"I had no choice!" : Challenges in the informed consent and decision-making process for allogeneic stem cell transplantation : a qualitative method triangulation

Abstract

Background

For some patients allogeneic stem cell transplantation (alloSCT) offers the only chance for cure. There is limited empirical data on the informed consent (IC) process and respective perceptions and evaluations of alloSCT patients so far. Objective

The objective of this single centre empirical-ethical study is to explore the IC and decision-making process in the context of alloSCT at a German university hospital, with a particular focus on ethical challenges. Study design

From 10/2021 to 12/2023, 8 patients were followed during 16 separate IC consultations on alloSCT, by non-participant observation respectively. In addition, a separate interview in the absence of other medical personnel was conducted with the patients after alloSCT about the consultations and the reasons for their decision. Transcripts were analysed using the Qualitative Analysis Guide of Leuven and included triangulation of interview and observational data. Results

We observed eight patients at the two IC consultations each and interviewed seven after completed alloSCT. Consultations were carried out by three different physicians and together lasted a median of 89 min. The patient surveys were conducted at the time of the patients’ discharge from hospital, after the transplant had been performed. Patients had a positive overall impression of the information process and appreciated it. A central theme in the analysis was patients’ impression of having had “no choice” in the treatment decision. Various possible reasons for this narrative could be identified in the interviews and triangulated with the results of our observations. The patients’ motives for their choice were: the therapeutic goal of healing; fear of death; the desire to live longer and trust in medical expertise. There was often a lack of awareness about other treatment options on the side of the patients. Observations suggest that the consultations focused on the physician’s recommendations while palliative treatment was presented in a limited way. Extensive planning which is necessary for successful alloSCT may be perceived as organisational pressure on decision-making by patients. Conclusion

The narrative of not having had a choice is complex and should be explored further by a specific catalog of specific questions. In particular, the organisational processes and the pressure they may place on patients should be examined more closely and reflected upon.