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    <front>
        <journal-meta>
            <journal-id journal-id-type="publisher-id">JMIR</journal-id>
            <journal-id journal-id-type="nlm-ta">J Med Internet Res</journal-id>
            <journal-title>Journal of Medical Internet Research</journal-title>
            <issn pub-type="epub">14388871</issn>
            <publisher>
                <publisher-name>JMIR Publications Inc.</publisher-name>
                <publisher-loc>Toronto, Canada</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="publisher-id">v15i8e179</article-id>
            <article-id pub-id-type="pmid">23958686</article-id>
            <article-id pub-id-type="doi">10.2196/jmir.2845</article-id>
            <article-categories>
                <subj-group subj-group-type="article-type">
                    <subject>Letter to the Editor</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Claiming Positive Results From Negative Trials: A Cause for Concern in Randomized Controlled Trial Research</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="editor">
                    <name>
                        <surname>Eysenbach</surname>
                        <given-names>Gunther</given-names>
                    </name>
                </contrib>
            </contrib-group>
            <contrib-group>
                <contrib contrib-type="reviewer">
                    <name>
                        <surname>Moyer</surname>
                        <given-names>Anne</given-names>
                    </name>
                </contrib>
                <contrib contrib-type="reviewer">
                    <name>
                        <surname>Hester</surname>
                        <given-names>Reid</given-names>
                    </name>
                </contrib>
            </contrib-group>
            <contrib-group>
                <contrib contrib-type="author" id="contrib1" corresp="yes">
                    <name name-style="western">
                        <surname>Cunningham</surname>
                        <given-names>John A</given-names>
                    </name>
                    <xref ref-type="aff" rid="aff1">1</xref>
                    <address>
                        <institution>Centre for Mental Health Research</institution>
                        <institution>The Australian National University</institution>
                        <addr-line>Building 63,</addr-line>
                        <addr-line>Canberra, 0200</addr-line>
                        <country>Australia</country>
                        <phone>61 6125 1859</phone>
                        <fax>61 6125 0733</fax>
                        <email>john.cunningham@anu.edu.au</email>
                    </address>
                    <xref ref-type="aff" rid="aff2">2</xref>
                </contrib>
            </contrib-group>
            <aff id="aff1" rid="aff1">
                <sup>1</sup>
                <institution>Centre for Mental Health Research</institution>
                <institution>The Australian National University</institution>
                <addr-line>Canberra</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff2" rid="aff2">
                <sup>2</sup>
                <institution>Centre for Addiction and Mental Health</institution>
                <addr-line>Toronto, ON</addr-line>
                <country>Canada</country>
            </aff>
            <author-notes>
                <corresp>Corresponding Author: John A Cunningham <email>john.cunningham@anu.edu.au</email>
                </corresp>
            </author-notes>
            <pub-date pub-type="collection">
                <month>08</month>
                <year>2013</year>
            </pub-date>
            <pub-date pub-type="epub">
                <day>19</day>
                <month>08</month>
                <year>2013</year>
            </pub-date>
            <volume>15</volume>
            <issue>8</issue>
            <elocation-id>e179</elocation-id>
            <!--history from ojs - api-xml-->
            <history>
                <date date-type="received">
                    <day>23</day>
                    <month>07</month>
                    <year>2013</year>
                </date>
                <date date-type="accepted">
                    <day>15</day>
                    <month>08</month>
                    <year>2013</year>
                </date>
            </history>
            <!--(c) the authors - correct author names and publication date here if necessary. Date in form ', dd.mm.yyyy' after jmir.org-->
            <copyright-statement>&#169;John A Cunningham. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.08.2013. </copyright-statement>
            <copyright-year>2013</copyright-year>
            <license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0/">
                <p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.</p>
            </license>
            <self-uri xlink:href="http://www.jmir.org/2013/8/e179/" xlink:type="simple" />
            <kwd-group>
                <kwd>research methods</kwd>
                <kwd>randomised controlled trials</kwd>
                <kwd>alcohol</kwd>
                <kwd>Internet</kwd>
                <kwd>brief intervention</kwd>
            </kwd-group>
        </article-meta>
    </front>
    <body>
        <p>One of the challenging issues facing the randomized controlled trial (RCT) researcher is how to interpret the results of studies where there are improvements in the behaviour under study but where the degree of improvement does not differ between the experimental conditions [<xref ref-type="bibr" rid="ref1">1</xref>]. This is especially a challenge when the RCT involves the comparison of two or more interventions rather than an intervention compared to some form of no-intervention control group.</p>
        <p>One possible cause of the observed improvement in such trials is that both interventions were &#8220;active&#8221; - that both interventions were effective in facilitating or causing a change among participants.&#160; Unfortunately, there is no way to determine if this claim is definitely true from the results of a negative RCT. Other interpretations of the results include: 1) that the change over time is due to regression to the mean [<xref ref-type="bibr" rid="ref2">2</xref>, <xref ref-type="bibr" rid="ref3">3</xref>]; 2) due to natural history maturation (meaning that participants were in a period in their lives where, on average, a downward trend in quantity of drinking could be expected); or 3) the trial recruited participants who were already motivated to change and who would have done so anyway without exposure to the interventions under study [<xref ref-type="bibr" rid="ref4">4</xref>].</p>
        <p>Any of these alternate explanations could apply to the recent trial by Hester and colleagues [<xref ref-type="bibr" rid="ref1">1</xref>]. Further, there is a well-established finding in the alcohol research field that participants in the no intervention control condition of intervention trials show improvements in their drinking from baseline to follow-up [<xref ref-type="bibr" rid="ref5">5</xref>]. This may be particularly the case in trials recruiting participants from the community rather than from treatment settings where intractable alcohol problems are more common [<xref ref-type="bibr" rid="ref6">6</xref>]. Essentially, the assumption that any changes over time are due to the intervention in a negative trial is predicated on the assumption that the participants would show no improvement without receiving some type of intervention. There may be some behaviours where this is the case. However, alcohol abuse is demonstrably not one of them. Thus, it is unwise to favour an intervention effect explanation over other causes when faced with the results of an RCT where participants show improvement over time but that there are no significant statistical differences between intervention conditions.</p>
    </body>
    <back>
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</article>
