TY - JOUR
T1 - Establishing a Core Outcome Measure for Peritoneal Dialysis-related Peritonitis
T2 - A Standardized Outcomes in Nephrology—Peritoneal Dialysis Consensus Workshop Report
AU - Shen, Jenny I.
AU - Cho, Yeoungjee
AU - Manera, Karine E.
AU - Brown, Fiona
AU - Dong, Jie
AU - Al Sahlawi, Muthana
AU - Acevedo, Rafael G.
AU - Htay, Htay
AU - Ito, Yasuhiko
AU - Kanjanabuch, Talerngsak
AU - Nessim, Sharon J.
AU - Ngaruiya, Grace
AU - Piraino, Beth
AU - Szeto, Cheuk-Chun
AU - Teitelbaum, Isaac
AU - Amir, Noa
AU - Craig, Jonathan C.
AU - Baumgart, Amanda
AU - Gonzalez, Andrea M.
AU - Scholes-Robertson, Nicole
AU - Viecelli, Andrea K.
AU - Wilkie, Martin
AU - Tong, Allison
AU - Perl, Jeffrey
AU - SONG-PD Infection Workshop Investigators
AU - Wang, Angela
AU - Hemmelgarn, Brenda
AU - Manns, Braden
AU - Wheeler, David
AU - Gill, John
AU - Tugwell, Peter
AU - Pecoits-Filho, Roberto
AU - Crowe, Sally
AU - Harris, Tess
AU - Van Biesen, Wim
AU - Winkelmayer, Wolfgang
AU - Johnson, David W.
AU - Brown, Edwina
AU - Brunier, Gillian
AU - Manera, Karine
AU - Mehrotra, Rajnish
AU - Dunning, Sue-Ann
AU - Dunning, Tony
AU - Forfang, Derek
AU - Gomez, Rafael
AU - Martin, Adam
AU - Bernier-Jean, Amelie
AU - Ju, Angela
AU - Teixera-Pinto, Armando
AU - Sautenet, Benedicte
AU - Hanson, Camilla
AU - Guha, Chandana
AU - Sumpton, Daniel
AU - Hannan, Elyssa
AU - O'Lone, Emma
AU - Au, Eric
AU - Kerklaan, Jasmijn
AU - Dunn, Louese
AU - Howell, Martin
AU - Nataatmadja, Melissa
AU - Evangelidis, Nicole
AU - Natale, Patrizia
AU - Cazzolli, Rosanna
AU - Anumudu, Samaya
AU - Carter, Simon
AU - Gutman, Talia
AU - Rahim Vastani, Thomas Vastani
AU - Abu-Alfa, Ali
AU - Aufricht, Christoph
AU - Wallace, Eric
AU - Dasgupta, Indranil
AU - Knight, John
AU - Foo, Marjorie
AU - Lambie, Mark
AU - Schreiber, Martin
AU - Pisoni, Ronald
AU - Apata, Ronke
AU - Antwi, Sampson
AU - Novosad, Shannon
AU - Davies, Simon
AU - Booth, Stephanie
AU - Lau, Agnes
AU - Chi, Allen
AU - Heckendorn, Barbara
AU - Allen, Brandie
AU - Dewey, Brenda
AU - Horton, Danielle
AU - Edwards, Dawn
AU - Robinson, Evelyn
AU - Franco, Freddy
AU - Braddock, Gary
AU - Grossman, George
AU - Chestney, Juliana
AU - Laws, Karmen
AU - Clark, Karrin
AU - Penningtown, Keith
AU - Richardson, Lisa
AU - Verdin, Nancy
AU - Jefferson, Nichole
AU - Gedney, Nieltje
AU - Chestney, Norman
AU - Griffiths, Pamela
AU - Kidwell, Sharon
AU - Downs, Shelley
AU - Ball, Terence
AU - Yaeger, Thomas
AU - Elly, Virna
AU - Senior, Wiliam
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Introduction: Peritoneal dialysis (PD)-related peritonitis is one of the leading causes of discontinuation of PD and is considered a critically important outcome for patients on PD. However, there is no universally accepted method of measuring this outcome in clinical trials. Methods: We convened an online consensus workshop to establish a core outcome measure for PD-related peritonitis in clinical trials. Results: A total of 53 participants, including 18 patients and caregivers, from 12 countries engaged in breakout discussions in this workshop. Transcripts were analyzed thematically. We identified the following 3 themes: (i) feasibility and applicability across diverse settings, which reflected the difficulty with implementing laboratory-based measures in resource-limited environments; (ii) ensuring validity, which included minimizing false positives and considering the specificity of symptoms; and (iii) being meaningful and tangible to patients, which meant that the measure should be easy to interpret, reflect the impact that symptoms have on patients, and promote transparency by standardizing the reporting of peritonitis among dialysis units. Conclusion: A core outcome measure for PD-related peritonitis should include both symptom-based and laboratory-based criteria. Thus, the International Society for Peritoneal Dialysis (ISPD) definition of peritonitis is acceptable. However, there should be consideration of reporting suspected peritonitis in cases where laboratory confirmation is not possible. The measure should include all infections from the time of catheter insertion and capture both the rate of infection and the number of patients who remain peritonitis free. A core outcome measure with these features would increase the impact of clinical trials on the care and decision-making of patients receiving PD.
AB - Introduction: Peritoneal dialysis (PD)-related peritonitis is one of the leading causes of discontinuation of PD and is considered a critically important outcome for patients on PD. However, there is no universally accepted method of measuring this outcome in clinical trials. Methods: We convened an online consensus workshop to establish a core outcome measure for PD-related peritonitis in clinical trials. Results: A total of 53 participants, including 18 patients and caregivers, from 12 countries engaged in breakout discussions in this workshop. Transcripts were analyzed thematically. We identified the following 3 themes: (i) feasibility and applicability across diverse settings, which reflected the difficulty with implementing laboratory-based measures in resource-limited environments; (ii) ensuring validity, which included minimizing false positives and considering the specificity of symptoms; and (iii) being meaningful and tangible to patients, which meant that the measure should be easy to interpret, reflect the impact that symptoms have on patients, and promote transparency by standardizing the reporting of peritonitis among dialysis units. Conclusion: A core outcome measure for PD-related peritonitis should include both symptom-based and laboratory-based criteria. Thus, the International Society for Peritoneal Dialysis (ISPD) definition of peritonitis is acceptable. However, there should be consideration of reporting suspected peritonitis in cases where laboratory confirmation is not possible. The measure should include all infections from the time of catheter insertion and capture both the rate of infection and the number of patients who remain peritonitis free. A core outcome measure with these features would increase the impact of clinical trials on the care and decision-making of patients receiving PD.
KW - core outcome measure
KW - peritoneal dialysis
KW - peritonitis
KW - trial design
UR - http://www.scopus.com/inward/record.url?scp=85133259328&partnerID=8YFLogxK
U2 - 10.1016/j.ekir.2022.05.020
DO - 10.1016/j.ekir.2022.05.020
M3 - Article
AN - SCOPUS:85133259328
VL - 7
SP - 1737
EP - 1744
JO - Kidney International Reports
JF - Kidney International Reports
SN - 2468-0249
IS - 8
ER -