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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: