Reassessing the approach to informed consent: the case of unrelated hematopoietic stem cell transplantation in adult thalassemia patients.

INTRODUCTION: The informed consent process is the legal embodiment of the fundamental right of the individual to make decisions affecting his or her health., and the patient's permission is a crucial form of respect of freedom and dignity, it becomes extremely important to enhance the patient's understanding and recall of the information given by the physician. This statement acquires additional weight when the medical treatment proposed can potentially be detrimental or even fatal. This is the case of thalassemia patients pertaining to class 3 of the Pesaro classification where Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative treatment. Unfortunately, this kind of intervention is burdened by an elevated transplantation-related mortality risk (TRM: all deaths considered related to transplantation), equal to 30% according to published reports. In thalassemia, the role of the patient in the informed consent process leading up to HSCT has not been fully investigated. This study investigated the hypothesis that information provided by physicians in the medical scenario of HSCT is not fully understood by patients and that misunderstanding and communication biases may affect the clinical decision-making process. METHODS: A questionnaire was either mailed or given personally to 25 patients. A second questionnaire was administered to the 12 physicians attending the patients enrolled in this study. Descriptive statistics were used to evaluate the communication factors. RESULTS: The results pointed out the difference between the risks communicated by physicians and the risks perceived by patients. Besides the study highlighted the mortality risk considered to be acceptable by patients and that considered to be acceptable by physicians. CONCLUSIONS: Several solutions have been suggested to reduce the gap between communicated and perceived data. A multi-disciplinary approach may possibly help to attenuate some aspects of communication bias. Several tools have also been proposed to fill or to attenuate the gap between communicated and perceived data. But the most important tool is the ability of the physician to comprehend the right place of conscious consent in the relationship with the patient.

Ethical issues of unrelated hematopoietic stem cell transplantation in adult thalassemia patients.

BACKGROUND: Beta thalassemia major is a severe inherited form of hemolytic anemia that results from ineffective erythropoiesis. Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative therapy. Unfortunately, the subgroup of adult thalassemia patients with hepatomegaly, portal fibrosis and a history of irregular iron chelation have an elevated risk for transplantation-related mortality that is currently estimated to be about 29 percent. DISCUSSION: Thalassemia patients may be faced with a difficult choice: they can either continue conventional transfusion and iron chelation therapy or accept the high mortality risk of HSCT in the hope of obtaining complete recovery.Throughout the decision making process, every effort should be made to sustain and enhance autonomous choice. The concept of conscious consent becomes particularly important. The patient must be made fully aware of the favourable and adverse outcomes of HSCT. Although it is the physician's duty to illustrate the possibility of completely restoring health, considerable emphasis should be put on the adverse effects of the procedure. The physician also needs to decide whether the patient is eligible for HSCT according to the "rule of descending order". The patient must be given full details on self-care and fundamental lifestyle changes and be fully aware that he/she will be partly responsible for the outcome. SUMMARY: Only if all the aforesaid conditions are satisfied can it be considered reasonable to propose unrelated HSCT as a potential cure for high risk thalassemia patients.

Cesarean section without clinical indication versus vaginal delivery as a paradigmatic model in the discourse of medical setting decisions.

Natural childbirth has ceased to be considered the gold standard in the delivery room. For this reason cesarean section on demand is increasing. Many obstetricians justify this phenomenon on evidence-based obstetrical practice. However, other pieces of evidence demonstrate that the data are often a product of the social milieu, and as stated by Wendland, "technology magically wards off the unpredictability and danger of birth". In a recent paper, Kalish pointed out several problems with cesarean deliveries in the absence of medical indications regarding issues of good clinical practice, autonomy, and informed consent. From the late 1990s, the medical community began to speak in favor of women's autonomy in childbirth decisions thus supporting the maternal choice and request for a cesarean section. Starting from these new considerations, it is of primary importance to understand whether emphasizing patient's autonomy is the best, or the only, way to helping the medical decisional process. This general approach may be helpful in all the other cases in which patient's autonomy and physician's responsibility appear to be intertwined in an apparent conflicting manner. We fear that the rhetoric of autonomous choice represents a fundamental shift from medicine-based beneficence toward a perilous relationship founded mainly on patient's wishes, representing a dangerous slippery slope where the physician could be reduced to the role of a functionary delegated to execute patient's claims and demands.

Different perception of surgical risks between physicians and patients undergoing laparoscopic cholecystectomy.

BACKGROUND: Data on the quality of communication during informed consent for surgery is sparse; we investigated this issue in a cohort of patients undergoing laparoscopic cholecystectomy (LC). METHODS: Two hundred and seven consecutive patients with benign biliary disease who had undergone LC completed 2 questionnaires. We investigated the patient choice to undergo the surgical procedure along with perceptions of risk complications presented by the surgeon. Nineteen attending surgeons also completed a questionnaire giving information on their recall perception on the information they provided. Multiple logistic regression analyses determined the predictors of perceived communication factors during the informed consent process. RESULTS: One hundred eighty-one patients (87.4%) returned questionnaires. Younger patients (<50 y) with lower education perceived higher level of risk complications compared with older and higher educated patients (P=0.04 and P<0.001). Younger patients felt psychologic support was necessary (P<0.001) and that quality of life issues related to the interventions were under addressed (P=0.018). Differences were observed between patients' recalled risk of complications and the risk to convert LC to open laparotomy and physicians' perception of information provided to patients regarding these aspects (P<0.01). CONCLUSION: Although informed consent for surgical procedures requires that the procedures are explained and that the patient understands the procedures and risks, our data suggest different perceptions of the quality of information provided during this process between patients and physicians. Physicians should be aware that surgical risks might be perceived differently by patients and this perception might be influenced, for example, by patients' age and education. Major efforts should be directed to improve communications skills in surgical laparoscopy.

[Iatrogenic lesions of the common bile duct in laparoscopic cholecystectomy: three fundamental requirements for their prevention]. / Le lesioni iatrogene della via biliare principale in churgia videoassistita: tre esigenze in tema di prevenzione.

Laparoscopic cholecystectomy has become the gold standard in the treatment of benign biliary disease. Common bile duct injuries are the most serious and feared complications of laparoscopic cholecystectomy, since they cause substantial morbidity and increased hospital stay, and increasingly often are the subject of legal disputes. The causes of these kinds of lesions, according to the international literature, are usually inadequate normal and pathological anatomical knowledge, an incomplete learning curve, inadequate surgical technique, and lastly insufficient compliance of the surgeon. Another important, though underestimated, role in the aetiology of these lesions is played by the human factor, and particularly by a peculiar preconceived attitude. The latter manifests itself as a lack of realism, reasonableness and morality. These three basic requirements are part of universal human experience in the dynamics of knowing and, although not statistically quantifiable, may play a role comparable to that of the technical quality of the surgical performance. In our study we have tried to show, with regard to the prevention of biliary lesions during laparoscopic cholecystectomy, the extent of the importance of these three requirements in the dynamics of knowing, particularly in laparoscopic surgery, where they are not adequately taken into consideration. The analysis of the profound interaction between these requisites and surgical practice may allow correct identification of this preconceived attitude on the part of the operator, which can be avoided or minimized only through appropriate surgical training.