Download Presentación de PowerPoint

F U
DESIGN OF AN INFORMED CONSENT DOCUMENT
FOR QUANTITATIVE MUSCLE ASSESSMENT (QMA)
IN PATIENTS WITH ALS?
N D E L A
Marí
Marín S1, Valera F2, Minaya F2, Valera MA3, Mora J1, Salas T4
1Dept
of Neurology; 2Dept of Physical Therapy; Neuromuscular Research Unit, Hospital Carlos III,
Madrid, Spain; 3Dept of Pedagogy, Institute of Education, Murcia,
Murcia, Spain; 4FUNDELA, ALS Research
Foundation, Madrid, Spain.
In the last thirty years, the clinical relationship between health
health professionals and patients
has been rather modified. There are several factors that have contributed
contributed to this change:
a) Development of new techniques; b) Recognition of patients' autonomy to decide about
their own lives,
lives, health and their own bodies; c) The increasing number of lawsuits,
lawsuits,
complaints and trials about the problems that clinical information
information involves, particularly the
informed consent in clinical practice.
practice.
Patient should know and make the decision together with the health
health professional on each
one of the procedures that are carried out in health attention.
Informed consent document is necessary for the realization of the
the QMA since they are tests
that require the patient's maximum effort and, therefore they bear
bear a series of risks or
complications that should know and accept.
OBJETIVES:
Design an appropriate informed consent document (ICD) for the performance of the QMA in
patients with ALS.
METHODS:
A series of stages were followed in the elaboration of the ICD:
ICD: 1) Initial design of the
document for a group of health professionals (n=5). 2) Revision of the document for a
pedagogue.
pedagogue. 3) Focal group of patients (n =10); the document was explained and analyzed for
their best understanding. 4) Document was revised to carry out the necessary changes.
changes.
RESULTS:
H O S P I T A L
The final text include the following aspects:
1.
2.
3.
Patient's personal data.
Name of physiotherapist that informs.
Procedure’
Procedure’s name that will be carried out, with simple explanation of the
objective of the same one, on what it consists, and the way it will be carried
out.
4. Description of the sure consequences of the intervention, whenever
whenever they are
considered excellent or important.
5. Description of the typical risks of the procedure.
6. Description of the personalized risks: related with the personal
circumstances of the patients and they make reference to their previous
previous
state of health, age, profession, beliefs, values and attitudes, or other
circumstance of similar nature.
7. To the doctor's approach the information can be included that makes
makes
reference to the probable nuisances of the procedure and its consequences.
consequences.
8. Physiotherapist's explicit readiness to enlarge the information if the patient
wants it.
9. Patient's declaration of having received information about procedure
procedure
indicated in the previous sections, as well as of alternative different
different to the
procedure (manual muscle assessment).
10. Patient’
Patient’s manifestation of being satisfied with the received information and
of having obtained explanation on the outlined doubts, as well as
as of the
possibility of revoking in any moment the ICD without cause expression.
expression.
11. Date and physiotherapist's and patient’
patient’s signatures.
12. Section for the consent, through legal representative, in the event
event of the
patient's inability.
13. Section for the reject of the consent that figure in the own document.
document.
CONCLUSIONS:
Sinesio Delgado, 10
28029 – MADRID
CARLOS III
Telefs. (91) 314 8914
(91) 314 08 07
Fax . (91) 733 66 14
CONSENTIMIENTO INFORMADO
PRUEBA DE CUANTIFICACIÓN NEUROMUSCULAR
1er Apellido
2º apellido
SERVICIO: FISIOTERAPIA
EVALUADOR:
Nombre
DNI
Nº Hª
Fecha:
1º Procedimiento
Se solicita su consentimiento para realizar una prueba de cuantificación neuromuscular.
Consideramos que esta prueba puede aportar información muy valiosa para un conocimiento más
completo de su enfermedad y su evolución.
Consiste en obtener tres medidas de fuerza isométrica de 7 grupos musculares distintos
colocándose para ello en supino y/o sentado. Su medición se realizará través de un dinamómetro
electrónico, con el fin de obtener una valor objetivo, real y fiable de su fuerza.
2º Alternativas
Esta es la prueba más fiable que existe para evaluar el estado actual de su fuerza física por
grupos musculares, otra forma es la que se realiza de forma manual por su neurólogo en la
consulta pero menos objetiva y precisa.
3º Riesgos
En general la prueba se tolera perfectamente, aunque se puede referir fatiga posterior, aumento
de la tensión arterial, alteraciones del ritmo cardiaco y disnea transitoria.
Otros riesgos o complicaciones que pueden aparecer dependen de sus circunstancias personales
(estado de salud previa, edad, alergias, medicación que esté tomando, etc) y que Vd. Deberá
comunicar previamente al fisioterapeuta:
4º Declaraciones y firmas
Declaro que he sido informado de forma comprensible de la utilidad, naturaleza y riesgos del
procedimiento mencionado, así como de sus alternativas. Estoy satisfecho con la información
recibida, he podido formular todas las preguntas que he creído convenientes y me han sido
aclaradas todas mis dudas. Queda claro que puedo retirar este consentimiento cuando lo desee.
Firma del paciente
Firma del fisioterapeuta
Fecha
Fecha
Nombre del representante legal del paciente en caso de incapacidad del paciente para consentir
Nombre:
DNI
Firma y fecha:
The final ICD for the performance of the QMA is based on the consent among professionals
and it has been revised by patients who improved their understanding of it.
International
International Symposium
Symposium on
on ALS/MND
ALS/MND
INTRODUCTION: