TESSy - The European
Surveillance System
Lyme neuroborreliosis
Reporting protocol 2019
March 2019
link to page 4 link to page 4 link to page 4 link to page 4 link to page 4 link to page 5 link to page 6 link to page 6 link to page 6 link to page 6 link to page 7 link to page 7 link to page 9 link to page 9 link to page 9 link to page 9 link to page 10 link to page 10
Contents
Aim ........................................................................................................................... 3
Objectives ................................................................................................................. 3
Finding further information ......................................................................................... 3
Copyright .................................................................................................................. 3
TESSy HelpDesk ......................................................................................................... 3
Case definition ........................................................................................................... 4
Reporting of Lyme neuroborreliosis .............................................................................. 5
Reporting intervals and data format ....................................................................................... 5
Data sources ........................................................................................................................ 5
Reporting deadlines .................................................................................................... 5
Annex 1: Lyme neuroborreliosis ................................................................................... 6
Case-based metadata ........................................................................................................... 6
Annex 2: Overview of reporting to TESSy ..................................................................... 8
Preparing data ...................................................................................................................... 8
Checking metadata ............................................................................................................... 8
Checking your data source profile .......................................................................................... 8
Submitting your data ............................................................................................................ 9
Finalising your submission ..................................................................................................... 9
Page 1 of 10
Lyme neuroborreliosis Surveillance Protocol
Aim
The transmission of Lyme neuroborreliosis, a complication of Lyme disease which is caused by the
bacterium Borrelia burgdorferi and transmitted to humans through the bite of infected ticks, is a
concern for the EU. Systematic surveillance is needed to monitor its epidemiology in order to support
measures to prevent and control the disease and its complications (see for more information:
Commission implementing decision (EU) 2018/945 of 22 June 2018 on the communicable diseases
and related special health issues to be covered by epidemiological surveillance as well as relevant
case definitions).
Objectives
To estimate and monitor the incidence of Lyme neuroborreliosis in the EU/EEA;
To describe the geographical distribution of Lyme neuroborreliosis at subnational level in the
EU/EEA;
To strengthen Lyme neuroborreliosis case classification according to a standardised case definition.
Finding further information
The Lyme neuroborreliosis reporting protocol is supplemente
d by the Technical Annex, which contains
updated generic information for TESSy data collection.
Copyright
© European Centre for Disease Prevention and Control, 2019. Reproduction is authorised, provided the
source is acknowledged.
TESSy HelpDesk
Email:
xxxxx@xxxx.xxxxxx.xx
Telephone number:
+46-(0)8-5860 1601
Availability: 9:00 – 16:00 Stockholm time, Monday to Friday (except ECDC Holidays)
Page 3
Lyme neuroborreliosis Surveillance Protocol
Case definition
Table 1: Case definition for surveillance of Lyme neuroborreliosis
Definition
Clinical criteria
Neurological symptoms according to European Federation of
Neurological Societies (EFNS) suggested case definition 1, without other
obvious reasons
Laboratory criteria
Laboratory criteria for a probable case
— Pleocytosis in cerebrospinal fluid AND positive Lyme borreliosis
serology in cerebrospinal fluid
OR
— Specific intrathecal Lyme borreliosis antibody production
Laboratory criteria for a confirmed case
Pleocytosis in cerebrospinal fluid, AND
— Evidence of intrathecal production of Lyme borreliosis antibodies, OR
— Borrelia burgdorferi s.l. isolation in cerebrospinal fluid, OR
— nucleic acid detection in cerebrospinal fluid
OR
— Detection of IgG Lyme borreliosis antibodies in blood specimen only
for children (age under 18) with facial palsy or other cranial neuritis and
a recent (< 2 months) history of erythema migrans
Epidemiological Criteria Not applicable
Classification
Probable case
Any person meeting the clinical criteria and at least one of the laboratory
criteria for probable cases
Confirmed case
Any person meeting the clinical criteria and at least one of the laboratory
criteria for confirmed cases
1 EFNS guidelines on the diagnosis and management of European Lyme neuroborreliosis, European Journal of
Neurology 17, 8–16: doi:10.1111/j.1468-1331.2009.02862.x
(link)
Page 4
link to page 7 link to page 9
Lyme neuroborreliosis Surveillance Protocol
Reporting of Lyme neuroborreliosis
Reporting intervals and data format
Member States should report Lyme neuroborreliosis cases among their residents annually.
Further details are available in
Annex 1: Lyme neuroborreliosis metadata. An overview of reporting to TESSy is provided in
Annex 2: Overview of reporting to TESSy.
Data sources
A data source profile contains information about the surveillance system in the country from which
data are reported. These include the surveillance subject(s) reported, what types of data are
available, the case definitions used, etc. The information contained in the profile is linked to each
data record that specifies a particular data source. Typically, these profiles are maintained in the
TESSy Web application (Data sources tab) by the National Surveillance Focal Points.
Different record types should be reported from different data sources to avoid overwriting of data
from overlapping reporting periods. Since a country may need to report three different record types
(aggregated travel-associated cases, aggregated locally-acquired cases and case-based data), three
separate data sources may need to be set up in TESSy.
Reporting deadlines
The deadline for the annual data collection covering 2018 Lyme neuroborreliosis data is
31 May 2019.
Page 5
Lyme neuroborreliosis Surveillance Protocol
Annex 1: Lyme neuroborreliosis
Case-based metadata
The record type version for case-based Lyme neuroborreliosis records is
LYMENEURO.
Table 2: Lyme neuroborreliosis case-based variables
Field
Description
RecordId
Unique identifier for each record within and across the national surveillance system
– MS selected and generated.
Required field.
Subject
Subject of the data reported.
Required field.
The subject is LYME.
RecordType
Structure and format of the data (case based reporting or aggregate reporting).
Required field.
The record type is LYMENEURO.
RecordTypeVersion
Indicates the version of the Record type used in the reported batch. If no
RecordTypeVersion is provided in the batch, it is set automatically with current
version of the Record type. RecordTypeVersion is required when no metadata set is
provided at upload or when a RecordTypeVersion, other than the current one,
needs to be used. The current record type version for case-based Lyme
neuroborreliosis records is LYMENEURO.1.
Status
Status of reporting NEW/UPDATE or DELETE (inactivate).
Default if left out: NEW/UPDATE.
If set to DELETE, the record with the given recordId will be deleted from the TESSy
database (or more correctly, invalidated).
If set to NEW/UPDATE or left empty, the record is newly entered into the database.
ReportingCountry
The country reporting the record.
Required field.
DataSource
The data source (surveillance system) that the record originates from.
Required field.
DateUsedForStatistics
The reference date used for standard reports that is compared to the reporting
period. The date used for statistics can be any date that the reporting country finds
applicable, e.g. date of notification, date of diagnosis or any other date.
DateOfOnset
Date of onset of neurological symptom. If the date of onset is not known please
use 'UNK'.
Required field.
DateOfDiagnosis
First date of clinical or lab diagnosis. This corresponds to either at the time of
clinical diagnosis or first laboratory sample.
Validation: Date of onset must be before date of diagnosis.
Gender
Gender of the reported case.
F = Female
M = Male
O = Other (e.g., transsexual)
UNK = Unknown
Required field.
Age
Age of patient in years as reported in the national system at the time of disease
onset.
Required field.
Page 6
Lyme neuroborreliosis Surveillance Protocol
Field
Description
AgeMonth
Age of patient in months as reported in the national system for cases < 2 years of
age at the time of disease onset.
Classification
This variable indicates the case classification according to the EU case definition.
Required field.
Allowed values:
CONF = Confirmed
PROB = Probable
Unk = Unknown
ClinicalCriteria
Presence of neurological symptoms according to European Federation of
Neurological Societies (EFNS) suggested case definition, without other obvious
reasons.
Required field.
Allowed values:
Yes
No
UNK
Validation: ‘No’ produces the following error message: “The diagnosis of Lyme
neuroborreliosis requires neurological symptoms”.
ClinicalPresentation
Description of neurological symptoms according to European Federation of
Neurological Societies (EFNS) suggested case definition.
Allowed values:
CNS = Symptoms with central nervous system manifestations
CNSPNS = Symptoms of both central and peripheral nervous system
PNS = Symptoms confined to peripheral nervous system
UNK
LabMethod
Laboratory method(s) used to ascertain the diagnosis. More than one method can
be indicated.
Allowed values:
CULT = Isolation of Borrelia burdgorferi s.l in CSF
INTRA = Evidence of intrathecal production of Lyme borreliosis antibodies
NUC = Nucleic acid detection of Borrelia burdgorferi s.l in CSF
PLEO = Pleocytosis in CSF
SERO = Detection of IgG antibodies in blood specimen for children
SEROCSF = Positive Lyme borreliosis serology in CSF
UNK = Unknown
Outcome
Death should be directly due to Lyme neuroborreliosis.
Allowed values:
Alive
Died
UNK
Imported
Infection has occurred following exposure outside the reporting country during a
time compatible with the incubation period of the infection.
Required field.
Allowed values:
Yes
No
UNK
PlaceOfInfectionEVD
The probable place of infection should be provided at the NUTS 3 level. If the
probable case of infection is not an EU/EEA country, then use GAUL nomenclature,
if no NUTS levels are available. Note this is a repeatable field.
Required field.
PlaceOfResidence
Place of residence of patient at the time of disease onset. Select the most detailed
NUTS level possible. UNK is allowed.
Required field.
Page 7
link to page 9 link to page 9 link to page 9 link to page 10 link to page 10
Lyme neuroborreliosis Surveillance Protocol
Annex 2: Overview of reporting to TESSy
This section provides both an overview of the TESSy reporting process and tips on where you can find
useful information.
The overall process is:
1.
Prepare (export and transform) your data.
2.
Check that your data comply with the metadata.
3.
Check that your data source profile is up-to-date.
4.
Submit your file(s) to TESSy.
5.
Finalise and approve your submission.
Preparing data
After you have exported the Lyme neuroborreliosis data from your national database, you need to
ensure that they are in a format that TESSy can accept. This applies both to the type of file submitted
to TESSy (only CSV and XML files can be submitted) and to the format of the data in certain fields.
Tutorials covering how you can transform your data to the correct TESSy format using Excel or
Access are available on the
TESSy documents website. Information on the file formats is available in
the CSV Transport Protocol and XML Transport Protocol.
Checking metadata
The TESSy metadata define the fields and data formats that are valid as input to TESSy for Lyme
neuroborreliosis.
It is especially important to focus on:
Field formats
Many fields require that data are formatted in a specific way. For example, dates must be in the
YYYY-MM-DD format; dates in the DD/MM/YYYY format will be rejected.
Coded values
Some fields only permit the use of specific values (coded values). For example,
M,
F,
UNK, or
Other are the
coded values for Gender and any other value in a Gender field will be rejected.
The metadata file contains all the definitions and rules you need to comply with to format your data
correctly. The file can be downloaded as an Excel file from the TESSy documents website.
The
Technical Annex provides an overview of how you work with the metadata file, and the
TESSy user documentation provides in-depth details on metadata.
Checking your data source profile
Before submitting your file(s), please review the profile for your data source(s) in TESSy (go to
Data
Sources), and update the information, if necessary.
Complete and up-to-date data source information for each subject is important for improving
interpretation of data - each surveillance system has different features that need to be taken into
account when comparing data at an international level.
If your data source information is out-of-date and you do not have access rights to update it, please
request your National Focal Point for Surveillance or National Coordinator to do so.
Page 8
Lyme neuroborreliosis Surveillance Protocol
In-depth information on the data source variables is available in the
TESSy user documentation.
Submitting your data
Data are submitted through the TESSy web interface (go to
Upload).
The
Technical Annex provides an overview of how you submit files to TESSy, and the
TESSy user
documentation provides in-depth descriptions of all the upload methods.
Finalising your submission
The compliance of your data with the validation rules in the metadata is checked automatically during
the data upload process.
The result of your upload – i.e. rejected or validated – is displayed immediately after the conclusion
of the check in the
Validation details webpage. Please review the result carefully:
If your file has been rejected, there will be a message explaining each instance of non-
compliance with the metadata that you need to correct.
If your file has been validated, there might be warnings and remarks relating to possible data
quality issues or to potential overwriting of existing records that you should consider.
When your file has been validated and you are satisfied that all corrections have been made, please
ensure prompt approval – unapproved uploads can block the approval of other uploads.
The
TESSy user documentation provides information on reviewing validation results and adjusting
reporting periods to avoid overwriting existing records.
Page 9