AustralieFrV1, PascalFrancis, Corpus, bibRecord, 000632

Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review

Identifieur interne : 000632 ( PascalFrancis/Corpus ); précédent : 000631; suivant : 000633

Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review

Auteurs : Julien Peron ; Denis Maillet ; Hui K. Gan ; Eric X. Chen ; Benoit You

Source :

Journal of clinical oncology [ 0732-183X ] ; 2013.

RBID : Pascal:14-0010407

Descripteurs français

Pascal (Inist)
- Cancer, Adhérence, Effet secondaire, Tumeur maligne, Toxicité, Recommandation, Essai clinique, Randomisation, Traitement, Revue systématique, Médecine factuelle, Cancérologie.

English descriptors

KwdEn :
- Adhesion, Cancer, Cancerology, Clinical trial, Evidence-based medicine, Malignant tumor, Randomization, Recommendation, Secondary effect, Systematic review, Toxicity, Treatment.

Abstract

Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08	`01`	`1`	`ENG`	`@1 Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review`
A11	`01`	`1`		`@1 PERON (Julien)`
A11	`02`	`1`		`@1 MAILLET (Denis)`
A11	`03`	`1`		`@1 GAN (Hui K.)`
A11	`04`	`1`		`@1 CHEN (Eric X.)`
A11	`05`	`1`		`@1 YOU (Benoit)`
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A64	`01`	`1`		`@0 Journal of clinical oncology`
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C01	`01`		`ENG`	@0 Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.
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Format Inist (serveur)

NO :	PASCAL 14-0010407 INIST
ET :	Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review
AU :	PERON (Julien); MAILLET (Denis); GAN (Hui K.); CHEN (Eric X.); YOU (Benoit)
AF :	Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon/Pierre-Bénite/France (1 aut., 2 aut., 5 aut.); Hospices Civils de Lyon/France (1 aut.); Université de Lyon/Lyon/France (1 aut.); Centre National de la Recherche Scientifique Unite Mixte de Recherche 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé/Villeurbanne/France (1 aut., 5 aut.); EMR UCBL/ HCL 3738, Faculté de Médecine Lyon-Sud/Oullins/France (5 aut.); Joint Austin-Ludwig Oncology Unit, Austin Hospital/Melbourne, Victoria/Australie (3 aut.); Princess Margaret Hospital, University Health Network/Canada (4 aut.); University of Toronto/Toronto, Ontario/Canada (4 aut.)
DT :	Publication en série; Compte-rendu; Niveau analytique
SO :	Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2013; Vol. 31; No. 31; Pp. 3957-3963; Bibl. 34 ref.
LA :	Anglais
EA :	Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.
CC :	002B04C
FD :	Cancer; Adhérence; Effet secondaire; Tumeur maligne; Toxicité; Recommandation; Essai clinique; Randomisation; Traitement; Revue systématique; Médecine factuelle; Cancérologie
FG :	Pratique basée sur des preuves
ED :	Cancer; Adhesion; Secondary effect; Malignant tumor; Toxicity; Recommendation; Clinical trial; Randomization; Treatment; Systematic review; Evidence-based medicine; Cancerology
EG :	Evidence-based practice
SD :	Cáncer; Adherencia; Efecto secundario; Tumor maligno; Toxicidad; Recomendación; Ensayo clínico; Aleatorización; Tratamiento; Revisión sistemática; Medicina basada en pruebas; Cancerología
LO :	INIST-20094.354000501045470180
ID :	14-0010407

Links to Exploration step

Pascal:14-0010407

Le document en format XML

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<front><div type="abstract" xml:lang="en">Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.</div>
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<sZ>5 aut.</sZ>
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<fA14 i1="02"><s1>Hospices Civils de Lyon</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Université de Lyon</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Centre National de la Recherche Scientifique Unite Mixte de Recherche 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé</s1>
<s2>Villeurbanne</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>EMR UCBL/ HCL 3738, Faculté de Médecine Lyon-Sud</s1>
<s2>Oullins</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Joint Austin-Ludwig Oncology Unit, Austin Hospital</s1>
<s2>Melbourne, Victoria</s2>
<s3>AUS</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Princess Margaret Hospital, University Health Network</s1>
<s3>CAN</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>University of Toronto</s1>
<s2>Toronto, Ontario</s2>
<s3>CAN</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA20><s1>3957-3963</s1>
</fA20>
<fA21><s1>2013</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
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<s1>© 2014 INIST-CNRS. All rights reserved.</s1>
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<fA45><s0>34 ref.</s0>
</fA45>
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</fA47>
<fA60><s1>P</s1>
<s3>C</s3>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B04C</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Adhérence</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Adhesion</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Adherencia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Effet secondaire</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Secondary effect</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Efecto secundario</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Toxicité</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Toxicity</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Toxicidad</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Recommandation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Recommendation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Recomendación</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Essai clinique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Clinical trial</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Ensayo clínico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Randomization</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Aleatorización</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Traitement</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Treatment</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Revue systématique</s0>
<s2>FM</s2>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Systematic review</s0>
<s2>FM</s2>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Revisión sistemática</s0>
<s2>FM</s2>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Médecine factuelle</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Evidence-based medicine</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Medicina basada en pruebas</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Cancerology</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>18</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pratique basée sur des preuves</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Evidence-based practice</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Práctica basada en la evidencia</s0>
</fC07>
<fN21><s1>006</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
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<server><NO>PASCAL 14-0010407 INIST</NO>
<ET>Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review</ET>
<AU>PERON (Julien); MAILLET (Denis); GAN (Hui K.); CHEN (Eric X.); YOU (Benoit)</AU>
<AF>Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon/Pierre-Bénite/France (1 aut., 2 aut., 5 aut.); Hospices Civils de Lyon/France (1 aut.); Université de Lyon/Lyon/France (1 aut.); Centre National de la Recherche Scientifique Unite Mixte de Recherche 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé/Villeurbanne/France (1 aut., 5 aut.); EMR UCBL/ HCL 3738, Faculté de Médecine Lyon-Sud/Oullins/France (5 aut.); Joint Austin-Ludwig Oncology Unit, Austin Hospital/Melbourne, Victoria/Australie (3 aut.); Princess Margaret Hospital, University Health Network/Canada (4 aut.); University of Toronto/Toronto, Ontario/Canada (4 aut.)</AF>
<DT>Publication en série; Compte-rendu; Niveau analytique</DT>
<SO>Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2013; Vol. 31; No. 31; Pp. 3957-3963; Bibl. 34 ref.</SO>
<LA>Anglais</LA>
<EA>Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.</EA>
<CC>002B04C</CC>
<FD>Cancer; Adhérence; Effet secondaire; Tumeur maligne; Toxicité; Recommandation; Essai clinique; Randomisation; Traitement; Revue systématique; Médecine factuelle; Cancérologie</FD>
<FG>Pratique basée sur des preuves</FG>
<ED>Cancer; Adhesion; Secondary effect; Malignant tumor; Toxicity; Recommendation; Clinical trial; Randomization; Treatment; Systematic review; Evidence-based medicine; Cancerology</ED>
<EG>Evidence-based practice</EG>
<SD>Cáncer; Adherencia; Efecto secundario; Tumor maligno; Toxicidad; Recomendación; Ensayo clínico; Aleatorización; Tratamiento; Revisión sistemática; Medicina basada en pruebas; Cancerología</SD>
<LO>INIST-20094.354000501045470180</LO>
<ID>14-0010407</ID>
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Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review

Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review

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