Transplant Trial Watch

Do Clinical Trials Reflect Reality? A Systematic Review of Inclusion/Exclusion Criteria in Trials of Renal Transplant Immunosuppression.

Ayaz-Shah AA, Hussain S, et al.

Transplant International 2017 [record in progress]: 23.

To conduct a systematic review of the inclusion and exclusion criteria of immunosuppression randomised controlled trials (RCTs) in renal transplant populations and identify the extent of discrepancies in the reporting of inclusion/exclusion criteria of trial registry records and manuscripts.

The Transplant Library database which includes all reports from RCTs sourced from Medline, the Cochrane Library and hand searches of relevant conference abstracts, was searched for RCTs comparing two or more immunosuppressive strategies (induction or maintenance) in adult renal transplant recipients, published in English between 1 January 2010 and 31 December 2014. Screening of the results and data extraction were independently performed by two reviewers and any discrepancies agreed by discussion. Risk of bias for each study was assessed via Jadad score, use of intention-to-treat analysis and description of adequate allocation concealment.

174 RCTs were included in the systematic review.

Measured outcomes included donor and recipient criteria and discrepancies between trial registry record and final manuscript.

Median length of follow-up was 52 weeks (range 1–932).

CET Conclusions
This systematic review evaluates the inclusion and exclusion criteria of kidney transplant patients participating in immunosuppression RCTs. RCTs for inclusion were sourced from the Transplant Library and two reviewers independently screened the search results. Data were extracted by two independent reviewers and risk of bias of RCTs was assessed using the Jadad scale plus the items allocation concealment and intention to treat analysis. The review included 174 RCTs and identified commonly reported donor and recipient exclusion criteria. The authors conclude that applying strict inclusion/exclusion criteria to patients included in RCTs results in lack of generalizability of results from these trials. The review also found significant discrepancies between the description of inclusion/exclusion criteria in trial registry records and published manuscripts, showing the description only matched in 8% of published reports!

Quality notes
Quality assessment not appropriate

Trial registration

Funding source
Non-industry funded