Identification, description, and quality assessment of controlled clinical trials published in orthopedics and traumatology journals from Latin America and Spain

Article type
Year
Authors
Arevalo-Rodriguez I1, Muñoz E2, Garzon V3, Buitrago D3, Pardo-Hernandez H4, Bonfill X5
1Instituto de Evaluación Tecnológica en Salud- IETS, Colombia
2Department of Orthopedic Surgery and Traumatology, Hospital San José. Fundación Universitaria de Ciencias de la Salud, Colombia
3Division of research, Fundación Universitaria de Ciencias de la Salud, Colombia
4Biomedical Research Institute Sant Pau (IIB Sant Pau), Iberoamerican Cochrane Centre, Spain
5CIBER Epidemiología y Salud Pública (CIBERESP) - Universitat Autònoma de Barcelona, Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), Spain
Abstract
Background: Few orthopedics and traumatology journals from Latin America and Spain are indexed in major databases. Controlled clinical trials (CCT) published in these journals cannot be exhaustively retrieved using electronic literature searches.

Objectives: To identify, describe and assess the quality of CCTs published in orthopedics and traumatology journals from Latin America and Spain. To submit these CCTs for inclusion in CENTRAL.

Methods: Following Cochrane recommendations, we handsearched all eligible orthopedics and traumatology journals from their inception until July 2015. We conducted a descriptive analysis of the main characteristics of the identified CCTs, as well as a quality assessment using the Cochrane 'Risk of bias' tool.

Results: We identified 52 CCTs in 24 eligible journals. Twenty-three (44.2%) of these CCTs had not been included in any major databases. Twenty (38.5%) of them were published in Mexican journals. Fifteen (28.8%) trials addressed issues related to knee or hip lesion management. The average sample size was 79.4 paticipants (range: 8 to 300). Over 50% of trials were considered to have unclear risk of bias in several domains, including random sequence generation, allocation concealment, and blinding. 47 (90.4%) of the trials did not report source of funding. Twenty-five (48.1%) studies did not find statistically/clinically significant differences between the assessed interventions. No trials reported using the CONSORT (Consolidated Standards of Reporting Trials) statement to report findings.

Conclusions: Orthopedics and traumatology journals from Latin America and Spain publish few CCTs. There are serious shortcomings in the reporting of results, which impedes proper assessment of the methodological quality of this body of evidence. We call for adherence to the CONSORT statement when reporting study findings in this and other fields. Almost half of the identified CCTs would not have been retrieved using an electronic search strategy, making handsearching an important tool for ensuring access to all published CCTs.