Evidence map›Paper›PMID 28196521›Full record

ArticleSystematic reviews2017

Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project.

Jeffrey Low, Joseph S Ross, Jessica D Ritchie, Cary P Gross, Richard Lehman, Haiqun Lin, Rongwei Fu, Lesley A Stewart, Harlan M Krumholz

Abstract readComparative Study
In one paragraph

Article in Systematic reviews, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jeffrey LowDepartment of Internal Medicine, Yale School of Medicine, 333 Cedar Street, New Haven, CT, 06510, USA.
Joseph S RossCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, 1 Church Street, Suite 200, New Haven, CT, 06510, USA.
Jessica D RitchieCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, 1 Church Street, Suite 200, New Haven, CT, 06510, USA.
Cary P GrossSection of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, P.O. Box 208093, New Haven, CT, 06510, USA.
Richard LehmanDepartment of Primary Care Health Sciences, Oxford University, 33 St Ebbes Street, Oxford, OX1 1PU, UK.
Haiqun LinCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, 1 Church Street, Suite 200, New Haven, CT, 06510, USA.
Rongwei FuDepartment of Public Health and Preventive Medicine, Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR, 97239-3098, USA.
Lesley A StewartCentre for Reviews and Dissemination, University of York, Heslington, York, YO10 5DD, UK.
Harlan M KrumholzCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, 1 Church Street, Suite 200, New Haven, CT, 06510, USA. harlan.krumholz@yale.edu.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Center for Cardiovascular Outcomes Research at Yale UniversityU01HL105270 · NHLBI · YALE UNIVERSITY · PI CURTIS, JEPTHA PELHAM, KRUMHOLZ, HARLAN MARC · 2010 to 2013
$5.8M
Impact of Publicity Reporting Hospital Outcome Measures for Older AdultsK08AG032886 · NIA · YALE UNIVERSITY · PI ROSS, JOSEPH SOLOMON · 2008 to 2012
$738k
Medical Research Council G0801402NCATS NIH HHS UL1 TR001863NHLBI NIH HHS U01 HL105270NIA NIH HHS K08 AG032886
6 · The paper itself

Abstract

backgroundIt 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.

methodsTwo 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.

resultsThe 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.

conclusionsTwo 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 CRD42012002040 and CRD42012001907 .

Indexed as

Review Literature as TopicBone Morphogenetic Protein 2Data Interpretation, StatisticalHumansMeta-Analysis as TopicRecombinant ProteinsRetrospective StudiesRisk FactorsTransforming Growth Factor betaTreatment OutcomeBone Morphogenetic Protein 2recombinant human bone morphogenetic protein-2Recombinant ProteinsTransforming Growth Factor betaData interpretationData sharingMeta-analysisSystematic review

Identifiers

PMID28196521
PMCPMC5310069

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.