[Evaluation of thoroughness and legibility of informed consent documents in pediatric surgery].
BACKGROUND
The written information that is provided to the patient must gather a series of characteristics, quantitative and qualitative, so that fulfill the ethical criteria that govern the theory of the Informed Consent.


OBJECTIVE
To evaluated the degree of exhaustivity and readability of a series of Informed Consents forms in Pediatric Surgery units.


METHODS
1. Forms: We evaluated 118 consent forms submitted by 17 pediatric surgery units. 2. Exhaustivity: The studied variables have been: name of the hospital, name of the patient, name of the physician, date, description of the procedure, objectives, risks mention, personalized risks, possibility of recovery, benefits of the procedure, alternatives, possibility from withdrawing the assent, arrangement to widen the information, comprehension of the document, express assent and signatures. All the variables are dichotomics, being collected your presence or absence. 3. Readability: Each document has been introduced in the program "Corel Word Perfect". It was applied to the usefulness "Grammatik" and were collected: number of words, number of phrases, Flesch/Kincaid index, Orational Complexity index and LEGIN index.


RESULTS
1. Exhaustivity: The paragraphs presence in the different forms by order of frequency were: physician signature (100%), express assent (100%), signatures (100%), date (98%), name of the patient (97%), comprehension of the forms (97%), name of the physician (94%), risks mention (92%), name of the hospital (85%), description of the procedure (78%), possibility from withdrawing the assent (70%), personalized risks (67%), arrangement to widen information (43%), to explain alternatives (41%), objectives of the procedure (36%), benefits (36%), and possibility of the recovery (16%). 2. Readability: 11.1% of the forms fulfills the Flesch index, 27.9% the Orational Complexity index, and 22.1% LEGIN index.


CONCLUSIONS
Most of the documents offer sufficient quantity of information with respect to the formal aspect and the risks an less with respect to the benefits. This seems to indicate your defensive character. Equally, they are difficult to reading and by difficult to understanding.
Jiménez Alvarez
C
C
Unidad de Calidad, Hospital Universitario Virgen de las Nieves, Granada.
Morales Torres
J L
JL
Pereira Rodríguez
M J
MJ
D002648:Child; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D013514:Surgical Procedures, Operative