Volume 15, Issue 6 p. 447-454
Original Article

Comparison of the Quality of Pediatric Randomized Controlled Trials Published in Both Nursing and Medical Journals: Adherence to the CONSORT Statement

Flora Devos MSc

Corresponding Author

Flora Devos MSc

Nurse

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Clinical research Unit, Assistance Publique - Hôpitaux de Paris : Necker Hospital, Paris, France

Address correspondence to Flora Devos, Necker Hospital, IMAGNE, 149 rue de Sèvres, 75015 Paris, France; [email protected]Search for more papers by this author
Nour Ibrahim MD, MSc

Nour Ibrahim MD, MSc

Doctor of medicine

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Clinical research Unit, Assistance Publique - Hôpitaux de Paris : Necker Hospital, Paris, France

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Frantz Foissac PhD

Frantz Foissac PhD

Biostatistician

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Clinical research Unit, Assistance Publique - Hôpitaux de Paris : Necker Hospital, Paris, France

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Naim Bouazza PhD

Naim Bouazza PhD

Biostatistician

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Clinical research Unit, Assistance Publique - Hôpitaux de Paris : Necker Hospital, Paris, France

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Pierre-Yves Ancel PhD, MD

Pierre-Yves Ancel PhD, MD

Doctor of medicine

Clinical Research Unit, Assistance Publique - Hôpitaux de Paris : Cochin Hotel-Dieu Hospital, Paris, France

INSERM, Epidemiology and Biostatistics Sorbonne, Paris Cité Research Center, Obstetrical, Perinatal, and Pediatric Epidemiology Group, Paris, France

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Hélène Chappuy PhD, MD

Hélène Chappuy PhD, MD

Doctor of medicine

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Pediatric Emergency Department, Assistance Publique - Hôpitaux de Paris : Armand Trousseau Hospital, Paris, France

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Caroline Elie PhD, MD

Caroline Elie PhD, MD

Doctor of medicine

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Clinical research Unit, Assistance Publique - Hôpitaux de Paris : Necker Hospital, Paris, France

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Jean-Marc Tréluyer PhD, MD

Jean-Marc Tréluyer PhD, MD

Doctor of medicine

Pharmacology and Drug Evaluation in Children and Pregnant Women, Paris Descartes University, Sorbonne Paris Cité, France

Clinical research Unit, Assistance Publique - Hôpitaux de Paris : Necker Hospital, Paris, France

Clinical Research Unit, Assistance Publique - Hôpitaux de Paris : Cochin Hotel-Dieu Hospital, Paris, France

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First published: 15 October 2018
Citations: 12
We would like to thank the authors who agreed to share their articles for this study. We are also grateful to the Assistance Publique Hôpitaux de Paris (AP-HP) and all members of the Pharmacology and Drug Evaluation in Children and Pregnant Women EA 7323 group for their advice and support.

Abstract

Background

Nursing care should be based on scientific evidence. However, studies must be performed rigorously with accurate reporting for their findings to be applicable to practice. Since the body of scientific nursing literature is broad, the quality and validity of its findings should be regularly controlled and verified to ensure their application and their practical impact.

Purpose

To compare reporting quality of pediatric randomized controlled trial (RCT) articles in nursing and medical journals.

Methods

Randomly selected articles were reviewed and scored to assess the number of CONSORT items that were adequately reported, generating a CONSORT score. The CONSORT scores for 28 items were compared between the two journal types.

Results and Discussion

The CONSORT scores by journal type were not significantly different: (19.2 [16.2; 22] for medical journals and 19.5 [16.1; 21.5] for nursing journals, = .77). The reporting of CONSORT items was poor for both journal types. However, there were two significant differences: item 19 (Declaration of all important harm or unintended effects, = .0006) and item 23 (Registration number of the study, = .0003), were reported more often in medical journals. The adherence of journals to the CONSORT statement and large sample size was associated with better quality of the reporting of studies.

Conclusions

Based on reporting quality, nursing studies have the same scientific credibility and rigor as medical studies in the pediatric field.

Linking Evidence to Action

The findings of this study could help researchers improve the reporting of their studies and highlight the importance of reporting quality for future knowledge transfer and practical use. The quality of research and its reporting is necessary to improve knowledge transfer into practice.