@article{3d86ed4465f94e128e34e45de80554e3,
title = "Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): The Yale Open Data Access Medtronic Project",
abstract = "Background: It is uncertain whether the replication of systematic reviews, particularly those with the same objectives and resources, would employ similar methods and/or arrive at identical findings. We compared the results and conclusions of two concurrent systematic reviews undertaken by two independent research teams provided with the same objectives, resources, and individual participant-level data. Methods: Two centers in the USA and UK were each provided with participant-level data on 17 multi-site clinical trials of recombinant human bone morphogenetic protein-2 (rhBMP-2). The teams were blinded to each other's methods and findings until after publication. We conducted a retrospective structured comparison of the results of the two systematic reviews. The main outcome measures included (1) trial inclusion criteria; (2) statistical methods; (3) summary efficacy and risk estimates; and (4) conclusions. Results: The two research teams' meta-analyses inclusion criteria were broadly similar but differed slightly in trial inclusion and research methodology. They obtained similar results in summary estimates of most clinical outcomes and adverse events. Center A incorporated all trials into summary estimates of efficacy and harms, while Center B concentrated on analyses stratified by surgical approach. Center A found a statistically significant, but small, benefit whereas Center B reported no advantage. In the analysis of harms, neither showed an increased cancer risk at 48 months, although Center B reported a significant increase at 24 months. Conclusions reflected these differences in summary estimates of benefit balanced with small but potentially important risk of harm. Conclusions: Two independent groups given the same research objectives, data, resources, funding, and time produced broad general agreement but differed in several areas. These differences, the importance of which is debatable, indicate the value of the availability of data to allow for more than a single approach and a single interpretation of the data. Systematic review registration: PROSPERO CRD42012002040and CRD42012001907.",
keywords = "Data interpretation, Data sharing, Meta-analysis, Systematic review",
author = "Jeffrey Low and Ross, {Joseph S.} and Ritchie, {Jessica D.} and Gross, {Cary P.} and Richard Lehman and Haiqun Lin and Rongwei Fu and Stewart, {Lesley A.} and Krumholz, {Harlan M.}",
note = "Funding Information: The authors thank Mark Simmonds and Mark Rodgers (Team A, University of York) and Roger Chou and Marian McDonagh (Team B, Oregon Health and Science University) for commenting on the previous drafts of this paper. Funding Dr. Krumholz is supported by grant U01 HL105270-05 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute. Dr. Ross is supported by grant K08 AG032886 from the National Institute on Aging and by the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program. The funders were not involved in the design of the study, conduct of the work, or the development and submittal of the work for publication. Funding Information: Dr. Krumholz is supported by grant U01 HL105270-05 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute. Dr. Ross is supported by grant K08 AG032886 from the National Institute on Aging and by the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program. The funders were not involved in the design of the study, conduct of the work, or the development and submittal of the work for publication. Funding Information: Dr. Krumholz chairs a cardiac scientific advisory board for UnitedHealth. Dr. Gross receives research funding from 21st Century Oncology. Dr. Fu previously received funding from the Yale Open Data Access (YODA) Project to carry out the analyses attributed to Team B in this paper. Dr. Stewart is employed as Director of the Centre for Reviews and Dissemination at the University of York and is in receipt of research funding to carry out health technology assessments including systematic reviews and meta-analyses for the National Institute for Health Research, and she previously received funding from the YODA project to carry out the analyses attributed to Team A in this paper; the Centre for Reviews and Dissemination has a policy not to conduct work for or on behalf of the pharmaceutical or medical devices industry. The other authors do not have competing interests to report. Funding Information: Drs. Gross, Krumholz and Ross are funded by research agreements from Medtronic and from Johnson & Johnson (Janssen), through Yale University, to develop methods of clinical trial data sharing. Drs. Krumholz and Ross work under contract to the Centers for Medicare & Medicaid Services to develop and maintain performance measures and are the recipients of research support from the Food and Drug Administration, through Yale University, to develop methods for post-market surveillance of medical devices. Publisher Copyright: {\textcopyright} 2017 The Author(s).",
year = "2017",
month = feb,
day = "15",
doi = "10.1186/s13643-017-0422-x",
language = "English (US)",
volume = "6",
journal = "Systematic Reviews",
issn = "2046-4053",
publisher = "BioMed Central",
number = "1",
}