Shanti Seaman1, Diane Brown1, Ann Eno1, Sile Yu2, Allan B Massie2,3, Aaron A R Tobian3,4, Christine M Durand1, Dorry L Segev2,3, Albert W Wu1,3,5, Jeremy Sugarman6,7. 1. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 2. Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 3. Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA. 4. Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 5. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. 6. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. jsugarman@jhu.edu. 7. Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA. jsugarman@jhu.edu.
Abstract
BACKGROUND: Transplantation 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. RESULTS: PROMETHEUS 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. CONCLUSIONS: We 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.
BACKGROUND: Transplantation 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. RESULTS: PROMETHEUS 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. CONCLUSIONS: We 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.
Entities:
Keywords:
Acquired immunodeficiency syndrome; Care delivery; Ethics; Organ procurement and transplantation; Patient safety; Patient-reported experiences; Quality of care
Authors: Camilla S Hanson; Steve J Chadban; Jeremy R Chapman; Jonathan C Craig; Germaine Wong; Angelique F Ralph; Allison Tong Journal: Transplantation Date: 2015-03 Impact factor: 4.939
Authors: Nicole M Steffens; Jennifer L Tucholka; Michael J Nabozny; Andrea E Schmick; Karen J Brasel; Margaret L Schwarze Journal: JAMA Surg Date: 2016-10-01 Impact factor: 14.766