Obtaining Patient Informed Consent (IC) for Hematopoietic Cell Transplantation. How Much Information Is Enough?.

Abstract

Introduction: Importance of the IC process emerges from the respect of individual autonomy and the right to self-determination. Beyond being informed, consent involves evaluating, making and signifying a decision. Hematopoietic cell transplantation (HCT) is a complex therapeutic option of “last resort” requiring patients' full understanding and approval. Candidates shall sign detailed documents describing potentially lethal complications and percentages of survival and cure, before HCT.Objectives-Methods: One hundred twenty post-HCT patients were studied after giving IC. They answered a questionnaire and participated in semi-structured interviews focusing on their experience of consent process. Our aim was to evaluate: a) patients' comprehension, perception and impact of the IC process, b) the degree to which they assimilated purposes, risks and benefits of transplantation, c) factors influencing patients' decision to proceed with HCT, d) patient's psychological status at the time of giving IC.Results: IC was considered as an important medico-legal aspect of HCT by 82% of the population. The transition from informal verbal agreement to a formal written contract implied an important psychological impact for the patient. Significant distress occurred by detailed descriptions of potential side effects and mortality. The awareness of only hope of cure centered patient's attention negatively on numeric data regarding death risks and survival. Discordance was showed between pre-HCT expectations and actual outcomes. Consent process failed to prepare patients for the post-HCT difficulties of recovery. Patients indicated insufficient provision of information regarding the impact of HCT in their quality of life. Patients made the decision to undergo HCT prior to possessing any substantial knowledge of risks and benefits of the procedure. Decision was largely based on positive outcome expectation. HCT was valued as a cure and therefore this belief determined their decision. Degree of comprehension depended on age, emotional resources, educational level, familial relationships and physician's personality.Conclusions: Despite patients' claim to understand important information regarding HCT (treatment risks, side effects, outcome probabilities) IC resulted in confusion and anxiety. Considerable distress occurred by detailed descriptions of potential side effects and mortality. Numeric data was proven useless and seriously altered the physician-patient interaction. Providing details of risks and benefits during the IC process may have little impact on the patients' decision-making. Patient's life-threatening illness and limitations on treatment options alter the voluntary nature of their decision. IC has little significance to the patient in terms of his autonomous decision to proceed with treatment. Patient's continuing education is critical and can help HCT candidates to accept what to expect at different stages of treatment. Comprehensiveness of HCT information is a cognitive, emotional and relational procedure demanding appropriate approach to be successful. Providing information is required at every stage of the HCT procedure and has great importance for the development of a trusting relationship with doctors. Accurate counseling empowers patients to make informed decisions. The findings of the present study give implications for clinical practice and for further research.