بسم الله الرحمن الرحيم
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مبادئ جودة معلومات المرض وخيارات العلاج المقدمة للمريض
=====================
الموضوعية والحياد
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التوجه نحو المريض
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المثبتة بالبينات
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حديثة
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معول عليها
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مفهومة
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متاحة
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شفافة
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ذات صلة ومناسبة
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متوافقة مع الوضع القانوني
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Core quality principles for patient information on diseases and
treatment options
=====================
High quality information must meet the criteria set out in these
principles and
should also have a clear process for compliance/certification.
Information
provided by a Member State and/or the European Commission
should be done
without restricting or replacing other sources.
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Objective and unbiased
----------------------------
Information is objective when it is based on facts and not
influenced by
prejudices or personal perceptions. Information is unbiased when it
is impartial,
non-directive and balanced.
These two definitions do not relate to the source of information
which is a
separate issue (see the ‘Transparent’ principle).
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Patient oriented
------------------
Information provided should be patient-centred taking into account
patients’
needs and expectations in order to empower patients. Patients
should be
involved in the production and dissemination of information on
diseases and
treatment options wherever possible.
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Evidence-based
--------------------
The evidence base for any information resource needs to be clearly
stated,
including making clear the level of evidence. Information should be
verifiable,
based on comparisons and backed up by scientific peer review
where possible.
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Up-to-date
--------------
Information should be kept up-to-date and the date of publication
should be
included.
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Reliable
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Information needs to be factually correct and not misleading.
Information should
be scientifically valid and reflect latest knowledge.
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Understandable
---------------------
Information provided should be comprehensible for a
patient/citizen.
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Accessible
--------------
Information should be easily accessible via different mechanisms
for example,
through written documents, websites of certified official bodies etc.
Information
should also be accessible to people with disabilities.
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Transparent
----------------
Informed choice requires transparency. That entails transparency
of what is
known as well as what is not known. Funding, sources of
information, evidence
for that source and transparency when there is known controversy
about a
particular treatment, for example, all need to be made clear.
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Relevant
-------------
Information should include issues of relevance and importance to
patients’
decision-making e.g. including adverse effects. Impact on quality of
life and the
consequences of the disease on contribution of the patient to
society/the work
place are important elements of information on disease.
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Consistent with Statutory Information
----------------------------------------------------
Information not regulated by statute should, nevertheless, be
consistent with the
legal requirements of European law (e.g. must not be designed to
promote a
prescription only medicine, reflecting the prohibition of direct to
consumer
advertising of prescription only medicines, must not be misleading
etc.) and
should refer, where appropriate, to statutory information approved
through the
process of regulation.
==========
المصدر
Pharmaceutical Forum
Second Progress Report, 26 June 2007