature of the ISS is the full level of detail that is available (on Home andLeisure Accidents). As the ISS contains raw data, a short full text description of eachaccident and up to three related products gives valuable clues for injury prevention.

4 http://europa.eu.int/comm/health/ph_information/indicators/Indic_data_en.htm





Parallel to the ISS a data-base containing so-called“raw aggregated data” ofEHLASS has existed alreadybefore and is located withinthe Health Information Ex-change and Monitoring Sys-tem (HIEMS) of the EC.Both systems are accessi-ble with password protec-tion via internet; access isgiven by the National DataAdministrators (NDA) of theEHLASS / ISS data collection(see chap. External Docu-ments).

• HIEMS/EHLASS (aggregated data):

https://hiems.euphin.cec.eu.int/hiems/plsql/hiems_package.start_hiems

• ISS/EHLASS (raw data):

https://iss.euphin.cec.eu.int/iss/plsql/start_iss.page_home

Within both systems the termindicator refers to the vari-ables that are contained inthe EHLASS data set (cur-rently based on the V.96 ofthe Coding Manual; seechap. External Documents).As already mentionedEHLASS data is sample dataand – at the time being – notpopulation based. Compari-sons of “Indicators” betweenMember States are thereforeonly possible in a relativeway, e.g. percentage distri-bution of indicators (Figure 5).





Figure 5: In the current EHLASS data comparison of “Indicators” betweenMember States is only possible in a relative way (here: distribution of cases bysex)

ABBREVIATIONSIssue Nr.: 01Page 1 of 1



Name / Organisation Date SignatureCreated by: IPP Project 2000/1070 30.06.2002 [email protected] by: NN / IPP SecretariateApproved by: H. Friza / EC DG SANCO


AbbreviationsDG SANCO The Commission’s Directorate-General of Health and Consumer affairs

EC European Commission

ECHI European Community Health Indicators

EU European Union

EUPHIN European Union Public Health Information Network

EUROHIS Project carried out by WHO-Europe and partners and co-sponsored by EU topresent recommended instruments on HIS items.

FAT Factory Acceptance Test

GHQ General Health Questionnaire

HES Health Examination Survey

HFA WHO’s Health For All

HIEMS Health Information and Exchange between Member States

HIS Health Interview Survey

HLA Home and Leisure Accidents

HMP Health Monitoring Program

ICD International Classification of Diseases

ICHI International Compendium of health Indicators

ICIDH International Classification of Impairments, Disabilities and Handicaps

IDA Interchange between Administrations

ISCO International Standard Classification of Occupations

ISS Injury Surveillance System

MS Member State(s)

NDA National Data Administrator

NUTS Nomenclature of Territorial Units for Statistics

OECD Organization of Economic Cooperation and Development

PYLL Potential Years of Life Lost

QC Quality Contrail

QM Quality Management

SDR Standardized Death Rate

SES Socio-Economic Status

WHO World Health Organization

ABBREVIATIONSIssue Nr.: 01Page 1 of 1





External Resources and Documents

1 DG SANCO Homepage

Figure 6: DG SANCOhttp://europa.eu.int/comm/health/ph_information/indicators/Indic_data_en.htm

2 CIRCA – EHLASS Interest Group and IPP Reports

2.1 GeneralCIRCA is an extranet tool, developed under the European Commission IDA pro-gram, and tuned towards Public Administrations needs.

It enables a given community (e.g. committee, working group, project group etc.)geographically spread across Europe (and beyond) to maintain a private space onthe Internet where they can share information, documents, participate in discussion

EXT RESOURCEIssue Nr.: 01Page 2 of 2




fora and various other functionalities.

Figure 7: EHLASS Interest Grouphttp://forum.europa.eu.int/Members/irc/sanco/ehlass

2.2 Access to Group EHLASS - Injury Prevention IPP/ISS

1. Via DG SANCO G3: [email protected]. Self-Registration

People interested in the CIRCA services may use the Self-Registration mechanism toapply for an account. After registering, they can apply for membership in one or moreInterest Groups. The Self-Registration form can be accessed from the Main CIRCApage. The applicant should follow the following procedure in order to self register:• Click on the link in the CIRCA Main page. The Self Registration form appears.• Provide his/her first name, surname, email address, password, phone number

and postal address. Optionally the applicant can provide his/her certificate (usedfor secure interchange of data), some organizational data, fax number and theURL address of his/her personal web site.





An Email is posted to the email address provided in the application form. By thisemail the applicant is informed about the user name and the transaction number.Additional instructions on how to complete the registration procedure are also in-cluded in the email. The user must login to the CIRCA application within the time pe-riod specified in the email, otherwise he will be deleted. In the first login the user willhave to login using the given username and the password he specified in the selfregistration form. After login the user will be redirected to type the transaction numberand specify his new password.

Figure 8: CIRCA Self Registration

When the self registration procedure is completed, the user has to login to CIRCAusing the new account. After logging in, a list of Interest Groups appears where theuser can apply for membership. By clicking on the icon next to Interest Group name,the user is asked to suggest the Class (access rights) that he/she requests to havein the particular Interest Group.





2.3 ContentsThe Information Resource Centre (IRC) is a WWW-based environment providing on-line-services thatoffers a common virtual space for work-groups and projects, to enable the effectivesharing andutilization of resources to satisfy the needs of Public Administrations across Europe.The IRC (Information Resource Centre) is designed to support the collection, storageand disseminationof information between partners spread across Europe. The IRC environment em-bodies a suite of Servicesand related processes, developed and constantly upgraded, so to meet the increas-ing need for a powerful,flexible, reliable, and user friendly Internet-based environment. These Services andprocesses aim toprovide an integrated environment to end-user in accomplishing their every day work:faster, morereliable, keeping overheads to a minimum under a fully customizable and controlledenvironment.The following summarizes, the portfolio of services provided by the IRC:• Information, for creating, managing and further publishing your own WEB space.• Library, much like the Windows Explorer but more powerful, where you can

place, access, move and delete documents.• Contacts, to create an address book of all the contact persons that are associ-

ated to your tasks.• Directory, that accommodates the user accounts including their privileges to the

various services of your private web space.• Meetings, serving as the board for announcing upcoming meetings, including the

agenda and contact information etc.• Newsgroups, set-up to serve as the fora for exchanging ideas on various topics.• E-mail, to facilitate your E-mail communication without having to launch external

mailers.• Search, to locate any piece of information deposited within the IRC.• Administrative1, facilities for the effective management of your web space.

All those services are supplemented with sophisticated access control functionalities





Figure 9: CIRCA Library





3 SafteyNet

A web-based resource center with close links to the DG SANCO CIRCA website isoperated by ECOSA at www.ecosa.org.





4 EHLASS Databases

4.1 ISS/EHLASS (raw data):

Figure 10: https://iss.euphin.cec.eu.int/iss/plsql/start_iss.page_home





4.2 HIEMS/EHLASS (aggregated data):

Figure 11:https://hiems.euphin.cec.eu.int/hiems/plsql/hiems_package.start_hiems





5 National EHLASS and IPP Reports

Available at• http://forum.europa.eu.int/Members/irc/sanco/ehlass/library• NDAs and Project-Coordinators:

http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm•

6 National Data Administrator (NDAs)

Form : List of participants of IPP coordinators + Network + NDA meeting,5-6 December 2002Country/Participant NameAustriaDr Robert BauerKuratorium für Schutz und Sicherheit - Institut "Sicher Leben" Ölzeltgasse 3A – 1031 WienAustriaTel: +43 1 715 6644 317Fax: +43 1 715 6644 30E-mail: [email protected]

Project leader: 2000/1070+1071+1072; 2001/1091+1116; 2002/203637Network memberISS National Data Administrator (NDA)

BelgiumPieter De MunckAdvisorCabinet of the Minister for Consumer InterestsKunstlaan 7 / Avenue des Arts, 7B-1210 BrusselsTel: +32-2-220 2087Fax: +32-2-220 20 67E-mail: [email protected]

ISS NDA





Country/Participant NameDenmarkMrs. Anne Mette Tranberg JohansenDansk Institut For Klinisk EpidemiologiSvanemollevej 25DK – 2100 CopenhagenDenmarkTel: +45 39 20 77 77Fax: +45 39 27 30 95E-mail: [email protected]

Project leader: 2001/1110ISS NDA

FinlandMr Hannu RintanenSTAKESP.O. Box 220FIN-00531 HelsinkiTel.: +358 9 3967 2456E-mail: [email protected]

ISS NDA

FranceM. Marc NectouxBiosta – Association Biomedicale etStatistique36, rue Irénée BlancF – 75020 ParisFranceTel: +33-1-44-50 26 16Fax: +33-1-42-96-34-97E-mail: [email protected]

Project leader: 1999/1024

GermanyDr Gerhard MurzaInstitute of Public Health North Rhine-Westphalia (LOEGD)Westerfeldstrasse 35-37D-33611 BielefeldGermanyTel: +49 521 8007 236Fax: +49 521 8007 296E-mail: [email protected]

Project leader: 2001/1090ISS NDA CDA





Country/Participant NameGreeceDr Eleni PetridouAthens UniversityDept. of Hygiene and EpidemiologyM. Asias 75EL - 11527 AthensGreeceTels: + 30 210 746 2187 / 210 746 2105Fax: + 30 210 777 3840E-mail: [email protected]

Project leader: 1999/1051; 2000/1064; 2001/1105+1106Network memberISS NDA

IrelandMr Hugh MAGEEDEPARTMENT OF HEALTH AND CHILDRENHawkins HouseIRL-2 DUBLINTel: +353 1 635 43 00Fax: +353 1 635 40 01E-mail: [email protected]

Network memberISS NDA

ItalyDr Gianni TessariAzienda ULSS 18 RovigoViale Tre Martiri, 89I-45100 RovigoItaliaTel: +39 425 393 674Fax: +39 425 394 618E-mail: [email protected]

ISS NDA

LuxembourgDr Yolande WagenerMinistère de l’Education et Ministère de la SantéVilla LouvignyL-2120 LuxembourgLuxembourgTel: +352 478 55 44Fax: +352 46 75 27E-mail: [email protected]

ISS NDANetwork member

Netherlands





Country/Participant NameMs Saakje MulderConsumer Safety InstituteP.O. Box 75169NL – 1070 AD AmsterdamNetherlandsTel: +31 20 511 45 57Fax: +31 20 669 28 31E-mail: [email protected]

Project leader: 2001/1101; 2002/203586+203979+203980ISS NDANetwork member

PortugalDr Baltazar NunesMinistério da SaúdeInstituto Nacionalde Saúde Dr.Ricardo JorgeAv. Padre Cruz,P-1649-016 LisboaPortugalTel: +351 21 751 93 79Fax: +351 21 752 46 31E-mail: [email protected]

Project leader: 2000/1059; 2001/1121ISS NDA

SpainIlma. Sra. María Dolores Flores CerdánInstituto Nacional del ConsumoPríncipe de Vergara, 5428006 MadridEspañaTel: +34 91 431 30 67/; 575 49 30Fax: +34 91 435 94 12E-mail: [email protected]

ISS NDA





Country/Participant NameSwedenMr Curt Lennart SpetzThe Swedish National Board of Health and Welfare,Centre for EpidemiologyRalambsvägen, 3S-10630 StockholmSwedenTel: +46 8 55 55 30 00Fax: +46 8 55 55 33 27E-mail: [email protected]

Project leader: 2002/203499ISS NDA

United KingdomDr. Philip RAINEDepartment of Trade and IndustryRoom 4361 Victoria StreetUK – London SW1H OETUnited KingdomTel: +44 207 215 03 81Fax: +44.207.215.03.57E-mail: [email protected]

Project leader: 2000/1058; 2001/1115; 2002/203361ISS NDANetwork member





7 ISS User Manual

User Manual

EUPHIN Injury Surveillance System (ISS) Developmentand Rollout

Figure 12: ISS User Manual -)

available at (ISS-MAN-001 (Version 1.0, 04-12-2001):CIRCA: http://forum.europa.eu.int/Members/irc/sanco/ehlass/library

8 V2000 Coding Manual

Available atCIRCA: http://forum.europa.eu.int/Members/irc/sanco/ehlass/library





9 EHLASS Coding Manual 96

Available at (in various languages)CIRCA: http://forum.europa.eu.int/Members/irc/sanco/ehlass/library

10 ECHI Report

DDEESSIIGGNN FFOORR AA SSEETT OOFF

EEUURROOPPEEAANN CCOOMMMMUUNNIITTYY

HHEEAALLTTHH IINNDDIICCAATTOORRSS

FINAL REPORT BY THE ECHI PROJECT

Available athttp://europa.eu.int/comm/health/ph_projects/2001/monitoring/monitoring_Project_2001_full_en.htm#8





11 (EHLASS) Research Database on Injuries

at: www.statens-folkesundhedsinstitut.dk/eireda

The establishment of a research database on injury was part of the Danish IPP proj-ect, COCOL, which was finished in November 2001. However, the continuation of thedatabase has been maintained by the Danish IPP secretariat in 2001/2002.The research/analysis entries are primarily based on EHLASS/ISS data

PIssue Nr.: 01Page 1 of 1




Procedures

P-1Issue Nr.: 01Page 1 of 1





1

Valid from: 01.01.02

P-1: Reporting and EHLASS data analysis Reference

1 AimQuality related goals and standards are developed by experts at EU level and en-forced by the CDA. Usually aggregated statistics and comparative reports give thefirst indication on desirable goals and standards in respect to data quality. The aim ofthe procedure „Reporting and EHLASS data analysis“ is therefore to provide an in-ventory of available tools and references that are available, in particular as a result ofEHLASS related IPP projects..

2 Related DocumentsNational EHLASS ReportsExternal Resources and DocumentsToolbox

3 Description

3.1 General

The following table informs about the currently proposed steps and tools and theirstatus of availability.

Procedure Step Level Tool Status No.Reporting andEHLASS dataanalysis

Yearly national report NDA Reference Reports En-abled

6

NDA ISS based Auto-reportingTool (for NDA adaptation)

In plan-ning

7

ISS Report CDA ISS based Auto-reportingTool

In plan-ning

7

EHLASS data analysis CDA/NDA/

Data Mining Tools (EHLA-SS compound indicators)

En-abled

8

Catchment / Referencepopulation calculation

NDA Method and Practice Ref-erence

Testing 9





3.2 Yearly national report

Most yearly national EHLASS reports are in accordance with a minimum commonstandard of contents defined by IREQ 1991. Basically this standard calls for a• one or two dimensional tabulation of all variables collected,• a „preamble“ about the general population data and the national health care sys-

tem and an overview of the general injury situation.See national EHLASS of Spain and Austria, for instance, for examples of an pream-ble and EHLASS result presentationSee IPP 2000 project report COMPREHENSIVE VIEW ON EUROPEAN (HLA)INJURY DATA for an example of an EU data model for the presentation of the na-tional injury situation.

3.3 ISS report (EU-level)

Respective tools might have been developed by some national EHLASS centres(NDAs). A respective tool for the automatic generation of an ISS-based EU-report isin planning for the new Public Health Program.

3.4 EHLASS data analysis

A number of IPP projects have produced special tools (usually software) for EHLASSspecific data analysis(http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm):

Project Title (funded in 1999) OrganizationETABLISSEMENT ET DÉVELOPPEMENT D'OUTILSD'AIDE À LA DÉCISION (SCORE SYNTHÉTIQUE DEDANGEROSITÉ, SYSTÈME D'ALERTEAUTOMATISÉE, ETC.) SUR LES DONNÉES ISSUESDES ACCIDENTS DOMESTIQUES ET DE LOISIRS,DANS LE CADRE DU PROGRAMME "PRÉVENTIONDES BLESSURES"

ASSOCIATION BIOMÉDICALEET STATISTIQUE - BIOSTA

HOME AND LEISURE ACCIDENTS - MICRO ANDMACRO ANALYSIS OF DATA (HLA MIAMA)

INSTITUTE OF PUBLICHEALTH NORTH RHINE-WESTPHALIA (LOEG)

Project Title (funded in 2000) OrganizationPREVENTIVE PRODUCT SAFETY ANALYSIS -HINTS ON RISK MINIMISATION IN PRODUCTDESIGN BY EXPLORATIVE HLA DATA ANALYSIS

KURATORIUM FÜR SCHUTZUND SICHERHEIT (AUSTRIANBOARD FOR SAFETY ANDPREVENTION) / INSTITUTE'SICHER LEBEN'





3.5 Catchment / Reference population calculation

With few exceptions (Spain, Germany, Luxembourg) EHLASS data is (has been)collected in a small number hospitals per country, yielding from 10.000 to 80.000cases per year for the ISS database. So far, national EHLASS data is uploaded with-out any statistical manipulation. As a result the EHLASS data is not populationbased.To address this problem the provision of a reference population for the EHLASShospital data is mandatory from the EHALSS/ISS data collection 2000 onwards. (seeProcedure: Transmission and Upload of Data and Meta-Data – central).However, no specific operationalisation has been provided with this new requirement.So far two possible methods could be identified form EHLASS NDAs that already hadexperience with the estimation of injury rates.1. National estimates (modified capture-recapture method): practiced form the NDA

in NL and AT (see External resources and documents for NDA list).2. Regional injury rates (hospital catchment or service population): pilot project of

NDA in AT.Method 1 is based on the calculation of weights for the EHLASS sample by mappingEHLASS data into a larger representative source (e.g. national hospital dischargeregister).Method 2 is based on the quantification of the service population of an individualhospital by patients area codes). Service population of individual hospitals can thenbe aggregated to gain a „national“ service population for the full EHLASS sample.

In addition, a methodological study is undertaken and survey prototype will be deve l-oped for the comparison of EHLASS hospital and respective household survey data(http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm):

Project Title (funded in 2002 OrganizationA Etablissement d'une Enquête Type sur les Accidentsde la Vie Courante (IPP/HLA) Complémentaire du Re-cueil Hospitalier

Institut de Veille Sanitaire,France






2

P-2: Standard Data Quality Control (QC-Software)

1 AimThe purpose of the quality control software is to assist those performing injury datacollection to have access to a software which performs the minimum quality controlsin a standardized process. The summary of all assessment results and quality indi-cators are given in a Quality Statement. This Quality Statement should be producedregularly as a feedback to each data transmission on both national or EU level, inorder to assist in quality control and improvement.

2 Related DocumentsProcedure „Data and Data Dictionary Upload“Coding Manual V.2000Tool „QC-Software and Manual“

3 Description

3.1 General

The QC-Software itself is only one implementation of a recommended set of controlsthat should be applied to the EHLASS data. Currently, the controls comprise formal,logical and information indicators on record and data set level. Controls of plausibilityand representativity are suggested. The recommended controls could also be imple-mented 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 applicablefor any injury database; EHLASS is presented here as an example. Therefore, thequality control principles are based on the 20 EHLASS variables; one can expand thechecks to control customized variables.





3.2 EHLASS Specific

The software program performs the standard quality controls and can be run with orwithout corrections. Controls for plausibility and representativity are optional. Afterthe control is performed, a quality control statement is produced which includes adescriptive summary of the dataset and a quality control score. This score is gener-ated in order to provide a baseline for quality improvement for each Member State.

Figure 13: Common Software for Quality Control – Start Menu

3.2.1 Stages of Control – EHLASS

The QC-Software can be implemented at all „stages“ of EHLASS data transmission:1. EU Stage: data input into the ISS database from the MS (NDAs)2. National Stage: data input and analysis from the local collection sites.3. Local Stage: collection of dataQuality control requirements are defined by certain standards and these standardsare implemented through controls. In a typical database, one has three levels of con-trol:

3.2.2 Levels of data control - EHLASS

1. Variable Level: single variables (20)





2. Record Level: inter-variable within a single record3. Dataset Level: inter-record

3.2.3 Dimensions of data control - EHLASS

Controls are suggested in several „dimensions“ of data quality (not all dimensions areyet implemented in the software):1. Conformity: formal check of data format and coding2. Wealth of information: missing and unspecific values are assessed3. Coherence: logical control between interdependent variables, mainly dates4. Plausibility: logical control between interdependent variables, e.g. type of injury

and body part (in preparation)5. Representativity: standard EHLASS tables and reference to external sources are

suggested to assess data representativityCriteria are established for performing the controls against the actual value and rec-ommended values are suggested to act as a guide regarding the potential forachieving high quality data.The following tables show the respective controls for EU-level application of QC-Software to a EHLASS V.2000 data set.





3.2.4 EHLASS Quality Controls: EU variable levelDimension Level of Control Name of Control

Wealth of information Var Control 1 Missing Valuescriteria: % missing code or empty free textactual valuerecommended value -error output see error log xxxmeasure / action 1 var remains missing

Wealth of information Var Control 2 Codes "Unknown"criteria: % unknownactual value:recommended value: -error output: see error log xxxmeasure / action 1: var remains unknown

Wealth of information Var Control 3 Codes "Unspecified/Other"criteria: % unspecified / otheractual valuerecommended value -error output see error log xxxmeasure / action 1 var remains unspecified/other

Wealth of information Var Control 4 Nonvalid Formatcriteria: % nonvalid format, # of digits checkactual valuerecommended value 0%error output see error log xxxmeasure / action 1 delete record if:

date of injury is missing or unknownWealth of information Var Control 5 Nonvalid Range Values

criteria: % nonvalid range according to time and date logicactual valuerecommended value 0%error output see error log xxxmeasure / action 1 set var to missing

Wealth of information Var Control 6 Codes Nonexistent Valuescriteria: % codes nonexistent in coding manual 1996actual valuerecommended valueerror outputmeasure / action 1 set var to missing





3.2.5 Quality controls: EU Record levelDimension Level of Control Name of Control

Coherence Rec Control 1 Dates Checkcriteria: % date of injury is after date of attendance (both values

must be valid)actual valuerecommended value 0%error output see error log xxxmeasure / action 1 Delete record if:

Date of injury is equal to or after date of attendanceCoherence Rec Control 2 Treatment and Discharge Date

criteria: % treatment var except treated and admitted (code 5)with a date of discharge

actual valuerecommended value 0%error output see error log xxxmeasure / action 1 set treatment var to admitted (code 5) if:

date of discharge is given but treatment var missingmeasure / action 2 set treatment var and date of discharge var to missing if:

Treatment var is not admitted (code 5)Coherence Rec Control 3 Treatment and Discharge Date

criteria: % treatment var treated and admitted (code 5) without adate of discharge

actual valuerecommended value 0%error output see error log xxxmeasure / action 1 set treatment var and date of discharge var to missing if:

Treatment or date of dischargeCoherence Rec Control 4 Activity and type of sport

criteria: % activity var other than sports (code 5) with a sportscode

actual valuerecommended value 0%error output see error log xxxmeasure / action 1 set activity var and sports var to missing

Coherence Rec Control 5 Activity and type of sportcriteria: % activity var sports (code 5) with a sports codeactual valuerecommended value 100%error output see error log xxxmeasure / action 1 set activity var and sports var to missing

Plausibility Variable Crosstables OptionalType of injury and bodypartActivity and type of sportActivity and place ofoccurrrence





3.2.6 Quality Controls: EU DatasetDimension Level of Control Name of Control

Conformity Dataset Control 1 Multiple Identical Records / double countscriteria: % double or multiple countsactual valuerecommended value 0%error output see error log xxxmeasure / action 1 only one complete record is kept (others deleted) if:

identical identifiers, identical free text, all other variablesidenticalone or more of the identifiers missing or in-complete, identi-cal free text, all other variables identical

3.2.7 Quality Controls: EU Cross-tables (Optional)Dimension Level of Control Name of Control

Representativity Dataset Control 1 Demographic Representativitycriteria: age by sex distribution (choose 5 age categories which

are internationally recognized)actual value see cross table % age by sexrecommended value if possible, compare to cross tables from other Member

Stateserror output see cross table % age by sexmeasure / action 1 if comparison shows large deviations: amend sampling

planRepresentativity Dataset Control 2 Type of injury by sex

criteria: Type of injury by sex distributionactual value see cross table % type of injury by sexrecommended value if possible, compare to cross tables from other Member

Statesmeasure / action 1 if comparison shows large deviations: amend sampling

planrepresentativity Dataset Control 3 Type of treatment by sex

criteria: Type of treatment by sex distributionactual value see cross table % type of treatment by sexrecommended value if possible, compare to other Member Stateserror output see cross table % type of treatment by sexmeasure / action 1 if comparison shows large deviations: amend sampling

planrepresentativity Dataset Control 4 Type of injury by treatment var admitted

criteria: Type of injury by treatment var admitted distributionactual value see cross table % type of injury by treatment var admit-

tedrecommended value if possible, compare to other Member Stateserror output see cross table % type of injury by treatment var admit-

tedmeasure / action 1 if comparison shows large deviations: amend sampling

plan





3.2.8 Quality Control Score (Q-Statement)

The summary of all assessment results and quality indicators are given in a QualityStatement for your national data set. This Quality Statement should be an integratedpart of each data set and may be produced quarterly, yearly in order to assist inquality control and improvement.The following table show a “Q-Statement“ - Statistics for quality control (HLA v2000)produced by the Common Software for Quality Control V2.1 - for a French hospitaldata set.

Input file characteristics

File name Oldest attendance

date

Youngest attendance

date

Number of records

C:\ehlass20\ehlass97\bor0402.v2K 20020430 20020401 1277

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 1277 100,00

Excluded records 0 00,00





Controls by variable

VariableMissing % Unknown % Other specified Non valid 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 00,08 0

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 373 29,21

% 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 20020430 20020401 1277

Error file characteristics

Entry file name Number of records in fatal error % of records in fata error

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






2

P-3: Maitenance and Training of the QM System

1 AimThe implementation of the Quality Control Manual would assist the Member States incomplying with the new DG-SANCO requirements, and greatly enhance the quality ofthe HLA data. As a future aspect, it would also enable DG-SANCO to partly decen-tralize the quality controls prior to aggregation and final acceptance. The nationalteams require training for this task to be performed effectively. Training is necessaryto facilitate standardization of HLA quality controls and coding practices.

2 Related DocumentsCoding Manual V.2000Procedure „Data and Data Dictionary Upload“Tool „QC-Software and Manual“

3 Description

3.1 General

The "Injury Prevention Program" (IPP) is already supporting initiatives to improve thequality of HLA data collection in terms of representativity (population incidences byhospital catchment areas) and coding conformity (V.2000 as common coding man-ual). In addition to the common IPP Coding Manual, a common Quality ManagementManual (QM-Manual) for HLA data collection is being developed (IPP/2000/1070).

However, no common control procedure for actively supporting and maintainingminimum requirements in the Member States has been implemented so far.

We therefore propose a pilot project for the Development of a Training Session forthe Member States on Common Quality and Coding Standards for HLA DataCollection. Provision and training for the Coding Manual and the QM-Manual wouldimprove the consistency of data collection methodology and coding practice betweenMember States. Training in these measures would improve the quality of the Euro-pean HLA databases within EUPHIN HIEMS and EUPHN INJURY.

3.2 EHLASS Specific

Procedural Specifications and Tools in Preparation according to the following taskand

Task and time line





Phase I: Develop the training module month 1-5

- Develop training material: Coding Guide, printed and computerized module, to beincluded in the HLA Coding Manual (currently v2000) which provides guidelinesand examples for consistent interpretation of codes and the Quality Control Man-ual, printed and computerized module

- Input from partners on format and content of training materials, agenda and con-tent of training session

Phase II: Pilot of the training session for use of the Manual and Guide month 5-10

- 2 day simulation training with HLA national partner teams for use of the QualityControl Manual and Coding Guide of HLA data, including tools and materials

- Incorporate feedback from test sites for a finalized version of the training session

Phase III: Dissemination and Maintenance Plan for implementation by DG-SANCOmonth 10-13

- Framework for DG-SANCO for dissemination of the training session to all HLAdata centers

- Maintenance plan for systematic updates of the training session according tochanges in requirements and national needs

Phase IV: Final report month 13-15

- ‘Use of a training session to improve the quality of HLA data ’





Expected results and proposed dissemination / utilization of results

The goal of the project is to improve the capability of Member States to fulfill qualityand comparability requirements of HLA data by:-Development and pilot of a training session: Tools for Common Coding Standardsand Quality Control of HLA Data, in the form of a 2 day workshop for national HLAteams, with interactive computer modules for usage of the Quality Control Manualand Coding Guide Module, implementation within existing tools-The final report ‘Use of a training session to improve the quality of HLA data ’ will beavailable to the IPP network (within the New Health Program) through the IRC of DGSANCO after approval by the EC.

Collaboration with partners from other Member States (Name, address, tele-phone and fax numbers)5

Denmark: National Institute of Public Health, Svanemollevej 23, 2100 Copenhagen –Tel. (+45) 39.20.77.77, Fax (+45) 39.20.80.10 (Bjarne Laursen)

Germany: Landesinstitut für den Oeffentlichen Gesundheitsdienst (loegd), Wester-feldstrasse 35-37, 33611 Bielefeld - Tel. +49/521/8007-216, Fax: +49/521/8007-297(Doris Bardehle)

France: SC PSYTEL, 36, Rue Irenee blanc, F-75020 Paris – Tel. (+33.1)43.79.71.92, Fax (331) 43 64 58 24 (Marc Nectoux).IVS, 36, Saint Maurice, F-94415 – Tel. (+33.1) 41.79.67.00, Fax (331) 41.79.67.67(Hubert Isnard).

Greece: Hellenic Soc. f Social Pediatrics a. Health Promotion, 15, Oceanidon st.,Athens 117 45, - Tel. (+301) 9354.179, Fax (301) 9324.300 (Eleni Petridou)

The Netherlands: Consumer Safety Institute, Epidemiology UnitPO Box 75.169, 1070 AD Amsterdam, Tel. (+31) 20.511.4511, Fax (+31)20.669.2831 (Saakje Mulder)

Italy: EU Projects Dept., Azienda ULSS 18 Rovigo - Tel: (+39) 0425 393674,Fax:+39 0425 393953 (Raffaello Raboni)

5 Attach another sheet of paper if necessary to list these partners

P-4aIssue Nr.: 01Page 2 of 1






P-4a: Transmission and Upload of Data and Meta-Data - central

1 AimThe purpose of the “Transmission and Upload of Data and Meta-Data“ procedure isto provide a standard process and format for data transmission from the MemberStates to the European Commission.

2 Related DocumentsCoding Manual 2000, April 2000ISS User ManualProcedure „Standard Data Quality Control (QC-Software)“Toolbox

3 DescriptionThe Data Transmission and Data Dictionary procedure is a quality control tool whichis disseminated to each Member State to clarify the appropriate format and contentfor transmission of EHLASS data to the Commission (CDA and/or DG SANCO), andfor upload to the ISS database in particular. Forms are provided at the moment forfour items:1. ISS Data Structure2. ISS Meta Data (for national register)3. Catchment Population4. Extended Meta-Data5. Quality statement from Standard QC-Software (Q-Statement)

Items 1.-3. are considered Minimum Requirements for ISS data upload. Eventually allitems should be integrated into one form that can be accessed and uploaded throughthe ISS.





3.1 ISS Data Structure

ISS Data Structure provides for the current data set structure and file format forEHLASS data transmission (see Toolbox T-1 for current structure).Note: The „ISS Data Structure“ is derived from the EHLASS Coding Manual 2000 (see external docu-

ments). The ISS database, however, is currently allowing only for Codes according to EHLASS Cod-

ing Manual V.96. Therefore a decentral upload of V.2000 data is currently not possible.

* The variable is optional and can be left empty

3.2 ISS Meta Data (for national register)

The ISS Meta Data (for nationalregister) provides the currentstructure and contents forEHLASS meta data transmis-sion (see Toolbox T-1 for cur-rent structure).This function is accessible byboth National Data and CentralAdministrators.Note: Currently, the ISS system is

designed in a way that it can hold only

one (sample) record for the National

Register information for each country.

3.3 Catchment Population

ISS Catchment Population Structure provides for the calculation of injury rates fromthe EHLASS sample (hospital) data. (see Toolbox T-1 and T-9 for details).Note: The „ISS Catchment Population“ can currently not be uploaded to the ISS. Calculation of injury

rates from the EHLASS data and „ISS Catchment Population“ has to be performed separately.

Field Number of positions Type of Data

Country code 2 Numeric

Sex 1 Numeric

Age (in 1-year age group) 3 Numeric

Number of catchment population 10 Numeric

3.4 Extended Meta-Data

„Extended Meta –Data“ has been suggested in the Injury Prevention Program (IPP)project „Development, testing and diffusion of a common software for quality control“to comprise the „ISS National Register“ information plus extra data dictionary infor-





mation. It can currently not be uploaded to the ISS. Extended Meta –Data comprisesinformation on1. Extended Data Set Information: equivalent to the ISS National Register but with

additional items and intended for yearly transmission as integral part of data de-livery.

2. Extended Hospital Information: equivalent to the ISS Data Item Register on vari-able Hospital but with additional items for catchment population calculation. Thisinformation is currently requested by the CDA through a separate questionnaire.

3.5 Quality statement from Standard QC-Software (Q-Statement)

The Q-Statement has been suggested in the Injury Prevention Program (IPP) project„Development, testing and diffusion of a common software for quality control“ as anadditional data dictionary information. It can currently not be uploaded to the ISS.See Procedure „Standard Data Quality Control (QC-Software)“ for more details.This following scores are the final results of a standard QC-Software check on a sin-gle hospital data set:

Final Scores







P-4bIssue Nr.: 01Page 2 of 1





P-4b: Transmission and Upload of Data and Meta-Data – decentral (disabled)

1 AimThe purpose of the “Transmission and Upload of Data and Meta-Data decentral“ pro-cedure is to provide a standard process and format for online data upload by theNDAs.

2 Related DocumentsEHLASS V.96 Coding ManualISS Coding Manual 2000ISS User ManualProcedure „Transmission and Upload of Data and Meta-Data – central“Procedure „Standard Data Quality Control (QC-Software)“Toolbox

3 Description

3.1 General

The Data Transmission and Data Dictionary procedure is a quality control tool whichis disseminated to each Member State to clarify the appropriate format and contentfor decentral online upload of EHLASS data to the ISS database.Only items 1 and 2 are available for online ISS upload from the forms 1.-3. currentlydefining requirements for EHLASS data and meta data provision.1. ISS Data Structure2. ISS Meta Data (for national register)3. Catchment Population4. Extended Meta –Data5. Quality statement from Standard QC-Software (Q-Statement)


Note: The „ISS Data Structure“ is derived from the EHLASS Coding Manual 2000(see external documents). The ISS database, however, is currently allowing only forCodes according to EHLASS Coding Manual V.96. Therefore a decentral upload ofV.2000 data is currently not possible.

P-4bIssue Nr.: 01Page 3 of 2




3.3 Upload/Remove Raw Data (Ref: IN_5.1)

These functions are only available forthe National Data and Central Adminis-trators. This option enables the NationalData Administrator to manage andmaintain the Raw Data sets that arecontained and uploaded into the sys-tem.The National Data Administrator canupload (create) Raw Data for a givenyear. The user profile of the NationalData Administrator defines which data-set(s) this user is authorized to manageand will be prompted only for these datasets.Warning: The ISS system does not contain any content validation function. The National Data Ad-

ministrator should understand that local validation of the data (use of codes for the different fields) is

needed prior to upload (see T-2 „QC-Software and Manual).

Please make sure the codes used in the upload files are consistent with the codesgiven in the ISS data dictionary (a code '1' is not the same as a code '01'!.Wrong data that have been uploaded accidentally can only be corrected by replacingthe entire data set for the country/year combination (Update action).


This function is accessible by both Na-tional Data and Central Administrators.The National Data Administrator canaccess the National Register Formpage by selecting the National Regis-ter option on Screen IN_5. If a NationalRegister entry for the specified countryexists, then the data is displayed inscreen IN_5.2.2, else the screen isdisplayed empty.Note: Currently, the ISS system is designed in

a way that it can hold only one (sample) record

for the National Register information for each country.

The national register information is independent of the other tables in the Data Dic-tionary and contains only general descriptive information of the national register.Remark: Currently, the ISS system is designed in a way that it can hold only one (sample) record for

The National Register information for each country.

.






P-5: Coding and Data Entry

1 AimThis procedure is still in preparation. It will aim at minimizing data entry errors by therecommendation and provision of Data Entry Check Tool and electronic versions ofthe coding manual.

2 Related DocumentsEHLASS V.96 Coding ManualISS Coding Manual 2000Toolbox

3 Description

3.1 General

The following steps and tools will be provided:Procedure Step Level Tool Status No.Coding and DataEntry Tools

Interview (point of contact) NDA /LDA

Interview Form (EHLASSQuestionnaire) - paper

En-abled

10

NDA Coding Manual – MS Ver-sions

En-abled

5

NDA /LDA

Interview Form (EHLASSQuestionnaire) – electronic

En-abled

11

CDA Coding Manual – Master -electronic

En-abled

4a

NDA Coding Manual – MS Ver-sions - electronic

En-abled

5a

Data entry check NDA /LDA

Data Entry Check Tool En-abled

12

3.2 Interview (point of contact)

Coding tools may have been developed and applied at some EHLASS data centres(NDA). “Common“ tools have been developed as part of the following IPP projects(http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm):





3.2.1 Interview Form (EHLASS Questionnaire) – paper:

HLA DATA COLLECTION KURATORIUM FÜR SCHUTZ UNDSICHERHEIT / INSTITUT SICHERLEBEN

3.2.2 Interview Form (EHLASS Questionnaire) – electronicContact NDAs for respective experience or tools (see External Resources andDocuments)

3.2.3 Coding Manual – MS VersionsContact CIRCA library for most current version (see External Resources and Docu-ments)

3.2.4 Coding Manual – Master – electronicContact CIRCA library for most current version (see External Resources and Docu-ments)

3.2.5 Coding Manual – MS Versions – electronicContact NDAs for respective experience or tools (see External Resources andDocuments)

3.3 Data entry check

3.3.1 Data Entry Check ToolContact NDAs for respective experience or tools (see External Resources andDocuments)A “common“ tool has been developed as part of the following IPP project(http://europa.eu.int/comm/health/ph_projects/injury_Project_en.htm):Project Title (funded in 2001) OrganizationDATA TRANSFORMATION FOR EUPHININJURY - INJURY HOME AND LEISUREACCIDENTS (IHLA) DATABASE FOR THEYEARS 2000 AND 2001 (TRANSINJURY)

INSTITUTE OF PUBLIC HEALTH NORTH

RHINE-WESTPHALIA (LOEG)

ToolboxIssue Nr.: 01Page 2 of 1





ToolboxProcedure Step Level Tool Status No.Reporting data analy-sis

Yearly national report NDA Reference Reports Enabled 6


In plan-ning

7


In plan-ning

7


Data Mining Tools (EHLASScompound indicators)

Enabled 8

Catchment / Reference popu-lation calculation

NDA Method and Practice Refer-ence

Testing 9

Training of the QMSystem

Standard QM and codingtraining (central / decentral)

ALL Standard QM Training Pack-age

In prog-ress

3

CDA Coding Manual – Master Enabled 4NDA Coding Manual – MS Ver-

sionsEnabled 5

Standard Data QualityControl

Standardized data qualitycheck

ALL QC-Software and Q- State-ment

Enabled

Data and Data Dic-tionary Upload

A. Central Transmission to CDA by NDA CDA/NDA

Data and Meta-Data Trans-mission Form

Enabled 1

Standard data quality controland feedback

CDA QC-Software and Q- State-ment

Enabled 2

FAT and HIEMS aggregation CDA FAT Protocol Enabled 1aB. Decentral Standard data quality control

by NDANDA QC-Software and Q- State-

mentEnabled 2

Online upload of ISS data andmetadata

NDA ISS Manual and online Help Disabled 3

Provision of extended meta-data

NDA Data and Meta-Data Trans-mission Form

Disabled 1

FAT / and HIEMS aggregation NDA FAT Protocol Disabled 1aCoding and DataEntry



Enabled 10


Enabled 5

NDA /LDA


Enabled 11

CDA Master Coding Manual –Master - electronic

Enabled 4a


Enabled 5a


Data Entry Check Tool Enabled 12






T-1: Data and Data Dictionary Upload FormsThis tool will be in the context of the following procedure (see this procedure foravailable tools):Procedure Step Level Tool Status No.Data and Data Dic-tionary Upload

A. Central Transmission to CDA byNDA

CDA/NDA

Data and Meta-DataTransmission Form

En-abled

1

Standard data quality con-trol and feedback

CDA QC-Software and Q-Statement

En-abled

2

FAT and HIEMS aggrega-tion

CDA FAT Protocol En-abled

1a

B. Decentral Standard data quality con-trol by NDA

NDA QC-Software and Q-Statement

En-abled

2

Online upload of ISS dataand metadata

NDA ISS Manual and onlineHelp

Dis-abled

3

Provision of extendedmeta-data

NDA Data and Meta-DataTransmission Form

Dis-abled

1

FAT / and HIEMS aggre-gation

NDA FAT Protocol Dis-abled

1a

1 Description – generalCentral: The purpose of this tool is to support the “Transmission and Upload of Dataand Meta-Data“ procedure which provides a standard process and format for datatransmission from the Member States to the European Commission.Decentral (currently disabled!): The purpose of The purpose of this tool is to sup-port the “Transmission and Upload of Data and Meta-Data“ procedure is to provide astandard process and format for online data upload by the NDAs.

2 Description – Central UploadThe Data Transmission and Data Dictionary procedure is a quality control tool whichis disseminated to each Member State to clarify the appropriate format and contentfor transmission of EHLASS data to the Commission (CDA and/or DG SANCO), andfor upload to the ISS database in particular. Forms are provided at the moment forfour items:1. ISS Data Structure2. ISS Meta Data (for national register)3. Catchment Population4. Extended Meta –Data5. Quality statement from Standard QC-Software (Q-Statement)

T-1Issue Nr.: 01Page 2 of 2




Items 1.-3. are considered Minimum Requirements for ISS data upload. Eventually allitems should be integrated into one form that can be accessed and uploaded throughthe ISS.


Note: The „ISS Data Structure“ is derived from the EHLASS Coding Manual 2000 (see external docu-



Field Number of positions6 Type of Data 7

Country code 2 TextHospital number 6 TextCase number 10 TextSex of patient 1 TextDate of Birth (yyyymmdd) 8 MUST be left emptyDate of injury (yyyymmdd) * 8 TextTime of injury 2 TextDate of attendance (yyyymmdd) * 8 TextTime of attendance 2 TextDate of discharge (yyyymmdd) 8 TextTreatment and follow-up 1 TextPlace of occurrence 2 TextMechanism of injury 2 TextActivity at time of accident 2 TextSports 3 TextType of injury 1 2 TextType of injury 2 2 TextPart of the body injured 1 2 TextPart of the body injured 2 2 TextProduct involved in the accident 5 TextProduct causing the injury 5 TextOther product 5 TextAccident description 120 TextAge of patient8 3 NumericNumber of hospitalized days9 2 Numeric

* The variable is optional and can be left empty

6 Preferred File Format: ASCII (plain text) undelimited or CSV (comma separated)7 As most codes ask for leading zeros (e.g. 01, 02) text or character is recommended as general data type8 Age of patient is derived from the date of birth9 Number of hospitalized days derived from date of discharge






Note: Currently, the ISS system is designed in a way that it can hold only one (sample) record for the

National Register information for each country.

Country ATAT 1

Register nameDate creation 29/11/2002Date update 19/02/2003

Purpose

Collection method

hospital based; Data are collected at thea&e units by specially trained interviewerswith the injury patients. Oral interviews bspecially trained interviewers with injurypatients at the a&e dept.,data arecollected at general a&e units; 4 hospitals

Collection methoddescription

Volume observation

Volume variables

General code information

Operation Create

Execute

Figure 14: ISS-online national register information form

This function is accessible by both National Data and Central Administrators. TheNational Data Administrator can access the National Register Form page by select-ing the National Register option on Screen IN_5. If a National Register entry for thespecified country exists, then the data is displayed in screen IN_5.2.2, else thescreen is displayed empty.





The national register informationis independent of the other ta-bles in the Data Dictionary andcontains only general descrip-tive information of the nationalregister. The National Data Ad-ministrator can access andmanage (create, update, delete)only the National Register entryof the country for which he/sheis responsible.Remark: Currently, the ISSsystem is designed in a waythat it can hold only one (sam-ple) record for the National Register information for each country.

The Central Administrator can manage any National Register entry. The NationalRegister Form contains the following non-editable fields:Country.

Displays the country for which the National Data Administrator is responsible. For theCentral Administrator, the selected country is displayed.Date creation.

Displays the creation date of the National Register entry. This field may be empty ifno information has been entered for this country.Date update.

Displays the last modification date of the National Register entry. This field may beempty if no update has been performed on the initial information entered for thiscountry.In order to create or update a National Register entry, the National Data/Central Ad-ministrator user can edit and should enter at least one of the following fields:Register name.

The National Data Administrator has to enter the name of the Register in the RegisterName text box (Mandatory).Purpose.

In this field, a description of the purpose and the contents (in broad terms) of the na-tional register could be entered. The text can be entered directly using the keyboardor by copying it from a text editor. The National Data Administrator is not required tofill this text area, as it is optional.





Collection method

This box corresponds to the code of data collection method used to populate theregister. The user can enter a numeric value (Optional).Collection method description.

A description of the data collection method used to populate the register. The textcan be entered directly using the keyboard or by copying it from a text editor. Entry ofthis field is Optional.Volume observation

This box corresponds to the number of observations in the register. This value is op-tional and should be numeric.Volume variables

This box corresponds to the number of variables in the register. This value is optionaland should be numeric.

2.3 Catchment Population

Note: The „ISS Catchment Population“ can currently not be uploaded to the ISS. Calculation of injury

rates from the EHLASS data and „ISS Catchment Population“ has to be performed separately.

Field Number of positions Type of Data

Country code 2 Numeric

Sex 1 Numeric

Age (in 1-year age group) 3 Numeric

Number of catchment population 10 Numeric

2.4 Extended Meta –Data

Note: The following table of „Extended Meta –Data“ has been suggested in the Injury Prevention Pro-

gram (IPP) project „Development, testing and diffusion of a common software for quality control“ to

comprise the „ISS National Register“ information plus extra data dictionary information. It can currently

not be uploaded to the ISS.

Extended Meta –Data comprises information on3. Extended Data Set Information: equivalent to the ISS National Register but with

additional items and intended for yearly transmission as integral part of data de-livery.

4. Extended Hospital Information: equivalent to the ISS Data Item Register on vari-able Hospital but with additional items for catchment population calculation. Thisinformation is currently requested by the CDA through a separate questionnaire.





1. Extended Data Set Information

General Information Description Comment

Country

Name of Datasource

Year of Data Collection

Responsible Organization

Responsible Authority

Year data collection started

Contact Person

Methodology Description NDA CDA

Setting (data collected in) General hospital

accident hospital

emergency department

other ______________________ (please list)

Method (data collected by): face to face interviews

mail survey

telephone survey


Subjects (data collected from): in-patient

out-patient

emergency department patients

Topics (data collected on): home and leisure


Data Description

Data set Number of variables collected ______

Coding EHLASS coding manual 1986

EHLASS coding manual 1996

EHLASS/ISS coding manual 2000

with additional national coding

Computing (software) SPSS

Access

Excel


Data Export ASCII format (undelimited)





2. HOSPITAL QUESTIONNAIRE

Would you please provide us with the following information regarding the characteristics of the hospi-

tals that took part in the EHLASS study for the year 2001. Please note that for each participant hospi-

tal a questionnaire for the requested year must be completed.

1. Please describe the hospital location (name and size of the city)

…....…………......…………........................................................................................

2. What type of hospital is it (general, pediatric, etc.) ?

…....…………......…………........................................................................................

3. Is it public or private ? if other, please specify

…....…………......…………........................................................................................

4. What is the size of the hospital (number of beds)

…....…………......…………........................................................................................

5. What is the approximate No. of persons covered by the hospital (catchment population)?

…....…………......…………........................................................................................

6. Does the patient have to pay for the medical care provided? If yes, please specify

…....…………......…………........................................................................................

7. Additional comments

…....…………......…………........................................................................................

8. Responsible authority for the information provided

…....…………......…………........................................................................................

Please return to:

Claus-Martin Heyer

Institute of Public Health

North Rhine-Westphalia Westerfeldstr. 35 – 37

33611 Bielefeld

Germany





2.5 Quality statement from Standard QC-Software (Q-Statement)

Note: The Q-Statement has been suggested in the Injury Prevention Program (IPP) project „Develop-

ment, testing and diffusion of a common software for quality control“ as an additional data dictionary

information. It can currently not be uploaded to the ISS. See Procedure „Standard Data Quality Con-

trol (QC-Software)“ for more details.

This following scores are the results of a Standard QC-Software check on a singlehospital data set:

Final Scores











3 Description – decentral UploadOnly items 1 and 2 are available for online ISS upload from the forms 1.-3. currentlydefining requirements for EHLASS data and meta data provision.6. ISS Data Structure7. ISS Meta Data (for national register)8. Catchment Population9. Extended Meta –Data10. Quality statement from Standard QC-Software (Q-Statement)


Note: The „ISS Data Structure“ is derived from the EHLASS Coding Manual 2000 (see external docu-



3.2 Upload/Remove Raw Data (Ref: IN_5.1)

These functions are only available forthe National Data and Central Ad-ministrators. This option enables theNational Data Administrator to man-age and maintain the Raw Data setsthat are contained and uploaded intothe system. The Upload/RemoveRaw Data screen (screen IN_5.1)offers the user the following function-ality:• CreationThe National Data Administrator canupload (create) Raw Data for a givenyear. The user profile of the National Data Administrator defines which data-set(s)this user is authorized to manage and will be prompted only for these datasets. TheUploaded data will be processed during the following night; this processing includessyntax control, database-update, indicator (multidimensional DB) recalculation andthe creation of a HIEMS file.• UpdateThe National Data Administrator can update Raw Data for a given year. If the Na-tional Data Administrator attempts to create data that has been previously loaded, amessage is displayed asking the user to confirm the replacement of the data for thegiven data set/year. The user profile of the National Data Administrator defines which





data-set(s) this user is authorized tomanage and will be prompted only forthese datasets.• DeleteThe authorized National Data Admin-istrator specifies the country and theyear of the dataset that has to be de-leted.

Warning: The ISS system does notcontain any content validation func-tion. The National Data Administratorshould understand that local validationof the data (use of codes for the different fields) is needed prior to upload.

Please make sure the codes used in the upload files are consistent with the codesgiven in the ISS data dictionary (a code '1' is not the same as a code '01'!.Wrong data that have been uploaded accidentally can only be corrected by replacingthe entire data set for the country/year combination (Update action).Upon filling up the requested fields described above for the upload function andclicking the Execute button, a result screen shown in screen OUT_5.1 will be dis-played. After successful input, the user is informed that the Raw Dataset file hasbeen accepted. The data in the upload file will be stored into the Raw data tablesduring an overnight process.Remark: The National Data Administrator can query these upload tables- just afterthe upload- using the Free Query tool. The data are processed and copied to theRaw Data tables during an overnight Just after the upload by the National Data Ad-ministrator, the uploaded records are stored in a temporary table (IHLA_UPL) onthe ISS database.The process. Verification of the data via the standard Raw Data Query function or theIndicator section is only possible on the day after upload.There are some cases where the upload file can be rejected, these could be:• The number of file records is not equal to the number National Data Administrator

entered into the Number of records text box. In this case an error message isproduced that informs the user about the error that occurred ('Wrong number ofrecords, upload rejected'), and an action message that prompts user to correctand resubmit the file.

• If Raw Data has already been uploaded for a given year and the National DataAdministrator tries to create data for the same year, then the file will be rejected.In this case, an error message is displayed to indicate the error occurred ('Dataalready uploaded for this reporting year, creation rejected'), and an action mes-sage that prompts user to resubmit the file in an upload action.





• If the file contains invalid data then an error message to clarify the error that oc-curred and an action message that prompts the user to correct and resubmit thefile. The following situations can occur:- Alphanumeric data found in numeric fields: the file should be corrected beforeupload.- Country field does not match with the input given in the screen IN_5.1

The Update and Delete operations on the Raw Data are handled in a similar way. Ifthe National Data/Central Administrator user tries to update a specific Raw Datasetthen a status message is produced to indicate that the update operation was suc-cessful.If the National Data/Central Administrator user tries to delete a specific Raw Datasetthat does not exist, then an error message is displayed to indicate the error occurredand an action message that prompts user to choose the right operation.Remark: The 'Delete' operation does not immediately remove data from the Raw da-tabase, but the data of the selected country/year combination is marked as 'to bedeleted'. The removal of the data is equally executed during the overnight process.






Note: Currently, the ISS system is designed in a way that it can hold only one (sample) record for the

National Register information for each country.

Country ATAT 1

Register nameDate creation 29/11/2002Date update 19/02/2003

Purpose

Collection method

hospital based; Data are collected at thea&e units by specially trained interviewerswith the injury patients. Oral interviews bspecially trained interviewers with injurypatients at the a&e dept.,data arecollected at general a&e units; 4 hospitals

Collection methoddescription

Volume observation

Volume variables

General code information

Operation Create

Execute

Figure 15: ISS-online national register information form

This function is accessible by both National Data and Central Administrators. TheNational Data Administrator can access the National Register Form page by select-ing the National Register option on Screen IN_5. If a National Register entry for thespecified country exists, then the data is displayed in screen IN_5.2.2, else thescreen is displayed empty.





The national register informationis independent of the other ta-bles in the Data Dictionary andcontains only general descrip-tive information of the nationalregister. The National Data Ad-ministrator can access andmanage (create, update, delete)only the National Register entryof the country for which he/sheis responsible.Remark: Currently, the ISSsystem is designed in a waythat it can hold only one (sam-ple) record for the National Register information for each country.

The Central Administrator can manage any National Register entry. The NationalRegister Form contains the following non-editable fields:Country.

Displays the country for which the National Data Administrator is responsible. For theCentral Administrator, the selected country is displayed.Date creation.

Displays the creation date of the National Register entry. This field may be empty ifno information has been entered for this country.Date update.

Displays the last modification date of the National Register entry. This field may beempty if no update has been performed on the initial information entered for thiscountry.In order to create or update a National Register entry, the National Data/Central Ad-ministrator user can edit and should enter at least one of the following fields:Register name.

The National Data Administrator has to enter the name of the Register in the RegisterName text box (Mandatory).Purpose.

In this field, a description of the purpose and the contents (in broad terms) of the na-tional register could be entered. The text can be entered directly using the keyboardor by copying it from a text editor. The National Data Administrator is not required tofill this text area, as it is optional.





Collection method

This box corresponds to the code of data collection method used to populate theregister. The user can enter a numeric value (Optional).Collection method description.

A description of the data collection method used to populate the register. The textcan be entered directly using the keyboard or by copying it from a text editor. Entry ofthis field is Optional.Volume observation

This box corresponds to the number of observations in the register. This value is op-tional and should be numeric.Volume variables

This box corresponds to the number of variables in the register. This value is optionaland should be numeric.






T-2: QC-Software and ManualThis tool will be in the context of the following procedure (see this procedure foravailable tools):Procedure Step Level Tool Status No.Training of the QMSystem


ALL Standard QM TrainingPackage

In prog-ress

3

CDA Coding Manual – Master En-abled

4


En-abled

5

CONTENTS

1 Introduction ................................................................................................................. 2

2 Related Documents................................................................................................... 2

3 Installation.................................................................................................................... 2

4 Data Format and Start of Program......................................................................... 3

5 Le logiciel développé ................................................................................................ 6

6 Principes des contrôles envisagés ....................................................................... 6

7 Détails des contrôles effectués.............................................................................. 7

8 Le listing des erreurs ..............................................................................................13

9 Fichier test..................................................................................................................13





1 IntroductionKuratorium für Schutz und Sicherheit (Austrian Board for Safety and Prevention) -INSTITUTE “SICHER LEBEN” was awarded funding for ‘Development, testing anddiffusion of a common software for quality control on Home and Leisure Accident(HLA) data Project’ by the Injury Prevention Program of the European Commission in2000. The goal of the project was to produce an HLA data quality control softwarepackage for use by the Member States and the Commission.

Please address ques-tions or comments to:Institute SICHER LEBENProject Leader:Dr. Robert [email protected]

The purpose of the qual-ity control software is toassist those performinginjury data collection tohave access to a soft-ware which performs theminimum quality controlsin a standardized proc-ess. The summary of all assessment results and quality indicators are given in aQuality Statement. This Quality Statement should be produced regularly as a feed-back to each data transmission on both national or EU level, in order to assist inquality control and improvement.

2 Related DocumentsProcedure „Standard Data Quality Control Tool (QC-Software)“Coding Manual V.2000

3 InstallationInstallation requirements : Access 19971. Open the Zip file2. Extract the data files in the C: drive, keeping the option ‘Use defined path’ (which

automatically creates a folder «def021112 » in the C: drive.3. Double click on ‘HLA-QC.mdb’ to start the program





4 Data Format and Start of ProgramThe input file must be in HLA V2000 format (version October 2002), ASCII, fixedlength and without delimitor records file (see the description format).

No. of chara c-ters Positions

COUNTRY CODE 2 1-2HOSPITAL NUMBER 6 3-8CASE NUMBER 10 9-18SEX OF PATIENT 1 19-19DATE OF BIRTH (YYYYMMDD) 8 20-27DATE OF INJURY (YYYYMMDD) 8 28-35TIME OF INJURY 2 36-37DATE OF ATTENDANCE (YYYYMMDD) 8 38-45TIME OF ATTENDANCE 2 46-47DATE OF DISCHARGE (YYYYMMDD) 8 48-55TREATMENT AND FOLLOW-UP 1 56-56PLACE OF OCCURRENCE 2 57-58MECHANISM OF INJURY 2 59-60ACTIVITY 2 61-62SPORTS 3 63-65TYPE OF INJURY Type 1 2 66-67 Type 2 2 68-69PART OF THE BODY INJURED Part 1 2 70-71 Part 2 2 72-73PRODUCT INVOLVED IN THE ACCIDENT 5 74-78PRODUCT CAUSING THE INJURY 5 79-83OTHER PRODUCT 5 84-88ACCIDENT DESCRIPTION 120 89-208

Bed-days are calculated as date of discharge minus date ofadmission. If the date of discharge is the same as date ofadmission the result is one bed-day

Figure 16: HLA record format V2000 (version October 2002)

Start the program by clicking on the arrow and under ‘Path of file to be verified’ typein the file name of the file to be checked. Next, under ‘Path where to put the cor-rected 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.





Figure 17: QC-Software data input menu

Figure 18: QC-Software data dictionary menu





Figure 19: QC-Software „Q-Statement“ page 1

Figure 20: QC-Software „Q-Statement“ page 2





5 Le logiciel développé10

Nous avons développé un programme de contrôle des données HLA (Home and Lei-sure Accidents) V2000, avant leur versement dans la base européenne ISS (InjurySurveillance System) des données non agrégées. Ce programme :

• édite les messages d’erreur des enregistrements contenant au moins une erreuret l’enregistrement lui-même

• écrit le fichier corrigé après les actions de correction des erreurs• édite un Etat Qualité

Fichier EHLASS V2000 à contrôler (format ASCII, de longueur fixe, sans délimiteur)

Procédure Quality Control

Edition d’un listing Erreur Ecriture du fichier corrigé Edition d’un EtatQualité

Liste des records en erreur Fichier V2000 après Tableaux caractérisant + messages d’erreur correction des erreurs la qualité du fichier de

données

Ce programme effectue les contrôles conformément aux instructions du manuel decodage V2000 (october 2002), avant le passage des données dans le format ISS.Ce logiciel fonctionne dans un environnement matériel et logiciel standard de typeWindows 95 et + en utilisant l’outil de gestion de base de données MicrosoftACCESS 97.

6 Principes des contrôles envisagés- On contrôle un fichier en entrée (nom de fichier à passer en paramètre), constituéd’enregistrements HLA au format V2000 (format ASCII, de longueur fixe, sans délim-iteur), puis on réécrit un fichier corrigé (nom de fichier à passer en paramètre) ensortie (format ASCII, de longueur fixe, sans délimiteur), en éditant un listing des rec-ords en erreur et un Etat Qualité.- Au niveau européen, il n’y a pas de contrôle sur les variables « Hospital Number »et « Case Number » de la V2000.

10 Marc Nectoux, Paris, le 6 novembre 2002





- Les seules variables obligatoires au niveau européen sont : « Country » et « Dateof attendance ». Si cette information de base est absente ou non valide, il y a exclu-sion de l’enregistrement. On présélectionne une année d’admission (Year of atten-dance à passer en paramètre) au lancement de la procédure de contrôle.- Les contrôles de conformité : pour chaque variable de code, le logiciel contrôle quele code saisi fait bien partie de la table des codes valides. Sinon, il émet un messaged’erreur. De même pour les dates, le logiciel contrôle que les dates saisies sont sousune forme valide.- Les contrôles logiques : le logiciel contrôle par exemple que les dates saisies sontdans une chronologie logique (Date of birth < or = Date of injury < or = Date of atten-dance < or= Date of discharge).- Les contrôles de plausibilité : Nous avons recensé six contrôles possibles de cetype : Activity x Free text, Activity x Type of injury, Type of injury x Body part, Activityx Product code, Activity x Sport, Activity x Place of occurrence. En l’absence d’unconsensus et d’une définition précise sur ce type de contrôle, le logiciel actuel ne lesprend pas en compte.- Les contrôles de représentativité : Ils sont à faire au niveau de chaque Etat sur desfichiers de données annuels et en tenant compte de données externes. Ils ne fontpas partie du présent logiciel.

7 Détails des contrôles effectués

7.1 Contrôles de conformité :

Dans le tableau suivant nous fournissons, pour chaque variable, le nombre de car-actères de la variable, son format, la valeur explicite de la modalité de la variable(ex : le code Unknown de la variable Sexe = 9) et les actions à effectuer en casd’erreur. La signification des éléments du tableau est la suivante :

- Num : format numérique, Date : format AAAAMMJJ, Alpha = alphanuméri-que

- Exclusion : exclusion du record entier => non réécrit dans le fichier corrigé- List : référence à la liste des codes de la V2000- Cpt : comptage de la modalité dans un compteur spécifique pour l’Etat

Qualité- Err : variable signalée en erreur dans le listing d’erreur- Colonne Non valid range « 99 » : forçage de la modalité à 99 dans le fich-

ier corrigé





Variable Nb car.-Format

Missing Unknown Other speci-fied

Non validrange

CountryAction

2 - Num « » - Cpt21Exclusion

99 - Cpt31Exclusion

98 - Cpt41 List - Cpt51Exclusion

Hospital 6-AlphaRecord 10-Alpha

SexAction

1 - Num « » - Cpt22 9 - Cpt32 List - Cpt52Err - 9

Date of birthAction

8 - Date « » - Cpt23 99999999-Cpt33

Cpt53Err - « »

Date of injuryAction

8 - Date « » - Cpt24 99999999 -Cpt34

Cpt54Err - « »

Time of injuryAction

2- Num « » - Cpt25 99 - Cpt35 0-23 - Cpt55Err - 99

Date attendanceAction

8 - Date « » - Cpt26Exclusion

99999999 -Cpt36 - Exclus

Cpt56Exclusion

Time attendanceAction

2- Num « » - Cpt27 99 - Cpt37 0-23 - Cpt57Err - 99

Date dischargeAction

8 - Date « » - Cpt28si Trt = 5,6,7

99999999 -Cpt38 si Trt =

5,6,7 « »

Cpt58 -Err - « »

TreatmentAction

1 - Num « » - Cpt29 9 - Cpt39 8 - Cpt49 List -Cpt59Err - 9

PlaceAction

2 - Num « » - Cpt210 99 - Cpt310 98 - Cpt410 List -Cpt510Err - 99

MechanismAction

2 - Num « » - Cpt211 99 - Cpt311 98 - Cpt411 List - Cpt511Err - 99

ActivityAction


SportAction

3 -Alpha « » - Cpt213si Activ=Sp.

Z99 - Cpt313si Activ=Sp.

Z98 - Cpt413si Activ=Sp.

List - Cpt513Err - Z99

Type of injury 1Action


Type of injury 2Action

2 - Num « » 99 - CptD314 98 - CptD414 List-CptD514Err - 99

Part of body 1Action


Part of body 2Action

2 - Num « » 99 - CptD315 98 - CptD415 List-CptD515Err - 99

Product involvedAction

5- Alpha « » -Cpt216 Z9999 - Cpt316 Z9998 -Cpt416 List - Cpt516Err - Z9999

Product causingAction

5- Alpha « » -Cpt217 Z9999 - Cpt317 Z9998 -Cpt417 List - Cpt517Err - Z9999

Other productAction

5- Alpha « » Z9999 -CptD317

Z9998 -CptD417

List -CptD517

Err - Z9999Description 120

Alpha« » -Cpt218





Lecture du tableau :

Prenons l’exemple de la variable « TREATMENT ». Cette variable est numérique(Num) sur 1 caractère. La liste des codes valides (List) comprend dans la V2000 lescodes numériques de 1 à 9 (voir manuel de codage).• Si la modalité de cette variable est = « » (Missing), on ajoute 1 au compteur du

nombre de modalités « Missing » pour cette variable (Cpt29).• Si la modalité de cette variable est = « 9 » (Unknown), on ajoute 1 au compteur

du nombre de modalités « Unknown » pour cette variable (Cpt39).• Si la modalité de cette variable est = « 8 » (Other), on ajoute 1 au compteur du

nombre de modalités « Other specified » pour cette variable (Cpt49).• Si la modalité de cette variable n’est ni Missing (« »), ni comprise dans la liste

des codes valides (par exemple, si cette valeur est = « M » ou « X », etc.), onajoute 1 au compteur du nombre de modalités « Non valid range » de cette vari-able (Cpt59), on signale le record en erreur pour cette variable dans le listing deserreurs (Err) et on force sa valeur à « 9 » dans le fichier des enregistrements cor-rigés.

Remarque :

- Pour les variables « Type of injury 2 » et « Part of body 2 », on ne crée pas decompteurs de qualité pour la modalité « Missing », car ces variables ne sont com-plétées que s’il y a une deuxième lésion (variables facultatives). Il en est de mêmepour la variable « Other product », on ne crée pas non plus de compteurs de qualitépour la modalité « Missing » (variable facultative).

7.2 Détails des contrôles logiques :

- Contrôles des dates :- Si (Date of birth renseignée > Date of injury renseignée) alors message

d’erreur L1- et Date of injury = missing- Si (Date of birth renseignée > Date of attendance) alors message d’erreur

L2- et Date of birth = missing- Si (Date of injury renseignée > Date of attendance) alors message d’erreur

L3- et Date of injury = missing

- Contrôle Hospitalisation / Dates :- Si Date of attendance > Date of discharge renseignée alors message





d’erreur L4et Date of discharge = missing- Si Date of discharge renseignée et Trt not = 5,6,7 alors message d’erreur L5et Trt = 5

- Contrôle Activity / Sport :- Si (Activity = Sport) et (Sport = Missing) alors message d’erreur L6 et Sport =Unknown (Z99)- Si (Activity not = Sport) et (Sport = code sport valide) alors message d’erreurL7et Activity = Sport unspecified (59)

7.3 Description de l’Etat Qualité

On édite un Etat Qualité pour chaque fichier contrôlé. Cet état comprend plusieurstableaux :

- Caractéristiques du fichier en entrée :

Nom du fichier La plus an-cienne dated’accident

La plus ré-centedate

d’accident

Nombre de rec-ords du fichier en

entrée

- Contrôles sur le fichier entier :

Nombre % / Nb de rec-ords en entrée

Records en double (1)Records avec au moins unevariable non remplie ou non

valide

(2)

Records exclus (3)

(1) à (6) : valeurs reprises dans le tableau donnant le score final de qualité du fichier.





- Contrôles logiques (multivariables) :

Nb des rec-ords

% / Nb de rec-ords en entrée

Erreur L1 (D. Birth > D. Injury) ouErreur L2 (D. Birth > D. Attendance) ouErreur L3 (D. Injury > D. Attendance)Erreur L4 (D. Attendance > D. Dis-

charge)Erreur L5 (D. Discharge => Trt=5)Erreur L6 (Activity=Sport => Sport)Erreur L7 (Sport => Activity=Sport)

% de records avec au moinsune erreur logique

(4)

- Contrôles de conformité (monovariables) :

Variable Missing

% record

Unknown

% record

Other speci-fied.

% record

Non validrange

% recordCountry x x x xSex x x xDate of birth x x xDate of injury x x xTime of injury x x xDate of attendance x x xTime of attendance x x xDate of discharge x x xTreatment x x x xPlace x x x xMechanism x x x xActivity x x x xSport x x x xType of injury 1 x x x xType of injury 2Part of body 1 x x x xPart of body 2Product involved x x x xProduct causing x x x xOther productDescription xAverage % by var. (5) (6)





Variables prises en compte pour le calcul des moyennes par variable (dernièreligne du tableau) :- Nous avons indiqué par des croix dans le tableau la liste des variables prises encompte dans le calcul des pourcentages moyens par variable.- Ainsi pour le calcul de « Average % of Missing value by variable », nous sommonsles pourcentages de records « Missing » de 18 variables et nous divisons par 18pour obtenir la moyenne.- Pour le calcul des moyennes des autres colonnes, nous ne prenons pas en compteles variables facultatives : Type of injury 2, Part of body 2, Other product pour nefaire porter cette moyenne que sur les variables les plus importantes.

- Caractéristiques du fichier corrigé :

Nom du fichier La plus an-cienne dated’accident

La plus ré-centedate

d’accident

Nombre de rec-ords du fichier en

sortie

- Caractéristiques du fichier des erreurs :

Nom du fichieren entrée

Nb des recordsavec au moins

une erreur

% des recordsavec au moins

une erreur

- Score final de qualité du fichier :

Ce tableau reprend des éléments d’information les plus significatifs des tableauxprécédents :

Score final de qualité du fichier1. % de records en double (1)

2. % de records exclus (3)

3. % de records avec au moins une

4. variable non remplie ou non valide (2)

5. % de records avec au moins une erreur logique (4)

6. % moyen de modalité non remplie (missing) par variable (5)

7. % moyen de modalité non valide par variable (6)





8 Le listing des erreursIl comprend :

- l’édition du tableau précédent : Caractéristiques du fichier des erreurs- l’édition des records exclus avec la cause d’exclusion (Country / Date of attendancemanquant)- l’édition de chaque record ayant au moins une erreur avec le ou les noms des vari-ables en erreur

9 Fichier testNous fournissons le logiciel avec un fichier test de 100 enregistrements HLA au for-mat V2000 où nous avons volontairement introduit de nombreuses erreurs. Le pro-gramme demande le nom du fichier en entrée (xxx\TestV2K2.txt) et le nom du fichiercorrigé en sortie. Il fournit après exécution :

- le nom du fichier des erreurs (.log) avec les causes d’erreur par enregis-trements

- la visualisation ou l’impression du tableau de bord « Statistics for QualityControl »

le fichier corrigé en sortie.






T-3: QM System Training PackageIn planning: This tool will be in the context of the following procedure (see this proce-dure for available tools):Procedure Step Level Tool Status No.Training of the QMSystem



In prog-ress

3


4


En-abled

5

Tools in Preparation under the IPP 2002 Project „Development of a Training Sessionfor the Member States on Common Quality and Coding Standards for HLA DataCollection“. See also Procedure „ Maintenance and Training of the QM System“.Expected results and proposed dissemination / utilization of results

The goal of the project is to improve the capability of Member States to fulfill qualityand comparability requirements of HLA data by:• -Development and pilot of a training session: Tools for Common Coding Stan-

dards and Quality Control of HLA Data, in the form of a 2 day workshop for na-tional HLA teams, with interactive computer modules for usage of the QualityControl Manual and Coding Guide Module, implementation within existing tools

• -The final report ‘Use of a training session to improve the quality of HLA data ’ willbe available to the IPP network (within the New Health Program) through the IRCof DG SANCO after approval by the EC.






T-4: Coding Manual – MasterThis section is in planning : This tool will be in the context of the following procedure(see this procedure and External resources and documents for available tools):Procedure Step Level Tool Status No.Training of the QMSystem



In prog-ress

3


4


En-abled

5






T-5: Coding Manual – MS VersionsThis section is in planning : This tool will be in the context of the following procedure(see this procedure and External resources and documents for available tools):Procedure Step Level Tool Status No.Training of the QMSystem



In prog-ress

3


4


En-abled

5






T-6: Reference ReportsIn planning: This tool will be in the context of the following procedure (see this proce-dure for available tools):


Yearly national report NDA Reference Reports In plan-ning

6


In plan-ning

7


In plan-ning

7



En-abled

8



Testing 9






T-7: ISS based Auto-reporting ToolThis section is in planning : This tool will be in the context of the following procedure(see this procedure for available tools):



6


In plan-ning

7


In plan-ning

7



En-abled

8



Testing 9






T-8: Data Mining ToolsThis section is in planning : This tool will be in the context of the following procedure(see this procedure for available tools):



6


In plan-ning

7


In plan-ning

7



En-abled

8



Testing 9






T-9: Catchment population -- Method and PracticeReferenceThis section is in planning : This tool will be in the context of the following procedure(see this procedure for available tools):



6


In plan-ning

7


In plan-ning

7



En-abled

8



Testing 9







T-10: Interview Form (EHLASS Questionnaire) - pa-perIn preparation: This tool will be in the context of the following procedure (see thisprocedure for available tools):

Procedure Step Level Tool Status No.Coding and DataEntry



En-abled

10


En-abled

5

NDA /LDA


En-abled

11


En-abled

4a


En-abled

5a

Data Entry Check NDA /LDA


12






T-11: Interview Form (EHLASS Questionnaire) – elec-tronicIn preparation: This tool will be in the context of the following procedure:




En-abled

10


En-abled

5

NDA /LDA


En-abled

11


En-abled

4a


En-abled

5a



12






T-12: Data Entry Check ToolIn preparation: This tool will be in the context of the following procedure (see thisprocedure for available tools):




En-abled

10


En-abled

5

NDA /LDA


En-abled

11


En-abled

4a


En-abled

5a



12

This report was produced by a contractor for Health & Consumer Protection Directorate General and represents the views of thecontractor or author. These views have not been adopted or in any way approved by the Commission and do not necessarilyrepresent the view of the Commission or the Directorate General for Health and Consumer Protection. The EuropeanCommission does not guarantee the accuracy of the data included in this study, nor does it accept responsibility for any use madethereof.