TY - JOUR Y1 - 2019/03// SN - 0027-8874 TI - A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation using Meta-analyses (ReSEEM) N1 - Copyright © The Author(s) 2019. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com PB - Oxford University Press (OUP) IS - 1 KW - medical oncology KW - guidelines KW - surrogate endpoints ID - discovery10065962 JF - Journal of the National Cancer Institute AV - public N2 - BACKGROUND: Meta-analysis of randomized controlled trials (RCTs) has been widely conducted for the evaluation of surrogate endpoints in oncology, but little attention has been given to the adequacy of reporting and interpretation. This review evaluated the reporting quality of published metaanalyses on surrogacy evaluation and developed recommendations for future reporting. METHODS: We searched PubMed to identify studies that evaluated surrogate endpoints using the metaanalyses of RCTs in oncology. Both individual-patient-data (IPD) and aggregate-data (AD) meta-analyses were included for the review. RESULTS: Eighty meta-analyses were identified: 22 used IPD and 58 used AD from multiple RCTs. We observed variability and reporting deficiencies in both IPD and AD meta-analyses, especially on reporting of trial selection, endpoint definition, study and patient characteristics for included RCTs and important statistical methods and results. Based on these findings, we proposed a checklist and recommendations to improve completeness, consistency and transparency of reports of meta-analytic surrogacy evaluation. We highlighted key aspects of the design and analysis of surrogate endpoints and presented explanations and rationale why these items should be clearly reported in surrogacy evaluation. CONCLUSION: Our ReSEEM guidelines and recommendations will improve the quality in reporting and facilitate the interpretation and reproducibility of meta-analytic surrogacy evaluation. Also, they 3 should help promote greater methodological consistency and could also serve as an evaluation tool in the peer review process for assessing surrogacy research. A1 - Xie, W A1 - Halabi, S A1 - Tierney, J A1 - Sydes, MR A1 - Collette, L A1 - DIgnam, JJ A1 - Buyse, M A1 - Sweeney, CJ A1 - Regan, MM UR - https://doi.org/10.1093/jncics/pkz002 VL - 3 ER -