Written informed consent (WIC ) of the Autonomous Community of Madrid.

Antecedentes.

The doctor-patient relationship has been recently undergoing a change. This is exerting an influence on doctor-patient communication and on the way clinical decisions involving the patient are taken. The written informed consent has emerged from this situation.

Objectives:

1) To describe how the physician and the patient view the doctor-patient relationship.

2) To describe how the physician and patient perceive doctor-patient communication.

3) To describe how physician and patient perceive the clinical decision-making process.

4) To describe how the WIC is perceived by doctor and patient.

Methodology:

The study design is a cross sectional descriptive analysis with qualitative and quantitative methodologies, applied to both doctors and patients.

Qualitative phase with physicians: the aim of this phase is to identify variables involved in the assessment made by physicians of the WIC. To this end, discussion groups and semi-structured interviews are carried out with doctors from public and private hospitals within the Autonomous Community of Madrid.

Quantitative phase with physicians: A questionnaire for this phase is prepared with the data obtained from the physicians during the qualitative phase. The aim of this phase is to learn how the doctors from public and private hospitals within the Autonomous Community of Madrid value the WIC process.

Qualitative phase with patients: Discussion groups and semi-structured interviews are organized. The opinions of the patients are then analyzed.

Participants, in addition to the Scientific Department of the Kovacs Foundation:

Research Unit of Health Care Services of the Carlos III Institute of the Spanish Ministry of Health, University Center for Public Health.

Financed by the Health Care Research Fund of the Ministry of Health.

Current Status of Project:

In progress. The results obtained have been presented in several meetings of the International Society of Assessment of Health Care Technology:

García Armesto S, Lázaro p. Written informed consent: the perspective of young and University educated users. Proceedings of the International Society of Technology Assessment in Health Care (ISTAHC) 15th Annual Meeting. Edinburgh, UK, 20-23 June 1999.

García Armesto S, Azcona B, Luengo S, Sánchez C, Lázaro P. Written Informed Consent: the Physician's Perspective. 14th Annual Meeting. ISTAHC. Ottawa, Canada, 1998.

García Armesto S, Lázaro P. Including customers in health technology assessment: a methodological proposal. 13 ISTAHC Annual Meeting. Barcelona, 1997.

In short, the results show that the physicians identify the WIC as a legal form which contains detailed data on the risks of procedures. They consider that the WIC does not serve as a doctor-patient communication instrument and may even prove to be detrimental for the patients and for the doctor-patient relationship itself. The physicians view the WIC as having an essentially defensive role, which caters to the needs of doctors more than those of patients. They doubt its effectiveness and , in practice, they view it as a mere bureaucratic requirement which does not help to inform patients nor ease their participation in the decision-making process.