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Is ‘informed consent’ an ‘understood consent’ in hematopoietic cell transplantation?

Abstract

Hematopoietic cell transplantation (HCT) is a complex and highly specialized medical treatment that is associated with significant risks, including death. Furthermore, transplantation is offered to patients who often have no other curative treatment alternatives. The routine-consent process for HCT typically occurs before HCT and is influenced by many factors related to patients, physicians and the transplant per se. These factors can impede the consent process and subsequently result in a failure of proper engagement in and an understanding of the procedure with resultant adverse consequences influencing patients and even the patient–physician relationship. We contend that informed consent is a dynamic and ongoing process and that better patient education can assist in the decision making, fulfill the ethical principle of respect for autonomy and engage the patient to maximize compliance and adherence to therapy. This manuscript reviews the key literature pertaining to the decision-making and consent process in HCT and proposes guidelines for improving the consent process. Strategies for improving patient comprehension, engagement and enhancing consent forms are discussed.

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References

  1. Schloendorff vs Society of New York Hospital 105 N.E. 92 (N.Y. 1914).

  2. Salgo vs Leland Stanford Jr. Univ. Bd Trustees. 154 Cal. App. 2d., 1957.

  3. Katz J . Informed consent—must it remain a fairy tale? J Contemp Health Law Pol 1994; 10: 69–91.

    CAS  Google Scholar 

  4. Schenker Y, Fernandez A, Sudore R, Schillinger D . Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making 2011; 31: 151–173.

    Article  Google Scholar 

  5. 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.

    Article  CAS  Google Scholar 

  6. Singer DA, Donnelly MB, Messerschmidt GL . Informed consent for bone marrow transplantation: identification of relevant information by referring physicians. Bone Marrow Transplant 1990; 6 431–437.

    CAS  PubMed  Google Scholar 

  7. Taylor HA . Barriers to informed consent. Semin Oncol Nurs 1999; 15: 89–95.

    Article  CAS  Google Scholar 

  8. Schenker Y, Meisel A . Informed consent in clinical care: practical considerations in the effort to achieve ethical goals. JAMA 2011; 305: 1130–1131.

    Article  CAS  Google Scholar 

  9. Beyer DR, Lauer MS, Davis S . Readability of informed-consent forms. New Engl J Med 2003; 348 2262–2263.

    Article  Google Scholar 

  10. Wise J . Patients do not read consent forms. BMJ 1996; 313: 1421.

    Article  Google Scholar 

  11. Penman DT, Holland JC, Bahna GF, Morrow G, Schmale AH, Derogatis LR et al. Informed consent for investigational chemotherapy: patients' and physicians' perceptions. J Clin Oncol 1984; 2 849–855.

    Article  CAS  Google Scholar 

  12. Paasche-Orlow MK, Taylor HA, Brancati FL . Readability standards for informed-consent forms as compared with actual readability. New Engl J Med 2003; 348 721–726.

    Article  Google Scholar 

  13. Jordens CF, Montgomery K, Forsyth R . Trouble in the gap: a bioethical and sociological analysis of informed consent for high-risk medical procedures. J Bioethic Inq 2013; 10 67–77.

    Article  Google Scholar 

  14. Fisch M, Unverzagt F, Hanna M, Bledsoe P, Menke C, Cornetta K . Information preferences, reading ability, and emotional changes in outpatients during the process of obtaining informed consent for autologous bone-marrow transplantation. J Cancer Educ 1998; 13 71–75.

    CAS  PubMed  Google Scholar 

  15. Stiff PJ, Miller LA, Mumby P, Kiley K, Batiste R, Porter N et al. Patients' understanding of disease status and treatment plan at initial hematopoietic stem cell transplantation consultation. Bone Marrow Transplant 2006; 37: 479–484.

    Article  CAS  Google Scholar 

  16. Cassileth BR, Zupkis RV, Sutton-Smith K, March V . Information and participation preferences among cancer patients. Ann Intern Med 1980; 92: 832–836.

    Article  CAS  Google Scholar 

  17. Cox K . Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Educ Counsel 2002; 46: 31–38.

    Article  Google Scholar 

  18. Patenaude AF, Rappeport JM, Smith BR . The physician's influence on informed consent for bone marrow transplantation. Theoret Med 1986; 7: 165–179.

    Article  CAS  Google Scholar 

  19. Hodkinson K . The need to know—therapeutic privilege: a way forward. Health Care Anal 2013; 21: 105–129.

    Article  Google Scholar 

  20. May T, Spellecy R . Autonomy, full information, and genetic ignorance in reproductive medicine. The Monist 2006; 89: 466–481.

    Article  Google Scholar 

  21. Forsyth R, Scanlan C, Carter SM, Jordens CF, Kerridge I . Decision making in a crowded room: the relational significance of social roles in decisions to proceed with allogeneic stem cell transplantation. Qual Health Res 2011; 21: 1260–1272.

    Article  Google Scholar 

  22. Grulke N, Bunjes D, Larbig W, Kachele H, Bailer H . Physicians' prognostic estimates of survival for patients undergoing allogeneic hematopoietic stem cell transplantation. J Psychosomat Res 2008; 65: 61–66.

    Article  Google Scholar 

  23. Lee SJ, Fairclough D, Antin JH, Weeks JC . Discrepancies between patient and physician estimates for the success of stem cell transplantation. JAMA 2001; 285: 1034–1038.

    Article  CAS  Google Scholar 

  24. Grulke N, Bailer H . Facing haematopoietic stem-cell transplantation: do patients and their physicians agree regarding the prognosis? Psycho-oncology 2010; 19: 1035–1043.

    Article  Google Scholar 

  25. Andrykowski MA, Brady MJ, Greiner CB, Altmaier EM, Burish TG, Antin JH et al. 'Returning to normal' following bone marrow transplantation: outcomes, expectations and informed consent. Bone Marrow Transplant 1995; 15: 573–581.

    CAS  PubMed  Google Scholar 

  26. Little M, Jordens CF, McGrath C, Montgomery K, Lipworth W, Kerridge I . Informed consent and medical ordeal: a qualitative study. Intern Med J 2008; 38: 624–628.

    Article  CAS  Google Scholar 

  27. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB . Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics 2013; 14: 28.

    Article  Google Scholar 

  28. Tamariz L, Palacio A, Robert M, Marcus EN . Improving the informed consent process for research subjects with low literacy: a systematic review. J Gen Intern Med 2013; 28: 121–126.

    Article  Google Scholar 

  29. MacDougall DS, Connor UM, Johnstone PA . Comprehensibility of patient consent forms for radiation therapy of cervical cancer. Gynecol Oncol 2012; 125: 600–603.

    Article  Google Scholar 

  30. Klitzman R . How US institutional review boards decide when researchers need to translate studies. J Med Ethics 2014; 40: 193–197.

    Article  Google Scholar 

  31. Denzen EM, Santibanez ME, Moore H, Foley A, Gersten ID, Gurgol C et al. Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biol Blood Marrow Transplant 2012; 18: 183–189.

    Article  Google Scholar 

  32. Martinez-Perez B, de la Torre-Diez I, Lopez-Coronado M, Sainz-de-Abajo B, Robles M, Garcia-Gomez JM . Mobile clinical decision support systems and applications: a literature and commercial review. J Med Syst 2014; 38: 4.

    Article  Google Scholar 

  33. Meropol NJ, Egleston BL, Buzaglo JS, Balshem A, Benson AB III, Cegala DJ et al. A web-based communication aid for patients with cancer: the CONNECT Study. Cancer 2013; 119: 1437–1445.

    Article  Google Scholar 

  34. Chen C, Haddad D, Selsky J, Hoffman JE, Kravitz RL, Estrin DE et al. Making sense of mobile health data: an open architecture to improve individual- and population-level health. J Med Internet Res 2012; 14: e112.

    Article  Google Scholar 

  35. Fleisher L, Ruggieri DG, Miller SM, Manne S, Albrecht T, Buzaglo J et al. Application of best practice approaches for designing decision support tools: the preparatory education about clinical trials (PRE-ACT) study. Patient Educ Counsel 2014; 96: 63–71.

    Article  Google Scholar 

  36. Mazanec S, Daly B, Meropol NJ, Step M . Facilitating enrollment in a Cancer Registry through modified consent procedures: a pilot study. J Empir Res Hum Res Ethics 2012; 7: 71–75.

    Article  Google Scholar 

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Acknowledgements

This publication was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant Number 8UL1TR000055. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. We thank Drs Cynthiane Morgenwech, MD, MA, and Hillard Lazarus, MD, for their constructive critique of this manuscript.

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D’Souza, A., Pasquini, M. & Spellecy, R. Is ‘informed consent’ an ‘understood consent’ in hematopoietic cell transplantation?. Bone Marrow Transplant 50, 10–14 (2015). https://doi.org/10.1038/bmt.2014.207

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