[Qualitative analysis of the perception of people who participate in a clinical trial, Navarra].
BACKGROUND
The objective of this study is to explore the perception that participants in a clinical trial have about the information disclosured by the physician, during patient recruitment and along the study as a preliminary stage for drafting a questionnaire.


METHODS
Qualitative study by means of quasi-structure interviews to subjects of different features taken from a patients list obtained by randomized selection of participants in clinical trials approved within the 1998-1999 period. For conducting the interviews, a guide was prepared based on the recommendations of the Helsinki Declaration.


RESULTS
Six (6) interviews were held with 7 individuals, as one married couple was interviewed. Most of the categories encountered belonged to the Helsinki Declaration. In addition, others being related to the fulfillment of expectations and to the balance of the risks/benefits done by the individuals for deciding to take part in the study.


CONCLUSIONS
The patients were acceptably informed of the most points dealt with under the Helsinki Declaration. The existence of lacking areas having a major impact on the fulfillment of their expectations however having been revealed.
Silvestre Busto
Carmen
C
Servicio de Medicina Preventiva y Gestión de la Calidad Asistencial, Hospital de Navarra, Avda. Irunlarrea 3, 31008 Pamplona. msilvesb@cfnavarra.es
Gost Garde
Javier
J
Astier Peña
Pilar
P
Ezpeleta Iturralde
Pilar
P
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000523:psychology*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D010465:Perception; D013030:Spain