Article type
Year
Abstract
Background:
The CONSORT reporting guideline was developed to improve the accuracy, completeness, and transparency of the reporting of randomised controlled trials (RCTs). Gaps and imprecisions of reporting hamper the assessment of the methodological quality and internal and external validity. Few studies have been conducted on the impact of CONSORT on RCTs published in Latin American and Spanish journals.
Objectives:
We aimed to assess the reporting quality of RCTs of three clinical specialities published in Spanish and Latin American journals, as well as to evaluate changes over time and associations of quality with journal and country indicators.
Methods:
We conducted a systematic survey of all RCTs published in Spanish-language journals in dentistry, neurology, and geriatrics. Our data source was the BADERI database that inputs into Cochrane Central. BADERI is a repository of journals that have been hand searched and RCTs that have been identified. We included randomised or quasi-randomised clinical trials with a recoverable full text published between 1990 and 2018. We excluded articles not addressing the clinical specialities of interest, conference proceedings, pilots or feasibility studies, secondary analysis on RCTs, translations of RCTs published elsewhere, letters, and editorials. After updating and completing BADERI to more recent years, we studied the whole population of RCTs for each clinical field, so no sample size calculation was done. We extracted data on 23 CONSORT items, plus four additional items (Table 1). The primary outcome was the total score of the predefined 23 CONSORT 2010 items for each RCT. The secondary outcome was the overall score for each CONSORT 2010 item predefined for this study.
Results:
We report the interim analysis on 165 included dental RCTs from a total of 369 eligible for selection. We report the number of RCTs published by country and by time periods (Table 2). Seven countries of the region have published RCTs with a mean score of 13.2 (score range, 0 to 34). The highest mean score is Colombia (15.0), and the lowest is Peru (7.7). The mean score in the 1990 to 2006 period was 10.9, which increased to 16.1 for the 2016 to 2018 period (Table 2).
Conclusions:
Despite the widespread adoption of the CONSORT reporting guideline, there is still a significant gap in reporting standards in the Spanish-language journals that may hamper the inclusion of RCTs from Latin America and Spain in systematic reviews. This study provides evidence of this gap and should raise awareness in the region for the need to strengthen the methodological competencies of local clinical investigators and editors.
Patient involvement:
None
The CONSORT reporting guideline was developed to improve the accuracy, completeness, and transparency of the reporting of randomised controlled trials (RCTs). Gaps and imprecisions of reporting hamper the assessment of the methodological quality and internal and external validity. Few studies have been conducted on the impact of CONSORT on RCTs published in Latin American and Spanish journals.
Objectives:
We aimed to assess the reporting quality of RCTs of three clinical specialities published in Spanish and Latin American journals, as well as to evaluate changes over time and associations of quality with journal and country indicators.
Methods:
We conducted a systematic survey of all RCTs published in Spanish-language journals in dentistry, neurology, and geriatrics. Our data source was the BADERI database that inputs into Cochrane Central. BADERI is a repository of journals that have been hand searched and RCTs that have been identified. We included randomised or quasi-randomised clinical trials with a recoverable full text published between 1990 and 2018. We excluded articles not addressing the clinical specialities of interest, conference proceedings, pilots or feasibility studies, secondary analysis on RCTs, translations of RCTs published elsewhere, letters, and editorials. After updating and completing BADERI to more recent years, we studied the whole population of RCTs for each clinical field, so no sample size calculation was done. We extracted data on 23 CONSORT items, plus four additional items (Table 1). The primary outcome was the total score of the predefined 23 CONSORT 2010 items for each RCT. The secondary outcome was the overall score for each CONSORT 2010 item predefined for this study.
Results:
We report the interim analysis on 165 included dental RCTs from a total of 369 eligible for selection. We report the number of RCTs published by country and by time periods (Table 2). Seven countries of the region have published RCTs with a mean score of 13.2 (score range, 0 to 34). The highest mean score is Colombia (15.0), and the lowest is Peru (7.7). The mean score in the 1990 to 2006 period was 10.9, which increased to 16.1 for the 2016 to 2018 period (Table 2).
Conclusions:
Despite the widespread adoption of the CONSORT reporting guideline, there is still a significant gap in reporting standards in the Spanish-language journals that may hamper the inclusion of RCTs from Latin America and Spain in systematic reviews. This study provides evidence of this gap and should raise awareness in the region for the need to strengthen the methodological competencies of local clinical investigators and editors.
Patient involvement:
None