Effects of study design and allocation on self-reported alcohol consumption: randomized trial
What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants tol...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2015-03, Vol.16 (1), p.127-127, Article 127 |
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| creator | Kypri, Kypros Wilson, Amanda Attia, John Sheeran, Paschal J McCambridge, Jim |
| description | What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group.
Students from four universities (N = 72,903) were invited to participate in a 'research project on student drinking'. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A ('cohort') were informed their drinking would be assessed at baseline and again in one month. Group B ('control') were told the study was an intervention trial and they were in the control group. Group C ('intervention') were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed.
In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, 'intervention' |
| doi_str_mv | 10.1186/s13063-015-0642-0 |
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Students from four universities (N = 72,903) were invited to participate in a 'research project on student drinking'. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A ('cohort') were informed their drinking would be assessed at baseline and again in one month. Group B ('control') were told the study was an intervention trial and they were in the control group. Group C ('intervention') were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed.
In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, 'intervention' < 'control'). The 'cohort' and 'control' groups accessed the material to a similar extent (59% versus 57%) while the 'intervention' group were more likely to access it (78%) and to read it for longer (median 35 s (25th and 75th percentiles: 6, 97) versus medians of 7 s (0, 28) and 8 s (4, 42) for the 'cohort' and 'control' groups, respectively).
Although the context given to the research participants significantly influenced access to the online information and reading time, this did not translate into any effect on drinking behaviour, for either hypothesis. This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach.
Australian New Zealand Clinical Trials Registry ACTRN12610000846022.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-015-0642-0</identifier><identifier>PMID: 25872651</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Alcohol ; Alcohol Drinking ; Alcohol use ; Analysis ; Clinical trials ; Drinking of alcoholic beverages ; Effect Modifier, Epidemiologic ; Estimates ; Health aspects ; Humans ; Intervention ; Methodology ; Participation ; Placebo Effect ; Research Design ; Self Report ; Social aspects ; Students ; Universities</subject><ispartof>Current controlled trials in cardiovascular medicine, 2015-03, Vol.16 (1), p.127-127, Article 127</ispartof><rights>COPYRIGHT 2015 BioMed Central Ltd.</rights><rights>Kypri et al.; licensee BioMed Central. 2015. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Kypri et al.; licensee BioMed Central. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-fcc48bd1e16baf01ebf8d33983b820e3ea53b4ae12dba0de54655b7ed2ab8b413</citedby><cites>FETCH-LOGICAL-c494t-fcc48bd1e16baf01ebf8d33983b820e3ea53b4ae12dba0de54655b7ed2ab8b413</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393640/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393640/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25872651$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kypri, Kypros</creatorcontrib><creatorcontrib>Wilson, Amanda</creatorcontrib><creatorcontrib>Attia, John</creatorcontrib><creatorcontrib>Sheeran, Paschal J</creatorcontrib><creatorcontrib>McCambridge, Jim</creatorcontrib><title>Effects of study design and allocation on self-reported alcohol consumption: randomized trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group.
Students from four universities (N = 72,903) were invited to participate in a 'research project on student drinking'. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A ('cohort') were informed their drinking would be assessed at baseline and again in one month. Group B ('control') were told the study was an intervention trial and they were in the control group. Group C ('intervention') were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed.
In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, 'intervention' < 'control'). The 'cohort' and 'control' groups accessed the material to a similar extent (59% versus 57%) while the 'intervention' group were more likely to access it (78%) and to read it for longer (median 35 s (25th and 75th percentiles: 6, 97) versus medians of 7 s (0, 28) and 8 s (4, 42) for the 'cohort' and 'control' groups, respectively).
Although the context given to the research participants significantly influenced access to the online information and reading time, this did not translate into any effect on drinking behaviour, for either hypothesis. This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach.
Australian New Zealand Clinical Trials Registry ACTRN12610000846022.</description><subject>Alcohol</subject><subject>Alcohol Drinking</subject><subject>Alcohol use</subject><subject>Analysis</subject><subject>Clinical trials</subject><subject>Drinking of alcoholic beverages</subject><subject>Effect Modifier, Epidemiologic</subject><subject>Estimates</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Intervention</subject><subject>Methodology</subject><subject>Participation</subject><subject>Placebo Effect</subject><subject>Research Design</subject><subject>Self Report</subject><subject>Social aspects</subject><subject>Students</subject><subject>Universities</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptUltrFTEYDKLYWv0BvsiCL75szbe57K4PQin1AgVf9FFCLl9OU7KbY7Ir1F9vllNrK5JAQr6ZCTMMIS-BngIM8m0BRiVrKYiWSt619BE5hp6LVnYgHt-7H5FnpVxTytnI-FNy1Imh76SAY_L9wnu0S2mSb8qyupvGYQm7udGza3SMyeolpLmpu2D0bcZ9ygtuM5uuUmxsmss67TfQuyZXVprCrzpfctDxOXnidSz44vY8Id8-XHw9_9Refvn4-fzssrV85EvrreWDcYAgjfYU0PjBMTYOzAwdRYZaMMM1QueMpg4Fl0KYHl2nzWA4sBPy_qC7X82EzuK8ZB3VPodJ5xuVdFAPJ3O4Urv0U22BSE6rwJtbgZx-rFgWNYViMUY9Y1qLAtmzfmQAfYW-_gd6ndY8V3uq60fBgLJe_EXtdEQVZp_qv3YTVWeCgxirmqyo0_-g6nI4hZos-lDfHxDgQLA5lZLR33kEqrZOqEMnVO2E2jqhNm-v7odzx_hTAvYbNrWzCA</recordid><startdate>20150328</startdate><enddate>20150328</enddate><creator>Kypri, Kypros</creator><creator>Wilson, Amanda</creator><creator>Attia, John</creator><creator>Sheeran, Paschal J</creator><creator>McCambridge, Jim</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150328</creationdate><title>Effects of study design and allocation on self-reported alcohol consumption: randomized trial</title><author>Kypri, Kypros ; Wilson, Amanda ; Attia, John ; Sheeran, Paschal J ; McCambridge, Jim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-fcc48bd1e16baf01ebf8d33983b820e3ea53b4ae12dba0de54655b7ed2ab8b413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Alcohol</topic><topic>Alcohol Drinking</topic><topic>Alcohol use</topic><topic>Analysis</topic><topic>Clinical trials</topic><topic>Drinking of alcoholic beverages</topic><topic>Effect Modifier, Epidemiologic</topic><topic>Estimates</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Intervention</topic><topic>Methodology</topic><topic>Participation</topic><topic>Placebo Effect</topic><topic>Research Design</topic><topic>Self Report</topic><topic>Social aspects</topic><topic>Students</topic><topic>Universities</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kypri, Kypros</creatorcontrib><creatorcontrib>Wilson, Amanda</creatorcontrib><creatorcontrib>Attia, John</creatorcontrib><creatorcontrib>Sheeran, Paschal J</creatorcontrib><creatorcontrib>McCambridge, Jim</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kypri, Kypros</au><au>Wilson, Amanda</au><au>Attia, John</au><au>Sheeran, Paschal J</au><au>McCambridge, Jim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of study design and allocation on self-reported alcohol consumption: randomized trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2015-03-28</date><risdate>2015</risdate><volume>16</volume><issue>1</issue><spage>127</spage><epage>127</epage><pages>127-127</pages><artnum>127</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group.
Students from four universities (N = 72,903) were invited to participate in a 'research project on student drinking'. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A ('cohort') were informed their drinking would be assessed at baseline and again in one month. Group B ('control') were told the study was an intervention trial and they were in the control group. Group C ('intervention') were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed.
In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, 'intervention' < 'control'). The 'cohort' and 'control' groups accessed the material to a similar extent (59% versus 57%) while the 'intervention' group were more likely to access it (78%) and to read it for longer (median 35 s (25th and 75th percentiles: 6, 97) versus medians of 7 s (0, 28) and 8 s (4, 42) for the 'cohort' and 'control' groups, respectively).
Although the context given to the research participants significantly influenced access to the online information and reading time, this did not translate into any effect on drinking behaviour, for either hypothesis. This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach.
Australian New Zealand Clinical Trials Registry ACTRN12610000846022.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>25872651</pmid><doi>10.1186/s13063-015-0642-0</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Alcohol Alcohol Drinking Alcohol use Analysis Clinical trials Drinking of alcoholic beverages Effect Modifier, Epidemiologic Estimates Health aspects Humans Intervention Methodology Participation Placebo Effect Research Design Self Report Social aspects Students Universities |
| title | Effects of study design and allocation on self-reported alcohol consumption: randomized trial |
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