Development of a Patient Reported Measure of Experimental Transplants with HIV and Ethics in the United States (PROMETHEUS)

Journal of Patient-Reported Outcomes

Aaron A. R. Tobian¹  Diane Brown²  Ann Eno²  Christine M. Durand²  Shanti Seaman²  Jeremy Sugarman³  Albert W. Wu⁴  Sile Yu⁵  Allan B. Massie⁶  Dorry L. Segev⁶ 

[1] Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA;Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, 21205, Baltimore, MD, USA;Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA;Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA;

关键词: Acquired immunodeficiency syndrome;    Care delivery;    Ethics;    Organ procurement and transplantation;    Patient-reported experiences;    Patient safety;    Quality of care;   

DOI  :  10.1186/s41687-021-00297-y

来源: Springer

【 摘 要 】

BackgroundTransplantation of HIV-positive (HIV+) donor organs for HIV+ recipients (HIV D+/R+) is now being performed as research in the United States, but raises ethical concerns. While patient-reported outcome measures are increasingly used to evaluate clinical interventions, there is no published measure to aptly capture patients’ experiences in the unique context of experimental HIV D+/R+ transplantation. Therefore, we developed PROMETHEUS (patient-reported measure of experimental transplants with HIV and ethics in the United States). To do so, we created a conceptual framework, drafted a pilot battery using existing and new measures related to this context, and refined it based on cognitive and pilot testing. PROMETHEUS was administered 6-months post-transplant in a clinical trial evaluating these transplants. We analyzed data from the first 20 patient-participants for reliability and validity by calculating Cronbach’s alpha and reviewing item performance characteristics.ResultsPROMETHEUS 1.0 consisted of 29 items with 5 putative subscales: Emotions; Trust; Decision Making; Transplant; and Decision Satisfaction. Overall, responses were positive. Cronbach’s alpha was > 0.8 for all subscales except Transplant, which was 0.38. Two Transplant subscale items were removed due to poor reliability and construct validity.ConclusionsWe developed PROMETHEUS to systematically capture patient-reported experiences with this novel experimental transplantation program, nested it in an actual clinical trial, and obtained preliminary data regarding its performance.

【 授权许可】

CC BY