title: The Consistency and Reporting of Quality-of-Life Outcomes in Trials of Immunosuppressive Agents in Kidney Transplantation: A Systematic Review and Meta-analysis.
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.
  
  
  METHODS
  Systematic literature review.
  
  
  METHODS
  Kidney transplant recipients enrolled in randomized trials of maintenance immunosuppression.
  
  
  METHODS
  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.
  
  
  METHODS
  Maintenance immunosuppression (comparative studies, dose adjustment, and agent withdrawal).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.affiliation: 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.
authors.forename: Martin
authors.initials: M
authors.lastname: Howell
authors.affiliation: 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.
authors.forename: Germaine
authors.initials: G
authors.lastname: Wong
authors.affiliation: School of Public Health and Community Medicine, The University of New South Wales, Sydney, Australia.
authors.forename: Robin M
authors.initials: RM
authors.lastname: Turner
authors.affiliation: Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia; National University Hospital, Singapore.
authors.forename: Ho Teck
authors.initials: HT
authors.lastname: Tan
authors.affiliation: 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.
authors.forename: Allison
authors.initials: A
authors.lastname: Tong
authors.affiliation: 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.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
authors.affiliation: Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
mesh_terms: D003657:Decision Making; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D060046:Maintenance Chemotherapy; D063868:Patient Outcome Assessment; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results
chemical_list: D007166:Immunosuppressive Agents
keywords: Kidney transplantation; adverse events; end-stage renal disease (ESRD); health-related quality of life; immunosuppressive agent; maintenance immunosuppression; patient-centered care; patient-reported outcomes; post-transplant immunosuppression; quality of life (QoL); randomized controlled trials; side effects; symptoms; systematic review