Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation

Abstract

Background Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision-making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Methods In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During Round 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents’ scores, and comments. We calculated the median, mean, and proportion rating 7–9 (critically important), and analyzed comments thematically. Results 1018 participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed Round 1, and 779 (77%) completed Round 3. The top 8 outcomes that met the consensus criteria in Round 3 (mean ≥7.5, median ≥8 and proportion >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin) and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Conclusions Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.

Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop

“…39–42 These core outcome sets were developed using an evidence- and consensus-based process (systematic review, focus groups with nominal group technique, stakeholder interviews, an international Delphi Survey, and a consensus workshop) involving more than 1300 patients, caregivers, and health professionals from more than 70 countries in each stream (i.e., hemodialysis, kidney transplantation). 10–12,37,38,40,41 The findings from the workshop will inform strategies and pathways for implementing core outcomes, with a focus on trials in nephrology.…”

An International Delphi Survey on Exercise Priorities in CKD

“…The prioritization of mortality and graft function is consistent with the findings of another Delphi survey of patients/caregivers and health care providers on priority outcomes in kidney transplantation trials. 24 We extend these findings by identifying exercise, specifically pre- and postoperative rehabilitation, as a therapeutic strategy of interest to modify these outcomes. So far, studies have demonstrated that pretransplant rehabilitation is a potential intervention for increasing physical activity preoperatively and may also decrease post-transplant length of stay.…”

Systematic review of international Delphi surveys for core outcome set development: representation of international patients

“…Sautenet et al reported consensus outcomes for kidney transplantation among patients, caregivers and HCPs. 97 They found that patients/caregivers from certain countries ranked ‘depression’ or ‘cognition’ as less important and that ‘skin cancer’ received greater prioritisation in countries with public campaigns for prevention. Since none of the aforementioned outcomes were ranked in the ‘top eight’ of either patients or HCPs, these differences did not affect the final COS. Van Rijssen et al 73 reported consensus PROs for pancreatic cancer among European, North American and Asian participants.…”

“…A minority of studies (4%, n=4) analysed, or stated an intention to analyse, the Delphi survey responses by participants' geographical location, either by country 54 97 or continent. 73 Some differences in outcome prioritisation were minor, not affecting the final COS. 54 97 Park et al presented results from round 1 of their Delphi survey on patient-reported outcomes (PROs) for adult myositis. 54 They found that, unlike participants from the USA and South Korea, Swedish participants rated 'impact on household activity' less favourably, although this outcome was still retained for the second Delphi round.…”