A multiyear systematic survey of the quality of reporting for randomised trials in dentistry, neurology and geriatrics published in journals of Spain and Latin America

Vivienne C Bachelet,Álvaro A Ibarra,Nicolás Meza-Ducaud,Francisca J Lizana,Macarena G Saavedra,Rubén A Díaz,Víctor A Carrasco,María S Navarrete,Julio Villanueva,Constanza Barrera-Riquelme,Camila Tapia-Davegno,Matías Dallaserra,Alonso F Vergara

doi:10.1186/s12874-021-01337-3

Abstract

BackgroundThe Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain and Latin America. The project is called BADERI (Database of Iberoamerican Essays and Journal) and feeds the research articles, mainly randomised clinical trials (RCTs), into CENTRAL (Cochrane Collaboration Central Register of Controlled Trials). This study aims to assess the quality of reporting of RCTs published in Spanish and Latin American journals for three clinical fields and assess changes over time.MethodsWe did a systematic survey with time trend analysis of RCTs for dentistry, geriatrics, and neurology. These fields were chosen for pragmatic reasons as they had not yet been completed in BADERI. After screening RCTs from 1990 to 2018 for randomised or quasi-randomised clinical trials, we extracted data for 23 CONSORT items. The primary outcome was the total score of the 23 predefined CONSORT 2010 items for each RCT (score range from 0 to 34). The secondary outcome measure was the score for each one of these 23 items.ResultsA total of 392 articles from 1990 to 2018 were included as follows: dentistry (282), neurology (80), and geriatrics (30). We found that the overall compliance score for the CONSORT items included in this study for all 392 RCTs analysed was 12.6 on a scale with a maximum score of 34. With time, the quality of reporting improved slightly for all RCTs. None of the articles achieved the complete individual CONSORT item compliance score. The lowest overall compliance percentage was for item 10 (Randomisation implementation) and item 24 (Protocol registration), with a dismal 1% compliance across all included RCTs, regardless of country.ConclusionsCONSORT compliance is very poor in the 392 analysed RCTs. The impact of the CONSORT statement on improving the completeness of RCT reporting in Latin America and Spain is not clear. Iberoamerican journals should become more involved in endorsing and enforcing adherence to the CONSORT guidelines.

Highlights

Randomised clinical trials (RCTs) are considered the best study design to evaluate the effects, benefits, and harms of therapeutic interventions, drugs, devices, or techniques in humans [1, 2]
*Correspondence: vivienne.bachelet@usach.cl 1 Escuela de Medicina, Facultad de Ciencias Médicas, Universidad de Santiago de Chile (USACH), Avenida Libertador Bernardo OHiggins 3363, Santiago, Estación Central, Chile Full list of author information is available at the end of the article. This is the first study to conduct a systematic survey of reporting quality of randomised clinical trials for more than one clinical field
This study’s main limitations lie in the non-inclusion of randomised clinical trials (RCTs) from Brazil, the absence of a standardised CONSORT adherence extraction form designed for quality of reporting control, and the large team of reviewers that could affect the consistency of extraction

Summary

Introduction

Randomised clinical trials (RCTs) are considered the best study design to evaluate the effects, benefits, and harms of therapeutic interventions, drugs, devices, or techniques in humans [1, 2]. The quality of the RCTs depends on their internal validity, which results from their methodology, design, and execution. The Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanishlanguage journals that publish original clinical research in Spain and Latin America. The project is called BADERI (Data‐ base of Iberoamerican Essays and Journal) and feeds the research articles, mainly randomised clinical trials (RCTs), into CENTRAL (Cochrane Collaboration Central Register of Controlled Trials). This study aims to assess the quality of report‐ ing of RCTs published in Spanish and Latin American journals for three clinical fields and assess changes over time

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Methods

Results

Discussion

Conclusion