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

Philosophy, Ethics, and Humanities in Medicine

Giorgio La Nasa¹  Gary S Collins⁵  Maria Rita Pittau⁶  Federica Demuru²  Roberto Demontis⁶  Michela Pintor²  Carmen Addari⁴  Maria Grazia Orofino⁴  Eugenia Piras¹  Adriana Vacca¹  Fabio Efficace³  Ernesto d’Aloja²  Giovanni Caocci¹  Salvatore Pisu² 

[1] Bone Marrow Transplantation Center, Hospital “R. Binaghi”, Cagliari, Italy;Mediterranean Center of Clinical Bioethics, University of Cagliari-Sardegna Ricerche, Cagliari, Italy;Health Outcome Research Unit, Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA), Data Centre, Rome, Italy;Department of Biomedical Science and Biotechnology, Pediatric Clinic of the Bone Marrow Transplant Centre, University of Cagliari, Cagliari, Italy;Centre for Statistics in Medicine, University of Oxford, Oxford, UK;Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy

关键词: Conscious consent;    Communication bias;    Patient-doctor relationship;   

Others  :  1132175
DOI  :  10.1186/1747-5341-9-13

 received in 2013-07-28, accepted in 2014-06-29,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Pisu et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Paterick TJ, Carson GU, Allen MC, Paterick TE: Medical informed consent: general considerations for physicians. Mayo Clin Proc 2008, 83:313-319.
• [2]Schloendorff vv the society of the New York Hospital 1914. 211 NY 125 105 NE 92 1914 Lexis 1028
• [3]Surbled G: La Morale dans ses Rapports avec la Medicine et l’Hygiene. Paris: V. Retaux et fils; 1905:216-217.
• [4]Rund D, Rachmilewtz E: Beta thalassemia. New Engl J Med 2005, 353:1135-1146.
• [5]Borgna-Pignatti C, Rugolotto S, De Stefano P, Zhoo H, Cappellini MD, Del Vecchio GC, Romeo MA, Forni GL, Gamberini MR, Ghilardi R, Piga A, Cuccu A: Marrow transplantation in patients with thalassemia major treated with transfusion and deferoxamine. Haematologica 2004, 89:1187-1193.
• [6]Borgna Pignatti C, Rugolotto S, De Stefano P, Piga A, Di Gregorio F, Gamberini MR, Sabato U, Melevendi C, Cappellini MD, Verlato G: Survival and disease complications in thalassemia major. Ann New York Acad Sci 1998, 850:227-231.
• [7]Taher A, Jefri A, Elalfly MS, Al Zir K, Daar S, Rofail D, Baladi JF, Habr D, Kriemler-Krahn U, El-Beshlawy A: Improved treatment satisfaction and convenience with deferasirox in iron-overloaded patients with beta thalassemia: results from the ESCALATOR trial. Acta Haematol 2010, 123:220-225.
• [8]Cao A, Galanello R: Beta Thalassemia. Genet Med 2010, 12:61-76.
• [9]La Nasa G, Giarnini F, Colatelli F, Arras M, De Stefano P, Leda A, Pizzati A, Sanna MA, Vacca A, Lucarelli G, Contu L: Unrelated donor bone marrow transplantation for thalassemia: the effect of extended haplotypes. Blood 2002, 99:4350-4356.
• [10]Caocci G, Pisu S, Argioulu F, Giardini C, Locatelli F, Vacca A, Orofino MG, Piras E, De Stefano P, Addari MC, Ledda A, La Nasa G: Unrelated donor bone marrow transplantation in adult patients with thalassemia. Bone Marrow Transplant 2006, 37:165-169.
• [11]Locatelli F: Outcome of unrelated donor bone marrow transplantation for thalassemia major patients [abstract]. Blood 2011, 118:149.
• [12]Bernardo ME, Piras E, Vacca A, Giorgiani G, Zecca M, Bertaina A, Pagliara D, Contoli B, Pinto RM, Caocci G, Mastronuzzi A, La Nasa G, Locatelli F: Allogeneic hematopoietic stem cell transplantation in thalassemia major: results of a reduced-toxicity conditioning regimen based on the use of treosulfan. Blood 2012, 120:473-476.
• [13]Merckaert I, Libert Y, Bron D, Jaivenois MF, Martiat P, Slachmuyalder JL, Razavi D: Impact of life-threatening risk information on the evolution of patient’ anxiety and risk recall: the specific context of informed consent for experimental stem cell transplant. Patient Educ Couns 2009, 75:192-198.
• [14]Mazur DJ, Hickam DH: Patients’ preferences for risk disclosure and role in decision making for invasive medical procedures. J Gen Intern Med 1997, 12:114-117.
• [15]Kerr J, Engel J, Schlesinger-Raab A, Sauer H, Holzel D: Communication, quality of life and age: results of a 5 year prospective study in breast cancer patients. Ann Oncol 2003, 14:421-427.
• [16]Redelmeier DA: The cognitive psychology of missed diagnoses. Ann Intern Med 2005, 142:115-120.
• [17]Meropol NJ, Weinfurt KP, Burnett CB, Balshem A, Benson AB 3rd, Castel L, Corbett S, Diefenbach M, Gaskin D, Li Y, Manne S, Marshall J, Rowland JH, Slater E, Sulmasy DP, Van Echo D, Washinfion S, Schulman KA: Perceptions of patients and physician regarding phase-1 cancer clinical trials: implications for physician-patient communication. J Clin Oncol 2003, 21:2589-2596.
• [18]Kaplan ER, Meier P: Non parametric estimation from incomplete observation. J Am Stat Assoc 1958, 53:457-481.
• [19]Schofield PE, Butow PN, Thompson JF, Tattersall MH, Beeney LJ, Dunn SM: Psychological responses of patients receiving a diagnosis of cancer. Ann Oncol 2003, 14:48-56.
• [20]Ptacek JT, Eberhardt TL: The patient-physician relationship. Breaking bad news: a review of the literature. J Am Med Assoc 1996, 276:492-496.
• [21]Kinnersley P, Philips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AGK: Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures (review). Cochrane Libr 2013, (7):CD009445.
• [22]Gillett G, Walker S: The evolution of informed consent. J Law Med 2012, 19(4):673-677.
• [23]Paling J: Strategies to help patients understand risk. Br Med J 2003, 327:745-748.
• [24]Elwyn G, Edwards A, Gwyn R, Grol R: Towards a feasible model for shared decision making: focus group with general practice registrars. Br Med J 1999, 319:753-756.
• [25]Sardell AN, Trierweiler SJ: Disclosing the cancer diagnosis. Procedures that influence patient hopefulness. Cancer 1997, 72:3355-3365.
• [26]Reyna VF, Hamilton AJ: The importance of memory in informed consent for surgical risk. Med Decis Making 2001, 21:152-155.
• [27]Fortin JM, Hirota LK, Bond BE, O’Cobbor AM, Col NF: Identifying patient preferences for communicating risk estimates: a descriptive pilot study. BMC Med Inform Decis Mak 2001, 1:2. BioMed Central Full Text
• [28]Agre P, Kurtz RC, Krauss BJ: A randomized trial using videotape to present consent information from colonoscopy. Gastrointest Endosc 1994, 40:271-276.
• [29]Festinger DS, Dugosh KL, Croft JR, Arabia PL, Marlowe DB: Corrected feedback: a procedure to enhance recall of informed consent to research among substance abusing offenders. Ethics Behav 2010, 20(5):387-399.
• [30]Kubler Ross E: On Death and Dying. London UK: Routledge; 1973.
• [31]Mallardi V: The origin of informed consent. Acta Otorhinolaryngol Ital 2005, 25:312-327.
• [32]Laforet EG: The fiction of informed consent. J Am Med Assoc 1997, 235:1579-1584.
• [33]Devettere RJ: Pratical Decision Making in Health Care Ethics. Washington D.C: Georgetown University Press; 2000:99-100.
• [34]Will JF: A brief historical and theoretical perspective on patient autonomy and medical decision making. Chest 2011, 139(3):669-673.
• [35]Shorter E: The troubled history of doctors and patients. New York: Simon and Shuster ed; 1985.
• [36]Sreenivasan G: Does informed consent to research require comprehension? Lancet 2003, 362:2016-2018.
• [37]Beauchamp TL, Childress JF: Principles of Biomedical Ethics. New York-Oxford: Oxford University Press; 2009.
• [38]Engelhardt HT: The foundations of Bioethics. New York-Oxford: Oxford University Press; 1996.
• [39]Pellegrino ED, Thomasma D: For the Patient Good. The Restoration of Beneficence in Health Care. New York-Oxford: Oxford University Press; 1988.
• [40]Caocci G, La Nasa G, d’Aloja E, Vacca A, Piras E, Pintor M, Demontis R, Pisu S: Ethical issues on unrelated hematopoietic stem cell transplantation in adult thalassemia patients. BMC Med Ethics 2011, 12:4. BioMed Central Full Text
• [41]d’Aloja E, Pintor M, Paribello F, Pisu S: Neither freedom nor autonomy without beneficence. Arch Intern Med 2008, 168:548-549.
• [42]Jacoby LH, Maloy B, Cirenza E, Shelton W, Goggins T, Balint J: The basis of informed consent for BMT patients. Bone Marrow Transplant 1999, 23:711-717.
• [43]Terri RF, Bradley EH, Towle VR, Allore H: Understanding the treatment preferences of seriously ill patients. New Engl J Med 2002, 346:1061-1066.
• [44]Lee SJ: Putting shared decision making into practice. ASH Education Book. 2002, 473-477.
• [45]Pisu S, Caocci G, La Nasa G, De Stefano F: The Role of Consent in the Relationship between Physician and Patient. In Decision Making on Medicine and Health Care. Edited by Tolana PC. New York: Nova Biomedical Books; 2008:1-5.
• [46]Gillet G: Intention, autonomy, and brain events. Bioethics 2009, 23(6):330-339.
• [47]d’Aloja E, Floris L, Muller M, Birocchi F, Fanos V, Paribello F, Demontis R: Shared decision-making in neonatology: an utopia or an attainable goal? J Matern Fetal Neonatal Med 2010, 23(3):56-58.
• [48]Mazur DJ: The new medical conversation. Boston: Rowman & Littlefield Publishers; 2003:99-100.