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Revista Española de Salud Pública

On-line version ISSN 2173-9110Print version ISSN 1135-5727


CALLE-URRA, José Eduardo et al. Evaluation and Improvement of the Informed Consent Documents in 9 Hospitals, Spain. Rev. Esp. Salud Publica [online]. 2015, vol.89, n.3, pp.307-319. ISSN 2173-9110.

Background: Informed consent forms are very important in the process of medical information. The aim of this study was to assess the changes in the formal quality levels of these documents, as a result of corrective measures implemented after the first evaluation. Methods: Complete cycle of evaluation and quality improvement, with 4 assessments between the years 2007 and 2013. They were assessed 19 criteria in 3,045 documents belonging to 9 hospitals of Murcian Health Service. In the first evaluation the universe was studied and in the others a random sample. From the results of the first assessment corrective measures were implemented. To evaluate its effectiveness the percentage of non-observances per criteria was obtained, calculating the percentage of relative improvement between the first and the last evaluation. To assess the variability among hospitals the high-low ratio in the average number of defects per document was obtained. Results: The percent of improvement achieved was 40.8%. This ranged from 94% in the name of the centre to 17.6% in the relevant consequences, being statistically significant in 16 of the 19 criteria. The average number of defects per document decreased from 7.6 to 4.5, with a high-low ratio among hospitals of 8.33. Conclusions: The improvement achieved in the quality of informed consent documents is related to the effectiveness of corrective measures implemented.

Keywords : Consent forms; Standards; Evaluation studies; Quality improvement; Hospitals; Quality control.

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