CKD patients and erythropoietin: do we need evidence-based informed consent?
BACKGROUND
Consent to therapy is increasingly requested in the form of ''informed consent''.


OBJECTIVE
To validate an evidence-based informed consent form for erythropoietin (EPO) therapy and to evaluate patient opinions about the informed consent approach.


METHODS
An evidence-based informed consent form was developed as part of the Evidence-Based-Medicine course at the Medical School of Turin, Italy. It was validated by anonymous questionnaires (0-10 analogical scales and open answers) administered to patients at different stages of CKD (19 pre-ESRD, 26 hemodialysis, 12 transplant patients) attending an outpatient unit of the University of Turin, to 8 nurses, and to 26 medical students.


RESULTS
All individuals filled in the questionnaire. Interest in a detailed explanation of the therapy was high (median 9), as was comprehension (median 9), with no differences between patients with regard to disease stage (pre-ESRD vs. RRT) or educational level. Prior knowledge of the therapy was affected by the educational level (p=0.013 for the advantages and p=0.004 for the side effects) and the professional role (patients vs caregivers: p=0.009 for the advantages and p<0.001 for side affects); patient knowledge of the advantages (median 6) tended to increase as the disease progressed (p=0.015). The most common response by patients was that informed consent was necessary for all drugs (35.1%); 73.1% of the caregivers considered it necessary only for severe side effects. The preferred modality of consent was discussion with the caregiver during the clinical controls (42% of all cases).


CONCLUSIONS
Patient interest in and comprehension of an informed consent form with a detailed explanation of the therapy was high; the caregiver's opinion was still the most valued teaching tool.
Mezza
E
E
Department of Internal Medicine, University of Torino, Torino, Italy.
Consiglio
V
V
Soragna
G
G
Putaggio
S
S
Burdese
M
M
Perrotta
L
L
Jeantet
A
A
Segoloni
G P
GP
Piccoli
G B
GB
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D032962:Consent Forms / Q000592:standards*; D004522:Educational Status; D004921:Erythropoietin / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D007558:Italy; D007676:Kidney Failure, Chronic / Q000188:drug therapy; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009726:Nurses; D010353:Patient Education as Topic; D011994:Recombinant Proteins; D006435:Renal Dialysis; D013337:Students, Medical; D011795:Surveys and Questionnaires
D011994:Recombinant Proteins; D004921:Erythropoietin