Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation

Abstract

Background: Current clinical trials of new antibiotics facilitate bringing new drugs to market but often fail to provide useful information for clinical decision making. Methods: Literature review of desirability of outcome ranking (DOOR) in antibiotic clinical trials and description how DOOR can fit into design, administration, and assessment of clinical trials. Results: DOOR is an approach that addresses many of the shortcomings of current trials by incorporating efficacy and safety into a single outcome to analyze the patient experience in its entirety. Application of partial credit, tiebreaker strategies including response adjusted for duration of antibiotic risk (RADAR), and DOOR for Management of Antimicrobial Therapy (DOOR MAT) provides additional nuance and granularity. To address pitfalls of DOOR, investigators must develop the DOOR a priori, ideally with input from and incorporation of patient voices, and should perform component analysis to ensure that imbalances in key components are detected. Conclusion: Inclusion of DOOR in clinical trials will enrich our understanding of how new antibiotics might benefit patients who have had transplantation. Additional work to develop best practices for DOOR selection, analysis, and interpretation must continue, and incorporation of the patient perspective is essential. K E Y W O R D S antibiotic-resistant bacteria, clinical trial design, desirability of outcome ranking, health-related quality of life THE CURRENT STATE OF CLINICAL TRIALS FOR NEW ANTIBIOTICSAntibiotics have saved millions of lives in the modern medical era and helped pave the way for modern surgical development, including solid organ transplantation. 1,2 However, in the setting of immunosuppression, anatomic issues that arise after surgery, donor-derived

Antimicrobial stewardship in solid organ transplantation—A call for action!

“…3 The use of the Desirability of Outcome ranking for new interventions so that we can have a better understanding of what is successful in this population. 4 New outcomes metrics, 5 how to measure antibiotic use, and stewardship of antifungals 6 and antivirals. 7 Also, diagnostic stewardship, short course antimicrobial therapy in the transplant recipient, 8 allergy delabeling, 9 and perioperative and outpatient stewardship, 10 all areas that need addressing in the real world of transplantation.…”

“…We have articles on important areas such as how to implement an Antimicrobial Stewardship Program in a transplant program, and how to measure success or failure 3 . The use of the Desirability of Outcome ranking for new interventions so that we can have a better understanding of what is successful in this population 4 . New outcomes metrics, 5 how to measure antibiotic use, and stewardship of antifungals 6 and antivirals 7 .…”