Highlighting the experiences of female participants with lower extremity amputation during daily activities and comparisons of sex-related factors during a clinical trial

BACKGROUND: Biological female participants with lower extremity amputation (LEA) report decreased satisfaction with their prosthesis and increased pain and social isolation after amputation, compared with male participants. Despite representing 33% of amputees in the United States, female participants are often underrepresented in research, which can perpetuate health disparities. Female participants with LEA report feeling invisible and that their needs are unmet currently. A deeper understanding of female participants with LEA lived experiences and activities can help improve health outcomes and decrease health disparities. OBJECTIVES: To highlight female participants with LEA experiences during a clinical trial and compare the lived experiences of female and male participants with LEA during the trial. STUDY DESIGN: Secondary qualitative analysis. METHODS: Twenty-four semi-structured interview transcripts were reviewed that explored participants' experiences while testing a novel prosthetic foot (2 interviews per participant). Two reviewers independently reviewed all self-identified female participants (n = 6) and randomly selected self-identified male participants (n = 6) using an inductive, phenomenological approach, practicing reflexivity and peer debriefing. RESULTS: Four distinct themes were identified, highlighting female participants' experiences and comparing the female and male participants' interviews: (1) experiences of embodiment, (2) the progression of apprehension toward confidence while participating in a clinical trial, (3) footwear as a form of self-expression and functional ability, and (4) using side-to-side movement to navigate tight and community spaces. CONCLUSION: Female participants discussed some aspects of daily experiences and prosthesis needs different from male participants. Therefore, it is vital to include a diversity of sexes in clinical trials involving people with LEAs to improve health outcomes and reduce health disparities.