CCCF Academy

Meade, Maureen¹; D'Aragon, Frederick²; Dhanani, Sonny³; Arseneau, Erika¹;  Faroutan, Farid¹; Ribic, Christine⁴;  Gangi, Azim⁴; Guyatt, Gordon^1
1Clinical Epidemiology & Biostatistics, McMaster University, Hamilton ON Canada
²Department of Anaesthesia, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
³CHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa ON Canada
⁴Department of Medicine, McMaster University, Hamilton ON Canada

 

Introduction/Background:  Deceased donors can provide up to 8 organs for transplantation. One important challenge for clinical trials in medical management of organ donors is integrating the impact of a treatment on several organs from a single donor (1).  Another challenge is the impracticability of trials designed to detect differences in graft survival – and the resultant need for a satisfactory intermediate outcome.  To address these issues, we developed a generic instrument to measure graft function across all organs.   
 
Objectives: We aim to develop a generic instrument capable of measuring graft function across all organs. We aim to use this instrument in a national prospective observational cohort study on deceased organ donors and in future clinical trials in the management of organ donors.
 
Methods:  We consulted iteratively with experts in research methodology, biostatistics, deceased donation and multi-organ transplant medicine.  First, we tabled the various methodologic, pragmatic and ethical challenges to a generic instrument.  We considered all possible formats (binary, categorical, ordinal and continuous), perspectives (prospective vs. retrospective), assessors (expert physicians, other clinicians, or non-clinical personnel), and the timing of measurement. 
 
Results:  Table 1 shows the current (abbreviated) generic instrument. Within 1 month of transplantation, expert physicians prospectively classify the function of each transplant with the assistance of user-friendly, organ-specific guidelines.
 
Table 1.
1. Normal or near-normal function
2. Impaired function
     a) likely to have normal graft longevity
     b) unlikely to have normal graft longevity
3. Severely impaired function, or barely functioning
     a) likely to regain some function
     b) unlikely to regain function
4. Irreversible failure (or death)
 
Conclusions:  Working together, donation and transplant communities can advance research in deceased donation.  We have developed a generic instrument for the measurement of graft function that has face validity among clinical experts and researchers in organ donation and transplantation.  Future work will further refine this instrument and focus on the reliability and validity of organ-specific guidelines for application in clinical research.