Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate
Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differenc...
Ausführliche Beschreibung
Autor*in: |
de Boer, Michiel R [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2015 |
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Anmerkung: |
© de Boer et al.; licensee BioMed Central. 2015 |
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Übergeordnetes Werk: |
Enthalten in: International journal of behavioral nutrition and physical activity - London : BioMed Central, 2004, 12(2015), 1 vom: 24. Jan. |
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Übergeordnetes Werk: |
volume:12 ; year:2015 ; number:1 ; day:24 ; month:01 |
Links: |
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DOI / URN: |
10.1186/s12966-015-0162-z |
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Katalog-ID: |
SPR028922352 |
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520 | |a Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. | ||
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700 | 1 | |a Steenhuis, Ingrid HM |4 aut | |
700 | 1 | |a Twisk, Jos WR |4 aut | |
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10.1186/s12966-015-0162-z doi (DE-627)SPR028922352 (SPR)s12966-015-0162-z-e DE-627 ger DE-627 rakwb eng de Boer, Michiel R verfasserin aut Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Boer et al.; licensee BioMed Central. 2015 Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. Epidemiology (dpeaa)DE-He213 Methods (dpeaa)DE-He213 Reporting (dpeaa)DE-He213 Nutrition behavior research (dpeaa)DE-He213 Statistical analyses (dpeaa)DE-He213 Waterlander, Wilma E aut Kuijper, Lothar DJ aut Steenhuis, Ingrid HM aut Twisk, Jos WR aut Enthalten in International journal of behavioral nutrition and physical activity London : BioMed Central, 2004 12(2015), 1 vom: 24. Jan. (DE-627)378572342 (DE-600)2134691-4 1479-5868 nnns volume:12 year:2015 number:1 day:24 month:01 https://dx.doi.org/10.1186/s12966-015-0162-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4598 GBV_ILN_4700 AR 12 2015 1 24 01 |
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10.1186/s12966-015-0162-z doi (DE-627)SPR028922352 (SPR)s12966-015-0162-z-e DE-627 ger DE-627 rakwb eng de Boer, Michiel R verfasserin aut Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Boer et al.; licensee BioMed Central. 2015 Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. Epidemiology (dpeaa)DE-He213 Methods (dpeaa)DE-He213 Reporting (dpeaa)DE-He213 Nutrition behavior research (dpeaa)DE-He213 Statistical analyses (dpeaa)DE-He213 Waterlander, Wilma E aut Kuijper, Lothar DJ aut Steenhuis, Ingrid HM aut Twisk, Jos WR aut Enthalten in International journal of behavioral nutrition and physical activity London : BioMed Central, 2004 12(2015), 1 vom: 24. Jan. (DE-627)378572342 (DE-600)2134691-4 1479-5868 nnns volume:12 year:2015 number:1 day:24 month:01 https://dx.doi.org/10.1186/s12966-015-0162-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4598 GBV_ILN_4700 AR 12 2015 1 24 01 |
allfields_unstemmed |
10.1186/s12966-015-0162-z doi (DE-627)SPR028922352 (SPR)s12966-015-0162-z-e DE-627 ger DE-627 rakwb eng de Boer, Michiel R verfasserin aut Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Boer et al.; licensee BioMed Central. 2015 Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. Epidemiology (dpeaa)DE-He213 Methods (dpeaa)DE-He213 Reporting (dpeaa)DE-He213 Nutrition behavior research (dpeaa)DE-He213 Statistical analyses (dpeaa)DE-He213 Waterlander, Wilma E aut Kuijper, Lothar DJ aut Steenhuis, Ingrid HM aut Twisk, Jos WR aut Enthalten in International journal of behavioral nutrition and physical activity London : BioMed Central, 2004 12(2015), 1 vom: 24. Jan. (DE-627)378572342 (DE-600)2134691-4 1479-5868 nnns volume:12 year:2015 number:1 day:24 month:01 https://dx.doi.org/10.1186/s12966-015-0162-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4598 GBV_ILN_4700 AR 12 2015 1 24 01 |
allfieldsGer |
10.1186/s12966-015-0162-z doi (DE-627)SPR028922352 (SPR)s12966-015-0162-z-e DE-627 ger DE-627 rakwb eng de Boer, Michiel R verfasserin aut Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Boer et al.; licensee BioMed Central. 2015 Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. Epidemiology (dpeaa)DE-He213 Methods (dpeaa)DE-He213 Reporting (dpeaa)DE-He213 Nutrition behavior research (dpeaa)DE-He213 Statistical analyses (dpeaa)DE-He213 Waterlander, Wilma E aut Kuijper, Lothar DJ aut Steenhuis, Ingrid HM aut Twisk, Jos WR aut Enthalten in International journal of behavioral nutrition and physical activity London : BioMed Central, 2004 12(2015), 1 vom: 24. Jan. (DE-627)378572342 (DE-600)2134691-4 1479-5868 nnns volume:12 year:2015 number:1 day:24 month:01 https://dx.doi.org/10.1186/s12966-015-0162-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4598 GBV_ILN_4700 AR 12 2015 1 24 01 |
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10.1186/s12966-015-0162-z doi (DE-627)SPR028922352 (SPR)s12966-015-0162-z-e DE-627 ger DE-627 rakwb eng de Boer, Michiel R verfasserin aut Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Boer et al.; licensee BioMed Central. 2015 Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. Epidemiology (dpeaa)DE-He213 Methods (dpeaa)DE-He213 Reporting (dpeaa)DE-He213 Nutrition behavior research (dpeaa)DE-He213 Statistical analyses (dpeaa)DE-He213 Waterlander, Wilma E aut Kuijper, Lothar DJ aut Steenhuis, Ingrid HM aut Twisk, Jos WR aut Enthalten in International journal of behavioral nutrition and physical activity London : BioMed Central, 2004 12(2015), 1 vom: 24. Jan. (DE-627)378572342 (DE-600)2134691-4 1479-5868 nnns volume:12 year:2015 number:1 day:24 month:01 https://dx.doi.org/10.1186/s12966-015-0162-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4598 GBV_ILN_4700 AR 12 2015 1 24 01 |
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Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate |
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Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. © de Boer et al.; licensee BioMed Central. 2015 |
abstractGer |
Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. © de Boer et al.; licensee BioMed Central. 2015 |
abstract_unstemmed |
Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. © de Boer et al.; licensee BioMed Central. 2015 |
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Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate |
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Waterlander, Wilma E Kuijper, Lothar DJ Steenhuis, Ingrid HM Twisk, Jos WR |
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