Development of an international Delphi survey to establish core outcome domains for trials in adults with glomerular disease

被引:5
作者
Carter, Simon A. [1 ,2 ]
Logeman, Charlotte [2 ]
Howell, Martin [1 ,2 ]
Cattran, Dan [3 ,4 ]
Lightstone, Liz [5 ]
Bagga, Arvind [6 ]
Barbour, Sean J. [7 ]
Barratt, Jonathan [8 ,9 ]
Boletis, John [10 ,11 ]
Caster, Dawn J. [12 ]
Coppo, Rosanna [13 ]
Fervenza, Fernando C. [14 ]
Floege, Jurgen [15 ]
Hladunewich, Michelle A. [3 ,16 ]
Hogan, Jonathan J. [17 ]
Kitching, A. Richard [18 ,19 ]
Lafayette, Richard A. [20 ]
Malvar, Ana [21 ]
Radhakrishnan, Jai [22 ]
Rovin, Brad H. [23 ]
Scholes-Robertson, Nicole [1 ,2 ]
Trimarchi, Hernan [24 ,25 ]
Zhang, Hong [26 ]
Cho, Yeoungjee [27 ,28 ,29 ]
Dunn, Louese [30 ]
Gipson, Debbie S. [31 ]
Liew, Adrian [32 ]
Sautenet, Benedicte [33 ,34 ]
Viecelli, Andrea K. [27 ,28 ]
Harris, David [35 ,36 ]
Johnson, David W. [27 ,28 ,29 ]
Wang, Angela Yee-Moon [37 ]
Teixeira-Pinto, Armando [1 ,2 ]
Alexander, Stephen I. [2 ]
Martin, Adam [2 ]
Tong, Allison [1 ,2 ]
Craig, Jonathan C. [38 ]
机构
[1] Univ Sydney, Sydney Sch Publ Hlth, Sydney, NSW, Australia
[2] Childrens Hosp Westmead, Ctr Kidney Res, Sydney, NSW 2145, Australia
[3] Univ Toronto, Fac Med, Toronto, ON, Canada
[4] Toronto Gen Res Inst, Toronto, ON, Canada
[5] Imperial Coll London, Ctr Inflammatory Dis, Fac Med, London, England
[6] All India Inst Med Sci, Dept Pediat, New Delhi, India
[7] Univ British Columbia, Div Nephrol, Dept Med, Vancouver, BC, Canada
[8] Univ Leicester, Dept Cardiovasc Sci, Leicester, Leics, England
[9] Leicester Gen Hosp, John Walls Renal Unit, Leicester, Leics, England
[10] Univ Athens, Med Sch, Laiko Hosp, Nephrol Dept, Athens, Greece
[11] Univ Athens, Med Sch, Laiko Hosp, Renal Transplantat Unit, Athens, Greece
[12] Univ Louisville, Div Nephrol, Louisville, KY USA
[13] Regina Margherita Hosp, Fdn Ric Molinette, Turin, Italy
[14] Mayo Clin, Dept Internal Med, Div Nephrol & Hypertens, Rochester, MN USA
[15] Univ Hosp, Rhein Westfal Tech Hsch, Dept Nephrol & Clin Immunol, Aachen, Germany
[16] Sunnybrook Hlth Sci Ctr, Dept Med, Div Nephrol, Toronto, ON, Canada
[17] Univ Penn, Sch Med, Perelman Sch Med, Philadelphia, PA 19104 USA
[18] Monash Hlth, Dept Nephrol, Melbourne, Vic, Australia
[19] Monash Univ, Ctr Inflammatory Dis, Dept Med, Melbourne, Vic, Australia
[20] Stanford Univ, Med Ctr, Dept Med, Div Nephrol, Stanford, CA 94305 USA
[21] Hosp Fernandez, Dept Nephrol, Buenos Aires, DF, Argentina
[22] Columbia Univ, Med Ctr, Div Nephrol, New York, NY USA
[23] Ohio State Univ, Dept Internal Med, Div Nephrol, Wexner Med Ctr, Columbus, OH 43210 USA
[24] Hosp Britan Buenos Aires, Nephrol Serv, Buenos Aires, DF, Argentina
[25] Hosp Britan Buenos Aires, Kidney Transplantat Unit, Buenos Aires, DF, Argentina
[26] Peking Univ First Hosp, Renal Div, Beijing, Peoples R China
[27] Princess Alexandra Hosp, Dept Nephrol, Brisbane, Qld, Australia
[28] Univ Queensland, Australasian Kidney Trials Network, Brisbane, Qld, Australia
[29] Translat Res Inst, Brisbane, Qld, Australia
[30] Sheffield Teaching Hosp Natl Hlth Serv Fdn Trust, Sheffield Kidney Inst, Sheffield, S Yorkshire, England
[31] Univ Michigan, Dept Pediat, Ann Arbor, MI 48109 USA
[32] Mt Elizabeth Novena Hosp, Kidney & Transplant Practice, Singapore, Singapore
[33] Univ Tours, Fac Med, Tours, France
[34] Tours Hosp, Dept Nephrol & Clin Immunol, Tours, France
[35] Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia
[36] Univ Sydney, Sydney Med Sch, Sydney, NSW, Australia
[37] Univ Hong Kong, Queen Mary Hosp, Dept Med, Hong Kong, Peoples R China
[38] Flinders Univ S Australia, Coll Med & Publ Hlth, Adelaide, SA, Australia
基金
英国医学研究理事会; 澳大利亚国家健康与医学研究理事会; 美国国家卫生研究院;
关键词
consensus; glomerulonephritis; patient outcome assessment; treatment outcome; trials; QUALITY-OF-LIFE; PATIENT-REPORTED OUTCOMES; KIDNEY-DISEASE; MEMBRANOUS NEPHROPATHY; REMISSION; TRANSPLANTATION; MORTALITY; BURDEN;
D O I
10.1016/j.kint.2021.04.027
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Outcomes relevant to treatment decision-making are inconsistently reported in trials involving glomerular disease. Here, we sought to establish a consensus-derived set of critically important outcomes designed to be reported in all future trials by using an online, international two-round Delphi survey in English. To develop this, patients with glomerular disease, caregivers and health professionals aged 18 years and older rated the importance of outcomes using a Likert scale and a Best-Worst scale. The absolute and relative importance was assessed and comments were analyzed thematically. Of 1198 participants who completed Round 1, 734 were patients/ caregivers while 464 were health care professionals from 59 countries. Of 700 participants that completed Round 2, 412 were patients/caregivers and 288 were health care professionals. Need for dialysis or transplant, kidney function, death, cardiovascular disease, remission-relapse and life participation were the most important outcomes to patients/caregivers and health professionals. Patients/ caregivers rated patient-reported outcomes higher while health care professionals rated hospitalization, death and remission/relapse higher. Four themes explained the reasons for their priorities: confronting death and compounded suffering, focusing on specific targets in glomerular disease, preserving meaning in life, and fostering self-management. Thus, consistent reporting of these critically important outcomes in all trials involving glomerular disease is hoped to improve patient-centered decision-making.
引用
收藏
页码:881 / 893
页数:13
相关论文
共 44 条
[1]   Patient-reported outcomes in lupus clinical trials with biologics [J].
Annapureddy, N. ;
Devilliers, H. ;
Jolly, M. .
LUPUS, 2016, 25 (10) :1111-1121
[2]   The population-level costs of immunosuppression medications for the treatment of glomerulonephritis are increasing over time due to changing patterns of practice [J].
Barbour, Sean ;
Lo, Clifford ;
Espino-Hernandez, Gabriela ;
Sajjadi, Sharareh ;
Feehally, John ;
Klarenbach, Scott ;
Gill, Jagbir .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2018, 33 (04) :626-634
[3]   Health-related quality of life in glomerular disease [J].
Canetta, Pietro A. ;
Troost, Jonathan P. ;
Mahoney, Shannon ;
Kogon, Amy J. ;
Carlozzi, Noelle ;
Bartosh, Sharon M. ;
Cai, Yi ;
Davis, T. Keefe ;
Fernandez, Hilda ;
Fornoni, Alessia ;
Gbadegesin, Rasheed A. ;
Herreshoff, Emily ;
Mahan, John D. ;
Nachman, Patrick H. ;
Selewski, David T. ;
Sethna, Christine B. ;
Srivastava, Tarak ;
Tuttle, Katherine R. ;
Wang, Chia-shi ;
Falk, Ronald J. ;
Gharavi, Ali G. ;
Gillespie, Brenda W. ;
Greenbaum, Larry A. ;
Holzman, Lawrence B. ;
Kretzler, Matthias ;
Robinson, Bruce M. ;
Smoyer, William E. ;
Guay-Woodford, Lisa M. ;
Reeve, Bryce ;
Gipson, Debbie S. ;
Ahn, Wooin ;
Appel, Gerald B. ;
Babayev, Revekka ;
Batal, Ibrahim ;
Bomback, Andrew S. ;
Brown, Eric ;
Campenot, Eric S. ;
Canetta, Pietro ;
Carlassara, Lucrezia ;
Chan, Brenda ;
Chatterjee, Debanjana ;
D'Agati, Vivette D. ;
Delbarba, Elisa ;
Dogra, Samriti ;
Foroncewicz, Bartosz ;
Ghiggeri, Gian Marco ;
Hines, William H. ;
Husain, S. Ali ;
Jain, Namrata G. ;
Khairallah, Pascale .
KIDNEY INTERNATIONAL, 2019, 95 (05) :1209-1224
[4]   Identifying Outcomes Important to Patients with Glomerular Disease and Their Caregivers [J].
Carter, Simon A. ;
Gutman, Talia ;
Logeman, Charlotte ;
Cattran, Dan ;
Lightstone, Liz ;
Bagga, Arvind ;
Barbour, Sean J. ;
Barratt, Jonathan ;
Boletis, John ;
Caster, Dawn ;
Coppo, Rosanna ;
Fervenza, Fernando C. ;
Floege, Juergen ;
Hladunewich, Michelle ;
Hogan, Jonathan J. ;
Kitching, A. Richard ;
Lafayette, Richard A. ;
Malvar, Ana ;
Radhakrishnan, Jai ;
Rovin, Brad H. ;
Scholes-Robertson, Nicole ;
Trimarchi, Hernan ;
Zhang, Hong ;
Azukaitis, Karolis ;
Cho, Yeoungjee ;
Viecelli, Andrea K. ;
Dunn, Louese ;
Harris, David ;
Johnson, David W. ;
Kerr, Peter G. ;
Laboi, Paul ;
Ryan, Jessica ;
Shen, Jenny, I ;
Ruiz, Lorena ;
Wang, Angela Yee-Moon ;
Lee, Achilles Hoi Kan ;
Fung, Samuel ;
Tong, Matthew Ka-Hang ;
Teixeira-Pinto, Armando ;
Wilkie, Martin ;
Alexander, Stephen, I ;
Craig, Jonathan C. ;
Tong, Allison .
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2020, 15 (05) :673-684
[5]   Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD): establishing a core outcome set for trials in patients with glomerular disease [J].
Carter, Simon A. ;
Lightstone, Liz ;
Cattran, Daniel ;
Bagga, Arvind ;
Barbour, Sean J. ;
Barratt, Jonathan ;
Boletis, John ;
Caster, Dawn ;
Coppo, Rosanna ;
Fervenza, Fernando C. ;
Floege, Jurgen ;
Hladunewich, Michelle ;
Hogan, Jonathan J. ;
Kitching, A. Richard ;
Lafayette, Richard ;
Malvar, Ana ;
Radhakrishnan, Jai ;
Rovin, Brad H. ;
Zhang, Hong ;
Gutman, Talia ;
Howell, Martin ;
Logeman, Charlotte ;
Shen, Jenny I. ;
Teixeira-Pinto, Armando ;
Alexander, Stephen I. ;
Cho, Yeoungjee ;
Craig, Jonathan C. ;
Harris, David ;
Johnson, David W. ;
Kerr, Peter G. ;
Ryan, Jessica ;
Viecelli, Andrea K. ;
Wang, Angela Yee-Moon ;
Wilkie, Martin ;
Scholes-Robertson, Nicole ;
Tong, Allison .
KIDNEY INTERNATIONAL, 2019, 95 (06) :1280-1283
[6]   Membranous Nephropathy: Quantifying Remission Duration on Outcome [J].
Cattran, Daniel C. ;
Kim, Esther D. ;
Reich, Heather ;
Hladunewich, Michelle ;
Kim, S. Joseph .
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2017, 28 (03) :995-1003
[7]   Toward quantitating the burden of glomerulonephritis in the United States [J].
Cattran, Daniel C. .
KIDNEY INTERNATIONAL, 2016, 90 (04) :732-734
[8]   Immunosuppressive treatment for idiopathic membranous nephropathy in adults with nephrotic syndrome [J].
Chen, Yizhi ;
Schieppati, Arrigo ;
Chen, Xiangmei ;
Cai, Guangyan ;
Zamora, Javier ;
Giuliano, Giovanni A. ;
Braun, Norbert ;
Perna, Annalisa .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2014, (10)
[9]   Core Outcome Domains for Trials in Autosomal Dominant Polycystic Kidney Disease: An International Delphi Survey [J].
Cho, Yeoungjee ;
Rangan, Gopala ;
Logeman, Charlotte ;
Ryu, Hyunjin ;
Sautenet, Benedicte ;
Perrone, Ronald D. ;
Nadeau-Fredette, Annie-Claire ;
Mustafa, Reem A. ;
Htay, Htay ;
Chonchol, Michel ;
Harris, Tess ;
Gutman, Talia ;
Craig, Jonathan C. ;
Ong, Albert C. M. ;
Chapman, Arlene ;
Ahn, Curie ;
Coolican, Helen ;
Kao, Juliana Tze-Wah ;
Gansevoort, Ron T. ;
Torres, Vicente ;
Pei, York ;
Johnson, David W. ;
Viecelli, Andrea K. ;
Teixeira-Pinto, Armando ;
Howell, Martin ;
Ju, Angela ;
Manera, Karine E. ;
Tong, Allison .
AMERICAN JOURNAL OF KIDNEY DISEASES, 2020, 76 (03) :361-373
[10]   Estimated glomerular filtration rate and functional status among older people: A systematic review [J].
Corsonello, Andrea ;
Roller-Wirnsberger, Regina ;
Di Rosa, Mirko ;
Fabbietti, Paolo ;
Wirnsberger, Gerhard ;
Kostka, Tomasz ;
Guligowska, Agnieszka ;
Tap, Lisanne ;
Mattace-Raso, Francesco ;
Gil, Pedro ;
Guardado-Fuentes, Lara ;
Meltzer, Itshak ;
Yehoshua, Ilan ;
Artzi-Medevdik, Rada ;
Formiga, Francesc ;
Moreno-Gonzalez, Rafael ;
Weingart, Christian ;
Freiberger, Ellen ;
Arnlov, Johan ;
Carlsson, Axel C. ;
Lattanzio, Fabrizia .
EUROPEAN JOURNAL OF INTERNAL MEDICINE, 2018, 56 :39-48