Knowledge and practices of obtaining informed consent for medical procedures among specialist physicians: Questionnaire study in 6 croatian hospitals

Abstract

Aim To assess physicians' knowledge and practices for obtaining patients' informed consent to medical procedures. Methods An anonymous and voluntary survey of knowledge and practices for obtaining informed consent was conducted among 470 physicians (63% response rate) working in 6 hospitals: 93 specialists in anesthesiology, 166 in internal medicine, and 211 in surgery. Results Only 54% physicians were acquainted with the fact that the procedure for obtaining consent was regulated by the law. Internists and surgeons were better informed than anesthesiologists (P = 0.024). More than a half of respondents (66%) were familiar with the fact that a law on patient rights was passed in Croatia; there were no differences among different specialties (P = 0.638). Only 38% of the physicians were fully informed about the procedure of obtaining consent. Internists and surgeons provided detailed information to the patient in 33% of the cases and anesthesiologists in 16% of the cases (P < 0.050). Internists reported spending more time on informing the patient than anesthesiologists and surgeons (P < 0.001). There were no differences in knowledge and practices for obtaining informed consent between physicians working in university and those working in community hospitals (P ≥ 0.05 for all questions). Conclusion Physicians in Croatia have no formal education on informed consent and implement the informed consent process in a rather formal manner, regardless of the type of hospital or medical specialty. Systemic approach at education and training at the national level is needed to improve the informed consent process. Informed consent is a professional ethics issue emanating from the fiduciary responsibility of the physician to the patient. It is an integral component of the physician's fiduciary responsibility. In many countries informed consent for medical procedures is a standard procedure (1-9) for providing the patients with the information on diagnostic and treatment procedures, risks, complications, and alternative treatment options in non-emergency cases (5,9,10), thereby considerably improving the communication between physician and patient. A signed form is the evidence that their conversation led to a mutual understanding. However, the implementation of the informed consent process differs among countries because informing the patient and requiring the consent are still not regarded as a legal obligation of the physician (6). In the clinical setting, the term "informed consent" was developed in the USA in 1957. It was further developed in the Declaration of Helsinki in 1964, which established worldwide ethical principles for medical research involving human participants. In its current, 2008 version (11), the article 24 states: "In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed." (citation, paragraph 24). The Belmont Report from 1979 outlined the guidelines for the protection of human participants of research. In Croatia, the requirement to obtain treatment consent was first legally introduced in 1997 (12) and the Act on The Protection of Patent's Rights was passed in 2004 (13). The regulations proscribe that patients are entitled to get full information on their health condition, including medical assessment of the results and outcomes of a certain diagnostic or therapeutic procedure and recommended examinations and procedures, and to know the dates when they are to get that information. The patients should be informed on the possible advantages of performing or not performing the procedures recommended and risks involved, and possible alternatives for the procedures. Thereafter, they have the right to make a decision to accept or reject the outlined treatment. The information should be clearly explained having in mind the patients' age, education, and mental abilities. A signed form is just evidence that a conversation between physician and patient led to that mutual understanding. Physicians' knowledge and attitudes toward informed consent considerably differ in various countries and among different medical specialists (14-17). We conducted this study to compare knowledge and practices for obtaining informed consent for medical procedures between 3 groups of specialists. We compared the specialists in anesthesiology, internal medicine and related medical specialties, and in surgery, who obtain informed consent for medical procedures on a daily basis.