The Consistency and Reporting of Quality-of-Life Outcomes in Trials of Immunosuppressive Agents in Kidney Transplantation: A Systematic Review and Meta-analysis

Howell, Martin; Wong, Germaine; Turner, Robin; Tan, Ho Teck; Tong, Allison; Craig, Jonathan C.; Howard, Kirsten

doi:10.1053/j.ajkd.2015.11.006

Cited by 29 publications

(30 citation statements)

References 65 publications

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“…Patient‐reported endpoints were particularly poorly reported, with only five of the 213 manuscripts reporting quality‐of‐life measures on a validated scale. This is in keeping with the recent analysis from Howell et al., who found infrequent reporting of quality‐of‐life (QOL) measures with significant risk of bias due to inconsistent and incomplete reporting . This analysis concentrated on the use of formal instruments for QOL reporting, whereas in the present study, we have included all patient‐reported outcomes.…”

Section: Discussionsupporting

confidence: 58%

“…A recent systematic review examined the quality of reporting of quality-of-life outcomes in immunosuppression trials in renal transplantation. 10 These outcomes were reported in only 2% of studies and were incompletely reported in the majority leading the authors to conclude that there is a significant risk of bias and limited utility for clinical decision making in existing trials.…”

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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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Section: Discussionsupporting

confidence: 58%

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confidence: 99%

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

Hussain

Knight

2016

Clinical Transplantation

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“…The full study will be published separately. The Delphi survey included outcome domains reported in trials in kidney transplantation (as identified in our systematic review) and from previous studies with kidney transplant recipients 16,35–39 . In total, 461 patients/caregivers and 557 health professionals from 79 countries participated.…”

Section: Methodsmentioning

confidence: 99%

Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation

et al. 2017

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Background Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. Methods We convened 2 international SONG-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. Results Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders – inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. Conclusions Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation.

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“…We identified the outcome domains from a systematic review of outcomes reported in trials in kidney transplant recipients, studies on kidney transplant recipient preferences for outcomes (21), and studies focusing on patient-reported outcomes (22–23). The list of outcomes was reviewed by the investigators, and piloted among 8 patients.…”

Section: Methodsmentioning

confidence: 99%

“…Only 58% of trials report infection and 48% of trials report cancer (9). Less than 2% of trials of maintenance immunosuppression interventions report quality of life outcomes, with nearly all favoring the intervention (10). The heterogeneity of outcomes, many of which may not be directly relevant to patients, and selective reporting of outcomes diminishes the reliability and relevance of clinical trials for decision-making (11).…”

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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The Consistency and Reporting of Quality-of-Life Outcomes in Trials of Immunosuppressive Agents in Kidney Transplantation: A Systematic Review and Meta-analysis

Cited by 29 publications

References 65 publications

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

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

Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation

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

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