Martin Howell1, Germaine Wong2, Robin M Turner3, Ho Teck Tan4, Allison Tong5, Jonathan C Craig5, Kirsten Howard6. 1. Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia; Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia. Electronic address: martin.howell@health.nsw.gov.au. 2. Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia; Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia; Centre for Transplant and Renal Research, Westmead Hospital, Westmead, Sydney, Australia. 3. School of Public Health and Community Medicine, The University of New South Wales, Sydney, Australia. 4. Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia; National University Hospital, Singapore. 5. Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia; Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia. 6. Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia.
Abstract
BACKGROUND: Shared decision making regarding immunosuppression in kidney transplantation requires an understanding of effects on quality of life (QoL). Our aim was to review the frequency and reliability of QoL measures reported in randomized controlled trials of maintenance immunosuppression following kidney transplantation. STUDY DESIGN: Systematic literature review. SETTING & POPULATION: Kidney transplant recipients enrolled in randomized trials of maintenance immunosuppression. SELECTION CRITERIA FOR STUDIES: Systematic search of the Cochrane Kidney and Transplant register, CENTRAL, MEDLINE, EMBASE, PsycINFO, and CINAHL databases to January 2014 identifying maintenance immunosuppression trials. An EQUATOR Network-endorsed checklist was used to assess QoL reporting and effect sizes estimated. INTERVENTION: Maintenance immunosuppression (comparative studies, dose adjustment, and agent withdrawal). OUTCOMES: Any quantitative patient-reported measure of physical, emotional, or social well-being. RESULTS: Of 2,272 reports, 41 (2%; involving 4,549 participants from 23 trials) included QoL outcomes using 22 instruments (8 generic, 2 disease specific, and 12 symptom specific). Reporting was incomplete for the majority with 1 (4%) addressing all 11 items of the checklist, 4 (17%) addressing clinical significance, and 15 (65%) reporting outcomes selectively. Almost all (n = 96 [95%]) effect size estimates for 101 QoL outcomes (18 trials; 3,919 participants) favored the interventions, with 37 (37%) statistically significant. In comparison, 30 (73%) clinical outcomes favored the intervention and 13 (31%) were significant. LIMITATIONS: QoL outcomes are commonly secondary outcomes and may not be indexed or found using text word searches. Effect sizes were estimated from different QoL measures, populations, and interventions. The small number of trials limits the ability to identify statistically significant associations between effect size and study-/patient-related factors. CONCLUSIONS: QoL is infrequently reported in immunosuppression trials in kidney transplantation, appears subject to major biases, and thus may be unreliable for decision making.
BACKGROUND: Shared decision making regarding immunosuppression in kidney transplantation requires an understanding of effects on quality of life (QoL). Our aim was to review the frequency and reliability of QoL measures reported in randomized controlled trials of maintenance immunosuppression following kidney transplantation. STUDY DESIGN: Systematic literature review. SETTING & POPULATION: Kidney transplant recipients enrolled in randomized trials of maintenance immunosuppression. SELECTION CRITERIA FOR STUDIES: Systematic search of the Cochrane Kidney and Transplant register, CENTRAL, MEDLINE, EMBASE, PsycINFO, and CINAHL databases to January 2014 identifying maintenance immunosuppression trials. An EQUATOR Network-endorsed checklist was used to assess QoL reporting and effect sizes estimated. INTERVENTION: Maintenance immunosuppression (comparative studies, dose adjustment, and agent withdrawal). OUTCOMES: Any quantitative patient-reported measure of physical, emotional, or social well-being. RESULTS: Of 2,272 reports, 41 (2%; involving 4,549 participants from 23 trials) included QoL outcomes using 22 instruments (8 generic, 2 disease specific, and 12 symptom specific). Reporting was incomplete for the majority with 1 (4%) addressing all 11 items of the checklist, 4 (17%) addressing clinical significance, and 15 (65%) reporting outcomes selectively. Almost all (n = 96 [95%]) effect size estimates for 101 QoL outcomes (18 trials; 3,919 participants) favored the interventions, with 37 (37%) statistically significant. In comparison, 30 (73%) clinical outcomes favored the intervention and 13 (31%) were significant. LIMITATIONS: QoL outcomes are commonly secondary outcomes and may not be indexed or found using text word searches. Effect sizes were estimated from different QoL measures, populations, and interventions. The small number of trials limits the ability to identify statistically significant associations between effect size and study-/patient-related factors. CONCLUSIONS: QoL is infrequently reported in immunosuppression trials in kidney transplantation, appears subject to major biases, and thus may be unreliable for decision making.
Authors: Simon A Carter; Talia Gutman; Charlotte Logeman; Dan Cattran; Liz Lightstone; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hérnan Trimarchi; Hong Zhang; Karolis Azukaitis; Yeoungjee Cho; Andrea K Viecelli; Louese Dunn; David Harris; David W Johnson; Peter G Kerr; Paul Laboi; Jessica Ryan; Jenny I Shen; Lorena Ruiz; Angela Yee-Moon Wang; Achilles Hoi Kan Lee; Samuel Fung; Matthew Ka-Hang Tong; Armando Teixeira-Pinto; Martin Wilkie; Stephen I Alexander; Jonathan C Craig; Allison Tong Journal: Clin J Am Soc Nephrol Date: 2020-04-30 Impact factor: 8.237
Authors: Bénédicte Sautenet; Allison Tong; Karine E Manera; Jeremy R Chapman; Anthony N Warrens; David Rosenbloom; Germaine Wong; John Gill; Klemens Budde; Lionel Rostaing; Lorna Marson; Michelle A Josephson; Peter P Reese; Timothy L Pruett; Camilla S Hanson; Donal O'Donoghue; Helen Tam-Tham; Jean-Michel Halimi; Jenny I Shen; John Kanellis; John D Scandling; Kirsten Howard; Martin Howell; Nick Cross; Nicole Evangelidis; Philip Masson; Rainer Oberbauer; Samuel Fung; Shilpa Jesudason; Simon Knight; Sreedhar Mandayam; Stephen P McDonald; Steve Chadban; Tasleem Rajan; Jonathan C Craig Journal: Transplantation Date: 2017-08 Impact factor: 4.939
Authors: Allison Tong; John Gill; Klemens Budde; Lorna Marson; Peter P Reese; David Rosenbloom; Lionel Rostaing; Germaine Wong; Michelle A Josephson; Timothy L Pruett; Anthony N Warrens; Jonathan C Craig; Benedicte Sautenet; Nicole Evangelidis; Angelique F Ralph; Camilla S Hanson; Jenny I Shen; Kirsten Howard; Klemens Meyer; Ronald D Perrone; Daniel E Weiner; Samuel Fung; Maggie K M Ma; Caren Rose; Jessica Ryan; Ling-Xin Chen; Martin Howell; Nicholas Larkins; Siah Kim; Sobhana Thangaraju; Angela Ju; Jeremy R Chapman Journal: Transplantation Date: 2017-08 Impact factor: 4.939
Authors: Simon A Carter; Liz Lightstone; Dan Cattran; Allison Tong; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn J Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle A Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hernán Trimarchi; Hong Zhang; Samaya Anumudu; Yeoungjee Cho; Talia Gutman; Emma O'Lone; Andrea K Viecelli; Eric Au; Karolis Azukaitis; Amanda Baumgart; Amelie Bernier-Jean; Louese Dunn; Martin Howell; Angela Ju; Charlotte Logeman; Melissa Nataatmadja; Benedicte Sautenet; Ankit Sharma; Jonathan C Craig Journal: Clin J Am Soc Nephrol Date: 2021-12-30 Impact factor: 8.237
Authors: Allison Tong; Braden Manns; Angela Yee Moon Wang; Brenda Hemmelgarn; David C Wheeler; John Gill; Peter Tugwell; Robert Pecoits-Filho; Sally Crowe; Tess Harris; Wim Van Biesen; Wolfgang C Winkelmayer; Adeera Levin; Aliza Thompson; Vlado Perkovic; Angela Ju; Talia Gutman; Amelie Bernier-Jean; Andrea K Viecelli; Emma O'Lone; Jenny Shen; Michelle A Josephson; Yeoungjee Cho; David W Johnson; Bénédicte Sautenet; Marcello Tonelli; Jonathan C Craig Journal: Kidney Int Date: 2018-10-22 Impact factor: 10.612
Authors: Vasiliki Tsarpali; Karsten Midtvedt; Kjersti Lønning; Tomm Bernklev; Nanna von der Lippe; Anna Varberg Reisæter; Cathrine Brunborg; Kristian Heldal Journal: Kidney Med Date: 2021-07-22
Authors: Allison Tong; Klemens Budde; John Gill; Michelle A Josephson; Lorna Marson; Timothy L Pruett; Peter P Reese; David Rosenbloom; Lionel Rostaing; Anthony N Warrens; Germaine Wong; Jonathan C Craig; Sally Crowe; Tess Harris; Brenda Hemmelgarn; Braden Manns; Peter Tugwell; Wim Van Biesen; David C Wheeler; Wolfgang C Winkelmayer; Nicole Evangelidis; Benedicte Sautenet; Martin Howell; Jeremy R Chapman Journal: Transplant Direct Date: 2016-05-19