Establishing a Core Outcome Measure for Graft Health:A Standardized Outcomes in Nephrology-Kidney Transplantation (SONG-Tx) Consensus Workshop Report

Background: Kidney transplantation confers substantial survival and quality of life benefits for many patients with end-stage kidney disease compared with dialysis but complications and side-effects of immunosuppression can impair participation in daily life activities. Life participation is a critically important patient-reported outcome for kidney transplant recipients but it is inconsistently and infrequently measured in trials. We convened a consensus workshop on establishing a core outcome measure for life participation for use in all trials in kidney transplantation. Methods: Twenty-five (43%) kidney transplant recipients/caregivers and 33 (57%) health professionals from eight countries participated in six facilitated breakout group discussions. Transcripts were analyzed thematically. Results: Four themes were identified. Returning to normality conveyed the patients’ goals to fulfill their given roles (i.e. in their family, work, and community) and re-establish a normal lifestyle after transplant. Recognizing the diverse meaning and activities of ‘life’ explicitly acknowledged life participation as a subjective concept that could refer to different activities (e.g. employment, recreation, family duties) for each individual patient. Capturing vulnerability and fluctuations post-transplant (e.g. due to complications and side-effects) distinguished between experiences in the first year post-transplant and the long-term impact of transplantation. Having a scientifically rigorous, feasible and meaningful measure was expected to enable consistent and frequent assessment of life participation in trials in kidney transplantation. Conclusions: A feasible and validated core outcome measure for life participation is needed so critically important patient-reported outcome can be consistently and meaningfully assessed in trials in kidney transplantation to inform decision-making and care of recipients

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

There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes

Preoperative psychological evaluation of transplant patients: challenges and solutions

Martin Kumnig,1 Sheila Jowsey-Gregoire2 1Center for Advanced Psychology in Plastic and Transplant Surgery (CAPPTS), Department of Medical Psychology, Medical University of Innsbruck, Innsbruck, Austria; 2Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA Abstract: Psychological assessments are crucial for the evaluation and optimization of the suitability of transplant patients. The interdisciplinary evaluation in modern transplantation medicine focuses on important psychosocial issues, such as assessing patients’ characteristics that predict best postoperative outcome after solid organ transplantation. When assessing patients for reconstructive hand transplantation, the psychological evaluation should identify whether reconstructive hand transplantation is the best treatment option to regain functionality and sensation, to resolve body image concerns, and to improve health-related quality of life (HRQOL) for each patient. These psychosocial issues in transplantation medicine are receiving increased attention; however, standardized psychological evaluation and follow-up protocols are still being developed. Previously published reports in transplantation medicine have attempted to identify psychosocial factors important in the evaluation of transplant patients and that predict psychosocial outcomes. This review will provide an overview of recent investigations in solid organ and vascularized composite allotransplantation (VCA), including the domains of evaluation, pre- and posttransplant follow-up, psychiatric complications, evaluation of body image, and HRQOL. Recent work highlights the potential for a multicenter research approach utilizing standardized assessment strategies and emphasizing the need for a shared assessment approach to understand psychosocial outcomes. For example, the Chauvet Workgroup convened in 2014 in Paris with stakeholders in the assessment of psychosocial factors to discuss key areas and propose an ongoing shared effort across centers in addressing important questions related to psychosocial care of VCA. A successful transplantation requires a multistaged multidisciplinary psychosocial evaluation to identify those most suited to solid organ or reconstructive transplantation and minimize psychological morbidity. With this in place, current transplant psychosocial practices can be useful for solid organ transplantation and refined for VCA. This review will present potential challenges and solutions for guideline development in both solid organ and VCA. Keywords: assessment, evaluation, multicenter research approach, psychology, psychometric instruments, standardization, transplantatio

Establishing a core outcome measure for life participation: a Standardized outcomes in Nephrology – kidney transplantation (SONG-Tx) consensus workshop report

Background: Kidney transplantation confers substantial survival and quality of life benefits for many patients with end-stage kidney disease compared with dialysis but complications and side-effects of immunosuppression can impair participation in daily life activities. Life participation is a critically important patient-reported outcome for kidney transplant recipients but it is inconsistently and infrequently measured in trials. We convened a consensus workshop on establishing a core outcome measure for life participation for use in all trials in kidney transplantation. Methods: Twenty-five (43%) kidney transplant recipients/caregivers and 33 (57%) health professionals from eight countries participated in six facilitated breakout group discussions. Transcripts were analyzed thematically. Results: Four themes were identified. Returning to normality conveyed the patients’ goals to fulfill their given roles (i.e. in their family, work, and community) and re-establish a normal lifestyle after transplant. Recognizing the diverse meaning and activities of ‘life’ explicitly acknowledged life participation as a subjective concept that could refer to different activities (e.g. employment, recreation, family duties) for each individual patient. Capturing vulnerability and fluctuations post-transplant (e.g. due to complications and side-effects) distinguished between experiences in the first year post-transplant and the long-term impact of transplantation. Having a scientifically rigorous, feasible and meaningful measure was expected to enable consistent and frequent assessment of life participation in trials in kidney transplantation. Conclusions: A feasible and validated core outcome measure for life participation is needed so critically important patient-reported outcome can be consistently and meaningfully assessed in trials in kidney transplantation to inform decision-making and care of recipients

Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

BACKGROUND: Kidney transplantation confers substantial survival and quality of life benefits for many patients with end-stage kidney disease compared with dialysis, but complications and side effects of immunosuppression can impair participation in daily life activities. Life participation is a critically important patient-reported outcome for kidney transplant recipients but is infrequently and inconsistently measured in trials. We convened a consensus workshop on establishing an outcome measure for life participation for use in all trials in kidney transplantation. METHODS: Twenty-five (43%) kidney transplant recipients/caregivers and 33 (57%) health professionals from 8 countries participated in 6 facilitated breakout group discussions. Transcripts were analyzed thematically. RESULTS: Four themes were identified. Returning to normality conveyed the patients' goals to fulfill their roles (ie, in their family, work, and community) and reestablish a normal lifestyle after transplant. Recognizing the diverse meaning and activities of "life" explicitly acknowledged life participation as a subjective concept that could refer to different activities (eg, employment, recreation, family duties) for each individual patient. Capturing vulnerability and fluctuations posttransplant (eg, due to complications and side-effects) distinguished between experiences in the first year posttransplant and the long-term impact of transplantation. Having a scientifically rigorous, feasible, and meaningful measure was expected to enable consistent and frequent assessment of life participation in trials in kidney transplantation. CONCLUSIONS: A feasible and validated core outcome measure for life participation is needed so that this critically important patient-reported outcome can be consistently and meaningfully assessed in trials in kidney transplantation to inform decision making and care of recipients.status: publishe

Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report

BACKGROUND: Kidney transplantation confers substantial survival and quality of life benefits for many patients with end-stage kidney disease compared with dialysis, but complications and side effects of immunosuppression can impair participation in daily life activities. Life participation is a critically important patient-reported outcome for kidney transplant recipients but is infrequently and inconsistently measured in trials. We convened a consensus workshop on establishing an outcome measure for life participation for use in all trials in kidney transplantation. METHODS: Twenty-five (43%) kidney transplant recipients/caregivers and 33 (57%) health professionals from 8 countries participated in 6 facilitated breakout group discussions. Transcripts were analyzed thematically. RESULTS: Four themes were identified. Returning to normality conveyed the patients' goals to fulfill their roles (ie, in their family, work, and community) and reestablish a normal lifestyle after transplant. Recognizing the diverse meaning and activities of "life" explicitly acknowledged life participation as a subjective concept that could refer to different activities (eg, employment, recreation, family duties) for each individual patient. Capturing vulnerability and fluctuations posttransplant (eg, due to complications and side-effects) distinguished between experiences in the first year posttransplant and the long-term impact of transplantation. Having a scientifically rigorous, feasible, and meaningful measure was expected to enable consistent and frequent assessment of life participation in trials in kidney transplantation. CONCLUSIONS: A feasible and validated core outcome measure for life participation is needed so that this critically important patient-reported outcome can be consistently and meaningfully assessed in trials in kidney transplantation to inform decision making and care of recipients

International consensus recommendations on face transplantation: A 2-step Delphi study

: face transplantation is a viable reconstructive approach for severe craniofacial defects. despite the evolution witnessed in the field, ethical aspects, clinical and psychosocial implications, public perception, and economic sustainability remain the subject of debate and unanswered questions. furthermore, poor data reporting and sharing, the absence of standardized metrics for outcome evaluation, and the lack of consensus definitions of success and failure have hampered the development of a "transplantation culture" on a global scale. we completed a 2-round online modified delphi process with 35 international face transplant stakeholders, including surgeons, clinicians, psychologists, psychiatrists, ethicists, policymakers, and researchers, with a representation of 10 of the 19 face transplant teams that had already performed the procedure and 73% of face transplants. themes addressed included patient assessment and selection, indications, social support networks, clinical framework, surgical considerations, data on patient progress and outcomes, definitions of success and failure, public image and perception, and financial sustainability. the presented recommendations are the product of a shared commitment of face transplant teams to foster the development of face transplantation and are aimed at providing a gold standard of practice and policy