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Reporting of Harm in Randomized, Controlled Trials of Nonpharmacologic Treatment for Rheumatic Disease

Morgane Ethgen, MSc; Isabelle Boutron, MD; Gabriel Baron, MSc; Bruno Giraudeau, PhD; Jean Sibilia, MD, PhD; and Philippe Ravaud, MD, PhD
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From Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France; Hôpital Bretonneau, Tours, France; and Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe Hospitalier Bichat-Claude Bernard, and Université Paris VII, Paris, France.


Acknowledgments: The authors thank David Moher (Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, and University of Ottawa) for his comments and help in improving this report.

Grant Support: Dr. Boutron was supported by a grant from the Caisse Nationale d'Assurance Maladie des Professions Indépendantes and Assistance Publique des Hôpitaux de Paris.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Isabelle Boutron, MD, Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM U738, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 Paris Cedex 18, France; e-mail, isabelle.boutron@bch.ap-hop-paris.fr.

Current Author Addresses: Ms. Ethgen: Service de Rhumatologie, INSERM U738, Centre Hospitalier Universitaire de Hauptpierre, 1 Avenue Molière, 67098, Strasbourg, France.

Dr. Sibilia: Service de Rhumatologie, Centre Hospitalier Universitaire de Hautepierre, 1 Avenue Molière, 67098 Strasbourg, France.

Drs. Boutron and Ravaud and Mr. Baron: Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM U738, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 Paris, France.

Dr. Giraudeau: INSERM CIC 202, Hôpital Bretonneau, 2 boulevard Tonnelle, 37044 Tours CEDEX 9, France.

Author Contributions: Conception and design: M. Ethgen, I. Boutron, J. Sibilia, P. Ravaud.

Analysis and interpretation of the data: M. Ethgen, I. Boutron, G. Baron, B. Giraudeau, J. Sibilia, P. Ravaud.

Drafting of the article: M. Ethgen, I. Boutron.

Critical revision of the article for important intellectual content: G. Baron, B. Giraudeau, J. Sibilia, P. Ravaud.

Final approval of the article: M. Ethgen, I. Boutron, G. Baron, B. Giraudeau, J. Sibilia, P. Ravaud.

Provision of study materials or patients: M. Ethgen, I. Boutron.

Statistical expertise: G. Baron, B. Giraudeau.


Ann Intern Med. 2005;143(1):20-25. doi:10.7326/0003-4819-143-1-200507050-00006
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We assessed the reporting of harm in published randomized, controlled trials of pharmacologic and nonpharmacologic treatment for rheumatoid arthritis and hip or knee osteoarthritis during a 6-year period. Our results highlight that harm was described less in reports of nonpharmacologic treatment trials than in reports of pharmacologic treatment trials. These results remained true after adjustment for confounding factors and are consistent with those of a study of mental health interventions (6).

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Grahic Jump Location
Figure.
Study screening process.

RA = rheumatoid arthritis; TENS = transcutaneous electrical nerve stimulation.

Grahic Jump Location

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