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      The effect of journal impact factor, reporting conflicts, and reporting funding sources, on standardized effect sizes in back pain trials: a systematic review and meta-regression

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          Abstract

          Background

          Low back pain is a common and costly health complaint for which there are several moderately effective treatments. In some fields there is evidence that funder and financial conflicts are associated with trial outcomes. It is not clear whether effect sizes in back pain trials relate to journal impact factor, reporting conflicts of interest, or reporting funding.

          Methods

          We performed a systematic review of English-language papers reporting randomised controlled trials of treatments for non-specific low back pain, published between 2006-2012. We modelled the relationship using 5-year journal impact factor, and categories of reported of conflicts of interest, and categories of reported funding (reported none and reported some, compared to not reporting these) using meta-regression, adjusting for sample size, and publication year. We also considered whether impact factor could be predicted by the direction of outcome, or trial sample size.

          Results

          We could abstract data to calculate effect size in 99 of 146 trials that met our inclusion criteria. Effect size is not associated with impact factor, reporting of funding source, or reporting of conflicts of interest. However, explicitly reporting ‘no trial funding’ is strongly associated with larger absolute values of effect size (adjusted β=1.02 (95 % CI 0.44 to 1.59), P=0.001). Impact factor increases by 0.008 (0.004 to 0.012) per unit increase in trial sample size ( P<0.001), but does not differ by reported direction of the LBP trial outcome ( P=0.270).

          Conclusions

          The absence of associations between effect size and impact factor, reporting sources of funding, and conflicts of interest reflects positively on research and publisher conduct in the field. Strong evidence of a large association between absolute magnitude of effect size and explicit reporting of ‘no funding’ suggests authors of unfunded trials are likely to report larger effect sizes, notwithstanding direction. This could relate in part to quality, resources, and/or how pragmatic a trial is.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12891-015-0825-6) contains supplementary material, which is available to authorized users.

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          Most cited references356

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          Improved tests for a random effects meta-regression with a single covariate.

          The explanation of heterogeneity plays an important role in meta-analysis. The random effects meta-regression model allows the inclusion of trial-specific covariates which may explain a part of the heterogeneity. We examine the commonly used tests on the parameters in the random effects meta-regression with one covariate and propose some new test statistics based on an improved estimator of the variance of the parameter estimates. The approximation of the distribution of the newly proposed tests is based on some theoretical considerations. Moreover, the newly proposed tests can easily be extended to the case of more than one covariate. In a simulation study, we compare the tests with regard to their actual significance level and we consider the log relative risk as the parameter of interest. Our simulation study reflects the meta-analysis of the efficacy of a vaccine for the prevention of tuberculosis originally discussed in Berkey et al. The simulation study shows that the newly proposed tests are superior to the commonly used test in holding the nominal significance level. Copyright 2003 John Wiley & Sons, Ltd.
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            Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

            To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
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              CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

              The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
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                Author and article information

                Contributors
                r.froud@warwick.ac.uk
                tomeirikkjeldsen87@yahoo.com
                philbright@eso.ac.uk
                devanrajendran@eso.ac.uk
                rachelle.buchbinder@monash.edu
                m.underwood@warwick.ac.uk
                dwe@backpainclinic.co.uk
                s.eldridge@qmul.ac.uk
                Journal
                BMC Musculoskelet Disord
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                30 November 2015
                30 November 2015
                2015
                : 16
                : 370
                Affiliations
                [ ]Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL UK
                [ ]Norge Helsehøyskole,, Campus Kristiania, Prinsens Gate 7-9, 0152, Oslo, Norway
                [ ]European School of Osteopathy, The Street, ME14 3DZ Boxley, Maidstone, UK
                [ ]Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB Whitechapel UK
                [ ]Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, Monash University, Suite 41, Cabrini Medical Centre, 183 Wattletree Road, Malvern, 3144, Melbourne, Victoria Australia
                Article
                825
                10.1186/s12891-015-0825-6
                4663726
                26620449
                29a6761d-cfb8-4a95-ba90-7f00af13d82f
                © Froud et al. 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 15 May 2015
                : 20 November 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Orthopedics
                back pain,impact factor,effect size,conflicts of interest,funding,reporting,publication bias,meta-regression,reml

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