P05.232 Written Consent Form Fulfilment Revisited

M. Zelada Aliaga1, M. de la Torre Carpente2, S. Sanchez Ramon3, C. Fernandez Alonso4, M. Zelada Aliaga5, A. Gomez Arranz4, A. de la Cal de la Fuente6, M. Acu¤a Lorenzo2, M. Rollan Gomez2, M. Menendez Suarez7;
1Gerencia de Atenci¢n Primaria. Centro de Salud Parquesol. VA/O, Valladolid, Spain, 2Hospital Universitario Rio Hortega. Servicio de Cardiologia, Valladolid, Spain, 3Hospital Universitario Rio Hortega, Valladolid, Spain, 4Gerencia Atencion Primaria. Centro Salud Casa del Barco. VA/O, Valladolid, Spain, 5Gerencia de Atenci¢n Primaria. Centro de Salud Parquesol.VA/O, Valladolid, Spain, 6Gerencia Atencion Primaria. Centro Salud Casa del Barco VA/O, Valladolid, Spain, 7Hospital Clinico Universitario, Valladolid, Spain.
Susana Sanchez Ramon
Hospital Universitario Rio Hortega. Urgencias
Zip: 47008
Email: sussanchez1@gmail.com
Phone: +34670202245
Informed consent is both an ethical obligation and a legal requirement. The written consent form is only a part of the whole process of communication but it is important to record it properly because written consent forms document the process and the form can serve as evidence that informed consent indeed took place.
Aim: to retrospectively assess if a written consent form was properly fulfilled.
Methods: we retrospectively review the clinical record of 155 patients that underwent exercise stress testing. For this procedure, The Spanish Society of Cardiology has endorsed a written consent form with several blanks to be filled in, some of them by physicians and some others by patients. We selected the following required yes or no items to be analysed: written consent form, physician who informed the patient, physician who is going to do the test, proper patient identification (social security number or clinical record number), patient name and surname, date of the procedure, signature of the patient, physician?s stamp. We also recorded sex and age
Results: There were 110 males (70.5%), mean age 56.9 years. Only 1.9% patients had all the studied items properly filled in. In 3.2% the clinical record did not include a written consent form though the patient underwent the procedure. Physician who informed the patient was missing in 28 (18.1%) physician doing the test was recorded in 43,2% cases. Proper patient identification was present in 105 (67.7%) cases and patient name and surname in 94 (60.6%) cases. Form included date of procedure in 63.2% of the records. There was a signature in all the reviewed forms, in all minors a legal representative signed it. Finally, the physicianïs stamp blank was present in 7.1% forms.
Conclusions: First, in this sample of patients we have found that most of the clinical records included the written consent form but it was missing in a minority of them. Second, the fulfilment of the form was not correct in most of the cases due to a lack of several compulsory items. Therefore, we must pay more attention and interest to this issue in order to improve these data
Written consent form fulfilment revisited