Adverse Symptoms of Immunosuppressants: The Patient Perspective

Background: Solid organ transplant recipients require lifelong immunosuppressive therapy in order to prevent graft rejection. Unfortunately, these multiple-drug regimens are associated with frequent adverse effects that can negatively impact quality of life (QoL), cause interruptions in treatment, and may even contribute to treatment failure (i.e., graft rejection). Objectives: To develop and pilot test a survey that characterizes patient perceptions of adverse symptoms of immunosuppressants (ASI), QoL, and medication adherence in a population of patients who have received a solid organ transplant. Methods: A literature review was undertaken to identify tools assessing patient symptom experience, QoL, and adherence in transplant recipients. A single questionnaire was developed to assess all of these domains. On completion of the survey development phase, the tool was piloted electronically to all adult transplant recipient members of the Canadian Transplant Association. Questionnaires were interpreted using descriptive analysis and frequencies, and respondent’s comments were qualitatively assessed using thematic analysis. Feasibility was assessed by response rate, patient’s feedback and missing data. Results: The literature search identified three tools that were incorporated into the questionnaire: the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD), the Short Form- 12 (SF- 12), and the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) to measure symptom experience, QoL, and nonadherence to immunosuppressive medications, respectively. The questionnaire was distributed to 249 solid organ transplant recipients and achieved a 51% response rate (n=127). Mean age of survey respondents was 55.5 ±13.2 years, most had good allograft function, few co-morbidities, and reported a similar QoL to that of the general public. More than half of the respondents (61%) received their transplant over 6 years ago, and respondents reported a median of 19 different adverse symptoms (IQR 12- 27). The most prevalent symptoms for both men and women were tiredness, flatulence, and lack of energy (reported at an incidence of 84%, 82% and 70% for women and 80%, 76%, and 66% for men, respectively), while the most distressing symptoms were tiredness, flatulence, and sleeplessness (mean 2.2, 2.2 and 2.1 on a scale of 0 to 4, respectively) in men and joint pain, diarrhea, and lack of energy in women (mean 2.4, 2.4, and 2.3 on a scale of 0 to 4, respectively). Nonadherence to immunosuppressive medications was reported by 29-50% of respondents. Conclusion: It is feasible to assess symptom experience, QoL and nonadherence to immunosuppressive medications using a single tool in transplant recipients. Despite the high prevalence of adverse symptoms, QoL remained high in members of the Canadian Transplant Association. Wider application of this tool will determine if the findings from this study sample are representative of a general population of patients with solid organ transplants.