The leap to trust: perspective of cholecystectomy patients on informed decision making and consent

BACKGROUND: Although experts in ethics and law prescribe autonomous decision making as an essential component of informed consent to operative treatment, patients with esophageal cancer told us in a previous study that they preferred to entrust decision making to their caregivers in the context of life-threatening illness. The purpose of this study was to describe the patients' perspective on the process of informed decision making and consent to operative treatment in the context of a less frightening illness and intervention. STUDY DESIGN: Face-to-face interviews with 33 patients recovering from elective cholecystectomy for cholelithiasis were conducted at Toronto General Hospital in Ontario, Canada. The views of patients were analyzed using a qualitative approach. RESULTS: Patients described a spectrum of initial attitudes toward operative treatment ranging from profound distrust to unquestioning faith. Important factors influencing the decision to accept cholecystectomy included increasingly intolerable symptoms and fear of complications of the disease. Patients managed their doubts and fear by various means, without fully resolving them. CONCLUSIONS: In the context of symptomatic chronic cholelithiasis, pathways to consent for operative treatment originated at diverse, culturally determined starting points. Patients work their way through the decision process along many paths. Some rely on gathering information, but eventually all set aside unresolved residual doubts and fears, enabling a leap to trust and a decision to act.     

Anxiety and informed consent

Forty-three consecutive patients were interviewed on the eve of elective gynaecological surgery to determine the effect of anxiety on the granting of informed consent to participate in an hypothetical study. Anxiety was assessed using the Spielberger state-trait anxiety inventory and 10-cm linear analogue scale. A standardised explanation of an hypothetical premedication study was given and the patients' consent requested. Results were grouped for those who granted (n = 33) and those who withheld (n = 10) consent: anxiety scores for the latter were significantly higher (p less than 0.01). It is concluded that patients with high pre-operative anxiety levels are more likely to withhold consent for inclusion in premedication studies than are those who are less anxious. Seeking informed consent would introduce bias into studies of anxiolytic premedication.     

Human rights and informed consent

The right to information is a right that all human beings have; it is unrenounceable and confers to the human being the Rights to the Political Constitution of the United States of Mexico, the Universal Declaration of Human Rights, the Declaration of Geneva, and the Code of Behavior for Health Personnel. Information given to a sick person should suffice so that he/she can make a decision on management and treatment. Information is related directly with medical ethics and is obligatory not only for health workers but for all professionals in general.     

Operative risk. Patient evaluation, informed consent

It is mandatory, the Authors say, to obtain a previous and definite consent before the patient undergoes the operation. Moreover the patient shall be well acquainted about the risk connected to the operation before he gives his consent. On the contrary, as already confirmed by the Italian Supreme Court of Justice, the consent shall not be valid and the Doctors could be found guilty of "psychic violence". Finally the Authors, to evaluate the probable risks liked to the operation, use scales as ASA and prognostic indexes as SAPS to avoid appraisage too subjective.