Desde la perspectiva del paciente: ¿Existe una necesidad de mejorar la calidad de consentimiento informado para cirugía en los hospitales de formación?
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From the Patient's Perspective: Is There a Need to Improve the Quality of Informed Consent for Surgery in Training Hospitals?
Cawich SO, Barnett AT, Crandon IW, Drew SD, Gordon-Strachan G.
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Perm J. 2013 Fall;17(4):22-6. doi: 10.7812/TPP/13-032.
Abstract
OBJECTIVE: This study was performed to evaluate the presurgical informed consent process at a training hospital in Jamaica. METHODS:A postoperative survey was administered to all consecutive able and willing adult patients who underwent the presurgical informed consent process with surgical residents during a 5-week period. Information was collected on patient demographics and patients' perception and satisfaction with the informed consent process. RESULTS: There were 210 surveys completed. Patients were unaware of the training status of the physician involved with their presurgical informed consent process in 48% of cases. Nineteen (9%) patients were instructed to sign a consent document without any discussion. An attempt was made to secure a signature after some discussion with the remaining 191 patients. Patients reported that details of the operation were discussed 74% of the time; potential benefits of the surgery, 72% of the time; potential morbidity, 84% of the time; potential mortality, 19% of the time; predicted postoperative course, 49% of the time; projected recovery, 26% of the time; and other treatment options, 33% of the time. Forty-five patients believed that they were instructed to sign the consent document with minimal discussion. At termination of the consent process, only 70% of the 210 patients reported that they signed the consent form voluntarily. Overall, 67% of patients thought the current informed consent process was unsatisfactory. CONCLUSION: The current informed consent process in use in the surgical training program at the University Hospital of the West Indies requires improvement to meet expected ethical and legal standards.
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Como los IRBs (Institutional Review Board) ven y hacen decisiones sobre los consentimientos informados
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How IRBs view and make decisions about consent forms. Klitzman RL. J Empir Res Hum Res Ethics. 2013 Feb;8(1):8-19. doi: 10.1525/jer.2013.8.1.8.Abstract IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn't been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how "perfect" forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also "nitpick" these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research.
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| Consentimiento preoperatorio informado: ¿Está realmente informado? |
Preoperative informed consent: is it truly informed?
Jawaid M, Farhan M, Masood Z, Husnain S.
Iran J Public Health. 2012;41(9):25-30. Epub 2012 Sep 1.
Abstract
BACKGROUND:Pre-operative informed consent is an important aspect of surgery, yet there has been no formal training regarding it in Pakistan. This study was done to assess the preoperative informed consent practice. METHODS: After taking informed permission, a questionnaire was filled in during an interview with 350 patients, who have undergone elective surgical procedures under routine practice conditions from July to October 2010. All the patients were asked a set of standard questions which related to the information they were provided before the operation as a part of standard informed consent practice. RESULTS: Most i.e. 307 (87.7%) patients were informed about their condition but very few 12 (3.4%) were briefed regarding complications. Only 17 (4.9%) patients said they knew about the risks and complications of proposed anesthesia. One hundred thirty-eight (39.4%) patients said that they were allowed to ask questions while giving consent. Most of the time 196 (56%) consent was taken one day before surgery but in few 2 (0.6%) instances it was taken on the morning of surgery and on operation table in some cases 3 (0.9%) as reported by patients. The consent form was signed by the patients themselves in only 204 (58.3%) cases and by their relatives in the rest. About half the number of patients 171 (48.9%) interviewed were satisfied from the information they received as informed consent process. CONCLUSION: This study highlights the poor quality of patient knowledge about surgical procedures and the inadequate information provided.
KEYWORDS: Informed consent, Operative risks, Pakistan, Surgical ethics
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