Dipartimento Interaziendale di
Diagnostica per Immagini
CONSENSO INFORMATO PER L'ESAME DI RISONANZA MAGNETICA (RM)
INFORMED CONSENT FOR MAGNETIC RESONANCE TEST (MRI)
(To be attached to the referral and given to the radiologist immediately before the test)
Name ______________________ Surname ______________________
Weight (Kg) _____
1Outpatient
Date of birth _________
1 Inpatient Ward/ Day Hospital/__________________________
Test: MRI __________________________________________
INFORMAZIONI E DICHIARAZIONE DEL MEDICO CHE CHIEDE L’ESAME
INFORMATION AND DECLARATION OF DOCTOR REQUESTING THE TEST
I have informed the patient about:
1) the general nature of the test and its procedures. I have said that it is not painful and that it is
performed using a magnetic field and radio waves.
2) the purpose of the test: to produce images that help confirm a diagnosis, or to see the state of
an already diagnosed illness;
3) the consequences if the patient does not undergo the test: failure to define or a less accurate
definition of the illness.
Tests usually carried out senza mezzo di contrasto/without contrast agent:
- tests on the apparato osteoarticolare/osteoarticular apparatus; - tests on the rachide/vertebral
column with suspected disc pathologies in patients who have not undergone surgery.
Tests carried out with con mezzo di contrasto/with contrast agent
In some cases it is necessary to use a mezzo di contrasto/contrast agent (the liquid is
administered by injection and makes it easier to see the size, shape and outline of the part of the
body).
In many cases the mezzo di contrasto/contrast agent containing gadolinio/gadolinium is well
tolerated and the test does not cause problems. A contrast agent can cause:
- mild reactions: discomfort at the site of the injection, nausea, vomiting, headache, vertigo,
itching, tingling. These occur in less than 1% of tests;
- moderate reactions: eritema e orticaria/ redness and hives. Even rarer, with a likelihood of
less than 1/1000;
- reazioni cardiocircolatorie gravi/severe cardiocirculatory reactions , life-threatening only in
very rare instances. These are possible but very, very rare (about 1/ 100,000 – 350,000 tests);
also reported is a serious but extremely rare syndrome known as Fibrosi sistemica
nefrogenica/Nephrogenic systemic fibrosis (NSF), which can occur only if there is significant
kidney failure (especially with a Filtrato Glomerulare inferiori a 30
ml/minuto/1,73m2/Glomerular filtration rate of below 30 ml/minute/1,73m2 , or in patients
in emodialisi /haemodialysis or dialisi peritoneale /peritoneal dialysis, and in patients waiting
for liver transplants.
It is currently unclear whether the syndrome is caused by the contrast agent with gadolinium;
in any case it is extremely rare. Kidney function should however be examined in anyone at
risk from insufficienza renale /kidney failure.
This box must be filled in whenever a contrast agent is used
To my knowledge , I declare that the patient suffers from :
Dipartimento Interaziendale di
Diagnostica per Immagini
- insufficienza renale/kidney failure
No ‰ Yes ‰
- risk factors for insufficienza renale/ kidney failure (e.g. ipertensione arteriosa/high blood
pressure, diabete mellito/ diabetes mellitus, nefropatia nota/known nephropathy, età superiore a 60
anni/ age over 60, altre condizioni predisponenti all’insufficienza renale/other conditions inducing
kidney failure)
No‰ Yes ‰
- the patient is a trapianto epatico/liver transplant candidate
No‰ Yes ‰
If even one answer is positive, Glomerular filtration rate (GF) should be checked or a
creatininemia/ creatinine test performed (not more than 1-3 months before the MRI or even previous
to that, at the referring doctor’s discretion).
Glomerular filtration rate (GF) is _________ ml/minute/1,73m2 on (date) _________
Or:
Creatinine level is _________ mg/dl
on (date) ___________
Or:
‰ I have requested creatinine and/or GF tests and have instructed the patient to hand
the results to the radiologist prior to the test.
Remarks
..………………………………………………………………………………………………………………
…..
………………………………………………………………………………………………………………
………………………
Date ____________________
_________________________________________
Medical Doctor
DICHIARAZIONE DEL PAZIENTE/PATIENT DECLARATION
I the undersigned ..............................................................................................................................
(exercising my parental rights for minor / as guardian of ………….......................................... )
date of birth …………………………
a.
b.
c.
declare :
I wear a stimolatore cardiaco /Pacemaker
I have metal elements in the eyes such as:
frammenti, schegge, punti di sutura/fragments, splinters/stitches,
I suffer from claustrofobia/claustrophobia
NO 1
YES 1
NO 1
NO 1
YES 1
YES 1
YES to any of the questions a), b) and c) may represent an absolute contraindication and should be evaluated by the
radiologist directly.
d.
I have elementi metallici/metal elements in my body such as:
fragments, splinters, stitches, …
NO 1
YES 1
e. I have a protesi ferromagnetiche/ferromagnetic prosthesis
NO 1
YES 1
f.
I have a pompe sottocutanee per infusione:
(port-a-cath, pompe peristaltiche, pompe da insulina)/ subcutaneous infusion pump:
(Port-a-cath, peristaltic pump, insulin pump)
NO 1
YES 1
g. I wear lenti a contatto/contact lenses
NO 1
YES 1
h. I have an spirale/intrauterine device
NO 1
YES 1
Dipartimento Interaziendale di
Diagnostica per Immagini
i.
j.
k.
l.
m.
n.
o.
p.
q.
I am pregnant
NO 1
YES 1
I have a protesi del cristallino/crystalline lens prosthesis
NO 1
YES 1
I have apparecchi acustici o impianti per udito/a hearing aid or implant
NO 1
YES 1
I have trucchi permanenti, tatuaggi, piercing/permanent make up, tattoos, piercing or
other metallic objects
NO 1
YES 1
I have already had a reaction to contrast agents for MRI
NO 1
YES 1
I have an allergy to drugs
NO 1
YES 1
I have or have had bronchial asthma
NO 1
YES 1
I have or have had emosiderosi/haemosiderosis or emocromatosi/haemochromatosis
NO 1
YES 1
I have had a reaction to destrano/dextran
NO 1
YES 1
(NB. This declaration can be filled out with the help and confirmation of a doctor)
I confirm that I have been informed about what is written in this document and that I have
received clear and comprehensive answers to my questions, and that I have understood
them.
I have been given answers and explanations that I understand fully, and I have made my
decision. Therefore:
… ACCONSENTO/ I CONSENT … NON ACCONSENTO/I DO NOT CONSENT
all’esecuzione dell’esame di Risonanza magnetica/to an MRI test ‰con/with ‰senza
la somministrazione di mezzo di contrasto/without contrasting agent.
NOTES………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………
Date ____/___/_____
right/guardian
Legible signature of patient/parent exercising parental
……….…………………………………………………………………………..
(If the patient is aged between 14 and 17 his/her consent should also be sought)
Signature of radiologist performing the scan
…………………………………………………………..
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ISTRUZIONI PER FARE L’ESAME/INSTRUCTIONS
ALL REMOVABLE METAL OBJECTS ARE TO BE LEFT IN THE CHANGING ROOM:
eyewear, hairclips, coins, keys, belts, mobile dentures, watches, magnetic cards, body
piercing items, etc.
It is preferable not to wear eye or face make up, hair lacquer or gel.
Dipartimento Interaziendale di
Diagnostica per Immagini
-
It is important to keep completely still during the scan.
The patient is observed in the magnet room and the staff can communicate by intercom.
There is an alarm button which can be pressed at any moment.