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

5 July 2005 | Volume 143 Issue 1 | Pages 20-25

Background: Reports of clinical trials usually emphasize benefits and give less attention to harms.

Purpose: To compare the reporting of harm in trials of pharmacologic and nonpharmacologic treatment.

Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials.

Study Selection: Reports of randomized, controlled trials assessing treatment of rheumatic disease that were published between January 1999 and January 2005.

Data Extraction: A standardized abstraction form was used to extract data.

Data Synthesis: 193 articles were analyzed. After adjustment for medical area, sample size, funding source, and multicenter trials, data on harm were more often described in pharmacologic treatment reports than in nonpharmacologic treatment reports in reporting adverse events (odds ratio, 5.2 [95% CI, 2.1 to 12.9]), reporting withdrawals due to adverse events (odds ratio, 4.6 [CI, 2.0 to 10.9]), reporting severity (odds ratio, 3.7 [CI, 1.5 to 9.1]), and allocating space for describing harm (odds ratio, 1.6 [CI, 1.2 to 2.3]).

Limitations: Extrapolating results to trials in areas other than rheumatic disease is questionable.

Conclusions: The lack of reporting harm in trials assessing nonpharmacologic treatment in rheumatic disease is an important barrier to evaluating the benefit-harm balance of nonpharmacologic treatments.

Editors' Notes Context We need rigorous randomized, controlled trial evaluations of nonpharmacologic, as well as pharmacologic, treatments. Contribution This analysis of 193 treatment trials for rheumatic disease found that trials evaluating pharmacologic therapies reported data about potential adverse events and harm more often than trials evaluating nonpharmacologic treatments. Fewer than half of the nonpharmacologic treatment trials reported any harm data. Cautions Generalizing these findings to areas other than rheumatic disease is difficult. Implications Trials of nonpharmacologic therapies must report data about harm so that clinicians and patients can make informed decisions about these therapies. –The Editors

 

Author and Article Information

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{at}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.