Chiari Malformation Project Database CM1 D

Orfeo Mazzella | CM1D database 1

Introduction
The involvement of the patient on the part of the scientific community and the of
voluntary associations in the collection and sharing of online data is as follows:

– for the promotion of health and for the study of it’s natural evolution

– Quality of Life

– for the improvement of auditing “ clinical risk”

– for the distribution and common usage of scientific knowledge

– to supply a scientific base for the comprehension and the study of health

– to establish a universal language to describe health and it’s conditions in order
to improve communication between diverse users: medical staff, researchers,
political exponents and the population

– to render possible a comparison between data collection worldwide

– to supply a systematic coding scheme for in house healthcare IT systems


The collection of data adheres to all privacy norms

www.garanteprivacy.it/garante/navig/jsp/index.jsp


Data according to SISMEC and CEAS recommendations

Recommendations of good practice in the research of epidemiology
and clinical environment

www.sismec.info


Recommendations

The publication of means of mass media must come
about only after the results have been revealed in an
appropriate scientific contest and, possibly, through
divulging the source

(According to clinical environment - SISMEC)


The collection of patient data: Quality of life


The collection of data adheres to the principles

GPC (Guideline for Good Clinical Practice)

Principals of ethics of the Helsinky declaration


Data sharing
The sharing and availability of data allows to “audit” thus allowing

a guarantee that the patient receives the best possible treatment

clinical practice improvement

the work to improve generally

an optimal supply of resources

this service becomes an opportunity for training and up - to - date
research

8

Why collect the data?

The systematic compilation of data and of
information is a fundamental element in
healthcare. The world of healthcare is in charge
of organizing this data in a systematic and
trustworthy fashion, so that a decision maker
put in such a situation of having to look at all
relevant material available can readily use the
necessary data at hand

The same goes for the patient end – user who is
also guaranteed a more trusting rapport with his
doctor if the data can be efficiently found at
hand


Registry, archive or database?


Definition of a database

• A database, or data bank, is a structured collection of
records or filing system that is stored in a computer
system. The structure is achieved by organizing the data
according to a database model. It can be accessed (for
data inputting, research, management and data
maintenance) via system software

• The database is a gathering of information, of data which
is then subdivided into a logic order into tables to be then
split up into fields


Definition of data source

1.51 Source Data
All information in original records and certified copies of
original records of clinical findings, observations, or other
activities in a clinical trial necessary for it’s reconstruction
and evaluation. Source data are contained in source
documents (original records or certified copies)

European Medicines Agency July 2002 Guideline for Good Clinical Practice


Definition of document source

1.52 Documents Source
• Original documents, data, and records (e.g., hospital
records, clinical and office charts, laboratory notes,
memoranda, subjects' diaries or evaluation checklists,
pharmacy dispensing records, recorded data from
automated instruments, copies or transcriptions certified
after verification as being accurate copies, microfiches,
photographic negatives, microfilm or magnetic media, x-
rays, subject files, and records kept at the pharmacy, at the
laboratories and at medico-technical departments involved
in the clinical trial).

European Medicines Agency July 2002 Guideline for Good Clinical Practice


Generic database for rare illnesses on internet

•NORD (National Organization Rare Disorders)

•ORDR (Office Rare Disease Research)

•SRDD (Swedish Rare Disease Database)

ORPHANET
•CNMR (Centro Nazionale Malattie Rare)


NORD
www.rarediseases.org


ORDR
www.rarediseases.info.nih.gov

16

SRDD www.socialstyrelsen.se/en/rarediseases


ORPHANET www.orpha.net


CNMR www.iss.it/cnmr


Specific database for rare illnesses on internet

• ORCID (Orthopaedic Rare Conditions Internet database)

• RBDD (Rare Bleeding Disorder Database)

• GDMCC (Genetic Disorder Mucociliary Consortium)

• EN-RBD (European Network Rare Bleeding Database)

• ESID (European Society for Immunodeficiensies Database)

• CM1D (Chiari Malformation 1 Database)


ORCID Orthopaedic Rare Conditions Database


RBDD Rare Bleeding Disorder Database


EN-RBD European Network Rare Bleeding Database


ESID European Society for Immunodeficiencies


CM1D Chiari Malformation 1 Database

http://aismac.unior.it


What is the database used for?

– Mainly to observe the natural history of
pathologies

– For observational studies

– To promote the knowledge and sharing
new discoveries on MC1 e SM

– To reunite distributed data with
countries out of reach


What info to is required?

– Info related to the quality of life

– Info from the patient records according to
the present consensus

– The patient’s outcome


Is the data input anonymous?

– Yes, it is anonymous and scrambled
anonymous
user


Who inserts the data?

– The doctors

– The patients

Onto the records of the health care centre


Is the data constantly updated?

– Yes, on the basis of a yearly follow- up


How is the data collected?

– Via a programme on a remote
Italian server


Where is the server that hosts the database?


Do you need to install a program on the PC to access?


Is it possible to share the found data on a network?

– Yes, it is

– You can do this simultaneously
between multiple users


From where is the data accessible?

– Wherever you are

– Anywhere in the world via the
internet connecting you to the
project page


Are there any otherways of accessing the data?

– Yes, every user has his own
personal password for access


Is there a way of controlling the data’s safety against fraud?

– Yes, for example you cannot
duplicate any data entered


Is it possible to add X rays to the database?

– Yes, in addition to the DICOM data
the X ray would automatically be erased
afterwards ensuring privacy by using a
program especially for this purpose


Is the information of the patient’s privacy safe?

– Yes, the patient is identified in
the database through a number
generated at random


How do you surf the database?

– Through some cards linked to
eachother


Who owns the data?

– The patients who have authorised
this in written format (art.26 D.lgs
196/2003)

– An authorised person is named who
guarantees safety of the data (art. 28
D.lgs 196/2003)


Can the data be used to carry out a study?

– Yes, in an anonymous way


CM1D Chiari Malformation 1 Datebase



http://aismac.unior.it/Adesione.php?IdLingua=2


Partnership


Thank you for your kind attention



aismac@alice.it


Chiari Malformation Project Database CM1 D

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