AustralieFrV1, PascalFrancis, Corpus, bibRecord, 001110

Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review

Identifieur interne : 001110 ( PascalFrancis/Corpus ); précédent : 001109; suivant : 001111

Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review

Auteurs : Julien Peron ; Gregory R. Pond ; Hui K. Gan ; Eric X. Chen ; Roula Almufti ; Denis Maillet ; Benoit You

Source :

Journal of the National Cancer Institute [ 0027-8874 ] ; 2012.

RBID : Pascal:12-0331457

Descripteurs français

Pascal (Inist)
- Tumeur maligne, Qualité, Document publié, Cancérologie, Revue bibliographique, Traitement, Homme, Essai randomisé contrôlé.

English descriptors

KwdEn :
- Bibliographic review, Cancerology, Human, Malignant tumor, Published document, Quality, Randomized controlled trial, Treatment.

Abstract

Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A03		`1`		`@0 J. Natl. Cancer Inst.`
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A08	`01`	`1`	`ENG`	`@1 Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review`
A11	`01`	`1`		`@1 PERON (Julien)`
A11	`02`	`1`		`@1 POND (Gregory R.)`
A11	`03`	`1`		`@1 GAN (Hui K.)`
A11	`04`	`1`		`@1 CHEN (Eric X.)`
A11	`05`	`1`		`@1 ALMUFTI (Roula)`
A11	`06`	`1`		`@1 MAILLET (Denis)`
A11	`07`	`1`		`@1 YOU (Benoit)`
A14	`01`			`@1 Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon @2 Pierre-Bénite @3 FRA @Z 1 aut. @Z 5 aut. @Z 6 aut. @Z 7 aut.`
A14	`02`			`@1 Ontario Clinical Oncology Group, Department of Oncology, McMaster University @2 Hamilton, ON @3 CAN @Z 2 aut.`
A14	`03`			`@1 Joint Austin-Ludwig Oncology Unit, Austin Hospital @2 Melbourne, VIC @3 AUS @Z 3 aut.`
A14	`04`			`@1 Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network @2 Toronto, ON @3 CAN @Z 4 aut.`
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A44				`@0 0000 @1 © 2012 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.
C02	`01`	`X`		`@0 002B04C`
C03	`01`	`X`	`FRE`	`@0 Tumeur maligne @2 NM @5 01`
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C03	`06`	`X`	`FRE`	`@0 Traitement @5 08`
C03	`06`	`X`	`ENG`	`@0 Treatment @5 08`
C03	`06`	`X`	`SPA`	`@0 Tratamiento @5 08`
C03	`07`	`X`	`FRE`	`@0 Homme @5 09`
C03	`07`	`X`	`ENG`	`@0 Human @5 09`
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Format Inist (serveur)

NO :	PASCAL 12-0331457 INIST
ET :	Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review
AU :	PERON (Julien); POND (Gregory R.); GAN (Hui K.); CHEN (Eric X.); ALMUFTI (Roula); MAILLET (Denis); YOU (Benoit)
AF :	Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon/Pierre-Bénite/France (1 aut., 5 aut., 6 aut., 7 aut.); Ontario Clinical Oncology Group, Department of Oncology, McMaster University/Hamilton, ON/Canada (2 aut.); Joint Austin-Ludwig Oncology Unit, Austin Hospital/Melbourne, VIC/Australie (3 aut.); Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network/Toronto, ON/Canada (4 aut.)
DT :	Publication en série; Niveau analytique
SO :	Journal of the National Cancer Institute; ISSN 0027-8874; Etats-Unis; Da. 2012; Vol. 104; No. 13; Pp. 982-989; Bibl. 33 ref.
LA :	Anglais
EA :	Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.
CC :	002B04C
FD :	Tumeur maligne; Qualité; Document publié; Cancérologie; Revue bibliographique; Traitement; Homme; Essai randomisé contrôlé
FG :	Cancer
ED :	Malignant tumor; Quality; Published document; Cancerology; Bibliographic review; Treatment; Human; Randomized controlled trial
EG :	Cancer
SD :	Tumor maligno; Calidad; Documento publicado; Cancerología; Revista bibliográfica; Tratamiento; Hombre; Ensayo aleatorio controlado
LO :	INIST-3364.354000508337720040
ID :	12-0331457

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Pascal:12-0331457

Le document en format XML

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<front><div type="abstract" xml:lang="en">Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.</div>
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<fA14 i1="02"><s1>Ontario Clinical Oncology Group, Department of Oncology, McMaster University</s1>
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<fC01 i1="01" l="ENG"><s0>Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B04C</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>01</s5>
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<fC03 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>01</s5>
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<fC03 i1="02" i2="X" l="FRE"><s0>Qualité</s0>
<s5>02</s5>
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<fC03 i1="02" i2="X" l="ENG"><s0>Quality</s0>
<s5>02</s5>
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<s5>08</s5>
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<s5>08</s5>
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<s5>08</s5>
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<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Human</s0>
<s5>09</s5>
</fC03>
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<s5>09</s5>
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<s4>CD</s4>
<s5>96</s5>
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<s4>CD</s4>
<s5>96</s5>
</fC03>
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<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Cáncer</s0>
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<server><NO>PASCAL 12-0331457 INIST</NO>
<ET>Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review</ET>
<AU>PERON (Julien); POND (Gregory R.); GAN (Hui K.); CHEN (Eric X.); ALMUFTI (Roula); MAILLET (Denis); YOU (Benoit)</AU>
<AF>Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon/Pierre-Bénite/France (1 aut., 5 aut., 6 aut., 7 aut.); Ontario Clinical Oncology Group, Department of Oncology, McMaster University/Hamilton, ON/Canada (2 aut.); Joint Austin-Ludwig Oncology Unit, Austin Hospital/Melbourne, VIC/Australie (3 aut.); Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network/Toronto, ON/Canada (4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Journal of the National Cancer Institute; ISSN 0027-8874; Etats-Unis; Da. 2012; Vol. 104; No. 13; Pp. 982-989; Bibl. 33 ref.</SO>
<LA>Anglais</LA>
<EA>Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed.The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials.Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.</EA>
<CC>002B04C</CC>
<FD>Tumeur maligne; Qualité; Document publié; Cancérologie; Revue bibliographique; Traitement; Homme; Essai randomisé contrôlé</FD>
<FG>Cancer</FG>
<ED>Malignant tumor; Quality; Published document; Cancerology; Bibliographic review; Treatment; Human; Randomized controlled trial</ED>
<EG>Cancer</EG>
<SD>Tumor maligno; Calidad; Documento publicado; Cancerología; Revista bibliográfica; Tratamiento; Hombre; Ensayo aleatorio controlado</SD>
<LO>INIST-3364.354000508337720040</LO>
<ID>12-0331457</ID>
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Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review

Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review

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