Consistency and Completeness of Reported Outcomes in Randomized Trials of Primary Immunosuppression in Kidney Transplantation

Masson, Philip; Duthie, Fiona; Ruster, Lorenn P.; Kelly, Patrick J.; Merrifield, Alistair; Craig, Jonathan C.; Webster, Angela C

doi:10.1111/ajt.12444

Cited by 15 publications

(13 citation statements)

References 24 publications

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“…Trials in kidney transplantation are often short-term, and important outcomes such as mortality, graft loss and kidney function are inconsistently and incompletely reported in randomized trials in kidney transplantation; with just 1/3 reporting all 3 outcomes (8). Only 58% of trials report infection and 48% of trials report cancer (9).…”

Section: Introductionmentioning

confidence: 99%

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation

et al. 2017

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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 rerated 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 8 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 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 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.

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Section: Introductionmentioning

confidence: 99%

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation

et al. 2017

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“…Existing analyses of outcome reporting quality in trials of immunosuppression following renal transplantation have concentrated mainly on primary efficacy outcomes such as acute rejection, graft and patient survival, and graft function . Fritsche et al .…”

Section: Introductionmentioning

confidence: 99%

“…7 Existing analyses of outcome reporting quality in trials of immunosuppression following renal transplantation have concentrated mainly on primary efficacy outcomes such as acute rejection, graft and patient survival, and graft function. 8,9 Fritsche et al 8 assessed the methodological and reporting quality of 63 large multicenter randomized controlled trials (RCTs) and identified inconsistency in the reporting of acute rejection rates and graft survival measures. About 33.3% studies did not report acute rejection rates, and in 27%, it was unclear as to whether graft survival rates were censored for patient death.…”

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confidence: 99%

“…In the larger analysis of 179 trials by Masson and colleagues, similar inconsistency of reporting of these keys outcomes was seen. 9 In particular, incomplete data for graft function outcomes (glomerular filtration rate, GFR, and serum creatinine) were provided in over two-thirds of studies reporting these outcomes, making meta-analysis impossible.…”

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confidence: 99%

“…Whilst the findings regarding safety outcomes are novel, inconsistencies in commonly reported efficacy endpoints have been noted previously. Masson and colleagues analyzed reporting of four efficacy outcomes (patient and graft survival, serum creatinine, and GFR) in a cohort of 179 trials, demonstrating that all four of these key outcomes were only reported in 34% studies 9. Similar variability in definitions of outcomes was identified, although formal analysis of the quality of outcome definition was not performed.Frequency of complete outcome reporting in the present study was higher than in the report from Masson and colleagues.…”

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confidence: 99%

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Quality and consistency of outcome reporting in clinical trials of immunosuppression in renal transplantation

Hussain

Knight

2016

Clinical Transplantation

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Interpretation, comparison, and combination of results of clinical trials are reliant on accurate and complete reporting of outcomes. This study aimed to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. A total of 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis; 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR: 0.022, P<.001) or patient-reported outcome measures (PROMs) (OR: 0.014, P<.001). PROMs were reported in less than half of manuscripts, and only five reported quality-of-life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult.

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Belatacept for kidney transplant recipients

Masson

Henderson

Chapman

et al. 2014

Cochrane Database of Systematic Reviews

101

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Cochrane Database of Systematic Reviews Main resultsWe included five studies that compared belatacept and calcineurin inhibitors (CNI) that reported data from a total of 1535 kidney transplant recipients. Of the five studies, three (478 participants) compared belatacept and cyclosporin and two (43 recipients) compared belatacept and tacrolimus. Co-interventions included basiliximab (4 studies, 1434 recipients); anti-thymocyte globulin (1 study, 89 recipients); alemtuzumab (1 study, 12 recipients); mycophenolate mofetil (MMF, 5 studies, 1509 recipients); sirolimus (1 study, 26 recipients) and prednisone (5 studies, 1535 recipients).Up to three years following transplant, belatacept and CNI-treated recipients were at similar risk of dying (4 studies, 1516 recipients: RR 0.75, 95% CI 0.39 to 1.44), losing their kidney transplant and returning to dialysis (4 studies, 1516 recipients: RR 0.91, 95% CI 0.61 to 1.38), and having an episode of acute rejection (4 studies, 1516 recipients: RR 1.56, 95% CI 0.85 to 2.86). Belatacept-treated kidney transplant recipients were 28% less likely to have chronic kidney scarring (3 studies, 1360 recipients: RR 0.72, 95% CI 0.55 to 0.94) and also had better gra function (measured glomerular filtration rate (GFR) (3 studies 1083 recipients): 10.89 mL/min/1.73 m , 95% CI 4.01 to 17.77; estimated GFR (4 studies, 1083 recipients): MD 9.96 mL/min/1.73 m , 95% CI 3.28 to 16.64) than CNI-treated recipients. Blood pressure was lower (systolic (2 studies, 658 recipients): MD -7.51 mm Hg, 95% CI -10.57 to -4.46; diastolic (2 studies, 658 recipients): MD -3.07 mm Hg, 95% CI -4.83 to -1.31, lipid profile was better (non-HDL (3 studies 1101 recipients): MD -12.25 mg/dL, 95% CI -17.93 to -6.57; triglycerides (3 studies 1101 recipients): MD -24.09 mg/dL, 95% CI -44.55 to -3.64), and incidence of new-onset diabetes a er transplant was reduced by 39% (4 studies (1049 recipients): RR 0.61, 95% CI 0.40 to 0.93) among belatacept-treated versus CNI-treated recipients.

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Consistency and Completeness of Reported Outcomes in Randomized Trials of Primary Immunosuppression in Kidney Transplantation

Cited by 15 publications

References 24 publications

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation

Quality and consistency of outcome reporting in clinical trials of immunosuppression in renal transplantation

Belatacept for kidney transplant recipients

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