Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation:A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals

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 re-rated 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 eight 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 six outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified five 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

Barriers associated with the treatment of hepatitis C virus infection among illicit drug users

Background: Illicit drug users account for the majority of cases of HCV in the developed world, but few have received treatment. Methods: We evaluated barriers to initiating HCV treatment – including general treatment willingness – and factors associated with these among HCV infected illicit drug users. Participants were recruited via convenience sampling from two community clinics in Canada. Individuals age >18 years with a history of illicit drug use completed interviewer-administered surveys. Those reporting positive HCV testing underwent additional questioning on willingness, uptake and barriers to treatment for HCV. Results: Of 188 HCV positive illicit drug users, 16% (n = 30) received treatment for HCV. Factors associated with a decreased treatment uptake included current heroin use and HIV/HCV co-infection. Among those not having received therapy, 77% (117/153) indicated a willingness to receive treatment. Factors associated with treatment willingness included not being infected with HIV, having not recently used drugs by injection and having reported physical health problems. Among those not having sought treatment (n = 107), the major reasons for not doing so were: lack of information about HCV or knowledge that treatment was available (23%), the absence of symptoms (20%) and the perceived side effects of treatment (14%). Conclusions: Among illicit drug users attending inner city clinics, we have observed a low uptake of HCV treatment, but a high willingness to receive therapy. An increased focus on improving education about the long-term consequences of HCV and the availability of effective treatment are important components for expanding HCV treatment among illicit drug users.Medicine, Faculty ofNon UBCAnesthesiology, Pharmacology and Therapeutics, Department ofMedicine, Department ofReviewedFacultyResearcherGraduat

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

BackgroundInconsistencies 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.MethodsIn 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 rounds 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 to 9 (critically important), and analyzed comments thematically.ResultsOne thousand eighteen 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; 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.ConclusionsGraft 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