Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation
| Autor: | Karine E. Manera, John S. Gill, Germaine Wong, Allison Tong, John Kanellis, Lionel Rostaing, Rainer Oberbauer, Bénédicte Sautenet, Nicholas B Cross, Timothy L. Pruett, Jeremy R. Chapman, Tasleem Rajan, Klemens Budde, Simon R. Knight, Helen Tam-Tham, Lorna Marson, Sreedhar Mandayam, Stephen P. McDonald, David Rosenbloom, Jonathan C. Craig, Kirsten Howard, Samuel Fung, Nicole Evangelidis, Jean-Michel Halimi, Michelle A. Josephson, Donal O'Donoghue, Anthony N. Warrens, Peter P. Reese, Martin Howell, Shilpa Jesudason, Jenny I. Shen, Philip Masson, John D. Scandling, Camilla S. Hanson, Steve Chadban |
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| Přispěvatelé: | MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques |
| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Kidney Disease Consensus Outcome Assessment Delphi Technique Adolescent Health Personnel [SDV]Life Sciences [q-bio] Renal and urogenital 030232 urology & nephrology Delphi method MEDLINE Medical and Health Sciences Outcome (game theory) Young Adult 03 medical and health sciences 0302 clinical medicine Clinical Research Surveys and Questionnaires Behavioral and Social Science Health care Journal Article medicine Humans 030212 general & internal medicine Young adult Kidney transplantation Aged Clinical Trials as Topic Transplantation Health professionals business.industry Organ Transplantation Middle Aged medicine.disease Kidney Transplantation 3. Good health Health Care Good Health and Well Being Caregivers Multinational corporation Family medicine Surgery business |
| Zdroj: | Sautenet, B, Tong, A, Manera, K E, Chapman, J R, Warrens, A N, Rosenbloom, D, Wong, G, Gill, J, Budde, K, Rostaing, L, Marson, L, Josephson, M A, Reese, P P, Pruett, T L, Hanson, C S, O'Donoghue, D, Tam-Tham, H, Halimi, J-M, Shen, J I, Kanellis, J, Scandling, J D, Howard, K, Howell, M, Cross, N, Evangelidis, N, Masson, P, Oberbauer, R, Fung, S, Jesudason, S, Knight, S, Mandayam, S, McDonald, S P, Chadban, S, Rajan, T & Craig, J C 2017, ' Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation : A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals ', Transplantation, vol. 101, no. 8, pp. 1875-1886 . https://doi.org/10.1097/TP.0000000000001776 Transplantation Transplantation, 2017, 101 (8), pp.1875-1886. ⟨10.1097/TP.0000000000001776⟩ Transplantation, vol 101, iss 8 |
| ISSN: | 0041-1337 |
| DOI: | 10.1097/tp.0000000000001776 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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